[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 55908-56168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21920]



[[Page 55907]]

Vol. 80

Thursday,

No. 180

September 17, 2015

Part II





Department of Health and Human Services





-----------------------------------------------------------------------





Food and Drug Administration





-----------------------------------------------------------------------





21 CFR Parts 1, 11, 16, 106, 110, et al.





Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food; Final Rule

  Federal Register / Vol. 80 , No. 180 / Thursday, September 17, 2015 / 
Rules and Regulations  

[[Page 55908]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 
211

[Docket No. FDA-2011-N-0920]


Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending our 
regulation for Current Good Manufacturing Practice In Manufacturing, 
Packing, or Holding Human Food in two fundamental ways. First, we are 
modernizing the long-standing current good manufacturing practice 
requirements. Second, we are adding requirements for domestic and 
foreign facilities that are subject to our regulation for Registration 
of Food Facilities to establish and implement hazard analysis and risk-
based preventive controls for human food. We also are revising certain 
definitions in our regulation for Registration of Food Facilities to 
clarify the scope of the exemption from registration requirements 
provided for ``farms'' and, in so doing, to clarify which domestic and 
foreign facilities are subject to the requirements for hazard analysis 
and risk-based preventive controls for human food. We are taking this 
action as part of our announced initiative to revisit the current good 
manufacturing practice requirements since they were last revised in 
1986 and to implement new statutory provisions in the FDA Food Safety 
Modernization Act. The rule is intended to build a food safety system 
for the future that makes modern, science- and risk-based preventive 
controls the norm across all sectors of the food system.

DATES: This rule is effective November 16, 2015, except for the 
amendment to part 110 in instruction 13, which is effective September 
17, 2018 and paragraph (2) of the definition of ``qualified auditor'' 
in Sec.  117.3, and Sec. Sec.  117.5(k)(2), 117.8, 117.405(a)(2), 
117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) 
and 117.475(c)(13). FDA will publish a document in the Federal Register 
announcing the effective dates of paragraph (2) of the definition of 
``qualified auditor'' in Sec.  117.3, and Sec. Sec.  117.5(k)(2), 
117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 
117.435(d), 117.475(c)(2), and 117.475(c)(13). See section LVI for the 
compliance dates.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety 
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary
    Purpose and Coverage of the Rule
    Summary of the Major Provisions of the Rule
    Costs and Benefits
I. Background
    A. FDA Food Safety Modernization Act
    B. Stages in the Rulemaking for the Human Preventive Controls 
Rule
    C. Summary of the Major Provisions of Proposed Human Preventive 
Controls Rule
    D. Draft Risk Assessment
    E. Definition of ``Retail Food Establishment''
    F. Public Comments
II. Legal Authority
    A. Changes to Current 21 CFR Part 1, Subparts H, I, and J
    B. Changes to Current 21 CFR Part 110
    C. Hazard Analysis and Risk-Based Preventive Controls
    D. Comments on Legal Authority
III. General Comments on the Proposed Rule
IV. Comments on Proposed Revisions to the Definitions in the Section 
415 Registration Regulations (21 CFR Part 1, Subpart H) and the 
Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)
    A. Definitions That Impact a Determination of Whether an 
Establishment Is a ``Farm''
    B. Proposed Revisions to the Definition of Farm
    C. Proposed New Definition of Harvesting
    D. Proposed Revision to the Definition of Holding
    E. Proposed Revision to the Definition of Manufacturing/
Processing
    F. Proposed New Definition of Mixed-Type Facility
    G. Proposed Revision to the Definition of Packing
V. Comments on the Organizing Principles for How the Status of a 
Food as a Raw Agricultural Commodity or as a Processed Food Affects 
the Requirements Applicable to a Farm Under Sections 415 and 418 of 
the FD&C Act
VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm 
Activities
    A. Section 103(c)(1)(C) of FSMA
    B. Comments on Qualitative Risk Assessment of On-Farm Activities 
Outside of the Farm Definition
    C. Comments Regarding an Exemption for Small and Very Small Farm 
Mixed-Type Facilities Under Section 421 of the FD&C Act
VII. Comments on Proposed General Revisions to Current Part 110 
(Final Part 117)
    A. Title of Part 117
    B. Proposed Revisions for Consistency of Terms
    C. Proposed Additions Regarding Allergen Cross-Contact
    D. Proposed Revisions for Consistency With the Definition of 
``Food''
    E. Proposed Revisions To Address Guidance in Current Part 110
    F. Proposed Editorial Changes
    G. General Comments on Current Part 110 (Final Part 117)
VIII. Subpart A: Comments on Proposed Sec.  117.1--Applicability and 
Status
    A. Comments on Proposed Sec.  117.1(a)--Applicability
    B. Comments on Proposed Sec.  117.1(b)--Prohibited Act
    C. Comments on Proposed Sec.  117.1(c)--Specific CGMP 
Requirements
IX. Subpart A: Comments on Proposed Sec.  117.3--Definitions
    A. Redesignation
    B. Definitions in Current Part 110 That We Proposed To Delete
    C. Definitions That We Proposed To Establish in Part 117
    D. Comments Asking FDA To Establish Additional Definitions or 
Otherwise Clarify Terms Not Defined in the Rule
    E. Additional Definitions To Clarify Terms Not Defined in the 
Proposed Rule
X. Subpart A: Comments on Qualifications of Individuals Who 
Manufacture, Process, Pack, or Hold Food
    A. Applicability and Qualifications of All Individuals Engaged 
in Manufacturing, Processing, Packing, or Holding Food (Final Sec.  
117.4(a), (b), and (d))
    B. Additional Requirements Applicable to Supervisory Personnel 
(Final Sec.  117.4(c))
XI. Subpart A: Comments on Proposed Sec.  117.5--Exemptions
    A. General Comments on the Proposed Exemptions
    B. Proposed Sec.  117.5(a)--Exemption Applicable to a Qualified 
Facility
    C. Proposed Sec.  117.5(b) and (c)--Exemptions Applicable to 
Food Subject to HACCP Requirements for Fish and Fishery Products (21 
CFR Part 123) or for Juice (21 CFR Part 120)
    D. Proposed Sec.  117.5(d)--Exemption Applicable to Food Subject 
to Part 113--Thermally Processed Low-Acid Foods Packaged In 
Hermetically Sealed Containers
    E. Proposed Sec.  117.5(e)--Exemption Applicable to a Facility 
That Manufactures, Processes, Packages, or Holds a Dietary 
Supplement
    F. Proposed Sec.  117.5(f)--Exemption Applicable to Activities 
Subject to Standards for Produce Safety in Section 419 of the FD&C 
Act
    G. Proposed Sec. Sec.  117.5(g) and (h)--Exemptions Applicable 
to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small 
or Very Small Business
    H. Proposed Sec.  117.5(i)--Exemption Related to Alcoholic 
Beverages
    I. Proposed Sec.  117.5(j)--Exemption Applicable to Facilities 
Solely Engaged in Storage of Raw Agricultural Commodities Other Than 
Fruits and

[[Page 55909]]

Vegetables Intended for Further Distribution or Processing
    J. Proposed Sec.  117.5(k)--Exemption Applicable to Farms, 
Fishing Vessels, Activities of ``Farm Mixed-Type Facilities'' Within 
the Definition of ``Farm,'' the Holding or Transportation of One or 
More Raw Agricultural Commodities, and Specified Activities 
Conducted on Specified Raw Agricultural Commodities
    K. Comments Requesting Additional Exemptions
XII. Subpart A: Comments on Proposed Sec.  117.7--Applicability of 
Part 117 to a Facility Solely Engaged in the Storage of Unexposed 
Packaged Food
XIII. Subpart B: Comments on Proposed Sec.  117.10--Personnel
    A. Management Responsibility for Requirements Applicable to 
Personnel
    B. Proposed Sec.  117.10(a)--Disease Control
    C. Proposed Sec.  117.10(b)--Cleanliness
XIV. Subpart B: Comments on Proposed Sec.  117.20--Plant and Grounds
    A. Proposed Sec.  117.20(a)--Grounds
    B. Proposed Sec.  117.20(b)--Plant Construction and Design
XV. Subpart B: Comments on Proposed Sec.  117.35--Sanitary 
Operations
    A. Proposed Sec.  117.35(a)--General Maintenance
    B. Proposed Sec.  117.35(b)--Substances Used in Cleaning and 
Sanitizing; Storage of Toxic Materials
    C. Proposed Sec.  117.35(c)--Pest Control
    D. Proposed Sec.  117.35(d)--Sanitation of Food-Contact Surfaces
    E. Proposed Sec.  117.35(d)(1)--Food-Contact Surfaces Used for 
Manufacturing/Processing or Holding
    F. Proposed Sec.  117.35(d)(2)--Wet Cleaning
    G. Proposed Sec.  117.35(d)(3)--Single-Service Articles
    H. Proposed Sec.  117.35(e)--Sanitation of Non-Food-Contact 
Surfaces
    I. Proposed Sec.  117.35(f)--Storage and Handling of Cleaned 
Portable Equipment and Utensils
XVI. Subpart B: Comments on Proposed Sec.  117.37--Sanitary 
Facilities and Controls
    A. Proposed Sec.  117.37(a)--Water Supply
    B. Proposed Sec.  117.37(b)--Plumbing
    C. Proposed Sec.  117.37(c)--Sewage Disposal
    D. Proposed Sec.  117.37(d)--Toilet Facilities
    E. Proposed Sec.  117.37(e)--Hand-Washing Facilities
XVII. Subpart B: Comments on Proposed Sec.  117.40--Equipment and 
Utensils
    A. Proposed Sec.  117.40(a)--Design, Construction, Use, 
Installation, and Maintenance of Equipment and Utensils
    B. Proposed Sec.  117.40(b)--Seams on Food-Contact Surfaces
    C. Proposed Sec.  117.40(c)--Construction of Equipment
    D. Proposed Sec.  117.40(d)--Holding, Conveying, and 
Manufacturing Systems
    E. Proposed Sec.  117.40(e)--Freezer and Cold Storage 
Compartments
    F. Proposed Sec.  117.40(f)--Accurate and Precise Instruments 
and Controls
    G. Proposed Sec.  117.40(g)--Compressed Air or Other Gases
XVIII. Subpart B: Comments on Proposed Sec.  117.80(a)--General 
Processes and Controls
    A. Proposed Sec.  117.80(a)(1)--Adequate Sanitation Principles
    B. Proposed Sec.  117.80(a)(2)--Quality Control Operations
    C. Proposed Sec.  117.80(a)(3)--Supervision of Overall 
Sanitation
    D. Proposed Sec.  117.80(a)(4)--Production Procedures
    E. Proposed Sec.  117.80(a)(5)--Chemical, Microbial, or 
Extraneous-Material Testing Procedures
    F. Proposed Sec.  117.80(a)(6)--Contaminated Food
XIX. Subpart B: Comments on Proposed Sec.  117.80(b)--Processes and 
Controls for Raw Materials and Other Ingredients
    A. Proposed Sec.  117.80(b)(1)--Inspection, Segregation and 
Handling of Raw Materials and Other Ingredients
    B. Proposed Sec.  117.80(b)(2)--Levels of Microorganisms in Raw 
Materials and Other Ingredients
    C. Proposed Sec.  117.80(b)(3)--Natural Toxins in Raw Materials 
and Other Ingredients
    D. Proposed Sec.  117.80(b)(4)--Pests, Undesirable 
Microorganisms and Extraneous Materials in Raw Materials and Other 
Ingredients
    E. Proposed Sec.  117.80(b)(5)--Holding Raw Materials, Other 
Ingredients, and Rework in Bulk
    F. Proposed Sec.  117.80(b)(7)--Liquid or Dry Raw Materials and 
Other Ingredients
    G. Proposed Sec.  117.80(b)(8)--Raw Materials and Other 
Ingredients That Are Food Allergens
XX. Subpart B: Comments on Proposed Sec.  117.80(c)--Manufacturing 
Operations
    A. Proposed Sec.  117.80(c)(1)--Condition of Equipment, 
Utensils, and Finished Food Containers
    B. Proposed Sec.  117.80(c)(2)--Conditions and Controls for Food 
Manufacturing, Processing, Packing, and Holding
    C. Proposed Sec.  117.80(c)(3)--Food That Can Support the Rapid 
Growth of Undesirable Microorganisms
    D. Proposed Sec.  117.80(c)(4)--Measures To Destroy or Prevent 
the Growth of Undesirable Microorganisms
    E. Proposed Sec.  117.80(c)(5)--Work-in-Process and Rework
    F. Proposed Sec.  117.80(c)(6)--Finished Food
    G. Proposed Sec.  117.80(c)(7)--Equipment, Containers, and 
Utensils
    H. Proposed Sec.  117.80(c)(8)--Metal or Other Extraneous 
Material
    I. Proposed Sec.  117.80(c)(9)--Disposal of Adulterated Food, 
Raw Materials, and Other Ingredients
    J. Proposed Sec.  117.80(c)(10)--Performing Manufacturing Steps
    K. Proposed Sec.  117.80(c)(11)--Heat Blanching and Growth and 
Contamination by Thermophilic Microorganisms During Manufacturing 
Operations
    L. Proposed Sec.  117.80(c)(12)--Batters, Breading, Sauces, 
Gravies, Dressings, and Other Similar Preparations
    M. Proposed Sec.  117.80(c)(13)--Filling, Assembling, Packaging 
and Other Operations
    N. Proposed Sec.  117.80(c)(14)--Food That Relies on the Control 
of Water Activity for Preventing the Growth of Undesirable 
Microorganisms
    O. Proposed Sec.  117.80(c)(15)--Food That Relies on the Control 
of pH for Preventing the Growth of Undesirable Microorganisms
    P. Proposed Sec.  117.80(c)(16)--Requirements for Ice Used in 
Contact With Food
    Q. Proposed Deletion of Current Sec.  110.80(b)(17)--Food-
Manufacturing Areas and Equipment
XXI. Subpart B: Comments on Proposed Sec.  117.93--Warehousing and 
Distribution
XXII. Subpart B: Comments on Proposed Sec.  117.110--Natural or 
Unavoidable Defects in Food for Human Use That Present No Health 
Hazard
XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis 
and Risk-Based Preventive Controls
XXIV. Subpart C: Comments on Proposed Sec.  117.126--Food Safety 
Plan
    A. Proposed Sec.  117.126(a)(1)--Requirement for a Food Safety 
Plan
    B. Proposed Sec.  117.126(a)(2)--Preparation of the Food Safety 
Plan by a Preventive Controls Qualified Individual
    C. Proposed Sec.  117.126(b)--Contents of a Food Safety Plan
    D. Proposed Sec.  117.126(c)--Records
    E. Comments on Potential Requirements for Submission of a 
Facility Profile to FDA
XXV. Subpart C: Comments on Proposed Sec.  117.130--Hazard Analysis
    A. Proposed Sec.  117.130(a)--Requirement for a Written Hazard 
Analysis
    B. Proposed Sec.  117.130(b)--Hazard Identification
    C. Proposed Sec.  117.130(c)--Evaluation of Whether a Hazard 
Requires a Preventive Control
XXVI. Subpart C: Comments on Proposed Sec.  117.135--Preventive 
Controls
    A. Proposed Sec.  117.135(a)--Requirement To Identify and 
Implement Preventive Controls
    B. Proposed Sec.  117.135(b)--Requirement for Written Preventive 
Controls
    C. Proposed Sec.  117.135(c)(1)--Process Controls
    D. Proposed Sec.  117.135(c)(2)--Food Allergen Controls
    E. Proposed Sec.  117.135(c)(3)--Sanitation Controls
    F. Proposed Sec.  117.135(c)(4)--Supply-Chain Controls
    G. Proposed Sec.  117.135(c)(5)--Recall Plan
    H. Proposed Sec.  117.135(c)(6)--Other Controls
XXVII. Subpart C: Circumstances in Which the Owner, Operator, or 
Agent in Charge of a Manufacturing/Processing Facility Is Not 
Required To Implement a Preventive Control (Final Sec. Sec.  117.136 
and 117.137)
XXVIII. Subpart C: Comments on Proposed Requirements for a Recall 
Plan (Final Sec.  117.139)
    A. Proposed Sec.  117.137(a)--Requirement for a Written Recall 
Plan (Final Sec.  117.139(a))
    B. Proposed Sec.  117.137(b)--Procedures That Describe the Steps 
To Be Taken, and Assign Responsibility for Taking Those Steps (Final 
Sec.  117.139(b))

