[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)] [Rules and Regulations] [Pages 55908-56168] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2015-21920] [[Page 55907]] Vol. 80 Thursday, No. 180 September 17, 2015 Part II Department of Health and Human Services ----------------------------------------------------------------------- Food and Drug Administration ----------------------------------------------------------------------- 21 CFR Parts 1, 11, 16, 106, 110, et al. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule Federal Register / Vol. 80 , No. 180 / Thursday, September 17, 2015 / Rules and Regulations [[Page 55908]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA-2011-N-0920] Current Good Manufacturing Practice, Hazard Analysis, and Risk- Based Preventive Controls for Human Food AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk- based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for ``farms'' and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system. DATES: This rule is effective November 16, 2015, except for the amendment to part 110 in instruction 13, which is effective September 17, 2018 and paragraph (2) of the definition of ``qualified auditor'' in Sec. 117.3, and Sec. Sec. 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) and 117.475(c)(13). FDA will publish a document in the Federal Register announcing the effective dates of paragraph (2) of the definition of ``qualified auditor'' in Sec. 117.3, and Sec. Sec. 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 117.475(c)(13). See section LVI for the compliance dates. FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Rule Summary of the Major Provisions of the Rule Costs and Benefits I. Background A. FDA Food Safety Modernization Act B. Stages in the Rulemaking for the Human Preventive Controls Rule C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule D. Draft Risk Assessment E. Definition of ``Retail Food Establishment'' F. Public Comments II. Legal Authority A. Changes to Current 21 CFR Part 1, Subparts H, I, and J B. Changes to Current 21 CFR Part 110 C. Hazard Analysis and Risk-Based Preventive Controls D. Comments on Legal Authority III. General Comments on the Proposed Rule IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J) A. Definitions That Impact a Determination of Whether an Establishment Is a ``Farm'' B. Proposed Revisions to the Definition of Farm C. Proposed New Definition of Harvesting D. Proposed Revision to the Definition of Holding E. Proposed Revision to the Definition of Manufacturing/ Processing F. Proposed New Definition of Mixed-Type Facility G. Proposed Revision to the Definition of Packing V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities A. Section 103(c)(1)(C) of FSMA B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-Type Facilities Under Section 421 of the FD&C Act VII. Comments on Proposed General Revisions to Current Part 110 (Final Part 117) A. Title of Part 117 B. Proposed Revisions for Consistency of Terms C. Proposed Additions Regarding Allergen Cross-Contact D. Proposed Revisions for Consistency With the Definition of ``Food'' E. Proposed Revisions To Address Guidance in Current Part 110 F. Proposed Editorial Changes G. General Comments on Current Part 110 (Final Part 117) VIII. Subpart A: Comments on Proposed Sec. 117.1--Applicability and Status A. Comments on Proposed Sec. 117.1(a)--Applicability B. Comments on Proposed Sec. 117.1(b)--Prohibited Act C. Comments on Proposed Sec. 117.1(c)--Specific CGMP Requirements IX. Subpart A: Comments on Proposed Sec. 117.3--Definitions A. Redesignation B. Definitions in Current Part 110 That We Proposed To Delete C. Definitions That We Proposed To Establish in Part 117 D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food (Final Sec. 117.4(a), (b), and (d)) B. Additional Requirements Applicable to Supervisory Personnel (Final Sec. 117.4(c)) XI. Subpart A: Comments on Proposed Sec. 117.5--Exemptions A. General Comments on the Proposed Exemptions B. Proposed Sec. 117.5(a)--Exemption Applicable to a Qualified Facility C. Proposed Sec. 117.5(b) and (c)--Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products (21 CFR Part 123) or for Juice (21 CFR Part 120) D. Proposed Sec. 117.5(d)--Exemption Applicable to Food Subject to Part 113--Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers E. Proposed Sec. 117.5(e)--Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement F. Proposed Sec. 117.5(f)--Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act G. Proposed Sec. Sec. 117.5(g) and (h)--Exemptions Applicable to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business H. Proposed Sec. 117.5(i)--Exemption Related to Alcoholic Beverages I. Proposed Sec. 117.5(j)--Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and [[Page 55909]] Vegetables Intended for Further Distribution or Processing J. Proposed Sec. 117.5(k)--Exemption Applicable to Farms, Fishing Vessels, Activities of ``Farm Mixed-Type Facilities'' Within the Definition of ``Farm,'' the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities K. Comments Requesting Additional Exemptions XII. Subpart A: Comments on Proposed Sec. 117.7--Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food XIII. Subpart B: Comments on Proposed Sec. 117.10--Personnel A. Management Responsibility for Requirements Applicable to Personnel B. Proposed Sec. 117.10(a)--Disease Control C. Proposed Sec. 117.10(b)--Cleanliness XIV. Subpart B: Comments on Proposed Sec. 117.20--Plant and Grounds A. Proposed Sec. 117.20(a)--Grounds B. Proposed Sec. 117.20(b)--Plant Construction and Design XV. Subpart B: Comments on Proposed Sec. 117.35--Sanitary Operations A. Proposed Sec. 117.35(a)--General Maintenance B. Proposed Sec. 117.35(b)--Substances Used in Cleaning and Sanitizing; Storage of Toxic Materials C. Proposed Sec. 117.35(c)--Pest Control D. Proposed Sec. 117.35(d)--Sanitation of Food-Contact Surfaces E. Proposed Sec. 117.35(d)(1)--Food-Contact Surfaces Used for Manufacturing/Processing or Holding F. Proposed Sec. 117.35(d)(2)--Wet Cleaning G. Proposed Sec. 117.35(d)(3)--Single-Service Articles H. Proposed Sec. 117.35(e)--Sanitation of Non-Food-Contact Surfaces I. Proposed Sec. 117.35(f)--Storage and Handling of Cleaned Portable Equipment and Utensils XVI. Subpart B: Comments on Proposed Sec. 117.37--Sanitary Facilities and Controls A. Proposed Sec. 117.37(a)--Water Supply B. Proposed Sec. 117.37(b)--Plumbing C. Proposed Sec. 117.37(c)--Sewage Disposal D. Proposed Sec. 117.37(d)--Toilet Facilities E. Proposed Sec. 117.37(e)--Hand-Washing Facilities XVII. Subpart B: Comments on Proposed Sec. 117.40--Equipment and Utensils A. Proposed Sec. 117.40(a)--Design, Construction, Use, Installation, and Maintenance of Equipment and Utensils B. Proposed Sec. 117.40(b)--Seams on Food-Contact Surfaces C. Proposed Sec. 117.40(c)--Construction of Equipment D. Proposed Sec. 117.40(d)--Holding, Conveying, and Manufacturing Systems E. Proposed Sec. 117.40(e)--Freezer and Cold Storage Compartments F. Proposed Sec. 117.40(f)--Accurate and Precise Instruments and Controls G. Proposed Sec. 117.40(g)--Compressed Air or Other Gases XVIII. Subpart B: Comments on Proposed Sec. 117.80(a)--General Processes and Controls A. Proposed Sec. 117.80(a)(1)--Adequate Sanitation Principles B. Proposed Sec. 117.80(a)(2)--Quality Control Operations C. Proposed Sec. 117.80(a)(3)--Supervision of Overall Sanitation D. Proposed Sec. 117.80(a)(4)--Production Procedures E. Proposed Sec. 117.80(a)(5)--Chemical, Microbial, or Extraneous-Material Testing Procedures F. Proposed Sec. 117.80(a)(6)--Contaminated Food XIX. Subpart B: Comments on Proposed Sec. 117.80(b)--Processes and Controls for Raw Materials and Other Ingredients A. Proposed Sec. 117.80(b)(1)--Inspection, Segregation and Handling of Raw Materials and Other Ingredients B. Proposed Sec. 117.80(b)(2)--Levels of Microorganisms in Raw Materials and Other Ingredients C. Proposed Sec. 117.80(b)(3)--Natural Toxins in Raw Materials and Other Ingredients D. Proposed Sec. 117.80(b)(4)--Pests, Undesirable Microorganisms and Extraneous Materials in Raw Materials and Other Ingredients E. Proposed Sec. 117.80(b)(5)--Holding Raw Materials, Other Ingredients, and Rework in Bulk F. Proposed Sec. 117.80(b)(7)--Liquid or Dry Raw Materials and Other Ingredients G. Proposed Sec. 117.80(b)(8)--Raw Materials and Other Ingredients That Are Food Allergens XX. Subpart B: Comments on Proposed Sec. 117.80(c)--Manufacturing Operations A. Proposed Sec. 117.80(c)(1)--Condition of Equipment, Utensils, and Finished Food Containers B. Proposed Sec. 117.80(c)(2)--Conditions and Controls for Food Manufacturing, Processing, Packing, and Holding C. Proposed Sec. 117.80(c)(3)--Food That Can Support the Rapid Growth of Undesirable Microorganisms D. Proposed Sec. 117.80(c)(4)--Measures To Destroy or Prevent the Growth of Undesirable Microorganisms E. Proposed Sec. 117.80(c)(5)--Work-in-Process and Rework F. Proposed Sec. 117.80(c)(6)--Finished Food G. Proposed Sec. 117.80(c)(7)--Equipment, Containers, and Utensils H. Proposed Sec. 117.80(c)(8)--Metal or Other Extraneous Material I. Proposed Sec. 117.80(c)(9)--Disposal of Adulterated Food, Raw Materials, and Other Ingredients J. Proposed Sec. 117.80(c)(10)--Performing Manufacturing Steps K. Proposed Sec. 117.80(c)(11)--Heat Blanching and Growth and Contamination by Thermophilic Microorganisms During Manufacturing Operations L. Proposed Sec. 117.80(c)(12)--Batters, Breading, Sauces, Gravies, Dressings, and Other Similar Preparations M. Proposed Sec. 117.80(c)(13)--Filling, Assembling, Packaging and Other Operations N. Proposed Sec. 117.80(c)(14)--Food That Relies on the Control of Water Activity for Preventing the Growth of Undesirable Microorganisms O. Proposed Sec. 117.80(c)(15)--Food That Relies on the Control of pH for Preventing the Growth of Undesirable Microorganisms P. Proposed Sec. 117.80(c)(16)--Requirements for Ice Used in Contact With Food Q. Proposed Deletion of Current Sec. 110.80(b)(17)--Food- Manufacturing Areas and Equipment XXI. Subpart B: Comments on Proposed Sec. 117.93--Warehousing and Distribution XXII. Subpart B: Comments on Proposed Sec. 117.110--Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and Risk-Based Preventive Controls XXIV. Subpart C: Comments on Proposed Sec. 117.126--Food Safety Plan A. Proposed Sec. 117.126(a)(1)--Requirement for a Food Safety Plan B. Proposed Sec. 117.126(a)(2)--Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual C. Proposed Sec. 117.126(b)--Contents of a Food Safety Plan D. Proposed Sec. 117.126(c)--Records E. Comments on Potential Requirements for Submission of a Facility Profile to FDA XXV. Subpart C: Comments on Proposed Sec. 117.130--Hazard Analysis A. Proposed Sec. 117.130(a)--Requirement for a Written Hazard Analysis B. Proposed Sec. 117.130(b)--Hazard Identification C. Proposed Sec. 117.130(c)--Evaluation of Whether a Hazard Requires a Preventive Control XXVI. Subpart C: Comments on Proposed Sec. 117.135--Preventive Controls A. Proposed Sec. 117.135(a)--Requirement To Identify and Implement Preventive Controls B. Proposed Sec. 117.135(b)--Requirement for Written Preventive Controls C. Proposed Sec. 117.135(c)(1)--Process Controls D. Proposed Sec. 117.135(c)(2)--Food Allergen Controls E. Proposed Sec. 117.135(c)(3)--Sanitation Controls F. Proposed Sec. 117.135(c)(4)--Supply-Chain Controls G. Proposed Sec. 117.135(c)(5)--Recall Plan H. Proposed Sec. 117.135(c)(6)--Other Controls XXVII. Subpart C: Circumstances in Which the Owner, Operator, or Agent in Charge of a Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control (Final Sec. Sec. 117.136 and 117.137) XXVIII. Subpart C: Comments on Proposed Requirements for a Recall Plan (Final Sec. 117.139) A. Proposed Sec. 117.137(a)--Requirement for a Written Recall Plan (Final Sec. 117.139(a)) B. Proposed Sec. 117.137(b)--Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps (Final Sec. 117.139(b)) [[Page 55910]] XXIX. Comments on Proposed Sec. 117.140--Preventive Control Management Components A. Proposed Sec. 117.140(a)--Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification B. Proposed Sec. 117.140(b)--Applicability of Preventive Control Management Components to the Supply-Chain Program C. Proposed Sec. 117.140(c)--Recall Plan is Not Subject to Preventive Control Management Components XXX. Subpart C: Comments on Proposed Sec. 117.145--Monitoring A. Our Tentative Conclusion To Require Monitoring of the Performance of Preventive Controls B. Proposed Sec. 117.145(a)--Flexibility in Requirements for Monitoring C. Proposed Sec. 117.145(b)--Records XXXI. Subpart C: Comments on Proposed Sec. 117.150--Corrective Actions and Corrections A. Proposed Sec. 117.150(a)(1)--Requirement To Establish and Implement Corrective Action Procedures B. Proposed Sec. 117.150(a)(2)--Content of Corrective Action Procedures C. Proposed Sec. 117.150(b)--Corrective Action in the Event of an Unanticipated Problem D. Proposed Sec. 117.150(c)--Corrections E. Proposed Sec. 117.150(d)--Records XXXII. Subpart C: Comments on Proposed Sec. 117.155--Verification A. Flexibility in Requirements for Verification B. Proposed Sec. 117.155(a)--Verification Activities C. Proposed Sec. 117.155(b)--Documentation of Verification Activities D. Comments on Potential Requirements Regarding Complaints XXXIII. Subpart C: Comments on Proposed Sec. 117.160--Validation A. Flexibility in the Requirements To Validate Preventive Controls B. Proposed Sec. 117.160(b)(1)--When Validation Must Be Performed and Role of the Preventive Controls Qualified Individual in Validation C. Proposed Sec. 117.160(b)(2)--What Validation Must Include D. Proposed Sec. 117.160(b)(3)--Preventive Controls for Which Validation Is Not Required XXXIV. Subpart C: Comments on Proposed Sec. 117.165--Verification of Implementation and Effectiveness A. Flexibility in the Requirements To Conduct Activities To Verify Implementation and Effectiveness B. Proposed Sec. 117.165(a)(1)--Calibration C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed Sec. 117.165(a)(2) and (b)(2)) and Environmental Monitoring (Proposed Sec. 117.165(a)(3) and (b)(3)) D. Proposed Sec. 117.165(a)(2)--Product Testing E. Proposed Sec. 117.165(a)(3)--Environmental Monitoring F. Proposed Sec. 117.165(a)(4)--Review of Records G. Proposed Sec. 117.165(b)--Written Procedures XXXV. Subpart C: Comments on Proposed Sec. 117.170--Reanalysis A. Proposed Sec. 117.170(a)--Circumstances Requiring Reanalysis B. Proposed Sec. 117.170(b)--Timeframe To Complete Reanalysis C. Proposed Sec. 117.170(c)--Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed D. Proposed Sec. 117.170(d)--Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual E. Proposed Sec. 117.170(e)--Reanalysis on the Initiative of FDA XXXVI. Subpart C: Comments on Proposed Sec. 117.180--Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor A. Proposed Sec. 117.180(a) and (b)--What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee B. Proposed Sec. 117.180(c)--Qualification Requirements C. Proposed Sec. 117.180(d)--Records XXXVII. Subpart C: Comments on Proposed Sec. 117.190-- Implementation Records A. Proposed Sec. 117.190(a)--List of Required Records B. Proposed Sec. 117.190(b)--Applicability of Subpart F XXXVIII. Subpart D: Comments on Proposed Sec. 117.201--Modified Requirements That Apply to a Qualified Facility A. Comments on Submission of a Certification Statement B. General Comments on Modified Requirements That Apply to a Qualified Facility C. Proposed Sec. 117.201(a)--Documentation To Be Submitted D. Proposed Sec. 117.201(b)--Procedure for Submission E. Proposed Sec. 117.201(c)--Frequency of Determination and Submission F. Proposed Sec. 117.201(d)--Notification to Consumers (Final Sec. 117.201(e)) G. Proposed Sec. 117.201(e)--Records (Final Sec. 117.201(f)) XXXIX. Subpart D: Comments on Proposed Sec. 117.206--Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Food A. Proposed Sec. 117.206(a)--Modified Requirements for Unexposed Refrigerated Packaged Food That Requires Time/Temperature Controls B. Proposed Sec. 117.206(b)--Records XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption A. Proposed Sec. 117.251--Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption B. Proposed Sec. 117.254--Issuance of an Order To Withdraw a Qualified Facility Exemption C. Proposed Sec. 117.257--Contents of an Order To Withdraw a Qualified Facility Exemption D. Proposed Sec. 117.260--Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption E. Proposed Sec. 117.264--Procedure for Submitting an Appeal F. Proposed Sec. 117.267--Procedure for Requesting an Informal Hearing G. Proposed Sec. 117.270--Requirements Applicable to an Informal Hearing H. Proposed Sec. 117.287--Reinstatement of a Qualified Facility Exemption That Was Withdrawn I. Conforming Amendment to 21 CFR part 16 J. Other Comments on the Withdrawal Provisions XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements A. Proposed Sec. 117.301--Records Subject to the Requirements of Subpart F B. Proposed Sec. 117.305--General Requirements Applying to Records C. Proposed Sec. 117.310--Additional Requirements Applying to the Food Safety Plan D. Proposed Sec. 117.315--Requirements for Record Retention E. Proposed Sec. 117.320--Requirements for Official Review F. Proposed Sec. 117.325--Public Disclosure G. Proposed Sec. 117.330--Use of Existing Records H. Final Sec. 117.335--Special Requirements Applicable to a Written Assurance I. Other Comments on the Recordkeeping Requirements of Subpart F XLII. Subpart G: General Comments on Proposed Requirements for a Supply-Chain Program XLIII. Subpart G: Comments on Requirement To Establish and Implement a Supply-Chain Program A. Requirement for a Written Supply-Chain Program (Final Sec. 117.405(a)(1) and (b)) B. Circumstances That Do Not Require a Written Supply-Chain Program (Final Sec. 117.405(a)(2)) C. Exemption for Food Supplied for Research or Evaluation (Final Sec. 117.405(a)(3)) D. Additional Requirements for Non-Suppliers (Final Sec. 117.405(c)) E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed Sec. 117.136(a)(4) and (5)) XLIV. Subpart G: Comments on General Requirements Applicable to a Supply-Chain Program A. Description of What the Supply-Chain Program Must Include (Final Sec. 117.410(a)) B. Appropriate Supplier Verification Activities ((Final Sec. 117.410(b)) C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final Sec. 117.410(c)) D. Factors That Must Be Considered When Approving Suppliers and Determining Appropriate Supplier Verification Activities for Raw Materials and Other Ingredients (Final Sec. 117.410(d)) E. Supplier Non-Conformance (Final Sec. 117.410(e)) XLV. Subpart G: New Requirement Specifying Responsibilities of the Receiving Facility (Final Sec. 117.415) XLVI. Subpart G: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification Activities [[Page 55911]] A. Using Approved Suppliers (Final Sec. 117.420) B. Determining Appropriate Verification Activities (Final Sec. 117.425) XLVII. Subpart G: Comments on Conducting Supplier Verification Activities for Raw Materials and Other Ingredients A. Requirement to Conduct One or More Supplier Verification Activities (Final Sec. 117.430(a)) B. Requirement for an Onsite Audit as a Verification Activity When a Hazard Has a Reasonable Probability of Resulting in Serious Adverse Health Consequences or Death to Humans (Final Sec. 117.430(b)) C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final Sec. 117.430(c)) D. Alternative Verification Activity When the Supplier Is a Produce Farm That Is Not a ``Covered Farm'' for the Purposes of the Future Produce Safety Rule (Final Sec. 117.430(d)) E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final Sec. 117.430(e)) F. Independence of Persons Who Conduct Supplier Verification Activities (Final Sec. 117.430(f)) XLVIII. Subpart G: Comments on Onsite Audit A. Requirements Applicable to an Onsite Audit (Final Sec. 117.435(a) and (b)) B. Substitution of Inspection by FDA or an Officially Recognized or Equivalent Food Safety Authority C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of Section 808 of the FD&C Act XLIX. Subpart G: Comments on Records Documenting the Supply-Chain Program A. Applicability of the Recordkeeping Requirements of Subpart F (Final Sec. 117.475(a)) B. Requirement To Review Records of the Supply-Chain Program (Final Sec. 117.475(b)) C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final Sec. 117.475(c)(5)) D. Documentation of the Conduct of an Onsite Audit (Final Sec. 117.475(c)(7)) E. Documentation of Sampling and Testing (Final Sec. 117.475(c)(8)) F. Documentation of Other Appropriate Supplier Verification Activity (Final Sec. 117.475(c)(10)) G. Documentation of an Alternative Verification Activity for a Supplier That Is a Farm That Is Not a ``Covered Farm'' for the Purposes of the Future Produce Safety Rule (Final Sec. 117.475(c)(13)) L. Holding Human Food By-Products Intended for Use in Animal Food LI. Comments by Foreign Governments and Foreign Businesses LII. Editorial and Conforming Changes LIII. Comments on FSMA's Rulemaking Provisions A. Comments on Requirements in Section 418(n)(3) of the FD&C Act Regarding Content B. Comments on Requirements in Section 418(n)(5) of the FD&C Act Regarding Review of Hazard Analysis and Preventive Controls Programs in Existence on the Date of Enactment of FSMA LIV. Comments on Proposed Removal of 21 CFR part 110--Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food LV. Comments on Proposed Conforming Amendments LVI. Effective and Compliance Dates A. Effective and Compliance Dates for Part 117 B. Effective and Compliance Dates for Revisions to Part 1 C. Effective Dates for Conforming Amendments D. Delayed Effective Dates for Provisions That Refer to the Forthcoming Rules for Produce Safety and Third-Party Certification LVII. Compliance and Enforcement LVIII. Executive Order 13175 LIX. Economic Analysis of Impacts LX. Analysis of Environmental Impact LXI. Paperwork Reduction Act of 1995 LXII. Federalism LXIII. References Executive Summary Purpose and Coverage of the Rule This rule is part of FDA's implementation of the FDA Food Safety Modernization Act (FSMA), which intends to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. This rule creates certain new requirements for the production of human food by registered food facilities, and revises previous requirements, in three key ways. First, this rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk- based preventive controls for human food. In general, these requirements apply to establishments that are required to register with FDA as a food ``facility.'' This portion of the rule requires registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards, unless an exemption applies. Facilities must also monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions. Second, this rule modernizes FDA's long-standing current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food. We have updated, revised, and otherwise clarified certain requirements within the CGMP regulations, which were last updated in 1986. Third, this rule clarifies the scope of the exemption for ``farms'' in FDA's current food facility registration regulations and makes corresponding revisions to FDA's current regulations for the establishment, maintenance, and availability of records. These revisions affect who is subject to the existing regulations for registration and recordkeeping, as well as the new requirements for hazard analysis and risk-based preventive controls requirements established here. This final rule is the result of significant stakeholder engagement, beginning before the proposed rule. In response to extensive stakeholder input on the proposed rule, we revised key provisions in a supplemental notice of proposed rulemaking. After the supplemental notice of proposed rulemaking, we conducted even more outreach to the stakeholder community to ensure that the risk-based, preventive requirements in this final rule are practical and protective of public health. Summary of the Major Provisions of the Rule The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the rule establishes requirements for:A written food safety plan; Hazard analysis; Preventive controls; Monitoring; Corrective actions and corrections; Verification; Supply-chain program; Recall plan; and Associated records. We have added flexibility and clarity to these provisions in response to comments. Although there are similarities between these requirements of FSMA and the requirements of food safety systems known as Hazard Analysis and Critical Control Point (HACCP) systems, not every provision in FSMA is identical to the provisions of HACCP systems, and we have revised much of our terminology to distinguish FSMA's requirements for hazard analysis and risk-based preventive controls from HACCP requirements. A facility subject to the rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether [[Page 55912]] there are any hazards requiring preventive controls. The first step of a hazard analysis is hazard identification, which must consider known or reasonably foreseeable hazards, including biological, chemical, and physical hazards. The hazard analysis must consider hazards that may be present in the food because they occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain. We continue to believe that hazards that may be intentionally introduced for economic gain will need preventive controls in rare circumstances, usually in cases where there has been a pattern of economically motivated adulteration in the past. Economically motivated adulteration that affects product integrity or quality, for example, but not food safety, is out of the scope of this rule. A facility subject to the rule must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. The rule establishes preventive control management components (monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls. One way we have clarified the risk-based flexibility of these requirements is by clearly stating in the final rule that a facility must take into account the nature of the preventive control and the facility's food safety system when considering which activities are appropriate for that facility. We have also added flexibility and made risk-based modifications for specific preventive control management components. For example, the final rule allows flexibility for the specific records required to document monitoring of refrigeration controls during storage of a food that requires time/temperature control for safety. These records can be either affirmative records demonstrating temperature is controlled or ``exception records'' demonstrating loss of temperature control. As another example, the rule includes tailored, less burdensome requirements for corrections. A correction is defined in this rule as an action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). The final rule clarifies that corrections must be taken in a timely manner and must be recorded when appropriate, but they do not, for example, need to be included in a written plan or accompanied by a reanalysis of the written food safety plan. As a third example, the final rule provides flexibility for which verification activities must occur. In general, a facility is required to conduct verification activities, as appropriate to the nature of the preventive control and its role in the facility's food safety system, including validation, verification of monitoring, verification of corrective actions, verification of implementation and effectiveness, and reanalysis. Validation is not required for all controls. For example, the rule specifies that validation is not required for certain types of preventive controls (i.e., food allergen controls, sanitation controls, supply-chain controls, and the recall plan) and provides flexibility for the facility to not validate other preventive controls with a written justification based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility's food safety system. Product testing and environmental monitoring are listed as possible verification activities, but, like other preventive control management components in general, they are only required as appropriate to the food, facility, the nature of the preventive control, and the preventive control's role in the facility's food safety system. In many cases, neither product testing nor environmental monitoring will be appropriate. For example, there would be little or no benefit to product testing or environmental monitoring in facilities that pack or hold produce raw agricultural commodities that are rarely consumed raw, such as potatoes. A facility must reanalyze the food safety plan as a whole at least once every three years. The final rule provides the flexibility for a facility to only reanalyze the applicable portion of the food safety plan under certain other circumstances, such as when a facility becomes aware of new information about potential hazards associated with a food. The final rule also adds flexibility to the preventive controls requirements and recognizes the reality of modern distribution chains by not requiring a manufacturing/processing facility to implement a preventive control in certain circumstances when the hazard requiring a preventive control will be controlled by another entity in the distribution chain. For example, if a facility's customer (or another entity in the distribution chain) will control the hazard, then that facility can rely on its customer to provide written assurance that the identified hazard will be controlled by an entity in the distribution chain, with flexibility for how the customer provides that written assurance depending on whether the customer, or an entity subsequent to the customer, will control the hazard. We have identified four specific circumstances in which a manufacturing/processing facility can rely on another entity in the distribution chain to control a hazard, with practical solutions explained further in section XXVII. We also have provided flexibility for a facility to establish, document, and implement an alternative system that ensures adequate control, at a later distribution step, of the hazards in the food product distributed by a manufacturing/processing facility such that the facility would not need to implement a preventive control. We revised the proposed provisions for a supplier program to add flexibility, recognizing that the receiving facility and the supplier may be separated by several entities in a supply chain. We are allowing entities such as distributors, brokers, and aggregators to determine, conduct, and document appropriate supplier verification activities as a service to the receiving facility, provided that the receiving facility reviews and assesses applicable documentation provided by the other entity and documents that review and assessment. However, because the approval of suppliers is ultimately the responsibility of the receiving facility, the rule specifies that only a receiving facility can approve suppliers. To improve clarity and readability we redesignated the proposed provisions into eight distinct sections of regulatory text in a newly established subpart G (Supply-Chain Program). Each facility subject to the rule must have a recall plan for a food with a hazard requiring a preventive control. Many activities required by the final rule must be conducted (or overseen) by a preventive controls qualified individual, a new term we are coining here. A preventive controls qualified individual is a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The rule establishes several exemptions (including modified requirements in some cases) from the requirements for hazard analysis and risk-based preventive controls. All of [[Page 55913]] these exemptions are expressly authorized by FSMA. A facility that manufactures, processes, packs, or holds food and that is required to register with FDA would be required to comply with the requirements for hazard analysis and risk-based preventive controls unless it is covered by an exemption, as shown in the following table. 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 Notes risk-based preventive controls ------------------------------------------------------------------------ ``Qualified Facility'' as defined by Modified requirements apply-- FSMA: i.e., a qualified facility is Business with average annual required to: sales of <$500,000 and at least half Notify FDA about its the sales to consumers or local status; and retailers or restaurants (within the Either: same state or within 275 miles); or. [cir] Notify FDA that it is Very small business, which the addressing hazards through rule defines as a business (including preventive controls and any subsidiaries and affiliates) monitoring; or averaging less than $1,000,000, [cir] Notify FDA that it adjusted for inflation, per year, complies with applicable non- during the 3-year period preceding the Federal food safety applicable calendar year in sales of regulations, and notify human food plus the market value of consumers of the name and human food manufactured, processed, complete business address of packed, or held without sale (e.g., the facility where the food held for a fee). was manufactured or processed. The notification is in the form of an attestation, and must be submitted every two years, during the same timeframe as the facility is required to update its facility registration. Low-risk, on-farm activities Small and very small on-farm performed by small business (<500 full- businesses conducting only the time equivalent employees). specified low-risk activities -or-................................... are exempt from the Low-risk, on-farm activities requirements for hazard performed by a very small business analysis and risk-based (dollar threshold of $1,000,000, as preventive controls. described previously). We define the low-risk, on-farm activities that qualify for the exemption, including the specific foods to which they relate (such as making jams, jellies, and preserves from acid fruits, and making milled grain products such as cornmeal). Activities that are subject to the The facility must be in seafood HACCP requirements of part 123 compliance with part 123. (21 CFR part 123). Activities that are subject to the The facility must be in juice HACCP requirements of part 120 compliance with part 120. (21 CFR part 120). Activities that are subject to the The exemption applies ``low-acid canned food'' requirements only with respect to of part 113 (21 CFR part 113). microbiological hazards regulated under part 113. The facility must be in compliance with part 113. The manufacturing, processing, The facility must be packaging, or holding of a dietary in compliance with part 111. supplement that is subject to the CGMP The facility must be requirements of part 111 (21 CFR part in compliance with 111). requirements for serious adverse event reporting for dietary supplements. Activities of a facility that are These activities will be subject to section 419 of the Federal established in FDA's Food, Drug, and Cosmetic Act forthcoming rule for produce (Standards for Produce Safety). safety. Alcoholic beverages at a facility that The exemption also applies to is required to obtain a permit from, food other than alcoholic register with, or obtain approval of a beverages at such a facility, notice or application from the provided that the food is in Secretary of the Treasury as a prepackaged form and condition of doing business in the constitutes not more than 5 United States. percent of the overall sales of the facility. Facilities that are solely engaged in A facility that stores raw the storage of raw agricultural agricultural commodities that commodities (other than fruits and are fruits and vegetables is vegetables) intended for further not exempt. distribution or processing. A facility solely engaged in the Modified requirements apply for storage of packaged food that is not the storage of unexposed exposed to the environment. packaged food that must be refrigerated for safety. ------------------------------------------------------------------------ The rule includes procedures for withdrawing a qualified facility exemption, in the event of an active investigation of a foodborne illness outbreak that is directly linked to the facility, or if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on relevant conditions or conduct associated with the qualified facility. The final rule provides procedures for a facility to appeal an order to withdraw a qualified facility exemption, for a facility to request an informal hearing, for the conduct of an informal hearing, for an appeal, for revoking an order to withdraw a qualified facility exemption, and for reinstating an exemption that was withdrawn. The rule finalizes recordkeeping provisions associated with the new provisions for hazard analysis and risk-based preventive controls. These records allow facilities to show, and FDA to determine, compliance with the new requirements. To meet these requirements, a facility may use existing records as appropriate. In addition to finalizing new requirements for hazard analysis and risk-based preventive controls as required by FSMA, the rule does two more key things. First, it modernizes the existing CGMPs. Second, it revises the ``farm'' definition. The rule makes several revisions to the CGMPs to update and clarify them. For example, the final CGMPs do not include nonbinding provisions, because it is no longer FDA's practice to include guidance in the regulatory text. The rule finalizes some of the previously nonbinding provisions in the CGMPs as binding requirements, including a requirement for education and training, but deletes other nonbinding provisions. We have revised some key terms for consistency and clarity. And we have clarified FDA's long-standing position that the CGMPs address allergen cross-contact by making that explicit in the regulatory text. Finally, the rule revises a long-standing exemption from the CGMP requirements regarding specific activities conducted on raw agricultural commodities to reflect the contemporary regulatory framework associated with the ``farm'' definition. In addition, elsewhere in this issue of the Federal [[Page 55914]] Register, in a final rule that establishes requirements for hazard analysis and risk-based preventive controls for food for animals, FDA is establishing an additional revision to the human food CGMPs to address comments about the practice of human food manufacturers sending by-products to local farmers or animal food manufacturers for use as animal food. Because we proposed these requirements as part of the rulemaking for the animal preventive controls rule, we are finalizing these provisions in the final animal preventive controls rule rather than in this rule. Finally, the rule clarifies the ``farm'' definition that is central to the determination of whether certain entities must register as a food facility and, thus, become subject to the new requirements for hazard analysis and risk-based preventive controls. The final ``farm'' definition reflects current farming practices, differentiates between two types of farm operations (i.e., a ``primary production farm'' and a ``secondary activities farm''), and allows for a consistent--although not identical--regulatory approach across similar operations, to the extent possible. In general, a ``primary production farm'' is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. A farm packs and holds raw agricultural commodities and may conduct certain manufacturing/ processing activities (i.e., drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling). The term farm also now includes a ``secondary activities farm,'' which is an operation, not located on a primary production farm, devoted to the key farming operations of harvesting, packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grow, harvest, and/or raise the majority of the raw agricultural commodities 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. Costs and Benefits This final regulation requires domestic and foreign facilities to adopt a food safety plan, perform a hazard analysis, and to institute preventive controls for the mitigation of those hazards. It also includes requirements for facilities to institute risk-based environmental monitoring, product testing, and a supply-chain program as appropriate to the food, the facility, and the nature of the preventive controls, as well as a requirement to institute controls to help prevent hazards associated with economically motivated adulteration. The total annualized domestic costs are estimated to be approximately $381 million per year, estimated with a 3 percent discount rate, and $382 million per year, estimated at 7 percent when discounted over 10 years. We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion. Our break-even analysis shows that for the rule to be cost effective, it would have to prevent $382 million worth of foodborne illness; approximately 17 percent of the total annual illnesses, or approximately 157,000 illnesses when using a discount rate of 7 percent. For the rule to be cost effective using a discount rate of 3 percent, it would have to prevent $381 million worth of foodborne illness (about 17 percent or 156,000 illnesses). Costs and Health Benefits [$ millions] -------------------------------------------------------------------------------------------------------------------------------------------------------- One-time cost One-time cost second yr third yr One-time cost compliance period compliance period Annual cost Total annualized Total Annualized PCHF Provision first yr (small (very small (annually cost at 7% cost at 3% compliance period businesses <500 businesses <$1 recurring costs) FTE's) million) -------------------------------------------------------------------------------------------------------------------------------------------------------- Learn about Rule...................... $6 $96 $21 $0 $16 $14 Total Costs Subparts A & D............ 17 148 88 15 43 41 Total Costs Subparts C & G............ 9 183 0 340 323 326 Total Domestic Costs.................. 32 427 109 355 382 381 Total Foreign Costs................... 68 915 234 760 820 817 ----------------------------------------------------------------------------------------------------------------- Total Costs........................... 100 1,342 344 1,115 1,202 1,198 ----------------------------------------------------------------------------------------------------------------- Total Health Benefits................. Not Quantified. Break-even occurs when 157,000 illnesses are prevented per year (based on domestic costs discounted at 7 percent). -------------------------------------------------------------------------------------------------------------------------------------------------------- Table of Abbreviations and Acronyms ------------------------------------------------------------------------ Abbreviation/acronym What it means ------------------------------------------------------------------------ Bioterrorism Act............................... Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188). CFSAN.......................................... Center for Food Safety and Applied Nutrition. CGMP........................................... Current Good Manufacturing Practice. Codex.......................................... Codex Alimentarius Commission. [[Page 55915]] Codex Validation Guidelines.................... Codex Guidelines for the Validation of Food Safety Control Measures. CSA............................................ Community Supported Agriculture. CPG............................................ Compliance Policy Guide. EO............................................. Executive Order. 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. 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. GFSI........................................... Global Food Safety Initiative. HACCP.......................................... Hazard Analysis and Critical Control Point. HIPAA.......................................... Health Insurance Portability and Accountability Act of 1996. Infant formula rule............................ Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula, June 10, 2014 (79 FR 33057). ISO............................................ International Organization for Standardization. LACF........................................... Thermally Processed Low- Acid Foods Packaged in Hermetically Sealed Containers (commonly called ``Low-Acid Canned Foods''). N/A............................................ Not Applicable. NCIMS.......................................... National Conference on Interstate Milk Shipments. NIFA........................................... National Institute of Food and Agriculture. NOP............................................ National Organic Program. OMB............................................ Office of Management and Budget. PHS Act........................................ Public Health Service Act. PMO............................................ Pasteurized Milk Ordinance. PMO facilities................................. Facilities that comply with the PMO and are regulated under the NCIMS system. PFP............................................ Partnership for Food Protection. PRA............................................ Paperwork Reduction Act. PSA............................................ Produce Safety Alliance. RAC............................................ Raw agricultural commodity. RFR............................................ Reportable Food Registry. Section 103(c)(1)(C) draft RA.................. Draft Qualitative Risk Assessment: 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: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (Final). SBA............................................ Small Business Administration. SECG........................................... Small Entity Compliance Guide. TCS food....................................... Time/Temperature Control for Safety Food. USDA........................................... U.S. Department of Agriculture. ------------------------------------------------------------------------ I. Background A. FDA Food Safety Modernization Act The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities. A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food. To that end, we proposed the seven foundational rules listed in table 1 and requested comments on all aspects of these proposed rules. Table 1--Published Foundational Rules for Implementation of FSMA ------------------------------------------------------------------------ Title Abbreviation Publication ------------------------------------------------------------------------ Current Good Manufacturing 2013 proposed 78 FR 3646, Practice and Hazard Analysis human preventive January 16, 2013 and Risk-Based Preventive controls rule. Controls for Human Food. Standards for the Growing, 2013 proposed 78 FR 3504, Harvesting, Packing, and produce safety January 16, 2013 Holding of Produce for Human rule. Consumption. Current Good Manufacturing 2013 proposed 78 FR 64736, Practice and Hazard Analysis animal preventive October 29, 2013 and Risk-Based Preventive controls rule. Controls for Food for Animals. Foreign Supplier Verification 2013 proposed FSVP 78 FR 45730, July Programs (FSVP) for Importers rule. 29, 2013 of Food for Humans and Animals. Accreditation of Third-Party 2013 proposed 78 FR 45782, July Auditors/Certification Bodies third-party 29, 2013 to Conduct Food Safety Audits certification and to Issue Certifications. rule. [[Page 55916]] Focused Mitigation Strategies To 2013 proposed 78 FR 78014, Protect Food Against intentional December 24, 2013 Intentional Adulteration. adulteration rule. Sanitary Transportation of Human 2014 proposed 79 FR 7006, and Animal Food. sanitary February 5, 2014 transportation rule. ------------------------------------------------------------------------ We also issued a supplemental notice of proposed rulemaking for the rules listed in table 2 and requested comments on specific issues identified in each supplemental notice of proposed rulemaking. Table 2--Published Supplemental Notices of Proposed Rulemaking for the Foundational Rules for Implementation of FSMA ------------------------------------------------------------------------ Title Abbreviation Publication ------------------------------------------------------------------------ Current Good Manufacturing 2014 supplemental 79 FR 58524, Practice and Hazard Analysis human preventive September 29, and Risk-Based Preventive controls notice. 2014 Controls for Human Food. Standards for the Growing, 2014 supplemental 79 FR 58434, Harvesting, Packing, and produce safety September 29, Holding of Produce for Human notice. 2014 Consumption. Current Good Manufacturing 2014 supplemental 79 FR 58476, Practice and Hazard Analysis animal preventive September 29, and Risk-Based Preventive controls notice. 2014 Controls for Food for Animals. Foreign Supplier Verification 2014 supplemental 79 FR 58574, Programs (FSVP) for Importers FSVP notice. September 29, of Food for Humans and Animals. 2014 ------------------------------------------------------------------------ As FDA finalizes these seven foundational rulemakings, we are putting in place a framework for food safety that is modern and brings to bear the most recent science on provisions to enhance food safety, that is risk-based and focuses effort where the hazards are reasonably likely to occur, and that is flexible and practical given our current knowledge of food safety practices. To achieve this, FDA has engaged in a great deal of outreach to the stakeholder community to find the right balance in these regulations of flexibility and accountability. Since FSMA was enacted in 2011, we have been involved in approximately 600 engagements on FSMA and the proposed rules, including public meetings, webinars, listening sessions, farm tours, and extensive presentations and meetings with various stakeholder groups (Ref. 1) (Ref. 2). As a result of this stakeholder dialogue, FDA decided to issue the four supplemental notices of proposed rulemaking to share our current thinking on key issues and get additional stakeholder input on those issues. As we move forward into the next phase of FSMA implementation, we intend to continue this dialogue and collaboration with our stakeholders, through guidance, education, training, and assistance, to ensure that everyone understands and engages in their role in food safety. FDA believes these seven foundational final rules, when implemented, will fulfill the paradigm shift toward prevention that was envisioned in FSMA and be a major step forward for food safety that will protect consumers into the future. B. Stages in the Rulemaking for the Human Preventive Controls Rule With regard to this rulemaking, we published proposed provisions in the 2013 proposed human preventive controls rule and we published new and re-proposed provisions in the 2014 supplemental human preventive controls notice. In the 2014 supplemental human preventive controls notice, we reopened the comment period only with respect to specific proposed provisions. In addition, we emphasized that the re-proposed provisions we included in the regulatory text were based on a preliminary review of the comments. In this document, we use the broad term ``proposed human preventive controls rule'' to refer to the complete proposed regulatory text, including both the proposed provisions we published in the 2013 proposed human preventive controls rule and the new and re-proposed provisions we published in the 2014 supplemental human preventive controls notice. We use the narrow terms ``2013 proposed human preventive controls rule'' and ``2014 supplemental human preventive controls notice'' to refer to specific text published in the Federal Register of January 16, 2013 (78 FR 3646) and September 29, 2014 (79 FR 58524), respectively. We use the terms ``final human preventive controls rule'' and ``this rule'' to refer to the regulations we are establishing as a result of this rulemaking. We issued a notice correcting several typographical and stylistic errors in the 2013 proposed human preventive controls rule and a mistake in the date of a reference (78 FR 17142, March 20, 2013). In that correction notice, we republished the Appendix in its entirety (78 FR 17142 at 17143 through 17155; the corrected Appendix) because all the references to the Appendix as published in the 2013 proposed human preventive controls rule (78 FR 3646 at 3812 through 3824) had been numbered incorrectly. We also extended the comment periods for the 2013 proposed human preventive controls rule, its information collection provisions, and a related risk assessment (see section I.D) in response to several requests that we do so. C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule As part of our announced initiative (Ref. 3) to revisit the CGMP requirements since they were last revised in 1986, we proposed to amend our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (currently established in part 110 (21 CFR part 110)) to: (1) Modernize it; (2) adjust and clarify what activities fall within the long-standing exemption from the CGMP requirements for establishments engaged solely in the harvesting, storage, or distribution of one or more raw agricultural commodities (RACs) based on experience and changes in related areas [[Page 55917]] of the law since issuance of the CGMP regulation; (3) delete some non- binding provisions of current part 110; and (4) re-establish the provisions of current part 110 in new part 117 (21 CFR part 117). We also requested comment on: (1) Additional proposed revisions or clarifications to our CGMP regulations, including whether to further implement opportunities for CGMP modernization, such as on how best to revise the current provisions for training; and (2) whether to revise some non-binding provisions to establish new requirements in proposed part 117, or to simply retain them as useful provisions of a comprehensive CGMP. As part of our implementation of new statutory provisions in FSMA, we also proposed to add, in newly established part 117, requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. As directed by FSMA (see section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), these new provisions would apply to domestic and foreign facilities that are required to register under section 415 of the FD&C Act and our regulation for Registration of Food Facilities (21 CFR part 1, subpart H; the section 415 registration regulations). As directed by FSMA (see sections 418(l) and (m) of the FD&C Act), we proposed to establish modified requirements for certain facilities. We requested comment on all aspects of the proposed requirements, including an opportunity for public comment on potential requirements for product testing, environmental monitoring, a supply-chain program, and hazards that may be intentionally introduced for purposes of economic gain. As directed by section 103 of FSMA, we proposed to clarify the scope of the exemption from the section 415 registration regulations for ``farms'' by revising the ``farm'' definition and by adding or modifying the definitions for certain activities (i.e., for ``harvesting,'' ``holding,'' ``manufacturing/processing,'' and ``packing'' activities) that govern, in part, whether a business that is devoted to the growing of crops, the raising of animals, or both is within the ``farm'' definition. We also proposed to add or revise these definitions in our current regulation (implementing section 414 of the FD&C Act) for Establishment and Maintenance of Records for Foods (21 CFR part 1, subpart J; the section 414 recordkeeping regulations), which also have an exemption for ``farms.'' We proposed to establish the requirements for CGMPs, for hazard analysis and risk-based preventive controls, and related requirements in new part 117 as shown in table 3: Table 3--Proposed Subparts in New Part 117 ------------------------------------------------------------------------ Subpart Title ------------------------------------------------------------------------ A............................... General Provisions. B............................... Current Good Manufacturing Practice. C............................... Hazard Analysis and Risk-Based Preventive Controls. D............................... Modified Requirements. E............................... Withdrawal of an Exemption Applicable to a Qualified Facility. F............................... Requirements Applying to Records That Must Be Established and Maintained. ------------------------------------------------------------------------ D. Draft Risk Assessment We issued for public comment a ``Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the section 103(c)(1)(C) draft RA) (78 FR 3824, January 16, 2013). The purpose of the section 103(c)(1)(C) draft RA was to provide a science-based risk analysis of those activity/food combinations that would be considered low risk when conducted in a facility co-located on a farm. We used the tentative conclusions of the section 103(c)(1)(C) draft RA to propose to exempt food facilities that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities from the requirements for hazard analysis and risk-based preventive controls. We are including the final risk assessment (the section 103(c)(1)(C) RA) in the docket established for this document (Ref. 4). E. Definition of ``Retail Food Establishment'' An establishment that meets the definition of ``retail food establishment'' is exempt from the requirements of the section 415 registration regulations and, thus, from FSMA's requirements for hazard analysis and risk-based preventive controls. Section 102(c) of FSMA requires that we revise the definition of ``retail food establishment'' in Sec. 1.227 to clarify its intent. We are addressing the requirements of section 102(c) of FSMA in a separate rulemaking and issued a separate proposed rule to amend the definition of ``retail food establishment'' in the section 415 registration regulations and the section 414 recordkeeping regulations (80 FR 19160, April 9, 2015). We intend to issue a final rule to amend the definition of ``retail food establishment'' in the section 415 registration regulations in the near future. F. Public Comments We received more than 8,000 public submissions on the 2013 proposed human preventive controls rule, and more than 1,300 public submissions on the 2014 preventive controls supplemental notice, each containing one or more comments. We received submissions from diverse members of the public, including food facilities (including facilities co-located on a farm); farms; cooperatives; coalitions; trade organizations; consulting firms; law firms; academia; public health organizations; public advocacy groups; consumers; consumer groups; Congress; Federal, State, local, and tribal Government Agencies; and other organizations. Some submissions included signatures and statements from multiple individuals. Comments address virtually every provision of the proposed human preventive controls rule. In the remainder of this document, we describe these comments, respond to them, and explain any revisions we made to the proposed human preventive controls rule. Some comments address issues that are outside the scope of this rule. For example, some comments express concern over pesticides being used on local crops being harmful to the honeybee population. Other comments address the requirements of the proposed produce safety rule, such as standards for water quality. Other comments express concern about the use of bioengineered food ingredients, and ask that foods containing such ingredients be labeled so that consumers can identify such foods and choose whether to consume them. Other comments assert that the rules should address social issues. We do not discuss such comments in this document. II. Legal Authority The proposed rule contained an explanation of its legal basis under authorities in the FDA Food Safety Modernization Act, the FD&C Act, and the Public Health Service Act. After considering comments received in response to the 2013 proposed human preventive controls rule and 2014 supplemental human preventive controls notice, FDA made changes in the final rule. The legal authorities relied on for the final rule are the same as in the proposed rule unless otherwise described in the sections that follow. [[Page 55918]] A. Changes to Current 21 CFR Part 1, Subparts H, I, and J Sections 103(c)(2)(A) and (B) of FSMA require that the Secretary adopt final rules for purposes of section 415 of the FD&C Act (Registration of Food Facilities) with respect to ``activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership'' and ``activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.'' In section IV, we discuss our revision of the section 415 registration regulations (21 CFR part 1, subpart H) to clarify the types of activities that are included as part of the definition of the term ``facility'' under section 415 of the FD&C Act and the scope of the exemption for ``farms'' provided by section 415 of the FD&C Act. The final rule also makes corresponding changes in part 1, subpart I (Prior Notice of Imported Food) and in part 1, subpart J (Establishment, Maintenance, and Availability of Records). FDA's legal authority to modify these regulations is derived from section 103(c) of FSMA and sections 414, 415, 381(m) and 371(a) of the FD&C Act (21 U.S.C. 350c, 350d, 801(m), and 701(a)). B. Changes to Current 21 CFR Part 110 The changes to the current CGMP regulation finalized in this document clarify the existing requirements of the regulation and update existing requirements to reflect changes in the food industry and in scientific understanding of food safety since issuance of the current regulation. FDA's legal authority to require Current Good Manufacturing Practices derives from sections 402(a)(3), (a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The revisions we are making to the current CGMP regulation are necessary to prevent food from containing filthy, putrid, or decomposed substances, being otherwise unfit for food, or being prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. In addition to the FD&C Act, FDA's legal authority for the changes to current CGMP requirements derives from the PHS Act to the extent such measures are related to communicable disease. Authority under the PHS Act is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as ``are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State'' (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary.) The revisions we are making to the current CGMP regulation are necessary to prevent the spread of communicable disease. C. Hazard Analysis and Risk-Based Preventive Controls Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418, which mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary issue regulations ``to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls. . . .'' Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms ``small business'' and ``very small business,'' taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Further, section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit ``[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].'' In addition to rulemaking requirements, section 418 contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is to ``prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 [of the FD&C Act] or misbranded under section 403(w) [of the FD&C Act]. . . .'' In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include hazard analysis (section 418(b)), preventive controls (section 418(c)), monitoring (section 418(d)), corrective actions (section 418(e)), verification (section 418(f)), recordkeeping (section 418(g)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Section 103(c)(2)(C) of FSMA requires that the Secretary adopt a final rule with respect to the requirements under sections 418 and 421 of the FD&C Act from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities. Sections 418(j)-(m) of the FD&C Act and sections 103(c)(1)(D) and (g) of FSMA provide authority for certain exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to seafood and juice HACCP, and low-acid canned food (section 418(j)); activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety) (section 418(k)); qualified facilities (section 418(l)); facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment (section 418(m)); facilities engaged only in certain low-risk on-farm activities on certain foods conducted by small or very small businesses (section 103(c)(1)(D) of FSMA), and dietary supplements (section 103(g) of FSMA). In sections XI, XII, XXXVIII, and XXXIX, we discuss provisions that implement these exemptions and modified requirements. In the 2014 supplemental human preventive controls notice, we included potential requirements for a supplier program, environmental monitoring, and product testing. We are including provisions for such activities in the final [[Page 55919]] rule. Section 418(o)(3) of the FD&C Act provides supplier verification activities and an environmental monitoring program as examples of preventive controls. Section 418(f)(4) of the FD&C Act provides for the use of environmental and product testing programs as part of required verification that the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards. In certain circumstances, the final rule does not require a manufacturing/processing facility to implement a preventive control for a hazard requiring a preventive control. Instead, the facility is permitted to rely on a subsequent entity in the distribution chain to significantly minimize or prevent the hazard. In such a circumstance, a facility must disclose in documents accompanying the food, that the food is ``not processed to control [identified hazard].'' This requirement is supported by sections 418 and 701(a) of the FD&C Act (21 U.S.C. 350g and 371(a)). The requirement that facilities apply preventive controls to significantly minimize or prevent hazards is fundamental to the public health benefits of the rule. To accommodate the realities of modern food production, the rule allows a facility to rely on a subsequent entity in the distribution chain rather than requiring that facility to apply the control. A food may pass through multiple entities in the distribution chain before it reaches consumers. Further, ordinarily it is not apparent from visual examination of the food whether a hazard requiring a preventive control has been addressed. Consequently, without labeling, a facility might not know that a facility upstream in the supply chain has not applied a preventive control and is relying on a downstream entity to do so. Therefore, the agency concludes that information that food has not been processed to control an identified hazard is necessary for a facility to fulfil its obligation under section 418 when a facility is relying on a subsequent entity to control the hazard. The agency also concludes that such labeling is necessary for the efficient enforcement of the Act because the labelling is critical for FDA to hold facilities responsible for their obligations under this regulatory scheme. Further, when the hazard can cause a communicable disease, FDA concludes that the requirement is necessary to prevent the spread of communicable disease from one state into another state and relies on sections 311, 361, and 368 of the PHS Act. FDA concludes that the provisions in subpart C and related requirements in subparts A, D, F, and G should be applicable to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (Sec. 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility from the requirements because food from such a facility is not in interstate commerce. Further, the prohibited act provision associated with section 418 (section 301(uu) of the FD&C Act) does not require interstate commerce for a violation. FDA also is issuing the provisions in subpart C and related requirements in Subparts A, D, F, and G, under sections 402(a)(3), 402(a)(4), 403(w), and 701(a) of the FD&C Act to the extent such requirements are necessary to prevent food from being held under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health, or being unfit for food; and to the extent necessary to prevent food from being misbranded under section 403(w). FDA also is finalizing those provisions under sections 311, 361, and 368 of the PHS Act relating to communicable disease to the extent those provisions are necessary to prevent the interstate spread of communicable disease. D. Comments on Legal Authority (Comment 1) One comment asserts that FDA does not have authority to regulate intrastate commercial activities. Another comment asserts that FDA does not have authority to regulate farms that are selling wholly intrastate. (Response 1) With regard to farms, this rule does not apply. With respect to farms that engage in activities outside the farm definition (i.e., farm mixed-type facilities), this rule applies to the non-farm portion of the operation. FDA disagrees with the comments regarding application of this rule to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (Sec. 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility because food from such a facility is not in interstate commerce. Section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) provides that ``the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418'' is a prohibited act. Notably, other subsections in section 301 of the FD&C Act, and section 304 of the FD&C Act (21 U.S.C. 334) demonstrate that Congress has included a specific interstate commerce nexus in the provisions of the FD&C Act when that is its intent. Accordingly, it is reasonable to interpret sections 418 and 301(uu) of the FD&C Act as not limiting the application of the rule only to those facilities with a direct connection to interstate commerce. FDA is mindful that its interpretation of FSMA and the FD&C Act should not cast doubt on their constitutionality. (See Solid Waste Agency of Northern Cook County v. U.S., 531 U.S. 159 (2001)). FDA has considered the relevant provisions of FSMA and the FD&C Act, FDA's responsibilities in implementing those laws, and the law interpreting the commerce clause of the Constitution (Article I, section 8). Congress' power to legislate under the commerce clause is very broad. However, such power is not without limits, see United States v. Lopez, 514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S. 598, 618 (2000), and these limits have been construed in light of relevant and enduring precedents. In particular, in Lopez, supra, the Supreme Court acknowledged the continuing vitality of Wickard v. Filburn, 317 U.S. 111 (1942), noting that ``although Filburn's own contribution to the demand for wheat may have been trivial by itself, that was not `enough to remove him from the scope of Federal regulation where, as here, his contribution, taken together with that of many others similarly situated, is far from trivial.' '' (514 U.S. at 556.) See also Gonzales v. Raich, 545 U.S. 1, 17-25 (2005). This principle applies to the application of sections 418 and 301(uu) of the FD&C Act, as added by section 104 of FSMA. Accordingly, given the collective impact on commerce of facilities that manufacture, process, pack, or hold food that is sold in intrastate commerce, FDA concludes that such facilities should be subject to the rule. FDA notes that to the extent these facilities are very small, they are subject to modified requirements under Sec. 117.201. This outcome regarding intrastate commerce is consistent with section 709 of the FD&C Act (21 U.S.C. 379a), which states that in any action to enforce the act's requirements respecting foods, drugs, devices, and cosmetics, any necessary connection [[Page 55920]] with interstate commerce is presumed. Likewise, this outcome is consistent with FSMA's risk-based, preventive approach to food safety because the risk presented by unsafe food can be significant, whether or not the food moves from one state to another. III. General Comments on the Proposed Rule (Comment 2) Several comments ask us to develop guidance to accompany the rule, particularly with respect to the new requirements for hazard analysis and risk-based preventive controls. For example, comments ask us to provide guidance on topics such as hazard analysis, environmental monitoring, and validation. Some of these comments ask that drafts of the guidance first be made available for public comment. Other comments emphasize the importance of education and outreach and ask us to provide support for ongoing education and outreach, including an active role in providing needed instructional examples and lessons learned from current investigations and foodborne outbreaks. Some comments ask us to convene a scientific workgroup that includes experts in food and laboratory science, public health, proficiency testing, quality control, and other areas on at least an annual basis to assess what pathogens should be addressed in a food safety plan. Some comments ask that funding and information on funding for training be provided. Other comments assert that we must make available adequate resources to support outreach and technical assistance delivered by State regulatory agencies, as well as Cooperative Extension programs and non-governmental organizations that work directly with farmers and facilities. (Response 2) We are developing several guidance documents, including general guidance on hazard analysis and preventive controls, as well as guidance on specific aspects such as environmental monitoring and food allergen control (Ref. 5). We also intend to develop guidance specific to a variety of food types based in part on technical information we obtained through a grant for this purpose, as well as on other topics, such as validation. We will develop and issue this guidance in accordance with our good guidance practices regulation, which establishes criteria for when we issue a guidance document as an initial draft, invite public comment, and prepare a final version of the guidance document that incorporates suggested changes, when appropriate (Sec. 10.115(g)) (21 CFR 10.115(g)). The public may submit comments on any guidance document at any time (Sec. 10.115(g)(5)). We agree with comments that stress the importance of education and outreach. A central element of our strategy to gain industry compliance is to help make available to facilities subject to this rule the education and technical assistance they need to understand and implement the requirements (Ref. 6). Within the Agency we are establishing a Food Safety Technical Assistance Network and seeking funding to increase FDA staffing to provide a central source of information to support industry understanding and implementation of FSMA standards (Ref. 6). This will allow us to respond in a timely and consistent way to industry questions on preventive controls technical and compliance issues (Ref. 6). We also are working in collaboration with the Food Safety Preventive Controls Alliance (FSPCA) to develop training materials and establish training and technical assistance programs (Ref. 5) and (Ref. 7). The Alliance includes members from FDA, State food protection agencies, the food industry, and academia. It is funded by a grant to the Illinois Institute of Technology's Institute for Food Safety and Health, a nationally-recognized leader in food safety. In addition to developing a standardized preventive controls training curriculum, the FSPCA is developing selected sections of model food safety plans for several food types that will provide needed instructional examples. Although we have provided funding to the FSPCA to develop a standardized preventive controls training curriculum, we are unable to fund training for individual groups who might need particular training materials. We also are partnering with the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) to administer the FSMA-mandated National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program, a grant program to provide technical assistance for FSMA compliance to owners and operators of small and medium-size farms and small food processors (Ref. 8). Such efforts will help ensure widespread voluntary compliance by encouraging greater understanding and adoption of established food safety standards, guidance, and protocols. At this time, we intend to rely on scientific publications and epidemiological findings to assess the potential that new pathogens, or more virulent pathogenic strains, have emerged, and do not intend to convene annual workgroups to assess that data and information. (Comment 3) Several comments ask us to classify specific on-farm activities as harvesting, packing, holding, or manufacturing/processing so that an operation that conducts these activities on a farm can determine whether conducting that specific activity is within, or outside, the ``farm'' definition. These comments emphasize that a farm operation needs to know when a specific activity that it conducts would be outside the ``farm'' definition for the purposes of the requirements to register as a food facility and, thus, require that the farm operation both register as a food facility and comply with the new requirements for hazard analysis and risk-based preventive controls. Some of these comments focus on activities that we have previously classified in more than one way (e.g., ``washing,'' which we have previously classified as both ``harvesting'' and ``manufacturing/ processing,'' depending on when the activity occurs) (See table 1 in the Appendix to the 2014 supplemental human preventive controls rule, 79 FR 58524 at 58571-58572.) Other comments ask us to periodically review our lists of harvesting, packing, holding, and manufacturing/ processing activities to ensure that they reflect current practices. Some comments ask us to make a table of activities prominently available on our Internet site for easy access whenever the public seeks out information regarding the forthcoming produce safety rule and the human preventive controls rule. (Response 3) We have added several examples of ``harvesting,'' ``packing,'' ``holding,'' and ``manufacturing/processing'' to the regulatory text (see Sec. Sec. 1.227, 1.328, and 117.3 and Response 27, Response 28, Response 29, Response 31, Response 37, Response 38 and Response 39). However, it is not practical to include every possible activity conducted by farm operations in the regulatory text. Attempting to include a more extensive set of examples in the regulatory text has the potential to signal--incorrectly--that any activity not specified in the regulatory text cannot be considered to be within the definition of that activity. In addition, we have not previously discussed our approach to classifying some of the activities mentioned in the comments, and we believe that we should provide an opportunity for public comment on a more extensive list of activities classified as ``harvesting,'' packing,'' ``holding,'' or ``manufacturing/processing.'' [[Page 55921]] To address these comments, in the near future we intend to issue a draft guidance with our current thinking on the classification of activities as ``harvesting,'' packing,'' ``holding,'' or ``manufacturing/processing.'' In accordance with our regulation on good guidance practices (Sec. 10.115(g)(1)), we will review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate; publish a notice in the Federal Register announcing that the guidance document is available; and post the guidance document on the Internet and make it available in hard copy. Under our good guidance practices regulation (Sec. 10.115(g) and (h)), the public can comment on any guidance document at any time, and we will revise guidance documents in response to public comments when appropriate. In addition, our previously issued ``Guidance for Industry: Questions and Answers Regarding Food Facility Registration'' (Ref. 9) is in its sixth edition, and we intend to update it in the near future to reflect the changes to the definitions of ``farm,'' ``harvesting,'' packing,'' ``holding,'' and ``manufacturing/processing'' that we are establishing in this rulemaking. (Comment 4) Some comments ask us to prepare a table or flow chart of activities that make an operation a farm, a retail food establishment, or a facility because food businesses will need to be able to easily determine their regulatory classification to comply with the applicable regulations. Other comments ask us to amend the definition of ``manufacturing/processing'' to ensure that community supported agriculture (CSA) programs will not become subject to the requirements for hazard analysis and risk-based preventive controls. Other comments ask us to clarify how the revised definitions we are establishing in the section 415 registration regulations will affect entities classified as research and development entities, pilot plants, test kitchens, shared use storage facilities, co-packers, sales offices, corporate offices, private residences, and registered foreign facilities that only send samples to the United States. Some comments ask us to clarify how the revised definitions we are establishing in the section 415 registration regulations will affect a determination of whether an entity or program (such as a farmers' market, roadside stand, CSA program, commissary kitchen, community and incubator kitchens) is a retail food establishment that is not required to register as a food facility in the human preventive controls rule rather than through a separate rulemaking. One comment notes that its farm has a store and a caf[eacute] that use products from the farm, and it is not clear if the store and caf[eacute] will be under regulations while nearby restaurants and grocery stores are not. Some comments ask us to define farmers' markets, CSA programs, roadside stands, and other direct-to-consumer programs as retail food establishments not subject to registration as part of the human preventive controls rulemaking rather than through a separate rulemaking. (Response 4) Section 102(c) of FSMA requires that we revise the definition of ``retail food establishment'' in Sec. 1.227 to clarify that, in determining the primary function of an establishment or a retail food establishment under the section 415 registration regulations, the sale of food products directly to consumers by such establishments includes the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; the sale and distribution of such food through a CSA program; and the sale and distribution of such food at any other such direct sales platform as determined by the Secretary of HHS. As discussed in section I.E, we have begun the process of amending the definition of ``retail food establishment'' in a separate rulemaking conducted under section 102(c) of FSMA, and are continuing that separate rulemaking by issuing a separate final rule. We intend to issue a final rule to amend the definition of ``retail food establishment'' in the section 415 registration regulations in the near future. We also intend to update our previously issued ``Guidance for Industry: Questions and Answers Regarding Food Facility Registration'' (Ref. 9) to reflect any changes to a determination of whether an entity is a retail food establishment as a result of that rulemaking. In the meantime, commenters may find our existing guidance helpful in addressing their questions. (Comment 5) Some comments ask us to explain how we will enforce the rule, particularly with respect to coordination with State and local authorities and with other Federal agencies. For example, some comments ask whether FDA or the States will pay for inspections, whereas other comments ask us to coordinate inspection of imports with USDA's Food Safety and Inspection Service (FSIS) or ask us to combine our inspections with those of USDA where possible (such as when USDA conducts inspections for adherence to organic standards). Some comments express concern about the time gap between the effective date of this rule and the time it will take to incorporate applicable provisions into State law. (Response 5) We are working through the Partnership for Food Protection (PFP) (a group of dedicated professionals from Federal, State, local, tribal, and territorial governments with roles in protecting the food supply and public health) to develop and implement a national Integrated Food Safety System consistent with FSMA's emphasis on establishing partnerships for achieving compliance (see section 209(b) of FSMA). For an example of our current thinking on establishing partnerships for achieving compliance, see the ``best practices'' document made available by PFP (Ref. 10). This ``best practices'' document provides information to FDA field and State programs on a variety of issues, including how to coordinate compliance activities. Our document entitled ``Operational Strategy for Implementing FSMA'' also recognizes the importance of developing operational partnerships with States and other government counterparts to optimize the effectiveness, efficiency, and consistency of FSMA implementation domestically (Ref. 11). We are implementing a new inspection paradigm focused on whether firms are implementing systems that effectively prevent food contamination, requiring fundamentally different approaches to food safety inspection and compliance (Ref. 12). This new paradigm involves a major reorientation and retraining, for which we are seeking funding, of more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety activities, as well as thousands of State, local, and tribal inspectors (Ref. 12). (Comment 6) Some comments ask us to specify that the human preventive controls rule does not apply to activities subject to the animal preventive controls rule. (Response 6) The human preventive controls rule does not apply to activities subject to the animal preventive controls rule. The title of the rule (i.e., Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) narrows its applicability to human food. Moreover, regulations directed to food for animals are established in subchapter E of 21 CFR (i.e., Animal Drugs, Feeds, And Related Products, parts 500-599), whereas regulations directed to human food are established [[Page 55922]] in subchapter B of 21 CFR (i.e., Food For Human Consumption, parts 100- 199). (Comment 7) Some comments ask us to look to existing industry information technology solutions where possible to lower the burden on industry for implementation. These comments also ask us to adopt a centralized information technology solution with robust functionality to facilitate tracking stakeholders' compliance with the rule. (Response 7) The rule allows for use of any available information technology (e.g., in the creation and retention of records) that will allow industry to comply with the rule, and we encourage the use of information technology to streamline compliance. The long-standing CGMP requirements allow for the use of automated systems (see Sec. 117.40(d)). We are developing new electronic systems to track compliance. However, our internal procedures for tracking compliance are outside the scope of this rule. (Comment 8) Some comments ask us to re-evaluate the proposed human preventive controls rule, compare it with existing programs, and identify a mechanism for integrating compliance verification with existing industry and governmental programs. These comments note that many handlers/processors use and understand voluntary food safety management systems such as HACCP and HACCP-based certification programs (e.g., certification to Global Food Safety Initiative (GFSI) benchmark schemes) and ask us why we proposed to create a separate inspection framework for FSMA, without integrating that inspection framework with existing programs. (Response 8) We decline this request. As previously discussed, we are establishing this rule as required by section 103 of FSMA (78 FR 3646 at 3657-3659 and 3668-3669). However, where compliance with this rule mirrors compliance with existing regulatory requirements, there is no need to duplicate existing records, which may be supplemented as necessary to include all of the required information. (See also Response 5 regarding implementation of a national Integrated Food Safety System.) (Comment 9) Some comments ask us to make the various rules we are establishing to implement FSMA consistent with each other. (Response 9) We have aligned the provisions of the various rules to the extent practicable. For example, we use the same definitions of ``farm'' and the same terms used in the definition of ``farm'' (i.e., harvesting, packing, holding, and manufacturing/processing) in this rule, the animal preventive controls rule, and the proposed produce safety rule. However, the statutory direction is not the same for all the rules, and this difference in statutory direction does lead to some differences between the rules. For example, section 418(l) of the FD&C Act (which relates to this rule) provides for modified requirements for facilities that are very small businesses in addition to facilities that satisfy criteria for sales to qualified end-users, but section 419(f) of the FD&C Act (which relates to the proposed produce safety rule) only provides for modified requirements for direct farm marketing. Likewise, we have worked to align the provisions of this rule with the provisions of the FSVP rule. Again, however, there are statutory differences that lead to some differences between the rules. For example, section 805 of the FD&C Act (21 U.S.C. 348a) applies to an importer whereas section 418 of the FD&C Act applies to a facility that is required to register under section 415 of the FD&C Act. (Comment 10) Some comments ask us to clarify how the requirements for hazard analysis and risk-based preventive controls will apply to an establishment that supplies raw materials and other ingredients to a registered facility. (Response 10) The requirements for hazard analysis and risk-based preventive controls apply to facilities that are required to register under section 415 of the FD&C Act. If an establishment that supplies raw materials and other ingredients to a registered facility is itself a facility that is required to register under section 415 of the FD&C Act, that establishment is subject to the requirements for hazard analysis and risk-based preventive controls. If that establishment is not itself a facility that is required to register under section 415 of the FD&C Act, that establishment is not subject to the requirements for hazard analysis and risk-based preventive controls. However, such facilities may be subject to verification activities of manufacturers/ processors that are required to verify controls implemented by their suppliers. (Comment 11) Some comments express concern about the potential for unfair enforcement of the rule relating to business size. Some comments assert that we should strictly enforce the rule for big industry, but be lenient towards small farms. (Response 11) We intend to enforce the rule in a fair and reasonable manner. We note that farms are not covered by this rule, and the rule contains special provisions applicable to a farm mixed-type facility that is a small or very small business. Specifically, a small or very small business that is a farm mixed-type facility is exempt from the requirements for hazard analysis and risk-based preventive controls if the only activities that it conducts are the low-risk activity/food combinations listed in Sec. 117.5(g) and (h). A very small business that is a farm mixed-type facility, but does not satisfy the criteria for the exemptions for only conducting low-risk activity/ food combinations, is eligible for modified requirements as a qualified facility, and we will enforce the modified requirements, rather than the full requirements for hazard analysis and risk-based preventive controls, for such very small businesses. (Comment 12) Some comments express concern that we will enforce the rule more strictly for domestic facilities than for foreign facilities--e.g., because we lack the funds and manpower to enforce the rule for foreign facilities. Other comments assert that it is unprecedented for importing countries to regulate the production processes in exporting countries and that no scientific evidence supports such regulation. These comments express concern that this regulatory requirement will greatly increase trading costs and might constitute a barrier to trade for exporting countries. (Response 12) We intend to enforce this rule in a consistent manner to ensure that imported and domestically produced foods are in full compliance with the requirements of this rule. We note that the forthcoming FSVP rule will require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under this rule. The implementation of these supplier verification programs by U.S. importers will thus provide assurances that imported food is in compliance with this regulation. We disagree that we are seeking to ``regulate the production processes in exporting countries'' inappropriately. This rule provides for a flexible set of principles and a framework for hazard analysis and risk-based preventive controls to be applied to a given production process in order to ensure the production of safe food destined for the United States. Mandating that a finished food is manufactured under general methods applicable to all foods (e.g., good manufacturing practices) is a widely accepted regulatory practice and [[Page 55923]] fundamentally different than mandating that food be produced in a certain way. We note that many countries have adopted food safety regulations that mandate certain principles and conditions be applied to food manufacturing. These include mandatory HACCP programs for seafood and other foods. For example, in a guidance document on food safety import requirements, the European Commission stated: ``The EU rules on food hygiene confirm that all food businesses in third countries after primary production must put in place, implement and maintain a procedure based on the HACCP principles.'' The mandate that preventive controls be applied to control hazards in the production of foods in this rule is similar to the European Union (EU) rules. Because the requirements being implemented by FDA under this regulation are flexible and not prescriptive, we do not agree that this regulation will significantly increase costs or impede trade. We also disagree that there is no scientific evidence supporting this rule. In the 2013 proposed preventive controls rule, we provided an extensive background discussing the scientific evidence and international food safety standards upon which this rule is based (78 FR 3646 at 3659 through 3667, January 16, 2013). That discussion reviews a number of well documented food safety risks and how they can be controlled by modern food safety systems including the Codex HACCP principles contained in the HACCP Annex of the Codex General Principles of Food Hygiene (78 FR 3646 at 3667, January 16, 2013). In that discussion we stated: ``The proposed rule would require that a food safety system similar to HACCP be implemented in food facilities and would harmonize our requirements with the recommendations and requirements of internationally recognized food safety experts/ authorities, such as experts/authorities in [Codex Alimentarius], [Food Safety Authority Australia New Zealand], [Canadian Food Inspection Agency], and the European Union.'' (78 FR 3646 at 3663, January 16, 2013) In addition, the Appendix to the 2013 proposed preventive controls rule provided additional scientific information on activities such as product testing and environmental monitoring to support their role in ensuring safe food and how these align with international standards such as those of Codex Alimentarius (78 FR 3646 at 3818- 3820); republished in its entirety with corrected reference numbers on March 20, 2013, 78 FR 17142 at 17149-17151). (Comment 13) Some comments assert that the rule should be more concise, and that the average person without a team of experts should be able to understand the rule and manage the application of the rule. (Response 13) We agree the rule needs to be understandable. We have incorporated plain language techniques--e.g., by using active voice in the new requirements for hazard analysis and risk-based preventive controls. We also have established additional definitions that enable us to improve readability (e.g., ``qualified facility exemption,'' ``raw agricultural commodity,'' ``unexposed packaged food,'' and ``you.'') The comprehensive nature of the new requirements for hazard analysis and risk-based preventive controls reflects the extensive statutory provisions they implement and the broad range of activities and foods covered. We have used examples in the regulatory text, where relevant, and provided examples throughout the preamble to assist with understanding the requirements. Likewise, the long-standing CGMP requirements need to be comprehensive, because they are broadly directed to all stages of the production of food. We will be producing guidance documents that will be helpful in understanding the rule (see Response 2). We will issue a Small Entity Compliance Guide (SECG) in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). A Small Entity Compliance Guide is a guidance that explains the actions a small or very small business must take to comply with a rule. (Comment 14) Some comments ask whether we will translate the rule into foreign languages, such as Japanese. (Response 14) We do not intend to translate the rule. As discussed in Response 13, to help small and very small businesses comply with a rule we issue a SECG. We are considering whether to translate the SECG and outreach and technical assistance materials into additional languages. (Comment 15) Some comments assert that the rule incorrectly assumes that all bacteria are harmful. (Response 15) We have long recognized that some bacteria have a role in food production, such as the lactic-acid producing bacteria that our regulations explicitly acknowledge as being added to yogurt (see, e.g., the standards of identity for yogurt, low fat yogurt, and nonfat yogurt, in 21 CFR 131.200, 131.203, and 131.206, respectively). The rule defines the terms ``microorganism'' and ``pathogen,'' and the definition of ``microorganism'' explains that the term ``undesirable microorganism'' includes those microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. The CGMP provisions directed to either preventing the growth of undesirable microorganisms or preventing contamination with undesirable microorganisms are long-standing, and these comments do not provide any examples of how we have interpreted the CGMP requirements in the past in a way that does not recognize that some bacteria have a role in food production or that creates practical problems for the future. With regard to biological hazards, the new requirements for hazard analysis and risk-based preventive controls focus on pathogens. (Comment 16) Some comments assert that the rule will disproportionately affect New England farmers because they are small and production costs are higher compared to elsewhere in the country and that the cost of the rule will have negative consequences on New England's food supply. Other comments assert that the rule will force small farmers out of business, forcing us to rely on foreign suppliers who are under very little FDA oversight, and that FDA oversight should be reduced so that the public can continue supporting small, local farmers. Other comments express concern that excessive rules will discourage farmers from supplying the Farm to School market. (Response 16) We believe that the ``farm'' definition that we are establishing in this rule greatly reduces the impact on farms of all size, because several operations that would have been required to register as a food facility under the section 415 registration regulations as established in 2003 (68 FR 58894, October 10, 2003) will no longer be required to do so. (See the discussion of the changes to the ``farm'' definition in section IV.B) In addition, a farm mixed-type facility that is a small or very small business, and that only conducts low-risk activity/food combinations for manufacturing, processing, packing, and holding foods that are not RACs, is exempt from the new requirements for hazard analysis and risk-based preventive controls. A farm mixed-type facility that does not satisfy these criteria for exemption, but is a very small business, is a qualified facility that is subject to modified requirements. All of these factors will reduce the burden on small farms. [[Page 55924]] (Comment 17) Some comments express concern about contamination of produce and other food in open containers by sulfuric hydrogen being discharged from lead acid batteries that are used to operate forklifts. (Response 17) The long-standing CGMP provisions require that the food establishment must appropriately use equipment to avoid the adulteration of food with such contaminants (see Sec. 117.40(a)(2)). (Comment 18) Some comments assert that we do not address comments submitted by individuals. (Response 18) We address comments on the provisions of the rule regardless of who submits the comments. However, we group similar comments together, and do not discuss the specific text of each submitted comment letter when the point being made by one comment letter can be included in a general discussion of several comment letters that express similar points of view. (Comment 19) Some comments assert that we need specific standards and quantifiable guidelines for compressed air. (Response 19) We agree that specific standards and quantifiable guidelines for material such as compressed air could be useful to food establishments that use such material in the production of food. However, we disagree that such standards and guidelines need to be included in the rule. The rule is intended to establish procedures for the safe manufacturing, processing, packing, and holding of food, and for hazard analysis and risk-based preventive controls in the production of food, rather than to set standards for specific levels of contaminants in specific raw materials and other ingredients. If a facility believes that its use of compressed air should be addressed in its food safety plan, then it should do so. (Comment 20) Some comments ask us to address model laboratory standards and accreditation to ensure that laboratories are using sound and reliable test methods for detecting and identifying pathogens. (Response 20) We decline this request. A separate section of FSMA addresses ``Laboratory Accreditation For Analyses Of Foods'' (see section 202 of FSMA). This rule focuses on section 103 of FSMA (section 418 of the FD&C Act). IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J) A. Definitions That Impact a Determination of Whether an Establishment Is a ``Farm'' We previously described section 103(c) of FSMA (78 FR 3646 at 3674). In brief, section 103(c) of FSMA directs us to conduct rulemaking to clarify the on-farm manufacturing, processing, packing, and holding activities that would trigger a requirement for a farm to register as a food facility and, thus, be subject to section 418 of the FD&C Act. We discussed the current legal and regulatory framework for farms under sections 415 and 418 of the FD&C Act, and explained how the status of a food as a RAC or a processed food affects the requirements applicable to a farm under sections 415 and 418 of the FD&C Act. We then articulated a comprehensive set of organizing principles that formed the basis for proposed revisions to the section 415 registration regulations. Because these definitions also are established in the section 414 recordkeeping regulations, these organizing principles also formed the basis for proposed revisions to definitions in the section 414 recordkeeping regulations. Our previous description (78 FR 3646 at 3675-3676) of the current legal and regulatory framework that governs the determination of when an establishment is required to register as a food facility in accordance with the section 415 registration regulations focused on the framework that governs whether an establishment that grows and harvests crops or raises animals satisfies the definition of ``farm,'' because the facility registration requirements of section 415 of the FD&C Act do not apply to ``farms.'' Under that framework, a key factor in whether an establishment falls within the definition of ``farm,'' even with respect to crops it grows and harvests itself, is whether the activities conducted by the establishment fall within definitions of ``harvesting,'' ``packing'' or ``holding'' (which are within the ``farm'' definition). Another key factor is whether activities conducted by the establishment fall within the definition of manufacturing/processing (which have been outside the ``farm'' definition). We previously described comments regarding proposed revisions to the definitions of ``farm,'' ``harvesting,'' ``packing'' and ``holding,'' as well as comments regarding the triggers for an activity to be considered manufacturing/processing (79 FR 58524 at 58530-58538). In the 2014 supplemental human preventive controls notice, we proposed additional revisions to the definitions of ``farm,'' ``harvesting,'' ``packing,'' and ``holding'' to address these comments. Even after the revisions we proposed in the 2014 supplemental human preventive controls notice, some comments assert that the overall ``farm'' definition still presents an unrealistic and incomplete understanding of how most farms in the United States are structured with regard to their physical location(s) and business models. Most of the comments suggest alternative or additional regulatory text (see, e.g., Comment 22, Comment 23, Comment 24, Comment 25, Comment 27, Comment 37, Comment 39, and Comment 50) or ask us to clarify how we will interpret the provisions (see, e.g., Comment 26, Comment 28, Comment 29, Comment 40, Comment 41, Comment 42, Comment 43, Comment 44, Comment 47, and Comment 48). As discussed in section I.A, there are several FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food (see the seven foundational rules listed in table 1). Two of the proposed rules listed in table 1 (i.e., the 2013 proposed animal preventive controls rule and the 2013 proposed intentional adulteration rule) proposed to include a cross-reference to the ``farm'' definition in Sec. 1.227, and a third proposed rule (i.e., the 2013 proposed produce safety rule) proposed to establish the same ``farm'' definition as would be in Sec. 1.227. A fourth proposed rule (i.e., the 2013 proposed FSVP rule) did not propose to establish the ``farm'' definition (or a cross-reference to the ``farm'' definition in Sec. 1.227), but under its proposed definition of ``foreign supplier'' some foreign suppliers would be farms--i.e., establishments that harvest food that is exported to the United States. As a result, we received comments relevant to the ``farm'' definition for all of these rules. The majority of the comments submitted to these other rulemakings addressed issues that were the same as, or similar to, the issues raised in the comments submitted to this rulemaking. One comment submitted to the proposed rulemaking for the forthcoming FSVP rule requested clarification regarding harvesting companies, and we are also providing [[Page 55925]] that clarification in this rulemaking. See Response 32. We proposed to redesignate all definitions in Sec. 1.227 in the section 415 registration regulations (i.e., current Sec. 1.227) to eliminate paragraph designations (such as (a) and (b)). We received no comments that disagreed with our proposed redesignations and are finalizing them as proposed. We proposed several technical amendments and conforming changes to the section 415 registration regulations and to the section 414 recordkeeping regulations. No comments opposed the proposed technical amendments and conforming changes, except for comments noting that our proposed technical amendment to Sec. 1.361 was unnecessary because we had already made this change in a different rulemaking (see 77 FR 10662, February 23, 2012). We are finalizing these technical amendments and conforming changes without change. In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed definitions as shown in table 4, with editorial and conforming changes as shown in table 52. We also are establishing a new provision to allow off-farm establishments that package, pack, and hold RACs that are produce as will be defined in the produce safety rule to comply with the CGMPs in part 117, subpart B by complying with the applicable requirements for packing and holding that will be established in the final produce safety rule (see Sec. 117.8 and Response 25). Because the new provision refers to provisions in a future produce safety rule, we will publish a document in the Federal Register announcing the effective date of Sec. 117.8 once we finalize the produce safety rule. 