[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 55907-56168]
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





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Food and Drug Administration





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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]]


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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.

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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