[[Page 55910]]

XXIX. Comments on Proposed Sec.  117.140--Preventive Control 
Management Components
    A. Proposed Sec.  117.140(a)--Flexible Requirements for 
Monitoring, Corrective Actions and Corrections, and Verification
    B. Proposed Sec.  117.140(b)--Applicability of Preventive 
Control Management Components to the Supply-Chain Program
    C. Proposed Sec.  117.140(c)--Recall Plan is Not Subject to 
Preventive Control Management Components
XXX. Subpart C: Comments on Proposed Sec.  117.145--Monitoring
    A. Our Tentative Conclusion To Require Monitoring of the 
Performance of Preventive Controls
    B. Proposed Sec.  117.145(a)--Flexibility in Requirements for 
Monitoring
    C. Proposed Sec.  117.145(b)--Records
XXXI. Subpart C: Comments on Proposed Sec.  117.150--Corrective 
Actions and Corrections
    A. Proposed Sec.  117.150(a)(1)--Requirement To Establish and 
Implement Corrective Action Procedures
    B. Proposed Sec.  117.150(a)(2)--Content of Corrective Action 
Procedures
    C. Proposed Sec.  117.150(b)--Corrective Action in the Event of 
an Unanticipated Problem
    D. Proposed Sec.  117.150(c)--Corrections
    E. Proposed Sec.  117.150(d)--Records
XXXII. Subpart C: Comments on Proposed Sec.  117.155--Verification
    A. Flexibility in Requirements for Verification
    B. Proposed Sec.  117.155(a)--Verification Activities
    C. Proposed Sec.  117.155(b)--Documentation of Verification 
Activities
    D. Comments on Potential Requirements Regarding Complaints
XXXIII. Subpart C: Comments on Proposed Sec.  117.160--Validation
    A. Flexibility in the Requirements To Validate Preventive 
Controls
    B. Proposed Sec.  117.160(b)(1)--When Validation Must Be 
Performed and Role of the Preventive Controls Qualified Individual 
in Validation
    C. Proposed Sec.  117.160(b)(2)--What Validation Must Include
    D. Proposed Sec.  117.160(b)(3)--Preventive Controls for Which 
Validation Is Not Required
XXXIV. Subpart C: Comments on Proposed Sec.  117.165--Verification 
of Implementation and Effectiveness
    A. Flexibility in the Requirements To Conduct Activities To 
Verify Implementation and Effectiveness
    B. Proposed Sec.  117.165(a)(1)--Calibration
    C. Comments Directed to Proposed Requirements for Both Product 
Testing (Proposed Sec.  117.165(a)(2) and (b)(2)) and Environmental 
Monitoring (Proposed Sec.  117.165(a)(3) and (b)(3))
    D. Proposed Sec.  117.165(a)(2)--Product Testing
    E. Proposed Sec.  117.165(a)(3)--Environmental Monitoring
    F. Proposed Sec.  117.165(a)(4)--Review of Records
    G. Proposed Sec.  117.165(b)--Written Procedures
XXXV. Subpart C: Comments on Proposed Sec.  117.170--Reanalysis
    A. Proposed Sec.  117.170(a)--Circumstances Requiring Reanalysis
    B. Proposed Sec.  117.170(b)--Timeframe To Complete Reanalysis
    C. Proposed Sec.  117.170(c)--Requirement To Revise the Written 
Food Safety Plan or Document Why Revisions Are Not Needed
    D. Proposed Sec.  117.170(d)--Requirement for Oversight of 
Reanalysis by a Preventive Controls Qualified Individual
    E. Proposed Sec.  117.170(e)--Reanalysis on the Initiative of 
FDA
XXXVI. Subpart C: Comments on Proposed Sec.  117.180--Requirements 
Applicable to a Preventive Controls Qualified Individual and a 
Qualified Auditor
    A. Proposed Sec.  117.180(a) and (b)--What a Preventive Controls 
Qualified Individual or Qualified Auditor Must Do or Oversee
    B. Proposed Sec.  117.180(c)--Qualification Requirements
    C. Proposed Sec.  117.180(d)--Records
XXXVII. Subpart C: Comments on Proposed Sec.  117.190--
Implementation Records
    A. Proposed Sec.  117.190(a)--List of Required Records
    B. Proposed Sec.  117.190(b)--Applicability of Subpart F
XXXVIII. Subpart D: Comments on Proposed Sec.  117.201--Modified 
Requirements That Apply to a Qualified Facility
    A. Comments on Submission of a Certification Statement
    B. General Comments on Modified Requirements That Apply to a 
Qualified Facility
    C. Proposed Sec.  117.201(a)--Documentation To Be Submitted
    D. Proposed Sec.  117.201(b)--Procedure for Submission
    E. Proposed Sec.  117.201(c)--Frequency of Determination and 
Submission
    F. Proposed Sec.  117.201(d)--Notification to Consumers (Final 
Sec.  117.201(e))
    G. Proposed Sec.  117.201(e)--Records (Final Sec.  117.201(f))
XXXIX. Subpart D: Comments on Proposed Sec.  117.206--Modified 
Requirements That Apply to a Facility Solely Engaged in the Storage 
of Unexposed Packaged Food
    A. Proposed Sec.  117.206(a)--Modified Requirements for 
Unexposed Refrigerated Packaged Food That Requires Time/Temperature 
Controls
    B. Proposed Sec.  117.206(b)--Records
XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of 
a Qualified Facility Exemption
    A. Proposed Sec.  117.251--Circumstances That May Lead FDA To 
Withdraw a Qualified Facility Exemption
    B. Proposed Sec.  117.254--Issuance of an Order To Withdraw a 
Qualified Facility Exemption
    C. Proposed Sec.  117.257--Contents of an Order To Withdraw a 
Qualified Facility Exemption
    D. Proposed Sec.  117.260--Compliance With, or Appeal of, an 
Order To Withdraw a Qualified Facility Exemption
    E. Proposed Sec.  117.264--Procedure for Submitting an Appeal
    F. Proposed Sec.  117.267--Procedure for Requesting an Informal 
Hearing
    G. Proposed Sec.  117.270--Requirements Applicable to an 
Informal Hearing
    H. Proposed Sec.  117.287--Reinstatement of a Qualified Facility 
Exemption That Was Withdrawn
    I. Conforming Amendment to 21 CFR part 16
    J. Other Comments on the Withdrawal Provisions
XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements
    A. Proposed Sec.  117.301--Records Subject to the Requirements 
of Subpart F
    B. Proposed Sec.  117.305--General Requirements Applying to 
Records
    C. Proposed Sec.  117.310--Additional Requirements Applying to 
the Food Safety Plan
    D. Proposed Sec.  117.315--Requirements for Record Retention
    E. Proposed Sec.  117.320--Requirements for Official Review
    F. Proposed Sec.  117.325--Public Disclosure
    G. Proposed Sec.  117.330--Use of Existing Records
    H. Final Sec.  117.335--Special Requirements Applicable to a 
Written Assurance
    I. Other Comments on the Recordkeeping Requirements of Subpart F
XLII. Subpart G: General Comments on Proposed Requirements for a 
Supply-Chain Program
XLIII. Subpart G: Comments on Requirement To Establish and Implement 
a Supply-Chain Program
    A. Requirement for a Written Supply-Chain Program (Final Sec.  
117.405(a)(1) and (b))
    B. Circumstances That Do Not Require a Written Supply-Chain 
Program (Final Sec.  117.405(a)(2))
    C. Exemption for Food Supplied for Research or Evaluation (Final 
Sec.  117.405(a)(3))
    D. Additional Requirements for Non-Suppliers (Final Sec.  
117.405(c))
    E. Proposed General Requirements for the Supply-Chain Program 
That We Are Not Including in the Final Rule (Proposed Sec.  
117.136(a)(4) and (5))
XLIV. Subpart G: Comments on General Requirements Applicable to a 
Supply-Chain Program
    A. Description of What the Supply-Chain Program Must Include 
(Final Sec.  117.410(a))
    B. Appropriate Supplier Verification Activities ((Final Sec.  
117.410(b))
    C. Purpose of Supplier Verification Activities for Raw Materials 
and Other Ingredients (Final Sec.  117.410(c))
    D. Factors That Must Be Considered When Approving Suppliers and 
Determining Appropriate Supplier Verification Activities for Raw 
Materials and Other Ingredients (Final Sec.  117.410(d))
    E. Supplier Non-Conformance (Final Sec.  117.410(e))
XLV. Subpart G: New Requirement Specifying Responsibilities of the 
Receiving Facility (Final Sec.  117.415)
XLVI. Subpart G: Comments on Using Approved Suppliers and 
Determining Appropriate Supplier Verification Activities