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 production 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 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 harvesting (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 of Farm We proposed to revise the ``farm'' definition to: (1) Provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs; (2) include, within the ``farm'' definition, a description of packing activities that include packaging RACs grown or raised on a farm without additional manufacturing/processing; and (3) provide for drying/dehydrating RACs to create a distinct commodity (such as the on-farm drying of grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing, to remain within the farm definition. We also requested comment on whether we should retain, remove, or modify the phrase ``in one general physical location'' in the ``farm'' definition. (Comment 21) Most of the comments support our proposed revision to provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs. However, some comments oppose this proposed revision. Some comments ask us to require that a farm that packs, packs and sells, commingles lots, and holds produce grown on a farm under different ownership comply with the requirements of this rule for hazard analysis and risk-based preventive controls for six reasons: (1) Commingling. Contamination from one farm could find its way to another farm, leading to potential contamination of products from both farms, making it difficult to pinpoint the source of contamination in the event of a recall. (2) Recall Plan. It is critical for everyone in the produce supply chain to be ``recall ready,'' especially those packing, commingling lots, and selling produce grown on another farm under different ownership. (3) Traceability. It is important that produce be traceable from the specific farm where it was grown to the end-user, and from the end-user back to the farm where it was grown. (4) Exemptions. A covered farmer packing, packing and selling, commingling lots, or holding others' produce might be doing so from a farm that is exempt from the produce safety rule. (5) Supplier program. Under the [[Page 55926]] human preventive controls rule a farmer would be required to have a valid supplier program. (We note that a farmer might be a supplier to a facility that is subject to the human preventive controls rule, and could be subject to the facility's supplier program, but would not itself be required to ``have a valid supplier program.'') With this requirement, receiving facilities could purchase in confidence knowing that if the farm did pack others' produce it was produced in accordance with the rules required by FSMA. (6) Conflict with the National Organic Program (NOP). Under the NOP, a grower that purchases produce from another farm under different ownership, packs produce from another farm, or mixes produce is no longer considered a crop producer and must seek certification as a handler--an operation that has additional requirements to approve suppliers, segregate product, and maintain records necessary to demonstrate compliance. Comments assert that this NOP requirement is logical and is a practice that FDA should take into consideration. Other comments assert that allowing a farm to pack produce from another farm must account for the problem created by our proposal to exempt farm vehicles transporting RACs from the sanitary transportation rule. These comments argue that unless we revise that rule to prevent possible contamination during transport, we should develop guidance for farms packing produce that is transported from another farm, particularly where the commodity is high risk. (Response 21) The final ``farm'' definition continues to provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs. We have acknowledged that doing so would have consequences such as those described in these comments, as well as other consequences (see 79 FR 58524 at 58532). Although comments pointed out consequences that we had already considered, they did not point to any other consequences. Therefore, we affirm our tentative conclusion that impacts such as these, while not always optimal, are necessary to establish a sensible framework of risk-based regulations that both implement FSMA and reflect common farm activities. We intend to issue the final produce safety rule in the near future and respond to comments related to traceability of produce, including whether to include a requirement that a farm supplying produce to another farm that will pack or hold that produce should provide to the farm that receives the produce its name, complete business address, and description of the produce in any individual shipment, as well as respond to comments on whether it would be appropriate to also require the farm that receives the shipment maintain such record of information and, if so, for what specified period of time. In the 2014 proposed sanitary transportation rule, we explained our reasons for tentatively concluding that the sanitary transportation practices that would be required by that proposed rule are not necessary to prevent RACs from becoming adulterated during transportation by farms (79 FR 7006 at 7016, February 5, 2014). For example, we explained that we are not aware of instances in which insanitary conditions (e.g., improper temperature control, improper equipment construction, inadequate equipment cleaning) with regard to transportation operations conducted by farms involving the transportation of RACs have contributed to foodborne illness, regardless of whether the farms are conducting transportation operations for their own RACs or for others' RACs. We will consider comments we receive on our proposal to exempt farm vehicles transporting RACs from the sanitary transportation rule when we issue a final sanitary transportation rule. We will consider necessary guidance in light of the final sanitary transportation rule, but we note that good transportation practices are already included in our 1998 guidance for industry entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables'' (Ref. 13). (Comment 22) Some comments assert that farms are neither facilities nor establishments. These comments ask us to revise the ``farm'' definition to use a term more suited to the nature of farming. (Response 22) We consider a farm to be a type of ``establishment'' but have nonetheless revised the ``farm'' definition to refer to an ``operation'' rather than an ``establishment'' as requested by these comments. (Comment 23) Many comments address the role of ``ownership'' in the ``farm'' definition. Some of these comments emphasize that farming operations are complex, with complex business structures, and are often not held under sole ownership. Some comments describe the role of multiple business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and food hubs) in modern farming and ask us to revise the ``farm'' definition to provide for such business models. Other comments emphasize ownership of the land on which crops are grown or animals are raised, noting that some farms are operated by ``tenant'' farmers who do not own the land used in the farm's operations. Some comments ask us to replace the concept of ownership with the concept of a responsible party, such as a ``farm operator'' and to define a farm operator as ``the person or entity that has operational control over the farm and benefits in whole or in part from the farm's normal operation. A farm operator may be an owner, a tenant, a partner, or an employee.'' Some comments ask us to remove the phrase ``under one ownership'' to allow sugar makers who share equipment and sugarhouses to qualify as a farm. Other comments ask us to clarify how renting or leasing storage rooms or facilities would affect the definition of a farm. (Response 23) We have revised the ``farm'' definition by replacing the phrase ``under one ownership'' with the phrase ``under one management.'' Although the original phrase ``under one ownership'' was not referring to a single owner, we agree that the ``farm'' definition should reflect modern business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and food hubs) and use language that the modern farming community understands. We decline the request to define and introduce a new term, such as ``farm operator.'' The term ``management'' has a common meaning that captures the request of these comments and is suitable for the purposes of the farm definition. (Management. The person or persons controlling and directing the affairs of a business, institution, etc.) (Ref. 14). Under either the previous or the revised ``farm'' definition, leasing land to grow or store crops or raise animals does not impact whether an operation is within the ``farm'' definition. Under the previous definition, ``ownership'' focused on ownership of the business entity conducting farm operations, not ownership of the land. Leasing land is a business practice common to a variety of business types, not just farms. Likewise, leasing buildings to store RACs does not impact whether an operation is within the ``farm'' definition. See also Response 24 regarding comments on ``one general physical location.'' To the extent that sugar makers who share equipment and sugarhouses only conduct activities that are within the ``farm'' definition, the revision from ``under one ownership'' to ``under one management'' should clarify that those operations would be within the ``farm'' [[Page 55927]] definition. However, when sugar makers conduct operations outside the ``farm'' definition, they are facilities that are required to register under the section 415 registration regulations, not ``farms'' that are exempt from that registration requirement. A sugar maker that is a small or very small farm mixed-type facility that only conducts the low-risk activity/food combinations listed in the exemptions in Sec. 117.5(g) and (h) (such as making syrup and sugar (e.g., making maple syrup from maple sap)) is exempt from the requirements of this rule. However, a farm mixed-type facility that is not a small or very small business as those terms are defined in this rule, or that conducts activities in addition to the low-risk activity/food combinations listed in the exemptions in Sec. 117.5(g) and (h), is subject to the requirements for hazard analysis and risk-based preventive controls. Consistent with the discussion in Response 228, a farm mixed-type facility that must comply with the requirements for hazard analysis and risk-based preventive controls and makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (i.e., that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. For additional information about the section 103(c)(1)(C) RA and the exemptions for on-farm low-risk activity/food combinations for farm mixed-type facilities that are small or very small businesses, see sections VI and XI.G. (Comment 24) Many comments address the role of ``one general physical location'' in the ``farm'' definition and ask us to revise the ``farm'' definition to acknowledge that farms may be composed of multiple parcels, buildings, or structures that may or may not be contiguous. Some comments point out that there are many farming operations that may fall under the same management and ownership, but are separated by either a strip of land, body of water, or another structure, particularly with respect to sites designated for packing and holding operations. Some comments assert that as long as an economic unit is operating a farm it should be irrelevant where the land is located, and state that this interpretation is consistent with a USDA definition of a ``farm operator.'' Some comments note that sugar makers rely on sap from existing stands of trees that are often not concentrated in a single area or even nearby the sugarhouse where the maple products are made. Some comments suggest that the term ``reasonable distance'' could be used to better define ``general physical location.'' Some comments ask us to issue guidance that will clarify and further designate the boundaries of ``one general physical location.'' Some comments note that the ``farm'' definition we proposed in the 2014 supplemental human preventive controls notice correctly considers a farm operation to remain within the ``farm'' definition even if it packs and holds produce from another farm. However, these comments state that it is confusing that if the same two farms pack and hold produce together at an off-farm location, using the exact same practices, that packing location is considered a ``facility'' even though there is no difference in risk. Other comments state that both in-line and off-line egg production facilities should be considered farms. According to these comments, off-line egg production facilities receive eggs laid by hens at nearby farms, whereas in-line egg production facilities receive eggs laid by hens in henhouses adjacent to the plant and located on the same property. Some comments ask us to retain ``one general physical location'' in the ``farm'' definition because the word ``farm,'' and USDA's definition of ``farm,' are ``place-based.'' Other comments assert that if we delete the phrase ``in one general physical location'' then a fully integrated operation could be a single farm even though it was made up of numerous distinct farms possibly in several different states. Other comments ask us to retain ``one general physical location'' in the ``farm'' definition because different locations may have different food safety risks, different water sources, different personnel, and even different types of crops. Some comments assert that considering each unique and individually State-permitted dairy farm to be an individual ``farm'' regardless of common ownership or geographic proximity will prevent conflict and interference with the permitting and inspection activities of the Grade ``A'' program while maintaining food safety. Other comments state that regardless of whether we retain ``one general physical location'' in the ``farm'' definition, we must interpret the term ``farm'' to cover a very limited geographic area and that separate locations that are not in close proximity to each other should not be considered the same ``farm.'' (Response 24) We have revised the ``farm'' definition to specify that a farm is ``in one general (but not necessarily contiguous) physical location.'' We have concluded that adding ``not necessarily contiguous'' makes it clear that farming operations that are under one management but have some physical separation (e.g., with respect to the location of packing operations) can remain within the ``farm'' definition and that both in-line and off-line egg production facilities would be considered ``farms.'' We agree that separate locations that are not in close proximity to each other should not be considered the same ``farm.'' As the comments point out, there already is a framework of State inspections for farms such as dairy farms, and we will need to work with our State regulatory partners to identify farms covered by the produce safety rule. However, even without the new phrase ``not necessarily contiguous,'' some situations would be complex. We intend to address these types of situations with our State food safety partners. (See Response 5.) We do not see that adding ``not necessarily contiguous'' creates a ``farm'' definition that is not ``place-based,'' as was asserted by some comments, because the definition continues to specify ``in one general physical location.'' We also do not see that adding ``not necessarily contiguous'' presents any food safety concerns, as asserted by comments noting that different locations may have different food safety risks, different water sources, different personnel, and different types of crops. For example, a farm that will be covered by the forthcoming produce safety rule will be subject to standards for all of its water sources, all of its personnel, and all food subject to that rule. Likewise, we also do not believe that adding ``not necessarily contiguous'' affects a determination of whether a fully integrated operation could be a single farm. (Comment 25) Some comments ask us to consider revising the regulatory text to ensure that similar activities would be treated the same way under either the produce safety rule or the human preventive controls rule and be held to the same risk-based requirements. These comments point out some of the differences between the requirements that would be established under the proposed human preventive controls rule and the requirements that would be established under the proposed produce safety rule. For example, comments state that the proposed human [[Page 55928]] preventive controls rule, but not the proposed produce safety rule, would require off-farm packinghouses and off-farm cooling and storage facilities to have a written hazard analysis; written preventive controls; written procedures for monitoring and corrective actions; validation of process controls; a written recall plan; environmental monitoring and product testing requirements; and a written supplier program. As another example, comments state that off-farm packing and holding operations would be required to comply with the human preventive controls rule one year earlier than we proposed that similar sized on-farm packing and holding operations would be required to comply with the forthcoming produce safety rule. Some comments recommend options to achieve the goal of regulating on-farm and off-farm packinghouses the same way. These options include adding an exclusion to the ``farm'' definition in the produce safety rule; adding provisions to the human preventive controls rule to enable off-farm packinghouses to meet their obligation by complying with specified, applicable subparts of the produce safety rule; shortening the ``farm'' definition to simply state ``Farm means an establishment under one ownership devoted to the growing and/or harvesting of crops, the raising of animals (including seafood), or any or all of these activities;'' addressing off-farm establishments engaged solely in ``low-risk'' farming and harvesting activities by adding low-risk activities such as hulling, shelling, and drying of tree nuts; expanding the scope of the produce safety rule to include registered facilities; and allowing modified requirements in the human preventive controls rule to allow off-farm packinghouses to be subject to requirements (and exemptions) of the produce safety rule within the framework of the human preventive controls rule. Some comments emphasize that farm activities are farm activities, regardless of where they happen. Some comments assert that establishments that are engaged solely in traditional harvesting, holding, or packing activities associated with a RAC that will be covered by the produce safety rule should be subject to the produce safety rule, rather than the human preventive controls rule, regardless of physical location, ownership, or legal ties to an operation devoted to the growing and harvesting of produce. Some comments assert that an off-farm operation that packs and holds RACs could be regulated in an identical fashion to an on-farm operation that packs and holds RACs without changing the section 415 requirement for registration by making them subject to the requirements of the produce safety rule for compliance purposes. Some comments ask us to provide an exemption from, or waiver for, the requirements of the human preventive controls rule if a business entity provides documentation that the entity is following the standards of the produce safety rule even though it is not on a farm. Other comments ask us to clarify that a farm can pack or hold RACs that have already undergone packing or holding activities by another farm. Some comments ask to revise the ``farm'' definition to include establishments solely engaged in ``packing'' and ``holding'' activities performed on RACs, regardless of whether the establishment grows crops. Other comments emphasize that any revisions to the ``farm'' definition must allow genuine farm operators to carry out harvesting, packing, and holding without opening loopholes for packing and processing businesses. Some comments ask us to revise the ``farm'' definition to provide for a multi-ownership operation provided that all of the partial owners are themselves farmers. Some comments ask us to provide that off-farm packing and holding operations that do not change the status of a RAC into a processed food should be able to comply with either the produce safety rule or with the CGMPs in subpart B of the human preventive controls rule. According to these comments, we could simply apply the same logic that we applied when providing that the packing and holding of RACs that have been dried/dehydrated to create a distinct commodity that is a processed food (i.e., no longer a RAC) may achieve compliance with the CGMP requirements by complying either with subpart B of the human preventive controls rule or by complying with the applicable requirements for packing and holding produce RACs in the produce safety rule (see Sec. 117.5(k)(2)). (Response 25) We have revised the ``farm'' definition to provide for two types of farms: (1) A primary production farm and (2) a secondary activities farm (see Sec. 117.3). We use the term ``primary production farm'' to refer to the ``farm'' definition as proposed, with the revisions described in this final rule. We use the term ``secondary activities farm'' to mean an operation, not located on a primary production farm, devoted to harvesting (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. With the added definition of ``secondary activities farm,'' off-farm packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the ``farm'' definition. We are making these changes to reflect the current reality of what it means to be a farm. The changes will allow farms that use certain business models to harvest, pack, and/or hold produce to be able to comply with the produce safety rule for all of their operations. We believe that this flexibility allows for the requirements of the produce safety rule to apply to a wider array of activities than our original proposal without opening the ``farm'' definition to operations that have no connection to the growing of crops or the raising of animals--the core activities of a farm. By specifying that the farms that grow or raise the majority of the RACs harvested, packed, and/or held by the operation must own, or jointly own, a majority interest in the secondary activities farm, the revised ``farm'' definition does, as requested by comments, allow ``farms'' to carry out harvesting, packing, and holding activities in the same way as the produce safety rule. We are, as requested by some comments, establishing a new provision to allow off-farm establishments that package, pack, and hold RACs that are produce as will be defined in the produce safety rule to comply with the CGMPs in part 117, subpart B by complying with the applicable requirements for packing and holding that will be established in the final produce safety rule (see Sec. 117.8). Because the new provision refers to provisions in a future produce safety rule, we will publish a document in the Federal Register announcing the effective date of that provision once we finalize the produce safety rule. However, the revised ``farm'' definition does not, as requested by some comments, establish the exact same regulatory framework for operations, such as certain packinghouses and hulling/shelling operations, that are within the ``farm'' definition as for operations that conduct similar activities but are outside the ``farm'' definition by allowing off-farm operations to be subject to the produce [[Page 55929]] safety rule rather than the requirements for hazard analysis and risk- based preventive controls. We disagree that the statutory framework provides flexibility for entities such as packinghouses and hulling/ shelling operations that do not have a connection to a farm to be subject to the requirements of the produce safety rule for compliance purposes. (See the discussion at 79 FR 58524 at 58536.) We continue to believe that an off-farm packinghouse that is subject to this rule will be able to draw from the provisions of the produce safety rule in developing its food safety plan and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. For example, as previously discussed (79 FR 58524 at 58536) we expect that the food safety plan for an off-farm packinghouse would focus on a few key preventive controls, including some that would have counterparts in the proposed produce safety rule, such as maintaining and monitoring the temperature of water used during packing (which would have counterparts under proposed Sec. 112.46(c) in the proposed produce safety rule). We also expect that an off-farm packinghouse would establish sanitation controls to address the cleanliness of food- contact surfaces (including food-contact surfaces of utensils and equipment) and the prevention of cross-contamination from insanitary objects and from personnel to food, food-packaging material, and other food-contact surfaces. On-farm packinghouses would be subject to similar, but not identical, requirements (see e.g., proposed Sec. 112.111(b) for cleanliness of food-contact surfaces and proposed Sec. 112.113 for protection against contamination). We acknowledge that some of the provisions of the human preventive controls rule have no explicit counterparts in the proposed produce safety rule (e.g., the requirements for product testing and environmental monitoring as verification activities). As discussed in Response 525, we do not expect either product testing or environmental monitoring to be common in facilities that process, pack, or hold produce RACs. Finally, in response to comments that ask for a clarification that a farm can pack or hold RACs that have already undergone packing or holding activities by another farm, we presume that the commenter was asking about a case where the farm that did the previous packing and holding activities was not the farm on which the RACs were grown and harvested. The definition of ``farm'' allows packing and holding of one's own RACs and other's RACs, even if they have been previously packed or held by another farm that was not the farm on which the RACs were grown and harvested. (Comment 26) Some comments ask us to clarify whether the ``and'' between provisions that allow a farm to dry/dehydrate RACs to create a distinct commodity, and provisions that allow a farm to package and label RACs, means that an operation must do both of these activities to remain within the farm definition. These comments state that they do not think this is the intended (or logical) outcome, which is to provide that farms can do either or both activities and still be within the farm definition and ask us to consider editorial changes (such as replacing ``and'' with ``or,'' or adding a new paragraph that would encompass both activities). (Response 26) The rule does not require a farm to do both activities (i.e., drying/dehydrating RACs to create a distinct commodity, and packaging and labeling RACs) to remain within the farm definition. (Comment 27) Some comments ask us to add artificial ripening of RACs as an activity that is within the farm definition. Some comments assert that artificial ripening of RACs is not manufacturing/processing because artificial ripening does not transform a RAC into a processed food. (Response 27) We have revised the ``farm'' definition to specify that treatment to manipulate the ripening of RACs (such as by treating produce with ethylene gas), and packaging and labeling the treated RACs, without additional manufacturing/processing, are within the ``farm'' definition. We agree that a treatment such as artificial ripening does not transform a RAC into a processed food but disagree that such a treatment is not manufacturing/processing. To make that clearer, we have added ``treating to manipulate ripening'' to the list of examples of manufacturing/processing in the definition of that term. As discussed during the rulemaking to establish the section 415 registration regulations, artificial ripening constitutes manufacturing/processing because it involves treating, modifying, or manipulating food (68 FR 58894 at 58912, October 10, 2003). See also our previous statements about artificial ripening in this rulemaking (78 FR 3646 at 3683 and 79 FR 58524 at 58572). As previously discussed, the activities that transform a RAC into a processed food (and are sometimes therefore referred to as ``processing'' in the context of a food's status as a RAC or processed food) are not coextensive with the activities described in our definition of ``manufacturing/processing'' (78 FR 3646 at 3679). When we first established the section 415 registration regulations, a key criterion in determining whether a business entity was a ``farm'' or a ``facility'' was whether the operation conducted activities classified as ``manufacturing/processing.'' Indeed, in the 2013 proposed preventive controls rule we continued to rely on that key criterion in proposing revisions to the ``farm'' definition. However, as already discussed, some changes to the ``farm'' definition are necessary to establish a sensible framework of risk-based regulations that both implement FSMA and reflect common farm activities (see Response 21). One of these changes is to specify those manufacturing/processing activities that are within the ``farm'' definition, rather than attempt to re-classify an activity that arguably is manufacturing/processing as harvesting, packing, or holding in order to provide for the activity to remain within the ``farm'' definition. (Comment 28) Some comments disagree that we should provide for drying/dehydrating RACs to create a distinct commodity to be within the ``farm'' definition because this activity is a manufacturing/processing activity and should be subject to the requirements for hazard analysis and risk-based preventive controls. Other comments agree that we should provide for this activity but assert that ``drying/dehydrating RACs to create a distinct commodity'' is confusing to the average reader and ask us to add examples of what this means. Some comments ask us to clarify whether this activity applies to specific situations, such as drying/baling of hops (because hops are a low-risk product and beer brewing should eliminate any pathogens on the hops), drying plums to create prunes, and concentrating maple sap into maple syrup, cream, and candy. Some comments assert that maple syrup should be considered a RAC because the process of producing maple syrup mirrors the regulatory text ``drying/dehydrating RACs to create a distinct commodity,'' because maple syrup can only be produced through the concentration of maple sap and the process of that concentration is akin to the harvesting of other raw products. Other comments assert that the processing of sap is more appropriately viewed as a harvesting activity (rather than food manufacturing). [[Page 55930]] Other comments ask us to clarify the specific methods of drying/ dehydrating that we would consider to be within the ``farm'' definition--e.g., whether drying/dehydrating is constrained to in situ, with no heat or mechanical air circulation, because the example we discussed in the 2014 supplemental preventive controls notice was ``natural condition raisins.'' These comments ask us to specify the allowable methods of drying to avoid confusion, and assert that there is no food safety reason to exclude use of heat or air, especially if sun and light are to be permitted. Other comments ask us to clarify what we mean by ``without additional manufacturing/processing.'' (Response 28) We are retaining drying/dehydrating RACs to create a distinct commodity as an activity that is within the ``farm'' definition even though it is manufacturing/processing. As previously discussed, the processes (described in comments to the 2013 proposed human preventive controls rule) for drying grapes to ``natural condition raisins'' are akin to other harvesting activities traditionally conducted by farms on RACs grown and harvested on farms, because they are traditionally performed by farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as food (79 FR 58524 at 58533). As also previously discussed, the information provided by the comments to the 2013 proposed human preventive controls rule included information that ``natural condition raisins'' are produced with either sun-drying or artificial dehydration (79 FR 58524 at 58533). We did not intend to limit the processes for drying/dehydrating RACs to sun-drying, and the regulatory text includes no such limitation. We decline the request to specify specific methods of drying/dehydrating that would remain within the ``farm'' definition because doing so could imply that the list of methods was exhaustive and preclude use of new technology in the future. However, we are adding ``boiling'' and ``evaporating'' to the list of activities that we classify as manufacturing/processing to preclude interpretations, such as those expressed in some of these comments, that the processes to produce products such as maple syrup, maple cream, and maple candy are ``drying/dehydrating.'' In the 2013 proposed human preventive controls rule we included ``Boiling/evaporation of maple sap to make maple syrup'' as a low-risk manufacturing/processing activity/food combination in the exemption for small and very small businesses that only conduct specified on-farm low-risk activity/food combinations (proposed Sec. 117.5(h)), and we have retained--and broadened--that activity/food combination as an on-farm, low-risk manufacturing/processing activity/food combination in the final human preventive controls rule (see Sec. 117.5(h), which includes making sugar and syrup from fruits and vegetables (e.g., dates), grains (e.g., rice, sorghum), other grain products (e.g., malted grains such as barley), saps (e.g., agave, birch, maple, palm), sugar beets, and sugarcane). Processes such as ``boiling,'' ``concentrating,'' and ``evaporating'' are not ``drying/dehydrating'' as the term ``drying/ dehydrating'' is used in this rule, and maple syrup is a processed food, not a RAC. See also the discussion in Response 23 regarding how a farm mixed-type facility that makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (i.e., that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A farm mixed-type facility that makes maple products from maple sap could follow the same approach. We have added ``slicing'' to the regulatory text as an example of additional manufacturing/processing that would be outside the ``farm'' definition. We also have added ``drying/dehydrating grapes to produce raisins'' to the regulatory text as an example of what we mean by ``drying/dehydrating RACs to create a distinct commodity.'' Drying plums to produce prunes is another example of drying/dehydrating RACs to create a distinct commodity. Drying/baling hops is within the ``farm'' definition, but as a ``holding'' activity because drying/ baling hops does not create a distinct commodity. As discussed in Response 39, we have revised the definition of ``holding'' to add drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa) as an example of a holding activity. (Comment 29) Some comments agree that the activities of packaging and labeling RACs should remain within the ``farm'' definition but ask us to reclassify these activities so that they are not considered manufacturing/processing because they do not transform a RAC into a processed food or change the nature of the RAC. These comments ask us to add examples to regulatory text to explain what we mean by ``packaging and labeling without additional manufacturing/processing.'' As an example, these comments ask whether a farm that packs produce grown by another farm, and washes the produce before packing it, would be conducting ``additional manufacturing/processing.'' Other comments ask us to clarify whether packaged RACs are processed food because ``packaging'' is defined as a manufacturing/ processing operation. These comments also ask us to clarify whether a farm would be precluded from holding RACs packaged in retail form because the packaged RACs are processed food. (Response 29) See Response 27. We decline the request to reclassify packaging and labeling so that they would not be considered manufacturing/processing. Although we classify packaging and labeling as manufacturing/processing, packaging and labeling RACs do not transform the RACs into processed food, and we classify ``packaged RACs'' as RACs. We classify washing RACs as a harvesting or packing activity when done on RACs before or during packing or packaging, regardless of whether a farm is packing or packaging its own RACs or others' RACs. As requested by the comments, we have added an example of additional manufacturing/processing that would not be within the ``farm'' definition--i.e., irradiating--to both the ``farm definition'' and to the definition of ``manufacturing/processing.'' This example is different from the example we used in the preamble of the 2014 supplemental human preventive controls notice to describe a limitation on activities within the ``farm definition''--i.e., ``modified atmosphere packaging'' (see 79 FR 58524 at 58532). We have decided to not restrict the specific types of packaging procedures that are within the ``farm'' definition because doing so could be confusing. Moreover, the specific safety concern that can be associated with modified atmosphere packaging (i.e., the production of Clostridium botulinum toxin), would be addressed by a proposed provision in the forthcoming produce safety rule, if that provision is finalized (see proposed Sec. 112.115; 78 FR 3504 at 3589 and 3638). To clarify that ``modified atmosphere packaging'' is a type of ``packaging,'' we have revised the definition of ``manufacturing/processing'' to specify ``packaging (including modified atmosphere packaging)'' as an example of a manufacturing/processing activity. (Comment 30) Some comments assert that non-produce botanicals require treatments that do not create a new commodity and ask us to recognize these treatments as farm activities rather than manufacturing/processing activities. As examples, these comments [[Page 55931]] assert that activities such as cutting, slicing, drying, freezing, wet or dry heat treating to kill plant tissues, and aging or fermenting are all activities that are traditionally performed by farms on non-produce botanicals for the purpose of removing non-produce botanical RACs from the place where they were grown and preparing them for use as food. These comments also assert that we have been inconsistent in our activity classifications because we both state that ``heat treatment'' is a food processing activity and state that activities traditionally performed by farmers to prepare crops for use are farm activities. These comments express concern that farmers won't use heat treatments to control pests, based on a misunderstanding of what constitutes ``food processing.'' (Response 30) We note that these comments used the term ``non- produce botanicals,'' which is not a term we have used or defined, and it is not clear to us what the commenters intended this term to represent. In this document, we are not addressing the question of whether certain ``botanicals'' are or are not ``produce.'' The term ``produce'' was proposed to be defined in the forthcoming produce safety rule, and we intend to define it in that rule. However, we can address in this rule these commenters' questions about activity classification. Some of these activities are within the ``farm'' definition. For example, drying/dehydrating a RAC without creating a distinct commodity is part of ``holding'' and drying/ dehydrating a RAC that creates a distinct commodity, without additional manufacturing/processing, is manufacturing/processing that is included within the ``farm'' definition. (See Response 28.) Cutting (or otherwise separating) the edible portion of the RAC from the crop plant and removing or trimming part of the RAC (e.g., foliage, husks, roots or stems) are harvesting activities. (See Response 37.) We have revised the definition of ``holding'' to include the example of ``fumigating food during storage.'' (See Response 39.) We decided to include this example of a holding activity based on previous discussions of how we classify fumigating as a type of pest control (see, e.g., 78 FR 3646 at 3682 and 79 FR 28524 at 28571). Although we have not previously classified heat treatment for purposes of pest control, we agree that we should classify heat treatment for purposes of pest control the same way that we have classified fumigating for purposes of pest control-- i.e., as a holding activity. Regarding classification of the other activities listed in these comments, see Response 3. (Comment 31) Some comments assert that the ``farm'' definition is too limited and ask us to include standard farm activities such as culling, conveying, sorting, waxing, labeling, storing, packaging and shipping of raw, whole produce. These comments assert that these normal activities do not change the shape or structure of RACs, or alter the hazards, and should be covered under the produce safety rule rather than the human preventive controls rule. (Response 31) All of the activities described by these comments could be within the ``farm'' definition (see 79 FR 58524 at 58571- 58572), either because they are specified in the ``farm'' definition itself or because they are examples of activities within the definition of ``packing'' or holding.'' Packaging and labeling RACs, without additional manufacturing/processing, are specified in the regulatory text of the ``farm'' definition. Sorting and culling are included in the regulatory text of the definition of ``packing.'' Storing is simply another term for ``holding.'' We had already included ``weighing and conveying'' as an example of a low-risk packing or holding activity in the exemption applicable to on-farm low-risk activity/food combinations (Sec. 117.5(g)). To give more prominence to this packing activity, we have added it to the definition of ``packing'' as well. (Comment 32) One comment, submitted to Docket No. FDA-2011-N-0143 for the FSVP rulemaking, notes that RACs often are harvested by a contract harvest company (Ref. 16). This comment asks us to clarify what is meant by ``establishment that harvests a food'' in the definition of ``foreign supplier'' and whether, in such circumstances, the supplier of the RAC would be the contract harvest company or the establishment that owns the crop and sells it to an importer. (Response 32) The 2014 supplemental human preventive controls notice had similar phrasing (``establishment that harvests the food'') in the definition of ``supplier.'' In the final rule the definition of ``supplier'' has changed in relevant part to include the ``establishment that grows the food,'' consistent with changes to the farm definition and as described in the following paragraphs. There are several different business models in which RACs are harvested by a contract harvester (Ref. 17). In one business model, a grower contracts with a harvester to perform harvesting on behalf of the grower. In another business model, a third-party handler enters into separate contracts with the grower and the harvester. In another business model, a grower sells its crop to an entity that contracts with a separate harvester to harvest the RACs and then packs the RACs. There are variations on these business models, such as when a grower sells its crop to an entity that both harvests and packs the RACs, without a contract with a separate harvester. Growing and harvesting operations are not under the same management in some of these business models. As discussed in Comment 23, comments emphasize that farming operations can have complex business structures, and ask us to revise the ``farm'' definition to provide for these business models. To explicitly include these business models in the ``farm'' definition, we have revised the ``farm'' definition to mean an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. With this revision, an operation can be within the ``farm'' definition if it grows crops but does not harvest them or if it harvests crops but does not grow them. The ``farm'' definition established in the section 415 registration regulations in 2003 (68 FR 58894), and the proposed revisions to the ``farm'' definition in the 2013 proposed human preventive controls rule and the 2014 supplemental human preventive controls notice, all describe a ``farm'' as an entity ``devoted to the growing and harvesting of crops'' (emphasis added). In light of the revision to the ``farm'' definition and as discussed more fully in section IX.C.35, we have revised the ``supplier'' definition to include the establishment that ``grows the food'' rather than the establishment that ``harvests the food.'' With this change in the ``supplier'' definition, the supplier is the farm that grows the food regardless of the business model for harvesting the food. (Comment 33) Some comments ask us to modify the ``farm'' definition to exclude feed mills that provide feed to more than 5 other farms. These comments assert that egg farms are most likely to be company owned and the median number of farms owned by a company is under 8 and cite USDA as the source of this information. These comments assert that setting the limit at 5 would not automatically exempt feed mills operated by these large egg laying businesses from the animal preventive controls rule. (Response 33) We decline this request. The statutory exemption from [[Page 55932]] the section 415 registration regulations (and, thus, from the requirements for hazard analysis and risk-based preventive controls) for ``farms'' is based on the activities that an operation conducts rather than on the size of the operation. (Comment 34) Some comments assert that the hulling or dehydration of walnuts should not be considered processing and, thus, that an establishment that conducts hulling or dehydration activities on tree nuts such as walnuts should not be considered a facility subject to the requirements for hazard analysis and risk-based preventive controls. These comments also assert that all growers who hull and dry should operate under the same rules, regardless of whether or not they own their own crop. Some comments assert that the hulling and shelling operations in the nut industry are part of the harvesting operation in which the outer shells are removed. These comments state that regardless of whether activities are conducted on the farm in which they are grown or at an off-farm facility that provides hulling and shelling services, the food is a RAC, the activity is low-risk and does not transform the RAC into a processed food, and the product is delivered to a processing facility and is not distributed in commerce. The comments argue that for all these reasons and because hulling and shelling activities are not subject to subpart B, it is not appropriate to subject facilities that conduct such activities to subpart C. Comments request that hulling, shelling, and drying of tree nuts be considered ``on farm'' for the purposes of this rule. Other comments ask us to specify that the production of ``natural dried raisins,'' dried plums, and dried hops are within the ``farm'' definition. (Response 34) Hulling of tree nuts (such as walnuts, almonds, and pistachios) is a harvesting activity that is within the ``farm'' definition when conducted on a farm or the farm part of a farm mixed- type facility. Drying/dehydrating RACs without creating a distinct commodity (such as drying walnuts and hops) is a holding activity that also is within the ``farm'' definition when conducted on a farm or farm mixed-type facility. As discussed in Response 25, we have revised the ``farm'' definition to provide that an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the ``farm'' definition (as a ``secondary activities farm''), 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. Drying/dehydrating RACs (such as grapes and plums) to create a distinct commodity, and packaging and labeling such commodities, without additional manufacturing/processing is within the ``farm'' definition when conducted on a farm or farm mixed-type facility. (See Response 28.) However, additional manufacturing/processing activities (such as removing pits from dried plums) are outside the ``farm'' definition, and a farm or farm mixed-type facility that conducts such activities becomes a facility that is required to register and is subject to the requirements for hazard analysis and risk-based preventive controls for those activities outside the farm definition. The exception is when a farm is a small or very small business eligible for the exemptions in Sec. 117.5(g) and (h) for a farm mixed-type facility that only conducts low-risk activity/food combinations. Such a small or very small business must still register as a food facility, but will be exempt from the requirements for hazard analysis and risk- based preventive controls. (See also the discussion in in the 2014 supplemental human preventive controls notice (79 FR 58524 at 58533- 58534 and table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572)). (Comment 35) Some comments assert that we have referred to raw milk as being ``inherently dangerous'' and should not consider any activities that result in the preparation of an inherently unsafe product for sale to consumers to be within the ``farm'' definition (i.e., production of raw milk for direct human consumption should not be considered ``harvesting'' or ``packing''). These comments ask us to re[hyphen]consider the definition of ``farm'' as it applies to the production of raw milk for human consumption. Specifically, these comments ask us to consider such activities to be outside the traditional business of a dairy farm and to subject businesses that conduct such activities to FSMA's requirements for hazard analysis and risk-based preventive controls requirements as a means of advancing public health. (Response 35) We decline this request. Producing milk is a traditional activity of a dairy farm, regardless of whether the milk produced by that dairy farm is pasteurized and introduced into interstate commerce in accordance with Sec. 1240.61 (Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption) or sold unpasteurized to consumers within a State consistent with applicable State laws and regulations. Distributing raw milk in interstate commerce would be unlawful, but would not form the basis for a decision that the business is ``not a farm.'' (Comment 36) Some comments express concern that farmers who grow seed that is sold as animal feed must register as a food facility. These comments ask why sales of grain for animal feed are included in a rule that is focused on the safety of human food and ask us to exempt this category of farms and their sales of grain for animal feed from the registration rule. (Response 36) Establishments that satisfy the ``farm'' definition, including farms that grow seed that is sold as animal food, are not required to register as a food facility. These comments may mistakenly believe that we intended any food establishment that is required to register as a food facility to comply with the regulations we are establishing in part 117 regarding human food, regardless of whether the facility produces food for consumption by humans or food for consumption by animals. This is not the case. We simply proposed to revise definitions in the section 415 registration regulations relevant to the definition of ``facility'' in the same notice in which we proposed to modernize the current CGMPs for food and establish requirements for hazard analysis and risk-based preventive controls for human food, because section 103 of FSMA addresses the definitions in the section 415 registration regulations, as well as the requirements for hazard analysis and risk-based preventive controls. If a facility sells grain for use as animal food, and is not exempt from the section 415 registration regulations, that facility would be subject to the animal preventive controls rule, not the human preventive controls rule that is the subject of this document. C. Proposed New Definition of Harvesting We proposed to define ``Harvesting,'' as a new definition in Sec. Sec. 1.227 and 1.328, to apply to farms and farm mixed-type facilities and to mean activities that are traditionally performed by farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as food. We proposed that harvesting be limited to activities performed on RACs on a farm, and that harvesting does not include activities that transform a RAC into a processed [[Page 55933]] food. The proposed definition included examples of activities that would be harvesting. As noted in table 52 of this document, we have reorganized the listed examples of harvesting to present them in alphabetical order. We also have modified the proposal that harvesting be limited to activities performed on RACs on a farm to provide that harvesting can also be performed on processed foods created by drying/ dehydrating a RAC without additional manufacturing/processing, because processed foods created by drying/dehydrating RACs are within the ``farm'' definition. See Response 28 and 79 FR 58524 at 58533 regarding drying/dehydrating RACs to create a distinct commodity. (Comment 37) Some comments ask us to provide more examples of harvesting activities, in the regulatory text and in guidance. Examples of the requested activities include braiding; bunching; cutting the edible portion of the crop from the plant; hydro-cooling; maintaining hydration of product; refrigerating; removing foliage; removing free water from (e.g., spinning); removing or trimming roots; trimming the tops of bunches of allium crops such as leeks, chives, or garlic and root crops such as carrots, beets, turnips, parsnips, etc. to prepare them for sale; and trimming the lower stems of harvested herb crops such as parsley, basil, or cilantro, or the lower stems of leafy greens. Other comments ask us to specify that harvesting also encompasses seed conditioning (i.e., cleaning the seed, including removal of leaves, stems, and husks to prepare for marketing), ripening (artificial or natural) of fruit, and waxing or coating of RACs. (Response 37) We have added or modified several examples of harvesting in the regulatory text (i.e., cutting (or otherwise separating) the edible portion of the RAC from the crop plant, removing or trimming part of the RAC (e.g., foliage, husks, roots or stems), field coring, and hulling). In table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571- 58572), we provided a more extensive list of examples of harvesting activities, including examples that are not in the regulatory text. Although we have classified some of these activities in more than one way (see 79 FR 58524 at 58571-58572), in general these activities would fall within the ``farm'' definition when conducted on RACs that are not otherwise processed. For example, coating RACs with wax/oil/resin for the purpose of storage or transport can be a packing (not harvesting) activity, but waxing also has long been considered a manufacturing/ processing activity during the production of processed food (because it involves making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food) (see 78 FR 3646 at 3679). Artificial ripening of fruit is manufacturing/processing (not harvesting), but is now within the ``farm'' definition (see Sec. 117.3 and Response 27). Regarding classification of the other activities listed in these comments, see Response 3. (Comment 38) Some comments assert that fermenting cocoa beans and coffee beans should be classified as ``harvesting'' rather than ``holding.'' (Response 38) We agree that the process of fermenting cocoa beans and coffee beans begins as a ``harvesting'' activity, when the pods are harvested and the beans are removed; it continues as ``holding,'' while the harvested beans ferment. Thus, fermenting cocoa beans and coffee beans has elements of both ``harvesting'' and ``holding,'' which are both within the ``farm'' definition. It is not necessary to place the process of fermenting cocoa beans and coffee beans squarely in one activity or the other for the regulatory purpose of determining whether an operation is within the ``farm'' definition. See also Response 41. D. Proposed Revision to the Definition of Holding We proposed to revise the definition of ``Holding'' in Sec. Sec. 1.227 and 1.328 to add that holding also includes activities performed incidental to storage of a food, but does not include activities that transform a RAC into a processed food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. (Comment 39) Some comments ask us to provide more examples of holding activities, in the regulatory text and in guidance. Examples of the requested activities include fumigating RACs; application of chemicals (including fungicides, sanitizers, and anti-oxidants); application of ripening agents; using wax as a carrier of fungicides or anti-oxidants applied before storage; and waxing or coating of RACs, including ``coating'' grain RACs with diatomaceous earth to control insects. According to these comments, these activities are incidental to storage and do not transform RACs into processed food. (Response 39) We have added or modified several examples of holding in the regulatory text (i.e., fumigating food during storage, and drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). In table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572), we provided a more extensive list of examples of holding activities, including examples that are not in the regulatory text. We have previously classified some of these activities in more than one way (see 79 FR 58524 at 58571- 58572) depending on when the activity occurs. For example, sorting, culling, and grading RACs can be either a holding activity or a packing activity. Drying/dehydrating RACs is holding when the drying/ dehydrating does not create a distinct commodity, but is manufacturing/ processing when the drying/dehydrating creates a distinct commodity (see Response 28). Regarding classification of the other activities listed in these comments, see Response 3. (Comment 40) Some comments ask us to clarify that mixing or blending intact RACs is considered ``holding'' regardless of whether the RACs are the same or different. (Response 40) We use the term ``blending'' when referring to RACs such as grain and when the RACs are the same. For example, we consider the activity of ``blending'' different lots of the same grain to meet a customer's quality specifications to be a practical necessity for product distribution and, thus, to be within the definition of ``holding'' (see 79 FR 58524 at 58537). However, we use the term ``mixing'' when the RACs are different. For example, we consider the activity of ``mixing'' corn and oats in the production of animal food to be manufacturing/processing, because mixing two different foods is ``making food from one or more ingredients'' (which is our definition of ``manufacturing/processing''), and the animal food produced by mixing corn and oats is a processed food. We classify ``mixing'' intact RACs that does not create a processed food as incidental to, and therefore part of, ``packing'' or ``holding'' as applicable. (Comment 41) Some comments ask us to clarify whether the expanded definition of holding that we proposed in the 2014 supplemental human preventive controls notice would mean that a warehouse that both stores cocoa beans and fumigates the cocoa beans to prevent pest infestation would be exempt from the requirements for hazard analysis and risk- based preventive controls for a facility solely engaged in the storage of RACs (other than fruits and vegetables) for further distribution or processing (Sec. 117.5(j)). [[Page 55934]] (Response 41) Fumigating RACs such as cocoa beans to prevent pest infestation would be within the definition of ``holding.'' Therefore, such fumigation would not prevent a facility that stores RACs (other than fruits and vegetables) from being eligible for the exemption in Sec. 117.5(j), provided that the facility does not conduct other activities not classified as ``holding.'' However, a threshold question for any facility solely engaged in the storage of RACs is whether the stored RACs are fruits or vegetables. We classify cocoa beans within the category of ``fruits and vegetables'' (78 FR 3646 at 3690) and, thus, a facility that stores cocoa beans is not eligible for the exemption in Sec. 117.5(j). (Comment 42) Some comments ask us to clarify whether there is a timeframe associated with holding and to better distinguish between ``holding'' and ``storage.'' (Response 42) There is no timeframe (maximum or minimum) associated with holding. The definition of holding states ``Holding means storage of food'' and, thus, there is no distinction between ``holding'' and ``storing.'' (Comment 43) Some comments ask us to clarify how the definition of holding relates to practices, such as fumigation, on almond hull stockpiles held on a farm, a farm mixed-type facility, or off-farm. (Response 43) Practices that are incidental to storage of food, such as fumigation of almond hull stockpiles, are holding, regardless of whether they are conducted on-farm, on a farm mixed-type facility, or off-farm. (Comment 44) Some comments ask us to clarify that value added activities (such as repacking and blast freezing) conducted in facilities such as warehouses would be considered holding when product is not exposed to the environment. (Response 44) We consider the activities described in these comments to be activities performed as a practical necessity for the distribution of the food and, thus, to be within the definition of holding. (Comment 45) Some express concern that the definition of holding would prevent a facility that samples food (such as sugar) for grading or quality control purposes from qualifying for the exemption for facilities engaged solely in holding unexposed packaged food because they would temporarily expose otherwise unexposed packaged food to the environment. These comments ask us to make clear that the requirements for hazard analysis and risk-based preventive controls only apply to the sampling activities and that engaging in sampling activities does not remove a warehouse's exemption altogether. (Response 45) We consider that sampling food in the manner described by this comment is a practical necessity for the distribution of the food within the definition of ``holding,'' and that the exemption still applies to a facility that conducts such sampling. Importantly, the sampling must be in done in accordance with CGMPs such that the exposure does not result in contamination of the food. E. Proposed Revision to the Definition of Manufacturing/Processing We proposed to revise the definition of ``Manufacturing/ Processing'' in Sec. Sec. 1.227 and 1.328 by adding to the existing definition a criterion applicable to farms and farm mixed-type facilities. As noted in table 52, we have reorganized the listed examples of manufacturing/processing to present them in alphabetical order. (Comment 46) Some comments express concern that some activities included in the definition of ``manufacturing/processing'' overlap with activities (such as trimming, washing, and cooling) included in the definition of ``harvesting.'' (Response 46) We acknowledge that there is some overlap in the activities that the regulatory text lists as examples of both ``manufacturing/processing'' and ``harvesting,'' because some activities can occur during more than one operation (see also the discussion at 79 FR 58524 at 58538 and table 1 in the Appendix to the 2014 supplemental human preventive controls notice (79 FR 58524 at 58571-58572)). For example, ``cutting'' the core of the lettuce from the crop plant can occur on-farm in the field where the lettuce is harvested, and ``cutting'' the core of the lettuce from the rest of the harvested lettuce also can occur in a fresh-cut processing facility. An important consequence of the multiple revisions we have made to the ``farm'' definition in this rulemaking is that there are fewer situations in which classification of a particular activity is the only trigger for an operation to be subject to the section 415 registration regulations. For example, the revised ``farm'' definition no longer classifies the packing and holding of others' RACs to be a manufacturing/processing activity that triggers the registration requirement. As another example, the revised ``farm'' definition specifies three manufacturing/processing activities that are within the ``farm'' definition. We conclude that the overlap in the examples of activities listed in the definitions of ``harvesting'' and ``manufacturing/processing'' does not create problems with determining the status of an operation as a ``farm'' or a ``facility'' and we are retaining examples in both definitions because doing so reflects current practices on farms and in manufacturing/processing facilities. (Comment 47) Some comments ask us to clarify that the traditional activities of a packing shed--cleaning and packing intact fruits and vegetables--do not constitute ``manufacturing/processing'' that would trigger the requirement to register as a facility. (Response 47) Packing activities are within the definition of ``packing,'' and holding activities are within the definition of ``holding,'' regardless of whether the packing or holding activities take place on-farm or off-farm. In other words, neither packing produce nor holding produce would be classified as manufacturing/processing merely because the business entity conducting the activity is a facility that is subject to the section 415 registration regulations. As discussed in Response 25, we have revised the ``farm'' definition to provide that an operation devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the ``farm'' definition (as a ``secondary activities farm''), 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. With this revision, some off-farm packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the ``farm'' definition, provided that the primary production farm(s) that grows, harvests, 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 packing operation. (Comment 48) Some comments ask us to make clear, in our response to comments in the final rule, that any adjustments we make to the definition of manufacturing/processing in no way change the definitions of ``raw agricultural commodity,'' ``processing,'' and ``processed food,'' which were mutually agreed to by EPA and FDA (Ref. 15) to address regulatory responsibilities for antimicrobials applied to food, process water contacting food, or hard food-contact surfaces. (Response 48) The revisions we made to the ``farm'' definition, and to the classification of activities relevant to the [[Page 55935]] ``farm'' definition, do not change the statutory definitions of ``raw agricultural commodity,'' and ``processed food,'' or impact our interpretation of the definition of ``processing,'' with respect to regulatory jurisdiction for antimicrobials applied to food, process water contacting food, or hard food-contact surfaces. F. Proposed New Definition of Mixed-Type Facility We proposed to define ``Mixed-type facility,'' as a new definition in Sec. Sec. 1.227 and 1.328, to mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. We specified in the regulatory text that an example of such a facility is a ``farm mixed-type facility,'' which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. As a conforming change associated with the revisions to the ``farm'' definition, we have revised the example of a ``farm mixed-type facility'' to specify that it is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered. (Comment 49) Some comments assert that there is no scientific basis for the definition of mixed-type facility. (Response 49) The proposed definition is not a science-based definition. It is a descriptive term that we are using to refer to certain food establishments. We used this same term during the rulemaking to establish the section 415 registration regulations (see response to comment 46, 68 FR 58894 at 58906, October 10, 2003). (Comment 50) Some comments ask us to revise the definition to add more details about activities that are inside the farm definition and activities that are outside the farm definition. (Response 50) We decline the request of these comments. Adding such details would detract from the focus of the definition--i.e., that it refers to a facility that conducts both activities that are inside the farm definition and activities that are outside the farm definition. We have included additional examples of ``harvesting,'' ``packing,'' and ``holding'' activities in the regulatory text of the definitions for those terms (see Sec. Sec. 1.227, 1.328 and 117.3 and Response 31, Response 37 and Response 39). (See also Response 3.) (Comment 51) Some comments ask us to revise the definition to exclude those establishments that only conduct low-risk activities specified in the exemptions for on-farm, low-risk activity/food combinations (Sec. 117.5(g) and (h)). (Response 51) We decline this request. Whether a particular establishment that falls within the definition of ``mixed-type facility'' is subject to the requirements for hazard analysis and risk- based preventive controls is governed by the exemptions established in this rule. G. Proposed Revision to the Definition of Packing We proposed to revise the definition of ``Packing'' in Sec. Sec. 1.227 and 1.328 by adding that packing includes activities performed incidental to packing a food, but does not include activities that transform a RAC into a processed food. We have revised the definition to clarify that packing includes ``re-packing.'' (Comment 52) Some comments ask us to include minimal ``manufacturing/processing'' of RACs in the definition of packing when the minimal ``manufacturing/processing'' does not transform the RAC into a processed food. The comments describe waxing of fresh fruit (such as apples) and vegetables as examples of activities that do not transform a RAC into a processed food. (Response 52) As already discussed, the activities that transform a RAC into a processed food (and are sometimes therefore referred to as ``processing'' in the context of a food's status as a RAC or processed food) are not coextensive with the activities described in our definition of ``manufacturing/processing.'' (See Response 27.) Although waxing has long been considered a manufacturing/processing activity during the production of processed food (because it involves making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food), we classify coating RACs with wax/oil/resin for the purpose of storage or transport as a packing activity. (See Response 37). (Comment 53) Some comments ask us to clarify the distinction between ``packing'' and ``packaging'' because the terms are different but seem to be used interchangeably. These comments express concern that ``placing food into containers'' on farms that have traditionally done so will be classified as ``manufacturing/processing'' and trigger the requirement to register as a food facility and ask us to reclassify ``packaging'' within the definition of ``packing.'' Other comments ask us to remove the words ``other than packaging of food'' from the definition of ``packing.'' Some comments state that when a RAC is packed in the field and/or is placed into a clamshell container, as a practical matter it is considered to have been ``packed,'' not ``packaged.'' (Response 53) We acknowledge that farms traditionally refer to field packing, including placing RACs into clamshell containers that will serve as a consumer package, as ``packing,'' not ``packaging.'' Indeed, in the 2013 human preventive controls rule we proposed to revise the definition of ``packing'' to specify that, for farms and farm mixed-type facilities, ``packing'' includes ``packaging.'' However, in the 2014 supplemental human preventive controls notice we proposed a simpler approach to accommodate requests such as those in these comments, by simply specifying in the ``farm'' definition that packaging and labeling RACs, without additional manufacturing/ processing, is within the ``farm'' definition. We conclude that the distinctions between the terms ``packing'' and ``packaging'' do not create problems with determining the status of an operation as a ``farm'' or a ``facility.'' Further, we note that we have given these terms identical meanings across multiple FDA regulations that are applicable to facilities. (Comment 54) Some comments refer to discussions at a ``listening session'' regarding harvesting several varieties of lettuce, washing them, and combining heads or bunches of the different varieties in one bag that is sealed with a knot or twist tie. During these discussions, this type of activity was classified as being within the ``farm'' definition. These comments ask how this activity can be classified as being within the ``farm'' definition when mixing and washing are listed as manufacturing/processing activities that trigger registration as a food facility and whether there is a discrepancy between what the rule requires and what they heard at the listening session. Other comments express the view that mixing RACs that have not been transformed into processed food (such as bagging mixed greens or different types of whole produce, such as potatoes, beets, and carrots) should not put a farm in the category of a mixed-type facility. (Response 54) Removing several varieties of lettuce from the place in which they were grown, washing them on the farm, and combining heads or bunches of the different varieties in one bag that is sealed with a knot or twist tie on the farm are all activities within the ``farm'' definition. We classify ``washing'' and ``mixing'' in more than one way depending on when the activity occurs, and the ``farm'' definition now specifies that [[Page 55936]] ``packaging'' RACs (without additional manufacturing/processing, such as slicing) is a farm activity, even though it is a type of ``manufacturing/processing.'' We have recognized ``washing'' as a harvesting activity since we first issued the section 415 registration regulations (68 FR 58894 at 58961, October 10, 2003), even though we also classify ``washing'' RACs as ``manufacturing/processing'' when done in a food processing facility (such as a fresh-cut processing facility). We classify ``mixing'' intact RACs that does not create a processed food as incidental to, and therefore part of, ``packing'' or ``holding'' as applicable. Mixing heads or bunches of lettuce as described in the example does not create a processed food, because he mixing has not created a distinct commodity, but only a set of mixed RACs. On the other hand, mixing that creates a processed food is not ``packing'' or ``holding.'' The definitions of both ``packing'' and ``holding'' are limited so that they do not include activities that transform a RAC into processed food. Some kinds of mixing of RACs do create a distinct commodity (for example, mixing corn and oats to make animal food). In such cases, the mixing is manufacturing/processing and is not within the farm definition. Likewise, although we classify placing RACs in a plastic bag with a twist tie as ``packaging'' rather than ``packing'' when the plastic bag is the container that the consumer receives, we have provided for ''packaging'' RACs as an activity within the ``farm'' definition. V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act In the 2014 supplemental human preventive controls notice, we discussed comments on the organizing principles that formed the basis for proposed revisions to the section 415 registration regulations and the section 414 recordkeeping regulations (79 FR 58524 at 58538). We also explained how our proposed revisions to the ``farm'' definition would require us to reconsider those organizing principles (79 FR 58524 at 58538). (Comment 55) Some comments assert that we should revise the organizing principles to reflect the realities and range of activities that farms conduct to prepare their crops for market and to make the organizing principles consistent with FSMA's risk-based mandate. These comments ask us to revise the organizing principles as follows: (1) The basic purpose of farms is to produce RACs and deliver them for sale to end-users or other buyers; (2) activities that involve RACs and that farms perform for the purposes of selling their own RACs, including growing them, harvesting them, preparing them for consumption in their raw and unprocessed state, and packing, sorting, grading, packaging, labeling, holding, transporting, marketing, and delivering them, should all be within the definition of ``farm;'' (3) even though farms traditionally also do a wide variety of activities that may be considered processing, for the purpose of these organizing principles, activities should be classified based on whether the activity transforms a RAC into a processed food (as defined by these rules); (4) manufacturing/processing, packing, or holding food--whether RACs or processed foods, from any source--for consumption on the farm should remain within the farm definition. (Response 55) We have revised the ``farm'' definition to refer to farms as ``operations'' rather than ``facilities'' or ``establishments''; reflect modern business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and some types of food hubs (e.g., those that consolidate and distribute RACs but do not conduct activities that transform the RACs into a processed food)); specify that a farm is in one general (but not necessarily contiguous) physical location; and provide that an operation devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the ``farm'' definition as a secondary activities farm, 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 (e.g., an off-farm produce packinghouse owned by farmers or a farmer-owned tree nut hulling and drying operation). (See Response 22, Response 23, Response 24, and Response 25.) All of these changes to the ``farm'' definition do, as requested by these and other comments, reflect the realities and range of activities that farms conduct. See table 5 for organizing principles regarding classification of activities on-farm and off-farm in light of the changes to the ``farm'' definition. Table 5--Organizing Principles Regarding Classification of Activities On- Farm and Off-Farm ------------------------------------------------------------------------ No. Organizing principle ------------------------------------------------------------------------ 1........................... The basic purpose of farms is to produce RACs, and RACs are the essential products of farms. 2........................... A farm is in one general (but not necessarily contiguous) location. 3........................... Farm operations include business models such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and some types of food hubs. 4........................... Activities that involve RACs and that farms traditionally do for the purposes of growing RACs, removing them from the growing areas, and preparing them for use as a food RAC, and for packing, holding, and transporting them, are all within the ``farm'' definition. 5........................... Activities are classified based in part whether the activity transforms a RAC into a processed food. 6........................... A limited number of traditional operations that farms do for the purpose of preparing RACs for use as a food RAC, but that are classified as ``manufacturing/ processing,'' are within the ``farm'' definition. These are: (1) Drying/ dehydrating RACs to create a distinct commodity, and packaging and labeling such commodities, without additional manufacturing/processing; (2) treatment to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without additional manufacturing/ processing; and (3) packaging and labeling RACs, when these activities do not involve additional manufacturing/ processing. 7........................... Manufacturing/processing, packing, or holding food--whether RACs or processed foods, from any source--for consumption on the farm is within the farm definition. ------------------------------------------------------------------------ [[Page 55937]] VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities A. Section 103(c)(1)(C) of FSMA We previously described provisions of FSMA that direct us to conduct a science-based risk analysis to cover specific types of on- farm packing, holding, and manufacturing/processing activities that would be outside the ``farm'' definition and, thus, subject to the requirements for hazard analysis and risk-based preventive controls (see section 103(c)(1)(C) of FSMA and 78 FR 3646 at 3674 and 3689- 3691). Consistent with this statutory direction, we developed the section 103(c)(1)(C) draft RA and made it available for public comment (Ref. 18 and 78 FR 3824). We are including the final risk assessment (the section 103(c)(1)(C) RA) in the docket established for this document (Ref. 4). We previously described provisions of FSMA that direct us to consider the results of the science-based risk analysis and exempt facilities that are small or very small businesses from the requirements for hazard analysis and risk-based preventive controls (or modify these requirements, as we determine appropriate), if such facilities are engaged only in specific types of on-farm activities that we determine to be low risk involving specific foods that we determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR 3646 at 3675, 3691, and 3705-3707). Later in this document (see section XI.G), we discuss the provisions we are establishing in Sec. 117.5(g) and (h), based on the results of the section 103(c)(1)(C) RA, to exempt farm mixed-type facilities that are small or very small businesses from requirements for hazard analysis and risk-based preventive controls if the only activities that the business conducts that are subject to those requirements are low-risk activity/food combinations. We also previously described provisions of FSMA that direct us to: (1) Identify high risk-facilities and allocate resources to inspect facilities according to the known safety risks of the facilities (as determined by several factors) and immediately increase the frequency of inspection of all facilities (see the discussion of section 421 of the FD&C Act at 78 FR 3646 at 3654-3655); and (2) consider a possible exemption from or modification of requirements of section 421 of the FD&C Act as we deem appropriate (see the discussion of section 103(c)(1)(D) of FSMA at 78 FR 3646 at 3658). We tentatively concluded that we should not exempt or modify the frequency requirements under section 421 based solely upon whether a facility only engages in low- risk activity/food combinations and is a small or very small business and requested comment on this tentative conclusion. B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition (Comment 56) Some comments address the qualitative nature of the section 103(c)(1)(C) draft RA and assert that it is based on professional judgment rather than data. These comments ask us to update the section 103(c)(1)(C) draft RA when more data become available. Some comments assert that we should not rely on data from the Food Processing Sector Study (Ref. 19), but instead collect data from large- scale surveys of actual farm mixed-type facilities and their activities. Other comments ask us to dedicate resources and enter into agreements with agencies/organizations to collect, analyze, and interpret data. Some comments ask us to consult with subject matter experts to ensure that the final risk assessment reflects sufficient geographic diversity. (Response 56) We have acknowledged the limitations of the section 103(c)(1)(C) draft RA (Ref. 18; see section I.F in that document). Rather than limit public input to subject matter experts, we requested comment from all interested persons, and received a number of comments alerting us to activity/food combinations conducted on farms and farm mixed-type facilities, including comments from diverse geographic areas. We also received comments about activity/food combinations focused on botanicals that might be used in the production of dietary ingredients. We disagree that we need to conduct large scale surveys, or enter into agreements with agencies/organizations, to collect additional information in light of the previous opportunity for broad public input regarding the activity/food combinations conducted on farms and farm mixed-type facilities. (See also Response 139 regarding the Food Processing Sector Study.) (Comment 57) Some comments state that it is not clear how certain high- or moderate-risk practices (e.g., washing), which are necessary to move product from the field, will affect exemptions. These comments recommend that future risk assessments examine the impact of these practices by commodity and volume of intact fruits and vegetables marketed through small and very small farm mixed-type facilities. Other comments ask us to re-examine our data sources in assessing commodity- specific risks, and assert that it is likely that many will be found to be low risk. Other comments suggest that the Centers for Disease Control and Prevention (CDC) expand its data analysis effort (Ref. 20) to separate out commodities to assess attribution of foodborne illnesses for additional commodities. (Response 57) Because of changes we made to the farm definition, practices such as washing that are necessary to move product from the field are within the farm definition and are not addressed in the section 103(c)(1)(C) RA. We disagree that we should re-examine our data sources in assessing commodity-specific risks. As we discussed in the section 103(c)(1)(C) draft RA, we focused on considering the risk of activity/food combinations rather than separately considering the risk of specific food categories because doing so would better enable us to focus on whether a specific manufacturing, processing, packing, or holding activity conducted on food by a farm mixed-type facility warranted an exemption from, or modified requirements for, the provisions of section 418 of the FD&C Act. The comments did not identify additional data sources to use in assessing commodity-specific risks. However, we did revise the section 103(c)(1)(C) draft RA by taking into consideration: (1) Comments submitted to Docket FDA-2012-N- 1258 on the section 103(c)(1)(C) Draft RA; (2) comments submitted to Docket FDA-2011-N-0920 on the proposed rule relevant to activities conducted on foods on farms; and (3) a revised Food Processing Sector Study on domestic establishments co-located on farms (Ref. 21). This led us to include additional activity/food combinations in our evaluation, and many were found to be low risk. With respect to CDC expanding its data analysis effort, the CDC publication cited by the comments (Ref. 20) is the most up-to-date publication available, and more finely grained data for additional commodities are not currently available. (Comment 58) Some comments assert that we should revise the section 103(c)(1)(C) draft RA and then make it available for additional public comment before finalizing the rule. (Response 58) As we previously noted (78 FR 3824 at 3826, January 16, 2013), we subjected the section 103(c)(1)(C) draft RA to peer review in accordance with the requirements of the Final Information Quality Bulletin for Peer Review (issued by the Office of Management and Budget to implement the Information Quality Act (Pub. L. 106-554)) before we made it available for broader public comment during a [[Page 55938]] time period that exceeded 10 months. The additional iterative process recommended by these comments is not necessary and would go beyond the processes we routinely apply for public input on a risk assessment. C. Comments Regarding an Exemption for Small and Very Small Farm Mixed- Type Facilities Under Section 421 of the FD&C Act 1. Request for Comment on Data Submission Requirements We requested comment on whether we should establish data submission requirements that would allow us to identify types of facilities in order to exempt them from the inspection frequencies, or modify the inspection frequencies that apply to them, under section 421 of the FD&C Act. We provided examples of such data elements, including identification of a facility as a farm mixed-type facility, annual monetary value of sales, number of employees, and food category/ activity type. We also requested comment on any other criteria that may be appropriate for the purposes of allocating inspection resources to these facilities. Comments did not support these data submission requirements. We are not establishing any data submission requirements that would allow us to identify types of facilities in order to exempt them from the inspection frequencies, or modify the inspection frequencies that apply to them, under section 421 of the FD&C Act. 2. Request for Comment on an Exemption From the Requirements of Section 421 of the FD&C Act We received no comments that disagreed with our tentative conclusion that we should not exempt or modify the inspection frequency requirements under section 421 based solely upon whether a facility only engages in low-risk activity/food combinations and is a small or very small business. We are not establishing any exemption from, or modification to, the inspection frequency requirements under section 421 for facilities that only engage in low-risk activity/food combinations and are a small or very small business. VII. Comments on Proposed General Revisions to Current Part 110 (Final Part 117) We proposed some general revisions to the CGMP requirements in part 110, including revising the title; redesignating the provisions in part 117; revising some terms for consistency within the rule; referring to the ``owner, operator, or agent in charge'' rather than to ``plant management'' or ``operator''; revising provisions directed to preventing contamination of food and food-contact substances so that they also are consistently directed to preventing contamination of food-packaging materials; revising several provisions to explicitly address allergen cross-contact, as well as contamination; referring to ``raw materials and ingredients'' rather than ``raw materials and other ingredients''; deleting some non-binding provisions; and making some editorial revisions (78 FR 3646 at 3692 to 3693). Some comments support one or more of these proposed general revisions without change. For example, some comments agree that there is no meaningful distinction between ``manufacturing/processing,'' ``packing,'' and ``holding'' as defined in the proposed revisions to Sec. Sec. 1.227 and 1.328 and those terms as they have been used in the long-standing CGMP requirements. These comments also agree that consistent use of these terms throughout proposed part 117, in reference to activities taking place in food facilities, establishments, or plants, would make the regulations more clear and have no substantive effect on the current requirements. Other comments support the proposed replacement of the term ``facility'' or ``facilities'' in the CGMP requirements with the term ``establishment'' or ``plant'' whenever the term ``facility'' or ``facilities'' could be confused with the firms that are subject to the proposed requirements for hazard analysis and risk-based preventive controls. Other comments agree that it is appropriate to replace the word ``shall'' with the term ``must.'' Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 59, Comment 63, and Comment 65). We received no comments that disagreed with our proposed redesignations and are finalizing them as proposed. In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed provisions as shown in table 6. Table 6--Outcome of the Proposed General Revisions to Part 110 ------------------------------------------------------------------------ Proposed revision Outcome ------------------------------------------------------------------------ Establish the title of part 117... We have revised the title to read ``Current Good Manufacturing Practice, Hazard Analysis, and Risk- Based Preventive Controls for Human Food.'' Consistency of terms: Activities We are establishing in part 117 the subject to part 117. same definitions for the terms ``manufacturing/processing,'' ``packing,'' and '' holding'' as we are establishing in the section 415 registration regulations and the section 414 recordkeeping regulations. Consistency of terms: Facility.... We have made the following changes to the proposed rule: 1. We have revised the definition of ``plant'' to focus it on the building, structure, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food. 2. We have revised applicable provisions to use ``establishment'' rather than ``plant'' when focusing on a business entity rather than on buildings or other structures. 3. We have made conforming changes throughout the rule. Consistency of terms: Owner, We are: (1) Defining the term operator, or agent in charge. ``you'' to mean, for purposes of part 117, the owner, operator, or agent in charge of a facility and (2) limiting use of the term ``you'' to provisions directed to ``facilities'' (i.e., provisions in subparts C, D, E, and G). Consistency of terms: Food- We received no comments that packaging materials. disagreed with our proposal that provisions of current part 110 directed to preventing contamination of food and food- contact substances consistently be directed to preventing contamination of food-packaging materials as well and are finalizing the applicable provisions as proposed. Additions regarding allergen cross- The CGMPs that we are establishing contact. in subpart B explicitly address allergen cross-contact. [[Page 55939]] Revisions for consistency with the We have retained the current phrase definition of ``food''. ``raw materials and other ingredients'' (rather than the proposed phrase ``raw materials and ingredients'') throughout the rule to make it clear that raw materials are ingredients. Revisions to delete some non- We are deleting those nonbinding binding provisions. provisions of current part 110 that we proposed to delete. (For a list of these deleted provisions, see table 8 in the 2013 proposed human preventive controls rule, 78 FR 3646 at 3714). Revisions to re-establish some non- With one exception, we are, as binding provisions of part 110 as proposed, re-establishing certain binding provisions in part 117. non-binding provisions of part 110 in part 117 as binding provisions. See table 11 in the 2013 proposed human preventive controls rule (78 FR 3646 at 3728). The exception is one provision of Sec. 110.80(b)(1) regarding inspecting containers of raw materials on receipt, which we are deleting rather than re-establishing it as a requirement. Editorial changes................. We are finalizing the proposed editorial changes regarding ``Federal Food, Drug, and Cosmetic Act,'' ``includes, but is not limited to,'' ``must,'' ``adulteration,'' and ``when'' as proposed, except that we are retaining the term ``such as'' in place of the proposed term ``including'' in two provisions. ------------------------------------------------------------------------ A. Title of Part 117 We proposed to re-establish the provisions of current part 110 in new part 117 and to establish the title of part 117 as ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' (78 FR 3646 at 3691). (Note that in the 2013 proposed human preventive controls rule, we described this as revising the title of ``current subpart B.'' We should have described this as revising the title of current part 110.) (Comment 59) Some comments ask us to revise the title to read ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' (Response 59) We have revised the title of the rule as requested. B. Proposed Revisions for Consistency of Terms 1. Activities Subject to Proposed Part 117 We noted that we had previously described activities that may be considered ``manufacturing, processing, packing, or holding'' by establishing definitions for these terms in the section 415 registration regulations and the section 414 recordkeeping regulations (78 FR 3646 at 3692). We proposed to revise these existing definitions (see sections IV.D, IV.E, and IV.G) and to incorporate the revised definitions in part 117. We tentatively concluded that there is no meaningful distinction between these terms as we would define them in the revised definitions and these terms as they had been used in the CGMPs. We also tentatively concluded that consistent use of these terms throughout part 117, in reference to activities taking place in food facilities, establishments, or plants, would make the regulations more clear and have no substantive effect on the current requirements (78 FR 3646 at 3692). In the 2014 preventive controls supplemental notice, we proposed revisions to the definitions of ``holding'' and ``packing'' after considering comments submitted to the 2013 proposed human preventive controls rule. (Comment 60) Some comments ask us to clarify how we were ``revising'' the definitions of the terms manufacturing, processing, packing, and holding because these terms had not been defined in the CGMPs in part 110. (Response 60) The comments are correct that these terms had not been defined in the CGMPs in part 110. We proposed to ``revise'' these definitions in the section 415 registration regulations and the section 414 recordkeeping regulations and then establish in part 117 those revised definitions. (Comment 61) Some comments from the produce industry state that it is difficult to assess whether there is a meaningful distinction between ``packing'' and ``holding'' as would be defined in the proposed human preventive controls rule and as had been used in the CGMPs in part 110 because most harvesting and post-harvest handling activities of RACs had been excluded from the CGMP requirements under Sec. 110.19. (Response 61) We assume that these comments are concerned about distinguishing ``packing'' from ``holding'' because some exemptions (e.g., the exemption in Sec. 117.5(k) from the CGMP requirements for holding RACs and the exemption in Sec. 117.5(j) from the requirements for hazard analysis and risk-based preventive controls) apply to ``holding'' RACs. As previously discussed, we have previously classified several on-farm activities in more than one way (79 FR 58524 at 58538 and 58571) depending on when the activity occurs. For example, sorting, culling, and grading RACs can occur during both packing and holding activities. However, we disagree that the full regulatory text of the definitions for ``packing'' and ``holding'' are not adequate to provide a meaningful distinction between the two terms. ``Packing'' means, in part, ``placing food into a container'' whereas holding means, in part ``storage of food.'' ``Placing food into a container'' is in no way similar to ``storage of food.'' (Comment 62) Some comments disagree with our tentative conclusion that there is no meaningful distinction between ``manufacturing/ processing,'' ``packing,'' and ``holding'' as we would define them in the revised definitions and these terms as they had been used in the CGMPs. These comments ask us to define these terms differently in the human preventive controls rule. These comments state that although they do not object to the consistent use of these terms throughout part 117 in reference to activities taking place in food facilities, establishments, or plants, they believe there are significant distinctions in these terms that need to be considered when finalizing the requirements of part 117. (Response 62) These comments provide neither specific suggestions for how we should define these terms for the purpose of the human preventive controls rule nor specific reasons for their assertion that there are significant distinctions in these terms that need to be considered when finalizing the requirements of part 117. Without more specific information, we assume that the changes we have made to the definitions of ``farm,'' ``holding,'' and ``packing'' adequately address these comments. 2. The Term ``Facility'' We proposed to replace the term ``facility'' or ``facilities'' in current part 110 with the term ``establishment'' or ``plant'' in proposed part 117 whenever the term ``facility'' or ``facilities'' could be confused with the firms that are subject to the proposed requirements for hazard analysis and risk-based [[Page 55940]] preventive controls required by section 418 of the FD&C Act (78 FR 3646 at 3692). However, we tentatively concluded that it would not be necessary to replace the use of the term ``facilities'' in current requirements directed to specific functional parts of a plant or establishment, such as ``toilet facilities'' and ``hand-washing facilities,'' because the use of the term ``facilities'' in these contexts would not create confusion. (Comment 63) Some comments state that it would not be helpful to use ``plant'' interchangeably with ``establishment'' when referring to a business that is not required to register. These comments ask us to consistently use one of these terms and to define a term that would mean ``a business that is not required to register'' to help distinguish such businesses from ``facilities.'' (Response 63) We agree that it is appropriate to consistently use one term when referring to a business entity. However, we disagree that it is necessary to establish a definition for a business entity that is not required to register. A business that meets the definition of ``facility'' is required to register; a business that is not required to register is simply a business that does not meet the definition of ``facility.'' To address these comments, we have revised provisions of the rule in three ways. First, we have revised the definition of ``plant'' to focus it on the building, structure, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food, rather than on the ``building or establishment.'' Second, we have revised applicable provisions of part 117 to use ``establishment'' rather than ``plant'' when focusing on a business entity rather than on buildings or other structures. Third, we have revised provisions that use the terms ``plant,'' ``establishment,'' or both to conform to the definition of ``plant'' and the described usage of ``establishment.'' For example, Sec. 117.10 establishes requirements for ``the management of the establishment'' rather than ``plant management,'' because ``establishment'' is the term focusing on the business entity. As another example, Sec. 117.20(a)(1) establishes requirements for properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the ``plant'' rather than within the immediate vicinity of the ``plant buildings or structures,'' because the defined term ``plant'' focuses on the buildings and structures, and it is not necessary to repeat ``buildings and structures'' when the term ``plant'' is used. 3. Owner, Operator, or Agent in Charge In the 2013 proposed human preventive controls rule, we requested comment on whether there is any meaningful difference between the persons identified in current part 110 and the ``owner, operator, or agent in charge'' identified in section 418 of the FD&C Act. We also requested comment on whether it would be appropriate to refer to the ``owner, operator, or agent in charge'' of a plant, establishment, or facility throughout proposed part 117 and, if so, whether the requirements would be clear if we revised the proposed rule to use pronouns (such as ``you'' and ``your'') within proposed part 117 (78 FR 3646 at 3693). In the 2014 supplemental human preventive controls notice, we described comments on these issues and we tentatively concluded that we could simplify the regulations directed to the ``owner, operator, or agent in charge of a facility'' in provisions in subparts C, D, and E by using pronouns, without creating confusion, if we (1) define the term ``you'' to mean, for purposes of part 117, the owner, operator, or agent in charge of a facility and (2) limit use of the term ``you'' to provisions in proposed subparts C, D, and E (79 FR 58524 at 58556). We received no comments that disagreed with the proposed definition of ``you'' and are finalizing that proposed definition without change. 