Vol. 80 Thursday, No. 180 September 17, 2015

Part III

Department of Health and Human Services

Food and Drug Administration 21 CFR Parts 11, 16, 117, et al. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Final Rule

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DEPARTMENT OF HEALTH AND Administration, 7519 Standish Pl., IX. Subpart A: Comments on Qualifications HUMAN SERVICES Rockville, MD 20855, 240–402–6246, of Individuals Who Manufacture, email: [email protected]. Process, Pack, or Hold Animal Food Food and Drug Administration A. Applicability and Qualifications of All SUPPLEMENTARY INFORMATION: Individuals Engaged in Manufacturing, Table of Contents Processing, Packing, or Holding Animal 21 CFR Parts 11, 16, 117, 500, 507, and Food (Final § 507.4(a), (b), and (d)) 579 Executive Summary B. Additional Requirements Applicable to Purpose and Coverage of the Rule Supervisory Personnel (Final § 507.4(c)) [Docket No. FDA–2011–N–0922] Summary of the Major Provisions of the Rule X. Subpart A: Comments on Proposed RIN 0910–AG10 Costs and Benefits § 507.5—Exemptions I. Background A. General Comments on the Proposed Current Good Manufacturing Practice, A. FDA Food Safety Modernization Act Exemptions Hazard Analysis, and Risk-Based B. Stages in the Rulemaking for the Animal B. Proposed § 507.5(a)—Exemption for Food Preventive Controls Rule Facilities Not Required To Register Preventive Controls for Food for C. Summary of the Major Provisions of Under Section 415 Regulations Animals Proposed Rule for Preventive Controls C. Proposed § 507.5(b)—Exemption for Food for Animals Applicable to Food Subject to 21 CFR AGENCY: Food and Drug Administration, D. Draft Risk Assessment part 113—Thermally Processed Low- HHS. E. Public Comments Acid Foods Packaged in Hermetically ACTION: Final rule. II. Legal Authority Sealed Containers A. Current Good Manufacturing Practice D. Proposed § 507.5(c)—Exemption SUMMARY: The Food and Drug Regulations Applicable to Activities Subject to Administration (FDA or we) is adding B. Hazard Analysis and Risk-Based Standards for Produce Safety in Section regulations for the Current Good Preventive Controls 419 of the FD&C Act Manufacturing Practice, Hazard III. General Comments on the Proposed Rule E. Proposed § 507.5(d)—Exemption Analysis, and Risk-Based Preventive IV. Definitions in the Section 415 Applicable to a Qualified Facility Controls for Food for Animals. These Registration Regulations (21 CFR Part 1, F. Proposed § 507.5(e) and (f)—Exemptions Subpart H) Applicable to On-Farm Low-Risk regulations will, for the first time, A. Definitions That Impact a Determination Activity/Animal Food Combinations establish requirements for the current of Whether an Establishment Is a ‘‘Farm’’ Conducted by a Small or Very Small good manufacturing practice (CGMP) for B. Proposed Revisions to the Definition of Business food for animals. In addition, we are Farm G. Proposed § 507.5(g)—Exemption adding requirements for certain C. Proposed Revisions to Definitions of Applicable to Facilities Solely Engaged domestic and foreign animal food Harvesting, Holding, Manufacturing/ in Storage of Raw Agricultural facilities to establish and implement Processing, Mixed-Type Facility, and Commodities Other Than Fruits and hazard analysis and risk-based Packing Vegetables Intended for Further preventive controls for food for animals. D. Comments on Feed Mills Associated Distribution or Processing With Fully Vertically Integrated Farming H. Proposed § 507.5(h)—Exemption We are taking this action to provide Operations Applicable to the Holding or greater assurance that animal food is V. Comments on the Organizing Principles Transportation of One or More Raw safe and will not cause illness or injury for How the Status of a Food as a Raw Agricultural Commodities to humans and animals and to Agricultural Commodity or as a I. Comments Requesting Additional implement new statutory provisions in Processed Food Affects the Requirements Exemptions the FDA Food Safety Modernization Act Applicable to a Farm Under Sections 415 XI. Subpart A: Comments on Proposed (FSMA). The rule is intended to build and 418 of the FD&C Act § 507.7—Requirements That Apply to a an animal food safety system for the VI. Rulemaking Required by Section 103(c) of Qualified Facility future that makes modern science- and FSMA: On-Farm Activities A. Comments on Submission of a A. Section 103(c)(1)(C) of FSMA Certification Statement risk-based preventive controls the norm B. Comments on Qualitative Risk B. General Comments on Requirements across all sectors of the animal food Assessment of On-Farm Activities That Apply to a Qualified Facility system. Outside of the Farm Definition C. Proposed § 507.7(a)—Documentation To DATES: This rule is effective November C. Comments Regarding an Exemption for Be Submitted 16, 2015, except for paragraph (2) of the Small and Very Small Farm Mixed-Type D. Proposed § 507.7(b)—Procedure for Facilities Under Section 421 of the FD&C Submission definition of ‘‘qualified auditor’’ in Act E. Proposed § 507.7(c)—Frequency of § 507.3, and §§ 507.12(a)(1)(ii), VII. Subpart A: Comments on Proposed Determination and Submission 507.105(a)(2), 507.105(c), § 507.1—Applicability and Status F. Proposed § 507.7(d)—Notification to 507.110(d)(2)(ii), 507.130(d), 507.135(d), A. Comments on Proposed § 507.1(a)— Consumers (Final § 507.7(e)) 507.175(c)(2), and 507.175(c)(13). FDA Applicability G. Proposed § 507.7(e)—Records (Final will publish a document in the Federal B. Comments on Proposed § 507.1(b)— § 507.7(f)) Register announcing the effective dates Prohibited Act XII. Subpart A: Comments on Proposed of paragraph (2) of the definition of C. Comments on Proposed § 507.1(c)— § 507.10—Applicability of Part 507 to a ‘‘qualified auditor’’ in § 507.3, Specific CGMP Requirements Facility Solely Engaged in the Storage of D. Comments on Proposed § 507.1(d)— Unexposed Packaged Animal Food §§ 507.12(a)(1)(ii), 507.105(a)(2), Human Food Facilities That Manufacture XIII. Subpart A: Comments on Proposed 507.105(c), 507.110(d)(2)(ii), 507.130(d), Animal Food § 507.12—Applicability of Part 507 to the 507.135(d), 507.175(c)(2), and VIII. Subpart A: Comments on Proposed Holding and Distribution of Human Food 507.175(c)(13). Certain provisions have § 507.3—Definitions By-Products for Use as Animal Food later compliance dates as discussed in A. Definitions We Proposed To Establish in XIV. Subpart B: General Comments on section LIII ‘‘Effective and Compliance Part 507 Proposed Subpart B—Current Good Dates.’’ B. Comments Asking FDA To Establish Manufacturing Practice Additional Definitions or Otherwise XV. Subpart B: Comments on Proposed FOR FURTHER INFORMATION CONTACT: Clarify Terms Not Defined in the Rule § 507.14—Personnel Jeanette Murphy, Center for Veterinary C. Additional Definitions To Clarify Terms A. Proposed § 507.14(a)(1)—Personal Medicine (HFV–200), Food and Drug Not Defined in the Proposed Rule Cleanliness (Final § 507.14(b)(1))

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B. Proposed § 507.14(a)(2)—Hand Washing E. Proposed § 507.25(a)(5)—Responsibility B. Proposed § 507.31(b)—Preparation of the (Final § 507.14(b)(2)) for Overall Plant Cleanliness (Final Food Safety Plan by a Preventive C. Proposed § 507.14(a)(3)—Unsecured § 507.25(a)(4)) Controls Qualified Individual Jewelry and Other Objects (Final F. Proposed § 507.25(a)(6)—Contamination C. Proposed § 507.31(c)—Contents of a § 507.14(b)(3)) Precautions (Final § 507.25(a)(5)) Food Safety Plan D. Proposed § 507.14(a)(4)—Storing G. Proposed § 507.25(a)(7)—Testing D. Proposed § 507.31(d)—Records Clothing and Personal Belongings (Final Procedures (Final § 507.25(a)(6)) E. Comments on Potential Requirements § 507.14(b)(4)) H. Proposed § 507.25(a)(8)—Contaminated for Submission of a Facility Profile to E. Proposed § 507.14(a)(5)—Taking Other Product (Final § 507.25(a)(7)) FDA Necessary Precautions (Final I. Proposed § 507.25(a)(9)—Protecting XXV. Subpart C: Comments on Proposed § 507.14(b)(5)) Against Contamination (Final § 507.33—Hazard Analysis XVI. Subpart B: Comments on Proposed § 507.25(a)(8)) A. Proposed § 507.33(a)—Requirement for § 507.17—Plant and Grounds J. Proposed § 507.25(b)(1)—Raw Materials a Written Hazard Analysis A. Proposed § 507.17(a)—Grounds and Ingredients B. Proposed § 507.33(b)—Hazard Identification Surrounding an Animal Food Plant K. Proposed § 507.25(b)(1)(i)—Shipping C. Proposed § 507.33(c) and (d)— B. Proposed § 507.17(b)(1)—Adequate Containers Evaluation of Whether a Hazard Requires Space Between Equipment, Walls, and L. Proposed § 507.25(b)(1)(ii)—Raw Stored Materials a Preventive Control Materials XXVI. Subpart C: Comments on Proposed C. Proposed § 507.17(b)(2)—Dripping and M. Proposed § 507.25(b)(1)(iii)—Raw Condensation § 507.36—Preventive Controls (Final Materials § 507.34) D. Proposed § 507.17(b)(3)—Ventilation N. Proposed § 507.25(b)(2)—Raw Materials E. Proposed § 507.17(b)(4)—Lighting A. Proposed § 507.36(a)—Requirement To Susceptible to Mycotoxins F. Proposed § 507.17(b)(5)—Glass Identify and Implement Preventive O. Proposed § 507.25(b)(3)—Raw Materials G. Proposed § 507.17(b)(6)—Outdoor Controls (Final § 507.34(a)) and Rework (Final § 507.25(b)(1)(iii)) Storage B. Proposed § 507.36(b)—Requirement for P. Proposed § 507.25(b)(4)—Frozen Raw XVII. Subpart B: Comments on Proposed Written Preventive Controls (Final Materials (Final § 507.25(b)(3)) § 507.19—Sanitation § 507.34(b)) Q. Proposed § 507.25(c)(1)—Appropriate A. Proposed § 507.19(a)—Buildings C. Proposed § 507.36(c)(1)—Process Conditions for Animal Food B. Proposed § 507.19(b)—Cleaning Controls (Final § 507.34(c)(1)) R. Proposed § 507.25(c)(2)—Control of C. Proposed § 507.19(b)(1)—Wet Cleaning D. Proposed § 507.36(c)(2)—Sanitation Undesirable Microorganisms Controls (Final § 507.34(c)(2)) D. Proposed § 507.19(b)(2)—Wet S. Proposed § 507.25(c)(3)—Work-in- E. Proposed § 507.36(c)(3)—Supply-Chain Processing Process and Rework Controls (Final § 507.34(c)(3)) E. Proposed § 507.19(c)—Cleaning F. Proposed § 507.36(c)(4)—Recall Plan Compounds and Sanitizing Agents T. Proposed § 507.25(c)(4)—Processing (Final § 507.34(c)(4)) F. Proposed § 507.19(d)(1)—Toxic Steps U. Proposed § 507.25(c)(5)—Processing G. Proposed § 507.36(c)(5)—Other Controls Materials (Final § 507.34(c)(5)) G. Proposed § 507.19(d)(2)—Identification, Operations V. Proposed § 507.25(c)(6)—Controlling XXVII. Subpart C: Circumstances in Which Use, and Storage of Toxic Materials the Owner, Operator, or Agent in Charge H. Proposed § 507.19(e)—Pest Control Water Activity (aw) W. Proposed § 507.25(c)(7)—Controlling of a Manufacturing/Processing Facility Is I. Proposed § 507.19(f)—Trash and Garbage Not Required To Implement a Preventive XVIII. Subpart B: Comments on Proposed pH X. Proposed § 507.25(c)(8)—Ice Control (Final §§ 507.36 and 507.37) § 507.20—Water Supply and Plumbing XXVIII. Subpart C: Comments on Proposed A. Proposed § 507.20(a)—Water Supply XXI. Subpart B: Comments on Proposed § 507.27—Holding and Distribution § 507.38—Recall Plan B. Proposed § 507.20(b)—Plumbing A. Proposed § 507.38(a)—Requirement for C. Proposed § 507.20(c)—Sewage A. Proposed § 507.27(a)—Holding and Distribution a Written Recall Plan D. Proposed § 507.20(d)—Toilet Facilities B. Proposed § 507.38(b)—Procedures That E. Proposed § 507.20(e)—Hand-Washing B. Proposed § 507.27(a)(1)—Containers C. Proposed § 507.27(a)(2)—Protection Describe the Steps To Be Taken, and Facilities Assign Responsibility for Taking Those From Contamination XIX. Subpart B: Comments on Proposed Steps D. Proposed § 507.27(a)(3)—Labeling of § 507.22—Equipment and Utensils XXIX. Comments on Proposed § 507.39— Animal Food Held for Distribution (Final A. Proposed § 507.22(a)(1)—Plant Preventive Control Management § 507.27(b)) Equipment and Utensils Components E. Proposed § 507.27(b)—Shipping B. Proposed § 507.22(a)(2)—Design of A. Proposed § 507.39(a)—Flexible Equipment and Utensils Containers (Final § 507.27(c)) Requirements for Monitoring, Corrective C. Proposed § 507.22(a)(3)—Equipment F. Proposed § 507.27(c)—Returned Animal Actions and Corrections, and Installation Food (Final § 507.27(d)) Verification D. Proposed § 507.22(a)(4)—Animal Food G. Proposed § 507.27(d)—Unpackaged Bulk B. Proposed § 507.39(b)—Applicability of Contact Surfaces Animal Food (Final § 507.27(e)) Preventive Control Management E. Proposed § 507.22(a)(5)—Non-Animal XXII. Subpart B: Comments on Proposed Components to Supply-Chain Program Food Contact Equipment (Final § 507.28—Holding and Distribution of C. Proposed § 507.39(c)—Recall Plan is Not § 507.22(a)(1)) Human Food By-Products for Use as Subject to Preventive Control F. Proposed § 507.22(b)—System Design Animal Food Management Components and Construction A. Proposed § 507.28(a)—Contamination XXX. Subpart C: Comments on Proposed G. Proposed § 507.22(c)—Monitoring Cold B. Proposed § 507.28(a)(1)—Containers § 507.40—Monitoring Storage Temperatures C. Proposed § 507.28(a)(2)—Protection A. Our Tentative Conclusion To Require H. Proposed § 507.22(d)—Instruments From Contamination Monitoring of the Performance of I. Proposed § 507.22(e)—Compressed Air D. Proposed § 507.28(a)(3)—Labeling Preventive Controls XX. Subpart B: Comments on Proposed E. Proposed § 507.28(b)—Shipping B. Proposed § 507.40(a) and (b)—Flexibility § 507.25—Plant Operations Containers in Requirements for Monitoring A. Proposed § 507.25(a)(1)—CGMPs XXIII. Subpart C: Comments on Overall C. Proposed § 507.40(c)—Records B. Proposed § 507.25(a)(2)—Identifying Framework for Hazard Analysis and XXXI. Subpart C: Comments on Proposed Contents of Containers Risk-Based Preventive Controls § 507.42—Corrective Actions and C. Proposed § 507.25(a)(3)—Labeling of XXIV. Subpart C: Comments on Proposed Corrections Finished Product (Final § 507.27(b)) § 507.31—Food Safety Plan A. Proposed § 507.42(a)(1)(i)—Requirement D. Proposed § 507.25(a)(4)—Animal Food A. Proposed § 507.31(a)—Requirement for To Establish and Implement Corrective Packaging Material (Final § 507.25(a)(3)) a Food Safety Plan Action Procedures

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B. Proposed § 507.42(a)(2)—Content of Preventive Controls Qualified Individual XLIII. Subpart E: New Requirement Corrective Action Procedures and a Qualified Auditor Specifying the Responsibilities of the C. Proposed § 507.42(b)—Corrective Action A. Proposed § 507.53(a) and (b)—What a Receiving Facility (Final § 507.115) in the Event of an Unanticipated Preventive Controls Qualified Individual XLIV. Subpart E: Comments on Using Problem or Qualified Auditor Must Do or Oversee Approved Suppliers and Determining D. Proposed § 507.42(c)—Corrections B. Proposed § 507.53(c)—Qualification Appropriate Supplier Verification E. Proposed § 507.42(d)—Records Requirements Activities XXXII. Subpart C: Comments on Proposed C. Proposed § 507.53(d)—Records A. Using Approved Suppliers (Final § 507.45—Verification XXXVIII. Subpart C: Comments on Proposed § 507.120) A. Flexibility in Requirements for § 507.55—Implementation Records B. Determining Appropriate Verification Verification XXXIX. Subpart D: Comments on Proposed Activities (Final § 507.125) B. Proposed § 507.45(a)—Verification New Provisions for Withdrawal of a XLV. Subpart E: Comments on Conducting Activities Qualified Facility Exemption Supplier Verification Activities for Raw C. Proposed § 507.45(b)—Documentation of A. Proposed § 507.60—Circumstances That Materials and Other Ingredients Verification Activities May Lead FDA To Withdraw a Qualified A. Requirement To Conduct One or More D. Comments on Potential Requirements Facility Exemption Supplier Verification Activities (Final Regarding Complaints B. Proposed § 507.62—Issuance of an Order § 507.130(a)) XXXIII. Subpart C: Comments on Proposed To Withdraw a Qualified Facility B. Requirement for an Onsite Audit as a § 507.47—Validation Exemption Verification Activity When a Hazard Has A. Flexibility in the Requirements To C. Proposed § 507.65—Contents of an a Reasonable Probability of Resulting in Validate Preventive Controls Order To Withdraw a Qualified Facility Serious Adverse Health Consequences or B. Proposed § 507.47(b)(1)—When Exemption Death to Humans or Animals (Final Validation Must Be Performed and Role D. Proposed § 507.67—Compliance With, § 507.130(b)) of Preventive Controls Qualified or Appeal of, an Order To Withdraw a C. Alternative Verification Activity When Individual in Validation Qualified Facility Exemption the Supplier Is a Qualified Facility (Final C. Proposed § 507.47(b)(2)—What E. Proposed § 507.69—Procedure for § 507.130(c)) Validation Must Include Submitting an Appeal D. Alternative Verification Activity When D. Proposed § 507.47(b)(3)—Preventive F. Proposed § 507.71—Procedure for the Supplier Is a Produce Farm That Is Controls for Which Validation Is Not Requesting an Informal Hearing Not a ‘‘Covered Farm’’ for the Purposes Required G. Proposed § 507.73—Requirements of the Future Produce Safety Rule (Final XXXIV. Subpart C: Comments on Proposed Applicable to an Informal Hearing § 507.130(d)) § 507.49—Verification of Implementation H. Proposed § 507.85—Reinstatement of a E. Alternative Verification Activity When and Effectiveness Qualified Facility Exemption That Was the Supplier Is a Shell Egg Producer That A. Flexibility in the Requirements To Withdrawn Has Less Than 3,000 Laying Hens (Final Conduct Activities To Verify I. Conforming Amendment to 21 CFR Part § 507.130(e)) Implementation and Effectiveness 16 F. Independence of Persons Who Conduct B. Proposed § 507.49(a)(1)—Calibration J. Other Comments on the Withdrawal C. Comments Directed to Proposed Supplier Verification Activities (Final Provisions Requirements for Both Product Testing § 507.130(f)) (Proposed § 507.49(a)(2) and (b)(2)) and XL. Subpart E: General Comments on XLVI. Subpart E: Comments on Onsite Audit Environmental Monitoring (Proposed Proposed Requirements Applicable to a A. Requirements Applicable to an Onsite § 507.49(a)(3) and (b)(3)) Supply-Chain Program Audit (Final § 507.135(a) and (b)) D. Proposed § 507.49(a)(2)—Product XLI. Subpart E: Comments on Requirement B. Substitution of Inspection by FDA or an Testing To Establish and Implement a Supply- Officially Recognized or Equivalent Food E. Proposed § 507.49(a)(3)—Environmental Chain Program Safety Authority Monitoring A. Requirement for a Written Supply-Chain C. Onsite Audit by a Third-Party Auditor F. Proposed § 507.49(a)(4)—Review of Program (Final § 507.105(a)(1) and (b)) Accredited for the Purposes of Section Records B. Circumstances That Do Not Require a 808 of the FD&C Act G. Proposed § 507.49(b)—Written Written Supply-Chain Program (Final XLVII. Subpart E: Comments on Records Procedures § 507.105(a)(2)) Documenting the Supply-Chain Program XXXV. Subpart C: Comments on Proposed C. Exemption for Animal Food Supplied A. Applicability of the Recordkeeping § 507.50—Reanalysis for Research or Evaluation (Final Requirements of Subpart F (Final A. Proposed § 507.50(a)—Circumstances § 507.105(a)(3)) § 507.175(a)) Requiring Reanalysis D. Additional Requirements for Non- B. Requirement To Review Records of the B. Proposed § 507.50(b)—Timeframe To Suppliers (Final § 507.105(c)) Supply-Chain Program (Final Complete Reanalysis E. Proposed General Requirements for the § 507.175(b)) C. Proposed § 507.50(c)—Requirement To Supply-Chain Program That We Are Not C. Documentation Demonstrating Use of Revise the Written Food Safety Plan or Including in the Final Rule (Proposed the Written Procedures for Receiving Document Why Revisions Are Not § 507.37(a)(4) and (5)) Raw Materials and Other Ingredients Needed XLII. Subpart E: Comments on General (Final § 507.175(c)(5)) D. Proposed § 507.50(d) —Requirement for Requirements for the Supply-Chain D. Documentation of the Conduct of an Oversight of Reanalysis by a Preventive Program Onsite Audit (Final § 507.175(c)(7)) Controls Qualified Individual A. Description of What the Supply-Chain E. Documentation of Sampling and Testing E. Proposed § 507.50(e)—Reanalysis on the Program Must Include (Final (Final § 507.175(c)(8)) Initiative of FDA § 507.110(a)) F. Documentation of Other Appropriate XXXVI. Subpart C: Comments on Proposed B. Appropriate Supplier Verification Supplier Verification Activity (Final § 507.51—Modified Requirements That Activities ((Final § 507.110(b)) § 507.175(c)(10)) Apply to a Facility Solely Engaged in the C. Purpose of Supplier Verification G. Documentation of an Alternative Storage of Unexposed Packaged Animal Activities for Raw Materials and Other Verification Activity for a Supplier That Food Ingredients (Final § 507.110(c)) Is a Farm That Is Not a ‘‘Covered Farm’’ A. Proposed § 507.51(a)—Modified D. Factors That Must Be Considered When for the Purposes of the Future Produce Requirements for Unexposed Approving Suppliers and Determining Safety Rule (Final § 507.175(c)(13)) Refrigerated Packaged Animal Food That Appropriate Supplier Verification XLVIII. Subpart F: Comments on Proposed Requires Time/Temperature Controls Activities for Raw Materials and Other New Recordkeeping Requirements B. Proposed § 507.51(b)—Records Ingredients (Final § 507.110(d)) A. Proposed § 507.200—Records Subject to XXXVII. Subpart C: Comments on Proposed E. Supplier Non-Conformance (Final the Requirements of Subpart F and § 507.53—Requirements Applicable to a § 507.110(e)) Requirements for Official Review

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B. Proposed § 507.202—General safety plan, perform a hazard analysis, hazard analysis and risk-based Requirements Applying to Records and institute preventive controls for the preventive controls. Specifically, the C. Proposed § 507.206—Additional mitigation of those hazards, unless an rule establishes requirements for: Requirements Applying to the Food exemption applies. Facilities must also • A written food safety plan; Safety Plan monitor their controls, conduct • Hazard analysis; D. Proposed § 507.208—Requirements for • verification activities to ensure the Preventive controls; Record Retention • Monitoring; E. Proposed § 507.212—Use of Existing controls are effective, take appropriate • corrective actions, and maintain records Corrective actions and corrections; Records • Verification; F. Final § 507.215—Special Requirements documenting these actions. • Supply-chain program; Applicable to a Written Assurance This final rule is the result of • XLIX. Comments by Foreign Governments Recall plan; and significant stakeholder engagement, • Associated records. and Foreign Businesses beginning before the proposed rule. In L. Editorial and Conforming Changes We have added flexibility and clarity response to extensive stakeholder input to these provisions in response to LI. Comments on FSMA’s Rulemaking on the proposed rule, we revised key Provisions comments. Although there are A. Comments on Section 418(m) of the provisions in a supplemental notice of similarities between these requirements FDA&C Act Regarding Modified proposed rulemaking. After the of FSMA and the requirements of food Requirements for Facilities Solely supplemental notice of proposed safety systems known as Hazard Engaged in the Production of Food for rulemaking, we conducted even more Analysis and Critical Control Point Animals Other Than Man outreach to the stakeholder community (HACCP) systems, not every provision B. Comments on Requirements in Section to ensure that the risk-based, preventive in FSMA is identical to the provisions 418(n)(3) of the FD&C Act Regarding requirements in this final rule are Content of HACCP systems, and we have revised practical and protective of public much of our terminology to distinguish LII. Comments on Proposed Conforming (human and animal) health. Amendments FSMA’s requirements for hazard LIII. Effective and Compliance Dates Summary of the Major Provisions of the analysis and risk-based preventive A. Effective and Compliance Dates for Part Rule controls from HACCP requirements. A 507 facility subject to the rule must conduct The final rule establishes CGMP B. Effective Dates for Conforming a hazard analysis to identify and provisions to ensure the safety and Amendments evaluate known or reasonably C. Delayed Effective Dates for Provisions suitability of animal food. Specifically, foreseeable hazards for each type of That Refer to the Forthcoming Rules for the rule establishes requirements in the animal food manufactured, processed, Produce Safety and Third-Party following areas: packed, or held at the facility to Certification • Personnel; LIV. Compliance and Enforcement • Plant and grounds; determine whether there are any LV. Executive Order 13175 • Sanitation; hazards requiring preventive controls. LVI. Economic Analysis of Impacts • Water supply and plumbing; The first step of a hazard analysis is LVII. Analysis of Environmental Impact • Equipment and utensils; hazard identification, which must LVIII. Paperwork Reduction Act of 1995 • Plant operations; consider known or reasonably LIX. Federalism • Holding and distribution; and foreseeable hazards, including LX. References • Holding and distribution of human biological, chemical, and physical Executive Summary food by-products for use as animal food. hazards. The hazard analysis must We have added flexibility and clarity consider hazards that may be present in Purpose and Coverage of the Rule to the CGMPs in response to comments. the animal food because they occur This rule is part of FDA’s These CGMPs establish baseline naturally, are unintentionally implementation of FSMA, which standards for producing safe animal introduced, or are intentionally intends to better protect public (human food that take into consideration the introduced for purposes of economic and animal) health by, among other unique aspects of the animal food gain. We continue to believe that things, adopting a modern, preventive, industry and provide flexibility for the hazards that may be intentionally and risk-based approach to food safety wide diversity in types of animal food introduced for economic gain will need regulation. This rule establishes new facilities. In addition, the CGMPs in this preventive controls in rare requirements for the production of final regulation allow human food circumstances, usually in cases where animal food by registered food facilities facilities subject to and in compliance there has been a pattern of economically in two ways. with CGMPs for human food and in motivated adulteration in the past. First, this rule creates new CGMP compliance with all applicable FDA Economically motivated adulteration regulations that specifically address the human food safety requirements to only that affects product integrity or quality, manufacturing, processing, packing, and follow the specific CGMPs for the for example, but not animal food safety, holding of food for animals. These holding and distribution of human food is out of the scope of this rule. requirements apply to establishments by-products for use as animal food, as A facility subject to the rule must that are required to register with FDA as long as they do not further process the identify and implement preventive a food ‘‘facility.’’ Second, this rule by-product. Under this final rule, all controls to provide assurances that any creates new requirements for certain other requirements of part 507, hazards requiring a preventive control domestic and foreign facilities to including the hazard analysis, will be significantly minimized or establish and implement hazard preventive controls and supply-chain prevented and the animal food analysis and risk-based preventive program provisions, would not apply to manufactured, processed, packed, or controls for food for animals. As with these by-products of human food held by the facility will not be the CGMPs, these requirements apply to production. adulterated. The rule establishes establishments that are required to The final rule implements the preventive control management register with FDA as a food facility. This requirements of FSMA for covered components (monitoring, corrective portion of the rule requires registered facilities to establish and implement a actions and corrections, and animal food facilities to maintain a food food safety system that includes a verification) as appropriate to ensure the

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effectiveness of the preventive controls. such as the nature of the hazard, and the ensures adequate control, at a later One way we have clarified the risk- nature of the preventive control and its distribution step, of the hazards in the based flexibility of these requirements is role in the facility’s food safety system. food product distributed by a by clearly stating in the final rule that Product testing and environmental manufacturing/processing facility such a facility must take into account the monitoring are listed as possible that the facility would not need to nature of the preventive control and the verification activities, but, like other implement a preventive control. facility’s food safety system when preventive control management We revised the proposed provisions considering which activities are components in general, they are only for a supplier program to add flexibility, appropriate for that facility. required as appropriate to the animal recognizing that the receiving facility We have also added flexibility and food, facility, the nature of the and the supplier may be separated by made risk-based modifications for preventive control, and the preventive several entities in a supply chain. We specific preventive control management control’s role in the facility’s food safety are allowing entities such as components. For example, the final rule system. In many cases, neither product distributors, brokers, and aggregators to allows flexibility for the specific records testing nor environmental monitoring determine, conduct, and document required to document monitoring of will be appropriate. For example, there appropriate supplier verification refrigeration controls during storage of would be little or no benefit to product activities as a service to the receiving an animal food that requires time/ testing or environmental monitoring in facility, provided that the receiving temperature control for safety. These facilities that pack or hold raw facility reviews and assesses applicable records can be either affirmative records agricultural commodities that are rarely documentation provided by the other demonstrating temperature is controlled consumed unprocessed, such as entity and documents that review and or ‘‘exception records’’ demonstrating soybeans. assessment. However, because the loss of temperature control. As another A facility must reanalyze the food approval of suppliers is ultimately the example, the rule includes tailored, less safety plan as a whole at least once responsibility of the receiving facility, burdensome requirements for every 3 years. The final rule provides the rule specifies that only a receiving corrections. A correction is defined in the flexibility for a facility to only facility can approve suppliers. To this rule as an action to identify and reanalyze the applicable portion of the improve clarity and readability we correct a problem that occurred during food safety plan under certain other redesignated the proposed provisions the production of animal food, without circumstances, such as when a facility into eight distinct sections of regulatory other actions associated with a becomes aware of new information text in a newly established subpart E corrective action procedure (such as about potential hazards associated with (Supply-Chain Program). actions to reduce the likelihood that the an animal food. problem will recur, evaluate all affected The final rule also adds flexibility to Each facility subject to the rule must food for safety, and prevent affected the preventive controls requirements have a recall plan for an animal food animal food from entering commerce). and recognizes the reality of modern with a hazard requiring a preventive The final rule clarifies that corrections distribution chains by not requiring a control. must be taken in a timely manner and manufacturing/processing facility to Many activities required by the final must be recorded when appropriate, but implement a preventive control in rule must be conducted (or overseen) by they do not, for example, need to be certain circumstances when the hazard a preventive controls qualified included in a written plan or requiring a preventive control will be individual, a new term we are coining accompanied by a reanalysis of the controlled by another entity in the here. A preventive controls qualified written food safety plan. distribution chain. For example, if a individual is a qualified individual who As a third example, the final rule facility’s customer (or another entity in has successfully completed certain provides flexibility for which the distribution chain) will control the training in the development and verification activities must occur. In hazard, then that facility can rely on its application of risk-based preventive general, a facility is required to conduct customer to provide written assurance controls or is otherwise qualified verification activities, as appropriate to that the identified hazard will be through job experience to develop and the nature of the preventive control and controlled by an entity in the apply a food safety system. its role in the facility’s food safety distribution chain, with flexibility for The rule establishes several system, including validation, how the customer provides that written exemptions (including modified verification of monitoring, verification assurance depending on whether the requirements in some cases) from the of corrective actions, verification of customer, or an entity subsequent to the requirements for hazard analysis and implementation and effectiveness, and customer, will control the hazard. We risk-based preventive controls. All of reanalysis. Validation is not required for have identified four specific these exemptions are expressly all controls. For example, the rule circumstances in which a authorized by FSMA. A facility that specifies that validation is not required manufacturing/processing facility can manufactures, processes, packs, or holds for certain types of preventive controls rely on another entity in the distribution food and that is required to register with (i.e., sanitation controls, supply-chain chain to control a hazard, with practical FDA would be required to comply with controls, and the recall plan) and solutions explained further in section the requirements for hazard analysis provides flexibility for the facility to not XXVII. We also have provided flexibility and risk-based preventive controls validate other preventive controls with for a facility to establish, document, and unless it is covered by an exemption, as a written justification based on factors implement an alternative system that shown in the following table.

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PROPOSED EXEMPTIONS FROM THE NEW REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS

Who or what is exempt from the requirements for hazard analysis and risk-based preventive controls Notes

‘‘Qualified Facility’’ as defined by FSMA: Modified requirements apply—i.e., a qualified facility is required to: Business with average annual sales of <$500,000 and at least half • Notify FDA about its status and either: the sales to consumers or local retailers or restaurants (within Æ Notify FDA that it is addressing hazards through preventive the same state or within 275 miles); or controls and monitoring; or • Very small business, which the rule defines as a business Æ Notify FDA that it complies with applicable non-Federal food (including any subsidiaries or affiliates) averaging less than safety regulations, and notify consumers of the name and $2,500,000, adjusted for inflation, per year, during the 3- complete business address of the facility where the animal year period preceding the applicable calendar year in sales food was manufactured or processed. of animal food plus the market value of animal food manu- • The notification is in the form of an attestation, and must be factured, processed, packed, or held without sale (e.g., held submitted every 2 years, during the same timeframe as the facil- for a fee or supplied to a farm without sale) ity is required to update its facility registration. • Low-risk, on-farm activities performed by small business (<500 full- Small and very small on-farm businesses conducting only the specified time equivalent employees). low-risk activities are exempt from the requirements for hazard anal- ysis and risk-based preventive controls. -or- • Low-risk, on-farm activities performed by a very small business (dol- We define the low-risk, on-farm activities that qualify for the exemption, lar threshold of $2,500,000, as described previously). including the specific animal foods to which they relate (such as re- packing roughage products, or cracking grains). Activities that are subject to the ‘‘low-acid canned food’’ requirements • The exemption applies only with respect to microbiological hazards of part 113 (21 CFR part 113). regulated under part 113. • The facility must be in compliance with part 113. Activities of a facility that are subject to section 419 of the Federal These activities will be established in FDA’s forthcoming rule for Food, Drug, and Cosmetic Act (Standards for Produce Safety) (21 produce safety. U.S.C. 350h). Facilities that are solely engaged in the storage of raw agricultural A facility that stores raw agricultural commodities that are fruits and commodities (other than fruits and vegetables) intended for further vegetables is not exempt. distribution or processing. A facility solely engaged in the storage of unexposed packaged animal Modified requirements apply for the storage of unexposed packaged food that does not require time/temperature control to significantly animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens. minimize or prevent the growth of, or toxin production by, pathogens.

The rule includes procedures for and for reinstating an exemption that preventive control. It also includes withdrawing a qualified facility was withdrawn. requirements for facilities to institute exemption, in the event of an active The rule finalizes recordkeeping risk-based environmental monitoring, investigation of a foodborne illness provisions associated with the new product testing, and a supply-chain outbreak that is directly linked to the provisions for hazard analysis and risk- program as appropriate to the animal facility, or if FDA determines that it is based preventive controls. These food, the facility and the nature of the necessary to protect the public (human records allow facilities to show, and preventive controls, as well as a and animal) health and prevent or FDA to determine, compliance with the requirement to institute controls to help new requirements. To meet these mitigate a foodborne illness outbreak prevent hazards associated with requirements, a facility may use existing based on relevant conditions or conduct economically motivated adulteration. records as appropriate. associated with the qualified facility. The total annualized costs are estimated The final rule provides procedures for a Costs and Benefits at $139.0 to $170.7 million per year facility to appeal an order to withdraw This final regulation requires (over 10 years at a 7 percent discount a qualified facility exemption, for a domestic and foreign facilities to adopt rate), and $135.6 to $166.7 million per facility to request an informal hearing, a food safety plan, perform a hazard year (over 10 years at a 3 percent for the conduct of an informal hearing, analysis, and to institute preventive discount rate). The total annualized for an appeal, for revoking an order to controls for the mitigation of those benefits to pets are estimated at $10.1– withdraw a qualified facility exemption, hazards identified as requiring a $138.0 million.

ESTIMATED TOTAL COSTS AND BENEFITS [Millions]

Total Total One-time Annual annualized annualized cost at 7% 1 cost at 3% 1

Total Costs ...... $135.6 to $160.1 $119.7 to $147.9 $139.0 to $170.7 $135.6 to $166.7 Total Benefits to Pets ...... 2 N/A $10.1 to $138.0 $10.1 to $138.0 $10.1 to $138.0 1 Total annualized cost equal to annualized one-time cost plus annual cost. 2 N/A = Not applicable

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TABLE OF ABBREVIATIONS AND ACRONYMS

Abbreviation/Acronym What it means

AAFCO ...... Association of American Feed Control Officials. AFSS ...... Animal Feed Safety System. BAM ...... Bacteriological Analytical Method. Bioterrorism Act ...... Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107–188). CCP ...... Critical Control Point. CFR ...... Code of Federal Regulations. CGMP ...... Current Good Manufacturing Practice. Codex ...... Codex Alimentarius Commission. CPG ...... Compliance Policy Guide. CVM ...... Center for Veterinary Medicine. EPA ...... U.S. Environmental Protection Agency. EU ...... European Union. FDA ...... U.S. Food and Drug Administration. FD&C Act ...... Federal Food, Drug, and Cosmetic Act. FOIA ...... Freedom of Information Act. FSIS ...... Food Safety and Inspection Service of the U.S. Department of Agriculture. FSIS Validation Guidelines ...... FSIS’ Compliance Guidelines on HACCP Systems Validation. FSMA ...... FDA Food Safety Modernization Act. FSPCA ...... Food Safety Preventive Controls Alliance. FSVP ...... Foreign Supplier Verification Programs. GAP ...... Good Agricultural Practices. GFSI ...... Global Food Safety Initiative. GRAS ...... Generally Recognized as Safe. HACCP ...... Hazard Analysis and Critical Control Point. HHS ...... U.S. Department of Health and Human Services. ISO ...... International Organization for Standardization. LACF ...... Thermally processed low-acid foods packaged in hermetically sealed contain (commonly called ‘‘low-acid canned foods’’). N/A ...... Not Applicable. NACMCF ...... The National Advisory Committee on Microbiological Criteria for Foods (advisory committee chartered under the USDA). NIFA ...... National Institute of Food and Agriculture of the U.S. Department of Agriculture. OMB ...... Office of Management and Budget. PAS ...... British Standards Institute ‘‘Publically Available Specification 222:2011’’. PFP ...... Partnership for Food Protection. PHS ...... Public Health Service Act. PRA ...... Paperwork Reduction Act. PSA ...... Protein Surveillance Assignment. RA ...... Risk Assessment. RAC ...... Raw Agricultural Commodity. RFR ...... Reportable Food Registry. Section 103(c)(1)(C) draft RA ...... Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm. Section 103(c)(1)(C) RA ...... Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (Final). TCS ...... Time/Temperature Control for Safe Animal Food. USDA ...... U.S. Department of Agriculture.

I. Background than relying primarily on reacting to and territorial authorities. A top priority A. FDA Food Safety Modernization Act problems after they occur. The law also for FDA are those FSMA-required provides new enforcement authorities to regulations that provide the framework The FDA Food Safety Modernization help achieve higher rates of compliance for industry’s implementation of Act (FSMA) (Pub. L. 111–353), signed with risk-based, prevention-oriented preventive controls and enhance our into law by President Obama on January safety standards and to better respond to ability to oversee their implementation 4, 2011, is intended to allow FDA to and contain problems when they do for both domestic and imported animal better protect public (human and occur. In addition, the law contains food. To that end, we proposed the animal) health by helping to ensure the safety and security of the food supply. important new tools to better ensure the seven foundational rules listed in table FSMA enables us to focus more on safety of imported foods and encourages 1 and requested comments on all preventing food safety problems rather partnerships with State, local, tribal, aspects of these proposed rules.

TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

Title Abbreviation Publication

Current Good Manufacturing Practice and Hazard Analysis and Risk- 2013 proposed rule for preventive 78 FR 64736, October 29, 2013. Based Preventive Controls for Food for Animals. controls for animal food.

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TABLE 1—PUBLISHED FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA—Continued

Title Abbreviation Publication

Current Good Manufacturing Practice and Hazard Analysis and Risk- 2013 proposed rule for preventive 78 FR 3646, January 16, 2013. Based Preventive Controls for Human Food. controls for human food. Standards for the Growing, Harvesting, Packing, and Holding of 2013 proposed produce safety rule 78 FR 3504, January 16, 2013. Produce for Human Consumption. Foreign Supplier Verification Programs (FSVP) for Importers of Food 2013 proposed FSVP rule ...... 78 FR 45730, July 29, 2013. for Humans and Animals. Accreditation of Third-Party Auditors/Certification Bodies to Conduct 2013 proposed third-party certifi- 78 FR 45782, July 29, 2013. Food Safety Audits and to Issue Certifications. cation rule. Focused Mitigation Strategies To Protect Food Against Intentional 2013 proposed intentional adulter- 78 FR 78014, December 24, 2013. Adulteration. ation rule (human food only). Sanitary Transportation of Human and Animal Food ...... 2014 proposed sanitary transpor- 79 FR 7006, February 5, 2014. tation rule.

We also issued a supplemental notice listed in table 2 and requested in each supplemental notice of of proposed rulemaking for the rules comments on specific issues identified proposed rulemaking.

TABLE 2—PUBLISHED SUPPLEMENTAL NOTICES OF PROPOSED RULEMAKING FOR THE FOUNDATIONAL RULES FOR IMPLEMENTATION OF FSMA

Title Abbreviation Publication

Current Good Manufacturing Practice and Hazard Analysis and Risk- 2014 supplemental notice...... 79 FR 58476, September 29, Based Preventive Controls for Food for Animals. 2014. Current Good Manufacturing Practice and Hazard Analysis and Risk- 2014 supplemental human preven- 79 FR 58524, September 29, Based Preventive Controls for Human Food. tive controls notice. 2014. Standards for the Growing, Harvesting, Packing, and Holding of 2014 supplemental produce safety 79 FR 58434, September 29, Produce for Human Consumption. notice. 2014. Foreign Supplier Verification Programs (FSVP) for Importers of Food 2014 supplemental FSVP notice... 79 FR 58574, September 29, for Humans and Animals. 2014.

As FDA finalizes these seven food safety. FDA believes these seven notice’’ to refer to specific text foundational rulemakings, we are foundational final rules, when published in the Federal Register of putting in place a framework for food implemented, will fulfill the paradigm October 29, 2013 (78 FR 64736) and safety that is modern and brings to bear shift toward prevention that was September 29, 2014 (79 FR 58476), the most recent science on provisions to envisioned in FSMA and be a major step respectively. We use the terms ‘‘final enhance food safety, that is risk-based forward for food safety that will protect preventive controls rule for animal and focuses effort where the hazards are consumers into the future. food’’ and ‘‘this rule’’ to refer to the reasonably likely to occur, and that is regulations we are establishing as a B. Stages in the Rulemaking for the flexible and practical given our current result of this rulemaking. Animal Food Preventive Controls Rule knowledge of food safety practices. To C. Summary of the Major Provisions of achieve this, FDA has engaged in a great With regard to this rulemaking, we Proposed Rule for Preventive Controls deal of outreach to the stakeholder published proposed provisions in the for Food for Animals community to find the right balance in 2013 proposed animal food preventive these regulations of flexibility and controls rule and we published new and As part of our implementation of new accountability. re-proposed provisions in the 2014 statutory provisions in FSMA, we Since FSMA was enacted in 2011, we supplemental notice. In the 2014 proposed to add, in newly established have been involved in approximately supplemental notice, we reopened the part 507, regulations for CGMPs. In 600 engagements on FSMA and the comment period only with respect to addition, we proposed to add proposed rules, including public specific proposed provisions. In requirements for certain domestic and meetings, Webinars, listening sessions, addition, we emphasized that the re- foreign facilities to establish and farm tours, and extensive presentations proposed provisions we included in the implement hazard analysis and risk- and meetings with various stakeholder regulatory text were based on a based preventive controls for food for groups (Refs. 1 and 2). As a result of this preliminary review of the comments. animals. As directed by FSMA (see stakeholder dialogue, FDA decided to In this document, we use the broad section 418 of the Federal Food, Drug, issue the four supplemental notices of term ‘‘proposed animal food preventive and Cosmetic Act (FD&C Act) (21 U.S.C. proposed rulemaking to share our controls rule’’ to refer to the complete 350g)), these new provisions would thinking on key issues and get proposed regulatory text, including both apply to domestic and foreign facilities additional stakeholder input on those the proposed provisions we published that are required to register under issues. As we move forward into the in the 2013 proposed animal food section 415 of the FD&C Act (21 U.S.C. next phase of FSMA implementation, preventive controls rule and the new 350d) and our regulation for we intend to continue this dialogue and and re-proposed provisions we Registration of Food Facilities (21 CFR collaboration with our stakeholders, published in the 2014 supplemental part 1, subpart H; the section 415 through guidance, education, training, notice. We use the narrow terms ‘‘2013 registration regulations). As directed by and assistance, to ensure that everyone proposed preventive controls rule for FSMA (see section 418(l) and (m) of the understands and engages in their role in animal food’’ and ‘‘2014 supplemental FD&C Act), we proposed to establish

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modified requirements for certain submissions from diverse members of part of any filthy, putrid, or facilities. We requested comment on all the public, including animal food decomposed substance, or if it is aspects of the proposed requirements, facilities (including facilities co-located otherwise unfit for food. Section including an opportunity for public on a farm); farms; cooperatives; 402(a)(4) of the FD&C Act provides that comment on potential requirements for coalitions; trade organizations; a food is adulterated if it has been product testing, environmental consulting firms; law firms; academia; prepared, packed, or held under monitoring, a supplier program, and public health organizations; public insanitary conditions whereby it may hazards that may be intentionally advocacy groups; consumers; pet have become contaminated with filth, or introduced for purposes of economic owners, consumer groups; Congress, whereby it may have been rendered gain. Federal, State, local, and foreign injurious to health. Under section 701(a) We proposed to establish the Government Agencies; and other of the FD&C Act, FDA is authorized to requirements for CGMPs, for hazard organizations. Some submissions issue regulations for the efficient analysis and risk-based preventive included signatures and statements from enforcement of the FD&C Act. The controls, and related requirements in multiple individuals. Comments CGMP regulations we are establishing new 21 CFR 507 as shown in table 3: address virtually every provision of the are necessary to prevent animal food proposed animal preventive controls from containing filthy, putrid, or TABLE 3—PROPOSED SUBPARTS IN rule. In the remainder of this document, decomposed substances, being NEW PART 507 we describe these comments, respond to otherwise unfit for food, or being them, and explain any revisions we prepared, packed, or held under Subpart Title made to the proposed preventive insanitary conditions whereby it may controls rule for animal food. have become contaminated with filth, or A ...... General Provisions. Some comments address issues that whereby it may have been rendered B ...... Current Good Manufacturing are outside the scope of this rule. For injurious to health. Practice. example, some comments ask for more In addition to the FD&C Act, FDA’s C ...... Hazard Analysis and Risk-Based inspections of pet food facilities. Other Preventive Controls. legal authority for establishing CGMP comments express concern about the requirements derives from the PHS Act D ...... Withdrawal of an Exemption Ap- use of bioengineered animal food plicable to a Qualified Facility. to the extent such measures are related E ...... Reserved. ingredients, and ask that animal foods to communicable disease. Authority F ...... Requirements Applying to containing such ingredients not be used under the PHS Act is derived from the in pet food. Other comments have Records That Must be Estab- provisions of sections 311, 361, and 368 concerns with FDA’s general obligations lished and Maintained. (42 U.S.C. 243, 264, and 271) that relate for the outcome of regulations it issues to communicable disease. The PHS Act and implements, general concerns with D. Draft Risk Assessment authorizes the Secretary to make and FDA’s regulation and oversight of enforce such regulations as ‘‘are We issued for public comment a industry, concerns about banning necessary to prevent the introduction, ‘‘Draft Qualitative Risk Assessment of specific products or imports from transmission, or spread of Risk of Activity/Animal Food specific countries, testing procedures at communicable diseases from foreign Combinations for Activities (Outside the the borders, and concerns about animal countries into the States * * * or from Farm Definition) Conducted in a food marketing. We do not discuss such one State * * * into any other State’’ Facility Co-Located on a Farm’’ (the comments in this document. section 103(c)(1)(C) draft risk (section 361(a) of the PHS Act). (See sec. assessment (RA)) (78 FR 64428, October II. Legal Authority 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 29, 2013). The purpose of the section The proposed rule contained an 202 for transfer of authority from the 103(c)(1)(C) draft RA was to provide a explanation of its legal basis under Surgeon General to the Secretary.) The science-based risk analysis of those authorities in FSMA, the FD&C Act, and CGMP regulations are necessary to activity/animal food combinations that the Public Health Service Act (the PHS prevent the spread of communicable would be considered low risk when Act). After considering comments disease. conducted in a facility co-located on a received in response to the 2013 The CGMP regulations finalized in farm. We used the tentative conclusions proposed rule and the 2014 this document include limited labeling of the section 103(c)(1)(C) draft RA to supplemental notice, we made changes requirements. These requirements are propose to exempt food facilities that in the final rule. The legal authorities partly to help prevent accidental co- are small or very small businesses that relied on for the final rule are generally mingling or mix-ups of products at the are engaged only in specific types of on- the same as in the proposed rule unless facility, which could result in farm manufacturing, processing, otherwise described. contaminated animal food. Thus, FDA’s packing, or holding activities from the legal authority for these requirements requirements for hazard analysis and A. Current Good Manufacturing Practice derives from its authority to require risk-based preventive controls. We are Regulations current good manufacturing practice. including the final risk assessment (the The CGMP regulations finalized in The labeling requirements also are section 103(c)(1)(C) RA) in the docket this document establish current good intended to enable animal producers established for this document (Ref. 3). manufacturing practice requirements for and owners, and facilities receiving the the manufacturing, processing, packing animal food for further manufacture, to E. Public Comments and holding of animal food. FDA’s legal use the animal food appropriately. We received more than 2400 public authority to require current good Accordingly, the requirements are submissions on the 2013 proposed manufacturing practice derives from supported by section 403(a)(1) of the preventive controls rule for animal food, sections 402(a)(3) and (4) and 701(a) of FD&C Act, which states that a food is and more than 140 public submissions the FD&C Act (21 U.S.C. 342(a)(3) and misbranded if its labeling is false or on the 2014 preventive controls (4), and 371(a)). Section 402(a)(3) of the misleading in any particular, and by supplement notice, each containing one FD&C Act provides that a food is section 403(i) of the FD&C Act, which or more comments. We received adulterated if it consists in whole or in states that a food is misbranded unless

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its label bears the common or usual from which the Secretary may issue facility to rely on a subsequent entity in name of the food or its ingredients. exemptions or modifications of the the distribution chain rather than requirements for certain types of requiring that facility to apply the B. Hazard Analysis and Risk-Based facilities. Sections 418(j) to (m) of the control. An animal food may pass Preventive Controls FD&C Act and sections 103(c)(1)(D) and through multiple entities in the Section 103 of FSMA, Hazard (g) of FSMA provide authority for distribution chain before it reaches Analysis and Risk-Based Preventive certain exemptions and modifications to consumers. Further, ordinarily it is not Controls, amends the FD&C Act to the requirements of section 418 of the apparent from visual examination of the create a new section 418, which FD&C Act. These include provisions animal food whether a hazard requiring mandates rulemaking. Section related to low-acid canned food (section a preventive control has been addressed. 418(n)(1)(A) of the FD&C Act requires 418(j)); activities of facilities subject to Consequently, without labeling, a that the Secretary issue regulations ‘‘to section 419 of the FD&C Act (Standards facility might not know that a facility establish science-based minimum for Produce Safety) (section 418(k)); upstream in the supply chain has not standards for conducting a hazard qualified facilities (section 418(l)); applied a preventive control and is analysis, documenting hazards, facilities that are solely engaged in the relying on a downstream entity to do so. implementing preventive controls, and production of food for animals other Therefore, the agency concludes that documenting the implementation of the than man, the storage of raw agricultural information that animal food has not preventive controls. . . .’’ Section commodities (other than fruits and been processed to control an identified 418(n)(1)(B) of the FD&C Act requires vegetables) intended for further hazard is necessary for a facility to fulfil that the regulations define the terms distribution or processing, or the storage its obligation under section 418 when a ‘‘small business’’ and ‘‘very small of packaged foods that are not exposed facility is relying on a subsequent entity business,’’ taking into consideration the to the environment (section 418(m)); to control the hazard. The agency also study of the food processing sector and facilities engaged only in certain concludes that such labeling is required by section 418(l)(5) of the low-risk on-farm activities on certain necessary for the efficient enforcement FD&C Act. Further, section 103(e) of foods conducted by small or very small of the FD&C Act because the labelling is FSMA creates a new section 301(uu) in businesses (section 103(c)(1)(D) of critical for FDA to hold facilities the FD&C Act (21 U.S.C. 331(uu)) to FSMA). In sections X, XI, XII, and responsible for their obligations under prohibit ‘‘(t)he operation of a facility XXXVI we discuss provisions that this regulatory scheme. Further, when that manufactures, processes, packs, or implement these exemptions and the hazard can cause a communicable holds food for sale in the United States modified requirements. disease, FDA concludes that the if the owner, operator, or agent in charge In the supplemental notice, we requirement is necessary to prevent the of such facility is not in compliance included potential requirements for a spread of communicable disease from with section 418 (of the FD&C Act).’’ supplier program, environmental one state into another state and relies on In addition to rulemaking monitoring, and product testing. We are sections 311, 361, and 368 of the PHS requirements, section 418 contains including provisions for such activities Act. requirements applicable to the owner, in the final rule. Section 418(o)(3) of the FDA concludes that the provisions in operator, or agent in charge of a facility FD&C Act provides supplier verification subpart C and related requirements in required to register under section 415. activities and an environmental subparts A, E and F should be Section 418(a) is a general provision monitoring program as examples of applicable to activities that are intrastate that requires the owner, operator, or preventive controls. Section 418(f)(4) of in character. Facilities are required to agent in charge of a facility to evaluate the FD&C Act provides for the use of register under section 415 of the FD&C the hazards that could affect food environmental and product testing Act regardless of whether the food from manufactured, processed, packed, or programs as part of required verification the facility enters interstate commerce held by the facility, identify and that the preventive controls are (§ 1.225(b) (21 CFR 1.225(b))). The plain implement preventive controls, monitor effectively and significantly minimizing language of section 418 of the FD&C Act the performance of those controls, and or preventing the occurrence of applies to facilities that are required to maintain records of the monitoring. identified hazards. register under section 415 (section Section 418(a) specifies that the purpose In certain circumstances, the final 418(o)(2) of the FD&C Act) and does not of the preventive controls is to ‘‘prevent rule does not require a manufacturing/ exclude a facility from the requirements the occurrence of such hazards and processing facility to implement a because food from such a facility is not provide assurances that such food is not preventive control for a hazard requiring in interstate commerce. Further, the adulterated under section 402 (of the a preventive control. Instead, the facility prohibited act provision associated with FD&C Act). . . .’’ In addition to the is permitted to rely on a subsequent section 418 (section 301(uu) of the general requirements in section 418(a) entity in the distribution chain to FD&C Act) does not require interstate of the FD&C Act, sections 418(b) to (i) significantly minimize or prevent the commerce for a violation. contain more specific requirements hazard. In such a circumstance, a FDA also is issuing the provisions in applicable to facilities. These include facility must disclose in documents subpart C and related requirements in hazard analysis (section 418(b)), accompanying the animal food, that the subparts A, E and F, under sections preventive controls (section 418(c)), food is ‘‘not processed to control 402(a)(3) and (4), and 701(a) of the monitoring (section 418(d)), corrective [identified hazard].’’ This requirement is FD&C Act to the extent such actions (section 418(e)), verification supported by sections 418 and 701(a) of requirements are necessary to prevent (section 418(f)), recordkeeping (section the FD&C Act (21 U.S.C. 350g and animal food from being held under 418(g)), a written plan and 371(a)). The requirement that facilities insanitary conditions whereby it may documentation (section 418(h)), and apply preventive controls to become contaminated with filth or reanalysis of hazards (section 418(i)). significantly minimize or prevent rendered injurious to health, or being Section 103(c)(2)(C) of FSMA requires hazards is fundamental to the public unfit for food. FDA also is finalizing that the Secretary adopt a final rule with health benefits of the rule. To those provisions under sections 311, respect to the requirements under accommodate the realities of modern 361, and 368 of the PHS Act relating to sections 418 and 421 of the FD&C Act food production, the rule allows a communicable disease to the extent

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those provisions are necessary to appropriate (§ 10.115(g)) (21 CFR adoption of established food safety prevent the interstate spread of 10.115(g)). The public may submit standards, guidance, and protocols. communicable disease. comments on any guidance document at (Comment 2) Some comments ask us any time (§ 10.115(g)(5)). In addition, we to explain how we will enforce the rule, III. General Comments on the Proposed intend to review current guidance particularly with respect to coordination Rule documents and make a determination with State and local authorities and (Comment 1) Several comments ask whether they need to be withdrawn or with other Federal Agencies. For us to develop guidance to accompany revised based on this final rule. example, some comments ask whether the rule, particularly with respect to the We agree with comments that stress FDA or the States will pay for new requirements for hazard analysis the importance of education and inspections, whereas other comments and risk-based preventive controls. For outreach. A central element of our ask us to coordinate inspection of example, comments ask us to provide strategy to gain industry compliance is imports with USDA’s Food Safety and guidance on topics such as hazard to help make available to facilities Inspection Service (FSIS) or ask us to analysis, environmental monitoring, and subject to this rule the education and combine our inspections with those of validation. Some of these comments ask technical assistance they need to USDA where possible. Some comments that drafts of the guidance first be made understand and implement the express concern about the time gap available for public comment. Some of requirements (Ref. 5). Within the between the effective date of this rule these comments request that the Agency we are establishing a Food and the time it will take to incorporate guidance be available as soon as Safety Technical Assistance Network applicable provisions into State law. possible and before the rule becomes and seeking funding to increase FDA (Response 2) We are working through effective. Some comments request staffing to provide a central source of the Partnership for Food Protection guidance specific to small businesses. information to support industry (PFP) (a group of dedicated Several comments suggest FDA revisit understanding and implementation of professionals from Federal, State, local, some current compliance policy FSMA standards (Ref. 5). This will tribal, and territorial governments with guidances in light of FSMA and the roles in protecting the food supply and allow us to respond in a timely and proposed rules. public health) to develop and consistent way to industry questions on Other comments emphasize the implement a national Integrated Food preventive controls technical and importance of education and outreach Safety System consistent with FSMA’s compliance issues (Ref. 5). and ask us to provide support for emphasis on establishing partnerships ongoing education and outreach, We also are working in collaboration for achieving compliance (see section including an active role in providing with the Food Safety Preventive 209(b) of FSMA). For an example of our needed instructional examples and Controls Alliance (FSPCA) to develop current thinking on establishing lessons learned from current training materials and establish training partnerships for achieving compliance, investigations and foodborne outbreaks. and technical assistance programs (Refs. see the ‘‘best practices’’ document made Some comments ask us to convene a 5 and 6). The Alliance includes available by PFP (Ref. 8). This ‘‘best scientific workgroup that includes members from FDA, State food practices’’ document provides experts in food and laboratory science, protection Agencies, the food (human information to FDA field and State public health, proficiency testing, and animal) industry, and academia. It programs on a variety of issues, quality control, and other areas on at is funded by a grant to the Illinois including how to coordinate compliance least an annual basis to assess what Institute of Technology’s Institute for activities. Our document entitled hazards should be addressed in food Food Safety and Health, a nationally ‘‘Operational Strategy for Implementing safety plan. Other comments ask us to recognized leader in food safety. In FSMA’’ also recognizes the importance engage universities and extension in addition to developing a standardized of developing operational partnerships education and training efforts. preventive controls training curriculum, with States and other government Some comments ask that funding and the FSPCA is developing selected counterparts to optimize the information on funding for training be sections of model food safety plans for effectiveness, efficiency, and provided. Other comments assert that several food types that will provide consistency of FSMA implementation we must make available adequate needed instructional examples. domestically (Ref. 9). resources to support outreach and Although we have provided funding to We are implementing a new technical assistance delivered by State the FSPCA to develop a standardized inspection paradigm focused on regulatory Agencies, as well as preventive controls training curriculum, whether firms are implementing Cooperative Extension programs and we are unable to fund training for systems that effectively prevent food non-governmental organizations that individual groups who might need contamination, requiring fundamentally work directly with farmers and particular training materials. different approaches to food safety facilities. We also are partnering with the inspection and compliance (Ref. 10). (Response 1) We are developing National Institute of Food and This new paradigm involves a major several guidance documents, including Agriculture (NIFA) of the U.S. reorientation and retraining, for which general guidance on hazard analysis and Department of Agriculture (USDA) to we are seeking funding, of more than preventive controls, as well as guidance administer the FSMA-mandated 2,000 FDA inspectors, compliance for complying with the CGMP National Food Safety Training, officers, and other staff involved in food requirements of subpart B (Ref. 4). We Education, Extension, Outreach, and safety activities, as well as thousands of will develop and issue this guidance in Technical Assistance Program, a grant State, local, and tribal inspectors (Ref. accordance with our good guidance program to provide technical assistance 10). practices regulation, which establishes for FSMA compliance to owners and (Comment 3) Some comments ask us criteria for when we issue a guidance operators of small and medium-size to reevaluate the proposed animal food document as an initial draft, invite farms and small food processors (Ref. 7). preventive controls rule, compare it public comment, and prepare a final Such efforts will help ensure with existing programs, and identify a version of the guidance document that widespread voluntary compliance by mechanism for integrating compliance incorporates suggested changes, when encouraging greater understanding and verification with existing industry and

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governmental programs. These a manufacturer/processor, an importer We disagree that we are seeking to comments note that many handlers/ must conduct a hazard analysis as part ‘‘regulate the production processes in processors use and understand of the foreign supplier verification exporting countries’’ inappropriately. voluntary food safety management requirements, whereas a facility that is This rule provides for a flexible set of systems such as HACCP and HACCP- a manufacturer/processor must conduct principles and a framework for hazard based certification programs and ask us a hazard analysis to determine whether analysis and risk-based preventive why we proposed to create a separate the requirements of the animal food controls to be applied to a given inspection framework for FSMA, preventive controls rule apply to it. As production process in order to ensure without integrating that inspection another example, section 805 of the the production of safe animal food framework with existing programs. FD&C Act does not provide an destined for the United States. (Response 3) We decline this request. exemption for small or very small Mandating that a finished animal food As previously discussed, we are entities, whereas section 418 of the is manufactured under general methods establishing this rule as required by FD&C Act provides an exemption for applicable to all animal foods (e.g., good section 103 of FSMA (78 FR 64736 at ‘‘qualified facilities,’’ which include manufacturing practices) is a widely 64743 through 64745 and 64817 through very small businesses. accepted regulatory practice and 64818). However, where compliance To the extent possible, we have fundamentally different than mandating with this rule mirrors compliance with attempted to harmonize the animal food that animal food be produced in a existing regulatory requirements, there preventive controls final rule with the certain way. We note that other is no need to duplicate existing records, human food preventive controls final countries have adopted animal food which may be supplemented as rule. The CGMP (subpart B) safety regulations that mandate certain necessary to include all of the required requirements address the principles and conditions be applied to information. (See also Response 2 manufacturing, processing, packing, and animal food manufacturing. Because the regarding implementation of a national holding practices at animal food plants, requirements being implemented by Integrated Food Safety System.) but are similar to those for human food, FDA under this regulation are flexible (Comment 4) Some comments ask us where appropriate. Furthermore, and not prescriptive, we do not agree to make the various rules we are § 507.1(d) contains provisions for a that this regulation will significantly establishing to implement FSMA human food facility that also increase costs or impede trade. consistent with each other. One manufactures, processes, packs, or holds We also disagree that there is no comment specifically asks us to animal food. This is intended to reduce scientific evidence supporting this rule. harmonize the human and animal food confusion and increase flexibility for In the 2013 proposed preventive preventive controls final rules to avoid facilities that produce both human and controls rule for human and animal confusion by firms that produce both food, we provided an extensive animal food. human and animal food. background discussing the scientific (Comment 5) Some comments express (Response 4) We have aligned the evidence upon which this rule is based provisions of the various rules to the concern that we will enforce the rule (78 FR 3646 at 3659 through 3667, extent practicable. For example, we use more strictly for domestic facilities than January 16, 2013 and 78 FR 64736 at the same definitions of ‘‘farm’’ and the for foreign facilities, e.g., because we 64745, October 29, 2013). In addition, same terms used in the definition of lack the funds and manpower to enforce the Appendix to the 2013 proposed ‘‘farm’’ (i.e., packing, holding, and the rule for foreign facilities. Other preventive controls rule provided manufacturing/processing) in this rule, comments assert that it is additional scientific information on the human food preventive controls unprecedented for importing countries activities such as product testing and rule, and the proposed produce safety to regulate the production processes in environmental monitoring to support rule. However, the statutory direction is exporting countries and that no their role in ensuring safe food and how not the same for all the rules, and this scientific evidence supports such these align with international standards difference in statutory direction does regulation. These comments express such as those of Codex Alimentarius (78 lead to some differences between the concern that this regulatory requirement FR 64736 at 64834 through 64836). rules. For example, section 418(l) of the will greatly increase trading costs and (Comment 6) Many comments from FD&C Act (which relates to this rule) might constitute a barrier to trade for pet owners are generally supportive of provides for modified requirements for exporting countries. the rule; however, some request facilities that are very small businesses (Response 5) We intend to enforce additional regulations and oversight for in addition to facilities that satisfy this rule in a consistent manner to pet food. Many comments state that pet criteria for sales to qualified end-users, ensure that imported and domestically food should meet the same standards as but section 419(f) of the FD&C Act produced animal foods are in full human food. Some comments request (which relates to the proposed produce compliance with the requirements of that pet food be required to be tested for safety rule) only provides for modified this rule. We note that the forthcoming safety. requirements for direct farm marketing. FSVP rule will require importers to help (Response 6) The CGMP requirements Likewise, we have worked to align the ensure that animal food imported into in subpart B are intended to serve as provisions of this rule with the the United States is produced in baseline standards for producing safe provisions of the Foreign Supplier compliance with processes and animal food across all types of animal Verification Program (FSVP) rule. procedures, including reasonably food facilities, including pet food Again, however, there are statutory appropriate risk-based preventive facilities. For discussion of the differences that lead to some differences controls, that provide the same level of relevance of the CGMP requirements to between the rules. For example, section public (human and animal) health pet food, see Response 163. Many pet 805 of the FD&C Act (21 U.S.C. 348a), protection as those required under this food facilities (as well as facilities applies to an importer, whereas section rule. The implementation of these producing other animal food) will be 418 of the FD&C Act applies to a facility supplier verification programs by U.S. subject to the preventive controls that is required to register under section importers will thus provide assurances requirements of subpart C. These 415 of the FD&C Act. Except in the that imported animal food is in provisions require the pet food circumstance where an importer is also compliance with this regulation. manufacturer to identify and evaluate

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potential hazards for the pet food to with State and local regulatory partners IV. Definitions in the Section 415 determine whether a preventive control during the implementation of this final Registration Regulations (21 CFR Part is required (see § 507.33). These could rule. 1, Subpart H) be hazards to the pet consuming the pet (Comment 8) Some comments request A. Definitions That Impact a food or the person handling the pet food that this final rule have a provision Determination of Whether an (e.g., Salmonella). The preventive similar to the proposed produce safety Establishment Is a ‘‘Farm’’ controls provisions also include rule that allows a state or foreign requirements for product testing for The 2013 proposed rule for human pathogens or other hazards and country to request a variance from the food preventive controls contained a environmental monitoring for pathogens rule’s requirements due to procedures, description (78 FR 3646 at 3675 through under certain circumstances (see processes, and practices that ensure a 3676) of the current legal and regulatory § 507.49), in order to help ensure the product is not adulterated. framework that governs the safety of the pet (animal) food. (Response 8) We are implementing determination of when an establishment Currently, low-acid canned animal food these regulations according to the is required to register as a food facility in a hermetically sealed container (such statutory direction of FSMA. A variance in accordance with the section 415 as canned pet food) is subject to the request and review process is specified registration regulations. That requirements of § 500.23 (21 CFR for produce in section 419(c)(2) of the description focused on the framework 500.23) and part 113 to control FD&C Act; however, there are no similar that governs whether an establishment microbiological hazards. provisions in FSMA directing FDA to that grows and harvests crops or raises animals satisfies the definition of (Comment 7) Some comments request create a variance process for facilities ‘‘farm,’’ because the facility registration communication and coordination with subject to the preventive controls requirements of section 415 of the FD&C state regulators throughout the FSMA regulations and we therefore are Act do not apply to ‘‘farms.’’ Under that implementation phase. Some comments declining to do so. specifically request training of FDA staff framework, a key factor in whether an and regulatory partners to inspect (Comment 9) Some comments ask us establishment falls within the definition animal food facilities because there are to take a ‘‘BASE’’ approach to of ‘‘farm,’’ even with respect to crops it differences between animal food and implementing FSMA. These comments grows and harvests itself, is whether the human food facilities. Some comments describe this approach as follows: B activities conducted by the request that inspectors receive training stands for borders, a critical area where establishment fall within definitions of on the broad range of animal food FDA should be focusing its attention ‘‘harvesting,’’ ‘‘packing,’’ or ‘‘holding’’ manufacturing. At least one comment and resources; A stands for audits, (which are within the ‘‘farm’’ requests we establish a national recognizing that FDA will need to definition). Another key factor is advisory committee to provide ongoing actively audit states and foreign whether activities conducted by the input throughout FSMA suppliers; S stands for standard, establishment fall within the definition implementation and enforcement. Some representing the standards FDA will set of manufacturing/processing (which comments request that we provide by which firms will be audited; and E have been outside the ‘‘farm’’ methods for communication with State stands for education, ensuring that all definition). and other regulatory partners, including stakeholders know their roles and In the 2014 supplemental human possibly a call center or other direct- responsibilities required by the rules. preventive controls notice, comments contact resource for regulators and were described regarding proposed (Response 9) While we do not intend industry to obtain information on revisions to the definitions of ‘‘farm,’’ to follow the BASE approach described FSMA. ‘‘harvesting,’’ ‘‘packing’’ and ‘‘holding,’’ (Response 7) As discussed in in the comment, we expect that some of as well as comments regarding the Response 1, we are working in our implementation efforts will be triggers for an activity to be considered collaboration with the FSPCA to similar to the approach described. For manufacturing/processing (79 FR 58524 develop training materials and programs discussion of our implementation at 58530 through 58538). Additional to be used by industry and regulators. planning, see Responses 1 and 2. To the revisions were proposed to the The training will be specific to human extent this comment is referring to definitions of ‘‘farm,’’ ‘‘harvesting,’’ or animal food and will include animal food from foreign suppliers ‘‘packing’’ and ‘‘holding’’ to address information on developing a food safety presented for import, this is a subject of these comments. plan tailored to each facility’s unique the forthcoming FSVP rule. Even after the revisions we proposed hazards. We will consider these and (Comment 10) Some comments in the 2014 supplemental human other recommendations for the content requested exceptions or reduced preventive controls notice, some of such training as part of that requirements that were not previously comments assert that the overall ‘‘farm’’ collaborative effort. proposed. One comment requests a definition still presents an unrealistic As discussed in Responses 1 and 2, narrower scope of requirements for and incomplete understanding of how we are working through two working facilities involved in the production of most farms in America are structured groups (FSCPA and PFP) that involve chemicals used as food additives or in with regard to their physical location(s) State and local regulators in order to accordance with generally recognized as and business models. See table 4 for implement this final rule. We will revised definitions that are being safe (GRAS) standards. continue to work through these groups, finalized in the human food preventive as well as use other methods of (Response 10) We decline these controls for the section 415 registration communication and coordination (e.g., requests. The CGMPs in subpart B and regulations and the section 414 arranged teleconference meetings with preventive controls in subpart C are recordkeeping regulations. the States (i.e., 50-State calls) to written to serve as baseline standards In section IV of the final rule for collaborate with State and local for producing safe animal food across all preventive controls for human food, regulatory officials to implement this types of animal food facilities, including published elsewhere in this issue of the final rule. We will consider these those producing food additives or other Federal Register, comments on the recommendations as we communicate ingredients. proposed changes to the section 415

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registration regulations and to the section 414 recordkeeping regulations are discussed.

TABLE 4—REVISIONS TO THE PROPOSED DEFINITIONS IN THE SECTION 415 REGISTRATION REGULATIONS AND THE SECTION 414 RECORDKEEPING REGULATIONS

Definition Revision

Farm ...... • A farm is an ‘‘operation’’ rather than an ‘‘establishment.‘‘ • There are two types of farms: (1) Primary production farm; and (2) secondary activities farm. Primary production farm ...... • A primary production farm is ‘‘under one management’’ rather than ‘‘under one ownership.’’ • Although a primary production farm continues to be ‘‘in one general physical location,’’ we have clarified that ‘‘one general physical location is ‘‘not necessarily contiguous.’’ • A primary production farm is an operation devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. Although some primary pro- duction farms both grow and harvest crops, other primary production farms grow crops but do not harvest them, and other primary production farms harvest crops but do not grow them. • Treatment to manipulate the ripening of raw agricultural commodities (RACs), and packaging and labeling the treated RACs, without additional manufacturing/processing, is within the ‘‘farm’’ definition. • We added an example of drying/dehydrating RACs to create a distinct commodity that would fall within the ‘‘farm’’ definition (i.e., drying/dehydrating grapes to produce raisins), as well as an example of additional manufacturing/processing that would cause an operation that dries/dehydrates RACs to create a distinct commodity to fall outside the ‘‘farm’’ definition (i.e., slicing). • We added an example of additional manufacturing/processing that can cause an operation that packages and labels RACs to fall outside the ‘‘farm’’ definition (i.e., irradiation). Secondary activities farm ...... • A ‘‘secondary activities farm’’ is an operation, not located on a primary production farm, devoted to har- vesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. • A secondary activities farm may also conduct those additional activities allowed on a primary production farm. Harvesting ...... • We added additional examples of harvesting activities. Holding ...... • We added additional examples of holding activities. Manufacturing/Processing ...... • We added additional examples of manufacturing/processing activities.

B. Proposed Revisions to the Definition management.’’ As discussed in section poultry processor’s behalf, the poultry of Farm IV.B of the final rule for preventive processor and the primary production controls for human food, although the farm are not ‘‘under one management,’’ In the human food proposed original phrase ‘‘under one ownership’’ even if their contract strictly controls preventive controls rule, we proposed to was not referring to a single owner, the almost all aspects of the raising of the revise the ‘‘farm’’ definition to (1) ‘‘farm’’ definition should reflect modern poultry. The poultry processor and the Provide for on-farm packing and business models (such as cooperatives, primary production farm have separate holding of RACs to remain within the on-farm packinghouses under and independent management farm definition regardless of ownership ownership by multiple growers, food structures because they are separate and of the RACs; (2) include, within the aggregators, and food hubs) and use independent businesses. ‘‘farm’’ definition, a description of language that the modern farming In the final rule for preventive packing activities that include community understands. The term controls for human food, we also packaging RACs grown or raised on a ‘‘under one management’’ refers to the revised the farm definition to add a new farm without additional manufacturing/ control structure of the business, that is, category: A ‘‘secondary activities farm.’’ processing; and (3) provide for drying/ the management of the business entity (See Response 25 in the final rule for dehydrating RACs to create a distinct that is the farm operation. Thus, for preventive controls for human food). An commodity (such as the on-farm drying example, a primary production farm important limitation on the types of of grapes to produce raisins), and that hires another company as a contract operations that fit within this category packaging and labeling such harvester to perform harvesting services is that they must be majority owned (or commodities, without additional on the primary production farm’s behalf majority jointly owned) by the primary manufacturing/processing, to remain is not ‘‘under one management’’ with production farm(s) that grows, harvests, within the farm definition. See section the primary production farm just and/or raises the majority of the RACs IV.B of the final rule for preventive because the primary production farm is the secondary activities farm harvests, controls for human food, published directing the contractor’s activities packs, and/or holds. Thus, both product elsewhere in this issue of the Federal performed on the primary production and majority ownership must link a Register, for a full discussion of farm’s behalf. The primary production secondary activities farm to a primary comments and responses on the farm and the contract harvester have production farm(s). proposed revisions to the farm separate and independent management For example, a primary production definition. structures because they are separate and farm may own a majority interest in a In the final rule for preventive independent businesses. (See Response separate business that holds RACs and controls for human food, published 25 in the final rule for preventive processes them into animal food (e.g., a elsewhere in this issue of the Federal controls for human food). As another feed mill). If the majority of the RACs Register, we have revised the definition example, if a poultry processing held by the feed mill come from the of farm to replace the term ‘‘under one company contracts with a primary primary production farm that owns the ownership’’ with the term ‘‘under one production farm to raise chickens on the feed mill’s majority interest, the feed

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mill is a secondary activities farm and should be required to register under harmful error. Some comments note that may manufacture/process animal food section 415 of the FD&C Act (and thus for large farming operations, feeding of within the farm definition, but only to would be subject to the rule). For the animals is overseen by dedicated the extent that the animal food comments that supported applying the individuals, such as a nutritionist, manufactured is consumed at the feed final preventive controls rule to feed which ensures an extra layer of mill or on another farm whose ‘‘one mills that are part of fully vertically oversight for the safety of animal food. management’’ is the same management integrated farming operations, we Some comments express concern that as the feed mill. However, if the feed requested input on how the farm feed mills associated with contract mill in this example manufactures/ definition should be modified. If they farming operations (contract feed mills) processes animal food that is consumed were required to register, we also will be treated differently because, as on farms that are not under the same requested comment on whether there proposed in the 2013 proposed rule, management as the feed mill, that should be exemptions from registration they would need to comply with the manufacturing/processing is outside the under section 415 based on size, such as rule unlike the feed mills that are part farm definition, the feed mill is subject number of animals being fed or the of fully vertically integrated farming to registration under section 415 of the amount of animal food being fed (based operations. These comments FD&C Act, and its manufacturing/ on tonnage, monetary value, or some recommend modifications to the farm processing of animal food for other factor). Lastly, since there would definition to incorporate the contract consumption on farms not under the be no total annual sales figure for the feed mills into the farm definition, same management is subject to the animal food produced by these feed resulting in the contract feed mills no requirements of this rule. mills, we requested comment on how to longer being required to register under To further clarify, a feed mill that is value the animal food being fed to section 415 and therefore no longer not majority owned by a primary animals for purposes of determining being subject to the requirements of this production farm(s) cannot be a whether the feed mill would be a rule. Some comments (including ones secondary activities farm. Also, a feed qualified facility (proposed § 507.7) and that support and ones that oppose mill that does not receive more than half in particular a very small business. modifying the farm definition) generally of the RACs it holds from primary (Comment 11) Some comments agree there is no evidence that the safety production farm(s) that own a majority generally agree with our recognition that of animal food varies depending on interest in the feed mill cannot be a there are different types of farm models whether a feed mill is associated with secondary activities farm. For example, for raising animals but request vertically integrated or contract farming. a feed mill owned by a poultry additional clarification on what we These comments also state that the farm processing company will be required to mean by a fully vertically integrated definition as proposed has the potential register as a food facility, unless the feed farming operation and the depth of to create disparity in regulatory mill otherwise meets the definition of integration within an operation. requirements that feed mills must ‘‘farm.’’ When a feed mill is owned by (Response 11) Feed mills that are part follow based solely on the type of a company such as a poultry processor, of fully vertically integrated farming farming model with which they are it is not majority owned by the primary operations, or certain cooperative associated (i.e., some will be subject to production farm(s) that supply the farming operations that meet the CGMP and preventive controls majority of the RACs it holds, and definition of a farm (see § 1.227, as requirements, while some will be therefore the feed mill cannot be a revised by the final rule for preventive subject to neither). secondary activities farm. controls for human food published Some comments support modifying elsewhere in this Federal Register), are the farm definition to subject feed mills C. Proposed Revisions to Definitions of not subject to this final rule because that are part of fully vertically integrated Harvesting, Holding, Manufacturing/ they are not required to register under farming operations to the requirements Processing, Mixed-Type Facility, and section 415 of the FD&C Act (see of this final rule, and some of those Packing § 507.5(a)). Because expanding on the comments also support providing an See section VIII. for a discussion of characteristics of a fully integrated exclusion if it is limited to small on- comments and responses and revisions farming operation is beyond the scope farm animal food mixers. Other to the definitions in part 507 of of this rule, we decline to further clarify comments contend that some of the feed harvesting, holding, manufacturing/ the fully vertically integrated farming mills that are part of fully vertically processing, mixed-type facility, and operation farming model discussed in integrated farming operations produce packing. For a discussion of comments the 2014 supplemental notice. large volumes of animal food that feed and responses to these definitions in the (Comment 12) Some comments do not a substantial portion of the U.S. food- section 415 registration regulations and support modifying the farm definition to producing animal population and that the section 414 recordkeeping subject feed mills that are part of fully these feed mills should be subject to the regulations, see section IV.C through vertically integrated farming operations final rule to ensure continual IV.G of the final rule for preventive to the requirements of this final rule. production of safe animal food. Some controls for human food, published These comments state that these feed comments state concern that the feed elsewhere in this issue of the Federal mills are currently making safe animal mills that are part of fully vertically Register. food and that some are following integrated farming operations could industry best practices that would meet introduce food safety hazards into the D. Comments on Feed Mills Associated or exceed the requirements of our human food supply because they are not With Fully Vertically Integrated Farming proposed CGMPs. Some comments also being adequately controlled due to the Operations state that these feed mills are producing feed mills’ exemption from this rule. In the 2014 supplemental notice for a narrower range of animal food when Comments that support modifying the animal food, we requested comment on compared to independent feed mills farm definition to subject feed mills that whether feed mills that are part of fully because these integrated feed mills are part of fully vertically integrated vertically integrated farming operations, typically provide animal food to a single farming operations to the requirements including cooperatives that fit this species and therefore utilize fewer of this final rule recommend that any model, that meet the farm definition ingredients, resulting in less chance of exemption from this final rule

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applicable to farms be limited based on mills that are part of fully vertically and risk-based preventive controls (see the volume of the animal feed produced integrated farming operations that are section 103(c)(1)(C)) of FSMA and 78 FR or animal equivalency units. not required to register under section 64736 at 64751 and 64752 through (Response 12) The farm definition in 415, but produce a large volume of 64754). Consistent with this statutory 21 CFR part 1 has been modified based animal food. One reason we are not direction, we developed the section on other comments received to both the finalizing new food safety requirements 103(c)(1)(C) draft RA and made it 2014 supplemental notice for human for feed mills that are part of fully available for public comment (Ref. 11 food preventive controls and to the 2014 integrated farming operations in this and 78 FR 64428). We are including the supplemental notice for animal food rulemaking is that we need more final risk assessment (the section preventive controls (see section IV.B of information to help guide the scope of 103(c)(1)(C) RA) in the docket the final rule for preventive controls for the requirements. As part of the future established for this document (Ref. 3). human food published elsewhere in this rulemaking process we will seek input We previously described provisions of issue of the Federal Register). However, on the best way to subject vertically FSMA that direct us to consider the feed mills that are part of fully vertically integrated feed mills that produce large results of the science-based risk analysis integrated farming operations still meet volumes of animal food to food safety and exempt facilities that are small or the definition of farm. As a result, they requirements while avoiding very small businesses from the are not required to register as a food overburdening on-farm feed mixers that requirements for hazard analysis and facility under section 415 and are not produce a small amount of food for a risk-based preventive controls (or subject to the requirements of this rule small number of animals. The proposed modify these requirements, as we including CGMPs (subpart B) and rulemaking would not change the determine appropriate), if such facilities Hazard Analysis and Risk-Based applicability of subpart C, ‘‘Hazard are engaged only in specific types of on- Preventive Controls (subpart C), and Analysis and Risk-Based Preventive farm activities that we determine to be supply-chain program (subpart E). We Controls,’’ for feed mills that are part of low risk involving specific animal foods remain concerned that this leaves a gap a farm. Because farms meeting the that we determine to be low risk (see in the protection of public (human and definition of § 1.227 are not required to section 103(c)(1)(D) of FSMA and 78 FR animal) health because these feed mill register under section 415 of the FD&C 64736 at 64751, 64753 through 64754, operations manufacture significant Act, § 507.5(a) exempts them from and 64763 through 64764). In section amounts of animal food. While some of compliance with subpart C, as required X.F, we discuss the provisions we are these feed mills may be voluntarily by FSMA. establishing in § 507.5(e) and (f), based implementing some type of animal food on the results of the section 103(c)(1)(C) safety measures, not all feed mills that V. Comments on the Organizing RA, to exempt farm mixed-type facilities are part of vertically integrated farming Principles for How the Status of a Food that are small or very small businesses operations do. In addition, the voluntary as a Raw Agricultural Commodity or as from requirements for hazard analysis measures adopted by some feed mills a Processed Food Affects the and risk-based preventive controls if the may not meet the standards of the food Requirements Applicable to a Farm only activities that the business safety requirements in this rule. Under Sections 415 and 418 of the conducts that are subject to those Moreover, we do not and cannot enforce FD&C Act requirements are low-risk activity/ compliance with purely voluntary In the 2014 supplemental notice (79 animal food combinations. practices. Finally, we recognize that FR 58476 at 58482), we referred to the We also previously described other feed mills not part of a ‘‘farm’’ as 2014 supplemental human preventive provisions of FSMA that direct us to: (1) defined in part 1 will have to comply controls notice that discussed comments Identify high risk-facilities and allocate with the requirements of this rule on the organizing principles that formed resources to inspect facilities according (unless they qualify for an exemption). the basis for proposed revisions to to the known safety risks of the facilities As we have previously stated, we do not section 415 registration regulations and (as determined by several factors) and have evidence that the safety of animal the section 414 recordkeeping immediately increase the frequency of inspection of all facilities (see the food varies depending on whether a regulations (79 FR 58524 at 58538). We discussion of section 421 of the FD&C feed mill is part of vertically integrated also explained how its proposed Act at 78 FR 64736 at 64754) and (2) or contract farming. Therefore, we revisions to the ‘‘farm’’ definition would consider a possible exemption from or intend to publish a proposed rule that require FDA to reconsider those modification of requirements of section would require some feed mill operations organizing principles (79 FR 58524 at 421 of the FD&C Act as we deem that currently are part of a farm to 58538). comply with the CGMPs (subpart B) of For discussion of comments, see appropriate (see the discussion of this rule. section V of the final rule for preventive section 103(c)(1)(D) of FSMA at 78 FR The animal food CGMP requirements controls for human food, published 64736 at 64744). We tentatively help ensure that animal food is elsewhere in this issue of the Federal concluded that we should not exempt or protected from contamination during Register. modify the frequency requirements manufacturing, processing, packing, and under section 421 based solely upon holding (see sections XIV to XXII for VI. Rulemaking Required by Section whether a facility only engages in low- further discussion of the animal food 103(c) of FSMA: On-Farm Activities risk activity/animal food combinations CGMP). By implementing these CGMPs, A. Section 103(c)(1)(C) of FSMA and is a small or very small business we believe that feed mills not currently and requested comment on this covered by this rule would be able to We previously described provisions of tentative conclusion. provide a baseline level of animal food FSMA that direct us to conduct a safety, thus further protecting the public science-based risk analysis to cover B. Comments on Qualitative Risk (human and animal) health. We will specific types of on-farm packing, Assessment of On-Farm Activities continue to review the comments holding, and manufacturing/processing Outside of the Farm Definition received from the 2014 supplemental activities that would be outside the (Comment 13) Some comments proposed rule and other available data ‘‘farm’’ definition and, thus, subject to address the qualitative nature of the in considering a proposed rule for feed the requirements for hazard analysis section 103(c)(1)(C) draft RA and assert

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that it is based on professional judgment C. Comments Regarding an Exemption preventive controls rule for human food, rather than data. These comments ask us for Small and Very Small Farm Mixed- we proposed that the facility must to update the section 103(c)(1)(C) draft Type Facilities Under Section 421 of the comply with either rule for the animal RA when more data become available. FD&C Act food, as long as the food safety plan addresses hazards unique to animal Some comments assert that we should 1. Request for Comment on Data food. Some comments support the not rely on data from the Food Submission Requirements Processing Sector Study (Ref. 12), but proposed provisions without change. We requested comment on whether instead collect data from large-scale Some comments that support the we should establish data submission surveys of actual farm mixed-type proposed provisions ask us to clarify requirements that would allow us to how we will interpret the provisions. facilities and their activities. Other identify types of facilities in order to In the following paragraphs, we comments ask us to collect, analyze, and exempt them from the inspection discuss comments that ask us to clarify interpret data about the levels of frequencies, or modify the inspection the proposed requirements, disagree hazards from animal food samples taken frequencies that apply to them, under with, or suggest one or more changes to, from small and very small mixed-type section 421 of the FD&C Act. We the proposed requirements. After facilities and use consumption to provided examples of such data considering these comments, we have estimate the likelihood of exposure to elements, including identification of a revised the proposed requirements hazards in animal food from such facility as a farm mixed-type facility, along with editorial and conforming facilities. Some comments ask us to annual monetary value of sales, number changes as shown in table 31. consult with subject matter experts to of employees, and animal food category/ A. Comments on Proposed § 507.1(a)— activity type. We also requested ensure that the final risk assessment Applicability reflects sufficient geographic diversity. comment on any other criteria that may be appropriate for the purposes of We proposed that the criteria and (Response 13) We have acknowledged allocating inspection resources to these definitions in part 507 apply in the limitations of the section facilities. determining whether a food is 103(c)(1)(C) draft RA (Ref. 11 and 78 FR Comments did not support these data adulterated: (1) Within the meaning of 64428; see section I.F in that document). submission requirements. We are not section 402(a)(3) of the FD&C Act in that Rather than limit public input to subject establishing any data submission the food has been manufactured under matter experts, we requested comment requirements that would allow us to such conditions that it is unfit for food; from all interested persons, and identify types of facilities in order to or (2) Within the meaning of section received a number of comments about exempt them from the inspection 402(a)(4) of the FD&C Act in that the activity/animal food combinations frequencies, or modify the inspection food has been prepared, packed, or held conducted on farms and farm mixed- frequencies that apply to them, under under insanitary conditions whereby it type facilities, including comments from section 421 of the FD&C Act. may have become contaminated with diverse geographic areas comprising filth, or whereby it may have been 2. Request for Comment on an both areas where farms and farm mixed- rendered injurious to health. We also Exemption From the Requirements of proposed that the criteria and type facilities tend to be small and Section 421 of the FD&C Act where they tend to be large. We disagree definitions in part 507 also apply in that we need to conduct large scale We received no comments that determining whether an animal food is surveys, or enter into agreements with disagreed with our tentative conclusion in violation of section 361 of the PHS agencies/organizations, to collect that we should not exempt or modify Act. the frequency requirements under (Comment 15) Some comments note additional information in light of the section 421 based solely upon whether that FSMA granted FDA mandatory previous opportunity for broad public a facility only engages in low-risk recall authority for adulterated food. input regarding the activity/animal food activity/animal food combinations and These comments express concern that combinations conducted on farms and is a small or very small business. We are theoretically we could use a violation of farm mixed-type facilities. not establishing any exemption from, or the requirements for hazard analysis (Comment 14) Some comments assert modification to, the frequency and risk-based preventive controls to that we should revise the section requirements under section 421 for determine that food is adulterated, 103(c)(1)(C) draft RA and then make it facilities that only engage in low-risk thereby providing the basis for a available for additional public comment activity/animal food combinations and mandatory recall of that food. These before finalizing the rule. are a small or very small business. comments raise three issues relevant to how we will apply § 507.1(a), with (Response 14) We subjected the VII. Subpart A: Comments on Proposed consequences for a potential mandatory section 103(c)(1)(C) draft RA to peer § 507.1—Applicability and Status recall of food. review in accordance with the We proposed in § 507.1 to establish First, these comments note that the requirements of the Final Information the significance of this part in regulatory text stating that the ‘‘criteria Quality Bulletin for Peer Review (issued determinations of whether animal food and definitions’’ apply in making a by the Office of Management and is adulterated. We also proposed a determination of adulteration appears to Budget to implement the Information provision relevant to FSMA’s statutory encompass the entirety of the rule. As Quality Act (Pub. L. 106–554)) before provisions for a prohibited act under a result, farms or facilities that violate we made it available for broader public section 301(uu) of the FD&C Act. We any of the requirements in the proposed comment during a time period that proposed that animal food covered by rules, including components not exceeded 10 months. The additional specific CGMPs would also be subject to directly related to the safety of the food iterative process recommended by these those requirements. For facilities (such as recordkeeping requirements), comments is not necessary and would required to comply with CGMPs and could face a risk that we would deem go beyond the processes we routinely preventive controls for both the their food adulterated. apply for public input on a risk proposed preventive controls rule for Second, these comments assert that assessment. animal food and the proposed the regulatory text suggests that we

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would not automatically consider a food not comply with provisions that it is not would only need to comply with adulterated as a result of a violation of subject to. proposed § 507.28 in part 507 and the proposed rule, because it states that proposed § 117.95 in part 117 (79 58476 B. Comments on Proposed § 507.1(b)— the criteria and definitions ‘‘apply in at 58487 to 58489). (See section XIII for Prohibited Act determining’’ whether a food will be a discussion of comments received on considered adulterated, rather than that We proposed that the operation of a proposed § 507.12.) We are finalizing the food ‘‘is’’ adulterated. facility that manufactures, processes, the proposed provisions in 507.1(d) Third, these comments state that it is packs, or holds animal food for sale in with the exceptions in § 507.12. not clear how the exemption applicable the United States is a prohibited act For further discussion of comments to qualified facilities is included in the under section 301(uu) of the FD&C Act on applicability and status, see section ‘‘criteria and definitions’’ used in if the owner, operator, or agent in charge VIII in the final rule for preventive making a determination of adulteration. of such facility is required to comply controls for human food published These comments ask us to clarify that with, and is not in compliance with, elsewhere in this issue of the Federal we will not just automatically assume section 418 of the FD&C Act or subparts Register. C, D, or F of part 507 and § 507.7 that qualified facilities are selling VIII. Subpart A: Comments on (proposed § 507.1(b)). adulterated food because they are by Proposed § 507.3—Definitions definition exempt from the (Comment 16) Some comments from We proposed definitions in the requirements for hazard analysis and State regulatory Agencies note that this preventive controls rule for animal food risk-based preventive controls. new provision is not covered under the to be consistent with the proposed (Response 15) The comments are applicable state statute and that making preventive controls rule for human food correct that the criteria and definitions any changes to the state statute can be a lengthy process that takes up to 3 with some minor differences and ‘‘apply in determining’’ whether an clarifications applicable to animal food animal food will be considered years to complete. (Response 16) See Response 2 for a (e.g., adding ‘‘animal’’ before ‘‘food’’). adulterated, rather than that the animal discussion of our approach to working Some comments support one or more of food ‘‘is’’ adulterated. In determining with our food safety partners in the these proposed definitions without whether an animal food that is States. change. For example, some comments manufactured, processed, packed, or state that they support the proposed held in violation of part 507 (including C. Comments on Proposed § 507.1(c)— definitions for ‘‘microorganism’’ and a violation of the recordkeeping Specific CGMP Requirements ‘‘subsidiary’’ with no suggested requirement) is adulterated, we would We proposed § 507.1(c) would revisions. Some comments support our consider the totality of the available establish that animal food covered by proposal in the 2014 supplemental data and information about the violation specific current good manufacturing notice to use the phrase ‘‘chemical and the animal food before reaching a practice regulations also be subject to (including radiological)’’ in the conclusion that the animal food is the requirement of those regulations. We definition of ‘‘hazard,’’ noting that doing adulterated. received no comments that disagreed so is consistent with FSMA, current Although this rule does not address with our proposal, and are finalizing the industry practice, and Codex and global the mandatory recall provisions of proposed provision without change. HACCP standards. Some comments that FSMA, the statutory provisions support a proposed definition suggest D. Comments on Proposed § 507.1(d)— establish two basic criteria. (See section alternative or additional regulatory text, Human Food Facilities That 423(a) of the FD&C Act (21 U.S.C. such as adding examples to make the Manufacture Animal Food 3501).) First, we must determine that definition clearer. Some comments that there is a ‘‘reasonable probability’’ that We proposed in § 507.1(d) that a support a proposed definition ask us to the animal food is adulterated under facility that would be required to clarify how we will interpret the section 402 of the FD&C Act. A violation comply with subpart B of part 507 and definition. Comments generally ask that of part 507 would be relevant to would be required to comply with we maintain consistency of terms determining whether an animal food is subpart B of proposed part 117 for among the FSMA rules to avoid adulterated under section 402 of the human food, may choose to comply confusion and ensure regulatory FD&C Act. Second, we must determine with part 117 for the animal food. We compliance. that there is a reasonable possibility that also proposed that a facility that would We did not receive comment on the the use of, or exposure to, that animal be required to comply with subpart C of following terms and therefore, are food will cause serious adverse health part 507 and would be required to finalizing them as proposed: ‘‘calendar consequences or death to humans or comply with subpart C of proposed part day,’’ ‘‘FDA,’’ ‘‘pest,’’ ‘‘water activity,’’ animals. Not all animal food that is 117 for human food, may choose to and ‘‘you.’’ adulterated has a reasonable probability comply with part 117 for the animal We removed some proposed of causing serious adverse health food as long as the food safety plan also definitions because the final rule does consequences or death to humans or addressed hazards that are reasonably not use them. The proposed definitions animals. For examples of animal food likely to occur in the animal food. We that are removed in this final rule are contamination with a reasonable also proposed that when applying the ‘‘batter,’’ ‘‘blanching,’’ ‘‘packaging,’’ probability of causing serious adverse requirements of part 117 to animal food, ‘‘quality control operation,’’ ‘‘safe health consequences or death to humans the term ‘‘food’’ in part 117 would moisture level,’’ ‘‘should,’’ and or animals, see the annual reports of the include animal food. ‘‘significant hazard.’’ Reportable Food Registry (RFR) (Refs. Based on comments received in the In the following sections, we discuss 13, 14, 15, and 16). 2014 supplemental notice, we proposed comments that ask us to clarify A facility that is exempt from any in § 507.12 that human food by-products proposed definitions or that disagree requirement of part 507, including the held by the human food processor for with, or suggest one or more changes to, requirements for hazard analysis and distribution for use as animal food a proposed definition. After considering risk-based preventive controls, would without additional manufacturing/ these comments, we have revised the not be in violation of part 507 if it did processing by the human food processor proposed requirements with editorial

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and conforming changes as shown in very specific procedures and practices (Response 20) We decline to change table 31. where additional interpretation from the definition. We do not expect that the We also discuss definitions for FDA might be appropriate. inclusion of the term ‘‘raw materials’’ in additional terms (i.e., ‘‘audit,’’ the definition for animal food will 2. Affiliate and Subsidiary ‘‘correction,’’ ‘‘full-time equivalent change current practices, noting that a employee,’’ ‘‘hazard requiring a We proposed to define the term facility producing raw materials for preventive control,’’ ‘‘qualified facility ‘‘affiliate’’ to mean any facility that animal food is already required to exemption,’’ ‘‘raw agricultural controls, is controlled by, or is under register. The definition of ‘‘animal food’’ commodity,’’ ‘‘supply-chain-applied common control with another facility. is intended to clarify that the rule refers control,’’ ‘‘unexposed packaged animal We proposed to define the term to ‘‘food for animals’’ and not ‘‘food food,’’ and ‘‘written procedures for ‘‘subsidiary’’ to mean any company derived from animals.’’ which is owned or controlled directly or receiving raw materials and other 4. Critical Control Point ingredients’’) that we are establishing in indirectly by another company. These the final rule to simplify the regulatory proposed definitions would incorporate We proposed to define the term text throughout the regulations and the definition in section 418(l)(4)(A) and ‘‘critical control point’’ (CCP) to mean a improve clarity. We also discuss a new (D) of the FD&C Act and would make point, step, or procedure in a food name (i.e., ‘‘preventive controls the meanings of these terms clear when process at which control can be applied qualified individual’’) for the definition used in the proposed definition of and is essential to prevent or eliminate of a term that we had proposed to name ‘‘qualified facility.’’ a food safety hazard or reduce such ‘‘qualified individual,’’ and are (Comment 18) Some comments ask us hazard to an acceptable level. establishing a new definition for the to clarify that a facility that has no (Comment 21) Some comments term ‘‘qualified individual.’’ Finally, we material connection with another food oppose the use of ‘‘critical control also discuss definitions that comments processing operation would not be point’’ in the rule because the term is ask us to add, but that we did not add, considered as an ‘‘affiliate’’ of that confusing and not understood by the to the final rule. operation. relevant industry in the context of (Response 18) It is not clear what the FSMA and the required preventive A. Definitions We Proposed To Establish comments mean by ‘‘no material controls. The comments suggest critical in Part 507 connection with another food control point is a HACCP term and not 1. Adequate processing operation.’’ To the extent appropriate for use in this rule where that a facility does not control, is not the scope is defined differently by the We proposed to define the term controlled by, or is not under common statute. ‘‘adequate’’ to mean that which is control with another facility, we agree (Response 21) We decline to modify needed to accomplish the intended that the facility would not be considered or remove the definition as these purpose in keeping with good public an affiliate of that food processing comments request because we believe health practice. operation. the term is helpful to industry. The (Comment 17) Some comments (Comment 19) Some comments assert proposed definition matches the express concern that there is no that the definitions of ‘‘affiliate’’ and statutory definition in section 418(o)(1) standard or definition for ‘‘good public ‘‘subsidiary’’ fail to account for the legal of the FD&C Act and is consistent with health practice’’ and, for animal food differences between a piece of property definitions in the Federal HACCP establishments, the term ‘‘good public (i.e., a facility) and a business entity or regulations for seafood, juice, and meat health practice’’ creates more person. These comments ask us to and poultry (parts 123 and 120 (21 CFR uncertainty than it removes. The consider amending the proposed part 123 and 120) and 9 CFR part 417 comments request that we remove from definition of ‘‘qualified facility’’ to respectively). By specifying that a point, the definition the term ‘‘good public clarify what sales to include in step, or procedure in an animal food health practice.’’ Other comments ask us determining whether a facility so safety process would reduce a hazard to to develop guidance on thresholds and qualifies. an ‘‘acceptable level,’’ the definition processes that qualify as ‘‘adequate.’’ (Response 19) See Response 57. provides flexibility for a facility to Other comments assert that the word 3. Animal Food determine an appropriate level in a ‘‘adequate’’ must be used in particular circumstance. combination with the word We proposed to define the term (Comment 22) Some comments ‘‘reasonable’’ to properly describe the ‘‘animal food’’ to mean food for animals request that we define the term ‘‘control intended measures and precautions. other than man that includes pet food, point.’’ The comments suggest defining (Response 17) We disagree that there animal feed, and raw materials and this term as a point, step, or procedure is no standard for ‘‘good public health ingredients. in the production of an animal food at practice.’’ However, we have revised the (Comment 20) Several comments which a control may be applied. definition to add after public ‘‘(human voice concerns about including within (Response 22) We decline this and animal)’’ to clarify it includes both. the definition of animal food the term request. We define ‘‘critical control Our intent in using the term ‘‘adequate’’ ‘‘raw materials.’’ The main concern is point’’ as a point, step, or procedure in is to provide flexibility for an animal whether firms producing raw materials a food process at which control can be food establishment to comply with the for animal food must register and create applied and is essential to prevent or requirement in a way that is most animal food safety plans. The comments eliminate a food safety hazard or reduce suitable for its establishment. We fear firms would dispose of the raw such hazard to an acceptable level. Also, decline the request to develop guidance material products due to the high cost ‘‘control point’’ is not a term used in the to explicitly address ‘‘thresholds’’ or to of developing and maintaining safety regulatory text of the rule and therefore describe processes that qualify as plans, and disposal of those raw does not need to be defined. adequate. The CGMPs and preventive material products would have a controls requirements established in significant economic impact due to a 5. Environmental Pathogen this rule are broadly applicable considerable increase in the cost of We proposed to define the term procedures and practices rather than animal food in the United States. ‘‘environmental pathogen’’ to mean a

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pathogen capable of surviving and generally are more aggressive than modified from their natural sources, and persisting within the manufacturing, routine sanitation procedures. result in food safety hazards that are processing, packing, or holding quite different from finished food 6. Facility environment such that food for animals preparations. These comments also may be contaminated and may result in We proposed to define the term explain that food additives and GRAS foodborne illness if that animal food is ‘‘facility’’ to mean a domestic facility or substances are often produced using not treated to significantly minimize or a foreign facility that is required to processes that minimize microbial prevent the environmental pathogen. register under section 415 of the FD&C contamination hazards and are almost We also proposed to specify that Act in accordance with the always used in food products that environmental pathogen does not requirements of part 1, subpart H. undergo further downstream processing. include the spores of pathogenic Comments directed to the meaning of These comments assert that food sporeformers. By ‘‘pathogenic the term ‘‘facility’’ address its meaning additives and GRAS substances sporeformers,’’ we mean ‘‘pathogenic as established in the section 415 generally present a significantly lower sporeforming bacteria,’’ and we are registration regulations, rather than this public health hazard compared to substituting the term ‘‘pathogenic definition established in part 507. finished food and should be regulated sporeforming bacteria’’ for ‘‘pathogenic For a discussion of comments on accordingly. sporeformers’’ in the definition of definitions in part 1, see section IV of (Response 26) Substances such as ‘‘environmental pathogen’’ to make that the final rule for preventive controls for food additives and GRAS substances are clearer. human food published elsewhere in this food and are subject to the requirements (Comment 23) Some comments ask us issue of the Federal Register. of this rule. Both the CGMP requirements in subpart B and the to include Salmonella spp. and Listeria 7. Farm monocytogenes in the regulatory text as requirements for hazard analysis and We proposed to define the term examples of environmental pathogens. risk-based preventive controls in ‘‘farm’’ by reference to the definition of Other comments believe the definition subparts C and E provide flexibility to that term in § 1.227(b) rather than by is too broad because it would include address all types of food. (As discussed repeating the full text of the ‘‘farm’’ any pathogen that is capable of in section XL, the final rule establishes definition in part 507. For a discussion surviving or persisting in the the requirements for a supply-chain of comments to the farm definition and environment, and the definition should program in subpart E, rather than within of the ‘‘farm’’ definition that we are be limited to the pathogenic bacteria subpart C as proposed. As a result, this establishing in § 1.227, see section IV of that are more appropriate for protecting document refers to subparts C and E the final rule for preventive controls for animal food safety. when broadly referring to the human food published elsewhere in this (Response 23) We agree that requirements for preventive controls.) A issue of the Federal Register. Salmonella spp. and L. monocytogenes manufacturer of a food additive or are useful examples of environmental 8. Food GRAS substance has flexibility to comply with the requirements of the pathogens and have added these two We proposed to define the term examples to the proposed definition, rule based on the nature of the ‘‘food’’ to mean food as defined in production processes and the outcome which had not included examples. section 201(f) of the FD&C Act and to Adding these two examples to the of the hazard analysis for that animal include raw materials and ingredients. food substance. definition does not mean that these two Under section 201(f), the term ‘‘food’’ pathogens are the only environmental means: (1) Articles used for food or 9. Food-Contact Surfaces pathogens that a facility must consider drink for man or other animals, (2) We proposed to define ‘‘food-contact in its hazard analysis. New chewing gum, and (3) articles used for surfaces’’ to mean those surfaces that environmental pathogens can emerge at components of any such article. contact animal food and those surfaces any time, and other pathogens can also (Comment 25) Some comments ask us from which drainage, or other transfer, be environmental pathogens. to include examples in the definition. onto the food or onto surfaces that Salmonella spp in pet food have been These comments also ask us to clarify contact the food ordinarily occurs involved in foodborne illness outbreaks whether the definition applies to food during the normal course of operations. in humans (78 FR 64736 at 64747). In for human consumption, animal ‘‘Food-contact surfaces’’ include food- addition, there have been recalls of pet consumption, or both. contact surfaces of utensils and food found to contain L. (Response 25) We decline the request equipment. monocytogenes, though no human or to include examples in the definition. (Comment 27) Several comments state animal illnesses were associated with There are many examples of food and that the terms ‘‘drainage’’ and ‘‘utensils’’ these recalls to date (Refs. 17 and 18). adding a limited list of examples could are not widely used or understood (Comment 24) Some comments ask us be confusing rather than helpful. within animal feed and pet food to clarify the meaning of the term Although the definition of food includes industry and that the definition for ‘‘persisting’’ as used in the definition, food for both human consumption and ‘‘food-contact surfaces’’ should be such as whether it means that a animal consumption, the provisions of revised by deleting ‘‘drainage, or other,’’ sanitation process will not remove the the rule are clearly directed to food for and by replacing ‘‘utensils’’ with microorganism. animal consumption. ‘‘tools.’’ (Response 24) We use the term (Comment 26) Some comments ask us (Response 27) We decline these ‘‘persisting’’ to mean that a pathogen to consider fundamental and important requests. See our discussion of the term can get established if cleaning is not differences between food additives and ‘‘utensils’’ in Response 169. We believe adequate. Once a pathogen gets GRAS substances and finished food. the term ‘‘drainage’’ is commonly established, appropriate sanitation These comments explain that food understood. measures can remove the pathogen. additives and GRAS substances may be However, sanitation procedures synthesized using various chemical and 10. Harvesting necessary to eliminate an environmental biochemical processes, or may be We proposed to define the term pathogen that has become established extracted, hydrolyzed or otherwise ‘‘harvesting’’ to apply to farms and farm

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mixed-type facilities and to mean notice (79 FR 58476 at 58520 through hazards and to provide examples in activities that are traditionally 58521), we provided a more extensive guidance as to how these terms will be performed by farms for the purpose of list of examples of harvesting activities, applied in determining compliance with removing RACs from the place they including examples that are not in the the rule. Other comments express were grown or raised and preparing regulatory text. We have classified some concern that the definitions do not them for use as food. We proposed that of these activities in more than one way establish a meaningful distinction harvesting be limited to activities (see 79 FR 58476 at 58520 through between ‘‘hazard’’ and ‘‘significant performed on RACs on a farm, and that 58521). For example, trimming of outer hazards’’ and do not sufficiently harvesting does not include activities leaves from RACs can be a harvesting distinguish between the hazards that transform a RAC into a processed activity, as well as a manufacturing/ identified in the first and second steps food. The proposed definition included processing activity. Artificial ripening of of the hazard analysis (first narrowing examples of activities that would be fruit is manufacturing/processing (not hazards to ‘‘known or reasonably harvesting. harvesting), but is now within the foreseeable hazards’’ and then In this final rule, we added or ‘‘farm’’ definition. narrowing the ‘‘known or reasonably modified several examples of harvesting (Comment 29) Some comments ask us foreseeable hazards’’ to ‘‘significant (see Response 28). As noted in table 31, to periodically review the list of hazards’’). we have reorganized the listed examples harvesting activities to ensure that it (Response 31) The rule uses three of of harvesting to present them in reflects current practices. these terms (i.e., ‘‘hazard,’’ ‘‘known or alphabetical order. (Response 29) If particular activities reasonably foreseeable hazard,’’ and the We are defining the term ‘‘harvesting’’ present questions in the future about proposed term ‘‘significant hazard’’) to to apply to farms and farm mixed-type whether the activity is a harvesting establish a tiered approach to the facilities and to mean activities that are activity within the ‘‘farm’’ definition, or requirements for hazard analysis and traditionally performed on farms for the a manufacturing/processing activity that risk-based preventive controls. The term purpose of removing RACs from the is outside the ‘‘farm’’ definition, we will ‘‘hazard’’ is the broadest of these three place they were grown or raised and consider issuing guidance or updating terms—any biological, chemical preparing them for use as animal food. any existing guidance to clarify our (including radiological), or physical The definition includes examples of recommended classification of the agent has the potential to cause illness activities that are harvesting, as activity. or injury. To conduct its hazard described in this section. Harvesting is (Comment 30) Some comments note analysis, a facility starts by first also limited to activities performed on that the proposed definition for narrowing down the universe of all RACs, or on processed foods created by ‘‘harvesting’’ seems to be much more potential hazards to those that are drying/dehydrating a RAC without inclusive than FDA’s original proposed ‘‘known or reasonably foreseeable’’ for additional manufacturing/processing, regulation, but is significantly more each type of food for animals on a farm. restrictive than the current regulation in manufactured, processed, packed, or (Comment 28) Some comments ask us part 1 because it excludes future held at its facility. The outcome of the to provide more examples of harvesting technological developments. The facility’s hazard analysis is a activities, in the regulatory text and in comment further notes as technology determination of ‘‘significant hazards,’’ guidance. Examples of the requested and harvesting techniques advance, the i.e., the subset of those known or activities include braiding; bunching; risk of tying the definition to traditional reasonably foreseeable hazards that cutting the edible portion of the crop activities will have a negative effect on require a preventive control. from the plant; hydro-cooling; agriculture’s ability to adapt. To make this clearer, we have: (1) maintaining hydration of product; Furthermore, harvesting is merely the Revised the proposed definitions of refrigerating; removing foliage; first step in transforming a RAC into ‘‘hazard’’ and (2) changed the term removing free water from (e.g. processed food. ‘‘significant hazard’’ to ‘‘hazard spinning); removing or trimming roots; (Response 30) The comment did not requiring a preventive control’’ trimming the tops of bunches of allium make a specific request or provide any (formerly ‘‘significant hazard’’). See crops such as leeks, chives, or garlic and suggestions as to how future Responses 32 and 62. root crops such as carrots, beets, technological developments should be The rule does not define the term turnips, parsnips, etc. to prepare them handled; therefore, we are finalizing the ‘‘serious adverse health consequences or for sale; and trimming the lower stems definition with the changes previously death to humans or animals’’ hazard. of harvested herb crops such as parsley, described. However, the requirements for a supply- basil, or cilantro, or the lower stems of chain program refer to a hazard for leafy greens. Other comments ask us to 11. Hazard which there is a reasonable probability specify that harvesting also We proposed to define the term that exposure to the hazard will result encompasses seed conditioning (i.e., ‘‘hazard’’ to mean any biological, in serious adverse health consequences cleaning the seed, including removal of chemical (including radiological), or or death to humans or animals (see leaves, stems, and husks to prepare for physical agent that is reasonably likely § 507.130(b)). For additional marketing), ripening (artificial or to cause illness or injury in humans or information on how we interpret natural) of fruit, and waxing or coating animals in the absence of its control. ‘‘serious adverse health consequences or of RACs. (Comment 31) Some comments death to humans or animals,’’ see our (Response 28) We have added or express concern that the rule would guidance regarding the RFR (Refs. 19 modified several examples of harvesting refer to four levels of ‘‘hazard,’’ i.e., and 20), which addresses statutory in the regulatory text (i.e., cutting (or ‘‘hazard,’’ ‘‘known or reasonably requirements regarding ‘‘reportable otherwise separating) the edible portion foreseeable hazard,’’ ‘‘significant foods.’’ As explained in that guidance, of the RAC from the crop plant, hazard,’’ and ‘‘serious adverse health a ‘‘reportable food’’ is an article of food removing or trimming part of the RAC consequences or death to humans or for which there is a reasonable (e.g., foliage, husks, roots or stems) and animals’’ hazard. These comments ask probability that the use of, or exposure field coring and hulling). In table 1 in us to provide sufficient clarity to be able to, such article of food will cause the Appendix to the 2014 supplemental to distinguish between these types of serious adverse health consequences or

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death to humans or animals. The the distribution of that food (such as ‘‘holding’’ (see 79 FR 58476 at 58483). guidance includes examples of blending of the same RAC and breaking However, we use the term ‘‘mixing’’ circumstances under which food might down pallets)), but not including when the RACs are different. For be reportable. activities that transform a RAC into a example, we consider the activity of (Comment 32) Some comments assert processed food. We proposed that ‘‘mixing’’ corn and oats in the that the distinction between the holding facilities could include production of animal food to be definitions of ‘‘hazard’’ and ‘‘significant warehouses, cold-storage facilities, manufacturing/processing, because hazard’’ is not discernable because the storage silos, grain elevators, and liquid- mixing two different foods is ‘‘making proposed definition of ‘‘hazard’’ storage tanks. food from one or more ingredients’’ currently takes into account whether or (Comment 34) Some comments ask us (which is our definition of not a ‘‘hazard’’ is or is not controlled. to provide more examples of holding ‘‘manufacturing/processing’’) and the These comments ask us to delete the activities, in the regulatory text and in animal food produced by mixing corn phrase ‘‘in the absence of its control’’ guidance. Examples of the requested and oats is a processed food. from the definition of ‘‘hazard’’ to activities include fumigating RACs; We classify ‘‘mixing’’ intact RACs that clarify that hazards are simply the application of chemicals (including does not create a processed animal food agents that are reasonably likely to fungicides, sanitizers, and anti- as incidental to, and therefore part of, cause illness or injury. Likewise, other oxidants); and ‘‘coating’’ grain RACs ‘‘packing’’ or ‘‘holding’’ as applicable. comments assert that any hazard that is with diatomaceous earth to control For example, mixing heads or bunches ‘‘reasonably likely to cause illness or insects. According to these comments, of lettuce does not create a processed injury in the absence of its control’’ will, these activities are incidental to storage food, because the mixing has not created if known or reasonably foreseeable, and do not transform RACs into a distinct commodity, but only a set of likely be controlled by any processed food. Other comments mixed RACs. On the other hand, mixing knowledgeable person. wanted examples of holding of human- that creates a processed animal food is (Response 32) We have deleted the food by-products destined for animal not ‘‘packing’’ or ‘‘holding.’’ The phrase ‘‘in the absence of its control’’ food (for example wet pasta that dries definitions of both ‘‘packing’’ and from the definition of ‘‘hazard.’’ We naturally while being held). ‘‘holding’’ are limited so that they do agree that deleting this phrase from the (Response 34) We have added or not include activities that transform a definition of ‘‘hazard’’ will more clearly modified several examples of holding in RAC into processed animal food. Some distinguish between the terms ‘‘hazard’’ the regulatory text (i.e., fumigating kinds of mixing of RACs does create a and ‘‘hazard requiring a preventive animal food during storage, and drying/ distinct commodity (for example, control’’ that we are establishing in this dehydrating RACs when the drying/ mixing corn and oats to make animal rule. dehydrating does not create a distinct food). In such cases, the mixing is We also replaced the phrase ‘‘that is commodity (such as drying/dehydrating manufacturing/processing and is not reasonably likely to cause illness or hay or alfalfa)). In table 1 in the within the farm definition. injury’’ with ‘‘that has the potential to Appendix to the 2014 supplemental (Comment 36) Some comments ask us cause illness or injury’’ to more clearly notice (79 FR 58476 at 58520 through to clarify whether the expanded distinguish ‘‘hazard’’ from ‘‘known or 58521), we provided a more extensive definition of holding that we proposed reasonably foreseeable hazard.’’ This list of examples of holding activities, in the 2014 supplemental human increases the alignment of the definition including examples that are not in the preventive controls notice would mean of ‘‘hazard’’ in this rule with the Codex regulatory text. We have previously that a warehouse that both stores and definition of ‘‘hazard.’’ classified some of these activities in fumigates a RAC to prevent pest (Comment 33) Some comments ask us more than one way (see 79 FR 58476 at infestation would be exempt from the to include ‘‘in the intended species’’ in 58520 through 58521) depending on requirements for hazard analysis and the definition of ‘‘hazard.’’ when the activity occurs. For example, risk-based preventive controls for a (Response 33) We decline this sorting, culling, and grading RACs can facility solely engaged in the storage of request. During the hazard analysis the be either a holding activity or a packing RACs (other than fruits and vegetables) facility must identify and evaluate, activity. Drying/dehydrating RACs is for further distribution or processing based on experience, illness data, holding when the drying/dehydrating (§ 507.5). scientific reports, and other information, does not create a distinct commodity, (Response 36) Fumigating RACs to known or reasonably foreseeable but is manufacturing/processing when prevent pest infestation would be hazards for each type of animal food the drying/dehydrating creates a distinct within the definition of ‘‘holding’’ and manufactured, processed, packed, or commodity (see section IV). Holding of therefore would not prevent a facility held at the facility to determine whether certain human food by-products for use that stores RACs (other than fruits and there are hazards requiring a preventive as animal food is discussed in sections vegetables) from being eligible for the control (§ 507.33(a)). During the hazard XIII and XXII. exemption in § 507.5(g), provided that evaluation, the facility must consider (Comment 35) Some comments ask us the facility does not conduct other the effect of the intended or reasonably to clarify that mixing or blending intact activities not classified as ‘‘holding.’’ foreseeable use on the safety of the RACs is considered ‘‘holding’’ However, a threshold question for any finished animal food for the intended regardless of whether the RACs are the facility solely engaged in the storage of animal (§ 507.33(d)(8)). same or different. RACs is whether the stored RACs are (Response 35) We use the term fruits or vegetables. 12. Holding ‘‘blending’’ when referring to RACs such (Comment 37) Some comments ask us We proposed to define ‘‘holding’’ to as grain and when the RACs are the to clarify whether there is a timeframe mean storage of food, including same. For example, we consider the associated with holding and to better activities performed incidental to activity of ‘‘blending’’ different lots of distinguish between ‘‘holding’’ and storage of a food (e.g., activities the same grain to meet a customer’s ‘‘storage.’’ performed for the safe or effective quality specifications to be a practical (Response 37) There is no timeframe storage of that food and activities necessity for product distribution and, (maximum or minimum) associated performed as a practical necessity for thus, to be within the definition of with holding. The definition of holding