[[Page 55911]]

    A. Using Approved Suppliers (Final Sec.  117.420)
    B. Determining Appropriate Verification Activities (Final Sec.  
117.425)
XLVII. Subpart G: Comments on Conducting Supplier Verification 
Activities for Raw Materials and Other Ingredients
    A. Requirement to Conduct One or More Supplier Verification 
Activities (Final Sec.  117.430(a))
    B. Requirement for an Onsite Audit as a Verification Activity 
When a Hazard Has a Reasonable Probability of Resulting in Serious 
Adverse Health Consequences or Death to Humans (Final Sec.  
117.430(b))
    C. Alternative Verification Activity When the Supplier Is a 
Qualified Facility (Final Sec.  117.430(c))
    D. Alternative Verification Activity When the Supplier Is a 
Produce Farm That Is Not a ``Covered Farm'' for the Purposes of the 
Future Produce Safety Rule (Final Sec.  117.430(d))
    E. Alternative Verification Activity When the Supplier Is a 
Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final Sec.  
117.430(e))
    F. Independence of Persons Who Conduct Supplier Verification 
Activities (Final Sec.  117.430(f))
XLVIII. Subpart G: Comments on Onsite Audit
    A. Requirements Applicable to an Onsite Audit (Final Sec.  
117.435(a) and (b))
    B. Substitution of Inspection by FDA or an Officially Recognized 
or Equivalent Food Safety Authority
    C. Onsite Audit by a Third-Party Auditor Accredited for the 
Purposes of Section 808 of the FD&C Act
XLIX. Subpart G: Comments on Records Documenting the Supply-Chain 
Program
    A. Applicability of the Recordkeeping Requirements of Subpart F 
(Final Sec.  117.475(a))
    B. Requirement To Review Records of the Supply-Chain Program 
(Final Sec.  117.475(b))
    C. Documentation Demonstrating Use of the Written Procedures for 
Receiving Raw Materials and Other Ingredients (Final Sec.  
117.475(c)(5))
    D. Documentation of the Conduct of an Onsite Audit (Final Sec.  
117.475(c)(7))
    E. Documentation of Sampling and Testing (Final Sec.  
117.475(c)(8))
    F. Documentation of Other Appropriate Supplier Verification 
Activity (Final Sec.  117.475(c)(10))
    G. Documentation of an Alternative Verification Activity for a 
Supplier That Is a Farm That Is Not a ``Covered Farm'' for the 
Purposes of the Future Produce Safety Rule (Final Sec.  
117.475(c)(13))
L. Holding Human Food By-Products Intended for Use in Animal Food
LI. Comments by Foreign Governments and Foreign Businesses
LII. Editorial and Conforming Changes
LIII. Comments on FSMA's Rulemaking Provisions
    A. Comments on Requirements in Section 418(n)(3) of the FD&C Act 
Regarding Content
    B. Comments on Requirements in Section 418(n)(5) of the FD&C Act 
Regarding Review of Hazard Analysis and Preventive Controls Programs 
in Existence on the Date of Enactment of FSMA
LIV. Comments on Proposed Removal of 21 CFR part 110--Current Good 
Manufacturing Practice in Manufacturing, Packing, or Holding Human 
Food
LV. Comments on Proposed Conforming Amendments
LVI. Effective and Compliance Dates
    A. Effective and Compliance Dates for Part 117
    B. Effective and Compliance Dates for Revisions to Part 1
    C. Effective Dates for Conforming Amendments
    D. Delayed Effective Dates for Provisions That Refer to the 
Forthcoming Rules for Produce Safety and Third-Party Certification
LVII. Compliance and Enforcement
LVIII. Executive Order 13175
LIX. Economic Analysis of Impacts
LX. Analysis of Environmental Impact
LXI. Paperwork Reduction Act of 1995
LXII. Federalism
LXIII. References

Executive Summary

Purpose and Coverage of the Rule

    This rule is part of FDA's implementation of the FDA Food Safety 
Modernization Act (FSMA), which intends to better protect public health 
by, among other things, adopting a modern, preventive, and risk-based 
approach to food safety regulation. This rule creates certain new 
requirements for the production of human food by registered food 
facilities, and revises previous requirements, in three key ways.
    First, this rule creates new requirements for certain domestic and 
foreign facilities to establish and implement hazard analysis and risk-
based preventive controls for human food. In general, these 
requirements apply to establishments that are required to register with 
FDA as a food ``facility.'' This portion of the rule requires 
registered food facilities to maintain a food safety plan, perform a 
hazard analysis, and institute preventive controls for the mitigation 
of those hazards, unless an exemption applies. Facilities must also 
monitor their controls, conduct verification activities to ensure the 
controls are effective, take appropriate corrective actions, and 
maintain records documenting these actions.
    Second, this rule modernizes FDA's long-standing current good 
manufacturing practice (CGMP) regulations regarding the manufacturing, 
processing, packing, or holding of human food. We have updated, 
revised, and otherwise clarified certain requirements within the CGMP 
regulations, which were last updated in 1986.
    Third, this rule clarifies the scope of the exemption for ``farms'' 
in FDA's current food facility registration regulations and makes 
corresponding revisions to FDA's current regulations for the 
establishment, maintenance, and availability of records. These 
revisions affect who is subject to the existing regulations for 
registration and recordkeeping, as well as the new requirements for 
hazard analysis and risk-based preventive controls requirements 
established here.
    This final rule is the result of significant stakeholder 
engagement, beginning before the proposed rule. In response to 
extensive stakeholder input on the proposed rule, we revised key 
provisions in a supplemental notice of proposed rulemaking. After the 
supplemental notice of proposed rulemaking, we conducted even more 
outreach to the stakeholder community to ensure that the risk-based, 
preventive requirements in this final rule are practical and protective 
of public health.

Summary of the Major Provisions of the Rule

    The final rule implements the requirements of FSMA for covered 
facilities to establish and implement a food safety system that 
includes a hazard analysis and risk-based preventive controls. 
Specifically, the rule establishes requirements for:
     A written food safety plan;
     Hazard analysis;
     Preventive controls;
     Monitoring;
     Corrective actions and corrections;
     Verification;
     Supply-chain program;
     Recall plan; and
     Associated records.
    We have added flexibility and clarity to these provisions in 
response to comments. Although there are similarities between these 
requirements of FSMA and the requirements of food safety systems known 
as Hazard Analysis and Critical Control Point (HACCP) systems, not 
every provision in FSMA is identical to the provisions of HACCP 
systems, and we have revised much of our terminology to distinguish 
FSMA's requirements for hazard analysis and risk-based preventive 
controls from HACCP requirements. A facility subject to the rule must 
conduct a hazard analysis to identify and evaluate known or reasonably 
foreseeable hazards for each type of food manufactured, processed, 
packed, or held at the facility to determine whether

[[Page 55912]]

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

[[Page 55913]]

these exemptions are expressly authorized by FSMA. A facility that 
manufactures, processes, packs, or holds food and that is required to 
register with FDA would be required to comply with the requirements for 
hazard analysis and risk-based preventive controls unless it is covered 
by an exemption, as shown in the following table.

  Proposed Exemptions From the New Requirements for Hazard Analysis and
                     Risk-Based Preventive Controls
------------------------------------------------------------------------
     Who or what is exempt from the
  requirements for hazard analysis and                Notes
     risk-based preventive controls
------------------------------------------------------------------------
``Qualified Facility'' as defined by     Modified requirements apply--
 FSMA:                                    i.e., a qualified facility is
 Business with average annual     required to:
 sales of <$500,000 and at least half     Notify FDA about its
 the sales to consumers or local          status; and
 retailers or restaurants (within the     Either:
 same state or within 275 miles); or.    [cir] Notify FDA that it is
 Very small business, which the   addressing hazards through
 rule defines as a business (including    preventive controls and
 any subsidiaries and affiliates)         monitoring; or
 averaging less than $1,000,000,         [cir] Notify FDA that it
 adjusted for inflation, per year,        complies with applicable non-
 during the 3-year period preceding the   Federal food safety
 applicable calendar year in sales of     regulations, and notify
 human food plus the market value of      consumers of the name and
 human food manufactured, processed,      complete business address of
 packed, or held without sale (e.g.,      the facility where the food
 held for a fee).                         was manufactured or processed.
                                          The notification is in
                                          the form of an attestation,
                                          and must be submitted every
                                          two years, during the same
                                          timeframe as the facility is
                                          required to update its
                                          facility registration.
 Low-risk, on-farm activities    Small and very small on-farm
 performed by small business (<500 full-  businesses conducting only the
 time equivalent employees).              specified low-risk activities
-or-...................................   are exempt from the
 Low-risk, on-farm activities     requirements for hazard
 performed by a very small business       analysis and risk-based
 (dollar threshold of $1,000,000, as      preventive controls.
 described previously).                  We define the low-risk, on-farm
                                          activities that qualify for
                                          the exemption, including the
                                          specific foods to which they
                                          relate (such as making jams,
                                          jellies, and preserves from
                                          acid fruits, and making milled
                                          grain products such as
                                          cornmeal).
Activities that are subject to the       The facility must be in
 seafood HACCP requirements of part 123   compliance with part 123.
 (21 CFR part 123).
Activities that are subject to the       The facility must be in
 juice HACCP requirements of part 120     compliance with part 120.
 (21 CFR part 120).
Activities that are subject to the        The exemption applies
 ``low-acid canned food'' requirements    only with respect to
 of part 113 (21 CFR part 113).           microbiological hazards
                                          regulated under part 113.
                                          The facility must be
                                          in compliance with part 113.
The manufacturing, processing,            The facility must be
 packaging, or holding of a dietary       in compliance with part 111.
 supplement that is subject to the CGMP   The facility must be
 requirements of part 111 (21 CFR part    in compliance with
 111).                                    requirements for serious
                                          adverse event reporting for
                                          dietary supplements.
Activities of a facility that are        These activities will be
 subject to section 419 of the Federal    established in FDA's
 Food, Drug, and Cosmetic Act             forthcoming rule for produce
 (Standards for Produce Safety).          safety.
Alcoholic beverages at a facility that   The exemption also applies to
 is required to obtain a permit from,     food other than alcoholic
 register with, or obtain approval of a   beverages at such a facility,
 notice or application from the           provided that the food is in
 Secretary of the Treasury as a           prepackaged form and
 condition of doing business in the       constitutes not more than 5
 United States.                           percent of the overall sales
                                          of the facility.
Facilities that are solely engaged in    A facility that stores raw
 the storage of raw agricultural          agricultural commodities that
 commodities (other than fruits and       are fruits and vegetables is
 vegetables) intended for further         not exempt.
 distribution or processing.
A facility solely engaged in the         Modified requirements apply for
 storage of packaged food that is not     the storage of unexposed
 exposed to the environment.              packaged food that must be
                                          refrigerated for safety.
------------------------------------------------------------------------