4. Food-Packaging Materials We proposed that provisions of current part 110 directed to preventing contamination of food and food-contact surfaces consistently be directed to preventing contamination of food-packaging materials as well (78 FR 3646 at 3693). We received no comments that disagreed with this proposal and are finalizing provisions directed to preventing contamination of food-packaging materials as proposed. For additional discussion regarding the term ``food-packaging materials,'' see Comment 107. C. Proposed Additions Regarding Allergen Cross-Contact We proposed to revise several CGMP provisions to explicitly address cross-contact (see 78 FR 3646 at 3693 and table 10 of the 2013 proposed human preventive controls rule, 78 FR 3646 at 3718-3719). In the 2014 supplemental human preventive controls notice, we proposed to define and use the term ``allergen cross-contact'' rather than ``cross- contact,'' and we are finalizing the definition of the term ``allergen cross-contact'' in this rule (see Sec. 117.3). As discussed in sections XIII-XXII, the CGMPs that we are establishing in subpart B explicitly address allergen cross-contact, with some revisions requested by comments. (Comment 64) Some comments ask us to clarify that allergen cross- contact has a meaning that is distinct from ``contamination.'' (Response 64) We previously noted that, in the past, inadvertent incorporation of an allergen into a food was referred to as ``contamination'' or ``cross-contamination,'' but that more recently the term ``cross-contact'' (rather than ``contamination'' or ``cross- contamination'') has been applied with respect to unintentional transfer of allergenic proteins from a food containing the proteins to one that does not, because an allergen is a normal component of food, and not itself a contaminant (78 FR 3646 at 3693). Given this shift in the scientific literature distinguishing ``cross-contact'' from ``contamination'' and ``cross-contamination,'' we tentatively concluded that we should begin using the term ``cross-contact'' (now ``allergen cross-contact'') to describe inadvertent incorporation of an allergen into food, rather than the general term ``contamination,'' for purposes of clarity. In this final rule, we affirm that tentative conclusion. To further improve clarity, we reviewed the provisions of the rule directed to preventing both allergen cross-contact and preventing contamination and made editorial changes throughout. For example, Sec. 117.10(b)(1) requires that hygienic practices must include wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of food, food-contact surfaces, or food-packaging materials. For additional provisions that include these editorial changes, see table 52. D. Proposed Revisions for Consistency With the Definition of ``Food'' We proposed to retain the definition for ``food'' as already defined in Sec. 110.3 (78 FR 3646 at 3693). Food means food as defined in section 201(f) of the FD&C Act and includes raw materials and ingredients. For consistency with the definition of food (which refers to ``raw materials and ingredients'' rather than ``raw materials and other ingredients''), we proposed to change the title of current Sec. 110.80(a) (which would be proposed Sec. 117.80(b)) to ``Raw materials and ingredients'' rather than ``Raw materials and other ingredients.'' As a [[Page 55941]] companion change to this change in title, we proposed to substitute ``ingredients'' for ``other ingredients'' throughout provisions in current Sec. 110.80 that refer to both raw materials and ingredients (78 FR 3646 at 3693-3694). (Comment 65) Some comments ask us to add a definition for ``raw materials.'' (Response 65) We decline this request. During a previous rulemaking to revise the umbrella CGMPs, we explained that it is not possible to categorically distinguish raw materials and other ingredients because raw materials are ingredients, and both raw materials and ingredients are food within the meaning of the FD&C Act (51 FR 22458 at 22461, June 19, 1986). We have broadly defined ``food'' in this rule to include both raw materials and ingredients. However, we have decided to retain the current phrase ``raw materials and other ingredients'' (rather than the proposed phrase ``raw materials and ingredients'') throughout the rule to make it clear that raw materials are ingredients. See the regulatory text of Sec. Sec. 117.80(b), 117.80(c)(6), (7), and (9); and 117.130(c)(2)(iii). (Comment 66) Some comments ask us to revise the current definition of food (see Comment 87, Comment 88, and Comment 89). (Response 66) See Response 87, Response 88, and Response 89 for our reasons for declining to revise the definition of ``food'' in this rule. E. Proposed Revisions To Address Guidance in Current part 110 We proposed to delete some non-binding provisions of current part 110 (e.g., provisions using ``should'' or ``compliance may be achieved by'') (78 FR 3646 at 3694 and 3714-3717). We also requested comment on whether to revise other non-binding provisions to establish new requirements in proposed part 117 or to simply retain them as useful provisions of a comprehensive CGMP (78 FR 3646 at 3694 and 3728-3729). (Comment 67) Some comments ask us to retain the provisions we proposed to delete--e.g., because the information helps to clarify the intended effect of the regulations, suggests means of compliance with the requirements, and can educate small, new, or foreign companies. These comments assert that the benefits to both the regulated industry and to the general public of retaining the information we proposed to delete far outweigh any stylistic or other concerns. Likewise, some comments ask us to retain any non-binding provisions that we proposed to re-establish as requirements if, after considering comments, we do not finalize these provisions as requirements. (Response 67) We agree that the non-binding provisions we proposed to delete, or considered re-establishing as requirements, provide useful information for reasons such as those mentioned in the comments. However, these provisions are more appropriately included in guidance, and we are deleting those non-binding provisions of part 110 that we are not establishing as requirements. We intend to transfer some of the CGMP recommendations that are currently in part 110, but that will be deleted from part 117, to guidance with editorial changes and changes that reflect current technology and industry practices. For a list of non-binding provisions that we are deleting, see table 7 in this document and table 8 in the 2013 proposed human preventive controls rule (78 FR 3646 at 3714-3717). See Response 321 for a discussion of our reasons for deleting the recommendation listed in table 7 in this document. Table 7--Nonbinding Provisions That We Are Deleting in Addition to the Non-Binding Provisions Listed in Table 8 in the 2013 Proposed Human Preventive Controls Rule ------------------------------------------------------------------------ Designation in part 110 Description ------------------------------------------------------------------------ Sec. 110.80(a)(1) (Processes and Containers and carriers of raw controls--raw materials and materials should be inspected on ingredients--final sentence). receipt to ensure that their condition has not contributed to the contamination or deterioration of food. ------------------------------------------------------------------------ F. Proposed Editorial Changes We proposed to revise current part 110 to make five editorial changes: (1) Refer to the ``Federal Food, Drug, and Cosmetic Act'' rather than to ``the act''; (2) replace the term ``shall'' with the term ``must''; (3) replace the phrase ``includes, but is not limited to'' with ``includes''; (4) replace the phrase ``adulteration within the meaning of the act'' with the single term ``adulteration''; and (5) replace the term ``whenever'' with ``when.'' We received no comments that disagreed with our proposed editorial changes regarding ``Federal Food, Drug, and Cosmetic Act,'' ``must,'' ``adulteration,'' and ``when'' and are finalizing these editorial changes as proposed. (Comment 68) Some comments ask us to either retain ``includes, but is not limited to'' wherever the list which follows is not intended to be exhaustive, or replace ``includes, but is not limited to'' with ``such as,'' to make clear that a following list is not complete. (Response 68) The word ``include'' means to have (someone or something) as part of a group or total; to contain (someone or something) in a group or as a part of something (Ref. 22). The word ``includes'' does not need to be followed by ``but is not limited to'' to clearly communicate that a following list is not complete. We proposed that two provisions (proposed Sec. 117.80(c)(14) and (15)) replace the term ``such as'' with the term ``including'' (or variations of ``including''). In light of the comment's view that ``such as'' would be clearer, we have retained the term ``such as'' in those provisions. We decline the request to more broadly revise the rule to replace ``includes'' with ``such as.'' In many cases the term ``such as'' cannot replace ``includes'' when used as a verb. We note that several provisions of the rule do use ``such as'' when that term is grammatically appropriate, such as in parenthetical phrases (see, e.g., the definitions of ``holding'' and ``packing'' in Sec. 117.3). G. General Comments on Current Part 110 (Final Part 117) We proposed specific revisions and deletions to our long-standing umbrella CGMP requirements to modernize them. We also proposed to redesignate some of these CGMP requirements. For example, we proposed to redesignate the provisions found in six sentences that precede current Sec. 110.80(a) by creating paragraph designations (a)(1) through (6) in new Sec. 117.80. As corresponding changes, we proposed to redesignate current Sec. 110.80(a) as Sec. 117.80(b) and to redesignate current Sec. 110.80(b) as Sec. 117.80(c). Several comments suggest specific modifications to the umbrella CGMPs beyond what we proposed to revise. In [[Page 55942]] this section and in sections XIII through XXII, we address these specific suggestions and have amended the regulatory text where warranted. (Comment 69) Some comments ask us to reorganize some of the current provisions to reduce redundancy, such as by combining provisions that address similar topics or deleting some provisions that the comments view as unnecessary in light of other provisions. For example, one comment suggests we move Sec. 117.80(b)(5) (storage of raw materials, other ingredients, and rework) to Sec. 117.80(a)(1) (general requirements) and another comment suggests we delete requirements in Sec. 117.80(b)(1) for storing raw materials and ingredients because they are redundant with the storage requirements in Sec. 117.80(b)(7). (Response 69) We decline these requests. We acknowledge that there is some redundancy in subpart B and that we could improve the logical structure of subpart B by moving some of the requirements as recommended by some comments. However, these provisions have been in effect for decades, either since 1969 (when the umbrella CGMPs were first established (34 FR 6977, April 26, 1969) or since 1986 (when we last revised the umbrella CGMPs (51 FR 22458, June 19, 1986), and the comments do not provide examples of how we have been interpreting these provisions in a way that does not accomplish the goal of the umbrella CGMPs. Furthermore, we disagree with some of the comments on whether some provisions are redundant. For example, we disagree that Sec. 117.80(b)(1) is redundant with Sec. 117.80(b)(7) because Sec. 117.80(b)(7) is narrowly directed to raw materials and other ingredients received in bulk and Sec. 117.80(b)(1) is more generally directed to all raw materials and other ingredients. Rather than reorganize and combine requirements, or delete requirements that some comments view as redundant with other requirements, we have focused on comments requesting specific changes to the current requirements to reflect current practices in the manufacturing, processing, packing, and holding of human food and to make these current requirements clearer (see sections XIII through XXII). Doing so is consistent with the goals of modernizing the umbrella CGMP requirements. However, we have declined many of these requests to make specific changes to particular CGMP provisions. In general, in evaluating the requested specific changes, we considered whether the comments described a problem with the current regulatory text, or instead focused on hypothetical problems that could occur in the future. Because most of these comments do not explain how the long- standing regulatory text has created a problem, we have declined many of these requests. Likewise, in this document, we describe several editorial revisions that we made to improve the clarity of the CGMP requirements. However, we do not discuss comments that suggest editorial changes that simply suggest using different words in the regulatory text, but without explaining why the editorial revisions would improve the clarity of the provisions. These long-standing CGMPs have been in place and interpreted for decades, and we see no reason to revise them without a reason to do so. (Comment 70) Some comments ask us to specify that several of the CGMP requirements in subpart B only apply ``where the potential for contamination exists.'' (See table 8.) Other comments ask us to change some requirements to recommendations or to specify that they only apply ``as appropriate.'' (See table 8.) Table 8--CGMP Requirements That Comments Ask Us To Apply ``Where the Potential for Contamination Exists'' or Ask Us To Change to Recommendations ------------------------------------------------------------------------ Examples of CGMP requirements that Examples of CGMP requirements comments ask us to apply ``where the that comments ask us to change potential for contamination exists'' to recommendations ------------------------------------------------------------------------ Sec. 117.20(a)--Management Sec. 117.35(a)--General responsibility for maintaining grounds. maintenance. Sec. 117.20(b)--Suitability of plant Sec. 117.35(b)(1)--Cleaning construction and design. Compounds and Sanitizing Agents. Sec. 117.35(a)--General maintenance.. Sec. 117.35(b)(2)-- Identification and Storage of Toxic Materials. Sec. 117.35(c)--Pest control......... Sec. 117.35(c)--Pest control. Sec. 117.37--Sanitary facilities and Sec. 117.35(d)--Sanitation of controls. food-contact surfaces. Sec. 117.40(a)(1)--Design of plant Sec. 117.40(a)(6)-- equipment and utensils. Maintenance of food-contact surfaces. Sec. 117.40(a)(3)--Installation and Sec. 117.40(b)--Seams on food- maintenance of equipment. contact surfaces. Sec. 117.40(b)--Seams on food-contact Sec. 117.40(c)--Construction surfaces. of equipment. Sec. 117.40(c)--Construction of Sec. 117.40(e)--Freezer and equipment. cold storage compartments. Sec. 117.40(d)--Holding, conveying, and manufacturing systems. Sec. 117.80(a)(1)--Adequate sanitation principles. Sec. 117.80(a)(3)--Supervision of overall sanitation. ------------------------------------------------------------------------ (Response 70) We decline these requests. These long-standing provisions apply generally to the plant, equipment and utensils in the plant, sanitary operations and sanitary facilities in a plant, and operations conducted in a plant. To suggest otherwise is inconsistent with the precepts of good manufacturing practices. For example, as required by Sec. 117.20(a), an establishment must have control of its grounds regardless of the specific food being produced, because litter, waste, weeds, and grass can all attract and harbor pests, and the first step for pest control in the plant is to avoid attracting pests. As required by Sec. 117.20(b), a plant requires suitable construction and design regardless of the specific potential for contamination at any particular location in the plant. Each of the seven more specific provisions governed by Sec. 117.20(b) adds the context that the requirements are directed to what is ``adequate'' (e.g., adequate space, adequate precautions, and adequate cleaning), and the defined term ``adequate'' provides context that the purpose of the requirements for plant construction and design are related to public health. As required by Sec. 117.40, a plant requires clean and sanitary equipment regardless of the specific potential for contamination associated with a particular piece of equipment or the type of food being produced, because dirty equipment at one location in a plant can attract pests or become a harborage for environmental pathogens that can eventually lead to contamination in multiple locations in the plant. As required by Sec. 117.80(a)(10), a food plant requires adequate sanitation regardless of the specific potential for contamination, and the term ``adequate'' provides flexibility for how an [[Page 55943]] establishment designs and implements its sanitation program when the potential for contamination is low. As required by Sec. 117.80(a)(3), a plant requires adequate sanitation regardless of the specific potential for contamination, and someone must be in charge of sanitation to determine what needs to be done, where it needs to be done, and how often it needs to be done. The individual(s) who supervises the sanitation of the plant has flexibility in the design and implementation of a sanitation program when the potential for contamination is low. In addition, the CGMP requirements are flexible requirements that each establishment can adapt to its own operations, equipment, and food products. For example, Sec. 117.35(a) requires that buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food- contact surfaces, or food-packaging materials. The standards established by the requirement are to protect against contamination and allergen cross-contact, and the defined term ``adequate'' provides the context that the specific measures adopted by an establishment are related to public health. (Comment 71) Some comments ask us to change the phrase ``work-in- process'' to ``in-process materials'' in several provisions throughout proposed subpart B because they believe ``in-process materials'' to be more familiar, straightforward, and commonly understood than ``work-in- process.'' (Response 71) ``Work-in-process'' is the common industry term used in widely disseminated industry publications (Ref. 23) (Ref. 24) and has been in use for more than 30 years in the umbrella CGMPs. In addition, we did not receive any comments objecting to the use of this term when we proposed to include it in previous revisions to the umbrella CGMPs (proposed rule 44 FR 33238 at 33247, June 8, 1979; final rule, 51 FR 22458, June 19, 1986). Therefore, we have retained the phrase ``work-in-process'' in the final rule. VIII. Subpart A: Comments on Proposed Sec. 117.1--Applicability and Status We proposed to redesignate Sec. 110.5 as proposed Sec. 117.1, and to add a provision relevant to FSMA's statutory provisions for a prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)). Some comments support the proposed provisions without change. For example, one comment expresses the view that one strength of the long-standing CGMPs is their applicability to the broad spectrum of food manufacturing, from the manufacture of processed products and packaging of fresh produce to production of food additives and GRAS substances. (We note that some packaging of fresh produce (e.g., packaging of RACs on a farm) is not subject to the CGMPs.) Some comments that support the proposed provisions ask us to clarify how we will interpret the provisions (see, e.g., Comment 72). In the following paragraphs, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we are finalizing the provisions as proposed, with editorial and conforming changes as shown in table 52. A. Comments on Proposed Sec. 117.1(a)--Applicability We proposed that the criteria and definitions in part 117 apply in determining whether a food is adulterated: (1) Within the meaning of section 402(a)(3) of the FD&C Act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the FD&C Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. We also proposed that the criteria and definitions in part 117 also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264). (Comment 72) Some comments ask us to clarify that part 117 does not apply to activities that are subject to the requirements for CGMPs, hazard analysis and risk-based preventive controls for animal food and feed by inserting ``intended for consumption by humans'' after ``food'' in Sec. 117.1(a). (Response 72) We decline this request. As discussed in Response 6, the applicability of these regulations to human food is specified in the regulatory text by the title of the rule and by its placement in Subchapter B, rather than Subchapter E, of 21 CFR. (Comment 73) Some comments assert that there is a clear difference between the criteria in proposed Sec. 117.1(a)(1) used to describe adulterated food and the referenced criteria in section 402(a)(3) of the FD&C Act, in that proposed Sec. 117.1(a)(1) describes manufacturing conditions whereas section 402(a)(3) of the FD&C Act describes actual adulterated product. (Response 73) We disagree with these comments. We interpret ``otherwise unfit for food'' in this long-standing statement of applicability to be broader than physical properties of the food and to apply to the manufacturing conditions of the food. (Comment 74) Some comments note that FSMA granted FDA mandatory recall authority for adulterated food. These comments express concern that theoretically we could use a violation of the requirements for hazard analysis and risk-based preventive controls to determine that food is adulterated, thereby providing the basis for a mandatory recall of that food. These comments raise three issues regarding how we will apply Sec. 117.1(a), with consequences for a potential mandatory recall of food. First, these comments note that the regulatory text stating that the ``criteria and definitions'' apply in making a determination of adulteration appears to encompass the entirety of the rule. As a result, farms or facilities that violate any of the requirements in the proposed rule, including components not directly related to the safety of the food (such as recordkeeping requirements), could face a risk that we would deem their food adulterated. Second, these comments assert that the regulatory text suggests that we would not automatically consider a food adulterated as a result of a violation of the proposed rule, because it states that the criteria and definitions ``apply in determining'' whether a food will be considered adulterated, rather than that the food ``is'' adulterated. Third, these comments state that it is not clear how the exemption applicable to qualified facilities is included in the ``criteria and definitions'' used in making a determination of adulteration. These comments ask us to clarify that we will not just automatically assume that qualified facilities are selling adulterated food because they are by definition exempt from the requirements for hazard analysis and risk-based preventive controls. (Response 74) The comments are correct that the criteria and definitions ``apply in determining'' whether a food will be considered adulterated, rather than that the food ``is'' adulterated. In determining whether a food that is manufactured, processed, packed, or held in violation of part 117 (including a violation of the recordkeeping [[Page 55944]] requirement) is adulterated, we would consider the totality of the available data and information about the violation and the food before reaching a conclusion that the food is adulterated. Although this rule does not address the mandatory recall provisions of FSMA, the statutory provisions establish two basic criteria. (See section 423(a) of the FD&C Act (21 U.S.C. 350l).) First, we must determine that there is a ``reasonable probability'' that the food is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. A violation of part 117 would be relevant to determining whether a food is adulterated under section 402. Second, we must determine that there is a reasonable possibility that the use of, or exposure to, that food will cause serious adverse health consequences or death to humans or animals. Not all food that is adulterated has a reasonable probability of causing serious adverse health consequences or death to humans or animals. For examples of food contamination with a reasonable probability of causing serious adverse health consequences or death to humans or animals, see the annual reports of the Reportable Food Registry (RFR) (Ref. 25) (Ref. 26) (Ref. 27) (Ref. 28). A facility that is exempt from any requirement of part 117, including the requirements for hazard analysis and risk-based preventive controls, would not be in violation of part 117 if it did not comply with provisions that it is not subject to. B. Comments on Proposed Sec. 117.1(b)--Prohibited Act We proposed that the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States is a prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the FD&C Act or subparts C, D, E, or F of part 117 (proposed Sec. 117.1(b)). (Comment 75) Some comments from State regulatory agencies note that this new provision is not covered under the applicable State statute and that making any changes to the State statute can be a lengthy process that takes up to 3 years to complete. (Response 75) See Response 5 for a discussion of our approach to working with our food safety partners in the States. C. Comments on Proposed Sec. 117.1(c)--Specific CGMP Requirements We proposed to redesignate Sec. 110.5(b) as proposed Sec. 117.1(c) with no changes. We received no comments that disagreed with our proposal, and are finalizing the proposed provision without change. IX. Subpart A: Comments on Proposed Sec. 117.3--Definitions We proposed to revise some definitions that had been established in part 110, redesignate and re-establish the remaining definitions in part 117 (except for the definition of ``shall,'' which we proposed to delete), and establish several new definitions in part 117. Some comments support one or more of these proposed definitions without change. For example, some comments state that they support the proposed definitions for the following terms with no suggested revisions: critical control point, facility, food allergen, food-contact surfaces, microorganism, mixed-type facility, monitor, plant, safe-moisture level, subsidiary, and validation. Some comments support our proposal, in the 2014 supplemental preventive controls notice, to use the phrase ``chemical (including radiological)'' in the definition of ``hazard,'' noting that doing so is consistent with FSMA, current industry practice, and Codex and global HACCP standards. Some comments that support a proposed definition suggest alternative or additional regulatory text, such as adding examples to make the definition clearer (see, e.g., Comment 81 and Comment 87). Some comments that support a proposed definition ask us to clarify how we will interpret the definition (see, e.g., Comment 77 and Comment 87). In the following sections, we discuss comments that ask us to clarify the proposed definitions or that disagree with, or suggest one or more changes to, the proposed definitions. After considering these comments, we have revised the proposed requirements as shown in table 9, with editorial and conforming changes as shown in table 52. We also have deleted the definition of ``should,'' because the final rule does not use that term. We also discuss definitions for additional terms (i.e., ``audit,'' ``correction,'' ``defect action level,'' ``full-time equivalent employee,'' ``qualified facility exemption,'' ``raw agricultural commodity,'' ``supply-chain-applied control,'' ``written procedures for receiving raw materials and other ingredients,'' and ``unexposed packaged food'') that we are establishing in the final rule to simplify the regulatory text throughout the regulations and improve clarity. We also discuss a new name (i.e., ``preventive controls qualified individual'') for the definition of a term that we had proposed to name ``qualified individual'' and are establishing a new definition for the term ``qualified individual.'' Finally, we discuss definitions that comments ask us to add, but that we did not add, to the final rule. Table 9--Definitions That We Proposed To Establish in Sec. 117.3 ---------------------------------------------------------------------------------------------------------------- Did we make any Did we receive any changes to the comments that proposed Current definition If current, did we disagreed with the definition other Definition (Sec. 110.3) or propose any definition we than the editorial new definition? revisions? proposed to and conforming include in part changes listed in 117? Table 52? ---------------------------------------------------------------------------------------------------------------- Acid foods or acidified foods... Current........... No................ No................ No. Adequate........................ Current........... No................ Yes............... No. Affiliate....................... New............... N/A............... Yes............... No. Allergen cross-contact.......... New............... N/A............... Yes............... No. Audit........................... New in the final N/A............... N/A............... N/A. rule. Batter.......................... Current........... No................ No................ No. Blanching....................... Current........... No................ No................ No. Calendar day.................... New............... N/A............... No................ No. Correction...................... New in the final N/A............... N/A............... N/A. rule. Critical control point.......... Current........... Yes............... Yes............... No. Defect action level............. New in the final N/A............... N/A............... N/A. rule. Environmental pathogen.......... New............... N/A............... Yes............... Yes. [[Page 55945]] Facility........................ New............... N/A............... Yes............... No. Farm............................ New............... N/A............... See discussion of No.\1\ Sec. 1.227 in section IV.B. FDA............................. New............... N/A............... No................ No. Food............................ Current........... No................ Yes............... No. Food allergen................... New............... N/A............... Yes............... No. Food-contact surfaces........... Current........... Yes............... No................ No. Full-time equivalent employee... New in the final N/A............... N/A............... N/A. rule. Harvesting...................... New............... N/A............... See discussion of Yes. Sec. 1.227 in section IV.C. Hazard.......................... New............... N/A............... Yes............... Yes. Holding......................... New............... N/A............... See discussion of Yes. Sec. 1.227 in section IV.D. Known or reasonably foreseeable New............... N/A............... Yes............... Yes. hazard. Lot............................. Current........... No................ Yes............... Yes. Manufacturing/processing........ New............... N/A............... See discussion of Yes. Sec. 1.227 in section IV.E. Microorganisms.................. Current........... Yes............... Yes............... No. Mixed-type facility............. New............... N/A............... See discussion of No. Sec. 1.227 in section IV.F. Monitor......................... New............... N/A............... Yes............... Yes. Packaging (when used as a verb). New............... N/A............... Yes............... The final rule does not include a definition of packaging (when used as a verb). Packing......................... New............... N/A............... See discussion of No. Sec. 1.227 in section IV.G. Pathogen........................ New............... N/A............... Yes............... No. Pest............................ Current........... No................ Yes............... No. Plant........................... Current........... Yes............... Yes............... Replace the term ``establishment'' with ``structure''. Preventive controls............. New............... N/A............... Yes............... No. Preventive controls qualified New............... N/A............... Yes............... No, except to individual. change the name of the term from ``qualified individual'' to ``preventive controls qualified individual''. Qualified auditor............... New............... N/A............... Yes............... Yes. Qualified end-user.............. New............... N/A............... Yes............... Yes. Qualified facility.............. New............... N/A............... Yes............... No. Qualified facility exemption.... New in the final N/A............... N/A............... N/A. rule. Qualified individual............ New in the final N/A............... N/A............... N/A. rule. Quality control operation....... Current........... No................ No................ No. Raw agricultural commodity...... New in the final N/A............... N/A............... N/A. rule. Ready-to-eat (RTE) food......... New............... N/A............... Yes............... No. Receiving facility.............. New............... N/A............... Yes............... No. Rework.......................... Current........... No................ No................ No. Safe-moisture level............. Current........... Yes............... No................ No. Sanitize........................ Current........... Yes............... Yes............... Yes. Should.......................... Current........... No................ No................ Deleted the definition. Significant hazard.............. New............... N/A............... Yes............... Yes, including changing the term to ``hazard requiring a preventive control''. Significantly minimize.......... New............... N/A............... Yes............... No. Small business.................. New............... N/A............... Yes............... Yes. Subsidiary...................... New............... N/A............... Yes............... No. Supplier........................ New............... N/A............... Yes............... Yes. Supply-chain -applied control... New in the final N/A............... N/A............... N/A. rule. Unexposed packaged food......... New in the final N/A............... N/A............... N/A. rule. [[Page 55946]] Validation...................... New............... N/A............... Yes............... Yes. Verification.................... New............... N/A............... Yes............... Yes. Very small business............. New............... N/A............... Yes............... Yes. Water activity.................. Current........... No................ No................ No. Written procedures for receiving New in the final N/A............... N/A............... N/A. raw materials and other rule. ingredients. You............................. New............... N/A............... No................ No. ---------------------------------------------------------------------------------------------------------------- \1\ The ``farm'' definition in Sec. 117.3 is a cross-reference to the ``farm'' definition in the section 415 registration regulations. Although we did revise the ``farm'' definition in the section 415 registration regulations (see section IV.B), the cross-reference we are establishing in Sec. 117.3 is unchanged. A. Redesignation We proposed to redesignate all definitions in Sec. 110.3(a) through (r) as proposed Sec. 117.3, eliminate paragraph designations (such as (a), (b), and (c)), and add new definitions in alphabetical order. We received no comments that disagreed with our proposal, and are finalizing the proposed redesignations. B. Definitions in Current Part 110 That We Proposed To Delete We proposed to delete the definition of ``shall'' and use ``must'' instead. We received no comments that disagreed with our proposal, and are deleting the definition of ``shall'' as proposed. C. Definitions That We Proposed To Establish in Part 117 1. Adequate We proposed to define the term ``adequate'' to mean that which is needed to accomplish the intended purpose in keeping with good public health practice. (Comment 76) Some comments assert that the definition is vague and ask us to clarify what constitutes ``adequate'' for systems such as operating systems for waste treatment and disposal. Other comments ask us to develop guidance on thresholds and processes that qualify as ``adequate.'' Other comments assert that the word ``adequate'' must be used in combination with the word ``reasonable'' to properly describe the intended measures and precautions. As an example, these comments assert that the definition of ``adequate'' could lead to excessive requirements when applied to the provisions for disease control and hygiene (Sec. 117.10). (Response 76) We disagree that this long-standing definition of the term ``adequate'' is vague. The comments do not provide any examples of how we have interpreted this definition in the past in a way that creates practical problems when applying CGMP requirements, including requirements directed to the management of waste or the provisions for disease control and hygiene. Our intent in using the term ``adequate'' is to provide flexibility for a food establishment to comply with the requirement in a way that is most suitable for its establishment. We decline the request to develop guidance to explicitly address ``thresholds'' or to describe processes that qualify as adequate. The CGMPs established in this are broadly applicable procedures and practices rather than very specific procedures and practices where additional interpretation from FDA might be appropriate. 2. Affiliate and Subsidiary We proposed to define the term ``affiliate'' to mean any facility that controls, is controlled by, or is under common control with another facility. We proposed to define the term ``subsidiary'' to mean any company which is owned or controlled directly or indirectly by another company. These proposed definitions would incorporate the definition in sections 418(l)(4)(A) and (D) of the FD&C Act and would make the meanings of these terms clear when used in the proposed definition of ``qualified facility.'' (Comment 77) Some comments ask us to clarify that a facility that has no material connection with another food processing operation would not be considered as an ``affiliate'' of that operation. (Response 77) It is not clear what the comments mean by ``no material connection with another food processing operation.'' To the extent that a facility does not control, is not controlled by, or is not under common control with another facility, we agree that the facility would not be considered an affiliate of that food processing operation. (Comment 78) Some comments assert that the definitions of ``affiliate'' and ``subsidiary'' fail to account for the legal differences between a piece of property (i.e., a facility) and a business entity or person. These comments ask us to consider amending the proposed definition of ``qualified facility'' to clarify what sales to include in determining whether a facility so qualifies. (Response 78) See Response 118. 3. Allergen Cross-Contact We proposed to define the term ``allergen cross-contact'' to mean the unintentional incorporation of a food allergen into a food. (Comment 79) Some comments assert that the term ``incorporation'' used in the definition is a vague term that has entirely different meanings when used by different segments of the food industry (e.g., the term would mean something different to a produce wholesaler than to a cereal manufacturer). These comments ask us to provide either a clarification or a definition for the term ``incorporation.'' (Response 79) By ``unintentional incorporation of a food allergen into food'' we mean that the food allergen would be in a food when the producer of the food did not intend it to be in the food--e.g., if a milk-based beverage contains soybeans in addition to milk. Several provisions of the rule require that a facility take steps to prevent such unintentional incorporation of a food allergen into food. See our previous discussion of the importance of preventing allergen cross- contact (78 FR 3646 at 3693). 4. Critical Control Point We proposed to revise the definition for ``critical control point'' to mean a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate [[Page 55947]] a food safety hazard or reduce such hazard to an acceptable level. (Comment 80) Some comments ask us to specify that a critical control point is essential to reduce the presence of hazards such as microorganisms to ``minimize the risk of foodborne illness'' rather than to ``reduce such hazard to an acceptable level.'' These comments assert that this revision would be consistent with the approach in the proposed produce safety rule. Other comments disagree with the proposed definition because it does not define a term (i.e., acceptable level) used in the definition. (Response 80) We decline to modify the definition as requested by these comments. The proposed definition matches the statutory definition in section 418(o)(1) of the FD&C Act and is consistent with definitions in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry (78 FR 3646 at 3695). The proposed produce safety rule, which did not propose to define ``critical control point,'' focused on biological hazards. However, critical control points may be established to control chemical or physical hazards in addition to biological hazards. The standard suggested by the comments is not inconsistent with the definition we proposed for ``critical control point'' in the human preventive controls rule, because preventing or eliminating a food safety hazard or reducing such hazard to an acceptable level would minimize the risk of foodborne illness. However, the standard suggested by the comments was narrowly directed to biological hazards, because chemical and physical hazards generally cause injury rather than illness. We do not need to define every term used in the definition. By specifying that a point, step, or procedure in a food safety process would reduce a hazard to an ``acceptable level,'' the definition provides flexibility for a facility to determine an appropriate level in a particular circumstance. Consistent with the approach recommended in the proposed produce safety rule (78 FR 3504 at 3545), a facility could use current FDA guidance on microbiological hazards (e.g., Ref. 29 and Ref. 30) to inform its decision on what constitutes an acceptable level. In those documents, we use the phrase ``adequately reduce'' to mean capable of reducing the presence of Salmonella to an extent sufficient to prevent illness. The extent of reduction sufficient to prevent illness usually is determined by the estimated extent to which Salmonella spp. may be present in the food combined with a safety factor to account for uncertainty in that estimate. For example, if it is estimated that there would be no more than 1000 (i.e., 3 logs) Salmonella organisms in the food, and a safety factor of 100 (i.e., 2 logs) is employed, a process adequate to reduce Salmonella spp. would be a process capable of reducing Salmonella spp. by 5 logs. 5. Environmental Pathogen We proposed to define the term ``environmental pathogen'' to mean a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize or prevent the environmental pathogen. We also proposed to specify that environmental pathogen does not include the spores of pathogenic sporeformers. (Comment 81) Some comments ask us to include Salmonella spp. and L. monocytogenes in the regulatory text as examples of environmental pathogens because of the likelihood that these environmental pathogens could contaminate ready-to-eat (RTE) food. Other comments ask us to provide a broader list (including Escherichia coli, Campylobacter, pathogenic Vibrio, Staphylococcus aureus, Clostridium botulinum, Shigella, Yersinia enterocolitica, and viruses such as rotoviruses and noroviruses) in the preamble to the final rule or in guidance, and to make clear that the list is not all-inclusive. Some comments emphasize the need for flexible language because any list of microorganisms might change over time, particularly as new environmental pathogens emerge. Some comments ask us to include the indicator organism Listeria spp. in the regulatory text, because analysis of Listeria spp. is faster than analysis of L. monocytogenes. Other comments ask us to include pathogens that have been associated with RACs, as reported by CDC. (Response 81) We agree that Salmonella spp. and L. monocytogenes are useful examples of environmental pathogens and have added these two examples to the proposed definition, which had not included examples. As the comments point out, adding these two examples to the definition does not mean that these two pathogens are the only environmental pathogens that a facility must consider in its hazard analysis. New environmental pathogens can emerge at any time, and other pathogens (e.g., Cronobacter spp.) can also be environmental pathogens (78 FR 3646 at 3816). We have not included the indicator organism Listeria spp. as an example of an environmental pathogen, whether in the regulatory text, in the preamble of this document, or in guidance. Although we agree that Listeria spp. is an appropriate indicator organism when conducting verification testing for sanitation controls, the definition in question is for a pathogen, not for indicators of a pathogen. Other provisions of the rule are more appropriate to provide the context that a facility has flexibility for how to conduct verification testing for an environmental pathogen, including an option to test for an indicator organism. (See, e.g., Sec. 117.165(a)(2) and (3).) L. monocytogenes, Salmonella spp., and some of the other pathogens mentioned in the comments have been associated with RACs. To the extent that the comments are asking us to identify some environmental pathogens that have been associated with RACs, by identifying these pathogens in the regulatory text or in this preamble we have done so. However, it is important to note that the term ``environmental pathogen'' as defined in this rule is directed to pathogens in the food processing environment (such as the insanitary conditions in a facility that packed cantaloupes linked to an outbreak of listeriosis (78 FR 3646 at 3814)), not to pathogens present in the growing environment for a RAC. (Comment 82) Some comments ask us to define ``environmental pathogen'' as a microorganism that is of public health significance and is capable of surviving and persisting within the manufacturing, processing, packing, and holding environment of the food being prepared. (Response 82) We decline this request. The definition of ``environmental pathogen'' should not change depending on the food being prepared in a particular facility. As a practical matter, the facility will consider the manufacturing, processing, packing, and holding environment of the food being prepared when it conducts its hazard analysis (Sec. 117.130). (Comment 83) Some comments ask us to focus attention on the areas where environmental monitoring is particularly important by modifying the definition to address the risk of contamination to RTE food and to foods exposed to the environment after a lethality step. Other comments ask us to consider the number and types of different products produced, the complexity of processing procedures, [[Page 55948]] the amount of product produced, and whether an environmental sampling program is in place. (Response 83) We decline these requests, which are asking us to specify in a definition factors associated with developing an environmental monitoring program. The purpose of a definition is to simply explain what a term means, not to establish requirements, or provide guidance about requirements, that use the term. (Comment 84) Some comments ask us to clarify the meaning of the term ``persisting'' as used in the definition, such as whether it means that a sanitation process will not remove the microorganism. (Response 84) We use the term ``persisting'' to mean that a pathogen can become established if cleaning is not adequate. Once a pathogen becomes established, appropriate sanitation measures can remove the pathogen. However, sanitation procedures necessary to eliminate an environmental pathogen that has become established generally are more aggressive than routine sanitation procedures. (Comment 85) Some comments ask us to revise the definition to specify that the microorganisms are ``potentially'' of public health significance. (Response 85) We decline this request. The definition is only directed at those microorganisms that are of public health significance. (Comment 86) One comment asserts that the proposed definition of ``environmental pathogen'' excludes the waterborne pathogens Cyclospora and Cryptosporidium and asks us to revise the definition so that these pathogens will be considered ``environmental pathogens'' for the purposes of the human preventive controls rule. The comment asserts that excluding these waterborne pathogens does not take into account the considerable food safety hazard of ``spores'' of ``pathogenic sporeformers'' that can be present in and delivered to a food processing facility by processing and ingredient water, both well water and surface water from either private or municipal supply, in both domestic and foreign facilities. The comment asks us to delete the statement that an environmental pathogen does not include the spores of pathogenic sporeformers so that, according to the comment, Cyclospora and Cryptosporidium would fall within the definition of ``environmental pathogen.'' (Response 86) We disagree that the pathogens Cyclospora and Cryptosporidium should be considered ``environmental pathogens'' as we use that term in this rule. Our definition of ``environmental pathogen'' is directed to those pathogens that are capable of surviving and persisting within the manufacturing, processing, packing, or holding environment of a food establishment, not the water that is used in a food processing establishment. See the discussion of environmental pathogens in the food processing environment in section I.D of the Appendix to the 2013 proposed human preventive controls rule (78 FR 3646 at 3813-3815, with corrected reference numbers at 78 FR 17142 at 17144-17146). As discussed in that Appendix, the available data and information associate insanitary conditions in food facilities with contamination of a number of foods with Salmonella spp. and L. monocytogenes. Such contamination has led to recalls and to outbreaks of foodborne illness. As a result, the rule includes several provisions directed to those pathogens, such as Salmonella spp. and L. monocytogenes, that are capable of surviving and persisting within a food establishment (thereby serving as a source of contamination of the food establishment environment) and uses the defined term ``environmental pathogens'' to describe those pathogens. These specific provisions do not apply to waterborne pathogens that do not survive and persist within a food establishment. By ``pathogenic sporeformers,'' we mean ``pathogenic sporeforming bacteria,'' and we are substituting the term ``pathogenic sporeforming bacteria'' for ``pathogenic sporeformers'' in the definition of ``environmental pathogen'' to make that clearer. Both of the waterborne pathogens discussed by this comment are protozoan parasites, not bacteria (Ref. 31). The fact that waterborne organisms such as Cyclospora and Cryptosporidium are not ``environmental pathogens'' as that term is used in this rule does not mean that a facility has no responsibility to evaluate whether Cyclospora or Cryptosporidium are known or reasonably foreseeable hazards that require a preventive control. For example, when a fresh-cut produce processing facility receives produce from a geographic region where Cyclospora or Cryptosporidium have been associated with food safety problems, the facility likely would address the potential for contamination of incoming produce with Cyclospora or Cryptosporidium in its supply-chain program (see subpart G for the requirements of the supply-chain program). 6. Facility We proposed to define the term ``facility'' to mean a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act in accordance with the requirements of 21 CFR part 1, subpart H. Comments directed to the meaning of the term ``facility'' address its meaning as established in the section 415 registration regulations, rather than this definition established in part 117. See Comment 4 and Response 4. 7. Farm We proposed to define the term ``farm'' by reference to the definition of that term in proposed Sec. 1.227 rather than by repeating the full text of the ``farm'' definition in part 117. See section IV.B for a discussion of the ``farm'' definition that we are establishing in Sec. 1.227. 8. Food We proposed to define the term ``food'' to mean food as defined in section 201(f) of the FD&C Act and to include raw materials and ingredients. Under section 201(f), the term ``food'' means: (1) Articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (Comment 87) Some comments ask us to include examples in the definition, particularly dietary supplements and dietary ingredients. These comments also ask us to clarify whether the definition applies to food for human consumption, animal consumption, or both. (Response 87) We decline the request to include examples in the definition. Dietary supplements and dietary ingredients are articles used for food or drink for man, as are many other articles. There are many examples of food and adding a limited list of examples could be confusing rather than helpful. Although the definition of food includes food for both human consumption and animal consumption, the provisions of the rule are clearly directed to food for human consumption (see Response 6 and Response 72). (Comment 88) Some comments ask us to consider fundamental and important differences between food additives and GRAS substances and finished food. These comments explain that food additives and GRAS substances may be synthesized using various chemical and biochemical processes, or may be extracted, hydrolyzed or otherwise modified from their natural sources, and result in food safety hazards that are quite different from finished food [[Page 55949]] preparations. These comments also explain that food additives and GRAS substances are often produced using processes that minimize microbial contamination hazards and are almost always used in food products that undergo further downstream processing. These comments assert that food additives and GRAS substances generally present a significantly lower public health hazard compared to finished food and should be regulated accordingly. (Response 88) Substances such as food additives and GRAS substances are food and are subject to the requirements of this rule. Both the CGMP requirements in subpart B and the requirements for hazard analysis and risk-based preventive controls in subparts C and G provide flexibility to address all types of food. (As discussed in section XLII, the final rule establishes the requirements for a supply-chain program in subpart G, rather than within subpart C as proposed. As a result, this document refers to subparts C and G when broadly referring to the requirements for preventive controls.) Some comments point out that one strength of the long-standing CGMPs is their applicability to the broad spectrum of food manufacturing, from the manufacture of processed products to production of food additives and GRAS substances (see section VIII). A manufacturer of a food additive or GRAS substance has flexibility to comply with the requirements of the rule based on the nature of the production processes and the outcome of the hazard analysis for that food substance. (See also Response 221.) (Comment 89) Some comments ask us to limit the definition of ``food'' as it would apply to the new requirements for hazard analysis and risk-based preventive controls to only cover produce and processed foods covered by the rules, rather than all food (human and animal, produce and non-produce, low-risk and high-risk). (Response 89) We decline this request. It is not necessary to modify the definition of ``food'' to limit applicability of the rule to human food. (See Response 6.) The umbrella CGMPs that we are establishing in subpart B are long-standing provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration and are not ``one-size-fits- all.'' (See Response 221.) The new requirements for hazard analysis and risk-based preventive controls likewise are not ``one-size-fits-all,'' and facilities that are subject to the rule would consider the risk presented by the products as part of their hazard evaluation; a facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. (See Response 222.) 9. Food Allergen We proposed to define the term ``food allergen'' to mean a major food allergen as defined in section 201(qq) of the FD&C Act. (Comment 90) Some comments ask us to narrow the definition of food allergen by specifying that a substance is only a food allergen when it is not disclosed on the product label. (Response 90) We decline this request, which appears to confuse the distinction between what a food allergen is and when a product would be misbranded under section 403(w) of the FD&C Act. The substances listed in section 201(qq) of the FD&C Act are food allergens; if any of those substances are not disclosed on the product label, then the product would be misbranded under section 403(w) of the FD&C Act. (Comment 91) Some comments ask us to expand the existing exemption for RACs from the definition of major food allergen in section 403(w)(1) of the FD&C Act to include raw fish. (Response 91) This comment is unclear and appears to be confusing the definition of ``major food allergen'' in section 201(qq) of the FD&C Act with criteria for when a food shall be deemed to be misbranded under section 403(w) of the FD&C Act. Under section 403(w), a food shall be deemed misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless certain labeling requirements are met. Under section 201(r) of the FD&C Act, the term ``raw agricultural commodity'' means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. Fish are food and, thus, raw, unprocessed fish are RACs within the meaning of section 403(w). Thus, the misbranding provisions of section 403(w) would not apply to raw, unprocessed fish, because those misbranding provisions do not apply to RACs. However, the exemption in section 403(w) from the conditions under which a food shall be deemed to be misbranded do not establish an exemption for RACs in the definition of ``major food allergen'' in section 201(qq). To the extent that the comment is asking us to revise either the statutory definition of ``major food allergen'' in section 201(qq) of the FD&C Act, or to revise the criteria for when a food shall be deemed misbranded under section 403(w) of the FD&C Act, we do not have authority to do so. (Comment 92) Some comments ask us to include an example of an ingredient derived from an allergen in the definition. (Response 92) We decline this request. The definition of ``major food allergen'' in section 201(qq) of the FD&C Act is sufficient to define the term. Casein and whey protein, each of which are derived from milk, are examples of ingredients that would satisfy the definition of ``major food allergen'' in section 201(qq). 10. Harvesting We proposed to establish in Sec. 117.3 the same definition of ``harvesting'' as we proposed to establish in Sec. Sec. 1.227 and 1.328. See section IV.C for a discussion of comments we received to the proposed definition of ``harvesting'' in Sec. Sec. 1.227 and 1.328, and our responses to those comments. 11. Hazard We proposed to define the term ``hazard'' to mean any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury in the absence of its control. (Comment 93) Some comments express concern that the rule would refer to four levels of ``hazard''--i.e., ``hazard,'' ``known or reasonably foreseeable hazard,'' ``significant hazard,'' and ``serious adverse health consequences or death to humans or animals'' hazard. These comments ask us to provide sufficient clarity to be able to distinguish between these types of hazards and to provide examples in guidance as to how these terms will be applied in determining compliance with the rule. Other comments express concern that the definitions do not establish a meaningful distinction between ``hazard'' and ``significant hazards'' and do not sufficiently distinguish between the hazards identified in the first and second steps of the hazard analysis (first narrowing hazards to ``known or reasonably foreseeable hazards'' and then narrowing the ``known or reasonably foreseeable hazards'' to ``significant hazards''). (Response 93) The rule uses three of these terms (i.e., ``hazard,'' ``known or reasonably foreseeable hazard,'' and the proposed term ``significant hazard'') to [[Page 55950]] establish a tiered approach to the requirements for hazard analysis and risk-based preventive controls. The term ``hazard' is the broadest of these three terms--any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury. To conduct its hazard analysis, a facility starts by first narrowing down the universe of all potential hazards to those that are ``known or reasonably foreseeable'' for each type of food manufactured, processed, packed, or held at its facility. The outcome of the facility's hazard analysis is a determination of ``significant hazards''--i.e., the subset of those known or reasonably foreseeable hazards that require a preventive control. To make this clearer, we have: (1) Revised the proposed definition of ``hazard''; (2) changed the term ``significant hazard'' to ``hazard requiring a preventive control''; and revised the definition of ``hazard requiring a preventive control'' (formerly ``significant hazard''). See Response 94, Response 126, Response 127, Response 128, and Response 129. The rule does not define the term ``serious adverse health consequences or death to humans or animals'' hazard. However, the requirements for a supply-chain program refer to a hazard for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans (see Sec. 117.430(b)). For additional information on how we interpret ``serious adverse health consequences or death to humans or animals,'' see our guidance regarding the Reportable Food Registry (Ref. 32) (Ref. 33), which addresses statutory requirements regarding ``reportable foods.'' As explained in that guidance, a ``reportable food'' is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. The guidance includes examples of circumstances under which food might be reportable. (Comment 94) Some comments assert that the distinction between the definitions of ``hazard'' and ``significant hazard'' is not discernable because the proposed definition of ``hazard'' currently takes into account whether or not a ``hazard'' is or is not controlled. These comments ask us to delete the phrase ``in the absence of its control'' from the definition of ``hazard'' to clarify that hazards are simply the agents that are reasonably likely to cause illness or injury. Likewise, other comments assert that any hazard that is ``reasonably likely to cause illness or injury in the absence of its control'' will, if known or reasonably foreseeable, likely be controlled by any knowledgeable person. (Response 94) We have deleted the phrase ``in the absence of its control'' from the definition of ``hazard.'' As previously discussed, the phrase ``in the absence of its control'' is not included in the definition of ``hazard'' in the Codex HACCP Annex, our HACCP regulation for seafood, or the HACCP regulation for meat and poultry, although it is included in the NACMCF HACCP Guidelines and our HACCP regulation for juice (78 FR 3646 at 3697). We agree that deleting this phrase from the definition of ``hazard'' will more clearly distinguish between the terms ``hazard'' and ``hazard requiring a preventive control'' that we are establishing in this rule. We see no reason to propose an analogous change to the definition of ``hazard'' in our HACCP regulation for juice because that regulation only defines the single term ``hazard'' and, thus, the issue discussed in these comments does not apply. We also replaced the phrase ``that is reasonably likely to cause illness or injury'' with ``that has the potential to cause illness or injury'' to more clearly distinguish ``hazard'' from ``known or reasonably foreseeable hazard.'' This increases the alignment of the definition of ``hazard'' in this rule with the Codex definition of ``hazard.'' (Comment 95) Some comments ask us to add that the term hazard also means any agent that would cause a food to become adulterated under section 402 of the FD&C Act. (Response 95) The suggested addition is inconsistent with current national and international understanding of what constitutes a hazard (Ref. 34) (Ref. 35) because it would include agents such as filth, which would adulterate food within the meaning of section 402(a)(4) of the FD&C Act but would be unlikely to cause illness or injury (Ref. 36). 12. Holding We proposed to establish in Sec. 117.3 the same definition of ``holding'' as we proposed to establish in Sec. Sec. 1.227 and 1.328. See section IV.D for a discussion of comments we received to the proposed definition of ``holding'' in Sec. Sec. 1.227 and 1.328, and our responses to those comments. 13. Known or Reasonably Foreseeable Hazard We proposed to define the term ``known or reasonably foreseeable hazard'' to mean a biological, chemical (including radiological), or physical hazard that has the potential to be associated with the facility or the food. (Comment 96) Some comments support the definition as proposed, noting that it implies that the implementation of a preventive control is based both on the severity and likelihood of the hazard, can help to distinguish between the requirements of this rule and HACCP requirements, and provides for the proper consideration of both the food and the facility when determining whether a hazard is ``known or reasonably foreseeable.'' Other comments ask us to modify the definition to specify that the term means a hazard ``that is known to be, or has the potential to be,'' associated with the facility or the food'' to better align with the term as FDA proposed to define it in the proposed FSVP rule. (See 79 FR 58574 at 58595.) (Response 96) We have revised the definition as requested by the comments to better align with the proposed FSVP rule. (Comment 97) Some comments ask us to revise the definition so that it addresses a hazard that is known to be, or has the potential to be, associated with a food, the facility in which it is manufactured/ processed, or the location or type of farm on which it is grown or raised. These comments assert that the type of farm may affect those hazards that are known or reasonably foreseeable. (Response 97) We decline this request, which appears related to another difference between the definition proposed in this rule and the definition of this term in the proposed FSVP rule. The proposed FSVP rule would define ``known or reasonably foreseeable hazard'' as a hazard that is known to be, or has the potential to be, associated with a food or the facility ``in which it is manufactured/processed.'' (See 79 FR 58574 at 58595.) In this rule, we do not need to specify that the applicable facility is the one ``in which the food is manufactured/ processed'' because this rule applies to the owner, operator, or agent in charge of the facility in which the food is manufactured, processed, packed, or held, and that applicability does not need to be repeated in each provision. To the extent that this comment is expressing concern about raw materials or other ingredients that a facility would receive from a farm, those concerns would be considered in the facility's hazard analysis, which would include a hazard evaluation that considers factors such as those related to the source of [[Page 55951]] raw materials and other ingredients (see Sec. 117.130(c)(2)(iii)). (Comment 98) Some comments ask us to include ``food allergens'' in the parenthetical where we list radiological hazards as a type of chemical hazard. (Response 98) We decline this request. As previously discussed, the definitions of ``hazard'' or ``food hazard'' in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry all define hazard with respect to biological, chemical, and physical agents, and we proposed to include radiological agents to implement section 418(b)(1)(A) of the FD&C Act (78 FR 3646 at 3697). We subsequently proposed to include radiological hazards as a subset of chemical hazards because comments recommended that we do so, and we believe that facilities in the past have considered radiological hazards as chemical hazards when conducting a hazard analysis for the development of HACCP plans (79 FR 58524 at 58557). In this document, we affirm our proposal to implement section 418(b)(1)(A) of the FD&C Act by specifically including radiological hazards in the definition of hazard. We acknowledge that food allergen hazards (together with pesticide and drug residues, natural toxins, decomposition, and unapproved food or color additives) also are a subset of chemical hazards but do not find it necessary to list all examples of chemical hazards in the definition of hazard, just as we do not find it necessary to list multiple examples of biological and physical hazards in the definition of hazard. The requirement to consider food allergen hazards in the hazard analysis is already explicit in the requirements for hazard identification (see Sec. 117.130(b)(1)(ii)). (Comment 99) Some comments suggest using the phrase ``reasonably anticipated contaminants'' as a useful phrase that clearly defines all hazards, whether deliberate or accidental, that can cause adulteration in the food supply. (Response 99) We decline this request. We see no meaningful difference between ``reasonably expected'' and ``reasonably anticipated.'' We also see no benefit in specifying that a hazard is a ``contaminant'' rather than an ``agent'' (which is the term used in the definition of ``hazard''). 14. Lot We proposed to define ``lot'' to mean the food produced during a period of time indicated by a specific code. (Comment 100) Some comments ask us to modify the proposed definition to make it more flexible and robust. These comments assert that the proposed definition appears to ignore other potential definitions, such as products with common characteristics (such as origin, variety, type of packing, packer, consignor, markings) and that multiple ``lots'' can be produced during the same time but with different lot designations. Other comments ask us to modify the proposed definition so that it is not limited by a period of time and suggest using an approach that would allow for a lot to be defined by either time or by a specific identifier. Other comments express the view that the individual operators should be able to define their lot designations and make these definitions available to FDA upon request. Other comments assert that the proposed definition is too prescriptive and inflexible in that timeframe is not necessarily the most logical way to identify a lot (e.g., for batch production). Some comments suggest specific changes to the text of the proposed definition, such as ``Lot means a body of food designated by the facility with common characteristics, e.g., origin, variety, type of packing, packer, consignor, markings or time of harvest, packing or processing, which is separable by such characteristics from other bodies of food.'' (Response 100) As judged by these comments, the long-standing definition of ``lot'' has the potential to be misinterpreted to mean that the ``specific code'' must be based on time, such as a date. This is not the case. Although the term ``lot'' is associated with a period of time, an establishment has flexibility to determine the code, with or without any indication of time in the code. For example, a code could be based on a date, time of day, production characteristic (such as those mentioned in the comments), combination of date/time/ production characteristic, or any other method that works best for the establishment. To clarify that the rule does not require that time be ``indicated'' by the code, and emphasize the establishment's flexibility to determine the code, we have revised ``period of time indicated by a specific code'' to ``period of time and identified by an establishment's specific code.'' (Comment 101) Some comments ask us to clarify the purpose of the ``specific code'' associated with the lot (i.e., that it should give insight into production history of the associated food) and to define a term such as ``lot code'' or ``production code.'' (Response 101) The purpose of the specific code associated with a lot is to identify the food and associated production records--e.g., when investigating a food safety problem or conducting a recall. We decline the request to define a term such as ``lot code'' or ``production code.'' The definition of ``lot'' is intended to provide flexibility for an establishment to determine the mechanism of assigning a code that is best suited to the food it produces. (Comment 102) Some comments ask us to clarify the factors that can affect the size of a ``lot.'' These comments assert that minimizing the size of a lot could be beneficial to an establishment if a recall is needed and express concern that our proposed definition may differ from that used by a specific establishment. (Response 102) The definition provides a company with flexibility to determine an appropriate size of a lot. 15. Manufacturing/Processing We proposed to establish in Sec. 117.3 the same definition of ``manufacturing/processing'' as we proposed to establish in Sec. Sec. 1.227 and 1.328. See section IV.E for a discussion of comments we received to the proposed definition of ``manufacturing/processing'' in Sec. Sec. 1.227 and 1.328, and our responses to those comments. 16. Microorganisms We proposed to define the term ``microorganisms'' to mean yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and include species having public health significance. We also proposed that the term ``undesirable microorganisms'' includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. (Comment 103) Some comments express concern that the term ``undesirable microorganisms'' includes microorganisms that subject food to decomposition. These comments assert that the definition would expand regulation beyond food safety and ask us to clarify that decomposition means a degradation of product that is only relevant when it affects the safety of the product, rather than simple spoilage, because the presence of microorganisms that can cause spoilage is an unavoidable condition of fresh produce. (Response 103) We have not modified the regulatory text of this long-standing definition of the term ``undesirable microorganisms'' regarding [[Page 55952]] microorganisms that subject food to decomposition. As we noted during the rulemaking to first establish this definition, the regulations are designed to prevent the growth of undesirable microorganisms, and the scope of the definition is not limited to pathogens because these regulations are also concerned with sanitation, decomposition, and filth (51 FR 22458 at 22460). The comments do not provide any examples of how we have interpreted this provision in the past in a way that creates practical problems to the fresh produce industry when applying CGMP requirements directed to preventing the growth of undesirable microorganisms. (Comment 104) Some comments ask us to specify that the term ``undesirable microorganisms'' includes microorganisms that are resistant to drugs or antibiotics. (Response 104) We decline this request. The requirements of this rule directed to preventing contamination with microorganisms are intended to keep microorganisms out of food regardless of whether a particular strain of a specific microorganism (including a pathogen, a microorganism that subjects food to decomposition, and a microorganism that indicates that food is contaminated with filth) has the particular characteristic of being resistant to drugs or antibiotics. (Comment 105) Some comments ask us to provide lists of microorganisms that we consider indicative of ``contamination with filth'' and our rationale for such consideration. (Response 105) We decline this request, which is better suited for guidance. In other circumstances, we have discussed coliforms and fecal coliforms as indicators that food has been contaminated by manufacturing practices conducted under insanitary conditions (see, e.g., the discussion in the proposed rule to establish Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula, 61 FR 36154 at 36171, July 9, 1996). As another example, ``Compliance Policy Guide Sec. 527.300 Dairy Products-- Microbial Contaminants and Alkaline Phosphatase Activity'' provides that dairy products may be considered adulterated within the meaning of section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, when (nontoxigenic) E. coli is found at certain levels (Ref. 37). 17. Mixed-Type Facility We proposed to establish in Sec. 117.3 the same definition of ``mixed-type facility'' as we proposed to establish in Sec. Sec. 1.227 and 1.328. See section IV.F for a discussion of comments we received to the proposed definition of ``mixed-typed facility'' in Sec. Sec. 1.227 and 1.328, and our responses to those comments. 18. Monitor We proposed to define the term ``monitor'' to mean to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification. (Comment 106) Some comments assert that our proposed definition of monitoring is directed to the narrow circumstance of monitoring that would be applied to a CCP under the NACMCF HACCP guidelines and the Codex HACCP Annex. These comments also assert that, using such definitions, monitoring would not apply to control measures for which parameters cannot be established and that are not amenable to documentation. These comments suggest that we use a definition of monitoring consistent with that provided in ISO 22000:2005 (conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended) to clarify that monitoring may be conducted where appropriate for preventive controls that are not CCPs. (ISO is an abbreviation for ``International Organization for Standardization.'' ISO develops and publishes international standards.) According to these comments, an advantage of this definition is that it also would clarify the difference between monitoring activities (observations conducted during the operation of a control measure to ensure that it is under control) and verification activities (to evaluate performance of a control measure). (Response 106) We have revised the definition of monitor to mean to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended. We agree that the revised definition, which reflects an international standard, more effectively communicates that monitoring also applies to controls that are not at CCPs and may apply to control measures for which parameters cannot be established. However, we disagree that this definition signals that it is not possible to obtain documentation when monitoring preventive controls that are not at CCPs, such as for controls that are not process controls and do not involve parameters and maximum or minimum values, or combinations of values, to which a parameter must be controlled to significantly minimize or prevent a hazard requiring a preventive control. For example, it is possible to monitor that a specific sanitation control activity has taken place, such as the cleaning of a piece of equipment to prevent allergen cross-contact. The requirement for documenting monitoring in records is established by the requirements for monitoring, not by the definition of monitor. As discussed in Response 468, we have made several revisions to the regulatory text, with associated editorial changes, to clarify that monitoring records may not always be necessary. 19. Packaging (When Used as a Verb) We proposed to establish in Sec. 117.3 the same definition of ``packaging (when used as a verb)'' as we proposed to establish in Sec. Sec. 1.227 and 1.328. (Comment 107) Some comments express concern about establishing the definition of ``packaging (when used as a verb)'' in part 117. These comments ask us to clarify how this proposed definition relates to other uses of the word ``packaging'' in part 117, including use as an adjective in the common phrase ``food-packaging materials,'' and including some provisions directed to controlling allergen cross- contact and contamination in ``food-packaging materials.'' Some comments ask us to establish definitions for terms such as ``food- packaging materials'' or ``primary packaging'' to clarify the meaning of the term ``packaging'' as it has previously been used in part 110. Other comments ask us to clarify that provisions directed to preventing allergen cross-contact and contamination in ``food-packaging materials'' apply only to ``food-contact packaging,'' not ``secondary packaging.'' Some comments focus on the differences between the definition of the term ``packing'' and ``packaging'' with respect to activities conducted on RACs. Some comments ask us to clarify how the term ``packaging (when used as a noun)'' would apply when used in part 117, even though we did not propose to establish a definition for ``packaging (when used as a noun)'' in part 117. (Response 107) We have decided not to establish the definition ``packaging (when used as a verb)'' in part 117. That definition was established in the section 415 registration regulations, in part, to identify those food establishments that would be subject to those regulations based, in part, on the activity of placing food into a container that directly [[Page 55953]] contacts the food and that the consumer receives. In addition, because the term ``packaging'' (when used as a noun) can be used in a very general way to refer to both the container that directly contacts the food and to the outer packaging of food that does not contact the food, the section 414 recordkeeping regulations established a definition of ``packaging'' (when used as a noun) to narrowly refer to ``the outer packaging of food that bears the label and does not contact the food,'' because this narrow definition was also necessary for the purposes of those recordkeeping regulations. However, the term ``packaging'' has long been used as a noun in the CGMPs to generally refer to the container that directly contacts the food, rather than to the outer packaging of food that does not contact the food (as it means in the section 414 recordkeeping regulations). Thus, the very specific connotation for the term ``packaging'' (when used as a noun) that was established in the section 414 recordkeeping regulations does not apply, and is causing confusion. As the comments point out, our proposed definition of ``packaging (when used as a verb)'' is already causing confusion in the context of part 117. Therefore, for clarity and simplicity in part 117 we are not including in the final rule a definition of ``packaging (when used as a verb).'' A definition for ``packaging (when used as a verb)'' remains in the section 415 registration regulations, where a business can continue to use the definition for purposes of determining whether either or both of those regulations applies to its business. Part 117 establishes requirements for manufacturing, processing, packing, and holding human food. The definition of ``manufacturing/ processing'' we are establishing in this rule makes clear that ``packaging'' (when used as a verb) is a manufacturing/processing activity and, thus, that requirements that apply to manufacturing or processing activities apply to packaging activities. Because part 117 is not the regulation that describes whether a food establishment is subject to the section 415 registration regulations or the section 414 recordkeeping regulations, it is not necessary for part 117 to do more. The comments that express concern about the distinction between ``packing'' and ``packaging (when used as a verb)'' with respect to activities conducted on RACs no longer apply in light of the revised ``farm'' definition that we are establishing in the section 415 registration regulations. The revised ``farm'' definition provides for packaging RACs when packaging does not involve additional manufacturing/processing (such as cutting). 20. Packing We proposed to establish in Sec. 117.3 the same definition of ``packing'' as we proposed to establish in Sec. Sec. 1.227 and 1.328. See section IV.G for a discussion of comments we received to the proposed definition of ``packing'' in Sec. Sec. 1.227 and 1.328, and our responses to those comments. 21. Pathogen We proposed to define the term ``pathogen'' to mean a microorganism of public health significance. (Comment 108) Some comments ask us to revise the definition to mean a ``microorganism of such severity and exposure that it would be deemed of public health significance'' because the significance of pathogens to public health depends on the organism's severity and the nature of exposure. (Response 108) We decline this request. Our purpose in defining the term pathogen was to simplify the regulations, including our long- standing CGMP regulations, by substituting a single term (i.e., ``pathogen'') for a more complex term (i.e., ``microorganism of public health significance'') throughout the regulations. These comments appear to be objecting to the use of the long-standing phrase ``microorganism of public health significance,'' which has been in our CGMP regulations for decades, rather than to our proposal to define and use a simpler term in its place. These comments fail to explain how we have interpreted the current term ``microorganism of public health significance'' in a way that does not take into account factors such as the severity of illness and the route of exposure. 22. Pest We proposed to define the term ``pest'' to refer to any objectionable animals or insects including birds, rodents, flies, and larvae. (Comment 109) Some comments ask us to include reptiles in the definition due to a past instance of Salmonella linked to lizard feces in an RTE nut-manufacturing facility. (Response 109) We decline this request. This long-standing definition does not limit pests to those already included as examples. Reptiles are objectionable animals that are known to carry human pathogens and are considered pests. (Comment 110) Some comments ask us to clarify the meaning of the term ``objectionable.'' These comments state that, under the Canadian Pest Control Products Act, objectionable means that an animal does not belong in a food processing environment and suggest that we follow this meaning of ``objectionable.'' These comments also note that there may be circumstances where the presence of an animal is acceptable, such as the use of guide dogs. (Response 110) We decline this request. The meaning of the term ``objectionable'' as described in these comments is consistent with our interpretation of this long-standing definition of ``pest,'' but we do not believe it is necessary to provide a definition. See the provisions for pest control (Sec. 117.35(c)), which allow the use of guard, guide, and pest-detecting dogs. 23. Plant We proposed to define the term ``plant'' to mean the building or establishment or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food. See Comment 63 for the comments on the definition of ``plant'' and Response 63 for our response to those comments. 24. Preventive Controls We proposed to define the term ``preventive controls'' to mean those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. (Comment 111) Some comments ask us to clarify the meaning of ``current scientific understanding'' because scientific understanding can vary depending on the risk profile of a commodity. (Response 111) By ``current scientific understanding,'' we mean to emphasize that scientific information changes over time and a facility needs to keep current regarding safe handling and production practices such that the facility has the information necessary to apply appropriate handling and production practices. 25. Preventive Controls Qualified Individual We proposed to define the term ``qualified individual'' to mean a person who has successfully completed training in the development and application of risk-based preventive [[Page 55954]] controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system. We have changed the proposed term ``qualified individual'' to ``preventive controls qualified individual'' because we are establishing a new definition for ``qualified individual,'' with a meaning distinct from ``preventive controls qualified individual.'' To minimize the potential for confusion for when the term ``qualified individual'' refers to the proposed meaning of the term and when the term ``qualified individual'' refers to the meaning of that term as finalized in this rule, in the remainder of this document we use the new term ``preventive controls qualified individual'' whenever we mean ``a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system,'' even though the proposed rule used the term ``qualified individual.'' Likewise, we use the new term ``preventive controls qualified individual'' for the proposed term ``qualified individual'' when describing the comments to the proposed rule, even though those comments use the term ``qualified individual.'' In the following paragraphs, we discuss comments on this proposed definition. (See also our discussion (in section XXXVI) of the requirements applicable to the preventive controls qualified individual (Sec. 117.180(c)).) (Comment 112) Some comments assert that the proposed definition of preventive controls qualified individual is ambiguous. (Response 112) The comments provide no basis for asserting that this definition is ambiguous, such as difficulties in how we have interpreted similar regulatory text in enforcing our HACCP regulations for seafood and juice (Sec. Sec. 123.10 and 120.13(b), respectively). The proposed definition includes a performance standard (qualified to develop and apply a food safety system), two criteria for how a person can become qualified (specialized training or job experience), and a description of the type of applicable training (development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum). The proposed definition provides flexibility for how an individual can become qualified, but this flexibility does not make the definition ambiguous. (Comment 113) Some comments ask us to expand the definition so that it includes a team of preventive controls qualified individuals, not just a single person. (Response 113) We decline this request. The definition applies to each preventive controls qualified individual that a facility relies on to satisfy the requirements of the rule without limiting the number of such preventive controls qualified individuals. The requirements of the rule make clear that a facility may rely on more than preventive controls qualified individual (see, e.g., Sec. 117.180(a)). (Comment 114) One comment asks us to include ``trusted trader'' (i.e., a company or entity in the supply chain proven to be low risk) in the definition of preventive controls qualified individual. (Response 114) We decline this request. The concept of ``trusted trader'' applies to a facility's suppliers, not to individuals qualified to develop and apply a food safety system. 26. Qualified Auditor We proposed to define the term ``qualified auditor'' to mean a person who is a preventive controls qualified individual as defined in this part and has technical expertise obtained by a combination of training and experience appropriate to perform the auditing function as required by Sec. 117.180(c)(2). As discussed in Response 569, we have revised the definition to specify that ``qualified auditor'' means a person who is a ``qualified individual'' as that term is defined in this final rule, rather than a ``preventive controls qualified individual,'' because some auditors may be auditing businesses (such as produce farms) that are not subject to the requirements for hazard analysis and risk-based preventive controls, and it would not be necessary for such an auditor to be a ``preventive controls qualified individual.'' We also have clarified that the technical expertise is obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function to align the description of applicable education, training, and experience with the description of applicable education, training, and experience in the definition of ``qualified individual'' (see Sec. 117.3). (Comment 115) Some comments ask us to revise the definition of qualified auditor to include persons who have technical expertise obtained by a combination of training, experience, or education appropriate to perform audits. Some comments ask us to recognize that training and/or experience can make a person a qualified auditor; the comments state that people with experience performing audits likely have applicable training but might not have completed a specific regimen of courses. Some comments maintain that we should recognize the role of the education of a potential qualified auditor, as well as training and experience to meet the criteria. (Response 115) We agree that a qualified auditor might obtain the necessary auditing expertise in part through education, as well as through training and experience, and we have revised the definition of qualified auditor accordingly. However, we conclude that a person must have at least some actual experience in auditing to meet the definition of a qualified auditor, i.e., the necessary technical expertise cannot be obtained solely through education and/or training. Therefore, the revised definition retains the proposed criterion that a qualified auditor has technical expertise obtained by experience, as well as by education and training. (Comment 116) Some comments that support the proposed definition ask us to revise the definition to specify certain individuals who would be considered qualified auditors, such as FDA inspectors, properly trained Federal auditors, and State and private auditors operating under a contract with the Federal Government. (Response 116) We have revised the regulatory text to specify that examples of a qualified auditor include: (1) A government employee, including a foreign government employee and (2) an audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M (i.e., regulations in our forthcoming third-party certification rule implementing section 808 of the FD&C Act (21 U.S.C. 348d)). Although we agree that it is useful to include examples of individuals who would have the appropriate qualifications, the example of an audit agent of a certification body that has been accredited in accordance with regulations in our forthcoming third-party certification rule adds context about the standard for such individuals. Because paragraph (2) of the new provision refers to provisions in a future third-party certification rule, we will publish a document in the Federal Register announcing the effective date of paragraph (2) once we finalize the third-party certification rule. [[Page 55955]] 27. Qualified End-user We proposed to define the term ``qualified end-user'' to mean, with respect to a food, the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in Sec. 1.227) that: (1) Is located (a) in the same State as the qualified facility that sold the food to such restaurant or establishment; or (b) not more than 275 miles from such facility; and (2) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment. We have revised the definition of ``qualified end-user'' to add ``or the same Indian reservation'' to clarify for purposes of this rule so that ``in the same State'' under section 418(l)(4)(B)(ii)(I) of the FD&C Act includes both within a State and within the reservation of a Federally-Recognized Tribe. (Comment 117) Some comments object to the description of a qualified end-user as being not more than 275 miles from a facility that sold the food and assert that there is no scientific or risk-based reason to support the distance of 275 miles. Other comments ask us to clarify whether the criterion of not more than 275 miles from a facility that sold the food would provide for qualified end-users to be located across State lines and/or international borders relative to the facility that sold the food. Other comments ask us to revise the definition of ``restaurant or retail food establishment'' to include businesses such as supermarkets, supermarket distribution centers, food hubs, farm stands, farmers markets, and CSA. (Response 117) We have not revised the definition of ``qualified end-user,'' which reflects section 418(l)(4) of the FD&C Act, in response to these comments. As discussed in Response 581, we intend to focus on records demonstrating that a facility is a very small business (i.e., financial records demonstrating that a business averages less than a specified dollar threshold) rather than records demonstrating sales directly to qualified end-users. Likewise, we have not revised the definition of ``restaurant or retail food establishment'' to clarify whether particular businesses such as those mentioned in the comments would be considered as ``qualified end-users.'' Focusing on whether a facility is a very small business makes it unnecessary to determine whether an enterprise that receives the food is a retail food establishment. However, as discussed in section I.E, we have issued a separate proposed rule to amend the definition of ``retail food establishment'' in the section 415 registration regulations. We intend to issue a final rule to amend the definition of ``retail food establishment'' in the section 415 registration regulations in the near future. (See also Response 4.) 28. Qualified Facility We proposed to define ``qualified facility'' by incorporating the description of ``qualified facility'' in section 418(l)(1) of the FD&C Act with editorial changes to improve clarity. That definition includes two types of facilities: (1) A facility that is a very small business as defined in this rule; and (2) A facility to which certain statutory criteria apply regarding the average monetary value of food sold by the facility and the entities to whom the food was sold. Some comments discuss issues related to the definition of very small business. See Comment 154, Comment 156, Comment 157, and Comment 158 and our associated responses. (Comment 118) Some comments assert that the definitions of ``affiliate'' and ``subsidiary'' in the definition of ``qualified facility'' fail to account for the legal differences between a piece of property (i.e., a facility) and a business entity or person. These comments ask us to consider revising the proposed definition of ``qualified facility'' to clarify what sales to include in determining whether a facility so qualifies. (Response 118) We have not revised the proposed definition of ``qualified facility'' as requested by these comments. The sales to be included when a facility determines whether it meets the definition of a qualified facility are the sales of human food by a business entity, which includes the parent company and all its subsidiaries and affiliates. The total sales are applicable to each entity, whether it is the parent, the subsidiary, or the affiliate. We intend to address issues such as these in guidance as directed by section 418(l)(2)(B)(ii) of the FD&C Act. (See also Comment 77 regarding the definitions of ``affiliate'' and ``subsidiary'' and our associated responses. See also Response 154 regarding the applicability of the monetary threshold of sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).) (Comment 119) Some comments ask us to clarify who will determine whether a particular facility is a qualified facility. (Response 119) Any facility that determines that it satisfies the criteria for a ``qualified facility'' must notify FDA of that determination (see Sec. 117.201) and, thus, the first determination will be made by the facility itself. During inspection, the investigator could ask to see the records that support the facility's determination to verify the facility's determination. (Comment 120) Some comments address that part of the definition that discusses ``average annual monetary value of the food manufactured, processed, packed, or held at such facility, that is sold.'' These comments ask us to clarify whether the operative word in the clause is ``held'' or ``sold.'' (Response 120) The operative word, for the purpose of calculating the average monetary value of that food, is ``sold.'' (See also Response 154 regarding the applicability of the monetary threshold of sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).) 29. Ready-to-Eat Food (RTE Food) We proposed to define the term ``ready-to-eat food'' to mean any food that is normally eaten in its raw state or any other food, including processed food, for which it is reasonably foreseeable that the food would be eaten without further processing that will significantly minimize biological hazards. (Comment 121) Some comments ask us to substitute ``reasonably expected'' for ``reasonably foreseeable.'' (Response 121) We decline this request. We see no substantive difference between ``reasonably expected'' and ``reasonably foreseeable.'' The term ``reasonably foreseeable'' is used in other provisions of the rule, including the defined term ``known or reasonably foreseeable hazard.'' (Comment 122) Some comments ask us to clarify the distinction between a food that satisfies the definition of ``ready-to-eat'' and a food that satisfies the definition of a RAC. Some of these comments express concern that if tree fruits are classified as ``RTE food'' rather than as a RAC, we could force packers to do mandatory product testing. (Response 122) The terms RTE food and RAC are not mutually exclusive. Some RACs (such as lettuce, tomatoes, berries, and apples) are ready-to-eat, whereas other RACs (such as artichokes and potatoes) are not. The requirements for product testing as a verification activity are flexible requirements that depend on the facility, the food, and the [[Page 55956]] nature of the preventive control (see Sec. 117.165). See also Response 525. 30. Receiving Facility We proposed to define the term ``receiving facility'' to mean a facility that is subject to subpart C of this part and that manufactures/processes a raw material or ingredient that it receives from a supplier. (Comment 123) Some comments ask us to modify the definition to specify that the receiving facility could receive the raw material or ingredient directly from a supplier or by means of an intermediary entity. These comments assert that without this added regulatory text the proposed definition implies that the material or ingredient must be received directly from the supplier. (Response 123) We decline this request. As discussed in Response 658, the two parties that are critical to the supplier verification program are the receiving facility and the supplier, even if there are entities in the supply chain between the two. The definition of receiving facility does not preclude the participation of intermediary entities in the supply chain, and the rule does provide for such participation (see Response 657). However, the definition of receiving facility does highlight the fact that a receiving facility must have a link to a supplier. (Comment 124) Some comments that support the definition of receiving facility ask us to clarify that a cold storage facility is not by definition a receiving facility because it is not engaged in manufacturing/processing, but could be a supplier if temperature controls are needed to control a significant hazard. (Response 124) We agree that a cold storage facility is not likely to be a receiving facility if it is not engaged in manufacturing/ processing. However, it is the nature of the activity as manufacturing/ processing, rather than the use of a preventive control for purposes other than manufacturing/processing, that is relevant here. By definition, the supplier must also be engaged in manufacturing/ processing, raising animals, or growing food (see the definition of ``supplier'' in Sec. 117.3). A cold storage facility has a responsibility to maintain foods that require temperature control for safety at an appropriate temperature, but generally does not engage in manufacturing/processing. However, a cold storage facility in the supply chain between the supplier and the receiving facility could participate in supplier verification activities (see Response 657). 31. Sanitize We proposed to define ``sanitize'' to mean to adequately treat cleaned food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. We proposed to revise this otherwise long-standing definition by inserting the term ``cleaned'' before ``food-contact surfaces'' because chemical sanitizers can be inactivated by organic material and, thus, are not effective unless used on clean surfaces (78 FR 3646 at 3697). (Comment 125) Some comments ask us to adopt a definition of ``sanitize'' similar to that found in the Pasteurized Milk Ordinance (PMO), which recognizes that cleaning and sanitizing do not always have to be separate, sequential steps. These comments report that the definition in the PMO is ``the application of any effective method or substance to properly cleaned surfaces for the destruction of pathogens, and other microorganisms, as far as is practicable.'' Other comments agree with the proposed definition as it applies to chemical sanitizers, but disagree that clean surfaces are required for effective sanitizing for those systems that use steam and dry heat, such as those authorized by Appendix F of the PMO. These comments ask us to clarify that the ``cleaning'' should be appropriate to the specific food system and method used for sanitizing, and that cleaning should only be required when the sanitizing process alone would not be effective without a prior cleaning step. Some comments express concern about whether the proposed definition of ``sanitize'' would preclude the continued, routine use of dry cleaning methods with no sanitizing step. These comments note that adding routine aqueous-based cleaning and sanitizing procedures could create a public health risk in certain operations such as low-moisture food production. These comments also note that dry cleaning procedures can result in equipment that, while sanitary, is neither visibly clean nor suitable for aqueous chemical sanitizers. (Response 125) We consider that systems such as steam systems clean the surfaces, as well as sanitize them and, thus, satisfy the definition of ``sanitize.'' The definition of ``sanitize'' does not preclude the continued use of dry cleaning methods with no sanitizing step because the definition describes the meaning of the term ``sanitize'' without establishing any requirement for when equipment must be sanitized. We have revised the definition so that it means adequately treating ``surfaces'' rather than ``food-contact surfaces.'' Doing so is consistent with the definition of ``sanitize'' in the PMO. As a technical matter, adequately treating any surface--regardless of whether it is a food-contact surface--by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer, is ``sanitizing'' the surface. Clarifying this technical meaning of the term ``sanitize'' imposes no requirements to sanitize surfaces other than food-contact surfaces; the requirements for sanitizing surfaces are established by provisions such as Sec. 117.37(d), not by the definition of the term ``sanitize.'' 32. Significant Hazard (Hazard Requiring a Preventive Control) We proposed to define the term ``significant hazard'' to mean a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent the hazard in a food. The rule would use the term ``significant hazard'' rather than ``hazard reasonably likely to occur'' to reduce the potential for a misinterpretation that all necessary preventive controls must be established at CCPs (79 FR 58524 at 58526). (Comment 126) Comments support using a term other than ``hazard reasonably likely to occur'' and agree that using a term other than ``hazard reasonably likely to occur'' throughout the rule will reduce the potential for a misinterpretation that all necessary preventive controls must be established at CCPs. Some comments support the regulatory text of the proposed definition of the term ``significant hazard.'' These comments state that the proposed regulatory text more closely aligns with the principles in FSMA (``reasonably foreseeable'' and ``significantly minimize or prevent'') and provides operators the flexibility to implement a range of preventive controls that are commensurate with the risk and probability posed by a specific hazard. Some comments agree that the proposed regulatory text can clarify the difference between HACCP rules and the human preventive controls rule. [[Page 55957]] Some comments state that the proposed regulatory text plainly reflects the concept that significant hazards are those hazards to be addressed through the very broad category of preventive controls, and the rule is explicit that preventive controls may be controls other than at CCPs. Some comments state that the definition reflects the risk-based nature (i.e., both the severity of a potential hazard and the probability that the hazard will occur) of the requirements and provides additional flexibility so that facilities can take into account the nature of the preventive control in determining when and how to establish and implement appropriate preventive control management components. Some comments support including the phrase ``based on the outcome of a hazard analysis'' in the definition because it ensures that identification of significant hazards will be risk based. Some comments ask us to preserve in the final definition two key aspects that grant the food industry the flexibility that it needs: (1) The logical conclusion that not all hazards will have the same impact or will even constitute ``significant hazards'' at all, depending on the facility's products and position in the supply chain; and (2) the fact that a ``person knowledgeable about the safe manufacturing, processing, packing, or holding of food'' must be knowledgeable about the specific food produced at that facility and in that specific sector of the food industry. Some of the comments that support the regulatory text of the proposed definition nonetheless express concern about the term ``significant hazard.'' Some of these comments express concern that a facility may not recognize hazards that need to be controlled because they do not rise to the commonly understood meaning of ``significant.'' Other comments express concern that the adjective ``significant'' is subject to many interpretations and suggest that the term ``hazard requiring control'' would be more straightforward, accurate, and suitable. Other comments express concern that the term ``significant hazard'' could cause confusion because it has implications in HACCP systems. For example, ``significant hazard'' is often used in the context of CCPs, and preventive controls are not necessarily established at CCPs. Some of these comments suggest that we eliminate the term and instead use the full regulatory text of the proposed definition in place of ``significant hazard'' throughout the regulations. Other comments suggest using a term such as ``food safety hazard'' or ``actionable hazard'' instead of ``significant hazard'' to avoid a term that has HACCP implications. Other comments state that the term ``significant hazard'' has implications for facilities that follow the Codex HACCP Annex and express concern that foreign facilities would be especially likely to be confused by the term ``significant hazard.'' Some comments ask us to ensure that the term ``significant hazard'' is used consistently and express the view that some regulatory text refers to a ``hazard'' or ``known or reasonably foreseeable hazard'' where ``significant hazard'' should instead be used. As discussed in Comment 93, some comments express concern that the rule would refer to multiple levels of hazard and ask us to provide sufficient clarity to be able to distinguish between these types of hazards. (Response 126) We have changed the term ``significant hazard'' to ``hazard requiring a preventive control.'' The new term uses the explicit language of FSMA (i.e., ``preventive control''), is consistent with the specific suggestion of one comment (i.e., hazard requiring a control''), and is not commonly associated with HACCP systems. We decline the request to use the term ``food safety hazard'' because that term already is established in Federal HACCP regulations for seafood and meat/poultry, and the comments are particularly concerned about using a term that has implications for HACCP systems. We also decline the request to use the term ``actionable hazard,'' because the term ``actionable'' is associated with violations at a food processing plant. We reviewed the full regulatory text of proposed subpart C and replaced ``significant hazard'' with ``hazard requiring a preventive control'' in most cases. See table 10 for the provisions where we made that change and for an explanation of those provisions where we replaced ``significant hazard'' with ``hazard'' or ``hazard requiring a process control.'' Table 10--Substitutions for the Term ``Significant Hazard'' ---------------------------------------------------------------------------------------------------------------- Reason for substituting Term substituted for a term other than Section Description ``significant hazard'' ``hazard requiring a preventive control'' ---------------------------------------------------------------------------------------------------------------- 117.130(a)(1)........................ Requirement to conduct Hazard requiring a N/A.\1\ a hazard analysis. preventive control. 117.135(a)(1)........................ Requirement to identify Hazard requiring a N/A.\1\ and implement preventive control. preventive controls. 117.135(c)(2)(ii).................... Maximum and minimum Hazard requiring a The provision is values associated with process control. narrowly directed to a process controls. specific category of preventive controls-- i.e., process controls. 117.139.............................. Recall plan............ Hazard requiring a N/A.\1\ preventive control. 117.160.............................. Validation............. Hazard................. Specifying that a facility must validate that the preventive controls are adequate to control ``the hazard'' adequately communicates the requirement. In contrast, specifying that a facility must validate that the preventive controls are adequate to control the ``hazard requiring a preventive control'' would be unnecessarily bulky and awkward. [[Page 55958]] 117.165(a)........................... Activities for Hazard................. Specifying that a verification of facility must verify implementation and that the preventive effectiveness of controls are preventive controls. consistently implemented and are effectively and significantly minimizing or preventing ``the hazards'' adequately communicates the requirement. In contrast, specifying that a facility must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing ``the hazards requiring a preventive control'' would be unnecessarily bulky and awkward. 117.165(a)(3)........................ Requirement for Hazard requiring a N/A.