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states ‘‘Holding means storage of food’’ and oilseeds would also be considered To the extent that this comment is and, thus, there is no distinction performed as a practical necessity for expressing concern about raw materials between ‘‘holding’’ and ‘‘storing.’’ the distribution of animal food within or other ingredients that a facility would (Comment 38) Some comments ask us the definition of ‘‘holding.’’ receive from a farm, those concerns to clarify how the definition of holding would be considered in the facility’s 13. Known or Reasonably Foreseeable relates to practices, such as fumigation, hazard analysis, which would include a Hazard on almond hull stockpiles held on a hazard evaluation that considers factors farm, a farm mixed-type facility or off- We proposed to define the term such as those related to the source of farm. ‘‘known or reasonably foreseeable raw materials and other ingredients (see (Response 38) Practices that are hazard’’ to mean a biological, chemical § 507.33(d)(3)). incidental to storage of food, such as (including radiological), or physical fumigation of almond hull stockpiles, hazard that has the potential to be 14. Lot are holding, regardless of whether they associated with the facility or the food. We proposed to define ‘‘lot’’ to mean are conducted on-farm, on a farm (Comment 41) Some comments the food produced during a period of mixed-type facility, or off-farm. support the definition as proposed, time indicated by a specific code. (Comment 39) Some comments ask us noting that it implies that the (Comment 43) Some comments state to clarify that value added activities implementation of a preventive control that many animal food processors (such as repacking and blast freezing) be based both on the severity and operate on a batch-production basis conducted in facilities such as likelihood of the hazard, can help to rather than a continuous-production warehouses would be considered distinguish between the requirements of basis and request that we take this into holding when product is not exposed to this rule and HACCP requirements, and account with respect to the definition of the environment. provides for the proper consideration of ‘‘lot.’’ Other comments suggest replacing (Response 39) We consider the both the food and the facility when ‘‘lot’’ with ‘‘lot identifier’’ where ‘‘lot activities described in these comments determining whether a hazard is identifier’’ means a unique identifier for to be activities performed as a practical ‘‘known or reasonably foreseeable.’’ each lot, batch or production run that necessity for the distribution of the food Other comments ask us to modify the enables the manufacturer to trace and, thus, to be within the definition of definition to specify that the term means accurately the complete manufacturing holding. a hazard ‘‘that is known to be, or has the and distribution history of the product. (Comment 40) Several comments do potential to be, associated with the Other comments ask us to modify the not support the proposed definition of facility or the food’’ to better align with proposed definition so that it is not ‘‘holding’’ stating that the definition the term as FDA proposed to define it limited by a period of time and suggest would exempt grain receiving and in the proposed FSVP rule. (See 79 FR using an approach that would allow for storage facilities that are the primary 58574 at 58595.) a lot to be defined by either time or by suppliers of the main ingredient in (Response 41) We have revised the a specific identifier. Other comments many animal foods including distiller’s definition as requested by the comments express the view that the individual products. Some comments ask us to to better align with the proposed FSVP operators should be able to define their clarify what is a practical necessity. rule. lot designations and make these (Response 40) Section 418(m) of the (Comment 42) Some comments ask us definitions available to FDA upon FD&C Act provides us with the to revise the definition so that it request. authority to exempt certain facilities addresses a hazard that is known to be, (Response 43) Although the term from the requirements of section 418, or or has the potential to be, associated ‘‘lot’’ is associated with a period of time, to modify those requirements. We with a food, the facility in which it is an establishment has flexibility to proposed to use this authority to exempt manufactured/processed, or the location determine the code, with or without any facilities that solely engage in the or type of farm on which it is grown or indication of time in the code. For storage (holding) of RACs (other than raised. These comments assert that the example, a code could be based on a fruits and vegetables) intended for type of farm may affect those hazards date, time of day, production further distribution or processing. We that are known or reasonably characteristic (such as origin, variety, tentatively concluded that there would foreseeable. and type of packing), combination of not be significant public (human and (Response 42) We decline this date/time/production characteristic, or animal) health benefit to be gained by request, which appears related to any other method that works best for the having these facilities subject to the another difference between the establishment. To clarify that the rule requirements of subpart C. Outbreaks of definition proposed in this rule and the does not require that time be illness associated with feeding RACs to definition of this term in the proposed ‘‘indicated’’ by the code, and emphasize animals have not been traced back to FSVP rule. The proposed FSVP rule the establishment’s flexibility to storage facilities solely engaged in the would define ‘‘known or reasonably determine the code, we have revised storage of RACs, therefore we think it is foreseeable hazard’’ as a hazard that is ‘‘period of time indicated by a specific appropriate to exempt them from the known to be, or has the potential to be, code’’ to ‘‘period of time and identified requirements of subparts C and E of the associated with a food or the facility ‘‘in by an establishment’s specific code.’’ final rule. Such facilities remain subject which it is manufactured/processed.’’ to the requirements of section 402 of the (See 79 FR 58574 at 58595.) In this rule, 15. Manufacturing/Processing FD&C Act that the animal food being we do not need to specify that the We proposed to define held is not adulterated. applicable facility is the one ‘‘in which ‘‘manufacturing/processing’’ to mean The revised definition of ‘‘holding’’ the food is manufactured/processed’’ making food from one or more encompasses activities performed as a because this rule applies to the owner, ingredients, or synthesizing, preparing, practical necessity for the distribution of operator, or agent in charge of the treating, modifying, or manipulating RACs, such as blending of the same facility in which the food is food, including food crops or RAC and breaking down pallets. manufactured, processed, packed, or ingredients. We proposed that examples Sampling for grading or quality control held, and that applicability does not of manufacturing/processing activities purposes, repacking, and drying grains need to be repeated in each provision. would be cutting, peeling, trimming,

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washing, waxing, eviscerating, 16. Microorganisms registered. As a conforming change rendering, cooking, baking, freezing, We proposed to define the term associated with the revisions to the cooling, pasteurizing, homogenizing, ‘‘microorganisms’’ to mean yeasts, ‘‘farm’’ definition, we have revised the mixing, formulating, bottling, milling, molds, bacteria, viruses, protozoa, and example of a ‘‘farm mixed-type facility’’ grinding, extracting juice, distilling, microscopic parasites, including species to specify that it is an establishment that labeling, or packaging. For farms and having animal or human health is a farm, but also conducts activities farm mixed-type facilities, significance. We also proposed that the outside the farm definition that require manufacturing/processing would not term ‘‘undesirable microorganisms’’ the establishment to be registered. (See section IV of the final rule for include activities that are part of includes those microorganisms that are preventive controls for human food harvesting, packing, or holding. In this of animal or human health significance, published elsewhere in this addition of rule, we add more examples to include, that subject food to decomposition, that the Federal Register.) ‘‘artificial ripening,’’ ‘‘boiling,’’ indicate that food is contaminated with ‘‘canning,’’ ‘‘drying/dehydrating raw (Comment 46) Some comments ask us filth, or that otherwise may cause food to revise the definition to exclude those agricultural commodities to create a to be adulterated. We have revised the distinct commodity (such as drying/ establishments that only conduct low- definition to replace ‘‘includes species risk activities specified in the dehydrating grapes to produce raisins),’’ having animal or human health ‘‘evaporating,’’ ‘‘extruding,’’ and exemptions for on-farm, low-risk significance’’ with ‘‘and includes activity/animal food combinations ‘‘pelleting.’’ We also alphabetize the list species that are pathogens,’’ and of examples. (§ 507.5(e) and (f)). replacing ‘‘’undesirable (Response 46) We decline this (Comment 44) Some comments microorganisms’’’ includes those request. Whether a particular express concern that some activities microorganisms that are of animal or establishment that falls within the included in the definition of human health significance’’ with definition of ‘‘mixed-type facility’’ is ‘‘manufacturing/processing’’ overlap ‘‘’undesirable microorganisms’’’ subject to the requirements for hazard with activities (such as trimming, includes those microorganisms that are analysis and risk based preventive washing, and cooling) included in the pathogens.’’ controls is governed by the exemptions definition of ‘‘harvesting.’’ (Comment 45) Some comments established in this rule. express concern that the term (Response 44) We acknowledge that ‘‘undesirable microorganisms’’ includes 18. Monitor there is some overlap in the activities microorganisms that subject food to We proposed to define the term that the regulatory text lists as examples decomposition. These comments assert ‘‘monitor’’ to mean to conduct a of both ‘‘manufacturing/processing’’ and that the definition would expand planned sequence of observations or ‘‘harvesting,’’ because some activities regulation beyond food safety and ask measurements to assess whether a can occur during more than one us to clarify that decomposition means process, point, or procedure is under operation (see table 1 in the Appendix a degradation of product that is only control and to produce an accurate to the 2014 supplemental notice (79 FR relevant when it affects the safety of the record for use in verification. 58476 at 58520 through 58521)). For product, rather than simple spoilage. (Comment 47) Some comments assert example, ‘‘cutting’’ lettuce from the crop (Response 45) We have not modified that our proposed definition of monitor plant occurs on-farm in the field where the regulatory text of this longstanding is directed to the narrow circumstance the lettuce is harvested, and ‘‘cutting’’ definition of the term ‘‘undesirable of monitoring that would be applied to the core of the lettuce from the rest of microorganisms’’ regarding a CCP under the National Advisory the harvested lettuce occurs in a fresh- microorganisms that subject food to Committee on Microbiological Criteria cut processing facility. An important decomposition. The regulations for Foods (advisory committee chartered consequence of the multiple revisions established by this rule are designed to under the USDA) (NACMCF) HACCP we have made to the ‘‘farm’’ definition prevent the growth of undesirable guidelines and the Codex HACCP in this rulemaking is that there are fewer microorganisms. The scope of the Annex. These comments also assert that, situations in which classification of a definition of ‘‘undesirable using such definitions, monitoring particular activity is the only trigger for microorganisms’’ is not limited to would not apply to control measures for an operation to be subject to the section microorganisms of public health which parameters cannot be established 415 registration requirements. For significance because these regulations and that are not amenable to example, the revised ‘‘farm’’ definition are also concerned with sanitation, documentation. These comments no longer classifies the packing and decomposition, and filth (51 FR 22458 suggest that we use a definition of holding of others’ RACs to be a at 22460, June 19, 1986). monitoring consistent with that manufacturing/processing activity that provided in ISO 22000:2005 triggers the registration requirement. As 17. Mixed-Type Facility (conducting a planned sequence of another example, the revised ‘‘farm’’ We proposed to define ‘‘mixed-type observations or measurements to assess definition specifies three facility’’ to mean an establishment that whether control measures are operating manufacturing/processing activities that engages in both activities that are as intended) to clarify that monitoring are within the ‘‘farm’’ definition. We exempt from registration under section may be conducted where appropriate for conclude that the overlap in the 415 of the FD&C Act and activities that preventive controls that are not CCPs. examples of activities listed in the require the establishment to be (ISO is an abbreviation for definitions of ‘‘harvesting’’ and registered. We proposed that an ‘‘International Organization for ‘‘manufacturing/processing’’ does not example of such a facility is a ‘‘farm Standardization.’’ ISO develops and create problems with determining the mixed-type facility,’’ which is an publishes International Standards.) status of an operation as a ‘‘farm’’ or a establishment that grows and harvests According to these comments, an ‘‘facility’’ and we are retaining examples crops or raises animals and may advantage of this definition is that it in both definitions because doing so conduct other activities within the farm also would clarify the difference reflects current practices on farms and definition, but also conducts activities between monitoring activities in manufacturing/processing facilities. that require the establishment to be (observations conducted during the

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operation of a control measure to ensure section 201(r) of the FD&C Act, into a However, we disagree that it is that it is under control) and verification processed food as defined in section necessary to establish a definition for a activities (to evaluate performance of a 201(gg). We have revised the definition business entity that is not required to control measure). to clarify that packing includes ‘‘re- register. A business that meets the (Response 47) We have revised the packing.’’ definition of ‘‘facility’’ is required to definition of monitor to mean to For comments on the definition of register; a business that is not required conduct a planned sequence of ‘‘packing,’’ see section IV.G of the final to register is simply a business that does observations or measurements to assess rule for preventive controls for human not meet the definition of ‘‘facility.’’ whether control measures are operating food, published elsewhere in this To address these comments, we have as intended. We agree that the revised addition of the Federal Register. revised provisions of the rule in three definition, which reflects an We are finalizing the definition as ways. First, we have revised the international standard, more effectively proposed, with the addition of another definition of ‘‘plant’’ to focus it on the communicates that monitoring also example of an activity performed for the building, structure, or parts thereof, applies to controls that are not at CCPs safe or effective packing of the food, i.e., used for or in connection with the and may apply to control measures for weighing or conveying incidental to manufacturing, processing, packing, or which parameters cannot be established. packing or repacking, and the addition holding of animal food, rather than on However, we disagree that this of ‘‘animal’’ in front of food. the ‘‘building or establishment.’’ definition signals that it is not possible Second, we have revised applicable to obtain documentation when 21. Pathogen provisions of part 507 to use monitoring preventive controls that are We proposed to define the term ‘‘establishment’’ rather than ‘‘plant’’ not at CCPs, such as for controls that are ‘‘pathogen’’ to mean a microorganism of when focusing on a business entity not process controls and do not involve public (human or animal) health rather than on buildings or other parameters and maximum or minimum significance. structures. Third, we have revised values, or combinations of values, to (Comment 48) Some comments ask us provisions that use the terms ‘‘plant,’’ which a parameter must be controlled to to revise the definition to mean a ‘‘establishment,’’ or both to conform to significantly minimize or prevent a ‘‘microorganism of such severity and the definition of ‘‘plant’’ and the hazard requiring a preventive control. exposure that it would be deemed of described usage of ‘‘establishment.’’ For For example, it is possible to monitor public health significance’’ because the example, § 507.14 establishes that a specific sanitation control activity significance of pathogens to public requirements for ‘‘the management of has taken place, such as the cleaning of health depends on the organism’s the establishment’’ rather than ‘‘plant a piece of equipment to prevent cross- severity and the nature of exposure. management,’’ because ‘‘establishment’’ contact. (Response 48) We decline this is the term focusing on the business The requirement for documenting request. Our purpose in defining the entity. As another example, monitoring in records is established by term pathogen was to simplify the § 507.17(a)(1) establishes requirements the requirements for monitoring, not by regulations, including our longstanding for properly storing equipment, the definition of monitor. As discussed CGMP regulations for human food, by removing litter and waste, and cutting in section XXX.C, we have made several substituting a single term (i.e., weeds or grass within the immediate revisions to the regulatory text, with ‘‘pathogen’’) for a more complex term vicinity of the ‘‘plant’’ rather than associated editorial changes, to clarify (i.e., ‘‘microorganism of public health within the immediate vicinity of the that monitoring records may not always (human and animal) significance’’) ‘‘plant buildings or structures,’’ because be necessary. throughout the regulations. These the defined term ‘‘plant’’ focuses on the comments fail to explain how we have buildings and structures, and it is not 19. Packaging (When Used as a Verb) interpreted the current term necessary to repeat ‘‘buildings and We proposed to define ‘‘packaging ‘‘microorganism of public health structures’’ when the term ‘‘plant’’ is (when used as a verb)’’ as placing food significance’’ in a way that does not take used. into a container that directly contacts into account factors such as the severity 23. Preventive Controls the food and that the consumer receives. of illness and the route of exposure. Based on comments received to the We proposed to define the term proposed rule for preventive controls for 22. Plant ‘‘preventive controls’’ to mean those human food, we have decided not to We proposed to define the term risk-based, reasonably appropriate establish the definition ‘‘packaging ‘‘plant’’ to mean the building or procedures, practices, and processes (when used as a verb)’’ in part 507. For establishment or parts thereof, used for that a person knowledgeable about the a discussion of those comments or in connection with the safe manufacturing, processing, packing, received to the human food preventive manufacturing, processing, packing, or or holding of food would employ to controls rule, see section IX.C.20 in the holding of animal food. significantly minimize or prevent the final rule for preventive controls for (Comment 49) Some comments state hazards identified under the hazard human food published elsewhere in this that it would not be helpful to use analysis that are consistent with the issue of the Federal Register. ‘‘plant’’ interchangeably with current scientific understanding of safe ‘‘establishment’’ when referring to a food manufacturing, processing, 20. Packing business that is not required to register. packing, or holding at the time of the We proposed to define ‘‘packing’’ as These comments ask us to consistently analysis. placing food into a container other than use one of these terms and to define a (Comment 50) Some comments ask us packaging the food, including activities term that would mean ‘‘a business that to clarify the meaning of ‘‘current performed incidental to packing a food is not required to register’’ to help scientific understanding’’ because (e.g., activities performed for the safe or distinguish such businesses from scientific understanding can vary effective packing of that food (such as ‘‘facilities.’’ depending on the risk profile of a sorting, culling and grading)), but not (Response 49) We agree that it is commodity. including activities that transform a raw appropriate to consistently use one term (Response 50) By ‘‘current scientific agricultural commodity, as defined in when referring to a business entity. understanding,’’ we mean to emphasize

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that scientific information changes over safety system), two criteria for how a including any associated time and a facility needs to keep current person can become qualified documentation. regarding safe handling and production (specialized training or job experience), See also our discussion in section practices such that the facility has the and a description of the type of XXXVII.B about the requirements information necessary to apply applicable training (development and applicable to the preventive controls appropriate handling and production application of risk-based preventive qualified individual (§ 507.53(c)). practices. controls at least equivalent to that 25. Qualified Auditor received under a standardized 24. Preventive Controls Qualified curriculum). The proposed definition We proposed to define the term Individual provides flexibility for how an ‘‘qualified auditor’’ to mean a person We proposed to define the term individual can become qualified, but who is a preventive controls qualified ‘‘qualified individual’’ to mean a person this flexibility does not make the individual as defined in this part and who has successfully completed definition ambiguous. has technical expertise obtained by a training in the development and (Comment 52) Some comments ask us combination of training and experience application of risk-based preventive to expand the definition so that it appropriate to perform the auditing controls at least equivalent to that includes a team of preventive controls function as required by § 507.53(c)(2). received under a standardized qualified individuals, not just a single As discussed in Response 399, we have curriculum recognized as adequate by person. revised the definition to specify that FDA, or is otherwise qualified through (Response 52) We decline this ‘‘qualified auditor’’ means a person who job experience to develop and apply a request. The definition applies to each is a ‘‘qualified individual’’ as that term food safety system. We have changed preventive controls qualified individual is defined in this final rule, rather than the proposed term ‘‘qualified that a facility relies on to satisfy the a ‘‘preventive controls qualified individual’’ to ‘‘preventive controls requirements of the rule without individual,’’ because some auditors may qualified individual’’ because we are limiting the number of such preventive be auditing businesses (such as produce establishing a new definition for controls qualified individuals. The farms) that are not subject to the ‘‘qualified individual,’’ with a meaning requirements of the rule make clear that requirements for hazard analysis and distinct from ‘‘preventive controls a facility may rely on more than one risk-based preventive controls, and it qualified individual.’’ To minimize the preventive controls qualified individual would not be necessary for such an potential for confusion, for when the (see, e.g., § 507.53(a)). auditor to be a ‘‘preventive controls term ‘‘qualified individual’’ refers to the (Comment 53) Several comments state qualified individual.’’ We also have proposed meaning of the term and when that there is a lack of specificity about clarified that the technical expertise is the term ‘‘qualified individual’’ refers to what constitutes appropriate training obtained through education, training, or the meaning of that term as finalized in and experience to qualify as a experience (or a combination thereof) this rule, in the remainder of this ‘‘preventive controls qualified necessary to perform the auditing document we use the new term individual.’’ Another comment asks us function to align the description of ‘‘preventive controls qualified to clarify how the qualification of the applicable education, training, and individual’’ whenever we mean ‘‘a ‘‘preventive controls qualified experience with the description of person who has successfully completed individual’’ will be assessed. One applicable education, training, and training in the development and comment asks how the resume and experience in the definition of application of risk-based preventive experience of preventive controls ‘‘qualified individual’’ (see § 507.3). controls at least equivalent to that qualified individuals in other countries (Comment 54) Some comments ask us received under a standardized will be evaluated by FDA to determine to revise the definition of qualified curriculum recognized as adequate by that they meet the required auditor to include persons who have FDA or is otherwise qualified through qualifications. technical expertise obtained by a job experience to develop and apply a (Response 53) As discussed further in combination of training, experience, or food safety system,’’ even though the Response 395, we do not expect to education appropriate to perform audits. proposed rule used the term ‘‘qualified directly assess the qualifications Some comments ask us to recognize that individual.’’ Likewise, we use the new (whether obtained by training or by job training and/or experience can make a term ‘‘preventive controls qualified experience) of persons who function as person a qualified auditor; the individual’’ for the proposed term preventive controls qualified comments state that people with ‘‘qualified individual’’ when describing individuals. Instead, we intend to focus experience performing audits likely the comments to the proposed rule, our inspections of both domestic and have applicable training but might not even though those comments use the foreign facilities on the adequacy of the have completed a specific regimen of term ‘‘qualified individual.’’ food safety plan prepared by the courses. Some comments maintain that In the following paragraphs, we preventive controls qualified individual we should recognize the role of the discuss comments on this proposed (or under their oversight). As necessary education of a potential qualified definition. (See also our discussion in and appropriate, we will consider auditor, as well as training and section XXXVII.B of the requirements whether deficiencies we identify in the experience to meet the criteria. applicable to the preventive controls food safety plan suggest that the (Response 54) We agree that a qualified individual (§ 507.53(c)).) preventive controls qualified individual qualified auditor might obtain the (Comment 51) Some comments assert may not have adequate training or necessary auditing expertise in part that the proposed definition of experience to carry out the required through education, as well as through preventive controls qualified individual functions. If the food safety plan training and experience, and we have is ambiguous. suggests the preventive controls revised the definition of qualified (Response 51) The comments provide qualified individual does not have auditor accordingly. The revised no basis for asserting that this definition adequate training or experience, we will definition states that a qualified auditor is ambiguous. The proposed definition perform a more in-depth review of the has technical expertise obtained through includes a performance standard preventive controls qualified education, training, or experience (or (qualified to develop and apply a food individual’s training or experience, the combination thereof).

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(Comment 55) Some comments that provided to animals. The comment also (Response 58) Any facility that support the proposed definition ask us suggests we modify the definition of determines that it satisfies the criteria to revise the definition to specify certain ‘‘qualified end-user’’ to be reflective of for a ‘‘qualified facility’’ must notify individuals who would be considered the customer who is the purchaser of FDA of that determination (see § 507.7) qualified auditors, such as FDA the animal food. and, thus, the first determination will be inspectors, properly trained Federal (Response 56) We decline these made by the facility itself. During auditors, and State and private auditors requests. The definition of ‘‘qualified inspection, the investigator could ask to operating under a contract with the end-user’’ is consistent with the see the records that support the facility’s Federal Government. definition in section 418(l)(4)(B) of the determination to verify the facility’s (Response 55) We have revised the FD&C Act. As discussed in Response 81, determination. regulatory text to specify that examples we decline to define consumer. In this rule, we remove the term of potential qualified auditors include: 27. Qualified Facility ‘‘quality control operation’’ because the (1) A government employee, including a term is very broad within the animal foreign government employee and (2) an We proposed to define ‘‘qualified food industry and may not be specific audit agent of a certification body that facility’’ by incorporating the to animal food safety. is accredited in accordance with description of ‘‘qualified facility’’ in regulations in part 1, subpart M (i.e., section 418(l)(1) of the FD&C Act with 28. Receiving Facility regulations in our forthcoming third- editorial changes to improve clarity. We proposed to define the term party certification rule implementing That definition includes two types of ‘‘receiving facility’’ to mean a facility section 808 of the FD&C Act (21 U.S.C. facilities: (1) A facility that is a very that is subject to subpart C of this part 348d)). Although we agree that it is small business as defined in this rule and that manufactures/processes a raw useful to include examples of and (2) a facility to which certain material or ingredient that it receives individuals who would have the statutory criteria apply regarding the from a supplier. appropriate qualifications, the example average monetary value of animal food (Comment 59) Some comments ask us of an audit agent of a certification body sold by the facility and the entities to to modify the definition to specify that that has been accredited in accordance which the animal food was sold. the receiving facility could receive the with our regulations in our forthcoming For the second type of facility, to raw material or ingredient directly from third-party certification rule adds represent accurately the language of a supplier or by means of an context about the standard for such section 418(l) of the FD&C Act, we have intermediary entity. These comments individuals. Because paragraph (2) of changed ‘‘animal food’’ to ‘‘food.’’ assert that without this added regulatory the new provision refers to provisions in Some comments discuss issues text the proposed definition implies that a future third-party certification rule, we related to the definition of very small the material or ingredient must be will publish a document in the Federal business. See section VIII.A.36 for the received directly from the supplier. Register announcing the effective date discussion of the definition of very (Response 59) We decline this of paragraph (2) when we finalize the small business. request. As discussed in section XLII.B third-party certification rule. (Comment 57) Some comments assert and C, the two parties that are critical that the definitions of ‘‘affiliate’’ and to the supplier verification program are 26. Qualified End-User ‘‘subsidiary’’ in the definition of the receiving facility and the supplier, We proposed to define the term ‘‘qualified facility’’ fail to account for even if there are entities in the supply ‘‘qualified end-user’’ to mean, with the legal differences between a piece of chain between the two. The definition respect to an animal food, the consumer property (i.e., a facility) and a business of receiving facility does not preclude of the food (where the term consumer entity or person. These comments ask us the participation of intermediary does not include a business); or a to consider revising the proposed entities in the supply chain, and the restaurant or retail food establishment definition of ‘‘qualified facility’’ to rule does provide for such participation (as those terms are defined in § 1.227(b)) clarify what sales to include in (see § 507.115). However, the definition that: (1) Is located (a) in the same State determining whether a facility so of receiving facility does highlight the as the qualified facility that sold the qualifies. fact that a receiving facility must have food to such restaurant or (Response 57) We have not revised a link to a supplier. establishment; or (b) is not more than the proposed definition of ‘‘qualified 275 miles from such facility; and (2) is facility’’ as requested by these 29. Rework purchasing the food for sale directly to comments. The sales to be included We proposed to define ‘‘rework’’ to consumers at such restaurant or retail when a facility determines whether it mean clean, unadulterated food that has food establishment. We have revised the meets the definition of a qualified been removed from processing for definition of ‘‘qualified end-user’’ to add facility are the sales of animal food by reasons other than insanitary conditions ‘‘or the same Indian reservation’’ to a business entity meeting the ‘‘very or that has been successfully clarify for purposes of this rule that ‘‘in small business’’ definition or food by a reconditioned by reprocessing and that the same State’’ under section business entity meeting the other is suitable for use as food. In this rule, 418(l)(4)(B)(ii)(I) of the FD&C Act qualified facility definition, each of we add ‘‘animal’’ before food for clarity. includes both within a State and within which includes the parent company and (Comment 60) Several comments the reservation of a Federally- all its subsidiaries and affiliates. The request that we replace ‘‘insanitary’’ Recognized Tribe. total sales are applicable to each entity, with ‘‘unclean’’ as the former term is not (Comment 56) One comment requests whether it is the parent, the subsidiary utilized in the animal food industry. the term ‘‘restaurant’’ be removed from or the affiliate. We intend to address Other comments state that the proposed the proposed definition of ‘‘qualified issues such as these in guidance as definition for ‘‘rework’’ is too narrow end-user’’ and replaced with the directed by section 418(l)(2)(B)(ii) of the and does not represent its use in animal appropriate definitional terms for FD&C Act. food production. ‘‘restaurant’’ provided in § 1.227: Pet (Comment 58) Some comments ask us (Response 60) We decline this shelters, kennels, and veterinary to clarify who will determine whether a request. The word ‘‘insanitary’’ is used facilities in which animal food is particular facility is a qualified facility. in the FD&C Act and human food

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regulations, including the Current Good moisture food production. These at CCPs (79 FR 58476 at 58477 through Manufacturing Practice in comments also note that dry cleaning 58478). Manufacturing, Packing, or Holding procedures can result in equipment that, (Comment 62) Comments support Human Food (currently 21 CFR part 110 while sanitary, is neither visibly clean using a term other than ‘‘hazard and updated and included in the final nor suitable for aqueous chemical reasonably likely to occur’’ and agree rule for preventive controls for human sanitizers. that using a term other than ‘‘hazard food (21 CFR part 117) published (Response 61) When the destruction reasonably likely to occur’’ throughout elsewhere in this Federal Register). of microorganisms is required, we use the rule will reduce the potential for a Because of the use of the term in the the terms ‘‘sanitize’’ or ‘‘sanitizing,’’ to misinterpretation that all necessary FD&C Act and various FDA regulations, differentiate from ‘‘cleaning’’ or preventive controls must be established we think industry is familiar with the ‘‘sanitation,’’ which is consistent with at CCPs. word ‘‘insanitary’’ and it is an how these terms are used throughout Some comments support the appropriate word to use in this final our current regulations for human food. regulatory text of the proposed rule. Therefore, we believe that ‘‘sanitize’’ is definition of the term ‘‘significant We disagree that the definition of the a word that is commonly understood by hazard.’’ These comments state that the term ‘‘rework’’ is too narrow. The industry and is used in this final rule in proposed regulatory text more closely definition allows the flexibility for an a way that is consistent with how it is aligns with the principles in FSMA establishment to consider clean, used in our other regulations relating to (‘‘reasonably foreseeable’’ and unadulterated animal food that was food. ‘‘significantly minimize or prevent’’) never adulterated or was successfully We consider that systems such as and provides operators the flexibility to reconditioned to be rework. steam systems clean the surfaces, as implement a range of preventive 30. Sanitize well as sanitize them and, thus, satisfy controls that are commensurate with the We proposed to define ‘‘sanitize’’ to the definition of ‘‘sanitize.’’ The risk and probability posed by a specific mean to adequately treat cleaned food- definition of ‘‘sanitize’’ does not hazard. Some comments agree that the contact surfaces by a process that is preclude the continued use of dry proposed regulatory text can clarify the effective in destroying vegetative cells of cleaning methods with no sanitizing difference between HACCP rules and microorganisms of animal or human step because the definition describes the the animal preventive controls rule. health significance, and in substantially meaning of the term ‘‘sanitize’’ without Some comments state that the proposed reducing numbers of other undesirable establishing any requirement for when regulatory text plainly reflects the microorganisms, but without adversely equipment must be sanitized. concept that significant hazards are affecting the product or its safety for We have revised the definition so that those hazards to be addressed through animals or humans. it means adequately treating ‘‘surfaces’’ the very broad category of preventive (Comment 61) Several comments rather than ‘‘food-contact surfaces.’’ As controls, and the rule is explicit that request that we replace the term a technical matter, adequately treating preventive controls may be controls ‘‘sanitize’’ with ‘‘clean,’’ as the former any surface—regardless of whether it is other than CCPs. Some comments state term is not utilized in the animal food a food-contact surface—by a process that the definition reflects the risk-based industry. Other comments ask us to that is effective in destroying vegetative nature (i.e., both the severity of a modify the definition because the cells of pathogens, and in substantially potential hazard and the probability that destruction of all microorganisms of reducing numbers of other undesirable the hazard will occur) of the animal or human health concern is not microorganisms, but without adversely requirements and provides additional always practical, and because the affecting the product or its safety for flexibility so that facilities can take into terminology ‘‘adversely affecting the animals or humans, is ‘‘sanitizing’’ the account the nature of the preventive product or its safety for animal or surface. Clarifying this technical control in determining when and how to humans’’ is ambiguous. Others ask us to meaning of the term ‘‘sanitize’’ imposes establish and implement appropriate revise the definition to state that no requirements to sanitize surfaces preventive control management ‘‘adequate’’ or ‘‘adequately’’ means to other than animal food-contact surfaces; components. Some comments support reduce the presence of organisms of the requirements for sanitizing surfaces including the phrase ‘‘based on the concern sufficient to help prevent are established by provisions such as outcome of a hazard analysis’’ in the illness through cleaning and sanitizing § 507.19(b)(2), not by the definition of definition because it ensures that using EPA registered/FDA regulated the term ‘‘sanitize.’’ identification of significant hazards will be risk based. Some comments ask us to food use antimicrobials and other means 31. Significant Hazard (Hazard be clear about FDA’s expectations such as heat, ozone, etc. Some Requiring a Preventive Control) comments ask us to clarify that the concerning a hazard analysis conducted ‘‘cleaning’’ should be appropriate to the We proposed to define the term by those involved in animal food specific food system and method used ‘‘significant hazard’’ to mean a known production. Some comments ask us to for sanitizing, and that cleaning should or reasonably foreseeable hazard for preserve in the final definition two key only be required when the sanitizing which a person knowledgeable about aspects that grant the animal food process alone would not be effective the safe manufacturing, processing, industry the flexibility that it needs: (1) without a prior cleaning step. packing, or holding of animal food The logical conclusion that not all Some comments express concern would, based on the outcome of a hazards will have the same impact or about whether the proposed definition hazard analysis, establish controls to will even constitute ‘‘significant of ‘‘sanitize’’ would preclude the significantly minimize or prevent the hazards’’ at all, depending on the continued, routine use of dry cleaning hazard in an animal food. The rule facility’s products and position in the methods with no sanitizing step. These would use the term ‘‘significant hazard’’ supply chain and (2) the fact that a comments note that adding routine rather than ‘‘hazard reasonably likely to ‘‘person knowledgeable about the safe aqueous-based cleaning and sanitizing occur’’ to reduce the potential for a manufacturing, processing, packing, or procedures could create a public health misinterpretation that all necessary holding of food’’ must be knowledgeable risk in certain operations such as low preventive controls must be established about the specific food produced at that

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facility and in that specific sector of the term that has implications for HACCP controls for human food, published food industry. systems. We also decline the request to elsewhere in this issue of the Federal Some of the comments that support use the term ‘‘actionable hazard,’’ Register). the regulatory text of the proposed because the term ‘‘actionable’’ is (Comment 63) Some comments ask us definition nonetheless express concern associated with violations at a food to allow facilities to continue to about the term ‘‘significant hazard.’’ processing plant. implement existing controls outside the Some of these comments express We reviewed the full regulatory text framework of this rule (i.e., outside the concern that a facility may not recognize of proposed subpart C and replaced framework that requires preventive hazards that need to be controlled ‘‘significant hazard’’ with ‘‘hazard control management components as because they do not rise to the requiring a preventive control’’ in most appropriate to ensure the effectiveness commonly understood meaning of cases. See table 31. of the preventive controls, taking into ‘‘significant.’’ Other comments express We also reviewed the full regulatory account the nature of the preventive concern that the adjective ‘‘significant’’ text of proposed subpart C to evaluate control and its role in the food safety is subject to many interpretations and whether there were any circumstances system) when a hazard addressed by the suggest that the term ‘‘hazard requiring where the regulatory text should more existing controls does not rise to the control’’ would be more straightforward, appropriately refer to ‘‘hazard requiring level of ‘‘significant hazard.’’ accurate, and suitable. a preventive control’’ rather than Other comments express concern that Other comments express concern that ‘‘hazard’’ or ‘‘known or reasonably the term ‘‘significant hazard’’ may create the term ‘‘significant hazard’’ could foreseeable hazard.’’ The term ‘‘known a disincentive for facilities to cause confusion because it has or reasonably foreseeable hazard’’ voluntarily implement preventive implications in HACCP systems. For appears only once, in the requirement controls for hazards that only pose a example, ‘‘significant hazard’’ is often for a facility to conduct a hazard remote risk or are very rarely used in the context of CCPs and analysis (§ 507.33(a)). We are retaining encountered, because implementing preventive controls are not necessarily ‘‘known or reasonably foreseeable preventive controls for hazards of very established at CCPs. Some of these hazard’’ in that requirement because it low probability and severity may be comments suggest that we eliminate the is necessary to implement the tiered misinterpreted as requiring preventive term and instead use the full regulatory approach to the requirements for hazard controls applicable to a ‘‘significant text of the proposed definition in place analysis and risk-based preventive hazard’’ even if the hazard does not of ‘‘significant hazard’’ throughout the controls (see Response 31). To reinforce meet the definition of ‘‘significant regulations. Other comments suggest this tiered approach, and emphasize hazard’’ established in the rule. Some using a term such as ‘‘food safety that the facility only conducts a hazard comments ask us to revise the definition hazard’’ or ‘‘actionable hazard’’ instead analysis for known or reasonably to provide facilities with the flexibility of ‘‘significant hazard to avoid a term foreseeable hazards, we revised and discretion to establish appropriate that has HACCP implications. Other ‘‘hazard’’ to ‘‘known or reasonably preventive controls for hazards that do comments state that the term foreseeable hazard’’ in two additional not rise to the criteria of a ‘‘significant ‘‘significant hazard’’ has implications provisions in the requirements for hazard,’’ as well as ensuring that for facilities that follow the Codex hazard identification (see the preventive controls that address remote HACCP Annex and express concern that introductory regulatory text for or very unlikely hazards not be subject foreign facilities would be especially § 507.33(b)(1) and (2)). to the preventive control management likely to be confused by the term In our review of the full regulatory requirements for a ‘‘significant hazard.’’ ‘‘significant hazard.’’ text of proposed subpart C, we did not (Response 63) We have revised the Some comments ask us to ensure that identify any circumstances where we definition to specify that the term the term ‘‘significant hazard’’ is used believe it is appropriate and necessary ‘‘hazard requiring a preventive control’’ consistently and express the view that to specify ‘‘hazard requiring a applies when a knowledgeable person some regulatory text refers to a ‘‘hazard’’ preventive control’’ in place of would, based on the outcome of a or ‘‘known and reasonably foreseeable ‘‘hazard.’’ It is not necessary for the hazard analysis, ‘‘establish one or more hazard’’ where ‘‘significant hazard’’ regulatory text of requirements for preventive controls’’ rather than should instead be used. As discussed in preventive controls, the supply-chain ‘‘establish controls.’’ By narrowing Comment 31, some comments express program, the recall plan, corrective ‘‘controls’’ to ‘‘one or more preventive concern that the rule would refer to actions, and verification to specify controls,’’ we mean to signify that the multiple levels of hazard and ask us to ‘‘hazard requiring a preventive control’’ proposed term ‘‘significant hazard’’ provide sufficient clarity to be able to every time that the requirements use the (which we now refer to as ‘‘hazard distinguish between these types of term ‘‘hazard’’ because the context of requiring a preventive control’’) only hazards. the requirement establishes the applies to those controls that the facility (Response 62) We have changed the applicability to ‘‘hazards requiring a establishes to comply with the term ‘‘significant hazard’’ to ‘‘hazard preventive control.’’ Although we requirements of subparts C and E for requiring a preventive control.’’ The acknowledge that using ‘‘hazard hazard analysis and risk-based new term uses the explicit language of requiring a preventive control’’ in place preventive controls. A facility that FSMA (i.e., ‘‘preventive control’’), is of ‘‘hazard’’ throughout applicable establishes other controls (such as those consistent with the specific suggestion provisions of proposed subpart C would that the comments describe as of one comment (i.e., hazard requiring a emphasize the tiered approach to the ‘‘prerequisite programs,’’ or controls control’’), and is not commonly requirements for hazard analysis and directed to hazards of very low associated with HACCP systems. We risk-based preventive controls, doing so probability and severity) for hazards decline the request to use the term would make the regulatory text that are not, based on the outcome of the ‘‘food safety hazard’’ because that term unnecessarily bulky and awkward and facility’s hazard analysis, ‘‘hazards already is established in Federal HACCP would be inconsistent with comments requiring a preventive control’’ would regulations for seafood and meat/ that ask us to make the regulatory text not need to establish preventive control poultry, and the comments are understandable (see Comment 13 in management components for such particularly concerned about using a section III of the final rule for preventive controls. However, some controls

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previously established in ‘‘prerequisite makes the risk-based nature of the preventive control and its role in the programs’’ would be considered determination clearer. facility’s food safety system.’’ ‘‘preventive controls.’’ We provide some We disagree that the proposed (Comment 66) Some comments assert flexibility for facilities with respect to definition was tautological and would that the problem is how to separate the how they manage preventive controls, collapse the second step of hazard hazards addressed by ‘‘HACCP’’ from and the preventive control management analysis into the first. A facility begins those addressed by CGMPs. These components may be different for its hazard analysis by narrowing down comments suggest that control measures hazards that have been managed as the universe of all potential hazards to that are implemented for hazards from ‘‘prerequisite programs’’ compared to those that are ‘‘known or reasonably ingredients and food-contact packaging those managed with CCPs. A facility foreseeable’’ for each type of animal material, and from production and that is concerned about the potential for food manufactured, processed, packed, process, be called CCPs and that control an investigator to disagree during or held at its facility. The outcome of measures that are implemented for inspection that certain controls are not the facility’s hazard analysis is a hazards from personnel, equipment, and directed to ‘‘hazards requiring a determination of a subset of those the plant be called preventive controls. preventive control’’ could, for example, known or reasonably foreseeable (Response 66) The facility must include information relevant to its hazards, i.e., those hazards requiring a control hazards through the application classification of those other controls in preventive control. To the extent that of CGMPs and preventive controls as its hazard analysis, whether by merely these comments are asserting that the appropriate to the hazard. Although listing the ‘‘other controls’’ or by tautology was created by the phrase ‘‘in some preventive controls will be providing a brief explanation why such the absence of its control’’ in the established at CCPs, and ‘‘CCP’’ is a controls are not ‘‘preventive controls’’ as proposed definition of ‘‘hazard,’’ we term commonly used in HACCP that term is defined in this rule. have deleted that phrase from the final systems, this rule establishes (Comment 64) Some comments assert definition of ‘‘hazard.’’ requirements for hazard analysis and risk-based preventive controls, not that the proposed definition of We decline the request to repeat in ‘‘HACCP,’’ and this rule provides that ‘‘significant hazard’’ is tautological the definition of ‘‘hazard requiring a preventive controls include controls at because it essentially establishes a preventive control’’ the requirement for CCPs, if there are any CCPs, as well as ‘‘significant hazard’’ to be a known or the types of information that a facility controls, other than those at CCPs, that reasonably foreseeable hazard (i.e., the would consider in conducting its hazard are also appropriate for animal food type of hazards identified in the first analysis. The requirements for hazard step of the analysis) for which safety (see § 507.34(a)(2)). analysis clearly specify that a facility preventive controls should be Under the rule, some hazards may be must conduct its hazard analysis based implemented. These comments assert addressed by CGMPs and others by on experience, illness data, scientific that the proposed definition of preventive controls. For example, a reports, and other information (see ‘‘significant hazard’’ would collapse the facility could control a physical hazard § 507.33(a)). second step of hazard analysis into the such as metal by using screens and first, which in turn would lead to the (Comment 65) Some comments that magnets under CGMPs and then use a unintended consequence of facilities broadly address the overall framework metal detector as a preventive control. identifying the same hazards in the for the new requirements for hazard (Comment 67) Some comments second step as in the first. Some analysis and risk-based preventive express concern that the term comments ask us to revise the definition controls ask us to consistently refer to ‘‘significant hazard’’ may lead to to include evaluation of severity and ‘‘the nature of the preventive control’’ misunderstanding by medium and probability, because these concepts are (rather than simply to ‘‘the preventive smaller processors and ask how integral for making a proper control’’) when communicating the businesses with limited food safety determination of whether a hazard is flexibility that a facility has in experience will understand the significant. Other comments ask us to identifying preventive controls and difference between a food safety hazard revise the definition to better reflect the associated preventive control that is ‘‘reasonably likely to occur’’ (and, risk-based approach that preventive management components. Other thus, must be controlled by a full controls be implemented to control comments that broadly address the HACCP Plan) and a ‘‘significant hazard’’ hazards that have a higher probability of overall framework for the new that can be controlled by a preventive resulting in public health consequence requirements for hazard analysis and control plan. in the absence of control. risk-based preventive controls ask us to (Response 67) It will not be necessary (Response 64) We have revised the emphasize that the requirements for for an animal food processor to definition of ‘‘significant hazard’’ preventive control management understand the difference between a (which we now refer to as ‘‘hazard components convey not only that the hazard that is ‘‘reasonably likely to requiring a preventive control’’) to application of a particular element is occur’’ in the concept of HACCP specify that the hazard analysis includes appropriate (i.e., capable of being requirements and a ‘‘hazard requiring a an assessment of the severity of the applied), but also necessary for food preventive control’’ in the context of illness or injury if the hazard were to safety. Some comments recommend that this rule. FDA does not have any occur and the probability that the we do so by specifying that preventive HACCP regulations that apply to animal hazard will occur in the absence of control management components take food. preventive controls. By specifying that into account the role of the preventive (Comment 68) Some comments ask us the determination of a ‘‘significant control in the food safety system. to concur that ‘‘temporal hazards’’ in hazard’’ is based on the outcome of a (Response 65) We agree with these some food products (specifically, hazard analysis, the proposed definition comments and have revised the aflatoxin, pesticides, and radiological did, as requested by the comments, definition of ‘‘hazard requiring a contamination) do not represent include the risk-based nature of the preventive control’’ to specify that ‘‘significant hazards’’ that require determination. However, explicitly preventive control management monitoring and verification activities on adding that the hazard analysis is based components are established as an ongoing basis. These comments also on probability and severity (i.e., risk) appropriate to ‘‘the nature of the ask us to acknowledge that in many

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cases the testing done by FDA and Research Service, USDA’s Agricultural This approach is similar to the approach others is sufficient for protecting public Marketing Service and the American the Agency used to calculate the small health and that it is not necessary to Farm Bureau to help oversee the revised business exemption for nutrition require ongoing monitoring by study. The revised Food Processing labeling of food (§ 101.9(j)(18)(iv)(D)). individual facilities in order to comply Sector Study is available in the docket Under this approach, the number of full- with the rule. of this rule (Ref. 21). time equivalent employees is (Response 68) We decline these Our original analysis was based on determined by dividing the total requests because such a determination the merger of Dun & Bradstreet data and number of hours of salary or wages paid should be facility specific. However, we FDA’s Food Facility Registration data to directly to employees of the business have revised the considerations for the help us estimate the number of entity claiming the exemption and of all hazard evaluation to clarify that in manufacturing facilities that are also of its subsidiaries and affiliates by the making the determination as to what classified as farms. We have updated number of hours of work in 1 year, hazards require preventive controls, the that data source and added data sources. 2,080 hours (i.e., 40 hours × 52 weeks). facility can consider factors such as the To better account for farms that perform The calculation for the number of temporal nature of the hazard (see processing activities, we included employees affects exemptions (i.e., the § 507.33 and section XXV). In Census of Agriculture (Ag Census) data exemptions for on-farm, low-risk determining the appropriate preventive both to provide a count of total U.S. activity/animal food combinations in control management components, the farms and to estimate the number of § 507.5(e) and (f), which apply only to facility can take into account the nature farms conducting food processing small and very small businesses), not of the preventive control and its role in activities, to the extent that the data just compliance dates. Therefore, we are the facility’s food safety system (see identifies processing activities. We also establishing the definition of ‘‘full-time § 507.39(a)). included the Agricultural Resource equivalent employee’’ in the definitions Management Survey (ARMS) data for this rule (§ 507.3) and modifying the 32. Significantly Minimize because it included questions about definition of ‘‘small business’’ to use the We proposed to define the term some processing activities for select term ‘‘500 full-time equivalent ‘‘significantly minimize’’ to mean to commodities. employees’’ rather than ‘‘500 persons.’’ reduce to an acceptable level, including Both the Ag Census and ARMS are (Comment 71) Some comments assert to eliminate. We did not receive silent about many processing activities. that there should be no exemption from comment and are finalizing it as Therefore, we also obtained estimates compliance with this rule based on total proposed. from commodity specialists at trade annual sales or number of employees, associations, USDA, and universities noting that all companies regardless of 33. Small Business with in-depth knowledge of the size should have food safety programs We proposed to define the term processing activities for specific in place. ‘‘small business’’ to mean, for the agricultural commodities. (Response 71) The definition of purposes of part 507, a business (Comment 70) Some comments ask us ‘‘small business’’ is relevant to the employing fewer than 500 persons. We to explain how to calculate the number exemptions for on-farm, low-risk conducted a Food Processing Sector of full-time equivalent employees, e.g., activity/animal food combinations for Study as required by section 418(l)(5) of with respect to temporary workers, manufacturing/processing, packing, and the FD&C Act (Ref. 12) and used the seasonal workers, and part-time holding animal food by mixed-type results of the study in defining the term workers. Other comments say it is facilities. This exemption is a risk-based ‘‘small business.’’ (78 FR 64736 at 64758 unclear whether fewer than 500 full- exemption, because it only applies to through 64759.) We made the results of time equivalent employees means those activity/animal food combinations that the Food Processing Sector Study involved in the entire business or those are low-risk and, thus, should not affect available in Docket No. FDA–2011–N– involved only in the animal food-related animal food safety. 0922 and requested public comment on portions of the business, noting that the that study. term ‘‘business’’ is unclear (i.e., whether 34. Supplier (Comment 69) Some comments business means a corporation and all its We proposed to define the term express concern that the Food subsidiaries or only the portion of the ‘‘supplier’’ to mean the establishment Processing Sector Study is not business related to animal food be it that manufactures/processes the food, comprehensive. Some comments assert animal feed, pet food and/or raises the animal, or harvests the food that FDA did not sufficiently collaborate ingredients). that is provided to a receiving facility with USDA, and that FDA significantly (Response 70) As previously without further manufacturing/ underestimated the number of mixed- discussed, we proposed to establish the processing by another establishment, use facilities, particularly by neglecting same definition for small business as except for further manufacturing/ to count farms that perform the that which has been established by the processing that consists solely of the processing steps on RACs to become a U.S. Small Business Administration addition of labeling or similar activity of processed food. Other comments assert under 13 CFR part 121 for most food a de minimis nature. that the Food Processing Sector Study is manufacturers, and the limit of 500 As discussed in section IV.B of the woefully inadequate and must be employees would include all employees final rule for preventive controls for undertaken again to comply with the of the business rather than be limited to human food, published elsewhere in law. the employees at a particular facility (78 this issue of the Federal Register, we (Response 692) We previously FR 64736 at 64759). We will base the have revised the ‘‘farm’’ definition to acknowledged the limitations of the calculation on ‘‘full-time equivalent explicitly include business models in Food Processing Sector Study (78 FR employees’’ and use the same approach which one operation grows crops but 64736 at 64758 through 64759). We to calculating full-time equivalent does not harvest them, and another have revised and extended the results of employees for the purpose of this rule operation, not under the same our earlier study by expanding our data as we used to calculate full-time management, harvests crops but does sources and by including equivalent employees in the section 414 not grow them. This revision represents representatives from USDA’s Economic recordkeeping regulations (see § 1.328). a change from the existing and proposed

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‘‘farm’’ definitions, which describe a definition of supplier in the case of procedures, tests and other evaluations, ‘‘farm’’ as an entity ‘‘devoted to the comingled RACs, such that the supplier in addition to monitoring, to determine growing and harvesting of crops’’ would be the person immediately back whether a control measure is or has (emphasis added). We proposed the from the receiving facility in the supply been operating as intended (Ref. 22). ‘‘supplier’’ definition in the context of a chain provided that this entity Some comments ask us to more single business entity ‘‘devoted to the (presumably a warehouse or aggregator) clearly distinguish between growing and harvesting of crops’’ voluntarily complies with the ‘‘validation’’ and ‘‘verification.’’ Some (emphasis added). We used the term requirements of subpart C of this part. comments assert that validation is not ‘‘harvesting,’’ rather than ‘‘growing,’’ to One comment asks us to clarify in our an element of verification as stated in reflect the last stage of production on a definition that the supplier must be the our proposed definition and suggest that farm, except for packing. establishment that controls the hazard we clearly separate requirements for Because the proposed ‘‘supplier’’ in question. validation from requirements for definition contemplated that the same (Response 73) We decline this verification, e.g., by moving the business entity that grows crops also request. As discussed in section XL, we proposed requirements for verification harvests them, we have revised the recognize that doing supplier to a distinct section in the regulatory ‘‘supplier’’ definition so that the grower verification with comingled products text. remains the supplier when the harvester will be a challenge. However, we (Response 75) We have explained is under separate management. believe it is important that there be a how our proposed definitions for Specifically, ‘‘supplier’’ is now defined link between the receiving facility ‘‘validation’’ and ‘‘verification’’ align to include an establishment that (which is manufacturing/processing the with a variety of widely recognized ‘‘grows’’ food rather than an animal food) and the supplier (who definitions, including definitions establishment that ‘‘harvests’’ food. controlled the hazard(s) in the animal established by Codex, the NACMCF Doing so focuses the requirements for food). We are allowing an entity such as HACCP guidelines, and Federal HACCP the supply-chain program (see subpart an aggregator or distributor to perform (78 FR 64736 at 64758). We disagree E) on the entity that produces the food, some verification activities, so the that validation is not an element of rather than on the entity that removes outcome requested by these comments verification, but acknowledge it is not the food from the growing area, when will be achieved while maintaining the necessary to say so within the definition the grower and the harvester are not identities of the two primary parties in of ‘‘validation.’’ Although we have under the same management. Doing so the supplier verification relationship moved the details of the requirements also simplifies the determination of who (see Response 492). for validation from its proposed location the supplier is in complex business (Comment 74) One comment asks us within the requirements for verification models, such as when a ‘‘handler’’ to clarify that the proposed definition of (i.e., proposed § 507.45(a)) to a separate arranges for harvest by another business supplier does not include sources of section (§ 507.47), we did so as an entity. processing aids or chemicals required editorial change to improve clarity and (Comment 72) Some comments assert for post-harvest treatments and packing readability rather than as a substantive that the definition of supplier is not processes (including waxes, fungicides, change to signal that validation is not an workable because the status of detergents and sanitizers). element of verification (see table 8, 79 warehouses and brokers is unclear in (Response 74) As defined, the FR 58476 at 58504). the definition. Other comments ask us supplier is the establishment growing We agree that validation can apply to to modify the definition to specify, in the food, not those establishments a specific control measure as specified addition to the proposed definition, that providing inputs (such as waxes, in the Codex definition. We also agree the supplier could be an intermediary fungicides, detergents and sanitizers) to that validation can apply to a entity that takes responsibility on behalf that entity. combination of control measures as of the receiving facility to ensure that specified in the Codex definition. The 35. Validation and Verification the food meets the requirements of this food safety plan is one example of a part. We proposed to define the term combination of control measures. (Response 72) As discussed in section ‘‘validation’’ to mean that element of Although we likewise agree that XL, we agree that the role of verification focused on collecting and verification can apply to a specific intermediaries in the supply chain is evaluating scientific and technical control measure as specified in the critical and we have added options for information to determine whether the Codex definition, we disagree that to be entities other than the receiving facility food safety plan, when properly consistent with the Codex definition we to perform certain supplier verification implemented, will effectively control should adopt a definition that excludes activities, provided that the receiving the identified hazards. We proposed to the application of verification to the facility reviews and assesses the define the term ‘‘verification’’ to mean food safety plan. It is well established documentation produced by the other those activities, other than monitoring, that some verification measures, such as entity and documents that review and that establish the validity of the food testing for a pathogen, verify that assessment. However, this does not safety plan and that the system is multiple control measures operated as mean that these entities take on the role operating according to the plan. intended. of the supplier. As discussed in (Comment 75) Some comments ask us To more clearly distinguish between Response 59 and in section XL, we to revise the definitions of ‘‘validation’’ ‘‘validation’’ and ‘‘verification,’’ the believe it is important to supplier and ‘‘verification’’ to be consistent with definition of ‘‘validation’’ we are verification to retain the identities of the Codex definitions. Codex defines establishing in this rule specifies that two parties involved—the receiving ‘‘validation’’ to mean obtaining validation means obtaining and facility and the supplier. Therefore, we evidence that a control measure or evaluating scientific and technical are retaining our definition of supplier, combination of control measures, if evidence that a control measure, with the minor change previously properly implemented, is capable of combination of control measures, or the discussed. controlling the hazard to a specified food safety plan as a whole, when (Comment 73) Some comments outcome. Codex defines ‘‘verification’’ properly implemented, is capable of regarding RACs ask us to modify the to mean the application of methods, effectively controlling the identified

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hazards (emphasis added). We also establishing whether a facility is a very year (see § 507.7(c)(1)). Although this made conforming changes associated small business. The comments state that requirement was implicit in the with the revised definition of this would account for the animal food proposed requirement that a facility ‘‘validation’’ in the requirements for manufactured by feed mills servicing must resubmit a notification to FDA if validation (see § 507.47(b)(2)). The contract farms. Some of these comments its status changes as a qualified facility definition of ‘‘verification’’ we are state that the value of food produced by (proposed § 507.7(c)(2), which we are establishing in this rule specifies that feed mills operating under this contract finalizing as § 507.7(c)(3)), we are verification means the application of model often exceeds the $2,500,000 making this requirement explicit to methods, procedures, tests and other threshold of the proposed very small clarify the responsibility of the facility evaluations, in addition to monitoring, business definition. They state that to affirmatively determine its status to determine whether a control measure because this proposed definition only when the calendar years that apply to or combination of control measures is or includes sales, it would allow large the 3-year average change. The July 1 has been operating as intended and to facilities to be considered very small deadline for a facility to determine its establish the validity of the food safety businesses (as they would have no or a status provides facilities with 6 months plan as a whole (emphasis added). very small amount of actual sales). to make the determination after the end Consistent with the request of the Other comments request that we of the previous 3 calendar years. comments, the definition of modify the proposed definition to We also are establishing an earlier ‘‘verification’’ uses the Codex specify that animal food produced for compliance date for the financial description of verification as the contract farms is not included in ‘‘sales’’ records that a facility maintains to application of methods, procedures, in the definition for very small business; support its status as a very small tests and other evaluations, in addition thereby allowing these feed mills to be business. Specifically, the compliance to monitoring. very small businesses, which would date for a facility to retain records to result in qualified facility status. support its status as a qualified facility 36. Very Small Business Some comments ask us to specify that is January 1, 2017. Even with this earlier We proposed to define the term ‘‘very the monetary threshold for the compliance date for these records, we small business’’ to mean, for the definition be based on average sales realize that although the calculation for purposes of proposed part 507, a during a 3-year period on a rolling basis ‘‘very small business’’ in the regulatory business that has less than $2,500,000 in because otherwise firms may be subject text is based on 3 calendar years, a total annual sales of food for animals, to significant changes in status from facility will only be required to have 2 adjusted for inflation. As discussed in year to year. These comments also ask calendar years of records as of the the proposed rule, we conducted a Food us to clarify that the sales are to be general compliance date for very small Processing Sector Study as required by evaluated retrospectively, not businesses. Specifically, by December section 418(l)(5) of the FD&C Act (Ref. prospectively. 16, 2019 a facility that begins retaining 12) and used the results of the study in (Response 76) We have revised the applicable financial records on January defining the term ‘‘very small business’’ definition of very small business to 1, 2017, would only have such records (78 FR 64736 at 64758 through 64760). specify that it is based on an average for 2 previous calendar years. Therefore, We made the results of the Food during the 3-year period preceding the it would be reasonable for a facility to Processing Sector Study available in applicable calendar year in sales of make the calculation based on the 2 Docket No. FDA–2011–N–0922. Some animal food plus the market value of previous calendar years. If a facility has comments support defining ‘‘very small animal human food manufactured, records for 3 previous calendar years, business’’ as a business that has less processed, packed, or held without sale the facility could make the calculation than $2,500,000 in total annual sales of (e.g., held for a fee or supplied to a farm based on the longer time period. During animal food, adjusted for inflation. without sale). The applicable calendar inspection in 2019, when a facility has Other comments disagree or offer year is the year after the 3 calendar records for the preceding 2 calendar alternative recommendations. years used to determine whether a years, but not for the preceding 3 (Comment 76) Some comments ask us facility is a very small business. The previous calendar years, we will accept to clarify how to classify the size of a most recent applicable calendar year is records for the preceding 2 calendar business that does not take ownership the current year. For example, on June years as adequate to support status as a or directly sell food (e.g., warehouses 3, 2024, 2024 is the most recent qualified facility based on calculating an and contract manufacturers) to applicable calendar year and is the average for those two years. We note determine status as a qualified facility. applicable calendar year when the 3 that in some situations, a shorter time Some comments recommend calendar years used to determine period is sufficient to determine that a modifications to the proposed very whether a facility is a very small facility is not a very small business. For small business definition based on a business are 2021 to 2023. The example, a facility with sales exceeding discussion of certain farming models in exception is when 3 calendar years of $7,500,000 for the preceding calendar the 2014 supplemental notice for animal records are not available, such as when year cannot qualify as a very small food (79 FR 58476 at 58482). These a facility begins business after the business because no amount of sales comments express concern that the compliance date for very small from other years will reduce average proposed definition of very small businesses. In such situations the sales below the threshold of $2,500,000. business would not account for animal applicable calendar year refers to the The available financial records for a food that is not ‘‘sold,’’ but is year during which the calculation is facility that begins operations between manufactured and then distributed to made but is not preceded by 3 calendar January 1, 2018 and September 17, 2019 another entity without a sale, such as in years used to determine whether a would not cover even 2 complete the contract farming model discussed in facility is a very small business. calendar years by September 17, 2019. the 2014 supplemental notice. As a companion change, we are During the first 3 calendar years of such Other comments recommend explicitly requiring that a facility a facility’s operation, it would be modifications to the definition to use determine and document its status as a reasonable for a facility to make the the value or volume of animal food qualified facility on an annual basis by calculation based on records it has (i.e., manufactured and distributed in no later than July 1 of each calendar for 1 or 2 preceding calendar years), and

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we will accept records for the preceding sufficient flexibility to companies that threshold exempts a greater portion of 1 or 2 years as adequate to support receive the exemption to allow them to the animal food supply than thresholds status as a qualified facility in these continue to operate. Some comments of either $500,000 or $1,000,000 (79 FR circumstances. say there should be no exemption from 58476 at 58502), but reaffirm that under When a facility does not begin compliance with this rule based on total the $2,500,000 threshold the businesses operations until after January 1, 2019, it annual sales or number of employees that would be exempt from the would be reasonable for the facility to and that all companies regardless of size requirements for hazard analysis and rely on a projected estimate of revenue should have food safety programs in risk-based preventive controls would (or market value) when it begins place. Several comments request represent a small portion of the operations. We would evaluate the different dollar amounts for determining potential risk of foodborne illness; credibility of the projection considering the threshold. businesses that fall within this factors such as the facility’s number of Some comments propose that the definition of ‘‘very small business,’’ full-time equivalent employees. After threshold should be $1,000,000, a figure collectively, produce less than 0.6 the facility has records for 1 or 2 that would provide greater coverage percent of the animal food supply (Ref. preceding calendar years, it would be than the $2,500,000 proposed threshold 3). In addition, most of these facilities reasonable for the facility to make the and also would simplify compliance will be subject to the CGMP calculation based on records it has (i.e., with all FSMA rules for animal food requirements in subpart B; the only for 1 or 2 preceding calendar years) and facilities. Other comments suggest the exemptions from those CGMP we will accept records for the preceding definition for a very small business requirements are the exemptions in 1 or 2 years as adequate to support should mean, for purposes of part 507, § 507.5(a) (which applies to farms and status as a qualified facility in these a business that has less than $1,000,000 activities of ‘‘farm mixed-type facilities’’ circumstances. in total annual sales of animal food, that fall within the definition of We agree with the comments that adjusted for inflation, and distributes ‘‘farm’’), and in § 507.5(h) (which state the animal food distributed, but less than 5,000 tons of animal food applies to: (1) The holding or not ‘‘sold,’’ by feed mills operating annually. Several comments urge us to transportation of one or more RACs; (2) under contract farming agreements (and consider applying a $500,000 threshold hulling, shelling, and drying nuts and required to register as a food facility to the value of animal feed produced by hulls (without manufacturing/ under section 415 of the FD&C Act) a facility, not just the value of animal processing); and (3) the ginning of should be included in determining food that is sold. The comments state cotton (without manufacturing/ whether a facility is a very small that the vertically integrated structure of processing)). Facilities subject to and in business. In addition to annual sales of some livestock and poultry operations compliance with human food CGMPs animal food, the market value of the means that some animal feed produced and applicable FDA human food safety animal food supplied to a farm(s) at large operations may never be sold requirements that process human food without sale must be included when because the company supplies feed to and ‘‘donate’’ or sell the human food by- determining if a business is a very small contract operations raising animals products without further processing for business for purposes of this rule. owned by the company. use as animal food are only subject to The qualified facility exemption of Other comments suggest ensuring certain provisions in subpart B for those § 507.7 applicable to very small sufficient flexibility for a diverse array by-products. This applies whether they businesses is intended to enable these of animal food businesses and that we are a qualified facility or not. They are businesses to comply with modified should establish an outright exemption not subject to the requirements of requirements because they have fewer from the rule for businesses with, at the subparts C and E for the human food by- resources to direct to full compliance very most, $100,000 or less in annual with subpart Cs and E of the rule and average monetary value of animal food products used for animal food. they provide a small volume of animal sold over the previous 3-year period, (Comment 78) Some comments ask us food for consumption. Many of the adjusted for inflation. Another comment to only include the total annual sales of businesses that have feed mills that suggests a threshold of $250,000. Other food in the United States, adjusted for provide animal food under contract comments recommend defining a very inflation, for foreign facilities that farming agreements are extensive and small business as one with less than export food to the United States. sophisticated businesses, such as some $10,000 in annual sales believing that a (Response 78) We decline this large-scale meat and poultry operations. rule encompassing virtually all request. The purpose of the definition of Such businesses are not the intended ingredient and feed manufacturing and ‘‘very small business’’ is principally to beneficiaries of the qualified facility distribution facilities will encourage enable such businesses to comply with exemption because they should have large firms to continue to do business modified requirements, because they adequate resources, such as personnel, with very small firms. One comment have fewer resources to direct to full equipment, and expertise, to implement suggested excluding the value of compliance with the rule. A foreign the requirements of subparts C and E at donated by-product in the calculation of business that sells more than the their feed mills. In addition, many of total annual sales of animal food. threshold dollar amount of animal food these feed mills manufacture and (Response 77) We are establishing a has more resources than the businesses distribute a large volume of animal food $2,500,000 threshold for the definition being excluded, even if less than that yearly. These were some of the factors of ‘‘very small business.’’ Under section threshold dollar amount reflects sales to we considered when we revised the 418(l)(1)(A) and (B) of the FD&C Act, a the United States. Likewise, a domestic proposed definition of a very small very small business is a qualified business that sells more than the business to include the market value of facility; under the exemption authorized threshold dollar amount of food has the animal food that is manufactured, in section 418(l)(2) of the FD&C Act, a more resources than the businesses processed, packed, or held without sales qualified facility is subject to modified being excluded, even if that domestic or supplied to a farm without sales. requirements rather than the business exports some of its food and, (Comment 77) Some comments requirements for hazard analysis and as a result, less than that threshold support the proposed dollar threshold of risk-based preventive controls. We have dollar amount reflects sales within the $2,500,000, noting that it would provide acknowledged that a $2,500,000 United States.

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(Comment 79) Some comments ask us B. Comments Asking FDA To Establish could refer to ‘‘prompt actions taken in to base the threshold on the total Additional Definitions or Otherwise response to minor and isolated ‘‘volume of product’’ or ‘‘amount of Clarify Terms Not Defined in the Rule deviations that do not directly impact product’’ handled or sold. These Some comments ask us to define product safety.’’ comments assert that an approach using certain terms such as ‘‘associated,’’ Other comments agree with the product volume or amount would be ‘‘contaminate,’’ ‘‘directly linked,’’ concept of simple ‘‘corrections’’ but more risk based because it would ‘‘integrated operator,’’ ‘‘material to the assert that the term ‘‘corrections’’ is correlate more closely to consumer safety of food,’’ ‘‘written,’’ and unnecessary and could be confusing exposures than dollar amounts, which ‘‘necessary.’’ We believe that it is not because different facilities may use the can be skewed by product values. necessary to define these and certain term differently. These comments other new terms proposed by the explain that sometimes ‘‘correction’’ is (Response 79) We acknowledge that used to refer to the action taken to fix dollar amounts can be skewed by comments. We discuss in this section of this document comments that ask us to a deviation, and may or may not be part product values but nonetheless disagree of an overall corrective action taken to that we should base the threshold on the establish other new terms or clarify terms in the rule not defined. identify the root cause of the deviation total ‘‘volume of product’’ or ‘‘amount of and to prevent a similar occurrence. product’’ handled or sold. We see no 1. Consumer/Final Consumer/Customer These comments suggest that the practical way to identify a threshold (Comment 81) A few comments provisions explain that prompt actions based on volume or amount of product request that we define consumer as the taken to address minor and isolated that could be applied across all product animal consuming the food. Some deviations are not subject to the same sectors, and the comments provide no comments ask us to define ‘‘customer’’ requirements as corrective actions to suggestions for how their as the purchaser of the animal food. address potentially systemic concerns, recommendation could be carried out. Other comments ask us to define ‘‘final without defining the term ‘‘corrections.’’ (Comment 80) Some comments consumer’’ to mean a person that feeds (Response 82) We are defining the express concern that establishing a animals under the control or ownership term ‘‘correction’’ to mean an action to threshold based on U.S. dollars would of that person. The comments suggest identify and correct a problem that place domestic firms at a disadvantage ‘‘final consumer’’ could be used in the occurred during the production of relative to foreign firms whose sales are animal food rule to help clarify the animal food, without other actions often denominated in currencies valued meaning of qualified end user. associated with a corrective action procedure (such as actions to reduce the lower than the dollar and often reflect (Response 81) We decline these likelihood that the problem will recur, much lower costs for factors such as requests. We stated that for purposes of evaluate all affected animal food for land, labor, and environmental the proposed rule, the term consumer refers to the person purchasing the safety, and prevent affected animal food compliance. These comments ask us to animal food to feed to an animal(s), as from entering commerce). We agree that base the threshold on an alternate well as the animal(s) consuming the clearly distinguishing between the terms measure, such as number of employees, food (78 FR 64736 at 64756 through ‘‘corrective actions’’ and ‘‘corrections’’ or to calculate the sales of foreign very 64757). To limit the definition of will be important for both industry and small businesses using an appropriate consumer to the animal consuming the regulators. We acknowledge that one measure of purchasing power parity, if food would be inconsistent with how way to distinguish between ‘‘corrective there is a straightforward way to do so. that term is used throughout FSMA and actions’’ and actions that we would (Response 80) We decline these would create confusion. Therefore, consider ‘‘corrections’’ could be to avoid requests. As previously discussed, we ‘‘consumer’’ also includes the person the term ‘‘corrections’’ and instead say use dollar estimates to evaluate the purchasing the animal food. what we mean each time the rule uses the term ‘‘corrections.’’ However, after percent of all food produced in the 2. Corrections United States that would not be covered reviewing the full regulatory text of by the rule (79 FR 58476 at 58502). We (Comment 82) Some comments assert proposed subpart C, we concluded that acknowledge that the definition of that clearly distinguishing between the it was not practical to do so, because the ‘‘small business’’ is based on number of terms ‘‘corrective actions’’ and term ‘‘corrections’’ was used more often ‘‘corrections’’ will be imperative for in a title or a cross-reference than in a employees, and that two exemptions industry to comply with the rule and for provision where the full text of what we (i.e., the exemptions in § 507.5(e) and (f) regulators to enforce the rule. Some mean by the term ‘‘corrections’’ is for on-farm, low-risk activity animal comments ask us to use the ISO necessary to communicate a food combinations) apply to small definitions of ‘‘corrective actions’’ and requirement. Our definition of businesses. However, the exemptions ‘‘corrections.’’ (According to ISO ‘‘corrections’’ focuses on the first step in for on-farm, low-risk activity animal 22000:2005 definition 3.13, a a ‘‘corrective action procedure’’ (i.e., food combinations are limited to a ‘‘correction’’ is action to eliminate a identify and correct the problem) and narrow sector of the animal food detected non conformity; according to also specifies those aspects of a industry, whereas the exemption ISO 22000:2005 definition 3.14, corrective action procedure that do not applicable to a very small business will corrective action is action to eliminate apply to a correction (i.e., actions to apply to all sectors of the animal food the cause of a detected non conformity reduce the likelihood that the problem industry. or other undesirable situation.) Other will recur, evaluate all affected animal We do not know of a straightforward comments ask us to eliminate the term food for safety, and prevent affected way to calculate the sales of foreign very ‘‘correction’’ and instead revise the rule animal food from entering commerce). small businesses using an appropriate to clarify the type of situation in which (A note to the ISO 22000:2005 definition measure of purchasing power parity ‘‘corrective actions’’ are neither of corrective action indicates that it and, thus, are basing the threshold only necessary nor appropriate. As an includes cause analysis and is taken to prevent recurrence.) We believe that this on U.S. dollars. example, these comments suggest that the proposed provisions for corrections definition will be adequate to

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distinguish ‘‘corrective actions’’ from 6. Prerequisite Program a preventive control or food safety plan ‘‘corrections.’’ (Comment 86) Some comments ask to control a hazard. As an example, if a facility applies that we adapt the definition of (Response 89) We decline this sanitation controls for an environmental prerequisite program from the ISO’s request. Section 418(i) of the FD&C Act pathogen such as Salmonella spp. and food safety standard, ISO 22000:2005, sets the requirement for conducting a animal food residue is observed on noting that the ISO definition is: Basic reanalysis, which is in the regulatory ‘‘clean’’ equipment prior to production, practices and procedures in animal food text in § 507.50, including how often corrections would involve re-cleaning production that are necessary for the and under what circumstances a and sanitizing the equipment before it is manufacture, handling and provision of reanalysis of the food safety plan must used. Because the observation of animal safe end products and safe food for be performed, and how to handle the food residue was made prior to animal consumption. results. Therefore, we have determined production of animal food, no animal (Response 86) We do not use the term that a definition of ‘‘reanalysis’’ is not food is affected, and no actions are ‘‘prerequisite program’’ in the necessary. For a discussion of the needed with respect to animal food. regulations established by this reanalysis requirement, see section Although there are actions that can be rulemaking and do not find it necessary XXXV. taken to prevent reoccurrence, such as to define it. We understand that some retraining sanitation personnel, these 10. Risk Assessment facilities may refer to practices and types of situations may reoccur from procedures such as CGMPs, training, or (Comment 90) Some comments time to time. certain controls for hazards as a request that we add a new term ‘‘risk 3. Crop ‘‘prerequisite program.’’ assessment’’ and define this term as a scientifically based process consisting of (Comment 83) Some comments 7. Qualified Facility Exemption hazard identification, hazard request we define a new term ‘‘crop’’ to characterization, exposure assessment, mean the edible or inedible cultivated (Comment 873) Some comments note that some of the terminology associated and risk characterization. or harvested plants. (Response 90) We do not use the term (Response 83) We decline this with the exemption for qualified facilities in the preventive controls rule ‘‘risk assessment’’ in the regulations request. The term ‘‘crop’’ has a common established by this rulemaking and do meaning, and it is not necessary to is different from terminology associated with an exemption in the proposed not find it necessary to define it. As establish a meaning for this term in this directed by section 103(c) of FSMA, we rule. produce safety rule. These comments point out that the exemption in the issued for public comment a draft risk 4. Establishment proposed produce safety rule refers to assessment, as described in section I.D (Comment 84) Several comments ‘‘qualified exemptions’’ (§ 112.5), and are including the final risk request we establish a definition for whereas the exemption in the proposed assessment in the docket established for establishment as it is used in the animal preventive controls rule refers to this rule. supplier definition. Also, the comments ‘‘exemptions’’ and ‘‘qualified facilities’’ The definition proposed by the suggest that we replace in the definition (§ 507.5(d)). comment is similar to the requirements of farm the term ‘‘establishment’’ with (Response 873) We have added a for the hazard analysis of § 507.33. The ‘‘operation.’’ definition for the term ‘‘qualified facility term ‘‘hazard analysis’’ comes from (Response 84) Comments concerning exemption,’’ to mean an exemption section 418 of the FD&C Act. For the meaning of the term applicable to a qualified facility under discussion of hazard analysis, see ‘‘establishment’’ as it relates to the § 507.5(d) (see the regulatory text in section XXV. ‘‘supplier’’ definition are addressed in § 507.3). We also have made conforming 11. Undesirable Microorganisms section XL pertaining to subpart E, the changes throughout the rule to use the supply-chain program. Comments term ‘‘qualified facility exemption’’ (Comment 91) Some comments directed to the meaning of the term when it applies. (See table 31). request we define a new term ‘‘undesirable microorganisms’’ as those ‘‘establishment’’ as it relates to the farm 8. Qualified Investigator definition are addressed in section IV.A microorganisms that are of animal or and B of the final rule for preventive (Comment 88) Once comment human health significance, thereby controls for human food, published proposes a new term ‘‘qualified rendering the animal food unfit for elsewhere in this issue of the Federal investigator’’ where the term ‘‘qualified consumption or distribution. Register. investigator’’ means an FDA or state (Response 91) We decline this commissioned investigator that has request. See Response 45. 5. Parameter and Value as Used in the successfully completed a formal training 12. Unexposed Packaged Animal Food Requirements for Process Controls course on inspections; CGMPs; hazard (Comment 85) Some comments ask us analysis and preventive controls for As discussed in section XXXVI, some to define the terms ‘‘parameter’’ and animal food facilities, both animal feed comments ask us to clarify that ‘‘value’’ used in the requirements for and pet food, and has demonstrated an modified requirements for packaged preventive controls (§ 507.34). These understanding of the differences animal food that is not exposed to the comments ask us to define ‘‘parameter’’ between pet food and animal feed environment only apply to such animal as a measurable attribute and ‘‘value’’ as manufacturing facilities. food that requires time/temperature a specific measurement. (Response 88) We decline this controls for safety (TCS animal food). To (Response 85) We decline this request. Our inspectors will be trained do so, we are defining the term request. Both of these terms are used in on the requirements of this part. ‘‘unexposed packaged animal food’’ to the context of process controls and both mean packaged animal food that is not have common meanings when 9. Reanalysis exposed to the environment and using associated with process controls. (Comment 89) Some comments this term throughout the rule. Doing so Therefore, it is not necessary for the rule request we define the term reanalysis to simplifies the regulatory text and makes to define them. mean a reassessment of the validity of it clearer.

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C. Additional Definitions To Clarify or hold safe animal food as appropriate principles and should be informed of Terms Not Defined in the Proposed Rule to the individuals assigned duties. A the danger of poor personal hygiene and qualified individual may be, but is not insanitary practices. We asked if the 1. Audit required to be, an employee of the recommendations should be As already noted, some comments ask establishment. requirements for employee education us to make the various rules we are and training (78 FR 64736 at 64778). In 4. Raw Agricultural Commodity establishing to implement FSMA addition, we requested comment on consistent with each other, and we have We have added a definition of the how best to implement section 418(o)(3) worked to align the provisions of this term ‘‘raw agricultural commodity’’ to of the FD&C Act and the rule with the provisions of the FSVP have the meaning given in section 201(r) recommendations of the CGMP Working rule to the extent practicable. (See of the FD&C Act. We decided to define Group for human food with respect to Comment 4 and Response 4.) To align this term in the rule to simplify the training (78 FR 64736 at 64778). We these provisions, we are establishing in provisions in part 507 that refer to raw requested comment on whether the rule this final rule a definition of ‘‘audit’’ agricultural commodities. should specify that each person engaged analogous to the definition of ‘‘audit’’ 5. Supply-Chain-Applied Control in animal food manufacturing, we proposed for the FSVP rule. For the processing, packing, or holding purposes of this rule, ‘‘audit’’ means the We have added a definition of the (including temporary and seasonal systematic, independent, and term ‘‘supply-chain-applied control’’ to personnel and supervisors) must receive documented examination (through mean a preventive control for a hazard training as appropriate to the person’s observation, investigation, records in a raw material or other ingredient duties; specifying the frequency of review, discussions with employees of when the hazard in the raw material or training (e.g., upon hiring and the audited entity, and, as appropriate, other ingredient is controlled before its periodically thereafter); specify that sampling and laboratory analysis) to receipt. We decided to define this term training include the principles of animal assess a supplier’s food safety processes in the rule to simplify the provisions in food hygiene and animal food safety, and procedures. part 507, and in this document, that including the importance of employee refer to preventive controls applied by 2. Full-Time Equivalent Employee health and personal hygiene, as applied a supplier before receipt by a receiving at the facility; and specify that records As discussed in Response 70, we have facility. document required training of personnel established a definition for ‘‘full-time and, if so, specify minimum equivalent employee’’ as a term used to 6. Written Procedures for Receiving Raw requirements for the documentation represent the number of employees of a Materials and Other Ingredients (e.g., the date of the training, the type of business entity for the purpose of We have added a definition of the training, and the person(s) trained). We determining whether the business term ‘‘written procedures for receiving also requested comment on whether to qualifies for the small business raw materials and other ingredients’’ to establish some or all of the potential exemption. The number of full-time mean written procedures to ensure that requirements for education and training equivalent employees is determined by raw materials and other ingredients are in subpart B, subpart C, or both. dividing the total number of hours of received only from suppliers approved salary or wages paid directly to by the receiving facility (or, when In the following paragraphs, we employees of the business entity and of necessary and appropriate, on a discuss comments that respond to our all of its subsidiaries and affiliates by temporary basis from unapproved requests for comment on potential the number of hours of work in 1 year, suppliers whose raw materials or other requirements for education and training 2,080 hours (i.e., 40 hours × 52 weeks). ingredients are subjected to adequate and whether to establish any If the result is not a whole number, verification activities before acceptance requirements in subpart B, subpart C, or round down to the next lowest whole for use). We decided to define this term both. After considering these comments, number. in the rule to simplify the provisions in we are establishing requirements for the part 507, and in this document, that qualifications of individuals engaged in 3. Qualified Individual refer to these procedures. manufacturing, processing, packing, or As discussed in section IX.A, we are holding animal food, as well as the clarifying in new § 507.4(b)(1) that each IX. Subpart A: Comments on associated recordkeeping requirements individual engaged in manufacturing, Qualifications of Individuals Who in new § 507.4 in subpart A. The processing, packing, or holding animal Manufacture, Process, Pack, or Hold regulatory text makes clear that these food (including temporary and seasonal Animal Food requirements, established in subpart A, personnel) or in the supervision thereof In the 2013 proposed preventive apply to individuals engaged in must have the education, training, or controls rule for animal food we manufacturing, processing, packing, or experience (or combination thereof) proposed that personnel responsible for holding animal food regardless of necessary to manufacture, process, pack, identifying sanitation failures or animal whether the individuals conduct these or hold safe animal food as appropriate food contamination should have a activities under the framework of the to the individual’s assigned duties. To background of education or experience, CGMPs established in subpart B or the better align with the FSVP rule, we use or a combination thereof, to provide a framework for hazard analysis and risk- the term ‘‘qualified individual’’ in new level of competency necessary for based preventive controls established in § 507.4 and are defining the term production of clean and safe animal subparts C, D, and E. The regulatory text ‘‘qualified individual’’ to mean a person food. Animal food handlers and also makes clear that the qualification who has the education, training, or supervisors should receive appropriate requirements apply to the recordkeeping experience (or a combination thereof) training in proper food handling requirements of subpart F. See table 5 necessary to manufacture, process, pack, techniques and food-protection for a description of these provisions.

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TABLE 5—PROVISIONS FOR QUALIFICATIONS OF INDIVIDUALS WHO MANUFACTURE, PROCESS, PACK OR HOLD ANIMAL FOOD

Proposed Final section designation section Description designation

507.4(a)(1) ...... N/A Applicability to individuals who manufacture, process, pack, or hold animal food subject to subparts B and F. 507.4(a)(2) ...... N/A Applicability to individuals who manufacture, process, pack, or hold animal food subject to subparts C, D, E, or F. 507.4(b)(1) ...... 507.14(b) Each individual engaged in manufacturing, processing, packing, or holding animal food must have the education, training, or experience (or combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appro- priate to the individual’s assigned duties. 507.4(b)(2) ...... 507.14(b) Required training in the principles of animal food hygiene and animal food safety, including the importance of employee health and personal hygiene. 507.4(c) ...... 507.14(c) Additional qualifications of supervisory personnel. 507.4(d) ...... 507.4(d) Records of required training. The required records are subject to the recordkeeping requirements of subpart F.

A. Applicability and Qualifications of for the facility’s preventive controls packing, or holding animal food All Individuals Engaged in qualified individuals be established (including temporary and seasonal Manufacturing, Processing, Packing, or under subpart C because this is directly personnel) or in the supervision thereof Holding Animal Food (Final § 507.4(a), related to the facility’s food safety plan. must have the education, training, or (b), and (d)) Other comments ask that training experience (or combination thereof) (Comment 92) Some comments prefer requirements be established in both necessary to manufacture, process, pack, that we continue to only provide subpart B and subpart C. Other or hold safe animal food as appropriate recommendations for education and comments say that including to the individual’s assigned duties training and allow the animal food requirements for education and training (§ 507.4(b)(1)). To better align with the industry to determine the appropriate in both subparts B and C would be forthcoming FSVP rule, we are using the level of specific employee training that confusing. term ‘‘qualified individual’’ in new may be needed. Some comments say (Response 92) We are establishing a § 507.4(b)(1) and are defining the term that we should allow facilities to series of requirements for the ‘‘qualified individual’’ to mean a person conduct employee training in a flexible qualifications of individuals engaged in who has the education, training, or manner, with the facility determining manufacturing, processing, packing, or experience (or combination thereof) the training content and frequency that holding animal food in new § 507.4. necessary to manufacture, process, pack, is appropriate for the duties of a given First, to clarify how these qualification or hold safe animal food as appropriate employee as they relate to ensuring the requirements apply to establishments to the individual’s assigned duties. A safe production and distribution of subject to subparts B and F, we are qualified individual may be, but is not animal food. requiring that the management of an required to be, an employee of the Some comments recommend that establishment ensure that all establishment. See the discussion of the employees be trained ‘‘initially’’ and individuals who manufacture, process, term ‘‘preventive controls qualified ‘‘periodically thereafter’’ but ask that we pack, or hold animal food subject to individual’’ in section VIII.A.10, recognize the seasonal nature of a subparts B and F are qualified to including a discussion of how we have facility’s workforce. Some comments perform their assigned duties changed the proposed term ‘‘qualified ask that the training include the (§ 507.4(a)(1)). To clarify how these individual’’ to ‘‘preventive controls principles of animal food hygiene and qualification requirements apply to qualified individual’’ because we are animal food safety, including the facilities, we are requiring that the establishing a new definition for importance of employee health and owner, operator, or agent in charge of a ‘‘qualified individual,’’ with a meaning personal hygiene as applied at the facility must ensure that all individuals distinct from ‘‘preventive controls facility. who manufacture, process, pack, or hold qualified individual.’’ Some comments ask that training animal food subject to subparts C, D, E, We also are requiring that each requirements be established in subpart or F are qualified to perform their individual engaged in manufacturing, B so that the requirements would also assigned duties (§ 507.4(a)(2)). processing, packing, or holding animal apply to establishments that We are not requiring training specific food (including temporary and seasonal manufacture, process, pack, or hold to the person’s assigned duties. Each personnel) or in the supervision thereof, animal food, including establishments establishment engaged in the receive training in the principles of that are not subject to FSMA’s manufacturing, processing, packing and animal food hygiene and animal food requirements for hazard analysis and holding of food for animal consumption safety, including the importance of risk-based preventive controls. Some would already have procedures in place employee health and personal hygiene, comments that recommend establishing to ensure that all individuals who as appropriate to the animal food, the the training requirement in subpart B manufacture, process, pack, or hold facility and the person’s assigned duties assert that training is more animal food know how to do their jobs. (see § 507.4(b)(2)). Records that appropriately considered a prerequisite However, to emphasize that we expect document this required training must be program than a preventive control that all individuals who conduct such established and maintained and are would belong in subpart C. activities to know how to do their jobs, subject to the recordkeeping Other comments ask that the training we are specifying that each individual requirements of subpart F (§ 507.4(d)). and related recordkeeping requirements engaged in manufacturing, processing, The rule does not specify the frequency

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of the required training. We expect that required training of personnel is we expect these training materials to be production employees will receive burdensome, arbitrary, and capricious. useful to small businesses to use for in- training before working in production (Response 93) The rule requires that house training. records that document training required operations. We expect that most B. Additional Requirements Applicable facilities will also provide some form of by § 507.4(b)(2) be established and maintained without prescribing any to Supervisory Personnel (Final refresher training. § 507.4(c)) We disagree that we should continue content of those records. Although one to only provide recommendations for approach to documenting training We proposed that responsibility for education and training. Although the would be to provide the date of training, ensuring compliance by all personnel comments express concern about overly a description of the training, and the with all requirements of this subpart prescriptive requirements that may not name of the person trained, the rule must be clearly assigned to competent consider variables that would affect an provides flexibility for each supervisory personnel in § 507.14(c). establishment’s training program (such establishment to document its training We are finalizing this provision in as training course content, training in a way that works best for that § 507.4(c). We are correcting ‘‘all provider, effectiveness of the course and establishment. We disagree that requirements of this subpart’’ to ‘‘all instructor and frequency of training per requiring records to document required requirements of this part.’’ As a topic, an employee’s type and length of training is burdensome, arbitrary, and conforming change for consistency with experience, nature of formal education, capricious in light of the flexibility the provisions of § 507.4(b), we are and the animal food product type and provided by the rule for the content of replacing the phrase ‘‘competent point in the animal food supply chain training records. supervisory personnel’’ with the phrase at which the employee works with the (Comment 94) Some comments agree ‘‘supervisory personnel who have the education, training, or experience (or a animal food product), the training that any requirements should include combination thereof) necessary to requirement we are establishing in the training appropriate to the person’s supervise the production safe animal rule provides flexibility for each duties but emphasize that the decision as to what is appropriate to the person’s food.’’ establishment to provide training, and assigned duties should be determined determine the scope and frequency of X. Subpart A: Comments on Proposed by the establishment. § 507.5—Exemptions the training, in a way that works best for (Response 94) The requirement for the establishment. employees to receive training in the We proposed to establish a series of We agree that it is appropriate to principles of animal food hygiene and exemptions from the requirements for establish training requirements so that animal food safety, including the hazard analysis and preventive controls the requirements apply to all importance of employee health and that would be established in subpart C, establishments that manufacture, personal hygiene, as appropriate to the with modified requirements in some process, pack, or hold animal food, person’s assigned duties, provides cases. including establishments that are not flexibility for the establishment to Some comments support one or more subject to FSMA’s requirements for provide training that is appropriate for of the proposed exemptions without hazard analysis and risk-based its employees in light of each person’s change. For example, some comments preventive controls, and we are assigned duties. However, the rule does note that the exemptions are specified establishing the qualification and not require training specific to the in FSMA and, thus, reflect the intent of training requirements in subpart A to person’s assigned duties. Congress. Some comments state that clarify the applicability of these (Comment 95) Some comments assert some exemptions (i.e., those for requirements to all establishments and that the training requirement would be products already subject to our facilities subject to part 507. Although an unreasonable burden for small regulations for the control of we agree that employees in facilities businesses and that companies may microbiological hazards for low-acid that are subject to the requirements for incur substantial cost for the time that canned foods (LACF)) make sense hazard analysis and risk-based workers would be in training rather than because they are risk-based. Other preventive controls need to understand in production. Some comments ask us comments that support one or more of their responsibilities under the facility’s to provide non-specific training the proposed exemptions ask us to food safety plan, we are setting forth a recommendations for smaller processors clarify particulars associated with these training requirement focused on the that need flexibility to control the cost exemptions or expand the scope of some principles of animal food hygiene and of training. Some comments assert that of these exemptions. Other comments animal food safety. We consider training the training and education requirements ask us to include additional exemptions in the principles of animal food hygiene must be accessible and flexible enough in the rule. and animal food safety, including the to allow employers to bring in In the remainder of this section, we importance of employee health and temporary help when demand is high discuss comments that ask us to clarify personal hygiene, to be fundamental to without causing a delay in hiring. the proposed exemptions or that the concept of CGMPs. We agree that (Response 95) All employees will disagree with, or suggest one or more establishing a training requirement in need enough training to do their job and changes to, the proposed exemptions. both subpart B and subpart C could be understand the importance of hygiene We also discuss comments that ask us confusing. for animal food safety. The training to include additional exemptions in the (Comment 93) Some comments agree offered does not need to be expensive rule. After considering these comments, that training should be documented and (e.g., offsite training or off-the-shelf we have revised the proposed assert that those records should show purchased training) and we expect that exemptions as shown in table 6 with the date of training, a description of the much of the training will be provided editorial and conforming changes as training, and the name of the person in-house by knowledgeable employees. shown in table 31. A key conforming trained. However, comments ask that we As discussed in Response 1, the FSPCA change that affects all proposed allow flexibility in the way these is developing a preventive controls exemptions from the requirements of records are kept. Other comments assert training curriculum. These training subpart C is that the final exemptions that requiring that records document materials will be available online, and are from the requirements of subpart E,

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as well as subpart C. As discussed in program in subpart E, rather than within section XL, the final rule establishes the subpart C as proposed. requirements for a supply-chain

TABLE 6—REVISIONS TO THE PROPOSED EXEMPTIONS

Section Exemption Modification

507.5(e) ...... From the requirements of subpart C for on-farm • Changes consequential to the revised ‘‘farm’’ definition—i.e., no packing or holding of food by a small or very longer identifying any packing or holding activities for any RACs. small business if the only packing and holding • Clarification that the modified requirements do not apply to on- activities subject to section 418 of the FD&C Act farm packing or holding of food by a very small business if the that the business conducts are the specified low- only packing and holding activities subject to section 418 of the risk packing or holding activity/animal food com- FD&C Act that the business conducts are the listed low-risk pack- binations. ing or holding activity/animal food combinations. • Updated animal food categories consistent with the animal food categories included in table 1 in the section 103(c)(1)(C) RA. • Additions of low-risk packing or holding activity/animal food com- binations as a result of an updated risk assessment. 507.5(f) ...... From the requirements of subpart C for on-farm • Changes consequential to the revised ‘‘farm’’ definition—i.e.: manufacturing/processing activities conducted by • No longer distinguishing between manufacturing/processing ac- a small or very small business for distribution into tivities conducted on a farm mixed-type facility’s own RACs and commerce if the only manufacturing/processing manufacturing/processing activities conducted on food other than the activities subject to section 418 of the FD&C Act farm mixed-type facility’s own RACs; and that the business conducts are the specified low- • Eliminating activities, conducted on others’ RACs, that would no risk manufacturing/processing activity/animal food longer be classified as manufacturing/processing and instead would combinations. be classified as harvesting, packing, or holding. • Clarification that the modified requirements do not apply to on- farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/ processing activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk manufacturing/proc- essing activity/animal food combinations. • Updated animal food categories consistent with the animal food categories included in table 1 in the section 103(c)(1)(C) RA. • Additions of low-risk manufacturing/processing activity/animal food combinations as a result of an updated risk assessment. 507.5(h) ...... From the requirements of subpart B for the holding Change from an exemption for specific activities (i.e., holding and and transportation of RACs. transportation of RACs) to facilities solely engaged in those activi- ties.

A. General Comments on the Proposed transportation of one or more RACs; (2) operation depends on the type of Exemptions hulling, shelling, and drying nuts and operation and the activities it is hulls (without manufacturing/ conducting. We believe the exemptions (Comment 96) Some comments ask us processing, such as grinding shells or as codified provide enough specificity to provide the same flexibility for roasting nuts); and (3) ginning of cotton for a facility to determine whether it foreign small businesses as for domestic (without manufacturing/processing, must comply with or is exempt from small businesses. such as extracting oil from cottonseed)). this final regulation, or certain (Response 96) The exemptions apply (Comment 98) Some comments provisions of the final regulation. to both foreign small businesses and request that we clearly articulate what (Comment 99) One comment domestic small businesses. activities are not covered and why; as expressed the opinion that exemptions (Comment 97) Some comments ask us well as what activities we are should be driven by risk of activities to clarify whether an establishment that specifically exempting and why. This rather than by whether they are is exempt from the requirements for comment requests clarification about conducted on or off a farm. hazard analysis and risk-based the differences between the categories of (Response 99) Consistent with the preventive controls in subpart C ‘‘not covered’’ and ‘‘exempt.’’ statutory direction in section 103(c) of remains subject to the CGMP (Response 98) We use the terms ‘‘not FSMA, including conducting a requirments in subpart B. covered’’ and ‘‘exempt’’ interchangeably qualitative risk assessment, we have (Response 97) An establishment that to describe what animal food operations finalized exemptions for on-farm is exempt from the requirements for or activities within an operation are not activity/animal food combinations hazard analysis and risk-based required to comply with all or parts of conducted by farm-mixed-type facilities preventive controls in subparts C and E this rule. Farms, for example, are ‘‘not that are small or very small businesses remains subject to the CGMP covered’’ by this rule, as established in as discussed further in sections VI and requirements in subpart B, unless that § 507.5, which lists certain exemptions. X. establishment is specifically exempt As another example, a business meeting from subpart B under § 507.5(a) (which the very small business criteria is a B. Proposed § 507.5(a)—Exemption for applies to farms and activities of ‘‘farm qualified facility subject to the Facilities Not Required To Register mixed-type facilities’’ that fall within requirements of § 507.7, but ‘‘exempt’’ Under Section 415 Regulations the definition of ‘‘farm’’); or § 507.5(h) from the requirements of subparts C and We proposed that this part does not (which applies to: (1) Establishments E (see § 507.5(d)). Whether a particular apply to establishments, including solely engaged in the holding or exemption applies to an animal food ‘‘farms’’ (as defined in § 1.227 of this

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chapter), that are not required to register requested comment on the criteria that plan. As with facilities subject to our under section 415 of the FD&C Act. should be used to determine whether a HACCP regulations, we expect that However, we proposed that subpart B facility is in compliance with § 500.23 situations in which enforcement actions would apply to the packaging, packing, and part 113 (78 FR 64736 at 64762). to ensure compliance with part 113 are and holding of dried commodities if a (Comment 101) Some comments insufficient to correct problems, and ‘‘farm’’ or ‘‘farm mixed-type facility’’ express concern that the partial lead to a facility losing its exemption dries/dehydrates raw agricultural exemption for products subject to part from the requirements of subparts C and commodities that are produce to create 113 could generate confusion for both E, will be rare and will depend on very a distinct commodity. regulators and regulated facilities. These specific circumstances. Therefore, at After reviewing all of the comments comments also assert that the partial this time we do not anticipate issuing concerning raw agricultural exemption for products subject to part guidance on when violations of part 113 commodities as discussed elsewhere in 113 would generate duplicative could lead to this outcome. this final rule, we have removed the recordkeeping requirements under the requirement that subpart B would apply two rules. D. Proposed § 507.5(c)—Exemption to the packaging, packing, and holding (Response 101) We acknowledge the Applicable to Activities Subject to of dried commodities from a ‘‘farm’’ or potential for confusion and expect any Standards for Produce Safety in Section ‘‘farm mixed-type facility’’ that dries/ confusion to decrease over time as both 419 of the FD&C Act dehydrates RACs that are produce to regulators and facilities gain experience We proposed that subpart C would create a distinct commodity. We have with the new requirements. We also not apply to activities of a facility that made this change because produce expect that in most instances a facility are subject to section 419 of the FD&C RACs are not typically dried or that is subject to § 500.23 and part 113, Act (Standards for Produce Safety) of dehydrated to create distinct animal and that evaluates potential the FD&C Act (21 U.S.C. 350h). microbiological hazards as part of its food commodities, as they are to create (Comment 103) Some comments hazard analysis, would conclude that human food commodities (e.g., drying/ request that we broaden the exemption the potential hazards are controlled by dehydrating grapes to make raisins). to operations that handle culls of raw, (Comment 100) One comment the targeted requirements of part 113 intact, fresh produce. One comment requests that we provide clarity and and conclude there are no significant requested that fresh citrus be considered examples for animal food facilities that microbiological hazards that require a low risk product or excluded from the are exempt from facility registration and preventive controls to significantly rule entirely. This comment requested therefore exempt from compliance with minimize or prevent the hazards. that culls should not be considered a by- part 507 because they are considered We disagree that the partial product of fresh citrus production. restaurants or retail food establishments. exemption for products subject to part (Response 100) Our food facility 113 would generate duplicative (Response 103) We decline these registration requirements are found in recordkeeping requirements. The requests. We have included a provision 21 CFR part 1, subpart H. Specifically, requirements of part 113 to control under § 507.12 that exempts by- ‘‘restaurant’’ and ‘‘retail food biological hazards are different from the products of off-farm packing and establishment’’ are defined in 1.227(b). requirements of subparts C and E to holding of RACs for animal food use Additional information may be found in conduct a hazard evaluation for from most of part 507 if ‘‘the human our ‘‘Guidance for Industry: Questions chemical and physical hazards, and food facility is subject to and in and Answers Regarding Food Facility implement preventive controls and compliance with § 117.8 of part 117, Registration (Sixth Edition)’’ (Ref. 23). associated preventive control and in compliance with all applicable As discussed in section I.E. of the final management components to address human food safety requirements of the rule for preventive controls for human significant chemical and physical Federal Food, Drug, and Cosmetic Act food published elsewhere in this issue hazards. Likewise, the records and implementing regulations.’’ The of the Federal Register, we are associated with the control of biological human food facility also must not addressing the requirements of section hazards under part 113 are not the same further manufacture or process the by- 102(c) of FSMA in a separate as the records associated with a hazard products intended for use as animal rulemaking and issued a separate analysis, preventive controls, and food. The resulting animal food must be proposed rule to amend the definition of associated preventive control held and distributed in accordance with ‘‘retail food establishment’’ in the management components for control of the CGMPs for the holding and section 415 registration regulations and chemical and physical hazards. distribution of human food by-products the section 414 recordkeeping However, to the extent that a facility for use as animal food in § 507.28 and regulations (80 FR 19160, April 9, 2015). determines that existing records § 117.95. Thus, facilities subject to and required by part 113 can be used to in compliance with § 117.8 and C. Proposed § 507.5(b)—Exemption comply with the requirements of applicable safety requirements of the Applicable to Food Subject to 21 CFR subparts C and E, a facility may rely on FD&C Act and its implementing Part 113—Thermally Processed Low- those records (see § 507.212). regulations, that pack or hold produce Acid Foods Packaged in Hermetically (Comment 102) Some comments ask culls off-farm for use as animal food Sealed Containers us to provide guidance to industry and (without manufacturing or processing We proposed that activities in animal the regulatory community regarding the the culls) would be exempt from part food facilities that are regulated under criteria that will be used to determine 507, except for the limited holding and and are in compliance with § 500.23 and when a facility is ‘‘in compliance with’’ distribution CGMPs in § 507.28. part 113 would be exempt from subpart part 113. Facilities that manufacture or process C only with respect to microbiological (Response 102) As an example, an culls of raw, intact, fresh produce for hazards regulated under part 113. We LACF manufacturing facility that has use as animal food would be subject to further proposed that the facilities must ongoing problems controlling biological part 507. Activities, such as packing comply with subparts C and F with hazards may be better able to address fresh citrus, of a facility that is subject regard to all other potential hazards and biological hazards by preparing and to section 419 of the FD&C Act are must comply with subparts A and B. We implementing a written food safety exempt from subparts C.

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E. Proposed § 507.5(d)—Exemption requirements for hazard analysis and (Response 107) We intend to Applicable to a Qualified Facility risk-based preventive controls, and will recommend in guidance how a qualified We proposed that subpart C would instead be subject to other requirements, facility could comply with the not apply to a qualified facility, except will produce a small portion of the requirements in § 507.7 without as provided by subpart D (Withdrawal animal food at potential risk of causing satisfying all of the requirements in of an Exemption Applicable to a foodborne illness (see the discussion at subparts C and E. Qualified Facility), and that qualified 79 FR 58476 at 58502). (Comment 105) Some comments F. Proposed § 507.5(e) and (f)— facilities would be subject to the assert that a qualified facility should be Exemptions Applicable to On-Farm requirements in § 507.7. exempt from the CGMP requirements of Low-Risk Activity/Animal Food (Comment 104) Some comments subpart B, as well as the requirements Combinations Conducted by a Small or support the proposed exemption for a for hazard analysis and risk-based Very Small Business qualified facility. Other comments preventive controls in subpart C. As discussed in section VI.A, oppose this proposed exemption, (Response 105) The exemption for consistent with the statutory direction asserting that it is not risk based and qualified facilities is expressly directed in section 103(c) of FSMA, including expressing concern that qualified by section 418(l) of the FD&C Act and conducting a qualitative risk facilities would cause significant food is limited to an exemption from the assessment, we proposed three safety problems. Some comments ask us requirements for hazard analysis and exemptions for on-farm activity/food to strictly construct and narrowly apply risk-based preventive controls in combinations conducted by farm-mixed- the exemptions to as few businesses as subparts C and E. The comments type facilities that are small or very possible. provide no basis for why new statutory small businesses (proposed §§ 507.5(e), Some comments do not agree that requirements for hazard analysis and (f)(1), and (f)(2)). qualified facilities should be subject to risk-based preventive controls should in 1. General Comments on the Proposed modified requirements because even the any way impact CGMP requirements Exemptions Applicable to On-Farm modified requirements are burdensome. that apply to the manufacturing, Low-Risk Activity/Animal Food Some comments assert that qualified processing, packing, and holding of Combinations Conducted by a Small or facilities having an average annual value animal food. CGMPs provide the basic Very Small Business of animal food sold during the previous requirements for ensuring production of 3-year period of $10,000 or less should safe animal food. Following the CGMPs (Comment 108) Some comments be exempt from all requirements related is essential to properly address public assert that conducting a low-risk to hazard analysis and risk-based (human and animal) health risks from activity/food combination should be preventive controls, including modified very small facilities that are provided an sufficient to qualify any facility for requirements. One comment does not exemption from subparts C and E in exemption from subpart C, regardless of specify an amount of annual sales of order to minimize the burden on such whether the activity is conducted on- animal food, but states that whether a facilities. farm or off-farm, or meets the economic facility is a qualified facility should be (Comment 106) Some comments ask threshold for a small or very small based on whether the facility has caused us to provide that a qualified facility business. any reported injury or illness to humans may voluntarily choose to comply with (Response 108) The statute provides or animals. the requirements for hazard analysis specific direction for those facilities that (Response 104) The exemption for and preventive controls. can qualify for this exemption. (See qualified facilities, including the criteria (Response 106) A qualified facility sections 418(l) and 418(o)(2) of the for being a qualified facility and the may voluntarily choose to comply with FD&C Act.) See also Response 104 in applicability of modified requirements, the requirements for hazard analysis this final rule, and Responses 220 and is expressly directed by section 418(l) of and risk-based preventive controls 222 in the final rule for preventive the FD&C Act. In defining ‘‘very small without a specific provision authorizing controls for human food published business’’ to mean a business (including it to do so. One way that a qualified elsewhere in this issue of the Federal any subsidiaries or affiliates) averaging facility could comply voluntarily would Register. less than $2,500,000, adjusted for be to simply not submit the attestation (Comment 109) Some comments state inflation, per year, during the 3-year that it is a qualified facility (see that the exemptions for farming period preceding the applicable § 507.7(b) for the requirement for a activities are confusing. calendar year in sales of animal food qualified facility to submit an attestation (Response 109) The activity/animal plus the market value of animal food regarding its status as a qualified food combinations listed in § 507.5(e) manufactured, processed, packed, or facility). When we inspect the facility, are directed to an exemption for packing held without sale (e.g., held for a fee or we would inspect the facility for and holding activities, whereas the supplied to a farm without sale), we compliance with the requirements for activity/animal food combinations listed constructed this exemption to apply to hazard analysis and risk-based in § 507.5(f) are directed to an businesses that, collectively, produce preventive controls. Another way for a exemption for manufacturing/ less than 2 percent of the dollar value facility to voluntarily comply would be processing activities. Although these of animal food produced in the United to submit the attestation, and specify exemptions are more complex than States. This is comparable to the that it will satisfy the statutory other exemptions (e.g., because they are percentage of the human food supply documentation requirement through directed to specific activities conducted that is exempt under the definition of documentation of its food safety on specific animal foods), the final very small business for human food (see practices rather than documentation ‘‘farm’’ definition has simplified them to section XI.B of the final rule for that it is in compliance with non- the extent practicable. For example, preventive controls for human food Federal food safety law. under the ‘‘farm’’ definition in the 2013 published elsewhere in this issue of the (Comment 107) Some comments ask proposed human preventive controls Federal Register). As previously us to specify in guidance that a qualified rule, whether an activity was packing or discussed in section VIII.A.36, the facility is not required to prepare and manufacturing/processing depended, in businesses that will be exempt from the implement a food safety plan. part, on whether the RACs being packed

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were the farm’s own RACs or others’ that the business conducts are the listed consequential change in light of the RACs. In contrast, under the ‘‘farm’’ low-risk manufacturing/processing final ‘‘farm’’ definition established in definition established in the final rule activity/animal food combinations. the final rule for preventive controls for for preventive controls for human food With these changes, a farm mixed- human food published elsewhere in this published elsewhere in this Federal type facility that is a very small business Federal Register, the exemption no Register, packing RACs is a ‘‘packing’’ and that only conducts the low-risk longer identifies any packing or holding activity, regardless of ownership of the activity/animal food combinations listed activities for any RACs (whether the RACs being packed. in § 507.5(e) and/or (f) may find it farm’s own RACs or others’ RACs), (Comment 110) Some comments note advantageous to classify itself as a very because an on-farm establishment a distinction between the exemptions small business eligible for the would no longer be subject to the for on-farm low-risk activity/animal exemption in § 507.5(e) and/or (f) rather requirements for hazard analysis and food combinations conducted by small than as a qualified facility, which would risk-based preventive controls (subpart and very small businesses and the be subject to the requirements in C) when it packs or holds RACs, exemption for qualified facilities. § 507.7. regardless of whether it is packing and Specifically, the comments state that a (Comment 111) Some comments ask holding its own RACs or others’ RACs. farm mixed-type facility that only for a process to keep the list of low-risk In light of the change in the ‘‘farm’’ conducts low-risk activity/animal food activity/food combinations up to date, definition, we have revised the section combinations (such as grinding grains) such as through guidance. 103(c)(1)(C) RA, starting with the list of would be exempt from the requirements (Response 111) We decline this on-farm activity/animal food of subpart C, whereas an off-farm request. The exemptions established in combinations outside the farm qualified facility grinding grains, while this rule are binding, whereas any list of definition in table 1, to exclude packing exempt from the requirements of additional activity/animal food and holding of RACs. subpart C, would nonetheless be subject combinations established in a guidance to the requirements for a qualified document would not be binding. We 3. Proposed § 507.5(f)—Exemption facility in § 507.7. These comments ask established the list of activity/animal Applicable to On-Farm Low-Risk whether it would be better for a farm or food combinations included in these Manufacturing/Processing Activity/ farm mixed-type facility that satisfies exemptions through an extensive public Animal Food Combinations Conducted criteria for a small or very small process, including a request for by a Small or Very Small Business business, and also satisfies criteria for a comments on the section 103(c)(1)(C) We proposed that subpart C would qualified facility, to classify itself as a draft RA. From this time forward, the not apply to on-farm low-risk small or very small business or to process available to a person who manufacturing/processing activities classify itself as a qualified facility. wishes us to consider an additional conducted by a small or very small (Response 110) In light of the final activity/animal food combination is to business if the only manufacturing/ ‘‘farm’’ definition, these comments no submit a citizen petition in accordance processing activities subject to section longer apply with respect to activities with 21 CFR 10.30. 418 of the FD&C Act that the business within the farm definition. conducts are those listed in the For activities conducted by a farm 2. Proposed § 507.5(e)—Exemption proposed exemption. The proposed mixed-type facility, we acknowledge Applicable to On-Farm Low-Risk exemption specified those activity/ that the exemptions provided by Packing or Holding Activity/Animal animal food combinations that would be § 507.5(e) and (f) for on-farm low-risk Food Combinations Conducted by a exempt when conducted on a farm activity/animal food combinations are Small or Very Small Business mixed-type facility’s own RACs and different from the exemption provided We proposed that subpart C would those activity/animal food combinations by § 507.5(a) for a qualified facility. A not apply to on-farm packing or holding that would be exempt when conducted farm mixed-type facility that only of animal food by a small or very small on animal food other than the farm conducts low-risk activity/animal food business if the only packing and holding mixed-type facility’s own RACs for combinations listed in § 507.5(e) and (f) activities subject to section 418 of the distribution into commerce. is fully exempt from the requirements of FD&C Act that the business conducts are As a consequential change in light of subparts C and E, and is not subject to low-risk packing or holding activity/ the final ‘‘farm’’ definition, the final the requirements for a qualified facility animal food combinations on animal exemption no longer distinguishes in § 507.7, even if that farm mixed-type food not grown, raised, or consumed on between manufacturing/processing facility is also a very small business that farm mixed-type facility or another activities conducted on a farm mixed- (and, thus, also is a qualified facility). farm or farm mixed-type facility under type facility’s own RACs and To make this clear, we have revised the same ownership. manufacturing/processing activities proposed § 507.5(e) to specify that (Comment 112) Many comments state conducted on animal food other than § 507.7 does not apply to on-farm that it is common practice among farms the farm mixed-type facility’s own packing or holding of animal food by a to hold RACs from farms under different RACs. As another consequential change, very small business if the only packing ownership and that classifying the exemption has been revised to and holding activities subject to section establishments as being within the eliminate activities, conducted on 418 of the FD&C Act that the business ‘‘farm’’ definition, or outside the ‘‘farm’’ others’ RACs, which no longer are conducts are the listed low-risk packing definition, based on who owns the classified as manufacturing/processing or holding activity/animal food RACs being packed is not a risk-based and instead are classified as harvesting, combinations. Likewise, we have classification. packing, or holding. In addition, we revised proposed § 507.5(f) to specify (Response 112) We proposed a revised have revised the final exemption to list that § 507.7 does not apply to on-farm definition of ‘‘farm’’ in the 2014 animal food categories consistent with manufacturing/processing activities preventive controls supplemental notice the animal food categories included in conducted by a very small business for for human food to include packing and table 1 in the section 103(c)(1)(C) RA distribution into commerce, if the only holding of RACs grown on another farm (Ref. 3), modified in response to manufacturing/processing activities not under the same ownership (79 FR revisions of the ‘‘farm’’ definition. (See subject to section 418 of the FD&C Act 58524 at 58531 through 58532). As a Response 112.) In constructing

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categories of animal food based upon proposed exemption would apply to concerns than their non-genetically the new ‘‘farm’’ definition, we grouped specific circumstances. engineered counterparts. We have a together processed grain products (e.g., (Comment 115) Some comments ask voluntary consultation process for foods flour, grits, etc.) and grain by-products whether this proposed exemption derived from genetically engineered (e.g., brewers’ grain, distillers’ grain, (proposed § 507.5(g)) would apply to plants through which we engage with and corn gluten meal). The category facilities such as peanut buying points the developers of genetically engineered does not include culled products from or bean elevators and assert that such plants to help ensure the safety of the processing grain for human food such as commodities are analogous to grains derived foods. Foods that have misshapen pasta. Pasta used in animal and the activities conducted at such undergone this consultation process are food falls under a new category (any facilities are analogous to those as safe as foods from conventionally other animal food that does not require performed by grain elevators. bred plants. Foods derived from time/temperature control for safety) that (Response 115) We classify peanuts genetically engineered plants, was added to include the wide range of and beans (such as kidney beans, lima irrespective of the method of possibilities for animal food that was beans, and pinto beans) within the development, are subject to the same originally processed to be human food, category of ‘‘fruits and vegetables’’; we food safety and other regulatory as well as other types of animal food not classify soybeans as grain (see the requirements as foods derived from listed separately. discussion of grains at 78 FR 64736 at conventionally-bred plants. Therefore (Comment 113) Some comments ask 64764 and 79 FR 58476 at 5848, and genetically engineered foods do not us to include in the exemption a single fruits and vegetables at 78 FR 3646 at need to be singled out as a hazard. list of low-risk manufacturing/ 3690 and proposed §§ 112.1 and 112.2 (Comment 117) Some comments processing activity/food combinations in the proposed produce safety rule). assert that the exemption for storage of applicable to farm mixed-type facilities The exemption for facilities solely raw agricultural commodities (other conducting activities on their own RACs engaged in storage of RACs intended for than fruits and vegetables) should and farm mixed-type facilities further distribution or processing does extend to those distinct and physically conducting activities on other’s RACs. not apply to facilities that store fruit and separate portions of oilseed processing (Response 113) These comments no vegetable RACs and, thus, does not facilities that are devoted solely to RAC longer apply. As a consequence of the apply to facilities such as peanut buying storage. According to these comments, ‘‘farm’’ definition established by the points and bean elevators. As discussed in the overwhelming majority of cases final rule for preventive controls for in section IV.B, we have revised the the inclusion of a separate RAC storage human food published elsewhere in this ‘‘farm’’ definition to provide that an area in the same building as the oilseed Federal Register, the exemption no operation devoted only to the harvesting processing area will not introduce longer distinguishes between (such as hulling or shelling), packing, additional risk either to the processing manufacturing/processing activities and/or holding of RACs is within the area or to the operations that take place conducted on a farm mixed-type ‘‘farm’’ definition, provided that the there and that storage areas, whether facility’s own RACs and manufacturing/ farms that grow or raise the majority of standing alone as a separate facility or processing activities conducted on the RACs harvested, packed, and/or incorporated into a larger processing animal food other than the farm mixed- held by the operation own, or jointly facility, store RACs safely. These type facility’s own RACs. own, a majority interest in the comments ask us to recognize that (Comment 114) Some comments ask operation. With this revision, some storage activities may include grain us to include manufacturing of animal operations dedicated to holding RACs, drying to standardize moisture levels food from low risk ingredients as including fruit and vegetable RACs, will and preserve product quality. additional activity/animal food be within the ‘‘farm’’ definition. (Response 117) The activities combinations in the exemption. Other Peanut buying points and bean included within the definition of comments support our conclusion that elevators that do not meet the revised holding include activities that are manufacturing animal food ready for farm definition are storing RACs that are performed as a practical necessity for consumption is not a low risk activity. ‘‘fruits and vegetables’’ and do not meet the distribution of RACs. In the 2014 (Response 114) We evaluated the criteria for exemption under supplemental notice, we explained that manufacturing of animal food as one of § 507.5(g). However, we would not facilities that conduct operations similar the activity/animal food combinations expect such facilities to need an to those conducted at grain elevators within the qualitative risk assessment extensive food safety plan. A facility and silos, such as some facilities that (Ref. 3). The 103(c)(1)(C) RA explains that appropriately determines through hold oilseeds, may satisfy the criteria for why we determined that manufacturing its hazard analysis that there are no exemption if activities other than animal food ready for consumption is hazards requiring preventive controls storage are performed as a practical not a low-risk activity/animal food would document that determination in necessity for the distribution of RACs combination. its written hazard analysis but would (see 79 FR 58476 at 58483 and the not need to establish preventive controls definition of ‘‘holding’’ in § 507.3). G. Proposed § 507.5(g)—Exemption and associated management Examples of holding activities include Applicable to Facilities Solely Engaged components. drying/dehydrating RACs when the in Storage of Raw Agricultural (Comment 116) One comment states drying/dehydrating does not create a Commodities Other Than Fruits and that genetically modified food should be distinct commodity (see § 507.3). Thus, Vegetables Intended for Further added to the list of hazards that are seen the specific example of drying grains to Distribution or Processing as potential risks for animals. standardize moisture levels and We proposed that subpart C would (Response 116) We decline this preserve product quality would fall not apply to facilities that are solely request. We have not seen evidence that within the definition of holding as a engaged in the storage of RACs (other foods derived from genetically practical necessity for the distribution of than fruits and vegetables) intended for engineered plants differ from other RACs. A facility that stores oilseeds, and further distribution or processing. In the foods in any meaningful or uniform dries them as a practical necessity for following paragraphs, we discuss way, or that, as a class, such foods the distribution of RACs, would be comments that ask us to clarify how the present different or greater safety covered by the exemption in § 507.5(g).