    The rule includes procedures for withdrawing a qualified facility 
exemption, in the event of an active investigation of a foodborne 
illness outbreak that is directly linked to the facility, or if FDA 
determines that it is necessary to protect the public health and 
prevent or mitigate a foodborne illness outbreak based on relevant 
conditions or conduct associated with the qualified facility. The final 
rule provides procedures for a facility to appeal an order to withdraw 
a qualified facility exemption, for a facility to request an informal 
hearing, for the conduct of an informal hearing, for an appeal, for 
revoking an order to withdraw a qualified facility exemption, and for 
reinstating an exemption that was withdrawn.
    The rule finalizes recordkeeping provisions associated with the new 
provisions for hazard analysis and risk-based preventive controls. 
These records allow facilities to show, and FDA to determine, 
compliance with the new requirements. To meet these requirements, a 
facility may use existing records as appropriate.
    In addition to finalizing new requirements for hazard analysis and 
risk-based preventive controls as required by FSMA, the rule does two 
more key things. First, it modernizes the existing CGMPs. Second, it 
revises the ``farm'' definition.
    The rule makes several revisions to the CGMPs to update and clarify 
them. For example, the final CGMPs do not include nonbinding 
provisions, because it is no longer FDA's practice to include guidance 
in the regulatory text. The rule finalizes some of the previously 
nonbinding provisions in the CGMPs as binding requirements, including a 
requirement for education and training, but deletes other nonbinding 
provisions. We have revised some key terms for consistency and clarity. 
And we have clarified FDA's long-standing position that the CGMPs 
address allergen cross-contact by making that explicit in the 
regulatory text. Finally, the rule revises a long-standing exemption 
from the CGMP requirements regarding specific activities conducted on 
raw agricultural commodities to reflect the contemporary regulatory 
framework associated with the ``farm'' definition. In addition, 
elsewhere in this issue of the Federal

[[Page 55914]]

Register, in a final rule that establishes requirements for hazard 
analysis and risk-based preventive controls for food for animals, FDA 
is establishing an additional revision to the human food CGMPs to 
address comments about the practice of human food manufacturers sending 
by-products to local farmers or animal food manufacturers for use as 
animal food. Because we proposed these requirements as part of the 
rulemaking for the animal preventive controls rule, we are finalizing 
these provisions in the final animal preventive controls rule rather 
than in this rule.
    Finally, the rule clarifies the ``farm'' definition that is central 
to the determination of whether certain entities must register as a 
food facility and, thus, become subject to the new requirements for 
hazard analysis and risk-based preventive controls. The final ``farm'' 
definition reflects current farming practices, differentiates between 
two types of farm operations (i.e., a ``primary production farm'' and a 
``secondary activities farm''), and allows for a consistent--although 
not identical--regulatory approach across similar operations, to the 
extent possible. In general, a ``primary production farm'' is an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. A farm packs and holds raw 
agricultural commodities and may conduct certain manufacturing/
processing activities (i.e., drying/dehydrating raw agricultural 
commodities to create a distinct commodity (such as drying/dehydrating 
grapes to produce raisins), treatment to manipulate the ripening of raw 
agricultural commodities (such as by treating produce with ethylene 
gas), and packaging and labeling). The term farm also now includes a 
``secondary activities farm,'' which is an operation, not located on a 
primary production farm, devoted to the key farming operations of 
harvesting, packing, and/or holding of raw agricultural commodities, 
provided that the primary production farm(s) that grow, harvest, and/or 
raise the majority of the raw agricultural commodities harvested, 
packed, and/or held by the secondary activities farm owns, or jointly 
owns, a majority interest in the secondary activities farm. A secondary 
activities farm may also conduct those additional activities allowed on 
a primary production farm.

Costs and Benefits

    This final regulation requires domestic and foreign facilities to 
adopt a food safety plan, perform a hazard analysis, and to institute 
preventive controls for the mitigation of those hazards. It also 
includes requirements for facilities to institute risk-based 
environmental monitoring, product testing, and a supply-chain program 
as appropriate to the food, the facility, and the nature of the 
preventive controls, as well as a requirement to institute controls to 
help prevent hazards associated with economically motivated 
adulteration. The total annualized domestic costs are estimated to be 
approximately $381 million per year, estimated with a 3 percent 
discount rate, and $382 million per year, estimated at 7 percent when 
discounted over 10 years. We estimate that processed foods covered by 
this rulemaking are responsible for approximately 903,000 foodborne 
illnesses each year, at a total cost to the American public of 
approximately $2.2 billion. Our break-even analysis shows that for the 
rule to be cost effective, it would have to prevent $382 million worth 
of foodborne illness; approximately 17 percent of the total annual 
illnesses, or approximately 157,000 illnesses when using a discount 
rate of 7 percent. For the rule to be cost effective using a discount 
rate of 3 percent, it would have to prevent $381 million worth of 
foodborne illness (about 17 percent or 156,000 illnesses).

                                                                Costs and Health Benefits
                                                                      [$ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             One-time cost      One-time cost
                                                               second yr           third yr
                                          One-time cost    compliance period  compliance period     Annual cost      Total annualized   Total Annualized
            PCHF Provision                   first yr            (small          (very small         (annually          cost at 7%         cost at 3%
                                        compliance period   businesses  <500   businesses  <$1   recurring  costs)
                                                                 FTE's)            million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Learn about Rule......................                 $6                $96                $21                 $0                $16                $14
Total Costs Subparts A & D............                 17                148                 88                 15                 43                 41
Total Costs Subparts C & G............                  9                183                  0                340                323                326
Total Domestic Costs..................                 32                427                109                355                382                381
Total Foreign Costs...................                 68                915                234                760                820                817
                                       -----------------------------------------------------------------------------------------------------------------
Total Costs...........................                100              1,342                344              1,115              1,202              1,198
                                       -----------------------------------------------------------------------------------------------------------------
Total Health Benefits.................      Not Quantified. Break-even occurs when 157,000 illnesses are prevented per year (based on domestic costs
                                                                                    discounted at 7 percent).
--------------------------------------------------------------------------------------------------------------------------------------------------------


                   Table of Abbreviations and Acronyms
------------------------------------------------------------------------
              Abbreviation/acronym                    What it means
------------------------------------------------------------------------
Bioterrorism Act...............................  Public Health Security
                                                  and Bioterrorism
                                                  Preparedness and
                                                  Response Act of 2002
                                                  (Pub. L. 107-188).
CFSAN..........................................  Center for Food Safety
                                                  and Applied Nutrition.
CGMP...........................................  Current Good
                                                  Manufacturing
                                                  Practice.
Codex..........................................  Codex Alimentarius
                                                  Commission.

[[Page 55915]]

 
Codex Validation Guidelines....................  Codex Guidelines for
                                                  the Validation of Food
                                                  Safety Control
                                                  Measures.
CSA............................................  Community Supported
                                                  Agriculture.
CPG............................................  Compliance Policy
                                                  Guide.
EO.............................................  Executive Order.
EPA............................................  U.S. Environmental
                                                  Protection Agency.
EU.............................................  European Union.
FDA............................................  U.S Food and Drug
                                                  Administration.
FD&C Act.......................................  Federal Food, Drug, and
                                                  Cosmetic Act.
FSIS...........................................  Food Safety and
                                                  Inspection Service of
                                                  the U.S. Department of
                                                  Agriculture.
FSIS Validation Guidelines.....................  FSIS' Compliance
                                                  Guidelines on HACCP
                                                  Systems Validation.
FSMA...........................................  FDA Food Safety
                                                  Modernization Act.
FSPCA..........................................  Food Safety Preventive
                                                  Controls Alliance.
GFSI...........................................  Global Food Safety
                                                  Initiative.
HACCP..........................................  Hazard Analysis and
                                                  Critical Control
                                                  Point.
HIPAA..........................................  Health Insurance
                                                  Portability and
                                                  Accountability Act of
                                                  1996.
Infant formula rule............................  Current Good
                                                  Manufacturing
                                                  Practices, Quality
                                                  Control Procedures,
                                                  Quality Factors,
                                                  Notification
                                                  Requirements, and
                                                  Records and Reports,
                                                  for Infant Formula,
                                                  June 10, 2014 (79 FR
                                                  33057).
ISO............................................  International
                                                  Organization for
                                                  Standardization.
LACF...........................................  Thermally Processed Low-
                                                  Acid Foods Packaged in
                                                  Hermetically Sealed
                                                  Containers (commonly
                                                  called ``Low-Acid
                                                  Canned Foods'').
N/A............................................  Not Applicable.
NCIMS..........................................  National Conference on
                                                  Interstate Milk
                                                  Shipments.
NIFA...........................................  National Institute of
                                                  Food and Agriculture.
NOP............................................  National Organic
                                                  Program.
OMB............................................  Office of Management
                                                  and Budget.
PHS Act........................................  Public Health Service
                                                  Act.
PMO............................................  Pasteurized Milk
                                                  Ordinance.
PMO facilities.................................  Facilities that comply
                                                  with the PMO and are
                                                  regulated under the
                                                  NCIMS system.
PFP............................................  Partnership for Food
                                                  Protection.
PRA............................................  Paperwork Reduction
                                                  Act.
PSA............................................  Produce Safety
                                                  Alliance.
RAC............................................  Raw agricultural
                                                  commodity.
RFR............................................  Reportable Food
                                                  Registry.
Section 103(c)(1)(C) draft RA..................  Draft Qualitative Risk
                                                  Assessment: Risk of
                                                  Activity/Food
                                                  Combinations for
                                                  Activities (Outside
                                                  the Farm Definition)
                                                  Conducted in a
                                                  Facility Co-Located on
                                                  a Farm.
Section 103(c)(1)(C) RA........................  Qualitative Risk
                                                  Assessment: Risk of
                                                  Activity/Food
                                                  Combinations for
                                                  Activities (Outside
                                                  the Farm Definition)
                                                  Conducted in a
                                                  Facility Co-Located on
                                                  a Farm (Final).
SBA............................................  Small Business
                                                  Administration.
SECG...........................................  Small Entity Compliance
                                                  Guide.
TCS food.......................................  Time/Temperature
                                                  Control for Safety
                                                  Food.
USDA...........................................  U.S. Department of
                                                  Agriculture.
------------------------------------------------------------------------

I. Background

A. FDA Food Safety Modernization Act

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

    Table 1--Published Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2013 proposed       78 FR 3646,
 Practice and Hazard Analysis      human preventive    January 16, 2013
 and Risk-Based Preventive         controls rule.
 Controls for Human Food.
Standards for the Growing,        2013 proposed       78 FR 3504,
 Harvesting, Packing, and          produce safety      January 16, 2013
 Holding of Produce for Human      rule.
 Consumption.
Current Good Manufacturing        2013 proposed       78 FR 64736,
 Practice and Hazard Analysis      animal preventive   October 29, 2013
 and Risk-Based Preventive         controls rule.
 Controls for Food for Animals.
Foreign Supplier Verification     2013 proposed FSVP  78 FR 45730, July
 Programs (FSVP) for Importers     rule.               29, 2013
 of Food for Humans and Animals.
Accreditation of Third-Party      2013 proposed       78 FR 45782, July
 Auditors/Certification Bodies     third-party         29, 2013
 to Conduct Food Safety Audits     certification
 and to Issue Certifications.      rule.