\1\ environmental preventive control. monitoring to verify implementation and effectiveness of preventive controls. ---------------------------------------------------------------------------------------------------------------- \1\ N/A = Not applicable. We also reviewed the full regulatory text of proposed subpart C to evaluate whether there were any circumstances where the regulatory text should more appropriately refer to ``hazard requiring a preventive control'' rather than ``hazard'' or ``known or reasonably foreseeable hazard.'' The term ``known or reasonably foreseeable hazard'' appears only once, in the requirement for a facility to conduct a hazard analysis (Sec. 117.130(a)). We are retaining ``known or reasonably foreseeable hazard'' in that requirement because it is necessary to implement the tiered approach to the requirements for hazard analysis and risk-based preventive controls (see Response 93). To reinforce this tiered approach, and emphasize that the facility only conducts a hazard analysis for known or reasonably foreseeable hazards, we revised ``hazard'' to ``known or reasonably foreseeable hazard'' in two additional provisions in the requirements for hazard identification (see the introductory regulatory text for Sec. 117.130(b)(1) and (2)). In our review of the full regulatory text of proposed subpart C, we did not identify any circumstances where we believe it is appropriate and necessary to specify ``hazard requiring a preventive control'' in place of ``hazard.'' It is not necessary for the regulatory text of requirements for preventive controls, the supply-chain program, the recall plan, corrective actions, and verification to specify ``hazard requiring a preventive control'' every time that the requirements use the term ``hazard'' because the context of the requirement establishes the applicability to ``hazards requiring a preventive control.'' Although we acknowledge that using ``hazard requiring a preventive control'' in place of ``hazard'' throughout applicable provisions of proposed subpart C would emphasize the tiered approach to the requirements for hazard analysis and risk-based preventive controls, doing so would make the regulatory text unnecessarily bulky and awkward and would be inconsistent with comments that ask us to make the regulatory text understandable (see Comment 13). (Comment 127) Some comments express concern that the proposed definition of ``significant hazard,'' which contains the phrase ``for which a person . . . would establish controls'' is problematic in that facilities are likely to have already established preventive controls for a variety of hazards that may not rise to the level of control management required for a ``significant hazard'' and would instead routinely be addressed in ``prerequisite programs.'' These comments express particular concern that identification of these hazards in and of themselves should not elevate control of these hazards to the category of being a ``significant hazard.'' Some comments ask us to allow facilities to continue to implement existing controls outside the framework of this rule (i.e., outside the framework that requires preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the food safety system) when a hazard addressed by the existing controls does not rise to the level of ``significant hazard.'' Other comments express concern that the term ``significant hazard'' may create a disincentive for facilities to voluntarily implement preventive controls for hazards that only pose a remote risk or are very rarely encountered, because implementing preventive controls for hazards of very low probability and severity may be misinterpreted as requiring preventive controls applicable to a ``significant hazard'' even if the hazard does not meet the definition of ``significant hazard'' established in the rule. Some comments ask us to revise the definition to provide facilities with the flexibility and discretion to establish appropriate preventive controls for hazards that do not rise to the criteria of a ``significant hazard,'' as well as ensuring that preventive controls that address remote or very unlikely hazards not be subject to the preventive control management requirements for a ``significant hazard.'' (Response 127) We have revised the definition to specify that the term ``hazard requiring a preventive control'' applies when a knowledgeable person would, based on the outcome of a hazard analysis, ``establish one or more preventive controls'' rather than ``establish controls.'' By narrowing ``controls'' to ``one or more preventive controls,'' we mean to signify that the proposed term ``significant hazard'' (which we now refer to as ``hazard requiring a preventive control'') only applies to those controls that the facility establishes to comply with the [[Page 55959]] requirements of subparts C and G for hazard analysis and risk-based preventive controls. A facility that establishes other controls (such as those that the comments describe as ``prerequisite programs,'' or controls directed to hazards of very low probability and severity) for hazards that are not, based on the outcome of the facility's hazard analysis, ``hazards requiring a preventive control'' would not need to establish preventive control management components for such controls. However, some controls previously established in ``prerequisite programs'' would be considered ``preventive controls.'' We provide some flexibility for facilities with respect to how they manage preventive controls, and the preventive control management components may be different for hazards that have been managed as ``prerequisite programs'' compared to those managed with CCPs. A facility that is concerned about the potential for an investigator to disagree during inspection that certain controls are not directed to ``hazards requiring a preventive control'' could, for example, include information relevant to its classification of those other controls in its hazard analysis, whether by merely listing the ``other controls'' or by providing a brief explanation why such controls are not ``preventive controls'' as that term is defined in this rule. (Comment 128) Some comments assert that the proposed definition of ``significant hazard'' is tautological because it essentially establishes a ``significant hazard'' to be a known or reasonably foreseeable hazard (i.e., the type of hazards identified in the first step of the analysis) for which preventive controls should be implemented. These comments assert that the proposed definition of ``significant hazard'' would collapse the second step of hazard analysis into the first, which in turn would lead to the unintended consequence of facilities identifying the same hazards in the second step as in the first. Other comments ask us to revise the definition to clarify and distinguish the two steps of the hazard analysis by specifying within the definition that a significant hazard is a known or reasonably foreseeable hazard for which there is a reasonable probability, based on experience, illness data, scientific reports, or other information relevant to the food or the facility, that adverse health consequence or death will occur in the absence of its control. Some comments ask us to revise the definition to include evaluation of severity and probability, because these concepts are integral for making a proper determination of whether a hazard is significant. Other comments ask us to revise the definition to better reflect the risk- based approach that preventive controls be implemented to control hazards that have a higher probability of resulting in public health consequence in the absence of control. (Response 128) We have revised the definition of ``significant hazard'' (which we now refer to as ``hazard requiring a preventive control'') to specify that the hazard analysis includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. By specifying that the determination of a ``significant hazard'' is based on the outcome of a hazard analysis, the proposed definition did, as requested by the comments, include the risk-based nature of the determination. However, explicitly adding that the hazard analysis is based on probability and severity (i.e., risk) makes the risk-based nature of the determination clearer. We disagree that the proposed definition was tautological and would collapse the second step of hazard analysis into the first. As discussed in Response 93, a facility begins its hazard analysis by narrowing down the universe of all hazards to those that are ``known or reasonably foreseeable'' for each type of food manufactured, processed, packed, or held at its facility. The outcome of the facility's hazard analysis is a determination of a subset of those known or reasonably foreseeable hazards--i.e., those hazards requiring a preventive control. To the extent that these comments are asserting that the tautology was created by the phrase ``in the absence of its control'' in the proposed definition of ``hazard,'' we have deleted that phrase from the final definition of ``hazard'' (see Response 94). We decline the request to modify the definition to specify that a hazard requiring a preventive control is one for which there is a reasonable probability, based on experience, illness data, scientific reports, or other information relevant to the food or the facility, that adverse health consequence or death will occur in the absence of its control. The standard for harm in the definition of ``hazard'' is illness or injury. We disagree that the standard for harm in the definition of ``hazard requiring a preventive control'' should be different from (i.e., adverse health consequences), or greater than (i.e., death), the standard for harm in the definition of ``hazard.'' We also disagree that the definition of ``hazard requiring a preventive control'' needs to be modified to state that preventive controls are implemented to control hazards that have a higher probability of resulting in public health consequence in the absence of control. The definition already communicates the role of risk (i.e., severity and probability) in conducting the hazard analysis that identifies those hazards requiring a preventive control. We also decline the request to repeat in the definition of ``hazard requiring a preventive control'' the requirement for the types of information that a facility would consider in conducting its hazard analysis. The requirements for hazard analysis clearly specify that a facility must conduct its hazard analysis based on experience, illness data, scientific reports, and other information (see Sec. 117.130(a)). (Comment 129) Some comments that broadly address the overall framework for the new requirements for hazard analysis and risk-based preventive controls ask us to consistently refer to ``the nature of the preventive control'' (rather than simply to ``the preventive control'') when communicating the flexibility that a facility has in identifying preventive controls and associated preventive control management components. (See Comment 455). Other comments that broadly address the overall framework for the new requirements for hazard analysis and risk-based preventive controls ask us to emphasize that the requirements for preventive control management components convey not only that the application of a particular element is appropriate (i.e., capable of being applied), but also necessary for food safety. Some comments recommend that we do so by specifying that preventive control management components take into account the role of the preventive control in the food safety system. (See Comment 455.) (Response 129) We agree with these comments and have revised the definition of ``hazard requiring a preventive control'' to specify that preventive control management components are established as appropriate to ``the nature of the preventive control and its role in the facility's food safety system.'' (See also Response 455, where we describe additional provisions that we have revised to clarify that preventive control management components are established as appropriate to the nature of the preventive control and its role in the facility's food safety system.) (Comment 130) Some comments ask us to modify the definition of ``significant hazard'' to specify that the [[Page 55960]] preventive control management components be established as appropriate to both the food and the intended use of the food. (Response 130) We decline this request. It is not necessary to repeat in the definition of ``hazard requiring a preventive control'' the requirement for the hazard evaluation to consider the intended use of the food. The requirements for hazard evaluation clearly specify that a facility must consider the intended or reasonably foreseeable use of the food (see Sec. 117.130(c)(2)(viii)). (Comment 131) Some comments assert that the problem is how to separate the hazards addressed by ``HACCP'' from those addressed by CGMPs. These comments suggest that control measures that are implemented for hazards from ingredients and food-contact packaging material, and from production and process, be called CCPs and that control measures that are implemented for hazards from personnel, equipment, and the plant be called preventive controls. (Response 131) The facility must control hazards through the application of CGMPs and preventive controls as appropriate to the hazard. Although some preventive controls will be established at CCPs, and ``CCP'' is a term commonly used in HACCP systems, this rule establishes requirements for hazard analysis and risk-based preventive controls, not ``HACCP,'' and this rule provides that preventive controls include controls at CCPs, if there are any CCPs, as well as controls, other than those at CCPs, that are also appropriate for food safety (see Sec. 117.135(a)(2)). Under the rule, some hazards may be addressed by CGMPs and others by preventive controls. For example, if a facility manufactures egg biscuit sandwiches, it could establish a preventive control, as a CCP, for cooking the eggs and establish CGMP controls to address the potential for personnel to contaminate the cooked egg and the egg biscuit sandwiches. As another example, a facility could control a physical hazard such as metal using screens and magnets under CGMPs and then use a metal detector as a preventive control. See also Response 437, in which we give examples regarding when a facility might control food allergen hazards through a combination of CGMP controls and ``food allergen controls,'' which are a particular type of preventive control (see Sec. 117.135(c)(2)). (Comment 132) Some comments ask us to add examples throughout the regulatory text (e.g., in the requirements for hazard analysis, preventive controls, and recall plan) to reflect food allergens as a significant hazard. (Response 132) We decline this request. Food allergens are included as an example of a chemical hazard that a facility must consider when determining whether there are any known or reasonably foreseeable hazards requiring a preventive control (Sec. 117.130(b)(1)(ii)), and the rule specifically provides for food allergen controls where relevant. It is not necessary to include examples of food allergens as hazards requiring a preventive control throughout the regulatory text. (Comment 133) Some comments express concern that too much flexibility may make it harder for us to inspect conditions in a facility over time. These comments emphasize that we must not permit facilities to interpret the term ``significant hazard'' as allowing them to substitute inadequate sanitation programs--which may not require documentation of monitoring or verification measures--for necessary critical control points. (Response 133) We acknowledge that there can be a tension between the need for flexible requirements that must apply to diverse food processing facilities and the regulatory need to evaluate compliance with requirements. See Response 5 regarding our approach to enforcing the rule. Although preventive controls, such as sanitation controls, are not always directed to critical control points (see Sec. 117.135(a)(2)(ii)), we agree that there could be circumstances where we would disagree with a facility about the measures it has in place regarding sanitation. We will address such circumstances on a case-by- case basis. (Comment 134) Some comments express concern that the term ``significant hazard'' may lead to misunderstanding by medium and smaller processors and ask how businesses with limited food safety experience will understand the difference between a food safety hazard that is ``reasonably likely to occur'' (and, thus, must be controlled by a full HACCP Plan) and a ``Significant Hazard'' that can be controlled by a preventive control plan. (Response 134) In most cases, it will not be necessary for a food processor to understand the difference between a hazard that is ``reasonably likely to occur'' in the concept of HACCP requirements and a ``hazard requiring a preventive control'' in the context of this rule. Instead, a food processor must identify those regulations that apply to it. For example, a processor of juice products is subject to our HACCP regulations for juice, but is not subject to the requirements of this rule. (Comment 135) Some comments express concern about the potential for divergent interpretations of the definition by industry and regulators. Some comments state that a baseline understanding between industry and regulatory officials will need to be established as to what constitutes a ``significant hazard'' and what preventive controls will be deemed to be adequate to control such a hazard. Some comments ask us to provide guidance or allow ``inter-state compacts'' to provide guidelines on what constitutes significant hazards in major food industries. Other comments assert that the FSPCA provides the best forum to identify what constitutes ``significant hazards'' in food, and to develop timely and appropriate guidance and training for addressing such hazards. Other comments ask to engage with us early and often on the development of applicable guidance documents regarding what constitutes a ``significant hazard'' for produce industry operations and provide an opportunity to explain and discuss current industry best practices and preventive controls to address identified significant hazards. Some comments ask us to develop an administrative procedure to adjudicate differences in professional opinion between a regulated firm and a Federal or State regulatory agency regarding hazard ``significance.'' (Response 135) We agree that guidance will help create an understanding between industry and regulatory officials as to FDA recommendations for hazards that require preventive controls and appropriate preventive controls for those hazards. See Response 2 and Response 5. We decline the request to develop an administrative procedure to adjudicate differences in professional opinion between a regulated firm and a Federal or State regulatory agency regarding hazard ``significance.'' We note that existing procedures provide for an outside party to obtain internal agency review of a decision by an employee other than the Commissioner (see Sec. 10.75). The comments do not explain what they mean by ``inter-state compacts'' or provide any examples of ``inter-state compacts'' and, thus, it is not clear what, if any, role an ``inter-state compact'' could play in determining what constitutes a significant hazard in major food industries. (Comment 136) Some comments ask us to concur that ``temporal hazards'' in milk and dairy products (specifically, [[Page 55961]] aflatoxin, pesticides, and radiological contamination) do not represent ``significant hazards'' that require monitoring and verification activities on an ongoing basis. These comments also ask us to acknowledge that in many cases the testing done by FDA and others is sufficient for protecting public health and that it is not necessary to require ongoing monitoring by individual dairy facilities to comply with the rule. (Response 136) We decline these requests because such a determination should be facility specific. However, we have revised the considerations for the hazard evaluation to clarify that in making the determination as to what hazards require preventive controls, the facility can consider factors such as the temporal nature of the hazard (see Sec. 117.130(c)(2)(x) and Response 407). In determining the appropriate preventive control management components, the facility can take into account the nature of the preventive control and its role in the facility's food safety system (see Sec. 117.140(a)). (Comment 137) One commenter asserts that municipal drinking water supplies can be variable such that they could be a hazard that is reasonably likely to occur and that relying on municipal water will compromise food safety. The commenter asks us to ``close the gap'' in Federal risk assessment policies by adding regulatory text to the proposed definition of ``significant hazard'' to specify that the hazards are based on the outcome of a hazard analysis that includes any water used by the facility, whatever its source. The commenter further asserts that FDA must require full scientific water risk analysis and written water safety plans and water treatment where necessary and that the written water safety plans must comply with FSMA standards for accurate and precise measurement instruments, monitoring, verification, and documentation. The commenter asserts that in lieu of a full assessment and testing, the plant could disinfect all incoming water to a preventive control standard, and track and document compliance. The commenter further asserts that its commercially available technology provides the most cost effective disinfection for a wide range of sporeformers, bacteria, viruses, algae and molds. In addition, the commenter asserts that food manufacturers who are not required to make a special effort to understand the status of their water supply through a required risk assessment process will not be aware of the need to institute preventive controls for their water supply. To support its position, the commenter makes assertions about the purpose of water standards established by the U.S. Environmental Protection Agency (EPA), the risk presented by water quality to the production of safe food, and the impact to food safety of EPA's 2013 changes to the National Primary Drinking Water regulations (EPA's NPDW regulations; 41 CFR parts 141 and 142) regarding total coliforms (EPA's total coliform rule) (78 FR 10270, February 13, 2013). The commenter asserts that EPA's NPDW regulations hold public water suppliers to a standard that is protective of drinking water, not food manufacturing water. For example, the commenter describes EPA's NPDW regulations as requiring water suppliers to treat at least 95 percent of the water they distribute to the public to the treatment technique standard of the treatment they use and then argues that a user of the water would not necessarily know if it was getting some of the ``allowable 5 percent off-spec water.'' The commenter also asserts that current standards in EPA's NPDW regulations are not universally achieved by all public water systems. The commenter also asserts that EPA's total coliforms rule further reduces the applicability of municipal water standards to food manufacturing (e.g., because it reduced the frequencies of water monitoring and public notices about water quality and instead shifted the regulatory scheme towards corrective action). According to the commenter 95,000 public water systems do not disinfect the water they provide to the public, and some studies have found infective viruses in drinking water samples in communities that did not disinfect their water. According to the commenter, water supplies close to aquifers that were not disinfected before distribution have recently had boil water advisories, demonstrating that problems with the water supply are reasonably likely to occur. The commenter questions whether the food manufacturing plants using that water had water safety back-up plans, stopped production, had monitoring measures in place to determine the impact of the unsafe water, or recalled product manufactured during the period when the municipal water systems had coliform positive tests but had not yet confirmed these tests and therefore had not yet issued the advisory. The commenter also asks whether the facilities relied on the traditional assumption that if they use municipal water their food safety risk analysis does not have to cover water, they do not need a written water safety plan, and they do not need to monitor the safety of their water. (Response 137) We decline the request to change the regulatory text to explicitly require that the hazard analysis address any water used by the facility, whatever its source. Many of the commenter's assertions address issues under the jurisdiction of EPA, such as ``allowing'' ``5 percent off-spec water''; whether current standards are universally achieved by all public water systems; and whether it is appropriate to allow some water systems to not disinfect the water they supply. Such issues that are under the jurisdiction of EPA are outside the scope of this rulemaking. We consider that water standards directed to drinking water for household use would also be adequate for the production of food products and, thus, have no reason to question whether a facility can rely on the standards in EPA's NPDW regulations to satisfy the long-standing CGMP requirement that any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality (Sec. 117.37(a)). For example, we consider that water standards that EPA concludes are appropriate for drinking water are also appropriate for the production of water-based beverages, which are mostly water. We also see no reason to specifically require that a facility that satisfies the CGMP requirement for water also address water quality in its hazard analysis. Further, if a facility chooses to address the safety of water in its hazard analysis (e.g., water used in washing fresh-cut produce), we consider it more likely that the facility would treat the water onsite, obtain the water supplier's records documenting the results of its water testing, or simply test the water on a periodic basis, rather than conduct a risk assessment for the water source. Under Sec. 117.37(a), we expect any food establishment--regardless of whether it is a facility subject to FSMA's requirements for hazard analysis and risk-based preventive controls--to be vigilant regarding public health advisories such as a ``boil water advisory'' and to take appropriate action in light of such advisories. It is not necessary for the regulatory text to specify each potential problem or to specify the actions a food establishment must take to address each potential problem. 33. Significantly Minimize We proposed to define the term ``significantly minimize'' to mean to reduce to an acceptable level, including to eliminate. [[Page 55962]] (Comment 138) Some comments assert that the definition of ``acceptable level'' for fresh produce is unclear because of the presence of spoilage microorganisms, which subject food to decomposition and reduce quality, but are not a public health concern. These comments ask us to revisit and change regulatory text that either does not clarify, or over-steps the intention of, the rule. (Response 138) We proposed to define ``significantly minimize'' to give context to the term used in FSMA to define ``preventive control.'' Thus, in this rule the term ``significantly minimize'' relates to hazards that will be addressed by preventive controls. The term ``significantly minimize'' would not be relevant to spoilage microorganisms unless the facility determines, through its hazard analysis, that the spoilage microorganisms are a hazard requiring a preventive control. The standard of ``acceptable level'' is a flexible standard. By ``acceptable level,'' we mean a level that will not cause illness or injury or result in adulterated food. 34. Small Business We proposed to define the term ``small business'' to mean, for the purposes of part 117, a business employing fewer than 500 persons. As previously discussed, we conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 19) and used the results of the study in defining the term ``small business'' (78 FR 3646 at 3700 to 3701). We made the results of the Food Processing Sector Study available in Docket No. FDA-2011-N-0920 and requested public comment on that study. (Comment 139) Some comments express concern that the Food Processing Sector Study is not comprehensive. Some comments assert that FDA did not sufficiently collaborate with USDA, and that FDA significantly underestimated the number of mixed-use facilities, particularly by neglecting to count farms that perform the processing steps on RACs to become a processed food. Other comments assert that the Food Processing Sector Study is woefully inadequate and must be undertaken again to comply with the law. (Response 139) We previously acknowledged the limitations of the Food Processing Sector Study (78 FR 3646 at 3700-3701). We have revised and extended the results of our earlier study by expanding our data sources and by including representatives from USDA's Economic Research Service, USDA's Agricultural Marketing Service, and the American Farm Bureau to help oversee the revised study. The revised Food Processing Sector Study is available in the docket of this rule (Ref. 21). Our original analysis was based on the merger of Dun & Bradstreet data and FDA's Food Facility Registration data to help us estimate the number of manufacturing facilities that are also classified as farms. We have updated that data source and added data sources. To better account for farms that perform processing activities, we included Census of Agriculture (Ag Census) data both to provide a count of total U.S. farms and to estimate the number of farms conducting food processing activities, to the extent that the data identifies processing activities. We also included the Agricultural Resource Management Survey (ARMS) data because it included questions about some processing activities for select commodities. Both the Ag Census and ARMS are silent about many processing activities. Therefore, we also obtained estimates from commodity specialists at trade associations, USDA, and universities with in-depth knowledge of the processing activities for specific agricultural commodities. We also reached out to directors of promotion and marketing boards, and considered marketing agreements and marketing orders for various vegetables, fruits, and tree nuts to obtain information about the portion of farms that conduct food processing activities for use in this study. (Comment 140) Some comments ask us to explain how to calculate the number of full-time equivalent employees--e.g., with respect to temporary workers, seasonal workers, and part-time workers. (Response 140) As previously discussed, we proposed to establish the same definition for small business as that which has been established by the U.S. Small Business Administration (SBA) under 13 CFR part 121 for most food manufacturers, and the limit of 500 employees would include all employees of the business rather than be limited to the employees at a particular facility (78 FR 3646 at 3701). We will base the calculation on ``full-time equivalent employees'' and use the same approach to calculating full-time equivalent employees for the purpose of this rule as we used to calculate full-time equivalent employees in the section 414 recordkeeping regulations (see Sec. 1.328). This approach is similar to the approach we used to calculate the small business exemption for nutrition labeling of food (21 CFR 101.9(j)(18)(iv)(D)). Under this approach, the number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity claiming the exemption and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). We received similar comments during the rulemaking to establish the section 414 recordkeeping regulations, and in response to those comments we established the definition of ``full-time equivalent employee'' in the definitions for that rule. As with the section 414 recordkeeping regulations and the nutrition labeling regulations, the calculation for the number of employees affects exemptions (i.e., the exemptions for on-farm, low-risk activity/food combinations in Sec. 117.5(g) and (h), which apply only to small and very small businesses), not just compliance dates. Therefore, we are establishing the definition of ``full-time equivalent employee'' in the definitions for this rule (Sec. 117.3) and modifying the definition of ``small business'' to use the term ``500 full-time equivalent employees'' rather than ``500 persons.'' (Comment 141) Some comments ask us to base the definition of ``small business'' on the amount of sales, rather than on the number of employees, for consistency with the definition of ``very small business.'' (Response 141) We decline this request. As previously discussed, we based the definition of ``very small business'' on sales because the criterion of being a ``very small business'' plays a significant role in determining whether a facility is a ``qualified facility,'' and because the other principal criterion for being a ``qualified facility'' is based on sales (section 418(l)(1)(C) of the FD&C Act; see 79 FR 58524 at 58556). In contrast, section 418(l) of the FD&C Act does not specify any particular criterion (whether sales or number of employees) for the definition of ``small business,'' other than direct us to consider the results of the Food Processing Sector Study. Basing the definition of ``small business'' on the number of employees is consistent with our approach to defining ``small business'' for our HACCP regulation for juice (Sec. 120.1(b)(1)), the section 414 recordkeeping regulations (69 FR 71562, December 9, 2004), and our CGMP regulation for manufacturing, packaging, labeling, or holding operations for dietary supplements (72 FR 34752, June 25, 2007). (Comment 142) Some comments assert that the specified number of [[Page 55963]] employees (i.e., 500) has no relevance to food safety. (Response 142) The definition of ``small business'' is relevant to two aspects of this rule. First, it is relevant to the compliance date for the establishment, and provides an additional year for establishments satisfying the definition to comply with the rule. As discussed in the Final Regulatory Impact Analysis (FRIA) (Ref. 38), we estimate that the number of small businesses that will be eligible is 45,936, accounting for 5.4 percent of the food supply. Although the purpose of the rule is to improve food safety, delaying the effective date for approximately 6 percent of the food supply will not significantly affect food safety in the long term. Second, the definition of ``small business'' is relevant to the statutory exemptions for on-farm, low-risk activity/food combinations for manufacturing/processing, packing, and holding food by farm mixed- type facilities. These statutory exemptions, although expressly authorized only for small and very small businesses, encompass risk and are limited, because a small or very small farm mixed-type facility is only eligible for the exemption if the only activities that the facility conducts are the specified on-farm low-risk activity/food combinations. (Comment 143) Some comments assert that the specified number of employees (i.e., 500) may or may not be indicative of business size. As an example, the comment notes that harvest employees may operate under contract rather than be the grower's employees. (Response 143) If a farm mixed-type facility that is subject to this rule employs harvest employees under contract, the facility would include these employees in its calculation of full-time equivalent employees and would adjust for the temporary, seasonal nature of the increased number of employees when it calculates the 12 month average number of full-time equivalent employees. (See Response 140 for the calculation of full-time equivalents.) (Comment 144) Some comments assert that the human preventive controls rule and the produce safety rule should use the same definition of ``small business.'' (Response 144) We tailored the definitions of ``small business'' to the characteristics of the sectors of industry subject to the two rules. (Comment 145) Some comments assert that the definition of a small business as less than 500 employees makes the very small business exemption irrelevant. These comments ask us to create a simple and broad small business exemption for any small business conducting ``low- risk activities.'' (Response 145) We disagree that the definition of a small business makes the very small business exemption irrelevant and decline the request to create a ``simple and broad small business exemption'' for any small business conducting ``low-risk activities.'' Although both small and very small businesses are eligible for the exemption for such businesses that only conduct specified low-risk activity/food combinations, other provisions apply solely to very small businesses. For example, the compliance date for a very small business is different from the compliance date for a small business, and a very small business (but not a small business) is eligible for modified requirements. 35. Supplier We proposed to define the term ``supplier'' to mean the establishment that manufactures/processes the food, raises the animal, or harvests the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature. As discussed in Response 32, we have revised the ``farm'' definition to explicitly include business models in which one operation grows crops but does not harvest them, and another operation, not under the same management, harvests crops but does not grow them. As also discussed in Response 32, this revision represents a change from the existing and proposed ``farm'' definitions, which describe a ``farm'' as an entity ``devoted to the growing and harvesting of crops'' (emphasis added). We proposed the ``supplier'' definition in the context of a single business entity ``devoted to the growing and harvesting of crops'' (emphasis added). We used the term ``harvesting,'' rather than ``growing,'' to reflect the last stage of production on a farm, except for packing. Because the proposed ``supplier'' definition contemplated that the same business entity that grows crops also harvests them, we have revised the ``supplier'' definition so that the grower remains the supplier when the harvester is under separate management. Specifically, ``supplier'' is now defined to include an establishment that ``grows'' food rather than an establishment that ``harvests'' food. Doing so focuses the requirements for the supply-chain program (see subpart G) on the entity that produces the food, rather than on the entity that removes the food from the growing area, when the grower and the harvester are not under the same management. Doing so also simplifies the determination of who the supplier is in complex business models, such as when a ``handler'' arranges for harvest by another business entity. As discussed in Response 22, we consider a farm to be a type of ``establishment'' even though we revised the ``farm'' definition to refer to an ``operation'' rather than an ``establishment'' within that definition. (Comment 146) Some comments assert that the definition of supplier is not workable because the status of warehouses and brokers is unclear in the definition. Other comments ask us to modify the definition to specify, in addition to the proposed definition, that the supplier could be an intermediary entity that takes responsibility on behalf of the receiving facility to ensure that the food meets the requirements of this part. (Response 146) As discussed in Response 657, we agree that the role of intermediaries in the supply chain is critical, and we have added options for entities other than the receiving facility to perform certain supplier verification activities, provided that the receiving facility reviews and assesses the documentation produced by the other entity and documents that review and assessment. However, this does not mean that these entities take on the role of the supplier. As discussed in Response 658 and Response 123, we believe it is important to supplier verification to retain the identities of two parties involved--the receiving facility and the supplier. Therefore, we are retaining our definition of supplier. (Comment 147) Some comments regarding RACs ask us to modify the definition of supplier in the case of commingled RACs, such that the supplier would be the person immediately back from the receiving facility in the supply chain provided that this entity (presumably a warehouse or aggregator) voluntarily complies with the requirements of subpart C of this part. (Response 147) We decline this request. As discussed in Response 657, we recognize that doing supplier verification with commingled products will be a challenge. However, we believe it is important that there be a link between the receiving facility (which is manufacturing/ processing the [[Page 55964]] food) and the supplier (who controlled the hazard(s) in the food). We are allowing an entity such as an aggregator or distributor to perform some verification activities, so the outcome requested by these comments will be achieved while maintaining the identities of the two primary parties in the supplier verification relationship (see Response 657). (Comment 148) One comment asks us to clarify who would be the supplier in a situation in which dairy farms are providing milk to a cooperative collecting milk. (Response 148) In this example, the dairy farms would be the suppliers because they are raising the animals. (Comment 149) One comment asks us to clarify that the proposed definition of supplier does not include sources of processing aids or chemicals required for post-harvest treatments and packing processes (including waxes, fungicides, detergents and sanitizers). (Response 149) As defined, the supplier is the establishment growing the food, not those establishments providing inputs (such as waxes, fungicides, detergents and sanitizers) to that entity. 36. Validation and Verification We proposed to define the term ``validation'' to mean that element of verification focused on collecting and evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the identified hazards. We proposed to define the term ``verification'' to mean those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan. (Comment 150) Some comments ask us to revise the definitions of ``validation'' and ``verification'' to be consistent with the Codex definitions. (Codex defines ``validation'' to mean obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. Codex defines ``verification'' to mean the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended (Ref. 39).) Some comments ask us to more clearly distinguish between ``validation'' and ``verification.'' Some comments assert that validation is not an element of verification as stated in our proposed definition and suggest that we clearly separate requirements for validation from requirements for verification--e.g., by moving the proposed requirements for verification to a distinct section in the regulatory text. (Response 150) We have explained how our proposed definitions for ``validation'' and ``verification'' align with a variety of widely recognized definitions, including definitions established by Codex, the NACMCF HACCP guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry (78 FR 3646 at 3700). We disagree that validation is not an element of verification, but acknowledge it is not necessary to say so within the definition of ``validation.'' Although we have moved the details of the requirements for validation from its proposed location within the requirements for verification (i.e., proposed Sec. 117.155(a)) to a separate section (Sec. 117.160), we did so as an editorial change to improve clarity and readability rather than as a substantive change to signal that validation is not an element of verification (see table 8 in the 2014 supplemental human preventive controls notice, 79 FR 58524 at 58557). We agree that validation can apply to a specific control measure as specified in the Codex definition. We also agree that validation can apply to a combination of control measures as specified in the Codex definition. The food safety plan is one example of a combination of control measures. Although we likewise agree that verification can apply to a specific control measure as specified in the Codex definition, we disagree that to be consistent with the Codex definition we should adopt a definition that excludes the application of verification to the food safety plan. It is well established that some verification measures, such as testing for a pathogen, verify that multiple control measures operated as intended. (See, e.g., Codex's discussion of verification for uncooked fermented sausages (Ref. 39)). To more clearly distinguish between ``validation'' and ``verification,'' the definition of ``validation'' we are establishing in this rule specifies that validation means obtaining and evaluating scientific evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards (emphasis added). We also made conforming changes associated with the revised definition of ``validation'' in the requirements for validation (see Sec. 117.160(b)(2)). The definition of ``verification'' we are establishing in this rule specifies that verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan as a whole (emphasis added). Consistent with the request of the comments, the definition of ``verification'' uses the Codex description of verification as the application of methods, procedures, tests and other evaluations, in addition to monitoring. 37. Very Small Business We proposed to define the term ``very small business'' to mean, for the purposes of proposed part 117, a business that has less than $1,000,000 in total annual sales of human food, adjusted for inflation. As discussed in the proposed rule, we conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 19) and used the results of the study in defining the term ``very small business'' (78 FR 3646 at 3700 to 3702). We made the results of the Food Processing Sector Study available in Docket No. FDA-2011-N-0920 and requested public comment on that study. As discussed in Response 139, we have updated that study (Ref. 21). (Comment 151) Some comments support the proposed dollar threshold of $1,000,000, noting that it would provide sufficient flexibility to companies that receive the exemption to allow them to continue to operate. Some comments that support the proposed dollar threshold of $1,000,000 state that this threshold is consistent with Congress's mandate that the FSMA rules provide flexibility for all sizes and types of businesses and facilities, including small processing facilities co- located on farms, and provide special considerations for small and very small businesses. These comments also state that our proposal to adopt the $1,000,000 threshold is appropriate in light of the two options Congress provided for facilities to qualify for modified requirements, and that although Congress directed us to consider the Food Processing Sector Study in establishing the very small business definition, it did not otherwise establish parameters for us to use in setting this definition, leaving it largely to our discretion. These comments argue that although Congress set out two options whereby facilities could qualify for modified requirements, Congress did not bind us to using both options. These comments express the view that when [[Page 55965]] Congress is silent on an issue, the agency may reasonably interpret its authority. These comments state that proposing the $1,000,000 threshold for a very small business is entirely reasonable given that businesses this size account for such a small percentage of the food supply, and given Congress's mandate that FDA establish flexible standards considering the effects of the rules on small and very small businesses. Other comments disagree with the proposed dollar threshold of $1,000,000. Some of these comments assert that the proposed dollar threshold of $1,000,000 would create a new category of exemption not contemplated by FSMA and will create confusion for both those who may be subject to the rule and those trying to enforce it. These comments ask us to instead adopt the $500,000 threshold we considered as ``Option 2'' in the 2013 proposed preventive controls rule (78 FR 3646 at 3702). Some comments assert that the proposed $1,000,000 threshold would expose a larger number of consumers to a heightened risk of contracting a foodborne illness. Other comments reiterate their previous assertions that any dollar threshold that exceeds $250,000 would be contrary to Congressional intent and conflict with section 418(l) of the FD&C Act. Some of these comments assert that adopting a $1,000,000 threshold would conflict with the statutory structure of the qualified facility program in a way that effectively nullifies a section of the law. Some of these comments assert that the discussion in the 2014 supplemental human preventive controls notice did not adequately address their comments submitted to the 2013 proposed human preventive controls rule because that discussion does not explain why we believe the proposed $1,000,000 threshold is consistent with the statute's definitions of a qualified facility in section 418(l)(1) of the FD&C Act. These comments assert that the discussion in the 2014 supplemental human preventive controls notice clearly indicates that the definition is intended to abrogate the definition of a qualified facility under section 418(l)(1)(C) of the FD&C Act because the ``definition would . . . simplify a facility's determination of whether it is a qualified facility because the facility would only need to calculate its total sales of human food rather than determine how much food was sold to qualified end[hyphen]users.'' The comments assert that this discussion shows that we have made a deliberate decision to write qualified facilities under section 418(l)(1)(C) and the limitations on sales under section 418(l)(4)(B) out of the law and state that an agency has no authority to repeal a well[hyphen]considered act of Congress by fiat in a rulemaking. (Response 151) We are establishing a $1,000,000 threshold for the definition of ``very small business.'' We disagree that a $1,000,000 threshold would create a new category of exemption not contemplated by FSMA. Under section 418(l)(1)(A) and (B) of the FD&C Act, a very small business is a qualified facility; under the exemption authorized in section 418(l)(2) of the FD&C Act, a qualified facility is subject to modified requirements rather than the requirements for hazard analysis and risk-based preventive controls. We have acknowledged that a $1,000,000 threshold exempts a greater portion of the food supply than thresholds of either $250,000 or $500,000 (79 FR 58524 at 58555), but reaffirm that under the $1,000,000 threshold the businesses that would be exempt from the requirements for hazard analysis and risk-based preventive controls would represent a small portion of the potential risk of foodborne illness; businesses that fall within this definition of ``very small business,'' collectively, produce less than 0.6 percent of the food supply (Ref. 38). In addition, most of these facilities will be subject to the CGMP requirements in subpart B; the only exemption from those CGMP requirements is the exemption in Sec. 117.5(k) (which applies to: (1) Farms; (2) certain fishing vessels; (3) establishments solely engaged in the holding and/or transportation of one or more RACs; (4) activities of ``farm mixed-type facilities'' that fall within the definition of ``farm''; and (5) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing)). We disagree that a $1,000,000 threshold for the definition of ``very small business'' will create confusion for both those who may be subject to the rule and those trying to enforce it; in contrast, it is our view that a $1,000,000 threshold will be less burdensome for both the qualified facilities and FDA. (See Response 581, where we explain that for compliance purposes we intend to focus on financial records demonstrating that a business averages less than the specified dollar threshold rather than records demonstrating that the average annual monetary value of the food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users during a three-year period exceeded the average annual monetary value of the food sold by the facility to all other purchasers.) We reaffirm our view, expressed in the 2014 supplemental human preventive controls notice, that section 418 of the FD&C Act does not limit how we may define ``very small business'' other than by requiring us to consider the Food Processing Sector Study, and we have done so. (See also Response 152.) Therefore, we disagree that adopting a $1,000,000 threshold would conflict with the statutory structure of the qualified facility program in a way that effectively nullifies an entire section of the law. We also disagree that our explanation in the 2014 supplemental human preventive controls notice demonstrates that we have made a deliberate decision to write qualified facilities under section 418(l)(1)(C) of the FD&C Act, and the limitations on sales under section 418(l)(4)(B) of the FD&C Act, out of the law. Likewise, we disagree that we are in any way ``repealing'' a well[hyphen]considered act of Congress by fiat in a rulemaking. (Comment 152) Some comments that support a dollar threshold of $250,000 rather than $1,000,000 assert that the rationale we presented in the 2014 supplemental human preventive controls notice for a $1,000,000 threshold is inconsistent with the rationale we presented in our ``original draft'' of the 2013 proposed human preventive controls rule. These comments quote that ``original draft'' of the 2013 proposed human preventive controls rule as follows: ``FDA is proposing to define the term ``very small business'' to mean, for the purposes of part 110, a business that has less than $250,000 in total annual sales of foods, adjusted for inflation. We are proposing to define very small business using a dollar amount that is, for practical purposes, the same as the dollar amount of sales by a qualified facility to end users other than those that would satisfy the definition of ``qualified end users.'' The proposed definition is consistent with the findings of a study that we conducted as required by section 418(l)(5) of the FD&C Act.'' These comments note that we acknowledged, in the 2014 supplemental preventive controls notice, that section 418(n)(1)(B) of the FD&C Act requires us to consider the Food Processing Sector Study for the purpose of defining ``very small business'' (79 FR 58524 at 58555) and argue that it is difficult to see how the same study that supported defining a very small business as one that has less than $250,000 in total annual sales of food now supports a definition that puts that threshold at less than $1,000,000. [[Page 55966]] (Response 152) These comments are citing a rationale in a draft version of the 2013 proposed human preventive controls rule, which we submitted to the Office of Management and Budget in 2011 (Ref. 40, p. 259). In that draft, we proposed a single option for the definition of ``very small business'' (i.e., less than $250,000) and explained the reasons for proposing that single option, including an explanation that the option was consistent with the findings of the Food Processing Sector Study. In contrast, in the published 2013 proposed human preventive controls rule that we issued for public comment we identified three options as part of a co-proposal for the definition of very small business, and provided a basis to support each option. For each option of the co-proposal, we made the same statement regarding the Food Processing Sector Study when we discussed the impact of the option on mixed-type facilities--i.e., that it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. We see no conflict between a statement (made in the context of a single proposed option for the definition of ``very small business'') that a specific proposed definition was consistent with the findings of the Food Processing Sector Study and a statement (made in the context of three proposed options for the definition of ``very small business'') that it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. (See also Response 139 regarding the Food Processing Sector Study.) (Comment 153) Some comments assert that the proposed $1,000,000 threshold would be inconsistent with our explanation, in the 2014 proposed sanitary transportation rule, of the definition of a ``non- covered business'' as one having less than $500,000 in total annual sales. These comments note that we considered whether a less than $1 million threshold should be applied but concluded: ``[W]e believe such an expansion would result in a greater risk of food becoming adulterated during transport due to insanitary food transportation practices.'' (Ref. 41) These comments assert that if we were to apply the same analysis we used in the 2014 proposed sanitary transportation rule to the human preventive controls rule, the threshold for a very small business would be below $500,000. (Response 153) The $500,000 threshold we proposed in the 2014 proposed sanitary transportation rule would apply to ``non-covered businesses''--i.e., businesses that would be completely exempt from the requirements of the sanitary transportation rule. In contrast, the $1,000,000 threshold we are establishing in this rule applies to very small businesses that will be subject to modified requirements rather than be completely exempt. A very small business will have two options to comply with the modified requirements in the human preventive controls rule (the food safety practices option and the option to demonstrate compliance with other applicable non-Federal food safety law; see Sec. 117.201(a)(2) and the discussion in sections XXXVIII.C.2 and XXXVIII.C.3). Regardless of which option a very small business chooses to comply with the modified requirements, we will inspect the business for compliance with the CGMPs and the modified requirements. In contrast, if the final sanitary transportation rule excludes a ``non-covered business'' as would be defined in that rule, that business would be completely exempt rather than subject to modified requirements and, thus, would be not be inspected for compliance with any aspect of the sanitary transportation rule. (Comment 154) Some comments ask us to clarify how to classify the size of a business that does not take ownership of or directly sell food (e.g., warehouses and re-packing facilities) to determine status as a qualified facility. (Response 154) We have revised the definition to specify that the $1,000,000 threshold applies to sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). When there are no sales of human food, market value of the human food manufactured, processed, packed, or held without sale is a reasonable approach to calculating the dollar threshold for very small business. (Comment 155) Some comments ask us to specify that the monetary threshold for the definition be based on average sales during a three- year period on a rolling basis because otherwise firms may be subject to significant changes in status from year to year. These comments also ask us to clarify that the sales are to be evaluated retrospectively, not prospectively. (Response 155) We have revised the definition of very small business to specify that it is based on an average during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). The applicable calendar year is the year after the 3 calendar years used to determine whether a facility is a very small business. The most recent applicable calendar year is the current year. For example, on June 3, 2024, 2024 is the most recent applicable calendar year and is the applicable calendar year when the 3 calendar years used to determine whether a facility is a very small business are 2021-2023. The exception is when 3 calendar years of records are not available, such as when a facility begins business after the compliance date for very small businesses. In such situations the applicable calendar year refers to the year during which the calculation is made but is not preceded by 3 calendar years used to determine whether a facility is a very small business. As a companion change, we are explicitly requiring that a facility determine and document its status as a qualified facility on an annual basis by no later than July 1 of each calendar year (see Sec. 117.201(c)(1)). Although this requirement was implicit in the proposed requirement that a facility must resubmit a notification to FDA if its status changes as a qualified facility (proposed Sec. 117.201(c)(2), which we are finalizing as Sec. 117.201(c)(3)), we are making this requirement explicit to clarify the responsibility of the facility to affirmatively determine its status when the calendar years that apply to the 3-year average change. The July 1 deadline for a facility to determine its status provides facilities with 6 months to make the determination after the end of the previous 3 calendar years. We also are establishing an earlier compliance date for the financial records that a facility maintains to support its status as a very small business that is eligible for the qualified facility exemption in Sec. 117.5(a). Specifically, the compliance date for a facility to retain records to support its status as a qualified facility is January 1, 2016. Even with this earlier compliance date for these records, we realize that although the calculation for ``very small business'' in the regulatory text is based on 3 calendar years, a facility will only be required to have 2 calendar years of records as of the general compliance date for very small businesses. Specifically, by September 17, 2018 a facility that begins retaining applicable financial records on January 1, 2016, would only have such records for 2 previous calendar years. Therefore, it would be reasonable for a facility to make the calculation based on the 2 previous calendar years. If a facility has records for 3 previous calendar years, the facility could make the calculation based on the longer time period. During inspection in 2018, when a facility has [[Page 55967]] records for the preceding 2 calendar years, but not for the preceding 3 previous calendar years, we will accept records for the preceding 2 calendar years as adequate to support status as a qualified facility. We note that in some situations, a shorter time period is sufficient to determine that a facility is not a very small business. For example, a facility with sales exceeding $3,000,000 for the preceding calendar year cannot qualify as a very small business because no amount of sales from other years will reduce average sales below the threshold of $1,000,000. The available financial records for a facility that begins operations between January 1, 2017 and September 17, 2018 would not cover even 2 calendar years by September 17, 2018. During the first 3 years of such a facility's operation, it would be reasonable for a facility to make the calculation based on records it has (i.e., for one or two preceding calendar years), and we will accept records for the preceding one or two years as adequate to support status as a qualified facility in these circumstances. When a facility does not begin operations until after January 1, 2018, it would be reasonable for the facility to rely on a projected estimate of revenue (or market value) when it begins operations. We would evaluate the credibility of the projection considering factors such as the facility's number of FTEs. After the facility has records for one or two preceding years, it would be reasonable for the facility to make the calculation based on records it has (i.e., for one or two preceding calendar years) and we will accept records for the preceding one or two calendar years as adequate to support status as a qualified facility in these circumstances. (Comment 156) Some comments ask us to only include the total annual sales of food in the United States, adjusted for inflation, for foreign facilities that export food to the United States. (Response 156) We decline this request. The purpose of the definition of ``very small business'' is principally to enable such businesses to comply with modified requirements, because they have fewer resources to direct to full compliance with the rule. A foreign business that sells more than the threshold dollar amount of food has more resources than the businesses being excluded, even if less than that threshold dollar amount reflects sales to the United States. Likewise, a domestic business that sells more than the threshold dollar amount of food has more resources than the businesses being excluded, even if that domestic business exports some of its food and, as a result, less than that threshold dollar amount reflects sales within the United States. As discussed in Response 154, to address facilities such as those warehouses and re-packing facilities that do not take ownership or directly sell food we have revised the definition of ``very small business'' to specify that the $1,000,000 threshold applies to sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). As with ``sales,'' facilities such as those warehouses and re-packing facilities that pack or hold more than the $1,000,000 threshold would have more resources than the facilities being excluded. (Comment 157) Some comments ask us to apply the rule to dairy farms with sales greater than $1 million annually of processed or packaged dairy products, rather than bulk sales of fluid milk. Other comments ask us to only include the annual monetary value of food covered by the preventive controls rule, rather than all human food. In particular, these comments argue that food covered by the produce safety rule should not be counted in the calculation of the sales of food for the purpose of defining very small business for the preventive controls rule. Some of these comments assert that basing the threshold on the monetary value of food covered by the preventive controls rule, rather than all human food, would be necessary to be consistent with the approach used in the proposed animal preventive controls rule, in which the sales threshold was based on sales of animal food (i.e., the product regulated by the rule). (Response 157) We decline these requests. As discussed in Response 156, the purpose of the definition of ``very small business'' is principally to enable such businesses to comply with modified requirements, because they have fewer resources to direct to full compliance with the rule. Because of the exemptions in the human preventive controls rule (e.g., for processors of seafood, juice, low- acid canned foods (LACF), and dietary supplements), basing the threshold on the monetary value of food covered by the preventive controls rule, rather than all human food, could lead to a situation where a very large food processor (such as a juice processor with more than $20,000,000 in annual sales) would not need to comply with the human preventive controls rule for milk- and soy-based beverages that it produces, if the annual sales of milk- and soy-based beverages is less than $1,000,000. We disagree that a threshold based on sales of human food, rather than food covered by the preventive controls rule, would be inconsistent with the threshold we proposed for the animal preventive controls rule. The threshold we proposed for the animal preventive controls rule was based on ``total annual sales of food for animals, adjusted for inflation,'' which is exactly parallel to our proposal to base the threshold on ``total annual sales of human food, adjusted for inflation.'' We proposed several exemptions to the animal preventive controls rule (see proposed Sec. 507.5 (proposed 21 CFR 507.5)) and, thus, not all food for animals will be subject to the animal preventive controls rule. (Comment 158) Some comments ask us to base the threshold on the total ``volume of product'' or ``amount of product'' handled or sold. These comments assert that an approach using product volume or amount would be more risk-based because it would correlate more closely to consumer exposures than dollar amounts, which can be skewed by product values. (Response 158) We use sales as a proxy for volume. We acknowledge that dollar amounts can be skewed by product values and, thus, sales are an imperfect proxy for volume. However, we are not aware of a more practical way to identify a threshold based on volume or amount of product that could be applied across all product sectors, and the comments provide no suggestions for how their recommendation could be carried out. (Comment 159) Some comments assert that our conclusion that our proposed definition of very small business is controlled by the two references in sections 418(l)(5) and 418(n)(1)(B) of the FD&C Act does not provide a reasonable justification for our decision. These comments assert that it is equally true that those two provisions would not prevent us from adopting one threshold (less than $250,000) for purposes of defining a qualified facility (and for a very small business conducting on[hyphen]farm low[hyphen]risk activity/food combinations) and another (less than $1 million) for setting compliance dates. These comments also assert that this is exactly the determination we made for our proposed animal preventive controls rule, where we proposed to define very small business, under the constraints of these same two references, as one with less than $2,500,000 in sales. To give full effect to the design of the qualified facility program while providing an adequate compliance deadline, these comments ask us to revise the definition of very small business to mean ``a business that has less than $250,000 in total annual [[Page 55968]] sales of human food, adjusted for inflation, except that for purposes of the effective dates in section 103(i) of the FDA Food Safety Modernization Act (21 U.S.C. 350g note) the term means less than $1,000,000 in total annual sales of human food.'' (Response 159) These comments are unclear. We agree that we proposed to define very small business, for the purposes of the animal preventive controls rule, as one with less than $2,500,000 in sales (79 FR 58476 at 58510), but disagree that we proposed to adopt one threshold for purposes of defining a qualified facility and another threshold for setting compliance dates. Regardless, we decline the request to adopt a threshold lower than $1,000,000 for purposes of defining a qualified facility, which appears to be the principal request of these comments (see Response 151). (Comment 160) Some comments support the proposed dollar threshold of $1,000,000, provided that we also make changes to the ``farm'' definition to encompass activities of food hubs performing low-risk packing and holding activities on RACs for distribution in local food markets. If we do not revise the ``farm'' definition to encompass such activities, these comments assert that a threshold dollar amount of $2,000,000 would be necessary to allay concerns that making food hubs subject to the requirements for hazard analysis and risk-based preventive controls would cause many food hubs to fail, and would prevent the start of new food hubs. (Response 160) See Response 23 and Response 25. Food hubs that pack and hold RACs are covered by the ``farm'' definition if the farm(s) that grow or raise the majority of the RACs packed and held by the food hub own, or jointly own, a majority interest in the food hub. Thus some food hubs will not be required to register as a food facility and, thus, will not be subject to the requirements for hazard analysis and risk-based preventive controls. Those food hubs that exceed the specified dollar threshold for a very small business and are not within the ``farm'' definition would be subject to the requirements for hazard analysis and risk-based preventive controls. However, the preventive controls that the food hub would establish and implement would depend on the food hub, the food, and the outcome of the facility's hazard analysis, and the preventive control management components that the food hub would establish and implement for its preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. (See Response 222). (Comment 161) Some comments express concern that establishing a threshold based on U.S. dollars would place domestic firms at a disadvantage relative to foreign firms whose sales are often denominated in currencies valued lower than the dollar and often reflect much lower costs for factors such as land, labor, and environmental compliance. These comments ask us to base the threshold on an alternate measure, such as number of employees, or to calculate the sales of foreign very small businesses using an appropriate measure of purchasing power parity, if there is a straightforward way to do so. (Response 161) We decline these requests. As previously discussed, we use dollar estimates to evaluate the percentage of all food produced in the United States that would not be covered by the rule (79 FR 58524 at 58555). We acknowledge that the definition of ``small business'' is based on number of employees, and that two exemptions (i.e., the exemptions in Sec. 117.5(g) and (h) for on-farm, low-risk activity/ food combinations) apply to small businesses. However, the exemptions for on-farm, low-risk activity/food combinations are limited to a narrow sector of the food industry, whereas the exemption applicable to a very small business will apply to all sectors of the food industry. We do not know of a straightforward way to calculate the sales of foreign very small businesses using an appropriate measure of purchasing power parity and are basing the threshold only on U.S. dollars. (Comment 162) Some comments assert that the reach of potential harm from foods imported from very small businesses that would meet the proposed threshold of $1,000,000 may be greater because they are more likely to be ingredients, such as spices, and argue that small amounts of spice can contaminate a large volume of food and, thus, cause widespread illnesses. Other comments assert that it is very likely that more facilities in exporting countries will be exempt under the definition, thus putting those located in the United States at a disadvantage. These comments assert that the definition of ``very small business'' should reflect the probability and severity of potential hazards in order to align with the rest of the regulation and promote public health interests. (Response 162) We acknowledge that ingredients such as spices, which have been associated with outbreaks of foodborne illness and large recalls, can contaminate a large volume of food (78 FR 3646 at 3665 and 3737). However, the suggestion that we define ``very small business'' in a way that reflects the probability and severity of potential hazards is neither practical nor aligned with a size-based nature of the term. The comments asserting that it is very likely that more facilities in exporting countries will be exempt under the definition, thus putting those located in the United States at a disadvantage, provided no basis for the assertion. As discussed in Response 156, we have declined the request to only include the total annual sales of food in the United States, adjusted for inflation, for foreign facilities that export food to the United States. (Comment 163) Some comments express concern that the Food Processing Sector Study is not comprehensive. (Response 163) See Response 139 regarding the Food Processing Sector Study. 38. You We proposed to define the term ``you'' for purposes of part 117, to mean the owner, operator, or agent in charge of a facility. We received no comments that disagreed with this proposed definition and are finalizing it as proposed. D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule 1. Corrections (Comment 164) Some comments assert that clearly distinguishing between the terms ``corrective actions'' and ``corrections'' will be imperative for industry to comply with the rule and for regulators to enforce the rule. Some comments ask us to use the ISO definitions of ``corrective actions'' and ``corrections.'' (According to ISO 22000:2005 definition 3.13, a ``correction'' is action to eliminate a detected nonconformity; according to ISO 22000:2005 definition 3.14, corrective action is action to eliminate the cause of a detected nonconformity or other undesirable situation.) Other comments ask us to eliminate the term ``correction'' and instead revise the rule to clarify the type of situation in which ``corrective actions'' are neither [[Page 55969]] necessary nor appropriate. As an example, these comments suggest that the proposed provisions for corrections could refer to ``prompt actions taken in response to minor and isolated deviations that do not directly impact product safety.'' Other comments agree with the concept of simple ``corrections'' but assert that the term ``corrections'' is unnecessary and could be confusing because different facilities may use the term differently. These comments explain that sometimes ``correction'' is used to refer to the action taken to fix a deviation, and may or may not be part of an overall corrective action taken to identify the root cause of the deviation and to prevent a similar occurrence. These comments suggest that the provisions explain that prompt actions taken to address minor and isolated deviations are not subject to the same requirements as corrective actions to address potentially systemic concerns, without defining the term ``corrections.'' (Response 164) We are defining the term ``correction'' to mean an action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). We agree that clearly distinguishing between the terms ``corrective actions'' and ``corrections'' will be important for both industry and regulators. We acknowledge that one way to distinguish between ``corrective actions'' and actions that we would consider ``corrections'' could be to avoid the term ``corrections'' and instead say what we mean each time the rule uses the term ``corrections.'' However, after reviewing the full regulatory text of proposed subpart C we concluded that it was not practical to do so, because the term ``corrections'' was used more often in a title or a cross-reference than in a provision where the full text of what we mean by the term ``corrections'' is necessary to communicate a requirement. Our definition of ``corrections'' focuses on the first step in a ``corrective action procedure'' (i.e., identify and correct the problem) and also specifies those aspects of a corrective action procedure that do not apply to a correction (i.e., actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). (A note to the ISO 22000:2005 definition of corrective action indicates that it includes cause analysis and is taken to prevent recurrence.) We believe that this definition will be adequate to distinguish ``corrective actions'' from ``corrections.'' As an example, if a facility applies sanitation controls for an environmental pathogen such as L. monocytogenes and food residue is observed on ``clean'' equipment prior to production, corrections would involve re-cleaning and sanitizing the equipment before it is used. Because the observation of food residue was made prior to production of food, no food is affected, and no actions are needed with respect to food. Although there are actions that can be taken to prevent reoccurrence, such as re-training sanitation personnel, these types of actions are not always needed. 2. Defect Action Level (Comment 165) Some comments that address the proposed provisions regarding ``defect action levels'' (proposed Sec. 117.110) ask us to define that term so that its meaning will be clear. (Response 165) We have added a definition of the term ``defect action level'' to mean a level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product ``adulterated'' and subject to enforcement action under section 402(a)(3) of the FD&C Act. This definition derives from the definition in our long-standing ``Defect Levels Handbook'' (Ref. 36), which we continue to reference in the provisions established in this rule regarding defect action levels. This definition also derives from the long-standing provisions in Sec. 110.110, which referred to natural or unavoidable defects in food for human use that present no health hazard and noted that some foods contain natural or unavoidable defects that at low levels are not hazardous to health. These long-standing provisions also noted that we establish maximum levels for these defects in foods produced under current good manufacturing practice and use these levels in deciding whether to recommend regulatory action. 3. Food-Packaging Material (Comment 166) Some comments point out that the proposed human preventive controls rule would amend certain provisions requiring prevention of contamination and allergen cross-contact of food and food-contact surfaces to add ``food-packaging materials,'' a term which is not defined. These comments ask us to clarify that ``food-packaging materials'' is limited to packaging materials that are capable of contaminating food and does not include shipping containers such as cartons and crates that pose no risk of introducing contaminants or food allergens into food. (Response 166) For the purposes of the provisions that require protection against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, the term ``food-packaging materials'' does not include shipping containers such as cartons and crates that pose no risk of introducing contaminants or food allergens into food. We are not adding a definition of ``food- packaging materials'' to the definitions in Sec. 117.3 because the provisions requiring protection against contamination are long-standing provisions that have been applied in the manner requested by the comment and, thus, adding a definition is not necessary to address the comment's request. 4. Must (Comment 167) Some comments ask us to define the term ``must.'' (Response 167) We decline this request. The term ``must'' has a common meaning, and it is not necessary to establish a specific meaning for this term specifically for this rule. 5. Parameter and Value as Used in the Requirements for Process Controls (Comment 168) Some comments ask us to define the terms ``parameter'' and ``value'' used in the requirements for preventive controls (Sec. 117.135). These comments ask us to define ``parameter'' as a measurable attribute and ``value'' as a specific measurement. (Response 168) We decline this request. Both of these terms are used in the context of process controls and both have common meanings when associated with process controls. Therefore, it is not necessary for the rule to define them. 6. Raw Materials Some comments ask us to define ``raw materials'' (see Comment 65). As discussed in Response 65, we have declined to do so. 7. Qualified Facility Exemption (Comment 169) Some comments note that some of the terminology associated with the exemption for qualified facilities in the human preventive controls rule is different from terminology associated with an exemption in the proposed produce safety rule. These comments point out that the exemption in the proposed produce safety rule refers to ``qualified exemptions'' (Sec. 112.5), whereas the [[Page 55970]] exemption in the proposed human preventive controls rule refers to ``exemptions'' and ``qualified facilities'' (Sec. 117.5(a)). These comments ask us to harmonize the terminology associated with the exemption for qualified facilities in the human preventive controls rule with the terminology associated with ``qualified exemptions'' in the proposed produce safety rule. (Response 169) We have revised the human preventive controls rule in two ways to better harmonize the terminology associated with the exemption for qualified facilities in the human preventive controls rule with an analogous exemption in the proposed produce safety rule. First, we have added a definition for the term ``qualified facility exemption,'' to mean an exemption applicable to a qualified facility under Sec. 117.5(a) (see the regulatory text in Sec. 117.3). Second, we also have made conforming changes throughout the rule to use the term ``qualified facility exemption'' when it applies. (See table 52.) It is not practical to fully harmonize the relevant terminology in these two rules due to differences in the framework applicable to food businesses subject to section 418 of the FD&C Act compared to the framework applicable to farms subject to section 419 of the FD&C Act. For example, a farm is not a ``facility'' and, thus, it would be confusing to refer to the applicable exemption established in the final produce safety rule as a ``qualified facility exemption'' or to refer to the business entities that would be exempt from the final produce safety rule as ``qualified facilities.'' 8. Unexposed Packaged Food As discussed in section XII, some comments ask us to clarify that modified requirements for packaged food that is not exposed to the environment only apply to such food that requires time/temperature control for safety (TCS food). To do so, we are defining the term ``unexposed packaged food'' to mean packaged food that is not exposed to the environment and using this term throughout the rule. Doing so simplifies the regulatory text and makes it clearer. (Comment 170) Some comments note that certain fruits and vegetables must be stored and distributed in vented packaging to allow for proper air circulation and the escape of gases produced in the ripening process. These comments ask us to interpret ``not exposed to the environment'' in a way that would include produce packed in such vented crates. Some comments assert that ``exposed to the environment'' must be meaningful from a food-safety standpoint and that produce shipped in vented crates presents virtually no food-safety risk because its environmental exposure is minimal. Some comments state that they do not believe Congress intended the term ``not exposed to the environment'' to mean only airtight, sealed containers. (Response 170) We acknowledge that certain fruits and vegetables may need to be distributed in vented crates but disagree that such produce is ``packaged food not exposed to the environment.'' We consider ``packaged food not exposed to the environment'' and ``unexposed packaged food'' to mean that the food is in a form that prevents any direct human contact with the food (78 FR 3646 at 3712). Although environmental exposure to produce packed in vented crates would be less than environmental exposure to produce packed in open crates, a vented crate can subject produce to contamination from condensate in aerosols carried by the air handling system, moisture dripping onto containers, particulates blown through the facility by the air handling system, fingers of handlers during handling of crates, objects that may be inadvertently inserted through the vents, pests that can access the produce through the vents, etc. We believe it is appropriate for facilities storing produce in vented crates to conduct a hazard analysis and evaluate whether there are hazards that would require a preventive control. (Comment 171) Some comments ask us to interpret ``not exposed to the environment'' to mean packaged with food grade material that is impermeable to outside bacteria or other contamination. These comments state that materials that prevent human contact with the food can nonetheless permit passage of contaminants and express concern about migration of chemicals, not approved as food-contact substances, from outer wrappers. (Response 171) We decline this request. A facility that packages ``unexposed packaged food'' is responsible for complying with all applicable requirements for the production of the food, including requirements established under section 409 of the FD&C Act (21 U.S.C. 348) regarding indirect food additives and food contact substances when packaging food. Likewise, a facility that packs ``unexposed packaged food'' in outer wrappers is responsible to ensure the safety of the food it packed, including ensuring that food is not contaminated from chemicals in the outer wrappers. The exemption applicable to ``unexposed packaged food'' applies to the storage of such foods, not the manufacturing, processing, or packing of such foods. For practical purposes, food that is not exposed to the environment will be protected from outside bacteria by the packaging. See also the discussions in Response 170 and Response 232 regarding produce packed in ``vented crates,'' which is not ``unexposed packaged food.'' E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule 1. Audit As already noted, some comments ask us to make the various rules we are establishing to implement FSMA consistent with each other, and we have worked to align the provisions of this rule with the provisions of the FSVP rule to the extent practicable. (See Comment 9 and Response 9.) To align these provisions, we are establishing in this final rule a definition of ``audit'' analogous to the definition of ``audit'' we proposed for the FSVP rule. For the purposes of this rule, ``audit'' means the systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess a supplier's food safety processes and procedures. 2. Full-Time Equivalent Employee As discussed in Response 140, we have established a definition for ``full-time equivalent employee'' as a term used to represent the number of employees of a business entity for the purpose of determining whether the business qualifies for the small business exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number. 3. Raw Agricultural Commodity We have added a definition of the term ``raw agricultural commodity'' to have the meaning given in section 201(r) of the FD&C Act. We decided to define this term in the rule to simplify the provisions in part 117 that refer to raw agricultural commodities. 4. Supply-Chain-Applied Control We have added a definition of the term ``supply-chain-applied control'' to mean a preventive control for a hazard [[Page 55971]] in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. We decided to define this term in the rule to simplify the provisions in part 117, and in the discussions in this document, that refer to preventive controls applied by a supplier before receipt by a receiving facility. 5. Written Procedures for Receiving Raw Materials and Other Ingredients We have added a definition of the term ``written procedures for receiving raw materials and other ingredients'' to mean written procedures to ensure that raw materials and other ingredients are received only from suppliers approved by the receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use). We decided to define this term in the rule to simplify the provisions in part 117, and in this document, that refer to these procedures. 6. Qualified Individual As discussed in section X.A., we are clarifying in new Sec. 117.4(b)(1) that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. To better align with the FSVP rule, we using the term ``qualified individual'' in new Sec. 117.4(b)(1) and are defining the term ``qualified individual'' to mean a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food In 2002, FDA convened a CGMP Modernization Working Group (CGMP Working Group) to determine whether part 110 is in need of further revision. In 2005, the CGMP Working Group issued a report (CGMP Working Group Report) summarizing the comments we received, as well as our key findings (78 FR 3646 at 3651). One of the specific areas identified in the CGMP Working Group Report that presented an opportunity to modernize the regulation was to ``require appropriate training for supervisors and workers to ensure that they have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to produce safe food products.'' (78 FR 3646 at 3729) As previously discussed, FSMA recognizes the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls, which identifies supervisor, manager, and employee hygiene training, and CGMPs under part 110, as some of the procedures, practices, and processes that may be included as preventive controls (see sections 418(o)(3)(B) and 418(o)(3)(F) of the FD&C Act, respectively) (78 FR 3646 at 3729). We proposed to re-establish part 110's recommendations for training as proposed Sec. 117.10(c) (FR 3646 at 3720). In addition, we requested comment on how best to revise part 110's current recommendations to implement section 418(o)(3) of the FD&C Act and the recommendations of the CGMP Working Group with respect to training (FR 3646 at 3729). Specifically, we requested comment on whether we should merely replace the current recommendations for personnel education and experience with requirements or whether more detail would be appropriate. As examples of additional specificity, we requested comment on whether the rule should specify that each person engaged in food manufacturing, processing, packing, or holding (including temporary and seasonal personnel and supervisors) must receive training as appropriate to the person's duties; specify the frequency of training (e.g., upon hiring and periodically thereafter); specify that training include the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as applied at the facility; and specify that records document required training of personnel and, if so, specify minimum requirements for the documentation (e.g., the date of the training, the type of training, and the person(s) trained). We also requested comment on whether to establish some or all of the potential requirements for education and training in subpart B, subpart C, or both. In the following paragraphs, we discuss comments that respond to our requests for comment on potential requirements for education and training and for whether to establish any requirements in subpart B, subpart C, or both. After considering these comments, we are establishing requirements for the qualifications of individuals engaged in manufacturing, processing, packing, or holding food in new Sec. 117.4 in subpart A, with associated recordkeeping requirements established in Sec. 117.9 in subpart A. The regulatory text makes clear that these requirements, established in subpart A, apply to individuals engaged in manufacturing, processing, packing, or holding food regardless of whether the individuals conduct these activities under the framework of the CGMPs established in subpart B or the framework for hazard analysis and risk-based preventive controls established in subparts C, D, E, and G. The regulatory text also makes clear that the qualification requirements apply to the recordkeeping requirements of subpart F. See table 11 for a description of these provisions. Table 11--Provisions for Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food ---------------------------------------------------------------------------------------------------------------- Proposed section Final section designation designation Description ---------------------------------------------------------------------------------------------------------------- 117.4(a)(1)............................. N/A........................ Applicability to individuals who manufacture, process, pack, or hold food subject to subparts B and F. 117.4(a)(2)............................. N/A........................ Applicability to individuals who manufacture, process, pack, or hold food subject to subparts C, D, E, F, or G. 117.4(b)(1)............................. N/A........................ Each individual engaged in manufacturing, processing, packing, or holding food must have the education, training, or experience (or combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. 117.4(b)(2)............................. 117.10(c).................. Required training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene. 117.4(c)................................ 117.10(d).................. Additional qualifications of supervisory personnel. 117.4(d)................................ N/A........................ Records of required training. [[Page 55972]] 117.9................................... N/A........................ The required records are subject to the recordkeeping requirements of subpart F. ---------------------------------------------------------------------------------------------------------------- A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food (Final Sec. 117.4(a), (b), and (d)) (Comment 172) Some comments support changing the current recommendations for training to requirements, e.g., by replacing ``should'' with ``must.'' However, some of these comments also ask that the requirement allow sufficient flexibility for establishments to determine the scope and frequency of the training based on the establishment, types of products, and job responsibilities of the employee. Some of these comments assert that this position is consistent with the concept in the food safety plan of tailoring controls to the specific facility and operations, and also aligns with the Global Food Safety Initiative guidance document, which was based on the recommendations of the Codex Alimentarius Commission (Codex). Some of these comments ask that we specify ``as applicable to the plant operation'' and ``applicable to their assigned duties'' to allow establishments flexibility in establishing risk-based training requirements specific to their operations. Other comments prefer more detail and ask that we establish requirements addressing all of the recommendations of the CGMP Working Group. Some of these comments note that doing so would be consistent with the proposed training requirements for the produce safety rule. Other comments prefer that we continue to only provide recommendations for education and training and allow the food industry to determine the appropriate level of specific employee training that may be needed. These comments assert that overly prescriptive and binding requirements may not consider variables such as training course content, training provider, effectiveness of the course, and instructor and frequency of training per topic. In addition, comments assert that factors such as an employee's type and length of experience, nature of formal education, and the food product type and point in the food supply chain at which the employee works with the food product (close to the farm or close to the fork) will need to be considered. Other comments ask us to establish the recommendations of the CGMP Working Group in guidance rather than in the rule. Some comments recommend that employees be trained ``initially'' and ``periodically thereafter'' but ask that we recognize the seasonal nature of a facility's workforce. Some comments ask that the training include the principles of food hygiene and food safety, including the importance of employee health and personal hygiene as applied at the facility. Some comments ask that training requirements be established in subpart B so that the requirements apply to all establishments that manufacture, process, pack, or hold food, including establishments that are not subject to FSMA's requirements for hazard analysis and risk- based preventive controls. These comments assert that this broad training requirement would improve food safety overall. Some comments that recommend establishing the training requirement in subpart B assert that training is more appropriately considered a prerequisite program than a preventive control that would belong in subpart C. Other comments ask that the training and related recordkeeping requirements for the facility's preventive controls qualified individuals be established under subpart C because this is directly related to the facility's food safety plan. Other comments ask that training requirements be established in both subpart B and subpart C. Other comments assert that including requirements for education and training in both subparts B and C would be confusing. (Response 172) We are establishing a series of requirements for the qualifications of individuals engaged in manufacturing, processing, packing, or holding food in new Sec. 117.4. First, to clarify how these qualification requirements apply to establishments subject to subparts B and F, we are requiring that the management of an establishment ensure that all individuals who manufacture, process, pack, or hold food subject to subparts B and F are qualified to perform their assigned duties (Sec. 117.4(a)(1)). To clarify how these qualification requirements apply to facilities, we are requiring that the owner, operator, or agent in charge of a facility ensure that all individuals who manufacture, process, pack, or hold food subject to subparts C, D, E, F, or G are qualified to perform their assigned duties (Sec. 117.4(a)(2)). We are not requiring training specific to the person's assigned duties. Each establishment engaged in the manufacturing, processing, packing, and holding of food for human consumption would already have procedures in place to ensure that all individuals who manufacture, process, pack, or hold food know how to do their jobs. However, to emphasize that we expect all individuals who conduct such activities to know how to do their jobs, we are specifying that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties (Sec. 117.4(b)(1)). To better align with the forthcoming FSVP rule, we are using the term ``qualified individual'' in new Sec. 117.4(b)(1) and are defining the term ``qualified individual'' to mean a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. See the discussion of the term ``preventive controls qualified individual'' in section IX.C.25, including a discussion of how we have changed the proposed term ``qualified individual'' to ``preventive controls qualified individual'' because we are establishing a new definition for ``qualified individual,'' with a meaning distinct from ``preventive controls qualified individual.'' We also are requiring that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof, [[Page 55973]] receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the person's assigned duties (see Sec. 117.4(b)(2)). Records that document this required training must be established and maintained and are subject to the recordkeeping requirements of subpart F (Sec. Sec. 117.4(d) and 117.9). The rule does not specify the frequency of the required training. We expect that production employees will receive training before working in production operations. Based on a 2010 survey of the domestic food manufacturing industry, we expect that most facilities will also provide some form of refresher training (Ref. 54). We disagree that we should continue to only provide recommendations for education and training. Although the comments express concern about overly prescriptive requirements that may not consider variables that would affect an establishment's training program (such as training course content, training provider, effectiveness of the course and instructor and frequency of training per topic, an employee's type and length of experience, nature of formal education, and the food product type and point in the food supply chain at which the employee works with the food product), the training requirement we are establishing in the rule provides flexibility for each establishment to provide training, and determine the scope and frequency of the training, in a way that works best for the establishment. We agree that it is appropriate to establish training requirements so that the requirements apply to all establishments that manufacture, process, pack, or hold food, including establishments that are not subject to FSMA's requirements for hazard analysis and risk-based preventive controls, and we are establishing the qualification and training requirements in subpart A to clarify the applicability of these requirements to all establishments and facilities subject to part 117. Although we agree that employees in facilities that are subject to the requirements for hazard analysis and risk-based preventive controls need to understand their responsibilities under the facility's food safety plan, we are setting forth a training requirement focused on the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as recommended in the report of the CGMP Working Group (Ref. 3). We consider training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, to be fundamental to the concept of CGMPs. We agree that establishing a training requirement in both subpart B and subpart C could be confusing. (Comment 173) Some comments ask that training not be limited to a narrow class of processors. Other comments assert that anyone who works in the food industry should have mandatory training and re-training. (Response 173) The training applies to all individuals engaged in manufacturing, processing, packing, or holding food, consistent with the requests of these comments. (Comment 174) Some comments agree that training should be documented and assert that those records should show the date of training, a description of the training, and the name of the person trained. However, comments ask that we allow flexibility in the way these records are kept. Other comments assert that requiring that records document required training of personnel is burdensome, arbitrary, and capricious. (Response 174) The rule requires that records that document training required by Sec. 117.4(b)(2) be established and maintained without prescribing any content of those records. Although one approach to documenting training would be to provide the date of training, a description of the training, and the name of the person trained, the rule provides flexibility for each establishment to document its training in a way that works best for that establishment. We disagree that requiring records to document required training is burdensome, arbitrary, and capricious in light of the strong support in the comments regarding CGMP modernization for records documenting training and the flexibility provided by the rule for the content of training records. (Comment 175) Some comments that support mandatory training nonetheless caution us to be flexible towards the development and deployment of mandatory training, including issuance of certificates, so as not to create road blocks for third-party service providers. These comments state that education and training and/or capacity building is a growing, rapidly evolving, and well-developed third-party service industry today, and that food companies often deliver their training to other raw material suppliers and contract manufacturers. Some comments assert that the training and education programs should be developed and implemented in close cooperation with State agencies, public institutions, and stakeholder organizations. (Response 175) The requirements do not address issuance of certificates or any other provisions that could create road blocks for third-party providers. An establishment has flexibility to develop or otherwise provide training in cooperation with public and private organizations in a manner that suits its needs. (Comment 176) Some comments agree that any requirements should include training appropriate to the person's duties but emphasize that the decision as to what is appropriate to the person's assigned duties should be determined by the establishment. (Response 176) The requirement for employees to receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the person's assigned duties, provides flexibility for the establishment to provide training that is appropriate for its employees in light of each person's assigned duties. However, the rule does not require training specific to the person's assigned duties. (Comment 177) Some comments assert that the training requirement would be an unreasonable burden for small businesses and that companies may incur substantial cost for the time that workers would be in training rather than in production. Some comments ask us to provide non-specific training recommendations for smaller food processors that need flexibility to control the cost of training. Some comments assert that the training and education requirements must be accessible and flexible enough to allow employers to bring in temporary help when demand is high without causing a delay in hiring. Some comments assert that we must provide ongoing education, training, and outreach for previously regulated firms, newly regulated firms, regulators that will be responsible for implementing the rules, and educators who will help farmers and facilities understand and manage the new requirements. Some comments assert that training is needed to educate farmers, the food industry, and State and local authorities as well. (Response 177) All employees will need enough training to do their jobs and understand the importance of hygiene for food safety. The training offered does not need to be expensive (e.g., off-site training or off-the-shelf purchased training) and we expect that much of the training will be provided in-house by knowledgeable employees. As discussed in Response 2, the FSPCA is developing a preventive controls training curriculum. These training [[Page 55974]] materials will be available online, and we expect these training materials to be useful to small businesses to use for in-house training. (Comment 178) Some comments ask us to continue to work with foreign governments on access to training and education to ensure that the industry as a whole is moving towards better advancements in food safety practices, no matter the size, channels of distribution, or geographic location. (Response 178) As discussed in Response 717, we intend to work with the food industry, education organizations, USDA, the U.S. Agency for International Development, and foreign governments to develop tools and training programs to facilitate implementation of this rule. (Comment 179) Some comments assert that the preventive controls qualified individual should perform the trainings. Some comments assert that the preventive controls qualified individual should be responsible for determining the appropriate frequency and scope of training for each facility and employee, and the records necessary to document that appropriate training has been conducted. (Response 179) We decline these requests. Although we agree that the person delivering such training should be knowledgeable, we are providing flexibility for facilities to provide training as appropriate to the facility, including through on-line CGMP or other food safety courses. (Comment 180) Some comments ask that this rule provide FDA (and those States under contract) the ability to require certification of industry managers and training of employees if serious operational hazards are found and management and staff are unable to answer basic questions concerning hazards and controls in the facility. (Response 180) We decline this request. We address each compliance situation on a case-by-case basis. B. Additional Requirements Applicable to Supervisory Personnel (Final Sec. 117.4(c)) We received no comments that disagreed with our proposal to retain the requirement in part 110 that responsibility for ensuring compliance by all personnel with all requirements of this subpart must be clearly assigned to competent supervisory personnel. We are correcting ``all requirements of this subpart'' to ``all requirements of this part.'' As a conforming change for consistency with the provisions of Sec. 117.4(b), we are replacing the phrase ``competent supervisory personnel'' with the phrase ``supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe food.'' XI. Subpart A: Comments on Proposed Sec. 117.5--Exemptions We proposed to establish a series of exemptions from the requirements for hazard analysis and risk-based preventive controls that would be established in subpart C, with modified requirements in some cases. We also proposed to redesignate Sec. 110.19(a) (a pre- existing exemption from CGMP requirements applicable to establishments engaged solely in the harvesting, storage, or distribution of one or more RACs) as Sec. 117.5(k) and to revise this exemption to adjust and clarify what activities fall within this exemption based on experience and changes in related areas of the law since issuance of the CGMP regulation. Some comments support one or more of the proposed exemptions without change. For example, some comments note that the exemptions are specified in FSMA and, thus, reflect the intent of Congress. Some comments state that some exemptions (i.e., those for products already subject to our HACCP regulations for seafood and juice, or to regulations for the control of microbiological hazards for LACF) make sense because they are risk-based. Other comments that support one or more of the proposed exemptions ask us to clarify particulars associated with these exemptions (see, e.g., Comment 209, Comment 210, Comment 211, and Comment 212) or expand the scope of some of these exemptions (see, e.g., Comment 185, Comment 196, Comment 197, Comment 208, and Comment 221). Other comments ask us to include additional exemptions in the rule (see section XI.K). In the remainder of this section, we discuss comments that ask us to clarify the proposed exemptions or that disagree with, or suggest one or more changes to, the proposed exemptions. We also discuss comments that ask us to include additional exemptions in the rule. After considering these comments, we have revised the proposed exemptions as shown in table 12 with editorial and conforming changes as shown in table 52. A key conforming change that affects all proposed exemptions from the requirements of subpart C is that the final exemptions are from the requirements of subpart G, as well as subpart C. As discussed in section XLII, the final rule establishes the requirements for a supply-chain program in subpart G, rather than within subpart C as proposed. Table 12--Revisions to the Proposed Exemptions ---------------------------------------------------------------------------------------------------------------- Section Exemption Modification ---------------------------------------------------------------------------------------------------------------- 117.5(g)........................... From the requirements of subpart C Made changes consequential for on-farm packing or holding of to the revised ``farm'' definition-- food by a small or very small i.e., no longer identifying any business if the only packing and packing or holding activities for holding activities subject to any RACs. section 418 of the FD&C Act that the Clarified that the modified business conducts are the specified requirements do not apply to on- low-risk packing or holding activity/ farm packing or holding of food by food combinations. a very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk packing or holding activity/food combinations. Updated food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA. Added low-risk packing or holding activity/food combinations as a result of an updated risk assessment. Added a description of the food categories included in Sec. 117.5(g) and (h). [[Page 55975]] 117.5(h)........................... From the requirements of subpart C Made changes consequential for on-farm manufacturing/processing to the revised ``farm'' definition-- activities conducted by a small or i.e.: very small business for distribution --No longer distinguish between into commerce if the only manufacturing/processing activities manufacturing/processing activities conducted on a farm mixed-type subject to section 418 of the FD&C facility's own RACs and Act that the business conducts are manufacturing/processing activities the specified low-risk manufacturing/ conducted on food other than the processing activity/food farm mixed-type facility's own combinations. RACs; and --Eliminated activities, conducted on others' RACs, that would no longer be classified as manufacturing/processing and instead would be classified as harvesting, packing, or holding. Clarified 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/ processing activity/food combinations. Updated food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA. Added low-risk manufacturing/ processing activity/food combinations as a result of an updated risk assessment. 117.5(k)(1)(iii)................... From the requirements of subpart B Changed from an exemption for for the holding and transportation specific activities (i.e., holding of RACs. and transportation of RACs) to establishments solely engaged in one or both of those activities. 