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However, we decline the request to 117, the activities included within the to enforce the CGMP requirements). For modify the exemption in § 507.5(g) to definition of holding include activities example, it does not make sense for the also apply to distinct and physically that are performed as a practical part of a facility that holds RACs prior separate storage areas that are used necessity for the distribution of RACs. to processing to be exempt and the parts solely for storage of RACs (other than Under § 507.5(h), subpart B does not of the facility that are processing the fruits and vegetables) intended for apply to the holding or transportation of RACs and storing them after processing further distribution or processing. To one or more RACs. (See section X.H.) to be covered. Likewise, it does not the extent that the comments are asking make sense for part of a transportation H. Proposed § 507.5(h)—Exemption us to do so to provide for facilities that vehicle to be covered and part to be Applicable to the Holding or conduct activities as a practical exempt. Transportation of One or More Raw necessity for the distribution of RACs to By revising the proposed ‘‘RAC Agricultural Commodities be eligible for the exemption, doing so exemption’’ so that it applies only to is not necessary in light of the definition We proposed to provide that subpart establishments ‘‘solely engaged’’ in the of holding. To the extent that the B would not apply to the holding or storage or transportation of RACs, we comments are asking us to do so to transportation of one or more RACs as are providing for a predictable provide for facilities that conduct defined in section 201(r) of the FD&C framework for interpreting exemptions manufacturing/processing activities in Act. for facilities ‘‘solely engaged’’ in other addition to holding activities, we (Comment 119) Some comments ask activities. For example, as discussed in disagree that doing so would be us to include the term ‘‘packing’’ in Comment 117, comments ask us to consistent with the statutory direction § 507.5(h) to say ‘‘Subpart B of this part expand the exemption (in § 507.5(g)) in FSMA. As previously discussed, does not apply to the packing and from the requirements for hazard section 418(m) of the FD&C Act holding or transportation of one or more analysis and risk-based preventive provides in relevant part that we may by raw agricultural commodities as defined controls for facilities that are ‘‘solely regulation exempt or modify the in section 201(r) of the Federal Food, engaged’’ in the storage of RACs (other requirements for compliance under Drug, and Cosmetic Act.’’ than fruits and vegetables) intended for section 418 of the FD&C Act with (Response 119) We decline the further distribution or processing to also respect to facilities that are solely request to add the term ‘‘packing’’ to apply to distinct and physically separate engaged in the storage of RACs (other § 507.5(h). As discussed in Response storage areas that are used solely for than fruits and vegetables) intended for 117, the activities included within the storage of such RACs. In our response, further distribution or processing (78 FR definition of holding include activities we noted that facilities that conduct 64736 at 64764). The plain meaning of that are performed as a practical manufacturing/processing activities in ‘‘solely’’ is only, completely, entirely; necessity for the distribution of RACs. addition to holding activities are not without another or others; singly; alone (Comment 120) Some comments ask ‘‘solely engaged’’ in the storage of such (Ref. 24). Facilities that conduct us to clarify that CGMP requirements RACs (see Response 117). In addition, as manufacturing/processing activities in (such as using protective coverings discussed in Comment 146, comments addition to holding activities are not where necessary and appropriate ask us to apply the exemption (in ‘‘solely’’ engaged in the storage of RACs (§ 507.17(c)) do not apply to the bulk § 507.10) from the requirements for (other than fruits and vegetables) outdoor storage of RACs for further hazard analysis and risk-based intended for further distribution and processing. preventive controls for facilities that are processing. (Response 120) We are returning to ‘‘solely engaged’’ in the storage of (Comment 118) Some comments the longstanding approach that the unexposed packaged food to storage request that the language of § 507.5(g) exemption applies to establishments areas of facilities that also engage in explicitly state that the exemption from ‘‘solely engaged’’ in specific activities. food processing activities, e.g., for subpart C would apply to facilities that Under the exemption we are distributors that are engaged in limited are solely engaged in the packing and establishing in § 507.5(h)(1), those food processing, such as blending seeds holding of raw agricultural commodities activities are holding and transportation to make bird food. In our response, we (other than fruits and vegetables) of RACs. We explain why in the noted that such distributors are not intended for further distribution or following paragraphs. ‘‘solely’’ engaged in the storage of processing. These comments indicate These comments appear to interpret unexposed packaged animal food (see that packing is frequently involved the proposed exemption in a way that Response 146). when a facility distributes raw goes beyond the longstanding ‘‘RAC The exemption we are establishing in agricultural commodities that they have exemption’’ in the human food CGMPs this rule for establishments solely been holding. They cite the § 110.19(a) in § 110.19 and is inconsistent with the engaged in the storage or transportation exemption from the human food CGMP intent in updating § 110.19 to adjust and of RACs remains consistent with our regulation for establishments ‘‘engaged clarify what activities fall within this announced intent to adjust and clarify solely in the harvesting, storage, or exemption based on experience and what activities fall within this distribution of one or more ‘raw changes in related areas of the law since exemption based, in part, on changes in agricultural commodities’ ’’ and remark issuance of this exemption from the related areas of the law since this that in application of the regulation, the CGMPs (78 FR 64736 at 64764 and 78 exemption from the CGMP requirements activity of packing has been FR 3646 at 3710). The suggestion of was first issued. As discussed in section encompassed within the term these comments, i.e., that CGMPs IV of the final rule for preventive ‘‘distribution.’’ In addition, some should not apply to the holding of controls for human food, published comments ask that the exemption RACS in a facility that manufactures, elsewhere in this issue of the Federal proposed in § 507.5(g) be extended to an processes, or packs RACs—would not Register, we have made a number of exemption from subpart B, as well as make sense in some circumstances and changes to the ‘‘farm’’ definition, from subpart C. would create complex situations for including changes that provide for an (Response 118) We decline the establishments (in determining how to operation devoted to harvesting, request to add the term ‘‘packing’’ to comply with the CGMP requirements) packing, and/or holding of RACs to be § 507.5(g). As discussed in Response and for regulators (in determining how a ‘‘farm’’ (i.e., a ‘‘secondary activities

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farm’’) (and, thus, be exempt from the within the ‘‘farm’’ definition when farm or farm mixed-type facility. CGMP requirements under § 507.5(a)) conducted on a farm or farm mixed-type Drying/dehydrating the cottonseed even though the operation does not facility. As discussed in section IV.B of without further processing is a holding grow RACs (see § 507.3). With this the final rule for preventive controls for activity that also is within the ‘‘farm’’ revised ‘‘farm’’ definition, some human food (published elsewhere in definition when conducted on a farm or establishments solely engaged in the this issue of the Federal Register) we farm mixed-type facility. (See Response ‘‘storage’’ of RACs will be exempt from have revised the ‘‘farm’’ definition to 122 for a discussion on modification to the CGMP requirements because they provide that an operation, not the farm definition). When done on a are a ‘‘farm.’’ For further discussion on conducted on a Primary Production primary production farm or by a this provision, see section XI.J in the Farm, devoted to the harvesting (such as secondary activities farm, these final rule for preventive controls for hulling or shelling), packing, and/or activities (ginning, drying, dehydrating) human food. holding of RACs is within the ‘‘farm’’ would not be subject to CGMPs, and definition (as a ‘‘secondary activities these activities do not transform the I. Comments Requesting Additional farm’’), provided that the primary RAC into a processed food. Therefore, Exemptions production farm(s) that grow or raise the we have added regulatory text in (Comment 121) Some comments majority of the RACs harvested, packed, § 507.5(h)(2) to provide an exemption request additional exemptions from the and/or held by the secondary activities from subpart B for the ginning of cotton requirements for hazard analysis and farm own, or jointly own, a majority (without further manufacturing/ risk-based preventive controls in interest in the operation. Non-farm processing) by a non-farm cotton subpart C, the CGMP requirements of facilities dedicated to the hulling, ginning facility because of the similarity subpart B, or both. shelling, and drying of nuts and hulls between a farm-owned operation and a (Response 121) We believe that our perform the same activities as those non-farm owned facility (See Response CGMP regulations, coupled with performed by farms. When done on a 122). However, non-farm facilities are implementation of FSMA’s directives to primary production farm or by a not exempt from subparts C and E under focus more on preventing food safety secondary activities farm, those § 507.5(g) as they are not solely engaged problems than on reacting to problems activities would not be subject to in the storage of raw agricultural after they occur, will play an important CGMPs. Furthermore, these activities do commodities. A facility that role in increasing animal food safety. not transform the RAC into a processed appropriately determines through its We did not propose any exemptions or food. Therefore, we have added hazard analysis that there are no exceptions from the requirements of regulatory text in § 507.5(h) to provide hazards requiring preventive controls subpart C other than those authorized an exemption from subpart B for would document that determination in by section 103 of FSMA (78 FR 64736 hulling, shelling, and drying nuts and its written hazard analysis but would at 64743 through 64744). We drew on hulls (without further manufacturing/ not need to establish preventive controls our experience with the CGMP processing) by a non-farm hulling/ and associated management regulation for human food and changes shelling/drying facility because of the components. in related areas of the FD&C Act since similarity in the activities of a farm- XI. Subpart A: Comments on Proposed issuance of the CGMP regulation (78 FR owned operation and a non-farm owned § 507.7—Requirements That Apply to a 3646 at 3709 through 3711) to adjust facility. However, non-farm facilities are Qualified Facility and clarify what activities fall within a not exempt from subparts C and E under longstanding exclusion related to raw § 507.5(g) as they are not solely engaged As previously discussed (78 FR 64736 agricultural commodities (see § 110.19) in the storage of raw agricultural at 64765), sections 418(l)(2)(A) and (B) and to modify the CGMPs for human commodities. A facility that of the FD&C Act provide that a qualified food by-products for use as food for appropriately determines through its facility must submit two types of animals. hazard analysis that there are no documentation to us. The first type of (Comment 122) Some comments state hazards requiring preventive controls required documentation relates to food that facilities that hull, shell, and dry would document that determination in safety practices at the facility, with two tree nuts without further processing its written hazard analysis but would options for satisfying this could be characterized as not need to establish preventive controls documentation requirement. Under the establishments engaged solely engaged and associated management first option, the qualified facility may in the harvesting, storage, or components. choose to submit documentation that distribution of one or more raw (Comment 123) Some comments state demonstrates that it has identified agricultural commodities. These that ginning cotton to separate cotton potential hazards associated with the comments express an expectation that fiber from cotton seed is a low-risk animal food being produced, is since hulled or shelled dried nuts retain harvesting activity. Comments further implementing preventive controls to their raw agricultural commodity status, note that since cotton seed used as address the hazards, and is monitoring that facilities hulling, shelling and animal food is a by-product from the the preventive controls to ensure that drying tree nuts without further production of cotton lint, the cotton such controls are effective. processing would qualify for exemption seed coming from a ginning facility Alternatively, under the second option, under both proposed §§ 507.5(g) and would not qualify as a human food by- the qualified facility may choose to 507.5(h). product. The comments request that submit documentation (which may (Response 122) Hulling and shelling facilities whose entire operation include licenses, inspection reports, of tree nuts (such as walnuts, almonds, consists of receiving and ginning cotton certificates, permits, credentials, and pistachios) are harvesting activities without further processing the cotton certification by an appropriate agency that are within the ‘‘farm’’ definition seeds be exempt from both subpart C (such as a State department of when conducted on a farm or farm under § 507.5(g) and subpart B under agriculture), or other evidence of mixed-type facility. Drying/dehydrating § 507.5(h). oversight), that the facility is in RACs without creating a distinct (Response 123) Ginning cotton is a compliance with State, local, county, or commodity (such as drying walnuts and harvesting activity that is within the other applicable non-Federal food safety hulls) is a holding activity that also is ‘‘farm’’ definition when conducted on a law. The second type of required

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documentation relates to whether the that a qualified facility must maintain In this section, we discuss comments facility satisfies the definition of a (proposed § 507.7(e)). that ask us to clarify the proposed qualified facility. In the 2013 proposed preventive requirements or that disagree with, or If a qualified facility does not prepare controls rule for animal food, we suggest one or more changes to, the documentation demonstrating that it has tentatively concluded that a certified proposed requirements. We also address identified potential hazards associated statement would be acceptable for the comments discussing our tentative purposes of satisfying the submission with the animal food being produced, is conclusion regarding the submission of requirements of proposed § 507.7(a). We implementing preventive controls to certified statements to FDA, including also requested comment on the address the hazards, and is monitoring submitting certified statements using efficiency and practicality of submitting the preventive controls to ensure that the existing mechanism for registration the required documentation using the such controls are effective, it must existing mechanism for registration of of food facilities. After considering these provide notification to consumers of food facilities, with added features to comments, we have revised the certain facility information by one of enable a facility to identify whether or proposed requirements as shown in two procedures, depending on whether not the facility is a qualified facility. table 7 with editorial and conforming an animal food packaging label is Some comments support one or more changes as shown in table 31. required on the animal food. of the proposed requirements without As discussed in Response 76, we have Consistent with the statutory change. For example, some comments revised the definition of very small direction of section 418(l) of the FD&C state that our proposed interpretation of business to specify that it is based on an Act, we proposed the following the statutory term ‘‘business address’’ is average (of sales plus market value of requirements for qualified facilities: (1) consistent with our use of the term animal food held without sale) during Submission of certain documentation ‘‘business address’’ in our regulations the 3-year period preceding the (proposed § 507.7(a)); (2) procedures for regarding information that must be applicable calendar year and, as a submission of the documentation included in a prior notice for imported companion change, we are explicitly (proposed § 507.7(b)); (3) the frequency food (§ 1.281). Some comments that of the submissions (proposed support the proposed provisions suggest requiring that a facility determine and § 507.7(c)); (4) notification to consumers alternative or additional regulatory text document its status as a qualified in certain circumstances (proposed or ask us to clarify how we will facility on an annual basis (see § 507.7(d)); and (5) applicable records interpret the provision. § 507.7(c)(1)).

TABLE 7—REVISIONS TO THE PROPOSED REQUIREMENTS FOR QUALIFIED FACILITIES

Section Description Revision

507.7(a) ...... Documentation to be • Specify that the submitted documentation is an ‘‘attestation.‘‘ submitted. • Add ‘‘tribal’’ as an example of applicable non-Federal food safety law. 507.7(b) ...... Procedure for submis- Update details regarding the electronic and paper submission of a form specific to the attes- sion. tation requirement. 507.7(c) ...... Frequency of deter- • New requirement to determine and document status as a qualified facility on an annual mination and sub- basis no later than July 1 of each calendar year. mission. • Specify that a facility that begins manufacturing, processing, packing, or holding animal food after September 17, 2019 must submit the attestation before beginning such oper- ations. • Specify that a facility must notify FDA of a change in status from ‘‘not a qualified facility’’ to ‘‘qualified facility’’ by July 31 of the applicable calendar year. • Specify that when the status of a facility changes from ‘‘qualified facility’’ to ‘‘not a quali- fied facility’’ based on the annual determination, the facility must notify FDA of that change in status using Form FDA 3942b by July 31 of the applicable calendar year. • Specify that the required biennial submissions of the attestations must be made during a timeframe that will coincide with the required biennial updates to facility registration. 507.7(d) ...... Timeframe for compli- When the status of a facility changes from ‘‘qualified facility’’ to ‘‘not a qualified facility,’’ the ance with the re- facility must comply with subparts C and E no later than December 31 of the applicable quirements of sub- calendar year unless otherwise agreed to by FDA and the facility. parts C and E. 507.7(e) ...... Notification to con- Conforming changes associated with the term ‘‘attestation.‘‘ sumers. 507.7(f) ...... Records ...... Conforming changes associated with the term ‘‘attestation.‘‘

A. Comments on Submission of a submission requirements, noting that it documents in determining compliance Certification Statement would save time and money and reduce with the documentation requirements the paperwork burden on qualified and assert that proof of qualification (Comment 124) Some comments ask facilities. Some comments ask us to requires more than a checked box in an us to clarify the distinction between the revise the proposed requirements to online registration database. Some documentation that would be submitted make this use of certified statements comments ask us to require that a to FDA and the records that a qualified explicit in the regulatory text. qualified facility affirm that it has the facility relies on to support the Other comments disagree with our original documents on file and available submitted documentation. tentative conclusion to use certified for FDA inspection. Other comments Some comments agree with our statements to satisfy the submission assert that requiring qualified facilities tentative conclusion to use certified requirements. These comments focus on to submit copies of the actual statements to satisfy the proposed the importance of actual copies of documentation would enable us to

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easily review food safety plans or not be imposed on other types of (Response 127) A facility that satisfies inspection reports and to target our exempted facilities. Some of these criteria to be a qualified facility compliance and enforcement activities comments question whether the continues to be responsible to produce to those qualified facilities that pose a exemption for qualified facilities is animal food that will not be adulterated greater risk because of inadequate meaningful in light of the significant under section 402 of the FD&C Act. prevention measures or deficient burden imposed by the proposed Such a facility is also subject to the inspections. requirements. Some comments contrast requirements of section 421 of the FD&C (Response 124) We are affirming our the proposed requirement for qualified Act regarding frequency of inspection of tentative decision that we will not facilities to submit documentation to all facilities and to the new require a qualified facility to submit to FDA with proposed requirements for all administrative tools provided by FSMA, FDA as part of its attestation the other facilities to simply establish and such as for suspension of registration underlying documentation that maintain applicable records. (section 415 of the FD&C Act) and for establishes its compliance. We agree (Response 125) The submission mandatory recall (section 423 of the that the underlying records are needed requirements that we are establishing in FD&C Act). As discussed in Response to determine compliance with the this rule for qualified facilities reflect 77, we expect that most qualified documentation requirements and that a the statutory framework for qualified facilities will be subject to the CGMP qualified facility must retain the facilities (section 418(l)(2)(B) of the requirements of subpart B. When they documents it is relying on to support its FD&C Act). Although the submission are inspected, we will be ensuring they attestation and make them available to requirements only apply to qualified are in compliance with the CGMP us during inspection. We also agree that facilities, the reporting burden requirements once the applicable the regulatory text needs to be explicit associated with submission of an compliance date is reached. regarding the required documentation attestation is much lower than the (Comment 128) Some comments ask and that we need to clearly distinguish recordkeeping burden for facilities that which exemption a farm mixed-type between the documentation that would are subject to the requirements for facility should follow if it satisfies be submitted to FDA and the records hazard analysis and risk-based criteria for a qualified facility that a qualified facility relies on to preventive controls (see section LVIII). (§ 507.5(d)), as well as criteria for a very support the submitted documentation. (Comment 126) Some comments ask small business that only conducts on- Therefore, we have made the following us to minimize setting different farm low-risk activity/animal food combinations (specified in § 507.5(e) three revisions to the proposed standards even though the requirements regulatory text. and (f)) and one comment suggests that reflect express statutory provisions. First, we have revised proposed FDA should allow such a facility to (Response 126) These comments § 507.7(a) to specify that the submitted choose which exemption to follow. documentation is an ‘‘attestation.’’ appear to be referring to the statutory (Response 128) We describe these Second, we have revised proposed provisions of section 418(n)(3)(C) of the comments in more detail in Comment § 507.7(b) to update details regarding FD&C Act, which specify that the 110. A farm mixed-type facility that is the electronic and paper submission of regulations we establish to implement a very small business and that only a form specific to this attestation section 418 of the FD&C Act conducts the low-risk activity/animal requirement. Third, we have revised acknowledge differences in risk and food combinations listed in § 507.5(e) proposed § 507.7(e) (final § 507.7(f)) to minimize, as appropriate, the number of and (f) may find it advantageous to specify that you must maintain those separate standards that apply to separate classify itself as a very small business records relied upon to support the foods. We disagree that the statutory eligible for the exemption in § 507.5(e) ‘‘attestations’’ that are required by provisions of section 418(n)(3)(C) are and (f) (which is not subject to the § 507.7(a). directly relevant to the submission requirements in § 507.7) rather than as We acknowledge that requiring requirements of this rule for qualified a qualified facility (which is subject to submission of the actual documentation facilities. The requirements for qualified the requirements in § 507.7). would enable us to easily review food facilities, but not other facilities, to (Comment 129) Some comments safety plans or inspection reports and to submit documentation to FDA reflect express concern about State access to target our compliance activities based different regulatory requirements. The the records that a qualified facility on information that we see in those food different regulatory requirements are maintains to support its attestations, safety plans or inspection reports. directed at different facilities, and do particularly when a State would However, as discussed in Response 245, not set separate standards for particular conduct an inspection for compliance we are not requiring that other facilities animal foods. Regardless, even if the with part 507 under contract to FDA. submit a ‘‘facility profile’’ that would statutory provisions of section These comments express concern about allow us to more broadly review food 418(n)(3)(C) were relevant to the the time and resources necessary to safety plans and target our compliance submission requirements of qualified verify the status of a facility as a activities based on information that we facilities, provisions of this rule that qualified facility and note that previous see in those food safety plans and will reflect express statutory provisions mechanisms whereby we provide instead explore other mechanisms to would not conflict with the statutory information to States in advance of achieve the goals we described in the direction in section 418(n)(3)(C). inspection have been slow. These 2013 proposed preventive controls rule (Comment 127) Some comments comments also express concern that if for animal food for a facility profile. emphasize that the requirements need to the state must verify the ‘‘qualified ensure adequate protection of public facility’’ status of all firms, including B. General Comments on Requirements health and state that we should those that are not FDA contracts, this That Apply to a Qualified Facility maintain and exercise oversight of could delay their ability to conduct (Comment 125) Some comments qualified facilities. Some comments ask timely inspections and increase assert that the proposed requirements that we provide enough specificity so inspection time, reducing the number of would create a costly burden for that qualified facilities know and inspections conducted. qualified facilities (e.g., registering and understand their food safety (Response 129) We are sensitive to the making submissions to FDA) that would responsibilities towards consumers. time required for various inspection

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activities and intend to communicate (Comment 132) Some comments ask (Response 133) We intend to use the with States regarding our expectations us to clarify the documentation required Federal calculation for the Gross for how to verify whether a facility is a to certify that an operation is a qualified Domestic Product price deflator, as qualified facility. facility. Some comments ask us to provided by the Bureau of Economic (Comment 130) Some comments point explicitly state that the documentation Analysis, to adjust for inflation. We will out that the proposed procedures for must include financial and sales records make the inflation-adjusted dollar value submission are silent on the process and of the business and its subsidiaries or to the baseline very small business timeframe for our review and approval affiliates. Some comments ask us to cutoffs (e.g. $2,500,000 in 2011) of the submitted documentation and ask clarify the types of records that would available on our Internet site. We will us to clarify this process and timeframe. be required to be submitted by foreign update the values for the very small Other comments ask us to clarify the establishments to support the business exemptions and qualifications consequences to a facility if its classification of a foreign establishment annually using this calculation. submission is found to be insufficient. as a ‘‘qualified facility.’’ (Response 132) The submission to 2. Proposed § 507.7(a)(2)(i)—First (Response 130) We will not be FDA will be an attestation rather than Option for Documentation: Food Safety approving the submitted attestations. the records that the qualified facility Practices. Instead, we intend to use the relies on to support the attestation; We proposed two options for information to determine whether the however, you must maintain those satisfying the statutory documentation facility should be inspected for records relied upon to support the requirement in section 418(l)(2)(B)(i) of compliance with the requirements for ‘‘attestations’’ (see § 507.7(f)). As the FD&C Act. Under the first option hazard analysis and risk-based previously discussed, consistent with (the food safety practices option), a preventive controls, or for compliance section 418(l)(2)(B)(ii) of the FD&C Act, qualified facility could submit with the requirements for a qualified we intend to issue guidance on the documentation demonstrating that it has facility. During the inspection, we records that a facility could retain to identified the potential hazards would ask to see the records that the demonstrate that it is a qualified facility associated with the animal food being facility maintains to support any (78 FR 64736 at 64767). As discussed in produced, is implementing preventive submitted attestations. Response 124, we have revised the controls to address the hazards, and is (Comment 131) Some comments ask regulatory text to provide for qualified monitoring the performance of the us to clarify whether a foreign facility facilities to submit an attestation that preventive controls to ensure that such would need to submit documentation of the facility is in compliance with State, controls are effective. As discussed in its status as qualified facility. These local, county, tribal, or other applicable Response 124, we have revised the comments note that a foreign facility non-Federal food safety law. We intend provision to specify that the submission also would be required to provide to focus on records demonstrating that is an attestation. information to an importer and assert a facility is a very small business (i.e., (Comment 134) Some comments that submitting information to both FDA financial records demonstrating that a assert that the rule is vague about what and an importer would be a duplication business averages less than $2,500,000 the applicable documentation should of effort. These comments ask us to adjusted for inflation, per year, during include and how exhaustive it should allow a foreign facility that is a qualified the 3-year period preceding the be. Some comments ask whether facility to submit information to either applicable calendar year in sales of documentation (such as a food safety FDA or the importer, rather than to both animal food plus the market value of plan) must address all operations at the FDA and the importer. animal food manufactured, processed, establishment or only those that trigger (Response 131) We decline this packed, or held without sale (e.g., held the registration of the establishment as request. Documentation submitted to an for a fee or supplied to a farm without a facility. Some comments ask us to importer would not reach FDA and, sale)) rather than records demonstrating clarify the difference between having thus, could not satisfy the requirements that the average annual monetary value documentation to support food safety of this rule. We are requiring of the food manufactured, processed, practices and attesting that the facility submission of an attestation, on a form packed or held at such facility that is has such documentation. Other that can be submitted either sold directly to qualified end-users comments ask whether a qualified electronically or on paper, rather than during a 3-year period exceeded the facility would need to have records submission of the underlying average annual monetary value of the documenting a risk analysis and information. food sold by the facility to all other monitoring. purchasers. We expect that financial (Response 134) If a qualified facility C. Proposed § 507.7(a)—Documentation records demonstrating that a business is submits an attestation regarding its food To Be Submitted a very small business will be less safety practices, the documentation that 1. Section 507.7(b)(1)—Documentation burdensome for a qualified facility to the facility maintains for review during That the Facility Is a Qualified Facility maintain and require fewer resources for inspection must specify that the facility FDA to review. has identified the potential hazards We proposed that a qualified facility During an inspection, we expect the associated with the animal food being must submit documentation that the facility to be able to show us how the produced, is implementing preventive facility is a qualified facility. We also facility is complying with the applicable controls to address the hazards, and is proposed that for the purpose of food safety regulation (including monitoring the performance of the determining whether a facility satisfies relevant licenses, inspection reports, preventive controls to ensure that such the definition of a qualified facility, the certificates, permits, credentials, or controls are effective (see baseline year for calculating the certifications), and producing safe § 507.7(a)(2)(i)). For example, a qualified adjustment for inflation is 2011. As animal food. facility that produces raw dog food discussed in Response 124, we have (Comment 133) Some comments ask might have documentation specifying revised the provision to specify that the how the adjustment for inflation will be that it has determined that Salmonella documentation that must be submitted calculated and how regulators such as is a hazard requiring a preventive is an attestation. the states will get this information. control, describing the process that will

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control Salmonella, describing responsible to produce animal food that regarding the electronic and paper sanitation controls to prevent will not be adulterated under section submission of a specific form. We are contamination of raw dog food with 402 of the FD&C Act. developing paper and electronic Salmonella, and describing an (Comment 136) Some comments ask versions of Form FDA 3942b, which is environmental monitoring program to us to specify that a qualified facility an information collection provision that verify that its sanitation controls are must document compliance with all is subject to review by OMB under the effective. Likewise, a qualified facility applicable non-Federal food safety laws. Paperwork Reduction Act of 1995 (44 that makes a custom cattle food might One comment asks what evaluation U.S.C. 3501 to 3520). We intend to make have documentation specifying that it FDA will conduct of any non-Federal the paper Form FDA 3942b available in has determined that metal objects are a food safety law before determining that the near future and invite comments hazard requiring a preventive control compliance with such law constitutes consistent with procedures for approval and supporting the use of a magnet to compliance under FSMA for a qualified of the form by OMB. remove metal objects from the cattle facility. (Comment 138) Some comments food, with procedures for monitoring (Response 136) We decline this recommend that any interface for the magnet’s use if applicable. request. Section 418(l)(2)(B)(i)(II) of the electronic submission of certification As discussed in Response 124, a FD&C Act refers to apply to compliance statements post adequate notice of qualified facility that chooses the food with ‘‘State, local, county, or other requirements the facility must meet and safety practices option for complying applicable non-Federal food safety law’’ warnings detailing potential penalties with the submission requirements of (emphasis added). As discussed in (e.g., for fraudulent submission). this rule will attest to that by checking Response 132, we have revised the (Response 138) We intend that the a statement on a form. In contrast, a regulatory text to provide for qualified electronic submission system will food safety plan (or other facilities to submit an attestation that operate in a manner similar to the documentation) that the qualified the facility is in compliance with State, existing electronic submission system facility relies on to support the local, county, or other applicable non- for registration of food facilities, attestation will be a record subject to the Federal food safety law During an including a certification statement recordkeeping requirements of inspection, we expect the facility to be advising the person signing the form subpart F. able to show us how the facility is that, under 18 U.S.C. 1001, anyone who complying with the applicable food makes a materially false, fictitious, or 3. Proposed § 507.7(a)(2)(ii)—Second safety regulation (including relevant fraudulent statement to the U.S. Option for Documentation: Compliance licenses, inspection reports, certificates, Government is subject to criminal With Other Applicable Non-Federal permits, credentials, or certifications), penalties. We intend to include a Food Safety Law and producing safe animal food. similar certification statement on paper Under the second option for satisfying (Comment 137) Some comments ask forms that will be available for qualified the statutory documentation us to provide resources to the States to facilities that choose to submit by paper requirement, a qualified facility could implement the proposed provision. rather than through the electronic submit documentation that it is in These comments also ask us to develop system. The electronic and paper compliance with State, local, county, or and implement a strategic plan to submission forms will focus on the other applicable non-Federal food safety provide resources (e.g. training, attestation statements rather than on law, including relevant laws and guidance) to State and local inspection other requirements to which the facility regulations of foreign countries. As agencies in advance of the anticipated is subject. The Small Entity Compliance discussed in Response 124, we have increased burden on State and local Guide that we will issue in accordance revised the provision to specify that the inspection programs that will be created with section 212 of the Small Business submission is an attestation. We also by the provision. Regulatory Enforcement Fairness Act have revised the provision to add (Response 137) We do not believe that (Pub. L. 104–121) will be better suited ‘‘tribal’’ as an example of applicable specific training for State or other to helping qualified facilities non-Federal food safety law to clarify government counterparts is necessary understand the requirements of the rule for purposes of this rule that a qualified for the purposes of inspecting a than information presented on a facility could submit an attestation that qualified facility that attested to having submission form. it is in compliance with tribal food documentation from a non-Federal safety law. regulatory authority. The State or other E. Proposed § 507.7(c)—Frequency of (Comment 135) Some comments government counterpart would merely Determination and Submission object to the proposed provision. These examine applicable documentation We proposed that the documentation comments point out that State and local (such as a license, inspection report, must be: (1) Submitted to FDA initially requirements are inconsistent and assert certificate, permit, credentials, or within 90 days of the applicable that such requirements are not certification by an appropriate agency compliance date and (2) resubmitted at sufficiently rigorous to substitute for the (such as a State department of least every 2 years, or whenever there is FSMA requirement to conduct a hazard agriculture)), which is specified in the a material change to the information analysis and establish and execute a provision. After inspecting such applicable to determining the status of documented food safety plan. One documentation, the State or other a facility. comment asserts that the state laws may government counterpart would focus on (Comment 139) Some comments not provide the same level of protection inspection for compliance with CGMPs. assert that the proposed timeframe of 90 to consumers. days to submit the required (Response 135) The provision reflects D. Proposed § 507.7(b)—Procedure for documentation would not provide the express statutory direction of section Submission sufficient time to gather and submit the 418(l)(2)(B)(i)(II) of the FD&C Act. Most We proposed that the documentation required documentation and ask us to of these qualified facilities are subject to must be submitted to FDA either extend the timeframe, e.g., to 120 or 180 the CGMP requirements of subpart B electronically or by mail. As discussed days. and a facility that satisfies criteria to be in Response 124, we have revised the (Response 139) We are retaining the a qualified facility continues to be regulatory text to update details proposed timeframe for the initial

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submission (within 90 days of the submissions of the required attestations (Comment 141) One comment asks us applicable compliance date). The only with the biennial registration will to specify that the required attestations documentation that the qualified facility reduce the cumulative economic impact be submitted every 5 years rather than will need to submit is an attestation, on the animal food industry of every 2 years. This comment asserts that which does not need to be gathered. complying with two separate doing so would be consistent with the Importantly, however, documentation requirements because qualified facilities statutory direction of section 201 of supporting the attestation must be that choose to submit electronically will FSMA (Targeting of Inspection available for inspection by September be able to submit electronically while Resources) for non-high risk food 17, 2019. As discussed in Response 76, accessing the same electronic portal facilities. This comment also asserts that the compliance date for a facility to used for facility registration. we did not provide specific reasons for retain records to support its status as a (Comment 140) Some comments ask the proposed 2-year timeframe and that qualified facility is January 1, 2017. As us to include an option within the resubmitting the attestations every 2 a companion change, we are explicitly system to notify us when a facility’s years will increase cost in time and requiring that a facility determine and status as a ‘‘qualified facility’’ changes, labor. document its status as a qualified e.g., because its business expands or (Response 141) We decline the facility on an annual basis by no later changes. request. The rule requires resubmission than July 1of each calendar year (see (Response 140) Notifying us when whenever there is a material change to § 507.7(c)(1)). there is a material change in the the information that changes the status In addition, we have revised proposed facility’s status from ‘‘qualified facility’’ of a facility as a qualified facility. § 507.7(c)(1) (which we are finalizing as to ‘‘not a qualified facility’’ is a Therefore, if the facility’s sales change § 507.7(c)(2)(i)(A), (B), and (C)) to requirement rather than an option. We its status, so that it is no longer a specify the timeframe for the initial included this requirement in the qualified facility, the rule requires that submission for three distinct proposed rule, and are establishing it in facility to notify us when its status circumstances: (A) By December 16, this final rule. We made editorial changes. (Note that the definition of 2019 for a facility that begins changes to the provision to make this very small business established in this manufacturing, processing, packing, or clearer. rule bases the threshold dollar amount holding animal food before September We also established a series of dates for a very small business on an average 17, 2019; (B) Before beginning associated with the facility’s change in (of sales plus the market value of animal operations, for a facility that begins status from ‘‘qualified facility’’ to ‘‘not food held without sale) during the 3- manufacturing, processing, packing or a qualified facility.’’ First, we are year period preceding the applicable holding animal food after September 17, specifying that when the status of a calendar year, rather than on annual 2019; or (C) By July 31 of the applicable facility changes from ‘‘qualified facility’’ sales plus market value. A biennial calendar year, when the status of a to ‘‘not a qualified facility’’ based on the submission is adequate to otherwise facility changes from ‘‘not a qualified required annual determination, the require a qualified facility to facility’’ to ‘‘qualified facility’’ based on facility must notify FDA of that change affirmatively attest that it continues to the annual determination required by in status using Form FDA 3942b by July satisfy the criteria for being a qualified paragraph (c)(1) of this section. See the 31 of the applicable calendar year (see facility. A biennial submission is not discussion in Response 76 regarding the § 507.7(c)(3)). We have provided the overly burdensome, because a facility approach we intend to take in a number facility with flexibility to wait until July can coordinate its biennial submission of circumstances that could lead to a 1 of a given calendar year to determine with its biennial update to its facility facility having records to support its whether its status changes (see registration. The suggested 5-year status as a qualified facility for fewer § 507.7(c)(1)); 30 days is an adequate submission based on the targeted than 3 preceding calendar years. timeframe to submit the form notifying inspection frequency for non-high risk We have revised the provision to us of the change in status. animal food facilities implies that all specify that the required biennial Second, we are specifying that when qualified facilities produce such animal submissions of the attestations must be the status of a facility changes from foods, which is not the case. made during a timeframe that will ‘‘qualified facility’’ to ‘‘not a qualified coincide with the required biennial facility,’’ the facility must comply with F. Proposed § 507.7(d)—Notification to updates to facility registration (see subparts C and E no later than December Consumers (Final § 507.7(e)) section 102 of FSMA), i.e., during the 31 of the applicable calendar year We proposed that a qualified facility period beginning on October 1 and unless otherwise agreed to by FDA and that does not submit documentation of ending on December 31, beginning in the facility (see § 507.7(d)). In essence, its food safety practices must provide 2020. In determining that 2020 would this provision can provide a facility notification to consumers as to the name be the first year for the required biennial with up to a full year to comply with the and complete business address of the submissions of the attestations, we first full requirements for hazard analysis facility where the animal food was considered that the first submission of and risk-based preventive controls when manufactured or processed (including an attestation would be approximately the facility determines its change in the street address, or P.O. Box, city, December 2019 for qualified facilities status early in the calendar year. A state, and zip code for domestic that are operating as of the date of this facility that does not determine that facilities, and comparable full address final rule (i.e., approximately 90 days change in status until the required date information for foreign facilities). after the date of publication of this rule). of July 1 would still have 6 months to (Comment 142) One comment For qualified facilities that do not begin comply with the full requirements for recommends that information giving the operations until after December 2019, hazard analysis and risk-based location of the manufacturing site, and the first biennial submission will be preventive controls. As we have done in not just the corporation contact required in a timeframe less than 2 the case of a qualified exemption being information, be provided on the animal years, but once the qualified facility has withdrawn (see § 507.65(d)(1)), we are food labels. Other comments state that made its first submission the subsequent providing flexibility for a facility to specifically for pet food and pet treats, biennial submissions will all be at 2- comply in an alternative timeframe if the manufacturer should be required to year intervals. Coordinating the biennial agreed to by FDA and the facility. include the co-packer information on

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the product labels to include the co- financial records would not be available that would be established in proposed packer’s name, private label contact to us because such records are excluded § 507.48 of subpart C (proposed information, address, and co-packer’s from the records that we have access to § 507.10(b)). contact information (phone and/or under the Public Health Security and Some comments support these email). Bioterrorism Preparedness and proposed provisions without change. (Response 142) Section 418(l)(7) of Response Act of 2002 (the Bioterrorism For example, one comment expresses the FD&C Act specifically mandates for Act), and as provided by § 1.362. a qualified facility that ‘‘the name and (Response 143) The rule explicitly the view that a facility solely engaged in business address of the facility where specifies that we have access to records the storage of packaged animal food that the food was manufactured or that are required by the rule (see does not require time/temperature processed,’’ not the corporate contact § 507.200). If a facility relies on control for safety does not need to information, be included on a label for financial records to demonstrate its conduct its own hazard analysis, nor a food for which a food packaging label status as a qualified facility, we will establish and implement preventive is required. It does not require co-packer have access to those financial records. controls because there would be no information. The statute makes no The exemption referred to by the hazards to trigger such activities. Other requirements for non-qualified facilities. comments for financial records (§ 1.362) comments that support the proposed is narrowly targeted to records required provisions ask us to clarify some aspects G. Proposed § 507.7(e)—Records (Final by the section 414 recordkeeping of the provisions or to clarify how the § 507.7(f)) regulations and does not apply to provisions will apply in particular We proposed that a qualified facility records required by this preventive circumstances. Other comments that must maintain those records relied upon controls rule for animal food. support the proposed provisions ask us to support the required documentation. to broaden them. We also proposed that the records that XII. Subpart A: Comments on Proposed a qualified facility must maintain would § 507.10—Applicability of Part 507 to a In the following paragraphs, we be subject to the requirements that Facility Solely Engaged in the Storage discuss comments that disagree with, or would be established in subpart F of of Unexposed Packaged Animal Food suggest one or more changes to, the this rule. As discussed in Response 124, We proposed that subpart C would proposed provisions. After considering after considering comments we have not apply to a facility solely engaged in these comments, we have revised the revised the rule to specify that a the storage of packaged animal food that proposed requirements as shown in qualified facility must maintain those is not exposed to the environment and table 8 with editorial and conforming records relied upon to support the does not require time/temperature changes as shown in table 31. A key required attestations (rather than the control to ensure the safety of the conforming change that affects § 507.10 required documentation). animal food (proposed § 507.10(a)). We is that it includes an exemption from (Comment 143) Some comments ask also proposed that a facility solely the requirements of subpart E, as well as us to explicitly specify that we have engaged in the storage of packaged subpart C. As discussed in section XL, access to documents that establish a animal food that is not exposed to the the final rule establishes the facility as a qualified facility. Some environment but requires time/ requirements for a supply-chain comments assert that a facility may temperature control for safety would be program in subpart E, rather than within reasonably assume that records such as subject to the modified requirements subpart C as proposed.

TABLE 8—REVISIONS TO THE PROPOSED APPLICABILITY OF SUBPART C TO A FACILITY SOLELY ENGAGED IN THE STORAGE OF UNEXPOSED PACKAGED ANIMAL FOOD

Section Description Revision

507.10(b) ...... Applicability of modified require- Clarification that § 507.51 of subpart C only applies to those unex- ments in § 507.51 of subpart C. posed packaged animal foods that require time/temperature control to significantly minimize or prevent the growth of, or toxin produc- tion by, pathogens.

(Comment 144) Some comments ask food that requires time/temperature tentatively concluded that it would be us to clarify that temperature controls control to significantly minimize or rare for a frozen animal food to be a TCS should be implemented when prevent the growth of, or toxin food (78 FR 64736 at 64802), and we determined to be necessary by the production by, pathogens is subject to affirm that conclusion in this document. facility or preventive controls qualified the modified requirements in § 507.51 of However, specifying in the regulatory individual. Some comments ask us to subpart C of this part for any unexposed text that a frozen animal food is not a clarify that if a facility stores both TCS packaged food that requires time/ TCS food would require us to conclude food and non-TCS food (i.e., unexposed temperature control to significantly that a frozen animal food would ‘‘never’’ packaged animal food that does not minimize or prevent the growth of, or (rather than ‘‘rarely’’) be a TCS food, require time/temperature control for toxin production by, pathogens. and we lack information to support safety), then the modified requirements (Comment 145) Some comments ask ‘‘never.’’ only apply for the portion of the facility us to revise the regulatory text to be (Comment 146) Some comments ask that holds the TCS foods. explicit that frozen unexposed packaged us to apply the exemption to storage (Response 144) We have revised food is not a TCS food subject to areas of facilities that also engage in § 507.10(b) to clarify that a facility modified requirements. food processing activities, e.g., for solely engaged in the storage of (Response 145) We decline this distributors that are engaged in limited unexposed packaged animal food, request. In the 2013 proposed animal food processing, such as blending seeds including unexposed packaged animal food preventive controls rule, we to make bird food. These comments

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assert that the intent of the term engaged in the storage of packaged foods will consider including guidance on ‘‘solely’’ is to make clear that a facility that are not exposed to the environment animal foods that are TCS foods in the that conducts an activity subject to the (section 418(m) of the FD&C Act). The implementing guidances we are exemption does not escape statute defines ‘‘facility’’ as a domestic developing (see Response 1). A facility responsibility for complying with the facility or a foreign facility that is solely engaged in storage of unexposed requirements for hazard analysis and required to register under section 415 of packaged animal food can work with the risk-based preventive controls when the FD&C Act (section 418(o)(2) of the manufacturer of the food to identify TCS conducting activities that are not FD&C Act). The section 415 registration food. Alternatively, such a facility could exempt. regulations define facility as ‘‘any simply treat any refrigerated food as a (Response 146) We disagree with the establishment, structure, or structures TCS food. comment’s interpretation of the term under one ownership at one general XIII. Subpart A: Comments on ‘‘solely.’’ The plain meaning of ‘‘solely’’ physical location . . .’’ The comment’s Proposed § 507.12—Applicability of is only, completely, entirely; without interpretation that we could view Part 507 to the Holding and another or others; singly; alone (Ref. 24). ‘‘areas’’ of registered facilities to be Distribution of Human Food By- The facility described in the comment is ‘‘facilities that are solely engaged in the Products for Use as Animal Food. not ‘‘solely’’ engaged in the storage of storage of packaged foods that are not unexposed packaged animal food. exposed to the environment’’ is We proposed to add provisions for Such a facility must conduct a hazard inconsistent with the statutory and human food by-products for use as analysis that addresses all activities regulatory framework under sections animal food. We proposed that the conducted by the facility. The 415 and 418 of the FD&C Act. requirements of this part would not preventive controls that the facility (Comment 148) Some comments ask apply to by-products of human food would establish and implement would us to consider an alternative to the production that are packed or held by depend on the facility, the animal food, exemption for unexposed packaged that human food facility for distribution and the outcome of the facility’s hazard foods when a facility conducts as animal food if: the facility is subject analysis and any preventive control manufacturing, processing, packing, or to and in compliance with subpart B of management components associated holding activities in addition to storing part 117 (the CGMPs in the proposed with a facility’s preventive controls unexposed packaged food. Specifically, preventive controls rule for human would be established as appropriate to these comments ask us to recognize that food) and in compliance with all other ensure the effectiveness of the the minimal risks of storing unexposed applicable human food safety preventive controls, taking into account packaged foods can be addressed requirements of the FD&C Act and the nature of the preventive control and through a combination of compliance implementing regulations; and the its role in the facility’s food safety with the modified requirements for TCS facility does not further manufacture or system. A facility that stores unexposed foods (if applicable) and the CGMPs in process the by-products intended for packaged animal food that is not a TCS subpart B and state that doing so would use as animal food. Proposed § 507.12(b) animal food could, for example, be consistent with our discussion in the would require that once the animal food determine that no preventive controls 2013 proposed animal food preventive was separated from the human food, the and associated management controls rule. facility would need to comply with components would be necessary. A (Response 148) These comments proposed §§ 507.28 and 117.95 of part facility that stores unexposed appear to suggest the outcome of a 117 for the holding and distribution of refrigerated packaged TCS animal food facility’s hazard analysis and food safety that animal food. We also proposed could, for example, determine that plan for storing unexposed packaged § 117.95 be added to the proposed preventive controls and management animal food, i.e., that the only preventive controls rule for human food components patterned after the significant hazards are the potential for and asked for comment on whether the modified requirements in § 507.51 are growth of pathogens in refrigerated requirements should be placed in both adequate to address significant hazards unexposed packaged animal foods and § 117.95 and § 507.28. associated with that animal food. that the preventive controls and Section 507.12 does not apply to (Comment 147) Some comments ask preventive control management human food by-products when us to allow a facility to designate a components specified in the modified contamination or other adulteration has storage area as a separate facility for requirements for TCS animal food are occurred that is materially related to purposes of compliance with the adequate to address such hazards. It is food safety. We handle requests for requirements for hazard analysis and the responsibility of the facility’s diversion of these products for animal risk-based preventive controls. In the preventive controls qualified individual food use on a case-by-case basis. comments’ view, an area solely engaged to identify the significant hazards Additional information on diversion of in the storage of unexposed packaged associated with the facility and the contaminated or adulterated food for food could fall within the exemption in animal food it stores, as well as the animal food use is available in § 507.10 even though other areas would appropriate preventive controls and compliance policy guidances (CPG) CPG be subject to the requirements for preventive control management Sec. 675.100 ‘‘Diversion of hazard analysis and risk-based components. However, we agree that in Contaminated Food for Animal Use’’ preventive controls. some cases the approach suggested in and CPG Sec. 675.200 ‘‘Diversion of (Response 147) We disagree that a these comments would be appropriate. Adulterated Food to Acceptable Animal designated storage area in an (Comment 149) Some comments Feed Use’’ (Refs. 25 and 26). We asked establishment that conducts assert that it is difficult to identify TCS for comment on whether we should manufacturing, processing, or packing foods. These comments ask us to work include regulations for these types of in addition to storage can fall within the with industry and professional requests. exemption for facilities ‘‘solely engaged organizations to develop guidance on Many comments generally support the in . . . storage.’’ The statute provides when the modified requirements apply. concept that certain human food by- authority for us to exempt or modify the (Response 149) This document does products intended for use as animal requirements for compliance with not include guidance on whether food which do not undergo further respect to ‘‘facilities’’ that are solely specific animal foods are TCS foods. We processing by the human food

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manufacturer only need to comply with requirements. We agree with this products from establishments that are proposed § 507.28 for holding and comment. A facility that manufactures not required to register as food facilities distribution of human food by-products and sells a food just for human would not be subject to part 507. for use as animal food. Some of these consumption is not subject to part 507, Facilities may be jointly regulated by comments note that human food by- even if the purchaser of that food may FDA and FSIS if they produce some products are an important source of use it for animal food. products that are under FDA animal food. Other comments agree but If a facility manufactures, processes, jurisdiction and some that are under request changes and/or additional packs, or holds human food and animal FSIS jurisdiction. Such facilities may be exemptions. food, and is subject to subpart C of part required to register as a food facility We have modified § 507.12 to clarify 117, it can comply with subpart C of under section 415 of the FD&C Act. that the requirements of part 507 do not part 117 for the animal food, but needs Examples of facilities jointly regulated apply to off-farm packing and holding of to address any hazards unique to the by FDA and FSIS include FSIS RACs packed or held by a human food animal food that require a preventive establishments that also process animal facility for distribution as animal food control, if applicable. Except as food (such as certain pet food), and provided certain conditions are met. For provided by § 507.12 for human food facilities that process meat and nonmeat off-farm packing and holding of produce by-products, if a facility is required to products (such as frozen entrees, some (as defined in part 112 of this chapter), comply with subpart B of part 507 and of which contain meat and are regulated if the human food facility is subject to also subpart B of part 117 because the by FSIS, and some of which do not and in compliance with § 117.8 of part facility manufactures, processes, packs, contain meat but which contain seafood 117 of this chapter and in compliance or holds human food and animal food, or vegetables that are regulated by FDA). with all applicable human food safety then the facility may comply with the FSIS establishments that are required requirements of the FD&C Act and requirements in subpart B of part 117, to register with FDA because they also implementing regulations, and the instead of subpart B of part 507, as to process FDA-regulated human food, human food facility does not further the manufacturing, processing, packing, must follow §§ 507.28 and 117.95 for manufacture or process the by-products and holding of animal food at that the holding and distribution of their intended for use as animal food, then facility (see the regulatory text for FDA-regulated human food by-products the requirements of part 507 do not § 507.1(d)). for use as animal food, if the apply to the by-products. (Comment 152) Some comments establishments meet the requirements of (Comment 150) Some comments request that facilities regulated by the § 507.12(a). FSIS establishments that are request that the proposed provisions be United States Department of Agriculture required to register with FDA because included in both this rule and the final (USDA) Food Safety and Inspection they also process FDA-regulated animal rule for preventive controls for human Service (FSIS) not be required to comply food must comply with the provisions food so that it would be easier for with part 507 for animal-derived human in the preventive controls rule for human food processors to understand food by-products intended for use as animal food (part 507). the requirements for human food by- animal food. Some comments state the (Comment 154) Some comments products intended for use as animal requirements are duplicative and are assert that requiring FSIS-regulated food. One comment does not support unnecessary because FSIS food safety establishments to comply with part 507 placing these provisions in both of the requirements are already in place, and would result in more by-products being final rules, preferring that all animal that oftentimes the FSIS establishment diverted to other disposal methods food provisions be in part 507, and that is unaware of what purpose or animal which might have an economic or part 117 should pertain only to human species the purchaser will use the by- environmental impact. food. product for as animal food. (Response 154) We do not agree that (Response 150) Section 117.95— (Response 152) Only animal food compliance with part 507 will likely ‘‘Holding and distribution of human facilities that are required to register as result in substantially less use of human food by-products for use as animal a food facility under section 415 of the food by-products as animal food food’’ is established in this rule. Section FD&C Act are required to comply with because it applies only to those 117.95 will appear in 21 CFR part 117, this rule. Establishments regulated establishments that are required to preventive controls for human food. The exclusively throughout by FSIS under register under section 415 of the FD&C by-products holding and distribution the Federal Meat Inspection Act, the Act. Furthermore, other disposal provisions also will appear in § 507.28, Poultry Products Inspection Act, or the methods for these products may be more the animal food CGMPs. The Egg Products Inspection Act, i.e., cost prohibitive than compliance with requirements of § 117.95 and § 507.28 establishments handling only meat, these regulations. are identical and appear in both places poultry, or certain egg products, are (Comment 155) One comment for the convenience of the facilities to exempt from registration under section requests the wording in proposed which the provisions would apply. 415 of the FD&C Act (see § 1.226(g) (21 § 507.12 be revised to explicitly exclude (Comment 151) Two comments state CFR 1.226(g))). Therefore, these animal-derived human food by-products it must be clear in the rule that not only establishments are not subject to this for use as animal food because of by-products but also products which are rule. pathogen risk. already authorized for food like gelatin (Comment 153) Some comments state (Response 155) Animal-derived or collagen must be authorized for food we did not provide support for the human food by-products have a long for animals, without further tentative conclusion that animal-derived history of use in the animal food requirements and additional CGMP by-products carry different risks than industry. These human food by- implementation. other by-products, and therefore did not products typically are sold from the (Response 151) We understand this provide a basis for why animal-derived human food facility to an animal food comment to be stating that a human by-products should be subject to all of manufacturer/processor, such as a pet food product that also may be used as part 507 while other human food by- food manufacturer, that uses the by- an animal food should not be required products are subject to only § 507.28. products as an ingredient in a finished to comply with part 507 if it is in (Response 153) As explained in animal food. These manufacturers/ compliance with human food Response 152, animal-derived by- processors are required to comply with

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part 507 and must address any potential holding and distribution provisions in food for animal food use in this final pathogens. Furthermore, 21 CFR proposed § 507.28. rule. We will continue to handle 589.2000 prohibits the use of (Response 158) We agree with these diversion requests on an individual mammalian protein in the manufacture comments. We did not receive basis. We will consider reviewing and of animal food given to ruminant comments indicating by-products from revising the current compliance policy animals, such as cows, sheep, and goats, these human foods have specific guidances, CPG Sec. 675.100, and regulations issued under the Swine problems if used as animal food. ‘‘Diversion of Contaminated Food for Health Protection Act (7 U.S.C. 3801 et Facilities that process seafood, dietary Animal Use’’ and CPG Sec. 675.200, seq.) are intended to ensure that food supplements, and infant formula that ‘‘Diversion of Adulterated Food to waste containing meat does not contain meet the requirements of § 507.12(a) Acceptable Animal Feed Use’’ (Refs. 25 active disease organisms that pose a risk must follow the requirements of and 26). to swine who eat it (see 9 CFR part 166). § 507.28 and § 117.95 for human food (Comment 161) One comment (Comment 156) A few comments state by-products for use as animal food. requests clarification on whether these (Comment 159) Some comments state that USDA, not FDA, should issue any provisions would apply to retail outlets that all human food by-products, regulations concerning the food safety of such as grocery stores or bakeries. One animal-derived by-products intended including those further processed, comment asserts that when a pig farmer for use as animal food. should only have to comply with the gets outdated milk from a dairy (Response 156) The FD&C Act gives holding and distribution requirements FDA certain authority to regulate food, in proposed § 507.28. Other comments processing bottling plant after the plant which includes food for animals. As support the requirement that human takes it back from grocery stores that the explained in section XV of the 2013 food by-products which are further dairy processor (the human food proposed preventive controls rule for processed should be required to comply manufacturer) would be exempt from animal food, the FD&C Act authorizes with all of proposed part 507. Some the animal food preventive controls FDA to issue CGMP and preventive comments request clarification about final rule. controls regulations to enhance the what constitutes further processing. (Response 161) Retail food safety of animal food, including human (Response 159) We decline the establishments such as grocery stores food by-products that are intended for request to exempt human food by- and bakeries are not required to register use as animal food. We decline to products that are further processed from as food facilities (see §§ 1.226(c) and address what USDA’s role in animal the requirements of part 507 because 1.227(b)(11)) and as a result are not food safety should be as is it out of the following CGMPs for the processing will required to comply with part 507. scope of this rulemaking. help ensure the animal food’s safety and However, the products they distribute (Comment 157) One comment because processing can introduce for animal food must not be adulterated. suggests an alternative approach to hazards requiring preventive controls. If milk has been returned to a animal-derived human food by- Further processing includes any processing plant because it is products. The comment suggests that we manufacturing/processing as defined in contaminated or adulterated, the facility consider a provision that would allow § 507.3 and includes activities such as must follow our compliance policy the purchaser to take legal responsibility cooking, freezing, pelleting, and milling. guidances for requests to divert human for evaluating and mitigating risk Some passive activities such as food for use as animal food (Refs. 25 and associated with by-products intended dewatering by holding a by-product in 26). If the returned milk is not for use as animal food if both parties a container with a screened bottom contaminated or adulterated, but is agree. which allows water to escape, or returned for a quality reason, the facility (Response 157) For facilities subject to holding in a perforated container which must follow the holding and subpart C, the supply-chain program in allows natural drying to occur are not distribution requirements of § 507.28 subpart E is required when the receiving considered further processing. Holding and § 117.95, but would be exempt from facility’s hazard analysis identifies a by-products at particular temperature to the other provisions in subpart B and hazard requiring a supply-chain-applied facilitate easier transportation of the by- subpart C of part 507. control and the receiving facility’s products is not considered further manufacturing/processing will not processing; however, cooking or (Comment 162) One comment control the hazard. However, when a freezing a by-product to prevent requests clarification on whether a manufacturer/processor identifies a deterioration or adulteration is facility that is producing human food hazard requiring a preventive control, considered further processing. Facilities by-products intended for animal food but can demonstrate and document that holding human food by-products for use that fall under proposed § 507.12 has to the hazard will be controlled by an as animal food must follow the state in its food safety plan that § 507.12 entity in its distribution chain (e.g., its requirements of § 507.28. applies. customer), then the manufacturer/ (Comment 160) Some comments state (Response 162) If the human food processor is not required to implement we should not include diversion processor meets the requirements in a preventive control (see §§ 507.36 and requests for contaminated or adulterated § 507.12(a), the facility only needs to 507.37). For a discussion of these human food to animal food in the comply with § 507.28 and § 117.95, for provisions, see section XXVII. For regulations; that the information the holding and distribution of the facilities exempt from the requirements contained in the guidance documents human food by-products for use as of subpart C, we are aware that parties should remain in guidance and be animal food. The facility does not need may enter into purchase contracts that handled on a case-by-case basis. to include this information in its food include specifications or information for However, some comments request that safety plan for the human food, but may the animal food purchased. the existing compliance policy choose to include it so that employees (Comment 158) The comments guidances be reviewed and updated and and other individuals viewing the food support seafood, dietary supplements, provide suggested changes. safety plan understand what regulatory and infant formula by-products (Response 160) We have not included requirements the human food processor intended for use as animal food without regulations for diversion of is applying to those human food by- further processing be subject only to the contaminated or adulterated human products intended for animal food.

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XIV. Subpart B: General Comments on CGMPs developed by organizations the animal food it produces are Proposed Subpart B—Current Good such as the British Standards Institute’s identified and controlled under subpart Manufacturing Practice Publicly Available Specification (PAS) C. We consider CGMPs to be a In the 2014 supplemental proposed 222 and the Association of American prerequisite program important for rule we revised the proposed CGMPs to Feed Control Officials (AAFCO) model effective preventive controls, and be more appropriate for the animal food GMPs for feed and feed ingredients believe that the CGMPs being finalized industry. Following are comments on (which are adopted by many states for in this rule provide enough flexibility the proposed CGMP requirements. regulation of animal food) (Refs. 27 and for a facility to use CGMPs to address (Comment 163) Some comments state 28). Both PAS 222 and AAFCO GMPs certain hazards so they do not become that the risks for pet food, especially apply to pet food and other animal food hazards that would require a preventive with respect to pathogens, are different such as feed for livestock. Many of the control. (Comment 166) One comment from a than the risks for livestock feed, and raw materials and other ingredients foreign government says that minimum therefore FDA should issue two sets of used in making finished animal food are used by multiple types of animal food requirements for recordkeeping and CGMPs. Some comments say that manufacturers producing a variety of traceability, which are recommended in CGMPs for pet food should be modeled animal food products. It would not be the CODEX Code of Practice on Good after the human food CGMPs because of feasible to enforce different sets of Animal Feeding, might be appropriate the high level of care people provide standards for pet food and livestock feed in subpart B so that they would apply and demand for their pets, pets may eat in a plant supplying the same to establishments exempt from subpart or sleep with humans, and pet owners ingredients to a pet food manufacturer C. often store pet food close to human and a livestock feed manufacturer. We (Response 166) We agree that food. expect our CGMP requirements to be traceability and associated (Response 163) We believe the single applied appropriately in all facilities recordkeeping are important tools for a set of CGMPs can serve as baseline manufacturing and processing animal facility to use for tracing animal food in standards for producing safe animal food. the event of a recall or foodborne illness food across all types of animal food (Comment 164) Some comments say outbreak. Recordkeeping requirements facilities and animal food. We that CGMP requirements for animal food currently exist in the Bioterrorism Act, considered the diverse needs of industry in general are not appropriate for some and implementing regulations in part 1 and the ultimate goal of animal food products used in animal food. subpart J for persons who manufacture, safety as we finalized the CGMP Comments provide examples such as process, pack, transport, distribute, regulations. We believe the final rendered products, which are thermally receive, hold, or import food in the requirements are flexible enough to be processed before being used as United States. In addition, the applied appropriately in various animal ingredients in animal food; humic responsible party at any food facility food production settings. For example, products because raw mined materials required to register under section 415 of § 507.19(b) contains requirements for are low risk; and oilseed products the FD&C Act (domestic and foreign) is the cleaning of animal food-contact because they have not been associated subject to the RFR requirements under surfaces of equipment and utensils to with any significant food safety risks section 417 of the FD&C Act. Section protect against contamination of animal and are intermediate ingredients that 417 requires under certain food. We do not specify exactly how will undergo a subsequent kill step. circumstances that the responsible party this is to be done (except some (Response 164) We understand that notify the previous source and requirements for cleaning with wet some ingredients utilized in the subsequent recipient of the article of processing of animal food), knowing production of animal food may pose a reportable food, providing traceability. that what constitutes adequate cleaning low risk. Nevertheless, facilities that are (Comment 167) Some comments will depend on the plant and the animal required to register under section 415 of request that we use the term food. (See Response 182). the FD&C Act and are suppliers of ‘‘adulteration’’ instead of As discussed in the 2013 proposed ingredients used in animal food will be ‘‘contamination’’ in subpart B of the rule for preventive controls for animal required to meet the CGMP final rule because ‘‘adulteration’’ of food food, in 2003 we introduced the concept requirements being finalized in this is the regulatory standard for action, of the Animal Feed Safety System rule. We believe these CGMPs provide whereas contamination is currently (AFSS) which was intended to address a great deal of flexibility in establishing undefined. These comments state that the safety of all animal food at all stages baseline standards for safely the term contamination should carry a of production and use. After obtaining manufacturing, processing, packing, or different meaning than in part 117 input from the general public, State holding the wide diversity of because what is considered a regulatory officials, industry, ingredients used in animal food. contaminant in human food may differ veterinarians, and consumers, the AFSS (Comment 165) One comment from what is considered a contaminant working group began developing a suggests that a new section be added at in animal food. proposed rule for process controls for the end of subpart B that would (Response 167) We decline this animal food, prior to FSMA, that was eliminate the need to comply with the request. Section 402(a)(3) and (4) of the intended to apply to all animal food CGMPs if a facility showed that the FD&C Act were added to expand our (including pet food, livestock feed, and hazard analysis and risk-based bases for initiating enforcement raw materials and other ingredients) (78 preventive controls required by subpart proceedings against adulterated food, FR 64736 at 64740). C had been properly conducted, particularly to allow us to act where a When we revised the proposed implemented and validated. food has been prepared, packed, or held CGMPs in the 2014 supplemental (Response 165) We decline this under insanitary conditions, whereby it notice, we not only consulted the request. The requested change is may have become contaminated. In human food CGMPs and their counter to the intent of this regulation, other words, a food need not be shown development history, but also reviewed that the CGMPs in subpart B provide to contain contaminants to be the draft AFSS process controls baseline safety and sanitation standards, adulterated; a showing that the food was proposed rule. We also reviewed while hazards specific to a facility and prepared, packed, or held under

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conditions whereby it may become consistent with how these terms are ‘‘establishment’’ for clarity. We are contaminated is sufficient to prove used throughout our current regulations finalizing the proposed list of methods adulteration. Thus, the word for human and animal food. The only for maintaining cleanliness that were ‘‘contamination’’ serves a necessary requirement for sanitizing in subpart B proposed in § 507.14(a)(1) through (5) in purpose in the context of adulteration. is in regards to wet processing (see new § 507.14(b)(1) through (5). We have The CGMPs in this final rule are regulatory text for § 507.19(b)(2)). added paragraph (b) to read: ‘‘the intended to help protect against the Therefore, we believe that ‘‘sanitation’’ methods for conforming to hygienic contamination of animal food, so that it is a word that is commonly understood practices and maintaining cleanliness will not become adulterated. by industry and is used in this final rule include.’’ The word ‘‘contamination’’ is used in a way that is consistent with how it widely in FDA regulations, including is used in our other regulations relating (Comment 171) Some comments ask our Current Good Manufacturing to human and animal food. us to remove ‘‘all’’ because it is too Practice for Medicated Feeds (21 CFR (Comment 169) Some comments extreme and prescriptive. part 225), Thermally Processed Low- request that we use ‘‘tools’’ instead of (Response 171) We have revised the Acid Foods Packaged in Hermetically ‘‘utensils’’ in the CGMPs to better fit the regulatory text to delete ‘‘all’’. We Sealed Containers (21 CFR part 113), terminology used in the animal food disagree that the term ‘‘all’’ is too and the Current Good Manufacturing industry. extreme and prescriptive, but conclude (Response 169) We decline this Practice in Manufacturing, Packing, or that the term ‘‘all’’ is not necessary to Holding Human Food (21 CFR part 110, request. We recognize that ‘‘utensil’’ is communicate the intent of the and updated and included in the final not commonly used in the animal food requirement. rule for preventive controls for human industry; however, we believe it is well food, 21 CFR part 117, published understood. The term ‘‘utensil’’ is used A. Proposed § 507.14(a)(1)—Personal elsewhere in this Federal Register). In in PAS–222 and Codex Good Practices Cleanliness (Final § 507.14(b)(1)) addition, ‘‘contamination’’ is used in for the Feed Industry, as well as in the Codex Good Practices for the Feed CGMPs for human food in part 110 and We proposed that the methods for Industry and PAS 222 (Ref. 27). Because in the revised CGMPs in the final rule maintaining cleanliness include of the wide use of the term throughout for preventive controls for human food, maintaining adequate personal current FDA regulations and in part 117 (Refs. 27 and 29). Further, cleanliness. We did not receive international standards, we conclude because ‘‘tools’’ is broadly used to refer comments specific to this provision and that industry is familiar with the word to such things as construction are finalizing it as proposed. ‘‘contamination’’ and it is an equipment, software, educational appropriate word to use in this final material, and even laws and regulations, B. Proposed § 507.14(a)(2)—Hand rule. we believe it is not a good substitute for Washing (Final § 507.14(b)(2)) We recognize that it may not always ‘‘utensils.’’ be possible to prevent contamination of (Comment 170) A number of We proposed that the methods for animal food. Therefore, we have comments request that wherever we maintaining cleanliness include changed the regulatory text throughout require measures to protect against washing hands thoroughly in an subpart B to stress that the goal of the contamination of animal food, animal adequate hand-washing facility as regulations is to ‘‘protect against’’ or food-contact surfaces, and animal food- necessary and appropriate to prevent ‘‘minimize’’ the contamination of packaging materials, that we delete contamination. animal food. We recognize that what is animal food-contact surfaces and animal (Comment 172) One comment considered contamination of human food-packaging materials because the disagrees with FDA’s decision to revise food may not be considered focus should be solely on the animal the language from the 2013 proposed contamination in animal food. food. rule by removing the parenthetic (Comment 168) Some comments (Response 170) We decline this statement about sanitizing hands if object to the use of the terms ‘‘sanitize’’ request. While the ultimate goal of the necessary to protect against and ‘‘sanitation’’ in the CGMPs, saying CGMP requirements is to protect against contamination with undesirable that the destruction of microorganisms contamination of animal food, we is not always necessary in animal food believe that protecting animal food- organisms. The comment recommends facilities and therefore ‘‘cleaning’’ or contact surfaces and animal food- that FDA add a qualifying statement that ‘‘housekeeping’’ should be used instead packaging material from contamination if hand washing facilities are not readily of ‘‘sanitizing.’’ Some of these is a necessary step to achieve this goal available, the use of hand sanitizers is comments also ask that we change the because the surfaces and packaging can permitted. title of proposed § 507.19 from be a source of contamination. (Response 172) We decline this ‘‘Sanitation’’ to ‘‘Cleaning and request. We deleted the parenthetic Housekeeping.’’ XV. Subpart B: Comments on Proposed § 507.14—Personnel statement because we did not intend to (Response 168) We decline this require hand sanitizing after hand request. We use the term ‘‘sanitation’’ in We proposed that plant management washing. We are providing flexibility for must take all reasonable measures and a general way that we believe is well plant management to determine if hand understood by the animal food industry precautions to ensure that all persons sanitizing after washing is necessary to and does not mean the destruction of working in direct contact with animal protect against contamination of animal microorganisms. For example, the term food, animal food-contact surfaces, and ‘‘sanitation’’ is defined in PAS–222 (Ref. animal food-packaging materials food with undesirable microorganisms. 27). When the destruction of vegetative conform to hygienic practices to the We recognize that there may be some cells of pathogens and substantial extent necessary to protect against the situations where hand washing facilities reduction of numbers of other contamination of animal food. We are are not readily available. The use of undesirable microorganisms is required, finalizing this provision with the waterless hand cleaners (including hand we use the terms ‘‘sanitize’’ or discussed changes in § 507.14(a). We sanitizers) may be adequate under these ‘‘sanitizing,’’ not ‘‘sanitation,’’ which is have changed ‘‘plant’’ to circumstances.

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C. Proposed § 507.14(a)(3)—Unsecured surfaces, or animal food packaging B. Proposed § 507.17(b)(1)—Adequate Jewelry and Other Objects (Final materials.’’ Space Between Equipment, Walls, and § 507.14(b)(3)) (Response 175) We believe this Stored Materials We proposed that personnel be provision indicates that the listed We proposed that the buildings, required to remove or secure jewelry requirements are not meant to be structures, fixtures, and other physical and other objects that might fall into exhaustive and provides needed facilities of the plant must be suitable in animal food, equipment, or containers. flexibility for the diverse animal food size, construction, and design to (Comment 173) One comment says industry to implement precautions facilitate cleaning, maintenance, and this requirement is unnecessary since specific to their operations to protect pest control to reduce the potential for the proposed CGMPs contain numerous against the contamination of animal contamination of animal food, animal other provisions that require facilities to food. We will consider providing food-contract surfaces, and animal food- protect against the adulteration of examples in any future guidance. packaging materials. We also proposed products. The focus placed on jewelry XVI. Subpart B: Comments on Proposed that the plant must provide adequate and other items that may potentially fall § 507.17—Plant and Grounds space between equipment, walls, and into products is unwarranted due to the stored materials to permit employees to limited risk of such occurrences. A. Proposed § 507.17(a)—Grounds perform their duties and to allow (Response 173) We believe that a Surrounding an Animal Food Plant cleaning and maintenance of specific provision to protect against We proposed that the grounds equipment. jewelry and other personal items falling surrounding an animal food plant under (Comment 178) Two comments into animal food is appropriate, and is the control of the operator must be kept disagree with this requirement. One not redundant to other requirements in in a condition that will protect against comment says that the focus is on the CGMPs that are intended to protect the contamination of animal food, equipment design and not protecting against adulteration of animal food. including provisions to keep areas from against animal food contamination. The being a harborage for pests, maintaining other comment suggests simplifying the D. Proposed § 507.14(a)(4)—Storing areas so they are not a source of requirement to provide access between Clothing and Personal Belongings (Final contamination, adequately draining equipment and walls. § 507.14(b)(4)) areas, and treating and disposing of (Response 178) We believe protecting We proposed requiring personnel to waste so it is not a source of animal food from contamination store clothing and other personal contamination. requires proper plant design. We belongings in areas other than where (Comment 176) One comment says decline the request to change the animal food is exposed or where that the term ‘‘surrounding’’ the plant is requirement by deleting the reference to equipment or utensils are cleaned. too ambiguous, and that we should stored materials because we do not (Comment 174) One comment says specify the distance from a plant that agree that stored materials should be that the requirement is not practical or must be controlled to prevent animal allowed to prevent employees from necessary to ensure the safety of animal food contamination. performing their duties or inhibit the food. The comment states that the (Response 176) We decline to specify cleaning and maintenance of temperature in a facility can be highly a distance from the plant because the equipment. We did modify the language variable, so it would be unreasonable to area that could impact plant operations in paragraph (b) to replace ‘‘buildings, require an employee to store clothing is highly variable from plant to plant. structures, fixtures, and other physical outside of areas where animal food is We have replaced the word facilities of the plant’’ with ‘‘the plant’’ exposed. ‘‘surrounding’’ with the word ‘‘around,’’ because the plant would include its (Response 174) We understand that meaning the grounds of the plant under buildings, structures, fixtures, and personnel may need layers of clothing control of the plant management that physical facilities. in certain plants that are exposed to could impact plant operations. C. Proposed § 507.17(b)(2)—Dripping varying temperatures. However, when (Comment 177) Some comments say and Condensation clothing is removed, it needs to be that the requirements are highly stored away from exposed animal food prescriptive and should be more We proposed that the plant must be so it does not become a source of flexible. Other comments state that the constructed in a manner such that drip contamination. We believe storing general language that requires the or condensate from fixtures, ducts, and clothing and other personal belongings grounds to be kept in a condition that pipes does not serve as a source of in areas other than where animal food will protect against the contamination of contamination. is exposed is a reasonable protection. animal food is sufficient and that the (Comment 179) One comment asks specific requirements should be that we allow for facilities to be E. Proposed § 507.14(a)(5)—Taking recommendations. ‘‘constructed or maintained,’’ rather Other Necessary Precautions (Final (Response 177) The specific than ‘‘constructed’’ only, to ensure that § 507.14(b)(5)) requirements provide the baseline drip or condensate does not serve as a We proposed that personnel must take expectations we have for plants to source of animal food contamination. any other necessary precautions to maintain their grounds in a way that Another comment asks that the protect against the contamination of does not result in the contamination of requirement be deleted, since it is animal food, animal food-contact animal food. The specific requirements generally not relevant and is redundant surfaces, or animal food-packaging are common to most plants and provide to the opening statement in proposed materials. necessary information to the plant paragraph (b). Other comments say that (Comment 175) One comment management about what it must do to requirements pertaining to the requests that we provide examples in a comply with this final rule. However, construction of buildings and structures guidance document for the requirement the requirements do not preclude a are too prescriptive and should specify to take ‘‘any other necessary precautions plant from addressing unique only that the plant be constructed in to protect against contamination of circumstances that could lead to the such a manner as to protect against animal food, animal food contact contamination of animal food. adulteration of animal food.

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(Response 179) We decline the processed, packed, or held, and areas XVII. Subpart B: Comments on requests to revise or delete this where equipment or utensils are Proposed § 507.19—Sanitation requirement. The requirements in (b)(1) cleaned. We received no comments on A. Proposed § 507.19(a)—Buildings to (5) are some of the specific this provision and are finalizing it as requirements that we believe are needed proposed. We proposed that buildings, to meet the general requirement in structures, fixtures, and other physical paragraph (b) that the plant be designed F. Proposed § 507.17(b)(5)—Glass facilities of the plant must be kept clean and constructed to reduce the potential We proposed that the plant must and in good repair to prevent animal for contamination. We believe it is provide safety-type light bulbs, fixtures, food from becoming contaminated. We important to specify that fixtures, ducts, and skylights, or other glass items received no comments on this and pipes be constructed so that they do suspended over exposed animal food in provision, however we are replacing not serve as a source of contamination any step of preparation, to protect ‘‘contaminated’’ with the broader because condensate and drip may serve against the contamination of animal standard ‘‘adulterated’’ as proposed in as a source of contamination. As food in case of glass breakage. We did the 2013 proposed preventive controls specified in § 507.20(b)(3), plumbing not receive specific comments on this rule for animal food. must be maintained to avoid being a paragraph. However, for clarity, we have B. Proposed § 507.19(b)—Cleaning source of contamination to animal food. replaced the term ‘‘safety-type’’ with In addition, as specified in 507.19(a), ‘‘shatter-resistant.’’ We proposed that animal food-contact the fixtures and physical facilities of the and non-contact surfaces of utensils and plant must be kept in good repair to G. Proposed § 507.17(b)(6)—Outdoor equipment must be cleaned and prevent animal food from becoming Storage maintained and utensils and equipment adulterated. This would include We proposed that animal food stored stored as necessary and appropriate to fixtures, ducts, and pipes. Thus, we outdoors in bulk be protected by any protect against the contamination of agree that one way to manage dripping effective means, including using animal food, animal food-contact and condensation is through protective coverings, controlling areas surfaces, or animal food-packaging maintenance or repair to the plumbing over and around the bulk animal food materials, and that when necessary, or structure, and do not intend that to eliminate harborages for pests, and equipment be disassembled for existing plants must be redesigned or checking on a regular basis for pests and thorough cleaning. reconstructed. pest infestation. (Comment 182) Two comments state that the proposed provision is too (Comment 181) Several comments say D. Proposed § 507.17(b)(3)—Ventilation prescriptive because of the requirement that protecting animal food stored We proposed that the plant must to disassemble equipment for cleaning outdoors is better addressed in proposed provide adequate ventilation or control when necessary. § 507.19 (Sanitation). One comment says equipment to minimize vapors (for (Response 182) We believe the that at livestock facilities and farms example, steam) and fumes in areas language provides flexibility for plants animal food such as hay, silage, grain, where they may contaminate animal to prevent contamination of animal food human food by-products, and other food, and locate and operate fans and contact and non-contact surfaces of commodities are commonly stored other air-blowing equipment in a utensils and equipment. The language outside with no cover. Another manner that minimizes the potential for ‘‘when necessary’’ provides the plant comment requests that the regulation be contaminating animal food. the option whether to disassemble the (Comment 180) One comment says revised to recommend rather than equipment for cleaning based on the that while steam is a key manufacturing require the provisions. manufacturer’s knowledge and component, it is unlikely to be a source (Response 181) While we disagree experience of when this cleaning of potentially hazardous contaminants. with the recommendation to move this procedure is necessary to protect against Several comments state that steam is not requirement to § 507.19 (Sanitation), we the contamination of animal food, commonly used in animal food moved it from proposed paragraph (b) to animal food-contact surfaces, or animal processing, and should not be specified new paragraph (c) in § 507.17 because food-packaging materials. in the rule, or language stating ‘‘where paragraph (b) pertains to buildings and C. Proposed § 507.19(b)(1)—Wet appropriate and necessary’’ should be structures and this requirement is about Cleaning included in the regulatory text. Other animal food stored outside of the comments suggest additional alternative building or structure. We have revised We proposed that when it is necessary language. the regulatory text in paragraph (c)(1) to to wet-clean animal food-contact (Response 180) We agree that not all read ‘‘Using protective coverings where surfaces used for manufacturing, plants use steam and the phrase ‘‘where necessary and appropriate’’ to account processing, packing, or holding low- appropriate and necessary’’ provides for the situations that may not require moisture animal food, the surfaces must that distinction and have added it to the protective coverings. In addition, we be thoroughly dried before subsequent regulatory text. We also recognize that have added checking for product use. animal food facilities commonly rely on condition related to the safety of the (Comment 183) One comment states natural ventilation. As a result, we have animal food in paragraph (c)(3) to that ‘‘low-moisture animal food’’ is not added the parenthetical (mechanical or ensure that if the animal food is not defined, so for clarity we should either natural) to the regulatory text to read: covered, animal food safety is define it or replace it with ‘‘safe ‘‘Provide adequate ventilation maintained. We decline to specify under moisture level animal food’’ because (mechanical or natural) . . .’’ what circumstance protective coverage ‘‘safe moisture level’’ is already defined is required (such as, to protect against in the proposed rule. E. Proposed § 507.17(b)(4)—Lighting adverse weather conditions) since there (Response 183) We agree that the term We proposed that the plant must could be several reasons for needing ‘‘low-moisture’’ is not well known when provide adequate lighting in hand- protective coverage to help protect applied to the animal food industry as washing areas, toilet rooms, areas where against contamination of the animal a whole and we have removed the term. animal food is received, manufactured, food. We believe that in most cases, animal

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food contact surfaces must be (Response 185) We believe this a sufficient physical barrier such that thoroughly dried after wet cleaning requirement is sufficiently flexible they are not able to contaminate the because the moisture could provide an because it applies only when necessary animal food. With this clarification, we environment for growth of undesirable to protect against the introduction of do not believe that establishments will microorganisms. However, we also undesirable microorganisms into animal need to make significant investments to understand that in some situations, for food. their buildings and structures to comply with these requirements. example in wet processing areas, it E. Proposed § 507.19(c)—Cleaning would not be necessary to dry surfaces Compounds and Sanitizing Agents G. Proposed § 507.19(d)(2)— thoroughly before subsequent use in We proposed that cleaning Identification, Use, and Storage of Toxic order to protect against contamination. Materials Therefore, we have inserted ‘‘when compounds and sanitizing agents must necessary,’’ so that the requirement is be safe and adequate under the We proposed that toxic materials appropriate for all types of animal food conditions of use. We received no described in paragraph (d)(1) of this facilities. comments on this provision and are section (for example, cleaning (Comment 184) Two comments note finalizing it as proposed. compounds, sanitizing agents, and pesticide chemicals) must be identified, that the proposed rule includes explicit F. Proposed § 507.19(d)(1)—Toxic used, and stored in a manner that requirements for wet cleaning, but none Materials for dry cleaning. One comment suggests protects against the contamination of We proposed that only certain toxic animal food, animal food-contact adding language to paragraph (b) for dry materials may be used or stored in a cleaning, including vacuuming or surfaces, or animal food-packaging plant where animal food is materials. sweeping. The second comment manufactured, processed, or exposed, (Comment 187) A number of suggests adding language for dry i.e., those that are required to maintain comments object to the use of ‘‘toxic’’ in cleaning when used solely for low- clean and sanitary conditions, those proposed paragraph (d)(2). Several moisture feed ingredients. necessary for use in laboratory testing comments suggest that ‘‘cleaning (Response 184) We decline these procedures, those necessary for plant materials’’ rather than ‘‘toxic cleaning requests. The regulatory text in and equipment maintenance and compounds’’ be used in paragraph (d)(2) paragraph (b) requires that utensils and operation, and those necessary for use because any substance may be equipment be cleaned and maintained, in the plant’s operations. considered ‘‘toxic’’ if handled or used but it does not specify the exact (Comment 186) Some comments say inappropriately. One comment asks that procedures. Adequate cleanout of so- that the proposed regulation would the term ‘‘toxic materials’’ be deleted called dry feeds has been an important require an absolute prohibition of any and requirements established instead for CGMP requirement applicable to potentially toxic materials that are the control of substances that are not medicated feed for more than 40 years stored but not used by an animal food approved for use in animal food. and, as such, some of the animal food plant. The comments note that animal (Response 187) We decline the industry is well aware of this practice. food plants that hold and distribute request. The term ‘‘toxic’’ is important The dry cleaning procedures suggested materials such as fertilizers and to specify that this paragraph applies to in the comments would be allowable pesticides would either need to toxic cleaning compounds. The term methods of cleaning and maintaining discontinue this practice or construct ‘‘cleaning compounds’’ would be too where appropriate to protect against the new storage buildings, which may be general and might include materials that contamination of animal food. We do expensive. Several comments suggest would not need to be handled as not believe additional language is alternative language to allow toxic specified in these requirements to necessary in the regulatory text for dry materials to be held and distributed in protect against the contamination of cleaning. The provisions in paragraph a way that would not require significant animal food. For example, water could (b)(1) for wet cleaning are in addition to physical improvements to the plant. be considered a cleaning compound, but the more general requirements in (Response 186) We agree that it might it is not considered toxic at regular use paragraph (b) to help ensure that water be common for an animal food plant to levels and we would not expect a plant from the wet-cleaning process does not have toxic materials not identified in to treat its use of cleaning water in a result in subsequent contamination of paragraph (d)(1), such as fertilizers or manner consistent with this animal food. other non-plant chemicals, as part of its requirement. We decline the request to business inventory. However, we D. Proposed § 507.19(b)(2)—Wet substitute ‘‘substances that are not disagree with the comments that state Processing approved for use in animal food’’ for the provisions in the rule would require ‘‘toxic materials.’’ Not all animal food We proposed that in wet processing, new investments in storage buildings. ingredients have been or must be when cleaning and sanitizing is The intent of the provision is to keep preapproved by the Agency before being necessary to protect against the toxic chemical categories not listed in used to produce animal food. introduction of undesirable paragraph (d)(1) out of the plant area so Additionally, ingredients that have not microorganisms into animal food, all animal food is not exposed. We revised been approved by the Agency would not animal food-contact surfaces must be the regulatory text to add paragraph necessarily be toxic. cleaned and sanitized before use and (d)(3), which reads ‘‘Other toxic after any interruption during which the materials (such as fertilizers and H. Proposed § 507.19(e)—Pest Control animal food-contact surfaces may have pesticides not included in paragraph We proposed that effective measures become contaminated. (d)(1) of this section) must be stored in must be taken to exclude pests from the (Comment 185) One comment says an area of the plant where animal food manufacturing, processing, packing, and the proposed requirements for cleaning is not manufactured, processed, or holding areas and to protect against the in wet processing areas should be more exposed.’’ We expect that this will contamination of animal food by pests. flexible and suggests the additional result in toxic materials not identified in The use of insecticides and rodenticides wording ‘‘as necessary to protect against paragraph (d)(1) being separated from in the plant is permitted only under adulteration of animal food.’’ animal food either by sufficient space or precautions and restrictions that will

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protect against the contamination of about what is expected of the water (Response 190) We decline these animal food, animal food-contact supply for the plant and the animal food requests. We believe these are basic and surfaces, and animal food-packaging being manufactured, processed, packed necessary requirements for helping materials. We received no comments on or held. We will consider including ensure production of safe animal food. this provision. We have replaced the water supply in any future guidance. The regulatory text requires adequate words ‘‘insecticides and rodenticides’’ (Comment 189) Two comments say floor drainage for areas where floors are with ‘‘pesticides’’ for simplicity and that that the requirements pertaining to subject to flooding-type cleaning or because we have defined pest as ‘‘any the water supply are overly prescriptive where normal operations release or objectionable animals or insects and we should require only that the discharge water or other liquid waste on including birds, rodents, flies, and water supply be adequate for the the floor. Plants that do not perform larvae.’’ Thus, pests are not limited to operations. Two comments suggest that these activities as part of their normal insects and rodents. the requirement about the reuse of water operations would not be expected to be reworded to provide more have floor drainage and vacuuming or I. Proposed § 507.19(f)—Trash and clarification on the recycling of water mopping may be adequate. Garbage within the plant. We proposed that trash and garbage (Response 189) We believe the source C. Proposed § 507.20(c)—Sewage must be conveyed, stored, and disposed of the water is relevant to ensuring that We proposed that sewage must be of in a way that protects against the animal food is protected from disposed of through an adequate contamination of animal food, animal contamination. We also believe sewerage system or through other food-contact surfaces, animal food- specifying that water be safe for its adequate means. packaging materials, water supplies, and intended use, and that it be provided at (Comment 191) Some comments say ground surfaces, and minimizes the a suitable temperature and pressure that the requirement to provide an potential for the trash and garbage to where it is needed for manufacturing, adequate sewer system is covered by the become an attractant and harborage or processing, cleaning, and hand washing requirement in proposed § 507.20(b)(2) breeding place for pests. We received no helps protect against animal food for plumbing and that one of the comments on this provision; however contamination. With respect to reuse of requirements should be deleted to we are removing the term ‘‘garbage.’’ water, we believe our statement that eliminate this redundancy. (See Response 227). water may be reused for washing, (Response 191) The requirement in rinsing, or conveying animal food if it paragraph (b)(2) is intended to make XVIII. Subpart B: Comments on does not increase the level of sure the plumbing in the plant is Proposed § 507.20—Water Supply and contamination of the animal food allows sufficient to remove sewage and liquid Plumbing flexibility for recycling water within the disposable waste from the points at A. Proposed § 507.20(a)—Water Supply plant. Additional clarification could which it is generated within the plant, (Final § 507.20(a)(1)–(4)) have the unintended effect of reducing while the requirement in paragraph (c) flexibility. is intended to make sure that the sewage We proposed that the water supply B. Proposed § 507.20(b)—Plumbing and liquid disposable waste created by must be adequate for the operations and the plant is delivered to a wastewater must be derived from a suitable source. We proposed that plumbing be system, such as a sewer or septic Running water at a suitable temperature, designed, installed, and maintained to system, which has a capacity adequate and under suitable pressure as needed, carry adequate quantities of water to to ensure that this wastewater does not must be provided in all areas where required locations throughout the plant; contaminate the animal food. required for the manufacturing or properly convey sewage and liquid processing of animal food, for the disposable waste from the plant; avoid D. Proposed § 507.20(d)—Toilet cleaning of equipment, utensils, and being a source of contamination to Facilities animal food-packaging materials, or for animal food, animal food-contact We proposed that each plant must employee hand-washing facilities. surfaces, or animal food-packaging provide employees with adequate, Water that contacts animal food, animal materials, water supplies, equipment, or readily accessible toilet facilities, and food-contact surfaces, or animal food- utensils, or creating an unsanitary that the toilet facilities be kept clean packaging materials must be safe for its condition; provide adequate floor and not be a potential source of intended use. Water may be reused for drainage in all areas where floors are contamination of animal food, animal washing, rinsing, or conveying animal subject to flooding-type cleaning or food-contact surfaces, or animal food- food if it does not increase the level of where normal operations release or packaging materials. contamination of the animal food. discharge water or other liquid waste on (Comment 192) Some comments (Comment 188) One comment the floor; and ensure there is no suggest adding ‘‘as appropriate’’ to the suggests that we develop an backflow or cross-connections between requirement to provide adequate toilet enforcement plan for water quality that piping for water for processing and for facilities for plant employees. takes into account the intended use of waste water. (Response 192) We decline this the animal food being manufactured. (Comment 190) One comment says we request. We understand that there may Another comment says that many of the are proposing to establish specific be an exception where toilet facilities details contained in this paragraph of requirements for plumbing design, are not inside a plant, but we believe it the proposed regulation should be installation, and maintenance that are is important that toilet facilities are handled as guidance rather than not necessary to prevent the available near the plant for employee regulation. adulteration of animal food, and use, and the requirement as proposed (Response 188) We believe that the suggests deleting the plumbing design provides this flexibility. details contained in this paragraph section entirely. Two comments say that should remain requirements because floor drains are not the only way to E. Proposed § 507.20(e)—Hand-Washing they are important to helping ensure the remove water or other fluids from floors, Facilities safety of animal food and to provide the and suggest we allow other options such We proposed that each plant must regulated facility with information as vacuuming, mopping, or fans. provide hand-washing facilities

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designed to ensure that an employee’s manufacturers/processers. Some utensils that could damage the hands are not a source of contamination comments also say that we should equipment. of animal food, animal food-contact clarify that we are not requiring the use surfaces, or animal food-packaging of food-grade lubricants. E. Proposed § 507.22(a)(5)—Non-Animal materials. (Response 195) We understand that Food Contact Equipment (Final (Comment 193) Some comments plants do not normally design and § 507.22(a)(1)) construct the equipment they use. suggest adding the words ‘‘as We proposed that equipment in the However, we believe it is the plant’s appropriate’’ to the requirement to animal food in manufacturing/ provide flexibility for those plants that responsibility to select equipment and processing area, that does not come into may not need hand-washing facilities. utensils that when used will not contact with animal food must be Another comment asks that we add an adulterate animal food. We have revised constructed in such a way that it can be option that allows for the use of hand the text to clarify that the presence of kept in a clean condition. sanitizing in plants that may not need non-food grade lubricants, fuel, metal hand-washing facilities. fragments, contaminated water, or other (Comment 198) One comment says (Response 193) We understand that contaminants in animal food may that this requirement should be deleted there may not be running water in every render it adulterated. We also have because it is highly prescriptive, plant, but we believe it is important that revised the wording for easier reading. redundant to proposed paragraph (a)(1), hand-washing facilities be available to We are not requiring that only food and not performance based or necessary. employees. We understand that in some grade lubricants be used in the plant, Further, the comment states FDA’s focus cases hand-washing facilities might but food grade lubricants must be used should be on whether the area is consist of waterless hand cleaners on equipment that comes in contact adequately cleaned, not on whether (including hand sanitizers). with animal food. When a non-food equipment that does not come in grade lubricant is used on non-food XIX. Subpart B: Comments on Proposed contact with animal food is properly contact equipment, it must not § 507.22—Equipment and Utensils designed. adulterate the animal food. We have (Response 198) We disagree that the A. Proposed § 507.22(a)(1)—Plant added the term ‘‘non-food grade’’ for requirement is too prescriptive. Equipment and Utensils lubricants to clarify this. However, we agree that there is some We proposed that all plant equipment C. Proposed § 507.22(a)(3)—Equipment redundancy between proposed and utensils must be designed and of Installation paragraphs (a)(1) and (a)(5). We have such material and workmanship to be We proposed that equipment should removed proposed paragraph (a)(5) and adequately cleanable, and must be be installed and maintained in such a have modified the regulatory text in properly maintained. way as to facilitate the cleaning of the paragraph (a)(1) as discussed in section (Comment 194) Some comments equipment and adjacent spaces. This XIX.A. suggest that this be a recommendation provision has been revised to be a F. Proposed § 507.22(b)—System Design rather than a requirement because it is requirement, not a recommendation as it too prescriptive and applies to all is a requirement, not guidance. and Construction equipment in a plant, rather than only (Comment 196) One comment We proposed that holding, conveying, to equipment used in the production of suggests that we combine proposed animal food. manufacturing, and processing systems, §§ 507.22(a)(1) and 507.22(a)(3). including gravimetric, pneumatic, (Response 194) We decline this (Response 196) We decline this closed, and automated systems, must be request. We believe that all plant request. The first provision requires that designed, constructed, and maintained equipment with the potential to equipment be properly designed and in a way that does not contaminate contaminate animal food must be constructed, and the second requires cleanable and maintained. To clarify that it be installed in a way that animal food. this requirement, we have added facilitates cleaning and maintenance. (Comment 199) Several comments language stating that this requirement We have revised the wording in (a)(3) suggest that this requirement be revised applies to equipment and utensils used for clarity. or deleted to allow plants the flexibility in manufacturing, processing, packing, to maintain their equipment in a D. Proposed § 507.22(a)(4)—Animal and holding animal food, as well as manner that is appropriate for their Food Contact Surfaces equipment and utensils that do not facility, and because it is redundant to come in contact with animal food but We proposed that animal food-contact proposed § 507.22(a)(1) through (4). could still serve as a source of surfaces must be made of materials that (Response 199) We decline to revise contamination of animal food. withstand the environment of their use or eliminate this provision. The and the action of animal food, and, if B. Proposed § 507.22(a)(2)—Design of applicable, the action of cleaning requirements in § 507.22(a) are specific Equipment and Utensils compounds, and sanitizing agents; be to individual pieces of equipment. The We proposed that the design, made of nontoxic materials; and requirement in § 507.22(b) is meant to construction, and use of equipment and maintained to protect animal food from address entire systems that may contain utensils must preclude the being contaminated. multiple pieces of equipment. While an contamination of animal food with (Comment 197) Some comments ask individual piece of equipment may be lubricants, fuel, metal fragments, us to specify that food-contact surfaces designed, constructed and maintained contaminated water, or any other must be designed to withstand cleaning so that it protects against the contaminants. procedures. contamination of animal food, when (Comment 195) Some comments say (Response 197) We have revised the that piece of equipment becomes part of that this requirement is too prescriptive regulatory text to include cleaning a system, its use in the system must be because equipment and utensils are procedures. For example animal food- in a manner that protects against the designed and constructed by entities contact surfaces must be designed to contamination of animal food. (See independent of the animal food withstand the actions of scrubbing Response 167.)

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G. Proposed § 507.22(c)—Monitoring B. Proposed § 507.25(a)(2)—Identifying both the person feeding the animal(s) Cold Storage Temperatures Contents of Containers and the downstream facilities that may We proposed that each freezer and We proposed that plant management use an ingredient or mixture of cold storage compartment used to hold must ensure that containers holding ingredients to further process, mix, or animal food must be fitted with an animal food, including raw materials, blend into an animal food product. accurate temperature-monitoring device. other ingredients, or rework, accurately Some animal food products may pose a (Comment 200) Some comments state identify the contents. food safety concern for some species for requiring monitoring devices for each (Comment 201) Some comments which the food is not intended, or may compartment goes too far. Facilities suggest that we revise the proposed pose a food safety concern for an should have flexibility in controlling requirements by clarifying that the intended species if not used properly. temperatures in freezers and cold contents of containers, not the For example, the manufacturer of a storage compartments. One comment containers themselves, are accurately copper product might include the use says this requirement should not require identified, and that we clarify that bulk levels for food for different species or a the use of continuous temperature- silos and bins are not required to be labeling statement specifying the monitoring devices. placarded, because this is impractical maximum safe level of copper in an (Response 200) We believe that a and not industry practice. animal food intended for sheep. temperature-measuring device for each (Response 201) We agree that the We have moved this requirement to compartment is necessary because the animal food in the containers is what paragraph (b) in § 507.27 ‘‘Holding and temperature may be different in each must be identified and have clarified the Distribution.’’ We believe that this move compartment. We have replaced the language in the regulatory text to require helps to clarify that the labeling is term ‘‘temperature -monitoring device’’ management to ensure animal food, intended for finished animal food with ‘‘temperature-measuring device’’ as including raw materials, other leaving the plant. We have renumbered we do not intend the establishment to ingredients, or rework is accurately the other requirements in this section use a continuous monitoring device or identified. We recognize that a variety of accordingly. temperature recording device. systems are used by establishments to D. Proposed § 507.25(a)(4)—Animal identify animal food within the plant Food Packaging Material (Final H. Proposed § 507.22(d)—Instruments including labeling, computer systems, § 507.25(a)(3)) We proposed that instruments and paper records, chalkboards, and other controls used for measuring, regulating, methods. It is necessary that plant We proposed that plant management must ensure that animal food-packaging or recording temperatures, pH, aw, or personnel be able to accurately identify other conditions that control or prevent animal food, including raw materials, materials are safe and suitable. the growth of undesirable other ingredients, or rework within the (Comment 203) One comment microorganisms in animal food must be plant so that animal food is not suggests that instead of requiring that accurate, precise, adequately commingled, substituted, or incorrectly animal food-packaging materials are safe maintained, and adequate in number for formulated in a manner that results in and suitable, we require that they are their designated uses. We received no adulterated animal food. safe and suitable for the intended use. (Response 203) We disagree that this comments on this provision and are C. Proposed § 507.25(a)(3)—Labeling of clarification is needed because the finalizing it as proposed. Finished Product (Final § 507.27(b)) intended use is inherent in the current I. Proposed § 507.22(e)—Compressed We proposed that plant management wording of this regulation. Air must ensure that the labeling for E. Proposed § 507.25(a)(5)— We proposed that compressed air or finished animal food product contains Responsibility for Overall Plant other gases mechanically introduced information and instructions for safely Cleanliness (Final § 507.25(a)(4)) into animal food or used to clean animal using the product for the intended We proposed that plant management food-contact surfaces or equipment animal species. must ensure that overall cleanliness of must be used in such a way so animal (Comment 202) Many comments the plant is under the supervision of one food is not contaminated. We received suggest that instead of specifying that or more competent individuals assigned no comments on this provision and are labeling for the finished animal food product contains information and responsibility for this function. finalizing it as proposed with the (Comment 204) One comment revision ‘‘to protect against the instructions for safely using the product for the intended animal species we suggests that we require that the contamination of animal food.’’ (See competent individuals responsible for Response 167.) specify only that labeling for finished animal food products conforms to overall cleanliness of the plant be XX. Subpart B: Comments on Proposed requirements in existing FDA ‘‘qualified competent individuals.’’ § 507.25—Plant Operations regulations. One comment asks that we (Response 204) As discussed in clarify that finished product means the Response 92, we expect all individuals A. Proposed § 507.25(a)(1)—CGMPs product that the animal receives. who perform activities required under We proposed that plant management (Response 202) We decline the part 507 to know how to do their jobs; must ensure that all operations in the request. We do not intend ‘‘finished thus, we are establishing new § 507.4(b), manufacturing, processing, packing, and animal food product’’ to mean only which specifies that all individuals who holding of animal food are conducted in product that the animal receives. A perform activities required under part accordance with the CGMP finished animal food product could be 507 must be ‘‘qualified individuals’’ as requirements of this subpart. We ready-to-eat animal food or it could be that term is defined in § 507.3 (i.e., a received no comments on this an ingredient or mixture of ingredients person who has the necessary provision. We are revising paragraph (a) that will be further processed, mixed, or education, training, and experience to to read ‘‘Management of the blended before it is suitable for feeding perform an activity required under part establishment must ensure that:’’ based to animals. 507). A qualified individual may be, but on the definition of ‘‘plant’’ (see section Labeling containing information and is not required to be, an employee of the VIII.A.23). instructions for safe use is important for establishment.

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F. Proposed § 507.25(a)(6)— are used to dispose of adulterated (Comment 208) Some comments ask Contamination Precautions (Final animal food, the methods should that we insert ‘‘as appropriate and § 507.25(a)(5)) comply with state and local necessary’’ into the requirement to We proposed that plant management requirements. inspect raw materials and ingredients to (Comment 206) One comment must ensure that reasonable precautions ensure that they are suitable for requests that if we require are taken so that plant operations do not manufacturing/processing into animal reconditioning of an animal found to be contribute to the contamination of food. Another comment says that adulterated, that we clarify that such a ‘‘minimize deterioration’’ and animal food, animal food-contact requirement does not apply to grains surfaces, and animal food packaging ‘‘deterioration’’ are highly subjective subject to the review inspection and should be deleted. materials. We received no comments on provisions provided for by 7 CFR (Response 208) We decline the this provision. We did replace the term 800.125 and 800.135. ‘‘reasonable’’ with the term ‘‘adequate’’ (Response 206) In most cases, grains requests. However, we have revised the to be more consistent with the rest of subject to the review inspection regulatory text by replacing ‘‘inspected’’ the regulatory text in subpart B. provisions provided for by 7 CFR with ‘‘examined.’’ We believe that the 800.125 and 800.135 are RACs that are use of the word ‘‘examined’’ provides G. Proposed § 507.25(a)(7)—Testing more clarity for the animal food Procedures (Final § 507.25(a)(6)) being held or transported and subpart B (including § 507.25(a)(7)) would not industry because the term ‘‘inspected’’ We proposed that plant management apply to the grains (see § 507.5(h)). In often implies a regulatory activity. We must ensure that chemical, microbial, or addition this provision only applies to believe such an examination is extraneous-material testing procedures animal food that has actually been necessary to protect against are used where necessary to identify found to be adulterated. The provisions contamination of animal food. An sanitation failures or possible animal provided for by 7 CFR 800.125 and examination of raw materials and other food contamination. 800.135 are administered by USDA’s ingredients may include basic activities (Comment 205) Some comments say Federal Grain Inspection Service and such as a simple visual examination of that the need for chemical, microbial, or relate to their mission of facilitating the the product (e.g., looking for broken extraneous-material testing should be marketing of grains and related bags), or performing a chemical or determined by a facility when commodities. microbial analysis. Deterioration of identifying hazards and controls under animal food includes the loss of subpart C, and therefore it should not be I. Proposed § 507.25(a)(9)—Protecting palatability or nutritive value typically required under CGMPs. One comment Against Contamination (Final associated with the animal food and we says that it should be deleted because it § 507.25(a)(8)) believe this could be a safety concern is already addressed under the testing We proposed that plant management because animals are often fed the same provisions in subpart C. must ensure that all animal food food containing the same ingredients for (Response 205) The CGMP regulations manufacturing, processing, packing, and prolonged periods of time. As a result, in subpart B are intended to establish holding is conducted under such food refusal or consumption of animal baseline requirements that apply to all conditions and controls as are necessary food containing fewer nutrients than the plants that manufacture, process, pack, to minimize the potential for the growth animal food is expected to provide may or hold animal food (and thus are of undesirable microorganisms or for the result in poor animal productivity or required to register as food facilities in contamination of animal food. health issues. Furthermore, accordance with § 415 of the FD&C Act). (Comment 207) Some comments deterioration can indicate that the Using testing procedures, where suggest that we remove the requirement animal food has been held under necessary, to identify sanitation failures to minimize the potential for the growth conditions that would also support the or to identify contaminated animal food of undesirable microorganisms, so that growth of undesirable microorganisms. may be an important component of the requirement would be to minimize K. Proposed § 507.25(b)(1)(i)—Shipping manufacturing, processing, packing, or contamination of animal food or Containers holding animal food. This type of protecting against adulteration of animal testing may be independent of the food. We proposed that shipping containers requirements of subpart C, hazard (Response 207) We decline this (for example, totes, drums, and tubs) analysis and risk based preventive request. In addition to other and bulk vehicles holding raw materials controls, and therefore we have contaminants, we conclude that it is and other ingredients must be inspected included it in the CGMP regulations. important for an establishment to upon receipt to determine whether The provision provides flexibility for address undesirable microorganisms contamination or deterioration of management to determine when testing because they are a common source of animal food has occurred. is required by providing that testing be contamination (78 FR 64736 at 64747). used ‘‘where necessary.’’ (Comment 209) Some comments say J. Proposed § 507.25(b)(1)—Raw that inspection of shipping containers H. Proposed § 507.25(a)(8)— Materials and Ingredients should be as appropriate and necessary, Contaminated Product (Final We proposed that raw materials and or at a frequency appropriate and § 507.25(a)(7)) ingredients must be inspected to ensure necessary. We proposed that plant management that they are suitable for manufacturing/ (Response 209) We decline this must ensure that animal food that has processing into animal food and request. We have revised the regulatory become contaminated to the extent that handled under conditions that protect text by replacing ‘‘inspected’’ with it is adulterated is rejected, disposed of, against contamination and minimize ‘‘examined.’’ We believe this change or if permissible, treated or processed to deterioration. We are revising the phrase better conveys our intent that incoming eliminate the adulteration. If disposed ‘‘raw materials and ingredients’’ to read containers consistently be checked to of, it must be done in a manner that ‘‘raw materials and other ingredients’’ to make sure there is no gross visible protects against the contamination of make it clear that raw materials are contamination or deterioration of other animal food. Whatever methods ingredients. animal food.

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L. Proposed § 507.25(b)(1)(ii)—Raw natural toxins must be evaluated and other ingredients must be tested for Materials used in a manner that does not result in pathogens. Instead, we have included We proposed that raw materials must animal food that can cause injury or requirements that are meant to be cleaned as necessary to minimize soil illness to animals or humans. minimize the growth of undesirable (Comment 212) Several comments or other contamination. microorganisms, and protect animal suggest that we eliminate this food from the contamination with (Comment 210) Many comments say requirement because this activity undesirable microorganisms from raw that it is not always necessary to belongs in subpart C, not subpart B. materials and other ingredients, minimize soil contamination of raw Other comments say that the including those that may be injurious to materials because livestock routinely requirement could be interpreted to human or animal health. We believe ingest soil when consuming pasture mean that every load of incoming cereal these requirements are sufficient to help plants, hay, and other feeds without grains must be evaluated for ensure the safety of animal food. adverse consequences. mycotoxins, which would not always be Recommendations are to delete necessary. Other suggestions are to O. Proposed § 507.25(b)(3)—Raw reference to soil or else insert ‘‘as remove ‘‘evaluated’’ from the Materials and Rework (Final appropriate.’’ requirement, leaving only the § 507.25(b)(1)(iii)) (Response 210) We agree. We have requirement that raw materials and We proposed that raw materials and revised the regulatory text to remove the ingredients susceptible to mycotoxin ingredients and all rework must be held words ‘‘soil or other’’ from the contamination be used in a manner that in containers designed and constructed requirement. does not result in harm to humans or in a way that protects against M. Proposed § 507.25(b)(1)(iii)—Raw animals. contamination, and must be held under Materials (Response 212) We are locating conditions, e.g., appropriate requirements that are common to most temperature and relative humidity, that We proposed that raw materials and establishments and plants and serve as will minimize the potential for growth ingredients must be stored under a baseline for animal food safety in of undesirable microorganisms and in a conditions that will protect against subpart B, current good manufacturing manner that prevents the animal food contamination and deterioration. practice. Also, we do not intend that from becoming adulterated. (Comment 211) One comment every load of grain received must be (Comment 214) Some comments say suggests that the requirement that raw tested before it can be used. We intend that requiring that rework be held under materials be stored under conditions for ‘‘evaluation’’ to be broad and flexible conditions that will minimize the that will protect against contamination enough to consider any information that potential for growth of undesirable and deterioration be qualified to say allows the plant to use the raw materials microorganisms is too prescriptive, and ‘‘unreasonable contamination’’ and and other ingredients in a manner that suggest that the requirement be ‘‘excessive deterioration’’ to be more does not result in harm to humans or modified to require that all rework must appropriate for raw materials that will animals. For example, an evaluation be held in a manner that prevents the be rendered. One comment asks that we could be based on a general review of animal food from becoming adulterated. delete ‘‘and deterioration.’’ Another the weather conditions during the Some comments say that this comment suggests that a new section be growing season and whether it could requirement should be addressed in added to require that air flow be result in mycotoxins. subpart C rather than subpart B. controlled so that contamination does (Comment 213) One comment (Response 214).We disagree that the not spread from the raw material areas disagrees with our decision in the 2014 requirement should be addressed in into the finished product areas of the supplemental proposed rule to remove a subpart C instead of subpart B because plant. requirement in § 507.25(b)(2) of the we consider this to be a baseline (Response 211) We believe the rule as 2013 proposed rule for preventive requirement that should apply to all proposed is clear, and that the qualifiers controls for animal food that raw establishments that manufacture, suggested do not help reduce materials and ingredients not contain process, pack, or hold animal food. subjectivity and may create confusion microorganisms injurious to human or However, we have decided that about what is considered unreasonable animal health. This comment says that proposed paragraph (b)(3) contains or excessive. We decline to add a we should have modified the regulatory requirements that are similar to requirement that specifically addresses text to require that raw materials that proposed § 507.25(b)(1)(iii). We have air flow, because ventilation is are expected to contain levels of moved this provision and included it in addressed in § 507.17(b)(3). Also, the microorganisms that may be injurious to paragraph (b)(1)(iii) in the final rule. broad language requires that raw animal or human health, such as materials and other ingredients must be materials to be rendered, be stored and P. Proposed § 507.25(b)(4)—Frozen Raw stored under conditions that will protect handled in a way that prevents Materials (Final § 507.25(b)(3)) against contamination, which would contaminating the facility and finished We proposed that raw materials and include protection from airborne product, and that the materials be ingredients, if frozen, must be kept contaminants. We have determined, treated (e.g., heat treated) during frozen. If thawing is required prior to however, that it is logical from a food manufacturing operations so that they use, it must be done in a manner that safety standpoint to include rework in no longer contain levels that would minimizes the potential for the growth this provision. Therefore, we have cause the product to be adulterated. of undesirable microorganisms. incorporated proposed § 507.25(b)(3) (Response 213) Incoming raw (Comment 215) One comment says into this requirement. materials and other ingredients may that the requirement to keep frozen raw contain microorganisms injurious to materials frozen or thaw them in a N. Proposed § 507.25(b)(2)—Raw human or animal health. As we stated manner that minimizes the potential for Materials Susceptible to Mycotoxins in the 2014 supplemental notice for the growth of undesirable We proposed that raw materials and animal food, we proposed to remove microorganisms is redundant to other ingredients susceptible to this requirement because we did not requirements in § 507.25(b)(1) and contamination with mycotoxins or other intend that incoming raw materials and therefore should be deleted.

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(Response 215) We decline this requirement should be removed from is the better word to use in this context. request. The requirements in the CGMPs. One comment recommends These specific requirements provide a § 507.25(b)(1) and 507.25(b)(1)(iii) deleting only the examples of measures level of detail that we believe is address raw material and other that might be taken. Another comment important because these activities are ingredient inspection, storage and recommends deleting the term common in the animal food industry handling in general. This requirement ‘‘significantly’’ as this term is not and can contribute to the contamination speaks specifically to the storage and defined and is difficult to quantify. of animal food. We believe that this handling of frozen raw materials. We (Response 217) We disagree that the requirement for these activities is not believe it is important for those requirement should be addressed in redundant to other requirements in this establishments that use frozen raw subpart C instead of subpart B. We final rule. material to thaw that material safely to consider controlling undesirable U. Proposed § 507.25(c)(5)—Processing minimize the potential for the growth of microorganisms to be a baseline Operations undesirable microorganisms during the requirement that should apply to all thawing process. establishments that manufacture, We proposed that filling, assembling, packaging, and other operations must be Q. Proposed § 507.25(c)(1)— process, pack, or hold animal food. We also decline the request to remove the performed in such a way that protects Appropriate Conditions for Animal against the contamination of animal Food examples of measures that can be used to significantly minimize or prevent the food and the growth of undesirable We proposed that animal food must growth of undesirable microorganisms microorganisms. be maintained under conditions, e.g., because they are examples of practical (Comment 220) One comment appropriate temperature and relative solutions already used by industry. We requests that we delete ‘‘and the growth humidity, that will minimize the decline to delete the term of undesirable microorganisms’’ and potential for growth of undesirable ‘‘significantly.’’ The term ‘‘significantly require only that operations be microorganisms and prevent the animal minimize’’ is defined in § 507.3 and performed in such a way that the animal food from becoming adulterated during means to reduce to an acceptable level, food is protected against adulteration. manufacturing, processing, packing, and including to eliminate. Another comment suggests that the holding. requirement be deleted because it is (Comment 216) Some comments say S. Proposed § 507.25(c)(3)—Work-in- redundant, but does not identify the that the requirement to hold and Process and Rework redundant section. manufacture products at a temperatures We proposed that work-in-process (Response 220) As discussed in and relative humidity that will and rework must be handled in such a Response 167, we believe contamination minimize the potential for growth of way that it is protected against is the better word to use in this context. undesirable microorganisms should be contamination and the growth of These specific requirements, including deleted because it is not relevant to undesirable microorganisms. the requirement for the protection most animal food facilities. With this (Comment 218) Some comments against the growth of undesirable deletion, the requirement would be that request that we delete ‘‘and the growth microorganisms, provide a level of animal food be maintained under of undesirable microorganisms’’ and detail that we believe is important conditions that would prevent the require only that work-in-process and because these activities are common in animal food from becoming adulterated rework be handled in such a way that the animal food industry and can during manufacturing, processing, it is protected against adulteration. contribute to the contamination of packing, and holding. (Response 218) We decline this animal food. We believe that these (Response 216) Temperature and request. Because undesirable requirements for these activities are not relative humidity are examples of microorganisms are a common source of redundant with other requirements in conditions and may not apply to all contamination of animal food, including this final rule. plants and animal food. This work-in-process and rework, we have V. Proposed § 507.25(c)(6)—Controlling requirement is important for animal decided to specify that establishments Water Activity (a ) food safety in plants that produce must protect against the growth of w animal food that must be handled under undesirable microorganisms, as well as We proposed that animal food that specific processing, packing or holding other contamination. relies on the control of water activity for conditions to prevent the growth of preventing the growth of undesirable undesirable microorganisms and T. Proposed § 507.25(c)(4)—Processing microorganisms must be processed to adulteration. Steps and maintained at a safe moisture level. We proposed that steps such as (Comment 221) Some comments R. Proposed § 507.25(c)(2)—Control of cutting, drying, defatting, grinding, request that we delete the requirement Undesirable Microorganisms mixing, extruding, pelleting, and because controlling water activity We proposed that measures taken cooling, must be performed in a way belongs in subpart C, not in the CGMP during manufacturing, processing, that protects against the contamination regulations. Another comment says that packing, and holding of animal food to of animal food. controlling moisture level is not significantly minimize or prevent the (Comment 219) One comment sufficient and the requirement should growth of undesirable microorganisms suggests that we revise the requirement be revised to require that animal food (for example, heat treating, freezing, to say that steps be performed in a way that relies on the control of water refrigerating, irradiating, controlling pH, that protects against animal food activity for preventing the growth of or controlling aw) must be adequate to adulteration rather than protects against undesirable microorganisms be prevent adulteration of animal food. animal food contamination. Another processed to and maintained at a (Comment 217) Most of the comments comment suggests that the requirement suitable water activity, not a safe say that measures to significantly be deleted because it is redundant to moisture level. We also received minimize or prevent the growth of other requirements in the proposed rule. comments asserting that water activity undesirable microorganisms should be (Response 219) As discussed in may not be the only factor responsible addressed under subpart C, and that this Response 167, we believe contamination for preventing the growth of undesirable

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microorganisms in dry products and manufacturing/processing of animal (Response 225) We decline the that we should modify the regulatory food. request. We believe the terms text to take into account other (Response 223) We decline this ‘‘designed’’ and ‘‘constructed of synergistic barriers for microbial growth request. We have established this appropriate material’’ are well and toxin formation. requirement to help ensure that when understood by the animal food industry (Response 221) We disagree that ice is used for the manufacture of and ‘‘fit for purpose’’ does not improve controlling water activity belongs in animal food, the ice is made from water clarity. subpart C. While not all animal food that is safe so that it does not (Comment 226) A few comments note establishments rely on the control of contaminate the animal food it contacts. water activity for preventing the growth containers used to hold animal food of undesirable microorganisms in their XXI. Subpart B: Comments on Proposed may include bins, totes or other animal food, we have determined it is § 507.27—Holding and Distribution intermediate storage containers, each of which may require differing levels and important to have this requirement in A. Proposed § 507.27(a)—Holding and frequency of cleaning. Some of these CGMP regulations for those Distribution establishments that do, considering the comments ask that we add the phrase We proposed that animal food held potential public health significance of ‘‘where necessary’’ when discussing for distribution must be held under undesirable microorganisms. We agree cleaning to provide flexibility. conditions that will protect against that the term ‘‘safe water activity level’’ (Response 226) We agree that contamination and minimize is more commonly understood by the containers used to hold animal food will deterioration. animal food industry than ‘‘safe require different cleaning methods and (Comment 224) A few comments moisture level’’ and we have revised the frequency of cleaning. These differences request that we remove ‘‘minimize regulatory text accordingly. We agree may result from the types of containers deterioration’’ from this requirement. with the comment that water activity used, the amount and type of animal These comments say that although may not be the only factor responsible food held, the frequency at which deterioration may lead to animals for preventing growth of undesirable containers are reused, as well as other refusing food, an animal’s refusal of microorganisms in certain animal food food does not necessarily mean that the factors. As a result, we agree that it is and have revised the regulatory text to food has deteriorated. The comments appropriate to include language that clarify that such products rely suggest that we instead use the phrase indicates that different methods and ‘‘principally’’ on the control of water ‘‘ensure product integrity throughout frequencies of cleaning may be activity. the intended shelf life,’’ or that we appropriate to protect against W. Proposed § 507.25(c)(7)—Controlling clarify the definition of deterioration if contamination of the animal food and pH we do not remove it. we have revised the regulatory text to add ‘‘as necessary’’ after cleaned. We proposed that animal food that (Response 224) We decline this relies principally on the control of pH request. We believe it is important that C. Proposed § 507.27(a)(2)—Protection for preventing the growth of undesirable animal food be held and distributed in From Contamination microorganisms must be monitored and manner that does not lead to maintained at the appropriate pH. deterioration. Deterioration of animal We proposed that animal food held (Comment 222) Some comments food includes the loss of palatability or for distribution must be held in a way request that we delete this proposed nutritive value typically associated with that prevents contamination from requirement because controlling pH the animal food and we believe this sources such as trash and garbage. belongs in subpart C, not in subpart B. could be a safety concern because (Comment 227) A few comments One comment also says that it is too animals are often fed the same food request that the phrase ‘‘from sources prescriptive and duplicative of containing the same ingredients for such as trash and garbage’’ be deleted. protections against adulteration in other prolonged periods of time. As a result, A few comments request that the term proposed sections of subpart B. food refusal or consumption of animal ‘‘garbage’’ not be used because some (Response 222) We decline the food containing fewer nutrients than the products that may be considered request. While not all animal food animal food is expected to provide may garbage may actually be suitable for use establishments principally rely on the result in poor animal productivity or as animal food. Some of these comments control of pH for preventing the growth health issues. Furthermore, suggested alternative language. of undesirable microorganisms in their deterioration can indicate that the (Response 227) We agree in part with animal food, we have determined it is animal food has been held under this comment. The mistaken inclusion important to have this requirement in conditions that would also support the the CGMP regulations for those growth of undesirable microorganisms. of trash or garbage into animal food could be a potential source of establishments that do, considering the B. Proposed § 507.27(a)(1)—Containers potential public health significance of contamination. The terms ‘‘trash’’ and undesirable microorganisms. We proposed that containers used for ‘‘garbage’’ are intended in their general holding animal food for distribution sense and refer to items that are not X. Proposed § 507.25(c)(8)—Ice must be designed, constructed of suitable for animal food, or are not We proposed that when ice is used in appropriate material, cleaned, and intended for animal food. However, contact with animal food, it must be maintained to prevent contamination of under the Swine Health Protection Act, made from water that is safe and must animal food. ‘‘garbage’’ as defined by the act is be used only if it has been manufactured (Comment 225) A few comments prohibited for use as food for swine, in accordance with current good request that the terms ‘‘designed’’ and unless it is treated to kill disease manufacturing practice as outlined in ‘‘constructed of appropriate material,’’ organisms. For this reason, and because this subpart. which may have different the terms can be considered synonyms, (Comment 223) One comment interpretations, be replaced by ‘‘fit for we are removing the term ‘‘garbage’’ suggests that this requirement be purpose’’ a term recognized by the throughout subpart B to avoid deleted because ice is rarely used in the animal food industry. confusion.