[[Page 55916]]

 
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24, 2013
 Intentional Adulteration.         adulteration rule.
Sanitary Transportation of Human  2014 proposed       79 FR 7006,
 and Animal Food.                  sanitary            February 5, 2014
                                   transportation
                                   rule.
------------------------------------------------------------------------

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

 Table 2--Published Supplemental Notices of Proposed Rulemaking for the
              Foundational Rules for Implementation of FSMA
------------------------------------------------------------------------
              Title                  Abbreviation         Publication
------------------------------------------------------------------------
Current Good Manufacturing        2014 supplemental   79 FR 58524,
 Practice and Hazard Analysis      human preventive    September 29,
 and Risk-Based Preventive         controls notice.    2014
 Controls for Human Food.
Standards for the Growing,        2014 supplemental   79 FR 58434,
 Harvesting, Packing, and          produce safety      September 29,
 Holding of Produce for Human      notice.             2014
 Consumption.
Current Good Manufacturing        2014 supplemental   79 FR 58476,
 Practice and Hazard Analysis      animal preventive   September 29,
 and Risk-Based Preventive         controls notice.    2014
 Controls for Food for Animals.
Foreign Supplier Verification     2014 supplemental   79 FR 58574,
 Programs (FSVP) for Importers     FSVP notice.        September 29,
 of Food for Humans and Animals.                       2014
------------------------------------------------------------------------

    As FDA finalizes these seven foundational rulemakings, we are 
putting in place a framework for food safety that is modern and brings 
to bear the most recent science on provisions to enhance food safety, 
that is risk-based and focuses effort where the hazards are reasonably 
likely to occur, and that is flexible and practical given our current 
knowledge of food safety practices. To achieve this, FDA has engaged in 
a great deal of outreach to the stakeholder community to find the right 
balance in these regulations of flexibility and accountability.
    Since FSMA was enacted in 2011, we have been involved in 
approximately 600 engagements on FSMA and the proposed rules, including 
public meetings, webinars, listening sessions, farm tours, and 
extensive presentations and meetings with various stakeholder groups 
(Ref. 1) (Ref. 2). As a result of this stakeholder dialogue, FDA 
decided to issue the four supplemental notices of proposed rulemaking 
to share our current thinking on key issues and get additional 
stakeholder input on those issues. As we move forward into the next 
phase of FSMA implementation, we intend to continue this dialogue and 
collaboration with our stakeholders, through guidance, education, 
training, and assistance, to ensure that everyone understands and 
engages in their role in food safety. FDA believes these seven 
foundational final rules, when implemented, will fulfill the paradigm 
shift toward prevention that was envisioned in FSMA and be a major step 
forward for food safety that will protect consumers into the future.

B. Stages in the Rulemaking for the Human Preventive Controls Rule

    With regard to this rulemaking, we published proposed provisions in 
the 2013 proposed human preventive controls rule and we published new 
and re-proposed provisions in the 2014 supplemental human preventive 
controls notice. In the 2014 supplemental human preventive controls 
notice, we reopened the comment period only with respect to specific 
proposed provisions. In addition, we emphasized that the re-proposed 
provisions we included in the regulatory text were based on a 
preliminary review of the comments.
    In this document, we use the broad term ``proposed human preventive 
controls rule'' to refer to the complete proposed regulatory text, 
including both the proposed provisions we published in the 2013 
proposed human preventive controls rule and the new and re-proposed 
provisions we published in the 2014 supplemental human preventive 
controls notice. We use the narrow terms ``2013 proposed human 
preventive controls rule'' and ``2014 supplemental human preventive 
controls notice'' to refer to specific text published in the Federal 
Register of January 16, 2013 (78 FR 3646) and September 29, 2014 (79 FR 
58524), respectively. We use the terms ``final human preventive 
controls rule'' and ``this rule'' to refer to the regulations we are 
establishing as a result of this rulemaking.
    We issued a notice correcting several typographical and stylistic 
errors in the 2013 proposed human preventive controls rule and a 
mistake in the date of a reference (78 FR 17142, March 20, 2013). In 
that correction notice, we republished the Appendix in its entirety (78 
FR 17142 at 17143 through 17155; the corrected Appendix) because all 
the references to the Appendix as published in the 2013 proposed human 
preventive controls rule (78 FR 3646 at 3812 through 3824) had been 
numbered incorrectly. We also extended the comment periods for the 2013 
proposed human preventive controls rule, its information collection 
provisions, and a related risk assessment (see section I.D) in response 
to several requests that we do so.

C. Summary of the Major Provisions of Proposed Human Preventive 
Controls Rule

    As part of our announced initiative (Ref. 3) to revisit the CGMP 
requirements since they were last revised in 1986, we proposed to amend 
our regulation for Current Good Manufacturing Practice In 
Manufacturing, Packing, or Holding Human Food (currently established in 
part 110 (21 CFR part 110)) to: (1) Modernize it; (2) adjust and 
clarify what activities fall within the long-standing exemption from 
the CGMP requirements for establishments engaged solely in the 
harvesting, storage, or distribution of one or more raw agricultural 
commodities (RACs) based on experience and changes in related areas

[[Page 55917]]

of the law since issuance of the CGMP regulation; (3) delete some non-
binding provisions of current part 110; and (4) re-establish the 
provisions of current part 110 in new part 117 (21 CFR part 117). We 
also requested comment on: (1) Additional proposed revisions or 
clarifications to our CGMP regulations, including whether to further 
implement opportunities for CGMP modernization, such as on how best to 
revise the current provisions for training; and (2) whether to revise 
some non-binding provisions to establish new requirements in proposed 
part 117, or to simply retain them as useful provisions of a 
comprehensive CGMP.
    As part of our implementation of new statutory provisions in FSMA, 
we also proposed to add, in newly established part 117, requirements 
for certain domestic and foreign facilities to establish and implement 
hazard analysis and risk-based preventive controls for human food. As 
directed by FSMA (see section 418 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act)), these new provisions would apply to domestic 
and foreign facilities that are required to register under section 415 
of the FD&C Act and our regulation for Registration of Food Facilities 
(21 CFR part 1, subpart H; the section 415 registration regulations). 
As directed by FSMA (see sections 418(l) and (m) of the FD&C Act), we 
proposed to establish modified requirements for certain facilities. We 
requested comment on all aspects of the proposed requirements, 
including an opportunity for public comment on potential requirements 
for product testing, environmental monitoring, a supply-chain program, 
and hazards that may be intentionally introduced for purposes of 
economic gain.
    As directed by section 103 of FSMA, we proposed to clarify the 
scope of the exemption from the section 415 registration regulations 
for ``farms'' by revising the ``farm'' definition and by adding or 
modifying the definitions for certain activities (i.e., for 
``harvesting,'' ``holding,'' ``manufacturing/processing,'' and 
``packing'' activities) that govern, in part, whether a business that 
is devoted to the growing of crops, the raising of animals, or both is 
within the ``farm'' definition. We also proposed to add or revise these 
definitions in our current regulation (implementing section 414 of the 
FD&C Act) for Establishment and Maintenance of Records for Foods (21 
CFR part 1, subpart J; the section 414 recordkeeping regulations), 
which also have an exemption for ``farms.''
    We proposed to establish the requirements for CGMPs, for hazard 
analysis and risk-based preventive controls, and related requirements 
in new part 117 as shown in table 3:

               Table 3--Proposed Subparts in New Part 117
------------------------------------------------------------------------
             Subpart                               Title
------------------------------------------------------------------------
A...............................  General Provisions.
B...............................  Current Good Manufacturing Practice.
C...............................  Hazard Analysis and Risk-Based
                                   Preventive Controls.
D...............................  Modified Requirements.
E...............................  Withdrawal of an Exemption Applicable
                                   to a Qualified Facility.
F...............................  Requirements Applying to Records That
                                   Must Be Established and Maintained.
------------------------------------------------------------------------

D. Draft Risk Assessment

    We issued for public comment a ``Draft Qualitative Risk Assessment: 
Risk of Activity/Food Combinations for Activities (Outside the Farm 
Definition) Conducted in a Facility Co-Located on a Farm'' (the section 
103(c)(1)(C) draft RA) (78 FR 3824, January 16, 2013). The purpose of 
the section 103(c)(1)(C) draft RA was to provide a science-based risk 
analysis of those activity/food combinations that would be considered 
low risk when conducted in a facility co-located on a farm. We used the 
tentative conclusions of the section 103(c)(1)(C) draft RA to propose 
to exempt food facilities that are small or very small businesses that 
are engaged only in specific types of on-farm manufacturing, 
processing, packing, or holding activities from the requirements for 
hazard analysis and risk-based preventive controls. We are including 
the final risk assessment (the section 103(c)(1)(C) RA) in the docket 
established for this document (Ref. 4).

E. Definition of ``Retail Food Establishment''

    An establishment that meets the definition of ``retail food 
establishment'' is exempt from the requirements of the section 415 
registration regulations and, thus, from FSMA's requirements for hazard 
analysis and risk-based preventive controls. Section 102(c) of FSMA 
requires that we revise the definition of ``retail food establishment'' 
in Sec.  1.227 to clarify its intent. We are addressing the 
requirements of section 102(c) of FSMA in a separate rulemaking and 
issued a separate proposed rule to amend the definition of ``retail 
food establishment'' in the section 415 registration regulations and 
the section 414 recordkeeping regulations (80 FR 19160, April 9, 2015). 
We intend to issue a final rule to amend the definition of ``retail 
food establishment'' in the section 415 registration regulations in the 
near future.

F. Public Comments

    We received more than 8,000 public submissions on the 2013 proposed 
human preventive controls rule, and more than 1,300 public submissions 
on the 2014 preventive controls supplemental notice, each containing 
one or more comments. We received submissions from diverse members of 
the public, including food facilities (including facilities co-located 
on a farm); farms; cooperatives; coalitions; trade organizations; 
consulting firms; law firms; academia; public health organizations; 
public advocacy groups; consumers; consumer groups; Congress; Federal, 
State, local, and tribal Government Agencies; and other organizations. 
Some submissions included signatures and statements from multiple 
individuals. Comments address virtually every provision of the proposed 
human preventive controls rule. In the remainder of this document, we 
describe these comments, respond to them, and explain any revisions we 
made to the proposed human preventive controls rule.
    Some comments address issues that are outside the scope of this 
rule. For example, some comments express concern over pesticides being 
used on local crops being harmful to the honeybee population. Other 
comments address the requirements of the proposed produce safety rule, 
such as standards for water quality. Other comments express concern 
about the use of bioengineered food ingredients, and ask that foods 
containing such ingredients be labeled so that consumers can identify 
such foods and choose whether to consume them. Other comments assert 
that the rules should address social issues. We do not discuss such 
comments in this document.

II. Legal Authority

    The proposed rule contained an explanation of its legal basis under 
authorities in the FDA Food Safety Modernization Act, the FD&C Act, and 
the Public Health Service Act. After considering comments received in 
response to the 2013 proposed human preventive controls rule and 2014 
supplemental human preventive controls notice, FDA made changes in the 
final rule. The legal authorities relied on for the final rule are the 
same as in the proposed rule unless otherwise described in the sections 
that follow.

[[Page 55918]]

A. Changes to Current 21 CFR Part 1, Subparts H, I, and J

    Sections 103(c)(2)(A) and (B) of FSMA require that the Secretary 
adopt final rules for purposes of section 415 of the FD&C Act 
(Registration of Food Facilities) with respect to ``activities that 
constitute on-farm packing or holding of food that is not grown, 
raised, or consumed on such farm or another farm under the same 
ownership'' and ``activities that constitute on-farm manufacturing or 
processing of food that is not consumed on that farm or on another farm 
under common ownership.'' In section IV, we discuss our revision of the 
section 415 registration regulations (21 CFR part 1, subpart H) to 
clarify the types of activities that are included as part of the 
definition of the term ``facility'' under section 415 of the FD&C Act 
and the scope of the exemption for ``farms'' provided by section 415 of 
the FD&C Act. The final rule also makes corresponding changes in part 
1, subpart I (Prior Notice of Imported Food) and in part 1, subpart J 
(Establishment, Maintenance, and Availability of Records). FDA's legal 
authority to modify these regulations is derived from section 103(c) of 
FSMA and sections 414, 415, 381(m) and 371(a) of the FD&C Act (21 
U.S.C. 350c, 350d, 801(m), and 701(a)).