117.5(k)(1)(v)..................... From the requirements of subpart B Changed from an exemption for for certain activities conducted on specific activities to nuts (without additional establishments solely engaged in manufacturing/processing). those activities. ---------------------------------------------------------------------------------------------------------------- A. General Comments on the Proposed Exemptions (Comment 181) Some comments ask us to provide the same flexibility for foreign small businesses as for domestic small businesses. (Response 181) The exemptions apply to both foreign small businesses and domestic small businesses. (Comment 182) Some comments note that proposed Sec. 117.10(c) recommends, but would not require, that the responsible individual at a food establishment have a background of education, experience or a combination of both to provide a level of competence necessary to produce clean and safe food. These comments ask us to make this a requirement, rather than a recommendation, for the responsible individual at any facility that is exempt from the requirements for hazard analysis and risk-based preventive controls. These comments also ask us to require presentation of the training information to us before an exemption is granted. (Response 182) We decline these requests. The statute does not require that we pre-qualify a facility for an exemption. (Comment 183) Some comments ask us to clarify whether an establishment that is exempt from the requirements for hazard analysis and risk-based preventive controls in subpart C remains subject to the CGMP requirements in subpart B. (Response 183) An establishment that is exempt from the requirements for hazard analysis and risk-based preventive controls in subparts C and G remains subject to the CGMP requirements in subpart B, unless that establishment is exempt from subpart B under Sec. 117.5(k) (which applies to: (1) Farms; (2) certain fishing vessels; (3) establishments solely engaged in the holding and/or transportation of one or more RACs; (4) activities of ``farm mixed-type facilities'' that fall within the definition of ``farm''; and (5) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing)). B. Proposed Sec. 117.5(a)--Exemption Applicable to a Qualified Facility We proposed that subpart C would not apply to a qualified facility, except as provided by subpart E (Withdrawal of an Exemption Applicable to a Qualified Facility), and that qualified facilities would be subject to the modified requirements in Sec. 117.201. (Comment 184) Some comments support the proposed exemption for a qualified facility and assert that all farms should be eligible for this exemption until it is shown that food obtained from these farms makes people sick. Other comments oppose this proposed exemption, asserting that it is not risk based and expressing concern that qualified facilities would cause significant food safety problems. Some comments ask us to strictly construct and narrowly apply the exemptions to as few businesses as possible. Some comments do not agree that qualified facilities should be subject to modified requirements because even the modified requirements are burdensome. Some comments assert that qualified facilities having an average annual value of food sold during the previous three-year period of $25,000 or less should be exempt from all requirements related to hazard analysis and risk-based preventive controls, including modified requirements. (Response 184) The exemption for qualified facilities, including the criteria for being a qualified facility and the applicability of modified requirements, is expressly directed by section 418(l) of the FD&C Act. In defining ``very small business'' to mean a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee), we constructed this exemption to apply [[Page 55976]] to businesses that, collectively, produce less than 0.6 percent of the food supply (Ref. 38). In addition, as discussed in Response 151, most of these facilities will be subject to the CGMP requirements in subpart B. (Comment 185) Some comments assert that a qualified facility should be exempt from the CGMP requirements of subpart B, as well as the requirements for hazard analysis and risk-based preventive controls in subpart C. (Response 185) The exemption for qualified facilities is expressly directed by section 418(l) of the FD&C Act and is limited to an exemption from the requirements for hazard analysis and risk-based preventive controls in subparts C and G. The comments provide no basis for why new statutory requirements for hazard analysis and risk-based preventive controls should in any way impact the long-standing CGMPs requirements that apply to the manufacturing, packing, and holding of human food. CGMPs provide the basic requirements for ensuring production of safe and sanitary food. Following the CGMPs is essential to properly address public health risks from very small facilities that are provided an exemption from subparts C and G in order to minimize the burden on such facilities. (See also Response 221.) (Comment 186) Some comments ask us to clarify how the exemption applies to diversified farms that produce both exempt and non-exempt products. (Response 186) We assume that this comment is referring to a farm mixed-type facility that produces some products (such as juice or dietary supplements) that are exempt from the requirements for hazard analysis and risk-based preventive controls, as well as some products that are not exempt from these requirements. The exemption only applies to products that are not otherwise exempt from the requirements for hazard analysis and risk-based preventive controls. However, see the discussion in Response 157 with our response to comments requesting that we base the dollar threshold for the definition of very small business only on the annual monetary value of food covered by the preventive controls rule, rather than all human food; we declined that request. (Comment 187) Some comments ask us to provide that a qualified facility may voluntarily choose to comply with the requirements for hazard analysis and risk-based preventive controls. (Response 187) A qualified facility may voluntarily choose to comply with the requirements for hazard analysis and risk-based preventive controls without a specific provision authorizing it to do so. (Comment 188) Some comments ask us to specify in guidance that a qualified facility is not required to prepare and implement a food safety plan. (Response 188) We intend to recommend in guidance how a qualified facility could comply with the modified requirements in Sec. 117.201 without satisfying all of the requirements in subparts C and G. C. Proposed Sec. 117.5(b) and (c)--Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products (21 CFR Part 123) or for Juice (21 CFR Part 120) We proposed that subpart C would not apply with respect to activities that are subject to part 123 (21 CFR part 123) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 123 with respect to such activities. We also proposed that subpart C would not apply with respect to activities that are subject to part 120 (21 CFR part 120) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 120 with respect to such activities. We requested comment on the criteria that should be used to determine whether a facility is in compliance with part 123 or part 120 (78 FR 3646 at 3704). (Comment 189) Some comments ask us to clarify whether a seafood allergen that is identified as a hazard should be included in a seafood HACCP plan or in a facility's food safety plan. These comments also ask whether a food allergen that is identified as a hazard in juice subject to part 120 should be included in a juice HACCP plan or in a facility's food safety plan (Response 189) There is no specific requirement in the seafood HACCP regulation in part 123 that food allergen hazards be addressed in the seafood HACCP plan. However, Chapter 19 in our guidance entitled ``Fish and Fishery Products Hazards and Controls Guidance (Fourth Edition)'' includes recommendations for the control of undeclared food allergens (Ref. 42). The juice HACCP regulation in part 120 requires that a juice processor consider the presence of undeclared ingredients that may be food allergens as part of its hazard analysis, and several sections in our guidance entitled ``Juice HACCP Hazards and Controls Guidance (First Edition)'' include recommendations for the control of food allergens (Ref. 43). Both seafood processors and juice processors would also address allergen hazards through application of CGMPs. Facilities that are exempt from the requirements of subparts C and G with respect to activities that are subject to part 120 or part 123 are not required to prepare and implement a food safety plan in addition to their HACCP plans. (Comment 190) Some comments note that our HACCP regulations for juice and seafood do not require facilities subject to those regulations to address radiological hazards and ask how radiological hazards should be addressed for activities that are subject to part 120 or part 123. (Response 190) A facility that conducts activities that are subject to part 120 or part 123 is not required to address radiological hazards in its HACCP plan if the facility is required to comply with, and is in compliance with, part 120 or part 123 with respect to such activities. However, under some circumstances radiological hazards might need to be considered. Moreover, the facility would be subject to the CGMP requirement that storage and transportation of food must be under conditions that will, among other things, protect against chemical (including radiological) contamination of food (Sec. 117.93). (Comment 191) Some comments state that what is needed to assess compliance with the applicable HACCP regulation is evidence of compliance with each specific requirement of the regulation, such as compliance with requirements for a written hazard analysis and Sanitation Standard Operating Procedures (SSOPs). Other comments ask us to provide guidance to industry and the regulatory community regarding the criteria that will be used to determine when a facility is ``in compliance with'' part 120 or part 123. Some comments note that any determination of compliance with one of our HACCP regulations would be product specific, and that we would only be able to assess compliance on the inspected product, not all of the products being produced at the facility. Some comments ask us to establish a transparent process to follow when determining when to nullify an exemption applicable to food subject to HACCP in part 120 or part 123. These comments made specific suggestions for such a process, including through a HACCP inspection of a domestic facility or a review of a facility's HACCP plan and corresponding HACCP records for a foreign facility. These comments assert that FDA actions such as issuing inspectional observations, issuing a Warning Letter, or making an imported product subject to detention without physical examination, should not be the basis for determining non-compliance [[Page 55977]] because in such situations a facility would have an opportunity to respond to FDA with its approach to correcting problems. Some comments assert that the key question for us to answer is when a situation will be so severe that it warrants requiring compliance with the human preventive controls rule rather than the applicable HACCP regulation. These comments raise questions about the practicality of requiring compliance with the human preventive controls rule for some products manufactured at a facility while continuing to require compliance with the applicable HACCP regulation for other products manufactured at that facility. These comments ask us to specify the added food safety protections that the human preventive controls rule can provide that cannot be obtained by compliance with the applicable HACCP regulation. These comments also ask us to consider the likelihood that a facility that cannot comply with the applicable HACCP regulation would be able to comply with the human preventive controls rule. Other comments ask whether we will modify existing guidance on compliance with applicable HACCP regulations to help facilities and inspectors understand what is needed for a facility to maintain its exemption. Some comments assert that the statutory intent for compliance would be satisfied by enforcement actions (such as administrative detention, registration suspension, or mandatory recall) that will either ensure compliance with the applicable HACCP regulation, or prohibit that facility from distributing food. (Response 191) We acknowledge the issues raised by these comments and agree that in many situations the appropriate action for us to take when a facility is out of compliance with an applicable HACCP regulation will be to employ existing enforcement tools to bring the facility into compliance with the applicable regulation. However, we also believe that there may be circumstances where an added food safety benefit could be achieved by requiring compliance with the human preventive controls rule when a facility does not comply with an applicable HACCP regulation. For example, the seafood HACCP regulation recommends--but does not require--that a seafood processor have and implement a written SSOP. In contrast, the human preventive controls rule requires that all preventive controls be written, and that preventive controls include, as appropriate to the facility and the food, sanitation controls, which include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards (Sec. 117.135(c)(3)). A seafood processing facility that has ongoing sanitation problems and contamination with, for example, an environmental pathogen, but does not have a written SSOP, may be better able to address its sanitation problems by a combination of written sanitation controls and verification of those sanitation controls through environmental monitoring (Sec. 117.165(a)(3)). Likewise, a juice processor that has ongoing problems with microbial contamination of fruit it receives for processing may be better able to address its supply of fruit by complying with the specific requirements of the human preventive controls rule for a supply-chain program (subpart G). We expect that situations in which enforcement actions to ensure compliance with an applicable HACCP regulation are insufficient to correct problems, and lead to a facility losing its exemption from the requirements of subparts C and G, will be rare and will depend on very specific circumstances. Therefore, at this time we do not anticipate issuing guidance on when violations of one of our HACCP regulations would cause us to require compliance with subparts C and G. (Comment 192) Some comments ask us to revise our HACCP regulations for seafood and juice to be consistent with subpart C to avoid the burden of having two systems within facilities that produce seafood or juice products, as well as other foods. (Response 192) We decline this request. Our HACCP regulations are already consistent with--though not identical to--subpart C. Further, it is not clear that such facilities would need two separate systems, given the similarities in requirements and flexibility we have provided for implementing preventive controls. The food safety plan for the products not subject to the HACCP regulations is likely to be very similar to that for the foods subject to the HACCP regulations (which includes monitoring of SSOPs). To the extent that subparts C and G contain additional requirements, a facility is free to perform similar actions for its products produced under a HACCP regulation. (Comment 193) Some comments ask us to exempt the production of fresh cider from the rule. (Response 193) Fresh cider is juice. A facility that produces fresh cider is eligible for the exemption for products subject to our HACCP regulation for juice. D. Proposed Sec. 117.5(d)--Exemption Applicable to Food Subject to Part 113--Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers We proposed that subpart C would not apply with respect to activities that are subject to part 113 at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 113 with respect to such activities. We also proposed that this exemption would apply only with respect to the microbiological hazards that are regulated under part 113. We requested comment on the criteria that should be used to determine whether a facility is in compliance with part 113 (78 FR 3646 at 3704). (Comment 194) Some comments express concern that the partial exemption for products subject to part 113 could generate confusion for both regulators and regulated facilities. These comments also assert that the partial exemption for products subject to part 113 would generate duplicative recordkeeping requirements under the two rules. (Response 194) We acknowledge the potential for confusion and expect any confusion to decrease over time as both regulators and facilities gain experience with the new requirements. We also expect that in most instances a facility that is subject to part 113, and that evaluates potential microbiological hazards as part of its hazard analysis, would conclude that the potential hazards are controlled by the targeted requirements of part 113 and conclude there are no microbiological hazards that require preventive controls to significantly minimize or prevent the hazards. We disagree that the partial exemption for products subject to part 113 would generate duplicative recordkeeping requirements. The requirements of part 113 to control biological hazards are different from the requirements of subparts C and G to conduct a hazard evaluation for chemical and physical hazards, and implement preventive controls and associated preventive control management components to address significant chemical and physical hazards. Likewise, the records associated with the control of biological hazards under part 113 are not the same as the records associated with a hazard analysis, preventive controls, and associated preventive control management components for control of [[Page 55978]] chemical and physical hazards. However, to the extent that a facility appropriately determines that existing records required by part 113 can be used to demonstrate compliance with the requirements of subparts C and G, a facility may rely on those records (see Sec. 117.330). (Comment 195) Some comments ask us to provide guidance to industry and the regulatory community regarding the criteria that will be used to determine when a facility is ``in compliance with'' part 113. (Response 195) We discuss similar comments regarding the exemptions for products subject to one of our HACCP regulations in Response 191. As an example, an LACF manufacturing facility that has ongoing problems controlling biological hazards may be better able to address biological hazards by preparing and implementing a written food safety plan. As with facilities subject to our HACCP regulations, we expect that situations in which enforcement actions to ensure compliance with part 113 are insufficient to correct problems, and lead to a facility losing its exemption from the requirements of subparts C and G, will be rare and will depend on very specific circumstances. Therefore, at this time we do not anticipate issuing guidance on when violations of part 113 could lead to this outcome. E. Proposed Sec. 117.5(e)--Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement We proposed that subpart C would not apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of part 111 (Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements) and section 761 (Serious Adverse Event Reporting for Dietary Supplements) of the FD&C Act. We requested comment on the criteria that should be used to determine whether a facility is in compliance with part 111 and section 761 of the FD&C Act (78 FR 3646 at 3705). As noted in table 52, we corrected the exemption to match the title of part 111--i.e., ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.'' (Comment 196) Some comments assert that the entire facility should be exempt from the requirements of subpart C if the facility implements the dietary supplement CGMP regulation even if the facility also makes food products that are not dietary supplements. Some comments assert that the exemption applicable to the manufacturing, processing, packing, or holding of a dietary supplement should also apply to the manufacturing, processing, packing, or holding of a dietary ingredient if the facility chooses to follow the dietary supplement CGMP regulation. (Response 196) The proposed exemption is directed by section 103(g) of FSMA. None of these comments explain how the desired expansion of the exemption is consistent with section 103(g), which limits the provision to ``the manufacturing, processing, packing, or holding of a dietary supplement'' (78 FR 3646 at 3705). (Comment 197) Some comments ask us to revise the exemption applicable to dietary supplements to add that subparts B and F do not apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of part 111. These comments assert that it would be illogical to subject the dietary supplement industry to industry- specific CGMPs (part 111), as well as a more general (and inherently less applicable) CGMP standard in part 117. These comments also assert that the intent of the CGMPs in part 117 is to regulate industries and industry segments that have not previously been regulated and that failing to acknowledge the regulations already applicable to dietary supplements would be duplicative, redundant, and provide no additional safety or public health protection. (Response 197) As discussed in the final rule establishing the dietary supplement CGMP regulation, we included in part 111 the existing requirements in part 110 that we believe are common to dietary supplement manufacturing (72 FR 34752 at 34764, June 25, 2007). We recognized that there may be operations related to the manufacturing of dietary supplements for which certain provisions in part 110 (now largely subpart B of part 117) apply, but that we did not determine to be common to most dietary supplement manufacturing operations (e.g., for dietary supplements that are dehydrated and rely on the control of moisture consistent with current Sec. 110.80(b)(14) (proposed Sec. 117.80(c)(14)). As was the case when we issued the final rule to establish dietary supplement CGMPs and continues to be the case now, a manufacturer would be required to comply with the CGMP regulations in subpart B of part 117 in addition to the regulations in part 111, unless the regulations conflict. To the extent that the regulations conflict, the dietary supplement manufacturer would comply with the regulation in part 111. (Comment 198) Some comments ask us to clarify how the exemption applies to foods, other than dietary supplements, that may be held in a facility that conducts activities in compliance with the dietary supplement CGMP regulation. (Response 198) The exemption does not apply to foods, other than dietary supplements, that may be held in a facility that conducts activities in compliance with the dietary supplement CGMP regulation. The owner, operator, or agent in charge of a facility that produces both dietary supplements and foods that are not dietary supplements must comply with the requirements of this rule for hazard analysis and risk-based preventive controls, unless another exemption applies as specified in Sec. 117.5. (Comment 199) Some comments ask us to use information collected in the biennial food facility registration to help determine whether a facility is in compliance with part 111. (Response 199) We decline this request. It would be the observations and findings from an inspection, rather than information in a facility's registration, that could help us determine whether a facility is in compliance with part 111. Information collected during registration provides information on how we should inspect a facility, but has no bearing on whether the facility is complying with applicable regulations. F. Proposed Sec. 117.5(f)--Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act We proposed that subpart C would not apply to activities of a facility that are subject to section 419 (Standards for Produce Safety) of the FD&C Act (21 U.S.C. 350h). We received no comments that disagreed with this proposal and are finalizing it as proposed. G. Proposed Sec. Sec. 117.5(g) and (h)--Exemptions Applicable to On- Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business As discussed in section VI.A, consistent with the statutory direction in section 103(c) of FSMA, including conducting a qualitative risk assessment, we proposed three exemptions for on-farm activity/food combinations conducted by farm-mixed-type facilities that are small or very [[Page 55979]] small businesses (proposed Sec. Sec. 117.5(g), (h)(1), and (h)(2)). 1. General Comments on the Proposed Exemptions Applicable to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business (Comment 200) Some comments assert that conducting a low-risk activity/food combination should be sufficient to qualify any facility for exemption from subpart C, regardless of whether the activity is conducted on-farm or off-farm, or meets the economic threshold for a small or very small business. (Response 200) The statute provides specific direction for those facilities that can qualify for this exemption. (See sections 418(l) and 418(o)(2) of the FD&C Act.) See also Response 184 and Response 222. (Comment 201) Some comments ask why the activity/food combinations listed in proposed Sec. 117.5(g) are not consistent with the activity/ food combinations listed in proposed Sec. 117.5(h). Some comments state that the exemptions for farming activities are confusing. (Response 201) The items listed in Sec. 117.5(g) only specify the food or food category (rather than an activity/food combination) because the activities addressed in Sec. 117.5(g) are, in all cases, the same--i.e., packing and holding activities. In contrast, the items listed in Sec. 117.5(h) specify a particular activity (e.g., coating, mixing) in addition to a food or food category (e.g., peanuts and tree nuts) because there are multiple manufacturing/processing activities, each associated with a particular food or food category, listed in the provisions. Although these exemptions are more complex than other exemptions (e.g., because they are directed to specific activities conducted on specific foods or food categories), the final ``farm'' definition has simplified them to the extent practicable. For example, under the ``farm'' definition in the 2013 proposed preventive controls rule, whether an activity was packing or manufacturing/processing depended, in part, on whether the RACs being packed were the farm's own RACs or others' RACs. In contrast, under the ``farm'' definition established in this rule, packing RACs is a ``packing'' activity, regardless of ownership of the RACs being packed. (Comment 202) Some comments note a distinction between the exemptions for on-farm low-risk activity/food combinations conducted by small and very small businesses and the exemption for qualified facilities. Specifically, a farm mixed-type facility that only conducts low-risk activity/food combinations (such as making certain jams or syrups) would be exempt from the requirements of subpart C, whereas an off-farm qualified facility making those same jams and syrups, while exempt from the requirements of subpart C, would nonetheless be subject to modified requirements in Sec. 117.201. These comments ask whether it would be better for a farm or farm mixed-type facility that satisfies criteria for a small or very small business, and also satisfies criteria for a qualified facility, to classify itself as a small or very small business or to classify itself as a qualified facility. (Response 202) In light of the final ``farm'' definition, these comments no longer apply with respect to activities within the farm definition. For activities conducted by a farm mixed-type facility, we acknowledge that the exemptions provided by Sec. 117.5(g) and (h) for on-farm low-risk activity/food combinations are different from the exemption provided by Sec. 117.5(a) for a qualified facility. A farm mixed-type facility that only conducts low-risk activity/food combinations listed in Sec. 117.5(g) and (h) is fully exempt from the requirements of subparts C and G, and is not subject to the modified requirements in Sec. 117.201, even if that farm mixed-type facility is also a very small business (and, thus, also is a qualified facility). To make this clear, we have revised proposed Sec. 117.5(g) to specify that Sec. 117.201 does not apply to on-farm packing or holding of food by a very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are the listed low-risk packing or holding activity/food combinations. Likewise, we have revised proposed Sec. 117.5(h) to specify that Sec. 117.201 does 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/processing activity/food combinations. With these changes, a farm mixed-type facility that is a very small business and that only conducts the low-risk activity/food combinations listed in Sec. 117.5(g) and/or (h) may find it advantageous to classify itself as a very small business eligible for the exemption in Sec. 117.5(g) and/or (h) rather than as a qualified facility, which would be subject to the modified requirements in Sec. 117.201. (Comment 203) Some comments ask us to list activity/food combinations that are not low-risk activity/food combinations, or that should have modified requirement rather than be exempt (e.g., if the foods have been the subject of Class I recalls or outbreaks of foodborne illness). (Response 203) We decline this request. With few exceptions, the exemptions are established by specifying the activities that are not subject to the requirements for hazard analysis and risk-based preventive controls, rather than the activities that are subject to these requirements. When an exemption does specify activities that are subject to certain requirements of the rule, the specified activities are a narrow exception (see Sec. 117.5(k)). In the case of the exemptions for the low-risk activity/food combinations listed in Sec. 117.5(g) and (h), the activity/food combinations that are subject to the requirements of subparts C and G are extensive and it is not feasible to identify and list all of them. In developing the low-risk activity/food combinations that are exempt from the requirements, we conducted a qualitative risk assessment (Ref. 4) that considered whether manufacturing, processing, packing, or holding activities conducted on a farm mixed-type facility had been implicated in food that has been the subject of a Class I recall or outbreak of foodborne illness. However, whether specific types of food had been the subject of a Class I recall or outbreak of foodborne illness was only one factor we considered. For example, we also considered factors that impact the frequency and levels of contamination of the food (Ref. 4). For additional discussion, see the section 103(c)(1)(C) RA (Ref. 4). (Comment 204) Some comments ask for a process to keep the list of low-risk activity/food combinations up to date, such as through guidance. (Response 204) We decline this request. The exemptions established in this rule are binding, whereas any list of additional activity/food combinations established in a guidance document would not be binding. We established the list of activity/food combinations included in these exemptions through an extensive public process, including a request for comments on the section 103(c)(1)(C) draft RA. From this time forward, the process available to a person who wishes us to consider an additional activity/food combination is to submit a citizen petition in accordance with 21 CFR 10.30. [[Page 55980]] 2. Proposed Sec. 117.5(g)--Exemption Applicable to On-Farm Low-Risk Packing or Holding Activity/Food Combinations Conducted by a Small or Very Small Business We proposed that subpart C would not apply to on-farm packing or holding of food by a small or very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are low-risk packing or holding activity/food combinations on food not grown, raised, or consumed on that farm mixed- type facility or another farm or farm mixed-type facility under the same ownership. As a consequential change in light of the final ``farm'' definition, the final exemption no longer identifies any packing or holding activities for any RACs (whether the farm's own RACs or others' RACs), because an on-farm establishment would no longer be subject to the requirements for hazard analysis and risk-based preventive controls when it packs or holds RACs, regardless of whether it is packing and holding its own RACs or others' RACs. (Comment 205) Some comments ask us to expand the list of on-farm low-risk packing and holding activities to include packing and holding of food products not expressly covered by the proposed exemption. See the food products listed in table 13 and table 14. (Response 205) We considered these comments within the context of the section 103(c)(1)(C) RA. Table 1 in the section 103(c)(1)(C) draft RA listed activity/food combinations that we identified as likely to be conducted by farm mixed-type facilities using broad food categories such as ``grain'' and ``grain products.'' In light of comments such as those described in Comment 205, table 1 in the final section 103(c)(1)(C) RA lists more types of food categories. The purpose of listing more types of food categories was to make it clearer when a particular food is encompassed within a particular activity/food combination. As one example, table 1 in the final section 103(c)(1)(C) RA lists food categories such as baked goods, milled grain products, and other grain products (e.g. dried pasta), in place of the original category ``grain products.'' As another example, table 1 in the section 103(c)(1)(C) RA lists the broad term ``sap'' and provides examples of different types of sap to make clear that activity/food combinations regarding sap are broader than ``maple sap.'' We have revised the final exemption to list food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA and include those packing and holding activity/food combinations that the section 103(c)(1)(C) RA determines to be low- risk. For additional details about the outcome of the section 103(c)(1)(C) RA on the specific activity/food combinations described in the comments, see the section 103(c)(1)(C) RA (Ref. 4). We also revised the proposed exemption to add two sets of information that we believe will be useful to a farm mixed-type facility when evaluating whether the farm's packing activities satisfy the criteria for the exemption. First, we have added a new provision (Sec. 117.5(g)((1)) explaining that the exemption in Sec. 117.5(g) applies to packing or holding of processed foods on a farm mixed-type facility, except for processed foods produced by drying/dehydrating RACs to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), the packing and holding of which are within the ``farm'' definition in Sec. 1.227. Activities that are within the ``farm'' definition, when conducted on a farm mixed-type facility, are not subject to the requirements of subparts C and G of this part and therefore do not need to be specified in the exemption. Second, we have added a provision (Sec. 117.5(g)((2)) describing the food categories listed in the exemption. For example, this provision explains that ``milled grain products'' include processed food products such as flour, bran, and cornmeal. The first column in table 13 lists the food or food category that comments ask us to include in the exemption for on-farm, low-risk packing and holding activities. The second column lists the regulatory citation for the relevant exemption for on-farm packing and holding. Importantly, the full regulatory text of the exemption includes some limitations that were not specified in the comments, and table 13 should not be viewed as equating the requests of the comments with the final regulatory text of the exemption. For example, Sec. 117.5(g)(2)(ix) specifies that the food category ``baked goods'' includes processed food products such as breads, brownies, cakes, cookies, and crackers, but does not include products that require time/ temperature control for safety (such as cream-filled pastries). See Sec. 117.5(g)(2) for a description of those food categories listed in the exemption for on-farm, low-risk packing and holding activity/food combinations in table 13. Table 13--Requested Food or Food Category and Relevant Exemption for On- Farm Low-Risk Packing and Holding Activities ------------------------------------------------------------------------ Food or food category requested in the comments Relevant regulatory section ------------------------------------------------------------------------ Barley malt syrup........... Sec. 117.5(g)(3)(xix)--Sugar. Barley malt extract......... Sec. 117.5(g)(3)(xx)--Syrups. Other concentrated grain Sec. 117.5(g)(3)(xxii)-- malt products in liquid or powder Vinegar. form. Sec. 117.5(g)(3)(xxiii)--Any other processed food that does not require time/temperature control for safety. Birch sap and syrup......... Sec. 117.5(g)(3)(xix)--Sugar. Cane syrup.................. Sec. 117.5(g)(3)(xx)--Syrups. Coconut sap and sugar....... Date sugar.................. Palm sap and sugar.......... Sorghum juice and syrup..... Other concentrated natural sweetener having a water activity lower than 0.85 and made with an adequate microbial reduction step. Chips................................ Sec. 117.5(g)(3)(xiii)--Other fruit and vegetable products. Crackers.................... Sec. 117.5(g)(3)(i)--Baked goods. Bread crumbs................ Dry bread................... [[Page 55981]] Crude ``dietary ingredient Sec. 117.5(g)(3)(xiii)--Other botanicals'' in cut, chopped, or fruit and vegetable products. powdered form. Sec. 117.5(g)(3)(xv) Other herb and spice products. Dried cereal................ Sec. 117.5(g)(3)(xiv)--Other grain products. Dried pasta................. Dried herbs and spices, chopped or Sec. 117.5(g)(3)(xv)--Other ground. herb and spice products. Dry legume products (e.g., chickpea Sec. 117.5(g)(3)(xiii)--Other flour). fruit and vegetable products. Dry, unsulfited, fruits and Sec. 117.5(g)(3)(xiii)--Other vegetables in cut, chopped, sliced, fruit and vegetable products. shredded, or other form. Gums and resins...................... Sec. 117.5(g)(3)(vii)--Gums, latexes, and resins that are processed foods. Herbal extracts (e.g., in solvents Sec. 117.5(g)(3)(xv)--Other such as glycerin, alcohol and oil). herb and spice products. Honey infused with dried Sec. 117.5(g)(3)(xv)--Other herbs or spices. herb and spice products. Oil and/or vinegar infused with dried herbs or spices. Jerky................................ Sec. 117.5(g)(3)(vi)--Game meat jerky. Molasses and treacle................. Sec. 117.5(g)(3)(xi)--Molasses and treacle. Potato starch........................ Sec. 117.5(g)(3)(xiii)--Other fruit and vegetable products. Popcorn.............................. Sec. 117.5(g)(3)(xiv)--Other grain products. Salt, baking powder.................. Sec. 117.5(g)(3)(xxiii)--Any other processed food that does not require time/temperature control for safety. Vitamins, minerals, and processed Sec. 117.5(g)(3)(xxiii)--Any dietary ingredients (e.g., bone other processed food that does meal) in powdered, granular, or not require time/temperature other solid form. control for safety. ------------------------------------------------------------------------ In table 14, we list those foods or food categories, requested by comments, that are not included in the exemption for on-farm, low-risk packing and holding activities, and explain why. Table 14--Why Certain Requested Food Categories Are Not Included in the Exemption for On-Farm Low-Risk Packing and Holding Activities ------------------------------------------------------------------------ Food or food group requested in the Why the food or food group is not comments listed in the exemption ------------------------------------------------------------------------ Barley malt and other grain malts.... Malting increases the potential for a hazard, e.g., growth of microbial pathogens such as Salmonella, during the germination process. (However, the risk is mitigated when malting is done in conjunction with making sugar, syrups or vinegar.) Crude ``dietary ingredient These are RACs, so packing and botanicals'' in whole, form. holding them is within the farm definition. Dates (RACs)......................... These are RACs, so packing and holding them is within the farm definition Dried intact herbs and spices........ Although these are processed foods, packing and holding them is specifically included within the farm definition. Dried legumes........................ Although these are processed foods, packing and holding them is specifically included within the farm definition. Gums, resins, and exudates in solid, Gums, resins and exudates powdered, granular, or paste form. (including latexes such as chicle) are RACs, so packing and holding them is within the ``farm'' definition. These products are made into processed foods in some cases, such as by boiling or cutting. The powdered, granular and paste forms from further processing are considered in the risk assessment as ``any other processed food that does not require time/temperature control for safety.'' ------------------------------------------------------------------------ 3. Proposed Sec. 117.5(h)--Exemption Applicable to On-Farm Low-Risk Manufacturing/Processing Activity/Food Combinations Conducted by a Small or Very Small Business We proposed that subpart C would not apply to on-farm low-risk manufacturing/processing activities conducted by a small or very small business if the only manufacturing/processing activities subject to section 418 of the FD&C Act that the business conducts are those listed in the proposed exemption. The proposed exemption specified those activity/food combinations that would be exempt when conducted on a farm mixed-type facility's own RACs and those activity/food combinations that would be exempt when conducted on food other than the farm mixed-type facility's own RACs for distribution into commerce. As a consequential change in light of the final ``farm'' definition, the final exemption no longer distinguishes between manufacturing/processing activities conducted on a farm mixed-type facility's own RACs and manufacturing/processing activities conducted on food other than the farm mixed-type facility's own RACs. As another consequential change, the exemption has been revised to eliminate activities, conducted on others' RACs, which no longer are classified as manufacturing/processing and instead are classified as harvesting, packing, or holding. In addition, as discussed in Response 205 we have revised the final exemption to list food categories consistent with the food categories included in table 1 in the section 103(c)(1)(C) RA. We also revised the proposed exemption to add two sets of information that we believe will be useful to a farm mixed-type facility when evaluating whether the farm's manufacturing/processing activities satisfy the criteria for the exemption. [[Page 55982]] First, we have added a new provision (Sec. 117.5(h)((1)) explaining that the exemption in Sec. 117.5(h) applies to manufacturing/processing of foods on a farm mixed-type facility, except for manufacturing/processing that is within the ``farm'' definition in Sec. 1.227. Drying/dehydrating RACs to create a distinct commodity (such as drying/dehydrating grapes to produce raisins, and drying/ dehydrating fresh herbs to produce dried herbs), and packaging and labeling such commodities, without additional manufacturing/processing (such as chopping and slicing), are within the ``farm'' definition in Sec. 1.227. In addition, treatment to manipulate the ripening of RACs (such as by treating produce with ethylene gas), and packaging and labeling the treated RACs, without additional manufacturing/processing, is within the ``farm'' definition. In addition, coating intact fruits and vegetables with wax, oil, or resin used for the purpose of storage or transportation is within the ``farm'' definition. Activities that are within the ``farm'' definition, when conducted on a farm mixed-type facility, are not subject to the requirements of subparts C and G of this part and therefore do not need to be specified in the exemption. Second, we have added a provision (Sec. 117.5(h)((2)) specifying that Sec. 117.5(g)(2) describes the food categories listed in the exemption. (Comment 206) Some comments ask us to include in the exemption a single list of low-risk manufacturing/processing activity/food combinations applicable to farm mixed-type facilities conducting activities on their own RACs and farm mixed-type facilities conducting activities on other's RACs. (Response 206) These comments no longer apply. As a consequence of the ``farm'' definition established by this rule, the exemption no longer distinguishes between manufacturing/processing activities conducted on a farm mixed-type facility's own RACs and manufacturing/ processing activities conducted on food other than the farm mixed-type facility's own RACs. (Comment 207) Some comments ask us to include additional activity/ food combinations in the exemption. See table 15 and table 16 for a list of the requested additional activity/food combinations. (Response 207) We evaluated each of the requested activity/food combinations within the qualitative risk assessment (Ref. 4), unless the activity/food combination was out of scope of this rule (for example, if the requested activity/food combination was directed to animal food rather than human food). See table 15 and table 16 for the outcome of our evaluation of these requests, based on the findings of the section 103(c)(1)(C) RA as to whether the requested activity/food combination satisfies the criteria in that risk assessment for a low- risk activity/food combination. When we determined through the section 103(c)(1)(C) RA that the requested activity/food combination did not satisfy the criteria for a low-risk activity/food combination, table 16 explains why. See Sec. 117.5(g)(2) for a description of the food categories listed in the exemption for on-farm, low-risk manufacturing/ processing activity/food combinations in table 15 and table 16. The first column in table 15 lists the activity/food combination that comments ask us to include in the exemption for on-farm, low-risk manufacturing/processing activity/food combinations. The second column lists the regulatory citation for the relevant exemption for an on-farm manufacturing/processing activity/food combination. Importantly, the full regulatory text of the exemption includes some limitations that were not specified in the comments, and table 15 should not be viewed as equating the requests of the comments with the final regulatory text of the exemption. For example, Sec. 117.5(g)(2)(ix) specifies that the food category ``baked goods'' includes processed food products such as breads, brownies, cakes, cookies, and crackers, but does not include products that require time/temperature control for safety (such as cream-filled pastries). Table 15--Requested Activity/Food Combinations and Relevant Exemption for On-Farm Low-Risk Manufacturing/Processing Activities ------------------------------------------------------------------------ Activity/food combination requested in Regulatory section listing the the comments exemption ------------------------------------------------------------------------ Baking activities involving grain Sec. 117.5(h)(3)(ix)--Making products. baked goods from milled grain products (e.g., breads and cookies). Chopping, coring, cutting, peeling, Sec. 117.5(h)(3)(ii)-- pitting, shredding, and slicing.. Chopping, coring, cutting, Crackers, dry bread, bread peeling, pitting, shredding, crumbs. and slicing: Dry cereal, popcorn........... Baked goods Gums, resins and exudates..... Other grain products Jerky......................... Gums/latexes/resins Game meat jerky. Cooking low-moisture foods with dry Sec. 117.5(h)(3)(xxv)-- heat. Roasting and toasting baked goods. Drying/dehydrating cut fruits and Sec. 117.5(h)(3)(iv)--Drying/ vegetables that are immediately moved dehydrating (that includes into a drying process. additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2, and other herb and spice products (e.g., chopped fresh herbs, including tea). Distilling mint............... Sec. 117.5(h)(3)(v)-- Extracting virgin olive oil... Extracting (including by Extracting oils from seeds pressing, by distilling, and (e.g., sunflower seeds, flax seeds). by solvent extraction) from: Making liquid botanical Dried/dehydrated herb extracts from dry botanical raw and spice products material with solvents such as Fresh herbs glycerin, ethanol, vinegar, honey. Fruits and vegetables Grains Other herb and spice products. Grinding/milling/cracking/crushing:.... Sec. 117.5(h)(3)(vii)-- Crackers, dry bread, bread Grinding/milling/cracking/ crumbs. crushing: Dry cereal, dry pasta, popcorn Baked goods Dry legumes................... Other grain products Dried/dehydrated fruit and vegetable products. Mixing................................. Sec. 117.5(h)(3)(xxii)-- Honey infused with dried herbs Mixing other herb and spice or spices. products. Oil and/or vinegar infused with dried herbs or spices. Making maple cream, maple sugar, and Sec. 117.5(h)(3)(x)--Making molded maple candy. candy. [[Page 55983]] Making molasses and treacle from Sec. 117.5(h)(3)(xiv)--Making sugarcane and sugar beets. molasses and treacle. Making apple syrup............ Sec. 117.5(h)(3)(xix)--Making Making syrups from sorghum, sugar and syrup from: rice. Fruits and vegetables Making syrups from malted Grains barley. Other grain products Making syrups such as birch Saps. and walnut syrup. Making vinegar, including infused and Sec. 117.5(h)(3)(xxi)--Making flavored vinegars. vinegar from fruits and vegetables, other fruit and vegetable products, and other grain products. Sec. 117.5(h)(3)(xxii)-- Mixing other herb and spice products. Processing tea......................... Sec. 117.5(h)(3)(iv)--Drying/ dehydrating (that includes additional manufacturing or is performed on processed foods) other fruit and vegetable products with pH less than 4.2, and other herb and spice products (e.g., chopped fresh herbs, including tea). ------------------------------------------------------------------------ Table 16--Why Certain Requested Activity/Food Combinations Are Not Included in the Exemption for On-Farm Low-Risk Manufacturing/Processing Activities ------------------------------------------------------------------------ Food or food group requested in the Why the food or food group is comments not listed in the exemption ------------------------------------------------------------------------ Acidifying, pickling, and fermenting Acidifying, pickling, and low-acid fruits and vegetables made in fermenting activities control compliance with CGMPs. microbial hazards and, thus, are not low-risk activities. Cucumbers, garlic scapes, peppers, and The production of low-acid other low-acid foods that are processed foods must control preserved. the microbial hazard C. botulinum and, thus, is not a low-risk activity. Drying/dehydrating tea leaves (e.g., by Drying/dehydrating tea leaves withering). is within the ``farm'' definition. Fermentation of vegetables............. Fermenting activities control microbial hazards and, thus, are not low-risk activities. Food processing conducted in compliance It is the risk associated with with relevant State regulation. the activity/food combination, not the regulatory oversight by a State, that is relevant of this exemption. Freezing fruit juices.................. Fruit juices are outside the scope of the RA based on the statutory framework of FSMA. Low-acid fruits and vegetables The production of low-acid manufactured in compliance with CGMPs processed foods must control under the FD&C Act. the microbial hazard C. botulinum and, thus, is not a low-risk activity. Making pickles and salsa............... The processes for making pickles and salsa must control microbial hazards and, thus, are not low-risk activities. Roasting grains for animal feed........ This activity involves the production of animal food, which is subject to the animal preventive controls rule rather than the human preventive controls rule. ------------------------------------------------------------------------ H. Proposed Sec. 117.5(i)--Exemptions Related to Alcoholic Beverages Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities) provides a rule of construction for certain facilities engaged in the manufacturing, processing, packing, or holding of alcoholic beverages and other food. In the proposed human preventive controls rule, we discussed our interpretation of section 116 of FSMA and requested comment on our interpretation. Based on our interpretation, we proposed that subpart C would not apply with respect to alcoholic beverages at facilities meeting two specified conditions (78 FR 3646 at 3707 to 3709). We also proposed that subpart C would not apply with respect to food other than alcoholic beverages at facilities described in the exemption, provided such food is in prepackaged form that prevents direct human contact with the food and constitutes not more than 5 percent of the overall sales of the facility. (Comment 208) Some comments ask us to include the production of spent grains, distillers' grains, grape pomace, and other by-products of the manufacturing process within the alcohol exemption. These comments argue that the mere act of separating and disposing of those by-products by sale or otherwise should not trigger an obligation to meet the requirements of subpart C. (Response 208) The exemption established under the rule of construction in section 116 of FSMA applies to alcoholic beverages, not to any other food (see section 116(c) of FSMA (21 U.S.C. 2206(c)), and we have revised the exemption to make the statutory applicability clearer (see table 52 and the regulatory text of Sec. 117.5(i)). As previously discussed (79 FR 58524 at 58558), the by-products described in these comments appear to be products that would be used in food for animals rather than in human food, and we addressed these by-products in the 2014 supplemental animal preventive controls notice (79 FR 58476 at 58487-58489). (See also the discussion in section L regarding the specific CGMP provisions that will apply to these foods.) I. Proposed Sec. 117.5(j)--Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and Vegetables Intended for Further Distribution or Processing We proposed that subpart C would not apply to facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. In the following paragraphs, we discuss comments that ask us to clarify how the proposed exemption would apply to specific circumstances. (Comment 209) Some comments ask whether this proposed exemption (proposed Sec. 117.5(j)) would apply to facilities such as peanut buying points or bean elevators and assert that such [[Page 55984]] commodities are analogous to grains and the activities conducted at such facilities are analogous to those performed by grain elevators. (Response 209) We classify peanuts and beans (such as kidney beans, lima beans, and pinto beans) within the category of ``fruits and vegetables''; we classify soybeans as grain (see the discussion of fruits and vegetables, 78 FR 3646 at 3690 and proposed Sec. Sec. 112.1 and 112.2 in the proposed produce safety rule). The exemption for facilities solely engaged in storage of RACs intended for further distribution or processing does not apply to facilities that store fruit and vegetable RACs and, thus, does not apply to facilities such as peanut buying points and bean elevators. As discussed in Response 25, we have revised the ``farm'' definition to provide that an operation devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs is within the ``farm'' definition as a secondary activities farm, 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. With this revision, some operations dedicated to holding RACs, including fruit and vegetable RACs, will be within the ``farm'' definition. Peanut buying points and bean elevators that do not meet the revised farm definition are storing RACs that are ``fruits and vegetables'' and do not meet the criteria for exemption under Sec. 117.5(j). However, we would not expect such facilities to need an extensive food safety plan. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. (Comment 210) Some comments refer to our statement that there would not be significant public health benefit to be gained by subjecting facilities that solely store non-fruit and vegetable RACs intended for further distribution or processing to the requirements of subpart C (78 FR 3646 at 3709) and assert that the same conclusion applies to those portions of oilseed processing facilities that are devoted solely to RAC storage. According to these comments, in the overwhelming majority of cases the inclusion of a separate RAC storage area in the same building as the oilseed processing area will not introduce additional risk either to the processing area or to the operations that take place there and that storage areas, whether standing alone as a separate facility or incorporated into a larger processing facility, store RACs safely. These comments ask us to recognize that storage activities may include grain drying to standardize moisture levels and preserve product quality. These comments also ask us to expand the exemption in Sec. 117.5(j) to also apply to distinct and physically separate storage areas that are used solely for storage of RACs (other than fruits and vegetables) intended for further distribution or processing. (Response 210) The activities included within the definition of holding include activities that are performed as a practical necessity for the distribution of RACs. In the 2014 supplemental human preventive controls notice, we explained that facilities that conduct operations similar to those conducted at grain elevators and silos, such as some facilities that hold oilseeds, may satisfy the criteria for exemption if activities other than storage are performed as a practical necessity for the distribution of RACs (see 79 FR 58524 at 58537 and the definition of ``holding'' in Sec. 117.3). Examples of holding activities include drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (see Sec. 117.3). Thus, the specific example of drying grains to standardize moisture levels and preserve product quality would fall within the definition of holding as a practical necessity for the distribution of RACs. A facility that stores oilseeds, and dries them as a practical necessity for the distribution of RACs, would be covered by the exemption in Sec. 117.5(j). However, we decline the request to modify the exemption in Sec. 117.5(j) to also apply to distinct and physically separate storage areas that are used solely for storage of RACs (other than fruits and vegetables) intended for further distribution or processing. To the extent that the comments are asking us to do so to provide for facilities that conduct activities as a practical necessity for the distribution of RACs to be eligible for the exemption, doing so is not necessary in light of the definition of holding. To the extent that the comments are asking us to do so to provide for facilities that conduct manufacturing/processing activities in addition to holding activities, we disagree that doing so would be consistent with the statutory direction in FSMA. As previously discussed, section 418(m) of the FD&C Act provides in relevant part that we may by regulation exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (78 FR 3646 at 3709). The plain meaning of ``solely'' is only, completely, entirely; without another or others; singly; alone (Ref. 44). Facilities that conduct manufacturing/ processing activities in addition to holding activities are not ``solely'' engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. See also Response 233 regarding a similar request regarding the applicability of the requirements for hazard analysis and risk-based preventive controls to a facility solely engaged in the storage of unexposed packaged food. J. Proposed Sec. 117.5(k)--Exemption Applicable to Farms, Fishing Vessels, Activities of ``Farm Mixed-Type Facilities'' Within the Definition of ``Farm,'' the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities We proposed to redesignate Sec. 110.19(a) as proposed Sec. 117.5(k) and revise the exemption that had been in Sec. 110.19(a) to provide that subpart B would not apply to: (1) Farms; (2) fishing vessels that are not required to register as a food facility; (3) the holding or transportation of one or more RACs; (4) activities of ``farm mixed-type facilities'' that fall within the definition of ``farm''; and (5) hulling, shelling, and drying nuts (without manufacturing/ processing, such as roasting nuts). (Comment 211) Some comments ask us to clarify whether the proposed exemption for the holding or transportation of one or more RACs (proposed Sec. 117.5(k)) would apply to any food establishment, or only apply to farms and farm mixed-type facilities. (Response 211) The exemption applies to any food establishment. (Comment 212) Some comments ask us to clarify that CGMP requirements (such as requirements for the plant design to permit the taking of adequate precautions to protect food in outdoor bulk vessels (Sec. 117.20(b)(3)) and requirements for warehousing and distribution (Sec. 117.93) do not apply to the bulk outdoor storage of RACs for further processing. (Response 212) We are returning to the long-standing approach that the exemption applies to establishments ``solely engaged'' in specific activities. Under the exemption we are [[Page 55985]] establishing in Sec. 117.5(k)(1)(iii), those activities are holding and/or transportation of RACs. Under the exemption we are establishing in Sec. 117.5(k)(1)(v), those activities are hulling, shelling, drying, packing, and/or holding nuts. We explain why in the following paragraphs. These comments appear to interpret the proposed exemption in a way that goes beyond the long-standing ``RAC exemption'' in Sec. 110.19 and is inconsistent with our intent in updating Sec. 110.19 to adjust and clarify what activities fall within this exemption based on experience and changes in related areas of the law since issuance of this exemption from the CGMPs (78 FR 3646 at 3710). The suggestion of these comments--i.e., that CGMPs should not apply to the holding of RACS in a facility that manufactures, processes, or packs RACs-would not make sense in some circumstances and would create difficulties for establishments (in determining how to comply with the CGMP requirements) and for regulators (in determining how to enforce the CGMP requirements). For example, it does not make sense for the part of a facility that holds RACs prior to processing to be exempt and the parts of the facility that are processing the RACs and storing them after processing to be covered. Likewise, it does not make sense for part of a transportation vehicle to be covered and part to be exempt. By revising these two proposed exemptions that derive from the ``RAC exemption'' so that they apply only to establishments ``solely engaged'' in the storage and/or transportation of RACs, and to establishments ``solely engaged'' in the hulling, shelling, drying, packing, and/or holding of nuts, we are providing for a predictable framework for interpreting exemptions for facilities ``solely engaged'' in other activities. For example, as discussed in Comment 209, comments ask us to expand the exemption (in Sec. 117.5(j)) from the requirements for hazard analysis and risk-based preventive controls for facilities that are ``solely engaged'' in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing to also apply to distinct and physically separate storage areas that are used solely for storage of such RACs. In our response, we noted that facilities that conduct manufacturing/processing activities in addition to holding activities are not ``solely engaged'' in the storage of such RACs (see Response 209). In addition, as discussed in Comment 233, comments ask us to apply the exemption (in Sec. 117.7) from the requirements for hazard analysis and risk-based preventive controls for facilities that are ``solely engaged'' in the storage of unexposed packaged food to storage areas of facilities that also engage in food processing activities--e.g., for distributors that are engaged in limited food processing, such as cutting vegetables or packing ready-to-eat foods. In our response, we noted that such distributors are not ``solely'' engaged in the storage of unexposed packaged food (see Response 233). The questions raised by these comments led us to reexamine the reasons we gave, in the 2013 proposed human preventive controls rule and the 2014 supplemental human preventive controls notice, for describing these exemption in terms of the activities conducted without specifying that the establishment is ``solely engaged'' in conducting these activities. For example, in the 2013 proposed human preventive controls rule we explained our assumption that if activities subject to the CGMPs take place in the same establishment, compliance with the CGMPs with respect to those activities should provide necessary protection. The comments led us to question that assumption. For example, with respect to the question posed by the comments about the outdoor bulk storage of RACs for further processing, it is not clear how conducting subsequent activities on the RACs in accordance with the CGMP requirements would protect the RACs during outdoor bulk storage. As discussed more fully in Response 660, processing fresh produce into fresh-cut products increases the risk of bacterial growth and contamination. RACs stored in bulk outdoors before being processed into fresh-cut produce must be stored in clean containers or vessels such that these do not contribute to contamination of the produce before it is processed. In addition, as already noted in this response, in interpreting the exemptions from subparts C and G for facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (Sec. 117.5(j)) and for facilities solely engaged in the storage of unexposed packaged food (Sec. 117.7), we do not consider that the exemption for these ``holding'' activities applies when holding is part of other operations conducted by the facility. For example, the exemption in Sec. 117.7 would not apply to a packaged food warehouse of a processing facility, even if the warehouse only stores unexposed packaged food. In the 2013 proposed human preventive controls rule we tentatively concluded that it would be reasonable to revise the RAC exemption in Sec. 110.19 so that it would exempt the specifically identified activities when performed on RACs, regardless of whether the establishment that conducts those activities also conducts other activities that do not qualify for the exemption, in part because the exemptions in section 418(j)(1) applied to ``activities'' (i.e., covered by parts 120, 123, and 113) (see 78 FR 3646 at 3710). However, section 418(j)(1) is premised on the existence of similar mandatory requirements for those specific foods. In contrast, there are no requirements similar to subpart B in some situations that would be exempt under an exemption broadly directed to the activities of holding and transportation. For example, there would be no other requirements similar to subpart B (e.g., for pest control) applicable to an off-farm establishment that stores apples in a controlled atmosphere storage facility or to an establishment that stores harvested dry beans. We now believe that a better comparison is to other exemptions in FSMA, such as the exemption in section 103(c)(1)(D)(i) of FSMA for facilities engaged only in specific types of on-farm manufacturing, processing, packing or holding activities, and the exemption in section 418(m) of the FD&C Act for facilities solely engaged in storage of RACs (other than fruits and vegetables) intended for further distribution or processing. It is reasonable to infer that one reason for the use of ``solely'' in the statutory provisions in section 103(c)(1)(D)(i) of FSMA and in section 418(m) of the FD&C Act is to avoid some of the problems we have discussed in this response. In the 2013 proposed human preventive controls rule, we stated our belief that activities should be regulated the same way regardless of whether activities subject to the CGMP requirements take place in same establishment. However, as with the exemptions in section 103(c)(1)(D)(i) of FSMA and section 418(m) of the FD&C Act, this is a situation where context matters. RACs that are the sole food in a warehouse are different from RACs being held in a manufacturing operation. As already noted in this response and as discussed more fully in Response 660, processing fresh produce into fresh-cut products increases the risk of bacterial growth and contamination, and produce being stored before processing into fresh-cut produce must be protected against contamination while being stored. The exemptions we are establishing in this rule for establishments solely engaged in the storage and/or [[Page 55986]] transportation of RACs, and for establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing, such as roasting nuts), remain consistent with our announced intent to adjust and clarify what activities fall within this exemption based, in part, on changes in related areas of the law since this exemption from the CGMP requirements was first issued. As discussed in section IV, we have made a number of changes to the ``farm'' definition, including changes that provide for an operation devoted to harvesting, packing, and/or holding of RACs to be a ``farm'' (i.e., a ``secondary activities farm'') (and, thus, be exempt from the CGMP requirements under Sec. 117.5(k)(1)(i)) even though the operation does not grow RACs (see Sec. 117.3). With this revised ``farm'' definition, some establishments that had relied on the ``RAC exemption'' in Sec. 110.19 to be exempt from CGMP requirements as establishments solely engaged in the ``storage'' of RACs, or because they were solely engaged in the harvesting (such as hulling and shelling) and storage (which includes drying) of nuts, will be exempt from the CGMP requirements because they are a ``farm.'' As a result, there are fewer operations that need to rely on exemptions that are an outgrowth of the long-standing RAC exemption in Sec. 110.19. K. Comments Requesting Additional Exemptions 1. Introduction (Comment 213) We received comments requesting several additional exemptions from the requirements for hazard analysis and risk-based preventive controls in subpart C, the CGMP requirements of subpart B, or both. See the remainder of section XI.K for a description of the specific requests. (Response 213) Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to recent estimates from the Centers for Disease Control and Prevention (CDC) (Ref. 45). This is a significant public health burden that is largely preventable. We believe that improvements to our CGMP regulations, coupled with implementation of FSMA's directives to focus more on preventing food safety problems than on reacting to problems after they occur, can play an important role in reducing foodborne illness (other than foodborne illnesses that are the result of improper food handling practices in the home and food service settings, which would not be addressed by this rule). We did not propose any exemptions or exceptions from the requirements of subpart C other than those contained in section 103 of FSMA (78 FR 3646 at 3657). Likewise, we did not propose any additional exemptions from the CGMP requirements other than to adjust and clarify what activities fall within a long-standing exemption related to RACs based on experience and changes in related areas of the law since issuance of the CGMP regulation (78 FR 3646 at 3709-3711). In the remainder of section XI.K, we respond to the specific requests for additional exemptions from the requirements of subparts C and G for hazard analysis and risk-based preventive controls. None of these specific requests describe (or otherwise provide) evidence demonstrating that the regulatory framework associated with the request would address all of the requirements of subparts C and G. Therefore, we have declined all of these requests. In some cases, a facility that is subject to other Federal, State, or local regulations that have some of the same requirements as subparts C and G will not have to repeat the same activity and will be able to use any existing records to demonstrate compliance and supplement those actions and records as necessary to demonstrate compliance with the remaining requirements of subparts C and G (see, e.g., 79 FR 58524 at 58542, Response 215, Response 216, Response 219, and the discussion of Sec. 117.330 in section XLI.G). In one case (for facilities subject to the PMO; see Response 214), we have extended the date for compliance with the requirements of subparts C and G in light of comments expressing an intent to revise the current requirements of a Federal/State cooperative program to incorporate the requirements of this rule. In other cases, a facility may determine and document through its hazard analysis that no preventive controls are necessary to prevent its food products from being adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act (see, e.g., Response 222, Response 226, Response 229, and the discussion of Sec. 117.130 in section XXV). Such facilities, although not exempt, will have a reduced burden to comply with the rule, if the outcome of their hazard analysis is that there are no hazards requiring preventive controls. Likewise, in the remainder of section XI.K we respond to the specific requests for additional exemptions from the CGMP requirements of subpart B. None of these requests provide a basis for why the long- standing CGMP provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration should no longer apply to a particular type of food establishment and, thus, we have declined these requests. 2. Facilities That Comply With the Pasteurized Milk Ordinance (Comment 214) Some comments discuss facilities that comply with the Grade ``A'' PMO and are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system (PMO facilities). NCIMS has been part of a cooperative program among the U.S. Public Health Service/FDA, the States and the dairy industry since 1950. Procedures for Governing the Cooperative Program of the NCIMS include procedures establishing milk sanitation standards, rating procedures, sampling procedures, laboratory procedures, laboratory evaluation and sample collector procedures. As previously discussed (78 FR 3646 at 3662), the PMO is a model regulation published and recommended by the U.S. Public Health Service/FDA for voluntary adoption by State dairy regulatory agencies to regulate the production, processing, storage and distribution of Grade ``A'' milk and milk products to help prevent milkborne disease. Appendix K--HACCP Program of the PMO--describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. A milk plant, receiving station or transfer station may not participate in the voluntary NCIMS HACCP Program unless the regulatory agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Currently all 50 States, the District of Columbia, and Puerto Rico have adopted the PMO by reference or have codified the PMO or similar provisions in State regulations. At its biennial conferences, the NCIMS considers changes and modifications to the Grade ``A'' PMO to further enhance the safety of Grade ``A'' milk and milk products, including the administrative and technical details on how to obtain satisfactory compliance. Changes ultimately accepted by NCIMS voting delegates (representatives from States and territories) are forwarded to FDA for concurrence before they become effective. Some comments recommend that we make full use of the existing milk safety system of State regulatory oversight for Grade ``A'' milk and milk products provided through the NCIMS and the food safety requirements of the PMO. Some comments assert that we are [[Page 55987]] exceeding our authority by requiring PMO-regulated facilities to comply with both the PMO and the requirements of FSMA for hazard analysis and risk-based preventive controls. Some comments ask us to exempt PMO-regulated facilities (or the PMO-regulated part of a PMO facility that also produces food products not covered by the PMO) from the requirements of the rule for hazard analysis and risk-based preventive controls, or to otherwise determine that facilities operating in compliance with the PMO are also in compliance with those requirements. These comments suggest we could, as an interim step if we find it necessary, stay the application of these requirements to PMO-regulated facilities and work with the NCIMS cooperative program to enact any modifications to the PMO as may be needed to warrant an exemption or comparability determination. The comments characterize these changes as ``minor.'' Some comments ask for clarification as to whether the human preventive controls rule would preempt the PMO if there are any conflicts or duplications between the human preventive controls rule and the PMO. Some comments ask us to explain our position concerning the interstate movement of milk and milk products and imported milk if the final rule does not recognize that PMO-regulated facilities are also in compliance with the requirements of the human preventive controls rule for hazard analysis and risk-based preventive controls. These comments ask: (1) Whether the final rule will become the de facto standard or the standard enforced by the FDA for the movement of milk in interstate commerce and for imported milk; (2) how the final rule will affect States that have adopted the PMO as their law/regulation for the production and processing of products such as fluid milk products and cottage cheese; and (3) how a final rule that does not recognize the PMO and the products made under the PMO will affect other Federal rules, policy, procedures, or practices that require compliance with the PMO. (Response 214) We agree that we should make use of the existing system of State regulatory oversight for Grade ``A'' milk and milk products provided through the NCIMS and the food safety requirements of the PMO. The NCIMS program has been effective from a regulatory standpoint, and has likely had a significant public health impact in reducing the incidence of foodborne illness attributable to milk and milk products. FDA is committed to the mission of the NCIMS and ensuring the continuance of an effective milk safety system with State regulatory oversight. However, the PMO does not address all of the requirements of subparts C and G, such as requirements relevant to the potential presence of environmental pathogens in the food processing environment (see, e.g., Sec. Sec. 117.130(c)(1)(ii) and 117.150(a)(1)(ii)(B)). Such provisions could help to prevent food safety problems from the consumption of food produced by PMO facilities and play an important role in reducing foodborne illness. For example, in 2007, contamination of a PMO-regulated facility with the environmental pathogen L. monocytogenes was the cause of three deaths via listeriosis (Ref. 46). As another example, there have been large- scale recalls as a result of contamination of dried milk with the environmental pathogen Salmonella (Ref. 47). In addition, the NCIMS HACCP Program is a voluntary program and, as of March 17, 2015, had been utilized by only 11 of approximately 625 PMO facilities (Ref. 48). Further, the current NCIMS HACCP Program does not address all of the requirements of subparts C and G, such as environmental monitoring as a verification of sanitation controls for environmental pathogens and a supply-chain program for non-dairy ingredients (Ref. 49). The PMO also does not address food allergen controls, which are appropriate for those Grade ``A'' facilities that also handle food containing allergens other than milk. The comments do not provide a basis for why we should exempt PMO facilities from the rule in light of the differences between the requirements of this rule and the requirements of the PMO. NCIMS has initiated work to modify the PMO and that work is expected to include all of the requirements in a final human preventive controls rule. FDA has committed resources to work with the appropriate NCIMS Committees to make the necessary changes. However, the NCIMS process will not be complete in time for PMO facilities to meet the first two compliance dates for this rule (i.e., September 19, 2016 for businesses other than small and very small businesses, and September 18, 2017 for small businesses), because the next scheduled Conference following the publication of this final rule would be April 2017. Therefore, to make use of the existing system of State regulatory oversight for Grade ``A'' milk and milk products provided through the NCIMS and the food safety requirements of the PMO, we are extending the compliance date for PMO-regulated facilities to comply with the requirements of subparts C and G to September 17, 2018. Doing so is consistent with the request of comments asking us to ``stay'' the application of the requirements for hazard analysis and risk-based preventive controls to PMO-regulated facilities and work with the NCIMS cooperative program to effect the necessary modifications to the PMO so that it will include all of the requirements in the human preventive controls rule. The extended compliance date is not equivalent to an exemption. Regardless of whether the PMO is modified to include the requirements of a final human preventive controls rule by the extended compliance date, PMO facilities must comply with the human preventive controls rule on September 17, 2018. The extended compliance date also is responsive to comments that identified complex implementation issues concerning the interstate movement of milk and milk products and imported milk. If the requirements of this rule for hazard analysis and risk-based preventive controls are incorporated into the PMO by the compliance date, such implementation issues will be moot, because a facility that complies with the revised PMO would also comply with this rule. As the compliance date approaches, it will be clearer as to whether any or all of the necessary revisions to the PMO will be in place by the compliance date for PMO facilities. If it appears that these revisions will not be in place by the compliance date for PMO facilities, we will take steps to address implementation issues specific to this Federal/ State cooperative program. In establishing a compliance date of September 17, 2018 for PMO facilities, we considered: (1) The extent of revisions that must be made to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO; (2) the process to revise the PMO; and (3) the date at which the necessary revisions to the PMO could begin to be made. We discuss each of these considerations in the following paragraphs. We disagree that the necessary revisions to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO are ``minor.'' There are gaps between the requirements of this rule and the current required and voluntary provisions of the PMO (Ref. 49), and gaps such as provisions directed to environmental [[Page 55988]] monitoring, supply-chain controls, and food allergen controls are not ``minor.'' With respect to process, NCIMS considers changes and modifications to the Grade ``A'' PMO at its biennial conferences, and proposals with the necessary changes must be voted on at such a biennial meeting. The next scheduled biennial conference is in the spring of 2017. Although it may be possible for NCIMS to convene a special conference in 2016 for the purpose of voting on proposals to revise the PMO to make it comply with the requirements of this rule, practicalities such as the availability of funds for a special conference could interfere with any plans for a special conference. In addition, given that we do not view the necessary changes as ``minor,'' it could take more than one round of proposals for revising the PMO before a proposal receives the votes necessary to be adopted. Because the provisions of this rule will not be established until the date of publication of this final rule, any preliminary drafts of proposals to modify the PMO (e.g., to incorporate the provisions that we proposed in the 2014 supplemental preventive controls notice) before today's date may need revision to reflect the final provisions of the rule. In light of all these considerations, we are establishing September 17, 2018 as the date for PMO facilities to comply with the requirements for hazard analysis and risk-based preventive controls in part 117, subparts C and G. The compliance date for PMO facilities to comply with the CGMP requirements of subpart B is also September 17, 2018, and PMO facilities will continue to comply with part 110 until that date. Under NCIMS procedures, changes agreed to by the voting delegates at the 2017 NCIMS conference (and to which FDA concurs) would be effective within one year of the electronic publication of the NCIMS documents; or by official notification by FDA to the States and the dairy industry of ``Actions from the 2017 NCIMS Conference;'' or by a previously determined effective date (e.g., September 17, 2018). We believe that the date of September 17, 2018 appropriately balances the need to realize the benefits of FSMA's requirements for hazard analysis and risk-based preventive controls with the practicalities associated with revising the PMO to incorporate the requirements of this rule. 3. Facilities That Have an Established HACCP Program (Comment 215) Some comments ask us to recognize operations that have an established HACCP Program implemented by a trained individual as meeting the requirements of the human preventive controls rule. Some of these comments note that the NCIMS HACCP Program describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. Other comments discuss the EU Dairy HACCP Program and assert that the preventive controls system mandated by FSMA is a HACCP-like system but is not as robust as the EU Dairy HACCP Program. Other comments ask us to support and recognize industry-driven, mandatory programs that afford the same level of public health protection as the human preventive controls rule. Other comments note that facilities such as pizza manufacturing facilities are ``dual jurisdiction'' facilities, regulated and inspected by both FDA and USDA's Food Safety and Inspection Service (FSIS). These comments assert that such facilities already are operating under FSIS-approved HACCP plans, and their HACCP plans cover FDA-regulated products, as well as FSIS-regulated products. These comments acknowledge that there are differences between FSIS' HACCP regulation and FDA's proposed requirements for hazard analysis and risk-based preventive controls but nonetheless assert that requiring dual jurisdiction facilities to operate under two different food safety plans would result in unnecessary duplication of effort and confusion. (Response 215) Whether a particular HACCP program implemented by a trained individual would satisfy the requirements of the human preventive controls rule will depend on whether the particular HACCP program satisfies all of the requirements of the rule. (See Response 213.) For operations that have implemented HACCP programs that are generally similar to the provisions of part 117, the burden of complying should be minimal in light of the provisions of Sec. 117.330, which provides for use of existing records. As an example, if a facility has an existing HACCP plan (or multiple HACCP plans for different types of foods), supported by certain prerequisite programs that include food safety controls, the facility would not need to duplicate or re-write its existing HACCP plans or prerequisite programs, as long as the existing HACCP plans and prerequisite programs contain all of the required information and satisfy the requirements of subpart F, or are supplemented as necessary to include all of the required information and satisfy the requirements of subpart F (see Sec. 117.330(a)). Because the rule also provides that the required information does not need to be kept in one set of records, a facility may supplement existing records associated with its HACCP plans and prerequisite programs with other required components of a food safety plan (such as recall plan and, when applicable, a supply-chain program and written verification procedures for environmental monitoring) (see Sec. 117.330(b)). Moreover, the rule provides additional flexibility for a facility that relies on both existing records and newly established records to keep the records either separately or combined (see Sec. 117.330(b)). The flexibility provided by the provisions for use of existing records also enables a facility to comply with the requirement (in Sec. 117.310) for the owner, operator, or agent in charge of a facility to sign and date the facility's food safety plan, even when components of the food safety plan are kept separately. For example, when the food safety plan consists of one or more existing HACCP plans, one or more prerequisite programs that include food safety controls, a recall plan, a written supply-chain program, written verification procedures such as environmental monitoring, and any other components required by the rule, one approach for signing and dating the food safety plan could be to collect all these documents in a single location (e.g., a binder or folder) with a cover page containing the signature of the owner, operator, or agent in charge of the facility and the date on which the cover page was signed. However, because the food safety plan also could be a set of documents kept in different locations within the facility, a facility could sign and date a list of the relevant documents (e.g., as in a Table of Contents). (See also the discussion in Response 369 that a food safety plan may be prepared as a set of documents kept in different locations within the facility (e.g., based on where they will be used)). 4. Facilities That Are Subject to Requirements for Acidified Foods (Comment 216) Some comments ask us to exempt (or partially exempt) facilities that produce acidified foods from the requirements of subpart C, because acidified foods are subject to the specific food safety regulation in part 114 (21 CFR part 114) in addition to the CGMP requirements in subpart B. If we do not do so, these comments ask us to clarify whether a scheduled process established for an acidified food would be accepted as a process that had been validated as a preventive control for a microbiological hazard. Some of these comments mention specific acidified food products, such as salsa. [[Page 55989]] Other comments ask us to withdraw part 114 and regulate acidified foods under part 117 to avoid confusion, and then consider acidification as a preventive control. (Response 216) We agree that the specific CGMP requirements already established in part 114 play a key role in the safe production of acidified foods, but disagree that it would be appropriate to exempt facilities that are subject to part 114 from the requirements of subparts C and G. As the comments suggest, the long-standing requirements of part 114 could function as a type of preventive control. However, part 114 does not address all of the requirements of subparts C and G, such as the requirement to address chemical and physical hazards. We also disagree that we should withdraw part 114 and simply consider acidification as a preventive control under subparts C and G. The long-standing requirements of part 114 provide many details that do not fit within the framework of this rule, and we do not believe that it is in the best interest of public health to simply eliminate those details. A processor of acidified foods can consider its current scheduled processes, established in accordance with part 114, when conducting the hazard analysis required by this rule (Sec. 117.130). A processor of acidified foods could, through its hazard analysis, determine and document that the microbiological hazards associated with its products are addressed by preventive controls in its scheduled processes established under part 114. To the extent that the processor considers an existing scheduled process to be a preventive control as that term is defined in this rule, the processor would establish and implement preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation)) as appropriate to ensure the effectiveness of that preventive control, taking into account the nature of the preventive control. Again, a processor of acidified foods can consider its current procedures, established in accordance with part 114, when determining what preventive control management components to establish and implement. For example, a facility that previously validated a scheduled process can rely on its existing validation records and would not need to repeat the validation or make a new record. Processes issued by a process authority for acidified foods are generally accepted as validated processes. As another example, a facility can consider its current procedures for complying with the requirements of part 114, including frequent pH testing and recording of results, to exercise sufficient control so that the finished equilibrium pH values for acidified foods are not higher than 4.6 (Sec. 114.80(a)(2)), and to address deviations from scheduled processes (Sec. 114.89). A facility that produces acidified foods could demonstrate compliance with the requirements of subparts C and G of this rule by relying on the records it is currently required to establish and maintain (Sec. 114.100), as applicable, supplemented as necessary (see Sec. 117.330). (Comment 217) Some comments ask whether a qualified facility with activities that are subject to part 114 (Acidified Foods) would be exempt from the requirements of Subpart C. (Response 217) A qualified facility is exempt from the requirements of subparts C and G, and instead subject to the modified requirements in Sec. 117.201, for all foods that it produces, including acidified foods. 5. Egg Facilities (Comment 218) Some comments ask us to exempt shell egg facilities that are also regulated by USDA and by State shell egg grading programs from the requirements of both subpart B and subpart C or at least recognize these establishments as meeting the requirements for subpart B and Subpart C without further routine FDA inspection. Some comments ask us to exempt shell egg establishments subject to part 118 (21 CFR part 118) (Production, Storage, And Transportation Of Shell Eggs) from the requirements of subpart C because part 118 already requires shell egg establishments to take specific, concrete, steps to prevent the hazard Salmonella from contaminating eggs on the farm and from further growth during storage and transportation. (Response 218) Shell eggs are RACs. The on-farm production of shell eggs is exempt from both the CGMP requirements in subpart B (see the exemption for farms in Sec. 117.5(k)(1)(i)) and from the requirements for hazard analysis and risk-based preventive controls in subparts C and G (because a ``farm'' is exempt from the requirement to register as a food facility). Likewise, the packing of shell eggs by egg packinghouses that are within the ``farm'' definition established during this rulemaking are exempt from both the CGMP requirements in subpart B and the requirements for hazard analysis and risk-based preventive controls in subparts C and G, (see Response 25). Establishments that are solely engaged in the holding or transportation of shell eggs are exempt from the CGMP requirements in subpart B (see the exemption for establishments solely engaged in the holding or transportation of one or more RACs in Sec. 117.5(k)(1)(iii)). Facilities that are required to register, but are solely engaged in the storage of shell eggs intended for further distribution or processing, are exempt from the requirements for hazard analysis and risk-based preventive controls in subparts C and G (see the exemption in Sec. 117.5(j)). Shell egg processing facilities that are regulated exclusively, throughout the entire facility, by USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) are exempt from the section 415 registration regulations and, thus, are not subject to the requirements of this rule for hazard analysis and risk-based preventive controls (subparts C and G). 6. Facilities That Produce Infant Formula (Comment 219) Some comments ask us to exempt the production of infant formula from the requirements of subpart C after we issue a final rule establishing requirements for CGMPs and quality control procedures for infant formula. (Response 219) We issued an interim final rule entitled ``Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' on February 10, 2014 (79 FR 7934) and a final rule (the infant formula rule) adopting, with some modifications, that interim final rule on June 10, 2014 (79 FR 33057). We agree that the requirements of the infant formula rule play a key role in the safe production of infant formula, but disagree that it would be appropriate to exempt facilities that are subject to the infant formula rule from the requirements of subparts C and G. The infant formula rule does not address all of the requirements of subparts C and G, such as requirements relevant to the potential presence of environmental pathogens in the food processing environment (see, e.g., Sec. Sec. 117.130(c)(1)(ii) and 117.150(a)(1)(ii)(B)). As with products such as acidified foods (see Response 216), a manufacturer of infant formula could demonstrate compliance with the requirements of subparts C and G of this rule by relying on the records it is currently required to establish and maintain (Sec. 106.100), as applicable, [[Page 55990]] supplemented as necessary (see Sec. 117.330). 7. Small Businesses (Comment 220) Some comments ask us to provide more exemptions for small farms and small facilities. (Response 220) We decline this request. As discussed in Response 213, the exemptions we are establishing are those provided by section 103 of FSMA. Small farm that only conduct activities within the ``farm'' definition are not subject to the human preventive controls rule. Small farms that also conduct activities outside the ``farm'' definition (such as manufacturing jams or jellies) (and, thus, are farm mixed-type facilities) are eligible for an exemption if the only such activities they conduct are the low-risk activity/food combinations specified in the exemptions in Sec. 117.5(g) and (h). Small farms that are subject to this rule as farm mixed-type facilities, and other small businesses, will have an extra year to comply with the rule. As discussed in Response 222, the new requirements for hazard analysis and risk-based preventive controls are flexible, and the preventive controls (if any) that a facility would establish and implement would depend on the outcome of the facility's hazard analysis and therefore would be tailored to the operation. These aspects of this rulemaking provide ample flexibility to small businesses. 8. Exemptions Based on Risk (Comment 221) Some comments ask us to exempt facilities identified as conducting low-risk activities from the CGMP requirements. (Response 221) We decline this request. The umbrella CGMPs that we are establishing in subpart B are long-standing provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration. For example, food that is exposed must be protected against contamination from the plant's grounds, the design and construction of the plant, and sanitary operations regardless of whether the uncontaminated food could be ``high-risk'' or ``low-risk''; contamination introduced during the production of food can adulterate any food. In addition, these umbrella CGMPs are not ``one-size-fits-all'' in that many provisions provide flexibility to tailor specific practices to the nature of the food and the activities being conducted. For example, many provisions establish a performance standard in which the measures taken must be ``adequate'' to comply with the rule, where adequate is defined as that which is needed to accomplish the intended purpose in keeping with good public health practice. As another example, provisions directed to raw materials require that they be washed or cleaned ``as necessary'' to remove soil or other contamination (see Sec. 117.80(b)(1)). Moreover, some comments point out that one strength of the long-standing CGMPs is their applicability to the broad spectrum of food manufacturing, from the manufacture of processed products and packaging of fresh produce to production of food additives and GRAS substances (see section VIII). (As already noted, some packaging of fresh produce (e.g., packaging of RACs on a farm) is not subject to the CGMPs.) (Comment 222) Some comments assert that we should not base the requirements for hazard analysis and risk-based preventive controls on the status of a business as a facility that is required to register under the section 415 registration regulations if there is no risk from consumption of food produced by that business. Some comments assert that a food safety plan should only be required for high-risk processing facilities because adhering to CGMPs is sufficient for low- risk facilities. Some comments assert a food safety plan should be required for large businesses, but not for small and medium-size businesses, including small businesses that manufacture low-risk foods that are sterilized before being eaten and already undergo a 48-point inspection twice a year. Some comments ask us to adopt a commodity-specific approach to the exemptions and to only apply the requirements for hazard analysis and risk-based preventive controls to RACs that fall within the five highest-risk commodity groups and to any other specific commodities that we determine pose a comparable risk based on outbreak history and the commodity's characteristics. Other comments note that some States provide ``exemptions'' for ``non-potentially-hazardous foods.'' These comments assert that there should be national agreement on what such foods are and, if such foods are truly low risk, there should not be onerous requirements regardless of the size of the business. (Response 222) We decline these requests to establish additional exemptions based on risk, other than the exemptions for on-farm low- risk activity/food combinations provided by section 103(c)(1)(D) of FSMA (Sec. 117.5(g) and (h)). The applicability of the requirements of the human preventive controls rule to facilities that are required to register is required by the statute (see the definition of facility in section 418(o)(2) of the FD&C Act). Section 418(h) of the FD&C Act requires that a facility prepare and implement a food safety plan, unless an exemption applies. Neither FSMA nor this rule establishes a broad exemption for ``low-risk'' facilities, including ``low-risk'' facilities that are regularly inspected by State, local, or tribal government agencies. As discussed in Response 213, the exemptions we are establishing are those specifically authorized by the statute. The new requirements for hazard analysis and risk-based preventive controls are not ``one-size-fits-all,'' and facilities that are subject to the rule would consider the risk presented by the products as part of their hazard evaluation. (See Sec. 117.130(c)(1)(i), which requires that the hazard analysis include an evaluation of identified known or reasonably foreseeable hazards to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.) Although each facility subject to the rule must prepare and implement a food safety plan, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis (Sec. Sec. 117.130 and 117.135(c)). In addition, the preventive control management components (i.e., monitoring, corrective actions and corrections, and verification) that a facility would establish and implement for its preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (Sec. 117.140(a)). A facility that appropriately determines through its hazard analysis that no preventive controls are necessary to prevent its food products from being adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act would document that determination in its written hazard analysis but would not need to establish preventive controls and associated preventive control management components for its products. A facility that is a very small business as that term is defined in this rule is exempt from the requirements of subparts C and G, including the requirement to prepare and implement a food safety plan, and is instead subject to the modified requirements in Sec. 117.201. [[Page 55991]] We expect that there will be many circumstances in which a facility appropriately determines that certain biological, chemical, or physical hazards are not hazards requiring a preventive control that must be addressed in the food safety plan. There are several types of food products for which a facility may determine that there are no hazards requiring a preventive control. Such products could include, but are not limited to: many crackers, most bread, dried pasta, many cookies, many types of candy (hard candy, fudge, maple candy, taffy and toffee), honey, molasses, sugar, syrup, soft drinks, and jams, jellies, and preserves from acid fruits. 9. Hullers/Shellers (Comment 223) Some comments ask us to clarify whether an operation solely engaged in hulling/shelling would qualify for the exemption from the requirements for hazard analysis and risk-based preventive controls for facilities that solely are engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (Sec. 117.5(j)). Other comments ask us to clarify whether an operation that is solely engaged in hulling/shelling and, thus, is exempt from the CGMP requirements of subpart B would also be exempt from the requirements for hazard analysis and risk-based preventive controls in subpart C. Some of these comments assert that it seems contrary to the principles of HACCP that a facility that is not required to implement CGMPs (which is a foundation of HACCP) would still need to develop a food safety plan. Some comments assert that requiring these operations to apply HACCP standards to what is an extension of harvesting is overkill, because the consumer is ultimately protected by processes at the handler (processor) level. Other comments assert that our clarification that operations that hull/shell/dry nuts are exempt from the CGMP requirements recognizes that hulling/shelling activities are low risk and do not alter the status of a RAC. Because the requirements for hazard analysis and risk-based preventive controls will be applied by those receiving product from the huller/sheller, it does not seem appropriate for an operation that is explicitly exempt from CGMP requirements to be required to conduct a hazard analysis, implement controls, conduct monitoring, etc. (Response 223) Under the revised ``farm'' definition, some hulling/ shelling operations will be within the ``farm'' definition (i.e., if the primary production farm(s) that grows, harvests, and/or raises the majority of the nuts owns, or jointly owns, a majority interest in the hulling/shelling operation). Because hulling/shelling is a harvesting activity, not a holding activity, those hulling/shelling operations that are not within the ``farm'' definition are not eligible for the exemption for facilities solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (Sec. 117.5(j)). As discussed in Response 222, there is no exemption for ``low-risk operations.'' However, a facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. 10. Fruit and Vegetable RACs (Comment 224) Some comments ask us to clarify the two exemptions applicable to RACs--i.e., the exemption from CGMP requirements for the holding or transportation of one or more RACs (Sec. 117.5(k)) and the exemption from the requirements for hazard analysis and risk-based preventive controls for facilities solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (Sec. 117.5(j)). These comments ask whether an off-farm holding facility that strictly deals with fruit and vegetable RACs would be exempt from subpart B, but not subpart C. Some comments assert that operations that pack RACs other than fruits and vegetables intended for further distribution or processing should be exempt from both CGMP requirements and requirements for hazard analysis and risk-based preventive controls. These comments ask us to expand the exemption from CGMP requirements for the holding or transportation of one or more RACs to include the packing of RACs (other than fruits and vegetables). These comments also ask us to include packing RACs in the exemption from subpart C for facilities solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. (Response 224) Under the revised ``farm'' definition, some operations that pack RACs will be within the ``farm'' definition (i.e., if the farms that grow or raise the majority of the RACs own, or jointly own, a majority interest in the packing operation). Packing operations that are within the ``farm'' definition are exempt from the CGMP requirements (Sec. 117.5(k)(1)). However, the packing of RACs is not otherwise exempt from either the CGMP requirements or the requirements for hazard analysis and risk-based preventive controls. As discussed in Response 221, the umbrella CGMPs that we are establishing in subpart B are long-standing provisions that establish basic requirements for the manufacturing, processing, packing, and holding of food to prevent adulteration. Packing operations that are within the ``farm'' definition are exempt from the requirements for hazard analysis and risk-based preventive controls (because ``farms'' are exempt from the section 415 registration requirements for ``facilities''). As discussed more fully in Response 222, the new requirements for hazard analysis and risk- based preventive controls are not ``one-size-fits-all.'' Although each facility subject to the rule must prepare and implement a food safety plan, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis. In addition, the preventive control management components that a facility would establish and implement for its preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. 11. Enclosed Outdoor Vessels (Comment 225) Some comments ask us to exempt enclosed outdoor vessels from the specific CGMP provisions (such as requirements for the plant design to permit the taking of adequate precautions to protect food in outdoor bulk vessels (Sec. 117.20(b)(3)) and requirements for warehousing and distribution (Sec. 117.93)) if they are properly ``risk assessed'' and covered by appropriate procedures for preventing contamination, and system verification is implemented. (Response 225) We decline this request. The long-standing CGMP requirements are comprehensive, interrelated provisions intended to prevent the adulteration of food. Specifying particular provisions that would not apply if a food establishment appropriately implements other provisions would be contrary to this comprehensive approach to food safety, in addition to being both impractical and difficult to administer. If a food establishment has appropriately determined that its procedures for preventing contamination adequately address the requirements for the safe storage of food in enclosed outdoor [[Page 55992]] vessels, it should have no difficulty demonstrating that during inspection. 12. Supermarket Distribution Centers (Comment 226) Some comments ask us to exempt supermarket distribution centers from the requirements of subpart C and instead require them to have written CGMPs. If this request is not accepted, then these comments ask us to either exempt supermarket distribution centers from the requirements of subpart C for those packaged foods not exposed to the environment (with modified requirements for unexposed, refrigerated, packaged TCS foods), or specify that there are no significant hazards for such a facility to address in a food safety plan. (Response 226) A supermarket distribution center must register as a food facility because it holds food for human consumption and does not satisfy any of the criteria for entities that are not required to register (see Sec. 1.226). As discussed in Response 222, the preventive controls that a facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. In the case of a facility that is a supermarket distribution center, the facility would, as part of its evaluation, determine whether any preventive controls are necessary for unexposed, non-refrigerated packaged foods. The facility might determine that the modified requirements in Sec. 117.206 for unexposed, refrigerated, packaged TCS foods are appropriate to apply to such foods that it holds. If so, the facility could establish its food safety plan by building on the provisions established in Sec. 117.206. 13. Local and Regional Facilities Such as Kitchen Incubators, Food Hubs, and Grower Marketing Cooperatives (Comment 227) Some comments ask us to provide flexibility to local and regional facilities that do not qualify for an exemption from subpart C (e.g., ``kitchen incubators'' and farm mixed-type facilities that are subject to State or local laws). Some comments ask us to exempt (or partially exempt) food hubs, grower marketing cooperatives, ``produce auctions,'' and similar entities. Some comments ask us not to cover facilities with less than $25,000 in annual sales (similar to a provision being considered under the 2013 proposed produce safety rule) or to establish a higher sales limit (i.e., $100,000) applicable to both the human preventive controls rule and the produce safety rule. (Response 227) We decline the requests to exempt (or partially exempt) the business models described in these comments. (See Response 213.) None of these requests describe or provide evidence that the regulatory framework associated with the business model would address all of the requirements of subparts C and G. Many of the types of facilities listed have multiple business models that conduct different types of activities. For example, USDA defines a regional food hub as ``a business or organization that actively manages the aggregation, distribution, and marketing of source-identified food products primarily from local and regional producers to strengthen their ability to satisfy wholesale, retail, and institutional demand.'' (Ref. 50). Some food hubs have facilities at which they conduct activities, including dry and cold storage, grading, packing, labeling, and light processing (trimming, cutting, and freezing), whereas other food hubs never physically handle the product sold but instead rely on farmers and contract trucking firms to provide aggregation and transportation services (Ref. 50). Some food hubs have a farm-to-business model (e.g., selling to food cooperatives, grocery stores, institutional foodservice companies, and restaurants), while others have a farm-to-consumer model (i.e., selling directly to the consumer, e.g., through a CSA), and some are hybrids that do both (Ref. 50). Some food hubs combine produce distribution with food processing operations (shared commercial processing space, or ``incubator kitchens''). Thus, some of these operations could be exempt. For example, some of these operations may fall within the revised ``farm'' definition (e.g., if the farms that grow or raise the majority of the RACs own, or jointly own, a majority interest in a food hub or a grower marketing cooperative and the food hub or grower marketing cooperative does not conduct any activities outside of the ``farm'' definition). Other operations could be exempt if they fall within the definition of ``retail food establishment'' (see Response 4). With respect to produce auction houses, to the extent that these operations are simply a location for buyers and sellers to meet and to sell and transfer produce and the food is not stored, we do not consider such facilities to be holding food and would not expect them to register; therefore these operations would not be subject to the requirements of subparts C and G for hazard analysis and risk-based preventive controls. We also decline the request not to cover facilities with less than $25,000 or $100,000 in annual sales. (See the discussion in Response 220, in which we declined the request to provide more exemptions for small farm mixed-type facilities and other small facilities). However, if a local or regional facility such as those described in the comments is a very small business, the facility would be subject to modified requirements (Sec. 117.201) rather than to the full requirements for hazard analysis and risk-based preventive controls. When such an operation is not a farm, a retail food establishment, or a very small business, the preventive controls that a facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. (See Response 222.) 