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D. Proposed § 507.27(a)(3)—Labeling of deleted the requirement that labeling food, or it could be simply knowing Animal Food Held for Distribution that identifies the product by the what the shipping container or vehicle (Final § 507.27(b)) common or usual name must be affixed had previously been used for and We proposed that labeling identifying to or accompany the animal food in this because of that, whether the container the product by the common or usual section because it is already covered by needed to be cleaned prior to use. We name must be affixed to or accompany current FDA regulations. do not expect a plant or facility to the animal food. E. Proposed § 507.27(b)—Shipping examine the shipping container or bulk (Comment 228) Some comments Containers (Final § 507.27(c)) vehicle when a customer transports the support the labeling requirement animal food or arranges for a third-party We proposed that shipping containers to pick up the animal food. However, a because accurate identification of (for example, totes, drums, and tubs) animal food throughout the distribution plant or facility may choose to examine and bulk vehicles used to distribute a customer’s shipping container or bulk chain is an important food safety step animal food must be inspected prior to and loss of identity can have serious vehicle as a business decision to ensure use to ensure the container or vehicle that shipping container or bulk vehicle animal and human health implications. will not contaminate the animal food. One comment suggests that this will not lead to the contamination or (Comment 229) Some comments state adulteration of the animal food. requirement be revised to specify that that the requirement to inspect shipping the proposed labeling be required containers is not practical because F. Proposed § 507.27(c)—Returned during holding and distribution of both containers are frequently reused without Animal Food (Final § 507.27(d)) packaged animal food and bulk animal intervening cleaning or because the We proposed that animal food food. One comment says that FDA’s animal food is distributed in dedicated returned from distribution must be primary interest should be containers or vehicles. One comment assessed for animal food safety to identification, not labeling, because says that it is pointless to inspect the determine the appropriate disposition. labeling for animal food being held for containers when the product being Returned animal food must be identified distribution in bulk is impractical. The distributed may be decayed and may be as such and segregated until assessed. comment also notes that plants may use dumped on the ground for the animals We received no comments on this a central computer system or other to eat. Other comments state that requirement and are finalizing it as method to identify animal food location. sometimes nobody is available to proposed. A few comments suggest that we should inspect the vehicle when third-party require that animal food held for transportation is used and that third- G. Proposed § 507.27(d)—Unpackaged distribution be labeled as required by party transportation vehicles may Bulk Animal Food (Final § 507.27(e)) regulations for finished products. already contain animal food or by- We proposed that unpackaged or bulk (Response 228) We agree that animal products because they are used to pick animal food must be held in a manner food may be identified in the plant up from several facilities. Some that does not result in cross through methods other than labeling. comments say that contractual contamination with other animal food. We expect that while animal food is provisions specify how third-party We received no comment on this being processed in the plant that the shipping container may be used, and requirement and are finalizing it as animal food is accurately identified as therefore inspection prior to each load proposed with one wording change. We required in § 507.25(a)(2) of this final would not be necessary to manage this have added the term ‘‘unsafe’’ to modify rule. risk. cross contamination to make it clear that We have moved the requirement that (Response 229) Though we disagree this requirement applies to cross labeling must include information and with the comments, we are revising the contamination that would result in instructions for safely using the animal regulatory text in §§ 507.27 and 507.28 unsafe animal food. food product for the intended animal to replace the word ‘‘inspected’’ with species from proposed § 507.25(a)(3) ‘‘examined’’. We believe that the use of XXII. Subpart B: Comments on ‘‘Plant operations’’ in the 2014 the word ‘‘examined’’ provides more Proposed § 507.28—Holding and supplemental proposed rule to clarity for the animal food industry Distribution of Human Food By- § 507.27(b) of ‘‘Holding and because the term ‘‘inspected’’ often Products for Use as Animal Food distribution’’ to clarify that this labeling implies a regulatory activity. This does We proposed to add provisions for information must be included when the not mean that the shipping container human food by-products for use as product is ready for distribution. We must be cleaned prior to each use. The animal food. We proposed that the think that placing the labeling plant or facility is responsible for requirements of this part (with the requirements for animal food products examining shipping containers and bulk exception of proposed § 507.28) would ready for distribution under ‘‘Holding vehicles that it uses to transport the not apply to by-products of human food and distribution’’ will help reduce animal food (e.g., the facility transports production that are packed and held by confusion and make these requirements the animal food, or arranges with a that facility for distribution as animal for labeling for distribution easier to third-party to distribute the animal food food if certain requirements were met find in the final rule. Labeling that to the facility’s customer). We expect (see discussion in section XIII). The meets applicable FDA labeling the plant or facility personnel involved facility would only need to comply with regulations must accompany or be in the process of loading the product proposed § 507.28 of this part and affixed to the animal food and that the into the shipping container or vehicle to proposed § 117.95 of part 117 (which labeling must include, when applicable, be aware of the condition of the contains identical requirements). information and instructions for safely shipping container or vehicle, and using the product for the intended consider whether its condition would A. Proposed § 507.28(a)— animal species. We have added the contaminate the animal food. This Contamination clarification that it is ‘‘when examination could include viewing the We proposed that human food by- applicable,’’ understanding that not all shipping container or vehicle to observe products held for distribution as animal animal food product will need whether there are any unusual residues food must be held under conditions that information on its safe use. We have in it that may contaminate the animal will protect against contamination.

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(Comment 230) Multiple comments animal) health. This may not require when determining whether to issue request that the term ‘‘human food by- cleaning after each use. additional guidance about the common products,’’ not ‘‘animal food,’’ be used or usual name of animal food. C. Proposed § 507.28(a)(2)—Protection throughout §§ 507.28 and 117.95 (of part (Comment 233) One comment From Contamination 117). These comments note that it is requests that FDA require human food important to make clear that human We proposed that animal food held manufacturers to document the food by-products do not change from for distribution must be held in a way recipient’s intended use of the by- human food to animal food until they to prevent contamination from sources products so the by-products do not are transferred to someone with the such as trash and garbage. As discussed become ingredients of human food. This intent to use it as an animal food. in Response 227, we have revised the comment also requests that these by- (Response 230) We disagree that regulatory text to remove the term products be required to be labeled with human food by-products are not animal garbage. We did not receive additional the statement ‘‘For Use as Animal Feed food until they have been transferred to comments related to this paragraph and Only.’’ someone with the intent to use it as are finalizing the proposed language (Response 233) We decline these animal food. Furthermore, we think that with changes previously discussed. (See requests. Human food is produced the use of the term ‘‘human food by- Responses 227 and 230.) under human food regulations, such as products’’ would be more confusing D. Proposed § 507.28(a)(3)—Labeling CGMPs, and HACCP regulations for here because not all human food by- juice and seafood, and facilities must We proposed that labeling identifying meet the applicable requirements for products are intended for use as animal the product by the common or usual food. However, we have revised the food that is manufactured, processed, name must be affixed to or accompany packed, or held to ensure the safety of regulatory text to use the term ‘‘human animal food. food by-products for use as animal that human food. This requirement in (Comment 232) Some comments state § 507.28 is meant only for human food food’’ throughout this section to that by-products only need to be differentiate it from other requirements by-products for use as animal food that reasonably identified while they are are only held and distributed (i.e. not in parts 117 and 507. The purpose of being held by the facility and state that these provisions in §§ 507.28 and 117.95 further processed). Human food by- once they are ready for distribution, products may be used as human food is to ensure that when the processer is they should be labeled in conformance holding and distributing human food ingredients as long as they are in with applicable regulatory compliance with the applicable human by-products for use as animal food, the requirements. One comment states that by-products are recognized as human food regulations. However, we would what is considered the ‘‘common and not object if a facility labels the human food by-products for use as animal food usual name’’ varies between the human by all employees and treated as such. food by-products for use as animal food food industry, the animal food industry, ‘‘For Use as Animal Food Only.’’ B. Proposed § 507.28(a)(1)—Containers producers and regulators. This comment suggests that FDA work with regulatory E. Proposed § 507.28(b)—Shipping We proposed that containers used to partners to provide guidance on the Containers hold animal food before distribution proper ‘‘common and usual name’’ of We proposed that shipping containers must be designed, constructed of by-products to promote consistency. (for example, totes, drums, and tubs) appropriate material, cleaned, and (Response 232) We agree in part with and bulk vehicles used to distribute maintained to prevent the these comments. As with animal food animal food must be inspected prior to contamination of animal food. subject to all of part 507, we expect that use to ensure the container or vehicle (Comment 231) Some comments state while human food by-product for use as will not contaminate the animal food. that the provisions about containers are animal food is being held in the human This provision is paragraph (c) of this too prescriptive because by-products food facility, it is accurately identified. section in the final rule. may be held and conveyed in ways that (See Response 201.) We have revised the (Comment 234) We received the same do not use containers (such as using regulatory text to clarify that the human comments on § 507.28(c) as § 507.27(c). storage silos, augers, pipes, chutes or food by-product for use as animal food (See Comment 229.) conveyor belts to convey product must be accurately identified while held (Response 234) We are revising the directly to transportation vehicles). in the human food facility (see regulatory text in §§ 507.28(c) and Some comments request clarification on § 507.28(a)(3) of the final rule). We 117.95(c). (See Response 229.) cleaning the containers because they are retained the requirement that when the frequently reused for holding by- human food by-product for use as XXIII. Subpart C: Comments on Overall product without intervening cleaning animal food is distributed, it must have Framework for Hazard Analysis and procedures. labeling that identifies the common or Risk-Based Preventive Controls (Response 231) We agree that human usual name of the product affixed to or In the 2014 supplemental notice for food by-products for use as animal food accompanying it (see § 507.28(b) of the preventive controls for animal food, we may be held and conveyed using final rule). proposed a series of changes to equipment instead of containers. We Our CPG Sec. 665.100 discusses proposed subpart C and reopened the have revised the regulatory text to add common or usual names for animal food comment period specifically with ‘‘equipment’’ in addition to containers, ingredients (Ref. 25). There are also respect to these changes. The proposed and have added the words ‘‘convey’’ industry and other regulatory resources changes included: (1) Eliminating the and ‘‘cleaned as necessary’’ (see that may assist facilities in determining term ‘‘hazard reasonably likely to regulatory text for §§ 507.28(a)(1) and the common or usual name of the occur’’ throughout proposed subpart C 117.95(a)(1)). We expect containers and animal food. For example, USDA (and, thus, deleting the definition we equipment to be cleaned at a frequency maintains the National Nutrient had proposed for this term); (2) adding that protects against contamination of Database for Standard Reference, a a new defined term, ‘‘significant human food by-products for use as database that includes a list of names for hazard,’’ and, in general, using this new animal food by contaminants that could human food items (Ref. 30). We will term instead of ‘‘hazard reasonably be harmful to the public (human and take into consideration these comments likely to occur’’ throughout the re-

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proposed regulations; (3) defining associated with the facility or the food’’; and risk-based preventive controls. We ‘‘known or reasonably foreseeable and (4) providing additional flexibility discuss each of these comments in the hazard’’ in place of ‘‘reasonably to address concerns about rewriting discussion of the specific regulatory text foreseeable hazard’’ and clarifying that existing plans or programs to conform applicable to each comment. We show the new term means a hazard ‘‘that has with the requirement of the preventive highlights of the changes we made after the potential to be associated with the controls rule. considering these comments in table 9. facility or the food’’ rather than ‘‘a We received many comments on the potential . . . hazard that may be overall framework for hazard analysis

TABLE 9—REVISIONS TO THE OVERALL FRAMEWORK FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS

Section Description Revision

507.3 ...... Definition of ‘‘significant hazard‘‘ ... Revise the proposed term ‘‘significant hazard’’ to ‘‘hazard requiring a preventive control’’ and revise the definition to emphasize the role of risk in determining whether a hazard requires a preventive con- trol. 507.3 ...... Definition of ‘‘corrections‘‘ ...... Define the term ‘‘correction’’ to distinguish ‘‘corrections’’ from ‘‘cor- rective actions.’’ 507.34(c)(1), 507.39(a), 507.40, Flexibility in preventive controls Clarify that preventive control management components depend on 507.45(a), 507.47(a), 507.49(a), and preventive control manage- the role of a preventive control in the facility’s food safety system, 507.49(b). ment components for moni- as well as the nature of the preventive control. toring, corrective actions and corrections, and verification. 507.33(b)(1) ...... Hazard identification ...... Emphasize that the hazard identification focuses on known or rea- 507.33(b)(2) ...... sonably foreseeable hazards (rather than on all hazards). 507.40(c)(2) ...... Monitoring records ...... Provide for the use of ‘‘exception records’’ for monitoring preventive controls. 507.42(a) ...... Corrective action procedures ...... Clarify that corrective action procedures depend on the nature of the hazard. 507.42(c) ...... Corrections ...... Provide for additional circumstances when corrections, rather than corrective actions, are warranted. 507.47(c) ...... Preventive controls that do not re- Clarify that a list of preventive controls that do not require validation quire validation. is not an exhaustive list. 507.49(a)(5) ...... Activities to verify implementation Clarify that there could be alternative verification activities of imple- and effectiveness. mentation and effectiveness other than those that we specify in the rule. 507.49(b) ...... Written procedures for verification Clarify that written procedures for verification of implementation and of implementation and effective- effectiveness are established and implemented as appropriate to ness. the role of the preventive control in the facility’s food safety system, as well as appropriate to the facility, the animal food, and the na- ture of the preventive control. 507.50(b) ...... Reanalysis ...... Provide for reanalysis of an applicable portion of the food safety plan (rather than the complete food safety plan) in specified cir- cumstances.

XXIV. Subpart C: Comments on ‘‘preventive controls qualified We proposed that several other Proposed § 507.31—Food Safety Plan individual’’ because we are establishing provisions of subpart C be under the oversight of a ‘‘qualified individual’’ We proposed requirements for a food a new definition for ‘‘qualified (now ‘‘preventive controls qualified safety plan. Some comments support the individual,’’ with a meaning distinct individual’’), and also proposed proposed requirements without change. from ‘‘preventive controls qualified requirements that would apply to the Some comments that support the individual.’’ To minimize the potential ‘‘qualified individual’’ (now ‘‘preventive proposed provisions suggest alternative for confusion for when the term controls qualified individual’’). See, e.g., or additional regulatory text or ask us to ‘‘qualified individual’’ refers to the §§ 507.47, 507.49, 507.50, 507.51, clarify how we will interpret the proposed meaning of the term and when the term ‘‘qualified individual’’ refers to 507.53, and 507.55). As discussed in the provision. preceding paragraph, in the remainder In the following sections, we discuss the meaning of that term as finalized in this rule, in the remainder of this of this document, we substitute the new comments that ask us to clarify the term ‘‘preventive controls qualified document we substitute the new term proposed requirements, or disagree individual’’ for the proposed term ‘‘preventive controls qualified with, or suggest one or more changes to ‘‘qualified individual,’’ when describing individual’’ for the proposed term the proposed requirements. After these proposed provisions and the considering these comments, we are ‘‘qualified individual,’’ even though the comments to these proposed provisions. finalizing the provisions as proposed, proposed rule used the term ‘‘qualified with editorial and conforming changes individual.’’ Likewise, we substitute the A. Proposed § 507.31(a)—Requirement as shown in table 31. new term ‘‘preventive controls qualified for a Food Safety Plan We proposed that the food safety plan individual’’ for the proposed term We proposed that you must prepare, be under the oversight of one or more ‘‘qualified individual’’ when describing or have prepared, and implement a ‘‘qualified individuals.’’ As discussed in the comments to the proposed rule, written food safety plan. section VIII.A.24, we have changed the even though those comments use the (Comment 235) Some comments ask proposed term ‘‘qualified individual’’ to term ‘‘qualified individual.’’ us to develop a final preventive controls

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rule with separate requirements for food and all of the animal species for which facilities have exactly the same safety plans for manufacturers of the food is intended. We recognize that, equipment and layout. Procedural livestock food and for manufactures of to the extent that the controls are the instructions must be tailored to the food for other animal species. same, there may be common controls equipment being used, and the layout of (Response 235) We decline this that broadly apply to some or all of a a facility may affect its approach to request. The required elements of the facility’s animal food products. preventive controls. food safety plan listed in § 507.31(c) However, any product-, process-, or (Comment 240) Some comments apply to each type of animal food animal species-specific differences must assert that a food safety plan should manufactured at a facility. Animal food be carefully delineated and observed in only be required for high-risk processing types or production method types may practice. facilities because adhering to CGMPs is be grouped together if the hazards, In some facilities with limited types sufficient for low-risk facilities. Some preventive controls, parameters, and of animal food products or animal comments assert that FSMA does not management components (monitoring, species for which the food is intended, authorize us to require farms to develop corrective actions and corrections, and the written food safety plan may contain food safety plans. verification) necessary to ensure the a single set of procedures that addresses (Response 240) We decline the effectiveness of the preventive controls all of the products produced. For other request to establish additional are essentially identical. We have facilities, there may not be a practical exemptions based on risk, other than the provided additional flexibility within way to group the products and the exemptions for on-farm low-risk the required elements of the food safety written food safety plan may need to activity/animal food combinations plan in the final rule. Therefore the contain more than one set of procedures provided by section 103(c)(1)(D) of same requirements for a food safety plan to address all of its products. FSMA (§ 507.5(e) and (f)). The are applicable to a facility that makes (Comment 238) Some comments ask applicability of the requirements of the food for livestock and one that makes us to emphasize that ‘‘written’’ means preventive controls rule to facilities that food for other animal species. ‘‘any type of recordable and are required to register is required by (Comment 236) Some comments ask reproducible format’’ (e.g., as paper or the statute (see the definition of facility us to add regulatory text to this section electronic documents). Some comments in section 418(o)(2) of the FD&C Act). stating that an existing written food ask us to specify that the components of Section 418(h) of the FD&C Act requires safety plan, including any plan intended the food safety plan need not be in a that a facility prepare and implement a to satisfy the requirements of a foreign single document or stored in one place. food safety plan, unless an exemption jurisdiction or that complies with (Response 238) A ‘‘written’’ food applies. Neither FSMA nor this rule existing standards developed by other safety plan can be either a paper establishes an exemption for ‘‘low-risk’’ organizations (such as PAS 222 (Ref. document or an electronic document, as facilities, including ‘‘low-risk’’ facilities 27)), satisfies the requirements of this provided for by § 507.202(a). The final that are regularly inspected by State, section if it contains the information rule specifies that required information local, or tribal government Agencies. A specified by § 507.31(c). (which would include the food safety farm is not subject to this rule for (Response 236) To the extent that an plan) does not need to be kept in one activities within the ‘‘farm’’ definition. existing food safety plan includes all set of records (see § 507.212(b)), and a A farm mixed-type facility that is a required information, a facility can use food safety plan may be prepared as a small or very small business and only such plans to meet the requirements of set of documents kept in different conducts the low-risk activity/animal this rule. We expect that many existing locations within the facility (e.g., based food combinations specified in plans will need only minor on where they will be used), provided § 507.5(e) and (f) is exempt from the supplementation to fully comply with that each set of documents is onsite. As requirements of subparts C and E, these requirements. Relying on existing provided in the recordkeeping including the requirement for a food records, with supplementation as provisions, electronic records are safety plan. necessary to satisfy the requirements of considered to be onsite if they are (Comment 241) Some comments ask the preventive controls rule, is accessible from an onsite location. us to clarify that a food safety plan is acceptable (see § 507.212). (Comment 239) Some comments ask not required when a facility is exempt (Comment 237) Some comments agree us to provide that the food safety plan as a qualified facility (§ 507.7(a)) or as with our previous statements that be handled at the corporate level rather a facility solely engaged in the storage facilities should be able to group animal than the facility level if a corporation of packaged food that is not exposed to food types or production method types owns many facilities. the environment (§ 507.10) if hazards, control measures, (Response 239) A corporation may (Response 241) A qualified facility is parameters, and required procedures, designate an individual at the corporate exempt from the requirements of such as monitoring, are identical (78 FR level as the owner, operator, or agent in subparts C and E, including the 64736 at 64779). Some comments ask us charge of a particular facility. In requirement to prepare and implement to emphasize that each facility needs addition, an employee of the a food safety plan, and is instead subject only one food safety plan, regardless of corporation, whether at headquarters or to the requirements in § 507.7. Likewise, how many animal species it makes food at another facility owned by the a facility solely engaged in the storage for, or how many different types of food corporation, may provide input into a of packaged animal food that is not it makes. These comments further state particular facility’s food safety plan. As exposed to the environment and does that facilities are under the impression previously discussed, the food safety not require time/temperature control to that any given facility will need plan does need to be facility specific significantly minimize or prevent the multiple food safety plans if they make (see the discussion of the facility-based growth of, or toxin production by, many food types or make food for nature of the food safety plan in the pathogens is exempt from the multiple animal species. 2013 proposed preventive controls rule requirements of subparts C and E, (Response 237) We are requiring that for animal food, 78 FR 64736 at 64780). including the requirement to prepare a facility have a written food safety plan For example, even if a corporation and implement a food safety plan. See that covers all types of animal food it makes similar products at two separate Response 242 for unexposed, packaged manufactures, processes, packs, or holds facilities, it is unlikely that the two TCS animal food.

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(Comment 242) Some comments ask (Comment 244) Some comments ask and any potential concerns with this us to clarify that a food safety plan is us to specify that sanitation controls approach. not required for facilities that store must be in the food safety plan. Some We noted that we had previously unexposed, refrigerated, packaged TCS comments ask us to require that the food announced an opportunity for public animal foods. safety plan include the qualifications of comment on the proposed collection of (Response 242) We agree that a the preventive controls qualified additional food facility profile facility ‘‘solely engaged’’ in the storage individual. information on a voluntary basis from of unexposed, refrigerated, packaged (Response 244) Sanitation controls are firms that complete the FDA food TCS animal food is exempt from the one type of preventive control. As facility registration process (Federal requirements of subparts C and E, appropriate to the facility and the Register of May 11, 2012, 77 FR 27779). including the requirement to prepare animal food (e.g., to control hazards In contrast to the voluntary submission and implement a food safety plan, and such as environmental pathogens), of food facility profile information instead is subject to the modified sanitation controls for cleanliness of described in that document, in the 2013 requirements in § 507.51 (see § 507.10). animal food-contact surfaces and proposed preventive controls rule for However, if a facility engages in other prevention of cross contamination are animal food we requested comment on activities in addition to the storage of required to be in the food safety plan whether the submission of such unexposed, refrigerated, packaged TCS (§ 507.34(c)(2)). information should be required. (Comment 245) Some comments state animal food, the exemption does not We are requiring that you document that submission of a facility profile apply. In such a case, the facility must all applicable training taken by the would be useful and support requiring prepare and implement a food safety preventive controls qualified individual such a submission. However, most of plan. However, the modified (see § 507.53(d)). This documentation requirements of § 507.51 can be the comments that addressed our must be established and maintained (see request for comments on such a informative with respect to what the § 507.55(a)(6)). food safety plan could include regarding submission express concern. Some the storage of unexposed, refrigerated, D. Proposed § 507.31(d)—Records comments assert that requiring packaged TCS animal food. submission of a facility profile is We proposed that the food safety plan outside of FDA’s statutory authority B. Proposed § 507.31(b)—Preparation of is a record that is subject to the under FSMA. Other comments assert the Food Safety Plan by a Preventive recordkeeping requirements of subpart that submitting a facility profile would Controls Qualified Individual F. We received no comments that not advance food safety goals or have a We proposed that the food safety plan disagreed with this proposed commensurate benefit to food safety. must be prepared, or its preparation requirement and are finalizing it as Some comments express concern about overseen, by one or more preventive proposed. protection of confidential information. controls qualified individuals. E. Comments on Potential Requirements Other comments express concerns that (Comment 243) Some comments ask for Submission of a Facility Profile to we would misinterpret the submitted us to provide for a group of qualified FDA information in the absence of discussion individuals to prepare, or oversee the with the facility. Some comments assert preparation of, a food safety plan. We requested comment on whether to that receiving and evaluating the (Response 243) The proposed require submission to FDA of a subset submitted information would be too regulatory text included in the 2014 of the information that would be in a time-consuming for FDA, whereas other supplemental notice provides for the food safety plan (78 FR 64736 at 64809). comments assert that submitting the food safety plan to be prepared, or its This information, which could be information would be too time- preparation overseen, by one or more referred to as a ‘‘facility profile,’’ could consuming for the facility. Some preventive controls qualified be submitted through an electronic form comments state that a subset of the individuals, and we are finalizing it as using a menu selection approach at the information that would be submitted proposed. same time as facility registration and could be found in the Establishment updated biennially simultaneously with Inspection Reports. Some comments C. Proposed § 507.31(c)—Contents of a the required biennial update of the food assert that we could use information Food Safety Plan facility registration. We described already available through the RFR to We proposed that the written food potential benefits to having a facility’s identify facilities that have needed to safety plan must include the written food safety plan in advance of an address a serious food safety violation hazard analysis, preventive controls inspection, such as aiding in the and target our inspectional resources to (including the supplier program and efficient oversight of preventive controls those facilities. Some comments state recall plan), procedures for monitoring by allowing us to better target that a facility profile is a not a static the implementation of the preventive inspectional activities to facilities that document and would be very difficult to controls, corrective action procedures, produce foods that have an increased keep up to date. Other comments state and verification procedures. As potential for contamination (particularly that such a profile would be of limited discussed in more detail in section XL, with biological hazards). We noted that or no use to FDA because information we have revised the phrase ‘‘supplier facilities could benefit from our advance regarding hazards and preventive program’’ to ‘‘supply-chain program’’ preparation through interaction with controls is best assessed in the context throughout the regulatory text. In the better-informed investigators and of a full food safety plan and related remainder of this document, we use the potentially reduced inspection time. We documentation. These comments further phrase ‘‘supply-chain program’’ in requested comment on the utility and state that food safety plans will section headings and when referring to necessity of such an approach and on constantly evolve as facilities undertake the provisions of the final rule. We the specific types of information that new activities and refine their continue to use the term ‘‘supplier would be useful in developing a facility processes; a profile would present only program’’ when describing the proposed profile. We also requested comment on a static picture of the food safety provisions and the comments regarding any additional benefits that might be measures in place at a given time; FDA the proposed provisions. obtained from using such an approach has already implemented changes to the

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registration process that require and hazard evaluation. Some comments evaluation make it clear that in such facilities to provide more information support the proposed requirements facilities environmental monitoring about the activities at the facility. One without change. For example, some would not be required. Some comments comment asks us to refrain from comments support our proposal for the that support the proposed provisions requiring written or electronic hazard analysis to address ‘‘known or suggest alternative or additional submission of facility profiles. reasonably foreseeable hazards’’ because regulatory text or ask us to clarify how (Response 245) We have decided that this is consistent with Codex. Other we will interpret the provision. we will not establish a requirement for comments agree that the hazard analysis submission of a facility profile. We will In the following sections, we discuss should address both the severity of the explore other mechanisms to achieve comments that ask us to clarify the potential hazard and the probability that the goals we described in the 2013 proposed requirements or that disagree the hazard will be present in an animal proposed preventive controls rule for with, or suggest one or more changes to, animal food. food product. Other comments state that the proposed requirements. After testing for environmental pathogens considering these comments, we have XXV. Subpart C: Comments on may be impractical in certain situations revised the proposed requirements as Proposed § 507.33—Hazard Analysis for facilities in chemical plants that also shown in table 10 with editorial and We proposed requirements for hazard produce food additives and that the conforming changes as shown in table analysis, including hazard identification proposed requirements for hazard 31.

TABLE 10—REVISIONS TO THE PROPOSED REQUIREMENTS FOR HAZARD ANALYSIS

Section Description Revision

507.33(a)(1) ...... Requirement for a hazard analysis Specify that a facility must ‘‘conduct a hazard analysis’’ to identify and evaluate known or reasonably foreseeable hazards, rather than merely specify that a facility must ‘‘identify and evaluate’’ known or reasonably foreseeable hazards. 507.33(a)(2) ...... Requirement for the hazard anal- Clarify that the hazard analysis must be written, regardless of its out- ysis to be written. come. 507.33(b)(1) and (b)(2) ...... Hazard identification ...... Emphasize that the hazard identification focuses on known or rea- sonably foreseeable hazards (rather than on all hazards). 507.33(b)(1)(ii) ...... Hazard identification ...... Replace ‘‘imbalances’’ with’’ deficiencies or toxicities’’ and provide ex- amples of these hazards. 507.33(b)(1)(iii) ...... Hazard identification ...... Add examples of physical hazards. 507.33(c)(2) ...... Hazard evaluation ...... Provide that hazard evaluation does not need to include an evalua- tion of environmental pathogens whenever finished animal food is exposed to the environment prior to packaging if the packaged food includes a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. 507.33(d)(10) ...... Hazard evaluation ...... Provide an example of ‘‘other relevant factor’’ that the hazard evalua- tion must consider (the example is the temporal (e.g., weather-re- lated) nature of some hazards (e.g., levels of some natural toxins)).

A. Proposed § 507.33(a)—Requirement (Response 246) As proposed, the whether there are any hazards requiring for a Written Hazard Analysis regulatory text would require a written a preventive control. If a facility hazard analysis even if the hazard appropriately determines, under the We proposed that you must identify analysis concludes that no hazards oversight of a preventive controls and evaluate, based on experience, exist. To make this clearer, we have qualified individual, that no such illness data, scientific reports, and other made two revisions to the regulatory hazards exist, then that is the outcome information, known or reasonably text. First, we have revised the of its hazard analysis, and the facility foreseeable hazards for each type of regulatory text to specify that a facility must document that outcome in its animal food manufactured, processed, must ‘‘conduct a hazard analysis’’ to written hazard analysis. packed, or held at your facility to identify and evaluate known or determine whether there are significant reasonably foreseeable hazards, rather We expect that there will be many hazards. We also proposed that the than merely specify that a facility must circumstances in which a facility hazard analysis must be written. ‘‘identify and evaluate’’ known or appropriately determines that certain reasonably foreseeable hazards. Second, biological, chemical, or physical As discussed in Response 62, we have hazards are not hazards requiring a revised the term ‘‘significant hazard’’ to we have revised the regulatory text to specify that the hazard analysis must be preventive control that must be ‘‘hazard requiring a preventive control.’’ addressed in the food safety plan. The In addition, we have revised the written regardless of its outcome. (Comment 247) Some comments provisions of the rule that allow a regulatory text to specify that the assert that a facility should not be able facility to appropriately determine that outcome of a hazard analysis is to to conclude that no hazard exists in its a particular hazard is not a hazard determine whether there are any production process and that any such requiring a preventive control in certain hazards requiring a preventive control. conclusion reached should be a ‘‘red animal food products are not equivalent (Comment 246) Some comments ask flag’’ to FDA investigators. to an exemption from the rule. For us to specify that the rule requires a (Response 247) The purpose of a example, a facility that appropriately written hazard analysis even if the hazard analysis is to identify and determines that there are no hazards hazard analysis concludes that no evaluate known or reasonably requiring a preventive control hazards exist. foreseeable hazards to determine associated with its animal food products

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must document that determination in its supplemental FSVP notice and be foreseeable hazard,’’ and ‘‘significant written hazard analysis (§ 507.33); consistent with the statutory standard hazard’’ (which we now refer to as however, no preventive controls, for hazard analysis in section 418(b)(1) ‘‘hazard requiring a preventive control’’) including supplier verification of the FD&C Act. and ask us to provide sufficient clarity activities, and associated management (Response 250) We have aligned the to be able to distinguish between these components would be required in such requirements of the animal food types of hazards. a situation. There are several types of preventive controls rule and the (Response 251) As discussed in animal food products for which a proposed FSVP rule to the extent Response 62, we have revised the facility may determine that there are no practicable, consistent with the requirements for hazard identification to hazards requiring a preventive control. applicable statutory requirements. emphasize that the hazard identification Such products include, but are not B. Proposed § 507.33(b)—Hazard focuses on known or reasonably limited to: alfalfa cubes, vegetable oils, Identification foreseeable hazards (rather than on all and molasses. hazards). However, we agree that our We proposed that the hazard (Comment 252) Some comments ask investigators should take appropriate identification must consider hazards us to include examples of physical steps to evaluate a facility’s hazard that include biological, chemical, and hazards in the regulatory text. physical hazards. We proposed analysis when the outcome is that there (Response 252) We have added examples of biological hazards (e.g., are no hazards requiring a preventive stones, glass, and metal fragments as microbiological hazards such as control. We expect that our investigators examples of physical hazards in the parasites, environmental pathogens, and would both review the facility’s written regulatory text. This is consistent with other pathogens) and chemical hazards hazard analysis and discuss the the regulatory text for biological and (e.g., radiological hazards and outcome with the facility. During the chemical hazards, even though the initial stages of implementation, we also substances such as pesticide and drug residues, natural toxins, decomposition, hazards listed in section 418(b)(1) of the expect that our investigators will ask FD&C Act include examples of chemical subject matter experts in our Center for unapproved food or color additives, and nutrient imbalances). and biological hazards but do not Veterinary Medicine (CVM) to review include examples of physical hazards. such a hazard analysis. Over time, as In the preamble for the 2013 proposed preventive controls rule for animal food, (Comment 253) Some comments ask our investigators gain experience with us to separately list some hazards (such appropriate determinations that there we explained that nutrient imbalance as parasites and drug residues) rather are no hazards requiring a preventive hazards can result from excessive levels than include them as examples of control, we expect that there will be of a nutrient in animal food resulting in biological hazards and chemical fewer circumstances in which our toxicity to the animal, or a nutrient hazards. investigators would consult CVM about deficiency in the animal food that can (Response 253) We decline this such an outcome. compromise the health of an animal and (Comment 248) Some comments ask provided examples (78 FR 64736 at request. Although section 418(b)(1)(A) us to require that the hazard analysis be 64782). These nutrient imbalance of the FD&C Act lists such items re-evaluated every 3 years and updated hazards are of particular concern for separately, we believe it is clearer to as needed. animals that consume one animal food acknowledge that some of the hazards (Response 248) The written hazard type as their sole source of nutrition. listed in the statute are in fact a subset analysis is one component of the food Because different species have different of the broader categories of biological safety plan, and the food safety plan is nutritional needs, certain quantities of a and chemical hazards. subject to reanalysis at least once every nutrient that are needed by one species (Comment 254) Some comments ask 3 years, and sooner under certain of animal could pose a health risk to us to rephrase the requirement for circumstances (see § 507.50). another species of animal. hazard identification to specify ‘‘The (Comment 249) Some comments ask In the preamble for the 2013 proposed hazard analysis must identify hazards’’ us to modify the provision to specify preventive controls rule for animal food rather than ‘‘The hazard identification that the hazard analysis identify and we also provided examples of physical must consider hazards.’’ evaluate known or reasonably hazards (e.g., stones, glass, or metal (Response 254) We decline this foreseeable hazards for each type of fragments that could inadvertently be request. The provision is directed to the animal food manufactured, processed, introduced into animal food) (78 FR first step of a hazard analysis, i.e., packed, or held at the facility, including 64736 at 64782) but did not include hazard identification, rather than to the hazards in the raw materials and these examples in the proposed overall hazard analysis (which is ingredients used in the animal food regulatory text. addressed in § 507.33(a)). The purpose (emphasis added). We also proposed that the hazard of the hazard identification is to (Response 249) We decline this identification must consider hazards consider the types of hazards listed as request. Other provisions in the that may be present in the animal food a step in determining whether there are requirements for hazard analysis specify if they occur naturally or may be any hazards requiring a preventive that the hazard evaluation must unintentionally introduced. In the 2014 control; the suggestion of the comments consider raw materials and ingredients preventive controls supplemental notice implies that such hazards will always be (see § 507.33(d)(3)). It is not necessary to for animal food we proposed to add that identified. As discussed in Response repeat the specific requirements the hazard analysis also must consider 247, the outcome of a hazard analysis associated with the hazard evaluation in hazards that may be intentionally for an animal food product could be that the provision that directs each facility to introduced for purposes of economic there are no hazards requiring a conduct a hazard analysis. gain (proposed § 507.33(b)(2)(iii)). preventive control. (Comment 250) Some comments state (Comment 251) As discussed in (Comment 255) Some comments ask that the standard for hazard analysis in Comment 62, some comments express us to revise the chemical hazard the preventive controls rule should both concern that the rule would refer to examples by replacing the term align with the reproposed requirements multiple levels of hazards (i.e., ‘‘nutrient imbalances’’ with ‘‘nutrient for hazard analysis set forth in the ‘‘hazard,’’ ‘‘known or reasonably deficiencies or toxicities.’’

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(Response 255) We agree that the young birds (Refs. 13 to 16); high levels (Comment 260) Some comments suggested revision adds clarity and have of salt in food for broilers; high levels assert that physical hazards in animal modified the regulatory text to replace of protein/urea in food for cattle; and food are not likely to cause any serious ‘‘nutrient imbalances’’ with ‘‘nutrient high levels of copper in food for sheep. injuries to humans as the contaminant deficiencies or toxicities,’’ and provide Many of these animal foods with is not assimilated into edible tissue. examples, such as ‘‘inadequate thiamine nutrient imbalances (deficiencies or (Response 260) We disagree with in cat food,’’ ‘‘excessive vitamin D in toxicities) resulted in a recall of the these comments. The rule defines the dog food’’, and ‘‘excessive copper in affected animal food (Refs. 31 to 39). term hazard to include a physical agent food for sheep.’’ Moreover, an analysis of thiamin that has the potential to cause injury or (Comment 256) Some comments levels in randomly selected commercial illness in animals, as well as humans. assert that nutrient imbalances should canned cat foods was conducted during Physical hazards in animal food can not be addressed in an animal food a period from December 2012 through cause illness or injury in animals. safety plan because they pose no threat January 2013 (Ref. 40). The study found (Comment 261) Some comments ask to humans. 13.3 percent of the cat foods tested fell us to delete ‘‘decomposition’’ from the (Response 256) We disagree with below the minimum set for thiamine by list of chemical hazards in this these comments. The preventive AAFCO and 15.6 percent were below provision. controls rule for animal food is intended the recommended allowance of the (Response 261) We decline this to protect animal health, as well as National Research Council. request. As discussed previously, human health. Section 418 of the FD&C We also disagree with the implication decomposition of animal food consists Act, which authorizes the preventive that facilities must address every of microbial breakdown of the normal controls rules, applies to facilities possible hazard. Facilities must identify food product tissues and the subsequent registered under section 415 of the and evaluate known or reasonably enzyme-induced chemical changes. FD&C Act, which includes facilities that foreseeable hazards for each type of These changes are manifested by manufacture, process, pack, and hold animal food manufactured, processed, abnormal odors, taste, texture, color, animal food. packed, or held at the facility to etc., and can lead to reduced food intake (Comment 257) Some comments determine whether there are any or rejection of the food by the intended assert that while serious, ongoing hazards requiring a preventive control. animal species, resulting in illness or imbalances of nutrients such as copper (Comment 258) Some comments death (see 78 FR 64736 at 64782). and selenium must be avoided with suggest that nutrient imbalances should (Comment 262) Some comments checks and balances, and perhaps be addressed through CGMPs. assert that we should not require all product testing, there could be a (Response 258) We disagree with food safety plans to specifically address multitude of other incidents that could these comments. We consider nutrient the likelihood of radiological hazards. occur without serious consequences and deficiencies and toxicities to be a type (Response 262) The rule only requires to address every possible scenario, by of chemical hazard that are that a facility consider whether species, when the Agency is aware of a appropriately addressed through radiological hazards are known or limited number of rare cases, is preventive controls. If a facility reasonably foreseeable, and we have unreasonable. Some comments state that identifies a nutrient deficiency or described situations where radiological the notion that nutrient deficiencies or toxicity as a hazard that is known or hazards could be considered to be toxicities for animals are hazards likely reasonably foreseeable in an animal known or reasonably foreseeable. A to occur in the manufacture of animal food and is a hazard that requires a facility that appropriately determines food seems like a poor fit in this set of preventive control, the facility must that no radiological hazards are known food safety regulations. implement preventive controls for that or reasonably foreseeable would (Response 257) The Agency has a hazard. The facility has flexibility in document that determination in its history of animal food incidents determining what preventive controls it written hazard analysis but would not resulting in recall of animal food and in needs to implement to control the need to establish preventive controls animal illnesses and deaths from hazard. Preventive controls for and associated preventive control nutrient deficiencies or toxicities. identified nutrient toxicity or deficiency management components to address From 2012 to 2014, FDA received hazards can include CGMPs, but the radiological hazards. multiple reports through its RFR that specific CGMP needs to be included in (Comment 263) Some comments were attributable to animal food the food safety plan (or for a qualified assert that predictable intentional associated with nutrient deficiencies or facility, the documentation supporting hazards should be in the food safety toxicities. For example, during the an attestation under § 507.7(a)(2)). plan but unexpected intentional hazards 2010/2011 reporting period, 3.57 (Comment 259) Some comments ask should be part of a food defense plan. percent of 224 primary (industry and us to consider revising the proposed (Response 263) This rule only voluntary) RFR entries were associated rule to include food allergens in animal requires a facility to consider with nutrient deficiencies or toxicities food much in the same way that they intentionally introduced hazards when in animal food. During the 2012/2013 have been proposed in the human food such hazards are introduced for period, 2.97 percent of 202 entries were rule. purposes of economic gain. Hazards that attributable to nutrient imbalances or (Response 259) We decline this may be intentionally introduced by acts toxicities in animal food (Refs. 14 and request. We are not aware of evidence of terrorism are the subject of the 2013 16). Reports included low levels of indicating that foodborne allergens pose proposed intentional adulteration rule thiamine in cat food; high levels of a significant health risk to animals (78 (78 FR 78014, December 24, 2013), vitamin D in dog food; low levels of FR 64736 at 64771). Animals with which applies only to human foods. vitamin D in food for swine; high levels actual food allergies typically have (Comment 264) Some comments of vitamin D in food for guinea pigs, digestive disorders or dermatologic disagree that the animal food preventive fish, and other animal species; high conditions, not the anaphylactic controls rule should address hazards levels of calcium and phosphorus in reaction that humans have to the major that are intentionally introduced for food for broiler chickens and turkeys food allergens (defined in section purposes of economic gain causing the death of several hundred 201(qq) of the FD&C Act). (economically motivated adulteration).

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Some of these comments assert that (Comment 265) Some comments We agree that these circumstances may economically motivated adulteration is express concern about identifying not lend themselves to the preventive not a good fit for the hazard analysis hazards that may be intentionally approach required here. We encourage, and preventive controls framework introduced for purposes of economic but do not mandate, that facilities adopt because it is, in all but the rarest of gain because there are potentially an other measures they deem appropriate circumstances, an issue of product unlimited number of unknown or yet-to- to mitigate the risks of economically integrity and quality, whereas food be identified hazards that could be motivated adulteration that this safety systems are designed and built to intentionally introduced for purposes of rulemaking does not address. Still, the prevent or mitigate food safety hazards. economic gain by an unscrupulous repeated use of melamine over the Some comments state that traditional supplier. These comments disagree with years, in animal foods and in foods for food safety hazards are primarily both our attempt to narrow the field of people, demonstrates that patterns of identified and addressed at the facility potential scenarios for economically economically motivated adulteration level, but economically motivated motivated adulteration to circumstances can emerge and should be considered as adulteration is typically handled by the where there has been a pattern of such part of a hazard analysis. corporate parent company, where adulteration in the past. (Comment 266) Some comments ask supply-chain management programs are Some comments assert that our us to limit the requirement to identify typically located. These comments also attempt to narrow the field of potential hazards that may be introduced for assert that food safety-related scenarios for economically motivated purposes of economic gain to only those economically motivated adulteration is adulteration is both too broad and too hazards that pose a risk to public health extremely rare and that predicting narrow at the same time. These for which there has been a pattern in the economically motivated adulteration to comments assert that our attempt is too past. Some comments assert that in prevent it is extremely difficult. Some broad, because we expect facilities to those few instances where a hazard was comments assert there will be no consider patterns of adulteration from intentionally introduced the underlying measurable benefit to food safety by the past ‘‘even though the past intention was to defraud rather than to imposing requirements to consider occurrences may not be associated with cause harm, and the food safety hazard economically motivated adulteration as the specific supplier or the specific food was an unintended consequence. Some part of a food safety plan and that doing product’’ and a requirement to consider comments ask us to focus the hazard so will consume limited resources every potential product and potential identification solely on inbound without a corresponding increase in supplier makes the task open ended. products, because it is obvious that consumer protection. Other comments These comments further assert that our hazards introduced by the facility itself assert that there is no need to require a attempt is too narrow, because a focus will not be prevented through a hazard facility to identify hazards intentionally on patterns of adulteration in the past is analysis. Some comments ask us to introduced for purposes of economic unlikely to reveal potential future narrow the scope of the requirement by gain because the misbranding and instances of economically motivated specifying that facilities focus on three adulteration provisions of the FD&C Act adulteration and because those situations: (1) Situations in which there already sufficiently provide safeguards intending to defraud purchasers for has been a pattern of similar against economic gain. economic gain are trying to avoid adulteration in the past; (2) animal (Response 264) We agree with the detection. According to these foods or ingredients for which quality comments that state that the comments, once an animal food safety assurance methods may not sufficiently requirement to consider hazards related instance of economically characterize the animal food or intentionally introduced for purposes of motivated adulteration is uncovered, ingredient to assure its identity, and; (3) economic gain is narrow. Such hazards perpetrators quickly move to carry out animal foods or ingredients for which will be identified in rare circumstances, their fraudulent activities in a different there are substitutes that are likely to be usually in cases where there has been a way. Some comments assert that there harmful that would be considered pattern of economically motivated are alternative ways to control hazards obvious to one skilled in food science. adulteration in the past. In addition, we that may be intentionally introduced for (Response 266) We decline to make define hazards to only include those purposes of economic gain without the changes suggested in these agents that have the potential to cause specific regulatory requirements, such comments because they are illness or injury. Economically as by having an effective supplier unnecessary. Because of our definition motivated adulteration that affects approval program with appropriate of hazard, the requirement is already product integrity or quality, for qualification and verification activities; limited to economically motivated example, but not animal food safety, is through business-to-business relations, adulteration that is reasonably likely to out of the scope of this rule. We expectations, and contracts; and through cause illness or injury. Under the final continue to believe that there is benefit a vulnerability assessment and control rule, a facility does not need to identify in taking this preventive approach to plan tailored specifically to a hazard related to economically economically motivated adulteration economically motivated adulteration. motivated adulteration when there is no and not relying solely on enforcing the (Response 265) We disagree that the risk to public health or when the preexisting misbranding and requirement is too broad. A facility must economically motivated adulteration is adulteration provisions of the FD&C Act conduct a hazard analysis for each type not known or reasonably foreseeable. after a violation occurs. of animal food manufactured, We agree that the three circumstances As discussed in sections XL through processed, packed, or held at the suggested by the comments are an XLVII, we are finalizing supply-chain facility. There is no requirement to appropriate focus for facilities who seek program provisions. It is consistent with consider every potential product or guidance on how to approach the the framework of this rule for a facility potential supplier. We also disagree that requirements, but decline the request to to address hazards requiring a the requirement is too narrow. Some specify these limitations of the scope in preventive control that may be individuals intending to defraud the regulatory text. As already noted, intentionally introduced for purposes of purchasers for economic gain will some comments assert that our attempt economic gain through the facility’s develop entirely novel ways of to narrow the field of potential scenarios supply-chain program. adulterating food to suit their purposes. for economically motivated adulteration

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is both too broad and too narrow at the manufacturing/processing procedures; ‘‘other relevant factors.’’ For example, same time. (See Comment 265.) (6) packaging activities and labeling hazards such as aflatoxin are subject to Although we continue to believe that activities; (7) storage and distribution; a weather-dependent effect in that the instances in which a facility will (8) intended or reasonably foreseeable aflatoxin levels in some RACs are more identify a hazard intentionally use; (9) sanitation, including employee of a problem in some years than in introduced for economic gain will be hygiene; and (10) any other relevant others. We have added the temporal rare, we also consider that limiting the factors (proposed § 507.33(d)(1) through nature of some hazards associated with scope of the requirement in the (10)). some RACs as an example of ‘‘other regulatory text would be both (Comment 268) Some comments ask relevant factors’’ to consider (see prejudging the future and inconsistent us to revise the requirement to include § 507.33(d)(10)). with the public health objectives of this an evaluation of environmental (Comment 270) Some comments ask rule. pathogens to avoid the implication that us to specify that the hazard evaluation (Comment 267) Some comments ask an intervention is needed when there be more specific about issues relevant to us to allow implementation of the major may be other controls (such as pH or raw materials and ingredients, including provisions in FSMA before establishing formulation) that would significantly how raw materials are selected and requirements to address economically minimize or prevent the pathogen. shipped, how suppliers are evaluated, motivated adulteration. These These comments suggest that we revise and how shipments are inspected on comments assert that economically the provision to require that a hazard receipt. motivated adulteration requires a evaluation include an evaluation of (Response 270) We decline this completely different paradigm than environmental pathogens whenever a request. When a hazard requiring a unintentional adulteration. In addition, food is exposed to the environment preventive control in a raw material or because economically motivated prior to packaging and the packaged other ingredient is controlled before adulteration is typically addressed food does not receive a treatment ‘‘or receipt, the receiving facility would through product specifications, supplier otherwise include a control measure’’ address such specifics in the supply- relationships, and good business that would significantly minimize the chain program that would be required as practices, implementation of these other pathogen. a preventive control (see subpart E). provisions of the animal food preventive (Response 268) We have revised the (Comment 271) Some comments controls rule are likely to have a provision on the hazard evaluation for assert that the proposed requirements positive effect on preventing environmental pathogens to specify that for hazard evaluation could be economically motivated adulteration. the packaged animal food does not interpreted in many ways. For example, (Response 267) We disagree that receive a treatment or otherwise include a facility could conclude that the economically motivated adulteration a control measure (such as a formulation presence of a hand sink or boot dip requires a completely different lethal to the pathogen) that would prior to entering the processing area will paradigm than unintentional significantly minimize the pathogen. We reduce the likelihood of environmental adulteration. Hazards intentionally agree that controls such as formulation pathogens and that environmental introduced for economic gain are can function as a ‘‘kill step’’ and that the pathogens are not a significant hazard, addressed here with the same provision should make clear that such whereas a regulator could interpret this preventive framework as every other controls can be used in lieu of provision to mean that a facility must hazard. As such, we do not see a ‘‘treatment.’’ always consider an environmental compelling reason to delay (Comment 269) Some comments ask pathogen to be a significant hazard implementation of the requirements to us to clarify what we meant by ‘‘other when the criteria in the provision are address economically motivated relevant factors’’ and note that natural met, unless the facility can provide adulteration. disasters (which we previously evidence to the contrary. discussed) (78 FR 64736 at 64785) are (Response 271) We agree that the C. Proposed § 507.33(c) and (d)— ‘‘usually exceptional events’’ that are requirements for hazard evaluation are Evaluation of Whether a Hazard best managed in a facility crisis subject to alternative interpretations. Requires a Preventive Control management plan. Other comments ask This is often the case, particularly when We proposed that the hazard analysis us to specify that the hazard evaluation a regulation is new. The provision must include an evaluation of the must consider any relevant geographic, specifies that a facility must evaluate identified hazards to assess the severity temporal, agricultural, or other factors whether an environmental pathogens is of the illness or injury if the hazard that may affect the severity or a hazard requiring a preventive control were to occur and the probability that probability of the hazard. in particular circumstances, i.e., the hazard will occur in the absence of (Response 269) We included ‘‘other whenever a finished animal food (for preventive controls; and environmental relevant factors’’ to emphasize that the which an environmental pathogen is pathogens whenever an animal food is list of factors in the provision is not an identified as a hazard) is exposed to the exposed to the environment prior to exhaustive list and that a facility is environment prior to packaging and the packaging and the packaged animal food responsible for considering those factors packaged animal food does not receive does not receive a treatment that would that play a role in its determination of a treatment or otherwise include a significantly minimize the pathogen whether a potential hazard is a hazard control measure (such as a formulation (proposed § 507.33(c)(2)). We also requiring a preventive control, lethal to the pathogen) that would proposed that the hazard evaluation regardless of whether those factors are significantly minimize the pathogen. must consider the effect of the following listed in the provision. A facility that The written hazard analysis must be on the safety of the finished animal food already addresses circumstances such as prepared (or its preparation overseen for the intended consumer: (1) The natural disasters in other plans may by) a preventive controls qualified formulation of the animal food; (2) the consider the applicable part of those individual (see § 507.31(b) and (c)(1)). condition, function, and design of the plans to be part of its food safety plan The preventive controls qualified facility and equipment; (3) raw (see § 507.212). individual for a facility that determines materials and ingredients; (4) We agree that geographic, temporal, that an environmental pathogen is not a transportation practices; (5) and agricultural factors are examples of hazard requiring a preventive control in

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such circumstances must document that outcome of a hazard analysis for human regulations; however, we have determination, and a regulator would food and animal food may not be concluded that HACCP is the consider the adequacy of the identical, in each case the purpose of a appropriate framework to reference in documented determination before hazard analysis is to identify and interpreting and implementing section reaching a conclusion as to whether the evaluate known or reasonably 103 of FSMA. For discussion, see facility had failed to satisfy the foreseeable hazards for the type of food section II.C.2. of the 2013 proposed requirements. However, the use of a manufactured, processed, packed, or preventive controls rule for human food hand sink or boot dip prior to entering held to determine whether there are any (78 FR 3646 at 3660). the processing areas to reduce the hazards requiring a preventive control. (Comment 275) Some comments ask likelihood of environmental pathogens As previously discussed in the 2013 us to allow consideration of both may also be considered to be part of the animal food preventive control severity and probability in the scientific sanitation controls for the proposed rule (78 FR 64736 at 64781), hazard analysis as this would be environmental pathogen. the process of identifying and consistent with international standards. (Comment 272) Some comments ask evaluating the hazards that may occur (Response 275) Section 507.33(c)(1) us to focus on language that will clearly for specific types of animal food requires that a hazard evaluation must differentiate between functions, handled in a facility provides an include an assessment of the severity of processes, and controls for facilities efficient means for keeping track of the injury or illness if a hazard were to with food safety plans that identify multiple hazards that may occur in a occur and the probability that the microbial hazards and those that do not facility that handles several types of hazard will occur in the absence of identify microbial hazards, and other animal food. Such a process also preventive controls. known or reasonably foreseeable provides an efficient means for ensuring For additional discussion of hazards. These comments assert that that preventive controls are applied to comments on hazard analysis, see sanitation of objects and surfaces may specific animal food products when section XXV in the final rule for be appropriate for the former, but not required. If a facility identifies a hazard preventive controls for human food necessarily for the latter. requiring a preventive control, the published elsewhere in this issue of the (Response 272) The facility is facility must determine an appropriate Federal Register. responsible for conducting a hazard preventive control and include that XXVI. Subpart C: Comments on analysis, and if hazards are identified preventive control in its food safety Proposed § 507.36—Preventive Controls that require a preventive control, the plan. A facility that establishes other (Final § 507.34) facility must consider the effect of controls (such as those that the sanitation on the safety of the finished comments describe as ‘‘prerequisite We proposed requirements to identify animal food for the intended animal (see programs’’) for hazards that are not, and implement preventive controls to § 507.33(d)). Based on the outcome of its based on the outcome of the facility’s provide assurances that significant hazard evaluation, the facility may hazard analysis, ‘‘hazards requiring a hazards will be significantly minimized determine that sanitation is not an preventive control’’ would not need to or prevented and the animal food appropriate preventive control for the establish preventive control manufactured, processed, packed, or hazards it identified. management components for such held by the facility will not be (Comment 273) Some comments controls. However, some controls adulterated under section 402 of the assert that a food safety plan and hazard previously established in ‘‘prerequisite FD&C Act. Some comments support the analysis should not include numerous programs’’ would be considered proposed requirements without change. hazards and hazard analysis steps. Some ‘‘preventive controls.’’ We provide some For example, some comments agree that comments assert that hazard analysis flexibility for facilities with respect to preventive controls must be written and should not be as detailed (stringent) for how they manage preventive controls, include process controls, sanitation animal food as it is for human food. and the preventive control management controls, a recall plan, and other These comments maintain that components may be different for controls as appropriate and necessary. prerequisite programs, which reduce the hazards that have been managed as Some comments that support the likelihood of a potential hazard to the ‘‘prerequisite programs’’ compared to proposed provisions suggest alternative point where the hazard is not those managed with CCPs. The same or additional regulatory text or ask us to reasonably likely to occur, would satisfy principles would apply for the hazards clarify how we will interpret the the requirement that the hazard be a facility identifies as needing a provision. adequately controlled, making it preventive control. In the following sections, we discuss unnecessary for a facility to include the (Comment 274) Some comments comments that ask us to clarify the identified hazards in its hazard analysis assert that the statutory language within proposed requirements or that disagree and preventive controls. Other FSMA does not mandate that covered with, or suggest one or more changes to, comments assert that many hazards can animal food and pet food facilities the proposed requirements. After be exclusively controlled through implement regulatory HACCP plans. considering these comments, we have prerequisite programs without a need These comments further urge us to revised the proposed requirements as for CCPs. remove reference to HACCP. shown in table 11, with editorial and (Response 273) While known and (Response 274) We agree that section conforming changes as shown in table reasonably foreseeable hazards and the 103 of FSMA does not mandate HACCP 31.

TABLE 11—REVISIONS TO THE PROPOSED REQUIREMENTS FOR PREVENTIVE CONTROLS

Section Description Revision

507.34(c)(1) ...... Process controls ...... Clarify that the requirements for process controls depend on the role of the process control in the food safety system.

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A. Proposed § 507.36(a)—Requirement to the facility and the animal food. food, if a hazard requiring a preventive To Identify and Implement Preventive Process controls include procedures, control is identified. Controls (Final § 507.34(a)) practices, and processes to ensure the (Comment 278) Some comments ask We proposed that you must identify control of parameters during operations us to delete the phrase ‘‘to significantly and implement preventive controls, such as heat processing, irradiating, and minimize or prevent a significant including at critical control points, if refrigerating animal foods. Process hazard.’’ (Response 278) We decline this any, to provide assurances that controls must include, as appropriate to request. ‘‘Significantly minimize or significant hazards will be significantly the applicable control, parameters prevent a significant hazard’’ (which we minimized or prevented and the animal associated with the control of the have revised to ‘‘significantly minimize food manufactured, processed, packed, hazard, and the maximum or minimum or prevent a hazard requiring a process or held by your facility will not be value, or combination of values, to control’’) is the standard for controlling adulterated under section 402 of the which any biological, chemical, or the hazards. Although the phrase could FD&C Act. We also proposed that these physical parameter must be controlled be viewed as redundant with the preventive controls include controls at to significantly minimize or prevent a standard in the requirement to identify CCPs, if there are any CCPs, and significant hazard. and implement preventive controls controls, other than those at CCPs, that (Comment 277) Some comments state (§ 507.34(a)(1)), repeating that standard are also appropriate for animal food that assigning a parameter and in the requirements for parameters and safety. associated minimum and maximum Some comments support the values for some process controls (such the minimum or maximum values flexibility provided to facilities to as refrigeration (including freezing), or associated with control of the hazard implement preventive controls that are water activity) may be possible, but not emphasizes the standard, which is appropriate to the facility and the be necessary for food safety. These appropriate for process controls. animal food. Other comments support comments ask us to require minimum D. Proposed § 507.36(c)(2)—Sanitation the clarification, in the 2014 and maximum values to be assessed Controls (Final § 507.34(c)(2)) supplemental notice, that not all against the applicable food safety need, We proposed that preventive controls preventive controls are established at or otherwise make clear that the include, as appropriate to the facility CCPs and that some food safety plans implications of not controlling and the animal food, sanitation controls will not have CCPs. We are finalizing minimum and maximum values must be that include procedures, practices, and the provision as proposed with the assessed in light of the circumstances. processes to ensure that the facility is editorial and conforming changes in Other comments express concern that maintained in a sanitary condition table 31. ‘‘as appropriate to the applicable adequate to significantly minimize or B. Proposed § 507.36(b)—Requirement control’’ could be interpreted as prevent hazards such as environmental for Written Preventive Controls (Final suggesting that if it is merely feasible to pathogens and biological hazards due to § 507.34(b)) establish parameters for a process employee handling. We also proposed control, they must be established. Other We proposed that preventive controls that sanitation controls must include comments express concern that the procedures, practices, and processes for must be written. proposed requirement suggests that if a (Comment 276) Some comments ask the cleanliness of animal food-contact parameter is not ‘‘controlled,’’ a surfaces, including animal food-contact us to clarify whether documentation of regulator could conclude that the treatment by a ‘‘custom processor’’ surfaces of utensils and equipment, and facility is not in compliance with the procedures for the prevention of cross- would be accepted as a ‘‘written rule because it necessarily has not preventive control’’ when the ‘‘custom contamination from insanitary objects significantly minimized or prevented a processor’’ controls the hazard. and from personnel to animal food, significant hazard. (Response 276) The question posed by animal food packaging material, and these comments highlights the Some comments recommend other animal food-contact surfaces and difference between the records required incorporating recognition that the from raw product to processed product. in the food safety plan and the records degree of rigor in application of subpart (Comment 279) One comment states documenting the implementation of the C parameters should be applied on a that sanitation is not always a feasible food safety plan. The ‘‘written sliding scale, commensurate with the step for facilities handling animal food, preventive controls’’ are part of the food nature of the risk and the preventive especially in dry blending facilities and safety plan, whereas the records control used. The comments request dry storage operations. The comment documenting treatment are that the language in this section is asks us to remove the reference to implementation records. altered to indicate that the parameters ‘‘sanitary condition’’ and replace it with Implementation records documenting will not always be applicable. language consistent with the GMP treatment, whether by a facility or its (Response 277) See Response 293. We section such as ‘‘to ensure the facility is ‘‘custom processor,’’ would not satisfy have revised the regulatory text to adequately cleaned and properly the requirements for written preventive specify that process controls must maintained to significantly minimize or controls. However, specifying that the include parameters and minimum or prevent hazards.’’ preventive control for a specific hazard maximum values as appropriate to both (Response 279) We decline this is a particular treatment by a ‘‘custom the nature of the applicable control and request. The sanitation controls are processor,’’ along with information that its role in the facility’s food safety flexible so that a facility can determine describes the treatment, would satisfy system. We decline the request to what sanitation controls are necessary the requirement for written preventive indicate that parameters of subpart C for their facility and animal food if they controls. will not always be applicable, as the identify a hazard requiring sanitation revised regulatory text provides controls as a preventive control. C. Proposed § 507.36(c)(1)—Process adequate flexibility for a facility to Replacing the term ‘‘sanitary condition’’ Controls (Final § 507.34(c)(1)) determine what preventive controls, with the suggested language would not We proposed that preventive controls including process controls, are improve the flexibility of the sanitation include process controls as appropriate appropriate to the facility and its animal control requirements.

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(Comment 280) Some comments facility may be different depending on (Comment 283) One comment asks us assert that sanitation controls are not whether the sanitation activity is used to require compliance with the good necessary to prevent any hazards in as general facility sanitation or manufacturing and feeding practices distribution facilities where animal specifically to control a hazard. Also, that apply to GRAS substances, found in food-contact surfaces are not present. sanitation as a preventive control is § 582.1(b), as a preventive control. Other comments assert that sanitation subject to the management components (Response 283) Facilities required to controls should be required in all cases of § 507.39. register that manufacture, process, pack, (rather than ‘‘as appropriate’’) given E. Proposed § 507.36(c)(3)—Supplier or hold GRAS substances are subject to their central importance. Controls (Final § 507.34(c)(3)) this final rule, including applicable (Response 280) Under the framework preventive controls requirements. established by FSMA, and implemented We proposed that supplier controls Preventive controls are intended to in this rule, each facility determines include the supplier program. See the address certain known or reasonably through its hazard analysis when discussion of comments on the supply- foreseeable hazards, not an animal food sanitation controls are necessary to chain program, now in subpart E, in facility’s compliance with the good control a hazard requiring a preventive sections XL through XLVII. manufacturing and feeding practices of control. The rule neither establishes F. Proposed § 507.36(c)(4)—Recall Plan § 582.1(b), although a facility may circumstances (such as in distribution (Final § 507.34(c)(4)) determine that a good manufacturing centers) where sanitation controls are We proposed that preventive controls practice is a preventive control for a not necessary nor prejudges whether include, as appropriate, a recall plan as particular hazard. sanitation controls are necessary in would be required by proposed specific circumstances. Although we do XXVII. Subpart C: Circumstances in § 507.38. See the discussion of not expect that facilities such as Which the Owner, Operator or Agent in comments on the recall plan in section distribution centers would determine Charge of a Manufacturing/Processing XXVIII. through their hazard analysis that Facility Is Not Required To Implement sanitation controls are required, we do G. Proposed § 507.36(c)(5)—Other a Preventive Control (Final §§ 507.36 expect all animal food establishments Controls (Final § 507.34(c)(5)) and 507.37) that are subject to the CGMP We proposed that preventive controls In the 2014 supplemental notice, we requirements established in subpart B to include any other procedures, practices, provided an opportunity for public fully comply with the applicable and processes necessary to satisfy the comment on potential requirements for requirements for sanitation. requirements of paragraph (a) of this a supplier program as a preventive (Comment 281) One comment states section. Examples of other controls control, including comments on when a that sanitation is discussed in two include hygiene training and other supplier program would not be sections, as a CGMP and as a preventive current good manufacturing practices. required. As discussed in more detail in control, and asks that all of the (Comment 282) Some comments ask section XL, we have revised the phrase discussion related to sanitation is us to specify that preventive controls ‘‘supplier program’’ to ‘‘supply-chain moved to one section. include controls on raw materials and program’’ throughout the regulatory (Response 281) The two sections other ingredients. text. As summarized in table 12 and discuss sanitation for different (Response 282) The final rule discussed more fully in the following purposes. The requirements for general specifies that preventive controls paragraphs, after considering comments sanitation are located in the CGMP include supply-chain controls as on when a supplier program would not regulations, which may be considered appropriate to the facility and the be required, we are establishing two prerequisites to the preventive controls. animal food. The request of these new provisions. Although both sets of The requirements for sanitation as a comments is addressed by the provisions have an effect on the preventive control are specific for requirements for the supply-chain required supply-chain program, they controlling an identified hazard. program (see § 507.34(c)(3) and subpart will be implemented outside the Sanitation activities conducted at a E). framework of a supply-chain program.

TABLE 12—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL

Final section Proposed section designation designation Description Revision

507.36(a)(1) ...... N/A ...... A manufacturer/processor is not required to implement a N/A. preventive control if it determines and documents that the type of animal food could not be consumed without application of an appropriate control. 507.36(a)(2) ...... 507.37(a)(1)(ii)(C) ...... A manufacturer/processor is not required to implement a Includes a requirement for preventive control if it relies on its customer, who is sub- documentation that the ani- ject to the requirements for hazard analysis and risk- mal food is ‘‘not processed based preventive controls in subpart C, to ensure that to control [identified haz- the identified hazard will be significantly minimized or ard].’’ prevented and both: (1) Discloses in documents accom- panying the animal food that the animal food is ‘‘not processed to control [identified hazard]’’ and (2) annually obtains from its customer written assurance that the cus- tomer has established and is following procedures that will significantly minimize or prevent the identified hazard.

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TABLE 12—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL—Continued

Final section Proposed section designation designation Description Revision

507.36(a)(3) ...... A manufacturer/processor is not required to implement a N/A. preventive control if it relies on its customer who is not subject to the requirements for hazard analysis and risk- based preventive controls in subpart C to provide assur- ance it is manufacturing, processing, or preparing the animal food in accordance with applicable animal food safety requirements and it: (1) Discloses in documents accompanying the animal food, in accordance with the practice of the trade, that the animal food is ‘‘not proc- essed to control [identified hazard]’’ and (2) annually ob- tains from its customer written assurance that it is manu- facturing, processing, or preparing the animal food in ac- cordance with applicable animal food safety requirements. 507.36(a)(4) ...... 507.37(a)(1)(ii)(C) ...... A manufacturer/processor is not required to implement a • Addresses the cir- preventive control if it relies on its customer to ensure cumstance where an entity that the animal food will be processed to control the (other than the facility’s identified hazard by an entity in the distribution chain customer) in the distribu- subsequent to the customer and both: (1) Discloses in tion chain controls the haz- documents accompanying the animal food that the ani- ard mal food is ‘‘not processed to control [identified hazard]’’ • Includes a requirement for and (2) annually obtains from its customer written assur- documentation that the ani- ance that the customer will both disclose the information mal food is ‘‘not processed that the animal food is ‘‘not processed to control [identi- to control [identified haz- fied hazard]’’ and will only sell to another entity that ard].’’ agrees, in writing, it will either follow procedures that will significantly minimize or prevent the identified hazard (if the entity is subject to subject to the requirements for hazard analysis and risk-based preventive controls in subpart C) or manufacture, process, or prepare the ani- mal food in accordance with applicable animal food safe- ty requirements (if the entity is not subject to the require- ments for hazard analysis and risk-based preventive con- trols in subpart C) or obtain a similar written assurance from the entity’s customer. 507.36(a)(5) ...... N/A ...... A manufacturer/processor is not required to implement a N/A. preventive control if it has established, documented, and implemented a system that ensures control, at a subse- quent distribution step, of the hazards in the animal food product it distributes and documents the implementation of that system. 507.36(b) ...... 507.37(g)(3) ...... Records documenting the applicable circumstances in Includes a requirement for § 507.36(a). documentation of the addi- tional circumstances in which a manufacturer/proc- essor is not required to im- plement a preventive con- trol. 507.36(c) ...... N/A ...... If a customer of the manufacturer/processer has deter- N/A. mined that the identified hazard is not a hazard in the animal food intended for use for a specific animal spe- cies, the customer may provide this determination (in- cluding animal species and why the identified hazard is not a hazard) in its written assurance under § 507.36(a)(2)(ii) instead of providing assurance of proce- dures established and followed that will significantly mini- mize or prevent the identified hazard. 507.36(d) ...... N/A ...... If a customer of the customer of the manufacturer/ N/A. processer (i.e., another entity in the distribution chain) has determined that the identified hazard is not a hazard in the animal food intended for use for a specific animal species, the entity may provide this determination (in- cluding animal species and why the identified hazard is not a hazard) in its written assurance under § 507.36(a)(4)(ii)(B instead of providing assurance of pro- cedures established and followed that will significantly minimize or prevent the identified hazard.

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TABLE 12—SUMMARY OF APPLICABLE PROVISIONS REGARDING WHEN THE OWNER, OPERATOR, OR AGENT IN CHARGE OF A MANUFACTURING/PROCESSING FACILITY IS NOT REQUIRED TO IMPLEMENT A PREVENTIVE CONTROL—Continued

Final section Proposed section designation designation Description Revision

507.37 ...... N/A ...... A facility that provides a written assurance under N/A. § 507.36(a)(2), (3), or (4) must act consistently with the assurance and document its actions taken to satisfy the written assurance.

The first provision allows a identified hazard before it reaches that passes through its facility satisfies manufacturer/processor to not consumers. These requirements are: (1) the criterion ‘‘could not be consumed implement a preventive control if the Documentation provided by the without application of the appropriate manufacturer/processor determines and manufacturer/processor to its direct control.’’ In other cases, a facility may documents that the type of animal food customer that the animal food is ‘‘not have determined through its hazard could not be consumed without processed to control [identified analysis that there are no hazards application of the appropriate control by hazard]’’; (2) written assurances from requiring a preventive control, and will an entity in the supply or distribution customers regarding appropriate not consider whether one of the chain other than that manufacturer/ procedures to ensure that the animal circumstances in new § 507.36 apply. processor (see § 507.36(a)(1)). We food will receive further processing to As a consequential addition, new describe comments leading to this control the identified hazards; and (3) § 507.36(b) specifies the records that a provision, and our response to those provisions relating to accountability for manufacturer/processor would need to comments, in Comment 284 and written assurances. (In these provisions, satisfy the documentation requirements Response 284 respectively. Although we ‘‘customer’’ means a commercial established in new § 507.36(a)(1), and are establishing these provisions outside customer, not a consumer.) we have added new § 507.36(b) to the the framework of the supply-chain (Comment 284) Some comments list of implementation records (§ 507.55) program, these provisions continue to express concern about the ability for that are subject to the recordkeeping play a role in the requirements for a distributors/cooperatives identify the requirements of subpart F. supply-chain program, because they individual raw material or other See also Comment 429, in which we also provide an exception to the ingredient supplier when the supplier discuss comments asking us to add requirements for a manufacturer/ that applied the control is more than flexibility to the requirements for a processor to establish and implement a one step back in the food chain. Some supply-chain program such that any supply-chain program. comments assert that receiving facilities entity other than the receiving facility The second provision relates to should not be required to verify can perform supplier verification comments we received on a proposed suppliers with which they do not have activities. As discussed in Response exception to the requirement for a a direct commercial relationship. For 429, the rule provides additional manufacturer/processor to establish and example, in the case of the soybean flexibility in the supply-chain program implement a supplier program supply chain, the U.S. processing with regard to who can perform certain (proposed § 507.37(a)(1)(ii)(C)). (See facility likely has no direct relationship activities (see § 507.115). Comment 285). Under proposed with the many farms involved in the (Comment 285) Some comments ask § 507.37(a)(1)(ii)(C), a receiving facility growing and harvesting of the soybeans. us to delete the criterion for control of would not have been required to have Some comments ask for an exemption the hazard by the receiving facility’s a supplier program if it relied on its from supplier verification activities for customer, with annual written customer to control the hazard and animal foods such as soybeans because assurance that the customer had annually obtained from its customer it is problematic to have a requirement established and was following written assurance that the customer has that potentially could necessitate trace procedures (identified in the written established and is following procedures back to farms. assurance) that would significantly (identified in the written assurance) that (Response 284) We are establishing a minimize or prevent the hazard. The will significantly minimize or prevent provision, applicable to both the supply stated reasons varied. For example, the hazard. As discussed in Response chain and the distribution chain of a some comments state that a receiving 285, we are replacing this provision manufacturer/processor, for a facility may have so many customers with several provisions that apply when circumstance when a manufacturer/ that it is not possible to obtain written a manufacturer/processor identifies a processor does not need to implement a assurance annually from all customers. hazard requiring a preventive control preventive control. We are providing Other comments express concern that a (‘‘identified hazard’’), does not control that a manufacturer/processor does not customer may be unwilling to describe the identified hazard, but can need to implement a preventive control confidential trade secrets in order to demonstrate and document that the if it determines and documents that the identify in writing the procedures the identified hazard will be controlled by type of animal food could not be customer has established and is an entity in its distribution chain. A consumed without application of the following to control the hazard. Other manufacturer/processor that satisfies the appropriate control (see § 507.36(a)(1)). comments express concern about ‘‘legal criteria in these provisions will not be However, depending on the facility, the issues’’ when a receiving facility needs required to implement a preventive raw material or other ingredient, and the to assess the adequacy of the customers’ control for the identified hazard. Under type of animal food produced by the procedures for controlling a hazard these provisions, the combination of manufacturer/processor, there may be because under current business three requirements will provide some circumstances where a practices a vendor can provide adequate assurance that the animal food manufacturer/processor could assurance to a buyer (its customer), but will be processed to control the determine that a particular animal food buyers do not typically provide such

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assurance to vendors. Some comments Under the first of these provisions documents accompanying the animal express concern that written assurance (§ 507.36(a)(2)), a manufacturer/ food, in accordance with the practice of does not guarantee that the customer is processor is not required to implement the trade, that the animal food is ‘‘not actually doing anything to significantly a preventive control if it relies on its processed to control [identified minimize or prevent the hazard. customer (who is subject to the hazard]’’; and (2) annually obtains from Some comments ask us to provide an requirements for hazard analysis and its customer written assurance, subject alternative that would allow the risk-based preventive controls in to the requirements of § 507.37, that the receiving facility to provide subpart C) to ensure that the identified customer will disclose in documents documentation to its customer about a hazard will be significantly minimized accompanying the animal food, in hazard that needs a preventive control or prevented and: (1) Discloses in accordance with the practice of the at a processing facility later in the documents accompanying the animal trade, that the animal food is ‘‘not distribution chain rather than obtain food, in accordance with the practice of processed to control [identified written assurance that its customer will the trade, that the animal food is ‘‘not hazard]’’. The manufacturer/processor control a hazard. If written assurance processed to control [identified also must obtain written assurance that must be required, these comments ask hazard]’’; and (2) annually obtains from its customer will only sell to another us to allow the written assurance its customer written assurance, subject entity that agrees, in writing, it will provided by the customer to state that to the requirements of § 507.37, that the either: (1) Follow procedures (identified the customer would evaluate the hazard customer has established and is in a written assurance) that will and if necessary establish and follow following procedures (identified in the significantly minimize or prevent the procedures to significantly minimize or written assurance) that will significantly hazard (if the entity is subject to the prevent the hazard. minimize or prevent the hazard. The requirements for hazard analysis and Some comments state the receiving manufacturer/processor would include risk-based preventive controls in facility may not know the identity of all the specific hazard requiring a subpart C), or manufacture, process, or its ultimate customers, particularly if preventive control (e.g., Salmonella) prepare the animal food in accordance the receiving facility sells its products to where the statement says ‘‘[identified with applicable animal food safety a distributor who then sells to other hazard].’’ A facility that provides the requirements (if the entity is not subject entities. Some comments ask us to written assurance must act consistently to the requirements for hazard analysis provide flexibility for facilities to with the assurance and document its and risk-based preventive controls in determine whether annual updates of actions taken to satisfy the written subpart C) or (2) obtain a similar written written assurance are necessary. Other assurance (see new § 507.37). The assurance from the entity’s customer. comments ask us to specify that a documents could be bills of lading or Under the fourth of these provisions receiving facility need not establish and other papers that accompany the animal (§ 507.36(a)(5)), a manufacturer/ implement a supplier program for raw food or labels on the containers of the materials and ingredients intended for processor is not required to implement animal food. a preventive control if it has established, further processing. Under the second of these provisions, documented, and implemented a system Some comments assert that the (§ 507.36(a)(3)), a manufacturer/ that ensures control, at a subsequent presence of low levels of pathogens on processor is not required to implement distribution step, of the hazards in the a raw product that will be subject to a a preventive control if it relies on its animal food product it distributes and lethal process further downstream does customer (who is not subject to the not pose a risk to the consumer, and requirements for hazard analysis and documents the implementation of that should not be considered a significant risk-based preventive controls in system. Comments did not provide hazard (i.e., a hazard requiring a subpart C), to provide assurance it is examples of such a system, but we do preventive control). These comments manufacturing, processing, or preparing not want to preclude the development also assert that if we maintain that the animal food in accordance with of such systems. Salmonella contamination is a applicable animal food safety We have added several other significant hazard for each member of requirements and it: (1) Discloses in requirements related to the four new the supply chain, then we should allow documents accompanying the animal provisions that we are specifically the preventive control to be applied in food, in accordance with the practice of establishing as circumstances in which a subsequent step at another facility. the trade, that the animal food is ‘‘not a manufacturer/processor need not Other comments ask us to clarify that a processed to control [identified implement a preventive control. As facility would not need to develop hazard]’’; and (2) annually obtains from already noted in this response, new preventive controls where it produces its customer written assurance that it is § 507.37 requires that a facility that raw materials or ingredients that are manufacturing, processing, or preparing provides a written assurance must act subject to subsequent processing that the animal food in accordance with consistently with the assurance and will address known or reasonably applicable animal food safety document its actions taken to satisfy the foreseeable hazards. requirements. By ‘‘customer who is not written assurance. In addition, new (Response 285) We are establishing required to implement preventive § 507.36(b)(2), (3), (4), and (5) specify several provisions, specifically controls under this part’’ we mean the records that a manufacturer/ applicable to the distribution chain of a entities such as qualified facilities and processor would need to satisfy the manufacturer/processor, for retail food establishments. documentation requirements circumstances when a manufacturer/ Under the third of these provisions established in new § 507.36(a)(2), (3), (4) processor does not need to implement a (§ 507.36(a)(4)), a manufacturer/ and (5), and new § 507.215 establishes preventive control (§§ 507.36(a)(2), (3), processor is not required to implement requirements applicable to the written (4), and (5); 507.36(b)(2), (3), (4) and (5); a preventive control if it relies on its assurance between a manufacturer/ 507.36(c); 507.36(c) and (d), 507.37; and customer to provide assurance that the processor and its customer. Taken 507.215). See Response 284 for another animal food will be processed to control together, the provisions of §§ 507.37 and new provision that applies to the supply the identified hazard by an entity in the 507.215 establish legal responsibilities chain in addition to the distribution distribution chain subsequent to the for a facility that provides a written chain (§ 507.36(a)(1)). customer and: (1) Discloses in assurance under § 507.36(a)(2), (3) or

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(4), even if that facility is not a For the written assurance required by XXVIII. Subpart C: Comments on manufacturer/processor. § 507.36(a)(2)(ii), new paragraph (c) of Proposed § 507.38—Recall Plan The point of these provisions is to this section provides that if the We proposed that you must establish ensure that hazards that a manufacturer/ customer has determined that the a written recall plan for animal food processor has determined, through its identified hazard is not a hazard in the with a significant hazard and that the hazard analysis, require a preventive animal food intended for use for a recall plan must include certain control, but are not controlled in the specific animal species, the customer’s procedures. Some comments support supply chain before the manufacturer/ written assurance may provide this the proposed requirements without processor or by the manufacturer/ determination (including animal species change. For example, some comments processor itself, are in fact controlled by and why the identified hazard is not a express the view that a written recall a subsequent entity in the distribution hazard) instead of providing assurance plan is critical in the event of a system chain. With the assurance from the of procedures established and followed manufacturer/processor’s customer that breakdown where adulterated animal that will significantly minimize or foods have been distributed. Some the hazards will be controlled after the prevent the identified hazard. animal food product leaves the comments that support the proposed manufacturer/processor it is not For the written assurance required by requirements suggest alternative or necessary for the first manufacturer/ § 507.36(a)(4)(ii)(B), new paragraph (d) additional regulatory text or other processor to implement the applicable of this section provides that if the entity changes. preventive control. We continue to in the distribution chain subsequent to In the following paragraphs, we believe that annual written assurance the customer is subject to subpart C and discuss comments that ask us to clarify from a manufacturer/processor’s direct has determined that the identified the proposed requirements or that customer is an appropriate mechanism hazard is not a hazard in the animal disagree with, or suggest one or more to ensure that its customer is aware of food intended for use for a specific changes to, the proposed requirements. the identified hazard and is taking steps animal species, that entity’s written After considering these comments, we to ensure that the animal food is assurance may provide this are finalizing the requirements as processed to control the identified determination (including animal species proposed with the conforming revision hazard. We do not believe that a and why the identified hazard is not a to use the term ‘‘hazard requiring a manufacturers/processor will need all of hazard) in its written assurance instead preventive control’’ rather than the details of its customer’s process to of providing assurance that the ‘‘significant hazard.’’ See Response 62 satisfy the requirement to state in identified hazard will be significantly and table 31. As discussed in section writing the procedures the customer has minimized or prevented. XXVII, we are establishing a provision applying to certain assurances in established and is following to control (Comment 286) Some comments that § 507.37. the hazard. For example, the customer ask us to delete the proposed could merely state that its requirement to maintain the written A. Proposed § 507.38(a)—Requirement manufacturing processes include a assurance as a record. Other comments for a Written Recall Plan lethality step for microbial pathogens of ask us to revise the regulatory text of the concern. We proposed that you must establish documentation requirement to focus on a written recall plan for animal food We agree that it is appropriate to documentation that (1) the receiving require that the manufacturer/processor with a significant hazard. facility has notified its customers of the (Comment 287) Some comments ask provide documentation to its customer existence of actual or potential hazards indicating that the animal food must be us to require a written recall plan for all in animal food provided to them by the animal food (rather than just for animal processed to control an identified receiving facility; or (2) the receiving hazard. Such documentation will be a food with a significant hazard) and to facility has notified its customers of the establish the requirements for a written means of clear communication from the existence of actual or potential hazards manufacturer/processor to its customer. recall plan as CGMP requirements in in animal food provided to them by the When the hazard will not be controlled subpart B rather than as part of the receiving facility and has received a by the customer, the customer will still requirements for hazard analysis and written assurance that the customer will have documentation that can be passed risk-based preventive controls in evaluate the hazard and, if necessary, on to the entity that is expected to subpart C. These comments assert that will follow procedures to significantly process the animal food to control the all products can be subject to a recall. minimize or prevent the hazard. identified hazard, so that it will be very These comments contrast recall plans clear to that entity that the identified (Response 286) We decline this with other preventive controls in that hazard still needs to be controlled. request. As already discussed in this recall plans are often specific to a firm We understand that not all identified section, it is the combination of or facility, but rarely are specific to hazards in an animal food will be a requirements (i.e., for documentation particular animal foods. In addition, hazard to all species of animals. For that the animal food is ‘‘not processed these comments note that a recall may example, we consider all serotypes of to control [identified hazard]’’; be administered and managed at the Salmonella to be a hazard for dog and assurance from customers regarding corporate office rather than at the cat food. However, we would not appropriate procedures to ensure that specific manufacturing facility that consider Salmonella Heidelberg a the animal food will receive further produced the animal food. hazard in food for cattle. Therefore, we processing to control the identified Some comments note the have added provisions to allow this hazards; and provisions relating to requirements for a written recall plan determination to be included in the accountability for written assurances) are sufficiently different from other customer’s written assurance regarding that will provide adequate assurance provisions in subpart C that we an identified hazard so that the that the animal food will be processed proposed to specify that the recall plan customer will not be required to assure to control the identified hazard before it would not be subject to the preventive it is controlling a hazard that it has reaches consumers. Records control management requirements for determined does not need to be documenting the written assurances are monitoring, corrective actions, and controlled for a specific animal species. a key component of the provisions. verification (see § 507.39(c)). Other

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comments assert that a recall plan is not requirement to apply to all animal food comments assert would be duplicative a preventive control because it deals establishments subject to the CGMP with the provisions of part 7. These with products after they have been requirements in subpart B. For now, comments ask us to address any more produced. Some comments note that animal food establishments that are not substantive requirements than are facilities that are exempt from the subject to subpart C can continue to already in part 7 as part of a review of requirements of subpart C, but remain follow our longstanding recall policy in part 7. These comments assert that part subject to the CGMP requirements, part 7 (21 CFR part 7). 507 should require a written recall plan, would not be required to have a recall Consistent with the overall framework but not require a written recall plan for plan unless we establish the of FSMA, a recall plan (like other the animal food, to be consistent with requirements in subpart B. Other preventive controls) is only required the approach of part 7. comments note that the requirement for when the facility has identified a hazard (Response 288) We decline these a recall plan is only if there is a hazard requiring a preventive control. A facility requests. Part 7 addresses enforcement that requires a preventive control, but could establish a recall plan that applies policy and the provisions for recalls in assert that a recall should only be to other animal foods it manufactures. subpart C of part 7 are ‘‘Guidance on initiated if a hazard has actually been We recognize that recalls may be Policy, Procedures, and Industry identified to be present in the product. managed by the corporate office of a Responsibilities.’’ These recall Some comments note that our firm rather than at the specific provisions do not establish authority to require recall plans is not manufacturing facility that produced the requirements and are not binding on limited to section 418 of the FD&C Act animal food. Nothing in the rule industry. They also are broadly directed and that we can use other legal precludes this approach. In such cases to recalls for all FDA-regulated authority to impose a requirement for the corporate recall policy would be products, not just food. As already recall plans in subpart B. Some reflected in a facility’s recall plan. (See discussed in Response 284, nothing in comments note that FSMA specifically also Response 239.) In addition, a this rule would prevent a facility that amended the FD&C Act to provide us facility that identifies one or more establishes a recall plan for a particular with the authority to mandate a food hazards requiring a preventive control animal food from using that recall plan recall (section 423 of the FD&C Act). in multiple animal food products could for any animal food product that the These comments assert that it would be use the same recall plan for all facility decides to recall. reasonable for us to conclude that in applicable animal food products. (Comment 289) Some comments order to efficiently carry out section 423 The rule specifies that the request that we have separate recall of the FD&C Act we should issue requirements for preventive control program requirements for human food requirements governing the conduct of management components (i.e., by-products so that by-products recalls, because section 423 of the FD&C monitoring, corrective actions and produced during the manufacture of Act requires that we provide a firm with corrections, and verification) apply as food and sold, or otherwise provided, an opportunity to voluntarily recall a appropriate to ensure the effectiveness for use in animal food would not be product before issuing an order to the of the preventive control, taking into recalled if the product for people is firm to cease distribution and recall a account the nature of the preventive recalled. Other comments assert we will product. control (§ 507.39(a)). As previously need to define the criteria for an animal (Response 287) We decline the discussed, the preventive control food recall in guidance. request to establish requirements for a management components are directed at (Response 289) We decline the written recall plan as a CGMP animal food that remains at the facility, request to have separate recall program requirement in subpart B and are whereas the recall plan addresses requirements for human food by- establishing the requirements as a animal food that has left the facility (78 products for use as animal food. preventive control in subpart C as FR 64736 at 64788). Our determination Whether or not the by-product of a proposed. We acknowledge that a recall that the nature of the recall plan does human food that is recalled should itself plan would be useful to all animal food not require these preventive control be recalled may depend on assessment establishments, and we encourage all management components demonstrates of several factors such as what the animal food establishments to have a the flexibility provided by FSMA and hazard is, whether the hazard for which recall plan. However, the report issued this rule, not that the recall plan must the human food is recalled is also a by the human food CGMP be considered a CGMP rather than a hazard for the animal(s) that consume Modernization Working Group did not preventive control. the by-product, and where the hazard identify the lack of a written recall plan We have not yet made a occurred in the manufacturing process. as something that needed to be changed determination of whether we should We have previously addressed the (Ref. 41). (See 78 FR 3646 at 3651, the issue requirements governing the request for guidance. (See Response 1.) proposed rule for preventive controls for conduct of recalls, rather than rely on human food, for a discussion of the the guidelines in part 7, in order to fully B. Proposed § 507.38(b)—Procedures CGMP Modernization Working Group implement section 423 of the FD&C Act. That Describe the Steps To Be Taken, and the process leading to its report.) However, we have issued a draft and Assign Responsibility for Taking However, going forward we intend to guidance entitled ‘‘Draft Guidance for Those Steps monitor whether the lack of a broader Industry: Questions and Answers We proposed that the recall plan must requirement for a recall plan leads to Regarding Mandatory Food Recalls’’ include procedures that describe the problems when animal food which, when finalized, would address steps to be taken, and assign establishments that are not subject to topics such as the criteria for a responsibility for taking those steps, to the requirements of subpart C are faced mandatory recall and the process that perform the following actions as with recall situations. As we gain FDA must follow for a mandatory recall appropriate to the facility: (1) Directly experience with the impact of the new (Ref. 42). notify the direct consignees of the requirement for a recall plan on those (Comment 288) Some comments ask animal food being recalled, including facilities subject to subpart C, we can us to cross-reference the provisions of how to return or dispose of the affected reassess at a later date whether to part 7 (21 CFR part 7) rather than animal food; (2) notify the public about conduct rulemaking to broaden the establish requirements that these any hazard presented by the animal

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food when appropriate to protect human system. These comments assert that consequences or death to humans or or animal health; (3) conduct additional procedures or means to animals), then section 417 of the FD&C effectiveness checks to verify that the notify us would involve unnecessary Act requires that the responsible party, recall is carried out; and (4) additional steps and be duplicative, as defined in section 417, submit a appropriately dispose of recalled animal with no improvement to the public report to FDA. food (e.g., through reprocessing, health. Some comments assert that if the We agree with comments that it is reworking, diverting to another use that recall is issued by a foreign facility, the important to notify appropriate State would not present a safety concern, or responsibility should be with the regulatory Agencies about a recall. We destroying). We requested comment on importer of the product for notifying generally request that FDA District whether: (1) The proposed procedures FDA. Some comments ask us to specify Offices notify State control officials of are appropriate for all types of facilities; that the appropriate State regulatory recalls issued by animal food (2) we should require a recall plan to Agency with inspection jurisdiction be manufacturers. Also, State officials with include procedures and assignment of notified in the event of a recall. responsibilities for regulating animal responsibility for notifying FDA of (Response 291) We agree with food can access our Web site for recalls subject to the plan; and (3) we comments that it is important to notify ‘‘Animal and Veterinary Recalls and should include a requirement for a us about a recall and that doing so can Withdrawals’’ where we post the mock recall as a verification activity. help to ensure that suppliers, retailers, current and most recent recalls of (Comment 290) Some comments ask and consumers will have adequate animal products, including animal food us to delete the proposed requirement notification of the recall action. We also (Ref. 46). We note that whatever that the recall plan include procedures agree that the existing procedures to methods are used to dispose of for a facility to notify the public about notify us through the RFR system can adulterated animal food, the methods any hazard presented by the animal accomplish this goal when an animal should comply with State and local food when appropriate to protect public food presents a risk of serious adverse requirements. health. These comments assert that such health consequences or death and that (Comment 292) Some comments ask a requirement would be highly it therefore is not necessary to duplicate us to add a requirement for mock recalls subjective and create a nebulous the notification procedures already on a regular basis, such as biannually. regulatory burden that could subject established in the RFR system in part Some of these comments state that mock facilities to unnecessary regulatory 507. However, we encourage facilities to recalls would familiarize the staff and oversight and enforcement actions. include in their recall plan any communications network(s) with the Other comments indicate that the procedures they have to comply with recall process and would improve the requirement for notifying the public the RFR or to include a cross-reference facility’s capacity to conduct effective should specifically prevent silent recalls to those procedures. Doing so may save and efficient recalls in the event of a when manufacturers pull products from time, which is critical during a recall. contamination event. Other comments store shelves without consumer When the recalled animal food does not assert that mock recalls would be the notification. present a risk of serious adverse health only way to determine the effectiveness (Response 290) We decline this consequences or death (and, thus, there of a recall program. Some comments request. Our guidance for a recall is not a report to the RFR), our guidance note that mock recalls would be strategy has long recommended issuing entitled ‘‘Guidance for Industry: Product particularly critical for manufacturers a public warning to alert the public that Recalls, Including Removals and that have limited experience in actual a product being recalled presents a Corrections’’ recommends that recalling recalls. serious hazard to health in urgent firms notify the local FDA District Some comments acknowledge that a situations where other means for Recall Coordinator as soon as a decision mock recall could be an important preventing use of the recalled product is made that a recall is appropriate and element of a recall plan but recommend appear inadequate (§ 7.42(b)(2)). prior to the issuance of press or written that mock recalls remain voluntary, Operationally, such notification to the notification to customers (Ref. 45). such as by including mock recalls as an public is so common that our current Including this guidance with the example of how verification may be home page on our Internet site (Ref. 43) facility’s recall procedures may also accomplished. Other comments note gives prominence to recall information save time. that the current recall procedures in part and we have established a free email We decline the request to designate 7 do not recommend mock recalls. Some subscription service for updates on that it is solely the importer of a food comments assert that a requirement to recalls (Ref. 44). Consistent with the manufactured by a foreign facility who include a mock recall as a verification longstanding recall policy in part 7, must notify FDA if the food is recalled activity would be an excessive and subpart C, the proposed requirement by the foreign facility. We are not inappropriate burden; that any gain in qualifies that the notification to the requiring that a recall plan include the protection of public health will not public is ‘‘when appropriate to protect procedures and assignments of offset the resource requirements to public health.’’ A market withdrawal of responsibility for notifying FDA of accomplish a mock recall; that resources a product (see § 7.3(j)) is not a recall that recalls subject to the recall plan. are better dedicated to developing a would be subject to public notification. Facilities should refer to our guidance robust plan; and, use of a mock recall (Comment 291) Some comments ask in part 7 entitled ‘‘Guidance for should be addressed in FDA guidance. us to specify that the procedures require Industry: Product Recalls, Including Some comments ask us to clarify the facilities to notify us about a recall to Removals and Corrections’’ for ‘‘metrics’’ for a mock recall, particularly ensure that all suppliers, retailers, and recommendations on conducting recalls with respect to the consequences of consumers will have adequate of food that does not present a risk of failing to meet an appropriate metric if notification of the recall action. Other serious adverse health consequences or a mock recall is conducted as a comments agree that it is important for death, including notification to FDA verification activity. facilities to involve us in a recall (Ref. 45). If the recalled food is a (Response 292) We agree that a mock situation as soon as possible, but assert reportable food (i.e., it does present a recall would familiarize the facility with that the best way to address such a reasonable probability that use will the recall process, could improve the notification is through the existing RFR cause serious adverse health facility’s capacity to conduct effective

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and efficient recalls during a recall as a verification activity for its XXIX. Comments on Proposed contamination event, may be recall plan so that the focus of the § 507.39—Preventive Control particularly helpful for manufacturers monitoring, corrective actions, and Management Components that have limited experience in actual verification in the rule remains focused recalls, and could support the on food being produced rather than on We proposed preventive control development of guidance on best food that is distributed in commerce. management components as appropriate practices for recalls, and we encourage We acknowledge that requiring mock to ensure the effectiveness of the facilities to conduct one or more mock recalls would go beyond our preventive controls, taking into account recalls to accomplish these goals. longstanding policies established in part the nature of the preventive control. However, as previously discussed, a 7. A facility that voluntarily conducts a Most of the comments that support the recall plan would address food that had mock recall would establish metrics proposed provisions suggest alternative left the facility, whereas the proposed appropriate to its plan and take action or additional regulatory text. requirements for monitoring, corrective (such as modifications to its procedures, In the following sections, we discuss actions, and verification would all be or additional training for its employees) comments that disagree with, or suggest directed at food while it remains at the if it is not satisfied with the results of one or more changes to, the proposed facility. Comments are mixed regarding the mock recall. requirements. After considering these whether the rule should require a mock We note that retail companies are not comments, we have revised the recall as a verification activity for the subject to this rule and, thus, are not proposed requirements as shown in recall plan, and we have decided to not subject to the requirement to have a table 13 with editorial and conforming require a facility to conduct a mock written recall plan. changes as shown in table 31.

TABLE 13—REVISIONS TO THE PROPOSED REQUIREMENTS FOR PREVENTIVE CONTROL MANAGEMENT COMPONENTS

Section Description Revision

507.39 ...... Flexible requirements Provide that preventive control management components take into account both the nature for preventive con- of the preventive control and its role in the facility’s food safety system. trol management components.

A. Proposed § 507.39(a)—Flexible actions, verification, and records. Other flexibility that a facility has in Requirements for Monitoring, Corrective comments state that the provisions will identifying preventive controls and Actions and Corrections, and allow businesses to allocate resources to associated preventive control Verification spend the most time and resources management components. controlling and monitoring those (Response 293) We agree that We proposed that, with some hazards that pose the greatest risk to preventive control management exceptions, the preventive controls public health. components should take into account would be subject to three preventive However, many of these comments both the nature of the preventive control control management components as also ask us to convey not only that the and its role in the facility’s food safety appropriate to ensure the effectiveness application of a particular management system and have modified the of the preventive controls, taking into component be appropriate (i.e., capable regulatory text of § 507.39 to incorporate account the nature of the preventive of being applied), but also that it be this suggestion. We reviewed the full control: Monitoring, corrective actions necessary for food safety (i.e., to meet regulatory text of proposed subpart C and corrections, and verification. the overall FSMA food safety goals or to and made similar modifications to the (Comment 293) Some comments ensure a particular control is effective) regulatory text for the definition of support our proposal to provide by specifying that the preventive control ‘‘hazard requiring a preventive control’’ flexibility in the oversight and management components take into (§ 507.3); process controls management of preventive controls, account both the nature of the (§ 507.34(c)(1)); monitoring (§ 507.40); including the explicit provision that preventive control and its role within verification (§ 507.45); validation preventive control management the facility’s overall food safety system. (§ 507.47); and verification of components take into account the Some of these comments ask us to make implementation and effectiveness nature of the preventive control. Some companion changes reflecting that the (§ 507.49). of these comments state that the preventive control management (Comment 294) Some comments provisions for the preventive control components take into account both the assert that the flexibility explicitly management components will allow nature of the preventive control and its provided in the regulatory text could facilities to tailor their food safety plans role within the facility’s overall food result in some facilities taking a broad to their specific facility, product, and safety system throughout applicable approach to significant hazards and process and ensure that the regulatory provisions of the rule, such as the other facilities taking a more detailed requirements are risk-based. Other definition of ‘‘significant hazard’’ approach. These comments express comments state that the proposed (which we now refer to as ‘‘hazard concern that inspectors will view the approach acknowledges the safety requiring a preventive control’’) and in detailed approach (e.g., with more benefits derived from the use of the requirements for preventive preventive controls), as the standard to prerequisite programs, such as CGMPs, controls, monitoring, corrective actions judge compliance with the rule. Other and provides for a framework whereby and corrections, and verification. Some comments express concern that appropriate decisions may be reached comments ask us to consistently refer to identifying a large number of preventive regarding hazards that require ‘‘the nature of the preventive control’’ controls could also undermine the value management controls that may include (rather than simply to ‘‘the preventive of HACCP programs because treating too monitoring, corrections or corrective control’’) when communicating the many controls as CCPs will pull

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resources from those controls that are practices and procedures in an organic are finalizing the provision that the truly critical. production or handling system plan recall plan not be subject to the (Response 294) We agree that facilities when we established our requirements preventive control management are likely to take different approaches to for monitoring preventive controls. components. complying with the rule. A facility- Specifically, we require that a facility For further discussion on comments specific approach is consistent with monitor the preventive controls with on preventive control management FSMA, which places responsibility for adequate frequency to ‘‘provide components, see section XXIX in the hazard analysis and risk-based assurance that they are consistently final rule for preventive controls for preventive controls on the owner, performed,’’ not to ‘‘verify that the plan human food, published elsewhere in operator, or agent in charge of the is effectively implemented.’’ Our this issue of the Federal Register. facility (section 418(a) of the FD&C Act). requirements more clearly distinguish We agree that having too many CCPs the purpose of monitoring and XXX. Subpart C: Comments on could dilute their significance, but not verification activities. See our previous Proposed § 507.40—Monitoring every hazard will require a CCP to be discussion of the relationship between controlled. See table 6 in the 2014 monitoring and verification, and our We proposed to establish supplemental notice for examples of tentative conclusion to require requirements for monitoring the preventive controls that would not be monitoring of the performance of the preventive controls. We also discussed CCPs (79 FR 58476 at 58493). preventive controls (78 FR 64736 at our tentative conclusion that the During the initial stages of 64790). We are affirming that language of section 418 of the FD&C Act implementation, we expect that our conclusion in this rule. (See Response regarding monitoring is ambiguous and investigators will ask subject matter 297.) that it would be appropriate to require experts in CVM to review the outcome monitoring of the ‘‘performance’’ of of the facility’s hazard analysis, the B. Proposed § 507.39(b)—Applicability preventive controls. preventive controls established by the of Preventive Control Management Some comments agree with our facility, and the associated preventive Components to the Supply-Chain tentative conclusion regarding the control management components that Program ambiguous nature of section 418. For the facility has established and We proposed that the supplier example, some comments state that our implemented. Over time, as our program (which we now refer to as interpretation seems appropriate investigators gain experience, we expect ‘‘supply-chain program’’) would be because requiring monitoring of the that there will be fewer circumstances subject to the following preventive ‘‘effectiveness’’ of the preventive in which our investigators would control management components as controls would be redundant with consult CVM about such an outcome. appropriate to ensure the effectiveness required verification activities. In (See also Response 2 and section LIV of the supplier program, taking into addition, requiring monitoring of the regarding our approach to compliance.) account the nature of the hazard performance of preventive controls is (Comment 295) Some comments state controlled before receipt of the raw consistent with applicable domestic and that USDA’s regulations (in 7 CFR material or ingredient: (1) Corrective internationally recognized standards. 205.201(a)(3)) for the National Organic actions and corrections, taking into Some comments agree that facilities Program include regulatory text to account the nature of any supplier non- must be required to maintain records; ‘‘ensure the effectiveness’’ of measures conformance; (2) review of records; and in that program and that this regulatory but disagree regarding the scope of (3) reanalysis. We address comments on monitoring. One comment agrees that text is similar to regulatory text in the the supply-chain program in sections requirements for preventive control monitoring the performance of XL through XLVII. We are finalizing the preventive controls would provide management components. These applicability of preventive control comments assert that this type of evidence that the preventive controls management components to the supply- established to control the identified regulatory text has created compliance chain program as proposed. challenges and ask us to consult with hazards are implemented appropriately. USDA about its experience with C. Proposed § 507.39(c)—Recall Plan Is Some comments support the proposed implementing effectiveness language Not Subject to Preventive Control provisions without change. Some associated with monitoring practices Management Components comments ask us to clarify how we will and procedures and ensure that the final We proposed that the recall plan that interpret the provision. rule uses regulatory text that will be would be established in § 507.38 would In the following paragraphs, we clearly understood and readily not be subject to the preventive control discuss comments that disagree with implementable by those subject to its management components. our tentative conclusion or with the provisions. (Comment 296) As discussed in proposed requirements, or ask us to (Response 295) Under the USDA Comment 287, some comments ask us to clarify the proposed requirements or regulation cited by these comments, an establish requirements for a written suggest one or more changes to the organic production or handling system recall plan as a CGMP requirement in proposed requirements. After plan must include a description of the subpart B rather than as a preventive considering these comments, we are monitoring practices and procedures to control in subpart C. As a companion affirming our tentative conclusion that be performed and maintained, including change, some of these comments ask us the language of section 418 of the FD&C the frequency with which they will be to delete our proposed provision that Act regarding monitoring is ambiguous performed, to ‘‘verify that the plan is the recall plan would not be subject to and that it would be appropriate to effectively implemented.’’ We have not the preventive control management require monitoring of the consulted with USDA regarding its components. ‘‘performance’’ of preventive controls. experience in evaluating compliance (Response 296) As discussed in We also have revised the proposed with this requirement because we Response 287, we are establishing the requirements as shown in table 14, with addressed the issue likely to cause these requirements as a preventive control in editorial and conforming changes as compliance challenges for monitoring subpart C as proposed. Therefore, we shown in table 31.

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TABLE 14—REVISIONS TO THE PROPOSED REQUIREMENTS FOR MONITORING

Section Description Revision

507.40 ...... Flexibility in requirements for mon- Provide that monitoring take into account both the nature of the pre- itoring. ventive control and its role in the facility’s food safety system. 507.40(c)(2)(i) ...... Records of monitoring ...... Provide that records of refrigeration temperature during storage of animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, patho- gens may be affirmative records demonstrating temperature is con- trolled or exception records demonstrating loss of temperature con- trol. 507.40(c)(2)(ii) ...... Records of monitoring ...... Provide for exception records for monitoring of preventive controls other than refrigeration.

A. Our Tentative Conclusion To Require with verification activities that address we decline to apply the rule only to Monitoring of the Performance of ongoing implementation of control animal foods deemed to be of higher Preventive Controls measures. risk. Instead, several provisions of the (Comment 297) Some comments (Comment 299) Some comments rule expressly qualify that the disagree with our tentative conclusion assert that authority should be explicitly requirements apply as appropriate to the that it would be appropriate to require granted to the States to conduct food facility, the animal food, the nature of monitoring of the ‘‘performance’’ of safety monitoring and that we should the preventive control, and its role in preventive controls and assert that the maintain our responsibilities for the facility’s food safety system, the concept of ‘‘performance evaluation’’ is product tracing. nature of the hazard, or a combination too complex to be included in the rule. (Response 299) These comments of these factors (e.g., monitoring (Response 297) These comments may misinterpret the provisions of section procedures must be established as have misinterpreted what we meant by 418 of the FD&C Act and this rule. appropriate to the nature of the ‘‘monitoring performance of preventive Section 418 places the responsibility for preventive control and its role in the controls.’’ We used the term establishing and implementing a food facility’s food safety system). For ‘‘performance’’ to mean ‘‘the execution safety system (including hazard example, the hazards in a facility and or accomplishment of an action, analysis, risk-based preventive controls, historical information on the operation, or process undertaken or preventive control management consistency of the control measure can ordered’’ (78 FR 64736 at 64790). We components (including monitoring, be factors in determining the frequency acknowledge that the definition of corrective action procedures, and of monitoring. verification), and recordkeeping) on the ‘‘monitoring’’ that we are establishing in B. Proposed § 507.40(a) and (b)— owner, operator, or agent in charge of a this rule includes that the purpose of Flexibility in Requirements for facility, not on FDA or any other observations or measurements Monitoring conducted as part of monitoring is to regulatory authority. This requirement ‘‘assess’’ whether control measures are for monitoring within the framework of We proposed that, as appropriate to operating as intended. However, we hazard analysis and risk-based the preventive control, you must provided examples showing that this preventive controls is distinct from establish and implement written assessment is a straightforward regulatory oversight of animal food procedures, including the frequency determination of whether a process is safety, such as during inspections and with which they are to be performed, for operating as intended and is not a investigations of outbreaks of foodborne monitoring the preventive controls, and complex evaluation as asserted by the illness, which generally involve product monitor the preventive controls with comments. (See, e.g., the discussion of tracing. We agree that it is important to adequate frequency to provide monitoring oven temperature to ensure coordinate regulatory oversight of assurance that they are consistently pathogen elimination during baking of a animal food safety with the States and performed. pet treat 78 FR 64736 at 64789 through other food safety partners. As discussed (Comment 301) Some comments agree 64790.) in Response 2, we are working through that frequency and areas to be tested (Comment 298) Some comments that the PFP to develop and implement a and monitored need to be determined support monitoring the performance of national Integrated Food Safety System based on each product and facility and preventive controls assert that our consistent with FSMA’s emphasis on ask us to allow each individual facility proposed definition of ‘‘monitoring’’ establishing partnerships for achieving to determine the frequency and areas to (proposed § 507.3), and our preamble compliance (see section 209(b) of be monitored based on a completed risk discussions of ‘‘monitoring,’’ have the FSMA). assessment. Some comments ask us to potential to confuse ‘‘monitoring the (Comment 300) One comment specify that the frequency of monitoring performance of preventive controls’’ requests that routine monitoring not be preventive controls must have a with verification activities that address required for feed mills unless they scientific basis. ongoing implementation of control manufacture pet food. (Response 301) It is unclear whether measures. (Response 300) We decline this the comment agreeing that monitoring (Response 298) See Response 47 in request. We assume this comment is frequency and areas to be tested need to which we discuss comments on the based on a presumption that pet food is be determined based on each product definition of monitoring and describe a higher risk product than livestock or and facility was directed to the the changes we have made to that poultry food. The exemptions from monitoring provision or to definition to address concerns about the preventive control requirements that we environmental monitoring. Regardless, potential to confuse ‘‘monitoring the are establishing are specifically by requiring written procedures for performance of preventive controls’’ provided by section 103 of FSMA and monitoring, and specifying that the

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procedures include the frequency with another example, a process that is monitoring systems can work which the procedures are to be operated at a point close to a food safety affirmatively or by exception and that performed, the rule provides that each parameter limit may be monitored more both types of systems and their related facility must determine the frequency of frequently than one where there is a documentation are acceptable. monitoring, as well as details such as large safety margin built into the (Response 302) We have made several the areas to be monitored. However, we process. revisions to the regulatory text, with associated editorial changes, to clarify decline the request to specify that these C. Proposed § 507.40(c)—Records procedures be based on a completed that monitoring records may not always ‘‘risk assessment.’’ The rule requires the We proposed that all monitoring of be necessary. We agree that the facility to conduct a hazard analysis, preventive controls must be exception reporting described in these which determines whether there are any documented in records that are subject comments, including validation and hazards requiring a preventive control, to verification and records review. periodic verification to ensure that the and the facility would establish (Comment 302) Some comments point system is working properly, would be preventive controls for such hazards as out that table 6 in the 2014 an acceptable monitoring system in the appropriate to the facility and the supplemental notice includes an circumstances provided in the animal food. The facility must consider example of a monitoring activity that comments, i.e., for monitoring factors associated with risk (i.e., the generally would not require monitoring refrigeration temperature. Therefore, we severity of the illness or injury if the records (i.e., monitoring for pieces of have revised the regulatory text to hazard were to occur and the probability ferrous material with magnets) (see 79 provide that records of refrigeration that the hazard will occur in the absence FR 585476 at 58493). These comments temperature during storage of food that of preventive controls) in evaluating assert that this example is in conflict requires time/temperature control to with the proposed regulatory text and whether any potential hazard is a significantly minimize or prevent the ask us to modify the regulatory text to hazard requiring a preventive control growth of, or toxin production by, provide the flexibility we acknowledged (§ 507.33(c)). Risk could be relevant to a pathogens may be affirmative records in the 2014 supplemental notice. One facility’s identification of appropriate demonstrating temperature is controlled comment states the examples provided preventive controls for a particular or exception records demonstrating loss by FDA for monitoring performance of hazard requiring a preventive control. of temperature control. Although the preventive controls pertain to However, it is the nature of the comments specifically requested that we preventive controls that have specific preventive control, rather than the risk clarify our view on exception records in parameters. The comment states in the associated with the hazard, that is more the preamble, we believe that clarifying absence of specific parameters for a the regulatory text will be more useful, relevant to the frequency of monitoring preventive control, monitoring is and the areas to be monitored. both to facilities and to regulatory neither necessary nor appropriate. Other agencies that conduct inspections for Accordingly, the rule specifies that the comments ask us to specify that facility establish written procedures, compliance with the rule. If a facility monitoring must be documented as uses ‘‘exception records,’’ the facility and conduct monitoring, as appropriate appropriate to the nature of the to the preventive control rather than must have evidence that the system is preventive control. working as intended, such as a record based on risk associated with the Some comments ask us to recognize hazard. (See, e.g., the discussion of that the system has been challenged by the acceptability of monitoring systems increasing the temperature to a point at monitoring oven temperature to ensure that exclusively provide exception which an ‘‘exception record’’ is pathogen elimination during baking of a reports. These comments describe generated. pet treat 78 FR 64736 at 64789 through exception reporting as a structure where We also have revised the regulatory 64790.) automated systems are designed to alert text to provide that exception records We decline the request to specify that operators and management on an may be adequate in circumstances other the frequency of monitoring preventive exception basis, i.e., only when a than monitoring of refrigeration controls must have a scientific basis. deviation from food safety parameter temperature. For example, in table 6 of Monitoring should take place with limits are observed by the system. These the 2014 supplemental notice the sufficient frequency to detect a problem comments assert that, in many cases, example we provided of a monitoring in the performance of a preventive monitoring of preventive controls can be activity that generally would not require control. The importance of the done by automated systems that provide monitoring records is monitoring for preventive control to the safety of the exception reporting in a much more pieces of ferrous material with magnets. animal food can be one factor in setting efficient manner than if performed by We believe that a magnet system that a frequency. We acknowledge that operators and that automated monitors for ferrous material would scientific information may be monitoring allows for increased result in a record only when the system appropriate in determining the sampling frequency (often continuous) detects ferrous material. frequency of monitoring in some cases. and reduction of human error. The For example, the frequency may be comments provide an example of a XXXI. Subpart C: Comments on statistically based, such as with refrigeration temperature control that Proposed § 507.42—Corrective Actions statistical process control. However, in notifies on exception (e.g., high and Corrections some cases, factors other than scientific temperature alarm) and may only record We proposed to establish information may be appropriate in temperatures that exceed the specified requirements for corrective actions and determining the frequency of temperature (without recording corrections. Some comments support monitoring. For example, historical temperatures that meet control the proposed requirements without information on the consistency of the requirements). These comments change. For example, some comments control measure can be a factor in acknowledge that such systems must be assert that there is virtually no reason to determining frequency. When validated and periodically verified to have a food safety plan unless there are variability of the process is low, the ensure they are working properly. These proper corrective actions in place so the frequency may be less than with a comments ask us to clarify in the product can be properly disposed of. process that has more variability. As preamble to the final rule that Some comments agree that there should

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be written procedures for corrective problem, and documenting all suggest one or more changes to, the actions and note the importance of corrective actions, contributes to a proposed requirements. After identifying and evaluating the problem, comprehensive safety plan. Some considering these comments, we have correcting it, and documenting the comments that support the proposed revised the proposed requirements as corrective action. Some comments provisions suggest alternative or shown in table 15 with editorial and express the view that the proposed additional regulatory text. conforming changes as shown in table requirement for clear corrective action In the following paragraphs, we 31. in the event of an unanticipated discuss comments that disagree with, or

TABLE 15—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CORRECTIVE ACTIONS AND CORRECTIONS

Section Description Revision

507.42(a) ...... Corrective action procedures ...... Clarify that corrective action procedures depend on the nature of the hazard, as well as the nature of the preventive control. 507.42(a)(1) ...... Corrective action procedures ...... Clarify that the specified list of corrective action procedures is not in- tended to be finite. 507.42(b) ...... Corrective action in the event of Specify that the requirement applies when ‘‘a corrective action proce- an unanticipated food safety dure’’ (rather than ‘‘a specific corrective action procedure’’) has not problem. been established. 507.42(b)(1)(ii) ...... Corrective action in the event of Specify that the requirement applies when a preventive control, com- an unanticipated food safety bination of preventive controls, or the food safety plan as a whole problem. is found to be ineffective (rather than just when a single preventive control has been found to be ineffective). 507.42(c)(2) ...... Corrections ...... Provide for additional circumstances when corrections, rather than corrective actions, are warranted.