B. Changes to Current 21 CFR Part 110

    The changes to the current CGMP regulation finalized in this 
document clarify the existing requirements of the regulation and update 
existing requirements to reflect changes in the food industry and in 
scientific understanding of food safety since issuance of the current 
regulation. FDA's legal authority to require Current Good Manufacturing 
Practices derives from sections 402(a)(3), (a)(4) and 701(a) of the 
FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 
402(a)(3) of the FD&C Act provides that a food is adulterated if it 
consists in whole or in part of any filthy, putrid, or decomposed 
substance, or if it is otherwise unfit for food. Section 402(a)(4) of 
the FD&C Act provides that a food is adulterated if it has been 
prepared, packed, or held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health. Under section 701(a) of the FD&C Act, FDA 
is authorized to issue regulations for the efficient enforcement of the 
FD&C Act. The revisions we are making to the current CGMP regulation 
are necessary to prevent food from containing filthy, putrid, or 
decomposed substances, being otherwise unfit for food, or being 
prepared, packed, or held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health.
    In addition to the FD&C Act, FDA's legal authority for the changes 
to current CGMP requirements derives from the PHS Act to the extent 
such measures are related to communicable disease. Authority under the 
PHS Act is derived from the provisions of sections 311, 361, and 368 
(42 U.S.C. 243, 264, and 271) that relate to communicable disease. The 
PHS Act authorizes the Secretary to make and enforce such regulations 
as ``are necessary to prevent the introduction, transmission, or spread 
of communicable diseases from foreign countries into the States * * * 
or from one State * * * into any other State'' (section 361(a) of the 
PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for 
transfer of authority from the Surgeon General to the Secretary.) The 
revisions we are making to the current CGMP regulation are necessary to 
prevent the spread of communicable disease.

C. Hazard Analysis and Risk-Based Preventive Controls

    Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive 
Controls, amends the FD&C Act to create a new section 418, which 
mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that 
the Secretary issue regulations ``to establish science-based minimum 
standards for conducting a hazard analysis, documenting hazards, 
implementing preventive controls, and documenting the implementation of 
the preventive controls. . . .'' Section 418(n)(1)(B) of the FD&C Act 
requires that the regulations define the terms ``small business'' and 
``very small business,'' taking into consideration the study of the 
food processing sector required by section 418(l)(5) of the FD&C Act. 
Further, section 103(e) of FSMA creates a new section 301(uu) in the 
FD&C Act (21 U.S.C. 331(uu)) to prohibit ``[t]he operation of a 
facility that manufactures, processes, packs, or holds food for sale in 
the United States if the owner, operator, or agent in charge of such 
facility is not in compliance with section 418 [of the FD&C Act].''
    In addition to rulemaking requirements, section 418 contains 
requirements applicable to the owner, operator, or agent in charge of a 
facility required to register under section 415. Section 418(a) is a 
general provision that requires the owner, operator, or agent in charge 
of a facility to evaluate the hazards that could affect food 
manufactured, processed, packed, or held by the facility, identify and 
implement preventive controls, monitor the performance of those 
controls, and maintain records of the monitoring. Section 418(a) 
specifies that the purpose of the preventive controls is to ``prevent 
the occurrence of such hazards and provide assurances that such food is 
not adulterated under section 402 [of the FD&C Act] or misbranded under 
section 403(w) [of the FD&C Act]. . . .'' In addition to the general 
requirements in section 418(a) of the FD&C Act, sections 418(b)-(i) 
contain more specific requirements applicable to facilities. These 
include hazard analysis (section 418(b)), preventive controls (section 
418(c)), monitoring (section 418(d)), corrective actions (section 
418(e)), verification (section 418(f)), recordkeeping (section 418(g)), 
a written plan and documentation (section 418(h)), and reanalysis of 
hazards (section 418(i)).
    Section 103(c)(2)(C) of FSMA requires that the Secretary adopt a 
final rule with respect to the requirements under sections 418 and 421 
of the FD&C Act from which the Secretary may issue exemptions or 
modifications of the requirements for certain types of facilities. 
Sections 418(j)-(m) of the FD&C Act and sections 103(c)(1)(D) and (g) 
of FSMA provide authority for certain exemptions and modifications to 
the requirements of section 418 of the FD&C Act. These include 
provisions related to seafood and juice HACCP, and low-acid canned food 
(section 418(j)); activities of facilities subject to section 419 of 
the FD&C Act (Standards for Produce Safety) (section 418(k)); qualified 
facilities (section 418(l)); facilities that are solely engaged in the 
production of food for animals other than man, the storage of raw 
agricultural commodities (other than fruits and vegetables) intended 
for further distribution or processing, or the storage of packaged 
foods that are not exposed to the environment (section 418(m)); 
facilities engaged only in certain low-risk on-farm activities on 
certain foods conducted by small or very small businesses (section 
103(c)(1)(D) of FSMA), and dietary supplements (section 103(g) of 
FSMA). In sections XI, XII, XXXVIII, and XXXIX, we discuss provisions 
that implement these exemptions and modified requirements.
    In the 2014 supplemental human preventive controls notice, we 
included potential requirements for a supplier program, environmental 
monitoring, and product testing. We are including provisions for such 
activities in the final

[[Page 55919]]

rule. Section 418(o)(3) of the FD&C Act provides supplier verification 
activities and an environmental monitoring program as examples of 
preventive controls. Section 418(f)(4) of the FD&C Act provides for the 
use of environmental and product testing programs as part of required 
verification that the preventive controls are effectively and 
significantly minimizing or preventing the occurrence of identified 
hazards.
    In certain circumstances, the final rule does not require a 
manufacturing/processing facility to implement a preventive control for 
a hazard requiring a preventive control. Instead, the facility is 
permitted to rely on a subsequent entity in the distribution chain to 
significantly minimize or prevent the hazard. In such a circumstance, a 
facility must disclose in documents accompanying the food, that the 
food is ``not processed to control [identified hazard].'' This 
requirement is supported by sections 418 and 701(a) of the FD&C Act (21 
U.S.C. 350g and 371(a)). The requirement that facilities apply 
preventive controls to significantly minimize or prevent hazards is 
fundamental to the public health benefits of the rule. To accommodate 
the realities of modern food production, the rule allows a facility to 
rely on a subsequent entity in the distribution chain rather than 
requiring that facility to apply the control. A food may pass through 
multiple entities in the distribution chain before it reaches 
consumers. Further, ordinarily it is not apparent from visual 
examination of the food whether a hazard requiring a preventive control 
has been addressed. Consequently, without labeling, a facility might 
not know that a facility upstream in the supply chain has not applied a 
preventive control and is relying on a downstream entity to do so. 
Therefore, the agency concludes that information that food has not been 
processed to control an identified hazard is necessary for a facility 
to fulfil its obligation under section 418 when a facility is relying 
on a subsequent entity to control the hazard. The agency also concludes 
that such labeling is necessary for the efficient enforcement of the 
Act because the labelling is critical for FDA to hold facilities 
responsible for their obligations under this regulatory scheme. 
Further, when the hazard can cause a communicable disease, FDA 
concludes that the requirement is necessary to prevent the spread of 
communicable disease from one state into another state and relies on 
sections 311, 361, and 368 of the PHS Act.
    FDA concludes that the provisions in subpart C and related 
requirements in subparts A, D, F, and G should be applicable to 
activities that are intrastate in character. Facilities are required to 
register under section 415 of the FD&C Act regardless of whether the 
food from the facility enters interstate commerce (Sec.  1.225(b)). The 
plain language of section 418 of the FD&C Act applies to facilities 
that are required to register under section 415 (section 418(o)(2) of 
the FD&C Act) and does not exclude a facility from the requirements 
because food from such a facility is not in interstate commerce. 
Further, the prohibited act provision associated with section 418 
(section 301(uu) of the FD&C Act) does not require interstate commerce 
for a violation.
    FDA also is issuing the provisions in subpart C and related 
requirements in Subparts A, D, F, and G, under sections 402(a)(3), 
402(a)(4), 403(w), and 701(a) of the FD&C Act to the extent such 
requirements are necessary to prevent food from being held under 
insanitary conditions whereby it may become contaminated with filth or 
rendered injurious to health, or being unfit for food; and to the 
extent necessary to prevent food from being misbranded under section 
403(w). FDA also is finalizing those provisions under sections 311, 
361, and 368 of the PHS Act relating to communicable disease to the 
extent those provisions are necessary to prevent the interstate spread 
of communicable disease.

D. Comments on Legal Authority

    (Comment 1) One comment asserts that FDA does not have authority to 
regulate intrastate commercial activities. Another comment asserts that 
FDA does not have authority to regulate farms that are selling wholly 
intrastate.
    (Response 1) With regard to farms, this rule does not apply. With 
respect to farms that engage in activities outside the farm definition 
(i.e., farm mixed-type facilities), this rule applies to the non-farm 
portion of the operation.
    FDA disagrees with the comments regarding application of this rule 
to activities that are intrastate in character. Facilities are required 
to register under section 415 of the FD&C Act regardless of whether the 
food from the facility enters interstate commerce (Sec.  1.225(b)). The 
plain language of section 418 of the FD&C Act applies to facilities 
that are required to register under section 415 (section 418(o)(2) of 
the FD&C Act) and does not exclude a facility because food from such a 
facility is not in interstate commerce. Section 301(uu) of the FD&C Act 
(21 U.S.C. 331(uu)) provides that ``the operation of a facility that 
manufactures, processes, packs, or holds food for sale in the United 
States if the owner, operator, or agent in charge of such facility is 
not in compliance with section 418'' is a prohibited act. Notably, 
other subsections in section 301 of the FD&C Act, and section 304 of 
the FD&C Act (21 U.S.C. 334) demonstrate that Congress has included a 
specific interstate commerce nexus in the provisions of the FD&C Act 
when that is its intent. Accordingly, it is reasonable to interpret 
sections 418 and 301(uu) of the FD&C Act as not limiting the 
application of the rule only to those facilities with a direct 
connection to interstate commerce.
    FDA is mindful that its interpretation of FSMA and the FD&C Act 
should not cast doubt on their constitutionality. (See Solid Waste 
Agency of Northern Cook County v. U.S., 531 U.S. 159 (2001)). FDA has 
considered the relevant provisions of FSMA and the FD&C Act, FDA's 
responsibilities in implementing those laws, and the law interpreting 
the commerce clause of the Constitution (Article I, section 8). 
Congress' power to legislate under the commerce clause is very broad. 
However, such power is not without limits, see United States v. Lopez, 
514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S. 598, 618 (2000), 
and these limits have been construed in light of relevant and enduring 
precedents. In particular, in Lopez, supra, the Supreme Court 
acknowledged the continuing vitality of Wickard v. Filburn, 317 U.S. 
111 (1942), noting that ``although Filburn's own contribution to the 
demand for wheat may have been trivial by itself, that was not `enough 
to remove him from the scope of Federal regulation where, as here, his 
contribution, taken together with that of many others similarly 
situated, is far from trivial.' '' (514 U.S. at 556.) See also Gonzales 
v. Raich, 545 U.S. 1, 17-25 (2005). This principle applies to the 
application of sections 418 and 301(uu) of the FD&C Act, as added by 
section 104 of FSMA. Accordingly, given the collective impact on 
commerce of facilities that manufacture, process, pack, or hold food 
that is sold in intrastate commerce, FDA concludes that such facilities 
should be subject to the rule. FDA notes that to the extent these 
facilities are very small, they are subject to modified requirements 
under Sec.  117.201. This outcome regarding intrastate commerce is 
consistent with section 709 of the FD&C Act (21 U.S.C. 379a), which 
states that in any action to enforce the act's requirements respecting 
foods, drugs, devices, and cosmetics, any necessary connection

[[Page 55920]]

with interstate commerce is presumed. Likewise, this outcome is 
consistent with FSMA's risk-based, preventive approach to food safety 
because the risk presented by unsafe food can be significant, whether 
or not the food moves from one state to another.