14. Production of Raw Sugar (Comment 228) Some comments ask us to exempt the production of raw sugar that is destined for refining from the requirements in subpart C for hazard analysis and risk-based preventive controls. (Response 228) Making sugar from sugarcane or sugar beets is a low- risk activity/food combination (see Sec. 117.5(h)), and the statutory exemption in Sec. 117.5(h) would apply to a small or very small business that makes sugar on-farm if the only other activities it conducts outside the farm definition are the low-risk activity/food combinations in Sec. 117.5(g) and (h). We decline the request to extend this exemption to a small or very small business that makes sugar off-farm or to a business that is not a small or very small business (see Response 213). As discussed in Response 222, the preventive controls that such businesses would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account [[Page 55993]] the nature of the preventive control and its role in the facility's food safety system. An off-farm facility that makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (i.e., that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. 15. Biological Hazards in Olive Oil (Comment 229) Some comments ask us to establish an exemption for the consideration of biological hazards such as Salmonella and pathogenic E. coli in olive oil. (Response 229) We decline this request. The rule requires the facility to conduct a hazard analysis to determine hazards requiring a preventive control. If the facility appropriately determines through its hazard analysis that biological hazards such as Salmonella and pathogenic E. coli are not hazards requiring a preventive control in its product, then these hazards would not be addressed in the facility's food safety plan. We expect that there will be many circumstances in which a facility appropriately determines that certain biological, chemical, or physical hazards are not hazards requiring a preventive control that must be addressed in the food safety plan. The provisions of the rule that allow a facility to appropriately determine that a particular hazard is not a hazard requiring a preventive control in certain food products are not equivalent to an exemption from the rule. For example, a facility that appropriately determines that there are no hazards requiring a preventive control associated with its food products must document that determination in its written hazard analysis (Sec. 117.130(a)(2)); however, no preventive controls, including supplier verification activities, and associated management components would be required in such a situation. As discussed in Response 222, there are several types of food products for which a facility may determine that there are no hazards requiring a preventive control. XII. Subpart A: Comments on Proposed Sec. 117.7--Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food We proposed that subpart C would not apply to a facility solely engaged in the storage of packaged food that is not exposed to the environment (proposed Sec. 117.7(a)). We also proposed that a facility solely engaged in the storage of packaged food that is not exposed to the environment would be subject to the modified requirements that would be established in Sec. 117.206 of subpart D (proposed Sec. 117.7(b)). Some comments support these proposed provisions without change. For example, one comment expresses the view that the safety of these products would be ensured during the manufacturing process by companies that comply with the stringent requirements of the proposed rule, and no new hazards will be introduced to the food at these facilities. Other comments that support the proposed provisions ask us to clarify some aspects of the provisions (see, e.g., Comment 230) or to clarify how the provisions will apply in particular circumstances (see, e.g., Comment 231 and Comment 232). Other comments that support the proposed provisions ask us to broaden them (see, e.g., Comment 233, Comment 234, and Comment 235). In the following paragraphs, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed requirements as shown in table 17, with editorial and conforming changes as shown in table 52. A key conforming change that affects Sec. 117.7 is that the final exemption is from the requirements of subpart G, as well as subpart C. As discussed in section XLII, the final rule establishes the requirements for a supply-chain program in subpart G, rather than within subpart C as proposed. Table 17-- Revisions to the Proposed Applicability of Subparts C and D to a Facility Solely Engaged in the Storage of Unexposed Packaged Food ------------------------------------------------------------------------ Section Description Revision ------------------------------------------------------------------------ 117.7(b)...................... Applicability of Clarification that subpart D. subpart D only applies to those unexposed packaged foods that require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens. ------------------------------------------------------------------------ (Comment 230) Some comments ask us to clarify the interplay between the proposed exemption (proposed Sec. 117.7) and the proposed modified requirements (proposed Sec. 117.206) to better reflect that the modified requirements would apply only to TCS foods. Some comments ask us to clarify that if a facility stores both TCS food and non-TCS food (i.e., unexposed packaged food that does not require time/temperature control for safety), then the modified requirements only apply for the portion of the facility that holds the TCS foods. (Response 230) We have revised Sec. 117.7(b) to clarify that a facility solely engaged in the storage of unexposed packaged food, including unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens is subject to the modified requirements in Sec. 117.206 of subpart D for any unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens. (Comment 231) Some comments ask us to revise the regulatory text to be explicit that frozen unexposed packaged food is not a TCS food subject to modified requirements. (Response 231) We decline this request. In the 2013 proposed human preventive controls rule, we tentatively concluded that it would be rare for a frozen food to be a TCS food (78 FR 3646 at 3774), and we affirm that conclusion in this document. However, specifying in the regulatory text that a frozen food is not a TCS food would require us to conclude that a frozen food would ``never'' (rather than ``rarely'') be a TCS food, and we lack information to support ``never.'' (Comment 232) Some comments assert that a hazard analysis of the risks associated with storage of produce in vented crates would reveal no significant hazards and, thus, that even [[Page 55994]] if we do not agree that produce packaged in vented crates satisfies the criterion ``not exposed to the environment,'' we should exercise enforcement discretion for produce packaged in vented crates. (Response 232) As discussed in Response 170, produce stored in vented crates is not ``unexposed packaged food.'' Although environmental exposure to produce packed in vented crates would be less than environmental exposure to produce packed in open crates, a vented crate can subject produce to contamination. Thus, we disagree that we should not enforce the provisions of the rule for such produce. A facility that stores produce packed in vented crates must conduct a hazard analysis and evaluate whether there are any hazards requiring a preventive control. However, as discussed in Response 222, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. A facility that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control associated with its food products would document that determination in its written hazard analysis (Sec. 117.130(a)(2)) but would not need to establish preventive controls and associated preventive control management components for its products. (Comment 233) Some comments ask us to apply the exemption to storage areas of facilities that also engage in food processing activities--e.g., for distributors that are engaged in limited food processing, such as cutting vegetables or packing RTE foods. These comments assert that the intent of the term ``solely'' is to make clear that a facility that conducts an activity subject to the exemption does not escape responsibility for complying with the requirements for hazard analysis and risk-based preventive controls when conducting activities that are not exempt. In the comment's example, a facility that cuts vegetables or packs RTE foods would prepare and implement a food safety plan for cutting vegetables and packing RTE foods, but would not conduct a hazard analysis to determine whether there are significant hazards for storing unexposed packaged food. (Response 233) We disagree with the comment's interpretation of the term ``solely.'' The plain meaning of ``solely'' is only, completely, entirely; without another or others; singly; alone (Ref. 44). The facility described in the comment is not ``solely'' engaged in the storage of unexposed packaged food. Such a facility must conduct a hazard analysis that addresses all activities conducted by the facility. As discussed in Response 222, the preventive controls that the facility would establish and implement would depend on the facility, the food, and the outcome of the facility's hazard analysis, and any preventive control management components associated with a facility's preventive controls would be established as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system. A facility that stores unexposed packaged food that is not a TCS food could, for example, determine that no preventive controls and associated management components would be necessary for those foods. A facility that stores unexposed refrigerated packaged TCS food could, for example, determine that preventive controls and management components patterned after the modified requirements in Sec. 117.206 are adequate to address hazards requiring a preventive control associated with that food. (Comment 234) Some comments ask us to allow a facility to designate a storage area as a separate facility for purposes of compliance with the requirements for hazard analysis and risk-based preventive controls. In the comments' view, an area solely engaged in the storage of unexposed packaged food could fall within the exemption in Sec. 117.7 even though other areas would be subject to the requirements for hazard analysis and risk-based preventive controls. Some comments contrast our proposed approach to applying the statutory provision for facilities ``solely engaged in . . . storage'' with our proposed approach to applying section 418 of the FD&C Act to farm mixed-type facilities and facilities that conduct activities subject to one of our HACCP regulations. These comments point out that, for farm mixed-type facilities, we determined that section 418 applies only with respect to the activities that trigger registration (78 FR 3646 at 3705). Likewise, these comments point out that for facilities that conduct activities subject to our HACCP regulations for seafood or juice, we determined that the facilities can be exempt from the requirements of section 418 with respect to the activities subject to those regulations but not with respect to other activities (78 FR 3646 at 3704). (Response 234) We disagree that a designated storage area in an establishment that conducts manufacturing, processing, or packing in addition to storage can fall within the exemption for facilities ``solely engaged in . . . storage.'' The statute provides authority for us to exempt or modify the requirements for compliance with respect to ``facilities'' that are solely engaged in the storage of packaged foods that are not exposed to the environment (section 418(m) of the FD&C Act). The statute defines ``facility'' as a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act (section 418(o)(2) of the FD&C Act). The section 415 registration regulations define facility as ``any establishment, structure, or structures under one ownership at one general physical location . . .'' The comment's interpretation that we could view ``areas'' of registered facilities to be ``facilities that are solely engaged in . . . the storage of packaged foods that are not exposed to the environment'' is inconsistent with the statutory and regulatory framework under sections 415 and 418 of the FD&C Act. See also the discussion in Response 233 regarding how a facility that both stores unexposed packaged food and conducts activities such as food processing or packing could address the requirements for hazard analysis and risk-based preventive controls for the storage activities conducted by the facility. (Comment 235) Some comments ask us to consider an alternative to the exemption for unexposed packaged foods when a facility conducts manufacturing, processing, packing, or holding activities in addition to storing unexposed packaged food. Specifically, these comments ask us to recognize that the minimal risks of storing unexposed packaged foods can be addressed through a combination of compliance with the modified requirements for TCS foods (if applicable) and the CGMPs in subpart B and state that doing so would be consistent with our discussion in the 2013 proposed human preventive controls rule. (Response 235) These comments appear to suggest the outcome of a facility's hazard analysis for storing unexposed packaged food--i.e., that the only hazards requiring a preventive control are the potential for growth of pathogens in refrigerated unexposed packaged foods and that the preventive controls and preventive control [[Page 55995]] management components specified in the modified requirements for TCS food are adequate to address such hazards. It is the responsibility of the facility's preventive controls qualified individual to identify the hazards requiring a preventive control associated with the facility and the food it stores, as well as the appropriate preventive controls and preventive control management components. However, we agree that in some cases the approach suggested in these comments would be appropriate. (Comment 236) Some comments assert that it is difficult to identify TCS foods and that the benefits of undertaking that work are unclear when existing CGMP requirements protect public health. These comments ask us to work with industry and professional organizations to develop guidance on when the modified requirements apply. Other comments ask us to specify that specific foods such as yogurt are not TCS foods and provide scientific information to support their request. (Response 236) This document does not include guidance on whether specific foods, such as yogurt, are TCS foods. Information on whether specific foods are TCS foods is already widely available--e.g., in Annex 3, Chapter 1 (Purpose and Definitions) of the Food Code (Ref. 51) and in a report prepared for us under contract by the Institute of Food Technologists (Ref. 52). A facility solely engaged in storage of unexposed packaged food can consult the Food Code or work with the manufacturer of the food to identify TCS food. Alternatively, such a facility could simply treat any refrigerated food as a TCS food. Although we agree with comments that in general yogurt would not be a TCS food, whether a particular yogurt is a TCS food would depend on what is added to the yogurt. For example, in 1989 an outbreak of foodborne botulism in the United Kingdom from the consumption of yogurt containing added hazelnut conserve (puree) caused 27 illnesses and one death (Ref. 53). The hazelnut puree had not been adequately processed to prevent toxin production by C. botulinum. Even though this particular outbreak was not related to the question of whether yogurt is a TCS food, it demonstrates the importance of having a preventive controls qualified individual consider all hazards associated with a product to determine whether there are hazards requiring a preventive control, including temperature control. XIII. Subpart B: Comments on Proposed Sec. 117.10--Personnel We proposed to re-establish the provisions of Sec. 110.10 in new Sec. 117.10 with some revisions to modernize them. Some comments agree with one or more of these proposed provisions without change. For example, some comments state that the proposed provisions for disease control are already widely practiced across the produce industry and are part of most food safety guidance and standards. Some comments that support the proposed revisions suggest alternative or additional regulatory text (see, e.g., Comment 243 and Comment 244) or ask us to clarify how we will interpret the revised provision (see, e.g., Comment 239). Other comments that support provisions that we proposed to re- establish in part 117 without change ask us to revise or clarify those provisions (see, e.g., Comment 237, Comment 238, Comment 240, and Comment 241). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we proposed to re-establish in Sec. 117.10 with no changes. After considering these comments, we have revised the proposed provisions as shown in table 18, with editorial and conforming changes as shown in table 52. Table 18--Personnel Provisions ---------------------------------------------------------------------------------------------------------------- Did we propose revisions or request Did we get comments that Did we modify the Provision comment on potential disagreed with the proposed regulatory revisions? proposed provision? text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.10--Management No...................... Yes..................... Yes. Responsibility. Sec. 117.10(a)--Disease Control... No...................... Yes..................... Yes. Sec. 117.10(b)--Cleanliness....... Yes..................... No...................... No. Sec. 117.10(b)(1)--Outer Garments. Yes..................... Yes..................... No. Sec. 117.10(b)(2)--Personal No...................... No...................... No. Cleanliness. Sec. 117.10(b)(3)--Washing Hands.. No...................... No...................... No. Sec. 117.10(b)(4)--Unsecured Yes..................... Yes..................... No. Jewelry and Other Objects. Sec. 117.10(b)(5)--Gloves......... Yes..................... Yes..................... No. Sec. 117.10(b)(6)--Hair Restraints No...................... No...................... No. Sec. 117.10(b)(7)--Clothing and Yes..................... Yes..................... No. Other Personal Belongings. Sec. 117.10(b)(8)--Eating Food, Yes..................... Yes..................... Yes. Drinking Beverages, and Using Tobacco. Sec. 117.10(b)(9)--Any Other Yes..................... Yes..................... No. Necessary Precautions. Sec. 117.10(c)--Education and Yes..................... Yes..................... Shifted to Sec. Training. 117.4 as a requirement rather than a recommendation. Sec. 117.10(d)--Supervision....... Yes..................... No...................... Shifted to Sec. 117.4. ---------------------------------------------------------------------------------------------------------------- A. Management Responsibility for Requirements Applicable to Personnel We proposed no revisions to the requirement that plant management must take all reasonable measures and precautions to ensure compliance with the provisions for disease control, cleanliness, and training. (Comment 237) Some comments ask us to remove ``all'' because it is too extreme and prescriptive. These comments ask us to instead specify that the intended measures and precautions must be ``adequate.'' (Response 237) We have revised the regulatory text to delete ``all.'' We disagree that the term ``all'' in this long-standing provision is too extreme and prescriptive, but find that the term ``all'' is not necessary to communicate the intent of the requirement. We decline the request to add ``adequate.'' The intent of the requirement is to communicate our expectation that these [[Page 55996]] measures and precautions are reasonable. Other, more specific provisions that management must address specify that particular measures and precautions must be ``adequate'' (see Sec. 117.10(b)(2), (3), and (4)). B. Proposed Sec. 117.10(a)--Disease Control We proposed no revisions to the requirement that any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food- contact surfaces, or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel must be instructed to report such health conditions to their supervisors. (Comment 238) Some comments ask us to provide flexibility to not exclude from operations personnel who have an open lesion (such as boils, sores or any other infected wounds) that is covered completely using appropriate first aid materials. (Response 238) We have revised the regulatory text to reflect flexibility such as that provided in FDA's Food Code (Ref. 51). Under the Food Code, workers need not be excluded if an open lesion on hands and wrists, or on exposed portions of arms, is protected by an impermeable cover, and workers need not be excluded if an open lesion on other parts of the body is covered by a dry, durable, tight-fitting bandage. C. Proposed Sec. 117.10(b)--Cleanliness 1. Proposed Sec. 117.10(b)(1)--Outer Garments We proposed that the methods for maintaining cleanliness include wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials and to protect against the cross-contact of food. (Comment 239) Some comments ask us to clarify whether the newly proposed requirement to prevent allergen cross-contact would require a line worker to change outer garments when switching between individual food-production lines if separate major allergens are present on the food production lines. (Response 239) The provision does not prescribe the specific methods by which wearing outer garments must protect against allergen cross-contact and, thus, the establishment has flexibility to take appropriate steps to satisfy the requirements in the context of the establishment and the food it produces. Requiring a line worker to change outer garments when switching between individual food-production lines could be an appropriate precaution for some establishments. When a facility that is subject to the requirements for hazard analysis and risk-based preventive controls determines that it is necessary to require a line worker to change outer garments to prevent allergen cross-contact between food-production lines, the facility could decide to establish such a procedure as a food allergen control under Sec. 117.135(c)(2). 2. Proposed Sec. 117.10(b)(4)--Unsecured Jewelry and Other Objects We proposed to require that the methods for maintaining cleanliness include removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials. (Comment 240) Some comments ask us to modify the requirements to provide that they only apply as appropriate to each operation and recommend that jewelry be removed when the company's hazard analysis determines that it is a hazard. These comments acknowledge that jewelry is a physical hazard in some instances, but assert that objects such as jewelry are not a physical hazard for operations conducted on many medium- to large-sized RACs (e.g., melons, apples, oranges, potatoes). (Response 240) We decline this request. We included this long- standing provision of the umbrella CGMPs during our last revision of the food CGMPs based on public comments during that rulemaking (51 FR 22458 at 22463). The provision provides flexibility for an establishment to do what is appropriate in the context of its own operations--e.g., by limiting some requirements to ``unsecured'' jewelry and by providing options to cover hand jewelry during periods in which food is manipulated by hand. Although a facility could decide to also establish preventive controls for jewelry as a physical hazard following a hazard analysis, such preventive controls would be distinct from the more general CGMP requirements in this provision. 3. Proposed Sec. 117.10(b)(5)--Gloves We proposed that the methods for maintaining cleanliness include maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. We also proposed to delete a recommendation that gloves should be of an impermeable material. Although some comments ask us to retain this nonbinding recommendation, as discussed in Response 67 we are deleting those non-binding recommendations of part 110 that we are not establishing as requirements. 4. Proposed Sec. 117.10(b)(7)--Clothing and Other Personal Belongings We proposed to require that the methods for maintaining cleanliness include storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. (Comment 241) Some comments ask us to specify that the requirements only apply to ``extra'' clothing. These comments express concern that the requirement otherwise might be interpreted to mean that no personal clothing is allowed in these areas (e.g., that employees are permitted to wear only company[hyphen]issued uniforms). (Response 241) We decline this request. This long-standing provision of the umbrella GMPs has been in place for decades. The comments do not provide any examples of how we have interpreted this provision in the past to mean that employees must wear company-issued uniforms. 5. Proposed Sec. 117.10(b)(8)--Eating Food, Drinking Beverages, and Using Tobacco We proposed to require that the methods for maintaining cleanliness include confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, drinking beverages, or using tobacco. (Comment 242) Some comments note that the provision would no longer require that chewing gum be confined to areas other than where food may be exposed or where equipment or utensils are washed. These comments ask us whether this omission was intentional, or whether we are simply considering that requirements applicable to ``chewing gum'' are covered by those for ``eating food.'' Some comments state that it would not be immediately obvious to many laypersons as to whether the chewing of gum is included in ``eating food.'' [[Page 55997]] (Response 242) We agree that removing the phrase ``chewing gum'' from this provision could make it unclear that this long-standing requirement regarding chewing gum still applies and we have revised the proposed regulatory text to retain the express requirement regarding chewing gum. As the comments point out, the statute includes chewing gum in its definition of ``food'' (see section 201(f) of the FD&C Act). However, in this long-standing provision, the term ``chewing gum'' is used to mean ``the act of chewing'' rather than to refer to the gum itself. (Comment 243) Some comments regarding processes conducted on RACs ask us to modify the regulatory text to distinguish ``drinking beverages'' from ``drinking water.'' These comments note that this provision is of concern to their industry because drinking water needs to be readily available to workers. (Response 243) We decline this request. We acknowledge that workers may need ready access to drinking water when conducting activities on RACs, particularly in an environment that is largely outdoors (such as in an off-farm packinghouse that has a roof but is otherwise largely unenclosed). However, this provision does not apply to on-farm activities such as harvesting of RACs. During packing activities covered by this rule, workers must move away from the packing operations to get a drink. The establishment can make drinking water available in a designated area that is nearby, and provide multiple designated areas when appropriate to make drinking water readily available to all workers. 6. Proposed Sec. 117.10(b)(9)--Any Other Necessary Precautions We proposed that the methods for maintaining cleanliness include taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin) and to protect against cross-contact of food. (Comment 244) Some comments ask us to specify that the provision applies to ``medicines or other products'' applied to the skin. (Response 244) We decline this request. The comment does not explain what ``other products'' applied to the skin are not already covered by ``cosmetics'' and ``medicines.'' For example, powders and lotions applied as ``make-up'' generally would be cosmetics and products such as sunscreen generally are classified as over-the-counter medicines. XIV. Subpart B: Comments on Proposed Sec. 117.20--Plant and Grounds We proposed to re-establish the provisions of Sec. 110.20 in new Sec. 117.20 with some revisions to modernize them. Some comments agree with one or more of these proposed revisions without change. Some comments that support the proposed revisions suggest alternative or additional regulatory text (see, e.g., Comment 251 and Comment 256) or ask us to clarify how we will interpret the revised provision (see, e.g., Comment 253). Other comments that support provisions that we proposed to re-establish in part 117 without change ask us to revise or clarify those provisions (see, e.g., Comment 246, Comment 247, Comment 248, Comment 250, and Comment 254). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we proposed to re-establish in Sec. 117.20 with no changes. After considering these comments, we have revised the proposed provisions as shown in table 19, with editorial and conforming changes as shown in table 52. Table 19--Provisions for Plant and Grounds ---------------------------------------------------------------------------------------------------------------- Did we propose revisions Did we get comments Did we modify the Provision or request comment on that disagreed with the proposed regulatory potential revisions? proposed provision? text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.20(a)--Grounds........... No...................... Yes.................... No. Sec. 117.20(a)(1)--Equipment, No...................... Yes.................... No. Litter, Waste, Weeds, and Grass. Sec. 117.20(a)(2)--Roads, Yards, No...................... No..................... No. and Parking Lots. Sec. 117.20(a)(3)--Draining Areas. No...................... No..................... No. Sec. 117.20(a)(4)--Operating No...................... Yes.................... Yes. Systems for Waste Treatment and Disposal. Sec. 117.20(a)(5)--Grounds Not Yes..................... Yes.................... Yes. Under the Operator's Control. Sec. 117.20(b)--Plant Construction Yes..................... Yes.................... No. and Design. Sec. 117.20(b)(1)--Space for No...................... Yes.................... Yes. Equipment and Materials. Sec. 117.20(b)(2)--Food Safety Yes..................... Yes.................... Yes. Controls, Operating Practices, or Design. Sec. 117.20(b)(3)--Outdoor Bulk Yes..................... Yes.................... Yes. Vessels. Sec. 117.20(b)(4)--Plant Yes..................... No..................... No. Construction. Sec. 117.20(b)(5)--Lighting....... No...................... Yes.................... Yes. Sec. 117.20(b)(6)--Ventilation.... Yes..................... Yes.................... Yes. Sec. 117.20(b)(7)--Screening or No...................... Yes.................... No. Other Protection. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.20(a)--Grounds 1. Proposed Sec. 117.20(a)--Management Responsibility for Maintaining Grounds We proposed no revisions to the requirement that the grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. (Comment 245) Some comments ask us to specify that the requirements do not apply to test/pilot kitchens. (Response 245) We decline this request. An establishment must have control of the grounds under its control regardless of the specific food or amount of food being produced, because litter, waste, weeds, and grass can all attract and harbor pests, and the first step for pest control in the plant is to avoid attracting pests. [[Page 55998]] 2. Proposed Sec. 117.20(a)(1)--Equipment, Litter, Waste, Weeds, and Grass We proposed no revisions to the requirement that the methods for adequate maintenance of grounds include properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. (Comment 246) Some comments ask us to specify ``immediately adjacent to'' rather than ``the immediate vicinity.'' These comments also ask us to provide guidance on the importance of pollinator habitat so that inspectors will view such areas within the greater context of the farm and not immediately see that the farm is out of compliance. (Response 246) We decline the request to modify the regulatory text of this long-standing provision. We note that a ``farm'' is not subject to the CGMP requirements of subpart B (see Sec. 117.5(k)). We do not see that the suggested modification would provide any specific information to investigators who are inspecting a food establishment (such as a farm mixed-type facility or packing shed) that has pollinator habitat near plant buildings or structures. We expect that investigators will adapt their inspection programs to account for such circumstances and food establishments will take steps to prevent weeds or grass in a pollinator habitat from leading to problems with pests in the plant. 3. Proposed Sec. 117.20(a)(4)--Operating Systems for Waste Treatment and Disposal We proposed no revisions to the requirement that the methods for adequate maintenance of grounds must include operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in Sec. 117.20(a)(1) through (a)(3), care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination. (Comment 247) Some comments assert that the term ``adequate'' has been added to this provision and is ambiguous when used to describe the way in which ``operating systems for waste treatment and disposal'' must be managed, even though that term is defined in the rule. These comments ask us to clarify what constitutes ``adequate'' for the purpose of this provision, such as whether it requires compliance with local plumbing codes. (Response 247) The term ``adequate'' has been in Sec. 110.20(a) and (a)(4) since 1986 (51 FR 22477). This long-standing provision addresses matters under FDA's jurisdiction rather than local plumbing codes. An example of waste disposal under FDA's jurisdiction is an operating system for water disposal. Such an operating system would be inadequate if it allowed water to accumulate on the facility grounds and become an attractant for pests. (Comment 248) Some comments ask us to clarify how the requirements in Sec. 117.20(a) would apply to potential problems associated with neighboring grounds. Other comments note that we proposed to address potential problems with neighboring grounds within the final sentence of this provision (proposed Sec. 117.20(a)(4)) and suggest editorial changes to more clearly identify the requirements regarding grounds under the control of a neighboring entity. (Response 248) These provisions do not require an establishment to take action on its neighbor's property to protect against contamination, but do require an establishment to be aware of any problems that may affect its own grounds. For example, if a neighbor's grass is long, the establishment is not required to mow the neighbor's grass, but if the long grass in the neighbor's property provides a breeding ground for pests, the establishment needs to be aware of this potential for contamination and may need to take mitigating actions (e.g., enhanced pest control in the bordering areas). We have clarified the proposed requirements by redesignating the final sentence of proposed Sec. 117.20(a)(4) as Sec. 117.20(a)(5) and specifying that the requirements of newly designated Sec. 117.20(a)(5) apply if the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in Sec. 117.20(a)(1) through (a)(4) (rather than in Sec. 117.20(a)(1) through (a)(3)). B. Proposed Sec. 117.20(b)--Plant Construction and Design 1. Proposed Sec. 117.20(b)--Suitability of Plant Construction and Design We proposed that the plant buildings and structure must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-production purposes (i.e., manufacturing, processing, packing, and holding). (Comment 249) Some comments ask us to specify that the requirements for suitability of plant construction and design apply only where the potential for contamination exists. (Response 249) We decline this request. A plant requires suitable construction and design regardless of the specific potential for contamination at any particular location in the plant. Each of the seven more specific provisions governed by Sec. 117.20(b) adds the context that the requirements are directed to what is ``adequate'' (e.g., adequate space, adequate precautions, and adequate cleaning). The defined term ``adequate'' provides context that the purpose of the requirements for plant construction and design are related to public health. 2. Proposed Sec. 117.20(b)(1)--Placement of Equipment and Storage of Materials We proposed no revisions to the requirement that the plant must provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. (Comment 250) Some comments assert that the phrase ``maintenance of sanitary operations'' is unclear because it does not clearly communicate that maintenance of equipment and the facility is necessary for the production of safe food. These comments ask us to revise the provision to specify that the plant must provide sufficient space for such placement of equipment and storage of materials as is necessary for maintenance, sanitary operations, and the production of safe food. (Response 250) We agree that the suggested revision adds clarity and have modified the provision as requested. The revised requirement is consistent with the governing paragraph in Sec. 117.20(b), which clearly addresses both maintenance and sanitary operations. 3. Proposed Sec. 117.20(b)(2)--Reduce Potential for Contamination and Allergen Cross-Contact Through Adequate Food Safety Controls and Operating Practices or Effective Design We proposed that the plant must permit the taking of proper precautions to reduce the potential for contamination of food, food- contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, and other extraneous material, and to reduce the potential for cross-contact. The potential for cross-contact and contamination may be reduced by adequate food safety controls and operating practices or effective design, [[Page 55999]] including the separation of operations in which cross-contact and contamination are likely to occur, by one or more of the following means: Location, time, partition, air flow, enclosed systems, or other effective means. (Comment 251) Some comments ask us to specify both air flow systems and dust control systems as examples of separation of operations in which allergen cross-contact and contamination are likely to occur. (Response 251) We agree that both air flow systems and dust control systems are appropriate examples of separation of operations and have added these examples as requested. 4. Proposed Sec. 117.20(b)(3)--Food in Outdoor Bulk Vessels We proposed that the plant must permit the taking of proper precautions to protect food in outdoor bulk vessels by any effective means, including using protective coverings, controlling areas over and around the vessels to eliminate harborages for pests, checking on a regular basis for pests and pest infestation, and skimming fermentation vessels. (Comment 252) Some comments express concern about applying these provisions to the transport of large RACs such as watermelons and assert that there would be no food safety advantage to doing so after the RACs had spent the growing season in an uncovered environment. (Response 252) The comments are mistaken about these requirements, which relate to installed bulk vessels such as outdoor tanks, silos, etc. Moreover, this section addresses the construction and design of the plant, not transportation. To make this clearer, we have revised the provision to specify that it applies to ``installed outdoor bulk vessels.'' (Comment 253) Some comments ask us to clarify that the requirements do not apply to open containers of RACs that are subject to further processing. Other comments assert that lugs, totes, corrugated bins, and harvest containers used to hold fruit are not bulk vessels that are subject to the provision. The comments explain that these containers are designed and built to be open at the top, with air holes on the sides and bottom that provide an adequate air flow to the fruit. (Response 253) The requirement applies to installed bulk vessels, not containers (including lugs, totes, corrugated bins, and harvest containers generally) that are delivered to a food establishment for packing or processing. (See discussion in Response 252.) Thus, the provision does not preclude the use of such containers. Although the provision specifies the use of protective coverings, it does so only as an example of an effective means of precautions to protect food held in outdoor vessels. Other specified examples of precautions to protect food held in outdoor bulk vessels include controlling areas over and around the vessels to eliminate harborages for pests, and checking on a regular basis for pests and pest infestation. Such measures to protect against pests are appropriate when food such as fruit is held in outdoor containers. (See also Response 327.) We agree that the measures taken by the establishment are those applicable to public health protection. To make this clearer, we have revised the provision to refer to ``adequate precautions'' rather than ``proper precautions,'' because the defined term ``adequate'' focuses on public health. 5. Proposed Sec. 117.20(b)(5)--Lighting We proposed no revisions to the requirement that the plant must provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. (Comment 254) Some comments ask us to add that the plant must provide adequate lighting in areas where food is packed and to substitute the term ``shatter-resistant'' for the term ``safety-type.'' (Response 254) We have revised the provision to specify that it applies to areas in the plant where food is examined, manufactured, processed, packed, or held. Doing so makes the terms in this provision consistent with terms used throughout the CGMPs (78 FR 3646 at 3692). We also have substituted the term ``shatter-resistant'' for the term ``safety-type.'' ``Shatter-resistant'' is a more modern term describing the safety features that are specified in the provision. 6. Proposed Sec. 117.20(b)(6)--Ventilation We proposed that a plant must provide adequate ventilation or control equipment to minimize odors and vapors in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food-contact surfaces and for cross-contact. (Comment 255) Some comments ask us to specify ``where necessary'' to modify ``adequate.'' (Response 255) We decline this request because ``where necessary'' is captured by ``is needed'' in the long-standing definition of ``adequate.'' (Comment 256) Some comments ask us to specify that the provision requires minimizing dust and that the applicable areas include areas where dust could cause allergen cross-contact. (Response 256) We agree that it is important to minimize dust (e.g., dust from milk powder that could be a source of allergen cross- contact) and have modified the provision as requested. 7. Proposed Sec. 117.20(b)(7)--Screening We proposed no revisions to the requirement that the plant must provide, where necessary, adequate screening or other protection against pests. (Comment 257) Some comments ask us to add examples of adequate screening, such as by window screens, door sweeps, gap sealant, or other appropriate measures. (Response 257) We decline this request. Although the examples suggested by the comment appear to be acceptable, examples of screening are not necessary in this long-standing requirement. XV. Subpart B: Comments on Proposed Sec. 117.35--Sanitary Operations We proposed to re-establish the provisions of Sec. 110.35 in new Sec. 117.35 with some revisions to modernize them. Some comments agree with one or more of these proposed provisions without change. Some comments that support the proposed revisions suggest alternative or additional regulatory text (see, e.g., Comment 258, Comment 261, Comment 263, Comment 269, Comment 272, and Comment 273) or ask us to clarify how we will interpret the revised provision (see, e.g., Comment 260, Comment 267, Comment 268, and Comment 270). We also proposed to delete current Sec. 110.35(d)(5) (requirements for sanitizing agents) because it would be redundant with another proposed provision (proposed Sec. 117.35(b)(1)). We received no comments that disagreed with this proposed deletion and are not re-establishing current Sec. 110.35(d)(5) in part 117. In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions. After considering these comments, we have revised the proposed provisions as [[Page 56000]] shown in table 20, with editorial and conforming changes as shown in table 52. Table 20--Provisions for Sanitary Operations ---------------------------------------------------------------------------------------------------------------- Did we propose revisions Did we get comments Did we modify the Provision or request comment on that disagreed with the proposed regulatory potential revisions? proposed provision? text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.35(a)--General Yes..................... Yes.................... Yes. Maintenance. Sec. 117.35(b)(1)--Substances Used Yes..................... Yes.................... Yes. in Cleaning and Sanitizing. Sec. 117.35(b)(2)--Storage of Yes..................... Yes.................... No. Toxic Materials. Sec. 117.35(c)--Pest Control...... Yes..................... Yes.................... Yes. Sec. 117.35(d)--Sanitation of Food- Yes..................... Yes.................... No. Contact Surfaces. Sec. 117.35(d)(1)--Food-Contact Yes..................... Yes.................... Yes. Surfaces Used for Manufacturing/ Processing or Holding. Sec. 117.35(d)(2)--Wet Cleaning... Yes..................... Yes.................... Yes. Sec. 117.35(d)(3)--Single-Service Yes..................... Yes.................... Yes. Articles. Sec. 117.35(e)--Sanitation of Non- Yes..................... Yes.................... Yes. Food-Contact Surfaces. Sec. 117.35(f)--Storage and Yes..................... Yes.................... No. Handling of Cleaned Portable Equipment and Utensils. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.35(a)--General Maintenance We proposed that buildings, fixtures, and other physical facilities of the plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food packaging materials. (Comment 258) Some comments ask us to specify that buildings, fixtures, and other physical facilities of the plant must be maintained in a ``clean'' condition in addition to a ``sanitary'' condition. (Response 258) We have revised the requirement as requested. Doing so is consistent with other provisions of subpart B that specify clean and sanitary conditions (e.g., the personnel cleanliness provisions in Sec. 117.10(b)(4) and (5)), including the requirements for sanitary operations (see the requirements for substances used in cleaning and sanitizing in Sec. 117.35(b)(1) and the requirements for sanitation of food-contact surfaces in Sec. 117.35(d)). (Comment 259) Some comments ask us to qualify the level of sanitation required for different areas of the plant because the degree of sanitation required for a warehouse or utility room is different from the degree of sanitation required for a processing room. (Response 259) We decline this request. The requirement is a long- standing provision that has been used in this context for decades. The comments do not provide any examples of how we have interpreted this provision in the past in a manner that does not acknowledge the appropriate degree of sanitation required in different areas of a plant. Importantly, however, the fact that the degree of sanitation may be different does not mean that it could be appropriate, for example, for pests to be present in areas, like utility rooms, that may not need the same degree of sanitation as a processing room. (Comment 260) Some comments assert that by its nature, the operations of some facilities generate dust and debris. For example, although equipment such as conveyors and screens used for hulling and shelling almonds can be cleaned before use, as soon as operations begin dust will accumulate on the surfaces of the equipment. Some comments ask us to clarify that the intent of the CGMP requirements for sanitary operations is to ensure that equipment is clean prior to use, with the understanding that once operations commence, dust will accumulate and that the presence of this type of dust and debris does not necessarily mean that sanitation is not being regularly conducted. (Response 260) We agree that the intent of the CGMP requirements for sanitary operations is to ensure that equipment is clean prior to use. However, the fact that dust and debris can accumulate during some production operations does not excuse the establishment from taking appropriate steps to prevent food from becoming contaminated. The timing and extent of such steps would depend on the nature of the food and the production operation. B. Proposed Sec. 117.35(b)--Substances Used in Cleaning and Sanitizing; Storage of Toxic Materials 1. Proposed Sec. 117.35(b)(1)--Cleaning Compounds and Sanitizing Agents We proposed that cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. We also proposed that mechanisms to comply with provisions related to cleaning compounds and sanitizing agents must be safe and effective and provided examples of ways to achieve such compliance (78 FR 3646 at 3721). Only the toxic materials listed in this provision may be used or stored in a plant where food is processed or exposed. (Comment 261) Some comments ask us to specify that ``Cleaning and sanitizing agents used on food-contact surfaces must contain only ingredients which are generally recognized as safe or are approved in Sec. 178.1010 for use in cleaning and sanitizing food-contact surfaces'' because this information will be useful to processors who may be unaware of the specific kinds of substances approved for food- contact surfaces. Other comments ask us to specify that residual levels of cleaning and sanitizing agents which are generally recognized as safe or are approved for use on food-contact surfaces are permissible. (Response 261) We decline these requests. Requirements such as those applicable to substances added to food or substances used in cleaning and sanitizing food-contact surfaces are available elsewhere in our regulations and it is neither practical nor necessary [[Page 56001]] to use the CGMP requirements of part 117 as a means to communicate some or all of these other requirements. For example, the manufacturer of a food product must also comply with food labeling regulations ranging from declaration of ingredients (Sec. 101.4) to health claims (part 101, subpart E). 2. Proposed Sec. 117.35(b)(2)--Identification and Storage of Toxic Materials We proposed that toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. We also proposed to remove a recommendation for following all relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of toxic cleaning compounds, sanitizing agents, and pesticides. (Comment 262) Some comments ask us to specify that we require that the compounds, agents, and pesticides be used according to the manufacturer's instructions. (Response 262) We decline this request. Such a recommendation is more properly addressed by the applicable Federal, State, and local government agencies. See the discussion at 78 FR 3646 at 3721. C. Proposed Sec. 117.35(c)--Pest Control We proposed that pests must not be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. (Comment 263) Some comments ask us to specify ``pest-detection'' dogs in addition to guard and guide dogs because the use of animals to detect pests is widespread in the professional pest management industry for concealed and difficult to find pests. Comments assert that like guard and guide dogs, detection dogs are well trained and should be permissible in areas of the plant where the presence of the dog is unlikely to result in contamination of the food, food-contact surfaces or food-packaging materials. Other comments ask us to specify that pests must not be allowed in any area of a food plant ``where appropriate'' or ``where the potential for contamination exists.'' Other comments assert that animals should be excluded from all areas that are used by production or packaging employees or that communicate with food processing, packing, or storage areas. Some comments ask us to clarify whether this provision includes administrative offices, cafeterias, and other rooms that are not directly involved in the processing, packing, or holding of food because the provision applies to ``any area of a food plant.'' (Response 263) We have revised the regulatory text to account for ``pest-detection dogs.'' However, we have not otherwise modified the regulatory text of this long-standing provision as a result of these comments. Areas of the food plant (such as a cafeteria) that are not directly involved with production may nonetheless be a source of contamination (e.g., if there are pests in that area). We have long provided that specified types of dogs may be allowed in some areas of a plant provided that the presence of the dogs is unlikely to result in contamination, and the comments provide no basis for why this qualified exception is no longer appropriate. (Comment 264) Some comments ask us to specify that insecticides and rodenticides are types of pesticides and that the use of these substances is permitted in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label precautions and restrictions. (Response 264) We have revised the regulatory text to specify the ``use of pesticides'' rather than the ``use of insecticides and rodenticides ``to use the broader term ``pesticides.'' We also modified the regulatory text to clarify that the restrictions on use of pesticides is when the pesticides are used ``to control pests.'' We made this modification because we are aware that some food processing processes (such as fumigating almonds) involve treating food with substances that are classified as ``pesticides.'' Without this modification, the provision could mistakenly appear to prevent establishments from conducting such processes. We decline to modify the text to account for FIFRA label precautions and restrictions. See (Response 262). (Comment 265) Some comments express concern that the phrases ``must not be allowed'' and ``exclude'' suggest that it is always possible to prevent all types of pests. Some comments assert that it is not always possible to prevent all types of pests, especially on farms and in areas where pests are prevalent because of the presence of conditions over which the food manufacturer has no control. Some comments assert that a food establishment should be required to take all reasonable measures to exclude pests, but an outright ``exclude'' is unrealistic. (Response 265) The requirements apply to activities conducted in a plant and do not apply to activities that are within the ``farm'' definition, such as harvesting RACs and on-farm packing of RACs. We disagree that effective measures cannot be taken to exclude pests from a plant that is fully enclosed. When a plant is only partially enclosed (e.g., a partially enclosed area that processes seafood taken off a fishing vessel, or a partially enclosed building on an off-farm establishment that packs RACs), we would interpret the provision in a manner consistent with the provisions of previous guidance, such as our 2005 ``Guide to Produce Farm Investigations'' and the final provisions of the produce safety rule. We are not modifying the requirement to incorporate this interpretation because pest control in buildings that are only partially enclosed will be a concern for only a small percentage of establishments subject to subpart B. D. Proposed Sec. 117.35(d)--Sanitation of Food-Contact Surfaces We proposed that all food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against cross-contact and contamination of food. (Comment 266) Some comments ask us to specify that all food-contact surfaces must also be sanitized. (Response 266) We decline this request. These long-standing requirements identify specific circumstances when food-contact surfaces must be sanitized (see Sec. 117.35(d)(2), which specifies circumstances when food-contact surfaces must be sanitized when used in wet processing operations). The comment provided no basis for why food- contact surfaces must be sanitized when they will be used in manufacturing/processing or holding low-moisture food or why food- contact surfaces must be sanitized when used in wet processing operations other than the circumstances specified in Sec. 117.35(d)(2). There are some situations in which food-contact surfaces do not need to be sanitized. For example, raw [[Page 56002]] materials and other ingredients for processing may be held in clean containers prior to processing with steps lethal to microorganisms; sanitizing such containers is not necessary for the production of safe food. (Comment 267) Some comments ask us to clarify that we are not requiring an absolutely allergen-free environment, but rather that the expectation is that the manufacturer will take steps to identify potential sources of allergen cross-contact and implement preventive measures. Some comments ask us to also clarify that dedicated lines or equipment are not required for effective preventive control of food allergens. Some comments discuss practical difficulties that arise when balancing the need to control microorganisms such as Salmonella in chocolate and low-moisture confectionary products (through procedures such as dry cleaning) with the control of allergens (which may be controlled better when wet cleaning procedures are used). (Response 267) See also the discussion of food allergen controls in Response 429. This rule does not establish a particular standard for preventing allergen cross-contact. In general, when we do establish a standard we avoid ``absolute'' standards such as the ``absolutely allergen-free'' standard mentioned by the comment. Likewise, the rule does not require the use of dedicated lines or equipment for effective prevention of allergen cross-contact. As the comments suggest, the intent of the requirement is for the manufacturer to take steps to identify potential sources of allergen cross-contact and implement preventive measures. (Comment 268) Some comments ask us to clarify that the use of advisory label statements is appropriate when allergen cross-contact has been reduced to the greatest extent possible, but cannot be eliminated with certainty. (Response 268) See Response 434 for a discussion about the use of advisory label statements. E. Proposed Sec. 117.35(d)(1)--Food-Contact Surfaces Used for Manufacturing/Processing or Holding We proposed that food-contact surfaces used for manufacturing/ processing or holding low-moisture food must be in a clean, dry, sanitary condition at the time of use. When the surfaces are wet- cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent use. (Comment 269) Some comments ask us to specify ``packing'' for clarity and completeness. (Response 269) We have revised the provision to specify that it applies to food-contact surfaces used for manufacturing, processing, packing, or holding low-moisture food. Doing so makes the terms in this provision consistent with terms used throughout the CGMPs (78 FR 3646 at 3692). (Comment 270) Some comments ask us to clarify that the proposed requirement to maintain food-contact surfaces in a sanitary condition is not a requirement to sanitize all product contact surfaces. These comments also ask us to specifically allow the continued use of cleaning methods based on a risk assessment, including dry cleaning with no sanitizing step. Some comments ask us to clarify that ``sanitary condition'' is not synonymous with ``sanitized'' from an antimicrobial standpoint. (Response 270) See Response 266. This provision does not require that all product contact surfaces be sanitized and, thus, it is not necessary to specify that dry cleaning methods with no sanitizing step are acceptable in certain circumstances. We do not consider ``sanitary condition'' to be synonymous with ``sanitized.'' We consider ``sanitary condition'' to be a state of cleanliness. Terms such as ``sanitize'' and ``sanitizing'' are associated with the reduction of microorganisms. (Comment 271) Some comments ask us to specify different requirements for food-contact surfaces used during different stages of manufacturing/processing or holding. These comments explain that the provision does not accommodate initial processing steps prior to moisture removal where food-contact surfaces will be exposed to moist (non-dry) conditions. These comments also explain that the provision also does not recognize that food-contact surfaces may not appear to be ``sanitary'' when raw materials handled at initial processing steps have not yet undergone subsequent processes designed to eliminate microorganisms of public health concern. Some comments ask us to specify that food-contact surfaces only need to be clean and sanitary ``before use and after any interruption during which the food-contact surfaces may have become contaminated.'' Comments also ask us to specify that ``finished product low-moisture food-contact surfaces must be maintained in a clean, dry, and sanitary condition.'' (Response 271) We decline these requests. This long-standing provision has been used in this context for decades. The full requirements for sanitation of food-contact surfaces (Sec. 117.35(d), (d)(1), and (d)(2)) address both processing of low-moisture foods and wet processing. It is not practical to describe all variations of complex manufacturing scenarios that may involve both wet processing and low-moisture foods. Instead, we expect both industry and regulators to appropriately apply the specific requirements associated with the sanitary condition of food-contact surfaces during such complex manufacturing scenarios. The comments do not provide any examples of how we have interpreted this provision in the past in a way that does not accommodate manufacturing processes such as those it describes. (Comment 272) Some comments ask us to specify that food-contact surfaces used for manufacturing/processing or holding low-moisture food be in a clean, dry, sanitary condition ``prior to use or the start of production'' instead of ``at time of use'' to more accurately reflect the reality of food processing. Some comments express concern that properly cleaned and sanitized food-contact surfaces begin to accumulate small dust particles on the surface of conveyors, sizing screens, and other equipment surfaces as soon as operations commence. These comments assert that it is unrealistic to keep the equipment in a clean, dry, sanitary condition during the entire operation. (Response 272) We have revised the regulatory text to specify that the requirement applies ``before use.'' We agree that ``before use'' more accurately describes the intent of the requirement. F. Proposed Sec. 117.35(d)(2)--Wet Cleaning We proposed that in wet processing, when cleaning is necessary to protect against cross-contact and the introduction of microorganisms into food, all food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food- contact surfaces of the equipment must be cleaned and sanitized as necessary. (Comment 273) Some comments ask us to specify that this requirement applies when cleaning is necessary to protect against allergen cross- contact or the introduction of microorganisms into food, not only when both conditions are satisfied. (Response 273) We have revised the regulatory text to specify ``necessary to protect against allergen cross-contact or the introduction of microorganisms into food.'' [[Page 56003]] G. Proposed Sec. 117.35(d)(3)--Single-Service Articles We proposed that single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food-packaging materials. We also requested comment on whether to require, rather than recommend, that single-service articles be stored in appropriate containers (78 FR 3646 at 3721). (Comment 274) Comments are mixed regarding whether to require, rather than recommend, that single-service articles be stored in appropriate containers. Some comments ask us to keep this provision as a recommendation, whereas other comments ask us to change this recommendation to a requirement. One comment asking us to retain the provision as a recommendation asserts that these practices have never resulted in a food safety risk. Other comments ask us to specify that ``single-service articles must be handled in a manner that protects against allergen cross- contact and contamination of food.'' These comments assert that the proposed use of ``must'' and ``appropriate'' in the same sentence will lead to inconsistency in determining what is ``appropriate'' for each individual situation. In addition, the comments assert that the common definition of ``handling'' encompasses ``appropriate storage, dispensing, usage, and disposal.'' (Response 274) We have decided to establish this provision as a requirement rather than as a recommendation. Articles used in the manufacturing, processing, packing, or holding of food must not cause allergen cross-contact or contamination of food, food-contact surfaces, or food-packaging materials, regardless of whether the articles are single-service or would be used multiple times. We have revised the regulatory text to accept some, but not all, of the suggestions in these comments. We deleted ``in appropriate containers'' so as not to prescribe a specific mechanism for complying with the requirement. We also deleted ``dispensed'' and ``used'' because we agree that these terms are captured by the term ``handled.'' We have not deleted ``stored'' because other provisions of these long- standing CGMPs refer to both storage and handling (see Sec. 117.35(f)) and, thus, we have not previously considered that the term ``handling'' includes ``storage'' in this context. See the regulatory text for the final provision containing all of these modifications. H. Proposed Sec. 117.35(e)--Sanitation of Non-Food-Contact Surfaces We proposed that non-food-contact surfaces of equipment used in the operation of a food plant should be cleaned in a manner and as frequently as necessary to protect against cross-contact and contamination of food, food-contact surfaces, and food-packaging materials. We also requested comment on whether to establish these recommendations as requirements (78 FR 3646 at 3722). (Comment 275) Some comments ask us to change this recommendation to a requirement to prevent the creation of insanitary conditions and the adulteration of product. (Response 275) We have revised the regulatory text to establish this recommendation as a requirement. (Comment 276) Some comments assert that it is impractical to sanitize all non-food-contact surfaces in a farm mixed-type facility and that this provision should only apply to those areas where a RAC is being transformed into a processed food. (Response 276) These comments appear to misinterpret the proposed provision, which does not require sanitizing any non-food-contact surfaces, but rather requires cleaning the non-food-contact surfaces of equipment. (See also Response 278.) (Comment 277) Some comments ask us to specify that this provision applies to non-food-contact surfaces of equipment used ``where food is exposed or in the food production sections.'' (Response 277) We decline these requests. The provision clearly addresses equipment used in the operation of a food plant, which includes food storage in addition to food production. Non-food-contact surfaces can become harborages for environmental pathogens (Ref. 55). Specifying that non-food-contact surfaces be cleaned as frequently as necessary to protect against allergen cross-contact and against contamination provides flexibility for industry and regulators to interpret this long-standing provision as appropriate to the establishment and the food being processed. (Comment 278) Some comments ask us to specify that non-food-contact surfaces be sanitized or ``sanitized where appropriate.'' Other comments assert that sanitizing of high touch areas in the non- processing areas of a food facility will help prevent transmission of public health pathogens into food processing areas. Some comments assert that sanitizing non-food-contact surfaces could also assist with minimizing risks from possible pathogen transfer to food-contact surfaces. (Response 278) We decline these requests. We acknowledge that there could be some benefit to sanitizing non-food-contact surfaces with substances that would reduce pathogens but disagree that treating non- food-contact surfaces with substances that would reduce pathogens is necessary if the surfaces are kept clean. The provision does not preclude an establishment from sanitizing non-food-contact surfaces in addition to cleaning them, if the establishment determines that doing so is necessary or prudent for its operations. See also Response 125. (Comment 279) Some comments ask us not to designate the frequency for cleaning of non-food-contact surfaces because doing so would create an unnecessary burden for smaller facilities. (Response 279) The provision does not specify the frequency for cleaning of non-food-contact surfaces. Instead, it specifies that the surfaces be cleaned ``as frequently as necessary.'' I. Proposed Sec. 117.35(f)--Storage and Handling of Cleaned Portable Equipment and Utensils We proposed that cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from cross-contact and contamination. We also requested comment on whether to establish this provision as a requirement rather than a recommendation (78 FR 3646 at 3722). (Comment 280) Comments are mixed regarding whether to require, rather than recommend, provisions for cleaned and sanitized portable equipment with food-contact surfaces and utensils. Some comments ask us to keep this provision a recommendation, whereas other comments ask us to change this recommendation to a requirement. Some comments agree that it is important that these food-contact surfaces are clean and sanitary when used, but because storage of equipment and utensils could be for an extended period of time, the comments ask us to specify that this requirement applies before the subsequent use of the equipment and utensils. (Response 280) The intent of the provision is to emphasize that equipment that is cleaned and sanitized at one location has the potential to [[Page 56004]] become contaminated or be subject to allergen cross-contact before or during movement to a location in which the equipment is used. Examples of such equipment are portable mixing kettles, tables, and slicers. We are establishing the provision as a requirement because of the importance of ensuring that food-contact surfaces are clean and sanitary at time of use. (Comment 281) Some comments assert that the manner in which this equipment is stored includes the location and therefore such wording is redundant. These comments ask us to modify the language to remove ``location.'' (Response 281) We acknowledge that ``manner'' in which the equipment is stored could be interpreted to include ``location'' but disagree that this interpretation would be universal. The storage location can affect the potential for the equipment to become contaminated or subject to allergen cross-contact, and we are retaining it in the rule. (Comment 282) Some comments state that they support the proposed revision for ``all new equipment installations being away from the wall,'' but request a waiver for equipment installed before this rule is issued. These comments ask for a clear definition of ``portable equipment'' because some large, stationary pieces of equipment may have wheels. (Response 282) The provision is directed to the storage of equipment that does not remain stationary in a given establishment, regardless of whether the equipment is designed in such a way so that it could readily be moved in that establishment or another establishment. These comments appear to misinterpret the proposed provision, which does not specify that equipment be installed away from a wall. (See also Response 296.) (Comment 283) Some comments ask us to clarify this provision to adapt industry practices for transport of watermelons because it is unrealistic and impractical to clean the carpet or replace the cardboard lining the harvest buses that transport watermelons on a regular basis. Other comments ask that the use of wooden totes to transport nuts from the field to the wash and dryer operators remains an option for this industry. (Response 283) These comments appear to have misinterpreted this provision, which relates to the storage and handling of cleaned portable equipment and utensils used within an establishment rather than to vehicles or equipment used to transport food to a location other than the establishment. XVI. Subpart B: Comments on Proposed Sec. 117.37--Sanitary Facilities and Controls We proposed to re-establish the provisions of Sec. 110.37 in new Sec. 117.37 with some revisions to modernize them. Some comments agree with one or more of these proposed provisions without change. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 285 and Comment 286). Other comments that support the proposed provisions ask us to revise or clarify current provisions that we proposed to re-establish in part 117 without change (see, e.g., Comment 290). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we proposed to re-establish in Sec. 117.37 with no changes. After considering these comments, we have revised the proposed provisions as shown in table 21, with editorial and conforming changes as shown in table 52. Table 21--Provisions for Sanitary Facilities and Controls ---------------------------------------------------------------------------------------------------------------- Did we propose revisions Did we get comments that Provision or request comment on disagreed with the Did we modify the potential revisions? proposed provision? proposed regulatory text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.37(a)--Water Supply. Yes...................... Yes...................... No. Sec. 117.37(b)--Plumbing..... No....................... No....................... No. Sec. 117.37 (b)(1), (2), and No....................... No....................... No. (3). Sec. 117.37(b)(4)--Adequate No....................... Yes...................... No. floor drainage. Sec. 117.37(b)(5)--Backflow.. Yes...................... No....................... No. Sec. 117.37(c)-- Sewage No....................... Yes...................... Yes. Disposal. Sec. 117.37(d)--Toilet Yes...................... Yes...................... No. Facilities. Sec. 117.37(e)--Hand-Washing Yes...................... Yes...................... No. Facilities. Sec. 117.37(f) --Rubbish and Yes...................... No....................... No. Offal Disposal. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.37(a)--Water Supply We proposed that the water supply must be sufficient for the operations intended and must be derived from an adequate source. Any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. (Comment 284) Some comments express concern that because the provision does not define specific microbial limits, it is possible that a packer or processor that is subject to the CGMPs for human food could have more flexibility in interpreting and following water quality expectations than a farm that will be subject to the produce safety rule. (Response 284) We expect that most facilities subject to this rule will have access to a public water supply that would not, under the provisions of the proposed produce safety rule, require testing to demonstrate that it complies with defined microbial standards. When facilities that pack or process produce subject to the produce safety rule use untreated ground water or surface water to wash produce, the measures described in the proposed produce safety rule are appropriate measures to demonstrate that water used in packing and processing of produce is safe and of adequate sanitary quality when the produce does not undergo any processing to reduce pathogens. (Comment 285) Some comments ask us to modify the requirement that water must be safe and of adequate sanitary quality by specifying that the standard [[Page 56005]] for water quality is ``as defined in 40 CFR part 141.'' These comments also ask us to specify that compliance with this requirement may be verified by any effective means, such as examination of the supplier's specifications or test reports; purchase of the water under a supplier's guarantee or certification; or analyzing the water. (Response 285) We decline these requests. The CGMP provisions apply to diverse establishments, including some establishments that do not have access to water that satisfies the drinking water requirements of 40 CFR part 141. For example, seafood processing vessels may need to use seawater to clean areas of the ship used for food processing. This long-standing provision has been in place since the umbrella CGMPs were first established and the comments do not provide any examples of food safety problems that would have been addressed by the proposed change. Moreover, the CGMP Working Group report (Ref. 3) did not identify the water quality standard as something that needed to be changed. (Comment 286) Some comments ask us to specify that running water be provided only ``at appropriate locations.'' (Response 286) We decline this request. We agree that running water must be provided only ``at appropriate locations.'' However, in the context of this provision ``appropriate locations'' means ``in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities'' as has been specified for decades. B. Proposed Sec. 117.37(b)--Plumbing We proposed that plumbing must be of adequate size and design and adequately installed and maintained to: (1) Carry sufficient quantities of water to required locations throughout the plant; (2) properly convey sewage and liquid disposable waste from the plant; (3) avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition; (4) provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and (5) provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing. (Comment 287) Some comments assert that requirements for adequate floor drainage are overly prescriptive and do not allow for any standing water subsequent to washing and sanitizing activities. (Response 287) This provision does not prohibit standing water-- e.g., during vegetable or other wet processing operations. However, floors should provide for drainage, e.g., be sloped towards drains, and standing water should be minimized to the extent possible to reduce the potential for contamination of food and food-contact surfaces. This is a long-standing provision and the comment does not provide any information as to how this has been interpreted in the past to not allow for standing water during processing or subsequent to washing and sanitizing activities. C. Proposed Sec. 117.37(c)--Sewage Disposal We proposed that sewage disposal must be made into an adequate sewerage system or disposed of through other adequate means. (Comment 288) Some comments ask us to specify that sewage ``must be disposed.'' (Response 288) We have revised the regulatory text to consistently use the verb ``dispose'' rather than to use a noun (i.e., ``disposal'') in the first clause. D. Proposed Sec. 117.37(d)--Toilet Facilities We proposed to replace the existing CGMP requirements for toilets (i.e., that each plant provide its employees with adequate, readily accessible toilet facilities, along with recommendations for how to comply with these requirements) with a requirement that each plant must provide its employees with adequate, readily accessible toilet facilities. We proposed that toilet facilities must be kept clean and must not be a potential source of contamination of food, food-contact, or food-packaging materials. We also proposed to delete the guidance on how to comply with the requirements. (Comment 289) Some comments ask us to retain the guidance we proposed to delete. Some comments ask us to retain some of the guidance and make some of it optional to allow for flexibility based on the design of the facility. Some comments provide specific editorial suggestions to include the guidance in this provision. (Response 289) We decline these requests. As noted in the final rule establishing CGMPs for dietary supplements (72 FR 34752 at 34817), it is unnecessary to require specific features because an establishment may be able to achieve compliance through other means better suited to its operations. E. Proposed Sec. 117.37(e)--Hand-Washing Facilities We proposed to replace the existing CGMP requirements for hand- washing facilities (i.e., that hand-washing facilities must be adequate and convenient and be furnished with running water at a suitable temperature, along with recommendations for how to comply with these requirements) with a requirement that each plant must provide hand- washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food- packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. We also proposed to delete the guidance on how to comply with the requirements. (Comment 290) Some comments ask us to clarify the meaning of ``suitable temperature'' in this provision. (Response 290) By ``suitable temperature,'' we mean a temperature that does not discourage employees from adequately washing hands, or from washing hands at all, because the water is either too cold or too hot. (Comment 291) Some comments ask that we specify that hot water should be provided so that this provision is more consistent with similar rules for most State and local jurisdictions that interpret ``suitable temperature'' as ``hot.'' Some comments ask whether we are deleting a current requirement for hot water to be provided at a hand- wash station. (Response 291) We are not deleting a current requirement for hot water to be provided at a hand-wash station. The comments may be mistaking our CGMP requirements with the provisions of our Food Code, which specify that a hand-washing sink shall be equipped to provide water at a temperature of at least 38 degrees C (110 degrees F) through a mixing valve or combination faucet (See section 5-202.12 of the Food Code) (Ref. 51). We decline the request to modify the regulatory text so that it requires that ``hot water'' be provided. This long-standing requirement for a ``suitable temperature,'' without specifying a requirement for ``hot water,'' means that the water should be neither too hot nor too cold to discourage personnel from washing their hands. We continue to believe that it is not necessary to specify a particular temperature or to use the subjective term ``hot.'' [[Page 56006]] XVII. Subpart B: Comments on Proposed Sec. 117.40--Equipment and Utensils We proposed to re-establish the provisions of Sec. 110.40 in new Sec. 117.40 with some revisions to modernize them. Some comments agree with one or more of these proposed provisions without change. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 301, Comment 305, and Comment 307) or ask us to clarify how we will interpret the provision (see, e.g., Comment 308). Other comments that support the proposed provisions ask us to revise or clarify current provisions that we proposed to re-establish in part 117 without change (see, e.g., Comment 292, Comment 300, and Comment 310). We also proposed to reorganize provisions found in current Sec. 110.40(a) by creating paragraph designations (a)(1) through (a)(6) with associated editorial changes. We received no comments that disagreed with this proposed redesignation and are finalizing it as proposed. In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we proposed to re-establish in Sec. 117.40 with no changes. After considering these comments, we have revised the proposed provisions as shown in table 22, with editorial and conforming changes as shown in table 52. Table 22--Provisions for Equipment and Utensils ---------------------------------------------------------------------------------------------------------------- Did we propose revisions Did we get comments that Provision or request comment on disagreed with the Did we modify the potential revisions? proposed provision? proposed regulatory text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.40(a)(1)--Design of No....................... Yes...................... No. Plant Equipment and Utensils. Sec. 117.40(a)(2)--Design No....................... Yes...................... Yes. Construction, and Use of Equipment and Utensils. Sec. 117.40(a)(3)-- Yes...................... Yes...................... Yes. Installation and Maintenance of Equipment. Sec. 117.40(a)(4)--Corrosion- No....................... Yes...................... No. Resistant Food-Contact Surfaces. Sec. 117.40(a)(5)--Food- No....................... Yes...................... Yes. Contact Surfaces and Nontoxic Materials. Sec. 117.40(a)(6)-- Yes...................... Yes...................... No. Maintenance of Food-Contact Surfaces. Sec. 117.40(b)--Seams on Food- Yes...................... Yes...................... No. Contact Surfaces. Sec. 117.40(c)--Construction No....................... Yes...................... Yes. of Equipment. Sec. 117.40(d)--Holding, No....................... Yes...................... Yes. Conveying, and Manufacturing Systems. Sec. 117.40(e)--Freezer and Yes...................... Yes...................... No. Cold Storage Compartments. Sec. 117.40(f)--Accurate and Yes...................... Yes...................... No. Precise Instruments and Controls. Sec. 117.40(g)--Compressed No....................... Yes...................... No. Air or Other Gases. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.40(a)--Design, Construction, Use, Installation, and Maintenance of Equipment and Utensils 1. Proposed Sec. 117.40(a)(1)--Design of Plant Equipment and Utensils We proposed no revisions to the requirement that all plant equipment and utensils must be so designed and of such material and workmanship as to be adequately cleanable, and must be properly maintained. (Comment 292) Some comments ask us to specify that this provision only applies to equipment and utensils used for, or in connection with, food manufacturing, processing, packing, or holding and appropriate to the stage of production it is used in. These comments assert that ``all plant equipment and utensils'' is too broad and that the requirements for cleanliness of the equipment and utensils differ at various stages of production. Other comments ask us to specify ``as needed to protect against allergen cross-contact and contamination.'' (Response 292) We agree that it is not necessary to apply the provision to all plant equipment and utensils, regardless of what the equipment is and whether it has any role in the production of food. For example, we agree that it is not necessary to apply the requirement to equipment such as welding equipment used in an establishment's machine shop. Accordingly, we have made the following modifications to the provision: (1) Specify that the provision applies to all plant equipment and utensils ``used in manufacturing, processing, packing, or holding food''; (2) specify that equipment and utensils must be ``adequately'' maintained, rather than ``properly'' maintained, to emphasize the public health goal of the requirement; and (3) specify that the purpose of the requirement is to protect against allergen cross-contact and contamination. 2. Proposed Sec. 117.40(a)(2)--Design, Construction, and Use of Equipment and Utensils We proposed no revisions to the requirement that the design, construction, and use of equipment and utensils must preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. (Comment 293) Some comments suggest editorial changes to the provision to improve clarity. (Response 293) We agree that the suggested changes improve the clarity of the provision and have incorporated them into the regulatory text. 3. Proposed Sec. 117.40(a)(3)--Installation and Maintenance of Equipment We requested comment on whether to establish the current recommendation that all equipment be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces as a requirement (78 FR 3646 at 3723). (Comment 294) Some comments assert that we should establish this recommendation as a requirement in light of recent findings of the pathogen L. monocytogenes in environmental swab samples taken from food processing plants. (Response 294) We agree with these comments that an additional reason to establish this recommendation as a requirement, in addition to the reasons we provided in the 2013 proposed preventive controls rule (78 FR 3646 at 3728), is that it could facilitate cleaning for environmental pathogens. We have revised the regulatory text to change ``should'' to ``must.'' (Comment 295) Some comments suggest that we make editorial changes, for clarity and completeness, to read ``so as to facilitate the cleaning and maintenance'' rather than ``so installed [[Page 56007]] and maintained as to facilitate the cleaning.'' (Response 295) We agree that the suggested changes improve the clarity of the provision and have incorporated them into the regulatory text. (Comment 296) Some comments support the proposed revision for ``all new equipment installations being away from the wall,'' but ask that we provide a waiver for equipment that has been installed prior to the issuance of this rulemaking. (Response 296) These comments appear to misinterpret the proposed provision, which does not specify that equipment be installed away from a wall. The requirement is to install equipment so as to facilitate both cleaning and maintenance. This provision has been a long-standing recommendation. Moreover, if the existing equipment is installed in a way that it cannot be cleaned, it would not have been in compliance with existing CGMP requirements for the design and construction of the plant (Sec. 110.20). For example, the current CGMPs have long required that the design and construction of the plant must provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food (Sec. 110.20(a)(1)). 4. Proposed Sec. 117.40(a)(4)--Corrosion-Resistant Food-Contact Surfaces We proposed no revisions to the requirement that food-contact surfaces must be corrosion-resistant when in contact with food. (Comment 297) Some comments ask us to specify that the requirement only applies where appropriate for food safety. Other comments ask us to specify that the food-contact surfaces be corrosion-resistant as appropriate to the type of food and other substances with which they come in contact. (Response 297) We decline these requests. We disagree with the implication that the condition of some food-contact surfaces would not be relevant to food safety. We also disagree that it would be acceptable for some food products to be in contact with surfaces susceptible to corrosion, regardless of the nature of the food product. 5. Proposed Sec. 117.40(a)(5)--Food-Contact Surfaces and Nontoxic Materials We proposed no revisions to the requirement that food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. (Comment 298) Some comments assert that food-contact surfaces or utensils could be dedicated to allergens only or non-allergens only. (Response 298) We agree that dedicating food-contact surfaces and utensils is one way to comply with various requirements of this rule to prevent allergen cross-contact, but disagree that we should require this particular mechanism to prevent allergen cross-contact. Other mechanisms can prevent allergen cross-contact, such as adequately cleaning equipment and surfaces between uses. (Comment 299) Some comments ask us to specify that food-contact surfaces must be made of food-grade materials and suitably durable. (Response 299) We decline these requests. Food-grade materials must be non-toxic. The comment provides no examples of circumstances in which the long-standing criterion of ``nontoxic'' is inadequate. We agree that ``suitably durable'' could be interpreted to capture the general intent of the current text that specifies ``designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents,'' but disagree that this interpretation would be universal and are retaining the long-standing regulatory text. (Comment 300) Some comments ask us to specify that food-contact surfaces must be designed to withstand cleaning procedures. (Response 300) We have revised the regulatory text to include cleaning procedures. For example, food-contact surfaces must be designed to withstand the actions of scrubbing utensils that could scratch or pit the equipment, creating cracks and crevices that could be difficult to clean and lead to a niche where environmental pathogens could lodge and potentially contaminate food produced using the equipment. 6. Proposed Sec. 117.40(a)(6))--Maintenance of Food-Contact Surfaces We proposed that food-contact surfaces must be maintained to protect food from cross-contact and from being contaminated by any source, including unlawful indirect food additives. As an inadvertent error, we specified that this requirement would be designated as Sec. 117.40(a)(5); we intended to specify that it be designated Sec. 117.40(a)(6). (Comment 301) Some comments ask us to specify that this requirement also applies to equipment and utensils but does not apply to single-use items. (Response 301) We decline these requests. As proposed, the requirement applies to all food-contact surfaces, including those on equipment and utensils; it is not necessary to separately specify that the requirement applies to equipment and utensils. We are not specifying that single-use food-contact surfaces do not need to be maintained. Using equipment or utensils that have single-use food- contact surfaces may be one way to satisfy the requirements of the provision, although single use items may still need to be protected from allergen cross-contact and from contamination, e.g., by protective packaging. (Comment 302) Some comments ask us to require that the surfaces also be appropriately cleaned and sanitized. (Response 302) We decline this request. Cleaning and sanitizing of food-contact surfaces is covered by Sec. 117.35(d) and does not need to be repeated here. (Comment 303) Some comments ask us to strike the phrase ``including unlawful indirect food additives.'' These comments assert that the wording would be equally effective without the phrase and that striking it would result in a stronger and more absolute requirement. (Response 303) We decline this request. Although some persons might realize that the provision requires them to protect against unlawful indirect food additives, such an interpretation may not be universal. B. Proposed Sec. 117.40(b)--Seams on Food-Contact Surfaces We proposed that seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter, and thus minimize the opportunity for growth of microorganisms and cross-contact. (Comment 304) Some comments assert that this provision should not apply to all establishments--e.g., that it seems directed towards bakeries but inapplicable to establishments that pack produce. (Response 304) The provision requires an establishment to minimize accumulation of food particles, dirt, and organic matter in seams on food-contact surfaces to minimize the opportunity for growth of microorganisms and allergen cross-contact and provides flexibility for how to comply with the requirement (i.e., through smoothly bonded seams or through maintenance). Minimizing the accumulation of food particles, dirt, and organic matter in seams on food-contact surfaces is appropriate for all establishments that produce food. [[Page 56008]] C. Proposed Sec. 117.40(c)--Construction of Equipment We proposed that equipment that is in the manufacturing or food- handling area and that does not come into contact with food must be so constructed that it can be kept in a clean condition. (Comment 305) Some comments ask us to specify ``areas where food is manufactured, processed, or packed'' and clarify that the equipment must be constructed so that it can be kept ``appropriately clean and sanitary.'' (Response 305) We have revised the provision to specify that it applies to areas in the plant where food is manufactured, processed, packed, or held. Doing so makes the terms in this provision consistent with terms used throughout the CGMPs (78 FR 3646 at 3692). Consistent with (Response 258, we also have modified the provision to specify that the equipment must be constructed so that it can be kept ``clean and sanitary.'' (Comment 306) Some comments ask us to consider inserting technical language to address systems used for sanitizing in food processing environments to ensure they meet generally accepted design principles for food grade equipment. Some comments ask us to specify that the equipment must be constructed of materials that will not get corroded by cleaning chemicals and that welded joints must be of non-corrosive materials and ``dressed'' to eliminate porous surfaces and occlusions. (Response 306) We decline these requests. It is not necessary to specify every type of equipment that could be used in a food processing environment or every situation that must be addressed to satisfy the specific requirements of this provision and the more general requirements of Sec. 117.40(a). D. Proposed Sec. 117.40(d)--Holding, Conveying, and Manufacturing Systems We proposed no revisions to the requirement that holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, must be of a design and construction that enables them to be maintained in an appropriate sanitary condition. (Comment 307) Some comments ask us to specify that these systems also need to be maintained in an appropriately clean condition in addition to a sanitary condition. (Response 307) Consistent with Response 258, we have revised the provision to specify that the equipment must be constructed so that it can be kept ``clean and sanitary.'' E. Proposed Sec. 117.40(e)--Freezer and Cold Storage Compartments We proposed that each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment. We also proposed to delete the recommendation that each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation. (Comment 308) Some comments ask us to clarify that this requirement is only for foods that require temperature control for food safety, and does not apply to any intact fruits or vegetables that are only held at specific temperatures for quality and shelf-life purposes. Some comments ask us to change this requirement to a recommendation for the same reason. Some comments assert that temperature control for intact fruits and vegetables is likely not always necessary or even desirable (e.g., to avoid chill damage). (Response 308) We decline this request. The requirement applies to refrigerated storage when the establishment has placed food in a refrigerated storage compartment, whether for food safety or for food quality (e.g., to prevent the growth of spoilage microorganisms). The provision, which is an existing requirement in Sec. 110.40, does not specify which foods must be refrigerated or what the refrigeration temperature must be. However, once the establishment has determined that refrigerated storage is appropriate, either for food safety or food quality, it is appropriate to require that the establishment have evidence that it is refrigerating the food as it has decided to do. F. Proposed Sec. 117.40(f)--Accurate and Precise Instruments and Controls We proposed that instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be accurate and precise and adequately maintained, and adequate in number for their designated uses. (Comment 309) Some comments ask us to specify ``calibrated'' for clarity, accuracy, and completeness. Some comments assert that proper calibration of such equipment is essential to ensure food safety, and does not entail so large a cost as to preclude even small companies from compliance. (Response 309) We decline this request. The request of this comment is already addressed by our proposal to revise this long-standing provision to require that these types of instruments be accurate, as well as precise. As discussed in Comment 519 and Response 519, some types of instruments generally are subject to accuracy checks rather than to calibration. G. Proposed Sec. 117.40(g)--Compressed Air or Other Gases We proposed no revisions to the requirement that compressed air or other gases mechanically introduced into food or used to clean food- contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives. (Comment 310) Some comments ask us to specify that compressed air or other gases must be ``filtered or otherwise treated'' for clarity. (Response 310) We decline this request. We agree that filtration is a common treatment to prevent contamination, but disagree that it is necessary to modify this long-standing requirement to add this particular example of a treatment to prevent contamination with unlawful indirect food additives. As written, the provision provides flexibility for an establishment to determine the appropriate treatment for compressed air or other gases in a manner that works best for its plant. (Comment 311) Some comments ask us to strike the phrase ``with unlawful indirect food additives.'' These comments assert that the wording would be equally effective without the phrase and that striking it would result in a stronger and more absolute requirement. (Response 311) We decline this request. Although some persons might realize that the provision requires them to protect against unlawful indirect food additives, such an interpretation may not be universal. XVIII. Subpart B: Comments on Proposed Sec. 117.80(a)--General Processes and Controls We proposed to re-establish the provisions of Sec. 110.80 in new Sec. 117.80(a) with some revisions to modernize them and with some [[Page 56009]] redesignations. Some comments support one or more of these proposed provisions without change. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 316) or ask us to clarify how we will interpret the provision (see, e.g., Comment 317). Other comments that support the proposed provisions ask us to revise or clarify current provisions that we proposed to re-establish in part 117 without change (see, e.g., Comment 312 and Comment 320). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we did not propose to revise. After considering these comments, we have revised the proposed provisions as shown in table 23, with editorial and conforming changes as shown in table 52. Table 23--Provisions for General Processes and Controls ---------------------------------------------------------------------------------------------------------------- Did we propose revisions Did we get comments that Provision or request comment on disagreed with the Did we modify the potential revisions? proposed provision? proposed regulatory text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.80(a)(1 )--Adequate No....................... Yes...................... No. sanitation principles. Sec. 117.80(a)(2)--Quality No....................... Yes...................... No. control operations. Sec. 117.80(a)(3)-- No....................... Yes...................... No. Supervising overall sanitation. Sec. 117.80(a)(4)--Production Yes...................... Yes...................... Yes. procedures. Sec. 117.80(a)(5)--Chemical, Yes...................... Yes...................... No. microbial, or extraneous- material testing procedures. Sec. 117.80(a)(6)-- No....................... Yes...................... No. Contaminated food. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.80(a)(1)--Adequate Sanitation Principles We proposed no revisions to the requirements of current Sec. 110.80 (proposed Sec. 117.80(a)(1)) that all operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspecting, transporting, and segregating) be conducted in accordance with adequate sanitation principles. (Comment 312) Some comments ask us to clarity ``adequate sanitation principles.'' Some of these comments express concern that facilities receiving raw produce that will be further cleaned or processed will be unable to meet this requirement and assert that this requirement will not provide additional public health benefits. (Response 312) These comments fail to explain how we have interpreted the provision in a way that has been problematic such that clarification is necessary. The term ``adequate'' is a long-standing term that we defined in its current form when we first established the umbrella CGMPs in 1969 (34 FR 6977 at 6978). Furthermore, during a previous rulemaking to revise the umbrella CGMPs and establish current Sec. 110.80 we explained that the phrase ``adequate sanitation principles'' must be broad so that industry can easily adapt sanitation principles to its existing procedures (51 FR 22458 at 22461). (Comment 313) Some comments ask us to specify that operations be conducted in accordance with adequate sanitation principles ``specific to the operation'' to provide for extended time intervals between sanitation procedures. These comments explain that in the case of low- moisture almonds, sanitation intervals may be extended in order to minimize addition of water into the facility. (Response 313) We decline this request. By specifying that sanitation principles must be ``adequate,'' the provision already provides flexibility such as that requested by these comments. In addition, the rule does not specify any time intervals for conducting sanitation operations and, thus, the provision needs no qualification to provide flexibility for an establishment to adopt a frequency of sanitation procedures consistent with its operations. B. Proposed Sec. 117.80(a)(2)--Quality Control Operations We proposed no revisions to the requirements of current Sec. 110.80 (proposed Sec. 117.80(a)(2)) that appropriate quality control operations be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. (Comment 314) Some comments assert that specifying that food- packaging materials must be ``safe and suitable'' is confusing because the definition for ``safe and suitable'' at Sec. 130.3(d) defines the phrase with respect to ingredients. (Response 314) The requirement is a long-standing provision that has been used in this context for decades. When we first proposed this provision during a previous rulemaking to revise the umbrella CGMPs, we included this exact phrase and did not receive any comments regarding its use (44 FR 33238 at 33246). Furthermore, as evidence that industry commonly understands the use of the term ``suitable'' in the context of CGMP requirements in addition to requirements applicable to ingredients used in standardized foods, we note that we substituted the term ``suitable'' for ``fit'' in another provision (Sec. 110.80(a)(1)) in response to comments from industry stating that ``suitable'' was a more familiar term than ``fit'' (51 FR 22458 at 22470). C. Proposed Sec. 117.80(a)(3)--Supervision of Overall Sanitation We proposed no revisions to the requirements of current Sec. 110.80 (proposed Sec. 117.80(a)(3)) that overall sanitation of the plant be under the supervision of one or more competent individuals assigned responsibility for this function. (Comment 315) Some comments ask us to revise this provision to specify that it applies to overall cleaning of the plant, as well as overall sanitation of the plant. (Response 315) We decline this request. Sanitation is a general term that already encompasses cleaning (and, as appropriate, sanitizing). D. Proposed Sec. 117.80(a)(4)--Production Procedures We proposed that all reasonable precautions must be taken to ensure that production procedures do not contribute to cross-contact and contamination from any source. (Comment 316) Some comments assert that the phrase ``all reasonable precautions'' is too extreme and prescriptive and suggest that ``adequate'' would be more appropriate than ``all'' to [[Page 56010]] describe the intended measures and precautions. (Response 316) We agree that ``adequate'' is more appropriate than ``all'' and have substituted the word ``adequate'' for ``all reasonable'' in the final rule. E. Proposed Sec. 117.80(a)(5)--Chemical, Microbial, or Extraneous- Material Testing Procedures We proposed that chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible cross-contact and food contamination. (Comment 317) Some comments ask whether the word ``must'' in the provision means that testing will always be required, including for food allergens. Other comments assert that testing should only be used when there is reason to suspect a specific problem has occurred and when methods are available. (Response 317) Testing is not always required. The provision provides flexibility for an establishment to test when appropriate, such as when a facility determines that it is necessary to use rapid ATP (adenosine triphosphate) swabs as an indicator of microbial or food residue contamination to verify cleaning of a line prior to running a different product (Ref. 56). Facilities commonly conduct tests on food for microorganisms that indicate sanitation failures, such as testing for total plate count, generic E. coli, total coliforms, etc. (Ref. 57). When the number of such organisms exceeds expectation, sanitation or other failures are suspected and the facility can take actions to determine the source of the problem. (Comment 318) Some comments oppose any implication that food manufacturers are required to develop test methods or analytical standards, or search out methods that are not readily available, for this or any other purpose. (Response 318) The provision does not require food manufacturers to develop test methods or analytical standards, or search out methods that are not readily available. (Comment 319) Some comments suggest that testing as part of an environmental monitoring program should be risk-based and include allergens, but should not be required for finished product. (Response 319) The provision does not use the term ``environmental monitoring,'' which is a term that has come to be associated with monitoring for environmental pathogens rather than for other substances that may contaminate the food processing environment. Likewise, the provision does not establish requirements for environmental monitoring for finished product. As discussed in Response 317, the provision provides flexibility for an establishment to test when testing is appropriate, such as when the facility determines testing would be useful to verify adherence to CGMPs or when there is a problem such as allergen cross-contact. F. Proposed Sec. 117.80(a)(6)--Contaminated Food We proposed no revisions to the requirements of current Sec. 110.80 (proposed Sec. 117.80(a)(6)) that all food that has become contaminated to the extent that it is adulterated be rejected, or if permissible, treated or processed to eliminate the contamination. (Comment 320) Some comments assert that the use of the phrase ``if permissible'' is vague and confusing and should be replaced by a statement of precisely what is impermissible. (Response 320) We acknowledge that the phrase ``if permissible'' does not communicate the circumstances under which it is permissible to treat or process a food to eliminate contamination. Rather than add such circumstances to the rule, we have replaced the phrase ``if permissible'' with ``if appropriate.'' In the following paragraphs, we discuss examples of when treatment or processing to eliminate contamination would or would not be appropriate. Some RACs, such as cocoa beans, can become adulterated with insects or filth but may be fumigated or cleaned in accordance with an application for reconditioning submitted to FDA to bring the product into compliance. Acid or acidified canned goods with microbial contamination due to a container defect may be reconditioned by sorting out the defective containers to ensure that containers released into commerce are intact and the product is not contaminated. Tree nuts with signs of mold growth can be reconditioned using methods that separate the moldy nuts from those that are not contaminated. Tree nuts found to be contaminated with Salmonella may be treated by processes such as steam or propylene oxide when such treatments have been validated to provide an adequate reduction of Salmonella. A heat-treated food contaminated from the environment, such as a heat-treated, dried protein product, can sometimes be rehydrated, and a food establishment could repeat the processing to reduce pathogens. Other products, such as many types of produce, are not normally processed to reduce pathogens, and product quality may be impacted by such treatments. Even though processing techniques such as irradiation have the potential to reduce pathogens, irradiation is a food additive that requires approval. For example, as of January 15, 2015, irradiation had been approved for control of foodborne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach, but not in other fresh leafy greens. Using irradiation for a purpose that has not been approved (such as for the irradiation of fresh leafy greens other than fresh iceberg lettuce and fresh spinach) would render the food adulterated under section 402(a)(2)(C)(i) of the FD&C Act and, thus, it would not be appropriate to treat or process fresh leafy greens other than fresh iceberg lettuce and fresh spinach using irradiation. XIX. Subpart B: Comments on Proposed Sec. 117.80(b)--Processes and Controls for Raw Materials and Other Ingredients We proposed to re-establish the provisions of Sec. 110.80(a) in new Sec. 117.80(b) with some revisions to modernize them. Some comments support one or more of these proposed provisions without change. For example, some comments support a new provision that would require raw materials and ingredients that are food allergens, and rework that contains food allergens, to be identified and held in a manner that prevents allergen cross-contact. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 324, Comment 325, Comment 328, and Comment 329) or ask us to clarify how we will interpret the provision (see, e.g., Comment 323 and Comment 327). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we did not propose to revise. After considering these comments, we have revised the proposed provisions as shown in table 24, with editorial and conforming changes as shown in table 52. [[Page 56011]] Table 24--Provisions for Processes and Controls for Raw Materials and Other Ingredients ---------------------------------------------------------------------------------------------------------------- Did we propose revisions Did we get comments that Provision or request comment on disagreed with the Did we modify the potential revisions? proposed provision? proposed regulatory text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.80(b)(1)-- Yes...................... Yes...................... Yes. Inspection, storage, and handling of raw materials and other ingredients. Sec. 117.80(b)(2)--Levels of Yes...................... Yes...................... No. microorganisms in raw materials and other ingredients. Sec. 117.80(b)(3)--Natural Yes...................... Yes...................... No. toxins in raw materials and other ingredients. Sec. 117.80(b)(4)--Pests, Yes...................... Yes...................... No. undesirable microorganisms, and extraneous material in raw materials and other ingredients. Sec. 117.80(b)(5)--Holding Yes...................... Yes...................... No. raw materials, other ingredients, and rework in bulk. Sec. 117.80(b)(6)--Frozen raw No....................... No....................... No. materials and other ingredients. Sec. 117.80(b)(7)--Liquid and Yes...................... Yes...................... No. dry raw materials and other ingredients. Sec. 117.80(b)(8)--Raw Yes...................... Yes...................... No. materials and other ingredients that are food allergens. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.80(b)(1)--Inspection, Segregation and Handling of Raw Materials and Other Ingredients We proposed that raw materials and ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and must be stored under conditions that will protect against cross-contact and contamination and minimize deterioration. Raw materials must be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food must be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food or cause cross-contact. We also proposed to continue to recommend that containers and carriers of raw materials be inspected on receipt to ensure that their condition has not contributed to cross-contact, contamination, or deterioration. However, we also requested comment on whether to establish this recommendation as a requirement (78 FR 3646 at 3724). (Comment 321) Some comments express concern about revising current Sec. 110.80(a)(1) to require, rather than recommend, that containers and carriers of raw materials be inspected on receipt. Some comments focus on practical problems associated with inspecting bins containing RACs such as produce. These comments explain that produce bins received by a packing establishment are too large to be handled directly and instead are delivered by a fork lift followed by automated travel through the establishment. (Response 321) We agree that circumstances such as those described in these comments make it appropriate to continue to recommend, but not require, that containers and carriers of raw materials be inspected on receipt to ensure that their condition has not contributed to allergen cross-contact, contamination, or deterioration. Therefore, we are not re-establishing this nonbinding recommendation as a requirement. Instead, as discussed in Response 67, we have deleted this non-binding provision from the rule. B. Proposed Sec. 117.80(b)(2)--Levels of Microorganisms in Raw Materials and Other Ingredients We proposed that raw materials and ingredients must either not contain levels of microorganisms that may render the food injurious to health of humans, or they must be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated. We also proposed to delete guidance regarding how to comply with this requirement. (Comment 322) Some comments ask us to supply the list of microorganisms that may render the food injurious to the health of humans. Some comments assert that we would have to establish acceptable pathogen concentration limits in order for industry to comply with this provision. (Response 322) We are not providing a list of microorganisms that may render the food injurious to the health of humans. CGMPs establish procedural requirements, not declarations of foods that are adulterated. It is not necessary for us to establish acceptable pathogen concentration limits in order for industry to comply with this provision. Moreover, several Compliance Policy Guides (CPGs) provide guidance to our investigators about agency policies that apply when food is contaminated with microorganisms, and these CPGs are available to industry (Ref. 58) (Ref. 59) (Ref. 60) (Ref. 61) (Ref. 62). (Comment 323) Some comments express concern about the requirement for pasteurization, explaining that fresh produce cannot be pasteurized. (Response 323) The proposed provision would not require pasteurization of products such as produce. The proposed provision clearly states that pasteurization or other treatment is only required when raw materials and other ingredients contain levels of microorganisms that may render the food injurious to health of humans. However, when products such as produce contain levels of microorganisms that may render the food injurious to health of humans, and the products cannot be pasteurized or otherwise treated so that they no longer contain levels that would cause the product to be adulterated, other provisions require that the product be rejected and disposed of in a manner that protects against the contamination of other food (see, e.g., Sec. Sec. 117.80(a)(6) and 117.80(c)(9)). (Comment 324) Some comments assert that this requirement is overly broad and should only apply to RTE food. These comments express the view that we should not focus on the issue of microbiological contamination in foods that are early in the supply chain (other than produce that will be consumed without adequate processing or cooking). Some comments suggest adding a statement to be provided in commercial documentation accompanying the sale of produce not covered by the proposed produce safety rule to alert potential purchasers to the hazard that may exist and allow them to determine whether the food offered for sale is suitable for their particular needs or whether the food requires commercial formulation, processing, or both to adequately reduce microorganisms. (Response 324) It is not necessary to narrow this requirement to RTE food to [[Page 56012]] provide for use of raw materials and other ingredients that are early in the supply chain. The requirement already clearly provides for pasteurization or other treatment during manufacturing operations so that the processed product would no longer contain levels that would cause the product to be adulterated. See also our previous discussion of the importance of this provision during a previous rulemaking to revise the umbrella CGMPs (51 FR 22458 at 22470). We decline the request to require a statement in commercial documentation when produce is not covered by the produce safety rule. As discussed in section XXVII, we are providing for a narrow use of commercial documentation, when a manufacturer/processor that has identified a hazard requiring a preventive control does not establish a preventive control because it: (1) Relies on its customer to ensure that an identified hazard will be controlled and (2) discloses, in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]'' (See Sec. 117.136(a)(2), (3), and (4)). That use of commercial documentation reflects the outcome of a hazard analysis--in particular, an outcome in which the manufacturer/processor determines that a hazard requires a preventive control. The vast majority of the produce that we proposed would not be subject to the requirements of the forthcoming produce safety rule would either be produce that is going to commercial processing that adequately reduces the presence of microorganisms of public health significance or produce that is rarely consumed raw. Thus, there would be no benefit to alert potential purchasers to a hazard because such produce has been determined to be low-risk, based on the findings of a qualitative assessment of risk (e.g., for produce rarely consumed raw) or because it will not go directly to the consumer but to commercial processing to adequately reduce pathogens. We see no reason to also establish a broad CGMP requirement that would apply regardless of the outcome of a hazard analysis. C. Proposed Sec. 117.80(b)(3)--Natural Toxins in Raw Materials and Other Ingredients We proposed that raw materials and ingredients susceptible to contamination with aflatoxin or other natural toxins comply with current FDA regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. We also proposed to delete guidance regarding how to comply with this requirement and to delete a requirement for compliance with action levels, which are not binding. (Comment 325) Some comments ask us to delete ``aflatoxin'' from the provision because it is redundant with ``other natural toxin.'' (Response 325) We decline this request. Aflatoxin is an important natural toxin that is an example illustrating what we mean when we refer to ``natural toxins.'' An illustrative example does not create a redundancy. D. Proposed Sec. 117.80(b)(4)--Pests, Undesirable Microorganisms and Extraneous Materials in Raw Materials and Other Ingredients We proposed that raw materials, ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material must comply with applicable FDA regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. We also proposed to delete guidance regarding how to comply with this requirement and to delete the requirement for compliance with action levels, which are not binding. (Comment 326) Some comments ask us to qualify that the requirement does not apply if the manufacturing process includes steps that serve to decontaminate the food. (Response 326) We decline this request. We have defined ``defect action level'' to mean a level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product ``adulterated'' and subject to enforcement action under section 402(a)(3) of the FD&C Act (see Sec. 117.3). It is not uncommon for an establishment to receive raw materials (such as RACs) that contain extraneous material that is removed before production. For example, some methods of harvesting vegetable RACs (e.g., pulling up most of the plant material in the field) result in inclusion of extraneous material that is removed during initial cleaning steps at processing facilities. It is not necessary to revise this long-standing requirement to provide for such common procedures. Moreover, in general we use the term ``decontaminate'' to refer to an action taken when the substance is a hazardous substance (such as a pathogen) rather than to a non-hazardous substance. E. Proposed Sec. 117.80(b)(5)--Holding Raw Materials, Other Ingredients, and Rework in Bulk We proposed that raw materials, ingredients, and rework must be held in bulk, or in containers designed and constructed so as to protect against cross-contact and contamination and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such. (Comment 327) Some comments express concern that this requirement would make the use of wooden bins in the produce industry problematic and ask us to clarify whether it is our intent to prohibit use of wooden bins. Some comments ask us to clarify whether the provision would preclude using or storing containers (such as trailers and gondolas used in the produce industry) outdoors because such containers cannot be covered. (Response 327) We do not intend to interpret this provision in such a way that would prohibit the use of wooden bins in the produce industry or preclude using and storing containers such as trailers and gondolas outside. Importantly, these CGMP requirements are long- standing provisions that we have not interpreted as prohibiting wooden containers in the produce industry. See also our ``Guide to Produce Farm Investigations'' (Ref. 63), which applies during investigations when an outbreak and traceback investigation implicates a farm and related operations, or as a follow-up to a produce sample that tests positive for contamination with a pathogen. (Comment 328) Some comments ask us to add ``in-process'' materials to the provision. (Response 328) We decline this request, which is already covered by Sec. 117.80(c)(7). We note that the requirements directed to raw materials and other ingredients are established in Sec. 117.80(b), whereas the requirements directed to in-process materials are established in Sec. 117.80(c). F. Proposed Sec. 117.80(b)(7)--Liquid or Dry Raw Materials and Other Ingredients We proposed that liquid or dry raw materials and ingredients received and stored in bulk form must be held in a manner that protects against cross-contact and contamination. (Comment 329) Some comments ask us to revise the proposed provision to clarify that liquid or dry raw materials and ingredients received and stored in bulk form must be held in a manner that [[Page 56013]] protects against deterioration, as well as in a manner that protects against allergen cross-contact and contamination. (Response 329) We decline this request. The rule already requires that raw materials and ingredients be stored under conditions that will minimize deterioration (see Sec. 117.80(b)(1)). G. Proposed Sec. 117.80(b)(8)--Raw Materials and Other Ingredients That Are Food Allergens We proposed to establish a new requirement that raw materials and ingredients that are food allergens, and rework that contains food allergens, be identified and held in a manner that prevents cross- contact. (Comment 330) Some comments ask us to exempt finished, packaged product that is later reworked from the proposed requirement. (Response 330) We decline this request. A product that is in finished, packaged form, including label information that identifies any food allergen, would be in compliance with the requirement and need not be exempted. However, when a product is packaged, but not yet labeled, it is necessary to identify the product in a way (other than a product label) that would prevent allergen cross-contact while the packaged product is being held. For example, shelves holding the product before labeling operations could have a sign such as ``Contains peanuts.'' (Comment 331) Some comments ask us to modify the proposed requirement to specify that it applies to raw materials and ingredients that ``are or contain'' food allergens and that it applies to in- process material, as well as to raw materials and ingredients and to rework. These comments explain that such modifications would provide clarity and completeness. (Response 331) We decline these requests. The rule defines ``food allergen'' to mean a major food allergen as defined in section 201(qq) of the FD&C Act, and section 201(qq) of the FD&C Act already specifies that a major food allergen is a food that is one of several specified foods and food groups, or contains protein derived from one of these foods or food groups (78 FR 3646 at 3697). Thus, the request that the provisions be directed to raw materials and other ingredients that ``are or contain'' food allergens is already addressed in the definition of food allergen. Requirements applicable to in-process material are addressed in Sec. 117.80(c)(5). XX. Subpart B: Comments on Proposed Sec. 117.80(c)--Manufacturing Operations We proposed that current Sec. 110.80(b) would become proposed Sec. 117.80(c). We also proposed revisions to all provisions that would be established in Sec. 117.80(c) except for the provisions that would be established in Sec. 117.80(c)(1) and (c)(16). Some comments support one or more of these proposed provisions without change. For example, some comments support provisions directed to control of, or preventing contamination with, undesirable microorganisms during manufacturing, storage, and handling. Other comments that support the proposed provisions suggest alternative regulatory text (see, e.g., Comment 334) or ask us to clarify how we will interpret the provision (see, e.g., Comment 345 and Comment 346). Other comments that support the proposed provisions ask us to revise or clarify provisions that we proposed to re-establish in part 117 without change (see, e.g., Comment 333). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we did not propose to revise. After considering these comments, we have revised the proposed provisions as shown in table 25, with editorial and conforming changes as shown in table 52. Table 25--Provisions for Processes and Controls for Manufacturing Operations ---------------------------------------------------------------------------------------------------------------- Did we propose revisions or request Did we get comments Did we modify the Provision comment on potential that disagreed with the proposed regulatory revisions? proposed provision? text? ---------------------------------------------------------------------------------------------------------------- Sec. 117.80(c)(1)--Condition of No..................... Yes.................... Yes. equipment, utensils, and finished food containers. Sec. 117.80(c)(2)--Conditions and Yes.................... Yes.................... Yes. controls for food manufacturing, processing, packing, and holding. Sec. 117.80(c)(3)--Food that can Yes.................... Yes.................... No. support the rapid growth of undesirable microorganisms. Sec. 117.80(c)(4)--Measures to Yes.................... Yes.................... No. destroy or prevent the growth of undesirable microorganisms. Sec. 117.80(c)(5)--Work-in-Process Yes.................... Yes.................... No. and Rework. Sec. 117.80(c)(6)--Finished food... Yes.................... Yes.................... No. Sec. 117.80(c)(7)--Equipment, Yes.................... Yes.................... No. containers, and utensils. Sec. 117.80(c)(8)--Metal and other Yes.................... Yes.................... Yes. extraneous material. Sec. 117.80(c)(9)--Disposal of Yes.................... Yes.................... Yes. adulterated food, raw materials, and other ingredients. Sec. 117.80(c)(10)--Manufacturing Yes.................... No..................... Yes. operations. Sec. 117.80(c)(11)--Heat blanching, Yes.................... Yes.................... Yes. and growth and contamination by thermophilic microorganisms, during manufacturing operations. Sec. 117.80(c)(12)--Batters, Yes.................... Yes.................... Yes. breading, sauces, gravies, dressings, and other similar preparations. Sec. 117.80(c)(13)--Filling, Yes.................... Yes.................... No. Assembling, Packaging and Other Operations. Sec. 117.80(c)(14)--Food that Yes.................... Yes.................... Yes. relies on the control of water activity for preventing the growth of undesirable microorganisms. Sec. 117.80(c)(15)--Food that Yes.................... Yes.................... Yes. relies on the control of pH for preventing the growth of undesirable microorganisms. Sec. 117.80(c)(16)--Requirements No..................... Yes.................... Yes. for ice used in contact with food. [[Page 56014]] Sec. 117.80(c)(17)--Food- Yes (proposed to Yes.................... No (deleted as manufacturing areas and equipment. delete). proposed). ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.80(c)(1)--Condition of Equipment, Utensils, and Finished Food Containers We proposed no revisions to the requirements of current Sec. 110.80(b)(1) (proposed Sec. 117.80(c)(1)) that equipment and utensils and finished food containers be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment must be taken apart for thorough cleaning. (Comment 332) Some comments assert that this provision precludes the use of wooden bins, because wooden bins cannot be sanitized. (Response 332) This requirement is a long-standing provision that provides flexibility for an establishment to sanitize when appropriate by specifying that equipment, utensils, and food containers be sanitized ``as necessary.'' For example, equipment food-contact surfaces are usually sanitized after cleaning to minimize the potential for contaminating food with undesirable microorganisms that accumulate during processing and grow in food residues on the equipment. When containers such as wooden bins cannot be sanitized, the establishment is responsible for taking appropriate steps to adequately clean and maintain the containers to minimize the potential for contaminating food with undesirable microorganisms. To clarify that the standard governing the condition of the equipment, utensils, and finished food containers is the same public health standard that applies to other provisions in Sec. 117.80, we have revised the provision to specify that containers be kept in ``adequate'' condition rather than ``acceptable'' condition. (Comment 333) Some comments ask us to delete the term ``finished'' from ``finished food containers'' so that the requirements applicable to the condition of equipment, utensils, and food containers will be more complete. (Response 333) We agree that the requirements should apply to all food containers used during manufacturing operations, not just to ``finished food containers.'' We note that we received comments about the most appropriate adjective to describe the food containers subject to this requirement during the rulemaking to establish this provision in part 110. (See the discussion at 51 FR 22458 at 22471, in which we responded to comments asking us to change ``finished product container to ``bulk product container'' by explaining that finished product containers includes bulk product containers.) Rather than perpetuate questions as to how we are interpreting ``finished,'' we have deleted this adjective. B. Proposed Sec. 117.80(c)(2)--Conditions and Controls for Food Manufacturing, Processing, Packing, and Holding We proposed that all food manufacturing, processing, packing, and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of food. We also proposed to delete guidance regarding how to comply with this requirement. (Comment 334) Some comments ask us to add ``in-process materials and rework,'' ``cross-contact,'' and ``or deterioration'' for clarity and completeness. (Response 334) We agree that adding ``allergen cross-contact'' is necessary for completeness and have revised the proposed provision to include it. We also agree that the provision needs to address deterioration; doing so is consistent with the requirements applicable to raw materials and other ingredients (see Sec. 117.80(b)(1)). We decline the request to add ``in-process materials and rework'' to this provision because in-process materials and rework are already covered by the phrase ``all food.'' C. Proposed Sec. 117.80(c)(3)--Food That Can Support the Rapid Growth of Undesirable Microorganisms We proposed that all food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding. We also proposed to delete recommendations for how to comply with this requirement. (Comment 335) Some comments ask us to keep requirements for specific temperatures for holding hot food and cold food because there is a direct correlation between temperature abuse and growth of pathogenic bacteria. (Response 335) We agree that temperature abuse can lead to growth of pathogenic bacteria. Importantly, the temperatures that have been in current Sec. 110.80(b)(3) were recommendations rather than requirements. As discussed in Response 67, we have deleted non-binding provisions from the rule and intend to issue guidance that will include much of the guidance that we have deleted from the umbrella CGMPs. As noted in the 2013 proposed human preventive controls rule (see table 8, 78 FR 3646 at 3715), the temperatures needed for safe holding may vary and the diversity of food to which the provision applies makes it inappropriate to specify these temperatures in regulation. There is information available currently on appropriate temperatures for a variety of foods (e.g., in the Food Code (Ref. 51) and the PMO (Ref. 64)). Moreover, a continued approach to specific temperatures for holding hot food and cold food through non-binding guidance is particularly appropriate because we can reasonably expect ongoing scientific advances that would alter our thinking on appropriate temperatures to hold hot food and cold food. (Comment 336) Some comments ask us to require that food that can support the rapid growth of undesirable microorganisms be held at temperatures or ``in another manner'' that will prevent the food from becoming adulterated. These comments assert that current or future technology may provide other means of preventing microbial growth besides temperature controls--e.g., through use of pressure or in another as[hyphen]yet[hyphen]unforeseen manner. (Response 336) We agree that current or future technology may provide other means of preventing microbial growth besides temperature controls. However, we disagree that it is necessary to modify the requirement to provide for preventing microbial growth by means other than temperature control, because the provision does not identify specific temperatures that must be used to prevent the food from becoming adulterated. If, for example, a food that currently requires refrigeration to [[Page 56015]] prevent adulteration becomes shelf-stable as a result of new technology, the provision as written would allow the food to be held at room temperature rather than under refrigeration. D. Proposed Sec. 117.80(c)(4))--Measures To Destroy or Prevent the Growth of Undesirable Microorganisms We proposed that measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling water activity that are taken to destroy or prevent the growth of undesirable microorganisms must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated. (Comment 337) Some comments express concern that the measures listed could be interpreted as an exhaustive list of processing methods and, thus, hinder the development of new technologies. These comments suggest adding ``or other measures'' at the end of the list. (Response 337) The phrase ``such as'' indicates that these are examples of processing methods and that the list is not all inclusive. We believe that the list of examples and wording of the provision adequately express the intent behind this provision and allow the use of other measures without the suggested addition. E. Proposed Sec. 117.80(c)(5)--Work-in-Process and Rework We proposed that work-in-process and rework must be handled in a manner that protects against cross-contact, contamination, and growth of undesirable microorganisms. (Comment 338) Comments that address this proposed requirement ask us to use the term ``in-process materials'' rather than ``work-in- process.'' (Response 338) As discussed in Response 71, we decline this request. F. Proposed Sec. 117.80(c)(6)--Finished Food We proposed that effective measures must be taken to protect finished food from cross-contact and contamination by raw materials, ingredients, or refuse. When raw materials, ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in cross- contact or contaminated food. Food transported by conveyor must be protected against cross-contact and contamination as necessary. (Comment 339) Some comments ask us to specify that raw materials, ingredients, or refuse that are unprotected not be handled simultaneously in ``the same area'' rather than in ``a receiving, loading, or shipping area.'' The comments assert that this would be clearer. (Response 339) We decline this request. We narrowly directed the provision to address the potential for allergen cross-contact and for contamination by unprotected raw materials, ingredients, and refuse when finished food is in a receiving, loading, or shipping area. Broadening the provision to prohibit handling raw materials, ingredients, or refuse in the same area as finished food would imply that raw materials, ingredients, or refuse will never be handled in the production area where they may be needed or generated during production. (Comment 340) Some comments ask us to revise the provision to add ``in-process'' food and ``cleaning and sanitizing agents, and other chemicals'' for clarity and completeness. (Response 340) We decline this request. Work-in-process foods are covered separately in Sec. 117.80(c)(5), and cleaning and sanitizing agents are addressed in the requirements for sanitary operations (see Sec. 117.35(b)(2)). G. Proposed Sec. 117.80(c)(7)--Equipment, Containers, and Utensils We proposed that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food must be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against cross-contact and contamination. (Comment 341) Some comments ask us to specify that the equipment, containers, and utensils also must be cleaned and sanitized during manufacturing, processing, packing, and holding in a manner that protects against cross[hyphen]contact and against contamination. (Response 341) We decline this request. Cleaning and sanitizing are addressed in the requirements for sanitary operations (see Sec. 117.35(a)) and do not need to be addressed again in the requirements for manufacturing operations. (Comment 342) Some comments ask us to add the phrase ``where appropriate for food safety'' at the beginning of the provision because food gases are manufactured, held, and distributed in a closed pressurized system and are therefore not exposed to personnel or environmental conditions where there is an impact on food safety. (Response 342) We decline this request. The closed pressurized system described by the comment appears to satisfy the requirements of the provision, as would other systems commonly used in the food industry. The purpose of the provision is to set the standard; it is not necessary to add that no specific actions are necessary for those systems that inherently comply with the requirement. H. Proposed Sec. 117.80(c)(8)--Metal or Other Extraneous Material We proposed that effective measures must be taken to protect against the inclusion of metal or other extraneous material in food and to delete guidance regarding how to comply with this requirement. (Comment 343) Some comments assert that it could be more effective from the perspective of food safety to use a risk-based approach to implementing protective measures against the inclusion of metal or other extraneous material in food. These comments assert that the risk of inclusion of metal is higher in cut fruits or vegetables than in fresh whole fruits or vegetables and, thus, the measures used to protect against the inclusion of metal should be different in cut fruits or vegetables than in fresh whole fruits or vegetables. (Response 343) We agree that the measures used to protect against the inclusion of metal likely will be different for cut fruits or vegetables than for fresh whole fruits or vegetables and that a risk- based approach can be helpful in determining how to comply with the requirement. To emphasize the utility of a risk-based approach, we have revised the provision to require ``adequate'' measures rather than ``effective'' measures; as defined in the rule (see Sec. 117.3), the term ``adequate'' means that which is needed to accomplish the intended purpose in keeping with good public health practice. I. Proposed Sec. 117.80(c)(9)--Disposal of Adulterated Food, Raw Materials, and Other Ingredients We proposed that food, raw materials, and ingredients that are adulterated must be disposed of in a manner that protects against the contamination of other food or, if the adulterated food is capable of being reconditioned, it must be reconditioned using a method that has been proven to be effective. We also proposed an editorial change to make clear that reconditioning, rather than disposal, is an option and to delete a provision that could be viewed as providing an option to simply [[Page 56016]] reexamine adulterated food and subsequently find it not to be adulterated. (Comment 344) Some comments ask us to retain the provision to reexamine adulterated food and subsequently find it not to be adulterated. These comments explain that there are processes that can remove contaminants such as pesticides and heavy metals from foods such as botanical extracts. Although laboratory studies or small[hyphen]scale pilot batches may give an indication that the reconditioning is likely to be effective, they cannot always guarantee the treatment will be equally effective when scaled up to commercial[hyphen]scale production batches. Because these methods have not been ``proven to be effective,'' the appropriate approach to determining whether the reconditioned food is no longer adulterated is reexamination after the reconditioning is complete. (Response 344) We agree with these comments and have revised the provision to make clearer that reexamination can only be used to subsequently find that the food is not adulterated after the food has been reconditioned. See the regulatory text of Sec. 117.80(c)(9). (Comment 345) Some comments ask us to clarify that the provision only applies if the food has actually been found to be adulterated. The comments assert that the provision should not apply where product has been placed ``on hold'' due to an equipment failure (e.g., if product is put on hold due to an inoperative metal detector until the establishment can retest for potential metal contaminants). (Response 345) The provision only applies if the food is adulterated. In the example described in these comments, if the food is not adulterated, the establishment would not need to dispose of, or recondition, the product. (Comment 346) Some comments ask us to clarify that the provision does not apply to grains subject to the review inspection provisions provided for by 7 CFR 800.125 and 800.135. (Response 346) In many cases, grains subject to the review inspection provisions provided for by 7 CFR 800.125 and 800.135 are RACs that are being held or transported by an establishment solely engaged in holding or transporting RACs and subpart B (including Sec. 117.80(c)(8)) would not apply to the grains (see Sec. 117.5(k)). In addition, as noted in Response 345, this provision only applies to food that is adulterated. J. Proposed Sec. 117.80(c)(10)--Performing Manufacturing Steps We proposed that steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming must be performed so as to protect food against cross-contact and contamination. We proposed that food should be protected from contaminants that may drip, drain, or be drawn into food and requested comment on whether to establish the recommendation regarding physical protection of food from contaminants that may drip, drain, or be drawn into the food as a requirement (78 FR 3646 at 3726). We also proposed to delete two recommendations regarding adequate cleaning and sanitizing of food- contact surfaces and regarding the use of time and temperature controls. (Comment 347) Some comments agree that we should require, rather than recommend, that food be protected from contaminants that may drip, drain, or be drawn into food. Other comments express concern that turning the current recommendation into a requirement could lead to a de facto requirement for closed systems to be used in food production. Some comments ask us to specify that the requirements only apply where food is exposed. (Response 347) We agree that we should require, rather than recommend, that food be protected from contaminants that may drip, drain, or be drawn into food. We have not revised the regulatory text to specify that the requirements only apply where food is exposed, because such protections would only be needed if foods are exposed to such conditions. Such a requirement would not lead to a de facto requirement for a closed system, because this is not the only way to protect food from such contaminants. For example, covers can be used on kettles and tanks, and shields can be placed over conveyor lines. K. Proposed Sec. 117.80(c)(11)--Heat Blanching and Growth and Contamination by Thermophilic Microorganisms During Manufacturing Operations We proposed that heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. We proposed that thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperature and by periodic cleaning and requested comment on whether to establish these two recommendations as requirements (78 FR 3646 at 3726). (Comment 348) Some comments support establishing the recommendations in this provision as requirements. Other comments oppose doing so and assert that these detailed steps may not be important to protect the public health. (Response 348) We disagree that the use of adequate operating temperature and periodic cleaning are not important to protect public health. Improper cooling can lead to growth of pathogenic sporeforming bacteria if product remains too long at temperatures that support their multiplication. In addition, growth of thermophiles, while not a public health issue, can lead to product spoilage, and, thus, adulteration. We are establishing these two recommendations as requirements in the regulatory text, along with associated editorial changes. L. Proposed Sec. 117.80(c)(12)--Batters, Breading, Sauces, Gravies, Dressings, and Other Similar Preparations We proposed that batters, breading, sauces, gravies, dressings, and other similar preparations must be treated or maintained in such a manner that they are protected against cross-contact and contamination. We also proposed to clarify that these steps require protection against cross-contact and to delete the recommendations for how to comply with this requirement. (Comment 349) Some comments agree that we should delete the provided examples of mechanisms to achieve compliance. (Response 349) We have deleted the examples as proposed. (Comment 350) Some comments ask us to modify the provision to clarify that it applies to preparations that are held and used repeatedly over time and to add ``dipping solutions'' as another example of such a preparation. (Response 350) We agree that the provision applies to preparations that are held and used repeatedly over time and that ``dipping solutions'' is a useful example to add. We have revised the regulatory text as requested by these comments. (Comment 351) Some comments ask us to add that another purpose of the requirement is to minimize the potential for the growth of undesirable microorganisms. (Response 351) This request would promote consistency in the requirements throughout Sec. 117.80 and [[Page 56017]] we have revised the regulatory text accordingly. M. Proposed Sec. 117.80(c)(13)--Filling, Assembling, Packaging and Other Operations We proposed that filling, assembling, packaging, and other operations must be performed in such a way that the food is protected against cross-contact, contamination, and growth of undesirable microorganisms. We also proposed to delete the recommendations for achieving compliance with this requirement. (Comment 352) Some comments ask us to specify that the requirement applies only to finished food to differentiate it from other provisions in Sec. 117.80 and assert that without the modification the provision would be redundant. (Response 352) The specific requirements of Sec. 117.80(c)(13) are not redundant with other provisions in Sec. 117.80. The long-standing provisions of Sec. 117.80 first address general requirements (Sec. 117.80(a)) and then address more specific requirements applicable to raw materials and other ingredients (Sec. 117.80(b)) and manufacturing operations (Sec. 117.80(c)). Although the comment does not define ``finished food,'' we consider that term to apply to a packaged and labeled food product; filling, assembling, and packaging operations would be conducted on in-process food to create a finished product. Regardless of whether the appropriate term would be ``finished'' or ``in-process food,'' the comment provides no reason for why this long- standing provision is not clear without specifying the production stage of a food product that is subject to filling, assembling, and packaging operations. N. Proposed Sec. 117.80(c)(14)--Food That Relies on the Control of Water Activity for Preventing the Growth of Undesirable Microorganisms We proposed that food, including dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of water activity for preventing the growth of undesirable microorganisms must be processed to, and maintained at, a safe moisture level. We also proposed to delete the recommendations for achieving compliance with this requirement. (Comment 353) Some comments assert that moisture level is not an adequate food safety control measure. The comments ask us to revise the requirement to reflect that it is the proper maintenance of water activity, rather than moisture level, that will prevent growth of undesirable microorganisms. (Response 353) The rule defines safe moisture level as a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product and notes that the safe moisture level is related to water activity (Sec. 117.3). Although in most cases water activity is the most suitable measurement to predict food safety, moisture content is frequently used to assess the stability of grains and nuts with respect to prevention of growth and mycotoxin production by molds. We are retaining the term ``safe moisture level'' as a broader term that takes into account the fact that measuring moisture level and measuring water activity are both common industry practice and, depending on the food, can be measures that are appropriate to assess safety. The comments provide no basis for the assertion that this long-standing provision is not an adequate food safety measure. (Comment 354) Some comments assert that water activity may not be the only factor responsible for preventing the growth of undesirable microorganisms in dry products and ask us to modify the regulatory text to take into account other synergistic barriers for microbial growth and toxin formation. (Response 354) We agree with these comments and have revised the regulatory text to clarify that such products rely ``principally'' on the control of water activity. (Comment 355) Some comments assert that nuts should be ``maintained'' at an appropriate moisture level rather than ``processed to'' an appropriate moisture level. (Response 355) We acknowledge that some products need only be ``maintained'' at a safe moisture level and may not need to be processed to achieve that level. However, we disagree that it is necessary to modify this long-standing requirement to specify this distinction. The comments do not provide examples of how we have been interpreting this provision in a way that does not accommodate the differences in products. (Comment 356) Some comments ask us to more closely adhere to the current regulatory text (i.e., food, such as dry mixes . . .) rather than the proposed regulatory text (i.e., food, including dry mixes . . .). (Response 356) The final rule retains the long-standing language ``such as'' as requested by the comments. (See also the discussion in Response 68.) O. Proposed Sec. 117.80(c)(15)--Food That Relies on the Control of pH for Preventing the Growth of Undesirable Microorganisms We proposed that food, including acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at a pH of 4.6 or below. We also proposed to delete the recommendations for how to comply with this requirement. (Comment 357) Some comments ask us to use the term ``equilibrated pH'' or ``finished equilibrium pH'' for consistency with part 114. Some comments ask us to add a definition for ``equilibrated pH'' in Sec. 117.3. (Response 357) We decline these requests. It is not necessary for this long-standing provision in the umbrella food CGMPs to use specialty terms used in the more specific CGMPs that apply to acidified foods in order to make clear that the operative pH for the safety of such foods is 4.6 or below. (Comment 358) Some comments ask us to more closely adhere to the current language (i.e., food such as acid and acidified food . . .) rather than the proposed language (i.e., food, including acid food and acidified food . . .) to make it clear that the list is not intended to be complete. (Response 358) The final rule retains the long-standing language ``such as'' as requested by the comments. (See also the discussion in Response 68.) P. Proposed Sec. 117.80(c)(16)--Requirements for Ice Used in Contact With Food We proposed no revisions to the requirements of current Sec. 110.80(b)(16) (proposed Sec. 117.80(c)(16)) that when ice is used in contact with food, it must be made from water that is safe and of adequate sanitary quality, and must be used only if it has been manufactured in accordance with current good manufacturing practice. (Comment 359) Some comments ask us to replace the requirement that water must be safe and of adequate sanitary quality with a cross- reference to the water quality requirements of Sec. 117.37(a). (Response 359) We acknowledge that cross-referencing the water quality requirements established in Sec. 117.37(a), without describing those requirements, would accurately convey the requirements for ice used in contact with food. However, we believe there is value added by continuing to emphasize the water quality standard within the requirements for ice used in contact [[Page 56018]] with food. We have added a cross-reference to Sec. 117.37(a) but have not deleted ``safe and of adequate sanitary quality.'' Q. Proposed Deletion of Current Sec. 110.80(b)(17)--Food-Manufacturing Areas and Equipment We proposed to delete the current recommendation that food- manufacturing areas and equipment used for manufacturing human food not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food. We tentatively concluded that this recommendation would be more appropriate in guidance, which could include examples of situations where there is no reasonable possibility for the contamination of the human food. (Comment 360) Some comments ask us to retain this provision for clarity and as a means to educate small, foreign, and new food processors. (Response 360) We decline this request. The focus of the provision is to emphasize the importance of manufacturing food in a way that prevents contamination. Other provisions (such as Sec. Sec. 117.10(b), 117.20(a), 117.35(a), 117.40(a)(1), 117.80(a), and 117.93) already require that an establishment prevent contamination from any source. (See also the discussion in Response 67 about our decision to delete those non-binding provisions of part 110 that we are not establishing as requirements.) XXI. Subpart B: Comments on Proposed Sec. 117.93--Warehousing and Distribution Current Sec. 110.93 requires that storage and transportation of finished food be under conditions that will protect food against physical, chemical, and microbial contamination, as well as against deterioration of the food and the container. We proposed a series of revisions to these current requirements--i.e., to apply the requirements to ``food'' rather than to ``finished food''; clarify that storage and transportation of food must be under conditions that will protect against allergen cross-contact in addition to protecting against contamination of food; add radiological hazards as an additional category of contaminants; and require protection against ``biological,'' rather than ``microbial'' contamination. With all of these revisions, we proposed that storage and transportation of food must be under conditions that will protect against cross-contact and biological, chemical, physical, and radiological contamination of food, as well as against deterioration of the food and the container. Some comments support one or more of these proposed revisions without change. For example, some comments support adding radiological hazards as an additional category of contaminants to the list of contaminants which may be encountered in warehousing and distribution because food may be subject to contamination with radiological hazards. Other comments that support the proposed provisions suggest alternative regulatory text (see, e.g., Comment 361) or ask us to clarify how we will interpret the provision (see, e.g., Comment 363). In the following sections, we discuss comments that ask us to clarify the proposed provision or that disagree with, or suggest one or more changes to, the proposed provision. After considering these comments, we are finalizing the provision as proposed (see table 26), with editorial and conforming changes as shown in table 52. Table 26--Provisions for Warehousing and Distribution ---------------------------------------------------------------------------------------------------------------- Did we propose revisions or request Did we get comments Did we modify the Provision comment on potential that disagreed with the proposed regulatory revisions? proposed provision? text? ---------------------------------------------------------------------------------------------------------------- 117.93--Warehousing and distribution. Yes.................... Yes.................... No. ---------------------------------------------------------------------------------------------------------------- (Comment 361) Some comments express concern that produce will spoil and deteriorate even under the best conditions. These comments ask us to modify the proposed requirements to address these concerns, such as by specifying that the conditions will ``reasonably protect'' or by revising ``will protect'' to ``will minimize to acceptable levels.'' (Response 361) We decline this request. In some cases, this provision will not apply to produce (i.e., when the produce is a RAC subject to the exemption for an establishment solely engaged in the holding or transportation of one or more RACs; see Sec. 117.5(k)). When the produce is not subject to the RAC exemption (e.g., when the produce is being handled in a fresh-cut processing facility), requiring storage and transportation of produce under the conditions specified in the provision is appropriate. The comments provide no basis that we have been enforcing this long-standing provision in a manner that does not acknowledge practical issues associated with the short shelf life of produce in such facilities and, thus, that modifications such as those suggested by the comments are necessary. (Comment 362) Some comments assert that regulations directed to radiological hazards will act as a double regulation to hinder amicable trade activities and will increase economic burden to manufacturers. As discussed in Comment 410, these same comments ask us to provide that a facility subject to the requirements for hazard analysis and risk-based preventive controls may rely on existing systems in place to manage radiological risks, such as steps taken by government officials to inspect ingredients obtained from a geographic region that has been the subject of a nuclear accident. (Response 362) See Response 410 for a discussion of how a facility may consider existing systems in place to manage radiological risks, but still has responsibilities to establish and implement preventive controls to address a radiological hazard when circumstances warrant. The comment provides no basis for its assertion that regulations directed to radiological hazards will act as a double regulation to hinder amicable trade activities and will increase economic burden to manufacturers. (Comment 363) Some comments support our proposal to specify that the requirements apply to ``food'' rather than to ``finished food,'' provided that doing so does not affect common and safe practices for the transportation of RACs, such as transporting raw produce from the field, or from packinghouses, in open top containers such as field boxes, totes and gondola trucks. (Response 363) As discussed in the 2013 proposed human preventive controls rule, we proposed to apply the CGMP requirements for storage and transportation to ``food'' rather than ``finished food'' to ensure food safety throughout the food chain, regardless of whether a food product is a raw material or ingredient or in its finished state (78 [[Page 56019]] FR 3646 at 3727). We intend this revision to clarify that the CGMP provisions for warehousing and distribution apply to raw materials and ingredients, including RACs. When a food establishment that stores and transports RACs is subject to the CGMP provisions, common and safe storage and transportation practices such as those described in our 1998 guidance entitled ``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (Ref. 13) would be appropriate. (Comment 364) As noted in Response 324, under the proposed produce safety rule a farm that produces covered produce that is distributed for commercial processing would be required to maintain documentation of the identity of the recipient of the commercial processor. Some comments appear to assume that a farm might distribute such products with information disclosing that such produce was not grown in compliance with part 112, should not be consumed raw, and/or requires commercial processing. These comments ask us to add a provision that no food whose labels, labeling, or commercial documentation accompanying the sale contain any of the following notices may be sold or otherwise distributed to any user except a commercial processor: Not grown in compliance with part 112; Not for fresh or raw consumption; May require commercial formulation, processing, or both to adequately reduce microorganisms. (Response 364) We decline to add such a provision to the CGMP requirements for distribution of food. As noted in Response 324, we do not see a benefit to labeling produce as indicated because we believe that the vast majority of such produce is low risk. However, as also noted in Response 324, we are providing for a narrow use of commercial documentation, which would include produce, when a manufacturer/ processor that has identified a hazard requiring a preventive control does not establish a preventive control because it: (1) Relies on its customer to ensure that an identified hazard will be controlled and (2) discloses, in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]'' (See Sec. 117.136(a)(2), (3), and (4)). XXII. Subpart B: Comments on Proposed Sec. 117.110 (Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazards) We proposed to revise the current provisions directed to natural or unavoidable defects in food for human use that present no health hazard. Some comments support one or more of these proposed provisions without change. Other comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 365, Comment 367, and Comment 368). In the following sections, we discuss comments that ask us to clarify the proposed provisions or that disagree with, or suggest one or more changes to, the proposed provisions, including comments on provisions that we did not propose to revise. After considering these comments, we have revised the proposed provisions as shown in table 27, with editorial and conforming changes as shown in table 52. Table 27--Provisions for Defect Action Levels ---------------------------------------------------------------------------------------------------------------- Did we propose revisions or request Did we get comments Did we modify the Provision comment on potential that disagreed with the proposed regulatory revisions? proposed provision? text? ---------------------------------------------------------------------------------------------------------------- 117.110(a) and (b)--Description of No..................... Yes.................... Yes. defect action levels. 117.110(c)--Quality control Yes.................... Yes.................... No. operations that reduce natural or unavoidable defects to the lowest level currently feasible. 117.110(d)--Mixing adulterated food Yes.................... Yes.................... Yes. with food that is not adulterated. 117.110(e)--How to obtain the booklet Yes (proposed to Yes.................... Yes (provided Internet ``Defect Action Levels''. delete). address). ---------------------------------------------------------------------------------------------------------------- We proposed that some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The proposed provisions specify that FDA establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action. The proposed provisions also specify that defect action levels are established for foods when it is necessary and feasible to do so, and that these levels are subject to change upon the development of new technology or the availability of new information (proposed Sec. 117.110(a) and (b)). We also proposed that compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the FD&C Act that food not be prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health, or the requirements in part 117 that food manufacturers, processers, packers, and holders must observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, processor, packer and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible (proposed Sec. 117.110(c)). We also proposed that the mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food. (Proposed Sec. 117.110(d)). We proposed to delete current Sec. 110.110(e), which specifies that a Defect Levels Handbook (a compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard) may be obtained upon request from the Center for Food Safety and Applied Nutrition. (Comment 365) Some comments assert that the word ``defects'' may cause confusion in industry, because the term ``defects'' is commonly used to describe quality or physical type attributes that do not pose a risk to [[Page 56020]] public health. These comments ask us to consider using another term, such as ``contaminant,'' in place of the term ``defect.'' (Response 365) We decline this request. The specific term requested by the comments (i.e., contaminant) often carries the connotation of hazardous to health. However, we have added a definition of the term ``defect action level'' to the rule (see Response 165 and Sec. 117.3). The defined term makes clear that the term does not refer to quality or physical type attributes such as those described in the comments. We also have deleted the first two full paragraphs of the proposed provision (proposed Sec. 117.110(a) and (b)), which are no longer necessary to provide context about the regulatory impact of the term ``defect action level,'' because the new definition of ``defect action level'' explains that a defect action level is a level of a non- hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product ``adulterated'' and subject to enforcement action under section 402(a)(3) of the FD&C Act. (Comment 366) Some comments assert that a facility subject to this provision will implement both CGMPs and a food safety plan as guiding ``quality control operations'' appropriate for this purpose. These comments also assert that reducing natural or unavoidable defects to ``the lowest level currently feasible'' does not require a facility to exceed CGMPs or go beyond preventive controls identified through a hazard analysis. In the view of these comments, doing so would run contrary to the risk-based principles that underlie FSMA and leading food safety programs by requiring that all hazards be managed equally without considering the outcomes of the hazard analysis. These comments assert that successful, responsible food safety programs allocate resources to hazards commensurate with their potential impact to the public health. (Response 366) We agree that reducing natural or unavoidable defects to ``the lowest level currently feasible'' does not require a facility to exceed CGMPs or go beyond preventive controls identified through a hazard analysis. (Comment 367) Some comments assert that the word ``reduce'' in Sec. 117.110 (c) may not be appropriate for all facilities. As an example, the comments explain that a brownskin almond facility that solely sizes and sorts product before packaging may not have processes to reduce microbial contaminants. Instead, that facility may rely upon custom processors to reduce the level of microbial contamination. In such a case, these comments note that it would be more accurate for the provision to specify using quality control operations that ensure the lowest level currently feasible for natural or unavoidable defects. (Response 367) We have not revised the provision to account for circumstances such as those described in these comments. We acknowledge that the production of some food products requires that food pass through multiple facilities before the finished food is distributed into commerce, and that a specific pathogen reduction step may occur at only one of the applicable facilities. The comments do not provide any examples of how we have interpreted this long-standing provision in the past in a way that creates practical problems when applying the provision to facilities such as those described in the comments. (Comment 368) Some comments ask us to retain the provision, in Sec. 110.110(e), specifying that the Defect Levels Handbook may be obtained upon request from the Center for Food Safety and Applied Nutrition. These comments also ask us to add an FDA Web site where the handbook may be obtained. (Response 368) We have added a reference to the Defect Levels Handbook (Ref. 36) to the provisions as examples of defect action levels that may render food adulterated, including an address on the FDA Web site where this handbook may be obtained. XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and Risk-Based Preventive Controls In the 2014 supplemental human preventive controls notice, we proposed a series of changes to proposed subpart C and reopened the comment period specifically with respect to these changes. The proposed changes included: (1) Eliminating the term ``hazard reasonably likely to occur'' throughout proposed subpart C (and, thus, deleting the definition we had proposed for this term); (2) adding a new defined term, ``significant hazard,'' and, in general, using this new term instead of ``hazard reasonably likely to occur'' throughout the re- proposed regulations; (3) defining ``known or reasonably foreseeable hazard'' in place of ``reasonably foreseeable hazard'' and clarifying that the new term means a hazard ``that has the potential to be associated with the facility or the food'' rather than ``a potential . . . hazard that may be associated with the facility or the food''; and (4) providing additional flexibility to address concerns about re- writing existing plans or programs to conform with the requirement of the human preventive controls rule. We received many comments on the overall framework for hazard analysis and risk-based preventive controls. We discuss each of these comments in the discussion of the specific regulatory text applicable to each comment. We show highlights of the changes we made after considering these comments in table 28. Table 28--Revisions to the Overall Framework for Hazard Analysis and Risk-Based Preventive Controls ------------------------------------------------------------------------ Section Description Revision ------------------------------------------------------------------------ 117.3........................... Definition of Revise the ``significant proposed term hazard''. ``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 control. 117.3........................... Definition of Define the term ``corrections''. ``correction'' to distinguish ``corrections'' from ``corrective actions.'' 117.135(c)(1), 117.140(a), Flexibility in Clarify that 117.145, 117.155(a), preventive preventive 117.160(a), 117.165(a), controls and control 117.165(b). preventive management control components depend management on the role of a components for preventive monitoring, control in the corrective facility's food actions and safety system, as corrections, and well as the verification. nature of the preventive control. 117.130(b)(1), 117.130(b)(2).... Hazard Emphasize that the identification. hazard identification focuses on known or reasonably foreseeable hazards (rather than on all hazards). [[Page 56021]] 117.145(c)...................... Monitoring records Provide for the use of ``exception records'' for monitoring preventive controls. 117.150(a)...................... Corrective action Clarify that procedures. corrective action procedures depend on the nature of the hazard. 117.150(c)...................... Corrections....... Provide for additional circumstances when corrections, rather than corrective actions, are warranted. 117.160(c)...................... Preventive Clarify that a controls that do list of not require preventive validation. controls that do not require validation is not an exhaustive list. 117.165(a)(5)................... Activities to Clarify that there verify could be implementation alternative and effectiveness. verification activities of implementation and effectiveness other than those that we specify in the rule. 117.165(b)...................... Written procedures Clarify that for verification written of implementation procedures for and effectiveness. verification of implementation and effectiveness are established and implemented as appropriate to the role of the preventive control in the facility's food safety system, as well as appropriate to the facility, the food, and the nature of the preventive control. 117.170(b)...................... Reanalysis........ Provide for reanalysis of an applicable portion of the food safety plan (rather than the complete food safety plan) in specified circumstances. ------------------------------------------------------------------------ XXIV. Subpart C: Comments on Proposed Sec. 117.126--Food Safety Plan We proposed requirements for a food safety plan. Some comments support the proposed requirements without change. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 377 and Comment 381) or ask us to clarify how we will interpret the provision (see, e.g., Comment 370). In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we are finalizing the provisions as proposed, with editorial and conforming changes as shown in table 52. We proposed that the food safety plan be under the oversight of one or more ``qualified individuals.'' As discussed in section IX.C.25, we have changed the proposed term ``qualified individual'' to ``preventive controls qualified individual'' because we are establishing a new definition for ``qualified individual,'' with a meaning distinct from ``preventive controls qualified individual.'' To minimize the potential for confusion for when the term ``qualified individual'' refers to the proposed meaning of the term and when the term ``qualified individual'' refers to the meaning of that term as finalized in this rule, in the remainder of this document we substitute the new term ``preventive controls qualified individual'' for the proposed term ``qualified individual,'' even though the proposed rule used the term ``qualified individual.'' Likewise, we substitute the new term ``preventive controls qualified individual'' for the proposed term ``qualified individual'' when describing the comments to the proposed rule, even though those comments use the term ``qualified individual.'' We proposed that several other provisions of subpart C be under the oversight of a ``qualified individual'' (now ``preventive controls qualified individual''), and also proposed requirements that would apply to the ``qualified individual'' (now ``preventive controls qualified individual''). See, e.g., Sec. Sec. 117.160, 117.165, 117.170, 117.180, 117.190, and 117.206). As discussed in the preceding paragraph, in the remainder of this document, we substitute the new term ``preventive controls qualified individual'' for the proposed term ``qualified individual,'' when describing these proposed provisions and the comments to these proposed provisions. A. Proposed Sec. 117.126(a)(1)--Requirement for a Food Safety Plan We proposed that you must prepare, or have prepared, and implement a written food safety plan. (Comment 369) Some comments ask us to emphasize that ``written'' means ``any type of recordable and reproducible format'' (e.g., as paper or electronic documents). Some comments ask us to specify that the components of the food safety plan need not be in a single document or stored in one place. (Response 369) A ``written'' food safety plan can be either a paper document or an electronic document, as provided by Sec. 117.305(a). The final rule specifies that required information (which would include the food safety plan) does not need to be kept in one set of records (see Sec. 117.330 (b)), and a food safety plan may be prepared as a set of documents kept in different locations within the facility (e.g., based on where they will be used), provided that each set of documents is onsite. As provided in the recordkeeping provisions, electronic records are considered to be onsite if they are accessible from an onsite location. (Comment 370) Some comments agree with our previous statements that facilities should be able to group food types or production method types if hazards, control measures, parameters, and required procedures, such as monitoring, are identical (78 FR 3646 at 3730). These comments note that exceptions should be carefully delineated and followed as appropriate. Some comments ask us to clarify that we will allow food safety plans to share common provisions where there are uniform systems in place. Some comments ask us to clarify whether one plan is required for the facility or for each crop/food item individually. (Response 370) We are requiring that a facility have a written food safety plan that covers all the foods that it manufactures, processes, packs, or holds. We recognize that, to the extent that the controls are the same, there may be common controls that broadly apply to some or all of a facility's food products. However, any product- or process- specific differences must be carefully delineated and observed in practice. In some facilities with limited types of products, the written food safety plan may contain a single set of procedures that addresses all of the products produced. For example, a facility [[Page 56022]] making fruit-flavored beverages may be able to address all of its beverages in the same set of procedures. For other facilities, there may not be a practical way to group the products and the written food safety plan may need to contain more than one set of procedures to address all of its products. For example, a facility that makes both RTE entrees and entrees that are not RTE may choose to group the RTE entrees in one set of procedures, but have a separate set of procedures for the entrees that are not RTE. However, to the extent that some of the written procedures in the food safety plan are the same for both RTE entrees and entrees that are not RTE, the facility need not duplicate those procedures in its written food safety plan. For example, a facility that uses an electronic food safety plan could store written procedures in multiple folders in the electronic system, and the food safety plan for individual products (or groups of products) could simply hyperlink to the written procedures applicable to each product. Likewise, a facility that uses a paper-based food safety plan could store written procedures in a binder or file cabinet, with written cross-references to procedures that apply to more than one product. (Comment 371) Some comments ask us to provide that the food safety plan be handled at the corporate level rather than the facility level if a corporation owns many facilities. (Response 371) A corporation may designate an individual at the corporate level as the owner, operator, or agent in charge of a particular facility. In addition, an employee of the corporation, whether at headquarters or at another facility owned by the corporation, may provide input into a particular facility's food safety plan. As previously discussed, the food safety plan needs to be facility specific (see the discussion of the facility-based nature of the food safety plan in the 2013 proposed human preventive controls rule, 78 FR 3646 at 3732). For example, even if a corporation makes similar products at two separate facilities, it is unlikely that the two facilities have exactly the same equipment and layout. Procedural instructions must be tailored to the equipment being used, and the layout of a facility may affect its approach to preventive controls such as food allergen controls. (Comment 372) Some comments ask us to provide for facilities that have HACCP plans to build off their existing HACCP programs. As an example, these comments state that we could allow facilities to use terms like ``critical limits'' for process controls rather than require these foundational documents to be rewritten simply to change terminology. (Response 372) A facility that has a HACCP plan (or other food safety plan) in place before this rule becomes effective can build off its existing program and can rely on existing records, supplemented as necessary to include all of the required information and satisfy the requirements of this rule (see Sec. 117.330). The rule does not preclude the use of terms like ``critical limits'' that are associated with HACCP systems. (Comment 373) Some comments ask us to provide templates that facilities can use as models to develop their food safety plans. Some comments ask us to accept Good Agricultural Practices (GAPs) food safety plan formats and/or HACCP plans. Some comments provide specific templates for us to consider. (Response 373) We decline the request to provide templates for facilities to use to develop their food safety plans. The rule does not specify the format of a food safety plan, and a facility has flexibility to format its food safety plan in a way that works best for the facility, provided that the plan includes all required information. In general, internationally recognized food safety plan formats would be acceptable, although modification and supplementation may be necessary to comply with all requirements of the rule (see Sec. 117.330 on the use and adaptation of existing records). Training materials being developed by the FSPCA may be useful in developing food safety plans (see Response 2). We note that activities of farm mixed-type facilities that are within the ``farm'' definition (e.g., packing and holding RACs) are not subject to the human preventive controls rule. However, to the extent that some components of GAPs-based food safety plans are relevant to a facility (e.g., for an off-farm packinghouse), the facility has flexibility to format its plan in a way that is consistent with GAPs- based food safety plans. (Comment 374) Some comments ask us to clarify that a food safety plan is not required when a facility is exempt as a qualified facility (Sec. 117.5(a)) or as a facility solely engaged in the storage of packaged food that is not exposed to the environment (Sec. 117.7). (Response 374) A qualified facility is exempt from the requirements of subparts C and G, including the requirement to prepare and implement a food safety plan, and is instead subject to the modified requirements in Sec. 117.201. Likewise, a facility solely engaged in the storage of packaged food that is not exposed to the environment is exempt from the requirements of subparts C and G, including the requirement to prepare and implement a food safety plan, and is instead subject to the modified requirements in Sec. 117.206. (Comment 375) Some comments ask us to clarify that a food safety plan is not required for facilities that store unexposed, refrigerated, packaged TCS foods. (Response 375) We agree that a facility ``solely engaged'' in the storage of unexposed, refrigerated, packaged TCS food is exempt from the requirements of subparts C and G, including the requirement to prepare and implement a food safety plan, and is instead is subject to the modified requirements in Sec. 117.206 (see Sec. 117.7). However, if a facility engages in other activities in addition to the storage of unexposed, refrigerated, packaged TCS foods, the exemption does not apply. In such a case, the facility must prepare and implement a food safety plan. However, the modified requirements of Sec. 117.206 can be informative with respect to what the food safety plan could include regarding the storage of unexposed, refrigerated, packaged TCS food. (Comment 376) Some comments ask us to explain why a written food safety plan is necessary, because adoption of a HACCP system is only voluntary under the Codex General Principles of Food Hygiene. (Response 376) The requirement to prepare and implement a written food safety plan is required by U.S. law (i.e., by section 418(h) of the FD&C Act). In contrast, Codex standards are recommendations for voluntary application by members and, thus, Codex provisions are only mandatory if the standard is adopted by a country in its national legislation. B. Proposed Sec. 117.126(a)(2)--Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual We proposed that the food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. (Comment 377) Some comments ask us to provide for a group of preventive controls qualified individuals to prepare, or oversee the preparation of, a food safety plan. (Response 377) The proposed regulatory text included in the 2014 supplemental human preventive controls notice provides for the food safety plan to be prepared, or its [[Page 56023]] preparation overseen, by one or more preventive controls qualified individuals, and we are finalizing that provision as proposed. (Comment 378) Some comments ask us to specify that oversight of the food safety plan is voluntary rather than required. (Response 378) We decline this request. The food safety plan is the foundation for a preventive approach to producing safe food. As previously discussed, the food safety plan must be designed to identify, and to significantly minimize or prevent, hazards for the purpose of preventing illness or injury (78 FR 3646 at 3731). The comments fail to explain how a facility could ensure the proper design of an effective food safety plan without oversight by an individual who satisfies the minimum requirements for a preventive controls qualified individual (see the discussion of the requirements for a preventive controls qualified individual in section XXXVI). (Comment 379) Some comments assert that oversight of the food safety plan by a preventive controls qualified individual should not be required for products subject to the PMO because the production of such products is subject to the NCIMS process. (Response 379) As discussed in Response 214, we agree we should make use of the existing system of oversight provided for by NCIMS, which has been part of a cooperative program among the U.S. Public Health Service/FDA, the States, and the dairy industry since 1950, and we have provided an extended compliance date in order that the PMO be revised for consistency with this rule. Under a revised PMO, Grade ``A'' facilities would need a preventive controls qualified individual to make decisions about hazards and verification procedures such as environmental monitoring specific to a facility and to review food safety records. (Comment 380) Some comments express concern about the cost associated with oversight of the food safety plan by a preventive controls qualified individual, regardless of whether the preventive controls qualified individual is employed by the facility or is a third party. These comments focus on the burden that this oversight would place on farms and small businesses, and note that the food industry is a ``low margin'' industry. Some comments ask us to provide for an officer or employee of a State agricultural agency to provide oversight of the food safety plan, because such persons have the most specialized knowledge concerning that State, it is more efficient for State officials to travel to nearby farms, and farmers feel more comfortable working with State employees. (Response 380) A farm is not subject to this rule for activities within the ``farm'' definition. A farm mixed-type facility that is a small or very small business and only conducts the low-risk activity/ food combinations specified in Sec. 117.5(g) and (h) is exempt from the requirements of subparts C and G, including the requirement for oversight of the food safety plan by a preventive controls qualified individual. Furthermore, a farm mixed-type facility that is a very small business, but does not satisfy the criteria for the exemptions specified in Sec. 117.5(g) and (h), is a qualified facility that is exempt from the requirements of subparts C and G, and is instead subject to modified requirements that do not require oversight of a food safety plan by a preventive controls qualified individual. Moreover, we expect that some training materials and courses will be available online, thereby helping to mitigate costs, both associated with training of a preventive controls qualified individual and loss of production manpower during training. We disagree that it would be appropriate for an officer or employee of a State agricultural agency to provide oversight of the food safety plan. The food safety plan and its oversight are the responsibility of the facility, not State government officials. The role of an officer or employee of a State agricultural agency would be in determining whether the applicable facility is in compliance with the rule, such as during inspection. State extension agents may be available to assist small businesses, even if those agents are not the designated preventive controls qualified individual for the facility, provided that such agents do not also have any role in determining whether the applicable facility is in compliance with the rule. We acknowledge that oversight of a food safety plan by a preventive controls qualified individual is a cost associated with the rule, and we have accounted for that cost in the FRIA for this rule (Ref. 38). To minimize the burden on the smallest businesses, the definition of ``very small business'' establishes a $1,000,000 threshold, adjusted for inflation, during the 3-year period preceding the applicable calendar year. As already noted, a facility that satisfies the definition of very small business is exempt from the requirements of subparts C and G and instead is subject to modified requirements (see Sec. 117.201), which do not require a food safety plan that is prepared or overseen by a preventive controls qualified individual. C. Proposed Sec. 117.126(b)--Contents of a Food Safety Plan We proposed that the written food safety plan must include the written hazard analysis, preventive controls (including the supplier program and the recall plan), procedures for monitoring the implementation of the preventive controls, corrective action procedures, and verification procedures. As discussed in more detail in section XLII, we have revised the phrase ``supplier program'' to ``supply-chain program'' throughout the regulatory text. In the remainder of this document, we use the phrase ``supply-chain program'' in section headings and when referring to the provisions of the final rule. We continue to use the term ``supplier program'' when describing the proposed provisions and the comments regarding the proposed provisions. (Comment 381) Some comments ask us to specify that sanitation controls must be in the food safety plan. Some comments ask us to require equipment standards in the food safety plan, noting that it is not possible to clean and sanitize equipment that is not designed and constructed to be cleanable by meeting specific standards. (Response 381) Sanitation controls are one type of preventive control. As appropriate to the facility and the food (e.g., to control hazards such as environmental pathogens), sanitation controls for cleanliness of food-contact surfaces and prevention of allergen cross- contact and cross contamination would be required to be in the food safety plan (Sec. 117.135(c)(3)). We are not adding a requirement to include equipment standards in the food safety plan. The CGMPs established in subpart B already require that all plant equipment and utensils be so designed and of such material and workmanship so to be adequately cleanable (Sec. 117.40(a)(1)). It is not practical to specify equipment standards in the CGMPs due to the wide range of equipment used by the food industry, including equipment subject to ongoing development and improvement. (Comment 382) Some comments ask us to recognize that existing HACCP plans, such as those developed in accordance with the EU 2004 Food Hygiene law and GFSI-compliant food safety plans, can satisfy the requirements for what must be in a food safety plan. (Response 382) To the extent that an existing HACCP plan or GFSI- compliant food safety plan includes all required information, a facility can use such [[Page 56024]] plans to meet the requirements of this rule. We expect that many existing plans will need only minor supplementation to fully comply with these requirements. Relying on existing records, with supplementation as necessary to demonstrate compliance with the requirements of the human preventive controls rule, is acceptable (see Sec. 117.330). (Comment 383) Some comments ask us to explain the differences between the food safety plan being established to implement FSMA and HACCP plans established under current requirements or guidelines for HACCP systems. These comments ask us to provide exporters with background information and specific examples of differences, including how firms are directed to set their critical control points and critical limits. (Response 383) Table 29 compares the provisions of the food safety plan required by this rule to the provisions of HACCP plans in some current requirements or guidelines for HACCP systems. See also the discussion in the 2013 proposed human preventive controls rule (78 FR 3646 at 3730-3732) and our memorandum comparing the provisions of this rule to various existing domestic and international HACCP-based standards (Ref. 65). This rule does not specify how a facility would identify any applicable CCPs or critical limits. Importantly, this rule explicitly provides that preventive controls include controls other than those at CCPs that are also appropriate for food safety (Sec. 117.135(a)(2)(ii)). See also Response 2, in which we discuss both future guidance and a preventive controls training curriculum being developed by the FSPCA. We expect that both of these resources will help facilities, including foreign facilities, understand the requirements for a food safety plan. Table 29--A Comparing the Food Safety Plan to HACCP Plans ---------------------------------------------------------------------------------------------------------------- Federal HACCP rules NACMCF HACCP for juice, seafood, Requirements PC Rule Guidelines Codex HACCP Annex and meat and poultry ---------------------------------------------------------------------------------------------------------------- Written plan.......... Yes.................. Yes.................. Yes................. Yes. Who is responsible for The owner, operator A HACCP team may need Individual The processor. preparing the plan? or agent in charge assistance from businesses, with of a facility must outside experts advice when prepare, or have knowledgeable in the necessary from prepared, and hazards associated other sources. implement a written with the product and food safety plan. process. The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. What does the plan Written Written Written Written contain? hazard analysis. hazard analysis. hazard analysis. hazard analysis. Written Must include Must Must list preventive controls. the hazard, the include CCPs and all food safety Written CCPs, and critical critical limits. hazards that are supply-chain program. limits. Must reasonably likely Written Must include include monitoring to occur, CCPs, and recall plan. monitoring procedures. critical limits. Written procedures. Must Must list procedures for Must include include corrective monitoring monitoring the corrective actions. actions. procedures. implementation of Must include Must Must the preventive verification include include corrective controls. procedures. verification action procedures. Written Must include procedures. Must corrective action recordkeeping Must include procedures. procedures. include records. verification Written procedures; verification Must procedures. include recordkeeping procedures. Is oversight required Yes.................. Yes.................. Yes................. Yes. by a person qualified by training and experience? ---------------------------------------------------------------------------------------------------------------- D. Proposed Sec. 117.126(c)--Records We proposed that the food safety plan is a record that is subject to the recordkeeping requirements of subpart F. We received no comments that disagreed with this proposed requirement and are finalizing it as proposed. E. Comments on Potential Requirements for Submission of a Facility Profile to FDA We requested comment on whether to require submission to FDA of a subset of the information that would be in a food safety plan (78 FR 3646 at 3768). This information, which could be referred to as a ``facility profile,'' could be submitted through an electronic form using a menu selection approach at the same time as facility registration, and could be updated biennially simultaneously with the required biennial update of the food facility registration. We described potential benefits to having a facility's food safety plan in advance of an inspection, such as aiding in the efficient oversight of preventive controls by allowing us to better target inspectional activities to facilities that produce foods that have an increased potential for contamination (particularly contamination with biological hazards). We noted that facilities could benefit from our advance [[Page 56025]] preparation through interaction with better-informed investigators and potentially reduced inspection time. We requested comment on the utility and necessity of such an approach and on the specific types of information that would be useful in developing a facility profile. We also requested comment on any additional benefits that might be obtained from using such an approach and any potential concerns with this approach. We noted that we had previously announced an opportunity for public comment on the proposed collection of additional food facility profile information on a voluntary basis from firms that complete the FDA food facility registration process (Federal Register of May 11, 2012, 77 FR 27779). In contrast to the voluntary submission of food facility profile information described in that notice, in the 2013 proposed human preventive controls rule we requested comment on whether the submission of such information should be required. (Comment 384) Some comments state that submission of a facility profile would be useful and support requiring such a submission. However, most of the comments that addressed our request for comments on such a submission express concern. Some comments assert that requiring submission of a facility profile is outside of FDA's statutory authority under FSMA. Other comments assert that submitting a facility profile would not advance food safety goals or have a commensurate benefit to food safety. Some comments express concern about protection of confidential information. Other comments express concern that we would misinterpret the submitted information in the absence of discussion with the facility. Some comments assert that receiving and evaluating the submitted information would be too time- consuming for FDA, whereas other comments assert that submitting the information would be too time-consuming for the facility. Some comments state that a subset of the information that would be submitted could be found in the Establishment Inspection Reports. Some comments assert that we could use information already available through the Reportable Food Registry to identify facilities that have needed to address a serious food safety violation and target our inspectional resources to those facilities. Some comments state that a facility profile is a not a static document and would be very difficult to keep up-to-date. (Response 384) We have decided that we will not establish a requirement for submission of a facility profile. We will explore other mechanisms to achieve the goals we described in the 2013 proposed human preventive controls rule. XXV. Subpart C: Comments on Proposed Sec. 117.130--Hazard Analysis We proposed requirements for hazard analysis, including hazard identification and hazard evaluation. Some comments support the proposed requirements without change. For example, some comments support our proposal for the hazard analysis to address ``known or reasonably foreseeable hazards'' because this is consistent with Codex. Other comments agree that the hazard analysis should address both the severity of the potential hazard and the probability that the hazard will be present in a food product. Other comments state that testing for environmental pathogens may be impractical in certain situations for facilities in chemical plants that also produce food additives and that the proposed requirements for hazard evaluation make it clear that in such facilities environmental monitoring would not be required. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 385, Comment 395, Comment 406, and Comment 407) or ask us to clarify how we will interpret the provision (see, e.g., Comment 418). In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed requirements as shown in table 30, with editorial and conforming changes as shown in table 52. Table 30--Revisions to the Proposed Requirements for Hazard Analysis ------------------------------------------------------------------------ Section Description Revision ------------------------------------------------------------------------ 117.130(a)(1)................. Requirement for a Specify that a hazard analysis. 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. 117.130(a)(2)................. Requirement for Clarify that the the hazard hazard analysis must analysis to be be written, written. regardless of its outcome. 117.130(b)(1) and (b)(2)...... Hazard Emphasize that the identification. hazard identification focuses on known or reasonably foreseeable hazards (rather than on all hazards). 117.130(b)(1)(iii)............ Hazard Add examples of identification. physical hazards. 117.130(c)(1)(ii)............. Hazard evaluation Provide that hazard evaluation does not need to include an evaluation of environmental pathogens whenever RTE 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. 