A. Proposed § 507.42(a)(1)— to testing results, other non- something (Ref. 47). The word Requirement To Establish and conformances, or other types of ‘‘includes’’ does not need to be followed Implement Corrective Action Procedures verification activities. These comments by ‘‘but is not limited to’’ to clearly assert that it would be better for food communicate that a following list is not We proposed that, with some safety if the regulatory requirements complete. We agree that the nature and exceptions, as appropriate to the took a more principled approach and extent of any corrective actions in preventive control you must establish generally required corrective action response to the findings of testing and implement written corrective action procedures, with the importance of programs should be proportional to the procedures that must be taken if corrective action procedures for testing nature of the test findings. (See preventive controls are not properly programs addressed through guidance. Response 304.) implemented. The corrective action If, however, we conclude that specific (Comment 304) Some comments state procedures must include procedures to requirements for corrective action that the nature and extent of the address, as appropriate, the presence of procedures for testing programs are corrective actions should be a pathogen or appropriate indicator necessary, these comments ask us to proportional to the nature of the testing organism in animal food detected as a clarify that the nature and extent of any results. These comments ask us to result of product testing, as well as the corrective actions should be require that a facility establish and presence of an environmental pathogen proportional to the nature of the test implement corrective action procedures or appropriate indicator organism findings. that must be taken if preventive controls detected through environmental (Response 303) We have revised the are not properly implemented as monitoring. regulatory text, with associated editorial appropriate to the nature of the hazard, (Comment 303) Some comments note revisions and redesignations, to clarify the nature of the control measure, and that we proposed to list two that the specified list of corrective the extent of the deviation. circumstances that require written action procedures is not intended to be (Response 304) We have revised the corrective active procedures (i.e., exhaustive (i.e., not limited to the two regulatory text to specify that the product testing and environmental corrective action procedures that we corrective action procedures are monitoring) and that it is not clear specified in the 2014 supplemental established and implemented based on whether this list is intended to be notice). The approach we used in the the nature of the hazard in addition to exhaustive or not (i.e., whether written modified regulatory text (i.e., ‘‘You must the nature of the preventive control. We corrective action procedures are establish and implement written agree that the nature of the hazard plays required in only these two corrective action procedures . . ., a key role in the corrective actions that circumstances, or whether there may be including procedures to address, as a facility would take. Although a other circumstances that require written appropriate . . .’’) is similar to the facility’s corrective action procedures corrective action procedures). These approach used in several other likely would specify actions to take comments ask us to insert ‘‘but are not provisions of the rule. (See, e.g., based on the extent of the deviation, we limited to’’ after ‘‘must include,’’ if we sanitation controls (§ 507.34(c)(2)); and consider this a detail that does not need intend that the list is not exhaustive. monitoring (§ 507.40(a)). We decline the to be specified in the rule. Likewise, other comments state our suggestion to modify the regulatory text (Comment 305) Some comments ask proposal to specifically require by adding ‘‘but is not limited to’’ after us to revise the provisions to clarify that corrective action procedures may result ‘‘includes’’. The word ‘‘includes’’ means corrective action procedures are not in a misunderstanding by some facilities to have (someone or something) as part always necessary when testing detects about the need to take corrective actions of a group or total; to contain (someone the presence of a pathogen or indicator in circumstances other than in response or something) in a group or as a part of organism. These comments assert that

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the extent of the corrective actions (see § 507.42(a)(2)(ii)). Root cause food safety issue. Other comments say should be proportional to the nature of analysis is simply part of a common that the animal food safety plan should the testing results themselves because approach to complying with this outline when a corrective action is the level of contamination matters for requirement. (Knowing the root cause is required, as well as the procedure to be those microorganisms with thresholds key to reducing the likelihood that a followed and the requirement should that need to be taken into account and problem will happen again.) The rule only focus on animal food safety issues because the location of contamination in also requires a review of records of and not quality issues. the food processing environment corrective actions, but does so as a (Response 309) As stated in Response matters (e.g., the zone in the facility verification activity rather than as part 304, we have revised the regulatory text where the contamination is detected). of the corrective action procedures (see to specify that the corrective action (For information about zones associated § 507.49(a)(4)). procedures are established and with environmental monitoring, see 78 (Comment 307) Some comments ask implemented based on the nature of the FR 3646 at 3816.) us to revise the proposed rule to address hazard in addition to the nature of the (Response 305) We decline this corrective actions in a more general way preventive control. We agree that the request. These comments appear to be and then outline areas where specific nature of the hazard plays a key role in confusing the requirement to establish corrective action procedures would be the corrective actions that a facility and implement corrective action helpful, such as for testing programs, in would take. The requirement is procedures with the content of the guidance. intended to address hazards and corrective action procedures. These (Response 307) The proposed therefore would not address animal food comments also appear to assume that a provisions do not prescribe the outcome quality issues unless they would present requirement to have corrective action of the corrective action procedures, but a hazard (e.g., if insufficient mixing procedures (which describe the steps to merely direct the facility to the types of would present the potential for nutrient be taken to ensure that appropriate actions that the procedures must deficiencies or toxicities). All corrective action is taken to identify and correct a address. In essence, the proposed actions must be documented in records problem and, when necessary, to reduce provisions already do, as the comments (see § 507.42(d)). the likelihood that the problem will request, address corrective actions in a B. Proposed § 507.42(a)(2)—Content of recur; that all affected animal food is general way. Corrective Action Procedures evaluated for safety; and that all affected (Comment 308) Some comments ask animal food is prevented from entering us to specify that the requirements to We proposed that corrective action into commerce when appropriate) pre- establish and implement written procedures must describe the steps to be determines the outcome of following the corrective action procedures also apply taken to ensure that: (1) Appropriate corrective action procedures. This is not when a preventive control is found to be action is taken to identify and correct a the case. If, as the comments assert, a ineffective. problem that has occurred with facility concludes, for example, that the (Response 308) We have not revised implementation of a preventive control; nature of some test results do not the regulatory text as requested by these (2) appropriate action is taken to reduce warrant steps to reduce the likelihood comments. The appropriate action when the likelihood that the problem will that a problem will recur and that a preventive control is found to be recur; (3) all affected animal food is affected animal food is safe and lawful ineffective is to reanalyze the food evaluated for safety; and (4) all affected (or, in the case of finding a pathogen in safety plan and to establish and animal food is prevented from entering some zones in the facility, that no implement a preventive control that is into commerce, if you cannot ensure animal food is affected), then that is effective, not follow a corrective action that the affected animal food is not what its corrective action procedures procedure. A corrective action adulterated under section 402 of the would say. The reason to have procedure is intended to address a FD&C Act. corrective action procedures is to problem that happens when following (Comment 310) Some comments consider the likely scenarios in advance, the procedures in a food safety plan that assert that the corrective action with appropriate input from the previously was verified to be valid, not procedures should not consider food to facility’s food safety team and to fix problems on an ongoing basis be ‘‘affected’’ if it is immediately preventive controls qualified individual, when a preventive control is ineffective subjected to an additional (or repeat) rather than react to these scenarios on (and, thus, the food safety plan is not preventive control after determining an ad hoc basis. valid). We agree that some of the steps that the initial preventive control was (Comment 306) Some comments ask that apply to corrective actions may not properly implemented. These us to require that corrective actions need to be taken, such as evaluating comments discuss an example in which include an analysis to determine the affected animal food for safety and there is a temperature deviation below root cause of a problem, not only ensuring that adulterated animal food accepted parameter limits for a given identify it. These comments also ask us does not enter commerce. This is process, and the incorrectly processed to require follow-up actions to ensure addressed by the provisions for product is re-processed correctly, and the corrective action was effective and corrective actions in the event of an assert that it would be illogical to assert that although the requirements unanticipated problem (§ 507.42(b)(1)), consider the food to be ‘‘affected’’ in the address the need to reanalyze the food which require specific corrective actions circumstance. Other comments ask us to safety plan they do not appear to to be taken (§ 507.42(b)(2)). modify the requirements to specify that specifically address a review of the (Comment 309) Some comments they apply to all affected food ‘‘if any.’’ corrective action. requests flexibility as every facility is One comment states the use of the term (Response 306) The requests of these different from the next so prescriptive ‘‘all’’ with ‘‘affected’’ is redundant and comments do not require any revisions corrective actions required by rules may may contribute to unwarranted and to the regulatory text. The rule does not not be applicable or possible in all unnecessary regulatory emphasis and use the term ‘‘root cause’’ but it does cases. Some commenters requested that requests that the word ‘‘all’’ be removed. require the facility to take appropriate documentation be maintained for (Response 310) We decline the action, when necessary, to reduce the corrective actions only if the corrective requests to modify the regulatory text to likelihood that the problem will recur action was made to address an animal remove the word ‘‘all’’ or specify that

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the requirements apply to all affected the likelihood that the problem will food safety problem and the animal food ‘‘if any.’’ Animal food is recur, evaluate all affected animal food requirements for reanalysis. To reduce ‘‘affected’’ if a preventive control is not for safety, and, as necessary, prevent redundant regulatory text, in the 2014 properly implemented during its affected animal food from entering supplemental notice we proposed to production. However, the rule does not commerce as would be done following modify the regulatory text of the pre-determine the consequences when a corrective action procedure if any of requirements for reanalysis to specify animal food is ‘‘affected.’’ Instead, the the following circumstances apply: (1) A that reanalysis is required when rule provides for the facility to evaluate preventive control is not properly appropriate after an unanticipated food the affected animal food for safety. If, as implemented and a specific corrective safety problem, and we are establishing in the example described by the action has not been established; (2) a that modified provision in this final comments, the facility reapplies the preventive control is found to be rule. Importantly, the provisions for preventive control such that the animal ineffective; or (3) a review of records reanalysis continue to require reanalysis food is safe and is not adulterated under finds that the records are not complete, when a preventive control is found to be section 402 of the FD&C Act, there the activities conducted did not occur in ineffective. We are not aware of any would be no need to take steps to accordance with the food safety plan, or circumstances in which it would not be prevent that animal food from entering appropriate decisions were not made appropriate to reanalyze the food safety commerce. about corrective actions. We also plan if a preventive control is found to (Comment 311) Some comments ask proposed that if any of these be ineffective. us to provide that requirements for circumstances apply, when appropriate (Comment 314) Some comments corrective actions be principle-based you must reanalyze the food safety plan assert that the word ‘‘specific’’ is not (e.g., affected product containment, to determine whether modification of appropriate as a modifier for ‘‘corrective control restored to operation before the food safety plan is required. action procedure’’ because many commencing production) rather than (Comment 313) Some comments ask preventive controls will have corrective prescriptive. us to delete the proposed requirement action procedures that allow flexibility (Response 311) The requirements for that a facility must reanalyze the food based upon the nature of the hazard and corrective actions established by this safety plan in the event of an control. These comments also state that rule are principle-based in that they unanticipated problem. These the term ‘‘specific’’ in this context is require the facility to describe the steps comments argue that FSMA does not more appropriate for a CCP control in a it will take rather than prescribe the specify reanalysis in the event of an HACCP system. steps it will take. unanticipated problem. In addition, (Response 314) We have revised the (Comment 312) Some comments ask these comments assert that the proposed regulatory text to delete the word us to revise the provision to make requirement for reanalysis in the event ‘‘specific.’’ resampling and/or retesting one of the of an unanticipated problem would be (Comment 315) Some comments ask first steps in a corrective action redundant with the proposed us to emphasize that reanalysis is procedure to take into account human requirements for reanalysis as a required only when a combination of error. These comments assert that verification activity (proposed § 507.50) two events occurs (i.e., a preventive mishandling during sampling, transport, and would not add value for food safety. control is not properly implemented and testing can contribute to a false These comments also assert that the and the facility has not established a positive result and that if the results of term ‘‘problem’’ is ambiguous and ask corrective action procedure). a followup test are negative, then the us to replace ‘‘problem’’ with ‘‘food (Response 315) In the 2014 previous test could be considered an safety issue’’ if we retain the provision supplemental notice, we proposed anomaly that could be ignored. in the final rule. revisions to the regulatory text to clearly (Response 312) We decline this (Response 313) We acknowledge that specify the circumstances requiring request. We disagree that an appropriate section 418 of the FD&C Act does not reanalysis. One such circumstance is approach to positive findings of a test explicitly specify that a facility must when a preventive control is not for contamination is to resample and reanalyze its food safety plan in the properly implemented and a corrective retest and to consider positive findings event of an unanticipated problem. In action procedure has not been to be an anomaly if subsequent test the 2014 supplemental notice, we established, as stated in results are negative. Many animal food clarified that reanalysis would be § 507.42(b)(1)(i)). The final provision products are not homogeneous and conducted ‘‘when appropriate.’’ For includes the revisions included in the contamination is localized. Even for example, if a problem occurs because 2014 supplemental notice and is homogeneous animal food products personnel did not understand the consistent with the request of these (such as liquids), the problem could be procedures or carry out the procedures comments. the sensitivity of the method if the level correctly, additional training for (Comment 316) Some comments ask of contamination is low. For further applicable personnel may be warranted, us to add that corrective actions in the discussion on our current thinking on but there likely would be no need to event of an unanticipated problem also presumptive positive results and reanalyze the food safety plan. apply when a preventive control is additional testing, see our guidance We disagree that the term ‘‘problem’’ ‘‘missing.’’ entitled ‘‘Guidance for Industry: Testing is ambiguous. The term ‘‘problem’’ (Response 316) We have revised the for Salmonella Species in Human Foods signifies that something is wrong, regulatory text to require corrective and Direct-Human-Contact Animal whereas the term suggested by the actions whenever a preventive control, Foods’’ (Ref. 48). comments (i.e., ‘‘issue’’) may or may not combination of preventive controls, or signify that something is wrong. We the food safety plan as a whole, is C. Proposed § 507.42(b)—Corrective agree that the requirements are directed ineffective. (See § 507.42(b)(1)(ii).) In Action in the Event of an Unanticipated to problems related to animal food assessing what the comment might Problem safety. mean by a preventive control that is With some exceptions, we proposed We agree that there is a relationship ‘‘missing,’’ we concluded that an that you must take corrective action to between the requirements for corrective unanticipated problem could, in some identify and correct a problem, reduce actions in the event of an unanticipated cases, mean that a combination of

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preventive controls, or the facility’s food actions and corrective action reanalysis from the single proposed safety plan as a whole (rather than a procedures, for minor and isolated section (proposed § 507.45) to separate single preventive control), simply was problems that do not directly impact sections (proposed §§ 507.47, 507.49, not effective. If this is the case, product safety. As discussed in and 507.50, respectively). In addition, to reanalysis would be appropriate, and we Response 82, we also have defined the address comments that asked us to also have modified the requirements for term ‘‘correction’’ to mean an action to provide more flexibility to facilities, reanalysis to specify that a facility must identify and correct a problem that including flexibility in determining reanalyze its food safety plan whenever occurred during the production of whether and how to conduct it finds that a preventive control, animal food, without other actions verification activities, in the 2014 combination of preventive controls, or associated with a corrective action supplemental notice we proposed that the food safety plan as a whole is procedure (such as actions to reduce the the verification activities be performed ineffective. likelihood that the problem will recur, ‘‘as appropriate to the preventive (Comment 317) Some comments ask evaluate all affected animal food for control.’’ us to replace the term ‘‘reanalyze’’ with safety, and prevent affected animal food In this section, we discuss the the term ‘‘reassess.’’ from entering commerce). proposed requirements for verification (Response 317) We decline this E. Proposed § 507.42(d)—Records of monitoring, verification of corrective request. Reanalysis goes beyond actions, and documentation of We proposed that all corrective assessing the validity of a preventive verification activities. See sections actions (and, when appropriate, control or food safety plan to control a XXXIII through XXXV for comments on corrections) must be documented in hazard. Reanalysis can also include the proposed requirements for records and that these records are assessing whether all hazards have been validation, verification of subject to the verification requirements identified, whether established implementation and effectiveness, in §§ 507.45(a)(3) and 507.49(a)(4)(i). procedures are practical and effective, written procedures, and reanalysis. See We received no comments that and other factors. tables 17, 18, and 19 for a summary of disagreed with this proposed the revisions to those proposed D. Proposed § 507.42(c)—Corrections requirement and are finalizing it as requirements. We proposed that you do not need to proposed. comply with the requirements for Some comments support the proposed corrective actions and corrections for XXXII. Subpart C: Comments on requirements for verification of conditions and practices that are not Proposed § 507.45—Verification monitoring, verification of corrective consistent with specified sanitation if In the 2013 proposed preventive actions, and documentation of you take action, in a timely manner, to controls rule for animal food, we verification activities without change. correct such conditions and practices. proposed verification activities that For example, comments support the (Comment 318) Some comments would include validation, verification of documentation of verification activities support our proposal to provide for monitoring, verification of corrective (see section XXXI.C). In the following corrections, rather than corrective actions, verification of implementation paragraphs, we discuss comments on actions, for sanitation controls in some and effectiveness, written procedures, the flexibility provided for a facility to circumstances. Other comments assert reanalysis, and documentation of all conduct verification activities as that situations in which ‘‘corrections’’ verification activities. We also requested appropriate to the nature of the can be applied are not limited to comment on whether we should specify preventive control. We also discuss sanitation controls and could include the verification activities that must be comments that address our request for actions to address other preventive conducted for verification of monitoring comment on whether we should revise controls such as preventive (78 FR 64736 at 64796) and for the regulatory text to specify the maintenance controls or CGMPs. As verification of corrective actions (78 FR verification activities that must be discussed in Comment 82, some 64736 at 64796), and if so, what conducted for verification of monitoring comments emphasize the importance of verification activities should be and for verification of corrective actions, distinguishing between the terms required. or express concern that the ‘‘correction’’ and ‘‘corrective action.’’ To improve clarity and readability, in requirements as proposed are too (Response 318) We have revised the the 2014 supplemental notice we prescriptive. After considering these regulatory text, with associated editorial proposed to move the more extensive comments, we have revised the revisions and redesignations, to provide verification requirements for validation, verification requirements described in for corrections, rather than corrective implementation and effectiveness, and § 507.45 as shown in table 16.

TABLE 16—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VERIFICATION

Section Description Revision

507.45(a) ...... Flexibility to conduct verification Provide that verification activities take into account both the nature of activities. the preventive control and its role in the facility’s food safety sys- tem.

A. Flexibility in Requirements for as appropriate to the preventive control, reanalysis). These comments emphasize Verification specified verification activities (i.e., that verification activities must be (Comment 319) Some comments validation, verification that monitoring tailored to the preventive control and support the flexibility provided by use is being conducted, verification that assert that the use of the word ‘‘must’’ of the phrase ‘‘as appropriate to the appropriate decisions about corrective is potentially confusing in light of this preventive control’’ in the requirement actions are being made, verification of flexibility, e.g., because not all that verification activities must include, implementation and effectiveness, and preventive controls must be validated

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for food safety, and those preventive 2. Proposed § 507.45(a)(2)—Verification should not be required to conduct controls that do not need monitoring of Monitoring product testing or environmental would not need verification of We proposed that verification monitoring to verify implementation monitoring. Other comments ask us to activities must include, as appropriate and effectiveness of preventive controls. allow facilities flexibility to verify that to the preventive control, verification The comment states that product testing preventive controls are effective in the that monitoring is being conducted in and environmental monitoring at a manner prescribed by FSMA, i.e., such accordance with § 507.40. We requested facility that is not using appropriate controls should be deemed to be comment on whether we should specify controls will not normally discover effective by an appropriate means as the verification activities that must be potential hazards. The comment also determined and supported by the conducted for monitoring, and if so, states that all of the safety requirements facility within its food safety plan. what verification activities should be necessary to protect the health of animals are already being met because (Response 319) The provisions for required. (Comment 320) Comments that this is necessary as a good business preventive control management practice and is required by customers. components make clear that all address our request for comment on whether we should specify the (Response 322) When a food safety preventive control management plan is completed by a preventive components, including verification, are verification activities that must be conducted for monitoring ask us to not controls qualified individual, they must required as appropriate to ensure the do so because this prescriptive approach ensure that the preventive controls in effectiveness of the preventive control, would be too limiting. These comments place are adequate to provide assurance taking into account the nature of the ask us to instead provide flexibility for that any hazards requiring a preventive preventive control and its role in the the facility to determine the appropriate control will be significantly minimized facility’s food safety system (see verification activities. or prevented. We have provided § 507.39). Likewise, the provisions for (Response 320) We agree that we adequate flexibility for a preventive each of the preventive control should provide flexibility for the facility controls qualified individual in an management components (i.e., to determine these verification animal food facility to determine if monitoring, corrective actions and activities, and are not specifying the product testing or environmental corrections, and verification) verification activities that must be monitoring is necessary considering the individually provide flexibility, either conducted for monitoring. facility, the animal food, the nature of by specifying that the provisions apply the preventive control, and its role in 3. Proposed § 507.45(a)(3)—Verification as appropriate to the nature of the the facility’s food safety system (for of Corrective Actions preventive control and its role in the further discussion see section XXXIV.C facility’s food safety system (i.e., for We proposed that verification and XXXIV.E). monitoring and verification) or both the activities must include, as appropriate We disagree that all food safety nature of the preventive control and the to the preventive control, verification measures necessary to protect the health nature of the hazard (i.e., for corrective that appropriate decisions about of animals are always being followed. actions and corrections). The word corrective actions are being made in Each year, animal food is recalled, often ‘‘must’’ specifies the type of activities accordance with § 507.42. We requested due to a hazard that could cause serious that a facility can use to satisfy the comment on whether this section health consequences or death. Animal requirements for a particular preventive should specify the verification activities food from a facility that is required to control management component. that must be conducted for corrective register and for which there is a actions, and if so, what verification We are retaining the term ‘‘must.’’ reasonable probability that use of or activities should be required. However, we agree that the rule should exposure to the food would cause (Comment 321) Some comments ask serious adverse health consequences or provide flexibility for additional us not to specify the verification verification of implementation and death to humans or animals is subject to activities that must be conducted for reporting to FDA under section 417 of effectiveness. To provide that additional corrective actions because this approach flexibility, we have revised the specific the FD&C Act (Reportable Food would be too limiting. These comments Registry). requirements for verification of ask us to instead provide flexibility for implementation and effectiveness to the facility to determine the appropriate 5. Proposed § 507.45(a)(5)—Reanalysis provide for other activities appropriate verification activities. We proposed that verification for verification of implementation and (Response 321) We agree that we activities must include, as appropriate effectiveness (see § 507.49(a)(5)). As a should provide flexibility for the facility to the preventive control, reanalysis in conforming revision, we have revised to determine the appropriate accordance with § 507.50. See section the requirement for review of records to verification activities for corrective XXXV for comments on reanalysis as a include a review of records of other actions, and are not specifying the verification activity. verification activities within a verification activities that must be reasonable time after the records are conducted for corrective actions. C. Proposed § 507.45(b)— created (see § 507.49(a)(4)(ii)). Documentation of Verification Activities 4. Proposed § 507.45(a)(4)—Verification We proposed that all verification B. Proposed § 507.45(a)—Verification of Implementation and Effectiveness activities must be documented in Activities We proposed that verification records. We received no comments that 1. Proposed § 507.45(a)(1)—Validation activities must include, as appropriate disagreed with this proposed to the preventive control, verification of requirement and are finalizing it as We proposed that verification implementation and effectiveness in proposed. activities must include, as appropriate accordance with § 507.49. See section to the preventive control, validation in XXXIV for comments on verification of D. Comments on Potential Requirements accordance with § 507.47. See section implementation and effectiveness. Regarding Complaints XXXIII for comments on validation as a (Comment 322) One comment We requested comment on whether verification activity. contends that animal food facilities and how a facility’s review of

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complaints, including complaints from the value of such a review is in review. Comments state that consumer consumers, customers, or other parties, providing information and feedback for complaint records are often kept at a should be required as a component of its continuous improvement of the food corporate level rather than at the activities to verify that its preventive safety management system rather than individual facility. One comment controls are effectively minimizing the as a verification of preventive controls. requests mandatory complaint occurrence of hazards (78 FR 64736 at These comments caution against use of monitoring for animal food 64809). consumer complaints as a regulatory manufacturers. One comment points out (Comment 323) Some comments ask requirement for verification of the food FDA already has access to records, us to require review of consumer safety plan because most complaints including complaint files, associated complaints as a verification activity and relate to product quality. If such a with animal food, which the Agency note that our HACCP regulations for requirement is nonetheless established reasonably believes to be adulterated seafood and juice require that in the final rule, these comments and presenting a threat of serious verification activities include a review recommend that the rule only require adverse health consequences. of consumer complaints to determine followup and documentation for the whether they relate to the performance (Response 323) We are not rare occurrences where consumer establishing a requirement for a review of the HACCP plan or reveal the complaints relate to food safety issues. existence of unidentified CCPs. Some of complaints as a verification activity. Other comments ask us not to require We agree that review of complaints is comments note circumstances in which review of complaints as a verification consumer complaints have identified more likely to be useful in providing activity. Some of these comments assert information and feedback for food safety problems that resulted in a that complaints rarely relate to food company report to the RFR. Other continuous improvement of the food safety or yield information that leads to safety system rather than as a comments assert that review of discovery of a food safety issue. Some customer complaint data should not be verification of preventive controls. comments assert that requiring review However, we encourage facilities to do required in the rule to verify that a of consumer complaints could result in facility’s preventive controls are such a review, as they occasionally do unnecessary time and effort being spent effectively minimizing the occurrence of uncover animal food safety issues. on an activity with a limited correlation hazards. XXXIII. Subpart C: Comments on Some comments state that the to food safety. Some comments assert frequency and type of complaints a that the provision would provide FDA Proposed § 507.47—Validation access unnecessarily to all complaint facility receives is a very good indicator We proposed to establish of the underlying issues associated with files and lead to unproductive and subjective evaluations as to whether a requirements for validation of food production, reviewing these preventive controls. Some comments records would provide valuable insight given complaint pertains to the performance of the food safety plan. support the proposed requirements into the type of issues that should be without change. For example, some investigated, and this type of Other comments assert that complaints would be acted upon immediately for comments agree that validation must be verification activity could therefore be performed by (or overseen by) a extremely effective with little to no cost business reasons, and that waiting to react to complaints until conducting a preventive controls qualified individual because the facility would already be and that some preventive controls (e.g., performing this type of activity. Some review of records as a verification sanitation controls and recall plans) do comments state that many foodborne activity would be too late. Other not require validation. Some comments outbreaks have been identified through comments assert that complaints are that support the proposed provisions complaints and a review of complaints sensitive business information. Other suggest alternative or additional is a critical component of a food safety comments assert that some consumer regulatory text or ask us to clarify how system. One comment says that many complaints are false or emotional (rather we will interpret the provision. times customer complaints may be the than factual) and have no place in first and only clue that problems exist development of preventive controls. In the following paragraphs, we in animal food because animal illnesses Some comments assert that FSMA does discuss comments that ask us to clarify are not subject to the same reporting not expressly direct us to require review the proposed requirements or that requirements as human illnesses, of complaints. Some comments assert disagree with, or suggest one or more resulting in a much weaker basis for that review of complaints is not a changes to, the proposed requirements. identifying, tracing, and correcting precise scientific process, and that After considering these comments, we foodborne problems. consumer comments are often open to have revised the proposed requirements Other comments state that a food different interpretations. as shown in table 17, with editorial and safety review of complaints is a prudent Some comments discuss the conforming changes as shown in table part of a food safety program but that feasibility of consumer complaint 31.

TABLE 17—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VALIDATION

Section Description Revision

507.47(a) ...... Flexibility for validating preventive Provide that validation be conducted as appropriate to both the na- controls. ture of the preventive control and its role in the facility’s food safety system. 507.47(b)(1) ...... Circumstances requiring validation Provide that, when necessary to demonstrate the control measures can be implemented as designed, validation may be performed (1) Within 90 calendar days after production of the applicable animal food first begins or (2) within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification.

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TABLE 17—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VALIDATION—Continued

Section Description Revision

507.47(b)(1) ...... Circumstances requiring validation Add an additional circumstance requiring validation, i.e., whenever a change to a control measure or combination of control measures could impact whether the control measure or combination of control measures, when properly implemented, will effectively control the hazards requiring a preventive control. 507.47(c) ...... Preventive controls that do not re- Clarify that a list of preventive controls that do not require validation quire validation. is not an exhaustive list.

A. Flexibility in the Requirements To preparation of) a written justification (Comment 326) Some comments Validate Preventive Controls that validation is not applicable based assert that validation is more With some exceptions (see discussion on factors such as the nature of the appropriate for a HACCP regulation and of proposed § 507.47(b)(3) in section hazard, and the nature of the preventive that requiring the validation of all XXXIII.D), we proposed that you must control and its role in the facility’s food preventive controls does not reflect the validate that the preventive controls safety system. We specified that the flexibility mandated by section identified and implemented in determination that validation is not 418(n)(3)(A) of FSMA. Other comments accordance with proposed § 507.36 to required must be made by the assert that effective preventive measures control the significant hazards are preventive controls qualified individual may be identified in the future that are adequate to do (proposed § 507.47(a)). to emphasize that specialized not amenable to validation and it would (Comment 324) Some comments experience is necessary to evaluate be counterproductive for them not to be assert that the regulatory text is in whether validation is required. We employed in food safety plans because conflict with the preamble discussion in made a conforming revision to the list they cannot meet the validation the 2014 supplemental notice because of responsibilities of the preventive requirements. These comments explain the regulatory text (i.e., ‘‘(e)xcept as controls qualified individual (see that certain control measures are not provided by . . .’’) narrowly provides § 507.53(a)). suitable for validation activities due to exceptions only for validation of (Comment 325) Some comments ask the nature of the activity or previous sanitation controls, supplier controls, us to separate requirements for validation by another entity (e.g., a and the recall plan, whereas the validation from requirements for supplier). preamble discussion provides other verification because verification and (Response 326) The 2013 proposed examples of preventive controls that validation are two different concepts preventive controls rule for animal food would not require validation (i.e., and combining them is confusing. One would not have required the validation zoning, training, preventive comment said that we reversed the of all preventive controls. For example, maintenance, and refrigerated storage). definitions of validation and we specifically proposed that the These comments also assert that verification, compared to the common validation of preventive controls need although the regulatory text specifies use of the terms in HACCP activities. not address sanitation controls and the that validation requirements apply ‘‘as Some comments point out that while recall plan. To emphasize that a facility appropriate to the nature of the section 418(f)(1) of the FD&C Act has flexibility in determining which preventive control,’’ that phrase could explicitly requires verification, it does other preventive controls require be interpreted to mean that only the not require validation. Some of these validation, in the 2014 supplemental validation act itself can be tailored and comments assert that our proposed notice we revised the proposed that the facility does not have the requirements for validation exceed the regulatory text to require validation ‘‘as flexibility to conclude that validation mandate of FSMA while others argue appropriate to the nature of the isn’t necessary. that the lack of explicit language in preventive control.’’ See Response 324 Some comments assert that the section 418 of the FD&C Act gives us for additional revisions we have made proposed regulatory text would prevent legal flexibility in determining whether to the regulatory text to provide us from requiring validation of specific and how to require validation. flexibility for a facility to determine that sanitation controls where it may be (Response 325) Our approach is validation is not necessary. prudent to do so, either now or in the consistent with section 418 of the FD&C (Comment 327) Some comments ask future as a result of a newly identified Act. Section 418(f)(1) of the FD&C Act us to allow validation of the whole hazard, or the development of a tool, requires verification of the preventive system instead of individual controls. such as a test method, that would enable controls, and validation is an element of (Response 327) See the discussion of validation of the control for the specific verification (see both the NACMCF the definition of validation in Response hazard. HACCP guidelines (Ref. 49) and our 75. Under the definition, validation can (Response 324) We have deleted HACCP regulation for juice (§ 120.3(p)). be directed to a control measure, ‘‘except as provided by paragraph (b)(3) We agree that the purpose of validation combination of control measures, or the of this section’’ from proposed is different from the purpose of other food safety plan as a whole. § 507.47(a) to remove the limitation seen verification activities, and we have (Comment 328) Some comments ask by the comments on the exceptions to revised the definitions of both terms to us to align validation requirements with the requirement for validation of make this clearer. Although we are the relative risk of operations. preventive controls. We also have establishing a separate regulatory (Response 328) Validation revised the regulatory text of § 507.47(c) section for the validation requirements, requirements apply only to preventive to provide that a facility does not need we did so to improve clarity and controls that are established and to validate other preventive controls, if readability rather than as a substantive implemented based on the outcome of a the preventive controls qualified change relevant to the issues discussed hazard analysis, which requires individual prepares (or oversees the in these comments. (See Response 75.) consideration of risk. We also require

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validation as appropriate to the nature with the FSPCA we are obtaining note that the seasonal nature of of the preventive control and its role in technical information useful for production of some food products may the facility’s food safety system. This developing guidelines for preventive make it impractical to perform all provides flexibility with respect to controls and outreach to industry, and required validations within 6 weeks. validation and allows consideration of we intend that effort to include Some comments suggest that validation risk. guidance on approaches to satisfy the be performed within a specified number (Comment 329) Some comments ask validation requirements of the rule. We of production batches, such as 10 us to provide guidance and clarification do not intend to develop a mechanism production batches. Some comments on topics relevant to validation, for certification of process authorities or emphasize the need for flexibility and especially for small facilities that may establish a liaison between FDA and ask us to both adopt a 90-day timeframe lack the resources needed to generate industry to ensure validation protocols and provide for a longer timeframe with studies and scientific data to validate are in compliance. The guidance we are a written justification, or provide for processes. Some comments ask us to developing on validation should help ongoing evidence of process validation. clarify our expectations for a validated industry determine whether their One comment recommends removing a process and on conducting studies for validation approaches are likely to be required timeframe for validation or validation purposes. Some comments acceptable to us. providing a compliance extension until ask us to provide resources for such time as we could better support the validation, noting that some preventive B. Proposed § 507.47(b)(1)—When Validation Must Be Performed and Role requirements, such as in guidance. One controls will be difficult to validate and comment asserts that the timeframe that no scientific research or data are of Preventive Controls Qualified Individual in Validation should be prior to implementation of available for certain controls. Some the food safety plan. Some comments comments indicate that validation We proposed that validation of the ask as us to specify that validation be information provided by FDA should be preventive controls must be performed performed within a reasonable time as in the form of non-binding guidance by (or overseen by) a preventive controls justified by the preventive controls documents. Some comments ask us to qualified individual prior to qualified individual. Some comments delay enforcement for the validation implementation of the food safety plan ask for more time for small businesses requirements until a readily accessible (or, when necessary, during the first 6 to perform validation studies. repository of validated processes, and weeks of production) and whenever a (Response 332) We note that the 90- scientific and technical information, can reanalysis of the food safety plan reveals be created to assist stakeholders in the need to do so. day timeframe for validation is complying with the validation (Comment 331) Some comments ask established in FSIS’ regulations at 9 CFR requirements. us to clarify whether an individual 304.3(b) and (c) and 9 CFR 381.22(b) (Response 329) We intend that the attending food safety training by an and (c) (Conditions for receiving guidance we are developing will entity such as a cooperative extension or inspection for meat and meat products address topics such as those a State department of agriculture could and poultry and poultry products, recommended in the comments. (See be a ‘‘preventive controls qualified respectively). The FSIS Validation Response 1). In addition, the FSPCA is individual’’ for the purpose of Guidelines are a companion to those developing information for training, performing or overseeing the validation regulations. We have revised the which may be useful to animal food of preventive controls. regulatory text, with associated editorial facilities. We are not requiring facilities (Response 331) See the discussion in changes, to make two changes to the to comply with the requirements of section XXXVII.B for additional proposed 6-week timeframe for subparts C and E of this rule, including information about training applicable to validation of preventive controls. First, the validation requirements, for 2, 3, or a preventive controls qualified we have adopted the 90-day timeframe 4 years depending on the size of the individual. We have not specified already established in the FSIS’ facility. We expect that segments of the additional requirements for a preventive regulations by specifying that when animal food industry will work together controls qualified individual with necessary to demonstrate the control and with the FSPCA to develop respect to validation. A person may be measures can be implemented as scientific and technical information that a preventive controls qualified designed, validation may be performed can be used as evidence to validate a individual through job experience, as within 90 days after production of the variety of preventive controls, and will well as training. Food safety training applicable animal food first begins. be helpful to facilities. provided by an entity such as a Although we had proposed a 6-week (Comment 330) Some comments cooperative extension specialist or a timeframe based on the 3 to 6 week indicate that the rule lacked State department of agriculture could be timeframe suggested in the Codex specifications for, and was unclear on, appropriate training for many of the Guidelines for the Validation of Food the process that FDA would utilize to functions of the preventive controls Safety Control Measures (Ref. 22), we approve or accept validation data and/ qualified individual if the training is agree that practical limitations or studies. Some comments ask us to consistent with the standardized associated with the production of some develop a mechanism for industry to curriculum being developed by the animal food products may make it make sure their approach and studies FSPCA. difficult to perform validation within 6 meet the requirements of the rule, such (Comment 332) Some comments weeks. The 90-day timeframe in FSIS’ as certification of process authorities or question whether 6 weeks is enough regulations, and incorporated into the the establishment of a liaison between time to perform all applicable validation FSIS Validation Guidelines, reflects FDA and industry to ensure validation studies that would address the more than 15 years of experience with protocols are in compliance. execution element of validation. Some validating HACCP systems for meat and (Response 330) As discussed in comments ask us to explain the basis for poultry. Although we have provided for Response 1, we are developing several the proposed 6-week timeframe. Some validation to be performed within 90 guidance documents within FDA, comments ask us to align with the 90- days after production of the applicable including guidance on validation. In day timeframe in the FSIS Validation food first begins, we do not believe it addition, as part of a collaborative effort Guidelines (Ref. 50). Some comments would take a full 90-days of production

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to determine whether the facility can after production begins (to demonstrate might be intended, or could be provide assurances that a control the control measures can be interpreted, to mean that firms are measure is working as intended to implemented as designed during full- required to develop or validate control the hazard. scale production), or both. analytical methods (either in general or Second, we have provided for for specific food matrices). These C. Proposed § 507.47(b)(2)—What validation within a reasonable comments assert that any such Validation Must Include timeframe, provided that the preventive requirement would incur extreme costs controls qualified individual prepares We proposed that the validation of and burdens without delivering (or oversees the preparation of) a written preventive controls must include commensurate public health benefits. justification for a timeframe that collecting and evaluating scientific and (Response 338) We do not intend the exceeds 90 days after production of the technical information (or, when such requirement to ‘‘conduct studies’’ to applicable animal food first begins. We information is not available or is mean that firms are required to develop acknowledge that practical limitations inadequate, conducting studies) to or validate analytical methods. such as those described in the determine whether the preventive (Comment 339) Some comments comments could prevent a facility from controls, when properly implemented, recommend validation via indirect performing the validation within 90 will effectively control the significant methods such as scientific publications, days after production of the applicable hazards. government documents, predictive animal food first begins. A timeframe (Comment 335) Some comments modeling and other technical that exceeds 90 days after production of assert that our discussion of validation information from equipment the applicable animal food first begins refers to ‘‘scientific proof’’ for the manufacturers and other sources. Other will be the exception rather than the validation of a processing step and ask comments assert that there are a variety norm and we are requiring that the us to define what is and is not of circumstances in which the collection preventive controls qualified individual considered scientific proof for and evaluation of scientific and provide (or oversee the preparation of) validation. technical information is not necessary a written justification for such a (Response 335) We used terms such as (e.g., the use of sieving or metal timeframe. We made a conforming ‘‘scientific and technical information’’ detectors to control physical hazards). revision to the list of responsibilities of and ‘‘scientific and technical basis’’ (Response 339) See Responses 324 the preventive controls qualified rather than ‘‘scientific proof’’ when and 326. We agree that not all individual (see § 507.53(a)). discussing validation. For information preventive controls require validation, (Comment 333) Some comments ask about what we mean by ‘‘scientific and and the facility has flexibility to take us to add another circumstance when technical information,’’ (see 78 FR into account the nature of the validation would be required, i.e., 64736 at 64794 through 64795). preventive control when determining whenever a change is made to the (Comment 336) Some comments ask whether to perform validation. The control being applied. us to clarify expectations of validations regulatory text, which provides for (Response 333) We have revised the for basic sanitary processes. Another scientific and technical evidence that a regulatory text to require validation comment asks us to exempt the control measure is capable of effectively whenever a change to a control measure validation of CGMPs. controlling the identified hazards, or combination of control measures (Response 336) The requirements for provides for the use of ‘‘indirect could impact whether the control validation only apply to preventive methods’’ as recommended by the measure or combination of control controls. Any practice governed by comments. However, even when sources measures, when properly implemented, CGMPs only requires validation if a such as scientific publications are the will effectively control the hazards facility identifies that practice as a basis for validation, studies may be requiring a preventive control. Under preventive control for a hazard. To the needed to demonstrate that the process this provision, a facility would extent that the comment is referring to used can be implemented in the facility revalidate a preventive control if, for sanitary practices governed by CGMPs to control the hazard. example, a different type of equipment (such as in § 507.19), the validation is used to deliver a heat process, requirements would not apply. To the D. Proposed § 507.47(c)(3)—Preventive because it would be necessary to extent that the comment is referring to Controls for Which Validation Is Not determine that the new equipment can sanitation controls established as a Required consistently achieve the required preventive control, those sanitation We proposed that validation need not temperature and time of the process. controls are excluded from the address sanitation controls, the recall However, a facility would not need to validation requirements (see plan, and the supplier program (which revalidate a preventive control if, for § 507.47(c)). we now refer to as the ‘‘supply-chain’’ example, a thermal process is changed (Comment 337) Some comments ask program). by increasing the time or temperature, that we not require further validation of (Comment 340) Some comments ask because a less stringent thermal process well-accepted preventive controls, such us to eliminate the specific list of would already have been validated. as refrigeration temperature. controls that are excluded from the (Comment 334) Some comments ask (Response 337) A facility may rely on validation requirement and instead us to require validation both before generally available scientific and revise the regulatory text to provide the production and 6 weeks after technical information to demonstrate facility with flexibility to determine production begins. the adequacy of controls such as when validation is appropriate. (Response 334) We decline this refrigeration but must obtain that (Response 340) As discussed in request. A facility has flexibility to information and establish it as a record Response 324, we have deleted ‘‘except perform validation as appropriate to the (see § 507.45(b)). as provided by paragraph (b)(3) of this nature of the preventive controls, (Comment 338) Some comments section’’ from proposed § 507.47(a) to whether before production (e.g., by express concern that specific methods remove the limitation seen by the obtaining and evaluating generally are not available to enable validation. comments on the exceptions to the available scientific and technical Some comments express concern that requirement for validation of preventive information or by conducting studies), the requirement to ‘‘conduct studies’’ controls. We also have revised the

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regulatory text of § 507.47(c) to provide prevent a facility from validating one of implement written procedures for the that a facility does not need to validate these preventive controls, such as a frequency of calibrating process other preventive controls, if the sanitation control, if it chooses to do so. monitoring instruments and verification preventive controls qualified individual XXXIV. Subpart C: Comments on instruments, product testing, and prepares (or oversees the preparation of) Proposed § 507.49—Verification of environmental monitoring. a written justification that validation is Implementation and Effectiveness Some comments that support the not applicable based on factors such as We proposed that you must verify that proposed provisions suggest alternative the nature of the hazard, and the nature the preventive controls are consistently or additional regulatory text or ask us to of the preventive control and its role in implemented and are effectively and clarify how we will interpret the the facility’s food safety system. We see significantly minimizing or preventing provision. In the following paragraphs, no reason to also eliminate the list of the significant hazards. We proposed we discuss comments that ask us to those controls for which we have that to do so you must conduct specified clarify the proposed requirements or already determined that validation is activities (i.e., calibration, product that disagree with, or suggest one or not necessary, and require each facility testing, environmental monitoring, and more changes to, the proposed to develop its own rationale for review of records) as appropriate to the requirements. After considering these concluding that validation is not facility, the animal food, and the nature comments, we have revised the necessary based on the nature of these of the preventive control. We also proposed requirements as shown in preventive controls. The rule would not proposed that you must establish and table 18.

TABLE 18—REVISIONS TO THE PROPOSED REQUIREMENTS FOR VERIFICATION OF IMPLEMENTATION AND EFFECTIVENESS

Section Description Revision

507.49(a) ...... Flexibility in the requirement to Provide that activities for verification of implementation and effective- conduct activities to verify imple- ness take into account both the nature of the preventive control mentation and effectiveness. and its role in the facility’s food safety system. 507.49(a)(1) ...... Verification of implementation and Provide for accuracy checks in addition to calibration. effectiveness for process moni- toring instruments and verification instruments. 507.49(a)(4)(i) ...... Timeframe for review of records of Provide for records review within 7 working days after the records are monitoring and corrective action created, or within or within a reasonable timeframe, provided that records. the preventive controls qualified individual prepares (or oversees the preparation of) a written justification. 507.49(a)(5) ...... Other activities appropriate for Clarify that there could be alternative verification activities of imple- verification of implementation mentation and effectiveness other than those that we specify in the and effectiveness. rule. 507.49(b) ...... Written procedures for verification Clarify that written procedures for verification of implementation and of implementation and effective- effectiveness are established and implemented as appropriate to ness. the role of the preventive control in the facility’s food safety system, as well as appropriate to the facility, the animal food, and the na- ture of the preventive control. 507.49(b)(1) ...... Written procedures for verification Require written procedures for accuracy checks in addition to calibra- of implementation and effective- tion. ness for process monitoring in- struments and verification instru- ments.

A. Flexibility in the Requirement To monitoring) in a manner that works best frequency. One comment says the Conduct Activities To Verify for the facility in light of its animal food provision will have limited value where Implementation and Effectiveness products and the nature of the the presence of some levels of pathogens We proposed that you must verify that preventive controls that would be is expected and is not necessarily an the preventive controls are consistently verified. In sections XXXIV.B through animal food safety problem. Some implemented and are effectively and XXXIV.F, we discuss the requirements comments agree with the proposed significantly minimizing or preventing for calibration, product testing, provisions because they address product the significant hazards by conducting environmental monitoring, and review testing through flexible written specified activities as appropriate to the of records more specifically. procedures that consider both testing facility, the animal food, and the nature (Comment 341) Some comments and corrective action plans rather than of the preventive control. We proposed express support for the flexibility through mandatory or prescribed to specify the following verification provided by specifying that verification requirements. Other comments agree activities: (1) Calibration; (2) product activities must be conducted ‘‘as with the proposed provisions because testing; (3) environmental monitoring; appropriate to the facility, the animal they require facilities to develop and and (4) review of records. food, and the nature of the preventive use testing programs that are tailored to In the following paragraphs, we control.’’ Some comments state that the their facility, equipment, processes, discuss comments generally directed to proposed provision means that, based products, and other specific the need for a facility to have flexibility on risk, an animal food manufacturer circumstances, and do not prescribe to apply these requirements could decide whether or not to do specific requirements for testing, such (particularly the requirements for product testing and, when applicable, as finished product testing. Some product testing and environmental the type of test and the testing comments state that product testing may

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not be effective in identifying the hazard and such facilities could focus animal food after a pathogen ‘‘kill step’’ acceptability of a specific ingredient or their resources on other controls. One must be tested before use when the raw finished product lot on any given day, comment says it does not agree that the material or other ingredient has been but it can help assess and verify the potential for later processing mitigates associated with a pathogen and has not effectiveness of a food safety plan as a the need for environmental monitoring been treated to significantly minimize or whole and the facility’s capability to because processes such as pelleting prevent that pathogen (e.g., poultry consistently deliver against it. reduce but do not entirely eliminate based flavoring spray applied on dry pet Some comments assert that the pathogens. food). Product testing would be required preamble discussion in the 2014 (Response 341) The provisions for because it is appropriate to the facility supplemental notice is in conflict with verification provide flexibility by (one making an animal food), the food the proposed regulatory text and ask us specifying that they apply as (pet food), and the nature of the to modify the regulatory text to provide appropriate to the nature of the preventive control (there is no control the flexibility we signaled in that preventive control and its role in the applied to the poultry based flavoring supplemental notice. These comments facility’s food safety system. As noted spray). express concern that the term ‘‘must’’ by some comments, the provisions When process control testing for an (i.e., ‘‘you must conduct activities that address testing through flexible written indicator organism, or environmental include the following’’) could be procedures that allow facilities to monitoring for an indicator organism, interpreted to mean that activities listed develop and use testing programs that indicates an animal food (e.g., dry pet in the regulatory text (in particular, are tailored to their facility, equipment, food) is reasonably likely to be product testing and environmental processes, products, and other specific contaminated with a pathogen, that monitoring) are always required in some circumstances. We agree that an animal food must be tested for the form. Some comments ask us to clarify appropriate outcome of the hazard pathogen. For example, if whether product testing and analysis for some facilities will be that environmental monitoring reveals environmental monitoring are required product testing and environmental animal food-contact surfaces or optional. Other comments assert that monitoring are not required; it is not contaminated with Salmonella and facilities should have the flexibility to necessary to grant an ‘‘exemption’’ to additional environmental monitoring determine whether to conduct product allow a facility to achieve this outcome. following corrective actions indicates testing and environmental monitoring For example, environmental monitoring animal food-contact surfaces are still based on a risk assessment. Some would be required to verify contaminated with Salmonella, product comments assert that there are effectiveness of sanitation controls testing would be required because it is circumstances (such as unpackaged when an animal food is exposed to the appropriate to the facility (one making animal food; ingredients for animal food environment prior to packaging and the that animal food), the animal food (pet stored in vented or open areas, in packaged food does not receive a food, which supports the growth of oilseed production; and rendering) treatment or otherwise include a control Salmonella), test results from where these tests would not be measure (such as a formulation lethal to environmental monitoring (which show necessary. Some comments assert that a the pathogen) that would significantly the presence of an indicator organism determination to conduct environmental minimize the pathogen because such for Salmonella on animal food-contact monitoring should be on a case-by-case environmental monitoring is surfaces in the animal food processing basis and that other verification appropriate to the facility (one environment), and the nature of the activities may be used (such as process manufacturing animal food), the food preventive control (sanitation controls verifications or testing of intermediates) (such as a dry (extruded) pet food to prevent contamination by to verify implementation and exposed to the environment), and the environmental pathogens, which appear effectiveness. Other comments ask us to nature of the preventive control to be inadequate). exempt operations when their hazard (sanitation controls). Animal food such The word ‘‘must’’ specifies the type of analysis appropriately concludes that as dry and raw pet food and pet treats activities that a facility can use to satisfy there is no foreseeable risk. One are among the products for which the requirements for a particular comment says FDA should not require manufacturing operations might need to preventive control management routine monitoring for feed mills unless have an environmental monitoring component, and we are retaining the they manufacture pet food. program when such animal food is term ‘‘must.’’ However, we agree that One comment says environmental exposed to the environment. the rule should provide flexibility for monitoring should not be required as a We discuss product testing for additional verification of verification activity for significant microbial pathogens in another FDA implementation and effectiveness. To hazards as other controls can be used memorandum, including the use of provide that additional flexibility, we and environmental monitoring will pathogens and indicator organisms and have revised the specific requirements impose undue burdens and costs to microbial testing of foods for process for verification of implementation and industry. Many comments state that control and for problem solving (Ref. effectiveness to provide for other environmental monitoring requirements 52). The circumstances in which activities appropriate for verification of should only be applied to ‘‘significant product testing would be required are implementation and effectiveness (see hazards,’’ if any, that are present within dependent on a variety of factors as § 507.49(a)(5)). the firm’s operation, and as with described in the Appendix to the 2013 We believe that the performance of product testing, animal food facilities proposed preventive controls rule for environmental monitoring, for an must be provided the flexibility to tailor animal food (78 FR 64736 at 64836). As appropriate microorganism of public their environmental monitoring with environmental monitoring, product (human and animal) health significance programs based on risk. Comments note testing must be conducted as or for an appropriate indicator that in cases where the animal food is appropriate to the facility, the animal organism, is particularly useful as a likely to undergo further processing that food, and the nature of the preventive verification measure for preventive would minimize or eliminate any control and its role in the facility’s food controls (i.e., sanitation controls) when microbiological hazards, environmental safety system. For example, a raw contamination of animal food with an pathogens would not be a significant material or other ingredient added to an environmental pathogen is a hazard

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requiring a preventive control. We requirements in the most effective and monitoring or product testing would not anticipate that facilities producing efficient manner using a risk-based be warranted. If a facility relies on its animal food that enters into the home approach and taking into account the customer to control an environmental and is frequently handled in the home specific conditions of their facilities and pathogen then the facility must follow will include biologic hazards of human operations. Some comments express the requirements in subpart E for health concerns associated with that concern that including a requirement supply-chain program. Moreover, the animal food, as well as those of animal makes it difficult for businesses to fact that further manufacturing might be health concerns in their hazards justify a conclusion that testing is not capable of eliminating an environmental requiring a preventive control. (See, for necessary. pathogen that has contaminated an example, our discussion of Salmonella Some comments ask us to solicit animal food is not a reason to not take in pet food in the 2013 proposed drafts of proposed guidance documents reasonable measures to prevent preventive controls rule for animal food from the sustainable agriculture and contamination from the environment (78 FR 64736 at 64747).) local/regional food system community; and to verify that such measures are (Comment 342) Many comments ask publish a list of possible topics for effective through environmental us to issue guidance, rather than future guidance each year; seek input in monitoring. requirements, for product testing and advance from the sustainable agriculture We have acknowledged limitations of environmental monitoring based on and local/regional food system product testing (79 FR 58476 at 58493 concerns such as the following: The community before preparing draft through 58494) and agree that a facility value of environmental monitoring will guidance (including public meetings, should consider such limitations when be reduced if it becomes a minimum workshops, and formation of an determining whether to conduct regulatory requirement; there are well- advisory committee); hold public product testing and keep such known limitations to product testing meetings on draft guidance after limitations in mind when obtaining and negative results from product publication; and present draft guidance negative results from product testing. testing can create a false sense of to an advisory committee including We also agree that product testing is not security; negative results are likely to representatives from the sustainable preventive. However, the mere facts that occur unless intensive sampling is agriculture and local/regional food there are limitations, and that product conducted dependent upon quality system community. testing is itself not a preventive sampling criteria; product testing is not Some comments suggest that an measure, do not eliminate all benefits of preventive, would put industry into a ingredient manufacturer may identify an product testing; we agree with reactive mode, and would pull valuable environmental pathogen but the facility comments that although product testing resources from activities focused on would not implement a preventive may not be effective in identifying the preventing contamination; there is control to significantly minimize or acceptability of a specific ingredient or limited technology available to test prevent the environmental pathogen finished product lot on any given day, contaminants in some animal food because the ingredient would be it can help assess and verify the matrices and limited time available for subsequently processed to control the effectiveness of a food safety plan as a perishable commodities; any regulatory hazard by another facility. whole and the facility’s capability to requirement will soon be outdated as (Response 342) We are retaining the consistently deliver against it. We agree products change and science improves; requirements for product testing and that there is limited technology and product testing would vastly environmental monitoring in the rule, available to test for some hazards in increase the cost of the rule and will with the revisions, already discussed, to animal food but expect that testing of drive many businesses out of business provide that verification activities animal food by a facility as the sole without necessarily improving animal depend on the role of the preventive verification of the effectiveness its food food safety; and requirements for control in the facility’s food safety safety plan as a whole would be the product testing would require the States system (see Response 293); corrective exception rather than the norm. to direct resources to respond to non- action procedures depend on the nature We disagree that regulatory compliant product testing results, and of the hazard (see Response 304); and requirements for product testing and such resources would be better directed written procedures for product testing environmental monitoring will soon be to environmental monitoring. and environmental monitoring are outdated as products change and Some of these comments emphasize established and implemented as science improves; the rule requires the need for flexibility so that product appropriate to the role of the preventive reanalysis of the food safety plan as a testing and environmental monitoring control in the facility’s food safety whole at least every 3 years, and are options that are available to the system. These revisions clarify in the requires reanalysis of the food safety facility rather than requirements for all regulatory text the flexibility that we plan as a whole, or the applicable facilities. Other comments assert that discussed in the 2014 supplemental preventive control, in light of new guidance provides greater opportunity notice (79 FR 58476 at 58493 through information (see § 507.50(a) and (b)). We for industry innovation and stakeholder 58495). Some of the comments that ask agree that there are some costs to participation to determine the us to issue guidance rather than product testing, but the rule provides appropriate use of verification requirements appear to believe that only flexibility for the facility to determine measures, and avoids a ‘‘one-size-fits- guidance can provide sufficient when product testing is appropriate. We all’’ approach to regulations. Some of flexibility for product testing and acknowledge that the States will be these comments state that we should environmental monitoring. This is not required, in many cases, to follow up on encourage environmental monitoring to the case. (See Response 341.) positive findings obtained during be conducted ‘‘through facility specific We disagree that environmental product testing but disagree that this is food safety plans,’’ which would monitoring will become a minimum a reason to eliminate the proposed provide the flexibility necessary to regulatory requirement in all cases; the requirements. The States would only be monitor risks associated with exposures decision to conduct environmental directing resources when the findings of animal foods. Other comments state monitoring is made by the facility and indicate contamination of animal food, that operators should be given the some comments discuss specific and doing so will protect public (human necessary flexibility to implement any examples of when environmental and animal) health.

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We will follow the procedures in measurement devices, and the strategies; and criteria for laboratories § 10.115 for issuing guidance appropriate corrective action may be conducting the testing. documents. Under § 10.115(f), members replacement or application of corrective (Response 345) We decline to revise of the public can suggest areas for values. These comments ask us to the regulatory text. The decision as to guidance document development and specify that an accuracy check may be whether product testing and submit drafts of proposed guidance used as a verification activity in lieu of environmental monitoring are documents for FDA to consider. Under calibration. warranted depends on the facility and § 10.115(g), after we prepare a draft (Response 344) We have revised the its animal food product, as well as the guidance we may hold public meetings proposed requirements to require nature of the preventive control and its or workshops, or present the draft calibration of process monitoring role in the facility’s food safety system, guidance document to an advisory instruments and verification and a slight variation on circumstances committee for review; doing so is not instruments, or checking them for that would lead one facility to conclude common and is determined on a case- accuracy. However, if the outcome of an that such testing programs were not by-case basis. accuracy check is that a process required could lead a different facility to (Comment 343) One comment monitoring instrument or verification the opposite conclusion. Memoranda requests that we add the additional instrument is not accurate, the facility placed in the docket for the 2014 factor of the ‘‘intended use of the animal must follow up by calibrating the preventive controls supplemental notice food’’ to help further clarify that these device, rather than by applying for human food provide additional activities should be conducted based corrective values, when it is practical to information on these topics requested in upon the appropriate end use of the do so and replace the device when it is the comment (Refs. 51 and 52). animal food as it was intended by the not practical to calibrate it. Although directed to product testing manufacturer, and not upon any and environmental monitoring for potential use of the product not C. Comments Directed to Proposed human food production, some of the originally intended. Requirements for Both Product Testing information is relevant to animal food, (Response 343) We believe the (Proposed § 507.49(a)(2) and (b)(2)) and as well. requirement as written allows the Environmental Monitoring (Proposed (Comment 346) Some comments ask manufacturer’s intended use to be taken § 507.49(a)(3) and (b)(3)) us to clarify that tests can be performed into consideration when conducting the by third-party facilities or laboratories, We proposed that to verify that the hazard analysis. However, to the extent as well as by the facility itself. Some preventive controls are consistently that these comments are asserting that a comments ask us to clarify that we will implemented and are effectively and facility can ignore consumer behavior accept test results in the same format as significantly minimizing or preventing that the facility considers contrary to the format used for other purposes, such principles of food safety, we disagree. the significant hazards you must as third-party certification services. For example, a facility could not conduct activities that include product (Response 346) The rule places no conclude that it need not identify and testing and environmental monitoring, restrictions on who conducts testing. evaluate a known or reasonably as appropriate to the facility, the animal However, facilities have a responsibility foreseeably hazard because the facility food, and the nature of the preventive to choose testing labs that will produce intends to provide safe handling control (§ 507.49(a)(2) and (a)(3)). We reliable and accurate test results. (See instructions on the label of a packaged also proposed that you must establish Response 348.) The rule does not pet food. We do recognize that if a and implement written procedures for specify the format of test results, manufacturer/processor has adequately product testing and for environmental provided that the record documenting controlled a hazard and has properly monitoring (§ 507.49(b)(2) and (b)(3)). testing satisfies the recordkeeping packaged, held, and labeled their (Comment 345) Some comments ask requirements of subpart F. product, they are not responsible for us to revise the regulatory text to be (Comment 347) Some comments unforeseeable misuse by a consumer, explicit that there are circumstances express concern about requirements for such as a person who intentionally when product testing and product testing and environmental feeds swine food to sheep even though environmental monitoring would not be monitoring in light of section 202 of the product is accurately labeled as necessary. One comment supports a FSMA (section 422 of the FD&C Act (21 containing copper which can be toxic requirement that incoming raw U.S.C. 350k)). (Section 422 of the FD&C for sheep. For manufacturers/processors materials and feed ingredients must be Act addresses laboratory accreditation that rely on their customer or another tested for harmful pathogens. Another for the analyses of foods, including use entity in the distribution chain to the comment opposes mandatory product of accredited laboratories in certain control a hazard, they must follow the testing for every lot of raw material circumstances and including requirements in § 507.36(a)(2), (3), (4) or received. Some comments discuss requirements for accredited laboratories (5). (See Response 285 for additional topics for us to include in guidance on to report the results of laboratory testing information.) procedures for product testing and to FDA in certain circumstances.) These environmental monitoring, such as comments express concern that B. Proposed § 507.49(a)(1)—Calibration which pathogens to test for; the range of requirements for facilities to submit We proposed to require calibration of products that should be tested; results of environmental monitoring to process monitoring instruments and circumstances that warrant testing; what us will create an additional disincentive verification instruments. a facility would document and what to looking for pathogens established in (Comment 344) Some comments factors the facility would consider the facility. These comments assert that distinguish ‘‘calibration’’ from an before determining that product testing the results of environmental monitoring accuracy check, which the comments is not appropriate for its animal food tests should be available to us for describe as a test to confirm that a product; frequency of sampling and inspection but not submitted to us if particular equipment or measurement number of samples to be collected; product has not been distributed and device is accurate. These comments actions to take after a positive result; that submitting the results of routine assert that calibration may not be available test methods; reporting tests would be burdensome without possible for certain equipment or requirements for results; compliance benefit. These comments ask us to

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clarify whether facilities or laboratories environmental monitoring and that the finished animal foods are exposed to the would be required to submit the results procedures for such testing be environment after undergoing a process of environmental monitoring tests to us. scientifically valid. One way to comply aimed at reducing pathogens (e.g., a heat Likewise, some comments ask us to with the requirement that testing kill step such as rendering or the clarify whether product testing procedures be scientifically valid is to extrusion process) or other hazards that (including testing of raw materials or use an accredited laboratory. could be transmitted through the other ingredients as part of supplier (Comment 348) Some comments ask environment. These comments say controls) is subject to the requirements us to expand the proposed requirement processing aimed at reducing hazards of section 422 of the FD&C Act for using to identify the laboratory conducting the will be ineffective if pathogen loads or accredited laboratories and for reporting testing to also specify whether that hazard levels going into the processing test results to us. Other comments ask laboratory is accredited and uses the are too high and are concerned that the us to establish standards and procedures appropriate standards (such as quality proposed rule would not require for certifying laboratories that would control, proficiency testing, and trained renderers, who often handle sick and perform the tests. These comments laboratory staff). These comments assert dead animals, to make sure that the assert that these standards and that such information would be useful plant environment is not a pathway for procedures are needed to ensure the to facilities. the recycling of pathogens into the credibility of the testing and to provide (Response 348) We decline this animal food system through direction for facilities that establish in- request. These comments appear to be contaminated animal products. Many house testing facilities. Other comments asking us to establish in the preventive comments state that all finished animal urge us to establish regulations controls for animal food rule food is ready to eat whether or not it is implementing section 422 of the FD&C requirements related to section 422 of packaged, so it is not reasonable to limit Act because they would complement the FD&C Act. Doing so in advance of environmental monitoring only to the requirements of the animal food regulations implementing section 422 of animal foods that may be packaged. the FD&C Act is premature. However, preventive controls rule and because (Response 350) We do not expect model laboratory standards that address facilities have a responsibility to choose testing labs that will produce reliable either product testing or environmental quality controls, proficiency testing, monitoring to be common in facilities training and education of laboratory and accurate test results even if the rule that process, pack, or hold RACs for personnel offer the protections does not require the facility to specify animal consumption. We agree that necessary for ensuring reliable, accurate whether the laboratory is accredited. there would be little or no benefit to test results. Other comments assert that (Comment 349) One comment product testing or environmental if laboratories are not accredited or requested the FSMA regulations monitoring in facilities that pack or hold samples are not collected in a sanitary regarding ISO methods for Listeria and RACs that are rarely consumed manner, there is no guarantee the results Salmonella be changed to using BAM unprocessed, such as soybeans, or for a will be scientifically valid. (Bacteriological Analytical Manual) (Response 347) Section 422 of the methodology. manufacturer/processor that will rely on FD&C Act would require, in relevant (Response 349) While we require its customer or another entity in the part, that food testing be conducted by scientifically valid procedures for distribution chain to control a hazard as an accredited laboratory (and the results testing, the rule does not specify a specified in § 507.36(a)(2), (3), and (4). of such testing be sent directly to FDA) particular method be used. A laboratory We expect that many facilities that whenever such testing is conducted in could use an FDA BAM method, an ISO conduct operations such as drying grain response to a specific testing method, or another method that is are likely to conclude, as a result of requirement under the FD&C Act or its validated in the relevant animal food their hazard analysis, that neither implementing regulations when applied matrix. product testing nor environmental to address an identified or suspected (Comment 350) Some comments say monitoring are warranted and would animal food safety problem or to that there is little scientific data to show direct their resources to food safety support admission of an animal food environmentally exposed animal food, practices and verification measures under an Import Alert that requires food such as raw liquid ingredients and other than environmental monitoring or testing. Although another rulemaking finished liquid animal food products, as product testing. While a hazard analysis will address the requirements of section well as food for livestock creates a must include an evaluation of 422 of the FD&C Act, our current potential for harmful biological hazards environmental pathogens when animal thinking is that routine product testing and an evaluation of environmental food is exposed to the environment and environmental monitoring pathogens should not be required as prior to packaging and the animal food conducted as a verification activity is part of the hazard analysis. Other does not include a control measure that not being applied to address an comments point out it is common would significantly minimize the identified or suspected animal food practice to store ingredients with some pathogens (see § 507.33(c)(2)), we agree safety problem that requires food testing exposure to the environment during a that holding animal food in areas and would not be subject to portion of their storage, complete exposed to the environment in some requirements to use an accredited outdoor storage is standard practice instances will present a low risk of laboratory that would submit the results both at the production facility, as well contamination from environmental to FDA. We will review the results of as where it will be consumed without pathogens. Facilities in these instances environmental monitoring and product resulting in harm. Some comments say will likely conclude there is not a testing, if any, during inspections. that mere exposure to the environment hazard requiring a preventive control. The primary concern expressed in does not inherently increase the risk of However, facilities that identify an these comments was with respect to contamination of animal food. environmental pathogen requiring a laboratories reporting results to FDA Some comments say environmental preventive control would conduct and not with use of accredited testing should only be required for environmental monitoring as laboratories. The rule requires a facility packaged animal foods and recommend appropriate to the facility, the animal to establish and implement written that environmental testing be required food, and the nature of the preventive procedures for product testing and whenever animal food ingredients or control.

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(Comment 351) Some comments product testing would play as a preventive control and its role in the express concern about the cost of testing verification activity, or as part of a facility’s food safety system. The factors and suggest creation of a one-time grant corrective action as a result of positive mentioned by the comment are program for very small businesses that findings from environmental examples of factors that a facility would would assist them in developing their monitoring, based on the facility, the consider in making its determination. initial food safety plans and testing animal food, the nature of the (Comment 355) Some comments ask programs. One comment says that preventive control, and the role of the us to revise the requirement for product segments of the animal food production preventive control in the facility’s food testing to clarify that product testing industry currently not performing these safety system. applies to significant hazards. types of activities will be challenged to (Comment 353) Some comments ask (Response 355) We decline this interpret the requirements and develop us to clarify (or specify) when product request. Product testing is a verification effective programs. The comment states testing would be directed at raw activity for a preventive control, and a that inconsistent interpretations of these materials and other ingredients and preventive control is established for a requirements by an industry fearful of when product testing would be directed ‘‘significant hazard’’ (which we now being found in violation of the rule may at finished product. Some comments refer to as ‘‘hazard requiring a lead to unnecessary testing and supplier favor testing raw materials and other preventive control’’). It is not necessary activities and needlessly drive up the ingredients as part of ‘‘product testing,’’ to repeat, for each type of verification cost of compliance. whereas other comments state that activity, that the activity applies to (Response 351) Very small businesses testing raw materials and other hazards requiring a preventive control. are qualified facilities that are subject to ingredients should be considered part of (Comment 356) Some comments modified requirements, which do not a supplier program rather than assert that the real point of product require testing or development of a food verification of implementation and testing is to test all lots or batches. safety plan. We intend that the guidance effectiveness. Other comments state that These comments explain that they we are developing will be helpful to all it is unclear what preventive control would be required to retest every lot of sizes of businesses, and particularly step would be verified by product product in order to pass an analysis of those not currently conducting these testing and what types of facilities the product on to its customers, even if activities, that are subject to the would be required to perform product testing had already been performed by requirements for product testing and testing. One comment states product their vendors (i.e., suppliers), because environmental monitoring. (See testing for animal food should solely each of their customers receives a Response 1.) focus on finished products that are proprietary blend. These comments consumed by animals in accordance further explain that it is not D. Proposed § 507.49(a)(2)—Product with their intended use as described in economically or physically possible to Testing the facility’s animal food safety plan. retest small lots of product already (Comment 352) Some comments ask (Response 353) We use the term tested by their vendors, and that the risk us to require finished product testing for ‘‘product testing’’ to mean testing any has already been mitigated by its food products designated as high-risk, animal food product, whether raw vendors. particularly when the product supports materials or other ingredients, in- (Response 356) The situation pathogen growth during its shelf life. process animal foods, or finished described by these comments appears to Other comments suggest that finished products and, thus, product testing can be a supplier-customer relationship in product or ingredient testing should be be directed to any of these animal food that the customer. not this rule, has implemented as appropriate in products. For example, testing raw established a requirement for a situations where a risk has been materials and other ingredients could be certificate of analysis for every lot of identified and an effective preventive verification of a supplier; testing in- received product. The product testing control cannot be implemented. Other process material after a kill step could that this rule requires as a verification comments ask us to require product be verification of process control; testing activity is to help assess and verify the testing if an environmental pathogen is finished product could be verification of effectiveness of a food safety plan and identified as a significant hazard. the food safety plan as a whole, and the facility’s capability to consistently (Response 352) We decline these capture a problem introduced during deliver against it, not to establish the requests. A facility’s decision to conduct manufacture, including from acceptability of every lot or batch. product testing, and to establish the contaminated raw materials and other (Comment 357) Some comments frequency of such testing, will reflect a ingredients, if raw materials and other assert product testing should primarily risk-based approach consistent with its ingredients had been tested before use. be used as a measure of process control, hazard analysis. Consequently, we Product testing generally is not the most not for acceptance testing; that product expect that facilities that produce effective means of measuring the testing should normally be viewed as a animal foods that have frequently been adequacy of cleaning and sanitation monitoring and review tool, not as a associated with outbreaks of foodborne programs, but such testing is common to product conformance verification tool. illness (in humans or animals), or track a facility’s overall hygienic The comment states testing programs for produce animal food for which an production measures. product conformance verification effective preventive control cannot be (Comment 354) Some comments should be the exception rather than the implemented, would establish product assert that a facility that implements rule. testing programs more often than supplier verification and environmental (Response 357) These comments facilities that do not produce such monitoring (or other measures) should appear to have misunderstood the animal foods. not be required to perform product proposed requirements for product A facility that identifies an testing in addition to the other controls testing. Consistent with the views environmental pathogen as a hazard and verification measures. expressed by these comments, we requiring a preventive control such as (Response 354) The facility proposed requirements for product sanitation controls would conduct determines whether product testing is testing as a verification measure of the environmental monitoring. Such a necessary as appropriate to the facility, food safety plan as a whole, not for facility would decide what, if any, role the animal food, and the nature of the product conformance.

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(Comment 358) One comment says threshold industry must meet should be (Response 360) We agree that test results, whether via voluntary developed and vetted. environmental monitoring may be company programs to verify process (Response 359) We decline these particularly relevant to pet food controls or mandated by regulation, requests. See the discussion in Response manufacturing and the majority of should not be required to be submitted 301, which explains how risk applies to environmental monitoring may occur in to FDA unless they indicate serious the facility’s hazard analysis and the dry or raw pet food manufacturing human or animal health consequences determination by the facility to establish facilities. However, its usefulness is not (i.e., necessitate a Class I recall) as is preventive controls for hazards limited exclusively to pet food required under the existing requiring a preventive control as production. Therefore, the requirement requirements for the RFR. Comments appropriate to the facility and the for environmental monitoring is flexible state that FDA inspectors should not animal food. In contrast, the to allow a facility to determine whether penalize facilities for finding potential requirements for environmental environmental monitoring is needed problems through verification if monitoring are a verification activity based on the facility, the type of animal appropriate corrective actions are taken. that a facility would conduct to verify food produced, the nature of the (Response 358) This comment appears that one or more preventive controls are preventive control for the to have misunderstood the requirements consistently implemented and are environmental hazard and its role in a for product testing, which do not effectively and significantly minimizing facility’s food safety system. include reporting product testing results or preventing the hazards requiring a We decline the request to require to FDA. However, during an inspection, preventive control and would be Salmonella testing as part of if product testing was used as a established as appropriate to the facility, environmental monitoring. We believe verification measure, the inspector may the animal food, and the nature of the that most facilities producing pet foods review the documentation for that preventive control rather than according (other than those subject to part 113 that testing and the records documenting to a risk analysis. The rule provides are exempt from subpart C with respect any corrective action procedures taken flexibility for the facility to determine to microbiological hazards regulated as a result of that testing. appropriate test methodologies and the under part 113) will identify Salmonella threshold appropriate for the spp. as a known or reasonably E. Proposed § 507.49(a)(3)— environmental pathogen being foreseeable hazard that requires a Environmental Monitoring monitored to verify the effectiveness of preventive control verified by environmental monitoring. We decline We proposed to require the facility’s preventive control. For the request to exempt livestock food or environmental monitoring, for an requirements that apply to hazards that animal food other than pet food from environmental pathogen or for an a customer of the facility, ‘‘or another the provisions for environmental appropriate indicator organism, if entity in the distribution chain,’’ will monitoring. However, we believe use of contamination of an animal food with control. See the requirements in environmental monitoring by a livestock an environmental pathogen is a § 507.36 and the discussion in section or poultry food facility as a verification significant hazard, by collecting and XXVII. of a preventive control would be the testing environmental samples. (Comment 360) Numerous comments exception rather than the norm. (Comment 359) Some comments ask request that we distinguish between us to specify that environmental production of pet food and other animal F. Proposed § 507.49(a)(4)—Review of monitoring of pathogens be executed food. Many comments state that FDA Records according to a risk analysis. Many has publically stated that it intends We proposed to require review of comments say environmental environmental monitoring to apply specified records by (or under the monitoring should be a verification tool mainly to facilities that manufacture pet oversight of) a preventive controls based on a risk assessment as different food and pet treats; however, the qualified individual, to ensure that the animals show different susceptibility to language extends the requirement to any records are complete, the activities pathogens, pathogen growth is facility that packages animal food that reflected in the records occurred in dependent upon the animal food, and does not receive a treatment to accordance with the food safety plan, pathogens grow differently in different minimize pathogens. Comments say it the preventive controls are effective, environments and seasons. Some must be made clear, through outreach, and appropriate decisions were made comments state that the corrective education, and compliance policy about corrective actions. We proposed actions for environmental monitoring guides, that the requirement to conduct to require review of records of should be risk based and take into environmental monitoring is intended monitoring and corrective action account information such as organism for a limited range of facilities, products records within a week after the records threshold, sampling, and analytical and processes, and does not apply to are made, and review of records of methodology. One comment says the livestock feed or animal food for which calibration, product testing, requirement should be applied only to environmental pathogens do not pose a environmental monitoring, and supplier ‘‘significant hazards’’ if any, that are significant hazard in the finished animal verification activities within a present within the operation. One food. Another comment expressed reasonable time after the records are comment states that it is not clear who concern because Salmonella has been made. would be responsible for environmental found in finished poultry feed. One (Comment 361) Some comments monitoring at various points in the comment says we should require assert that it is not necessary for a supply chain. The comment requests Salmonella testing as part of an preventive controls qualified individual more clarification on the ‘‘boundaries’’ environmental program. One comment to conduct or oversee review of records of responsibility for proposed measures asks us to explicitly recognize in the as a verification activity, noting that like environmental monitoring. One preamble to the final rule that review of records in another food safety comment says prior to including contamination of animal food with an regulation (i.e., the LACF requirements environmental monitoring in the environmental pathogen may be a in part 113) can be done by persons regulation, methodologies and significant hazard in many dry pet food adequately trained in recordkeeping and minimum standards that establish the manufacturing facilities. review of records.

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(Response 361) The rule does not controls qualified individual prepares further specify verification activities for preclude review of records by persons (or oversees the preparation of) a written corrective actions then we should other than the preventive controls justification for a timeframe that eliminate the proposed requirement to qualified individual, provided that the exceeds 7 working days. A timeframe review records of corrective actions. preventive controls qualified individual that exceeds 7 working days will be the (Response 364) Records are necessary provides oversight for that review. exception rather than the norm. For to document all verification activities Oversight by a preventive controls example, reviewing records before (see § 507.45(b)). The fact that the rule qualified individual is necessary release of product may be considered provides flexibility for the facility to because the review of records is critical adequate by a facility, although this may determine the verification activities for to assessing the facility’s application of be later than one week after the records corrective actions, rather than prescribes the preventive controls system and, were created. A facility may determine these verification activities, has no thus, is fundamental to ensuring its that all records for a lot of product will bearing on the requirement to document successful operation (78 FR 64736 at be reviewed after product testing or the verification activities. 64796 through 64797). Oversight by a environmental monitoring records (Comment 365) Some comments preventive controls qualified individual relevant to that lot of product are emphasize the importance of calibrating is consistent with requirements of available, which may be more than a those instruments and monitoring Federal HACCP regulations for seafood, week after monitoring records were devices that are critical to the juice, and meat and poultry (Ref. 49) (78 created. We made a conforming change preventive control, and reviewing the FR 64736 at 64796 through 64797). to the list of responsibilities of the associated records, before validation of (Comment 362) Some comments ask preventive controls qualified individual a lethality step and as frequently as us to provide for a timeframe longer to address the requirement for the necessary thereafter. These comments than 1 week (such as 7 working days) preventive controls qualified individual question whether requiring review of for review of records of monitoring and to provide (or oversee the preparation calibration records ‘‘within a reasonable corrective actions. Some comments ask of) a written justification for such a us to provide the same flexibility for timeframe (see § 507.53(a)). time’’ will be adequate. review of records of monitoring and We are not requiring that a facility (Response 365) We agree that corrective actions as we proposed for review records of monitoring and instruments and monitoring devices that review of records of calibration, product corrective actions before release of are critical to a preventive control testing, environmental monitoring, and product or that the timeframe for the should be calibrated, and calibration supplier verification activities (‘‘within review depends on the shelf life of the records should be reviewed, before a reasonable time’’ after the records are animal food. The purpose of reviewing conducting studies to validate a made), e.g., because some preventive records is not to determine whether to lethality step. However, the provision is controls may be monitored less release product. Instead, the purpose of directed at verification of frequently than is typical in a traditional reviewing records is to ensure that the implementation and effectiveness of HACCP plan dominated with CCPs. records are complete, the activities preventive controls on an ongoing basis. Some comments note that corrective reflected in the records occurred in This rule does not prescribe specific actions may not be fully implemented accordance with the food safety plan, steps that a facility must take before within 7 days and ask us to provide for the preventive controls are effective, conducting validation studies. review of these records within a week and appropriate decisions were made A facility has flexibility to or other timeframe determined to be about corrective actions. However, a appropriately determine the frequency appropriate to ensure that potentially facility will have flexibility to review of reviewing calibration records based hazardous goods do not enter records of monitoring and corrective on the facility, the animal food, and the commerce. Some comments ask us to actions within a timeframe that exceeds nature of the preventive control. We retain the 1 week timeframe for review 7 working days, such as before product agree that it would be prudent to review of records associated with perishable release, provided that the facility calibration records of those instruments foods, but to extend the timeframe to 1 provides a written justification for doing and monitoring devices that are critical month for nonperishable foods. so. Depending on the nature of the to the preventive control more Some comments state that some food record, a facility that reviews these frequently than of those instruments processors that operate on a batch types of records in a timeframe that and monitoring devices that are not production basis (rather than a exceeds 7 working days, and finds a critical to the preventive control. continuous production basis) review all problem, may be faced with recall Depending on the nature of the control records related to a particular batch all decisions for a relatively large number being calibrated, a facility that reviews at once just before release of the batch of affected lots of product. calibration records infrequently, and for distribution. These comments assert (Comment 363) Some comments ask finds a problem with calibration of that it would be inefficient, us to revise the provisions for review of process monitoring instruments and unnecessary, and needlessly records by more generally referring to verification instruments, may be faced complicated to require management to records of ‘‘verification testing (e.g., with recall decisions for a relatively review a few production records in product testing and/or environmental large number of affected lots of product. advance of the normal complete records monitoring as applicable).’’ review, particularly when laboratory (Response 363) We have revised the G. Proposed § 507.49(b)—Written testing conducted on the batch by an regulatory text to refer to records of Procedures outside laboratory takes several weeks ‘‘testing (e.g., product testing, 1. Proposed § 507.49(b)(1)—Frequency to complete. environmental monitoring).’’ of Calibration (Response 362) We have revised the (Comment 364) Some comments refer proposed requirement to require review to our request for comment on whether We proposed that you must establish of records of monitoring and corrective the regulatory text should specify the and implement written procedures for actions within 7 working days after the verification activities that must be the frequency of calibrating process records are made or within a reasonable conducted for corrective actions. These monitoring instruments and verification timeframe, provided that the preventive comments assert that if we do not instruments.

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(Comment 366) Some comments ask provisions. We disagree that we would (to establish that the sample obtained us to specify that an accuracy check interpret ‘‘scientifically valid’’ to mean adequately represents the lot of product may be used as a verification activity in that facilities are required to develop or the sample is intended to represent); lieu of calibration. These comments also validate analytical methods. We and include the procedures for sample ask us to specify that written procedures discussed our interpretation of the term quality control from field to lab. address the frequency of accuracy ‘‘scientifically valid’’ in the Appendix to (Response 368) We decline the checks, as well as calibration. the 2013 proposed preventive controls request to prescribe additional details, (Response 366) We have revised the rule (78 FR 64736 at 64834 through such as those described in these proposed requirement to specify that 64835), and noted that this comments, in the requirements for written procedures address the interpretation was consistent with our written procedures for product testing frequency of accuracy checks, as well as previous discussion of the term and environmental monitoring. As with calibration. ‘‘scientifically valid’’ (in place of other procedures required by the rule, those relating to environmental 2. Proposed § 507.49(b)(2) and (b)(3)— ‘‘validated’’) in the rulemaking to monitoring and product testing must be Product Testing and Environmental establish CGMP requirements for dietary adequate for their intended purpose. Monitoring supplements (68 FR 12158 at 12198, March 13, 2003). While validated Further, procedures will not be identical We proposed that you must establish methods are considered ‘‘scientifically in all circumstances. For example, a and implement written procedures for valid,’’ methods that have not gone facility that produces products with a product testing. We proposed that through formal validation processes but short shelf life may choose a different procedures for product testing must: (1) have been published in scientific frequency of swabbing and testing than Be scientifically valid; (2) identify the journals, for example, may also be a facility that produces products with a test microorganism(s); (3) specify the ‘‘scientifically valid.’’ We do expect long shelf life. procedures for identifying samples, methods used for testing to be adequate (Comment 369) Some comments ask including their relationship to specific for their intended use. us to provide more flexibility in product lots of product; (4) include the Although we agree that methods that testing by not requiring establishments procedures for sampling, including the are ‘‘scientifically valid’’ would also be to provide written procedures for number of samples and the sampling ‘‘technically sound,’’ we disagree that product testing and corrective action frequency; (5) identify the test(s) the hypothetical concern that we would procedures. conducted, including the analytical construe ‘‘scientifically valid’’ to mean (Response 369) These comments are method(s) used; (6) identify the ‘‘validated’’ warrants changing unclear. By requiring that a facility laboratory conducting the testing; and ‘‘scientifically valid’’ to a new term establish its own procedures, the rule (7) include the corrective action (such as ‘‘technically sound’’) in light of provides facilities with flexibility to procedures required by § 507.42(a)(1). our previous statements regarding this develop a product testing program that Likewise, we proposed that you must term and experience in the context of works best for its facility and its establish and implement written CGMP requirements. See the final rule products. We are retaining the procedures for environmental establishing the dietary supplement requirements for written procedures for monitoring. Procedures for CGMPs for additional discussion on the product testing, as well as for corrective environmental monitoring must: (1) Be terms ‘‘validated’’ and ‘‘scientifically action procedures. scientifically valid; (2) identify the test valid’’ (72 FR 34752 at 34853). (Comment 370) Some comments ask microorganism(s); (3) identify the (Comment 368) Some comments us to add a provision requiring that all locations from which the samples will support the proposed requirements for positive results must result in corrective be collected and the number of sites to written procedures for environmental action being taken. be tested during routine environmental monitoring, including providing (Response 370) We decline this monitoring; (4) identify the timing and flexibility to use indicator organisms request. The rule requires that a facility frequency for collecting and testing and to design the timing, location, and must establish and implement written samples; (5) identify the test(s) frequency of environmental monitoring corrective action procedures that must conducted, including the analytical programs in a risk-based manner, and in be taken if preventive controls are not method(s) used; (6) identify the not prescribing specific locations (e.g., properly implemented, including laboratory conducting the testing; and food-contact surfaces or ‘‘zone 1’’) or procedures to address, as appropriate, (7) include the corrective action sample quantities for testing. Other the presence of a pathogen or procedures required by comments ask us to add details to the appropriate indicator organism in an § 507.42(a)(1)(ii). written procedures for product testing animal food product detected as a result (Comment 367) Some comments and environmental monitoring of product testing and the presence of express concern that the word ‘‘valid’’ regarding when and where sampling is an environmental pathogen or in the phrase ‘‘scientifically valid’’ required and the number of samples to appropriate indicator organism detected could be construed to mean ‘‘validated’’ take. Some comments ask us to make through environmental monitoring (see because not all testing protocols can be sure the most current ‘‘sampling § 507.42(a)(1)). However, the rule does validated within the traditional meaning planning science’’ is used for not predetermine what corrective of the term. These comments state their environmental monitoring by specifying actions a facility must take when belief that what we intend is for these that procedures for environmental presented with positive results from testing programs to be ‘‘technically monitoring must employ sample quality product testing or environmental sound.’’ Other comments express criteria objectives. Other comments monitoring. The corrective action concern that ‘‘scientifically valid’’ may assert that the product testing procedure procedures that a facility would be interpreted to mean that firms are requirements are inadequate and ask us develop, and the actual corrective required to develop or validate to require that procedures for product actions that the facility would take, will analytical methods (either in general or testing specify the procedures for depend on the nature of the hazard and for specific food matrices). identifying samples (including their the nature of the preventive control, as (Response 367) We are retaining the relationship to specific lots of product); well as information relevant to the term ‘‘scientifically valid’’ in these describe how sampling was conducted positive result (e.g., pathogen or

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indicator organism, product or XXXV. Subpart C: Comments on suggest alternative or additional environment, animal food-contact Proposed § 507.50—Reanalysis regulatory text. surface or non-animal food-contact We proposed to establish In the following paragraphs, we surface). requirements for reanalysis of the food discuss comments that disagree with, or For additional discussion of safety plan. Some comments support the suggest one or more changes to, the comments on verification of proposed requirements without change. proposed requirements. After implementation and effectiveness, see For example, comments agree that a considering these comments, we have section XXXIV of the final rule for preventive controls qualified individual revised the proposed requirements as preventive controls for human food must perform (or oversee) the reanalysis shown in table 19, with editorial and published elsewhere in this issue of the (see section XXXV.D). Some comments conforming changes as shown in table Federal Register. that support the proposed provisions 31.

TABLE 19—REVISIONS TO THE PROPOSED REQUIREMENTS FOR REANALYSIS

Section Description Revision

507.50(b) ...... Circumstances that require reanalysis ..... Provide for reanalysis of an applicable portion of the food safety plan (rather than the complete food safety plan) in specified cir- cumstances. 507.50(b)(4) ...... Circumstances that require reanalysis ..... Require reanalysis of the food safety plan as a whole, or the applica- ble portion of the food safety plan, whenever a preventive control, combination of preventive controls, or the food safety plan as a whole is found to be ineffective. 507.507(c) ...... Timeframe to complete the reanalysis ..... Clarify that the requirement applies to completing the reanalysis and validating any additional preventive controls (as appropriate to the nature of the preventive control and its role in the facility’s food safety system), rather than to completing the reanalysis and imple- menting any additional preventive controls (emphasis added).

A. Proposed § 507.50(a)—Circumstances (Comment 372) Some comments ask conduct reanalysis when there is a Requiring Reanalysis us to define ‘‘reanalysis’’ to mean ‘‘a change in a preventive control. We proposed that you must conduct reassessment of the validity of a (Response 374) We are including a reanalysis of the food safety plan: (1) preventive control or food safety plan to these editorial changes in the regulatory At least once every 3 years; (2) control a hazard. Reanalysis may text, which now reads whenever ‘‘a whenever a significant change in the include a system review and, where significant change in the activities activities conducted at your facility necessary, activities to revalidate a conducted at your facility creates a creates a reasonable potential for a new control measure or combination of reasonable potential . . .’’ hazard or creates a significant increase control measures.’’ (Comment 375) Some comments in a previously identified hazard; (3) (Response 372) We decline this assert that the proposed requirement to whenever you become aware of new request. Reanalysis goes beyond conduct reanalysis whenever you information about potential hazards assessing the validity of a preventive become aware of new information about associated with the animal food; (4) control or food safety plan to control a potential hazards associated with the whenever appropriate after an hazard. Reanalysis can also include food does not align with FSMA unanticipated animal food safety assessing whether all hazards have been statutory language, is ambiguous, and problem; and (5) whenever you find that identified, whether established would establish vague compliance a preventive control is ineffective. procedures are practical and effective, obligations. (Comment 371) Some comments and other factors. (Response 375) We disagree that the assert that the need to reanalyze the (Comment 373) Some comments ask proposed requirement is ambiguous and food safety plan will depend on the us to require reanalysis on an annual would establish vague compliance nature of the preventive control and its basis, noting that annual reanalysis is obligations. See our previous discussion role in the food safety system. These required by Federal HACCP regulations regarding the emergence of the first comments also assert that if a specific for seafood, juice, and meat and poultry. outbreak of foodborne illness in the preventive control is found to be (Response 373) We decline this United States, in 2006–2007, caused by ineffective, only the applicable portion request. We proposed to require consumption of peanut butter of the food safety plan would need to be reanalysis at least once every 3 years as contaminated with Salmonella (78 FR reanalyzed. a minimum requirement in the event 64736 at 64798). Although we (Response 371) We agree and have that there is no other circumstance acknowledge that the proposed revised the regulatory text, with warranting reanalysis (see § 507.50(b)(2) requirement is not explicit in section associated editorial changes and through (4)). That 3-year minimum is 418(i) of the FD&C Act, we disagree it redesignation, to separate the consistent with the statute (see section is not in alignment with FSMA as a requirement to reanalyze the food safety 418(i) of the FD&C Act). As a practical whole. FSMA directs the owner, plan as a whole every 3 years from all matter, we expect that reanalysis will operator, or agent in charge of a facility other circumstances when reanalysis is occur more frequently as a result of to evaluate the hazards that could affect required ‘‘for cause.’’ When reanalysis is changes in the activities conducted at a food manufactured, processed, packed, ‘‘for cause,’’ the regulatory text provides facility (§ 507.50(b)(1) through (4)). or held by such facility and identify and that reanalysis is of the food safety plan (Comment 374) Some comments implement preventive controls to as a whole, or the applicable portion of suggest editorial changes to improve the significantly minimize or prevent the the food safety plan. readability of the requirement to occurrence of those hazards (see section

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418(a) of the FD&C Act). In other words, timeframe to complete validation (see after production of the applicable FSMA focuses on a system to prevent Response 332), we have revised the animal food first begins or within a food safety problems rather than a timeframe to complete the reanalysis reasonable timeframe, provided that the system to react to problems after they and validate, as appropriate to the preventive controls qualified individual occur. Requiring that a facility reanalyze nature of the preventive control and its provides (or oversees the preparation of) its food safety plan, or the applicable role in the facility’s food safety system, a written justification for a timeframe portion of the food safety plan, in any additional preventive controls to be that exceeds 90 days after production of response to information such as the within 90 days after production of the the applicable animal food first begins. emergence of a new foodborne applicable animal food first begins or In other words, if you decide to make pathogen, or an outbreak of foodborne within a reasonable timeframe, provided a change, you should conduct a illness from consumption of an animal that the preventive controls qualified reanalysis before you make that change food product (or handling by consumers individual provides (or oversees the if there is potential for that change to of a pet food product) not previously preparation of) a written justification for create or increase a hazard; a reanalysis associated with foodborne illness from a a timeframe that exceeds 90 days after that results in changes to preventive well-known pathogen, aligns very well production of the applicable animal controls should be completed and the with the statutory direction in FSMA. food first begins. We made a conforming preventive controls validated, as (Comment 376) Some comments ask change to the list of responsibilities of appropriate to the nature of the us to add a requirement to conduct the preventive controls qualified preventive control and its role in the reanalysis whenever a preventive individual (see § 507.53(a)). facility’s food safety system, before control is found to be ‘‘missing’’ in (Comment 378) Some comments state changes in activities to produce animal addition to whenever a preventive that the phrase ‘‘before the change in food using a new preventive control are control is found to be ‘‘ineffective.’’ activities at the facility is operative’’ is put into operation. However, we (Response 376) We have revised the ambiguous in that it is unclear if the acknowledge that it may be necessary to regulatory text to require reanalysis phrase is referencing the initial change produce product to demonstrate a whenever a preventive control, a in activities that triggered the reanalysis revised preventive control can be combination of preventive controls, or or a change in activities subsequent to implemented appropriately, and the food safety plan as a whole, is the reanalysis. These comments ask us provide for an extended timeframe to ineffective. (See § 507.50(b)(4).) A to clarify the requirement by make this assessment. ‘‘missing’’ preventive control could be substituting the phrase ‘‘before the discovered during verification to relevant process is operative.’’ C. Proposed § 507.50(c)—Requirement establish the validity of the food safety (Response 378) We agree that there To Revise the Written Food Safety Plan plan as a whole or as a result of an was ambiguity in this phrase, because or Document Why Revisions Are Not unanticipated problem. If circumstances changes in activities could result in the Needed lead a facility to conclude that an need for reanalysis and reanalysis could We proposed that you must revise the additional (or different) preventive result in the need for changes in written food safety plan if a significant control is necessary, the facility would activities, both of which can result in a change is made or document the basis include that preventive control in its new preventive control. We have made for the conclusion that no revisions are food safety plan along with associated several revisions to the regulatory text, needed. We received no comments that preventive control management with associated editorial changes, to disagreed with this proposed components, including verification to clarify the requirements for reanalysis. requirement and are finalizing it as establish the validity of the food safety First, we have clarified that reanalysis proposed. plan. can be routine (at least every 3 years) or ‘‘for cause’’ (i.e., a significant change D. Proposed § 507.50(d)—Requirement B. Proposed § 507.50(b)—Timeframe To that creates the potential for a new for Oversight of Reanalysis by a Complete Reanalysis hazard or an increase in a previously Preventive Controls Qualified Individual We proposed that you must complete identified hazard; when you become We proposed that a preventive the reanalysis and implement any aware of new information about controls qualified individual must additional preventive controls needed to potential hazards associated with the perform (or oversee) the reanalysis. We address the hazard identified, if any, animal food; when there is an received no comments that disagreed before the change in activities at the unanticipated animal food safety with this proposed requirement and are facility is operative or, when necessary, problem; or whenever a preventive finalizing it as proposed. See section during the first 6 weeks of production. control, combination of preventive XXXVII.B for comments on the We have clarified that the requirement controls or the food safety plan as a qualifications for a preventive controls is to complete the reanalysis and whole is ineffective). Second, we have qualified individual who would perform validate (rather than implement) any specified that the reanalysis ‘‘for cause’’ or oversee the reanalysis. additional preventive controls as may be for the entire food safety plan or appropriate to the nature of the only for an applicable portion. E. Proposed § 507.50(e)—Reanalysis on preventive control and its role in the In addition, we have clarified that the the Initiative of FDA facility’s food safety system. reanalysis and the validation, as We proposed that you must conduct (Comment 377) As discussed in appropriate to the nature of the a reanalysis of the food safety plan Comment 332, some comments question preventive control and its role in the when FDA determines it is necessary to whether 6 weeks is enough time to facility’s food safety system, of any respond to new hazards and perform all applicable validation studies additional preventive controls needed to developments in scientific that would address the execution address an identified hazard, would understanding. element of validation. Likewise, some need to be completed before any change (Comment 379) Some comments ask comments question whether 6 weeks is in activities (including any change in us to issue formal, written enough time to complete reanalysis. preventive controls) is operative. When communications about new hazards and (Response 377) Consistent with additional time is necessary, we have developments in scientific revisions we have made to the provided for a timeframe within 90 days understanding. These comments express

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concern that communications of this an organizational component (such as safety (TCS animal food) to significantly type could be inconsistent if they are CVM or a component of FDA’s Office of minimize or prevent the growth of, or communicated by individual Regulatory Affairs) that has operational toxin production by, microorganisms of investigators. Other comments ask us to responsibility for animal food safety and animal or human health significance. specify in the regulatory text that it is subject matter experts to advise the We requested comment on the proposed the Commissioner of Food and Drugs managers in those organizational list of modified requirements. Some who makes the determination that it is components. comments that support the proposed necessary to conduct a reanalysis of the provisions suggest alternative or food safety plan. XXXVI. Subpart C: Comments on Proposed § 507.51—Modified additional regulatory text or ask us to (Response 379) We agree that a clarify how we will interpret the communication from FDA about the Requirements That Apply to a Facility provision. need to reanalyze the food safety plan Solely Engaged in the Storage of should be issued in a formal written Unexposed Packaged Animal Food In this section, we discuss comments manner but disagree that it is necessary We proposed that if your facility is that ask us to clarify the proposed to specify that it is the Commissioner of solely engaged in the storage of requirements or that disagree with, or Food and Drugs who makes the packaged animal food that is not suggest one or more changes to, the determination that it is necessary to exposed to the environment, you must proposed requirements. After conduct a reanalysis of the food safety conduct certain activities for any such considering these comments, we have plan. The comment provides no basis refrigerated packaged animal food that revised the proposed requirements as for precluding such a determination by requires time/temperature controls for shown in table 20.

TABLE 20—REVISIONS TO THE PROPOSED MODIFIED REQUIREMENTS FOR UNEXPOSED, REFRIGERATED, PACKAGED ANIMAL FOOD

Section Description Revision

507.51(a) ...... Circumstances that make a facility Clarify that the requirements apply to a temperature control area in a subject to the modified require- facility that holds TCS animal food rather than to each product in ments for unexposed, refrig- the holding facility. erated packaged animal food. 507.51(a)(2) ...... Modified requirements for moni- Specify that it is the temperature controls that are consistently per- toring the temperature controls. formed. 507.51(a)(3) ...... Modified requirements for correc- Clarify that corrective actions need only be taken when a loss of tem- tive actions. perature control may impact the safety of the TCS animal food. 507.51(a)(4)(i) ...... Modified requirements for Provide additional flexibility for accuracy checks, in addition to cali- verification of temperature con- bration, to verify that temperature controls are consistently imple- trols. mented. 507.51(a)(4)(iii) ...... Modified requirements for Provide additional flexibility for reviewing records of monitoring and verification of temperature con- corrective actions either within 7-working days after the records are trols. made or within a reasonable timeframe. 507.51(a)(5)(i) ...... Records documenting the moni- Provide additional flexibility for records documenting the monitoring of toring of temperature controls. temperature controls to be kept either as affirmative records dem- onstrating temperature is controlled or as exception records dem- onstrating loss of temperature control. 507.51(a)(5)(ii) ...... Records documenting corrective Conforming change associated with the modified requirements for actions. corrective actions to clarify that records of corrective actions are re- quired when there is a loss of temperature control that may impact the safety of the TCS animal food.

A. Proposed § 507.51(a)—Modified refrigerated packaged animal food is a of the temperature controls rather than Requirements for Unexposed TCS animal food and, if so, what conduct activities ‘‘for any such Refrigerated Packaged Animal Food specific temperature controls are refrigerated packaged animal food.’’ That Requires Time/Temperature necessary for safe storage of the food. (Comment 381) Some comments Controls We requested comment on this tentative disagree with our tentative conclusion conclusion. that it would be rare for a facility solely 1. Proposed § 507.51(a)(1)—Establish (Comment 380) Some comments ask and Implement Temperature Controls us to clarify that the requirement to engaged in the storage of unexposed We proposed that if your facility is establish and implement temperature packaged animal food to not have subject to the modified requirements, controls applies to temperature control information regarding whether a you must establish and implement areas in a facility rather than to each refrigerated packaged food is a TCS temperature controls adequate to product in a facility. animal food and, if so, what specific significantly minimize or prevent the (Response 380) We agree that the temperature controls are necessary for growth of, or toxin production by, requirement to establish and implement safe storage of the animal food. These microorganisms of animal or human temperature controls applies to comments ask us to specify that the health significance. temperature control areas in a facility responsibility for determining whether We also tentatively concluded that it rather than to each product in a facility. an animal food is a TCS animal food would be rare for a facility solely To make this clearer, we have revised falls to the manufacturer of the animal engaged in the storage of unexposed the proposed requirement to clarify that food rather than the warehouse storing packaged animal food to not have the facility must conduct activities as the animal food, because the warehouse information regarding whether a appropriate to ensure the effectiveness merely provides a service. Other

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comments note that the animal food facilities and receiving facilities in the 3. Proposed § 507.51(a)(3)— product owners determine the optimal 2014 proposed sanitary transportation Requirement To Take Corrective conditions for storage of their products rule (79 FR 7006). We will address Actions based on their own hazard analysis and comments regarding the responsibilities We proposed that if your facility is preventive controls, and that the animal of shippers and receivers in the final subject to the modified requirements, food product owners can simply sanitary transportation rule. you must take appropriate corrective communicate those requirements to the 2. Proposed § 507.51(a)(2)—Monitor the actions if there is a problem with the warehouses that will store the products. temperature controls for a TCS animal (Response 381) In this type of Temperature Controls food. circumstance, it is appropriate for the We proposed that if your facility is (Comment 385) Some comments ask manufacturer of the animal food to subject to the modified requirements, us to narrow the term ‘‘temperature share the responsibility with the you must monitor the temperature control’’ to more specifically focus it on warehouse for proper storage of the controls with sufficient frequency to temperature controls that are relevant to animal food. The various provisions of provide assurance they are consistently section 418 of the FD&C Act explicitly food safety because some problems with performed. We requested comment on the controls may not impact the product place the responsibility for complying whether there would be a benefit to with the requirements for hazard temperature (and, thus, would not requiring a facility to develop written impact food safety). analysis and risk-based preventive procedures for monitoring temperature. controls, including modified (Response 385) We have revised the (Comment 383) Some comments ask proposed requirement (and the requirements, on the owner, operator, or us to explain in the preamble of the agent in charge of a facility and, thus, applicable recordkeeping requirement) final rule that we will accept monitoring to specify that corrective actions are a facility that is a warehouse is systems that provide exception reports responsible for its own food safety plan. necessary only when there is a loss of to satisfy the modified requirements. temperature control that may impact the Regardless, the manufacturer also has The comments describe exception responsibilities under section 418 of the safety of a TCS animal food. reporting as a structure where (Comment 386) Some comments FD&C Act to determine the storage automated systems are designed to alert conditions necessary for animal food assert that the responsibility for operators and management when the determining any corrective actions for a safety and to take steps to ensure that monitoring system observes a deviation the animal food is stored under TCS animal food when there is a loss of from an established limit. These temperature control falls to the conditions that will ensure its safety. comments assert that monitoring of It is not necessary to specify this joint manufacturer of the food rather than to preventive controls by automated responsibility for determining storage the warehouse. These comments also systems can be more efficient than conditions in the rule, because the rule assert that a warehouse is a third party monitoring by personnel, and can already clearly specifies that its who is not legally empowered to make eliminate human error. provisions apply to persons who independent decisions about when and manufacture/process animal food, as (Response 383) We have revised the where to ship the product, or not to ship well as to persons who hold animal recordkeeping provisions of these it at all. These comments ask us to food. Both the warehouse and the modified requirements to provide that clarify that the responsibility of a manufacturer have flexibility in the temperature monitoring records for warehouse for ‘‘preventing’’ affected determining how to comply with the the modified requirements may be kept food entering commerce ends when the rule, including the specific mechanism either as affirmative records product is returned to the manufacturer whereby the warehouse would receive demonstrating temperature is controlled or processor. information about storage of an animal or as exception records demonstrating (Response 386) Returning affected food product from the manufacturer or loss of temperature control. Although animal food to the manufacturer/ owner of the product. Moreover, a the comments explicitly asked us to processor or owner of the animal food citizen petition submitted to FDA provide a clarification in the preamble is one way to satisfy the requirement to (Docket No. FDA–2011–P–056), in of this rule, we decided the clarification prevent animal food from entering requesting an exemption or modified within the regulatory text would be commerce if the owner, operator, or requirements for facilities solely clearer to facilities that are subject to the agent in charge of a warehouse cannot engaged in the storage of packaged foods requirements, as well as to investigators ensure the affected animal food is not not exposed to the environment, asserts who will be inspecting facilities for adulterated under section 402 of the that such facilities work closely with compliance with the rule. FD&C Act, either on its own or after food manufacturers to understand the (Comment 384) Some comments state consultation with the manufacturer or conditions and controls needed to that written procedures for monitoring processor of the animal food. It is not ensure the quality of the foods they temperature are not necessary. One necessary to specify this specific action store and distribute and that reason provided by the comments is that on the part of a warehouse in the manufacturers appropriately instruct the the required records (specified in regulatory text. proposed § 507.51(a)(5)) would provide warehouses to ensure packaged 4. Proposed § 507.51(a)(4)— products are being properly stored (78 sufficient information on the type and frequency of monitoring. Another Requirement To Verify Consistent FR 64736 at 64768). Implementation of Temperature (Comment 382) Some comments ask reason is that the specific activities we Controls us to clarify which facility, the shipping proposed to ensure the effectiveness of facility or the receiving facility, will be the temperature controls already We proposed that if your facility is responsible for ensuring that address activities that a facility would subject to the modified requirements, temperature control is maintained include in a written procedure. you must verify that temperature during transportation of TCS animal (Response 384) We agree with the controls are consistently implemented foods. comments that we need not require that by: (1) Calibrating temperature (Response 382) We address specifics a facility develop written procedures for monitoring and recording devices; (2) about the responsibilities of shipping monitoring temperature. reviewing records of calibration within

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a reasonable time after the records are a written justification for a timeframe B. Proposed § 507.51(b)—Records made; and (3) reviewing records of that exceeds 7 working days. We proposed that the records that a monitoring and corrective actions taken (Comment 390) Some comments facility must establish and maintain for to correct a problem with the control of assert that the proposed verification and the proposed modified requirements are temperature within a week after the review activities are too prescriptive subject to the requirements that would records are made. because they require reviews that are be established in proposed subpart F. (Comment 387) Some comments not necessary. However, these We received no comments that assert that the proposed requirement to comments also assert that the proposed disagreed with our proposal, and are ‘‘calibrate’’ devices that monitor and verification activities are too vague finalizing proposed § 507.51(b) without record temperature is inconsistent with because they do not specify the reasons change. the requirement to test such devices for for reviewing the records. These XXXVII. Subpart C: Comments on accuracy in the LACF regulations in part comments ask us to focus the regulatory 113. These comments assert that Proposed § 507.53—Requirements text on achieving the overall objective of Applicable to a Preventive Controls ‘‘accuracy check’’ is a more appropriate the review (i.e., ensuring the adequacy term to use in the modified Qualified Individual and a Qualified of the control) and to provide examples Auditor requirements because many instruments of meaningful review activities in that monitor or record temperature have guidance. We proposed to establish very low drift values and may seldom requirements for the qualifications of a (Response 390) We disagree that the require calibration. preventive controls qualified individual proposed verification activities would (Response 387) We have revised the and a qualified auditor. Some comments require reviews that are not necessary. support the proposed requirements proposed requirements to require The purpose of the records review is verification that temperature controls without change. Some comments that both to identify a problem with a support the proposed provisions suggest are consistently implemented by temperature monitoring device that may calibrating temperature monitoring and alternative or additional regulatory text. not have been detected or corrected, and In the following paragraphs, we recording devices or checking them for to verify that the temperature controls accuracy. However, if the outcome of an discuss comments that ask us to clarify were consistently implemented and that the proposed requirements or that accuracy check is that a temperature corrective actions were taken if needed. monitoring or recording device is not disagree with, or suggest one or more The requirement is consistent with changes to, the proposed requirements. accurate, the facility must follow up by requirement for records review in calibrating or replacing the device. See After considering these comments, we subpart C (§ 507.49(a)(4)), which are finalizing the provisions as proposed also Comment 344 and Response 344. specifies records review as a verification (Comment 4388) Some comments with conforming changes as shown in activity to ensure that the records are table 31. assert that reviewing records of complete, the activities reflected in the calibration or accuracy checks is only records occurred in accordance with the A. Proposed § 507.53(a) and (b)—What needed if a designated tolerance is food safety plan, the preventive controls a Preventive Controls Qualified exceeded. are effective, and appropriate decisions Individual or Qualified Auditor Must Do (Response 4388) Although we were made about corrective actions. or Oversee recognize that in most instances an out- We proposed to list the functions that 5. Proposed § 507.51(a)(5)—Establish of-calibration device will be identified must be performed by one or more and Maintain Records and corrected at the time a calibration preventive controls qualified or accuracy check is performed, this is We proposed that if your facility is individuals (i.e., preparation of the food not always the case. The purpose of subject to the modified requirements, safety plan; validation of the preventive reviewing records of calibration or you must establish and maintain records controls; review of records for accuracy checks is to identify a problem that document monitoring, corrective implementation and effectiveness of that may have been missed or may not actions, and verification activities. preventive controls and appropriateness have been corrected rather than to react of corrective actions; and reanalysis of (Comment 391) Some comments state to a problem after the problem is the food safety plan) or by a qualified that temperature controls in refrigerated identified. The records review is also a auditor (i.e., conduct an onsite audit). warehouses are extremely reliable and verification that the temperature We proposed to list these functions for therefore extensive record keeping and controls were consistently implemented simplicity (i.e., to make it easy to see all record review are not value-added. and that corrective actions were taken if of the requirements in a single place). These comments ask us to revise the needed. We specified that this list of functions (Comment 389) Some comments ask proposed provision to require a record already proposed to be established in us to modify the frequency of checking only if a deviation in the environmental applicable sections of the rule did not monitoring records to specify that it be temperature from the prescribed limits in itself impose any additional done with a frequency to demonstrate was noted. requirements. control rather than within a week after (Response 391) We have revised the (Comment 392) Some comments ask the records are made. regulatory text to provide that us to clarify whether the preventive (Response 389) We have revised the temperature monitoring records may be controls qualified individual must be on proposed requirement to require review kept either as affirmative records the premises during operating hours. of records of monitoring (as well as demonstrating temperature is controlled Other comments ask us to clarify that records of corrective actions taken to or as exception records demonstrating the preventive controls qualified correct a problem with the control of loss of temperature control. The revised individual is not responsible for temperature) within 7-working days provision is consistent with the more performing laboratory testing, because after the records are created or within a general requirement for monitoring the preventive controls qualified reasonable timeframe, provided that the records of refrigeration temperature individual may not be appropriately preventive controls qualified individual during storage of TCS animal food (see educated and trained for laboratory prepares (or oversees the preparation of) § 507.40(c)(2)). testing.

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(Response 392) The rule does not experience will be recognized as whether individuals who have require that the preventive controls meeting the requirement, how FDA will successfully completed training in the qualified individual be onsite during recognize the experience and whether development and application of risk- operating hours. The rule also does not and how FDA will recognize industry based preventive controls through require that the preventive controls providers of training programs. Some programs delivered and recognized qualified individual be responsible for comments state that currently industry under the International HACCP Alliance performing laboratory testing, although members may choose from many private would be considered to have completed review of testing records (e.g., records of organizations and academia to obtain training ‘‘equivalent’’ to that recognized product testing or environmental training under established HACCP by FDA for the development and testing) must be conducted or overseen based training programs and audit application of risk-based preventive by a preventive controls qualified training programs. Some comments ask controls. individual. us to allow flexibility for industry to (Response 396) The requirements do (Comment 393) Some comments ask continue current training programs provide for qualification through us to consider the implication of having without receiving express approval from appropriate job experience, such as the preventive controls qualified the FSPCA. experience with successfully individual serve as the process (Response 394) As discussed in implementing HACCP systems or other authority, serve as the auditor, and offer Response 1, the FSPCA is establishing a preventive-based food safety systems. It final sign off on a validation and standardized curriculum. The is the responsibility of the owner, corrective actions, and suggest that a curriculum will focus on the specific operator, or agent in charge of the third party may be necessary to ensure requirements of the preventive controls facility to determine whether any that uniform standards are applied. rule. Training providers do not need individual who prepares (or oversees (Response 393) To the extent that the approval from the FSPCA to use the the preparation of) the food safety plan comment suggests that the functions of curriculum. has appropriate qualifications to do so, the preventive controls qualified (Comment 395) Some comments ask whether by on-the-job experience or by individual create a conflict of interest, who will assess the qualifications of a training. we disagree. The rule focuses on the particular preventive controls qualified There are some differences in the need for applicable training and individual or determine whether requirements of the animal food experience to perform certain functions. particular individuals are in fact preventive controls rule compared to The preventive controls qualified ‘‘qualified.’’ Some comments ask us to the requirements of HACCP regulations individual must develop (or oversee the use an outcome-based demonstration of for seafood, juice, and meat and poultry development of) the food safety plan competency. Some comments ask us to such that training provided by the that controls the identified hazards and specify that all work experience must be International HACCP Alliance may not then ensures through review of records comparable or that a preventive controls be equivalent. To avoid unnecessary that the plan is being implemented as qualified individual must pass a duplication of training, such an designed. The rule does not require that proficiency test. Some comments ask us individual may only need to attend a facility engage a third party to provide to establish minimum standards for partial, supplemental courses in order to oversight of any individual, including a competency. Some comments ask us to meet the training requirements. preventive controls qualified individual, clarify what job experiences would be Alternatively, a person who has but does not preclude a facility from sufficient. Some comments ask how we received the International HACCP doing so if it chooses. will verify that reported training and Alliance training and has implemented experience are true. a HACCP plan may be qualified through B. Proposed § 507.53(c)—Qualification (Response 395) We are not job experience. Requirements establishing minimum standards for (Comment 397) Some comments ask competency and do not intend routinely us to emphasize that a standardized 1. Proposed § 507.53(c)(1)—Preventive to directly assess the qualifications of curriculum in the development and Controls Qualified Individual persons who function as the preventive application of risk-based preventive We proposed that to be a preventive controls qualified individual, whether controls may not provide a preventive controls qualified individual, the by their training or by their job controls qualified individual with individual must have successfully experience. Instead, we intend to focus sufficient expertise to design and completed training in the development our inspections on the adequacy of the conduct robust, scientific validation and application of risk-based preventive food safety plan. As necessary and studies to support the adequacy of controls at least equivalent to that appropriate, we will consider whether control measures. received under a standardized deficiencies we identify in the food (Response 397) We acknowledge that curriculum recognized as adequate by safety plan suggest that the preventive a single training course may not provide FDA or be otherwise qualified through controls qualified individual may not adequate training for every function of job experience to develop and apply a have adequate training or experience to the preventive controls qualified food safety system. We also proposed carry out the assigned functions, individual for the animal foods that this individual may be, but is not including whether reported training and produced by a facility. In some cases an required to be, an employee of the experience is accurately represented. individual may gain the full facility. (Comment 396) Some comments ask complement of knowledge and (Comment 394) Some comments us to provide for competency experience through multiple, specific express concern that there is lack of requirements to be met through on-the- training courses; in other cases an specificity on what constitutes job experience in lieu of traditional individual may gain the full appropriate training and experience for classroom training. Some comments ask complement of knowledge and a preventive controls qualified us to clarify what we mean by training experience through job experience or individual and ask us to clarify what that is ‘‘at least equivalent’’ to that through a combination of training and FDA’s standardized curriculum for received under a standardized job experience. preventive controls qualified curriculum recognized as adequate by (Comment 398) Some comments ask individuals will consist of, what FDA. Some comments ask us to clarify us not to establish requirements that are

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overly strict because there is a finite documents in any guidance we may that Must be Established and supply of food safety experts in the issue regarding qualified auditors. Maintained’’). (Proposed subpart F country and many facilities will need (Response 400) At this time, we are would establish requirements that multiple preventive controls qualified not planning to specify a training would apply to all records that would individuals. curriculum for qualified auditors. If we be required by the various proposed (Response 398) We disagree that the develop guidance related to qualified provisions of proposed part 507.) We requirements applicable to the auditors, we will consider industry received no comments that disagreed preventive controls qualified individual documents that are already available. with this proposed provision and are finalizing it as proposed. should be designed to match any C. Proposed § 507.53(d)—Records current limitations in the number of We proposed that all applicable XXXIX. Subpart D: Comments on individuals who have the knowledge Proposed New Provisions for and skill to prepare (or oversee the training must be documented in records, including the date of the training, the Withdrawal of a Qualified Facility preparation of) a food safety plan. We Exemption expect that market forces will act to type of training, and the person(s) increase the number of preventive trained. For clarity, we have revised the In the 2013 proposed animal food controls qualified individuals to match requirement to specify the type of preventive controls rule, we proposed to the demand generated by this rule. In training that must be documented, i.e., establish procedural requirements that addition, as discussed in section LIII.A, applicable training in the development would govern our withdrawal of an we are further staggering the compliance and application of risk-based preventive exemption for a qualified facility dates for subparts C and E of the rule, controls (see 78 FR 64736 at 64804). (proposed subpart D; the withdrawal so that those businesses that are not (Comment 401) Some comments ask provisions). In the 2014 supplemental notice, we discussed several comments small will need to comply with subparts us to explain how job experience should we received on these withdrawal C and E of the rule within 2 years, and be documented in records to prove provisions and proposed modifications small businesses will need to comply qualifications. (Response 401) The rule does not and additions to them. Some of the with subparts C and E of the rule within require documentation of job reproposed provisions would modify 3 years. Very small businesses are not experience. A facility has flexibility to the provisions that we included in the required to develop a food safety plan determine whether and how to 2013 proposed preventive controls rule or conduct other activities that require document a preventive controls (such as the timeframe for compliance oversight by a preventive controls qualified individual’s job experience. with an order withdrawing an qualified individual. For example, a facility could ask a exemption), whereas others would be 2. Proposed § 507.53(c)(2)—Qualified preventive controls qualified individual new provisions (such as a procedure to Auditor to provide a resume documenting reinstate an exemption that had been applicable experience. As discussed in withdrawn). In this section of this We proposed that to be a qualified Response 395, we intend to focus our document we discuss comments that we auditor, a preventive controls qualified inspections on the adequacy of the food received on the withdrawal provisions individual must have technical safety plan. As necessary and in the 2013 proposed preventive expertise obtained by a combination of appropriate, we will consider whether controls rule, but did not address in the training and experience appropriate to deficiencies we identify in the food 2014 supplemental notice. We also perform the auditing function. safety plan suggest that the preventive discuss comments that we received on (Comment 399) Some comments controls qualified individual may not the re-proposed withdrawal provisions object to the proposed requirement that have adequate experience to carry out in the 2014 supplemental notice. a qualified auditor must be a preventive the assigned functions. Most of the comments support the controls qualified individual with For further discussion on comments proposed provisions, suggest alternative certain technical auditing expertise. One received to the proposed rule for or additional regulatory text, or ask us comment asserts that a qualified auditor preventive controls rule for human food, to clarify how we will interpret the should not be required to have the see the final rule of the human food provision. broader skills of a preventive controls preventive controls rule published For several provisions, we received no qualified individual. elsewhere in this issue of the Federal comments that disagreed with our (Response 399) We have revised the Register. proposal, and are finalizing the definition of ‘‘qualified auditor,’’ and provisions without change. These the requirements applicable to a XXXVIII. Subpart C: Comments on provisions are § 507.75 (Presiding ‘‘qualified auditor,’’ such that a Proposed § 507.55—Implementation officer for an appeal and for an informal ‘‘qualified auditor’’ means a person who Records hearing); § 507.77 (Timeframe for is a ‘‘qualified individual’’ as that term We proposed to list all records issuing a decision on an appeal); is defined in this final rule, rather than documenting implementation of the § 507.80 (Revocation of an order to a ‘‘preventive controls qualified food safety plan in § 507.55(a). We withdraw a qualified facility individual,’’ because some auditors may noted that proposed § 507.55(a) would exemption); and § 507.83 (Final agency be auditing businesses (such as produce not establish any new requirements but action). farms) that are not subject to the merely make it obvious at a glance what In the following paragraphs, we requirements for hazard analysis and implementation records are required discuss comments that ask us to clarify risk-based preventive controls, and it under proposed part 507, subpart C. We the proposed requirements or that would not be necessary for such an received no comments that disagreed disagree with or suggest one or more auditor to be a ‘‘preventive controls with this proposed provision and are changes to the proposed requirements. qualified individual.’’ finalizing it as proposed. After considering these comments, we (Comment 400) Some comments ask We proposed that the records that you have revised the proposed requirements us to consider specifying training for must establish and maintain are subject as shown in table 21 with editorial and qualified auditors. These comments also to the requirements of proposed subpart conforming changes as shown in table ask us to consider certain industry F (‘‘Requirements Applying to Records 31.