III. General Comments on the Proposed Rule

    (Comment 2) Several comments ask us to develop guidance to 
accompany the rule, particularly with respect to the new requirements 
for hazard analysis and risk-based preventive controls. For example, 
comments ask us to provide guidance on topics such as hazard analysis, 
environmental monitoring, and validation. Some of these comments ask 
that drafts of the guidance first be made available for public comment.
    Other comments emphasize the importance of education and outreach 
and ask us to provide support for ongoing education and outreach, 
including an active role in providing needed instructional examples and 
lessons learned from current investigations and foodborne outbreaks. 
Some comments ask us to convene a scientific workgroup that includes 
experts in food and laboratory science, public health, proficiency 
testing, quality control, and other areas on at least an annual basis 
to assess what pathogens should be addressed in a food safety plan.
    Some comments ask that funding and information on funding for 
training be provided. Other comments assert that we must make available 
adequate resources to support outreach and technical assistance 
delivered by State regulatory agencies, as well as Cooperative 
Extension programs and non-governmental organizations that work 
directly with farmers and facilities.
    (Response 2) We are developing several guidance documents, 
including general guidance on hazard analysis and preventive controls, 
as well as guidance on specific aspects such as environmental 
monitoring and food allergen control (Ref. 5). We also intend to 
develop guidance specific to a variety of food types based in part on 
technical information we obtained through a grant for this purpose, as 
well as on other topics, such as validation. We will develop and issue 
this guidance in accordance with our good guidance practices 
regulation, which establishes criteria for when we issue a guidance 
document as an initial draft, invite public comment, and prepare a 
final version of the guidance document that incorporates suggested 
changes, when appropriate (Sec.  10.115(g)) (21 CFR 10.115(g)). The 
public may submit comments on any guidance document at any time (Sec.  
10.115(g)(5)).
    We agree with comments that stress the importance of education and 
outreach. A central element of our strategy to gain industry compliance 
is to help make available to facilities subject to this rule the 
education and technical assistance they need to understand and 
implement the requirements (Ref. 6). Within the Agency we are 
establishing a Food Safety Technical Assistance Network and seeking 
funding to increase FDA staffing to provide a central source of 
information to support industry understanding and implementation of 
FSMA standards (Ref. 6). This will allow us to respond in a timely and 
consistent way to industry questions on preventive controls technical 
and compliance issues (Ref. 6).
    We also are working in collaboration with the Food Safety 
Preventive Controls Alliance (FSPCA) to develop training materials and 
establish training and technical assistance programs (Ref. 5) and (Ref. 
7). The Alliance includes members from FDA, State food protection 
agencies, the food industry, and academia. It is funded by a grant to 
the Illinois Institute of Technology's Institute for Food Safety and 
Health, a nationally-recognized leader in food safety. In addition to 
developing a standardized preventive controls training curriculum, the 
FSPCA is developing selected sections of model food safety plans for 
several food types that will provide needed instructional examples. 
Although we have provided funding to the FSPCA to develop a 
standardized preventive controls training curriculum, we are unable to 
fund training for individual groups who might need particular training 
materials.
    We also are partnering with the National Institute of Food and 
Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) to 
administer the FSMA-mandated National Food Safety Training, Education, 
Extension, Outreach, and Technical Assistance Program, a grant program 
to provide technical assistance for FSMA compliance to owners and 
operators of small and medium-size farms and small food processors 
(Ref. 8). Such efforts will help ensure widespread voluntary compliance 
by encouraging greater understanding and adoption of established food 
safety standards, guidance, and protocols.
    At this time, we intend to rely on scientific publications and 
epidemiological findings to assess the potential that new pathogens, or 
more virulent pathogenic strains, have emerged, and do not intend to 
convene annual workgroups to assess that data and information.
    (Comment 3) Several comments ask us to classify specific on-farm 
activities as harvesting, packing, holding, or manufacturing/processing 
so that an operation that conducts these activities on a farm can 
determine whether conducting that specific activity is within, or 
outside, the ``farm'' definition. These comments emphasize that a farm 
operation needs to know when a specific activity that it conducts would 
be outside the ``farm'' definition for the purposes of the requirements 
to register as a food facility and, thus, require that the farm 
operation both register as a food facility and comply with the new 
requirements for hazard analysis and risk-based preventive controls. 
Some of these comments focus on activities that we have previously 
classified in more than one way (e.g., ``washing,'' which we have 
previously classified as both ``harvesting'' and ``manufacturing/
processing,'' depending on when the activity occurs) (See table 1 in 
the Appendix to the 2014 supplemental human preventive controls rule, 
79 FR 58524 at 58571-58572.) Other comments ask us to periodically 
review our lists of harvesting, packing, holding, and manufacturing/
processing activities to ensure that they reflect current practices. 
Some comments ask us to make a table of activities prominently 
available on our Internet site for easy access whenever the public 
seeks out information regarding the forthcoming produce safety rule and 
the human preventive controls rule.
    (Response 3) We have added several examples of ``harvesting,'' 
``packing,'' ``holding,'' and ``manufacturing/processing'' to the 
regulatory text (see Sec. Sec.  1.227, 1.328, and 117.3 and Response 
27, Response 28, Response 29, Response 31, Response 37, Response 38 and 
Response 39). However, it is not practical to include every possible 
activity conducted by farm operations in the regulatory text. 
Attempting to include a more extensive set of examples in the 
regulatory text has the potential to signal--incorrectly--that any 
activity not specified in the regulatory text cannot be considered to 
be within the definition of that activity. In addition, we have not 
previously discussed our approach to classifying some of the activities 
mentioned in the comments, and we believe that we should provide an 
opportunity for public comment on a more extensive list of activities 
classified as ``harvesting,'' packing,'' ``holding,'' or 
``manufacturing/processing.''

[[Page 55921]]

    To address these comments, in the near future we intend to issue a 
draft guidance with our current thinking on the classification of 
activities as ``harvesting,'' packing,'' ``holding,'' or 
``manufacturing/processing.'' In accordance with our regulation on good 
guidance practices (Sec.  10.115(g)(1)), we will review any comments 
received and prepare the final version of the guidance document that 
incorporates suggested changes, when appropriate; publish a notice in 
the Federal Register announcing that the guidance document is 
available; and post the guidance document on the Internet and make it 
available in hard copy. Under our good guidance practices regulation 
(Sec.  10.115(g) and (h)), the public can comment on any guidance 
document at any time, and we will revise guidance documents in response 
to public comments when appropriate.
    In addition, our previously issued ``Guidance for Industry: 
Questions and Answers Regarding Food Facility Registration'' (Ref. 9) 
is in its sixth edition, and we intend to update it in the near future 
to reflect the changes to the definitions of ``farm,'' ``harvesting,'' 
packing,'' ``holding,'' and ``manufacturing/processing'' that we are 
establishing in this rulemaking.
    (Comment 4) Some comments ask us to prepare a table or flow chart 
of activities that make an operation a farm, a retail food 
establishment, or a facility because food businesses will need to be 
able to easily determine their regulatory classification to comply with 
the applicable regulations. Other comments ask us to amend the 
definition of ``manufacturing/processing'' to ensure that community 
supported agriculture (CSA) programs will not become subject to the 
requirements for hazard analysis and risk-based preventive controls. 
Other comments ask us to clarify how the revised definitions we are 
establishing in the section 415 registration regulations will affect 
entities classified as research and development entities, pilot plants, 
test kitchens, shared use storage facilities, co-packers, sales 
offices, corporate offices, private residences, and registered foreign 
facilities that only send samples to the United States. Some comments 
ask us to clarify how the revised definitions we are establishing in 
the section 415 registration regulations will affect a determination of 
whether an entity or program (such as a farmers' market, roadside 
stand, CSA program, commissary kitchen, community and incubator 
kitchens) is a retail food establishment that is not required to 
register as a food facility in the human preventive controls rule 
rather than through a separate rulemaking. One comment notes that its 
farm has a store and a caf[eacute] that use products from the farm, and 
it is not clear if the store and caf[eacute] will be under regulations 
while nearby restaurants and grocery stores are not. Some comments ask 
us to define farmers' markets, CSA programs, roadside stands, and other 
direct-to-consumer programs as retail food establishments not subject 
to registration as part of the human preventive controls rulemaking 
rather than through a separate rulemaking.
    (Response 4) Section 102(c) of FSMA requires that we revise the 
definition of ``retail food establishment'' in Sec.  1.227 to clarify 
that, in determining the primary function of an establishment or a 
retail food establishment under the section 415 registration 
regulations, the sale of food products directly to consumers by such 
establishments includes the sale of such food products or food directly 
to consumers by such establishment at a roadside stand or farmers' 
market where such stand or market is located other than where the food 
was manufactured or processed; the sale and distribution of such food 
through a CSA program; and the sale and distribution of such food at 
any other such direct sales platform as determined by the Secretary of 
HHS. As discussed in section I.E, we have begun the process of amending 
the definition of ``retail food establishment'' in a separate 
rulemaking conducted under section 102(c) of FSMA, and are continuing 
that separate rulemaking by issuing a separate final rule. We intend to 
issue a final rule to amend the definition of ``retail food 
establishment'' in the section 415 registration regulations in the near 
future. We also intend to update our previously issued ``Guidance for 
Industry: Questions and Answers Regarding Food Facility Registration'' 
(Ref. 9) to reflect any changes to a determination of whether an entity 
is a retail food establishment as a result of that rulemaking. In the 
meantime, commenters may find our existing guidance helpful in 
addressing their questions.
    (Comment 5) Some comments ask us to explain how we will enforce the 
rule, particularly with respect to coordination with State and local 
authorities and with other Federal agencies. For example, some comments 
ask whether FDA or the States will pay for inspections, whereas other 
comments ask us to coordinate inspection of imports with USDA's Food 
Safety and Inspection Service (FSIS) or ask us to combine our 
inspections with those of USDA where possible (such as when USDA 
conducts inspections for adherence to organic standards). Some comments 
express concern about the time gap between the effective date of this 
rule and the time it will take to incorporate applicable provisions 
into State law.
    (Response 5) We are working through the Partnership for Food 
Protection (PFP) (a group of dedicated professionals from Federal, 
State, local, tribal, and territorial governments with roles in 
protecting the food supply and public health) to develop and implement 
a national Integrated Food Safety System consistent with FSMA's 
emphasis on establishing partnerships for achieving compliance (see 
section 209(b) of FSMA). For an example of our current thinking on 
establishing partnerships for achieving compliance, see the ``best 
practices'' document made available by PFP (Ref. 10). This ``best 
practices'' document provides information to FDA field and State 
programs on a variety of issues, including how to coordinate compliance 
activities. Our document entitled ``Operational Strategy for 
Implementing FSMA'' also recognizes the importance of developing 
operational partnerships with States and other government counterparts 
to optimize the effectiveness, efficiency, and consistency of FSMA 
implementation domestically (Ref. 11).
    We are implementing a new inspection paradigm focused on whether 
firms are implementing systems that effectively prevent food 
contamination, requiring fundamentally different approaches to food 
safety inspection and compliance (Ref. 12). This new paradigm involves 
a major reorientation and retraining, for which we are seeking funding, 
of more than 2,000 FDA inspectors, compliance officers, and other staff 
involved in food safety activities, as well as thousands of State, 
local, and tribal inspectors (Ref. 12).
    (Comment 6) Some comments ask us to specify that the human 
preventive controls rule does not apply to activities subject to the 
animal preventive controls rule.
    (Response 6) The human preventive controls rule does not apply to 
activities subject to the animal preventive controls rule. The title of 
the rule (i.e., Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food) narrows its 
applicability to human food. Moreover, regulations directed to food for 
animals are established in subchapter E of 21 CFR (i.e., Animal Drugs, 
Feeds, And Related Products, parts 500-599), whereas regulations 
directed to human food are established