117.130(c)(2)(x).............. Hazard evaluation Provide an example of ``other relevant factor'' that the hazard evaluation must consider (the example is the temporal (e.g., weather-related) nature of some of some hazards (e.g., levels of some natural toxins)). ------------------------------------------------------------------------ A. Proposed Sec. 117.130(a)--Requirement for a Written Hazard Analysis We proposed that you must identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are significant hazards. We also proposed that the hazard analysis must be written. As discussed in Response 126, we have revised the term ``significant hazard'' to ``hazard requiring a preventive control.'' [[Page 56026]] (Comment 385) Some comments ask us to specify that the rule requires a written hazard analysis even if the hazard analysis concludes that no hazards exist. (Response 385) As proposed, the regulatory text would require a written hazard analysis even if the hazard analysis concludes that no hazards exist. To make this clearer, we have made two revisions to the regulatory text. First, we have revised the regulatory text to 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. Second, we have revised the regulatory text to specify that the hazard analysis must be written regardless of its outcome. (Comment 386) Some comments assert that a facility should not be able to conclude that no hazard exists in its production process and that any such conclusion reached should be a ``red flag'' to FDA investigators. (Response 386) The purpose of a hazard analysis is to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. If a facility appropriately determines, under the oversight of a preventive controls qualified individual, that no such hazards exist, then that is the outcome of its hazard analysis, and the facility must document that outcome in its written hazard analysis. (See also Response 222, Response 226, Response 229, Response 232, Response 397, Response 721, and Response 726.) However, we agree that our investigators should take appropriate steps to evaluate a facility's hazard analysis when the outcome is that there are no hazards requiring a preventive control. We expect that our investigators would both review the facility's written hazard analysis and discuss the outcome with the facility. During the initial stages of implementation, we also expect that our investigators will ask subject matter experts in our Center for Food Safety and Applied Nutrition (CFSAN) to review such a hazard analysis. Over time, as our investigators gain experience with appropriate determinations that there are no hazards requiring a preventive control, we expect that there will be fewer circumstances in which our investigators would consult CFSAN about such an outcome. (Comment 387) Some comments ask us to require facilities to provide supporting documentation in the hazard analysis and assert that such a requirement would be consistent with the requirements of the FSIS HACCP regulation for meat and poultry. (Response 387) We made no changes to the regulatory text to specifically require that a facility ``provide supporting documentation'' in its hazard analysis. A facility has flexibility to determine the appropriate content of its written hazard analysis, provided that the written hazard analysis complies with the requirements for hazard identification and hazard evaluation (see Sec. 117.130(b) and (c)). A facility must be able to justify its hazard analysis decisions, even if the supporting documentation is not specifically included with the hazard analysis. For example, a facility that relies on one or more scientific publications to support its hazard analysis might include a bibliography listing the relevant publications, but not include a copy of the listed publications. Differences in the regulatory text of this rule compared to the FSIS HACCP regulation for meat and poultry reflect the flexible framework provided by FSMA but do not create a conflict. (Comment 388) Some comments ask us to modify the provision to specify that the hazard analysis identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility, including hazards in the raw materials and ingredients used in the food (emphasis added). (Response 388) We decline this request. Other provisions in the requirements for hazard analysis specify that the hazard evaluation must consider raw materials and ingredients (see Sec. 117.130(c)(2)(iii)). It is not necessary to repeat the specific requirements associated with the hazard evaluation in the provision that directs each facility to conduct a hazard analysis. (Comment 389) Some comments ask us to modify the provision to use ``or'' instead of ``and'' in the clause ``based on experience, illness data, scientific reports, and other information'' because it is not necessary to evaluate all of the specified criteria in all cases. (Response 389) We decline this request. We agree that in some cases some of the specified types of information may not be available. For example, if a food product has not been associated with foodborne illness, there would be no illness data. However, modifying the provision as suggested by the comments would establish a regulatory requirement in which a facility could pick and choose which information to evaluate, irrespective of whether the information is available. (Comment 390) Some comments point out that the Codex HACCP Annex includes ``mileposts'' for the identification of hazards, recommending that the HACCP Annex apply to ``all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption.'' These comments ask us to include such ``mileposts'' in the requirements to conduct a hazard analysis to put the regulations in better alignment with the Codex HACCP Annex and underscore the fact that food producers cannot anticipate or be responsible for customer behavior that is contrary to general principles of food safety. (Response 390) By ``mileposts'' for hazard identification, we assume that the comments are referring to the steps included in the Codex HACCP Annex regarding the recommendation to list all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards. These steps include consideration of: (1) The likely occurrence of hazards and severity of their adverse health effects; (2) the qualitative and/or quantitative evaluation of the presence of hazards; (3) survival or multiplication of microorganisms of concern; (4) production or persistence in foods of toxins, chemicals or physical agents; and (5) conditions leading to these factors (Ref. 34). We agree that a hazard analysis should address known or reasonably foreseeable hazards at each step from primary production, processing, manufacture, and distribution until the point of consumption. For example, a facility that produces cut or shredded RTE carrots might consider pathogens such as Salmonella that can occur at primary production; metal from the slicers or shredders, and L. monocytogenes as an environmental pathogen, during manufacturing/processing; and refrigeration until the end of the shelf life to prevent the growth of pathogenic sporeforming bacteria. However, to the extent that these comments are asserting that a facility can ignore consumer behavior that the facility considers contrary to principles of food safety, we disagree. For example, a facility could not conclude that it need not identify and evaluate known or reasonably foreseeable hazards because the facility intends to provide cooking instructions on the label of a packaged food. Consumer research indicates that [[Page 56027]] consumer cooking practices are not uniform and that many consumers do not follow some cooking instructions, such as those on frozen foods or directions specifying that a product should be cooked until it reaches a certain temperature (Ref. 66) (Ref. 67). (Comment 391) Some comments ask us to require that the hazard analysis be re-evaluated every three years and updated as needed. (Response 391) The written hazard analysis is one component of the food safety plan, and the food safety plan is subject to reanalysis at least every three years (see Sec. 117.170). (Comment 392) Some comments state that the standard for hazard analysis in the human preventive controls rule should both align with the re-proposed requirements for hazard analysis set forth in the supplemental FSVP notice and be consistent with the statutory standard for hazard analysis in section 418(b)(1) of the FD&C Act. (Response 392) We have aligned the requirements of the human preventive controls rule and the proposed FSVP rule to the extent practicable, consistent with the applicable statutory requirements. (Comment 393) Some comments ask us to endorse a template, format, or style to be used for a hazard analysis to ensure these analyses are conducted consistently across the food industry and that auditors are consistent in their evaluation. (Response 393) We decline this request. See Response 373. B. Proposed Sec. 117.130(b)--Hazard Identification We proposed that the hazard identification must consider hazards that include biological, chemical, and physical hazards. We proposed to list examples of biological hazards (i.e., microbiological hazards such as parasites, environmental pathogens, and other pathogens) and chemical hazards (i.e., radiological hazards and substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens). In the preamble (78 FR 3646 at 3734)], we provided examples of physical hazards (i.e., stones, glass, or metal fragments that could inadvertently be introduced into food) but did not propose to include these examples in the regulatory text. We also proposed that the hazard identification must consider hazards that may be present in the food if they occur naturally, may be unintentionally introduced, or may be intentionally introduced for purposes of economic gain. (Comment 394) As discussed in Comment 126, some comments express concern that the rule would refer to multiple levels of hazards (i.e., ``hazards,'' ``known or reasonably foreseeable hazards,'' and ``significant hazards'' (which we now refer to as ``hazards requiring a preventive control'') and ask us to provide sufficient clarity to be able to distinguish between these types of hazards. (Response 394) As discussed in Response 126, we have revised the requirements for hazard identification to emphasize that the hazard identification focuses on known or reasonably foreseeable hazards (rather than on all hazards). (Comment 395) Some comments ask us to include examples of physical hazards in the regulatory text. (Response 395) We have added stones, glass, and metal fragments as examples of physical hazards in the regulatory text. This is consistent with the regulatory text for biological and chemical hazards, even though the hazards listed in section 418(b)(1) of the FD&C Act include examples of chemical and biological hazards but do not include examples of physical hazards. (Comment 396) Some comments ask us to separately list some hazards (such as parasites and drug residues) rather than include them as examples of biological hazards and chemical hazards. (Response 396) We decline this request. Although section 418(b)(1)(A) of the FD&C Act lists such items separately, we believe it is clearer to acknowledge that some of the hazards listed in the statute are in fact a subset of the broader categories of biological and chemical hazards. (Comment 397) Some comments ask us to rephrase the requirement for hazard identification to specify ``The hazard analysis must identify hazards'' rather than ``The hazard identification must consider hazards.'' (Response 397) We decline this request. The provision is directed to the first step of a hazard analysis--i.e., hazard identification-- rather than to the overall hazard analysis (which is addressed in Sec. 117.130(a)). The purpose of the hazard identification is to consider the types of hazards listed in the provision as a step in determining whether there are any hazards requiring a preventive control; the suggestion of the comments implies that such hazards will always be identified. As discussed in Response 386, the outcome of a hazard analysis for a food product could be that there are no hazards requiring a preventive control. (Comment 398) Some comments ask us to broaden the examples listed for chemical hazards to include ``allergens and ingredients associated with food sensitivities.'' (Response 398) We decline this request. Although the presence of an undeclared ingredient associated with a food sensitivity (such as the color additive Yellow #5) can be considered a chemical hazard for the sensitive population, it is neither practical nor necessary for the list of examples of chemical hazards in the regulatory text to be exhaustive. (Comment 399) Some comments assert that we should not require all food safety plans to specifically address the likelihood of radiological hazards. (Response 399) The rule only requires that a facility consider whether radiological hazards are known or reasonably foreseeable, and we have described situations where radiological hazards could be considered to be known or reasonably foreseeable (78 FR 3646 at 3667). A facility that appropriately determines that no radiological hazards are known or reasonably foreseeable would document that determination in its written hazard analysis but would not need to establish preventive controls and associated preventive control management components to address radiological hazards. (Comment 400) Some comments addressing radiological hazards ask us to clarify that radiological hazards are an example of chemical hazards; clarify the requirements by identifying specific radiological hazards and including them in the regulatory text; develop a baseline for acceptable levels and specific monitoring recommendations for each product; defer compliance on the control of radiological hazards until more comprehensive information is available to industry and regulators on how best to control for and assess compliance in controlling the hazard; clarify whether irradiation of produce for phytosanitary purposes must be considered as a potential radiological hazard; confirm that a facility is required to assess only two types of radiological hazards (production water and accidental contamination from accidental release from a nuclear facility); and clarify whether we will require consideration of radiological hazards by processors subject to our HACCP regulations for seafood and juice. (Response 400) The regulatory text specifies that radiological hazards are an example of chemical hazards. We decline the requests to identify specific radiological hazards, include them in [[Page 56028]] the regulatory text, and develop a baseline for acceptable levels, with specific monitoring recommendations for each product type. As discussed in the 2013 proposed human preventive controls rule (78 FR 3646 at 3667), radiological contamination of foods is a rare event. The most relevant information that would lead a food facility to consider and evaluate a specific radiological hazard to determine whether it is a hazard requiring a preventive control would be publicly disseminated information following a particular event, such as contamination arising from accidental release from a nuclear facility or from damage to a nuclear facility from a natural disaster. We already have issued guidance on levels of concern for radionuclides that could be a known or reasonably foreseeably hazard in certain circumstances, such as after an accident at a nuclear facility (Ref. 68). In light of this current guidance, we see no reason to provide additional guidance to address hypothetical circumstances or to defer compliance until more information is available. A facility does not need to consider sources of radiation used in accordance with a food additive regulation in its hazard analysis. Such sources are safe for their intended use. As with any other equipment and substances used in the manufacture of food, a facility must comply with all applicable safety requirements established either under the terms of a food additive regulation or by an authority such as the Occupational Safety and Health Administration. Although production water and accidental contamination from accidental release from a nuclear facility would be the two most likely sources of radiological hazards that a facility would need to address, we are not limiting the facility's responsibilities to these two sources. We cannot anticipate the future. We have not taken action to revise either our HACCP regulations for seafood and juice or our current guidance on hazards and controls for seafood and juice (Ref. 42) (Ref. 43) to require or recommend that processors of those products address radiological hazards in their food safety plans. However, in the event of a situation such as an accident at a nearby nuclear facility, it would be prudent for such processors to consider whether the potential for contamination with radiological hazards would warrant modification of their food safety plans. (Comment 401) Some comments assert that predictable intentional hazards should be in the food safety plan but unexpected intentional hazards should be part of a food defense plan. (Response 401) This rule only requires a facility to consider intentionally introduced hazards when such hazards are introduced for purposes of economic gain. Hazards that may be intentionally introduced by acts of terrorism are the subject of the 2013 proposed intentional adulteration rule (78 FR 78014, December 24, 2013). (Comment 402) Some comments disagree that the human preventive controls rule should address hazards that are intentionally introduced for purposes of economic gain (economically motivated adulteration). Some of these comments assert that economically motivated adulteration is not a good fit for the hazard analysis and preventive controls framework because it is, in all but the rarest of circumstances, an issue of product integrity and quality, whereas food safety systems are designed and built to prevent or mitigate food safety hazards. Some comments state that traditional food safety hazards are primarily both identified and addressed at the facility level, but economically motivated adulteration is typically handled by the corporate parent company, where supply chain management programs are typically located. These comments also assert that food safety-related economically motivated adulteration is extremely rare and that predicting economically motivated adulteration to prevent it is extremely difficult. Some comments assert there will be no measurable benefit to food safety by imposing requirements to consider economically motivated adulteration as part of a food safety plan and that doing so will consume limited resources without a corresponding increase in consumer protection. Other comments assert that there is no need to require a facility to identify hazards intentionally introduced for purposes of economic gain because the misbranding and adulteration provisions of the FD&C Act already sufficiently provide safeguards against economic gain. (Response 402) We agree with the comments stating that the requirement to consider hazards intentionally introduced for purposes of economic gain is narrow. Such hazards will be identified in rare circumstances, usually in cases where there has been a pattern of economically motivated adulteration in the past. In addition, we define hazards to only include those agents that have the potential to cause illness or injury. Economically motivated adulteration that affects product integrity or quality, for example, but not food safety, is out of the scope of this rule. We continue to believe that there is benefit in taking this preventive approach to economically motivated adulteration, and not solely on enforcing the preexisting misbranding and adulteration provisions of the FD&C Act after a violation occurs. As discussed in sections XLII through XLIX, we are finalizing supply-chain program provisions. It is consistent with the framework of this rule for a facility to address hazards requiring a preventive control that may be intentionally introduced for purposes of economic gain through the facility's supply-chain program. (Comment 403) Some comments express concern about identifying hazards that may be intentionally introduced for purposes of economic gain because there are potentially an unlimited number of unknown or yet-to-be-identified hazards that could be intentionally introduced for purposes of economic gain by an unscrupulous supplier. These comments disagree with our attempt to narrow the field of potential scenarios for economically motivated adulteration to circumstances where there has been a pattern of such adulteration in the past. Some comments assert that our attempt to narrow the field of potential scenarios for economically motivated adulteration is both too broad and too narrow at the same time. These comments assert that our attempt is too broad, because we expect facilities to consider patterns of adulteration from the past ``even though the past occurrences may not be associated with the specific supplier or the specific food product'' and a requirement to consider every potential product and potential supplier makes the task open ended. These comments further assert that our attempt is too narrow, because a focus on patterns of adulteration in the past is unlikely to reveal potential future instances of economically motivated adulteration and because those intending to defraud purchasers for economic gain are trying to avoid detection. According to these comments, once a food safety-related instance of economically motivated adulteration is uncovered, perpetrators quickly move to carry out their fraudulent activities in a different way. Some comments assert that there are alternative ways to control hazards that may be intentionally introduced for purposes of economic gain without specific regulatory requirements, such as by having an effective supplier approval program with appropriate qualification and verification activities; through business-to-business relations, expectations, and contracts; and through [[Page 56029]] a vulnerability assessment and control plan tailored specifically to economically motivated adulteration. (Response 403) We disagree that the requirement is too broad. A facility must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at the facility. There is no requirement to consider every potential product or potential supplier. We also disagree that the requirement is too narrow. Some individuals intending to defraud purchasers for economic gain will develop entirely novel ways of adulterating food to suit their purposes. We agree that these circumstances may not lend themselves to the preventive approach required here. We encourage, but do not mandate, that facilities adopt other measures they deem appropriate to mitigate the risks of economically motivated adulteration that this rulemaking does not address. Still, the repeated economically motivated adulteration of spices with toxic colorants demonstrates that patterns of economically motivated adulteration can emerge and should be considered as part of a food safety plan (see the examples in the 2014 supplemental human preventive controls notice, 79 FR 58524 at 58550-58551). (Comment 404) Some comments ask us to limit the requirement to identify hazards that may be introduced for purposes of economic gain to only those hazards that pose a risk to public health for which there has been a pattern in the past. Some comments assert that in those few instances where a hazard was intentionally introduced the underlying intention was to defraud rather than to cause harm, and the food safety hazard was an unintended consequence. Some comments ask us to focus the hazard identification solely on inbound products, because it is obvious that hazards introduced by the facility itself will not be prevented through a hazard analysis. Some comments ask us to narrow the scope of the requirement by specifying that facilities focus on three situations: (1) Situations in which there has been a pattern of similar adulteration in the past; (2) foods or ingredients for which quality assurance methods may not sufficiently characterize the food or ingredient to assure its identity, and; (3) foods or ingredients for which there are substitutes that are likely to be harmful that would be considered obvious to one skilled in food science. (Response 404) We decline to make the changes suggested in these comments, because they are unnecessary. Because of our definition of hazard, the requirement is already limited to economically motivated adulteration that has the potential to cause illness or injury. Under the final rule, a facility does not need to identify a hazard related to economically motivated adulteration when there is no risk to public health or when the economically motivated adulteration is not known or reasonably foreseeable. We agree that the three circumstances suggested by the comments are an appropriate focus for facilities who seek guidance on how to approach the requirements, but decline the request to specify these limitations of the scope in the regulatory text. As already noted, some comments assert that our attempt to narrow the field of potential scenarios for economically motivated adulteration is both too broad and too narrow at the same time (see Comment 403). Although we continue to believe that the instances in which a facility will identify a hazard intentionally introduced for economic gain will be rare, we also consider that limiting the scope of the requirement in the regulatory text would be both pre-judging the future and inconsistent with the public health objectives of this rule. (Comment 405) Some comments ask us to allow implementation of the major provisions in FSMA before establishing requirements to address economically motivated adulteration. These comments assert that economically motivated adulteration requires a completely different paradigm than unintentional adulteration. In addition, because economically motivated adulteration is typically addressed through product specifications, supplier relationships, and good business practices, implementation of these other provisions of the human preventive controls rule are likely to have a positive effect on preventing economically motivated adulteration. (Response 405) We disagree that economically motivated adulteration requires a completely different paradigm than unintentional adulteration. Hazards intentionally introduced for economic gain are addressed here with the same preventive framework as every other hazard. As such, we do not see a compelling reason to delay implementation of the requirements to address economically motivated adulteration. C. Proposed Sec. 117.130(c)--Evaluation of Whether a Hazard Requires a Preventive Control We proposed that the hazard analysis must include an evaluation of the identified hazards to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls; and environmental pathogens whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize the pathogen (proposed Sec. 117.130(c)(1)). We also proposed that the hazard evaluation must consider the effect of the following on the safety of the finished food for the intended consumer: (1) The formulation of the food; (2) the condition, function, and design of the facility and equipment; (3) raw materials and ingredients; (4) transportation practices; (5) manufacturing/processing procedures; (6) packaging activities and labeling activities; (7) storage and distribution; (8) intended or reasonably foreseeable use; (9) sanitation, including employee hygiene; and (10) any other relevant factors (proposed Sec. 117.130(c)(2)). (Comment 406) Some comments ask us to revise the requirement to include an evaluation of environmental pathogens to avoid the implication that an intervention is needed when there may be other controls (such as pH or formulation) that would significantly minimize or prevent the pathogen. These comments suggest that we revise the provision to require that a hazard evaluation include an evaluation of environmental pathogens whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment ``or otherwise include a control measure'' that would significantly minimize the pathogen. (Response 406) We have revised the provision on the hazard evaluation for environmental pathogens to specify that the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. We agree that controls such as formulation can function as a ``kill step'' and that the provision should make clear that such controls can be used in lieu of ``treatment.'' (Comment 407) Some comments ask us to clarify what we meant by ``other relevant factors'' and note that natural disasters (which we previously discussed) (78 FR 3646 at 3738) are ``usually exceptional events'' that are best managed in a facility crisis management plan. Other comments ask us to specify that the hazard evaluation must consider any relevant geographic, temporal, agricultural, or other factors that may affect the severity or probability of the hazard. [[Page 56030]] (Response 407) We included ``other relevant factors'' to emphasize that the list of factors in the provision is not an exhaustive list and that a facility is responsible to consider those factors that play a role in its determination of whether a potential hazard is a hazard requiring a preventive control, regardless of whether those factors are listed in the provision. A facility that already addresses circumstances such as natural disasters in other plans may consider the applicable part of those plans to be part of its food safety plan (see Sec. 117.330). We agree that geographic, temporal, and agricultural factors are examples of ``other relevant factors.'' For example, hazards such as aflatoxin are subject to a weather-dependent effect in that aflatoxin levels in some RACs are more of a problem in some years than in others. We have added the temporal nature of some hazards associated with some RACs as an example of ``other relevant factors'' to consider (see Sec. 117.130(c)(2)(x)). (Comment 408) Some comments assert that it is unnecessary to establish a specific provision that identifies environmental pathogens as a hazard that is required to be evaluated. (Response 408) We are retaining the provision, which we proposed to highlight the importance of environmental pathogens in some facilities and to make clear that sanitation controls, with appropriate verification, may be necessary in addition to sanitation measures that the facility establishes as a matter of CGMP. (Comment 409) Some comments assert that it can be difficult to determine ``the severity of the illness or injury if the hazard were to occur'' for a food that is not RTE food, especially for raw materials and ingredients. (Response 409) We acknowledge that determining the severity of the illness or injury if the hazard were to occur can be more difficult for some foods than for other foods. However, recent outbreaks and large- scale recalls demonstrate the potential for some raw materials and other ingredients to cause serious illness or injury (78 FR 3646 at 3656 and 3737). For reasons such as these, the rule requires that a facility identify and evaluate multiple sources of information (i.e., experience, illness data, scientific reports, and other information) and also requires that the food safety plan (which includes the written hazard analysis) be prepared, or its preparation overseen, by one or more preventive controls qualified individuals (see Sec. 117.126(a)(2)). (Comment 410) Some comments ask us to provide that a facility may rely on existing systems in place to manage radiological risks, such as steps taken by government officials to inspect ingredients obtained from a geographic region that has been the subject of a nuclear accident. (Response 410) A facility may consider all available resources in appropriately determining whether a known or reasonably foreseeable radiological hazard is a hazard requiring a preventive control and in appropriately determining what preventive controls, and associated preventive control management components, to establish and implement in light of a radiological hazard that is a hazard requiring a preventive control. However, existing systems in place to manage radiological risks, such as after a nuclear accident, do not absolve a facility of its responsibilities to establish and implement preventive controls to address a radiological hazard when circumstances warrant. (Comment 411) Some comments assert that there would be no need to evaluate an environmental pathogen if the finished food is inherently incapable of supporting pathogen survival (e.g., in acid or acidified foods). These comments ask us to modify the requirement to narrow the circumstances when it would apply to whenever an RTE food is ``capable of supporting pathogen growth to, or survival at, infectious levels.'' (Response 411) The suggestion of the comments pre-judges the outcome of the hazard analysis for a wide variety of food products. A facility can consider factors such as whether the formulation of a food would not support the growth of the pathogen to increased numbers, or would cause pathogens to die off over time, in determining whether an environmental pathogen is a hazard requiring a preventive control. Importantly, for many pathogens the mere presence of the pathogen presents a risk of illness, and the time necessary for pathogens in the food to die off due to the formulation of the food varies. Thus, a facility that appropriately determines that an environmental pathogen is not a hazard requiring a preventive control due to factors such as formulation of a food would need to document the basis for its determination in its written hazard analysis. (Comment 412) Some comments ask us to include a definition for ``exposed to the environment'' to avoid confusion. These comments state their understanding that this phrase means that the product is in a form that is exposed and/or subject to direct human contact. (Response 412) We decline this request. It is not necessary to define every term and phrase included in the rule. See the Appendix to the 2013 proposed preventive controls rule for examples of food products that are, or are not, exposed to the environment (78 FR 3646 at 3819). In the context of doing a hazard analysis, the facility must appropriately determine whether contamination of RTE foods with pathogenic organisms from the production environment can occur; to make such an appropriate determination does not require a definition of ``exposed to the environment.'' (Comment 413) Some comments assert that the proposed requirement to consider the effect of ``intended or reasonably foreseeable use'' on the safety of the finished food for the intended consumer is too open- ended and vague to provide clear direction to industry and regulators pertaining to compliance obligations. These comments ask us to substitute ``expected use'' for ``intended or reasonably foreseeable use.'' (Response 413) We decline this request. We agree that the term ``expected use'' has potential to communicate both intended use and reasonably foreseeable use but disagree that this interpretation would be universal. We are retaining ``intended or reasonably foreseeable use'' to be explicit that a facility must consider what is reasonably foreseeable in addition to what is intended. (See also Response 121.) (Comment 414) Some comments express concern about the potential for a hazard evaluation to overlook food allergens and assert that food allergens must be designated as significant hazards whenever they occur. Other comments assert that a determination of whether a food allergen is a significant hazard should consider protein levels in ingredients. Other comments assert that food allergens are not a problem in produce, except for tree nuts. (Response 414) The hazard identification must consider chemical hazards, including food allergens (Sec. 117.130(b)(1)(ii)). Thus, food allergens cannot be overlooked. Whether the protein level of a food allergen in ingredients is a factor that must be considered in the hazard evaluation would be determined by the preventive controls qualified individual who must conduct or oversee the hazard analysis. We agree that most produce does not satisfy the definition of food allergen, but the evaluation of whether a food allergen hazard exists in any particular food still must be considered by the preventive controls qualified individual [[Page 56031]] who must conduct or oversee the hazard analysis. (Comment 415) Some comments ask us to specify that the hazard evaluation be more specific about issues relevant to raw materials and ingredients, including how raw materials are selected and shipped, how suppliers are evaluated, and how shipments are inspected on receipt. (Response 415) We decline this request. When a hazard requiring a preventive control in a raw material or other ingredient is controlled before receipt, the receiving facility would address such specifics in the supply-chain program that would be required as a preventive control (see subpart G). In addition, the rule already specifies that the hazard evaluation must consider the effect of raw materials and other ingredients on the finished food (Sec. 117.130(c)(2)(iii)). (Comment 416) Some comments ask us to specify that a hazard evaluation consider the history of the class of product causing outbreaks from a particular pathogen. (Response 416) We decline this request. The rule already specifies that the hazard analysis must be based on experience, illness data, scientific reports, and other information (see Sec. 117.130(a)). (Comment 417) Some comments assert that a facility that exports fresh fruit to the United States should not be required to consider storage and distribution of the food because storage and distribution are parts of the supply chain that are not known or controlled by the supplier. These comments also assert that records showing where the facility sent the food should suffice when a facility exports fresh fruit to the United States. Likewise, some comments assert that a facility that exports fresh fruit to the United States should not be required to consider intended or foreseeable use because the facility could not necessarily ascertain the intended or foreseeable use. (Response 417) Each facility is part of a complex food supply chain and a supplier must consider how its food products are likely to be stored, distributed, and used. For example, entities that transport a food product generally rely on the shipper (in this case, the facility exporting the fruit) to provide information relevant to the safe handling of the food during transport. As another example, a facility exporting fruit could simply assume that its food product will be consumed without any processing to reduce any pathogens that may be on the fruit, unless it knows that its food product is destined for a commercial processing facility that makes processed fruit products using processes to adequately control pathogens. (Comment 418) Some comments note our previous discussion about conducting a hazard evaluation for pathogens, including addressing whether a specific product has been documented to be contaminated with such pathogens (78 FR 3646 at 3737). These comments ask us to clarify what we mean by ``documented,'' particularly in the context of a single incident. (Response 418) We expect a facility to take appropriate steps to remain aware of current reports of food contamination. For example, such reports are often disseminated through press releases that we post on our Web site when firms send them to us, and a facility can subscribe to our service that alerts interested persons to recalls, market withdrawals, and other safety alerts (Ref. 69). In appropriately determining whether a pathogen is a hazard requiring a preventive control, the facility would consider factors such as the severity of the hazard and the probability that the hazard would occur in the absence of preventive controls. Whether a single incident warrants consideration of a pathogen as a hazard requiring a preventive control may depend on the incident. (Comment 419) Some comments ask us to specify that the hazard analysis consider the impact of a pathogen on high-risk populations. (Response 419) We decline this request. The rule requires that a hazard evaluation consider the severity of the illness or injury if the hazard were to occur. This evaluation would consider the expected population of consumers and the severity of consequences when the expected population is exposed to a pathogen that is a known or reasonably foreseeable hazard in the food. (Comment 420) Some comments assert that the proposed requirements for hazard evaluation could be interpreted in many ways. For example, a facility could conclude that the presence of a hand sink or boot dip prior to entering the processing area will reduce the likelihood of environmental pathogens and that environmental pathogens are not a significant hazard, whereas a regulator could interpret this provision to mean that a facility must always consider an environmental pathogen to be a significant hazard when the criteria in the provision are met, unless the facility can provide evidence to the contrary. (Response 420) We agree that the requirements for hazard evaluation are subject to alternative interpretations. This is often the case, particularly when a regulation is new. The provision specifies that a facility must evaluate whether an environmental pathogen is a hazard requiring a preventive control in particular circumstances--i.e., whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. The written hazard analysis must be prepared (or its preparation overseen by) a preventive controls qualified individual (see Sec. 117.126(a)(2) and (b)(1)). The preventive controls qualified individual for a facility that determines that an environmental pathogen is not a hazard requiring a preventive control in such circumstances must document that determination, and a regulator would consider the adequacy of the facility's documented determination before reaching a conclusion as to whether the facility had failed to satisfy the requirements. However, the use of a hand sink or boot dip prior to entering the processing area to reduce the likelihood of environmental pathogens may also be considered to be part of the sanitation controls for the environmental pathogen. (Comment 421) Some comments assert that the hazard assessment must document that the benefits of using a particular chemical outweigh the potential risks, such as the risks of the chemical causing antibiotic resistance. Other comments ask us to consider the factors listed in the provision for potential benefits, as well as risks. (Response 421) A hazard is an agent that is reasonably likely to cause illness or injury in the absence of its control (Sec. 117.3). As previously discussed, the focus of the requirement on risk (i.e., the severity of the hazard and the likelihood that it will occur) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry (78 FR 3646 at 3735). None of these national or international guidelines or regulations suggest that a risk-benefit analysis is part of a hazard analysis. Moreover, these comments appear to be directed to a determination by a facility of which raw materials or other ingredients to intentionally add to a food product rather than to biological, chemical, or physical hazards that, for example, occur naturally in the raw materials or other ingredients or may be unintentionally introduced. Any raw material or other ingredient that a facility adds to a food product must be lawful. This rule does not address the [[Page 56032]] criteria for determining whether a particular raw material or other ingredient is lawful under the applicable statutory provisions (e.g., under section 409 of the FD&C Act regarding food additives). (Comment 422) Some comments object to the use of sucrose fatty acid esters as an example (in our previous discussion, 78 FR 3646 at 3737) for distinguishing between raw materials and ingredients because sucrose fatty acid esters are an obscure product and the example does not clearly distinguish between the two terms. (Response 422) As discussed in Response 65, we have decided to return to the phrase ``raw materials and other ingredients'' (rather than the proposed phrase ``raw materials and ingredients'') throughout the rule to make it clear that raw materials are ingredients. As a result, it is not necessary to provide a more broadly applicable example to distinguish between the terms. (Comment 423) Some comments ask us to clarify how the requirements of this rule apply to transportation practices and assert that a facility receiving product should not be responsible for hazards in foods that are not being transported under its custody. Other comments assert that we should require all entities across the supply chain to identify food transportation as a critical control point under the facility's hazard analysis. (Response 423) We address specifics about the responsibilities of shipping facilities and receiving facilities in the 2014 proposed sanitary transportation rule (79 FR 7006). We will address comments regarding the responsibilities of shippers and receivers in the final sanitary transportation rule. For the purpose of the hazard analysis, whether a particular facility would identify food transportation as a critical control point through its hazard analysis would depend on the circumstances, such as whether the food is a TCS food. We expect a facility that identifies temperature control, including during transportation, as a preventive control (whether or not as a CCP), to communicate the need for appropriate temperature control to the person transporting the food. (Comment 424) Some comments ask us to clarify our previous statements (78 FR 3646 at 3737) regarding whether and how label information, such as cooking instructions, may be a factor to consider in a hazard evaluation. (Response 424) See Response 390 regarding consumer research about consumer cooking practices. XXVI. Subpart C: Comments on Proposed Sec. 117.135--Preventive Controls We proposed requirements to identify and implement preventive controls to provide assurances that significant hazards will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. Some comments support the proposed requirements without change. For example, some comments agree that preventive controls must be written and include process controls, food allergen controls, sanitation controls, a recall plan, and other controls as appropriate and necessary. Some comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 428, Comment 431, Comment 432, and Comment 439) or ask us to clarify how we will interpret the provision (see, e.g., Comment 425, Comment 437, and Comment 440). In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed requirements as shown in table 31, with editorial and conforming changes as shown in table 52. Table 31--Revisions to the Proposed Requirements for Preventive Controls ---------------------------------------------------------------------------------------------------------------- Section Description Revision ---------------------------------------------------------------------------------------------------------------- 117.135(c)(1)........................... Process controls........... Clarify that the requirements for process controls depend on the role of the process control in the food safety system. 117.135(c)(2)(i)........................ Food allergen controls..... Specify that food be protected from allergen cross-contact during handling, as well as during storage. ---------------------------------------------------------------------------------------------------------------- A. Proposed Sec. 117.135(a)--Requirement To Identify and Implement Preventive Controls We proposed that you must identify and implement preventive controls, including at critical control points, if any, to provide assurances that significant hazards will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. We also proposed that these preventive controls include controls at CCPs, if there are any CCPs, and controls, other than those at CCPs, that are also appropriate for food safety. Some comments support the flexibility provided to facilities to implement preventive controls that are appropriate to the facility and the food. Other comments support the clarification, in the 2014 supplemental human preventive controls rule, that not all preventive controls are established at CCPs and that some food safety plans will have not CCPs. We are finalizing the provision as proposed with the editorial and conforming changes in table 52. B. Proposed Sec. 117.135(b)--Requirement for Written Preventive Controls We proposed that preventive controls must be written. (Comment 425) Some comments from the almond industry explain that USDA's regulations for a mandatory program for reduction of Salmonella on almonds require almond handlers (facilities) to subject almonds to a process that delivers a minimum 4-log destruction of Salmonella. The process can be applied by the almond handler (facility) or off-site at a ``custom processor.'' These comments agree that preventive controls should be written, but ask us to clarify whether documentation of treatment by its ``custom processor'' would be accepted as a ``written preventive control'' when the ``custom processor'' controls the hazard. (Response 425) The question posed by these comments highlights the difference between the records required in the food safety plan and the records documenting the implementation of the food safety plan. The ``written preventive controls'' are part of the food safety plan, whereas the records [[Page 56033]] documenting treatment are implementation records. Implementation records documenting treatment, whether by a facility or its ``custom processor,'' would not satisfy the requirements for written preventive controls. However, specifying that the preventive control for a specific hazard is a particular treatment by a ``custom processor,'' along with information that describes the treatment, would satisfy the requirement for written preventive controls. C. Proposed Sec. 117.135(c)(1)--Process Controls We proposed that preventive controls include process controls as appropriate to the facility and the food. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must include, as appropriate to the applicable control, parameters associated with the control of the hazard, and the maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a significant hazard. (Comment 426) Some comments state that assigning a parameter and associated minimum and maximum values for some process controls (such as refrigeration (including freezing), baking, or water activity) may be possible, but not be necessary for food safety. These comments ask us to require minimum and maximum values to be assessed against the applicable food safety need, or otherwise make clear that the implications of not controlling minimum and maximum values must be assessed in light of the circumstances. Other comments express concern that ``as appropriate to the applicable control'' could be interpreted as suggesting that if it is merely feasible to establish parameters for a process control, they must be established. Other comments express concern that the proposed requirement suggests that if a parameter is not ``controlled,'' a regulator could conclude that the facility is not in compliance with the rule because it necessarily has not significantly minimized or prevented a significant hazard. One comment provides two examples of refrigeration controls to explain its view that the management components for refrigeration controls will vary depending on the role of refrigeration within the facility's overall food safety system. (See Comment 455.) This comment also provides an example to make a point that water activity may not be necessary for food safety even when maximum or minimum values are assigned. In this example, a parameter for water activity could be set at less than 0.85 based on the control of Staphylococcus aureus, but such a parameter would not be necessary for food safety for a product such as a dry seasoning blend that has a water activity of 0.2-0.3. This comment also notes that when there are many different controls working together to minimize or prevent one hazard simultaneously (such as a formulation that uses a combination of moisture, pH, titratable acidity, and salt level), noncompliance with any one parameter will not necessarily result in an unsafe product. (Response 426) See Response 455. We have revised the regulatory text to specify that process controls must include parameters and minimum or maximum values as appropriate to both the nature of the applicable control and its role in the facility's food safety system. (Comment 427) Some comments ask us to delete the phrase ``to significantly minimize or prevent a significant hazard.'' (Response 427) We decline this request. ``Significantly minimize or prevent a significant hazard'' (which we have revised to ``significantly minimize or prevent a hazard requiring a preventive control'') is the standard for controlling the hazards. Although the phrase could be viewed as redundant with the standard in the requirement to identify and implement preventive controls (Sec. 117.135(a)(1)), repeating that standard in the requirements for parameters and the minimum or maximum values associated with control of the hazard emphasizes the standard, which is appropriate for process controls. D. Proposed Sec. 117.135(c)(2)--Food Allergen Controls We proposed that preventive controls include, as appropriate to the facility and the food, food allergen controls that include those procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage and use, and for labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the FD&C Act. (Comment 428) Some comments ask us to specify that food be protected from allergen cross-contact during handling, as well as during storage. (Response 428) We have revised the provision as requested by the comments. (Comment 429) Some comments assert that food allergen controls should be based on hazard analysis and risk. Other comments provide examples of existing industry guidance that addresses food allergen controls. Some comments note that food allergen controls are addressed in the PMO (e.g., Appendix K, the voluntary HACCP program). Other comments assert that establishing food allergen controls at this time is premature or that food allergen controls need to be balanced with pathogen controls. Some comments ask us to clarify whether the standard that would be established for food allergen controls is ``absolutely allergen free.'' (Response 429) We have acknowledged that it is premature to require validation of food allergen controls (see 78 FR 3646 at 3755 and Response 515). However, we disagree that requiring a facility to establish food allergen controls as a preventive control is premature at this time, as evidenced by the existing industry guidance, and requirements of programs such as Appendix K of the PMO, submitted by comments. We agree that whether a facility appropriately determines that food allergen controls are necessary will be based on the outcome of the hazard analysis (see the requirements for hazard analysis in Sec. 117.130(a) and (c)). A facility that already has established food allergen controls based on recommendations in industry guidelines or requirements of programs such as the voluntary HACCP program of the PMO can incorporate those established food allergen controls into its own, facility-specific food safety plan, and rely on its existing records for those food allergen controls to demonstrate compliance with the requirements of this rule (see Sec. 117.330). Whether a facility needs to establish food allergen controls in addition to pathogen controls depends on the outcome of the facility's hazard analysis; a facility that determines that both allergens and pathogens are hazards requiring a preventive control in the manufacturing, processing, packing, or holding of a food product must address both hazards. The requirements for food allergen controls do not establish a particular standard. In general, when we do establish a standard we avoid ``absolute'' standards such as the ``absolutely allergen free'' standard mentioned by the comment. We appreciate receiving examples of food allergen control guides. (Comment 430) Some comments ask us to revise the proposed requirement from ``food allergen controls must [[Page 56034]] include'' to ``food allergen controls include.'' (Response 430) In the 2014 supplemental human preventive controls notice, we proposed a series of revisions to the overall framework of the requirements for hazard analysis and risk-based preventive controls, including revisions to the requirements for preventive controls to emphasize that the preventive controls that a facility must establish and implement are those appropriate to the facility and the food (79 FR 58524 at 58541-58543). With respect to food allergen controls, we proposed to first specify what food allergen controls ``include'' (i.e., procedures, practices, and processes to control food allergens), as requested by these comments. However, we also proposed to continue to specify minimum requirements for what food allergen controls must include when a facility determines that a food allergen is a hazard requiring a preventive control--i.e., those procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact and for labeling the finished food. To the extent that these comments are asking us to clarify the distinction between a description of what constitutes a food allergen control and the minimum requirements for what food allergen controls must include when a facility determines that a food allergen is a hazard requiring a preventive control, the regulatory text we proposed in the 2014 supplemental human preventive controls notice modified the regulatory text as requested. However, to the extent that these comments are asking us to modify the provision so that it no longer establishes the minimum requirements for what food allergen controls must include when a facility determines that a food allergen is a hazard requiring a preventive control, we disagree. The listed minimum requirements are consistent with long-standing approaches to the control of food allergens and provide flexibility for a facility to identify and implement those procedures, practices, and processes most suited to the control of food allergen hazards in light of the facility and its food products (Ref. 70) (Ref. 71); see also the discussion at 78 FR 3646 at 3741. (Comment 431) Some comments ask us to revise the requirement that food allergen controls must include labeling controls by adding the phrase ``to ensure that major food allergens are properly disclosed.'' (Response 431) We decline this request. The provision requires that the procedures, practices, and processes employed for labeling the finished food include those for ensuring that the finished food is not misbranded under section 403(w) of the FD&C Act. Requiring that labeling procedures, practices, and processes ensure that major food allergens are properly disclosed would be redundant with the proposed requirement that they ensure that the finished food is not misbranded under section 403(w). (Comment 432) Some comments ask us to revise the requirement that food allergen controls must include labeling controls by adding the phrase ``as appropriate'' because section 201(qq)(2)(A) of the FD&C Act excludes highly refined oils from the definition of ``major food allergen.'' (Response 432) We decline this request because qualifying that the requirement applies ``as appropriate'' is not necessary to achieve the outcome requested by the rule comments. If a food ingredient, such as a highly refined oil, is not a major food allergen, it is not subject to the requirements for food allergen controls. (Comment 433) Some comments assert that quantification or measurement of specific parameters is not appropriate for some food allergen controls. (Response 433) We agree with these comments. In the 2014 supplemental human preventive controls notice, we clarified that the requirements for parameters and maximum and minimum values apply to process controls. (Comment 434) Some comments ask us to establish thresholds for food allergens. Other comments assert that we should not have a ``zero- tolerance'' approach to food allergens. Some comments ask us to require advisory labeling (such as a label statement that a food that does not contain an allergen ingredient was processed in a facility that also processes foods that do have specific allergen ingredients) if we do not establish a ``zero-tolerance'' policy for food allergen controls. Other comments assert we should allow advisory labeling in light of difficulties in developing food allergen controls. (Response 434) In 2008, we announced a public hearing on the use of advisory labeling of allergens in foods as part of a long-term strategy to help manufacturers use allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food-allergic consumers and their caregivers (73 FR 46302, October 8, 2008). In that document, we explained our concerns with food allergens, including food allergens inadvertently incorporated into manufactured foods, due to the number of reports concerning consumers who have experienced adverse reactions following exposure to an allergenic substance in a food. We also described our previous actions targeting food manufacturers, including: (1) A notice to manufacturers entitled ``Label Declaration of Allergenic Substances in Foods'' in 1996 (Ref. 72); (2) an FDA/state partnership to increase industry's understanding of food allergens and to identify effective manufacturing controls (Ref. 73); and (3) a statement of policy, to our staff, regarding food allergens (Ref. 74). In 2012, we requested comments relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens as defined in FALCPA (77 FR 74485, December 14, 2012). We noted that regulatory thresholds would help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls. However, establishing regulatory policy or requirements, such as a long-term strategy regarding use of allergen advisory labeling, or a specific threshold for a food allergen or a ``zero-tolerance'' policy, is outside the scope of this rule. The provisions of this rule, whether the CGMPs in subpart B or the requirements for hazard analysis and risk-based preventive controls in subparts C and G, are directed to procedures, practices, and processes for the safe manufacturing, processing, packing, and holding of food rather than to special labeling policies or specific levels of substances (such as food allergens) that would render food adulterated or misbranded. (Comment 435) Some comments assert that food allergen controls need not be required in specific situations, such as during the storage and transport of coffee and the storage of packaged foods not exposed to the environment. (Response 435) Whether food allergen controls are necessary in any particular circumstance depends on the outcome of the facility's hazard analysis. Although coffee is not a food allergen, whether coffee requires food allergen controls during storage and transport depends on factors such as how the coffee is stored and transported and whether there is potential for allergen cross-contact. Although we agree that the potential for allergen cross-contact during the storage of packaged foods not exposed to the environment is low, it is the responsibility of the preventive controls qualified individual who conducts or oversees the hazard analysis [[Page 56035]] to make an appropriate determination for an individual facility. (Comment 436) Some comments assert that implementation of food allergen controls poses particular challenges in the context of milling operations. As an example, these comments explain that most milling operations do not handle soy. However, allergen cross-contact between grains and soy can occur at various points in the chain of production and transport, such that grains arriving at a milling facility might already contain low levels of soy. These comments also assert that the presence in a desired grain of low levels of soy or of other grains is consistent with U.S. Grain Standards. For example, the Grain Inspection, Packers and Stockyards Administration (GIPSA) definition of corn allows for the presence of between 2 percent and 7 percent foreign material, depending on the grade of corn, and the presence of up to 10 percent of other grains for which standards have been set. Although millers use equipment that helps to separate the desired grain from soy or other grains, these comments assert that complete elimination of soy and other grains is not practicable even under CGMP. These comments ask us to acknowledge that complete elimination of allergen cross-contact is not feasible in certain operations even under CGMP and that the intermittent presence of undeclared allergens is possible in certain foods, notwithstanding the observance of CGMP. (Response 436) We acknowledge that GIPSA standards may allow for the presence of foreign material, and that foreign material could be a food allergen such as soy. However, such standards are not determinative as to whether hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by a facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. Thus, as the comments point out, grains that arrive at a facility for milling may contain levels of a food allergen that a milling operation would not be able to eliminate. In circumstances such as these, supply-chain controls directed to the supplier's cleaning procedures, in addition to separation techniques applied at milling, may be necessary to enable the milling operation to satisfy its responsibilities under this rule. For example, a supplier that uses storage bins to hold soybeans at some times and corn at other times could agree to additional ``cleaning'' of bins previously used to store soybeans by ``scouring'' the bin with corn before using the bin to hold corn intended for human consumption. The corn used for scouring would be handled appropriately--e.g., by diverting to use in animal food, because food allergens are not hazards requiring a preventive control in food for animals. Doing so would reduce the potential for residual soybeans to be present in the next lot of corn, sold for human consumption. (Comment 437) Some comments ask us to clarify when a facility would be expected to establish food allergen controls rather than rely on the CGMP requirements (in subpart B) to prevent allergen cross-contact, particularly for oilseed processors who only need to address soy allergens. (Response 437) Food allergen controls are applicable to facilities that handle any of the foods that are food allergens. Any facility that handles a single food allergen, such as a processor only handling soybeans to make soybean oil, may simply need to ensure that the products it ships into commerce are labeled with the food allergen. (If the oils are highly refined and do not contain soy proteins, the facility may need to prevent cross-contact with less highly refined oils that may contain soy proteins.) If the facility only produces foods that contain the single food allergen, there would not be any foods for which cross-contact could occur. For facilities that handle more than one allergen-containing food or both foods that contain a specific food allergen along with foods that do not contain that food allergen (such as a facility that roasts almonds, macadamia nuts, and cashews), the facility could establish preventive controls to ensure that common equipment is cleaned between each type of nut. The facility could use CGMPs to ensure that the different nuts are stored separately before and after roasting to prevent cross-contact. (Comment 438) Some comments ask us to confirm that FSMA does not change prior agency guidance on the reasonable steps that should be taken to prevent allergens from being unintentionally incorporated into the food and the limited use of allergen advisory statements where the risk of allergen cross-contact cannot be eliminated through CGMPs. (Response 438) Prior agency guidance on the reasonable steps that should be taken to prevent allergens from being unintentionally incorporated into the food and the limited use of allergen advisory statements is still applicable. (See also the discussion in Response 434.) E. Proposed Sec. 117.135(c)(3)--Sanitation Controls We proposed that preventive controls include, as appropriate to the facility and the food, sanitation controls that include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. We also proposed that sanitation controls must include procedures, practices, and processes for the cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment, and procedures for the prevention of allergen cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product. (Comment 439) Some comments ask us to use the term ``primary packaging material'' rather than ``food packaging material.'' (Response 439) We decline this request. See Response 166, in which we discuss what we mean by ``food packaging material'' (e.g., we do not intend the term ``food-packaging materials'' to include shipping containers such as cartons and crates that pose no risk of introducing contaminants or food allergens into food). (Comment 440) Some comments ask us to clarify whether the requirements for sanitation controls apply to all food facilities or only to those that make RTE products. (Response 440) The requirements for sanitation controls apply to all food facilities, not just those that make RTE products. The facility must determine through its hazard analysis when sanitation controls are necessary to address a hazard requiring a preventive control. It is reasonable to assume that sanitation controls will be more common in facilities that make RTE products than in facilities that make non-RTE products. (Comment 441) Some comments assert that sanitation controls are not necessary to prevent any hazards in distribution facilities where food- contact surfaces are not present. Other comments assert that sanitation controls should be required in all cases (rather than ``as appropriate'') given their central importance. (Response 441) Under the framework established by FSMA--and implemented in this rule--each facility determines through its hazard analysis [[Page 56036]] when sanitation controls are necessary to control a hazard requiring a preventive control. The rule neither establishes circumstances (such as in distribution centers) where sanitation controls are not necessary nor pre-judges whether sanitation controls are necessary in specific circumstances. Although we do not expect that facilities such as distribution centers would determine through their hazard analysis that sanitation controls are required, we do expect all food establishments that are subject to the CGMP requirements established in subpart B to fully comply with applicable requirements for sanitation. F. Proposed Sec. 117.135(c)(4)--Supply-Chain Controls We proposed that supplier controls include the supplier program. See the discussion of comments on the supplier program, now in subpart G, in sections XLII through XLIX. As discussed in more detail in section XLII, we have revised the phrase ``supplier program'' to ``supply-chain program'' throughout the regulatory text. As a companion change, we have revised Sec. 117.135(c)(4) to refer to ``supply-chain controls'' rather than ``supplier controls.'' G. Proposed Sec. 117.135(c)(5)--Recall Plan We proposed that preventive controls include, as appropriate, a recall plan as would be required by proposed Sec. 117.137. See the discussion of comments on the recall plan (final Sec. 117.139) in section XXVIII. H. Proposed Sec. 117.135(c)(6)--Other Controls We proposed that preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of Sec. 117.135(a). Examples of other controls include hygiene training and other current good manufacturing practices. (Comment 442) Some comments ask us to specify that preventive controls include controls on raw materials and other ingredients. (Response 442) The final rule specifies that preventive controls include supply-chain controls as appropriate to the facility and the food. The request of these comments is addressed by the requirements for the supply-chain program (see Sec. 117.135(c)(4) and subpart G). (Comment 443) Some comments refer to our discussion that an example of an ``other'' preventive control could include temperature control for a TCS refrigerated food, and our discussion that although many refrigerated foods only require refrigeration for food quality, some refrigerated foods do require refrigeration for food safety (78 FR 3646 at 3744). These comments ask us to be clearer about foods that require refrigeration for food quality rather than for food safety. (Response 443) Additional information about foods that do not require refrigeration for food safety is available in the Food Code (Ref. 51) (see, e.g., the definition of TCS food and the examples of foods that are not TCS foods in section 1-2 of the Food Code). XXVII. Subpart C: Circumstances in Which the Owner, Operator, or Agent in Charge of a Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control (Final Sec. Sec. 117.136 and 117.137) In the 2014 supplemental human preventive controls notice, we provided an opportunity for public comment on potential requirements for a supplier program as a preventive control, including comments on when a supplier program would not be required. As discussed in more detail in section XLII, we have revised the phrase ``supplier program'' to ``supply-chain program'' throughout the regulatory text. As summarized in table 32 and discussed more fully in the following paragraphs, after considering comments on when a supplier program would not be required, we are establishing two new provisions. Although both provisions have an effect on the required supply-chain program, they would be implemented outside the framework of a supply-chain program. Table 32--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 ---------------------------------------------------------------------------------------------------------------- Proposed section Final section designation designation Description Revision ---------------------------------------------------------------------------------------------------------------- 117.136(a)(1).................... N/A................. A manufacturer/processor is not N/A. required to implement a preventive control if it determines and documents that the type of food (e.g., RACs such as cocoa beans, coffee beans, and grains) could not be consumed without application of an appropriate control. 117.136(a)(2).................... 117.136(a)(1)(ii)(C) A manufacturer/processor is not Includes a required to implement a requirement for preventive control if it relies documentation that on its customer who is subject to the food is ``not the requirements for hazard processed to analysis and risk-based control preventive controls in subpart C [identified to ensure that the identified hazard].'' hazard will be significantly minimized or prevented and both (1) discloses in documents accompanying the food that the food is ``not processed to control [identified hazard]'' and (2) annually obtains from its customer written assurance that the customer has established and is following procedures that will significantly minimize or prevent the identified hazard. 117.136(a)(3).................... N/A................. A manufacturer/processor is not N/A. required to implement 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 assurance it is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements and it: (1) Discloses in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]''; and (2) annually obtains from its customer written assurance that it is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements. [[Page 56037]] 117.136(a)(4).................... 117.136(a)(1)(ii)(C) A manufacturer/processor is not Addresses required to implement a the circumstance preventive control if it relies where an entity on its customer to ensure that (other than the the food will be processed to facility's control the identified hazard by customer) in the an entity in the distribution distribution chain chain subsequent to the customer controls the and both: (1) Discloses in hazard. documents accompanying the food Includes a that the food is ``not processed requirement for to control [identified hazard]'' documentation that and (2) annually obtains from its the food is ``not customer written assurance that processed to the customer will both disclose control the information that the food is [identified ``not processed to control hazard].'' [identified hazard]'' and will only sell to another entity that agrees, in writing, it will follow procedures that will significantly minimize or prevent the identified hazard (if the entity is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C) or manufacture, process, or prepare the food in accordance with applicable food safety requirements (if the entity is not subject to the requirements for hazard analysis and risk- based preventive controls in subpart C), or obtain a similar written assurance from the entity's customer. 117.136(a)(5).................... N/A................. A manufacturer/processor is not N/A. required to implement a preventive control if it has established, documented, and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the food product it distributes and documents the implementation of that system. 117.136(b)....................... 117.136(g)(3)....... Records documenting the applicable Includes a circumstances in Sec. requirement for 117.136(a). documentation of the additional circumstances in which a manufacturer/ processor is not required to implement a preventive control. 117.137.......................... N/A................. A facility that provides a written N/A. assurance under Sec. 117.136(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 manufacturer/processor to not implement a preventive control if the manufacturer/processor determines and documents that the type of food (e.g., RACs such as cocoa beans, coffee beans, and grains) could not be consumed without application of the appropriate control (see Sec. 117.136(a)(1)). We describe comments leading to this provision, and our response to those comments, in Comment 444 and Response 444, respectively. Although we are establishing these provisions outside the framework of the supply-chain program, these provisions continue to play a role in the requirements for a supply-chain program, because they also provide an exception to the requirements for a manufacturer/processor to establish and implement a supply-chain program. The second provision relates to comments we received on a proposed exception to the requirement for a manufacturer/processor to establish and implement a supplier program (proposed Sec. 117.136(a)(1)(ii)(C)). (See Comment 445.) Under proposed Sec. 117.136(a)(1)(ii)(C), a receiving facility would not have been required to have a supplier program if it relied on its customer to control the hazard and annually obtained from its customer written assurance that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard. As discussed in Response 445, we are replacing this provision with several provisions that apply when a manufacturer/processor identifies a hazard requiring a preventive control (``identified hazard''), does not control the identified hazard, but can demonstrate and document that the identified hazard will be controlled by an entity in its distribution chain. A manufacturer/processor that satisfies the criteria in these provisions will not be required to implement a preventive control for the identified hazard. Under these provisions, the combination of three requirements will provide adequate assurance that the food will be processed to control the identified hazard before it reaches consumers. These requirements are: (1) Documentation provided by the manufacturer/processor to its direct customer that the food is ``not processed to control [identified hazard]''; (2) written assurance from customers regarding appropriate procedures to ensure that the food will receive further processing to control the identified hazards; and (3) provisions relating to accountability for written assurances. (In these provisions, ``customer'' means a commercial customer, not a consumer.) (Comment 444) Some comments express concern about the ability for distributors/cooperatives to identify the individual farms that harvested the produce when such farms are more than one step back in the food chain from the distributor/cooperative. Some comments assert that receiving facilities should not be required to verify suppliers with which they do not have a direct commercial relationship. These comments note that, in the case of the cocoa bean supply chain, the processing facility likely has no direct relationship with the thousands of farms involved in the growing and harvesting of the beans. Some comments ask for an exemption from supplier verification activities for foods such as cocoa beans because, [[Page 56038]] although cocoa processors do not currently rely on farms to control hazards, and would therefore not need to verify farms, it is problematic to have a requirement that potentially could necessitate traceback to farms. (Response 444) We are establishing a provision, applicable to both the supply chain and the distribution chain of a manufacturer/ processor, for a circumstance when a manufacturer/processor does not need to implement a preventive control. The specific food product identified by some of the comments (i.e., cocoa beans) is part of a class of food products (principally RACs) that could simply not be eaten without processing that would control the hazards requiring a preventive control. Other RACs in this class of food products are coffee beans, grains, and some RACs that are rarely consumed raw. Therefore, we are providing that a manufacturer/processor does not need to implement a preventive control if it determines and documents that the type of food (e.g., RACs such as cocoa beans, coffee beans, and grains) could not be consumed without application of the appropriate control (see Sec. 117.136(a)(1)). The regulatory text does not specify RACs ``rarely consumed raw'' because ``rarely consumed raw'' is not the same as ``could not be consumed without application of the appropriate control.'' However, depending on the facility, the RAC, and the food produced by the manufacturer/processor, there may be some circumstances where a manufacturer/processor could determine that a particular RAC that passes through its facility satisfies the criterion ``could not be consumed without application of the appropriate control.'' In other cases, a facility that conducts a manufacturing/processing activity on produce rarely consumed raw may satisfy the criteria in other new provisions (Sec. 117.136(a)(2), (3), and (4)) in which it relies on its customer to provide assurance that the food will be processed to control the identified hazard. In still other cases, such a facility may have determined through its hazard analysis that there are no hazards requiring a preventive control, and will not consider whether one of the circumstances in new Sec. 117.136 apply. As a consequential addition, new Sec. 117.136(b) specifies the records that a manufacturer/processor would need to satisfy the documentation requirements established in new Sec. 117.136(a)(1), and we have added new Sec. 117.136(b) to the list of implementation records (Sec. 117.190) that are subject to the recordkeeping requirements of subpart F. See also Comment 657, in which we discuss comments asking us to add flexibility to the requirements for a supply-chain program such that any entity other than the receiving facility can perform supplier verification activities. As discussed in Response 657, the rule provides additional flexibility in the supply-chain program with regard to who can perform certain activities (see Sec. 117.415). (Comment 445) Some comments ask us to delete the criterion for control of the hazard by the receiving facility's customer, with annual written assurance that the customer had established and was following procedures (identified in the written assurance) that would significantly minimize or prevent the hazard. The stated reasons varied. For example, some comments state that a receiving facility may have so many customers that it is not possible to obtain written assurance annually from all customers. Other comments express concern that a customer may be unwilling to describe confidential trade secrets in order to identify in writing the procedures the customer has established and is following to control the hazard. Other comments express concern about ``legal issues'' when a receiving facility needs to assess the adequacy of the customers' procedures for controlling a hazard because under current business practices a vendor can provide assurance to a buyer (its customer), but buyers do not typically provide such assurance to vendors. Some comments express concern that written assurance does not guarantee that the customer is actually doing anything to significantly minimize or prevent the hazard. Some comments ask us to provide an alternative that would allow the receiving facility to provide documentation to its customer about a hazard that needs a preventive control at a processing facility later in the distribution chain rather than obtain written assurance that its customer will control a hazard. If written assurance must be required, these comments ask us to allow the written assurance provided by the customer to state that the customer would evaluate the hazard and if necessary establish and follow procedures to significantly minimize or prevent the hazard. Some comments state the receiving facility may not know the identity of all its ultimate customers, particularly if the receiving facility sells its products to a distributor who then sells to other entities. Some comments ask us to provide flexibility for facilities to determine whether annual updates of written assurance are necessary. Other comments ask us to specify that a receiving facility need not establish and implement a supplier program for raw materials and ingredients that are RACs intended for further processing. Some comments assert that the presence of low levels of pathogens on a raw product that will be subject to a lethal process further downstream does not pose a risk to the consumer, and should not be considered a significant hazard (i.e., a hazard requiring a preventive control). These comments also assert that if we maintain that Salmonella contamination is a significant hazard for each member of the supply chain, then we should allow the preventive control to be applied in a subsequent step at another facility. Other comments ask us to clarify that a facility would not need to develop preventive controls where it produces raw materials or ingredients that are subject to subsequent processing that will address known or reasonably foreseeable hazards. (Response 445) We are establishing several provisions, specifically applicable to the distribution chain of a manufacturer/processor, for circumstances when a manufacturer/processor does not need to implement a preventive control (Sec. Sec. 117.136(a)(2), (a)(3), (a)(4) and (a)(5), (b)(2), (b)(3), (b)(4), and (b)(5), 117.137, and 117.335). See Response 444 for another new provision that applies to the supply chain in addition to the distribution chain (Sec. 117.136(a)(1)). Under the first of these provisions (Sec. 117.136(a)(2)), a manufacturer/processor is not required to implement a preventive control if it relies on its customer (who is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C) to ensure that the identified hazard will be significantly minimized or prevented and: (1) Discloses in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]''; and (2) annually obtains from its customer written assurance, subject to the requirements of Sec. 117.137, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard. The manufacturer/ processor would include the specific hazard requiring a preventive control (e.g., Salmonella) where the statement says ``[identified hazard].'' A facility that provides the written assurance must act consistently with the assurance and document its [[Page 56039]] actions taken to satisfy the written assurance (see new Sec. 117.137). The documents could be bills of lading or other papers that accompany the food, or labels on the containers of the food. Under the second of these provisions, (Sec. 117.136(a)(3)), a manufacturer/processor is not required to implement 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 assurance it is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements and it: (1) Discloses in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]''; and (2) annually obtains from its customer written assurance that it is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements. By ``customer who is not required to implement preventive controls under part 117'' we mean entities such as qualified facilities and retail food establishments. Under the third of these provisions (Sec. 117.136(a)(4)), a manufacturer/processor is not required to implement a preventive control if it relies on its customer to provide assurance that the food will be processed to control the identified hazard by an entity in the distribution chain subsequent to the customer and: (1) Discloses in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]''; and (2) annually obtains from its customer written assurance, subject to the requirements of Sec. 117.137, that the customer will disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is ``not processed to control [identified hazard]''. The manufacturer/processor also must obtain written assurance that its customer will only sell to another entity that agrees, in writing, it will: (1) Follow procedures (identified in a written assurance) that will significantly minimize or prevent the hazard (if the entity is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C), or manufacture, process, or prepare the food in accordance with applicable food safety requirements (if the entity is not subject to the requirements for hazard analysis and risk-based preventive controls in subpart C); or (2) obtain a similar written assurance from the entity's customer. Under the fourth of these provisions (Sec. 117.136(a)(5)), a manufacturer/processor is not required to implement a preventive control if it has established, documented, and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the food product it distributes and documents the implementation of that system. Comments did not provide examples of such a system, but we do not want to preclude the development of such systems. We have added several other requirements related to these new provisions that we are specifically establishing as circumstances in which a manufacturer/processor need not implement a preventive control. As already noted in this response, new Sec. 117.137 requires that a facility that provides a written assurance must act consistently with the assurance and document its actions taken to satisfy the written assurance. In addition, new Sec. 117.136(b)(2), (3), (4), and (5) specify the records that a manufacturer/processor would need to satisfy the documentation requirements established in new Sec. 117.136(a)(2), (3), (4), and (5), and new Sec. 117.335 establishes requirements applicable to the written assurance between a manufacturer/processor and its customer. Taken together, the provisions of Sec. Sec. 117.137 and 117.335 establish legal responsibilities for a facility that provides a written assurance under Sec. 117.136(a)(2), (3), or (4), even if that facility is not a manufacturer/processor. The point of these provisions is to ensure that hazards that a manufacturer/processor has determined, through its hazard analysis, require a preventive control, but are not controlled in the supply chain before the manufacturer/processor or by the manufacturer/ processor, are in fact controlled by a subsequent entity in the distribution chain. With the assurance from the first manufacturer/ processor's customer that the hazards will be controlled after the food product leaves the manufacturer/processor, it is not necessary for the first manufacturer/processor to implement the applicable preventive control. We continue to believe that annual written assurance from a manufacturer/processor's direct customer is an appropriate mechanism to ensure that its customer is aware of the identified hazard and is taking steps to ensure that the food is processed to control the identified hazard. We do not believe that a manufacturers/processor will need all of the details of its customer's process to satisfy the requirement to state in writing the procedures the customer has established and is following to control the hazard. For example, the customer could merely state that its manufacturing processes include a lethality step for microbial pathogens of concern. We agree that it is appropriate to require that the manufacturer/ processor provide documentation to its customer indicating that the food must be processed to control an identified hazard. Such documentation will be a means of clear communication from the manufacturer/processor to its customer. When the hazard will not be controlled by the customer, the customer will still have documentation that can be passed on to the entity that is expected to process the food to control the identified hazard, so that it will be very clear to that entity that the identified hazard still needs to be controlled. (Comment 446) Some comments ask us to delete the proposed requirement to maintain the written assurance as a record. (Response 446) We decline this request. As already discussed in this section, it is the combination of requirements (i.e., for documentation that the food is ``not processed to control [identified hazard]''; assurance from customers regarding appropriate procedures to ensure that the food will receive further processing to control the identified hazards; and provisions relating to accountability for written assurances) that will provide adequate assurance that the food will be processed to control the identified hazard before it reaches consumers. Records documenting the written assurances are a key component of the provisions. XXVIII. Subpart C: Comments on Proposed Requirements for a Recall Plan (Final Sec. 117.139) We proposed that you must establish a written recall plan for food with a significant hazard and that the recall plan must include certain procedures. Some comments support the proposed requirements without change. For example, some comments express the view that a written recall plan is critical in the event of a system breakdown where adulterated foods have been distributed. Some comments that support the proposed requirements note that many model plans are available to industry. Other comments state that the proposed requirements for a recall plan mirror guidelines in many fresh produce commodity-specific food safety guidelines and seem appropriate for all types of facilities handling fresh produce. Some comments that support the proposed provisions suggest [[Page 56040]] alternative or additional regulatory text (see, e.g., Comment 447, Comment 452, Comment 453, and Comment 454). In the following paragraphs, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we are finalizing the requirements as proposed with the conforming revision to use the term ``hazard requiring a preventive control'' rather than ``significant hazard.'' See Response 126 and table 52. We also are redesignating the requirements as Sec. 117.139. As discussed in section XXVII, we are establishing a provision applying to certain assurances in Sec. 117.137. A. Proposed Sec. 117.137(a)--Requirement for a Written Recall Plan (Final Sec. 117.139(a)) We proposed that you must establish a written recall plan for food with a significant hazard. (Comment 447) Some comments ask us to require a written recall plan for all food (rather than just for food with a significant hazard) and to establish the requirements for a written recall plan as CGMP requirements in subpart B rather than as part of the requirements for hazard analysis and risk-based preventive controls in subpart C. These comments assert that all products can be subject to a recall. These comments contrast recall plans with other preventive controls in that recall plans are often specific to a firm or facility, but rarely are specific to particular foods. In addition, these comments note that a recall may be administered and managed at the corporate office rather than at the specific manufacturing facility that produced the food. Some comments note the requirements for a written recall plan are sufficiently different from other provisions in subpart C that we proposed to specify that the recall plan would not be subject to the preventive control management requirements for monitoring, corrective actions, and verification (see Sec. 117.140(c)). Some comments note that facilities that are exempt from the requirements of subpart C, but remain subject to the CGMP requirements, would not be required to have a recall plan unless we establish the requirements in subpart B. Some comments note that our authority to require recall plans is not limited to section 418 of the FD&C Act and that we can use other legal authority to impose a requirement for recall plans in subpart B. Some comments note that FSMA specifically amended the FD&C Act to provide us with the authority to mandate a food recall (section 423 of the FD&C Act). These comments assert that it would be reasonable for us to conclude that in order to efficiently carry out section 423 of the FD&C Act we should issue requirements governing the conduct of recalls, because section 423 of the FD&C Act requires that we provide a firm with an opportunity to voluntarily recall a product before issuing an order to the firm to cease distribution and recall a product. (Response 447) We decline the request to establish requirements for a written recall plan as a CGMP requirement in subpart B and are establishing the requirements as a preventive control in subpart C as proposed. We acknowledge that a recall plan would be useful to all food establishments, and we encourage all food establishments to have a recall plan. However, the report issued by the CGMP Modernization Working Group did not identify the lack of a written recall plan as something that needed to be changed (Ref. 3). (See 78 FR 3646 at 3651 for a discussion of the CGMP Modernization Working Group and the process leading to its report.) However, going forward we intend to monitor whether the lack of a broader requirement for a recall plan leads to problems when food establishments that are not subject to the requirements of subpart C are faced with recall situations. As we gain experience with the impact of the new requirement for a recall plan on those facilities subject to subpart C, we can reassess at a later date whether to conduct rulemaking to broaden the requirement to apply to all food establishments subject to the CGMP requirements in subpart B. For now, food establishments that are not subject to subpart C can continue to follow our long-standing recall policy in part 7. Consistent with the overall framework of FSMA, a recall plan (like other preventive controls) is only required when the facility has identified a hazard requiring a preventive control. A facility could establish a recall plan that applies to other foods it manufactures. We recognize that recalls may be managed by the corporate office of a firm rather than at the specific manufacturing facility that produced the food. Nothing in the rule precludes this approach. In such cases the corporate recall policy would be reflected in a facility's recall plan. (See also (Response 371.) In addition, a facility that identifies one or more hazards requiring a preventive control in multiple food products could use the same recall plan for all applicable food products. The rule specifies that the requirements for preventive control management components (i.e., monitoring, corrective actions and corrections, and verification) apply as appropriate to ensure the effectiveness of the preventive control, taking into account the nature of the preventive control (Sec. 117.140(a)). As previously discussed, the preventive control management components are directed at food that remains at the facility, whereas the recall plan addresses food that has left the facility (78 FR 3646 at 3745). Our determination that the nature of the recall plan does not require these preventive control management components demonstrates the flexibility provided by FSMA and this rule, not that the recall plan must be considered a CGMP rather than a preventive control. We have not yet made a determination of whether we should issue requirements governing the conduct of recalls, rather than rely on the guidelines in part 7, in order to fully implement section 423 of the FD&C Act. However, we have issued draft guidance entitled ``Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls'' which, when finalized, would address topics such as the criteria for a mandatory recall and the process that FDA must follow for a mandatory recall (Ref. 75). (Comment 448) Some comments assert that the requirements for a recall plan should only apply to RTE food. (Response 448) These comments are suggesting that the rule predetermine the outcome of the hazard analysis at all facilities. The framework provided by FSMA and established in this rule makes it the responsibility of each facility to appropriately determine the hazards requiring a preventive control, and establish preventive controls as appropriate to the facility and the food. (Comment 449) Some comments ask us to cross-reference the provisions of part 7 (21 CFR part 7) rather than establish requirements that these comments assert would be duplicative with the provisions of part 7. These comments ask us to address any more substantive requirements than are already in part 7 as part of a review of part 7. These comments assert that part 117 should require a written recall plan, but not require a ``written recall plan for the food,'' to be consistent with the approach of part 7. (Response 449) We decline these requests. Part 7 addresses enforcement policy, and the provisions for recalls in subpart C of part 7 are ``Guidance on Policy, Procedures, and Industry Responsibilities.'' These recall [[Page 56041]] provisions do not establish requirements and are not binding on industry. They also are broadly directed to recalls for all FDA- regulated products, not just food. As already discussed (see Response 447), nothing in this rule would prevent a facility that establishes a recall plan for a particular food from using that recall plan for any food product that the facility decides to recall. B. Proposed Sec. 117.137(b)--Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps (117.139(b)) We proposed that the recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility: (1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food; (2) notify the public about any hazard presented by the food when appropriate to protect the public health; (3) conduct effectiveness checks to verify that the recall is carried out; and (4) appropriately dispose of recalled food (e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food). We requested comment on whether: (1) The proposed procedures are appropriate for all types of facilities; (2) we should require a recall plan to include procedures and assignment of responsibility for notifying FDA of recalls subject to the plan; and (3) we should include a requirement for a mock recall as a verification activity. (Comment 450) Some comments ask us to modify the proposed requirements for a recall plan to clearly differentiate between manufacturers and distributors. These comments note that distributors are often not the initial recalling firm and ask us to clarify that the manufacturer, rather than the distributor, is the responsible party for notifying the public. Other comments ask us to modify and simplify the details of the recall plan for smaller businesses based on product, distribution, and other factors. (Response 450) In the 2014 supplemental human preventive controls notice, we revised the proposed requirements for a recall plan by specifying that the procedures in the recall plan are ``as appropriate to the facility.'' As a result, the rule explicitly provides flexibility for a recall plan to be different based on characteristics such as size of the facility or the role of the facility in the food supply chain. For example, the rule provides flexibility for a small business to simply specify that it will telephone its customers. Although we decline the request to specify that the manufacturer, rather than the distributor, is the responsible party for notifying the public, the rule provides flexibility for a distributor to establish, through its business relationships with manufacturers, that this would be the procedure established in the distributor's recall plan. (Comment 451) Some comments ask us to delete the proposed requirement that the recall plan include procedures for a facility to notify the public about any hazard presented by the food when appropriate to protect public health. These comments assert that such a requirement would be highly subjective and create a nebulous regulatory burden that could subject facilities to unnecessary regulatory oversight and enforcement actions. (Response 451) We decline this request. Our guidance for a recall strategy has long recommended issuing a public warning to alert the public that a product being recalled presents a serious hazard to health in urgent situations where other means for preventing use of the recalled product appear inadequate (Sec. 7.42(b)(2)). Operationally, such notification to the public is so common that our current home page on our Internet site (Ref. 76) gives prominence to recall information, and we have established a free email subscription service for updates on recalls (Ref. 77). Consistent with the long-standing recall policy in part 7, subpart C, the proposed requirement qualifies that the notification to the public is ``when appropriate to protect public health.'' (Comment 452) Some comments ask us to specify that food recall plans include a minimum data requirement about the food product in question. These comments assert that information such as lot, batch, product size, and production date are critical in sorting defective products from non[hyphen]defective ones. (Response 452) The procedures that must be established in a recall plan are those that describe the steps that will be taken to notify entities that a product must be removed from commerce, to verify that product is removed, and to appropriately dispose of the product. Information (such as lot, batch, product size, and production date) is necessary to be able to carry out the steps that must be included in the procedures and can be a useful component of the procedures that a facility includes in its recall plan, because a facility would need to obtain such information about the specific product being recalled when conducting a recall. However, we decline the request to specify what a facility must include in its procedures because facilities may use different approaches in how they carry out recalls and the information they need to do so. For example, not all facilities use that same data for identifying the product that may be impacted by a recall. (Comment 453) Some comments ask us to specify that the procedures require facilities to notify us about a recall to ensure that all suppliers, retailers, and consumers will have adequate notification of the recall action. Other comments agree that it is important for facilities to involve us in a recall situation as soon as possible, but assert that the best way to address such a notification is through the existing RFR system. These comments assert that additional procedures or means to notify us would involve unnecessary additional steps and be duplicative, with no improvement to the public health. Some comments ask us to specify that the appropriate State regulatory agency with inspection jurisdiction be notified in the event of a recall. (Response 453) We agree with comments that it is important to notify us about a recall and that doing so can help to ensure that suppliers, retailers, and consumers will have adequate notification of the recall action. We also agree that the existing procedures to notify us through the RFR system can accomplish this goal when a food presents a risk of serious adverse health consequences or death and that it therefore is not necessary to duplicate the notification procedures already established in the RFR system in part 117. However, we encourage facilities to include in their recall plan any procedures they have to comply with the RFR or to include a cross-reference to those procedures. Doing so may save time, which is critical during a recall. When the recalled food does not present a risk of serious adverse health consequences or death (and, thus, there is no report to the RFR), our guidance entitled ``Guidance for Industry: Product Recalls, Including Removals and Corrections'' recommends that recalling firms notify the local FDA District Recall Coordinator as soon as a decision is made that a recall is appropriate and prior to the issuance of press or written notification to customers (Ref. 78). Including this guidance with the facility's recall procedures may also save time. Likewise, we agree with comments that it is important to notify appropriate State regulatory agencies about a recall. However, procedures are available for [[Page 56042]] State regulatory agencies to rapidly receive information from us about food recalls. For example, State regulatory agencies can receive automatic notification about food recalls that we post on our Web site (Ref. 79). We note that whatever methods are used to dispose of adulterated food should comply with State and local requirements. (Comment 454) Some comments ask us to add a requirement for mock recalls on a regular basis, such as annually. Some of these comments state that mock recalls would familiarize the staff and communications network(s) with the recall process and would improve the facility's capacity to conduct effective and efficient recalls in the event of a contamination event. Other comments assert that mock recalls would be the only way to determine the effectiveness of a recall program. Some comments note that mock recalls would be particularly critical for manufacturers that have limited experience in actual recalls. Other comments note that information from mock recalls could support development of guidance on best practices for recalls. Some comments recommend that any requirement for a mock recall as a verification measure include sufficient flexibility to accommodate diverse procedures and mechanisms. Some comments acknowledge that a mock recall could be an important element of a recall plan but recommend that mock recalls remain voluntary, such as by including mock recalls as an example of how verification may be accomplished. Other comments note that the current recall procedures in part 7 do not recommend mock recalls. Some comments assert that a requirement to include a mock recall as a verification activity would be an excessive and inappropriate burden. Some comments note that retail facilities execute multiple recalls each week and that adding the requirement to perform a mock recall would be an unnecessary burden on the retail industry. Likewise, some comments note that foodservice distributors are experts in conducting recall activities, because they are routinely affected by manufacturer recalls. Some comments ask us to clarify the ``metrics'' for a mock recall, particularly with respect to the consequences of failing to meet an appropriate metric if a mock recall is conducted as a verification activity. (Response 454) We agree that a mock recall would familiarize the facility with the recall process, could improve the facility's capacity to conduct effective and efficient recalls during a contamination event, may be particularly helpful for manufacturers that have limited experience in actual recalls, and could support the development of guidance on best practices for recalls, and we encourage facilities to conduct one or more mock recalls to accomplish these goals. However, as previously discussed, a recall plan would address food that had left the facility, whereas the proposed requirements for monitoring, corrective actions, and verification would all be directed at food while it remains at the facility. Comments are mixed regarding whether the rule should require a mock recall as a verification activity for the recall plan, and we have decided to not require a facility to conduct a mock recall as a verification activity for its recall plan so that the focus of the monitoring, corrective actions, and verification in the rule remains focused on food being produced rather than on food that is distributed in commerce. A facility that voluntarily conducts a mock recall would establish metrics appropriate to its plan and take action (such as modifications to its procedures, or additional training for its employees) if it is not satisfied with the results of the mock recall. We note that retail companies are not subject to this rule and, thus, are not subject to the requirement to have a written recall plan. XXIX. Comments on Proposed Sec. 117.140--Preventive Control Management Components We proposed preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control. Most of the comments that support the proposed provisions suggest alternative or additional regulatory text (see, e.g., Comment 455). In the following sections, we discuss comments that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed requirements as shown in table 33, with editorial and conforming changes as shown in table 52. Table 33--Revisions to the Proposed Requirements for Preventive Control Management Components ------------------------------------------------------------------------ Section Description Revision ------------------------------------------------------------------------ 117.140....................... Flexible Provide that requirements for preventive control preventive management control components take into management account both the components. nature of the preventive control and its role in the facility's food safety system. ------------------------------------------------------------------------ A. Proposed Sec. 117.140(a)--Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification We proposed that, with some exceptions, the preventive controls would be subject to three preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control: monitoring, corrective actions and corrections, and verification. (Comment 455) Some comments support our proposal to provide flexibility in the oversight and management of preventive controls, including the explicit provision that preventive control management components take into account the nature of the preventive control. Some of these comments state that the provisions for the preventive control management components will allow facilities to tailor their food safety plans to their specific facility, product, and process and ensure that the regulatory requirements are risk-based. Other comments state that the proposed approach acknowledges the safety benefits derived from the use of prerequisite programs, such as CGMPs, and provides for a framework whereby appropriate decisions may be reached regarding hazards that require management controls that may include monitoring, corrections or corrective actions, verification, and records. Other comments state that the provisions will allow businesses to allocate resources to spend the most time and resources controlling and monitoring those hazards that pose the greatest risk to public health. However, many of these comments also ask us to convey not only that the application of a particular management component be appropriate (i.e., capable [[Page 56043]] of being applied), but also that it be necessary for food safety (i.e., to meet the overall FSMA food safety goals or to ensure a particular control is effective) by specifying that the preventive control management components take into account both the nature of the preventive control and its role within the facility's overall food safety system. Some of these comments ask us to make companion changes reflecting that the preventive control management components take into account both the nature of the preventive control and its role within the facility's overall food safety system throughout applicable provisions of the rule, such as the definition of ``significant hazard'' (which we now refer to as ``hazard requiring a preventive control'') and in the requirements for preventive controls, monitoring, corrective actions and corrections, and verification. Some comments ask us to consistently refer to ``the nature of the preventive control'' (rather than simply to ``the preventive control'') when communicating the flexibility that a facility has in identifying preventive controls and associated preventive control management components. One comment provides two examples of refrigeration controls to explain its view that the management components for refrigeration controls will vary depending on the role of refrigeration within the facility's overall food safety system. In the first example, a facility that manages the process of cooling a cream cheese as a CCP would validate its refrigeration control, establish time and temperature parameters that must be met, monitor those parameters and confirm their use through verification, and, if the parameters were not met, then follow a specific corrective action procedure to address the situation. In contrast, after the initial cooling process for the hot-filled product, the facility would manage refrigerated storage differently. The facility would not keep validation data to support the specific temperature chosen because the temperatures needed to keep food safe are widely known and accepted. Although the facility may choose to establish temperature parameters, the facility typically would not apply such values as hard and fast limits in the same way as it would for a CCP (e.g., because a 5 degree increase over the upper end of the temperature range for a short time would not be meaningful to food safety). The facility may choose not to monitor temperature continuously and, even if the facility does monitor temperature continuously it would only generate ``exception records'' when the temperature exceeds a specific value. The facility also would find it unnecessary to verify its ongoing monitoring. (Response 455) We agree that preventive control management components should take into account both the nature of the preventive control and its role in the facility's food safety system and have modified the regulatory text of Sec. 117.140 to incorporate this suggestion. We reviewed the full regulatory text of proposed subpart C and made similar modifications to the regulatory text for the definition of ``hazard requiring a preventive control'' (Sec. 117.3); process controls (Sec. 117.135(c)(1)); monitoring (Sec. 117.145); verification (Sec. 117.155); validation (Sec. 117.160); and verification of implementation and effectiveness (Sec. 117.165). (Comment 456) Some comments assert that the flexibility explicitly provided in the regulatory text could result in some facilities taking a broad approach to significant hazards and other facilities taking a more detailed approach. These comments express concern that inspectors will view the detailed approach (e.g., with more preventive controls) as the standard to judge compliance with the rule. Other comments express concern that identifying a large number of preventive controls could also undermine the value of HACCP programs because treating too many controls as CCPs will pull resources from those controls that are truly critical. (Response 456) We agree that facilities are likely to take different approaches to complying with the rule. A facility-specific approach is consistent with FSMA, which places responsibility for hazard analysis and risk-based preventive controls on the owner, operator, or agent in charge of the facility (section 418(a) of the FD&C Act). We agree that having too many CCPs could dilute their significance, but not every hazard will require a CCP to be controlled. See table 6 in the 2014 supplemental preventive controls rule for two examples of preventive controls that would not be CCPs (79 FR 58524 at 58542). During the initial stages of implementation, we expect that our investigators will ask subject matter experts in CFSAN to review the outcome of the facility's hazard analysis, the preventive controls established by the facility, and the associated preventive control management components that the facility has established and implemented. Over time, as our investigators gain experience, we expect that there will be fewer circumstances in which our investigators would consult CFSAN about such an outcome. See also Response 5. (Comment 457) Some comments express concern with the number of provisions that will impact certain types of operations. As an example, these comments assert that a fresh-cut produce facility potentially could be required to implement supplier verification, environmental monitoring, and product testing, whereas a peanut butter producer may not be required to implement any of those three provisions. According to these comments, supplier verification most likely would not be required if the manufacturing operation of the peanut butter manufacturer includes a kill step to significantly minimize Salmonella, because the ``significant hazard'' would be addressed at the receiving facility. These comments interpret our previous discussions about product testing, in the 2013 proposed preventive controls rule, as evidence that such a peanut butter manufacturer also would likely not conduct product testing. If the peanut butter product is hot-filled into jars, there would be no RTE food exposed to the environment and, thus, the facility's hazard analysis would not be required to consider the potential for contamination with environmental pathogens. (Response 457) We acknowledge that some facilities will need to do more than others, because the rule is flexible and risk-based. Importantly, the rule does not require every fresh-cut produce operation to conduct environmental monitoring, even though it does require each fresh-cut produce operation to consider whether it is necessary. We disagree that the flexibility provided in the regulatory text would lead a peanut butter manufacturer to conclude that there would be no RTE food exposed to the environment when peanut butter is hot-filled into jars. In the production of peanut butter, the kill step (i.e., roasting) happens before the rest of the manufacturing process, and the roasted peanuts are exposed to the environment before the filling step. At the filling step, the temperature is hot enough to fill the jars but is not hot enough to act as a kill step to significantly minimize any pathogens that contaminated the peanuts after they were roasted. As a result, in contrast to the interpretation of the comments, the peanut butter production described by the comments does involve RTE food exposed to the environment, and the facility's hazard analysis must consider the potential for contamination with environmental pathogens. However, [[Page 56044]] when a peanut butter manufacturer concludes that it requires sanitation controls for environmental pathogens, it is more likely that the peanut butter manufacturer would conduct environmental monitoring (rather than product testing) as a verification of its sanitation controls. (The peanut butter manufacturer may also conclude that product testing is a useful tool to verify its overall food safety system.) Likewise, a facility that buys peanut butter for use in an RTE food would need to consider whether it needs supply-chain controls for the manufacturer that performed the kill step for Salmonella and whether it needs sanitation controls for environmental pathogens and environmental monitoring as verification of its sanitation controls. (Comment 458) Some comments state that USDA's regulations (in 7 CFR 205.201(a)(3)) for the NOP include regulatory text to ``ensure the effectiveness'' of measures in that program and that this regulatory text is similar to regulatory text in the requirements for preventive control management components. These comments assert that this type of regulatory text has created compliance challenges and ask us to consult with USDA about its experience with implementing effectiveness language associated with monitoring practices and procedures and ensure that the final rule uses regulatory text that will be clearly understood and readily implementable by those subject to its provisions. (Response 458) Under the USDA regulation cited by these comments, an organic production or handling system plan must include a description of the monitoring practices and procedures to be performed and maintained, including the frequency with which they will be performed, to ``verify that the plan is effectively implemented.'' We have not consulted with USDA regarding its experience in evaluating compliance with this requirement because we addressed the issue likely to cause these compliance challenges for monitoring practices and procedures in an organic production or handling system plan when we established our requirements for monitoring preventive controls. Specifically, we require that a facility monitor the preventive controls with adequate frequency to ``provide assurance that they are consistently performed,'' not to ``verify that the plan is effectively implemented.'' Our requirements more clearly distinguish the purpose of monitoring and verification activities. See our previous discussion of the relationship between monitoring and verification, and our tentative conclusion to require monitoring of the performance of the preventive controls (78 FR 3646 at 3747). We are affirming that conclusion in this rule (see Response 461). (Comment 459) Some comments assert that regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) would prevent a facility from monitoring employee health if it establishes a Good Worker Hygiene Program as a preventive control. (Response 459) The basis of these comments is unclear. We do not expect that activities associated with monitoring of employee health would include activities that would be contrary to provisions of the Health Insurance Portability and Accountability Act of 1996. Employee health could be addressed through long-standing CGMP provisions (see Sec. 117.10(a) and (b)). Specifically, with respect to disease control there could be supervisory observation of illness or conditions such as an open lesion, with appropriate action to exclude the worker from operations in which there is a reasonable possibility of food, food- contact surfaces, or food-packaging materials becoming contaminated (Sec. 117.10(a)). Generally, the regulations described in this comment (commonly referred to as ``the Privacy Rule'') apply to disclosures made by a health care pro