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TABLE 21—REVISIONS TO THE PROPOSED PROVISIONS FOR WITHDRAWAL OF A QUALIFIED FACILITY EXEMPTION

Section Description Revision

507.60(b)(2) ...... Timeframe for a qualified facility to re- Allow 15 calendar days, rather than 10 calendar days, for the facility to re- spond to a notification from FDA spond. about circumstances that may lead FDA to withdraw the facility’s exemp- tion. 507.65(c) ...... Contents of an order to withdraw a Editorial changes to clarify that the order will specify which of two cir- qualified facility exemption. cumstances that may lead FDA to withdraw a qualified facility exemption apply, or whether both of these two circumstances apply. 507.65(d)(1) ...... Contents of an order to withdraw a Specify that the timeframe for the qualified facility to comply with the order is qualified facility exemption. 120 calendar days after the date of receipt of the order, or within a reason- able timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of re- ceipt of the order. 507.65(d)(2) ...... Timeframe for a qualified facility to ap- Allow 15 calendar days, rather than 10 calendar days, for the facility to appeal peal an order withdrawing the facili- the order. ty’s exemption. 507.65(e) ...... Contents of an order to withdraw a Include a statement informing the facility that it may ask us to reinstate an ex- qualified facility exemption. emption that was withdrawn by following the procedures in § 507.85. 507.67 ...... Compliance with, or appeal of, an order Specifies that a qualified facility that loses its exemption would no longer need to withdraw a qualified facility exemp- to comply with the modified requirements that apply to qualified facilities that tion. have an active exemption. 507.67(a)(1) and Compliance with, or appeal of, an order Specify that the timeframe for the qualified facility to comply with the order is (c)(1). to withdraw a qualified facility exemp- 120 calendar days after the date of receipt of the order, or within a reason- tion. able timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of re- ceipt of the order.

A. Proposed § 507.60—Circumstances actions should be considered before (Response 402) We are retaining the That May Lead FDA To Withdraw a withdrawing a qualified facility provisions regarding certain actions we Qualified Facility Exemption exemption, and some comments agree may take, and other actions we must that it is appropriate to assess corrective take, before issuing an order to We proposed that we may withdraw actions taken by a qualified facility in withdraw a qualified facility exemption. the exemption that would apply to a response to an animal food safety We agree that it is customary for us to qualified facility in the event of an problem when considering whether to work with an animal food facility to active investigation of a foodborne withdraw its exemption. Other address problems before taking illness outbreak that is directly linked to comments agree that these provisions enforcement actions, but disagree that the qualified facility, or if we determine are reasonable and will provide specifying this customary practice in the that it is necessary to protect the public qualified facilities due process and rule would prevent us from acting (human or animal) health and prevent greater clarity on the withdrawal quickly to protect public (human or or mitigate a foodborne illness outbreak process, but suggest that we could issue animal) health. As previously discussed, based on conditions or conduct guidance rather than include these we consider that issuing an order to associated with a qualified facility that provisions in the rule to allow us greater withdraw an exemption would be a rare are material to the safety of the animal flexibility should we have to act quickly event, in part because alternative food manufactured, processed, packed, to protect the public (human or animal) actions such as those described in these or held at such facility. We also health. provisions may provide a more proposed that before we issue an order Other comments disagree with these expeditious approach to correcting a to withdraw an exemption, we: (1) May proposed provisions and ask us to problem than withdrawing an consider one or more other actions to delete them from the final rule. These exemption (79 FR 58524 at 58553). We protect the public health or mitigate a comments assert that FSMA does not also disagree that the rule binds us to foodborne illness outbreak; (2) must require us to describe the actions that take alternative regulatory action before notify you, in writing, of circumstances we may take prior to withdrawing a issuing an order to withdraw a qualified that may lead us to withdraw the qualified facility exemption and that it facility exemption, other than to notify exemption, and provide an opportunity is not necessary to do so because it is the facility in writing of circumstances for you to respond in writing, within 10 customary for us to work with an animal that may lead us to withdraw the calendar days of the date of receipt of food facility to address problems before exemption, provide an opportunity for the notification, to our notification; and taking enforcement actions. These the facility to respond in writing, and (3) must consider your actions to comments also express concern that consider the actions taken by the facility address the circumstances that may lead listing possible regulatory actions before to address the circumstances we us to withdraw the exemption. we would issue an order to withdraw a describe. The rule clearly specifies that (Comment 402) Some comments agree qualified facility exemption could create regulatory actions such as a warning with the proposed provisions regarding an expectation that we will always letter, recall, administrative detention, certain actions we may take, and other exercise such regulatory actions before suspension of registration, refusal of actions we must take, before issuing an issuing the order. These comments also animal food offered for import, seizure, order to withdraw a qualified facility express concern that being bound by and injunction are actions that we exemption. For example, some these provisions could prevent us from ‘‘may’’ (not ‘‘must’’) take before issuing comments agree that other regulatory acting quickly to protect public health. an order to withdraw a qualified facility

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exemption. Providing the facility with a facility to respond in writing to our make the administrative procedures an opportunity to correct the problems notification. The 15-day timeframe is associated with withdrawal of an before we take steps to withdraw an the same as the timeframe for exemption consistent to the extent exemption has the potential to save responding to a warning letter. practicable, including the timeframe for Agency resources associated with Circumstances that could lead us to responding to a notification. preparing an order, responding to an withdraw a qualified facility exemption (Comment 410) Some comments ask appeal of the order and request for a require prompt action on the part of a us to expand the scope of the hearing, and administering a hearing. facility, just as circumstances that lead withdrawal provisions to include Directing resources to help a facility us to issue a warning letter require facilities that would satisfy criteria for correct problems, rather than to prompt action. an exemption from the requirements for administer a withdrawal process that (Comment 406) Some comments ask hazard analysis and risk-based could be resolved by the time of a us to clarify how an exemption can be preventive controls for low-risk activity/ hearing, is appropriate public health revoked (and restored) on diversified food combinations (i.e., the exemptions policy. farms that produce both exempt and in proposed §§ 507.5(e) and (f)). (Comment 403) Some comments ask non-exempt products. (Response 410) We decline this us to specify that the notification of (Response 406) We assume that this request. Section 418 of the FD&C Act circumstances that may lead FDA to comment is referring to a farm mixed- does not provide for withdrawal of the withdraw the exemption must include type facility that produces some exemptions established in § 507.5(e) and facts specific to the situation and products (such as forage products or (f). The withdrawal provision in section information about how the facility can plant protein meals) that are exempt 418(l)(3) of the FD&C Act is limited to remedy the situation. from the requirements for hazard qualified facilities. (Response 403) By specifying that we analysis and risk-based preventive B. Proposed § 507.62—Issuance of an must notify the facility of circumstances controls, as well as some products that Order To Withdraw a Qualified Facility that may lead us to withdraw an are not exempt from these requirements. Exemption exemption, we mean that we would Neither withdrawing nor reinstating a include facts specific to the situation. It qualified facility exemption would have We proposed procedures for the steps is the responsibility of the facility, not any impact on products that are not we would take to issue an order to FDA, to remedy the situation. subject to the requirements for hazard withdraw an exemption applicable to a (Comment 404) Some comments ask analysis and risk-based preventive qualified facility, including procedures us to state affirmatively that we must controls. In contrast, administrative that would: (1) Emphasize that a senior not withdraw the exemption if the procedures such as injunction and FDA official (such as an FDA District facility has satisfactorily addressed the suspension of registration likely would Director, the Director of the Division of problematic conditions or conduct at apply to all animal food production by Compliance in CVM, or a more senior the facility. These comments assert that, the facility. FDA official) must approve an order to without this affirmative statement, the (Comment 407) Some comments ask withdraw the exemption before the requirement that we ‘‘consider the us to consistently use either ‘‘calendar order is issued; (2) provide that any actions taken by the facility’’ remains days’’ or ‘‘working days’’ throughout the officer or qualified employee of FDA unclear. provisions directed to withdrawal of an may issue the order after it has been (Response 404) We decline this exemption. Some comments ask us to approved; (3) specify that we would request. If the facility has satisfactorily use ‘‘business days’’ rather than issue the order to the owner, operator, addressed the problematic conditions or ‘‘calendar days’’ or ‘‘working days.’’ or agent in charge of the facility; and (4) conduct, there would be no problematic (Response 407) We have expressed require that the order be in writing and circumstances for us to describe in the the timeframes for all of the withdrawal be signed and dated by the officer or order withdrawing the qualified facility provisions in calendar days. qualified employee of FDA who is exemption. (Comment 408) Some comments ask issuing the order. (Comment 405) Some comments ask us to clarify that the decision to (Comment 411) Some comments ask us to provide additional time for a withdraw a qualified facility exemption us to include in the procedures qualified facility to respond, in writing, is an individualized determination and timeframes for: (1) Submitting an order to a notification of circumstances that will not be applied to a class of farmers after an initial determination that may lead us to withdraw its exemption. by stating this clearly in the preamble. criteria for withdrawing an exemption Comments suggest timeframes of 60, 90, (Response 408) The decision to are met; (2) approval or denial by the and 120 days as a reasonable or withdraw a qualified facility exemption FDA District Director; (3) issuing the appropriate period of time for a is an individualized determination and withdrawal (with automatic revocation qualified facility to compile information will not be applied to a class of facilities of order if FDA does not issue the order and documentation of facts and to or farmers. within the specified timeframe); and (4) respond to a notification of (Comment 409) Some comments delivery of the order to the owner, circumstances that may cause us to assert that the timeframes for operator, or agent in charge of the withdraw its exemption. Some of these responding to a notification that an facility. Other comments recommend comments express concern that the exemption may be withdrawn should be that the procedures for issuing an order proposed deadline is too short, and that the same regardless of whether the specify that we send the order in a way the short timeframe violates the intent notification is sent to a qualified facility that ensures its receipt, such as through of the exemption. Some comments ask subject to the human or animal food certified mail with confirmation of us to establish graduated response preventive controls rule or a farm delivery to ensure the facility operator times, with less response time allowed subject to the produce safety rule. These receives the order. for more serious animal food safety comments state that many small farms (Response 411) We are not concerns. do value-added processing and will be establishing timeframes for the steps we (Response 405) We have revised the subject to both rules. take before a facility receives an order provision to provide for 15 calendar (Response 409) Although the produce for withdrawal of an exemption. The days, rather than 10 calendar days, for safety rule is not yet final, we intend to timeframes surrounding our internal

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process for developing an order have no the content of an order to withdraw an would be the second time that the bearing on the time that a facility will exemption, including specific evidence facility hears about the problems (see need to respond to the order or on the about the circumstances leading to the § 507.60(b)(2)). We intend that the information it will need to do so. We order. The comments maintain that process of responding to the notification agree that it is appropriate to specify doing so would help the facility respond that we must send before issuing an timeframes for the procedural steps that with particularity to the facts and issues order to withdraw an exemption, follow a facility’s receipt of an order, contained in the order if the facility including discussing the problems with and the withdrawal procedures include appeals the order. The comments also FDA as warranted, would provide such timeframes. recommend that the order include the additional information to the facility to We are not specifying that we send an evidence on which the order is based enable the facility to both understand order in a way that ensures its receipt. including, as applicable, evidence the problem and respond to it. Although certified mail with linking the active investigation of a (Comment 414) Some comments ask confirmation of delivery is one way to foodborne illness outbreak directly to us to provide 15 ‘‘business days’’ from ensure receipt, other methods are the facility or measurable evidence date of receipt of the order, rather than available, including delivery through (collected using generally accepted the proposed 10 calendar days from date private carriers that provide scientific standards) indicating the of receipt of the order, for the facility to mechanisms to document receipt. In presence in the facility of pathogens that appeal the order. light of the provision (which we pose an imminent threat to public (Response 414) We have revised the included in the 2014 supplemental (human or animal) health, or conduct or provision to provide for 15 calendar notice) linking the timeframes for a conditions that are material to the safety days, rather than 15 business days, for facility to comply with, or appeal, an of animal food. The comments also a facility to appeal the order. We also order to the date of receipt of the order recommend that the order include, have made conforming changes to (rather than to the date of the order), it when applicable, a statement explaining establish the same 15 calendar day will be up to us to deliver the order in how altering the conduct or conditions timeframe in all provisions that specify a way that provides us with evidence of would prevent or mitigate a foodborne the timeframe to appeal the order (i.e., receipt. illness outbreak. §§ 507.67(a)(2), 507.69(a)(1), and 507.71(a)(2)). We also extended the C. Proposed § 507.65—Contents of an (Response 413) We agree that the timeframe for the hearing to be held to Order To Withdraw a Qualified Facility order must provide sufficient be within 15 calendar days, rather than Exemption information to enable a facility to the proposed 10 calendar days, after the We proposed specific information that respond with particularity to specific date the appeal is filed to provide more would be included in an order to evidence about the circumstances time for the facility to prepare for the withdraw an exemption, including (1) leading to the order. However, we hearing (see § 507.73(a)). The timeframe The date of the order and the name, disagree that the order must do so by for the hearing to be held continues to address, and location of the qualified including the specific information provide for an alternative timeframe facility; (2) a brief, general statement of recommended by the comments, and we agreed upon in writing by both the the reasons for the order, including have not revised the proposed facility and FDA; a facility that would information relevant to the withdrawal provisions to incorporate have preferred the proposed timeframe circumstances that led us to issue the the suggestions of these comments. The of 10 calendar days could request that order; (3) a statement that the facility comments appear to be more focused on the hearing be held more quickly than must either comply with subpart C whether the circumstances that lead us 15 calendar days. within 120 calendar days of receipt, or to issue an order meet an evidentiary The 15-day timeframe is the same as appeal the order within 10 calendar standard than on explaining the the timeframe for responding to a days of receipt; (4) the text of section problem so that a facility can both warning letter. Circumstances that could 418(l) of the FD&C Act and of the understand the problem and respond lead us to withdraw a qualified facility withdrawal provisions in part 507, with particularity to the facts and issues exemption require prompt action on the subpart D; (5) information about an contained in the order. The withdrawal part of a facility, just as circumstances informal hearing on an appeal of the provisions that we are establishing in that lead us to issue a warning letter order; and (6) contact information for this provision require the order to require prompt action. appropriate senior FDA officials, as well include a brief, general statement of the (Comment 415) Some comments as the name and the title of the FDA reasons for the order, including support the proposed timeframe of 120 representative who approved the order. information relevant to: (1) An active calendar days for a qualified facility (Comment 412) Some comments investigation of a foodborne illness whose exemption has been withdrawn recommend that the order specify which outbreak that is directly linked to the to comply with the animal food of the two circumstances that could lead facility; or (2) conditions or conduct preventive controls rule, but ask us to us to issue the order apply. associated with a qualified facility that make the timeframe for complying with (Response 412) We have made are material to the safety of the animal a FSMA rule the same regardless of editorial changes to the regulatory text food manufactured, processed, packed, whether the exemption is withdrawn to make it more clear that the provision or held at the facility. The requirements from a qualified facility subject to the requires us to specify which that we are establishing in this animal food preventive controls rule or circumstance applies. (i.e., an active provision would enable a qualified from a farm subject to the produce investigation of foodborne illness, or facility to both understand the problem safety rule. Other comments ask us to conduct or conditions associated with and respond to it. In addition, because extend the timeframe to come into the qualified facility), or whether both other requirements in these withdrawal compliance, e.g., to 1 or 2 years. Some of these two circumstances apply. See provisions specify that we must notify of these comments suggest that qualified the revised regulatory text for a qualified facility of circumstances that facilities should have 120 days to § 507.65(c). may lead us to withdraw its exemption develop a plan of action, but 2 years to (Comment 413) Some comments ask before we issue the actual order, the fully comply. Some of the comments us to add more specific requirements for order withdrawing the exemption argue that large farms and

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manufacturers are given a year to come withdraw the exemption for a qualified (Response 417) A qualified facility into compliance, and that requiring facility. that loses its exemption from the small and very small businesses to As already discussed, the new requirements for hazard analysis and comply in a shorter time period would requirements for hazard analysis and risk-based preventive controls would no effectively drive them out of business. risk-based preventive controls are not longer need to comply with the Other comments ask us to consider ‘‘one-size-fits-all.’’ Although each modified requirements that apply to provisions that would require facility subject to the rule must prepare qualified facilities that have an active compliance with only those portions of and implement a food safety plan, the exemption. To make this clearer, the the rule that formed the basis for the preventive controls that the facility final withdrawal procedures now revocation. would establish and implement would include this information (see the depend on the facility, the animal food, regulatory text for § 507.67(c)). (Response 415) We continue to and the outcome of the facility’s hazard believe that the 120-day timeframe is analysis. In addition, the preventive E. Proposed § 507.69—Procedure for adequate, but we have added flexibility control management components that a Submitting an Appeal such that a facility may request, with a facility would establish and implement We proposed that (1) To appeal an justification in writing to FDA, a for its preventive controls would be order, you must submit a written appeal reasonable timeframe for compliance established as appropriate to ensure the to FDA within 15 calendar days of that exceeds 120 calendar days from the effectiveness of the preventive controls, receipt and respond with particularity receipt of the order. FDA must grant the taking into account the nature of the to the facts and issues contained in the request for the facility to receive the preventive control and its role in the order, including any supporting extended timeframe. We are not facility’s animal food safety system. documentation upon which you rely; generally extending the timeframe Although the produce safety rule is and (2) In your written appeal, you may because circumstances that could lead not yet final, we intend to make the include a written request for an informal us to withdraw a qualified facility administrative procedures associated hearing. exemption require prompt action on the with withdrawal of an exemption (Comment 418) Some comments ask part of a facility. A qualified facility that consistent to the extent practicable, us to rely on records kept in the normal receives an order to withdraw its including the timeframe to comply with course of business for documentation exemption would have received the applicable rule if an exemption is that will be sufficient to respond to an advance notification of the withdrawn. order to withdraw a qualified facility’s circumstances leading to the order and (Comment 416) Some comments ask exemption, rather than requiring a would have had an opportunity to us to include in the order a statement facility to ‘‘respond with particularity to correct the problems rather than have us that a facility may request that FDA the facts and issues contained in the proceed to issue the order (see reinstate an exemption that was order, including any supporting § 570.60(b)). If the facility requests a withdrawn by following the procedures documentation upon which the owner, hearing, more than 40 days could elapse in § 507.85. operator or agent in charge of the facility between the date that the facility (Response 416) We have revised the relies.’’ These comments assert that we receives the order and the date that the requirements for the contents of an should not require a facility that presiding officer for the hearing order as requested by these comments. submits a written appeal to provide confirms the order to withdraw the D. Proposed § 507.67—Compliance documents and records that they are not exemption. Given that the With, or Appeal of, an Order To required to keep. (Response 418) We decline this circumstances that would lead us to Withdraw a Qualified Facility request. In a withdrawal action, FDA is issue the order involve either: (1) An Exemption providing a qualified facility multiple active investigation of a foodborne We proposed that: (1) You must either opportunities to persuade FDA that illness outbreak that is directly linked to comply with applicable requirements of withdrawal is not appropriate. If the the qualified facility or (2) a part 507 within 120 calendar days of facility relies on documentation as part determination that withdrawal of the receipt, or appeal the order within 10 of its response, it is reasonable to exemption is necessary to protect the calendar days of receipt; (2) submission require that this documentation be public (human or animal) health and of an appeal, including submission of a provided to FDA. prevent or mitigate a foodborne illness request for an informal hearing, will not outbreak based on conditions or operate to delay or stay any F. Proposed § 507.71—Procedure for conduct associated with the qualified administrative action unless the Requesting an Informal Hearing facility that are material to the safety of Commissioner of FDA, as a matter of We proposed that if you appeal the the animal food manufactured, discretion, determines that delay or a order: (1) You may request an informal processed, packed, or held at the stay is in the public interest; and (3) if hearing, and must do so together with facility, a delay of 1 to 2 years to comply you appeal the order, and we confirm your written appeal (within 15 calendar with the rule is not warranted. We also the order, you must comply with days of the date of receipt of the order do not believe that it would be applicable requirements of part 507 and (2) a request for an informal hearing appropriate to require a facility to come within 120 calendar days of may be denied, in whole or in part, if into compliance with only those confirmation of receipt of the order. the presiding officer determines that no provisions that formed the basis of the (Comment 417) Some comments ask genuine and substantial issue of revocation. The provisions of subparts C us to specify that a qualified facility that material fact has been raised by the and E are interrelated and operate as a loses its exemption from the material submitted; you would receive system and therefore are not optimized requirements for hazard analysis and written notice of the presiding officer’s through piecemeal implementation. risk-based preventive controls would no determination, explaining the reason for However, FDA may consider staggered longer need to comply with the the denial. implementation as an option in granting modified requirements that apply to (Comment 419) Some comments ask a request for an extension of the qualified facilities that have an active us to guarantee a hearing so that a timeframe to comply with an order to exemption. qualified facility can present its case in

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person before having its exemption H. Proposed § 507.85—Reinstatement of withdrawn does not preclude us from revoked. a Qualified Facility Exemption That providing for such a process (79 FR (Response 419) We decline this Was Withdrawn 58524 at 58553). Other comments request. We agree that a qualified We proposed four provisions for disagree with that tentative conclusion facility has a right to appeal an order to reinstating a withdrawn qualified and assert that Congress crafted the withdrawal provision as a ‘‘one strike, withdraw an exemption, and we have facility exemption. First, we proposed you’re out’’ provision. These comments provided for a right to appeal. that if the FDA District Director in whose district your facility is located also assert that including the G. Proposed § 507.73—Requirements (or, in the case of a foreign facility, the withdrawal provision as a ‘‘one strike, Applicable to an Informal Hearing Director of the Division of Compliance you’re out’’ provision was an essential part of the legislative agreement that in CVM) determines that a facility has We proposed that if you request an allowed for adoption of the qualified adequately resolved problems with the informal hearing, and we grant the facility exemption. These comments conditions and conduct that are material request: (1) The hearing will be held also assert that reinstatement would to the safety of the animal food within 10 calendar days after the date undermine the intent of the withdrawal manufactured, processed, packed, or the appeal is filed or, if applicable, provision because it would reduce the held at the facility and that continued within a timeframe agreed upon in incentive for small animal food withdrawal of the exemption is not writing by you and by us; (2) the processors to ensure that the products necessary to protect public health and presiding officer may require that the they sell are as safe as possible. These prevent or mitigate a foodborne illness hearing be completed within 1 calendar comments also assert that a recognized outbreak, the FDA District Director in principle of statutory interpretation day; and (3) we must conduct the whose district your facility is located (or hearing in accordance with part 16 (21 provides that exemptions to statutes in the case of a foreign facility, the should be strictly construed, CFR part 16), with some specified Director of the Division of Compliance modifications, including that no party particularly when the statute addresses in CVM) will, on his own initiative or public health and safety, and that we are shall have the right, under § 16.119, to on the request of a facility, reinstate the petition FDA for reconsideration or a giving the exemption an impermissibly exemption (proposed § 507.85(a)). broad construction. stay of the presiding officer’s final Second, we proposed that you may decision. Some comments ask why we believe ask FDA to reinstate an exemption that that a business deserves a ‘‘second bite (Comment 420) Some comments has been withdrawn by following of the apple’’ in light of the object to our proposal that no party shall specific steps (§ 507.85(b)(1) and (2)). understanding (under proposed have the right, under § 16.119 to Third, we proposed that if your § 507.60(b) and (c)) that we will first petition FDA for reconsideration or a exemption was withdrawn in the event seek to correct problems before stay of the presiding officer’s final of an active investigation of a foodborne considering withdrawal. These decision. These comments assert that illness outbreak that is directly linked to comments also question at what point a our justification (i.e., that the your facility and FDA later determines, facility would apply for reinstatement, circumstances that would lead to a after finishing the active investigation of and ask why we would allow a facility withdrawal merit prompt action and a foodborne illness outbreak, that the that has already come into compliance that a facility has the opportunity for outbreak is not directly linked to your with FSMA’s requirement to implement judicial review in accordance with 21 facility, FDA will reinstate your preventive controls to abandon those CFR 10.45) is not a sufficient argument qualified facility exemption and will controls in favor of reinstating its for justifying the removal of the option notify you in writing that your exempt exempt status. These comments ask us to file a motion for reconsideration or status has been reinstated. to eliminate the proposed provisions stay. These comments ask us to revise We proposed that if your exemption allowing for reinstatement. proposed § 507.73(c)(6) to specify that was withdrawn both in the event of an Some comments do not support the the qualified facility shall have the right active investigation of a foodborne proposed reinstatement provisions to file a motion for reconsideration or illness outbreak that is directly linked to when an animal food facility has been stay. your facility and because FDA had directly linked to a foodborne illness determined that it is necessary to outbreak. Some comments support the (Response 420) We decline this protect the public (human or animal) proposed reinstatement provisions only request. In the 2014 supplemental health and prevent or mitigate a when we determine, after finishing an controls notice, we proposed an foodborne illness outbreak based on active investigation of a foodborne additional mechanism for a qualified conditions or conduct associated with illness outbreak, that the outbreak is not facility to present its view that its your facility that are material to the directly linked to the facility that had its exemption should not be withdrawn, safety of the animal food manufactured, exemption withdrawn. i.e., by providing advance written processed, packed, or held at such (Response 421) We disagree that the notification to a qualified facility if we facility, and FDA later determines, after proposed reinstatement provisions are considering withdrawing an finishing the active investigation of a would give the exemption an exemption and providing an foodborne illness outbreak, that the impermissibly broad construction. The opportunity for the facility to respond outbreak is not directly linked to your express statutory language of section before we issue an order to withdraw an facility, FDA will inform you of this 418(l) of the FD&C Act does not support exemption. We also proposed to provide finding, and you may ask FDA to the comments’ assertion that the an opportunity for reinstatement of an reinstate your qualified facility withdrawal provision is a ‘‘one strike, exemption that had been withdrawn. exemption. you’re out’’ provision. We also disagree We believe the multiple opportunities (Comment 421) Some comments agree that reinstatement would undermine the now available to a facility provide with our tentative conclusion that the intent of the withdrawal provision adequate opportunities for a facility’s absence of a specific provision in because it would reduce the incentive views to be considered, and further section 418 of the FD&C Act for the for small animal food processors to mechanisms are not warranted. reinstatement of an exemption that is ensure that the products they sell are as

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safe as possible. We expect that the illness outbreak, that the outbreak is not (Response 426) In general, we work withdrawal provision itself provides a directly linked to the facility), our with our State partners and other big incentive for small animal food determination would be effective government counterparts in dealing processors to ensure that the products immediately. If we receive a request to with enforcement actions, including they sell are as safe as possible because reinstate a withdrawn exemption, we coordinating actions or deferring to each of the business disruption that would intend to respond in a reasonable other when one department has occur if they are subject to withdrawal timeframe consistent with available authority to swiftly act to protect the of the exemption. We proposed that a resources. In some cases, we may consumer. In the specific case of this facility would need to present data and respond that we need more information rule, we are working through the PFP to information to demonstrate that it has in order to evaluate your request. develop and implement a national adequately resolved the problems with (Comment 423) Some comments ask Integrated Food Safety System the conditions or conduct that are that the process for reinstatement consistent with FSMA’s emphasis on material to the safety of the animal food include at least one level of establishing partnerships for achieving manufactured, processed, packed, or administrative appeal if we deny a compliance (see Response 2 and section held at the facility, such that continued facility’s request for reinstatement. 209(b) of FSMA). withdrawal of the exemption is not (Response 423) We have not revised (Comment 427) Some comments ask necessary to protect public (human or the regulatory text to provide for an us to add provisions regarding animal) health and prevent or mitigate administrative appeal if we deny a notification of the appropriate State a foodborne illness outbreak. facility’s request for reinstatement. regulatory agency when a qualified We disagree that we should Existing procedures allow a facility to facility exemption is withdrawn and categorically refuse to consider ask for a meeting with applicable FDA reinstated. reinstating a qualified facility officials (see § 10.65(c)) and appeal our (Response 427) We decline this exemption if we had withdrawn the decision if we deny the request (see request. As previously noted, we are exemption because an animal food § 10.75). sensitive to the time required for various facility had been directly linked to a (Comment 424) Some comments ask inspection activities and intend to foodborne illness outbreak. First, if us to establish a 1-year probationary communicate with States regarding our information later comes to light to raise period before the withdrawn qualified expectations for how to verify whether considerable doubt that a qualified facility exemption could be fully a facility is a qualified facility. The facility had, indeed, been directly reinstated. status of a facility as a qualified facility linked to a foodborne illness outbreak, (Response 424) We decline this principally affects the requirements that and conditions and conduct at the request. We intend to act on a request it is subject to, and will be most useful facility do not otherwise warrant for reinstatement based on the merits of to FDA and our food safety partners withdrawing the facility’s exemption, it the data and information presented in when preparing for inspection. At this would be appropriate for us to reinstate the request, not after a pre-determined time we do not intend to establish a the facility’s exemption. Second, we timeframe. system notifying the applicable State would only reinstate the exemption if authorities at a point in time when the we determined that a facility has I. Conforming Amendment to 21 CFR status of a facility as a qualified facility adequately resolved any problems with Part 16 changes, whether as a result of the conditions and conduct that are We proposed to amend § 16.1(b)(2) to withdrawal or reinstatement of a material to the safety of the animal food include part 507, subpart D, relating to qualified facility exemption or because manufactured, processed, packed, or the withdrawal of an exemption the facility’s business has grown to the held at the facility and that continued applicable to a qualified facility, to the point where it exceeds the financial for withdrawal of the exemption is not list of regulatory provisions under very small business. necessary to protect public (human or which regulatory hearings are available. XL. Subpart E: General Comments on animal) health and prevent or mitigate We received no comments that Proposed Requirements for a Supply- a foodborne illness outbreak. disagreed with this proposed provision, Chain Program (Comment 422) Some comments that and are finalizing it as proposed. support the reinstatement of a In the 2014 supplemental notice, we withdrawn exemption ask us to J. Other Comments on the Withdrawal provided an opportunity for public establish a timeframe within which FDA Provisions comment on potential requirements for will reinstate an exemption. Some (Comment 425) Several comments ask a supplier program as a preventive comments ask us to specify in the us to provide clarification through control. The supplier program for a regulatory text that the reinstatement guidance, issued for public comment, receiving facility would be limited to would occur in a reasonable period of on a variety of topics associated with those raw materials and other time, both in circumstances where FDA the withdrawal provisions. ingredients for which the receiving has decided on its own initiative to (Response 425) We will consider the facility has identified a significant reinstate the exemption and in need for guidance in the future. At this hazard (which we now refer to as a circumstances where a facility submits time, we consider that withdrawing an ‘‘hazard requiring a preventive a request for reinstatement. Some exemption would be both rare and control’’). Under the definitions comments suggest 10 days is a dependent upon the circumstances. We established in this rule, ‘‘supplier’’ reasonable period of time within which need to direct our resources to means the establishment that FDA should reinstate an exemption. developing guidance on issues that manufactures/processes the food, raises (Response 422) We decline the would apply more broadly, and more the animal, or grows the food that is requests to establish a timeframe for generally, than the withdrawal provided to a receiving facility without reinstatement in the regulatory text. If provisions. further manufacturing/processing by we determine on our own initiative to (Comment 426) Some comments ask another establishment, except for reinstate an exemption (e.g., because we detailed questions about how we would further manufacturing/processing that later determine, after finishing the coordinate the withdrawal process with consists solely of the addition of active investigation of a foodborne the States. labeling or similar activity of a de

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minimis nature; ‘‘receiving facility’’ how) the final preventive controls rule editorial changes associated with the means a facility that is subject to for animal food should address the new structure of the redesignated subparts C and E and that manufactures/ potential for gaps in supplier controls regulations. See table 22 for the section processes a raw material or other when a hazard is controlled at Point A numbers and titles in subpart E. See ingredient that it receives from a in the supply chain, and Point B in the table 23 for an overview of the major supplier (see § 507.3). supply chain is a facility that only packs revisions to the proposed requirements We previously explained our or holds animal food, but does not for a supply-chain program. See sections understanding that, particularly for manufacture/process animal food (and XLI through XLVII for a discussion of RACs, there may be multiple therefore would not be required to have the specific provisions of the final establishments, including cooperatives, a supplier program) before passing it on requirements for a supply-chain packing houses, and distributors, to Point C in the supply chain. between a receiving facility and the In the remainder of this section, we program, and tables 24 to 29 for more establishment that would be considered discuss comments that address our detailed summaries of revisions to these the supplier, which would make request for comment on complex specific provisions. Because table 23 is supplier verification very challenging supply-chain scenarios such as those an overview, the changes identified in under certain circumstances (79 FR described in the 2014 supplemental table 23 appear again in, tables 24 to 29. 58476 at 58497). We requested comment notice. We also describe our reasons for Because the editorial changes associated on what verification activities would be revising the proposed requirements for with the redesignation are extensive, we appropriate for receiving facilities to a supplier program to provide do not list them in table 31. conduct when a raw material or additional flexibility for an entity other The title of subpart E is ‘‘Supply- ingredient passes through more than than the receiving facility to determine, Chain Program’’ rather than ‘‘Supplier one facility that would not be required conduct, and document the appropriate Program.’’ As shown in table 23 and to verify control of hazards if supplier supplier verification activities. When an discussed in more detail in section programs are limited to manufacturers/ entity other than the receiving facility XLI.D, we have added one requirement processors. We discussed an example in determines, conducts, or both applicable to non-suppliers. ‘‘Supply- which a receiving facility is a feed mill determines and conducts the chain program’’ is a more appropriate that receives oats from a distributor, appropriate supplier verification who receives grains from a cooperative, activities, the receiving facility must term to reflect a subpart that includes a and neither the distributor nor the review and assess that entity’s requirement applicable to nonsuppliers cooperative is required to establish applicable documentation, and in addition to the requirements supplier controls for the farms, where document the receiving facility’s review applicable to suppliers. In the the hazards are being controlled, and and assessment. Providing this remainder of this document, we use the asked what supplier controls should be additional flexibility required a series of phrase ‘‘supply-chain program’’ in applied for the grains coming from the changes to multiple proposed section headings and when referring to farms. We requested comment on provisions. To improve clarity and the provisions of the final rule. We whether and how the requirements for readability, we redesignated proposed continue to use the term ‘‘supplier supplier verification should address § 507.36 into eight distinct sections of program’’ when describing the proposed such situations. We also requested regulatory text in a newly established provisions and the comments regarding comment regarding whether (and, if so, subpart E (Supply-Chain Program), with the proposed provisions.

TABLE 22.4—REDESIGNATION OF THE REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM IN SUBPART E [Supply-chain program]

Section Description

507.105 ...... Requirement to establish and implement a supply-chain program. 507.110 ...... General requirements applicable to a supply-chain program. 507.115 ...... Responsibilities of the receiving facility. 507.120 ...... Using approved suppliers. 507.125 ...... Determining appropriate supplier verification activities (including determining the frequency of con- ducting the activity). 507.130 ...... Conducting supplier verification activities for raw materials and other ingredients. 507.135 ...... Onsite audit. 507.175 ...... Records documenting the supply-chain program.

TABLE 23.5—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM

Final section Proposed section designation designation Description Revision

Throughout ...... Throughout ...... The type of preventive control applicable to Refer to ‘‘supply-chain-applied control’’ rather the supply-chain program. than ‘‘preventive control’’ or variations such as ‘‘hazard requiring a preventive control when the hazard is controlled before re- ceipt of the raw material or other ingre- dient.’’ 507.36(a)(2) (in subpart 507.37(a)(1)(ii) ...... A supply-chain program is not required when Shifted to be in provisions outside the frame- C). the hazard will be controlled by the receiv- work of the supply-chain program in sub- ing facility’s customer in the distribution part E. chain.

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TABLE 23.5—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM—Continued

Final section Proposed section designation designation Description Revision

507.105(a)(2) ...... N/A ...... Circumstances that do not require a supply- The receiving facility does not need a supply- chain program. chain program when the receiving facility is an importer, is in compliance with the forth- coming FSVP requirements, and has docu- mentation of verification activities con- ducted under the forthcoming FSVP pro- gram. 507.105(a)(3) ...... N/A ...... Exemption from the requirements for a sup- Exemption for animal food supplied for re- ply-chain program. search or evaluation. 507.105(c) ...... N/A ...... Requirements applicable to non-suppliers ..... When a supply-chain-applied control is ap- plied by an entity other than the receiving facility’s supplier (e.g., when a nonsupplier applies controls to certain produce (i.e., produce that will be subject to the forth- coming produce safety rule), because growing, harvesting, and packing activities are under different management), the re- ceiving facility must (1) verify the supply- chain-applied control; or (2) obtain docu- mentation of an appropriate verification ac- tivity from another entity in the supply chain, review and assess the entity’s appli- cable documentation, and document that review and assessment. 507.110(c) ...... 507.37(a)(3)(ii) ...... Purpose of the supply-chain program ...... Specify only that the supply-chain program must provide assurance that a hazard re- quiring a supply-chain-applied control has been significantly minimized or prevented. 507.110(d) ...... 507.37(b) ...... Factors that must be considered in deter- • Clarification that these factors must be mining appropriate supplier verification ac- considered in approving suppliers, as well tivities. as in determining appropriate supplier verification activities. • Flexibility in the factors that must be con- sidered if a supplier is a qualified facility, a produce farm that will not be subject to the forthcoming produce safety rule on the basis of size and/or direct farm marketing, or a shell egg producer that is not subject to the requirements of 21 CFR part 118 (production, storage, and transportation of shell eggs) because it has less than 3,000 laying hens. 507.115(a) ...... N/A ...... Responsibilities of the receiving facility ...... Provide flexibility for an entity other than the receiving facility to determine, conduct, and document supplier verification activities, provided that the receiving facility reviews and assesses applicable documentation from that entity and documents the receiv- ing facility’s review and assessment. 507.115(b) ...... N/A ...... Responsibilities of the receiving facility ...... Specify documentation that a receiving facility may not accept from a supplier to satisfy the receiving facility’s responsibilities for its supply-chain program. 507.120(a) ...... 507.37(a)(3)(i) ...... Approval of suppliers ...... Explicit requirement for a receiving facility to approve its suppliers. 507.120(b) ...... 507.37(a)(3)(i) ...... Approval of suppliers ...... Explicit requirement for a receiving facility to establish and follow written procedures for receiving raw materials and other ingredi- ents. 507.130(e) ...... N/A ...... Alternative supplier verification activity ...... Provide for an alternative supplier verification activity when the supplier is a shell egg producer with less than 3,000 laying hens. 507.130(f) ...... N/A ...... Independence of the supplier ...... Specify that there must not be any financial conflicts of interests that influence the re- sults of the verification activities listed in § 507.110(b) and payment must not be re- lated to the results of the activity.

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TABLE 23.5—OVERVIEW OF REVISIONS TO THE PROPOSED REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM—Continued

Final section Proposed section designation designation Description Revision

507.135(c)(1) ...... 507.37(e) ...... Substitution of an inspection for an audit ...... Provide additional flexibility for domestic in- spection by representatives of other Fed- eral Agencies (such as USDA), or by rep- resentatives of State, local, tribal, or terri- torial agencies. 507.175 ...... 507.37(g) ...... Records documenting the supply-chain pro- List additional records associated with the re- gram. vised provisions.

(Comment 428) Several comments ask a person knowledgeable about food customers via product testing, audits us to issue guidance rather than safety would establish and implement and supplier verification,’’ asserting that establish requirements for a supplier in order to significantly minimize or this would discourage customers from program in the rule. Some comments prevent hazards requiring a preventive buying from entities such as repackers assert that the benefits of a supplier control in an incoming raw material or when they could go to the source. Some verification program do not outweigh other ingredient. comments state that we have not taken the costs; that we did not consider the Supplier verification is sufficiently into account the low-risk nature of some effects of such a requirement on farms important for the control of hazards in industries. Other comments ask us to and small businesses; and that FSMA both domestic and imported animal confirm that distributors and does not actually contain a requirement foods that FSMA contains provisions for warehouses are not included in the for a supplier verification program. both domestic and foreign supplier requirements for a supplier program Conversely, other comments support verification (sections 418(o)(3) and 805 because they would not likely meet the including a mandatory supplier program of the FD&C Act). Because we have definition of a receiving facility or a in the rule for hazards that are aligned the provisions for supplier supplier. controlled in raw materials and other verification in the FSVP rule with the (Response 429) We agree with ingredients before receipt by the provisions for a supply-chain program comments recommending additional receiving facility, although many in this rule, we are allowing importers flexibility in the supply-chain program comments assert that a supplier and receiving facilities to take advantage with regard to who can perform certain verification program should be viewed of that fact in considering compliance activities and have added this flexibility as a verification activity rather than a with both part 507 and our forthcoming to the final rule (see § 507.115). Because preventive control. Some comments FSVP regulations that we proposed to the receiving facility and the supplier assert that a mandatory domestic establish in part 1, subpart L, so that may be separated by several entities in supplier program is necessary to they do not have to duplicate a supply chain, we are allowing such provide parity with the requirements of verification activities (see entities (e.g., distributors, brokers, the FSVP rule authorized by FSMA, § 507.105(a)(2)). aggregators) to determine, conduct, and while other comments assert that (Comment 429) Some comments that document supplier verification FSMA’s authorization of foreign addressed questions we asked in the activities as a service to the receiving supplier verification should not be used 2013 proposed preventive controls rule facility, provided that the receiving to justify a domestic supplier program. for animal food and the 2014 facility reviews and assesses applicable Some of these comments single out our supplemental notice recommend that documentation provided by the other request for comment, in the proposed we add flexibility to the requirements entity and documents that review and FSVP rule, on whether to allow an for a supplier program such that any assessment. However, because the entity that would be both an importer entity in the supply chain between the approval of suppliers is ultimately the (under the FSVP rule) and a receiving supplier and the receiving facility can responsibility of the receiving facility, facility (under the animal food perform supplier verification activities. the rule specifies that only a receiving preventive controls rule) to be deemed Some comments ask us to allow a facility can approve suppliers (see in compliance with the FSVP rule if it receiving facility to have a supplier §§ 507.115(a)(1) and 507.120(a) and was in compliance with the supplier program established for it by another Response 430). verification provisions of the animal entity. Other comments assert that it We disagree that complex supply food preventive controls rule, and agree would be too burdensome for a chains make a supply-chain program too with such an approach (78 FR 45730 at receiving facility to consider any difficult and that a receiving facility 45748). information related to the supplier’s cannot be expected to reach further back (Response 428) We agree that it is supplier or to go further back in the in a supply chain than the entity necessary to include a mandatory supply chain beyond the entity that is immediately before it in the supply supply-chain program in the rule to one back from the receiving facility. chain. Supply-chain programs are ensure the safety of animal food where Other comments assert that we should currently used by facilities as a standard hazards are controlled in raw materials eliminate any requirements for a business practice and we understand and other ingredients before receipt by supplier program from the rule because that some of those supply chains are a receiving facility, and we are a supplier program involving more complex, with entities between the finalizing such a requirement in this entities than just the receiving facility receiving facility and the supplier. We rule. The statute specifically identifies and the supplier would become too acknowledge that complex supply supplier verification activities as a complex. Some comments express chains present a challenge because preventive control (see section 418(o)(3) concern that we would be creating ‘‘an information will need to flow through of the FD&C Act). Further, we believe a environment where our supply chain is several entities to allow the link supply-chain program is a measure that required to be disclosed to our between the receiving facility and the

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supplier. However, we believe a supply- for a supply-chain program without demonstrate that compliance in order to chain program is a critical preventive specifying roles and responsibilities for comply with a different regulation. control for receiving facilities that will the various entities involved. Although (Response 431) We disagree that a rely on suppliers to control hazards in we have added flexibility to provide requirement for a supply-chain program raw materials and other ingredients. that an entity other than the receiving in which compliance with an Although distributors, brokers, and facility may determine, conduct, and underlying regulation is demonstrated is other entities in the supply chain document supplier verification duplicative with the need to comply between a receiving facility and its activities (see § 507.115), we continue to with the underlying regulation. The supplier are not required to have a role believe it is important to clearly define requirement for a supply-chain program in supplier verification, they have the two roles in the supply chain that share is not mandating that the facility or farm option to determine, conduct, and the primary responsibility in the comply twice with the animal food document supplier verification supplier verification process—i.e., the preventive controls rule or the produce activities as a service to the receiving receiving facility and the supplier. In all safety rule; it is merely requiring that facility if they so choose. If these cases where we have added flexibility the compliance by the facility or the entities choose not to participate in for participation by an entity other than farm with the applicable regulation be supplier verification, the receiving the receiving facility, the responsibility verified to ensure that hazards requiring facility will need to reach back in the for the supply-chain program is clearly a preventive control are being supply chain past them. In such lodged with the receiving facility, and controlled. situations, it may be necessary for the linked to the supplier (see § 507.115). We are continuing to specify the basic entities between the receiving facility To emphasize the responsibility of the content of a supply-chain program, i.e., and the supplier to provide the identity receiving facility and its link to the using approved suppliers; determining of the supplier to the receiving facility, supplier, the final rule clearly states that appropriate supplier verification if that identity is not available on the the receiving facility must approve its activities; conducting supplier raw material or other ingredient or suppliers before receiving raw materials verification activities; and establishing otherwise apparent. In such cases, the and other ingredients (see § 507.120(a)). records documenting these activities role that distributors, brokers, For the supply-chain program to be (see § 507.110(a)). However, the rule aggregators and similar entities would meaningful and robust, there must be an provides flexibility in the choice of play in supplier verification would be exchange of information between these supplier verification activities and how minimal. We cannot determine whether two entities—the entity receiving the often such activities must be performed. having to provide the identity of the animal food and the entity that (See §§ 507.110(b)(4) and 507.130(b)(2), supplier to the receiving facility would controlled the hazard—even when an (c), (d), and (e)). In addition, the rule change buying practices. However, we entity other than the receiving facility provides for an alternative supplier believe that manufacturers consider a participates by determining, conducting, verification activity for certain entities number of factors in determining who and documenting some supplier (see § 507.130(c), (d), and (e) regarding they will purchase from, including the verification activities. The ultimate alternative supplier verification services provided, and that there will responsibility for supplier verification activities for qualified facilities, certain continue to be a role for aggregators, rests with the receiving facility through produce farms, and certain shell egg repackers, brokers and others. We have its determination in approving suppliers producers, respectively). provided flexibility for these entities to and in reviewing and assessing play a role in supplier verification if the applicable documentation provided by XLI. Subpart E: Comments on receiving facility and the business entity another entity. Therefore, we also Requirement To Establish and determine there is a benefit to do so. disagree that the definition of Implement a Supply-Chain Program See also the discussion in section ‘‘supplier’’ should be revised to be the XLIII regarding the specific provisions next entity back in a supply chain (e.g., We proposed that the receiving of § 507.115. Although comments focus the entity with which a receiving facility must establish and implement a on flexibility for an entity in the supply facility has a commercial relationship). risk-based supplier program for those chain between the supplier and the The entity with which a receiving raw materials and ingredients for which receiving facility to perform supplier facility has a commercial relationship the receiving facility has identified a verification activities, and such entities might be a distributor, broker or significant hazard when the hazard is are the most likely to be determining, aggregator. A distributor, broker or controlled before receipt of the raw conducting, and documenting supplier aggregator does not control an identified material or ingredient (proposed verification activities, the flexibility hazard and, therefore, cannot assume § 507.37(a)). We also proposed provided by the rule is not limited to the same role as an establishment that circumstances when a receiving facility such entities. manufactures/processes the animal would not be required to have a (Comment 430) Some comments ask food, raises the animal, or grows the supplier program. us to establish a general requirement for food. In the following sections, we discuss a supplier program without specifying (Comment 431) Some comments ask comments that ask us to clarify the roles and responsibilities for the various us to provide flexibility in the content proposed requirement to establish and entities involved. Other comments ask of the supplier program. Some implement a written supplier program us to define ‘‘supplier’’ as the entity comments assert that specifying the or that disagree with, or suggest one or with which the receiving facility has a content of the supplier program would more changes to, the proposed commercial relationship. result in duplicative requirements on requirements. After considering these (Response 430) We disagree that we suppliers, who must first comply with comments, we have revised the should establish a general requirement certain regulations and then regulatory text as shown in table 24.

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TABLE 24—REVISIONS TO THE PROPOSED REQUIREMENTS TO ESTABLISH AND IMPLEMENT A SUPPLY-CHAIN PROGRAM

Final section Proposed section designation designation Description Revision

N/A ...... 507.37(a)(1)(ii) ...... A supplier program is not required when Deleted as unnecessary. there are no hazards requiring a preventive control. N/A ...... 507.37(a)(1)(ii) ...... A supplier program is not required when the Deleted as unnecessary. preventive controls at the receiving facility are adequate to significantly minimize or prevent each of the hazards requiring a preventive control. 507.36(a)(2) ...... 507.37(a)(1)(ii) ...... A supplier program is not required when the Shifted to be in provisions outside the frame- hazard will be controlled by the receiving work of the supply-chain program in sub- facility’s customer in the distribution chain. part E. 507.105(a)(2) ...... N/A ...... Circumstances that do not require a supply- A receiving facility is an importer, is in com- chain program even though the receiving pliance with the FSVP requirements, and facility’s hazard analysis determines that a has documentation of verification activities hazard requires a supply-chain-applied conducted under the FSVP program. control. 507.105(a)(3) ...... N/A ...... Exemption from the requirements for a sup- Exemption for animal food supplied for re- ply-chain program. search or evaluation. 507.105(c) ...... N/A ...... Requirements applicable to non-suppliers ..... When a supply-chain-applied control is ap- plied by an entity other than the receiving facility’s supplier, the receiving facility must (1) verify the supply-chain-applied control; or (2) obtain documentation of an appro- priate verification activity from another enti- ty in the supply chain, review and assess the entity’s applicable documentation, and document that review and assessment.

A. Requirement for a Written Supply- (Response 432) See Response 428 for but are instead controlled through Chain Program (Final § 507.105(a)(1) a discussion of our reasons for declining factors such as product formulation and (b)) this request and establishing (e.g., controlling the levels of required requirements for a supply-chain or contaminating chemicals in each We proposed that the receiving program in the rule. ingredient depending on the proportion facility must establish and implement a (Comment 433) Some comments ask of the ingredient in the finished animal risk-based supplier program for those us to revise the regulatory text to food) and the amount fed. For example, raw materials and ingredients for which remove the condition that all hazards be some comments explain that mineral the receiving facility has identified a foreseeable so that the supplier program content of certain raw materials or significant hazard when the hazard is can address economically motivated ingredients may require control in some controlled before receipt of the raw adulteration. situations (e.g., copper content in food material or ingredient. We also (Response 433) This comment is for sheep) but not in other situations proposed that the supplier program unclear. The requirement for a supply- (e.g., copper content in swine food). One must be written. (See proposed chain program applies when the comment expresses concern about § 507.37(a)(1)(i) and (2).) To improve outcome of a hazard analysis is that a whether customers would be willing to clarity, we have revised the provision to known or reasonably foreseeable hazard provide the receiving facility with substitute the phrase ‘‘hazard requiring requires a preventive control, and the confidential information about the a supply-chain-applied control’’ for the hazard would be controlled by the customer’s own hazard analysis with phrase ‘‘significant hazard when the receiving facility’s supplier. The respect to sensitive topics. Furthermore, hazard is controlled before receipt of the requirement applies regardless of in such cases the receiving facility will raw material or ingredient.’’ We have whether the hazard requiring a not even know whether the chemical added a definition for the term ‘‘supply- preventive control is, or is not, a hazard contaminant constitutes an actual chain-applied control’’ to mean a that would be introduced into a food for ‘‘hazard’’ for the purposes of the preventive control for a hazard in a raw the purposes of economic gain. customer’s finished food. This comment material or other ingredient when the (Comment 434) Some comments ask also asserts that a Certificate of Analysis hazard in the raw material or other us to specify that a Certificate of provided to a receiving facility ingredient is controlled before its Analysis or other documentation of the constitutes ‘‘control before receipt of the receipt (see § 507.3) and use the more existence and/or level of a hazard could raw material or ingredient.’’ specific term ’’ supply-chain-applied be provided to the receiving facility to (Response 434) We do not understand control,’’ rather than the broader term indicate the potential for an actual the concern of this comment. A ‘‘preventive control,’’ throughout the existence of a hazard so that the receiving facility and a supplier do not provisions for a supply-chain program. receiving facility could evaluate need to share all of the details of (Comment 432) As discussed in whether the hazard requires a product formulation for a receiving Comment 428, several comments ask us preventive control. Some comments facility to communicate its requirements to issue guidance rather than establish state that chemical hazards such as to a supplier. In the example provided requirements for a supplier program in nutrient imbalances are not controlled by the comment, the receiving facility the rule. through easily described ‘‘procedures’’ could provide the supplier with a

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written specification for a contaminant minimize or prevent the hazard. (See duplicate verification activities (see such as lead, and the supplier could proposed § 507.37(a)(1)(ii)(A), (B), and § 507.105(a)(2)). demonstrate that it satisfied the (C).) (Comment 437) Some comments receiving facility’s specification by We are deleting the proposed support the specified criteria for when providing a Certificate of Analysis provision that a supplier program is not a receiving facility would not be showing the results of laboratory testing required for raw materials and required to establish and implement a for lead. Neither the written ingredients for which there are no supplier program. Other comments specification provided by the receiving ‘‘significant hazards’’ (which we now express concern that these criteria facility, nor the Certificate of Analysis refer to as ‘‘hazards requiring a suggest no supplier verification is provided by the supplier, would preventive control’’) because it is needed at all in some circumstances disclose confidential information about unnecessary. The supply-chain program despite supplier verification activities the formulations or procedures of either is required when a hazard identified in being potentially informative about a entity. the receiving facility’s hazard analysis particular supplier. These comments ask This comment also appears to identifies a hazard requiring a supply- us to establish some general misunderstand the applicability of the chain-applied control; it is not requirement to perform verification supply-chain program. The rule requires necessary to also state the converse. activities for all suppliers. a supply-chain program when the Likewise, we are deleting the proposed (Response 437) We decline this receiving facility has identified, through provision that a supplier program is not request because it is neither risk-based its hazard analysis, that there is a hazard required if the preventive controls at the nor consistent with the nature and requiring a supplier-applied control. In receiving facility are adequate to purpose of the supply-chain program, the circumstances described by the significantly minimize or prevent each which is to provide assurance that a comment, a Certificate of Analysis or of the significant hazards. In such a hazard requiring a supply-chain-applied other documentation of test results from case, the outcome of the hazard analysis control has been significantly the supplier to the receiving facility would not be that the hazard requires a minimized or prevented (see the could demonstrate that the supplier has supply-chain-applied control. regulatory text of § 507.110(c)). We agree that some degree of verification of all controlled the hazard to the receiving As discussed in section XXVII, after suppliers may prove useful to a facility’s specifications, but would not considering comments, we are shifting receiving facility for various purposes, overturn the outcome of the receiving the provision in which the receiving and the rule would not prevent a facility’s hazard analysis that there is a facility relies on its customer to control hazard requiring a preventive control, receiving facility from establishing a the hazard from the requirements for a and that the appropriate control is supply-chain program for all of its supply-chain program to a series of applied by the supplier. On the suppliers regardless of risk and provisions that apply when a contrary, the Certificate of Analysis regardless of whether the applicable manufacturer/processor identifies a simply demonstrates that the supply- hazard in a raw material or other hazard requiring a preventive control, chain-applied control functioned as ingredient is controlled before its but can demonstrate and document that intended. receipt. (Comment 435) One comment asks us the hazard will be controlled by an (Comment 438) Some comments ask to specify in the regulatory text that the entity in its distribution chain (see us to specify that a ‘‘kill step’’ would be supplier program must be written ‘‘if §§ 507.36 and 507.37). However, as an adequate indicator to significantly required’’ because there are specified discussed in Response 428 and section minimize or prevent significant hazards circumstances when a supplier program XLI.C, we also are establishing two identified by the receiving facility when is not required. additional circumstances when a the receiving facility controls the (Response 435) We decline this supply-chain program is not required hazard. request. Although the rule provides (see § 507.105(a)(2) and (3)). (Response 438) These comments circumstances when a supply-chain (Comment 436) As noted in Comment appear to misunderstand the program is not required (see 428, some comments single out our applicability of the supply-chain § 507.105(a)(2)), it is not necessary to request for comment, in the proposed program. The rule requires a supply- specify, for all other provisions of the FSVP rule, on whether to allow an chain program when the receiving supply-chain program, that the entity that would be both an importer facility has identified, through its provision only applies ‘‘if required.’’ (under the FSVP rule) and a receiving hazard analysis, that there is a hazard facility (under animal food the requiring a preventive control and the B. Circumstances That Do Not Require preventive controls rule) to be deemed receiving facility’s manufacturing/ a Written Supply-Chain Program (Final in compliance with the FSVP rule if it processing will not control the hazard. § 507.105(a)(2)) was in compliance with the supplier In the circumstances described by the We proposed that the receiving verification provisions of the animal comment, the receiving facility is facility is not required to establish and food preventive controls rule, and agree controlling the hazard and a supply- implement a supplier program for raw with such an approach (78 FR 45730 at chain program for the raw material or materials and ingredients for which 45748). other ingredient is not required. It is not there are no significant hazards; the (Response 436) As noted in Response necessary to specify the types of preventive controls at the receiving 428, we have aligned the provisions for controls that the receiving facility may facility are adequate to significantly supplier verification in the FSVP rule use to control the hazard. minimize or prevent each of the with the provisions for a supply-chain (Comment 439) Some comments ask significant hazards; or the receiving program in this rule, and we are us to specify that a receiving facility facility relies on its customer to control allowing importers and receiving need not establish and implement a the hazard and annually obtains from its facilities to take advantage of that fact in supplier program for raw materials and customer written assurance that the considering compliance with our ingredients if those raw materials or customer has established and is forthcoming FSVP regulations that we ingredients were received from an following procedures (identified in the proposed to establish in in part 1, affiliated party within the same written assurance) that will significantly subpart L, so that they do not have to corporate or controlling entity.

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(Response 439) We decline this D. Additional Requirements for Non- FD&C Act and § 507.34(a)). That request. With the revisions we have Suppliers (Final § 507.105(c)) obligation includes responsibilities for made to the proposed requirements for As discussed in section IV.B of this raw materials and other ingredients a supplier program, the supply-chain rule and in section IV.B of the final rule when a supply-chain-applied control is program that we are establishing in this for preventive controls for human food applied by an entity other than the rule provides ample opportunities for an as published elsewhere in this addition receiving facility’s supplier. To clarify affiliated party within the same of the Federal Register, the final rule for the receiving facility’s responsibilities corporate or controlling entity to preventive controls for human food when a supply-chain-applied control is establish and implement a supply-chain includes several revisions to the ‘‘farm’’ applied by a non-supplier, we are program that is suited to its relationship definition in response to comments. establishing a requirement specifying to these entities. For example, as One change includes adding a new that when a supply-chain-applied discussed in Response 458, a receiving definition for a ‘‘secondary activities control is applied by an entity other facility might be able to determine and farm,’’ which provides for practices than the receiving facility’s supplier, the document a justification for a supplier such as packing by cooperatives and receiving facility must: (1) Verify the verification activity other than an packing houses under the ownership of supply-chain-applied control or (2) annual audit when a supplier is an multiple growers to remain within the obtain documentation of an appropriate affiliated party based on the receiving ‘‘farm’’ definition (see Response 25 in verification activity from another entity facility’s knowledge of the corporate the final rule for preventive controls for in the supply chain, review and assess policies regarding animal food safety human food). Another change to the the entity’s applicable documentation, practices (see § 507.130(b)(2)). In ‘‘farm’’ definition accommodates and document that review and addition, as discussed in Response 461, business models in which one operation assessment. See § 507.105(c). Because we have agreed that the corporate parent grows crops but does not harvest them, § 507.105(c) refers to provisions in a of a facility can be active in developing future produce safety rule, we will and implementing the facility’s food and another operation, not under the same management, harvests crops but publish a document in the Federal safety plan (see section XXIV.A). If, for Register announcing the effective date example, a corporate headquarters does not grow them (see Response 32 in the final rule for preventive controls for of that provision when we finalize the establishes and implements a supply- produce safety rule. chain program for use company-wide, a human food). This revision is a change We do not expect the receiving receiving facility could rely on supplier from the ‘‘farm’’ definition established facility to follow all of the requirements verification activities conducted by its in the section 415 registration of subpart E applicable to ‘‘suppliers’’ corporate headquarters, with applicable regulations in 2003, and the proposed when verifying a control by a ‘‘non- documentation available during revisions to the ‘‘farm’’ definition in the supplier,’’ as required by § 507.105(c). inspection. 2013 proposed human food preventive controls rule and the 2014 supplemental Instead, we expect the receiving facility C. Exemption for Animal Food Supplied human food preventive controls notice, to take steps such as a review of the for Research or Evaluation (Final which all describe a ‘‘farm’’ as an entity non-supplier’s applicable food safety § 507.105(a)(3)) ‘‘devoted to the growing and harvesting records. For example, if a receiving We are establishing an exemption of crops’’ (emphasis added). facility receives produce from a supply from the requirement for a receiving We proposed the requirements for a chain that includes a separate grower, facility to establish and implement a supplier program in the context of a harvester, and packer, the grower is the supply-chain program when it receives single business entity ‘‘devoted to the supplier and the requirements of animal food for the purposes of research growing and harvesting of crops’’ subpart E applicable to ‘‘suppliers’’ or evaluation, provided that certain (emphasis added) in which packing apply to the grower. To verify controls conditions are met (see § 507.105(a)(3)). operations were often done by that same applied by the harvester, the receiving Those conditions are that the animal business entity. The final ‘‘farm’’ facility could review the harvester’s food: (1) Is not intended for retail sale definition accommodates business records, such as records of training for and is not sold or distributed to the models where growing, harvesting, and harvest workers and records of public; (2) is labeled with the statement packing operations will be done by agricultural water quality used in ‘‘Animal food for research or evaluation different business entities. Harvesting harvest operations. To verify controls use’’; (3) is supplied in a small quantity and packing operations include some applied by the packer, the receiving that is consistent with a research, supply-chain-applied controls, such as facility could review the packer’s analysis, or quality assurance purpose, controls on worker hygiene, quality of records, such as records of agricultural the animal food is used only for this water used during harvesting and water quality used in packing purpose, and any unused quantity is packing operations, and establishing operations. As discussed in Response properly disposed of; and (4) is and following water-change schedules 429, we are allowing entities such as accompanied with documents, in for recirculated water, even though the distributors, brokers, and aggregators to accordance with the practice of the harvesting and packing operations do determine, conduct, and document trade, stating that the animal food will not fall within the definition of verification activities that apply to be used for research or evaluation ‘‘supplier.’’ suppliers as a service to the receiving purposes and cannot be sold or A receiving facility has an obligation facility, provided that the receiving distributed to the public. The exemption to identify and implement preventive facility reviews and assesses applicable is analogous to an exemption we controls to provide assurances that any documentation provided by the other proposed for the FSVP rule under hazards requiring a preventive control entity and documents that review and section 805(f) of the FD&C Act. (See will be significantly minimized or assessment. Likewise, under proposed § 1.501(c), 78 FR 45730 at prevented and the animal food § 507.105(c)(2) a receiving facility could 45745.) We believe it is not necessary to manufactured, processed, packed, or obtain documentation of review of conduct supplier verification activities held by the facility will not be applicable records maintained by the when animal food is obtained in this adulterated under section 402 of the harvester or packer from another entity, limited circumstance. FD&C Act (see section 418(c) of the review and assess the entity’s applicable

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documentation, and document that the receiving facility must conduct the program (such as factors to consider in review and assessment. verification activity or activities determining appropriate supplier We recognize that 507.105(c) may appropriate for each of those hazards. verification activities (proposed have limited applicability to raw We also proposed that for some hazards, § 507.37(b)), as well as several material and other ingredients used in in some situations it will be necessary requirements more narrowly targeted to animal food. At this time, we do not to conduct more than one verification specific aspects of the supplier program have an example of when we would activity and/or to increase the frequency (such as requirements applicable to expect an animal food manufacturer to of one or more verification activities to onsite audits). As part of the verify non-supplier controls for its raw provide adequate assurances that the redesignation of proposed § 507.37 into materials or other ingredients. Although hazard is significantly minimized or subpart E, with eight distinct sections, we do not have examples and expect prevented. We have concluded that we are establishing the more general limited applicability of § 507.105(c)(2), these provisions are largely self-evident we have included these provisions to and need not be included in the requirements in § 507.110 (see table 25). provide for instances when an animal regulatory text. Therefore, we are not Most comments that support the food facility identifies situations in finalizing these proposed provisions. proposed provisions suggest alternative which controls applied by a ‘‘non- We will consider whether it will add or additional regulatory text. In the supplier’’ need to be verified as part of value to discuss the principles in these following sections, we discuss the facility’s supply-chain program. proposed provisions in guidance that comments that ask us to clarify the we intend to develop for the supply- E. Proposed General Requirements for proposed requirements or that disagree chain program. the Supply-Chain Program That We Are with, or suggest one or more changes to, Not Including in the Final Rule XLII. Subpart E: Comments on General the proposed requirements. After (Proposed § 507.37(a)(4) and (5)) Requirements for the Supply-Chain considering these comments, we have revised the regulatory text as shown in We proposed that when supplier Program table 25. verification activities are required for We proposed several requirements more than one type of hazard in a food, generally applicable to the supplier

TABLE 25—REVISIONS TO THE PROPOSED GENERAL REQUIREMENTS APPLICABLE TO A SUPPLY-CHAIN PROGRAM

Final section Proposed section designation designation Description Revision

507.110(a) ...... 507.37(a)(3) ...... What the supply-chain pro- Add that the supply-chain program includes, when ap- gram must include. plicable, verifying a supply-chain-applied control ap- plied by an entity other than the receiving facility’s supplier and documenting that verification, or obtain- ing documentation of an appropriate verification ac- tivity from another entity, reviewing and assessing that documentation, and documenting the review and assessment. 507.110(b) ...... 507.37(c)(1) ...... Appropriate supplier N/A. verification activities. 507.110(c) ...... 507.37(a)(3)(ii) ...... Purpose of supplier Specify only that the supply-chain program must pro- verification activities for vide assurance that a hazard requiring a supply- raw materials and other chain-applied control has been significantly mini- ingredients. mized or prevented. 507.110(d) ...... 507.37(b) ...... Factors that must be con- Clarify that the factors apply in approving suppliers, as sidered when approving well as in determining appropriate supplier suppliers and deter- verification activities. mining appropriate sup- plier verification activities for raw materials and other ingredients. 507.110(d) ...... 507.37(b) ...... Factors that must be con- • Specify that three of the factors relate to ‘‘supplier sidered when approving performance’’ suppliers and deter- • Specify ‘‘The entity or entities that will be applying mining appropriate sup- controls for the hazards requiring a supply-chain-ap- plier verification activities plied control’’ rather than ‘‘Where the preventive for raw materials and controls for those hazards are applied for the raw other ingredients; Sup- material and ingredients—such as at the supplier or plier performance.. the supplier’s supplier’’. • Add ‘‘other FDA compliance actions related to food safety’’ as an example of information relevant to the supplier’s compliance with applicable FDA food safety regulations. • Clarify that consideration of supplier performance in- cludes, when applicable, relevant laws and regula- tions of a country whose food safety system FDA has officially recognized as comparable or has de- termined to be equivalent to that of the United States and information relevant to the supplier’s compliance with those laws and regulations.

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TABLE 25—REVISIONS TO THE PROPOSED GENERAL REQUIREMENTS APPLICABLE TO A SUPPLY-CHAIN PROGRAM— Continued

Final section Proposed section designation designation Description Revision

• Provide flexibility in the factors that must be consid- ered if a supplier is a qualified facility, a produce farm that will not be subject to the forthcoming produce safety rule on the basis of size and/or di- rect farm marketing, or a shell egg producer that is not subject to the requirements of 21 CFR part 118 (production, storage, and transportation of shell eggs) because it has less than 3,000 laying hens. 507.110(e) ...... 507.37(f) ...... Supplier non-conformance N/A.

A. Description of What the Supply- requirement when a supply-chain- food safety plan and written procedures Chain Program Must Include (Final applied control is applied by an entity and to observe the implementation of § 507.110(a)) other than the receiving facility’s animal food safety procedures, as well We proposed to require that a supplier (see § 507.105(c)). For clarity, as to review the records related to the supplier program include verification § 507.110(a) states this general past application of control measures, activities, as appropriate to the hazard, requirement for the supply-chain including laboratory test results. Audits and documentation of these activities, to program in § 507.105(a)(5), and also provide the opportunity to ensure raw materials and ingredients are § 507.105(c) provides the specific interview employees to assess their received only from suppliers approved requirements that apply when a supply- understanding of the animal food safety for control of the hazard(s) in that raw chain-applied control is applied by an measures for which they are material or ingredient (or, when entity other than the receiving facility’s responsible. Thus, an audit can provide necessary and appropriate, on a supplier. for a more comprehensive assessment of temporary basis from unapproved B. Appropriate Supplier Verification animal food safety implementation by a suppliers) (proposed § 507.37(a)(3)(i)). Activities ((Final § 507.110(b)) facility. Comments that oppose We also proposed to require that a including onsite audits as a verification supplier program include verification We proposed to require that activity are concerned that farms will be activities, as appropriate to the hazard, appropriate supplier verification required to have audits to verify that and documentation of these activities. activities include: (1) Onsite audits; (2) they are in compliance with produce We also proposed requirements sampling and testing of the raw material safety standards or facilities will be applicable to the determination and or ingredient, which may be conducted required to have audits to verify documentation of appropriate supplier by either the supplier or receiving preventive controls. These comments verification activities (proposed facility; (3) review by the receiving apparently refer to the provision in § 507.37(b)). We also proposed specific facility of the supplier’s relevant food section 419(c)(1)(E) of the FD&C Act that documentation requirements for records safety records; or (4) other appropriate the regulation issuing standards for the associated with the supplier program supplier verification activities based on safety of produce ‘‘not require a (proposed § 507.37(g)). the risk associated with the ingredient business to hire a consultant or other The final rule specifies that the and the supplier (proposed third party to identify, implement, supply-chain program must include: (1) § 507.37(c)(1)). certify compliance with these Using approved suppliers; (2) (Comment 440) Some comments procedures, processes and practices,’’ or determining appropriate supplier support the inclusion of onsite audits as the provision in section 418(n)(3)(D) of verification activities (including an appropriate supplier verification the FD&C Act that the preventive determining the frequency of activity. However, other comments controls regulation ‘‘not require a conducting the activity); (3) conducting oppose it, and ask us to remove the facility to hire a consultant or other supplier verification activities; and (4) onsite audit requirement from the third party to identify, implement, documenting supplier verification supplier verification program, stating certify or audit preventative controls.’’ activities. For clarity, § 507.110(a) states that Congress prohibited FDA from The regulations proposed under section this general requirement for the supply- requiring third parties to verify or audit 419 of the FD&C Act would not impose chain program and §§ 507.120, 507.125, compliance with the rules. These such requirements. The requirements 507.130, 507.135, and 507.175 provide comments express concern that the for supplier verification in this rule the specific requirements for using supplier verification program effectively (under section 418 of the FD&C Act) approved suppliers, determining imposes an ‘‘entire second layer of provide for audits as one supplier appropriate supplier verification regulation’’ on farms that are supplying verification activity. Although the rule activities, conducting verification ingredients to processors, and claim this does specify an annual onsite audit as activities, specific requirements for is an unnecessary burden that is not the appropriate supplier verification onsite audits, and records, respectively. authorized by FSMA. activity when a hazard in a raw material See the discussion of the specific (Response 440) We are retaining or other ingredient will be controlled by requirements of §§ 507.120, 507.125, onsite audits as an appropriate supplier the supplier and is one for which there 507.130, 507.135, and 507.175 in verification activity. Onsite audits may is a reasonable probability that exposure sections XLIV, XLV, XLVI, and XLVII, be less commonly used by the animal to the hazard will result in serious respectively. food industry than the human food adverse health consequences or death to As discussed in section XLI.D, the industry. However, onsite audits humans or animals, the receiving final rule establishes a verification provide the opportunity to review the facility is not required to hire a third

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party to conduct the audit. Any rule for animal food (78 FR 64736 at food safety records.’’ The rule provides qualified auditor, other than the 64836)). We agree that there are benefits for onsite audits as a verification supplier, may conduct the audit, in having sampling and testing activity, as well as reviewing a including an employee of the receiving conducted by the supplier, because the ‘‘supplier’s relevant food safety facility or another entity, such as an supplier can then take appropriate records.’’ When an annual audit is entity in the supply chain between the action with respect to the findings, determined to be an appropriate supplier and the receiving facility. The including not shipping contaminated verification activity (see rule also provides that a receiving product. However, because § 507.130(b)(1)), the audit would be facility may determine and document contamination with some hazards is reviewed by the receiving facility, but a that other verification activities and/or likely to be non-homogeneous and for review of this audit is not what we less frequent onsite auditing of the microbial pathogens or microbial toxins meant by a ‘‘supplier’s relevant food supplier provide adequate assurance the numbers are likely to be low, a safety records.’’ As described in an FDA that the hazards are controlled (see negative test result does not guarantee memorandum on supplier programs, § 507.130(b)(1) and (2)). Audits already the absence of contamination. This food safety records are records conducted on a supplier’s facility or should be taken into account when documenting that the food safety operation for other business purposes deciding which verification activity (or procedures that have been established to may meet the requirement for supplier activities) is appropriate. Because of the control hazards are being followed and verification. In addition, the rule limitations of sampling and testing, the are adequately controlling such hazards provides alternative requirements for controls the supplier has in place to (Ref. 53). Thus, a receiving facility may verification of suppliers that are farms minimize contamination, and the obtain documentation of a supplier’s that grow produce and are not a covered management of those controls, are key control measures for a particular lot of farm under part 112 in accordance with in determining when sampling and a raw material or other ingredient § 112.4(a), or in accordance with testing is appropriate as a verification provided to the receiving facility, such §§ 112.4(b) and 112.5 (see § 507.130(d)). activity. For short shelf life products, as the records created when a process Finally, we have also provided that where holding product pending test control measure was applied. The food inspections may substitute for an audit results can negatively impact product safety records may also include supplier under specified circumstances (see quality and usefulness, an onsite audit records that show that the supplier’s § 507.135(c)). to verify control of hazards may be more supplier has controlled a hazard. Such While we realize that some farms may appropriate than sampling and testing. records may include audits, for receive audits under the supplier (Comment 442) Some comments ask example, when the supplier’s supplier verification provisions of part 507, we us to specify in the regulatory text that controls the hazard and the supplier’s anticipate that onsite audits will be used sampling and testing can be conducted records include records of an audit as a verification activity more frequently by or on behalf of the supplier or the conducted with respect to the hazard for non-farm facilities because hazards receiving facility. control activities of the supplier’s (Response 442) The provisions of associated with commercial animal food supplier. To emphasize that the review § 507.115 specify the responsibilities of production are not typically controlled of a supplier’s relevant food safety the receiving facility, and allow a by the farm, but rather during records can include records other than receiving facility to conduct all supplier manufacture or processing of the animal records of audits, we have revised the verification activities, including food. documentation requirements applicable (Comment 441) Some comments sampling and testing. These provisions to review of a supplier’s food safety support the inclusion of sampling and also provide that a supplier, or an entity records to specify that the testing of the raw material or other other than the receiving facility (such as ingredient as an appropriate supplier an entity in the supply chain between documentation must include the general verification activity, and note that the supplier and the receiving facility), nature of the records reviewed (see verification testing is more effective can conduct sampling and testing, § 507.175(c)(9)). By ‘‘general nature of when conducted by the supplier than provided that the receiving facility the records reviewed’’, we mean the receiving facility because the reviews and assesses the documentation information such as ‘‘records of process supplier can control the lot of product provided by the supplier. The rule controls.’’ tested. However, other comments places no restrictions on when a (Comment 444) Some comments oppose it, stating that sampling and receiving facility, a supplier, or an support the inclusion of other testing is not useful for products for entity other than the receiving facility appropriate supplier verification various reasons such as the non- could have a business relationship with activities based on the risks associated homogeneous distribution of some a third party (such as a contract with the ingredient and the supplier, hazards, or statistical limitations laboratory) to conduct sampling and because it provides flexibility for because of practical limits on number of testing. facilities to design risk-based programs samples or limited shelf life of some (Comment 443) Some comments that are appropriate for their operations. products. suggest that, for a facility regularly Comments suggest other verification (Response 441) We are retaining undergoing audits, reviewing a activities may include receiving raw sampling and testing as an appropriate ‘‘supplier’s relevant food safety records’’ materials and other ingredients from a supplier verification activity. As noted should allow for the receiving facility to supplier without a full audit report if in the FDA memorandum on supplier review documentation related to pre- the supplier maintains certification to a programs, sampling and testing are existing audits. These comments ask us standard recognized by the Global Food commonly used by industry in the to revise the provision to add Safety Initiative (GFSI); providing for verification of supplier performance ‘‘including, but not limited to, records documentary verification (such as fact- (Ref. 53). We have previously discussed related to audits previously performed specific questionnaires and factors that impact the utility and on the supplier’s facility.’’ representations exchanged between the frequency of raw material/ingredient (Response 443) We decline this supplier and the receiving facility); and testing (see the Appendix published in request. The comment misinterprets confirming that a facility, especially a the 2013 proposed preventive controls what we mean by a ‘‘supplier’s relevant small manufacturing facility, is licensed

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by the appropriate State or local revised the provision to specify that the D. Factors That Must Be Considered regulatory authority. supply-chain program must provide When Approving Suppliers and (Response 444) We are retaining this assurance that a hazard requiring a Determining Appropriate Supplier provision to allow other appropriate supply-chain-applied control has been Verification Activities for Raw Materials supplier verification activities based on significantly minimized or prevented. If and Other Ingredients (Final supplier performance and the risk the supply-chain program provides § 507.110(d)) associated with the raw material or assurance that a hazard requiring a We proposed that in determining and other ingredient (§ 507.110(b)(4)). We supply-chain-applied control has been documenting the appropriate have revised the regulatory text to refer significantly minimized or prevented, it verification activities, the receiving to ‘‘supplier performance and the risk is not necessary to also specify that the facility must consider the following: (1) associated with the raw material or incoming raw material or ingredient is The hazard analysis, including the other ingredient’’ because ‘‘supplier not adulterated under section 402 of the nature of the hazard, applicable to the performance’’ is more appropriate than FD&C Act. We also have deleted the raw material and ingredients; (2) where ‘‘risk associated with the supplier.’’ We requirement that the verification the preventive controls for those use the term ‘‘risk’’ as defined by the activities must verify that the incoming hazards are applied for the raw material Codex Alimentarius Commission to be raw material or ingredient is produced and ingredients, such as at the supplier ‘‘a function of the probability of an in compliance with the requirements of or the supplier’s supplier; (3) the adverse health effect and the severity of applicable FDA food safety regulations that effect, consequential to a hazard(s) supplier’s procedures, processes, and and instead focused that requirement as practices related to the safety of the raw in food’’ (Ref. 54). As discussed in a factor that must be considered in section XLII.D, the considerations for material and ingredients; (4) applicable approving suppliers and determining supplier performance, which can be FDA food safety regulations and the appropriate supplier verification related to the probability of a hazard in information relevant to the supplier’s activities and the frequency with which the raw material or ingredient and the compliance with those regulations, they are conducted rather than as one of severity of adverse health effects that including an FDA warning letter or can result, are broader than this. the stated purposes of the supply-chain import alert relating to the safety of the We do not believe that a supplier program. See the regulatory text of animal food; (5) the supplier’s food maintaining certification to an industry § 507.110(d)(i)(iii)(B). safety performance history relevant to standard would, by itself, serve as (Comment 445) Some comments ask the raw materials or ingredients that the verification that a supplier is controlling us to revise this provision to state that receiving facility receives from the the hazard; however we agree that this the receiving facility’s use of the supplier, including available can be a consideration in the incoming raw material or ingredient information about results from testing determination of the type and frequency will not cause the finished food to be raw materials or ingredients for hazards, of the verification activity conducted. adulterated under section 402 of the audit results relating to the safety of the Similarly, fact-specific questionnaires FD&C Act. These comments assert that food, and responsiveness of the supplier and representations exchanged between FSMA does not mandate, nor is it in correcting problems; and (6) any the supplier and the receiving facility reasonable to expect, that incoming raw other factors as appropriate and can be a consideration in the materials and ingredients will not be necessary, such as storage and determination of the type and frequency adulterated under section 402, and that transportation practices (proposed of the verification activity conducted. it is acceptable for a receiving facility to § 507.37(b)). Confirming that a facility is licensed by control the ‘‘adulterating hazard,’’ even As discussed in Responses 429 and 430 and section XLIV.A, we have the appropriate State or local regulatory if it relies on the supplier to control revised the regulatory text regarding use authority should not serve as the only other hazards. verification that a supplier is controlling of approved suppliers to more explicitly the hazard, because the requirements for (Response 445) We decline this state that the receiving facility must a license and the degree of inspectional request. We acknowledge that in some approve suppliers. The factors that must oversight could vary greatly. We do circumstances a receiving facility may be considered in determining the provide for modified supplier rely on the supplier to control certain appropriate supplier verification verification activities for qualified hazards, while controlling other hazards activities are equally relevant to facilities, which are very small itself. For example, a receiving facility approving suppliers, and the final rule businesses (§ 507.130(c)). that produces dry dog food that contains requires that these factors must be corn could rely on its supplier for the considered in approving suppliers, as C. Purpose of Supplier Verification control of the chemical hazard aflatoxin, well as in determining appropriate Activities for Raw Materials and Other but control the biological hazard supplier verification activities. For Ingredients (Final § 507.110(c)) Salmonella through its own heat- clarity and consistency with terms used We proposed to require that a treatment process. However, the supply- throughout the final provisions for a supplier program include verification chain program applies to hazards supply-chain program, the final rule activities, as appropriate to the hazard, requiring a supply-chain-applied specifies ‘‘the entity or entities that will and documentation of these activities, to control, and the purpose relates to those be applying controls for the hazards verify that: (1) The hazard is hazards. In the example where the requiring a supply-chain-applied significantly minimized or prevented; receiving facility is relying on the control’’ rather than ‘‘Where the (2) the incoming raw material or supplier to control aflatoxin, the preventive controls for those hazards are ingredient is not adulterated under provision would require the receiving applied for the raw material and section 402 of the FD&C Act of the facility to verify that the hazard ingredients—such as at the supplier or FD&C Act; and (3) the incoming raw (aflatoxin) has been significantly the supplier’s supplier.’’ material or ingredient is produced in minimized or prevented by the supplier As discussed in Response 444, we are compliance with the requirements of and that the level of aflatoxin in the using the term ‘‘supplier performance,’’ applicable FDA food safety regulations corn does not render it adulterated rather than ‘‘risk of supplier,’’ when (proposed § 507.37(a)(3)(ii)). We have under the FD&C Act. discussing factors associated with

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suppliers. The final rule groups three of activities. Some comments state that not hazard requiring a preventive control is the proposed factors as ‘‘supplier all of the factors that we proposed a controlled before receipt of a raw performance.’’ As a companion change receiving facility consider are relevant material or other ingredient, supplier to emphasize that ‘‘supplier for the process of selecting the oversight is needed. performance’’ applies to all three of verification activity. These comments We recognize that there is need for these factors, we refer to the supplier’s suggest changing the regulatory text to additional flexibility regarding ‘‘food safety history’’ rather than ‘‘food require a receiving facility to consider conducting supplier verification safety performance history.’’ ‘‘both food and supplier related risks, activities. As discussed in Response We also have revised the regulatory including the following, as appropriate’’ 429, we are providing significant text to clarify that consideration of and then listing the factors as proposed. additional flexibility to address this supplier performance includes, when Other comments suggested similar situation in the final rule. applicable, relevant laws and changes to the regulatory text. (Comment 449) Some comments regulations of a country whose food (Response 446) We disagree that not object to the proposed requirement to safety system FDA has officially all of the factors that we proposed a consider applicable FDA food safety recognized as comparable or has receiving facility to consider are regulations and information relevant to determined to be equivalent to that of relevant to determining the appropriate the supplier’s compliance with those the United States and information verification activity. Every factor might regulations, including an FDA warning relevant to the supplier’s compliance not be determinative in all cases, and letter or import alert relating to the with those laws and regulations. We our requirement merely to consider each safety of the food. These comments made this change because the final rule factor does not assume so. However, any assert that it is difficult for a receiving includes several provisions that one of these factors could be crucial facility to know a supplier’s compliance acknowledge that some animal food depending on the animal food, the status, because it is not easy to obtain establishments, including animal food hazard, and the nature of the preventive this kind of information in a timely establishments that are ‘‘suppliers’’ as control. We continue to consider it fashion. Some comments ask us to that term is defined in this rule, operate appropriate to require receiving develop an online database to house this in a foreign country. (See, e.g., the facilities to consider each of these information to help make it easier to definition of ‘‘qualified auditor’’ in factors in making their determinations find. Some comments ask us to replace § 507.3 and §§ 507.7(a)(2)(ii), 507.7(e), about the appropriate verification the broad requirement to consider 507.105(a)(2), 507.130(c), activities. applicable FDA food safety regulations 507.135(c)(1)(ii), 507.135(c)(2), and (Comment 447) Some comments ask and information relevant to the 507.175(c)(15)). Some of these us to clarify that the phrase ‘‘the nature supplier’s compliance with those provisions (e.g., §§ 507.105(a)(2), of the hazard’’ means the nature of the regulations with a narrower requirement 507.130(c), 507.135(c)(1)(ii), hazard requiring control. to only consider any FDA warning letter 507.135(c)(2), and 507.175(c)(15)) are in (Response 447) We have revised the or import alert relating to the safety of the requirements for a supply-chain regulatory text to specify ‘‘the nature of the food. program. When the supplier is in a the hazard controlled before receipt of (Response 449) We are retaining the foreign country whose food safety the raw material or other ingredient.’’ broad requirement to consider system FDA has officially recognized as The revised regulatory text is consistent applicable FDA food safety regulations comparable or determined to be with regulatory text in the provisions for and information relevant to the equivalent to that of the United States, the preventive control management supplier’s compliance with those a receiving facility may substitute the components (see § 507.39(b), which regulations. Such information is written results of an inspection by the specifies ‘‘taking into account the nature relevant to supplier performance applicable food safety authority for an of the hazard controlled before receipt regardless of whether there is an audit, provided that certain conditions of the raw material or other applicable warning letter or import are met (see § 507.135(c)(1)(ii) and (2)). ingredient’’). alert. However, as of August 30, 2015, FDA (Comment 448) Some comments agree We currently have a searchable online has not developed a systems recognition that a receiving facility must consider database for warning letters (Ref. 55) program for animal food; therefore, we where the preventive controls for and another searchable online database have no signed systems recognition hazards are applied for the raw for import alerts (Ref. 56). Both of these agreements with any foreign food safety materials and ingredients, such as at the databases are available to the public authority relating to animal food. The supplier or the supplier’s supplier. from our homepage at http:// currently existing systems recognition Other comments assert that this www.fda.gov. We also publicize actions agreement relates solely to human food consideration should not be used to to suspend a facility’s registration, such and does not apply to animal food. The determine if supplier oversight is as in our 2012 suspension of registration final rule provides flexibility for needed. Other comments state that it due to Salmonella contamination of nut alternative verification requirements for may be hard to review the procedures butter and nut products (including certain entities (see § 507.130(c), (d), used by a supplier’s supplier and ingredients used in animal foods) and (e)). We have revised the factors beyond and ask us to provide clear manufactured, processed, packed, and that must be considered regarding flexibility regarding requirements for held by the facility (Ref. 57). Under the supplier performance to reflect the the content and performance of a requirement to consider supplier flexibility the rule provides for receiving facility’s supplier program. performance with respect to applicable conducting supplier verification (Response 448) The purpose of the food safety regulations, a receiving activities for these entities (see requirement to consider where the facility cannot ignore published § 507.110(d)(2)). hazard is controlled is to assist a information relating to a supplier’s (Comment 446) Some comments receiving facility in determining what compliance with applicable FDA food support the flexibility for receiving supplier verification activities are safety regulations in determining the facilities to determine the appropriate appropriate, not to determine whether appropriate verification activities, such supplier verification activities and supplier oversight is needed. Once a as publicized information regarding frequency with which to conduct these receiving facility has determined that a suspension of registration. To

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emphasize this point, we have revised that it should implement verification ‘‘Responsibilities of the receiving the regulatory text to specify that the activities related to controlling for facility’’ to emphasize the responsibility applicable information includes ‘‘other physical hazards. of the receiving facility for its supply- FDA compliance actions related to (Comment 451) Some comments ask chain program. (See Responses 429 and animal food safety.’’ We also have us to replace the phrase ‘‘examples of 430.) Although comments focus on revised the regulatory text to specify factors that a receiving facility may flexibility for an entity in the supply that the compliance relates to an FDA determine are appropriate and necessary chain between the supplier and the warning letter or import alert relating to are storage and transportation’’ with receiving facility to perform supplier the ‘‘safety of animal food,’’ rather than ‘‘such as storage and transportation.’’ verification activities, and such entities the ‘‘safety of the animal food,’’ to (Response 451) We have made this are the most likely entities to be the provide flexibility for a receiving facility editorial change. entities determining, conducting, and to identify information that may raise a E. Supplier Non-Conformance (Final documenting supplier verification question about a supplier’s compliance § 507.110(e)) activities, the flexibility provided by the history in a more general way, rather rule is not limited to such entities. than only with respect to a particular We proposed that if the owner, The rule does, however, set some animal food. operator, or agent in charge of a bounds on the flexibility for (Comment 450) Some comments state receiving facility determines through determining, conducting, and we should only require consideration of auditing, verification testing, relevant documenting appropriate supplier the supplier’s food safety performance consumer, customer or other verification activities. For example, as history relevant to the hazards requiring complaints, or otherwise that the discussed in Responses 429 and 430, control in the raw materials or supplier is not controlling hazards that only the receiving facility can approve ingredients that the receiving facility the receiving facility has identified as its suppliers. As another example, receives from the supplier. significant, the receiving facility must although it would not be appropriate for (Response 450) Consideration of the take and document prompt action in a supplier to determine the appropriate supplier’s animal food safety history accordance with § 507.42 to ensure that supplier verification activities for itself, relevant to the raw materials or other raw materials or ingredients from the we had proposed that it would be ingredients that the receiving facility supplier do not cause food that is appropriate for a supplier to conduct receives from the supplier will be manufactured or processed by the sampling and testing of raw materials focused on the hazard that the supplier receiving facility to be adulterated and ingredients as a supplier is controlling because that is the food under section 402 of the FD&C Act verification activity (proposed safety information the receiving facility (proposed § 507.37(f)). will consider to be relevant and for (Comment 452) Some comments § 507.37(c)(1)(ii)), and we are retaining which the receiving facility would object to the use of the word that provision in the final rule (see develop a history. The information ‘‘significant’’ in this proposed provision, § 507.115(a)(4)). Likewise, it is common could indicate that certain verification recommending that we replace it with industry practice for a supplier to activities may be more appropriate than ‘‘requiring control by the supplier.’’ arrange for an audit by a third party others for verifying the control of the These comments reason that these (Ref. 53), and the new flexibility hazard at that particular supplier or activities are only necessary if the provision does not prohibit a receiving provide information useful in receiving facility is relying on the facility from relying on an audit determining a frequency for the supplier to control the specific hazards. provided by its supplier when the audit verification activity. However, we (Response 452) We have revised the of the supplier was conducted by a decline to revise the provision to specify regulatory text to state ‘‘a hazard third-party qualified auditor in that consideration should be limited to requiring a supply-chain-applied accordance with the requirements of the the hazards requiring control. Even control’’ rather than ‘‘significant.’’ rule applicable to audits (§ 507.135). See though this is the most relevant § 507.115 for the full text of this new information, a facility may become XLIII. Subpart E: New Requirement flexibility provision. aware of information with respect to a Specifying the Responsibilities of the Receiving Facility (Final § 507.115) XLIV. Subpart E: Comments on Using raw material or other ingredient Approved Suppliers and Determining provided to another customer of the As discussed in Response 429, after Appropriate Supplier Verification supplier that may suggest the need to considering comments we are providing Activities conduct a different verification activity. flexibility for an entity other than the For example, if the receiving facility is receiving facility to determine, conduct, We proposed requirements for the use obtaining mineral premix from a and document the appropriate supplier of approved suppliers (proposed supplier that is controlling for a nutrient verification activities, provided that the § 507.37(a)(3)(i)) and for determining imbalance of copper and molybdenum receiving facility reviews and assesses and documenting appropriate supplier and becomes aware that mineral the entity’s applicable documentation, verification activities (proposed premixes from this supplier have been and documents the receiving facility’s § 507.37(b)). See table 26 for a associated with a recall due to review and assessment. We are description of the final provisions and contamination with a physical hazard, specifying that flexibility in § 507.115. the changes we have made to clarify the the receiving facility would determine We have titled this section requirements.

TABLE 26—REVISIONS TO THE PROPOSED REQUIREMENTS FOR APPROVING SUPPLIERS AND FOR DETERMINING AND DOCUMENTING APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES

Final section Proposed section designation designation Description Revision

507.120(a) ...... 507.37(a)(3)(i) ...... The receiving facility must approve suppliers Explicit statement of this requirement. and document that approval.

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TABLE 26—REVISIONS TO THE PROPOSED REQUIREMENTS FOR APPROVING SUPPLIERS AND FOR DETERMINING AND DOCUMENTING APPROPRIATE SUPPLIER VERIFICATION ACTIVITIES—Continued

Final section Proposed section designation designation Description Revision

507.120(b)(1) ...... 507.37(a)(3)(i) ...... Written procedures for receiving raw mate- Explicit requirement for written procedures. rials and other ingredients must be estab- lished and followed. 507.120(b)(2) ...... The purpose of the written procedures is to N/A. ensure that raw materials and other ingre- dients are received only from approved suppliers (or, when necessary and appro- priate, on a temporary basis from unap- proved suppliers whose raw materials or other ingredients the receiving facility sub- jects to adequate verification activities be- fore acceptance for use). 507.120(b)(3) ...... 507.37(a)(3)(i) ...... Use of the written procedures for receiving Conforming change associated with the ex- raw materials and other ingredients must plicit requirement to establish and follow be documented. written procedures. 507.125 ...... 507.37(b) ...... Requirement to determine and document ap- N/A. propriate supplier verification activities.

A. Using Approved Suppliers (Final received only from suppliers approved basis in guidance that we intend to issue §§ 507.120) by the receiving facility (or, when regarding the supply-chain program. We We proposed to require that a necessary and appropriate, on a do not believe that the final supplier program include verification temporary basis from unapproved requirements regarding the use of activities, as appropriate to the hazard, suppliers whose raw materials or other approved suppliers will require and documentation of these activities, to ingredients are subjected to adequate increased implementation time. The ensure raw materials and ingredients are verification activities before acceptance principal change is to allow flexibility received only from suppliers approved for use), and use that term throughout for entities in the supply chain other for control of the hazard(s) in that raw subpart E. For example, a facility could than the receiving facility to establish material or ingredient (or, when design a checklist for employees to use written procedures for receiving raw necessary and appropriate, on a when raw materials and other materials and other ingredients and temporary basis from unapproved ingredients are delivered to the facility. document that written procedures for suppliers whose raw materials or We decided to specify use of written receiving raw materials and other ingredients the receiving facility procedures for receiving raw materials ingredients are being followed. and other ingredients in light of the subjects to adequate verification B. Determining Appropriate Verification flexibility the final rule provides for an activities before acceptance for use) Activities (Final § 507.125) (proposed § 507.37(a)(i)). entity other than the receiving facility This proposed requirement included (such as an entity in the supply chain The rule requires that a supply-chain an implicit requirement that a facility between the supplier) to conduct this program include determining must approve suppliers. For clarity, we activity (see § 507.115(a)(2)). Although appropriate supplier verification make that requirement, and we agree that such an entity can do this activities (including determining the documentation of that approval, explicit as a service to the receiving facility, a frequency of conducting the activity) in the final rule. (See § 507.120(a)). written procedure is appropriate to (see § 507.110(a)(2)). Comments that The rule continues to require that a ensure a robust and meaningful addressed the proposed provision for receiving facility ensure raw materials verification. As a companion change, we determining appropriate verification and other ingredients are received only revised the associated documentation activities (which provides flexibility to from suppliers approved for control of requirement to specify documentation the facility to determine the appropriate the hazard(s) in that raw material or of use of the written procedures. verification activities) did not disagree other ingredient (or, when necessary (Comment 453) Some comments with it. The rule also requires that and appropriate, on a temporary basis support the requirement to approve certain factors must be considered in from unapproved suppliers whose raw suppliers. Other comments ask us to determining appropriate verification materials or other ingredients are provide guidance for use of unapproved activities (§ 507.110(d)). We discuss subject to adequate verification suppliers on a temporary basis, because those factors, and comments that activities before acceptance for use), but the use of unapproved suppliers could addressed those factors, in section we revised the provision to specify that be a high risk situation. Other comments XLII.D. Both of these provisions (i.e., the receiving facility must do so by emphasize that if the final supplier § 507.110(a)(2) and § 507.110(d)) derive establishing and following written approval process is significantly from the proposed requirement procedures, and require documentation changed compared to the proposed regarding factors that must be that these procedures were followed. To supplier approval process, industry considered in determining appropriate simplify the provisions, we also must have enough time to plan and supplier verification activities established a definition for the term develop supplier verification plans and (proposed § 507.37(b)). To give ‘‘written procedures for receiving raw a process for unapproved sources. prominence to both the responsibility materials and other ingredients’’ to (Response 453) We will consider and the flexibility to determine mean written procedures to ensure that including guidance for use of appropriate supplier verification raw materials and other ingredients are unapproved suppliers on a temporary activities, and emphasize the factors

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that must be considered in addressing XLV. Subpart E: Comments on additional regulatory text or ask us to this responsibility, new § 507.125 Conducting Supplier Verification clarify how we will interpret the specifies that appropriate supplier Activities for Raw Materials and Other provision. In the following sections, we verification activities (including the Ingredients discuss comments that ask us to clarify frequency of conducting the activity) the proposed requirements or that must be determined in accordance with We proposed requirements applicable disagree with, or suggest one or more the requirements of § 507.110(d). to conducting supplier verification changes to, the proposed requirements. activities (proposed § 507.37(c)). Most After considering these comments, we comments that support the proposed have revised the proposed requirements provisions suggest alternative or as shown in table 27.

TABLE 27—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR RAW MATERIALS AND OTHER INGREDIENTS

Final section Proposed section designation designation Description Revision

507.130(a) ...... 507.37(c)(1) ...... Requirement to conduct one or more appro- Add reference to an additional provision that priate supplier verification activities. provides for alternative supplier verification activities for shell egg producers that have less than 3,000 laying hens. 507.130(b)(1) ...... 507.37(c)(2)(i) ...... Requirement to conduct an onsite audit as N/A. the supplier verification activity when the hazard being controlled by the supplier is one for which there is a reasonable prob- ability that exposure to the hazard will re- sult in serious adverse health con- sequences or death to humans or animals. 507.130(b)(2) ...... 507.37(c)(2)(ii) ...... Exception to the requirement to conduct an N/A. annual onsite audit with a written deter- mination. 507.130(c) ...... 507.37(c)(3) ...... Alternative supplier verification activity when • Modify the regulatory text to better align the supplier is a qualified facility. with the responsibilities of a qualified facil- ity to submit an attestation to FDA about its food safety practices or its compliance with State, local, county, tribal, or other applica- ble non-Federal food safety law, including relevant laws and regulations of foreign countries. • Clarify that the date for a receiving facility to obtain written assurance that a supplier is a qualified facility is before first approv- ing the supplier for an applicable calendar year, and on an annual basis thereafter, by December 31 of each calendar year for the following calendar year. • Provide for written assurance that, when applicable, the supplier is producing the raw material or other ingredient in compli- ance with relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States. 507.130(d) ...... 507.37(c)(4) ...... Alternative supplier verification activity when • Clarify that the applicable farms are ‘‘not the supplier is a farm that is not a ‘‘covered covered farms’’ rather than ‘‘not subject to farm’’ under part 112 in accordance with part 112’’ because some of these farms § 112.4(a) or in accordance with are subject to modified requirements in §§ 112.4(b) and 112.5. § 112.6. • Clarify that the date for a receiving facility to obtain written assurance from the farm about its status is before first approving the supplier for an applicable calendar year, and on an annual basis thereafter, by De- cember 31 of each calendar year for the following calendar year.

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TABLE 27—REVISIONS TO THE PROPOSED REQUIREMENTS FOR CONDUCTING SUPPLIER VERIFICATION ACTIVITIES FOR RAW MATERIALS AND OTHER INGREDIENTS—Continued

Final section Proposed section designation designation Description Revision

• Clarify that the written assurance from the farm is an acknowledgement that its food is subject to section 402 of the Federal Food, Drug, and Cosmetic Act (or, when applica- ble, that its food is subject to relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States). 507.130(e) ...... N/A ...... Alternative supplier verification activity when Specify an additional situation where the re- the supplier is a shell egg producer that ceiving facility can consider an alternative has fewer than 3,000 laying hens. supplier verification activity.

A. Requirement To Conduct One or apply if the receiving facility documents as a condition of doing business, that More Supplier Verification Activities its determination that other verification their suppliers become certified to food (Final § 507.130(a)) activities and/or less frequent onsite safety management schemes that auditing of the supplier provide With two exceptions, we proposed involve third-party audits (78 FR 64736 adequate assurance that the hazards are that the receiving facility must conduct at 64836 through 64837). We agree that controlled. (Proposed § 507.37(c)(2)). and document one or more specified onsite audits can identify problems in (Comment 454) Some comments ways that paperwork reviews cannot. supplier verification activities for each support the provision for audits when supplier before using the raw material Because an audit involves more than there is a reasonable probability that simply observing the facility producing or ingredient and periodically thereafter exposure to the hazard will result in (proposed § 507.37(c)(1)). See section an animal food product, we believe it is serious adverse health consequences or more than just a ‘‘snapshot’’ of the XLII.B for a discussion of comments death to humans or animals. Some of regarding the appropriate verification supplier’s programs. As discussed in these comments state that audits should Response 440, onsite audits can include activities (i.e., onsite audits, sampling be the default verification activity in and testing, records review, and other observations, records review and order to eliminate facilities choosing the employee interviews. appropriate supplier verification lowest cost option regardless of whether activities based on supplier performance it was best for food safety. Other The requirement to conduct an annual and the risk associated with the raw comments state that audits would be the audit in specified circumstances is risk- material or other ingredient). See best option for facilities that cannot visit based because the specified sections XLV.C and XLV.D for a each supplier annually and that onsite circumstances are limited to situations discussion of the proposed exceptions inspection can identify problems in where there is a reasonable probability to this requirement to conduct and ways that paperwork reviews cannot. that exposure to the hazard in the raw document verification activities. As However, other comments oppose this material or other ingredient will result discussed in section XLV.E, the final requirement. Some of these comments in serious adverse health consequences rule provides for an additional state that facilities should have or death to humans or animals. The food circumstance in which an alternative flexibility in choosing verification safety controls applied by suppliers of supplier verification activity may be activities, regardless of whether or not such raw materials or other ingredients conducted, i.e., when the supplier is a the hazards could result in serious are more important than for other types shell egg producer that has fewer than adverse health consequences or death to of hazards because of the serious 3,000 laying hens. humans or animals and express concern adverse health consequences that can that this requirement does not allow the occur if the hazards are not controlled. B. Requirement for an Onsite Audit as Annual audits are required of a Verification Activity When a Hazard necessary flexibility for a facility to tailor an effective supplier program certification schemes that are Has a Reasonable Probability of benchmarked to the Global Food Safety Resulting in Serious Adverse Health based upon risk. Other comments express concern that the provision sets Initiative Guidance Document for GFSI Consequences or Death to Humans or recognition (Ref. 58). We disagree that Animals (Final § 507.130(b)) a precedent that annual audits are the preferred or most effective verification this requirement does not provide We proposed that when a hazard in a measure and that other verification flexibility in choosing verification raw material or ingredient will be activities often can help paint a more activities; in recognition that other controlled by the supplier and is one for accurate picture of a supplier over time. verification activities can help paint a which there is a reasonable probability Other comments express concern that more accurate picture of a supplier over that exposure to the hazard will result audits only give a ‘‘snapshot’’ of a time, we have provided for alternative in serious adverse health consequences supplier’s performance at a given time verification activities or audit or death to humans or animals, the and ask that we not overemphasize frequencies if the receiving facility receiving facility must have audits. documents its determination that other documentation of an onsite audit of the (Response 454) We are retaining this verification activities and/or less supplier before using the raw material provision as proposed. As we indicated frequent onsite auditing of the supplier or ingredient from the supplier and at in the Appendix of our 2013 proposed provide adequate assurance that the least annually thereafter. We also preventive controls rule, an increasing hazards are controlled (see proposed that this requirement does not number of establishments are requiring, § 507.130(b)(2)).

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(Comment 455) Some comments ask (Response 457) We disagree that a ensure that hazards are adequately us to define those products that may requirement for an audit is ‘‘outside the controlled. trigger the requirement for an audit, scope of FSMA.’’ See the discussion in We disagree that the provision is especially with respect to farms. These Response 440 regarding the provision in meaningless because a farm or facility comments question how to assess section 419(c)(1)(E) of the FD&C Act that would see a legal risk in using an whether a hazard could result in serious the regulation issuing standards for the alternative to annual onsite audits as a adverse health consequences or death to safety of produce ‘‘not require a supplier verification activity. First, a humans or animals. business to hire a consultant or other farm would be a supplier and would not (Response 455) We decline this third party to identify, implement, be the entity that would determine request. Any list of such products certify compliance with the procedures, whether an onsite audit or some other would be extensive and it is unlikely we processes and practices’’ and the supplier verification activity is could capture all the circumstances in provision in section 418(n)(3)(D) of the appropriate. As established in § 507.115, which this could apply. Hazards for FD&C Act that the preventive controls determining the appropriate supplier which there is a reasonable probability regulation ‘‘not require a facility to hire verification activity would be the that exposure to the hazard will result a consultant or other third party to responsibility of a receiving facility, and in serious adverse health consequences identify, implement, certify or audit although appropriate supplier or death are those for which a recall of preventive controls.’’ As noted in that verification activities could be a violative product posing such a hazard response, a facility is not required to determined by another entity in the is designated as ‘‘Class 1’’ under 21 CFR hire a third party to conduct an audit. receiving facility’s supply chain as a 7.3(m)(1). Examples of such hazards (Comment 458) Some comments service, the supplier verification that, in some circumstances, have support the flexibility to not conduct an activities could not be determined by resulted in serious adverse health annual onsite audit if the receiving the supplier itself. Second, although consequences or death to humans or facility documents its determination there is always a potential for animals include pathogens or their that other verification activities and/or differences in interpretation between an toxins in animal food. Animal food less frequent onsite auditing of the FDA inspector and an inspected firm, containing a hazard for which there is supplier provide adequate assurance we are establishing a new inspection a reasonable probability that exposure to that the hazards are controlled. Other paradigm focused on whether firms are the hazard will result in serious adverse comments question how a facility implementing systems that effectively health consequences or death to humans would prove that alternative measures prevent food contamination, requiring or animals are considered reportable are equally effective as an annual audit, fundamentally different approaches to foods; examples of foods FDA has when it is not known how effective an food safety inspection and compliance. considered to present a reasonable annual audit is. Other comments assert For example, FDA intends to deploy probability of serious adverse health that the provision is meaningless specialized investigators, backed up by consequences or death can be found in because a farm or facility would not take technical experts, to assess the our Guidance for Industry: Questions the legal risk of verifying it has received soundness and performance of a and Answers Regarding the Reportable ‘‘adequate assurance,’’ because this facility’s food safety system (Ref. 10). In Food Registry as Established by the would be subject to an FDA inspector’s addition, a central element of FDA’s Food and Drug Administration interpretation. strategy to gain industry compliance is Amendments Act of 2007 (Refs. 19 and (Response 458) This provision to help make available to farmers, food 20). requires a facility to use a verification processors, and importers, especially (Comment 456) Some comments ask activity that provides adequate small businesses, the education and us to clarify the role of third-party assurance that a hazard is controlled, technical assistance they need to audits and the Good Agricultural not to determine how effective an audit understand and implement FSMA’s new Practice (GAP) program and ask us to is and assess whether alternative prevention-oriented standards (Ref. 5). allow GAPs to be a voluntary measures are equally effective. The new inspection paradigm and the mechanism to satisfy buyer demands for As an example of using an alternative assistance and training for industry food safety certification. approach to an annual onsite audit, should help minimize different (Response 456) Although the rule consider the situation in which a interpretations between industry and would not require a receiving facility to receiving facility is part of a large regulators. hire a third party to conduct an audit, corporation, is making a pet food, and (Comment 459) Some comments ask onsite audits can include third-party obtains meat and bone meal from a us to require facilities to notify us when audits. There are likely to be benefits for supplier that is a subsidiary of the they determine that an alternative to an suppliers having a third-party audit, corporation and is operating under the audit is an appropriate supplier because the same audit may be same food safety system as the receiving verification activity and be able to acceptable to multiple receiving facility. The receiving facility could justify and document how an alternative facilities as an appropriate supplier determine that the food safety verification activity provides the same verification activity. For farms, GAPs requirements established by the parent level of assurance as an onsite audit. audits may be viewed as an appropriate company and applied at the subsidiary (Response 459) We decline this supplier verification activity. GAPs provide the needed assurance that request. We will assess a facility’s audits and other third-party audits Salmonella in meat and bone meal is supplier verification activities during a would need to comply with the adequately controlled. The facility facility inspection, including the requirements of this rule applicable to could support its decision by documentation that an alternative onsite audits (see § 507.135). documenting this determination, verification activity provides the same (Comment 457) Some comments including the procedures in effect at the level of assurance as an onsite audit. assert that we should delete this supplier and the activities used by the (Comment 460) Some comments ask provision entirely, stating that this corporation to verify that the subsidiary us to specify the type of documentation requirement for an audit is ‘‘outside the operates in accordance with corporate required for our investigators to scope of FSMA.’’ food safety policies and practices to determine when the activities are ‘‘in

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compliance with the law and sufficient description of the processes and status as a qualified facility. Still other to protect public health.’’ procedures that the supplier is comments ask us to remove all (Response 460) We decline this following to ensure the safety of the provisions on qualified facilities request. The facility’s approach to the animal food. because they view these provisions as determination, and the applicable This rule has several provisions that effectively adding a second layer of documentation required to support that require written assurances. We have regulations on produce farms, and claim determination, would depend on the established specific elements that each this is not authorized by FSMA. Other circumstances. For example, in of these written assurances must comments ask us to delete the Response 458, we discuss a possible include, i.e., the effective date; printed requirement that the written assurance approach in a situation in which a names and signatures of authorized include a brief description of the receiving facility is part of a corporation officials; and the applicable assurance processes and procedures that the and obtains an ingredient from a (see § 507.215). supplier is following to ensure the supplier that is a subsidiary of the We have revised the provision to safety of the food. clarify that the receiving facility must corporation and is operating under the (Response 462) We have revised the have written assurance that a facility is same food safety system as the receiving provisions for an alternative verification a qualified facility: (1) Before first facility. Another situation could be activity for a qualified facility to better approving the supplier for an applicable when a receiving facility has many years align with the responsibilities of a calendar year and (2) by December 31 of of experience with the same supplier, qualified facility to submit an attestation each calendar year (rather than ‘‘at the but the approach and documentation in to FDA about its food safety practices that situation likely would be different end of the calendar year’’) and that the (§ 507.7(a)(2)(i)) or its compliance with from an approach and documentation written assurance is regarding the status State, local, county, tribal, or other used when the supplier and the of the qualified facility for the following applicable non-Federal food safety law, receiving facility are part of the same calendar year. By specifying ‘‘by including relevant laws and regulations corporation. December 31,’’ a receiving facility can (Comment 461) Some comments ask work with each applicable supplier to of foreign countries (§ 507.7(a)(2)(ii)) that we not limit the determination for determine the specific date within a (see the regulatory text of § 507.130(c)). a supplier verification activity other calendar year for that supplier to Importantly, a qualified facility is still than an onsite audit to a determination annually notify the receiving facility subject to CGMPs and the FD&C Act, by the receiving facility. These about its status. See also Responses 76, and, if the qualified facility is a supplier comments explain that the corporate 139, 140, the requirements in § 507.7(a) controlling a hazard, it is reasonable for parent of a facility can be the entity that for an annual determination of the a receiving facility to expect the makes this determination. These status of a facility as a qualified facility, qualified facility to provide to the comments suggest that we can account and the requirements in § 507.7(d) that receiving facility, an assurance that for the role of the corporation by apply when the status of a facility reflects an attestation the facility has specifying that a facility documents ‘‘the changes from ‘‘qualified facility’’ to ‘‘not made to FDA. As modified, one determination’’ (rather than ‘‘its’’ a qualified facility.’’ A receiving facility possibility is for a qualified facility to determination). and its suppliers have flexibility to provide a receiving facility with a brief (Response 461) We have agreed that approach the potential for the status of description of the preventive controls it the corporate parent of a facility can be a facility to shift between ‘‘qualified is implementing to control the active in developing and implementing facility’’ and ‘‘not a qualified facility’’ applicable hazard, consistent with an the facility’s food safety plan (see (or vice versa) in a way that works best attestation of its food safety practices in section XXIV.A). However, the specific for their specific business relationship. accordance with § 507.7(a)(2)(i). For suggestion of these comments is not As discussed in section XLII.D, we example, the qualified facility could necessary to achieve the outcome have revised the requirements for state that its manufacturing processes requested by the comments because of considering supplier performance to include a lethality step for microbial editorial changes we made to provide provide that the receiving facility may, pathogens of concern. As required by for entities other than the receiving when applicable, consider relevant laws § 507.7(f), a qualified facility that facility to determine and conduct the and regulations of a country whose food submits an attestation to FDA about its appropriate supplier verification safety system FDA has officially animal food safety practices would have activities. recognized as comparable or has documentation of those practices to determined to be equivalent to that of support its attestation to FDA and, thus, C. Alternative Verification Activity the United States, and information would have documentation to support When the Supplier Is a Qualified relevant to the supplier’s compliance its written assurance to the receiving Facility (Final § 507.130(c)) with those laws and regulations, rather facility. Although a qualified facility We proposed that if a supplier is a than consider applicable FDA food that submits an attestation to FDA about qualified facility the receiving facility safety regulations and information its food safety practices also would have need not comply with the specified relevant to the supplier’s compliance documentation of monitoring the verification requirements if the with applicable FDA food safety performance of the preventive controls receiving facility: (1) Documents, at the regulations. We have made a to ensure that such controls are effective end of each calendar year, that the conforming change to the alternative as required by § 507.7(a)(2)(i), we are supplier is a qualified facility and (2) verification activities for a qualified not requiring the qualified facility to obtains written assurance, at least every facility (see the regulatory text of describe its monitoring of the 2 years, that the supplier is producing § 507.130(c)(2)). performance of preventive controls to the raw material or ingredient in (Comment 462) Some comments ensure that they are effective. compliance with applicable FDA food support this alternative supplier Alternatively, a qualified facility could safety regulations and that the raw verification activity because it provides provide a receiving facility with a material or ingredient is not adulterated flexibility. Other comments ask us to statement that the facility is in under section 402 of the FD&C Act. The revise the provision so that it only compliance with State, local, county, written assurance must include a brief requires that the supplier document its tribal, or other applicable non-Federal

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food safety law, including relevant laws effective date; printed names and to apply to raw materials from farms and regulations of foreign countries. signatures of authorized officials; and that do not grow and harvest ‘‘produce’’ We disagree that the alternative the applicable assurance. as we proposed to define it in § 112.3(c) verification activity for produce farms Produce farms that are not ‘‘covered so that the alternative verification would add a second layer of regulations farms’’ under § 112.4 of the forthcoming requirements would apply to grain. on produce farms and are retaining this produce safety rule have less than Some comments assert that it is not provision. $25,000 in annual sales averaged over possible to receive ‘‘written assurances’’ (Comment 463) Some comments ask the previous 3-year period, or satisfy the of compliance from growers of grain us to remove the requirement that the requirements for a qualified exemption because there is no safety standard for written assurance be obtained at least in § 112.5 and associated modified grain growers, and that any such every 2 years. Other comments ask us to requirements in § 112.6 based on documents would be essentially revise the purpose of the written average monetary value of all food sold meaningless. assurance from ‘‘the raw material or (less than $500,000) and direct farm Some comments ask us to revise the ingredient is not adulterated’’ to ‘‘the marketing (during the previous 3-year requirement to obtain written assurance receiving facility’s use of the raw period, the average annual monetary so that it does not apply to ‘‘food not material or ingredient will not cause the value of food sold directly to qualified subject to the requirements of part 112 finished food to be adulterated.’’ end users exceeded the average annual of this chapter pursuant to part 112.2.’’ (Response 463) We decline these monetary value of the food sold to all Other comments assert that a requests. A supplier verification activity other buyers). In the 2014 supplemental documentation requirement for needs to consider supplier performance notice, we erroneously referred to these commodities that will be exempt from on an ongoing basis. Procedures and farms as farms ‘‘not subject to the the produce safety rule would increase practices evolve over time, and it is requirements established in part 112.’’ recordkeeping burdens without added appropriate for a receiving facility that While produce farms that make less benefit because produce that will be is obtaining written assurance from a than $25,000 are not subject to the exempt from the produce safety rule is supplier as an alternative verification requirements in part 112, produce farms low risk. activity to be aware of both procedures that satisfy the requirements for a Some comments assert that farms and practices that have changed, as well qualified exemption are not subject to should not have to provide written as procedures and practices that have the full requirements of part 112, but assurances because the requirement is stayed the same. The specified they do have certain modified ambiguous. These comments assert that timeframe for updating the written requirements that they must meet, as exempt farmers are small-scale assurance, i.e., at least every two years, described in § 112.6. We have corrected producers who are subject primarily to is reasonable. the description of these farms in state and local laws and this provision A supplier can only provide § 507.130(d). would require them to provide written assurance about raw materials and other We have revised the provision to assurances that they are complying with ingredients that it supplies to the clarify that the receiving facility must unspecified Federal regulations. The receiving facility, not about the animal have documentation that the raw comments claim that, without seeking food product that the receiving facility material or other ingredient provided by legal counsel, many exempt farmers will produce using the supplier’s raw the supplier is not subject to part 112 in would be unable to provide such material or other ingredients. accordance with § 112.4(a), or in assurances, limiting the ability of these D. Alternative Verification Activity accordance with §§ 112.4(b) and 112.5: farmers to market their products to non- When the Supplier Is a Produce Farm (1) Before first approving the supplier exempt facilities (the overwhelming That Is Not a ‘‘Covered Farm’’ for the for an applicable calendar year and (2) majority of the food market). (Response 464) We have revised the to Purposes of the Future Produce Safety by December 31 of each calendar year (rather than ‘‘at the end of the calendar specify that the written assurance from Rule (Final § 507.130(d)) year’’) and that the documentation is the farm must state that the farm We proposed that if a supplier is a regarding the status of supplier for the acknowledges that its food is subject to farm that is not subject to the following calendar year. By specifying section 402 of the FD&C Act (or, when requirements that we have proposed to ‘‘by December 31,’’ a receiving facility applicable, that its food is subject to be established in the produce safety rule can work with each applicable supplier relevant laws and regulations of a in accordance with proposed § 112.4 to determine the specific date within a country whose food safety system FDA regarding the raw material or ingredient calendar year for that supplier to has officially recognized as comparable that the receiving facility receives from annually notify the receiving facility or has determined to be equivalent to the farm, the receiving facility does not about its status. See also the discussion that of the United States). Any business need to comply with the verification in section XLV.C regarding a similar that introduces food into interstate requirements if the receiving facility: (1) revision we made when the supplier is commerce is subject the prohibited acts Documents, at the end of each calendar a qualified facility. provisions in section 301 of the FD&C year, that the raw material or ingredient (Comment 464) Some comments Act, and is accountable if it produces provided by the supplier is not subject support the proposed alternative food that is adulterated. to the produce safety rule and (2) supplier verification activity. Other As discussed in Response 284, new obtains written assurance, at least every comments support applying the § 507.36(a) allows a manufacturer/ 2 years, that the supplier is producing proposed alternative supplier processor to not implement a preventive the raw material or ingredient in verification activity more broadly, i.e., control if it determines and documents compliance with applicable FDA food to any farm that will not be subject to that the type of animal food (e.g., safety regulations and that the raw part 112 (e.g., a farm that grows wheat), soybeans) could not be consumed material or ingredient is not adulterated stating that both small and large non- without application of the appropriate under section 402 of the FD&C Act. See produce farms should have the same control. We believe most receiving also § 507.215, which establishes option as farms that are exempted under facilities will take advantage of this specific elements that this written § 112.4. Some comments ask us to revise provision, and not establish supply- assurance must include, i.e., the the alternative verification requirements chain controls under the supply-chain

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program in subpart E for some specific facility is small, and the exposure to their own company, which in turn owns RACs. food from such farms therefore is low. an interest in the supplier) should not This alternative supplier verification We disagree that it is appropriate to be disqualified from performing activity is intended to minimize the extend this alternative supplier verification activities. Comments also burden on suppliers that are small verification activity to larger farms indicate that a laboratory analyst farms. The amount of food produced by because such farms provide a larger performing ingredient testing should not such farms is small, and the exposure to volume of produce. be precluded from testing ingredients food from such farms therefore is low. A farm that has been subject to an from a supplier in which the analyst has We disagree that a written assurance audit that complies with the a potential conflict of interest, as long as from such a farm would be meaningless. requirements of this rule can provide the analyst is not aware of the identity Any business that distributes food in the results of the audit; a mere statement of the supplier at the time the test is interstate commerce is subject to the that the farm has been certified based on performed. FD&C Act, and must produce food that an audit is insufficient. (Response 467) We are establishing a is in compliance with the FD&C Act, requirement that there must not be any E. Alternative Verification Activity regardless of whether FDA has financial conflicts of interests that When the Supplier Is a Shell Egg established a specific regulation influence the results of the verification Producer That Has Less Than 3,000 governing the production of the food. activities listed in § 507.110(b) and Laying Hens (Final § 507.130(e)) (Comment 465) Some comments ask payment must not be related to the us to delete this alternative supplier We are establishing an additional results of the activity. This does not verification activity because they see it alternative supplier verification activity prohibit employees of a supplier from as a contradiction to the traceability when a supplier is a shell egg producer performing the functions specified in provisions of the Bioterrorism Act and that is not subject to the requirements of § 507.115 in accordance with § 507.115. FSMA, because ‘‘trace back’’ is only 21 CFR part 118 because it has less than For example, this provision would not required for ‘‘one step back’’ or for a 3,000 laying hens. See the regulatory prohibit an employee of a supplier from single supplier for a particular shipment text of § 507.130(e). The provision is conducting sampling and testing so that of food. analogous to the alternative supplier the supplier could provide the results in (Response 465) The supply-chain verification activity when a supplier is documentation provided to the program that is being established in this a farm that meets the criteria in receiving facility. The provisions would rule is a preventive control for the § 507.130(d) and would account for a not prevent a person who is employed ongoing production of safe animal food, very small amount of eggs in the food by a receiving facility from having an not a ‘‘trace back’’ provision, established supply. See also § 507.215, which indirect financial interest in a supplier under the Bioterrorism Act, to help establishes specific elements that the (e.g., if a company in which the address credible threats relating to food required written assurance must employee owns stock owns an interest that is reasonably believed to be include, i.e., the effective date; printed in the supplier). adulterated and to present a threat of names and signatures of authorized (Comment 468) Comments ask that we serious adverse health consequences or officials; and the applicable assurance. not preclude a supplier from hiring an death to humans or animals. outside party to perform onsite audits, F. Independence of Persons Who (Comment 466) Some comments ask food certifications, or sampling and Conduct Supplier Verification Activities us to specify 3 options for verification testing. if a supplier is a farm subject to the (Final § 507.130(f)) (Response 468) We have specified that requirements of part 112: (1) In the 2014 supplemental notice, we the requirements do not prohibit a Documentation at the end of each requested comment on whether we receiving facility from relying on an calendar year that the raw material or should include in the final preventive audit provided by its supplier when the ingredient provided by the supplier is controls rule requirements to address audit of the supplier was conducted by subject to part 112; (2) written conflicts of interest for individuals a third-party qualified auditor (see assurance, at least every 2 years, that the conducting verification activities and, if § 507.115(c)). We also have specified supplier is producing the raw material so, the scope of such requirements. that a supplier may conduct and or ingredient in compliance with (Comment 467) Some comments document sampling and testing of raw applicable FDA food safety regulations request that requirements to address materials and other ingredients, for the and that the raw material or ingredient conflicts of interest should not be hazard controlled by the supplier, as a is not adulterated under the FD&C Act; implemented or ask that conflict of supplier verification activity for a or (3) evidence that the supplier is interest provisions not be written too particular lot of product and provide the certified to a recognized third-party broadly, and be limited to documentation to the receiving facility GAP/GHP/GMP/HACCP audit scheme. circumstances where the individual (see § 507.115(a)(4)). This acknowledges (We note that we are assuming that employee carrying out the verification that it is common for suppliers to ‘‘GHP’’ is an abbreviation for ‘‘Good activities has a direct personal financial include Certificates of Analysis for tests Hygienic Practice.’’) interest in or financial ties to the conducted on specific lots of product (Response 466) We decline this supplier (e.g., owns a substantial along with the shipment to the receiving request. Documenting that a raw amount of stock in the supplier or is facility. material or other ingredient is subject to personally paid directly by the the produce safety rule has no bearing supplier). Comments state that it would XLVI. Subpart E: Comments on Onsite on whether the farm is complying with not be uncommon for a receiving facility Audit that rule to control the hazards. With to have a shared financial interest in the We proposed requirements that would respect to all farms subject to the supplier (e.g., partial ownership of one apply to an onsite audit. Most requirements of part 112 providing a by the other or both being owned by the comments that support the proposed written assurance, as discussed in same parent company). Thus, provisions suggest alternative or Response 464, the amount of food employees that have an indirect additional regulatory text or ask us to produced by the small farms that could financial interest (e.g., owning stock in clarify how we will interpret the provide written assurance to a receiving a supplier because they own stock in provision. In the following sections, we

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discuss comments that ask us to clarify changes to, the proposed requirements. have revised the proposed requirements the proposed requirements or that After considering these comments, we as shown in table 28. disagree with, or suggest one or more

TABLE 28—REVISIONS TO THE PROPOSED REQUIREMENTS FOR ONSITE AUDITS

Proposed section Final section designation designation Description Revision

507.135(a) ...... 507.37(d)(1) ...... An onsite audit of a N/A. supplier must be per- formed by a qualified auditor. 507.135(b) ...... 507.37(d)(2) ...... An onsite audit must Clarify that, when applicable, an onsite audit consider applicable may consider relevant laws and regulations of FDA regulations. a country whose food safety system FDA has officially recognized as comparable or has de- termined to be equivalent to that of the United States. 507.135(c)(1)(i) ...... 507.37(e)(1) ...... Substitution of inspec- Broaden the list of applicable inspections to in- tion for domestic sup- clude inspections by representatives of other pliers. Federal Agencies (such as the United States Department of Agriculture), or by representa- tives of State, local, tribal, or territorial agen- cies. 507.135(c)(1)(ii) and 507.135(c)(2) ... 507.37(e)(2) ...... Substitution of inspec- N/A. tion for foreign sup- pliers. 507.135(d) ...... N/A ...... Use of a third-party If the onsite audit is solely conducted to meet auditor that has been the requirements of the animal food preven- accredited in accord- tive controls rule by an audit agent of a certifi- ance with regulations cation body that is accredited in accordance that will be estab- with regulations that will be established in part lished in the forth- 1, subpart M, the audit is not subject to the coming third-party requirements in those regulations. certification rule.

A. Requirements Applicable to an with those laws and regulations, rather Other comments ask us to provide a list Onsite Audit (Final § 507.135(a) and (b)) than consider applicable FDA food of recognized private third-party food We proposed that an onsite audit of safety regulations and information safety schemes and consider making a supplier must be performed by a relevant to the supplier’s compliance third-party food safety certification to a qualified auditor. If the raw material or with applicable FDA food safety recognized audit scheme mandatory for ingredient at the supplier is subject to regulations. We have made a all food operations that grow, pack, hold one or more FDA food safety conforming change to the requirements and manufacture/process food for regulations, an onsite audit would need for an onsite audit to clarify that an wholesale markets. Other comments ask to consider such regulations and onsite audit may consider relevant laws us to further specify that FDA will audit include a review of the supplier’s and regulations of a country whose food all food facilities no less than once written plan (e.g., HACCP plan or other safety system FDA has officially every 5 years to verify that private third- food safety plan), if any, including its recognized as comparable or has party audits are consistent with FDA implementation, for the hazard being determined to be equivalent to that of audits and findings. audited (proposed § 507.37(d)). We have the United States. However, as of (Response 469) See our discussion in revised ‘‘including its implementation’’ August 30, 2015, FDA has not section XLVI.B of the final provisions to ‘‘and its implementation’’ to developed a systems recognition governing substitution of inspection for emphasize that implementation of the program for animal food; therefore, we an audit. We agree that onsite audits plan is distinct from the plan itself (e.g., have no signed systems recognition may be conducted by third parties, but § 507.31(c) establishes the agreements with any foreign food safety disagree that it is necessary to specify recordkeeping requirement for the food authority relating to animal food. The this in the rule. Nothing in this rule safety ‘‘plan,’’ and § 507.55 lists currently existing systems recognition prevents a facility from hiring a third implementation records.) agreement relates solely to human food party to conduct audits. As discussed in section XLII.D, we and does not apply to animal food. We decline the requests to provide a have revised the requirements for (Comment 469) Comments support a list of recognized private third-party considering supplier performance to requirement that an onsite audit be food safety schemes or to make third- provide that the receiving facility may, performed by a qualified auditor, party food safety certification to a when applicable, consider relevant laws provided that we finalize provisions (in recognized audit scheme mandatory for and regulations of a country whose food proposed § 507.37(e)) whereby an all food operations that grow, pack, hold safety system FDA has officially inspection by certain authorities could and manufacture/process animal food recognized as comparable or has substitute for an audit. Some comments for wholesale markets. The rule determined to be equivalent to that of ask us to specify that the rule permits provides flexibility regarding use of the United States, and information the use of audits conducted by private third-party auditors and the information relevant to the supplier’s compliance third-party food safety auditing firms. is easily obtained from other sources.

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Private third-party food safety audit be part of an overall supplier onsite audit would need to be within schemes are a function of the private verification program when the supplier the scope of the official recognition or sector, not a function of the Federal is controlling a hazard that could cause equivalence determination, and the government. Likewise, we decline the serious adverse health consequences or foreign supplier would need to be in, request to specify that FDA will ‘‘audit’’ death, but should not be tied to an and under the regulatory oversight of, all food facilities no less than once audit. These comments state that such country (proposed § 507.37(e)). every 5 years to verify that private third- receiving facilities may choose to use an As of August 30 2015, FDA has not party audits are consistent with FDA unannounced audit program where the developed a systems recognition audits and findings. We will inspect auditor spends time focusing on the program for animal food; therefore, we food facilities for compliance with this actual conditions on the production have no signed systems recognition rule, not to verify the findings of a third- floor, with a review of the supplier’s agreements with any foreign food safety party audit, with a frequency consistent food safety plan being done as a authority for animal food. A signed with our responsibilities under the separate verification activity. systems recognition agreement for FD&C Act. (Response 471) We decline this human food does not apply to animal (Comment 470) Some comments request. We agree that review of an food. express concern about the multiple applicable food safety plan should be (Comment 472) Some comments ask audits that facilities are subject to each part of an overall supplier verification us to allow State or local inspection year and ask us to encourage those program and that the review of the food reports, as well as FDA inspection subject to the rule to accept an audit safety plan may be conducted separately reports, to substitute for an onsite audit performed by any of the ‘‘bona fide from the observation of actual for small and very small facilities. Other authorities’’ where it is warranted. conditions on the production floor, comments ask us to create a ‘‘safe Other comments note that food provided that both are conducted within harbor’’ provision in which a supplier manufacturers conduct their own audits the annual timeframe. However, we providing a copy of permits obtained and have developed extensive expertise believe it important that the audit from the most recent inspection done by in doing so, and oppose any supplier address whether the food safety plan is Federal, State, or local health authorities verification requirement that would being implemented as designed and satisfies the supplier verification affect those audits. Other comments ask other comments to this rule support that requirement; if there are no permits, us to allow audits to industry standards view. For example, as discussed in review of relevant records and/or (such as GFSI or ISO) to satisfy supplier Comment 493 regarding our inspection sampling of raw material based on scale verification requirements to avoid of a food facility, some comments assert of production should be adequate. adding a new audit to audits currently that our access to company records must (Response 472) We have revised the being conducted. Some comments assert be conducted onsite in the course of an regulatory text to provide for an that audits to industry standards (such authorized inspection so that we may appropriate inspection of the supplier as GFSI or ISO) and other similarly understand the full context of what the for compliance with applicable FDA accredited audits should be considered records show. Thus, the onsite food safety regulations by FDA, by equivalent to onsite audits. Some observations and the food safety plan representatives of other Federal comments express concern that review cannot be entirely separated, as Agencies (such as USDA), or by requiring a new audit in addition to the comment seems to suggest. representatives of State, local, tribal, or audits already being conducted could We note that the requirement to territorial agencies. We are specifying lead to auditor shortages and include a review of the supplier’s food that the inspection must be unnecessary additional costs. safety plan only applies when the ‘‘appropriate’’ and be conducted for (Response 470) We expect that a supplier has a food safety plan. For compliance ‘‘with applicable FDA food facility will adopt an approach to audits example, we did not propose a safety regulations’’ to make clear that that works best for the facility and requirement for a farm that would be the inspection must be sufficiently minimizes the number of audits subject to the forthcoming produce relevant to an onsite audit to credibly conducted for the same facility. An safety rule to have a food safety plan. substitute for an onsite audit. For employee of a receiving facility may example, inspection by USDA to B. Substitution of Inspection by FDA or perform an audit, provided that the determine whether a farm satisfies the an Officially Recognized or Equivalent employee satisfies the criteria requirements of the produce safety rule Food Safety Authority established in the rule for qualified could constitute an appropriate auditors. Under § 507.3 and § 507.53, a We proposed that instead of an onsite inspection that could substitute for an qualified auditor is a qualified audit, a receiving facility may rely on audit, but an inspection by USDA to individual (as defined in § 507.3) and the results of an inspection of the determine whether a farm satisfies the has technical expertise obtained through supplier by FDA or, for a foreign requirements of the National Organic education, training, or experience (or a supplier, by FDA or the food safety Program could not. combination thereof) necessary to authority of a country whose food safety We have not provided for substitution perform the auditing function. For system FDA has officially recognized as of a ‘‘permit obtained from the most additional information, see Response comparable or has determined to be recent inspection’’ for an onsite audit. 700 in the final rule for preventive equivalent to that of the United States, We do not see how a ‘‘permit’’ could controls for human food published provided that the inspection was shed light on whether a business is elsewhere in this issue of the Federal conducted within 1 year of the date that complying with specific applicable FDA Register, in which we discuss auditor the onsite audit would have been regulations. We have provided for an qualifications with respect to the GFSI’s required to be conducted. For alternative verification activity to the auditor competency model. inspections conducted by the food annual onsite audit (such as a review of (Comment 471) Some comments ask safety authority of a country whose food relevant records and/or sampling of raw us to delete the proposed requirement safety system FDA has officially material) with a written justification for a review of the supplier’s written recognized as comparable or determined (see § 507.130(b)). The rule would not plan as part of an audit because review to be equivalent to that of the United preclude an appropriate review of of the supplier’s food safety plan should States, the food that is the subject of the records, or sampling and testing of raw

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materials, by other Federal Agencies, or recognition agreement relates solely to in records, including minimum by representatives of State, local, tribal, human food and does not apply to requirements for records documenting or territorial agencies, provided that the animal food. an audit, records of sampling and receiving facility satisfies the testing, and records documenting a C. Onsite Audit by a Third-Party requirements for an adequate written review by the receiving facility of the Auditor Accredited for the Purposes of justification. supplier’s relevant food safety records. Section 808 of the FD&C Act (Comment 473) Some comments ask We also proposed that the receiving us to clarify what we mean by ‘‘food We have proposed to establish facility must review such records in safety authority of a country whose food regulations (in part 1, subpart M) to accordance with the requirements safety system FDA has officially provide for accreditation of third-party applicable to review of records as a recognized as comparable or has auditors/certification bodies to conduct verification activity (i.e., in accordance determined to be equivalent to that of food safety audits of foreign food with § 507.49(a)(4)). the United States.’’ These comments entities, including registered foreign We did not receive comments on the also ask whether a specific country food facilities, and to issue food and documentation requirements associated qualifies and whether HACCP facility certifications (78 FR 45782, July with a written supplier program, certificates issued by a specific foreign 29, 2013). The purpose of the proposed determination of appropriate supplier government agency would replace an third-party certification rule is to help verification activities, review of records, onsite audit. us ensure the competence and supplier verification activities other (Response 473) A country whose food independence of third-party auditors/ than an annual onsite audit when the safety system FDA has officially certification bodies who conduct foreign hazard being controlled by the supplier recognized as ‘‘comparable’’ to that of food safety audits and to help ensure the is one for which there is a reasonable the United States would be one for reliability of food and facility probability that exposure to the hazard which there is a signed systems certifications issued by third-party will result in serious adverse health recognition arrangement or other auditors/certification bodies that we consequences or death to humans or agreement between FDA and the will use in making certain decisions animals, alternative supplier country establishing official recognition relating to imported animal food, such verification activity when the supplier of the foreign food safety system. as animal food certifications required by is a qualified facility, substitution of Information on FDA systems recognition FDA as a condition of granting inspection for an audit, or supplier can be found on the FDA Web site (Ref. admission to an animal food determined nonconformance (proposed 59). As of August 30 2015, FDA has not to pose a safety risk. § 507.37(g)(1), (2), (7), (9), (10), (12), and developed a systems recognition (Comment 475) Comments support (13), respectively). We are finalizing program for animal food; therefore, we use of third-party auditors, but these documentation requirements with have no signed systems recognition emphasize that such auditors need not editorial and conforming changes agreements with any foreign food safety be accredited under the requirements to associated with the final requirements authority relating to animal food. The be established under our forthcoming of the supply-chain program. currently existing systems recognition third-party certification rule. The supply-chain program includes agreement relates solely to human food (Response 475) We agree that a third- two provisions that are explicit and does not apply to animal food. We party auditor who conducts an audit as requirements of the final animal food would not accept a HACCP certificate a supplier verification activity to satisfy preventive controls rule, but had been issued by a foreign government as a the requirements of this rule need not be implicit requirements of the 2014 substitute for an onsite audit, but a accredited under our forthcoming third- supplemental notice. The first of these receiving facility could consider party certification rule. In addition, we provisions is the explicit requirement whether such a certificate could be part see no reason that any requirements of that the receiving facility must approve of its justification for conducting our forthcoming third-party certification suppliers in accordance with the another supplier verification activity in rule should apply to an audit merely requirements of § 507.110(d), and lieu of an annual onsite audit, or for because it was conducted by a person document that approval, before conducting an audit on a less frequent who had been accredited under that receiving raw materials and other basis than annually. rule. To make this clear, we have added ingredients from those suppliers (see (Comment 474) Some comments ask a provision to specify that if an onsite § 507.120(a)). The second of these us to clarify that the applicable audit is solely conducted to meet the requirements is that written procedures standards will be those applied by the requirements of this rule by an audit for receiving raw materials and other food safety authority of a country with agent of a certification body that is ingredients must be established and a food safety system recognized as accredited in accordance with followed (see § 507.120(b)(1)). We are comparable or equivalent rather than regulations in part 1, subpart M, the including in § 507.175 the having to achieve compliance with the audit is not subject to the requirements documentation associated with these applicable U.S. FDA food safety in those regulations. See § 507.135(d). requirements (see § 507.175(c)(3) and regulations. Because § 507.135(d) refers to (4)). (Response 474) The applicable provisions in a future third-party The supply-chain program includes standards will be those applied by the certification rule, we will publish a four provisions that were not in the food safety authority of a country with document in the Federal Register 2014 supplemental notice: (1) A a food safety system recognized as announcing the effective date of receiving facility that is an importer can comparable or equivalent to that of the § 507.135(d) when we finalize the third- comply with the foreign supplier United States. As of August 30, 2015, party certification rule. verification requirements in the FSVP FDA has not developed a systems rule rather than conduct supplier recognition program for animal food; XLVII. Subpart E: Comments on verification activities for that raw therefore, we have no signed systems Records Documenting the Supply-Chain material or other ingredient under this recognition agreements with any foreign Program (Final § 507.175) rule (§ 507.105(a)(2)); (2) a receiving food safety authority relating to animal We proposed to require facility may use an alternative food. The currently existing systems documentation of verification activities verification activity for a supplier that is

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a shell egg producer that is not subject determine, conduct, and document in § 507.175(c)(2), (14), (17), and (18), to the requirements established in part certain specified supplier verification respectively. 118 because it has less than 3,000 laying activities, provided that the receiving In the following sections, we discuss hens (§ 507.130(e)); (3) when applicable, facility reviews and assesses the other comments on the proposed records for a receiving facility must verify a supply- entity’s applicable documentation, and the supplier program. After considering chain-applied control applied by an documents its review and assessment these comments, we have revised the entity other than the receiving facility’s (§ 507.115). We are establishing the proposed requirements as shown in supplier (§ 507.105(c)); and (4) entities associated documentation requirements other than the receiving facility may table 29.

TABLE 29—REVISIONS TO THE PROPOSED REQUIREMENTS FOR RECORDS FOR THE SUPPLY-CHAIN PROGRAM

Did we receive Did we revise the documentation comments requirement other than editorial and Final section Proposed section Description regarding conforming changes associated with designation designation the proposed the final requirements for the requirement? supply-chain program?

507.175(a) ...... N/A ...... The records documenting the supply-chain N/A ...... Consequential change associated program are subject to the requirements with establishing the requirements of subpart F. for a supplier in subpart E rather than subpart C. 507.175(b) ...... 507.37(g) ...... The receiving facility must review the Yes ...... No. records in accordance with § 507.49(a)(4). 507.175(c)(1) ...... 507.37(g)(1) ...... The written supply-chain program ...... No ...... N/A. 507.36(b)(2) ...... 507.37(g)(3) ...... Annual written assurance from a receiving Yes ...... Shifted to be in provisions outside facility’s customer. the framework of the supply-chain program in subpart E. 507.175(c)(2) ...... N/A ...... Documentation obtained from an importer N/A ...... N/A. 507.175(c)(3) ...... 507.37(g)(1) ...... Documentation of the approval of a sup- No ...... No. plier. 507.175(c)(4) ...... 507.37(g)(1) ...... Written procedures for receiving raw mate- No ...... No. rials and other ingredients. 507.175(c)(5) ...... 507.37(g)(4) ...... Documentation demonstrating use of the Yes ...... Yes. written procedures for receiving raw ma- terials and other ingredients. 507.175(c)(6) ...... 507.37(g)(2) ...... Documentation of the determination of the No ...... No. appropriate supplier verification activities for raw materials and other ingredients. 507.175(c)(7) ...... 507.37(g)(5) ...... Documentation of the conduct of an onsite Yes ...... Added a requirement for the docu- audit. mentation to include the name of the supplier subject to the onsite audit. 507.175(c)(8) ...... 507.37(g)(6) ...... Documentation of sampling and testing Yes ...... Specify that the documentation in- conducted as a supplier verification activ- clude the date(s) on which the ity. test(s) were conducted and the date of the report. 507.175(c)(9) ...... 507.37(g)(7) ...... Documentation of the review of the sup- No ...... Specify that the documentation plier’s relevant food safety records. must include the general nature of the records reviewed and con- clusions of the review. 507.175(c)(10) ...... 507.37(g)(8) ...... Documentation of other appropriate sup- Yes ...... Specify that the other appropriate plier verification activities. supplier verification activities are based on supplier performance and the risk associated with the raw material or other ingredient. 507.175(c)(11) ...... 507.37(g)(9) ...... Documentation of any determination that No ...... No. verification activities other than an onsite audit, and/or less frequent onsite auditing of a supplier, provide adequate assur- ance that the hazards are controlled when a hazard in a raw material or other ingredient will be controlled by the sup- plier and is one for which there is a rea- sonable probability that exposure to the hazard will result in serious adverse health consequences or death to hu- mans or animals.

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TABLE 29—REVISIONS TO THE PROPOSED REQUIREMENTS FOR RECORDS FOR THE SUPPLY-CHAIN PROGRAM—Continued

Did we receive Did we revise the documentation comments requirement other than editorial and Final section Proposed section Description regarding conforming changes associated with designation designation the proposed the final requirements for the requirement? supply-chain program?

507.175(c)(12) ...... 507.37(g)(10) ...... Documentation of an alternative verification No ...... Provide for documentation, when activity for a supplier that is a qualified applicable, of a written assurance facility. that the supplier is producing the raw material or other ingredient in compliance with relevant laws and regulations of a country whose food safety system FDA has officially recognized as com- parable or has determined to be equivalent to that of the United States. 507.175(c)(13) ...... 507.37(g)(11) ...... Documentation of an alternative verification Yes ...... No. activity for a supplier that is a farm that supplies a raw material or other ingre- dient that would not be a covered farm subject to the forthcoming produce safety rule. 507.175(c)(14) ...... N/A ...... Documentation of an alternative verification N/A ...... N/A. activity for a supplier that is a shell egg producer that is not subject to the re- quirements established in part 118 be- cause it has less than 3,000 laying hens. 507.175(c)(15) ...... 507.37(g)(12) ...... The written results of an appropriate in- No ...... No. spection of the supplier by FDA, by rep- resentatives of other Federal Agencies (such as USDA), or by representatives from State, local, tribal, or territorial Agencies, or the food safety authority of another country when the results of such an inspection is substituted for an onsite audit. 507.175(c)(16) ...... 507.37(g)(13) ...... Documentation of actions taken with re- No ...... No. spect to supplier non-conformance. 507.175(c)(17) ...... N/A ...... Documentation of verification of a supply- N/A ...... N/A. chain-applied control applied by an entity other than the receiving facility’s supplier. 507.175(c)(18) ...... N/A ...... When applicable, documentation of the re- N/A ...... N/A. ceiving facility’s review and assessment of documentation of a supplier verification activity provided by a supplier or by an entity other than the receiving facility.

A. Applicability of the Recordkeeping B. Requirement To Review Records of facilities. The rule provides that offsite Requirements of Subpart F the Supply-Chain Program (Final storage of records is permitted if such § 507.175(b)) records can be retrieved and provided We have added new § 507.175(a) to We proposed that a receiving facility onsite within 24 hours of request for specify that the records documenting must review records documenting the official review and electronic records the supply-chain program in subpart E supplier program in accordance with are considered to be onsite if they are are subject to the requirements of the requirements applicable to review of accessible from an onsite location (see subpart F. Under the 2014 supplemental records as a verification activity (i.e., in § 507.208(c)). We expect that the facility notice, the documentation requirements accordance with § 507.49(a)(4)). would be able to access information and would have been in subpart C, and the (Proposed § 507.37(g).) records relevant to the supply-chain applicability of subpart F was specified (Comment 476) Some comments ask program within 24 hours (e.g., in § 507.55 in subpart C. The new us to provide consideration for records electronically) when the records are provision specifying the applicability of associated with the supplier program to maintained at corporate headquarters. subpart F to the records associated with be administered and maintained at As necessary and appropriate, we the supply-chain program is a corporate headquarters rather than at intend to work with facilities on a case- consequential change associated with individual facilities, because this is by-case basis to determine the best way establishing the requirements for a common industry practice. (Response 476) We are aware that to review records associated with the supply-chain program in subpart E, supply-chain program when the supply- rather than in subpart C. certain programs are administered, and records are maintained, at corporate chain program is administered at the headquarters rather than at individual corporate level.

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(Comment 477) Some comments ask to disclosure of other records required purpose of all the supplier verification us to clarify in the regulatory text that by this part (see Comments 490 and activities, is broader than identifying the required records are ‘‘as appropriate 491). We would establish the status of deficiencies that pose a risk to public to the supplier program.’’ supply-chain program records, such as (human and animal) health and (Response 477) We have revised the audit reports, as available for, or includes verifying whether a raw regulatory text to specify that the protected from, public disclosure on a material or other ingredient is required records are ‘‘as applicable to its case-by-case basis. As discussed in adulterated under section 402 of the supply-chain program’’ (see Response 491, we primarily intend to FD&C Act and is produced in § 507.175(c)). copy such records when we conduct an compliance with applicable FDA food inspection for cause or if the safety regulations (see § 507.110(c)). If, C. Documentation Demonstrating Use of preliminary assessment by our for example, a supplier’s facility has the Written Procedures for Receiving investigator during a routine inspection filthy conditions or the raw materials Raw Materials and Other Ingredients is that regulatory followup may be and other ingredients it supplies are (Final § 507.175(c)(5)) appropriate (e.g., if the report indicates contaminated with filth, a receiving We proposed to require that a significant food safety problem facility may find it inappropriate to documentation demonstrating that was noted). See Response 491 for a approve that supplier. Even though filth products are received only from discussion of situations in which often does not pose a risk to public approved suppliers (proposed records would, or would not, be (human and animal) health, a food may § 507.37(g)(4)). protected from disclosure. be deemed to be adulterated under (Comment 478) Some comments (Comment 481) Some comments section 402(a)(4) of the FD&C Act if it support the proposed requirement with express concern about maintaining has been prepared, packed, or held no changes. Other comments ask us to documentation of the conclusions of an under insanitary conditions whereby it specify ‘‘raw materials and ingredients’’ audit and documentation of corrective may have become contaminated with rather than ‘‘products’’ in the regulatory actions taken in response to significant filth. text. deficiencies identified during the audit. (Response 478) We have revised the These comments explain that FDA’s E. Documentation of Sampling and regulatory text to specify ‘‘raw materials access to such documentation during Testing (Final § 507.175(c)(8)) and other ingredients’’ with associated inspection might discourage suppliers We proposed to require records of conforming changes. from allowing unannounced audits. sampling and testing. These records These comments ask us to delete these must include: (1) Identification of the D. Documentation of the Conduct of an proposed requirements. If the raw material or ingredient tested Onsite Audit (Final § 507.175(c)(7)) requirement regarding documentation of (including lot number, as appropriate) We proposed to require corrective actions remains in the final and the number of samples tested; (2) documentation of an onsite audit. This rule, these comments ask us to limit identification of the test(s) conducted, documentation must include: (1) such documentation to situations in including the analytical method(s) used; Documentation of audit procedures; (2) which the identified deficiencies posed (3) the date(s) on which the test(s) were the dates the audit was conducted; (3) a risk to public health. conducted and the date of the report; (4) the conclusions of the audit; (4) (Response 481) We are retaining these the results of the testing; (5) corrective corrective actions taken in response to documentation requirements as actions taken in response to detection of significant deficiencies identified proposed. These comments appear to be hazards; and (6) information identifying during the audit; and (5) documentation suggesting that documentation the laboratory conducting the testing. that the audit was conducted by a requirements be established based on (Comment 482) Some comments ask qualified auditor. For clarity, we have whether a business entity would want us to not apply the requirement to revised the regulatory text to specify us to see information during inspection maintain records related to sampling documentation of the ‘‘conduct’’ of an rather than on the utility and value of and testing to the receipt of RACs audit and added a requirement for the the documentation. We expect that because sampling and testing of RACs is documentation to include the name of receiving facilities, in general, maintain neither common nor effective for the supplier subject to the onsite audit. documentation of the conclusions of detecting biological or chemical (Comment 479) Some comments ask audits that they have conducted or hazards, especially in raw, intact that we add ‘‘if applicable’’ to the arranged to have conducted. A receiving produce. requirement to maintain documentation facility must approve all of its suppliers, (Response 482) We decline this of an audit because an audit may not be and documentation of corrective actions request. These comments appear to necessary if a receiving facility has taken in response to significant suggest that documentation documented that other verification deficiencies identified during an audit requirements be established based on activities are appropriate. has value to a receiving facility in the frequency and utility of sampling (Response 479) We decline this determining whether to approve a and testing a particular commodity request. The documentation is always supplier before first receiving any raw rather than on a determination by a necessary if an audit is used as a materials or other ingredients and then receiving facility that sampling and verification activity. The provision is on an ongoing basis. testing is an appropriate supplier about maintaining documentation when The rule does not require that onsite verification activity for a particular an audit is conducted, not about when audits be unannounced, although we supplier. We disagree with such a an audit needs to be conducted. acknowledge that some receiving suggestion. A receiving facility that has (Comment 480) Some comments ask facilities may see value in unannounced determined that sampling and testing is us to maintain the confidentiality of audits. We decline the request to require an appropriate supplier verification audit reports and exempt such audit a receiving facility to maintain activity needs to maintain records of reports from disclosure under the documentation of corrective actions those results as it would for any other Freedom of Information Act (FOIA). only if the identified deficiencies posed supplier verification activity. To the (Response 480) These comments are a risk to public (human and animal) extent that these comments are similar to comments we received related health. The purpose of an audit, like the concerned that the supply-chain

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program requires sampling and testing activity be based on the risk associated authority relating to animal food. The of RACs, we emphasize that this is not with raw materials and suppliers. currently existing systems recognition the case. See also Response 350 for a (Response 485) We have revised the agreement relates solely to human food discussion of the usefulness of sampling regulatory text to specify and does not apply to animal food. and testing as a verification measure for ‘‘Documentation of other appropriate (Comment 486) Some comments ask RACs. supplier verification activities based on us to delete this documentation (Comment 483) Some comments ask the supplier performance and the risk requirement because RACs except fruits us to allow documentation of testing to associated with the raw material or and vegetables should be exempt from include the date the test results were other ingredient.’’ The revised supplier verification. reported as an alternative to the date(s) regulatory text of the documentation (Response 486) See Response 464. on which the test(s) were conducted. tracks the regulatory text of this ‘‘other’’ This alternative supplier verification (Response 483) We have revised the appropriate supplier verification activity is intended to minimize the provision to require ‘‘The date(s) on activity (see § 507.110(b)(4)). As burden on suppliers that are small which the test(s) were conducted and discussed in Response 444, ‘‘supplier farms. the date of the report.’’ We agree that the performance’’ is more appropriate than (Comment 487) Some comments ask date on which the test results are ‘‘risk associated with the supplier.’’ us to include a cross-reference to the reported can be important, but it should G. Documentation of an Alternative applicable requirement. not be a replacement for the date of the Verification Activity for a Supplier That (Response 487) We have not added test. Is a Farm That Is Not a ‘‘Covered Farm’’ this cross-reference. We agree that (Comment 484) Some comments ask for the Purposes of the Future Produce adding the cross-reference has the us to add ‘‘if necessary’’ to the end of Safety Rule (Final § 507.175(c)(13)) potential to be helpful, but it also has the proposed requirement for We proposed to require the potential to clutter the regulatory documentation of corrective actions documentation of an alternative text. We considered it would be more taken in response to detection of verification activity for a supplier that is useful to specify what the hazards. a farm that is not a ‘‘covered farm’’ for documentation needs to be rather than (Response 484) We decline this the purposes of the future produce to specify the cross-reference to the request. The documentation is always safety rule, including: (1) The applicable alternative supplier necessary if corrective actions are taken. documentation that the raw material or verification activity. The provision is about maintaining ingredient provided by the supplier is XLVIII. Subpart F: Comments on documentation when corrective actions not subject to the produce safety rule Proposed New Recordkeeping are taken, not about the fact that and (2) the written assurance that the Requirements corrective actions may not always be supplier is producing the raw material needed. or ingredient in compliance with We proposed to establish in subpart F requirements that would apply to all F. Documentation of Other Appropriate applicable FDA food safety regulations and that the raw material or ingredient records that would be required by the Supplier Verification Activity (Final various provisions of proposed part 507, § 507.175(c)(10)) is not adulterated under section 402 of the FD&C Act. We have revised the including general requirements related We proposed to require records of documentation to reflect the final to the content and form of records; other appropriate verification activities requirements of § 507.130(d)—i.e., to additional requirements specific to the based on the risk associated with the require: (1) Written assurance that the food safety plan; requirements for ingredient. For clarity and consistency, supplier is not a covered farm under record retention; requirements for we have revised the proposed part 112 in accordance with § 112.4(a), official review of records by FDA; and requirement to specify ‘‘documentation’’ or in accordance with §§ 112.4(b) and public disclosure. of the other appropriate supplier 112.5, before approving the supplier and Some comments support the proposed verification activity rather than on an annual basis thereafter and (2) the requirements without change. Some ‘‘records’’ of the activity. As a written assurance that the farm comments that support the proposed conforming change associated with acknowledges that its food is subject to provisions suggest alternative or using the term ‘‘supplier performance,’’ section 402 of the FD&C Act (or, when additional regulatory text or ask us to rather than ‘‘risk of supplier,’’ when applicable, that its food is subject to clarify how we will interpret the discussing factors associated with relevant laws and regulations of a provision. suppliers, the final requirement country whose food safety system FDA In the following paragraphs, we specifies that the other appropriate has officially recognized as comparable discuss comments that disagree with or supplier verification activities are based or has determined to be equivalent to suggest one or more changes to the on the supplier performance and the that of the United States). However as of proposed requirements. After risk associated with the raw material or August 30, 2015, FDA has not considering these comments, we have other ingredient. developed a systems recognition revised the proposed requirements as (Comment 485) Some comments ask program for animal food; therefore, we shown in table 30 with editorial and us to also specify that an ‘‘other’’ have no signed systems recognition conforming changes as shown in table appropriate supplier verification agreements with any foreign food safety 31.

TABLE 30—REVISIONS TO THE PROPOSED RECORDKEEPING REQUIREMENTS

Section Description Revision

507.200(b) ...... Requirements for public disclosure .. Specify that the requirement applies to records ‘‘obtained by FDA.’’ 507.200(c) ...... Requirements for official review ...... Clarify that FDA may copy records upon oral or written request by a duly authorized representative of the Secretary of Health and Human Services.

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TABLE 30—REVISIONS TO THE PROPOSED RECORDKEEPING REQUIREMENTS—Continued

Section Description Revision

507.202(b) ...... General requirements applying to Provide that the time of an activity being documented only include records. the time of the activity when appropriate. 507.202(c) ...... General requirements applying to Specify that electronic records are exempt from the requirements of records. 21 CFR part 11. 507.208(a)(2) ...... Requirements for record retention .... Specify that records that a facility relies on during the 3-year period preceding the applicable calendar year to support its status as a qualified facility must be retained at the facility for as long as nec- essary to support the status of a facility as a qualified facility during the applicable calendar year. 507.208(c) ...... Requirements for record retention .... Provide for offsite storage of all records other than the food safety plan, provided that the offsite records can be retrieved and pro- vided onsite within 24 hours of request for official review. 507.208(d) ...... Requirements for record retention .... Provide that the food safety plan may be transferred to some other reasonably accessible location if the plant or facility is closed for a prolonged period, provided that it is returned to the plant or facility within 24 hours of request for official review. 507.215 ...... Special requirements applicable to a • Establish requirements applicable to all written assurances required written assurance. by the rule. • Establish additional requirements applicable to written assurances that are required when a food product distributed by manufacturer/ processor requires further processing for food safety by a subse- quent manufacturer.

A. Proposed § 507.200—Records Subject practices) plans or under the second (Comment 489) Some comments to the Requirements of Subpart F and option for documentation (i.e. assert that the proposed requirements Requirements for Official Review compliance with non-Federal food governing public disclosure are not We proposed that all records required safety laws). These comments assert that aligned with other risk-based preventive by part 507 would be subject to all the proposed detailed record keeping controls programs, such as HACCP requirements of subpart F, except that requirements should apply to records programs. These comments argue that certain specific requirements (proposed relating to monitoring food safety these proposed requirements should be § 507.206) would apply only to the practices and ask us to revise the realigned with other risk-based written food safety plan. We also proposed requirements so that this preventive controls programs to proposed that certain proposed exemption would apply only to those preserve the privacy of information requirements (e.g., for records to contain qualified facilities that operate under maintained in required records unless the actual values and observations non-Federal food safety laws. that information has been otherwise made publicly available. Some obtained during monitoring and, as (Response 488) We decline this appropriate, during verification comments suggest that we revise the request. We based the proposed proposed requirements to be analogous activities) would not apply to the exemption on a statutory provision that records that would be kept by qualified to the public disclosure requirements in a qualified facility is not subject to our HACCP regulations for seafood and facilities. We proposed that records certain requirements, including the required by proposed part 507 are juice (see §§ 123.9(d) and 120.12(f), statutory recordkeeping requirements subject to the disclosure requirements respectively). (see section 418(l)(2) of the FD&C Act). under part 20 (21 CFR part 20). We (Response 489) We disagree that the Although the requirements that apply to proposed that all records required by proposed provisions governing public a qualified facility require submission of proposed part 507 be made promptly disclosure are not aligned with the certain attestations to FDA (see available to a duly authorized public disclosure provisions of our representative of the Secretary of HHS § 507.7(a) and (b)), and these attestations HACCP regulations for seafood and upon oral or written request. We also must be supported by documentation juice. Our regulations in part 20 asked for comment on whether we (see § 507.7(f)), the rule does not require regarding public information apply to should require a facility to send records that records kept by a qualified facility all Agency records, regardless of to us rather than make the records to support its attestations be the same whether a particular recordkeeping available for review at a facility’s place type of records that would be kept by a requirement says so. In the case of the of business and, if so, whether we facility subject to subparts C and E. For recordkeeping requirements for our should require that the records be example, if the facility attests that it has HACCP regulations for seafood and submitted electronically. identified the potential hazards juice, we framed the provisions (Comment 488) Some comments associated with the animal food being regarding public disclosure by disagree with the proposal to exempt produced, implemented preventive providing specific details about how the records that would be kept by controls to address the hazards, and is particular provisions in part 20 (i.e., qualified facilities from requirements to monitoring the performance of the § 20.61 (Trade secrets and commercial keep accurate, detailed records. The preventive controls, the qualified or financial information which is comments note that the proposed facility might support its attestation by privileged or confidential) and § 20.81 exemption would apply to qualified having a standard operating procedure (Data and information previously facilities regardless of whether they for monitoring preventive controls disclosed to the public)) would apply to operate under the first option for rather than detailed records of actual the applicable records. In the case of the documentation (i.e., food safety monitoring. recordkeeping requirements for this

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rule, we framed the provisions regarding may be appropriate (e.g., if these records a consumer complaint. See Response public disclosure by more broadly demonstrate that an environmental 490 for a discussion of how the FOIA referring to all the requirements of part pathogen has become established in a would apply to records, such as records 20, consistent with our more recent niche environment in an animal food of testing as a verification activity, that approach for framing the provisions processing plant). we copy during an inspection and regarding public disclosure in the rule (Comment 491) Some comments maintain in our system. ‘‘Prevention of Salmonella Enteritidis in assert that we should not copy (Comment 492) Some comments ask Shell Eggs During Production, Storage, documents as part of routine us to modify the proposed requirement and Transportation’’ (part 118; see investigations so as to prevent critical to clarify that it is ‘‘records required by § 118.10(f)). Provisions such as § 20.20 documents from release under the this part and provided to the Agency,’’ (Policy on disclosure of Food and Drug FOIA. These comments are particularly rather than ‘‘records obtained by the Administration records) apply to all concerned that our ability to copy Agency’’ that are subject to public records that we have in our system, verification records (such as testing disclosure. including HACCP records, even though records) and potentially release these (Response 492) We agree that it is the HACCP regulations do not specify records under the FOIA would appropriate to specify that the that this is the case. discourage facilities from testing as a disclosure requirements of this rule (Comment 490) Some comments ask verification activity. These comments apply to information that we maintain us to clarify that the disclosure also express concern that some facilities as a record (see the description of requirements of part 20 include would include in their food safety plans ‘‘record’’ in § 20.20(e)). (See also the protections for trade secrets and elements, not required by the proposed discussion (in the proposed rule to privileged or confidential commercial rule, that address food defense, as well establish our seafood HACCP regulation, information and financial information. as food safety, and that disclosure of 59 FR 4142 at 4160, January 28, 1994) Other comments ask us to clarify that such a food safety plan without proper that there are significant legal and written food safety plans and associated redaction could provide useful practical questions as to whether FDA records are not subject to public information to persons seeking to defeat has the authority to require disclosure of disclosure because they represent trade the facility’s food defense strategies. In industry records that are not in FDA’s secret or confidential commercial addition, these comments express possession.) However, we see no information. Other comments ask us to concern that the task of reviewing all of meaningful distinction between records clarify how the disclosure requirements these records and redacting trade secrets ‘‘provided to FDA’’ and records of part 20 would apply to verification and confidential information would ‘‘obtained by FDA,’’ and have revised records (such as testing records). further set back FDA’s already the provision to specify that records (Response 490) The questions raised overburdened FOIA offices and create obtained by FDA in accordance with in these comments are similar to some even longer delays in responding to this part are subject to the disclosure of the questions raised during the FOIA requests. requirements under part 20. The revised rulemaking to establish FDA’s HACCP (Response 491) We have revised the regulatory text makes clear that the regulation for seafood (see the proposed requirement to specify that all requirements of part 20 attach to those discussion at 60 FR 65096 at 65137 required records must be made documents obtained by FDA. To the through 65140, December 18, 1995). promptly available ‘‘for official review extent that these comments are FDA’s experience in conducting CGMP and copying’’ to increase the alignment addressing the difference between inspections in processing plants, our of the recordkeeping requirements of records provided during inspection and experience with enforcing the HACCP this rule with those of our HACCP records submitted to us, as already regulations for seafood and juice, and regulations for seafood and juice. The discussed we have decided not to our understanding from the Final issues raised by these comments are require submission of certain records to Regulatory Impact Analysis (FRIA) for similar to some of the issues raised by us (see Response 493). this rule (Ref. 60) make it clear that food comments during the rulemaking to (Comment 493) Some comments safety plans will take each facility some establish our HACCP regulations for strongly oppose any requirement for time and money to develop. Thus, we seafood (see the discussion at 60 FR submission of records to FDA remotely conclude that food safety plans 65096 at 65137 through 65140) and our and assert that there is no basis in generally will meet the definition of regulations in part 118 for the FSMA for such a requirement. Some trade secret, including the court’s prevention of Salmonella Enteritidis in comments express concern about our definition in Public Citizen Health shell eggs. We intend to copy records on ability to protect confidential Research Group v. FDA, 704 F.2d 1280 a case-by-case basis as necessary and information (such as supplier and (D.C. Cir. 1983). Plans that incorporate appropriate. We may consider it customer records received by a facility unique regimens or parameters to necessary to copy records when, for under the protection of confidentiality achieve product safety, which are the example, our investigators may need agreements) that is transmitted result of considerable research and assistance in reviewing a certain record electronically (e.g., the information that effort, will surely meet this definition. from relevant experts in headquarters. If might be released through computer We would establish the status of we are unable to copy the records, we hacking or leaks). Some comments note verification records, such as the results would have to rely solely on our that inadvertent disclosure of of product testing and environmental investigators’ notes and reports when information related to specific products, monitoring, as available for, or protected drawing conclusions. In addition, hazards, and preventive controls from, public disclosure on a case by copying records will facilitate followup implemented at food facilities could case basis. As discussed in Response regulatory actions. both prove harmful from a commercial 491, we primarily intend to copy such We primarily intend to copy records or competitive standpoint and expose records when we conduct an inspection such as the results of product testing or existing vulnerabilities in the U.S. food for cause. We also intend to copy such environmental monitoring when we supply, thus potentially rendering food records if the preliminary assessment by conduct an inspection for cause, e.g., as facilities susceptible to malicious attack. our investigator during a routine a result of an outbreak investigation, Some comments express concern over inspection is that regulatory followup violative sample results, or followup to any potential requirements to submit

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reports from third-party audits to FDA. date and time of the activity systems, so the burden and cost would The comments state that a requirement documented, the signature or initials of exponentially increase. These comments to submit audit reports, which may be the person performing the activity, and, ask us to instead require facilities that included as voluntary or required where appropriate, the identity of the use electronic records to a use secure components of a facility’s food safety product and the production code, if any. system that ensures records are plan, would not be of public health We have revised the provision to trustworthy, reliable, and generally benefit and could potentially impact a require information adequate to identify equivalent to paper records and facility’s willingness to use audits in the plant or facility (e.g., the name, and handwritten signatures executed on their food safety program. when necessary, the location of the paper. Some comments offered that instead plant or facility) rather than to always Other comments express concern of submission of the food safety plan, a require both the name and location of about the financial burden for small facility should submit a ‘‘certification’’ the plant or facility (see § 507.202(b)(1)). facilities such as farm mixed-type that the facility has a food safety plan In some cases, the name of the plant or facilities and ask us to either modify during the course of the facility facility will be adequate to identify it, requirements for farm mixed-type registration process. e.g., when a plant or facility is not part facilities, very small businesses, and Some comments oppose the concept of a larger corporation that has facilities small businesses or provide that such of a ‘‘desk audit’’ whereby our at more than one location. In other facilities be fully exempt from part 11 investigators conduct their inspections cases, the name of the plant or facility requirements for electronic records. from a remote office without actually may not, by itself, be adequate to Other comments state that, as with the visiting the facility and assert that our identify the plant or facility, e.g., when recordkeeping requirements under the access to company records must be a plant or facility is part of a larger Bioterrorism Act, such requirements are conducted on-site in the course of an corporation with more than one location disproportionate to the regulatory need. authorized inspection so that we may and the ‘‘name’’ of each plant or facility Some comments state that major understand the full context of what the is the same. advances in software technology have records show. Some comments point (Comment 494) Some comments been made since part 11 published in out that there would be challenges express concern about ‘‘apparent 1997, and such advances must be associated with credential validation mandates’’ that we will require records carefully considered in evaluating any when we asked for records to be sent to be kept as paper copies, even if the potential expansion or new applications remotely, such as in an email request. records were generated electronically, of part 11. These comments also state Some comments ask that we modify the for 2 years. that we already are in the process of proposed requirement to specify that (Response 494) We did not propose to reevaluating part 11 for the regulations records would only be made available to require that all records must be kept as for which it currently applies, citing us during a facility inspection. paper copies. A facility has the choice industry guidance issued more than 10 (Response 493) We have decided not to keep records as original records, true years ago in which we acknowledged to establish any requirements for a copies, or electronic records. that part 11 is unworkable in many facility to send records to us. We will (Comment 495) Some comments respects and decided to exercise review records when we are onsite in assert that compliance with part 11 for enforcement discretion for part of the the course of an authorized inspection, the secure operation of many systems regulations and announced plans to and copy records as necessary and currently in use is unnecessary and reexamine part 11 as a whole. appropriate. would create the need to redesign and Some comments recommend that we We are not modifying the proposed recreate existing systems, thus leading develop guidance, with input from key requirement to specify that records to considerable cost and complexity. stakeholders, to describe the kinds of would only be made available to us These comments identify the systems and steps that can be used to during a facility inspection because it is requirement for hardware and software assure records meet the required not necessary to do so. The regulatory to be validated as a key cost concern standard. This guidance should clearly text specifying that the records be made and assert that validation activities establish that specific security needs available to a duly authorized would be difficult to maintain and will depend on the circumstances, representative of the Secretary of HHS would not deliver added value. As an including the system at issue, its provides the context that the records example, these comments explain that intended use, the criticality of the would be made available during an expectation for validation of preventive control or other food safety inspection. electronic recordkeeping software and measure it is used to manage, and other hardware would be particularly relevant factors. For example, these B. Proposed § 507.202—General problematic because software patches comments explain that a quality system Requirements Applying to Records and security updates are distributed on used to manage CCP documentation We proposed that the records must: a nearly weekly basis, and express the would have greater security needs than (1) Be kept as original records, true view that validation procedures are a review of a Certificate of Analysis for copies, or electronic records (and that most appropriately applied before use of a non-sensitive ingredient. electronic records must be kept in a new system and after major software (Response 495) In light of the accordance with part 11 (21 CFR part changes or updates. These comments substantial burden that could be created 11)); (2) contain the actual values and also assert that it would be costly, by the need to redesign large numbers observations obtained during burdensome, and require specialized of already existing electronic records monitoring and, as appropriate, during resources to modify or replace existing and recordkeeping, we are providing in verification activities; (3) be accurate, electronic systems to comply with part new § 507.202(c) that records that are indelible, and legible; (4) be created 11. These comments provide an established or maintained to satisfy the concurrently with performance of the example in which a facility needed requirements of part 507 and that meet activity documented; (5) be as detailed more than 9 months to upgrade one the definition of electronic records in as necessary to provide history of work system alone to comply with part 11, § 11.3(b)(6) are exempt from the performed; and (6) include the name and note that it would not be unusual requirements of part 11. As we did in and location of the plant or facility, the for companies to employ multiple the section 414 recordkeeping

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regulations, we also are specifying that food manufacturing/processing, preventive controls qualified individual records that satisfy the requirements of packing, or holding environments for the facility. part 507, but that also are required would prove difficult, and we are not D. Proposed § 507.208—Requirements under other applicable statutory aware of any such example. For for Record Retention provisions or regulations, remain example, we are not aware of any subject to part 11. The rule provides that difficulty complying with longstanding We proposed that: (1) All required a facility may rely on existing records to similar requirements associated with records must be retained at the plant or satisfy the requirements of this rule, and our HACCP regulations for seafood and facility for at least 2 years after the date this rule does not change the status juice (see §§ 123.9(a)(4) and they were prepared; (2) records relating under part 11 of any such records if 120.12(b)(4), respectively). to the general adequacy of equipment or those records are currently subject to processes being used by a facility, part 11. As we did in the rulemaking to C. Proposed § 507.206—Additional including the results of scientific establish the section 414 recordkeeping Requirements Applying to the Food studies and evaluations, must be regulations, we are establishing a Safety Plan retained at the facility for at least 2 years conforming change in part 11 to specify We proposed that the food safety plan after their use is discontinued; (3) in new § 11.1(j) that part 11 does not must be signed and dated by the owner, except for the food safety plan, offsite apply to records required to be operator, or agent in charge of the storage of records is permitted after 6 established or maintained under part facility upon initial completion and months following the date that the 507, and that records that satisfy the upon any modification. records were made if such records can be retrieved and provided onsite within requirements of part 507, but that also (Comment 498) Some comments ask 24 hours of request for official review; are required under other applicable for clarification on who can sign and and (4) if the plant or facility is closed statutory provisions or regulations, date the food safety plan. Some for a prolonged period, the records may remain subject to part 11. comments state that the proposed rule be transferred to some other reasonably Although we are not specifying that would exclude the preventive controls accessible location but must be returned part 11 applies, facilities should take qualified individual from signing and to the plant or facility within 24 hours appropriate measures to ensure that dating the food safety plan unless the for official review upon request. records are trustworthy, reliable, and preventive controls qualified individual generally equivalent to paper records (Comment 499) Some comments ask is the owner, operator, or agent in us to clarify that the 2-year record and handwritten signatures executed on charge of the facility. These comments paper. retention requirement only applies to ask us to revise the rule to allow the (Comment 496) Some comments records created after the compliance preventive controls qualified individual assert that certain production and date for the final rule. associated activities are not time- to sign and date the food safety plan (Response 499) The retention sensitive and would not require (e.g., because it is the preventive requirements only apply to records documentation of the time the activity controls qualified individual who created after the applicable compliance is performed. These comments ask us to prepares (or oversees the preparation of) date for the final rule. See Response 76 modify the proposed requirements so the food safety plan). One comment and section LIII.A, which explain that that the records would only require the suggests that ‘‘agent in charge’’ be the compliance date for a facility to time of the activity documented where defined to include all preventive retain records to support its status as a appropriate for food safety. controls qualified individuals. Some qualified facility is January 1, 2017. See (Response 496) We agree that certain comments ask us to require that any also Response 502, which explains that activities (e.g., record review and preventive controls qualified we have revised the record retention verification activities) are not time- individuals who prepare (or oversee the provisions to specify that records that a sensitive and, thus, would not need to preparation of) specific sections of the facility relies on during the 3-year include the time that the activity was food safety plan sign and date period preceding the applicable performed. The final rule provides applicable sections. calendar year to support its status as a flexibility for the facility to determine (Response 498) We decline these qualified facility must be retained at the when to document the time by requests. The statute expressly directs facility for as long as necessary to specifying that the time be documented the owner, operator, or agent in charge support the status of facility as a ‘‘when appropriate’’ (see of a facility to prepare the food safety qualified facility during the applicable § 507.202(b)(2)). plan (see section 418(h) of the FD&C calendar year. (Comment 497) Some comments Act). As previously discussed, such a (Comment 500) Some comments ask assert that concurrent record creation signature would provide direct evidence us to delete the proposed requirement to will prove difficult in many animal of the owner, operator or agent’s keep records on site for 6 months or 2 food-processing environments. These acceptance of the plan and commitment years (depending on the record) and comments ask us to modify the to implementation of the plan (78 FR assert that it should suffice to require proposed requirement that records be 64736 at 64816). A facility has that records be available within 24 created concurrently with the flexibility to require the signature of one hours of request or within a reasonable performance of the activity documented or more preventive controls qualified period of time. Some comments assert to qualify that the requirement only individuals who prepared, or oversaw that records should be able to be kept applies where feasible, and that the the preparation of, its food safety plan in the location where they are created, records could be created as soon as in addition to the minimum signature which may be at corporate headquarters. possible thereafter under circumstances requirement specified in the rule. Other comments state that it may be where concurrent record creation is not Likewise, a facility also has flexibility to difficult to obtain records within 24 feasible. require the signature of one or more hours and requested additional time. (Response 497) We decline this members of its food safety team who Comments also assert that specifying the request. The comments did not provide contributed to the preparation of the location for record storage will increase any examples of activities where food safety plan, even if those costs but will not contribute to concurrent record creation in animal individuals are not serving as the improvements in public health. Some

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comments ask us to permit offsite applicable calendar year to support its that the food safety plan records need storage for all records over 6 months status as a qualified facility must be not be collected in a single location or old, in contrast to the 2-year retention retained at the facility as long as ‘‘reduced to a binder.’’ Likewise, the period we proposed for records relating necessary to support the status of a records documenting implementation of to the general adequacy of equipment or facility as a qualified facility during the the plan could be a ‘‘web of related processes being used by a facility, applicable calendar year. As discussed documents.’’ For example, a facility that including the results of scientific in section VIII.A, the definition of very collects samples of product and sends studies and evaluations. small business established in this rule is them to a laboratory for testing would (Response 500) We have revised the based on an average (of sales plus have records documenting its collection provisions to provide for offsite storage market value of animal food held of samples, as well as records of all records (except the food safety without sale) during the 3-year period documenting the laboratory’s test plan), provided that the records can be preceding the applicable calendar year. results. Consistent with the retrieved and made available to us Thus, both of the criteria for the requirements of the rule for written within 24 hours of request for official qualified facility exemption are based procedures for product testing review. We have determined that in on financial records associated with the (§ 507.49(b)(2)) and the general order to maintain inspectional preceding 3-year period. The actual recordkeeping requirements of subpart F efficiency, 24 hours is a reasonable retention time necessary to support the (§ 507.202), the sampling records would period to allow for retrieval of any status of a qualified facility during the contain information such as the name offsite records. We expect that many applicable calendar year could be as and location of the facility, the date records will be electronic records that long as 4 years. For example, if we when the samples were collected, the are accessible from an onsite location inspect a facility on May 1, 2024, the signature or initials of the person and, thus, would be classified as being facility would have retained the records collecting the samples, and the identity onsite (see § 507.208(c)). As a from 2021 to 2023 for 3 years and 4 and lot code of the sampled product. companion change, we have revised the months. If we inspect the facility on Likewise, the laboratory report would proposed provision directed to the December 28, 2024, the facility would contain information identifying the special circumstance of storing records have retained the records from 2021 to laboratory, the product tested (and when a facility is closed for prolonged 2023 for nearly 4 years. associated lot code), the test analyte, the periods of time so that it only relates to test(s) conducted (including the the offsite storage of the food safety plan E. Proposed § 507.212—Use of Existing analytical method(s) used), the date of in such circumstances (see Records the test(s), the test results, and the § 507.208(d)). We proposed that existing records signature or initials of the person who (Comment 501) Some comments (e.g., records that are kept to comply conducted the test. Alternatively, it assert that a 2-year retention period for with other Federal, State, or local would be acceptable to have the records is much longer than needed for regulations, or for any other reason) do signature or initials of the person who animal food products, as animal food is not need to be duplicated if they contain approved the release of the test results often consumed within a short time all of the required information and from the laboratory. Together, these after manufacture. These comments ask satisfy the requirements of subpart F. records contain all the required us to establish a 1-year period for record Existing records may be supplemented information to associate them with a retention, which would be similar to as necessary to include all of the facility, a specific lot of product, and the record retention periods required in required information and satisfy the results of laboratory testing on that other FDA regulations. Some comments requirements of subpart F. We also product. assert that records should be required to proposed that the information required Although the provisions for use of be kept for the shelf life of the product by part 507 does not need to be kept in existing records provide flexibility, plus an additional 6 months, for certain one set of records. If existing records there are some limitations. For example, animal foods such as pet foods. contain some of the required monitoring records must be created (Response 501) We decline these information, any new information concurrently with the monitoring requests. The proposed 2-year retention required by part 507 may be kept either activity and contain the signature or period is authorized by the statute (see separately or combined with the initials of the person conducting the section 418(g) of the FD&C Act). existing records. monitoring. If the facility has an existing Moreover, the reasons discussed by the Comments that address this proposed form that it uses to document the comments for linking the retention requirement support it. For example, monitoring activity, and that form does period to shelf life are more relevant to some comments state that this provision not provide (or have space to add) the record retention requirements for would provide flexibility to facilities to information adequate to identify the the purpose of tracking potentially comply with the record requirements in plant or facility (e.g., the name and, contaminated food (part 1, subpart J; see an efficient manner. Other comments when necessary, the location of the § 1.360) than to the record retention state that this provision would prevent facility), and does have (or have space requirements for the purpose of companies from having to duplicate to add) a place for the signature of the evaluating compliance with this rule. records or create new records solely to person performing the activity, we (Comment 502) Some comments ask satisfy recordkeeping requirements. expect the facility to modify the form us to require that qualified facilities (Comment 503) Some comments state rather than use the existing form. The keep financial and sales records for 3 or that food safety plan records are a ‘‘web provisions for ‘‘supplementing’’ existing 4 years, because a qualified facility must of related documents’’ that may be used records do not extend to providing document that the average value of food in other programs and cannot be information identifying the facility, or it sold over the prior 3 years did not collected or reduced to a ‘‘binder.’’ signatures, on separate pages. exceed $500,000 annually. (Response 503) We agree that food (Comment 504) Some comments state (Response 502) We have revised the safety plan records could be considered that our review of records should be record retention provisions to specify a ‘‘web of related documents,’’ i.e., a set limited to issues under our jurisdiction, that records that a facility relies on of records that could include documents regardless of the other information that during the 3-year period preceding the used in other programs. We also agree may be contained in the record. Other

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comments ask us to ensure that to the food by an entity in the after publication to comply with the inspectors are adequately trained on distribution chain before the food CGMP requirements and 4 years after how to review facility records for the reaches consumers. publication to comply with preventive requisite information across multiple controls requirements. We anticipate XLIX. Comments by Foreign sets of documents, as needed. that these extended implementation Governments and Foreign Businesses (Response 504) Section 418(h) of the periods for small businesses and very FD&C Act requires that the written plan We received several comments from small businesses will apply to a number that documents and describes the foreign governments and foreign of businesses in developing countries. procedures used by the facility to businesses covering a wide range of Because all of these time periods are comply with the requirements of section issues. Many of those comments were longer than the 6 month minimum 418, together with the documentation of similar to comments made on certain defined in the WTO Ministerial monitoring of preventive controls, topics by domestic stakeholders, so we Decision, we believe these instances of nonconformance material to are addressing those comments in other implementation periods are sufficient to food safety, the results of testing and sections throughout this preamble. In address the needs of businesses in other means of verification, instances this section, we are responding to developing countries, particularly for when corrective actions were comments that are primarily focused on small and very small businesses in such implemented and the efficacy of international issues, such as the countries. preventive controls and corrective obligations of the United States under In addition to the extended time actions, be made available to FDA. Our the World Trade Organization periods for compliance for small and inspectors will be trained to focus on Agreement (WTO). very small businesses, we have also the written food safety plan and the (Comment 505) Some comments by established modified requirements for records documenting implementation of foreign government representatives ask very small businesses, which we define the plan during inspections. Our us to provide extended periods of time as a business (including any inspectors have experience in the for the implementation of the rule for subsidiaries; and affiliates) averaging review of records that an animal food facilities in foreign countries. less than $2,500,000, adjusted for business establishes and maintains for (Response 505) The concept of special inflation, per year, during the 3-year more than one purpose—e.g., during the and differential treatment is period preceding the applicable review of records kept under the section incorporated in the WTO Agreements. calendar year, in sales of animal food 414 recordkeeping regulations during Article 10.2 of the WTO Sanitary and plus the market value of animal food the investigation of an outbreak of Phytosanitary (SPS) Agreement states: manufactured, processed, packed, or foodborne illness. ‘‘Where the appropriate level of sanitary held without sale (e.g., held for a fee or For further discussion of comments or phytosanitary protection allows supplied to a farm without sale). These received on recordkeeping scope for the phased introduction . . . modified requirements for very small requirements, see section XLI in the longer timeframes for compliance businesses are less burdensome and are final rulemaking for preventive controls should be accorded on products of described in § 507.7 of this regulation. for human food published elsewhere in interest to developing country Members In addition to the extended and this issue of the Federal Register. so as to maintain opportunities for their staggered time periods for compliance exports.’’ for all firms, and modified requirements F. Final § 507.215—Special In 2001, at the WTO Ministerial for very small businesses, we intend to Requirements Applicable to a Written Conference in Doha, WTO Members work with the animal food industry, Assurance issued a Ministerial Decision that education organizations, USDA, the As discussed in section XXVII, new interpreted the special and differential United States Agency for International § 507.215 establishes requirements obligations of the SPS Agreement (Ref. Development, and foreign governments applicable to the written assurance a 61). The Ministerial Decision defined to develop tools and training programs manufacturer/processor obtains from its ‘‘longer timeframe for compliance’’ to to facilitate implementation of this rule. customer. New § 507.215(a) applies to normally mean a period of not less than (Comment 506) Some comments all written assurances required by the 6 months. assert that the food safety systems of the rule, i.e., the assurance must contain the We recognize that businesses of all European Union and other countries effective date; printed names and sizes may need more time to comply afford a similar level of food safety signatures of authorized officials; and with the new requirements established protection and must therefore be the applicable assurance. under this rule. As discussed in section recognized by FDA as equivalent under The provisions of § 507.215(b), LIII, the compliance date for the WTO SPS Agreement. These together with another new provision implementation of subpart C, Hazard comments urge FDA to accept the (§ 507.37), establish legal Analysis and Preventive Controls is HACCP plans and other steps taken to responsibilities under the rule for a extended one year beyond the comply with European food safety laws facility that provides a written compliance date for the implementation as being sufficient to comply with this assurance regarding a food product that of subpart B, Current Good rule. a manufacturer/processor distributes Manufacturing Practice. Businesses (Response 506) The concept of without application of a preventive other than small and very small ‘‘equivalence’’ for food safety regulatory control that is needed to control a businesses will have 1 year after the measures is contained in Article 4 of the hazard. This responsibility exists even date of publication to comply with the World Trade Organization Agreement for a facility that is not itself a CGMP requirements and 2 years after on the Application of Sanitary and manufacturer/processor, such as for a publication to comply with preventive Phytosanitary Measures (the ‘‘SPS facility that is a distributor. We are controls requirements. Small businesses Agreement’’) (Ref. 62). That article establishing legal responsibilities for the will have 2 years after publication to provides that WTO Member countries facilities that provide these written comply with the CGMP requirements ‘‘shall accept the sanitary or assurances because following these and 3 years after publication to comply phytosanitary measures of other assurances is critical to ensuring that with preventive controls requirements. Members as equivalent, even if these required preventive controls are applied Very small businesses will have 3 years measures differ from their own or from

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those used by other Members trading in obligation to comply with the We also note that we intend to the same product, if the exporting requirements of this rule. Another publish a final FSVP rule in the near Member objectively demonstrates to the comment urges FDA to utilize the future. There, we intend to establish importing Member that its measures systems recognition process to recognize modified requirements for food achieve the importing Member’s the effectiveness of the European Union imported from a foreign supplier in, and appropriate level of sanitary or (EU) system in order to avoid under the regulatory oversight of, a phytosanitary protection.’’ This unnecessary or duplicative country whose food safety system FDA provision of the SPS Agreement requirements and controls on food has officially recognized as envisions a process in which the imports from the EU. Another comment ‘‘comparable’’ to that of the United exporting country provides evidence to requests that FDA coordinate inspection States. the food safety regulator in the and audits with the relevant competent Section 507.105(a)(2) of this rule importing country in order to authority. provides the option for a receiving ‘‘objectively demonstrate’’ that the food (Response 507) We agree, in part, with facility that is an importer to comply safety system in the exporting member this comment. We agree that the systems with the supplier verification meets the level of food safety protection recognition program can allow FDA to requirements in this rule or with the established by the importing country. take into account the effectiveness of a foreign supplier verification program To date, FDA has considered foreign food safety regulatory system as requirements that we will establish in equivalence as most appropriately we develop a compliance framework for part 1, subpart L for a raw material or applied to the assessment of a foreign imported foods from a country for other ingredient. We intend that the government’s specific programs for which we have made an affirmative final FSVP rule will contain a similar specific types of foods, such as shellfish determination of comparability via the provision (derived from proposed and dairy products. In that context, the systems recognition program. While we § 1.502), so that only one supplier equivalence assessment provides a very decline to add an exemption for food verification procedure needs to be detailed comparison of each measure imported from a country with undertaken in order to comply with that a country applies in controlling affirmative systems recognition both rules when the specified risks associated with the particular determination by FDA, we note that the conditions are met. commodity under review. FDA (Comment 508) Some comments continues to have latitude to engage in systems recognition program is based assert that a proper harmonization is equivalence determinations for market upon the concept that foreign food needed with international standards and access and as required by our businesses can meet U.S. food safety ask us to harmonize the FSMA regulations for certain commodities. requirements by providing assurances In contrast to the assessment of that these foods are produced according requirements for the food safety plan equivalence for the regulation of to the food safety standards of a country with international and domestic HACCP specific foods based upon a detailed that FDA has found to be comparable or programs. These comments also ask us review of an individual food safety equivalent to that of the United States. to explain any differences between the measure or group of measures applied to Several provisions of the supply-chain FSMA food safety plan and the existing a specific food, FDA has established a program specifically provide for HACCP programs and ask us to provide process of assessing foreign food safety consideration of relevant laws and exporters with background information systems to identify systems that offer a regulations of a country whose food and specific examples of differences, comparable level of public health safety system FDA has officially including how firms are directed to set protection as the U.S. food safety system recognized as comparable or has their CCPs and critical limits. for FDA regulated foods. We refer to that determined to be equivalent to that of (Response 508) We currently have no process as ‘‘systems recognition,’’ which the United States (see HACCP requirements applicable to we discuss in Response 507. §§ 507.110(d)(1)(iii)(B); 507.130(c)(2), animal food. For discussion of this (Comment 507) Some comments urge (d)(2), and (e)(2); and 507.135(b) and comment, see Response 725 in the final FDA to include a provision in this rule (c)(1)(ii)). However, as of August 30, rule for preventive controls for human that would reflect a determination made 2015, FDA has not developed a systems food, published elsewhere in this issue by FDA in the ‘‘systems recognition’’ recognition program for animal food; of the Federal Register. therefore, we have no signed systems process so that FDA’s compliance L. Editorial and Conforming Changes framework, including audit and recognition agreements with any foreign inspection activities, takes into account food safety authority relating to animal The revised regulatory text includes the effectiveness of the regulatory or food. The currently existing systems several changes that we have made to administrative control of food safety recognition agreement relates solely to make the requirements more clear and systems. These comments ask us to human food and does not apply to improve readability. The revised include a provision in this rule animal food. For further discussion of regulatory text also includes several establishing that an affirmative systems the systems recognition program, see conforming changes that we have made recognition determination by FDA for Response 718 of the final rule for when a change to one provision affects an exporting country would be a preventive controls for human food, other provisions. We summarize the sufficient basis to exempt exporting published elsewhere in this issue of the principal editorial and conforming businesses from that country from their Federal Register. changes in table 31.

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TABLE 31—PRINCIPAL EDITORIAL AND CONFORMING CHANGES

Designation in the revised regulatory text (§ ) Revision Explanation

• 11.1(j) ...... Specify that part 11 does not Conforming change associated with the recordkeeping require- apply to records required to be ments in § 507.202, which provide that part 11 does not apply established or maintained under to records required to be established or maintained under part part 507, and that records that 507. satisfy the requirements of part 507, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11. Throughout part 507 ...... • Substitute the term ‘‘adequate’’ Conforming change associated with our proposal, in the 2014 for the term ‘‘sufficient’’. supplemental animal preventive controls notice, to make this • Substitute the term ‘‘inadequate’’ substitution so that the rule consistently uses the term ‘‘ade- for the term ‘‘insufficient’’. quate.’’ Throughout part 507 ...... Substitute the term ‘‘pathogen’’ for Conforming change associated with the definition of ‘‘pathogen.’’ the term ‘‘microorganism of pub- lic health significance’’. Throughout part 507...... Substitute the term ‘‘preventive Conforming change associated with adding the term ‘‘preventive controls qualified individual’’ for controls qualified individual’’. the term ‘‘qualified individual’’. Throughout part 507...... Substitute the term ‘‘unexposed Conforming change associated with the definition of ‘‘unexposed packaged animal food’’ for the packaged animal food’’. phrase ‘‘packaged animal food that is not exposed to the envi- ronment’’. Throughout part 507...... Substitute the phrase ‘‘chemical Conforming change associated with the definition of ‘‘hazard’’. (including radiological) hazards’’ for phrases such as ‘‘chemical and radiological hazards’’. Throughout part 507 ...... Substitute the term ‘‘hazard requir- Conforming change associated with the proposed definition of ing a preventive control’’ for the ‘‘significant hazard’’ (which we now refer to as ‘‘hazard requiring term ‘‘significant hazard’’. a preventive control’’). Throughout part 507...... Shorten ‘‘raw agricultural com- Conforming change associated with the new definition of ‘‘raw ag- modity as defined in section ricultural commodity’’. 201(r) of the Federal Food, Drug, and Cosmetic Act’’ to ‘‘raw agricultural commodity’’. 507.1(a) ...... Redesignate subparagraphs to Improve clarity. distinguish between applying the provisions in determining wheth- er animal food is adulterated and applying the provisions in determining whether there is a violation of the PHS Act. 507.3 ...... Substitute ‘‘apply’’ for ‘‘are applica- Improve clarity. ble’’ in the introductory para- graph. 507.3 ...... Alphabetize the examples of har- Improve clarity. vesting activities in the definition of ‘‘harvesting’’. 507.3 ...... Alphabetize the examples of man- Improve clarity. ufacturing/processing activities in the definition of ‘‘manufac- turing/processing’’. 507.3 ...... Specify that the definition of ‘‘very Give prominence to this aspect of the definition of ‘‘very small small business’’ includes any business.’’ The relevance of subsidiaries and affiliates to the subsidiaries and affiliates. definition of ‘‘very small business’’ is established in the defini- tion of ‘‘qualified facility,’’ but including it again in the definition of ‘‘very small business’’ will help to ensure that it is considered when determining whether the business is within the dollar threshold established in the definition of ‘‘very small business’’. • 507.3 ...... Substitute ‘‘subparts C and E’’ for Conforming change associated with the redesignation of the re- • 507.5 ...... ‘‘subpart C’’. quirements for a supply-chain program in new subpart E. • 507.7(d) ...... • 507.10(a) ...... • 507.65(d)(1) ......

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TABLE 31—PRINCIPAL EDITORIAL AND CONFORMING CHANGES—Continued

Designation in the revised regulatory text (§ ) Revision Explanation

507.7(a)(2)(ii) ...... Editorial change to place the Improve clarity. clause ‘‘including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight’’ at the end of the provision, rath- er than in a parenthetical at the beginning of the provision. • 507.14 ...... Conforming changes associated The definition of ‘‘plant’’ focuses on the building, structure, or • 507.17(a) ...... with the definition of ‘‘plant’’. parts thereof, used for or in connection with the manufacturing, • 507.20(d) ...... processing, packing, or holding of animal food. The term ‘‘es- • 507.202(b) ...... tablishment’’ focuses on a business entity rather than on build- ings or other structures. 507.20(d) ...... Refer to ‘‘employees’’ rather than Editorial change. ‘‘its employees’’. • 507.25(a)(2) through(b)(1) ...... Changes to consistently refer to Conforming change with preventive controls rule for human food. • 507.33(d)(3) ...... raw materials and ‘‘other ingre- • 507.105(a)(1) ...... dients’’. • 507.110(b) through (e) ...... • 507.115(a) ...... • 507.120(a) and (b) ...... • 507.130 ...... • 507.175(c) ...... 507.31(b)(3), 507.34(c)(3), 507.39(b), Refer to ‘‘supply-chain program’’ Conforming change associated with the title of final subpart E 507.47(c)(3), 507.55(a)(5). rather than ‘‘supplier program’’. (proposed § 507.37). • 507.47(b)(2) ...... Conforming changes associated Improve clarity; consistency with the requirements for validation. • 507.50(b)(4) ...... with the definition of ‘‘validation’’. 507.49(a)(4)(ii) ...... Refer to ‘‘supply-chain verification Consequential change as a result of the requirement in activities,’’ as well as ‘‘supplier § 507.105(c) for verification of an entity that is in the supply- verification activities’’. chain but is not a supplier. 507.49(b)(1) ...... Changes to require written proce- Conforming change associated with the requirements to calibrate dures for method and frequency process monitoring instruments and verification instruments (or of accuracy checks for process check them for accuracy). monitoring instruments and verification instruments. 507.50(c)(2) ...... Conforming changes associated Consistency with the requirements for validating preventive con- with the timeframe for validating trols. preventive controls. 507.50(d) ...... Editorial changes to the require- Improve clarity. ment to revise the written food safety plan or document why re- visions are not needed. 507.51(a)(2) ...... Editorial change to specify ‘‘pro- Improve clarity. vide assurance that the tem- perature controls are consist- ently performed’’ rather than ‘‘provide assurance that they are consistently performed’’. • 507.51(a)(4)(ii) ...... Substitute the phrase ‘‘records are Consistency with other recordkeeping requirements of the rule. • 507.51(a)(4)(iii) ...... created’’ for the phrase ‘‘records are made’’. 507.51(a)(4)(iii) ...... Change ‘‘within a week’’ to ‘‘within Conforming change associated with review of records of moni- 7 working days’’. toring and corrective action records. 507.53(a)(3) ...... Change to specify the role of the Conforming change associated with flexibility to determine the preventive controls qualified in- timeframe for validation of a preventive control. dividual in determining an alter- native timeframe for validation. 507.53(a)(4) ...... Change to specify the role of the Conforming change associated with flexibility to determine that preventive controls qualified in- validation of a preventive control is not required. dividual in determining that vali- dation is not required. 507.53(a)(6) ...... Change to specify the role of the Conforming change associated with flexibility to determine the preventive controls qualified in- timeframe for review of records of monitoring and corrective ac- dividual in determining an alter- tions. native timeframe for review of records of monitoring and cor- rective actions.

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TABLE 31—PRINCIPAL EDITORIAL AND CONFORMING CHANGES—Continued

Designation in the revised regulatory text (§ ) Revision Explanation

507.53(a)(8) ...... Change to specify the role of the Conforming change associated with flexibility to determine the preventive controls qualified in- timeframe for completing reanalysis. dividual in determining an alter- native timeframe for completing reanalysis. Subpart D (title) ...... Substitute the term ‘‘qualified facil- Conforming change associated with the definition of ‘‘qualified fa- 507.60 ...... ity exemption’’ for the phrase cility exemption’’. 507.62 ...... ‘‘exemption applicable to a 507.65 ...... qualified facility’’ or the phrase 507.67 ...... ‘‘exemption applicable to a 507.80 ...... qualified facility under 507.85 ...... § 507.5(d)’’. 507.60(b)(1) ...... Change ‘‘import alert’’ to ‘‘refusal Align with statutory language regarding imports rather than with of animal food offered for im- specific procedures that FDA uses for refusing admission to port’’. animal foods offered for import. 507.62(a) ...... Change ‘‘FDA official senior to The provision refers to two ‘‘Directors’’ and the clause applies to such Director’’ to ‘‘FDA official either Director. senior to either such Director’’. 507.65(c)(2) ...... Refer to ‘‘conditions or conduct’’ Consistency with regulatory text in § 507.60(a)(2). rather than ‘‘conduct or condi- tions’’. • 507.67(a)(2) ...... Change ‘‘within 10 calendar days’’ Conforming change to reflect a timeframe of 15 calendar days, • 507.69(a)(1) ...... to ‘‘within 15 calendar days’’. rather than 10 calendar days, in the order withdrawing a quali- • 507.71(a)(2), ...... fied facility exemption. • 507.73(a) ...... • 507.85(a) ...... Specify ‘‘any problems with the Clarify that reinstatement of a qualified exemption that was with- • 507.85(b)(2) ...... conditions and conduct’’ rather drawn requires resolution of any problems, regardless of wheth- than ‘‘problems with the condi- er the problems related to conditions, conduct, or both condi- tions and conduct’’ or ‘‘problems tions and conduct. with the conditions or conduct’’. 507.202 ...... Refer to ‘‘lot code’’ rather than Consistency with the definition of ‘‘lot’’. ‘‘production code’’. 507.206 ...... Editorial changes to present the Improve clarity. requirement in active voice.

LI. Comments on FSMA’s Rulemaking health principles (78 FR 64736 at B. Comments on Requirements in Provisions 64745). Section 418(n)(3) of the FD&C Act Regarding Content A. Comments on Section 418(m) of the (Comment 509) Some comments agree FDA&C Act Regarding Modified with our proposal to establish only FSMA specifies that this rule Requirements for Facilities Solely minor modifications to the requirements acknowledge differences in risk and Engaged in the Production of Food for of section 418 of the FD&C Act for minimize, as appropriate, the number of Animals Other Than Man facilities solely engaged in the separate standards that apply to separate Section 418(m) of the FD&C Act production of food for animals other foods (section 418(n)(3)(C) of the FD&C authorizes the Secretary, by regulation, than man. Other comments ask that we Act). to modify the requirements for consider proposing more extensive (Comment 510) Some comments agree compliance under the section with modified requirements for animal food, that the proposed preventive controls respect to facilities that are solely or exempting feed mills, using the requirements reflect a risk-based engaged in the production of food for authority under section 418(m). approach and recognition that a ‘‘one- animals other than man. We tentatively (Response 509) We did not receive size-fits-all’’ approach is not appropriate concluded that the requirements of comments that provided sufficient data in the application of hazard analysis section 418 of the FD&C Act are needed and risk-based preventive controls and rationale to support changing our to ensure the safety of animal food and across the entire domestic and proposed modifications to the in turn the health of animals, the health international food industry. These of humans who are exposed to animal requirements in section 418 of the FD&C comments ask us to retain this food, and the safety of animal derived Act. However, the final rule provides flexibility in the final rule by describing products for human consumption. We risk-based flexibility in the preventive the required and expected results of the proposed certain limited exemptions, controls requirements and their program, but not going as far as described elsewhere in this rule, as management components by prescribing the process and provided by section 103 of FSMA. We recognizing the importance of the methodology taken to get there. Other sought comment on whether the facility, the food, the nature of the comments emphasize that the final rule requirements in section 418 of the FD&C preventive control, and its role in the must provide sufficient flexibility to Act should be modified further for facility’s food safety system. For our allow facilities to adopt practices that facilities that are solely engaged in the approach to feed mills, see our are practical and effective for their production of food for animals other discussion in section IV. specific, individual operations. One than man, based on scientific and public comment expressed the opinion that

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different manufacturing and distribution such foods that it holds. If so, the the following paragraphs, we discuss practices are necessary to ensure the facility could establish its food safety comments that disagree with, or suggest safety of human food, pet food, and plan by building on the provisions one or more changes to, these proposed livestock food. established in § 507.51. compliance dates. After considering (Response 510) The final rule directs these comments, we have concluded LII. Comments on Proposed Conforming the owner, operator, or agent in charge that additional time is needed for the Amendments of a facility to establish and implement animal food industry to comply with a food safety plan that includes a We proposed a series of conforming this final rule. Therefore, the written hazard analysis, preventive amendments to current regulations to compliance date for implementation of controls that the facility identifies to add a reference to part 507. The affected subpart C, Hazard Analysis and control hazards requiring a preventive sections in Title 21 CFR Chapter 1 are: Preventive Controls and subpart E, control, and establish and implement • § 11.1 Scope; • Supply-Chain Program, is extended one appropriate preventive control § 16.1 Scope; year beyond the compliance date for the • § 117.95 Holding and distribution of management components to ensure the implementation of subpart B, Current human food by-products for use as effectiveness of the preventive controls, Good Manufacturing Practice. animal food; taking into account the facility, the food, Businesses other than small and very • § 225.1 Current good manufacturing the nature of the hazard, the nature of small businesses will have 1 year after the preventive control and its role in the practice; • § 500.23 Thermally processed low- the date of publication to comply with facility’s food safety system. As the CGMP requirements and 2 years requested by the comments, the rule acid foods packaged in hermetically sealed containers; and after publication to comply with does not prescribe the process and • preventive controls and supply-chain methodology to ‘‘get there.’’ § 579.12 Incorporation of regulations in part 179. requirements. Small businesses will (Comment 511) Some comments have 2 years after publication to comply interpret the statutory direction in We received no comments that disagree with the proposed conforming with the CGMP requirements and 3 section 418(n)(3)(C) of the FD&C Act to years after publication to comply with mean that Congress granted us authority changes. Therefore, at this time we are amending each of these current preventive controls and supply-chain to provide flexibility for businesses of requirements. Very small businesses all sizes and types (i.e., not just small regulations so that they refer to part 507 except for the amendment to part 225. will have 3 years after publication to businesses), as well as to acknowledge comply with the CGMP requirements differences in risk. These comments We proposed to add a new paragraph (d) in § 225.1 stating that ‘‘In addition, and 4 years after publication to comply assert that section 418(n)(3)(C) grants us with preventive controls requirements. authority to exempt distribution centers nonmedicated feed is subject to part 507 from the requirements for hazard of this chapter.’’ All animal food In addition, we are establishing an analysis and risk-based preventive facilities that are required to register as earlier compliance date for the financial controls because: (1) Distribution a food facility under section 415 of the records that a facility maintains to centers are very low-risk facilities and FD&C Act are subject to the support its status as a very small (2) requiring distribution centers to requirements of part 507. This would business that is eligible for the qualified comply with those requirements would include those facilities that manufacture facility exemption in § 507.5(d). not be practicable. medicated animal feed, nonmedicated Specifically, the compliance date for a (Response 511) We disagree with animal feed, or both. Because of this, we facility to retain records to support its these comments. A pet food distribution do not think the conforming change to status as a qualified facility is January center must register as a food facility part 225 is necessary and we are not 1, 2017. (See Response 76.) because it holds food for animal finalizing this conforming change. We are also establishing separate consumption and does not satisfy any of LIII. Effective and Compliance Dates compliance dates for the supply-chain the criteria for entities that are not program provisions. As discussed in required to register (see § 1.226). The A. Effective and Compliance Dates for Response 515, a receiving facility’s preventive controls that such a facility Part 507 compliance date for the supply-chain would establish and implement would We proposed that the final rule based program provisions of this rule is the depend on the facility, the animal food, on proposed part 507 would become later of: (1) The receiving facility’s and the outcome of the facility’s hazard effective 60 days after its date of compliance date for the other preventive analysis, and any preventive control publication in the Federal Register, controls requirements under this management components associated with staggered compliance dates (78 FR rulemaking; (2) for a raw material or with a facility’s preventive controls 64736 at 64751). We tentatively other ingredient from a supplier subject would be established as appropriate to concluded that it was reasonable to to the preventive controls requirements ensure the effectiveness of the allow for 1 year after the date of of this rule, six months after the preventive controls, taking into account publication of the final rule for receiving facility’s supplier of that raw the nature of the preventive control and businesses other than small and very material or ingredient is required to its role in the facility’s food safety small businesses to comply with the comply with the preventive controls system. In the case of a facility that is rule. We also tentatively concluded that requirements of this rule; or (3) for a raw a pet food distribution center, the it was reasonable to allow for 2 years material or other ingredient that from a facility would, as part of its evaluation, after the date of publication of the final supplier subject to CGMPs, but not the determine whether any preventive rule for small businesses to comply with preventive controls requirements of this controls are necessary for unexposed, the rule, and 3 years after the date of rule, 6 months after the receiving non-refrigerated packaged animal foods. publication of the final rule for very facility’s supplier of that animal food is The facility might determine that the small businesses to comply with the required to comply with the CGMP modified requirements in § 507.51 for rule. requirements of this rule. See tables 32 unexposed, refrigerated, packaged TCS We received one comment agreeing and 33 for a summary of these animal foods are appropriate to apply to with our proposed compliance dates. In compliance dates.

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TABLE 32—COMPLIANCE DATES FOR THE REQUIREMENTS OF PART 507 OTHER THAN THE REQUIREMENTS FOR A SUPPLY-CHAIN PROGRAM (SUBPART E)

Compliance date for sub- part B Size of business and related Compliance date for subpart C and § 507.7 requirements

Qualified facility (including very small September 17, 2018 ...... September 17, 2019, except that the compliance date for a facility to business) as defined in § 507.3. retain records to support its status as a qualified facility is January 1, 2017. Small business as defined in § 507.3 ..... September 18, 2017 ...... September 17, 2018. All other businesses ...... September 19, 2016 ...... September 18, 2017.

TABLE 33—COMPLIANCE DATES FOR THE REQUIREMENTS OF THE SUPPLY-CHAIN PROGRAM (SUBPART E)

Situation Compliance date:

A receiving facility is a small business and its supplier will be subject to 6 months after the receiving facility’s supplier of that raw material or the CGMPs, but not the preventive control requirements, of the ani- other ingredient is required to comply with the CGMP requirements mal food preventive controls rule. of this rule. A receiving facility is a small business and its supplier is subject to the The later of: September 17, 2018 or 6 months after the receiving facili- animal food preventive controls rule. ty’s supplier of that raw material or other ingredient is required to comply with this rule. A receiving facility is not a small business or a very small business and 6 months after the receiving facility’s supplier of that raw material or its supplier will be subject to CGMPs, but not the preventive control other ingredient is required to comply with the CGMP requirements requirements, of the animal food preventive controls rule. of this rule. A receiving facility is not a small business or a very small business and The later of: September 18, 2017 or 6 months after the receiving facili- its supplier will be subject to the animal food preventive controls rule. ty’s supplier of that raw material or other ingredient is required to comply with the applicable rule.

We also are establishing two implement the practices and procedures developing and implementing the additional compliance dates applicable to comply with the new requirements. A applicable CGMPs for their facilities. to qualified facilities. We are few comments note that the complexity Many of these CGMPs are considered establishing December 16, 2019 first as of the proposed regulation presents a prerequisites for a preventive controls the compliance date for the initial challenge for compliance within the program. Having CGMPs well in place submission of the attestation by a proposed timeframes. Because both before having to implement the facility that it is a qualified facility (see CGMPs and preventive controls are new preventive controls requirements will § 507.7(a)(1)) and the attestation by a for the animal food industry, comments provide the facility with a better qualified facility about its food safety request additional time to comply with understanding of the additional controls practices (see § 507.7(a)(2)(i)), or that it the regulations. Some comments also that might be needed to significantly is in compliance with non-Federal food note that manufacturers of human food minimize or prevent any significant safety law (see § 507.7(a)(2)(ii)), and have had many years to comply with hazards associated with the animal food second as the compliance date for the CGMPs, and the expectation that the that the facility has identified. In notification requirement of § 507.7(e)(1). animal food industry will comply with addition, facilities will have more time A qualified facility that submits an both CGMP and preventive controls to educate and train their employees on attestation that it is in compliance with requirements in a narrow timeframe is the preventive controls requirements the applicable non-Federal food safety law not reasonable. The majority of facility will need to implement. FDA must notify consumers as to the name comments agree that the intends to work closely with the animal and complete business address of the implementation dates for the CGMP food industry, extension and education facility where the animal food was regulations should come before the organizations, and state partners to manufactured or processed (see implementation date of the preventive develop the tools and training programs § 507.7(e)). If an animal food packaging controls regulations. needed to facilitate implementation of label is required, the required (Response 512) We agree with the the final rule. notification must appear prominently comments and are extending the (Comment 513) Some comments and conspicuously on the label of the compliance date for implementation of recommend that compliance dates for animal food (see § 507.7(e)(1)). This the preventive controls regulations 1 the preventive controls rule for animal notification requirement may require year beyond the compliance date for the food be set for 3 years after the 60-day some qualified facilities to update the implementation of CGMP requirements. effective date of the rule, regardless of labels of their packaged animal food Because both the CGMP and preventive firm size. products. controls regulations are new to the (Response 513) We disagree with this (Comment 512) Some comments animal food industry, we understand comment. Although the requirements in disagree with the proposed compliance that these facilities would have been this final regulation are new for the dates and our tentative conclusion that learning and implementing many new animal food industry, some individual concepts in the CGMP regulations requirements during the proposed animal food facilities, either would not be new to the animal food timeframe. With an extra year before individually or through feed industry industry. Comments state that both large they must implement preventive associations, have implemented some and small facilities would need to controls requirements, animal food procedures that are consistent with the expend considerable resources to facilities will be able to focus on proposed requirements. Not all concepts

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and processes are new to the entire facility’s compliance date for the other §§ 507.12(a)(1)(ii), 507.105(a)(2), animal food industry, especially the preventive controls requirements under 507.105(c), 507.110(d)(2)(ii), 507.130(d), larger facilities. Therefore, we conclude this rulemaking; (2) for a raw material 507.135(d), 507.175(c)(2) and that these larger facilities should not or other ingredient from a supplier 507.175(c)(13). need 3 years to comply with the subject to the preventive controls LIV. Compliance and Enforcement requirements of this final regulation, in requirements of this rule, 6 months after contrast to some of the very small the receiving facility’s supplier of that Gaining industry compliance with the businesses. raw material or ingredient is required to provisions of this rule is as important as (Comment 514) Some comments ask comply with the preventive controls establishing the provisions. A central us to clarify when a very small business requirements of this rule; or (3) for a raw element of our strategy to gain industry would need to comply with the rule if material or other ingredient that from a compliance is to help make available to the business starts up after the rule goes supplier subject to CGMPs, but not the facilities subject to this rule the into effect. preventive controls requirements of this education and technical assistance they (Response 514) A very small business rule, 6 months after the receiving need to understand and implement the that is operating as of the date of facility’s supplier of that animal food is requirements (Ref. 5). Within the publication of the final rule, or begins required to comply with the CGMP Agency we are establishing a Food operating any time before the requirements of this rule. Safety Technical Assistance Network compliance date for very small and seeking funding to increase FDA businesses, must comply with the rule B. Effective Dates for Conforming staffing to provide a central source of by the compliance date for very small Amendments information to support industry businesses. A very small business that The conforming amendments to understanding and implementation of begins operation any time after the regulations in parts 500 and 579 are FSMA standards (Ref. 5). This will compliance date for very small technical amendments that add a cross- allow us to respond in a timely and businesses must comply with the rule reference to part 507. The conforming consistent way to industry questions on when it begins operation, and should amendment to part 11 adds a reference preventive controls technical and plan accordingly. to the scope of part 11 that the records compliance issues (Ref. 5). (Comment 515) Some comments required under part 507 are not subject We also are working in collaboration request that compliance dates for the to part 11. The conforming amendment with the FSPCA to develop training proposed preventive controls rule to part 16 adds a reference to the scope materials and establish training and coincide with the requirements of the of part 16 for new procedures in part technical assistance programs (Ref. 4) proposed foreign supplier verification 507, subpart D that provide a person and (Ref. 6). The FSPCA includes program rule. with an opportunity for a hearing under members from FDA, State food (Response 515) We are finalizing part 16. These conforming amendments protection agencies, the animal food separate compliance dates for the are effective on November 16, 2015, the industry, and academia. It is funded by supply-chain program provisions of this same date as the effective date of part a grant to the Illinois Institute of rule. While this adds complexity, we are 507. We are not establishing compliance Technology’s Institute for Food Safety doing this for two main reasons. First, dates for these conforming amendments. and Health, a nationally-recognized we are aligning, to the extent feasible, As a practical matter, compliance dates leader in food safety. In addition to the compliance dates of the supply- will be determined by the dates for developing a standardized preventive chain program provisions of this rule compliance with part 507. controls training curriculum, the FSPCA with the compliance dates of the is developing selected sections of model forthcoming FSVP rule, which we C. Delayed Effective Dates for Provisions food safety plans for several animal food intend to publish in the coming months. That Refer to the Forthcoming Rules for types that will provide needed Produce Safety and Third-Party This will provide greater coordination instructional examples. Although we Certification across the programs, particularly with have provided funding to the FSPCA to respect to the verification of domestic The following provisions refer to develop a standardized preventive and imported raw materials and other provisions we intend to establish in the controls training curriculum, we are ingredients. Second, we want to near future in part 112 (Standards for unable to fund training for individual minimize the likelihood that a receiving the Growing, Harvesting, Packing, and groups who might need particular facility will be required to comply with Holding of Produce for Human training materials. the supply-chain program provisions of Consumption): §§ 507.12(a)(1)(ii), We also are partnering with the NIFA this rulemaking before its supplier is 507.105(c), 507.110(d)(2)(ii), 507.130(d), of USDA to administer the FSMA- required to comply with applicable new and 507.175(c)(13). In addition, mandated National Food Safety food safety regulations implementing paragraph (2) of the definition of Training, Education, Extension, FSMA. Our goal is to avoid a situation ‘‘qualified auditor’’ in § 507.3 and Outreach, and Technical Assistance in which a receiving facility would be § 507.135(d) refers to provisions we Program, a grant program to provide required to develop a supply-chain intend to establish in the near future in technical assistance for FSMA program for an animal food from a part 1, subpart M (Accredited Third- compliance to owners and operators of particular supplier and then be required Party Food Safety Audits and Food or small and medium-size farms and small to revise this supply-chain program Facility Certification). In addition, food processors (Ref. 7). Such efforts shortly thereafter once the supplier is §§ 507.105(a)(2) and 507.175(c)(2) refer will help ensure widespread voluntary subject to an applicable new food safety to provisions we intend to establish in compliance by encouraging greater regulation—specifically, the preventive the near future in part 1, subpart L understanding and adoption of controls rule for animal food. Therefore, (Foreign Supplier Verification Programs established food safety standards, the compliance dates for the supply- for Food Importers). We will publish a guidance, and protocols. chain program have been revised. A document in the Federal Register With regard to inspections, we will receiving facility’s compliance date for announcing the effective dates of conduct regular inspections of domestic the supply-chain program provisions of paragraph (2) of the definition of facilities to ensure that facilities subject this rule is the later of: (1) The receiving ‘‘qualified auditor’’ in § 507.3, and to this rule are adequately implementing

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the required preventive controls and Executive Order 13563, the Regulatory LVII. Analysis of Environmental Impact supply-chain program, pursuant to our Flexibility Act (5 U.S.C. 601–612), and FDA has determined under 21 CFR inspection authority under section 704 the Unfunded Mandates Reform Act of 25.30(j) that this action is of a type that of the FD&C Act. Our inspections will 1995 (Pub. L. 104–4). Executive Orders does not individually or cumulatively verify that such facilities are 12866 and 13563 direct Agencies to have a significant effect on the human implementing systems that effectively assess all costs and benefits of available environment (Ref. 64). Therefore, protect against animal food regulatory alternatives and, when neither an environmental assessment contamination, and in particular, that regulation is necessary, to select nor an environmental impact statement they comply with the rule by regulatory approaches that maximize is required. implementing preventive controls, net benefits (including potential including supply-chain programs, to economic, environmental, public health LVIII. Paperwork Reduction Act of provide assurances that any hazard and safety, and other advantages; 1995 requiring a preventive control or distributive impacts; and equity). This final rule contains information supply-chain applied control has been Executive Order 13563 emphasizes the collection provisions that are subject to significantly minimized or prevented. importance of quantifying both costs review by the Office of Management and In order to effectively carry out this and benefits, of reducing costs, of Budget (OMB) under the Paperwork new paradigm of animal food safety, we Reduction Act of 1995 (44 U.S.C. 3501– will need to reorient and retrain our harmonizing rules, and of promoting 3520). The title, description, and staff. To this end, we are seeking flexibility. FDA has developed an FRIA respondent description of the additional funding, including for the that presents the benefits and costs of information collection provisions are training of more than 2,000 FDA this final rule (Ref. 60). The Office of shown in this section with an estimate inspectors, compliance officers, and Management and Budget (OMB) has of the annual reporting, recordkeeping, other staff involved in food safety determined that this final rule is an and third-party disclosure burden. activities (Ref. 10). economically significant regulatory We also plan to leverage the resources action as defined by Executive Order Included in the estimate is the time for of State, local, tribal, and territorial 12866. reviewing instructions, searching existing data sources, gathering and governments to conduct domestic The summary analysis of benefits and verification activities. We are working maintaining the data needed, and costs included in this document is completing and reviewing each with officials from these governments drawn from the detailed FRIA (Ref. 60) through the PFP to develop and collection of information. which is available at http:// Title: Current Good Manufacturing implement a national Integrated Food www.regulations.gov (enter Docket No. Practice, Hazard Analysis and Risk- Safety System, which will focus on FDA–2011–N–0922), and is also Based Preventive Controls for Food for establishing partnerships for achieving available on FDA’s Web site at http:// Animals. compliance (see section 209(b) of www.fda.gov/AboutFDA/ Description: Regulations issued in the FSMA), and which will allow us to ReportsManualsForms/Reports/ final rule entitled, ‘‘Current Good utilize the thousands of State, local, and EconomicAnalyses/default.htm. Manufacturing Practice, Hazard tribal inspectors available to help with Analysis and Risk-Based Preventive the domestic verification process. The Regulatory Flexibility Act Section 201 of FSMA mandates that requires Agencies to analyze regulatory Controls for Food for Animals,’’ FDA inspect domestic high-risk options that would minimize any implement section 418 of the FD&C Act, facilities no less than once every 3 significant impact of a rule on a as amended by the FDA Food Safety years. Consistent with FSMA, FDA will substantial number of small entities. Modernization Act (FSMA). The use its current resources, new resources Because the final rule would impose regulations establish science-based that it obtains, and its partnerships to annualized costs that range from minimum standards for conducting a conduct regular inspections of covered $25,000 to $34,000 on many small hazard analysis, documenting hazards facilities, focusing on those facilities entities, the Agency determined that the requiring preventive controls, that pose the highest risk to animal food final rule will have a significant implementing preventive controls, and safety. economic impact on a substantial documenting the implementation of the number of small entities. preventive controls by domestic and LV. Executive Order 13175 foreign animal food facilities registered Section 202(a) of the Unfunded In accordance with Executive Order with FDA under section 415 of the Mandates Reform Act of 1995 requires 13175, FDA has consulted with tribal FD&C Act. The regulations also that Agencies prepare a written government officials. A tribal summary establish current good manufacturing statement, which includes an impact statement has been prepared that practice for the manufacturing, assessment of anticipated costs and includes a summary of tribal officials’ processing, packing, and holding of benefits, before finalizing ‘‘any rule that concerns and how FDA has addressed animal food. includes any Federal mandate that may them (Ref. 63). Persons with access to The preventive controls regulations the Internet may obtain the tribal result in the expenditure by State, local, require animal food facilities to have a consultation report at http:// and tribal governments, in the aggregate, written food safety plan that includes a www.fda.gov/pcafrule or at http:// or by the private sector, of $100,000,000 hazard analysis; a description of www.regulations.gov. Copies of the or more (adjusted annually for inflation) preventive controls (including recall tribal summary impact statement also in any one year.’’ The current threshold procedures); a supply-chain program, a may be obtained by contacting the after adjustment for inflation is $144 description of procedures for person listed under FOR FURTHER million, using the most current (2014) monitoring the preventive controls; INFORMATION CONTACT. Implicit Price Deflator for the Gross corrective action if preventive controls Domestic Product. FDA expects this are not properly implemented; and a LVI. Economic Analysis of Impacts final rule will likely result in a 1-year description of procedures for verifying FDA has examined the impacts of the expenditure that will meet or exceed implementation and effectiveness of the final rule under Executive Order 12866, this amount. preventive controls.

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The regulations further require reporting requirements on facilities specifically addressing the four facilities to establish and implement claiming the very small business information collection topics solicited verification procedures for product qualified facility exemption. in both the 2013 proposed preventive testing and environmental monitoring, Description of Respondents: Facilities controls rule for animal food and the and require that the hazard analysis and that manufacture, process, pack, or hold 2014 supplemental notice, we have risk-based preventive controls for food for animals. Generally, a facility is revised our burden estimate consistent animal food take into account the required to register if it manufactures, with finalization of the rule’s possibility of economically motivated processes, packs, or holds animal food requirements. for consumption in the United States. At adulteration of animal food. Facilities FDA estimates the burden for this the time of this analysis, the number of that manufacture, process, pack, or hold information collection as follows: food for animals and foods for human animal food facilities registered with the consumption and are subject to part 117 Agency was 7,469. Reporting Burden In the Federal Register of October 29, (as finalized elsewhere in this issue of 2013 (78 FR 64736), FDA published a Table 34 shows the total estimated the Federal Register) may choose to proposed rule including a Paperwork annual reporting burden associated with comply with part 117 with respect to Reduction Act (PRA) analysis of the this final rule. This estimate is a the animal food, provided the food information collection provisions found revision from reporting estimates found safety plan addresses the hazards in the regulations. In the Federal in our proposed rulemaking, reflecting specific to animal food where Register of September 29, 2014 (79 FR an updated count of the number of applicable. 58476), FDA published a supplemental facilities registered with the Agency as The final rule also establishes certain notice of proposed rulemaking also animal food facilities, and resulting in exemptions, under applicable including a PRA analysis. Although an overall decrease from our previous regulations. The rule imposes specific FDA did not receive comments estimate.

TABLE 34—ESTIMATED ANNUAL REPORTING BURDEN 1

Average Number of Number of Total annual burden per 21 CFR Section; activity respondents responses per responses response Total hours respondent (in hours)

507.7 exemption: submit attestation that facility is a quali- fied facility and attestation of preventive controls or compliance with non-Federal food safety laws ...... 1,120 .5 560 *.5 280 507.67, 507.69, and 507.71; submission of an appeal, in- cluding submission of a request for an informal hearing 1 1 1 4 4 507.85(b); requests for reinstatement of exemption ...... 1 1 1 2 2

Total ...... 286 1 Capital and other costs of implementation and compliance for this final rule are discussed in the FRIA (Ref. 60). * (30 minutes).

Out of 7,469 animal food facilities portal maintained by FDA, and that this expects few, if any, requests for registered with FDA, we estimate will take approximately 0.5 hours (30 reinstatement of an exemption that has approximately 15% (1,120) could be minutes). been withdrawn under the regulations ‘‘qualified’’ facilities under the ‘‘very The estimated burden associated with and thus is providing an estimate of small business’’ definition as discussed the requirements under §§ 507.67, only 1 per year at this time. We estimate in the FRIA (Ref. 60), and thus eligible 507.69, and 507.71 of the regulations is the time necessary for making such a for certain limited exemptions under the reflected in table 34, row 2. Based on request to be no more than 2 hours, applicable regulations. Section 507.5 the limited data on foodborne illness which includes submitting the written exempts qualified facilities from subpart outbreaks originating at very small request and presenting information that C and E of the regulations, which animal food facilities, FDA does not the animal food safety problems were includes all of the hazard analysis and expect to withdraw many qualified adequately resolved and continued preventive controls requirements, facility exemptions and expects the withdrawal of the exemption is not including supply-chain program number of appeals to be even fewer. The necessary to protect public (human and requirements. The number of estimated number of respondents is animal) health. based on the Agency’s expectation that respondents in table 34, row 1 is Recordkeeping Burden derived from Agency estimates of the the number of appeals will be very few. number of qualified animal food The number of responses per Table 35 shows the total estimated facilities that must report their status as respondent reflects that the rule only annual recordkeeping burden associated such a facility every 2 years. The requires one submission per appeal. with this final rule. This estimate is a number of total annual responses is Given that facilities must respond with revision from the recordkeeping calculated by multiplying the number of particularity to the facts and issues estimates found in our proposed respondents by the number of responses contained in the withdrawal order, the rulemaking, reflecting an updated count submitted annually. The average hourly Agency estimates an average burden of of the number of registered animal food time burden per response found in table 4 hours per response. facilities, as well as additional 34, column 5 is based on FDA’s The estimated burden associated with recordkeeping requirements associated assumption that a facility will report its the requirements under § 507.85(b) is with the various preventive control status electronically through a Web reflected in table 34, row 3. The Agency provisions and recordkeeping

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requirements associated with the supply-chain program implemented at Subpart E.

TABLE 35—ESTIMATED ANNUAL RECORDKEEPING BURDEN

Average Number of Number of Total annual burden per 21 CFR part 507; activity recordkeepers records per records recordkeeping Total hours recordkeeper (in hours)

Subpart A—General Provisions

507.7(e); records attesting that the facility is a 1,120 .5 560 .1 (6 minutes) ...... 56 ‘‘qualified’’ facility. 507.4(d); documentation of animal food safety and 7,469 0.75 5,579 0.04 (2 minutes) .. 279 hygiene training.

Subpart C—Hazard Analysis and Risk-Based Preventive Controls

507.31–507.55; food safety plan, including hazard 7,469 519 3,876,411 .10 (6 minutes) .... 387,641 analysis, preventive controls, and procedures for monitoring, corrective actions, and verification; recall plan; validation; reanalysis; modifications; and implementation records.

Subpart E—Supply-Chain Program

507.105–507.175; written supply-chain program, in- 7,469 519 3,876,411 .10 (6 minutes) .... 387,641 cluding records documenting program.

Subpart F—Requirements Applying to Records

507.200–507.215; general requirements, additional 7,469 519 3,876,411 .10 (6 minutes) .... 387,641 requirements applying to food safety plan, re- quirements for record retention, use of existing records, and special requirements applicable to written assurance.

Total ...... 11,629,793 ...... 1,163,258 1 Capital and other costs of implementation and compliance with this final rule are discussed in the FRIA (Ref. 60).

Under the final rule, we estimate a the hazard-analysis and risk-based Third-Party Disclosure Burden total of 7,469 respondents (the number preventive controls, the supply-chain of registered animal food facilities) are program, and the requirements applying Table 36 shows the total estimated subject to recordkeeping requirements to records under part 507 subparts C, E, third-party disclosure burden associated found in the applicable regulations. and F, respectively, we have provided a with the final rule. This figure has been Although FDA believes that, in some cumulative burden and averaged burden revised from the third-party disclosure cases, all respondents will incur new per recordkeeping that we believe will estimates found in our proposed recordkeeping activities as a result of be incurred by the respondents under rulemaking. This revision reflects fewer the final rule (e.g., documentation of this final rule based on information than anticipated third-party disclosure training in the principles of animal food available to us at this time. After requirements under the final rule and hygiene and safety), we believe other allowing for implementation of the final results in an overall decrease to our total provisions may apply only to certain rule and upon seeking reauthorization estimated annual third-party disclosure respondents (e.g., documentation of a for its information collection provisions, burden by 36,315 hours. supply-chain program), depending upon FDA will reassess its burden estimate the applicable regulation. With regard to accordingly.

TABLE 36—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Average Number of Number of Total annual burden per 21 CFR Section; activity respondents disclosures per disclosures disclosure Total hours respondent (in hours)

507.27(b); labeling for the animal food product contains 330 10 3,300 0.25 (15 min- 825 the specific information and instructions needed so utes). the food can be safely used for the intended animal species. 507.7(e)(1); change labels on products with labels ...... 1,526 4 6,104 1 ...... 6,104 507.7(e)(2); change address on labeling (sales docu- 1,329 1 1,329 1...... 1,329 ments) for qualified facilities. 507.25(a)(2); animal food, including raw materials, 330 312 102,960 .01 (1 minute) 1,030 other ingredients, and rework, is accurately identified.

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TABLE 36—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued

Average Number of Number of Total annual burden per 21 CFR Section; activity respondents disclosures per disclosures disclosure Total hours respondent (in hours)

507.28(b); holding and distribution of human food by- 40,798 2 81,596 0.25 (15 min- 20,399 products for use as animal food. utes).

Total ...... 29,687 1 Capital and other costs of implementation and compliance for this final rule are discussed in the FRIAs (Ref. 60).

Under the final rule, we estimate all notify consignees and the public. (See between 9 a.m. and 4 p.m., Monday (7,469) respondents are subject to third- §§ 7.49 and 7.42(b)(1) and (2)).) through Friday, and are available party disclosure requirements found in Under section 507.28(b), labeling that electronically at http:// the applicable regulations. The number identifies the product by the common or www.regulations.gov. (FDA has verified in column 2 represents an estimated usual name must be affixed to or the Web site addresses in this section, annual number of those respondents we accompany the human food by-product but FDA is not responsible for any believe will incur third-party disclosure for use as animal food when distributed. subsequent changes to the Web sites burdens under the respective regulation The estimated number of disclosures after this document publishes in the shown in column 1. This figure is per respondent and average burden per Federal Register.) disclosure assumes that 60 percent of derived from our familiarity with third- 1. FDA, ‘‘Record of Outreach for Proposed party burden associated with similar the 67,996 domestic human food Rule for PC Animal Food,’’ 2014. FDA regulations. Upon implementation manufacturing facilities (Ref. 65) or 2. FDA, ‘‘ Record of Outreach for of the final rule, the Agency will 40,798 facilities are affected, and that Supplemental Rule for PC Animal reevaluate its estimate accordingly. two sets of labeling per facility per year Food,’’ 2015. To calculate the number of annual will be required. We estimate 0.25 hours 3. FDA, ‘‘ Qualitative Risk Assessment: Risk disclosures, we multiplied the number per disclosure to prepare labeling, and of Activity/Animal Food Combinations of respondents in column 2 by an affix to the containers, for a total of for Activities (Outside the Farm estimated number of disclosures in 20,399 burden hours. Definition) Conducted in a Facility Co- column 3. This figure represents the The information collection provisions Located on a Farm,’’ 2015. of this final rule have been submitted to 4. FDA, ‘‘Technical Staffing and Guidance estimated annual number of disclosures Development at FDA,’’ (http:// per respondent we attribute for the OMB for review. Prior to the effective www.fda.gov/Food/GuidanceRegulation/ respective requirement. To calculate the date of this final rule, FDA will publish FSMA/UCM436592.pdf), 2015 Accessed annual hourly burden, we multiplied a notice in the Federal Register on June 19, 2015. the number of annual disclosures by an announcing OMB’s decision to approve, 5. FDA, ‘‘Education and Technical Assistance estimated hourly burden in column 5. modify, or disapprove the information for Industry,’’ (http://www.fda.gov/ This figure represents the amount of collection provisions in this final rule. downloads/Food/GuidanceRegulation/ time we attribute to conducting the An Agency may not conduct or sponsor, FSMA/UCM436593.pdf), March 5, 2015. respective disclosure activities and a person is not required to respond Accessed on June 19, 2015. identified in column 1. to, a collection of information unless it 6. FDA, ‘‘Food Safety Preventive Controls Section 507.7(a)(2) provides that Alliance,’’ (http://www.fda.gov/food/ displays a currently valid OMB control guidanceregulation/fsma/ qualified facilities must either submit to number. ucm284406.htm), November 12, 2013. FDA attestation of hazard identification, LIX. Federalism Accessed on June 19, 2015. preventive controls implementation, 7. FDA, ‘‘FDA Announces Competitive Grant and monitoring, or attestation that the FDA has analyzed this final rule in Program with NIFA to Fund Food Safety facility is in compliance with applicable accordance with the principles set forth Training, Education and Technical non-Federal food safety law. in Executive Order 13132. FDA has Assistance,’’ (http://www.fda.gov/food/ Section 507.7(e) requires a qualified determined that the rule does not newsevents/constituentupdates/ facility that chose the latter to notify contain policies that have substantial ucm430492.htm), January 15, 2015. consumers of the name and business direct effects on the States, on the Accessed on June 19, 2015. address of the facility where the animal relationship between the National 8. Partnership for Food Protection National food was manufactured or processed: (1) Workplan Workgroup, ‘‘Model for Local Government and the States, or on the Federal/State Planning and Coordination On the label if a package label is distribution of power and of Field Operations and Training: A required by other provisions of the responsibilities among the various Partnership for Food Protection ‘‘Best FD&C Act or (2) on labeling at the point levels of government. Accordingly, the Practice’’,’’ (http://www.fda.gov/ of purchase if no label is required. Agency has concluded that the rule does downloads/ Section 507.25(a)(2) provides that the not contain policies that have ForFederalStateandLocalOfficials/ management of the plant must ensure federalism implications as defined in FoodSafetySystem/UCM373333.pdf) that animal food, including raw the Executive order and, consequently, October, 2013. Accessed on August 10, materials, other ingredients, or rework, a federalism summary impact statement 2015. is accurately identified as part of plant 9. FDA, ‘‘Operational Strategy for is not required. Implementing the FDA Food Safety operations. (See §§ 7.49 and 7.42(b)(1) LX. References Modernization Act (FSMA),’’ (http:// and (2) (21 CFR 7.49 and 7.42(b)(1) and www.fda.gov/Food/GuidanceRegulation/ (2)).) The following references have been FSMA/ucm395105.htm), May 2, 2014. Section 507.38(b)(1) and (2) does not placed on display in the Division of Accessed on June 25, 2015. add to the estimated hourly burden Dockets Management (see ADDRESSES) 10. FDA, ‘‘Inspection Modernization and because facilities initiating recalls may and may be seen by interested persons Training: Key Investments for

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See 10005B, Task Order 20), Final Report,’’ Announces Voluntary Recall in Reference 33 to the 2013 proposed rule 2015. Oklahoma and Texas,’’ (http:// for preventive controls for animal food. 22. Codex Alimentarius Commission, www.fda.gov/Safety/Recalls/ 12. Muth, M. K., C. Zhen, M. Coglaiti, S. ‘‘Guidelines for the Validation of Food ucm266082.htm), July 29, 2011. Karns, and C. Viator, ‘‘Food Processing Safety Control Measures, CAC/GL 69– Accessed on June 30, 2015. Sector Study,’’ 2011. See Reference 21 to 2008,’’ (http://www.codexalimentarius. 33. FDA, ‘‘Expanded Voluntary Recall of the 2014 supplemental notice. org/input/download/standards/11022/ Mazuri and LabDiet Feed Products Due 13. FDA, ‘‘The Reportable Food Registry: A CXG_069e.pdf), 2008. Accessed on June to Potential Elevated Vitamin D Level,’’ New Approach to Targeting Inspection 29, 2015. See Reference 79 to the 2013 (http://www.fda.gov/safety/recalls/ Resources and Identifying Patterns of proposed rule for preventive controls for ucm312988.htm), July 20, 2012. Adulteration—First Annual Report: animal food. Accessed on June 30, 2015. September 8, 2009–September 7, 2010,’’ 23. FDA, ‘‘Guidance for Industry: Questions 34. FDA, ‘‘ADM Alliance Nutrition Recalling (http://www.fda.gov/downloads/Food/ and Answers Regarding Food Facility MoorMan’s ShowTec 18 Elite Lamb ComplianceEnforcement/UCM291297 Registration (Sixth Edition),’’ (http:// Feed,’’ (http://www.fda.gov/Safety/ .pdf), January, 2011. Accessed on June www.fda.gov/downloads/Food/Guidance Recalls/ucm333676.htm), December 28, 29, 2015. See Reference 48 to the 2013 Regulation/UCM332460.pdf), 2014. 2012. Accessed on June 30, 2015. proposed rule for preventive controls for Accessed and printed on June 29, 2015. 35. FDA, ‘‘PGG/HSC Feed Company LLC animal food. 24. Dictionary.com, ‘‘Definition of ‘‘Solely’’,’’ Issues Voluntary Recall of Champion 14. FDA, ‘‘The Reportable Food Registry: (http://dictionary.reference.com/browse/ Lamb Texturized Feed B30, Lot– Targeting Inspection Resources and solely), 2015. Accessed on June 11, 2015. 88022114M908840,’’ (http:// Identifying Patterns of Adulteration— 25. FDA, ‘‘Compliance Policy Guide www.fda.gov/Safety/Recalls/ Second Annual Report: September 8, Sec.675.100 Diversion of Contaminated ucm399978.htm), June 4, 2014. Accessed 2010–September 7, 2011,’’ (http:// Food for Animal Use,’’ (http:// on June 30, 2015. www.fda.gov/downloads/Food/ www.fda.gov/iceci/compliancemanuals/ 36. FDA, ‘‘Cargill Conducts Voluntary Recall ComplianceEnforcement/UCM301013 compliancepolicyguidancemanual/ of Select Nutrena® NatureWise Meatbird .pdf), April 19, 2012. Accessed on June ucm074693.htm) Revised: March 1995, Feed Due to Possible Animal Health 29, 2015. Page Last Updated: December 15, 2009. Risk,’’ (http://www.fda.gov/Safety/ 15. FDA, ‘‘The Reportable Food Registry: Accessed on September 5, 2014. See Recalls/ucm403829.htm), July 1, 2014. Targeting Inspection Resources and Reference 11 to the 2014 supplemental Accessed on June 30, 2015. Identifying Patterns of Adulteration— notice. 37. FDA, ‘‘Natura Pet Recalls 5 Lots of Dry Third Annual Report: September 8, 26. FDA, ‘‘Compliance Policy Guide Cat and Dry Ferret Food due to Vitamin 2011–September 7, 2012,’’ (http:// Sec.675.200 Diversion of Adulterated Insufficiency,’’ (http://www.fda.gov/ www.fda.gov/downloads/Food/ Food to Acceptable Animal Feed Use.’’ Safety/Recalls/ucm424607.htm), ComplianceEnforcement/RFR/ (http://www.fda.gov/iceci/compliance November 24, 2014. Accessed on June UCM349856.pdf), May 1, 2013. Accessed manuals/compliancepolicyguidance 30, 2015. on June 29, 2015. manual/ucm074694.htm) Revised: 38. FDA, ‘‘Primal Pet Foods Voluntarily 16. FDA, ‘‘The Reportable Food Registry: March 1995. Page Last Updated: Recalls A Single Lot of Raw Frozen Cat Targeting Inspection Resources and December 15, 2009. Accessed on Food,’’ (http://www.fda.gov/Safety/ Identifying Patterns of Adulteration— September 5, 2014). See Reference 12 to Recalls/ucm438183.htm), March 13, Fourth Annual Report: September 8, the 2014 supplemental notice. 2015. Accessed on June 30, 2015. 2012–September 7, 2013,’’ (http:// 27. British Standards Institute (BSI), 39. FDA, ‘‘Ainsworth Pet Nutrition www.fda.gov/downloads/Food/ ‘‘Publicly Available Specification Voluntarily Recalls Five Nutrish Wet Cat ComplianceEnforcement/RFR/ (PAS)222:2011 Prerequisite Programmes Food Varieties for Potentially Elevated UCM395684.pdf), May 5, 2014. Accessed for Food Safety in the Manufacture of Vitamin D Levels,’’ (http://www.fda.gov/ on June 29, 2015. Food and Feed for Animals,’’ 2011. See Safety/Recalls/ucm449841.htm), June 4, 17. FDA, ‘‘Bravo Issues Nationwide Recall of Reference 44 to the 2013 proposed rule 2015. Accessed on June 30, 2015. Pet Food for Dogs and Cats,’’ (http:// for preventive controls for animal food. 40. Markovich, J.E., Freeman, L.M., and www.fda.gov/Safety/Recalls/ucm397362 28. Association of American Feed Control Heinze, C.R., ‘‘Analysis of thiamine .htm), May 14, 2014. Accessed on June Officials (AAFCO), ‘‘Model Good concentrations in commercial canned 26, 2015. Manufacturing Practice Regulations for foods formulated for cats,’’ Journal of the 18. FDA, ‘‘J.J. Fuds, Inc. Issues Recall of Pet Feed and Feed Ingredients’’, In: AAFCO American Veterinary Medical Food,’’ (http://www.fda.gov/Safety/ Official Publication, 210–215, 2010. See Association, Vol. 244, No. 2, January 15, Recalls/ucm431432.htm), January 20, Reference 42 to the 2013 proposed rule 2014. 2015. Accessed on July 1, 2015. for preventive controls for animal food. 41. FDA, ‘‘Food CGMP Modernization—A 19. FDA, ‘‘Draft Guidance for Industry: 29. Food and Agriculture Organization of the Focus on Food Safety,’’ (http:// Questions and Answers Regarding the United Nations (FAO) and World Health www.fda.gov/Food/ Reportable Food Registry as Established Organization (WHO), ‘‘Good Practices for GuidanceComplianceRegulatory by the Food and Drug Administration the Feed Industry—Implementing the Information/CurrentGoodManufacturing Amendments Act of 2007 (Edition 2),’’ Codex Alimentarius Code of Practice on PracticesCGMPs/ucm207458.htm), (http://www.fda.gov/downloads/Food/ Good Animal Feeding—Section 3 Good November 2, 2005. Accessed on June 29, GuidanceRegulation/UCM213214.pdf), Production Practices,’’ (http:// 2015. See Reference 49 to the 2013 May, 2010. Accessed on June 29, 2015. www.fao.org/docrep/012/i1379e/ proposed rule for preventive controls for 20. FDA, ‘‘Guidance for Industry: Questions i1379e00.htm), 2010. Accessed on June animal food. and Answers Regarding the Reportable 29, 2015. See Reference 14 in the 2014 42. FDA, ‘‘Draft Guidance for Industry: Food Registry as Established by the Food supplemental notice. Questions and Answers Regarding and Drug Administration Amendments 30. USDA National Nutrient Database for Mandatory Food Recalls,’’ (http:// Act of 2007,’’ (http://www.fda.gov/Food/ Standard Reference, (http:// www.fda.gov/Food/GuidanceRegulation/

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GuidanceDocumentsRegulatory default.htm), March 26, 2015. Accessed 21 CFR Part 500 Information/ucm445428.htm), May, on June 30, 2015. 2015. Accessed on June 30, 2015. 56. FDA, ‘‘Import Alerts,’’ (http:// Animal drugs, Animal feeds, Cancer, 43. FDA, ‘‘FDA Homepage,’’ (http:// www.fda.gov/ForIndustry/ Labeling, Packaging and containers, www.fda.gov/), March 25, 2015. ImportProgram/ImportAlerts/ Polychlorinated biphenyls (PCB’s). Accessed and printed on June 30, 2015. default.htm), 2015. Accessed on June 30, 44. FDA, ‘‘Recalls, Market Withdrawals, & 2015. 21 CFR Part 507 Safety Alerts (FDA Email Sign-up Web 57. FDA, ‘‘Letter to Sunland Inc. Concerning page),’’ (https://service.govdelivery.com/ Suspension of Food Facility Registration; Animal foods, Labeling, Packaging accounts/USFDA/subscriber/new?topic_ Notice of Opportunity for Hearing,’’ and containers, Reporting and _ id=USFDA 48), 2015. Accessed on June (http://www.fda.gov/aboutfda/ recordkeeping requirements. 30, 2015. centersoffices/officeoffoods/cfsan/ 45. FDA, ‘‘Guidance for Industry: Product cfsanfoiaelectronicreadingroom/ 21 CFR Part 579 Recalls, Including Removals and ucm329370.htm), November 26, 2012. Corrections,’’ (http://www.fda.gov/ Accessed June 30, 2015. Animal feeds, Animal foods, Safety/Recalls/IndustryGuidance/ 58. Global Food Safety Initiative, ‘‘GFSI Radiation protection. ucm129259.htm), November 3, 2003. Guidance Document, Version 6.3,’’ Accessed on June 30, 2015. (http://www.mygfsi.com/images/mygfsi/ Therefore, under the Federal Food, 46. FDA, ‘‘Animal and Veterinary Recalls and gfsifiles/gfsi_guidance/GFSI_Guidance_ Drug, and Cosmetic Act and under Withdrawals Web page,’’ (http:// Document_Over.pdf), 2013. Accessed on authority delegated to the Commissioner www.fda.gov/AnimalVeterinary/ June 30, 2015. of Food and Drugs, 21 CFR chapter I is SafetyHealth/RecallsWithdrawals/ 59. FDA, ‘‘Information for Foreign amended as follows: default.htm2015), 2015. Accessed on Governments: Frequently Asked June 30, 2015. Questions on Systems Recognition,’’ PART 11—ELECTRONIC RECORDS; 47. Merriam-Webster.com, ‘‘Definition of (http://www.fda.gov/Food/International ‘‘Include’’,’’ (http://www.merriam- InteragencyCoordination/ ELECTRONIC SIGNATURES webster.com/dictionary/include), 2015. ucm367400.htm), September 5, 2013. Accessed on June 30, 2015. Accessed on July 1, 2015. ■ 1. The authority citation for 21 CFR 48. FDA, ‘‘Guidance for Industry: Testing for 60. FDA, ‘‘FSMA Final Rulemaking for part 11 continues to read as follows: Salmonella in Human Foods and Direct- Current Good Manufacturing Practice, Human-Contact Animal Foods,’’ (http:// Hazard Analysis, and Risk-Based Authority: 21 U.S.C. 321–393; 42 U.S.C. www.fda.gov/food/guidanceregulation/ Preventive Controls for Food for Animals 262. guidancedocumentsregulatory Final Regulatory Impact Analysis,’’ 2015. ■ information/salmonella/ 61. World Trade Organization, ‘‘WTO 2. In § 11.1, add paragraph (j) to read ucm295271.htm), March, 2012. Accessed Ministerial Conference: Implementation- as follows: on June 30, 2015. Related Issues and Concerns,’’ (https:// 49. National Advisory Committee on www.wto.org/english/thewto_e/minist_e/ § 11.1 Scope. Microbiological Criteria for Foods, min01_e/mindecl_implementation_ * * * * * ‘‘Hazard Analysis and Critical Control e.pdf), November 20, 2001. Accessed on (j) This part does not apply to records Point Principles and Application July 1, 2015. Guidelines,’’ Journal of Food Protection, 62. World Trade Organization, ‘‘The WTO required to be established or maintained 61:1246–1259, 1998. See Reference 29 to Agreement on the Application of by part 507 of this chapter. Records that the 2013 proposed preventive controls Sanitary and Phytosanitary Measures satisfy the requirements of part 507 of rule for animal food. (SPS Agreement),’’ (https://www.wto.org/ this chapter, but that also are required 50. USDA Food Safety and Inspection english/tratop_e/sps_e/spsagr_e.htm), under other applicable statutory Service, ‘‘Compliance Guideline HACCP April 15, 1994. Accessed on July 1, 2015. provisions or regulations, remain Systems Validation,’’ (http:// 63. FDA, ‘‘Tribal Summary Impact _ subject to this part. www.fsis.usda.gov/shared/PDF/HACCP Statement,’’ 2015. Systems_Validation.pdf), May 2013. 64. Environmental Review of Final Rule: PART 16—REGULATORY HEARING Accessed on June 30, 2015. Current Good Manufacturing Practice, 51. FDA, ‘‘Memorandum on Environmental Hazard Analysis, and Risk-Based BEFORE THE FOOD AND DRUG Monitoring,’’ 2014. See Reference 23 to Preventive Controls for Food for ADMINISTRATION the 2014 supplemental human Animals, August 28, 2015. preventive controls notice, Docket No. 65. FDA, ‘‘Current Good Manufacturing ■ 3. The authority citation for 21 CFR FDA–2011–N–0920. Practice and Hazard Analysis and Risk- part 16 continues to read as follows: 52. FDA, ‘‘Memorandum on Product based Preventive Controls for Human Testing,’’ 2014. See Reference 18 to the Food—Preliminary Regulatory Impact Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 2014 supplemental human preventive Analysis,’’ 2013. See Reference 23 in the 141–149, 321–394, 467f, 679, 821, 1034; 28 controls notice, Docket No. FDA–2011– 2014 supplemental notice. U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. N–0920. 53. FDA, ‘‘Memorandum on Supplier List of Subjects ■ 4. In § 16.1(b)(2), add the following Programs,’’ 2014. See Reference 24 to the entry in numerical order to read as 2014 supplemental human preventive 21 CFR Part 11 follows: controls notice, Docket No. FDA–2011– Administrative practice and N–0920. § 16.1 Scope. 54. Codex Alimentarius Commission, ‘‘Codex procedure, Computer technology, Alimentarius Commission Procedural Reporting and recordkeeping * * * * * requirements. Manual, 23rd Edition,’’ (ftp://ftp.fao.org/ (b) * * * codex/Publications/ProcManuals/ 21 CFR Part 16 Manual_23e.pdf), 2015. Accessed on (2) * * * June 30, 2015. Administrative practice and §§ 507.60 through 507.85 (part 507, 55. FDA, ‘‘Inspections, Compliance, procedure. subpart D of this chapter) relating to Enforcement, and Criminal withdrawal of a qualified facility Investigations: Warning Letters,’’ (http:// 21 CFR Part 117 www.fda.gov/ICECI/ exemption. EnforcementActions/WarningLetters/ Food packaging, Foods. * * * * *

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PART 117—CURRENT GOOD § 500.23 Thermally processed low-acid 507.53 Requirements applicable to a MANUFACTURING PRACTICE, foods packaged in hermetically sealed preventive controls qualified individual HAZARD ANALYSIS, AND RISK– containers. and a qualified auditor. BASED PREVENTIVE CONTROLS FOR 507.55 Implementation records required Except as provided in § 507.5(b) of for this subpart. HUMAN FOOD this chapter, the provisions of parts 507 and 113 of this chapter apply to the Subpart D—Withdrawal of a Qualified ■ 5. The authority citation for 21 CFR manufacturing, processing, or packing Facility Exemption part 117 continues to read as follows: of low-acid foods in hermetically sealed 507.60 Circumstances that may lead FDA Authority: 21 U.S.C. 331, 342, 343, 350d containers, and intended for use as food to withdraw a qualified facility note, 350g, 350g note, 371, 374; 42 U.S.C. for animals. exemption. 243, 264, 271. 507.62 Issuance of an order to withdraw a ■ 9. Add part 507 to read as follows: qualified facility exemption. ■ 6. Add § 117.95 to subpart B to read 507.65 Contents of an order to withdraw a as follows: PART 507—CURRENT GOOD qualified facility exemption. MANUFACTURING PRACTICE, 507.67 Compliance with, or appeal of, an § 117.95 Holding and distribution of HAZARD ANALYSIS, AND RISK– order to withdraw a qualified facility human food by-products for use as animal BASED PREVENTIVE CONTROLS FOR exemption. food. 507.69 Procedure for submitting an appeal. FOOD FOR ANIMALS (a) Human food by-products held for 507.71 Procedure for requesting an distribution as animal food without Subpart A—General Provisions informal hearing. additional manufacturing or processing 507.73 Requirements applicable to an Sec. informal hearing. by the human food processor, as 507.1 Applicability and status. 507.75 Presiding officer for an appeal and identified in § 507.12 of this chapter, 507.3 Definitions. for an informal hearing. must be held under conditions that will 507.4 Qualifications of individuals who 507.77 Timeframe for issuing a decision on protect against contamination, including manufacture, process, pack, or hold an appeal. the following: animal food. 507.80 Revocation of an order to withdraw (1) Containers and equipment used to 507.5 Exemptions. a qualified facility exemption. convey or hold human food by-products 507.7 Requirements that apply to a 507.83 Final agency action. for use as animal food before qualified facility. 507.85 Reinstatement of a qualified facility 507.10 Applicability of subparts C and E of distribution must be designed, exemption that was withdrawn. this part to a facility solely engaged in constructed of appropriate material, the storage of unexposed packaged Subpart E—Supply-Chain Program cleaned as necessary, and maintained to animal food. 507.105 Requirement to establish and protect against the contamination of 507.12 Applicability of this part to the implement a supply-chain program. human food by-products for use as holding and distribution of human food 507.110 General requirements applicable to animal food; by-products for use as animal food. a supply-chain program. (2) Human food by-products for use as 507.115 Responsibilities of the receiving Subpart B—Current Good Manufacturing facility. animal food held for distribution must Practice be held in a way to protect against 507.120 Using approved suppliers. contamination from sources such as 507.14 Personnel. 507.125 Determining appropriate supplier 507.17 Plant and grounds. verification activities (including trash; and 507.19 Sanitation. determining the frequency of conducting (3) During holding, human food by- 507.20 Water supply and plumbing. the activity). products for use as animal food must be 507.22 Equipment and utensils. 507.130 Conducting supplier verification accurately identified. 507.25 Plant operations. activities for raw materials and other (b) Labeling that identifies the by- 507.27 Holding and distribution. ingredients. product by the common or usual name 507.28 Holding and distribution of human 507.135 Onsite audit. must be affixed to or accompany human food by-products for use as animal food. 507.175 Records documenting the supply- chain program. food by-products for use as animal food Subpart C—Hazard Analysis and Risk- when distributed. Based Preventive Controls Subpart F—Requirements Applying to (c) Shipping containers (e.g., totes, 507.31 Food safety plan. Records That Must Be Established and drums, and tubs) and bulk vehicles used 507.33 Hazard analysis. Maintained to distribute human food by-products 507.34 Preventive controls. 507.200 Records subject to the for use as animal food must be 507.36 Circumstances in which the owner, requirements of this subpart. examined prior to use to protect against operator, or agent in charge of a 507.202 General requirements applying to contamination of the human food by- manufacturing/processing facility is not records. products for use as animal food from the required to implement a preventive 507.206 Additional requirements applying container or vehicle when the facility is control. to the food safety plan. responsible for transporting the human 507.37 Provision of assurances required 507.208 Requirements for record retention. 507.212 Use of existing records. food by-products for use as animal food under § 507.36(a)(2), (3), and (4). 507.38 Recall plan. 507.215 Special requirements applicable to itself or arranges with a third party to 507.39 Preventive control management a written assurance. transport the human food by-products components. for use as animal food. Authority: 21 U.S.C. 331, 342, 343, 350d 507.40 Monitoring. note, 350g, 350g note, 371, 374; 42 U.S.C. 507.42 Corrective actions and corrections. 243, 264, 271. PART 500—GENERAL 507.45 Verification. 507.47 Validation. Subpart A—General Provisions ■ 7. The authority citation for 21 CFR 507.49 Verification of implementation and part 500 continues to read as follows: effectiveness. § 507.1 Applicability and status. 507.50 Reanalysis. Authority: 21 U.S.C. 321, 331, 342, 343, 507.51 Modified requirements that apply to (a) The criteria and definitions in this 348, 351, 352, 353, 360b, 371, 379e. a facility solely engaged in the storage of part apply in determining whether an ■ 8. Revise § 500.23 to read as follows: unexposed packaged animal food. animal food is:

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(1) Adulterated within the meaning such terms when used in this part. The Food-contact surfaces are those of: following definitions also apply: surfaces that contact animal food and (i) Section 402(a)(3) of the Federal Adequate means that which is needed those surfaces from which drainage, or Food, Drug, and Cosmetic Act in that to accomplish the intended purpose in other transfer, onto the animal food or the food has been manufactured under keeping with good public (human and onto surfaces that contact the animal such conditions that it is unfit for food; animal) health practice. food ordinarily occurs during the or Affiliate means any facility that normal course of operations. ‘‘Food- (ii) Section 402(a)(4) of the Federal controls, is controlled by, or is under contact surfaces’’ includes utensils and Food, Drug, and Cosmetic Act in that common control with another facility. animal food-contact surfaces of the food has been prepared, packed, or Animal food means food for animals equipment. held under insanitary conditions other than man and includes pet food, Full-time equivalent employee is a whereby it may have become animal feed, and raw materials and term used to represent the number of contaminated with filth, or whereby it ingredients. employees of a business entity for the may have been rendered injurious to Audit means the systematic, purpose of determining whether the health; and independent, and documented business qualifies for the small business (2) In violation of section 361 of the examination (through observation, exemption. The number of full-time Public Health Service Act (42 U.S.C. investigation, records review, equivalent employees is determined by 264). discussions with employees of the dividing the total number of hours of salary or wages paid directly to (b) The operation of a facility that audited entity, and, as appropriate, employees of the business entity and of manufactures, processes, packs, or holds sampling and laboratory analysis) to all of its affiliates and subsidiaries by animal food for sale in the United States assess a supplier’s food safety processes the number of hours of work in 1 year, if the owner, operator, or agent in charge and procedures. 2,080 hours (i.e., 40 hours × 52 weeks). of such facility is required to comply Calendar day means every day shown on the calendar. If the result is not a whole number, with, and is not in compliance with, round down to the next lowest whole section 418 of the Federal Food, Drug, Correction means an action to identify and correct a problem that occurred number. and Cosmetic Act or subparts C, D, E, Harvesting applies to farms and farm during the production of animal food, or F of this part and § 507.7 is a mixed-type facilities and means without other actions associated with a prohibited act under section 301(uu) of activities that are traditionally the Federal Food, Drug, and Cosmetic corrective action procedure (such as performed on farms for the purpose of Act. actions to reduce the likelihood that the removing raw agricultural commodities (c) Animal food covered by specific problem will recur, evaluate all affected from the place they were grown or current good manufacturing practice animal food for safety, and prevent raised and preparing them for use as regulations also is subject to the affected animal food from entering animal food. Harvesting is limited to requirements of those regulations. commerce). activities performed on raw agricultural (d) Except as provided by § 507.12, if Critical control point means a point, commodities, or on processed foods a facility is required to comply with step, or procedure in a food process at created by drying/dehydrating a raw subpart B of part 507 and is also which control can be applied and is agricultural commodity without required to comply with subpart B of essential to prevent or eliminate a food additional manufacturing/processing, part 117 of this chapter because the safety hazard or reduce such hazard to on a farm. Harvesting does not include facility manufactures, processes, packs, an acceptable level. activities that transform a raw or holds human food and animal food, Environmental pathogen means a agricultural commodity into a processed then the facility may choose to comply pathogen capable of surviving and food as defined in section 201(gg) of the with the requirements in subpart B of persisting within the manufacturing, Federal Food, Drug, and Cosmetic Act. part 117, instead of subpart B of part processing, packing, or holding Examples of harvesting include cutting 507, as to the manufacturing, environment such that food for animals (or otherwise separating) the edible processing, packing, and holding of may be contaminated and may result in portion of the raw agricultural animal food at that facility. If a facility foodborne illness if that animal food is commodity from the crop plant and is required to comply with subpart C of not treated to significantly minimize or removing or trimming part of the raw part 507 and is also required to comply prevent the environmental pathogen. agricultural commodity (e.g., foliage, with subpart C of part 117 of this Examples of environmental pathogens husks, roots or stems). Examples of chapter, then the facility may choose to for the purposes of this part include harvesting also include cooling, field comply with the requirements in Listeria monocytogenes and Salmonella coring, filtering, gathering, hulling, subpart C of part 117 as to the spp. but do not include the spores of removing stems and husks from, manufacturing, processing, packing, and pathogenic sporeforming bacteria. shelling, sifting, threshing, trimming of holding of animal food at the facility, Facility means a domestic facility or outer leaves of, and washing raw instead of subpart C of part 507, a foreign facility that is required to agricultural commodities grown on a provided the food safety plan also register under section 415 of the Federal farm. addresses hazards for the animal food, Food, Drug, and Cosmetic Act, in Hazard means any biological, if applicable, that require a preventive accordance with the requirements of chemical (including radiological), or control. When applying the part 1, subpart H of this chapter. physical agent that has the potential to requirements of part 117 of this chapter Farm means farm as defined in cause illness or injury in humans or to animal food, the term ‘‘food’’ in part § 1.227 of this chapter. animals. 117 includes animal food. FDA means the Food and Drug Hazard requiring a preventive control Administration. means a known or reasonably § 507.3 Definitions. Food means food as defined in section foreseeable hazard for which a person The definitions and interpretations 201(f) of the Federal Food, Drug, and knowledgeable about the safe contained in section 201 of the Federal Cosmetic Act and includes raw manufacturing, processing, packing, or Food, Drug, and Cosmetic Act apply to materials and ingredients. holding of animal food would, based on

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the outcome of a hazard analysis (which washing, or waxing. For farms and farm food manufacturing, processing, includes an assessment of the severity of mixed-type facilities, manufacturing/ packing, or holding at the time of the the illness or injury if the hazard were processing does not include activities analysis. to occur and the probability that the that are part of harvesting, packing, or Preventive controls qualified hazard will occur in the absence of holding. individual means a qualified individual preventive controls), establish one or Microorganisms means yeasts, molds, who has successfully completed more preventive controls to significantly bacteria, viruses, protozoa, and training in the development and minimize or prevent the hazard in an microscopic parasites and includes application of risk-based preventive animal food and components to manage species that are pathogens. The term controls at least equivalent to that those controls (such as monitoring, ‘‘undesirable microorganisms’’ includes received under a standardized corrections or corrective actions, those microorganisms that are curriculum recognized as adequate by verification, and records) as appropriate pathogens, that subject animal food to FDA, or is otherwise qualified through to the animal food, the facility, and the decomposition, that indicate that animal job experience to develop and apply a nature of the preventive control and its food is contaminated with filth, or that food safety system. role in the facility’s food safety system. otherwise may cause animal food to be Qualified auditor means a person who Holding means storage of animal food adulterated. is a qualified individual as defined in and also includes activities performed Mixed-type facility means an this part and has technical expertise incidental to storage of an animal food establishment that engages in both obtained through education, training, or (e.g., activities performed for the safe or activities that are exempt from experience (or the combination thereof) effective storage of that animal food, registration under section 415 of the necessary to perform the auditing such as fumigating animal food during Federal Food, Drug, and Cosmetic Act function. Examples of potential storage, and drying/dehydrating raw and activities that require the qualified auditors include: agricultural commodities when the establishment to be registered. An (1) A government employee, drying/dehydrating does not create a example of such a facility is a ‘‘farm including a foreign government distinct commodity (such as drying/ mixed-type facility,’’ which is an employee; and dehydrating hay or alfalfa)). Holding establishment that is a farm, but also (2) An audit agent of a certification also includes activities performed as a conducts activities outside the farm body that is accredited in accordance practical necessity for the distribution of definition that require the establishment with regulations in part 1, subpart M of that animal food (such as blending of to be registered. this chapter. Monitor means to conduct a planned the same raw agricultural commodity Qualified end-user, with respect to and breaking down pallets), but does sequence of observations or food, means the consumer of the food not include activities that transform a measurements to assess whether control (where the term consumer does not raw agricultural commodity into a measures are operating as intended. include a business); or a restaurant or processed food as defined in section Packing means placing animal food retail food establishment (as those terms 201(gg) of the Federal Food, Drug, and into a container other than packaging are defined in § 1.227 of this chapter) Cosmetic Act. Holding facilities could the animal food and also includes that: include warehouses, cold storage repacking and activities performed (1) Is located: facilities, storage silos, grain elevators, incidental to packing or repacking an and liquid-storage tanks. animal food (e.g., activities performed (i) In the same State or the same Known or reasonably foreseeable for the safe or effective packing or Indian reservation as the qualified hazard means a biological, chemical repacking of that animal food (such as facility that sold the food to such (including radiological), or physical sorting, culling, grading, and weighing restaurant or retail food establishment; hazard that is known to be, or has the or conveying incidental to packing or or potential to be, associated with the repacking)), but does not include (ii) Not more than 275 miles from facility or the animal food. activities that transform a raw such facility; and Lot means the animal food produced agricultural commodity into a processed (2) Is purchasing the food for sale during a period of time and identified food as defined in section 201(gg) of the directly to consumers at such restaurant by an establishment’s specific code. Federal Food, Drug, and Cosmetic Act. or retail food establishment. Manufacturing/processing means Pathogen means a microorganism of Qualified facility means (when making animal food from one or more public (human or animal) health including the sales by any subsidiary; ingredients, or synthesizing, preparing, significance. affiliate; or subsidiaries or affiliates, treating, modifying, or manipulating Pest refers to any objectionable collectively, of any entity of which the animal food, including food crops or animals or insects including birds, facility is a subsidiary or affiliate) a ingredients. Examples of rodents, flies, and larvae. facility that is a very small business as manufacturing/processing activities Plant means the building or structure, defined in this part, or a facility to include: Baking, boiling, bottling, or parts thereof, used for or in which both of the following apply: canning, cooking, cooling, cutting, connection with the manufacturing, (1) During the 3-year period preceding distilling, drying/dehydrating raw processing, packing, or holding of the applicable calendar year, the average agricultural commodities to create a animal food. annual monetary value of the food distinct commodity (such as drying/ Preventive controls means those risk- manufactured, processed, packed, or dehydrating grapes to produce raisins), based, reasonably appropriate held at such facility that is sold directly evaporating, eviscerating, extracting procedures, practices, and processes to qualified end-users (as defined in this juice, extruding, formulating, freezing, that a person knowledgeable about the part) during such period exceeded the grinding, homogenizing, irradiating, safe manufacturing, processing, packing, average annual monetary value of the labeling, milling, mixing, packaging or holding of animal food would employ food sold by such facility to all other (including modified atmosphere to significantly minimize or prevent the purchasers; and packaging), pasteurizing, peeling, hazards identified under the hazard (2) The average annual monetary pelleting, rendering, treating to analysis that are consistent with the value of all food sold during the 3-year manipulate ripening, trimming, current scientific understanding of safe period preceding the applicable

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calendar year was less than $500,000, combination of control measures, or the (1) Be a qualified individual as that adjusted for inflation. food safety plan as a whole, when term is defined in § 507.3, i.e., have the Qualified facility exemption means an properly implemented, is capable of education, training, or experience (or a exemption applicable to a qualified effectively controlling the identified combination thereof) necessary to facility under § 507.5(d). hazards. manufacture, process, pack, or hold safe Qualified individual means a person Verification means the application of animal food as appropriate to the who has the education, training, or methods, procedures, tests and other individual’s assigned duties; and experience (or a combination thereof) evaluations, in addition to monitoring, (2) Receive training in the principles necessary to manufacture, process, pack, to determine whether a control measure of animal food hygiene and animal food or hold safe animal food as appropriate or combination of control measures is or safety, including the importance of to the individual’s assigned duties. A has been operating as intended and to employee health and personal hygiene, qualified individual may be, but is not establish the validity of the food safety as appropriate to the animal food, the required to be, an employee of the plan. facility and the individual’s assigned establishment. Very small business means, for duties. Raw agricultural commodity has the purposes of this part, a business (c) Responsibility for ensuring meaning given in section 201(r) of the (including any subsidiaries and compliance by individuals with the Federal Food, Drug, and Cosmetic Act. affiliates) averaging less than requirements of this part must be clearly Receiving facility means a facility that $2,500,000, adjusted for inflation, per assigned to supervisory personnel who is subject to subparts C and E of this part year, during the 3-year period preceding have the education, training, or and that manufactures/processes a raw the applicable calendar year in sales of experience (or a combination thereof) material or other ingredient that it animal food plus the market value of necessary to supervise the production of receives from a supplier. animal food manufactured, processed, safe animal food. Rework means clean, unadulterated packed, or held without sale (e.g., held (d) Records that document training animal food that has been removed from for a fee or supplied to a farm without required by paragraph (b)(2) of this processing for reasons other than sale). section must be established and insanitary conditions or that has been Water activity (aw) means a measure of maintained and are subject to the successfully reconditioned by the free moisture in an animal food and recordkeeping requirements in subpart reprocessing and that is suitable for use is the quotient of the water vapor F of this part. as animal food. pressure of the substance divided by the § 507.5 Exemptions. Sanitize means to adequately treat vapor pressure of pure water at the same cleaned surfaces by a process that is temperature. (a) This part does not apply to effective in destroying vegetative cells of Written procedures for receiving raw establishments, including ‘‘farms’’ (as pathogens, and in substantially reducing materials and other ingredients means defined in § 1.227 of this chapter), that numbers of other undesirable written procedures to ensure that raw are not required to register under microorganisms, but without adversely materials and other ingredients are section 415 of the Federal Food, Drug, affecting the product or its safety for received only from suppliers approved and Cosmetic Act. animals or humans. by the receiving facility (or, when (b)(1) Subparts C and E of this part do Significantly minimize means to necessary and appropriate, on a not apply with respect to activities that reduce to an acceptable level, including temporary basis from unapproved are subject to § 500.23 and part 113 of to eliminate. suppliers whose raw materials or other this chapter (Thermally Processed Low- Small business means, for purposes of ingredients are subjected to adequate Acid Foods Packaged in Hermetically this part, a business employing fewer verification activities before acceptance Sealed Containers) at an animal food than 500 full-time equivalent for use). facility if you are required to comply employees. You means, for purposes of this part, with, and are in compliance with, part Subsidiary means any company the owner, operator, or agent in charge 113 of this chapter with respect to those which is owned or controlled directly or of a facility. activities. indirectly by another company. (2) The exemption in paragraph (b)(1) Supplier means the establishment that § 507.4 Qualifications of individuals who of this section is applicable only with manufactures/processes the animal manufacture, process, pack, or hold animal respect to those microbiological hazards food, raises the animal, or grows the food. regulated under part 113 of this chapter. food that is provided to a receiving (a)(1) The management of an (c) Subparts C and E of this part do facility without further manufacturing/ establishment must ensure that all not apply to activities of a facility that processing by another establishment, individuals who manufacture, process, are subject to section 419 of the Federal except for further manufacturing/ pack, or hold animal food subject to Food, Drug, and Cosmetic Act processing that consists solely of the subparts B and F of this part are (Standards for Produce Safety). addition of labeling or similar activity of qualified to perform their assigned (d) Except as provided in subpart D of a de minimis nature. duties; and this part, subparts C and E of this part Supply-chain-applied control means a (2) The owner, operator, or agent in do not apply to a qualified facility. preventive control for a hazard in a raw charge of a facility must ensure that all Qualified facilities are subject to the material or other ingredient when the individuals who manufacture, process, requirements in § 507.7. hazard in the raw material or other pack, or hold animal food subject to (e) For a farm mixed-type facility that ingredient is controlled before its subparts C, D, E, or F of this part are is a small or very small business, receipt. qualified to perform their assigned subparts C and E of this part do not Unexposed packaged animal food duties. apply to on-farm packing or holding of means packaged animal food that is not (b) Each individual engaged in processed animal food, and § 507.7 does exposed to the environment. manufacturing, processing, packing, or not apply to on-farm packing or holding Validation means obtaining and holding animal food (including of processed animal food by a very evaluating scientific and technical temporary and seasonal personnel) or in small business, if the only packing or evidence that a control measure, the supervision thereof must: holding activities subject to section 418

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of the Federal Food, Drug, and Cosmetic material, culled fruits and vegetables, (2)(i) An attestation that you have Act that the business conducts are the roughage (e.g., cobs, hulls, husks, and identified the potential hazards following low-risk packing or holding straws), or roughage products; associated with the animal food being activity/animal food combinations—i.e., (4) Ensiling (including chopping, produced, are implementing preventive packing (or repacking) (including shredding, mixing, storing, or controls to address the hazards, and are weighing or conveying incidental to fermenting), that is, making silage or monitoring the performance of the packing or repacking); sorting, culling, haylage from forage (e.g., sorghum preventive controls to ensure that such or grading incidental to packing or (milo), corn (maize), alfalfa, and grass), controls are effective; or storing; and storing (ambient, cold and grain, culled fruits and vegetables, or (ii) An attestation that the facility is controlled atmosphere) of: roughage; in compliance with State, local, county, (1) Roughage products (e.g., alfalfa (5) Extracting (mechanical) or wet tribal, or other applicable non-Federal meal, entire plant meal, stem meal, rolling grain, oilseed, brewers grain by- food safety law, including relevant laws pomace, and pulp); products, or distillers grain by-products; and regulations of foreign countries, (2) Plant protein meals (e.g., algae, (6) Labeling roughage products, plant including an attestation based on coconut (copra), guar, and peanut); protein meals, grain by-products and licenses, inspection reports, certificates, (3) Grain by-products and processed processed grain products, oilseed permits, credentials, certification by an grain products (e.g., bran, flour, germ products, molasses, animal protein appropriate agency (such as a State meal, grits, groats, hominy feed, malt meals, milk products, animal tissue- department of agriculture), or other sprouts, middlings, pearled grain, derived products, vitamins, minerals, evidence of oversight. polished grain, brewers grain, distillers concentrates, processing aids, finished (b) The attestations required by grain, and gluten meal); animal food, including animal food paragraph (a) of this section must be (4) Oilseed products (e.g., oil and ready for consumption, or any other submitted to FDA by any one of the meal of safflower, soybean, or processed animal food that does not following means: sunflower); require time/temperature control for (1) Electronic submission. To submit (5) Molasses (e.g., processed sugar safety; and electronically, go to http://www.fda.gov/ cane, sugar beets, and citrus).; (7) Packaging roughage products, furls and follow the instructions. This (6) Animal protein meals (e.g., blood, plant protein meals, grain by-products Web site is available from wherever the feather, meat, meat and bone, and and processed grain products, oilseed Internet is accessible, including marine (e.g., crab, fish, shrimp)); products, molasses, animal protein libraries, copy centers, schools, and (7) Milk products (e.g., casein, cheese meals, milk products, animal tissue- Internet cafes. FDA encourages rind, and lactalbumin); derived products, vitamins, minerals, electronic submission. (8) Animal tissue-derived products concentrates, processing aids, finished (2) Submission by mail. (i) You must (e.g., fat); animal food, including animal food use Form FDA 3942b. You may obtain (9) Vitamins, minerals, and ready for consumption, or any other a copy of this form by any of the concentrates; processed animal food that does not following mechanisms: (10) Processing aids (e.g., enzymes, require time/temperature control for (A) Download it from http:// preservatives, and stabilizers); and safety. www.fda.gov/pcafrule; (11) Any other processed animal food (g) Subparts C and E of this part do (B) Write to the U.S. Food and Drug that does not require time/temperature not apply to facilities that are solely Administration (HFS–681), 5100 Paint control for safety. engaged in the storage of raw Branch Parkway, College Park, MD (f) For a farm mixed-type facility that agricultural commodities (other than 20550; or is a small or very small business, fruits and vegetables) intended for (C) Request a copy of this form by subparts C and E of this part do not further distribution or processing. phone at 1–800–216–7331 or 301–575– apply to on-farm manufacturing/ (h) Subpart B of this part does not 0156. processing activities conducted by a apply to any of the following: (ii) Send a paper Form FDA 3942b to small or very small business for (1) Establishments solely engaged in the U.S. Food and Drug Administration distribution into commerce, and § 507.7 the holding and/or transportation of one (HFS–681), 5100 Paint Branch Parkway, does not apply to on-farm or more raw agricultural commodities; College Park, MD 20550. We manufacturing/processing activities (2) Establishments solely engaged in recommend that you submit a paper conducted by a very small business for hulling, shelling, drying, packing, and/ copy only if your facility does not have distribution into commerce, if the only or holding nuts and hulls (without reasonable access to the Internet. manufacturing/processing activities manufacturing/processing, such as (c)(1) A facility must determine and subject to section 418 of the Federal grinding shells or roasting nuts); and document its status as a qualified Food, Drug, and Cosmetic Act that the (3) Establishments solely engaged in facility on an annual basis no later than business conducts consists of the ginning of cotton (without July 1 of each calendar year. following low-risk manufacturing/ manufacturing/processing, such as (2) The attestations required by processing activity/animal food extracting oil from cottonseed). paragraph (a) of this section must be: combinations: (i) Submitted to FDA initially: (1) Chopping or shredding hay; § 507.7 Requirements that apply to a (A) By December 16, 2019 for a (2) Cracking, crimping, flaking, qualified facility. facility that begins manufacturing, pearling, peeling, shelling, or (a) A qualified facility must submit processing, packing, or holding animal wafering—grain (e.g., barley, sorghum, the following attestations to FDA: food before September 17, 2019; corn, oats, rice, rye, and wheat) or (1) An attestation that the facility is a (B) Before beginning operations, for a oilseed (e.g., beans, canola, cottonseed, qualified facility as defined in § 507.3. facility that begins manufacturing, linseed, soybeans, and sunflowers); For the purpose of determining whether processing, packing, or holding animal (3) Crushing, dry rolling, grinding, a facility satisfies the definition of food after September 17, 2019; or milling, pulverizing—grain, oilseed, qualified facility, the baseline year for (C) By July 31 of the applicable grain by-products and processed grain calculating the adjustment for inflation calendar year, when the status of a products, oilseed products, hay, ensiled is 2011; and facility changes from ‘‘not a qualified

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facility’’ to ‘‘qualified facility’’ based on (b) A facility solely engaged in the (2) Washing hands thoroughly in an the annual determination required by storage of unexposed packaged animal adequate hand-washing facility as paragraph (c)(1) of this section; and food, including unexposed packaged necessary and appropriate to protect (ii) Beginning in 2020, submitted to animal food that requires time/ against contamination; FDA every 2 years during the period temperature control to significantly (3) Removing or securing jewelry and beginning on October 1 and ending on minimize or prevent the growth of, or other objects that might fall into animal December 31. toxin production by, pathogens is food, equipment, or containers; (3) When the status of a facility subject to the modified requirements in (4) Storing clothing or other personal changes from ‘‘qualified facility’’ to ‘‘not § 507.51 for any unexposed packaged belongings in areas other than where a qualified facility’’ based on the annual animal food that requires time/ animal food is exposed or where determination required by paragraph temperature control to significantly equipment or utensils are cleaned; and (c)(1) of this section, the facility must minimize or prevent the growth of, or (5) Taking any other necessary notify FDA of that change in status toxin production by, pathogens. precautions to protect against the using Form FDA 3942b by July 31 of the contamination of animal food, animal § 507.12 Applicability of this part to the food-contact surfaces, or animal food- applicable calendar year. holding and distribution of human food by- (d) When the status of a facility products for use as animal food. packaging materials. changes from ‘‘qualified facility’’ to ‘‘not (a) Except as provided by paragraph a qualified facility,’’ the facility must § 507.17 Plant and grounds. (b) of this section, the requirements of comply with subparts C and E of this (a) The grounds around an animal this part do not apply to by-products of part no later than December 31 of the food plant under the control of the human food production, or the off-farm management of the establishment must applicable calendar year unless packing and holding of raw agricultural otherwise agreed to by FDA and the be kept in a condition that will protect commodities, that are packed or held by against the contamination of animal facility. that human food facility for distribution (e) A qualified facility that does not food. Maintenance of grounds must as animal food if: include: submit attestations under paragraph (1)(i) The human food facility is (a)(2)(i) of this section must provide (1) Properly storing equipment, subject to and in compliance with removing litter and waste, and cutting notification to consumers as to the name subpart B of part 117 of this chapter and and complete business address of the weeds or grass within the immediate in compliance with all applicable vicinity of the plant that may constitute facility where the animal food was human food safety requirements of the manufactured or processed (including an attractant, breeding place, or Federal Food, Drug, and Cosmetic Act harborage for pests; the street address or P.O. Box, city, and implementing regulations; or state, and zip code for domestic (2) Maintaining driveways, yards, and (ii) For the off-farm packing and parking areas so that they do not facilities, and comparable full address holding of produce (as defined in part information for foreign facilities) as constitute a source of contamination in 112 of this chapter), the human food areas where animal food is exposed; follows: facility is subject to and in compliance (1) If an animal food packaging label (3) Adequately draining areas that with § 117.8 of this chapter and in may contribute to contamination of is required, the notification required by compliance with all applicable human paragraph (e) of this section must animal food; and food safety requirements of the Federal (4) Treating and disposing of waste so appear prominently and conspicuously Food, Drug, and Cosmetic Act and on the label of the animal food. that it does not constitute a source of implementing regulations; and contamination in areas where animal (2) If an animal food packaging label (2) The human food facility does not is not required, the notification required food is exposed. further manufacture or process the by- (b) The plant must be suitable in size, by paragraph (e) of this section must products intended for use as animal appear prominently and conspicuously, construction, and design to facilitate food. cleaning, maintenance, and pest control at the point of purchase, on a label, (b) The human food by-products for to reduce the potential for poster, sign, placard, or documents use as animal food identified in contamination of animal food, animal delivered contemporaneously with the paragraph (a) of this section must be food-contact surfaces, and animal food- animal food in the normal course of held and distributed by that facility in packaging materials, including that the business, or in an electronic notice, in accordance with § 507.28 and § 117.95 plant must: the case of Internet sales. of this chapter. (f)(1) A qualified facility must (1) Provide adequate space between maintain those records relied upon to Subpart B—Current Good equipment, walls, and stored materials support the attestations that are required Manufacturing Practice to permit employees to perform their by paragraph (a) of this section. duties and to allow cleaning and § 507.14 Personnel. (2) The records that a qualified facility maintenance of equipment; must maintain are subject to the (a) The management of the (2) Be constructed in a manner such requirements of subpart F of this part. establishment must take reasonable that drip or condensate from fixtures, measures and precautions to ensure that ducts, and pipes does not serve as a § 507.10 Applicability of subparts C and E all persons working in direct contact source of contamination; of this part to a facility solely engaged in with animal food, animal food-contact (3) Provide adequate ventilation the storage of unexposed packaged animal surfaces, and animal food-packaging (mechanical or natural) where necessary food. materials conform to hygienic practices and appropriate to minimize vapors (a) Subparts C and E of this part do to the extent necessary to protect against (e.g., steam) and fumes in areas where not apply to a facility solely engaged in the contamination of animal food. they may contaminate animal food and the storage of unexposed packaged (b) The methods for conforming to in a manner that minimizes the animal food that does not require time/ hygienic practices and maintaining potential for contaminating animal food; temperature control to significantly cleanliness include: (4) Provide adequate lighting in hand- minimize or prevent the growth of, or (1) Maintaining adequate personal washing areas, toilet rooms, areas where toxin production by, pathogens. cleanliness; animal food is received, manufactured,

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processed, packed, or held, and areas (iii) Those necessary for plant and (2) Properly convey sewage and liquid where equipment or utensils are equipment maintenance and operation; disposable waste from the plant; cleaned; and and (3) Avoid being a source of (5) Provide shatter-resistant light (iv) Those necessary for use in the contamination to animal food, water bulbs, fixtures, and skylights, or other plant’s operations. supplies, equipment, or utensils, or glass items suspended over exposed (2) Toxic materials described in creating an unsanitary condition; animal food in any step of preparation, paragraph (d)(1) of this section (e.g., (4) Provide adequate floor drainage in to protect against the contamination of cleaning compounds, sanitizing agents, all areas where floors are subject to animal food in case of glass breakage. and pesticide chemicals) must be flooding-type cleaning or where normal (c) The plant must protect animal identified, used, and stored in a manner operations release or discharge water or food stored outdoors in bulk from that protects against the contamination other liquid waste on the floor; and contamination by any effective means, of animal food, animal food-contact (5) Ensure that there is no backflow including: surfaces, or animal food-packaging from, or cross-connection between, (1) Using protective coverings where materials; and piping systems that discharge waste necessary and appropriate; (3) Other toxic materials (such as water or sewage and piping systems that (2) Controlling areas over and around fertilizers and pesticides not included in carry water for animal food or animal the bulk animal food to eliminate paragraph (d)(1) of this section) must be food manufacturing. harborages for pests; and stored in an area of the plant where (c) Sewage and liquid disposal waste (3) Checking on a regular basis for animal food is not manufactured, must be disposed of through an pests, pest infestation, and product processed, or exposed. adequate sewerage system or through condition related to safety of the animal (e) Effective measures must be taken other adequate means. food. to exclude pests from the (d) Each plant must provide manufacturing, processing, packing, and employees with adequate, readily § 507.19 Sanitation. holding areas and to protect against the accessible toilet facilities. Toilet (a) Buildings, structures, fixtures, and contamination of animal food by pests. facilities must be kept clean and must other physical facilities of the plant The use of pesticides in the plant is not be a potential source of must be kept clean and in good repair permitted only under precautions and contamination of animal food, animal to prevent animal food from becoming restrictions that will protect against the food-contact surfaces, or animal food- adulterated. contamination of animal food, animal packaging materials. (b) Animal food-contact and non- food-contact surfaces, and animal food- (e) Each plant must provide hand- contact surfaces of utensils and packaging materials. washing facilities designed to ensure equipment must be cleaned and (f) Trash must be conveyed, stored, that an employee’s hands are not a maintained and utensils and equipment and disposed of in a way that protects potential source of contamination of stored as necessary to protect against the against the contamination of animal animal food, animal food-contact contamination of animal food, animal food, animal food-contact surfaces, surfaces, or animal food-packaging food-contact surfaces, or animal food- animal food-packaging materials, water materials. supplies, and ground surfaces, and packaging materials. When necessary, § 507.22 Equipment and utensils. minimizes the potential for the trash to equipment must be disassembled for (a) The following apply to plant thorough cleaning. In addition: become an attractant and harborage or breeding place for pests. equipment and utensils used in (1) When animal food-contact surfaces manufacturing, processing, packing, and used for manufacturing, processing, § 507.20 Water supply and plumbing. holding animal food: packing, or holding animal food are wet- (a) The following apply to the water (1) All plant equipment and utensils, cleaned, the surfaces must, when supply: including equipment and utensils that necessary, be thoroughly dried before (1) Water must be adequate for the do not come in contact with animal subsequent use; and operations and must be derived from an food, must be designed and constructed (2) In wet processing of animal food, adequate source; of such material and workmanship to be when cleaning and sanitizing is (2) Running water at a suitable adequately cleanable, and must be necessary to protect against the temperature, and under suitable properly maintained; introduction of undesirable pressure as needed, must be provided in (2) Equipment and utensils must be microorganisms into animal food, all all areas where required for the designed, constructed, and used animal food-contact surfaces must be manufacturing, processing, packing, or appropriately to avoid the adulteration cleaned and sanitized before use and holding of animal food, for the cleaning of animal food with non-food grade after any interruption during which the of equipment, utensils, and animal food- lubricants, fuel, metal fragments, animal food-contact surfaces may have packaging materials, or for employee contaminated water, or any other become contaminated. hand-washing facilities; contaminants; (c) Cleaning compounds and (3) Water that contacts animal food, (3) Equipment must be installed so as sanitizing agents must be safe and animal food-contact surfaces, or animal to facilitate the cleaning and adequate under the conditions of use. food-packaging materials must be safe maintenance of the equipment and (d) The following applies to toxic for its intended use; and adjacent spaces; materials: (4) Water may be reused for washing, (4) Animal food-contact surfaces must (1) Only the following toxic materials rinsing, or conveying animal food if it be: may be used or stored in the plant area does not increase the level of (i) Made of materials that withstand where animal food is manufactured, contamination of the animal food. the environment of their use and the processed, or exposed: (b) Plumbing must be designed, action of animal food, and, if applicable, (i) Those required to maintain clean installed, and maintained to: the action of cleaning compounds, and sanitary conditions; (1) Carry adequate quantities of water cleaning procedures, and sanitizing (ii) Those necessary for use in to required locations throughout the agents; laboratory testing procedures; plant; (ii) Made of nontoxic materials; and

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(iii) Maintained to protect animal food conducted under such conditions and protected against contamination and the from being contaminated. controls as are necessary to minimize growth of undesirable microorganisms; (b) Holding, conveying, the potential for the growth of (4) Steps such as cutting, drying, manufacturing, and processing systems, undesirable microorganisms to protect defatting, grinding, mixing, extruding, including gravimetric, pneumatic, against the contamination of animal pelleting, and cooling, must be closed, and automated systems, must be food. performed in a way that protects against designed, constructed, and maintained (b) Raw materials and other the contamination of animal food; in a way to protect against the ingredients: (5) Filling, assembling, packaging, and contamination of animal food. (1) Must be examined to ensure that other operations must be performed in (c) Each freezer and cold storage they are suitable for manufacturing and such a way that protects against the compartment used to hold animal food processing into animal food and must be contamination of animal food and the must be fitted with an accurate handled under conditions that will growth of undesirable microorganisms; temperature-measuring device. protect against contamination and (6) Animal food that relies principally (d) Instruments and controls used for minimize deterioration. In addition: on the control of water activity (aw) for measuring, regulating, or recording (i) Shipping containers (e.g., totes, preventing the growth of undesirable temperatures, pH, aw, or other drums, and tubs) and bulk vehicles microorganisms must be processed to conditions that control or prevent the holding raw materials and other and maintained at a safe aw level; growth of undesirable microorganisms ingredients must be examined upon (7) Animal food that relies principally in animal food must be accurate, receipt to determine whether on the control of pH for preventing the precise, adequately maintained, and contamination or deterioration of growth of undesirable microorganisms adequate in number for their designated animal food has occurred; must be monitored and maintained at uses. (ii) Raw materials must be cleaned as the appropriate pH; and (e) Compressed air or other gases necessary to minimize contamination; (8) When ice is used in contact with mechanically introduced into animal and animal food, it must be made from water food or used to clean animal food- (iii) Raw materials and other that is safe and must be used only if it contact surfaces or equipment must be ingredients, including rework, must be has been manufactured in accordance used in such a way to protect against the stored in containers designed and with current good manufacturing contamination of animal food. constructed in a way that protects practice as outlined in this subpart. § 507.25 Plant operations. against contamination and deterioration, § 507.27 Holding and distribution. and held under conditions, e.g., (a) Management of the establishment (a) Animal food held for distribution appropriate temperature and relative must ensure that: must be held under conditions that will (1) All operations in the humidity, that will minimize the protect against contamination and manufacturing, processing, packing, and potential for growth of undesirable minimize deterioration, including the holding of animal food (including microorganisms and prevent the animal following: operations directed to receiving, food from becoming adulterated; (1) Containers used to hold animal inspecting, transporting, and (2) Susceptible to contamination with food before distribution must be segregating) are conducted in mycotoxins or other natural toxins must designed, constructed of appropriate accordance with the current good be evaluated and used in a manner that material, cleaned as necessary, and manufacturing practice requirements of does not result in animal food that can maintained to protect against the this subpart; cause injury or illness to animals or contamination of animal food; and (2) Animal food, including raw humans; and (2) Animal food held for distribution materials, other ingredients, or rework is (3) If frozen, must be kept frozen. If must be held in a way that protects accurately identified; thawing is required prior to use, it must against contamination from sources (3) Animal food-packaging materials be done in a manner that minimizes the such as trash. are safe and suitable; potential for the growth of undesirable (b) The labeling for the animal food (4) The overall cleanliness of the plant microorganisms. product ready for distribution must is under the supervision of one or more (c) For the purposes of manufacturing, contain, when applicable, information competent individuals assigned processing, packing, and holding and instructions for safely using the responsibility for this function; operations, the following apply: animal food product for the intended (5) Adequate precautions are taken so (1) Animal food must be maintained animal species. that plant operations do not contribute under conditions, e.g., appropriate (c) Shipping containers (e.g., totes, to contamination of animal food, animal temperature and relative humidity, that drums, and tubs) and bulk vehicles used food-contact surfaces, and animal food- will minimize the potential for growth to distribute animal food must be packaging materials; of undesirable microorganisms and examined prior to use to protect against (6) Chemical, microbial, or prevent the animal food from becoming the contamination of animal food from extraneous-material testing procedures adulterated during manufacturing, the container or vehicle when the are used where necessary to identify processing, packing, and holding; facility is responsible for transporting sanitation failures or possible animal (2) Measures taken during the animal food itself or arranges with food contamination; manufacturing, processing, packing, and a third party to transport the animal (7) Animal food that has become holding of animal food to significantly food. adulterated is rejected, disposed of, or if minimize or prevent the growth of (d) Animal food returned from appropriate, treated or processed to undesirable microorganisms (e.g., heat distribution must be assessed for animal eliminate the adulteration. If disposed treating, freezing, refrigerating, food safety to determine the appropriate of, it must be done in a manner that irradiating, controlling pH, or disposition. Returned animal food must protects against the contamination of controlling aw) must be adequate to be identified as such and segregated other animal food; and prevent adulteration of animal food; until assessed. (8) All animal food manufacturing, (3) Work-in-process and rework must (e) Unpackaged or bulk animal food processing, packing, and holding is be handled in such a way that it is must be held in a manner that does not

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result in unsafe cross contamination preventive controls as required by otherwise include a control measure with other animal food. § 507.40(a)(1); (such as a formulation lethal to the (6) The written corrective action pathogen) that would significantly § 507.28 Holding and distribution of procedures as required by § 507.42(a)(1); minimize the pathogen. human food by-products for use as animal (d) The hazard evaluation must food. and (7) The written verification consider the effect of the following on (a) Human food by-products held for procedures as required by § 507.49(b). the safety of the finished animal food for distribution as animal food must be held (d) The food safety plan required by the intended animal: under conditions that will protect this section is a record that is subject to (1) The formulation of the animal against contamination, including the the requirements of subpart F of this food; following: part. (2) The condition, function, and (1) Containers and equipment used to design of the facility and equipment; convey or hold human food by-products § 507.33 Hazard analysis. (3) Raw materials and other for use as animal food before (a)(1) You must conduct a hazard ingredients; distribution must be designed, analysis to identify and evaluate, based (4) Transportation practices; constructed of appropriate material, on experience, illness data, scientific (5) Manufacturing/processing cleaned as necessary, and maintained to reports, and other information, known procedures; protect against the contamination of or reasonably foreseeable hazards for (6) Packaging activities and labeling human food by-products for use as each type of animal food manufactured, activities; animal food; processed, packed, or held at your (7) Storage and distribution; (2) Human food by-products for use as facility to determine whether there are (8) Intended or reasonably foreseeable animal food held for distribution must any hazards requiring a preventive use; be held in a way to protect against control; and (9) Sanitation, including employee contamination from sources such as (2) The hazard analysis must be hygiene; and (10) Any other relevant factors such as trash; and written regardless of its outcome. the temporal (e.g., weather-related) (3) During holding, human food by- (b) The hazard identification must nature of some hazards (e.g., levels of products for use as animal food must be consider: some natural toxins). accurately identified. (1) Known or reasonably foreseeable (b) Labeling that identifies the hazards that include: § 507.34 Preventive controls. product by the common or usual name (i) Biological hazards, including (a)(1) You must identify and must be affixed to or accompany the microbiological hazards such as implement preventive controls to human food by-products for use as parasites, environmental pathogens, and provide assurances that any hazards animal food when distributed. other pathogens; requiring a preventive control will be (c) Shipping containers (e.g., totes, (ii) Chemical hazards, including significantly minimized or prevented drums, and tubs) and bulk vehicles used radiological hazards, substances such as and the animal food manufactured, to distribute human food by-products pesticide and drug residues, natural processed, packed, or held by your for use as animal food must be toxins, decomposition, unapproved food facility will not be adulterated under examined prior to use to protect against or color additives, and nutrient section 402 of the Federal Food, Drug, the contamination of animal food from deficiencies or toxicities (such as and Cosmetic Act; and the container or vehicle when the inadequate thiamine in cat food, (2) Preventive controls required by facility is responsible for transporting excessive vitamin D in dog food, and paragraph (a)(1) of this section include: the human food by-products for use as excessive copper in food for sheep); and (i) Controls at critical control points animal food itself or arranges with a (iii) Physical hazards (such as stones, (CCPs), if there are any CCPs; and third party to transport the human food glass, and metal fragments); and (ii) Controls, other than those at CCPs, by-products for use as animal food. (2) Known or reasonably foreseeable that are also appropriate for animal food hazards that may be present in the safety. Subpart C—Hazard Analysis and Risk- animal food for any of the following (b) Preventive controls must be Based Preventive Controls reasons: written. (i) The hazard occurs naturally; (c) Preventive controls include, as § 507.31 Food safety plan. (ii) The hazard may be appropriate to the facility and animal (a) You must prepare, or have unintentionally introduced; or food: prepared, and implement a written food (iii) The hazard may be intentionally (1) Process controls. Process controls safety plan. introduced for purposes of economic include procedures, practices, and (b) One or more preventive controls gain. processes to ensure the control of qualified individuals must prepare, or (c)(1) The hazard analysis must parameters during operations such as oversee the preparation of, the food include an evaluation of the hazards heat processing, irradiating, and safety plan. identified in paragraph (b) of this refrigerating animal food. Process (c) The written food safety plan must section to assess the severity of the controls must include, as appropriate to include: illness or injury if the hazard were to the nature of the applicable control and (1) The written hazard analysis as occur and the probability that the its role in the facility’s food safety required by § 507.33(a)(2); hazard will occur in the absence of system: (2) The written preventive controls as preventive controls. (i) Parameters associated with the required by § 507.34(b); (2) The hazard evaluation required by control of the hazard; and (3) The written supply-chain program paragraph (c)(1) of this section must (ii) The maximum or minimum value, as required by subpart E of this part; include an evaluation of environmental or combination of values, to which any (4) The written recall plan as required pathogens whenever an animal food is biological, chemical, or physical by § 507.38(a)(1); exposed to the environment prior to parameter must be controlled to (5) The written procedures for packaging and the packaged animal food significantly minimize or prevent a monitoring the implementation of the does not receive a treatment or hazard requiring a process control.

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(2) Sanitation controls. Sanitation hazard (except as provided in paragraph control, at a subsequent distribution controls include procedures, practices, (c) of this section); step, of the hazards in the animal food and processes to ensure that the facility (3) You rely on your customer who is product you distribute and you is maintained in a sanitary condition not subject to the requirements for document the implementation of that adequate to significantly minimize or hazard analysis and risk-based system. prevent hazards such as environmental preventive controls in subpart C of this (b) You must document any pathogens and biological hazards due to part to provide assurance it is circumstance specified in paragraph (a) employee handling. Sanitation controls manufacturing, processing, or preparing of this section that applies to you, must include, as appropriate to the the animal food in accordance with including: facility and the animal food, procedures, applicable animal food safety (1) A determination in accordance practices, and processes for the: requirements and you: with paragraph (a) of this section that (i) Cleanliness of animal food-contact (i) Disclose in documents the type of animal food could not be surfaces, including animal food-contact accompanying the animal food, in consumed without application of an surfaces of utensils and equipment; and accordance with the practice of the appropriate control; (ii) Prevention of cross-contamination trade, that the animal food is ‘‘not (2) The annual written assurance from from insanitary objects and from processed to control [identified your customer in accordance with personnel to animal food, animal food- hazard]’’; and paragraph (a)(2) of this section; packaging material, and other animal (ii) Annually obtain from your (3) The annual written assurance from food-contact surfaces and from raw customer written assurance that it is your customer in accordance with product to processed product. manufacturing, processing, or preparing paragraph (a)(3) of this section; (4) The annual written assurance from (3) Supply-chain controls. Supply- the animal food in accordance with your customer in accordance with chain controls include the supply-chain applicable animal food safety paragraph (a)(4) of this section; and program as required by subpart E of this requirements; (4) You rely on your customer to (5) Your system, in accordance with part; paragraph (a)(5) of this section, that (4) A recall plan as required by provide assurance that the animal food will be processed to control the ensures control, at a subsequent § 507.38; and distribution step, of the hazards in the (5) Other preventive controls. These identified hazard by an entity in the distribution chain subsequent to the animal food product you distribute. include any other procedures, practices, (c) For the written assurance required and processes necessary to satisfy the customer and you: (i) Disclose in documents by paragraph (a)(2)(ii) of this section, if requirements of paragraph (a) of this your customer has determined that the section. Examples of other controls accompanying the animal food, in accordance with the practice of the identified hazard in paragraph (a) of this include hygiene training and other section is not a hazard in the animal current good manufacturing practices. trade, that the animal food is ‘‘not processed to control [identified food intended for use for a specific animal species, your customer’s written § 507.36 Circumstances in which the hazard]’’; and owner, operator, or agent in charge of a (ii) Annually obtain from your assurance may provide this manufacturing/processing facility is not customer written assurance, subject to determination (including animal species required to implement a preventive control. the requirements of § 507.37, that your and why the identified hazard is not a (a) If you are a manufacturer/ customer: hazard) instead of providing assurance processor, you are not required to (A) Will disclose in documents of procedures established and followed implement a preventive control when accompanying the animal food, in that will significantly minimize or you identify a hazard requiring a accordance with the practice of the prevent the identified hazard. (d) For the written assurance required preventive control (identified hazard) trade, that the animal food is ‘‘not by paragraph (a)(4)(ii)(B) of this section, and any of the following circumstances processed to control [identified if the entity in the distribution chain apply: hazard]’’; and (1) You determine and document that (B) Will only sell to another entity subsequent to your customer is subject the type of animal food could not be that agrees, in writing, it will: to subpart C of this part and has consumed without application of an (1) Follow procedures (identified in a determined that the identified hazard in appropriate control; written assurance) that will significantly paragraph (a) of this section is not a (2) You rely on your customer who is minimize or prevent the identified hazard in the animal food intended for subject to the requirements for hazard hazard (if the entity is subject to the use for a specific animal species, that analysis and risk-based preventive requirements for hazard analysis and entity’s written assurance may provide controls in subpart C of this part to risk-based preventive controls in this determination (including animal ensure that the identified hazard will be subpart C of this part), except as species and why the identified hazard is significantly minimized or prevented; provided in paragraph (d) of this not a hazard) instead of providing and you: section, or manufacture, process, or assurance that the identified hazard will (i) Disclose in documents prepare the animal food in accordance be significantly minimized or accompanying the animal food, in with applicable animal food safety prevented. accordance with the practice of the requirements (if the entity is not subject § 507.37 Provision of assurances required trade, that the animal food is ‘‘not to the requirements for hazard analysis under § 507.36(a)(2), (3), and (4). processed to control [identified and risk-based preventive controls in A facility that provides a written hazard]’’; and subpart C of this part); or assurance under § 507.36(a)(2), (3), or (ii) Annually obtain from your (2) Obtain a similar written assurance (4) must act consistently with the customer written assurance, subject to from the entity’s customer, subject to assurance and document its actions the requirements of § 507.37, that the the requirements of § 507.37, as in taken to satisfy the written assurance. customer has established and is paragraphs (a)(4)(ii)(A) and (B) of this following procedures (identified in the section, as appropriate; or § 507.38 Recall plan. written assurance) that will significantly (5)You have established, documented, (a) For animal food with a hazard minimize or prevent the identified and implemented a system that ensures requiring a preventive control you must:

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(1) Establish a written recall plan for (a) Establish and implement written (b)(1) Except as provided by the animal food; and procedures, including the frequency paragraph (c) of this section, you are (2) Assign responsibility for with which they are to be performed, for subject to the requirements of paragraph performing all procedures in the recall monitoring the preventive controls; and (b)(2) of this section if any of the plan. (b) Monitor the preventive controls following circumstances apply: (b) The written recall plan must with adequate frequency to provide (i) A preventive control is not include procedures that describe the assurance that they are consistently properly implemented and a corrective steps to perform the following actions as performed. action procedure has not been appropriate to the facility: (c)(1) You must document the established; (1) Directly notify direct consignees monitoring of preventive controls in (ii) A preventive control, combination about the animal food being recalled, accordance with this section in records of preventive controls, or the food safety including how to return or dispose of that are subject to verification in plan as a whole is found to be the affected animal food; accordance with § 507.45(a)(2) and ineffective; or (2) Notify the public about any hazard records review in accordance with (iii) A review of records in accordance presented by the animal food when § 507.49(a)(4)(i); with § 507.49(a)(4) finds that the records appropriate to protect human and (2)(i) Records of refrigeration are not complete, the activities animal health; temperature during storage of animal conducted did not occur in accordance (3) Conduct effectiveness checks to food that requires time/temperature with the food safety plan, or appropriate verify the recall has been carried out; control to significantly minimize or decisions were not made about and prevent the growth of, or toxin corrective actions. (4) Appropriately dispose of recalled production by, pathogens may be (2) If any of the circumstances listed animal food, e.g., through reprocessing, affirmative records demonstrating in paragraph (b)(1) of this section apply, reworking, diverting to another use that temperature is controlled or exception you must: would not present a safety concern, or records demonstrating loss of (i) Take corrective action to identify destroying the animal food. temperature control; and and correct the problem; § 507.39 Preventive control management (ii) Exception records may be (ii) Reduce the likelihood that the components. adequate in circumstances other than problem will recur; (a) Except as provided by paragraphs monitoring of refrigeration temperature. (iii) Evaluate all affected animal food (b) and (c) of this section, the preventive for safety; § 507.42 Corrective actions and (iv) As necessary, prevent affected controls required under § 507.34 are corrections. animal food from entering commerce as subject to the following preventive (a) As appropriate to the nature of the would be done following the corrective control management components as hazard and the nature of the preventive action procedure under paragraph (a)(2) appropriate to ensure the effectiveness control, except as provided by of this section; and of the preventive controls, taking into paragraph (c) of this section: (v) When appropriate, reanalyze the account the nature of the preventive (1) You must establish and implement food safety plan in accordance with control and its role in the facility’s food written corrective action procedures § 507.50 to determine whether safety system: that must be taken if preventive controls (1) Monitoring in accordance with modification of the food safety plan is are not properly implemented, required. § 507.40; including procedures to address, as (2) Corrective actions and corrections (c) You do not need to comply with appropriate: in accordance with § 507.42; and the requirements of paragraphs (a) and (i) The presence of a pathogen or (3) Verification in accordance with (b) of this section if: appropriate indicator organism in § 507.45. (1) You take action, in a timely (b) The supply-chain program animal food detected as a result of manner, to identify and correct established in subpart E of this part is product testing conducted in conditions and practices that are not subject to the following preventive accordance with § 507.49(a)(2); and consistent with the sanitation controls control management components as (ii) The presence of an environmental in § 507.34(c)(2)(i) or (ii); or appropriate to ensure the effectiveness pathogen or appropriate indicator (2) You take action, in a timely of the supply-chain program, taking into organism detected through the manner, to identify and correct a minor account the nature of the hazard environmental monitoring conducted in and isolated problem that does not controlled before receipt of the raw accordance with § 507.49(a)(3). directly impact product safety. (2) The corrective action procedures material or other ingredient: (d) All corrective actions (and, when (1) Corrective actions and corrections must describe the steps to be taken to appropriate, corrections) taken in in accordance with § 507.42, taking into ensure that: accordance with this section must be account the nature of any supplier non- (i) Appropriate action is taken to documented in records. These records conformance; identify and correct a problem that has are subject to verification in accordance (2) Review of records in accordance occurred with implementation of a with § 507.45(a)(3) and records review with § 507.49(a)(4)(ii); and preventive control; in accordance with § 507.49(a)(4)(i). (3) Reanalysis in accordance with (ii) Appropriate action is taken when § 507.45 Verification. § 507.50. necessary, to reduce the likelihood that (c) The recall plan established in the problem will recur; (a) Verification activities must § 507.38 is not subject to the (iii) All affected animal food is include, as appropriate to the nature of requirements of paragraph (a) of this evaluated for safety; and the preventive control and its role in the section. (iv) All affected animal food is facility’s food safety system: prevented from entering into commerce (1) Validation in accordance with § 507.40 Monitoring. if you cannot ensure the affected animal § 507.47; As appropriate to the nature of the food is not adulterated under section (2) Verification that monitoring is preventive control and its role in the 402 of the Federal Food, Drug, and being conducted as required by § 507.39 facility’s food safety system you must: Cosmetic Act. (and in accordance with § 507.40);

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(3) Verification that appropriate not applicable based on factors such as instruments (or checking them for decisions about corrective actions are the nature of the hazard, and the nature accuracy) as required by paragraph being made as required by § 507.39 (and of the preventive control and its role in (a)(1) of this section; in accordance with § 507.42); the facility’s food safety system. (2) Product testing as required by (4) Verification of implementation paragraph (a)(2) of this section. and effectiveness in accordance with § 507.49 Verification of implementation Procedures for product testing must: and effectiveness. § 507.49; and (i) Be scientifically valid; (5) Reanalysis in accordance with (a) You must verify that the (ii) Identify the test microorganism(s) § 507.50. preventive controls are consistently or other analyte(s); (b) All verification activities implemented and are effectively and (iii) Specify the procedures for conducted in accordance with this significantly minimizing or preventing identifying samples, including their section must be documented in records. the hazards. To do so, you must conduct relationship to specific lots of product; activities that include the following, as (iv) Include the procedures for § 507.47 Validation. appropriate to the facility, the animal sampling, including the number of (a) You must validate that the food, and the nature of the preventive samples and the sampling frequency; preventive controls identified and control and its role in the facility’s food (v) Identify the test(s) conducted, implemented in accordance with safety system: including the analytical method(s) used; § 507.34 are adequate to control the (1) Calibration of process monitoring (vi) Identify the laboratory conducting hazard as appropriate to the nature of and verification instruments (or the testing; and the preventive control and its role in the checking them for accuracy); (vii) Include the corrective action facility’s food safety system. (2) Product testing for a pathogen (or procedures required by § 507.42(a)(1). (b) The validation of the preventive appropriate indicator organism) or other (3) Environmental monitoring as controls: hazard; required by paragraph (a)(3) of this (1) Must be performed (or overseen) (3) Environmental monitoring, for an section. Procedures for environmental by a preventive controls qualified environmental pathogen or for an monitoring must: individual: appropriate indicator organism, if (i) Be scientifically valid; (i)(A) Prior to implementation of the contamination of an animal food with (ii) Identify the test microorganism(s); food safety plan or; an environmental pathogen is a hazard (iii) Identify the locations from which (B) When necessary to demonstrate requiring a preventive control, by samples will be collected and the the control measures can be collecting and testing environmental number of sites to be tested during implemented as designed: samples; and routine environmental monitoring. The (1) Within 90 calendar days after (4) Review of the following records number and location of sampling sites production of the applicable animal within the specified timeframes, by (or must be adequate to determine whether food first begins; under the oversight of) a preventive preventive controls are effective; (2) Within a reasonable timeframe, controls qualified individual, to ensure (iv) Identify the timing and frequency provided that the preventive controls the records are complete, the activities for collecting and testing samples. The qualified individual prepares (or reflected in the records occurred in timing and frequency for collecting and oversees the preparation of) a written accordance with the food safety plan, testing samples must be adequate to justification for a timeframe that the preventive controls are effective, determine whether preventive controls exceeds 90 calendar days after and appropriate decisions were made are effective; production of the applicable animal about corrective actions: (v) Identify the test(s) conducted, food first begins; (i) Monitoring and corrective action including the analytical method(s) used; (ii) Whenever a change to a control records within 7-working days after the (vi) Identify the laboratory conducting measure or combination of control records are created or within a the testing; and measures could impact whether the reasonable timeframe, provided that the (vii) Include the corrective action control measure or combination of preventive controls qualified individual procedures required by control measures, when properly prepares (or oversees the preparation of) § 507.42(a)(1)(ii). implemented, will effectively control a written justification for a timeframe the hazards; and that exceeds 7-working days; and § 507.50 Reanalysis. (iii) Whenever a reanalysis of the food (ii) Records of calibration, testing (a) You must conduct a reanalysis of safety plan reveals the need to do so. (e.g., product testing, environmental the food safety plan as a whole at least (2) Must include obtaining and monitoring), and supplier and supply- once every 3 years. evaluating scientific and technical chain verification activities, and other (b) You must conduct a reanalysis of evidence (or, when such evidence is not verification activities within a the food safety plan as a whole, or the available or is inadequate, conducting reasonable time after the records are applicable portion of the food safety studies) to determine whether the created; and plan: preventive controls, when properly (5) Other activities appropriate for (1) Whenever a significant change in implemented, will effectively control verification of implementation and the activities conducted at your facility the hazards. effectiveness. creates a reasonable potential for a new (c) You do not need to validate: (b) As appropriate to the facility, the hazard or creates a significant increase (1) The sanitation controls in food, the nature of the preventive in a previously identified hazard; § 507.34(c)(2); control, and the role of the preventive (2) Whenever you become aware of (2) The recall plan in § 507.38; control in the facility’s food safety new information about potential (3) The supply-chain program in system, you must establish and hazards associated with the animal subpart E of this part; and implement written procedures for the food; (4) Other preventive controls, if the following activities: (3) Whenever appropriate after an preventive controls qualified individual (1) The method and frequency of unanticipated animal food safety prepares (or oversees the preparation of) calibrating process monitoring problem in accordance with § 507.42(b); a written justification that validation is instruments and verification and

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(4) Whenever you find that a (3) If there is a loss of temperature (5) Review of records (§ 507.49(a)(4)); preventive control, combination of control that may impact the safety of (6) Written justification for review of preventive controls, or the food safety such refrigerated packaged animal food, records of monitoring and corrective plan as a whole is ineffective. take appropriate corrective actions to: actions within a timeframe that exceeds (c) You must complete the reanalysis (i) Correct the problem and reduce the 7-working days; required by paragraphs (a) and (b) of likelihood that the problem will recur; (7) Reanalysis of the food safety plan this section and validate, as appropriate (ii) Evaluate all affected animal food (§ 507.50(d)); and to the nature of the preventive control for safety; and (8) Determination that reanalysis can and its role in the facility’s food safety (iii) Prevent the animal food from be completed, and additional preventive system, any additional preventive entering commerce, if you cannot controls validated, as appropriate to the controls needed to address the hazard ensure the affected animal food is not nature of the preventive control and its identified: adulterated under section 402 of the role in the facility’s food safety system, (1) Before any change in activities Federal Food, Drug, and Cosmetic Act; in a timeframe that exceeds the first 90 (including any change in preventive (4) Verify that temperature controls calendar days of production of the control) at the facility is operative; or, are consistently implemented by: applicable animal food. (2) When necessary to demonstrate (i) Calibrating temperature monitoring (b) A qualified auditor must conduct the control measures can be and recording devices (or checking them an onsite audit (§ 507.135(a)). implemented as designed: for accuracy); (c)(1) To be a preventive controls (i) Within 90 calendar days after (ii) Reviewing records of calibration qualified individual, the individual production of the applicable animal within a reasonable time after the must have successfully completed food first begins; or records are created; and training in the development and (ii) Within a reasonable timeframe, (iii) Reviewing records of monitoring application of risk-based preventive provided that the preventive controls and corrective actions taken to correct a controls at least equivalent to that qualified individual prepares (or problem with the control of temperature received under a standardized oversees the preparation of) a written within 7-working days after the records curriculum recognized as adequate by justification for a timeframe that are created or within a reasonable FDA or be otherwise qualified through exceeds 90 calendar days after timeframe, provided that the preventive job experience to develop and apply a production of the applicable animal controls qualified individual prepares food safety system. Job experience may food first begins. (or oversees the preparation of) a written qualify an individual to perform these (d) You must revise the written food justification for a timeframe that functions if such experience has safety plan if a significant change in the exceeds 7-working days; provided an individual with knowledge activities conducted at your facility (5) Establish and maintain the at least equivalent to that provided creates a reasonable potential for a new following records: through the standardized curriculum. hazard or a significant increase in a (i) Records (whether affirmative This individual may be, but is not previously identified hazard, or records demonstrating temperature is required to be, an employee of the document the basis for the conclusion controlled or exception records facility; and that no revisions are needed. demonstrating loss of temperature (2) To be a qualified auditor, a (e) A preventive controls qualified control) documenting the monitoring of qualified individual must have individual must perform (or oversee) the temperature controls for any such technical expertise obtained through reanalysis. refrigerated packaged animal food; education, training, or experience (or a (f) You must conduct a reanalysis of (ii) Records of corrective actions taken combination thereof) necessary to the food safety plan when FDA when there is a loss of temperature perform the auditing function. (d) All applicable training in the determines it is necessary to respond to control that may impact the safety of development and application of risk- new hazards and developments in any such refrigerated packaged animal based preventive controls must be scientific understanding. food; and documented in records, including the (iii) Records documenting the § 507.51 Modified requirements that apply date of the training, the type of training, verification activities. to a facility solely engaged in the storage and the person(s) trained. of unexposed packaged animal food. (b) The records that a facility must establish and maintain under paragraph § 507.55 Implementation records required (a) If a facility that is solely engaged (a)(5) of this section are subject to the for this subpart. in the storage of unexposed packaged requirements of subpart F of this part. animal food stores any such refrigerated (a) You must establish and maintain the following records documenting packaged animal food that requires § 507.53 Requirements applicable to a time/temperature control to preventive controls qualified individual and implementation of the food safety plan: (1) Documentation, as required by significantly minimize or prevent the a qualified auditor. § 507.36(b), of the basis for not growth of, or toxin formation by (a) One or more preventive controls establishing a preventive control in pathogens, the facility must conduct the qualified individuals must do or oversee accordance with § 507.36(a); following activities as appropriate to the following: (2) Records that document the ensure the effectiveness of the (1) Preparation of the food safety plan monitoring of preventive controls; temperature controls: (§ 507.31(b)); (3) Records that document corrective (1) Establish and implement (2) Validation of the preventive actions; temperature controls adequate to controls (§ 507.47(b)(1)); (4) Records that document significantly minimize or prevent the (3) Written justification for validation verification, including, as applicable, growth of, or toxin formation by, to be performed in a timeframe that those related to: pathogens; exceeds the first 90 calendar days of (i) Validation; (2) Monitor the temperature controls production of the applicable animal (ii) Verification of monitoring; with adequate frequency to provide food; (iii) Verification of corrective actions; assurance that the temperature controls (4) Determination that validation is (iv) Calibration of process monitoring are consistently performed; not required (§ 507.47(c)(4)); and verification instruments;

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(v) Product testing; (b) Any officer or qualified employee information for the Director of the (vi) Environmental monitoring; of FDA may issue an order to withdraw Division of Compliance in the Center for (vii) Records review; and the exemption after it has been Veterinary Medicine); and (viii) Reanalysis; approved in accordance with paragraph (i) The name and the title of the FDA (5) Records that document the supply- (a) of this section. representative who approved the order. chain program; and (c) FDA must issue an order to (6) Records that document applicable withdraw the exemption to the owner, § 507.67 Compliance with, or appeal of, an training for the preventive controls order to withdraw a qualified facility operator, or agent in charge of the exemption. qualified individual and the qualified facility. auditor. (d) FDA must issue an order to (a) If you receive an order under (b) The records that you must withdraw the exemption in writing, § 507.65 to withdraw a qualified facility establish and maintain are subject to the signed and dated by the officer or exemption, you must either: requirements of subpart F of this part. qualified employee of FDA who is (1) Comply with applicable issuing the order. requirements of this part within 120 Subpart D—Withdrawal of a Qualified calendar days of the date of receipt of Facility Exemption § 507.65 Contents of an order to withdraw the order, or within a reasonable a qualified facility exemption. § 507.60 Circumstances that may lead FDA timeframe, agreed to by FDA, based on to withdraw a qualified facility exemption. An order to withdraw a qualified a written justification, submitted to (a) FDA may withdraw a qualified facility exemption under § 507.5(d) FDA, for a timeframe that exceeds 120 facility exemption under § 507.5(d): must include the following information: calendar days from the date of receipt of (1) In the event of an active (a) The date of the order; the order; or investigation of a foodborne illness (b) The name, address, and location of (2) Appeal the order within 15 outbreak that is directly linked to the the qualified facility; calendar days of the date of receipt of qualified facility; or (c) A brief, general statement of the the order in accordance with the (2) If FDA determines that it is reasons for the order, including requirements of § 507.69. necessary to protect the public (human information relevant to one or both of (b) Submission of an appeal, or animal) health and prevent or the following circumstances that leads including submission of a request for an mitigate a foodborne illness outbreak FDA to issue the order: informal hearing, will not operate to based on conditions or conduct (1) An active investigation of a delay or stay any administrative action, associated with the qualified facility foodborne illness outbreak that is including enforcement action by FDA, that are material to the safety of the directly linked to the facility; or unless the Commissioner of Food and animal food manufactured, processed, (2) Conditions or conduct associated Drugs, as a matter of discretion, packed, or held at such facility. with a qualified facility that are material determines that delay or a stay is in the (b) Before FDA issues an order to to the safety of the animal food public interest. withdraw a qualified facility exemption, manufactured, processed, packed, or (c) If you appeal the order, and FDA FDA: held at such facility. confirms the order: (1) May consider one or more other (d) A statement that the facility must (1) You must comply with applicable actions to protect the public (human or either: requirements of this part within 120 animal) health or mitigate a foodborne (1) Comply with subparts C and E of calendar days of the date of receipt of illness outbreak, including, a warning this part on the date that is 120 calendar the order, or within a reasonable letter, recall, administrative detention, days after the date of receipt of the order timeframe, agreed to by FDA, based on suspension of registration, refusal of or within a reasonable timeframe, a written justification, submitted to animal food offered for import, seizure, agreed to by FDA, based on a written FDA, for a timeframe that exceeds 120 and injunction; justification, submitted to FDA, for a calendar days from the date of receipt of (2) Must notify the owner, operator, or timeframe that exceeds 120 calendar the order; and agent in charge of the facility, in writing days from the date of receipt of the (2) You are no longer subject to the of circumstances that may lead FDA to order; or requirements in § 507.7. withdraw the exemption, and provide (2) Appeal the order within 15 calendar days of the date of receipt of § 507.69 Procedure for submitting an an opportunity for the owner, operator, appeal. or agent in charge of the facility to the order in accordance with the respond in writing, within 15 calendar requirements of § 507.69. (a) To appeal an order to withdraw a days of the date of receipt of the (e) A statement that a facility may qualified facility exemption, you must: notification, to FDA’s notification; and request that FDA reinstate an exemption (1) Submit the appeal in writing to the (3) Must consider the actions taken by that was withdrawn by following the FDA District Director in whose district the facility to address the circumstances procedures in § 507.85. the facility is located (or, in the case of that may lead FDA to withdraw the (f) The text of section 418(l) of the a foreign facility, the Director of the exemption. Federal Food, Drug, and Cosmetic Act Division of Compliance in the Center for and of this subpart; Veterinary Medicine), at the mailing § 507.62 Issuance of an order to withdraw (g) A statement that any informal address, email address, or facsimile a qualified facility exemption. hearing on an appeal of the order must number identified in the order within (a) An FDA District Director in whose be conducted as a regulatory hearing 15 calendar days of the date of receipt district the qualified facility is located under part 16 of this chapter, with of confirmation of the order; (or, in the case of a foreign facility, the certain exceptions described in § 507.73; (2) Respond with particularity to the Director of the Division of Compliance (h) The mailing address, telephone facts and issues contained in the order, in the Center for Veterinary Medicine), number, email address, and facsimile including any supporting or an FDA official senior to either such number of the FDA district office and documentation upon which you rely. Director, must approve an order to the name of the FDA District Director in (b) In a written appeal of the order withdraw the exemption before the whose district the facility is located (or, withdrawing an exemption provided order is issued. in the case of a foreign facility, the same under § 507.5(d), you may include a

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written request for an informal hearing whenever credibility is a material issue, (2) If FDA denies the request for a as provided in § 507.71. and must include a proposed decision, hearing, the presiding officer must issue with a statement of reasons. The hearing a final decision on the appeal § 507.71 Procedure for requesting an participant may review and comment on confirming or revoking the withdrawal informal hearing. the presiding officer’s report within 2 within 10 calendar days after the date (a) If you appeal the order, you: calendar days of issuance of the report. the appeal is filed. (1) May request an informal hearing; The presiding officer will then issue the and final decision. § 507.80 Revocation of an order to withdraw a qualified facility exemption. (2) Must submit any request for an (5) Section 16.80(a)(4) of this chapter informal hearing together with your does not apply to a regulatory hearing An order to withdraw a qualified written appeal submitted in accordance under this subpart. The presiding facility exemption is revoked if: with § 507.69 within 15 calendar days of officer’s report of the hearing and any (a) You appeal the order and request the date of receipt of the order. comments on the report by the hearing an informal hearing, FDA grants the (b) A request for an informal hearing participant under paragraph (c)(4) of request for an informal hearing, and the may be denied, in whole or in part, if this section are part of the presiding officer does not confirm the the presiding officer determines that no administrative record. order within the 10 calendar days after genuine and substantial issue of (6) No party shall have the right, the hearing, or issues a decision material fact has been raised by the under § 16.119 of this chapter to revoking the order within that time; or material submitted. If the presiding petition the Commissioner of Food and (b) You appeal the order and request officer determines that a hearing is not Drugs for reconsideration or a stay of the an informal hearing, FDA denies the justified, written notice of the presiding officer’s final decision. request for an informal hearing, and determination will be given to you (7) If FDA grants a request for an FDA does not confirm the order within explaining the reason for the denial. informal hearing on an appeal of an the 10 calendar days after the appeal is filed, or issues a decision revoking the § 507.73 Requirements applicable to an order withdrawing an exemption, the informal hearing. hearing must be conducted as a order within that time; or regulatory hearing under a regulation in (c) You appeal the order without If you request an informal hearing, requesting an informal hearing, and and FDA grants the request: accordance with part 16 of this chapter, except that § 16.95(b) does not apply to FDA does not confirm the order within (a) The hearing will be held within 15 the 10 calendar days after the appeal is calendar days after the date the appeal a hearing under this subpart. With respect to a regulatory hearing under filed, or issues a decision revoking the is filed or, if applicable, within a order within that time. timeframe agreed upon in writing by this subpart, the administrative record you and FDA. of the hearing specified in §§ 16.80(a)(1) § 507.83 Final agency action. (b) The presiding officer may require through (3), and (a)(5), of this chapter, and 507.73(c)(5) constitutes the Confirmation of a withdrawal order that a hearing conducted under this by the presiding officer is considered a subpart be completed within 1 calendar exclusive record for the presiding officer’s final decision. For purposes of final agency action for purposes of 5 day, as appropriate. U.S.C. 702. (c) FDA must conduct the hearing in judicial review under § 10.45 of this accordance with part 16 of this chapter, chapter, the record of the administrative § 507.85 Reinstatement of a qualified except that: proceeding consists of the record of the facility exemption that was withdrawn. (1) The order withdrawing an hearing and the presiding officer’s final (a) If the FDA District Director in exemption under §§ 507.62 and 507.65, decision. whose district your facility is located rather than the notice under § 16.22(a) § 507.75 Presiding officer for an appeal (or, in the case of a foreign facility, the of this chapter, provides notice of and for an informal hearing. Director of the Division of Compliance opportunity for a hearing under this The presiding officer for an appeal, in the Center for Veterinary Medicine) section and is part of the administrative and for an informal hearing, must be an determines that a facility has adequately record of the regulatory hearing under FDA Regional Food and Drug Director resolved any problems with the § 16.80(a) of this chapter. or another FDA official senior to an FDA conditions and conduct that are material (2) A request for a hearing under this District Director. to the safety of the animal food subpart must be addressed to the FDA manufactured, processed, packed, or District Director (or, in the case of a § 507.77 Timeframe for issuing a decision held at the facility and that continued foreign facility, the Director of the on an appeal. withdrawal of the exemption is not Division of Compliance in the Center for (a) If you appeal the order without necessary to protect public (human and Veterinary Medicine) as provided in the requesting a hearing, the presiding animal) health and prevent or mitigate order withdrawing an exemption. officer must issue a written report that a foodborne illness outbreak, the FDA (3) Section 507.75, rather than includes a final decision confirming or District Director in whose district your § 16.42(a) of this chapter, describes the revoking the withdrawal by the 10th facility is located (or, in the case of a FDA employees who preside at hearings calendar day after the appeal is filed. foreign facility, the Director of the under this subpart. (b) If you appeal the order and request Division of Compliance in the Center for (4) Section 16.60(e) and (f) of this an informal hearing: Veterinary Medicine) will, on his own chapter does not apply to a hearing (1) If FDA grants the request for a initiative or on the request of a facility, under this subpart. The presiding officer hearing and the hearing is held, the reinstate the exemption. must prepare a written report of the presiding officer must provide a 2 (b) You may ask FDA to reinstate an hearing. All written material presented calendar day opportunity for the hearing exemption that has been withdrawn at the hearing will be attached to the participants to review and submit under the procedures of this subpart as report. The presiding officer must comments on the report of the hearing follows: include as part of the report of the under § 507.73(c)(4), and must issue a (1) Submit a request, in writing, to the hearing a finding on the credibility of final decision within 10 calendar days FDA District Director in whose district witnesses (other than expert witnesses) after the hearing is held; or your facility is located (or, in the case

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of a foreign facility, the Director of the (ii) Is labeled with the statement (4) Other appropriate supplier Division of Compliance in the Center for ‘‘Animal food for research or evaluation verification activities based on supplier Veterinary Medicine); and use’’; performance and the risk associated (2) Present data and information to (iii) Is supplied in a small quantity with the raw material or other demonstrate that you have adequately that is consistent with a research, ingredient. resolved any problems with the analysis, or quality assurance purpose, (c) The supply-chain program must conditions and conduct that are material the animal food is used only for this provide assurance that a hazard to the safety of the animal food purpose, and any unused quantity is requiring a supply-chain-applied manufactured, processed, packed, or properly disposed of; and control has been significantly held at your facility, such that (iv) Is accompanied with documents, minimized or prevented. continued withdrawal of the exemption in accordance with the practice of the (d)(1) Except as provided by is not necessary to protect public trade, stating that the animal food will paragraph (d)(2) of this section, in (human and animal) health and prevent be used for research or evaluation approving suppliers and determining or mitigate a foodborne illness outbreak. purposes and cannot be sold or the appropriate supplier verification (c) If your exemption was withdrawn distributed to the public. activities and the frequency with which under § 507.60(a)(1) and FDA later (b) The supply-chain program must be they are conducted, the following must determines, after finishing the active written. be considered: (c) When a supply-chain-applied investigation of a foodborne illness (i) The hazard analysis of the animal control is applied by an entity other outbreak, that the outbreak is not food, including the nature of the hazard than the receiving facility’s supplier directly linked to your facility, FDA will controlled before receipt of the raw (e.g., when a non-supplier applies reinstate your exemption under material or other ingredient, applicable controls to certain produce (i.e., § 507.5(d), and FDA will notify you in to the raw material and other writing that your exempt status has been produce covered by part 112 of this chapter), because growing, harvesting, ingredients; reinstated. (ii) The entity or entities that will be (d) If your exemption was withdrawn and packing activities are under different management), the receiving applying controls for the hazards under both § 507.60(a)(1) and (2) and requiring a supply-chain-applied FDA later determines, after finishing the facility must: (1) Verify the supply-chain-applied control; active investigation of a foodborne control; or (iii) Supplier performance, including: illness outbreak, that the outbreak is not (2) Obtain documentation of an (A) The supplier’s procedures, directly linked to your facility, FDA will appropriate verification activity from processes, and practices related to the inform you of this finding and you may another entity, review and assess the safety of the raw material and other ask FDA to reinstate your exemption entity’s applicable documentation, and ingredients; under § 507.5(d) in accordance with the document that review and assessment. (B) Applicable FDA food safety requirements of paragraph (b) of this regulations and information relevant to section. § 507.110 General requirements applicable the supplier’s compliance with those to a supply-chain program. regulations, including an FDA warning Subpart E—Supply-Chain Program (a) The supply-chain program must letter or import alert relating to the § 507.105 Requirement to establish and include: safety of animal food and other FDA implement a supply-chain program. (1) Using approved suppliers as compliance actions related to animal required by § 507.120; (a)(1) Except as provided by food safety (or, when applicable, (2) Determining appropriate supplier relevant laws and regulations of a paragraphs (a)(2) and (3) of this section, verification activities (including the receiving facility must establish and country whose food safety system FDA determining the frequency of has officially recognized as comparable implement a risk-based supply-chain conducting the activity) as required by program for those raw materials and or has determined to be equivalent to § 507.125; that of the United States, and other ingredients for which the (3) Conducting supplier verification information relevant to the supplier’s receiving facility has identified a hazard activities as required by §§ 507.130 and compliance with those laws and requiring a supply-chain-applied 507.135; regulations); and control. (4) Documenting supplier verification (2) A receiving facility that is an activities as required by § 507.175; and (C) The supplier’s food safety history importer, is in compliance with the (5) When applicable, verifying a relevant to the raw materials or other foreign supplier verification supply-chain-applied control applied by ingredients that the receiving facility requirements under part 1, subpart L of an entity other than the receiving receives from the supplier, including this chapter, and has documentation of facility’s supplier and documenting that available information about results from verification activities conducted under verification as required by § 507.175, or testing raw materials or other § 1.506(e) of this chapter (which obtaining documentation of an ingredients for hazards, audit results provides assurance that the hazards appropriate verification activity from relating to the safety of the animal food, requiring a supply-chain-applied another entity, reviewing and assessing and responsiveness of the supplier in control for the raw material or other that documentation, and documenting correcting problems; and ingredient have been significantly the review and assessment as required (iv) Any other factors as appropriate minimized or prevented) need not by § 507.175. and necessary, such as storage and conduct supplier verification activities (b) The following are appropriate transportation practices. for that raw material or other ingredient. supplier verification activities for raw (2) Considering supplier performance (3) The requirements in this subpart materials and other ingredients: can be limited to the supplier’s do not apply to animal food that is (1) Onsite audits; compliance history as required by supplied for research or evaluation use, (2) Sampling and testing of the raw paragraph (d)(1)(iii)(B) of this section, if provided that such animal food: material or other ingredient; the supplier is: (i) Is not intended for retail sale and (3) Review of the supplier’s relevant (i) A qualified facility as defined by is not sold or distributed to the public; food safety records; and § 507.3;

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(ii) A farm that grows produce and is of the following as a supplier (b)(1) Except as provided by not a covered farm under part 112 of verification activity: paragraph (b)(2) of this section, when a this chapter in accordance with (1) A determination by its supplier of hazard in a raw material or other § 112.4(a), or in accordance with the appropriate supplier verification ingredient will be controlled by the §§ 112.4(b) and 112.5; or activities for that supplier; supplier and is one for which there is (iii) A shell egg producer that is not (2) An audit conducted by its a reasonable probability that exposure to subject to the requirements of part 118 supplier; the hazard will result in serious adverse of this chapter because it has less than (3) A review by its supplier of that health consequences or death to humans 3,000 laying hens. supplier’s own relevant food safety or animals: (e) If the owner, operator, or agent in records; or (i) The appropriate supplier charge of a receiving facility determines (4) The conduct by its supplier of verification activity is an onsite audit of through auditing, verification testing, other appropriate supplier verification the supplier; and document review, relevant consumer, activities for that supplier within the (ii) The audit must be conducted customer, or other complaints, or meaning of § 507.110(b)(4). before using the raw material or other otherwise that the supplier is not (c) The requirements of this section ingredient from the supplier and at least controlling hazards that the receiving do not prohibit a receiving facility from annually thereafter. facility has identified as requiring a relying on an audit provided by its (2) The requirements of paragraph supply-chain-applied control, the supplier when the audit of the supplier (b)(1) of this section do not apply if receiving facility must take and was conducted by a third-party there is a written determination that document prompt action in accordance qualified auditor in accordance with other verification activities and/or less with § 507.42 to ensure that raw §§ 507.130(f) and 507.135. frequent onsite auditing of the supplier materials or other ingredients from the § 507.120 Using approved suppliers. provide adequate assurance that the supplier do not cause animal food that (a) The receiving facility must hazards are controlled. is manufactured or processed by the approve suppliers in accordance with (c) If a supplier is a qualified facility receiving facility to be adulterated the requirements of § 507.110(d), and as defined by § 507.3, the receiving under section 402 of the Federal Food, document that approval, before facility does not need to comply with Drug, and Cosmetic Act. receiving raw materials and other paragraphs (a) and (b) of this section if § 507.115 Responsibilities of the receiving ingredients received from those the receiving facility: facility. suppliers; (1) Obtains written assurance that the supplier is a qualified facility as defined (a)(1) The receiving facility must (b)(1) Written procedures for receiving by § 507.3: approve suppliers. raw materials and other ingredients (2) Except as provided by paragraphs must be established and followed; (i) Before first approving the supplier (a)(3) and (4) of this section, the (2) The written procedures for for an applicable calendar year; and receiving facility must determine and receiving raw materials and other (ii) On an annual basis thereafter, by conduct appropriate supplier ingredients must ensure that raw December 31 of each calendar year, for verification activities, and satisfy all materials and other ingredients are the following calendar year; and documentation requirements of this received only from approved suppliers (2) Obtains written assurance, at least subpart. (or, when necessary and appropriate, on every 2 years, that the supplier is (3) An entity other than the receiving a temporary basis from unapproved producing the raw material or other facility may do any of the following, suppliers whose raw materials or other ingredient in compliance with provided that the receiving facility ingredients are subjected to adequate applicable FDA food safety regulations reviews and assesses the entity’s verification activities before acceptance (or, when applicable, relevant laws and applicable documentation, and for use); and regulations of a country whose food documents that review and assessment: (3) Use of the written procedures for safety system FDA has officially (i) Establish written procedures for receiving raw materials and other recognized as comparable or has receiving raw materials and other ingredients must be documented. determined to be equivalent to that of ingredients by the entity; the United States). The written § 507.125 Determining appropriate assurance must include either: (ii) Document that written procedures supplier verification activities (including for receiving raw materials and other determining the frequency of conducting (i) A brief description of the ingredients are being followed by the the activity). preventive controls that the supplier is implementing to control the applicable entity; and Appropriate supplier verification hazard in the animal food; or (iii) Determine, conduct, or both activities (including the frequency of (ii) A statement that the facility is in determine and conduct, the appropriate conducting the activity) must be compliance with State, local, county, supplier verification activities, with determined in accordance with the tribal or other applicable non-Federal appropriate documentation. requirements of § 507.110(d). (4) The supplier may conduct and food safety laws, including relevant document sampling and testing of raw § 507.130 Conducting supplier verification laws and regulations of foreign counties. materials and other ingredients, for the activities for raw materials and other (d) If a supplier is a farm that grows hazard controlled by the supplier, as a ingredients. produce and is not a covered farm under supplier verification activity for a (a) Except as provided by paragraphs part 112 of this chapter in accordance particular lot of product and provide (c), (d), or (e) of this section, one or with § 112.4(a), or in accordance with such documentation to the receiving more of the supplier verification §§ 112.4(b) and 112.5, the receiving facility, provided that the receiving activities specified in § 507.110(b), as facility does not need to comply with facility reviews and assesses that determined under § 507.110(d), must be paragraphs (a) and (b) of this section for documentation, and documents that conducted for each supplier before produce that the receiving facility review and assessment. using the raw material or other receives from the farm as a raw material (b) For the purposes of this subpart, ingredient from that supplier and or other ingredient if the receiving a receiving facility may not accept any periodically thereafter. facility:

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(1) Obtains written assurance that the implementation, for the hazard being activities conducted under § 1.506(e) of raw material or other ingredient controlled (or, when applicable, an this chapter; provided by the supplier is not subject onsite audit may consider relevant laws (3) Documentation of the approval of to part 112 of this chapter in accordance and regulations of a country whose food a supplier; with § 112.4(a), or in accordance with safety system FDA has officially (4) Written procedures for receiving §§ 112.4(b) and 112.5: recognized as comparable or has raw materials and other ingredients; (i) Before first approving the supplier determined to be equivalent to that of (5) Documentation demonstrating use for an applicable calendar year; and the United States). of the written procedures for receiving (ii) On an annual basis thereafter, by (c)(1) The following may be raw materials and other ingredients; December 31 of each calendar year, for substituted for an onsite audit, provided (6) Documentation of the the following calendar year; and that the inspection was conducted determination of the appropriate (2) Obtains written assurance, at least within 1 year of the date that the onsite supplier verification activities for raw every 2 years, that the farm audit would have been required to be materials and other ingredients; acknowledges that its food is subject to conducted: (7) Documentation of the conduct of section 402 of the Federal Food, Drug, (i) The written results of an an onsite audit. This documentation and Cosmetic Act (or, when applicable, appropriate inspection of the supplier must include: that its food is subject to relevant laws for compliance with applicable FDA (i) The name of the supplier subject to and regulations of a country whose food food safety regulations by FDA, by the onsite audit; safety system FDA has officially representatives of other Federal (ii) Documentation of audit recognized as comparable or has Agencies (such as the United States procedures; determined to be equivalent to that of Department of Agriculture), or by (iii) The dates the audit was the United States). representatives of State, local, tribal, or conducted; (e) If a supplier is a shell egg producer territorial agencies; or (iv) The conclusions of the audit; that is not subject to the requirements of (ii) For a foreign supplier, the written (v) Corrective actions taken in part 118 of this chapter because it has results of an inspection by FDA or the response to significant deficiencies less than 3,000 laying hens, the food safety authority of a country whose identified during the audit; and receiving facility does not need to food safety system FDA has officially (vi) Documentation that the audit was comply with paragraphs (a) and (b) of recognized as comparable or has conducted by a qualified auditor; this section if the receiving facility: determined to be equivalent to that of (8) Documentation of sampling and (1) Obtains written assurance that the the United States. testing conducted as a supplier shell eggs produced by the supplier are (2) For inspections conducted by the verification activity. This not subject to part 118 because the shell food safety authority of a country whose documentation must include: egg producer has less than 3,000 laying food safety system FDA has officially (i) Identification of the raw material or hens: recognized as comparable or determined other ingredient tested (including lot (i) Before first approving the supplier to be equivalent, the animal food that is number, as appropriate) and the number for an applicable calendar year; and the subject of the onsite audit must be of samples tested; (ii) On an annual basis thereafter, by within the scope of the official (ii) Identification of the test(s) December 31 of each calendar year, for recognition or equivalence conducted, including the analytical the following calendar year; and determination, and the foreign supplier method(s) used; (2) Obtains written assurance, at least must be in, and under the regulatory (iii) The date(s) on which the test(s) every 2 years, that the shell egg oversight of, such country. were conducted and the date of the producer acknowledges that its food is (d) If the onsite audit is solely report; subject to section 402 of the Federal conducted to meet the requirements of (iv) The results of the testing; Food, Drug, and Cosmetic Act (or, when this subpart by an audit agent of a (v) Corrective actions taken in applicable, that its food is subject to certification body that is accredited in response to detection of hazards; and relevant laws and regulations of a accordance with regulations in part 1, (vi) Information identifying the country whose food safety system FDA subpart M of this chapter, the audit is laboratory conducting the testing; has officially recognized as comparable not subject to the requirements in those (9) Documentation of the review of or has determined to be equivalent to regulations. the supplier’s relevant food safety that of the United States). records. This documentation must (f) There must not be any financial § 507.175 Records documenting the include: conflicts of interest that influence the supply-chain program. (i) The name of the supplier whose results of the verification activities (a) The records documenting the records were reviewed; listed in § 507.110(b) and payment must supply-chain program are subject to the (ii) The date(s) of review; not be related to the results of the requirements of subpart F of this part. (iii) The general nature of the records activity. (b) The receiving facility must review reviewed; the records listed in paragraph (c) of this (iv) The conclusions of the review; § 507.135 Onsite audit. section in accordance with and (a) An onsite audit of a supplier must § 507.49(a)(4). (v) Corrective actions taken in be performed by a qualified auditor. (c) The receiving facility must response to significant deficiencies (b) If the raw material or other document the following in records as identified during the review; ingredient at the supplier is subject to applicable to its supply-chain program: (10) Documentation of other one or more FDA food safety (1) The written supply-chain program; appropriate supplier verification regulations, an onsite audit must (2) Documentation that a receiving activities based on the supplier consider such regulations and include a facility that is an importer is in performance and the risk associated review of the supplier’s written plan compliance with the foreign supplier with the raw material or other (e.g., Hazard Analysis and Critical verification program requirements ingredient; Control Point (HACCP) plan or other under part 1, subpart L of this chapter, (11) Documentation of any food safety plan), if any, and its including documentation of verification determination that verification activities

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other than an onsite audit, and/or less or has determined to be equivalent to (c) All records required by this part frequent onsite auditing of a supplier, that of the United States); must be made promptly available to a provide adequate assurance that the (15) The written results of an duly authorized representative of the hazards are controlled when a hazard in appropriate inspection of the supplier Secretary of Health and Human Services a raw material or other ingredient will for compliance with applicable FDA for official review and copying upon be controlled by the supplier and is one food safety regulations by FDA, by oral or written request. for which there is a reasonable representatives of other Federal (d) The requirements of § 507.206 probability that exposure to the hazard Agencies (such as the United States apply only to the written food safety will result in serious adverse health Department of Agriculture), or by plan. consequences or death to humans or representatives from State, local, tribal, (e) The requirements of animals; or territorial agencies, or the food safety § 507.202(a)(2), (4), and (5) and (b) do (12) The following documentation of authority of another country when the not apply to the records required by an alternative verification activity for a results of such an inspection is § 507.7. substituted for an onsite audit; supplier that is a qualified facility: § 507.202 General requirements applying (i) The written assurance that the (16) Documentation of actions taken to records. supplier is a qualified facility as defined with respect to supplier non- (a) Records must: by § 507.3; and conformance; (17) Documentation of verification of (1) Be kept as original records, true (ii) The written assurance that the copies (such as photocopies, pictures, supplier is producing the raw material a supply-chain-applied control applied by an entity other than the receiving scanned copies, microfilm, microfiche, or other ingredient in compliance with or other accurate reproductions of the applicable FDA food safety regulations facility’s supplier; and (18) When applicable, documentation original records), or electronic records; (or, when applicable, relevant laws and (2) Contain the actual values and of the receiving facility’s review and regulations of a country whose food observations obtained during assessment of: safety system FDA has officially monitoring and as appropriate, during (i) Applicable documentation from an recognized as comparable or has verification activities; entity other than the receiving facility determined to be equivalent to that of (3) Be accurate, indelible, and legible; the United States); that written procedures for receiving (4) Be created concurrently with (13) The following documentation of raw materials and other ingredients are performance of the activity documented; an alternative verification activity for a being followed; and supplier that is a farm that supplies a (ii) Applicable documentation, from (5) Be as detailed as necessary to raw material or other ingredient and is an entity other than the receiving provide history of work performed. not a covered farm under part 112 of facility, of the determination of the (b) All records must include: this chapter: appropriate supplier verification (1) Information adequate to identify (i) The written assurance that supplier activities for raw materials and other the plant or facility (e.g., the name, and is not a covered farm under part 112 of ingredients; when necessary, the location of the this chapter in accordance with (iii) Applicable documentation, from plant or facility); § 112.4(a), or in accordance with an entity other than the receiving (2) The date and, when appropriate, §§ 112.4(b) and 112.5; and facility, of conducting the appropriate the time of the activity documented; (ii) The written assurance that the supplier verification activities for raw (3) The signature or initials of the farm acknowledges that its food is materials and other ingredients; person performing the activity; and subject to section 402 of the Federal (iv) Applicable documentation, from (4) Where appropriate, the identity of Food, Drug, and Cosmetic Act (or, when its supplier, of: the product and the lot code, if any. applicable, that its food is subject to (A) The results of sampling and (c) Records that are established or relevant laws and regulations of a testing conducted by the supplier; or maintained to satisfy the requirements country whose food safety system FDA (B) The results of an audit conducted of this part and that meet the definition has officially recognized as comparable by a third-party qualified auditor in of electronic records in § 11.3(b)(6) of or has determined to be equivalent to accordance with §§ 507.130(f) and this chapter are exempt from the that of the United States); 507.135; and requirements of part 11 of this chapter. (14) The following documentation of (v) Applicable documentation, from Records that satisfy the requirements of an alternative verification activity for a an entity other than the receiving this part, but that also are required supplier that is a shell egg producer that facility, of verification activities when a under other applicable statutory is not subject to the requirements supply-chain-applied control is applied provisions or regulations, remain established in part 118 of this chapter by an entity other than the receiving subject to part 11 of this chapter. facility’s supplier. because it has less than 3,000 laying § 507.206 Additional requirements hens: Subpart F—Requirements Applying to applying to the food safety plan. (i) The written assurance that the Records That Must Be Established and The owner, operator, or agent in shell eggs provided by the supplier are Maintained charge of the facility must sign and date not subject to part 118 of this chapter the food safety plan upon initial § 507.200 Records subject to the because the supplier has less than 3,000 completion and upon any modification. laying hens; and requirements of this subpart. (ii) The written assurance that the (a) Except as provided by paragraphs § 507.208 Requirements for record shell egg producer acknowledges that its (d) and (e) of this section, all records retention. food is subject to section 402 of the required by this part are subject to all (a)(1) All records required by this part Federal Food, Drug, and Cosmetic Act requirements of this subpart. must be retained at the plant or facility (or, when applicable, that its food is (b) Records obtained by FDA in for at least 2 years after the date they subject to relevant laws and regulations accordance with this part are subject to were prepared. of a country whose safety system FDA the disclosure requirements under part (2) Records that a facility relies on has officially recognized as comparable 20 of this chapter. during the 3-year period preceding the

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applicable calendar year to support its State, or local regulations, or for any assumes legal responsibility to act status as a qualified facility must be other reason) do not need to be consistently with the assurance and retained at the facility as long as duplicated if they contain all of the document its actions taken to satisfy the necessary to support the status of a required information and satisfy the written assurance; and facility as a qualified facility during the requirements of this subpart. Existing (2) Provision that if the assurance is applicable calendar year. records may be supplemented as terminated in writing by either entity, (b) Records that relate to the general necessary to include all of the required responsibility for compliance with the adequacy of the equipment or processes information and satisfy the applicable provisions of this part reverts being used by a facility, including the requirements of this subpart. to the manufacturer/processor as of the results of scientific studies and (b) The information required by this date of termination. evaluations, must be retained by the part does not need to be kept in one set facility for at least 2 years after their use of records. If existing records contain PART 579—IRRADIATION IN THE is discontinued (e.g., because the facility some of the required information, any PRODUCTION, PROCESSING, AND has updated the written food safety plan new information required by this part HANDLING OF ANIMAL FEED AND (§ 507.31) or records that document may be kept either separately or PET FOOD validation of the written food safety combined with the existing records. plan (§ 507.45(b))). ■ 10. The authority citation for 21 CFR (c) Except for the food safety plan, § 507.215 Special requirements applicable part 579 continues to read as follows: to a written assurance. offsite storage of records is permitted if Authority: 21 U.S.C. 321, 342, 343, 348, such records can be retrieved and (a) Any written assurance required by 371. this part must contain the following provided onsite within 24 hours of ■ 11. In § 579.12, add the following elements: request for official review. The food sentence to the end of the paragraph to (1) Effective date; safety plan must remain onsite. read as follows: Electronic records are considered to be (2) Printed names and signatures of onsite if they are accessible from an authorized officials; § 579.12 Incorporation of regulations in onsite location. (3) The applicable assurance under: part 179. (d) If the plant or facility is closed for (i) § 507.36(a)(2); * * * Any facility that treats animal a prolonged period, the food safety plan (ii) § 507.36(a)(3); feed and pet food with ionizing may be transferred to some other (iii) § 507.36(a)(4); radiation must comply with the reasonably accessible location but must (iv) § 507.130(c)(2); requirements of part 507 of this chapter be returned to the plant or facility (v) § 507.130(d)(2); or and other applicable regulations. (vi) § 507.130(e)(2). within 24 hours for official review upon Dated:August 31, 2015. request. (b) A written assurance required under § 507.36(a)(2), (3) or (4) must Leslie Kux, § 507.212 Use of existing records. include: Associate Commissioner for Policy. (a) Existing records (e.g., records that (1) Acknowledgement that the facility [FR Doc. 2015–21921 Filed 9–10–15; 8:45 am] are kept to comply with other Federal, that provides the written assurance BILLING CODE 4164–01–P

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