[[Page 55922]]

in subchapter B of 21 CFR (i.e., Food For Human Consumption, parts 100-
199).
    (Comment 7) Some comments ask us to look to existing industry 
information technology solutions where possible to lower the burden on 
industry for implementation. These comments also ask us to adopt a 
centralized information technology solution with robust functionality 
to facilitate tracking stakeholders' compliance with the rule.
    (Response 7) The rule allows for use of any available information 
technology (e.g., in the creation and retention of records) that will 
allow industry to comply with the rule, and we encourage the use of 
information technology to streamline compliance. The long-standing CGMP 
requirements allow for the use of automated systems (see Sec.  
117.40(d)). We are developing new electronic systems to track 
compliance. However, our internal procedures for tracking compliance 
are outside the scope of this rule.
    (Comment 8) Some comments ask us to re-evaluate the proposed human 
preventive controls rule, compare it with existing programs, and 
identify a mechanism for integrating compliance verification with 
existing industry and governmental programs. These comments note that 
many handlers/processors use and understand voluntary food safety 
management systems such as HACCP and HACCP-based certification programs 
(e.g., certification to Global Food Safety Initiative (GFSI) benchmark 
schemes) and ask us why we proposed to create a separate inspection 
framework for FSMA, without integrating that inspection framework with 
existing programs.
    (Response 8) We decline this request. As previously discussed, we 
are establishing this rule as required by section 103 of FSMA (78 FR 
3646 at 3657-3659 and 3668-3669). However, where compliance with this 
rule mirrors compliance with existing regulatory requirements, there is 
no need to duplicate existing records, which may be supplemented as 
necessary to include all of the required information. (See also 
Response 5 regarding implementation of a national Integrated Food 
Safety System.)
    (Comment 9) Some comments ask us to make the various rules we are 
establishing to implement FSMA consistent with each other.
    (Response 9) We have aligned the provisions of the various rules to 
the extent practicable. For example, we use the same definitions of 
``farm'' and the same terms used in the definition of ``farm'' (i.e., 
harvesting, packing, holding, and manufacturing/processing) in this 
rule, the animal preventive controls rule, and the proposed produce 
safety rule. However, the statutory direction is not the same for all 
the rules, and this difference in statutory direction does lead to some 
differences between the rules. For example, section 418(l) of the FD&C 
Act (which relates to this rule) provides for modified requirements for 
facilities that are very small businesses in addition to facilities 
that satisfy criteria for sales to qualified end-users, but section 
419(f) of the FD&C Act (which relates to the proposed produce safety 
rule) only provides for modified requirements for direct farm 
marketing.
    Likewise, we have worked to align the provisions of this rule with 
the provisions of the FSVP rule. Again, however, there are statutory 
differences that lead to some differences between the rules. For 
example, section 805 of the FD&C Act (21 U.S.C. 348a) applies to an 
importer whereas section 418 of the FD&C Act applies to a facility that 
is required to register under section 415 of the FD&C Act.
    (Comment 10) Some comments ask us to clarify how the requirements 
for hazard analysis and risk-based preventive controls will apply to an 
establishment that supplies raw materials and other ingredients to a 
registered facility.
    (Response 10) The requirements for hazard analysis and risk-based 
preventive controls apply to facilities that are required to register 
under section 415 of the FD&C Act. If an establishment that supplies 
raw materials and other ingredients to a registered facility is itself 
a facility that is required to register under section 415 of the FD&C 
Act, that establishment is subject to the requirements for hazard 
analysis and risk-based preventive controls. If that establishment is 
not itself a facility that is required to register under section 415 of 
the FD&C Act, that establishment is not subject to the requirements for 
hazard analysis and risk-based preventive controls. However, such 
facilities may be subject to verification activities of manufacturers/
processors that are required to verify controls implemented by their 
suppliers.
    (Comment 11) Some comments express concern about the potential for 
unfair enforcement of the rule relating to business size. Some comments 
assert that we should strictly enforce the rule for big industry, but 
be lenient towards small farms.
    (Response 11) We intend to enforce the rule in a fair and 
reasonable manner. We note that farms are not covered by this rule, and 
the rule contains special provisions applicable to a farm mixed-type 
facility that is a small or very small business. Specifically, a small 
or very small business that is a farm mixed-type facility is exempt 
from the requirements for hazard analysis and risk-based preventive 
controls if the only activities that it conducts are the low-risk 
activity/food combinations listed in Sec.  117.5(g) and (h). A very 
small business that is a farm mixed-type facility, but does not satisfy 
the criteria for the exemptions for only conducting low-risk activity/
food combinations, is eligible for modified requirements as a qualified 
facility, and we will enforce the modified requirements, rather than 
the full requirements for hazard analysis and risk-based preventive 
controls, for such very small businesses.
    (Comment 12) Some comments express concern that we will enforce the 
rule more strictly for domestic facilities than for foreign 
facilities--e.g., because we lack the funds and manpower to enforce the 
rule for foreign facilities. Other comments assert that it is 
unprecedented for importing countries to regulate the production 
processes in exporting countries and that no scientific evidence 
supports such regulation. These comments express concern that this 
regulatory requirement will greatly increase trading costs and might 
constitute a barrier to trade for exporting countries.
    (Response 12) We intend to enforce this rule in a consistent manner 
to ensure that imported and domestically produced foods are in full 
compliance with the requirements of this rule. We note that the 
forthcoming FSVP rule will require importers to help ensure that food 
imported into the United States is produced in compliance with 
processes and procedures, including reasonably appropriate risk-based 
preventive controls, that provide the same level of public health 
protection as those required under this rule. The implementation of 
these supplier verification programs by U.S. importers will thus 
provide assurances that imported food is in compliance with this 
regulation.
    We disagree that we are seeking to ``regulate the production 
processes in exporting countries'' inappropriately. This rule provides 
for a flexible set of principles and a framework for hazard analysis 
and risk-based preventive controls to be applied to a given production 
process in order to ensure the production of safe food destined for the 
United States. Mandating that a finished food is manufactured under 
general methods applicable to all foods (e.g., good manufacturing 
practices) is a widely accepted regulatory practice and

[[Page 55923]]

fundamentally different than mandating that food be produced in a 
certain way. We note that many countries have adopted food safety 
regulations that mandate certain principles and conditions be applied 
to food manufacturing. These include mandatory HACCP programs for 
seafood and other foods. For example, in a guidance document on food 
safety import requirements, the European Commission stated: ``The EU 
rules on food hygiene confirm that all food businesses in third 
countries after primary production must put in place, implement and 
maintain a procedure based on the HACCP principles.'' The mandate that 
preventive controls be applied to control hazards in the production of 
foods in this rule is similar to the European Union (EU) rules. Because 
the requirements being implemented by FDA under this regulation are 
flexible and not prescriptive, we do not agree that this regulation 
will significantly increase costs or impede trade.
    We also disagree that there is no scientific evidence supporting 
this rule. In the 2013 proposed preventive controls rule, we provided 
an extensive background discussing the scientific evidence and 
international food safety standards upon which this rule is based (78 
FR 3646 at 3659 through 3667, January 16, 2013). That discussion 
reviews a number of well documented food safety risks and how they can 
be controlled by modern food safety systems including the Codex HACCP 
principles contained in the HACCP Annex of the Codex General Principles 
of Food Hygiene (78 FR 3646 at 3667, January 16, 2013). In that 
discussion we stated: ``The proposed rule would require that a food 
safety system similar to HACCP be implemented in food facilities and 
would harmonize our requirements with the recommendations and 
requirements of internationally recognized food safety experts/
authorities, such as experts/authorities in [Codex Alimentarius], [Food 
Safety Authority Australia New Zealand], [Canadian Food Inspection 
Agency], and the European Union.'' (78 FR 3646 at 3663, January 16, 
2013) In addition, the Appendix to the 2013 proposed preventive 
controls rule provided additional scientific information on activities 
such as product testing and environmental monitoring to support their 
role in ensuring safe food and how these align with international 
standards such as those of Codex Alimentarius (78 FR 3646 at 3818-
3820); republished in its entirety with corrected reference numbers on 
March 20, 2013, 78 FR 17142 at 17149-17151).
    (Comment 13) Some comments assert that the rule should be more 
concise, and that the average person without a team of experts should 
be able to understand the rule and manage the application of the rule.
    (Response 13) We agree the rule needs to be understandable. We have 
incorporated plain language techniques--e.g., by using active voice in 
the new requirements for hazard analysis and risk-based preventive 
controls. We also have established additional definitions that enable 
us to improve readability (e.g., ``qualified facility exemption,'' 
``raw agricultural commodity,'' ``unexposed packaged food,'' and 
``you.'') The comprehensive nature of the new requirements for hazard 
analysis and risk-based preventive controls reflects the extensive 
statutory provisions they implement and the broad range of activities 
and foods covered. We have used examples in the regulatory text, where 
relevant, and provided examples throughout the preamble to assist with 
understanding the requirements. Likewise, the long-standing CGMP 
requirements need to be comprehensive, because they are broadly 
directed to all stages of the production of food. We will be producing 
guidance documents that will be helpful in understanding the rule (see 
Response 2).
    We will issue a Small Entity Compliance Guide (SECG) in accordance 
with section 212 of the Small Business Regulatory Enforcement Fairness 
Act (Pub. L. 104-121). A Small Entity Compliance Guide is a guidance 
that explains the actions a small or very small business must take to 
comply with a rule.
    (Comment 14) Some comments ask whether we will translate the rule 
into foreign languages, such as Japanese.
    (Response 14) We do not intend to translate the rule. As discussed 
in Response 13, to help small and very small businesses comply with a 
rule we issue a SECG. We are considering whether to translate the SECG 
and outreach and technical assistance materials into additional 
languages.
    (Comment 15) Some comments assert that the rule incorrectly assumes 
that all bacteria are harmful.
    (Response 15) We have long recognized that some bacteria have a 
role in food production, such as the lactic-acid producing bacteria 
that our regulations explicitly acknowledge as being added to yogurt 
(see, e.g., the standards of identity for yogurt, low fat yogurt, and 
nonfat yogurt, in 21 CFR 131.200, 131.203, and 131.206, respectively). 
The rule defines the terms ``microorganism'' and ``pathogen,'' and the 
definition of ``microorganism'' explains that the term ``undesirable 
microorganism'' includes those microorganisms that are pathogens, that 
subject food to decomposition, that indicate that food is contaminated 
with filth, or that otherwise may cause food to be adulterated. The 
CGMP provisions directed to either preventing the growth of undesirable 
microorganisms or preventing contamination with undesirable 
microorganisms are long-standing, and these comments do not provide any 
examples of how we have interpreted the CGMP requirements in the past 
in a way that does not recognize that some bacteria have a role in food 
production or that creates practical problems for the future. With 
regard to biological hazards, the new requirements for hazard analysis 
and risk-based preventive controls focus on pathogens.
    (Comment 16) Some comments assert that the rule will 
disproportionately affect New England farmers because they are small 
and production costs are higher compared to elsewhere in the country 
and that the cost of the rule will have negative consequences on New 
England's food supply. Other comments assert that the rule will force 
small farmers out of business, forcing us to rely on foreign suppliers 
who are under very little FDA oversight, and that FDA oversight should 
be reduced so that the public can continue supporting small, local 
farmers. Other comments express concern that excessive rules will 
discourage farmers from supplying the Farm to School market.
    (Response 16) We believe that the ``farm'' definition that we are 
establishing in this rule greatly reduces the impact on farms of all 
size, because several operations that would have been required to 
register as a food facility under the section 415 registration 
regulations as established in 2003 (68 FR 58894, October 10, 2003) will 
no longer be required to do so. (See the discussion of the changes to 
the ``farm'' definition in section IV.B) In addition, a farm mixed-type 
facility that is a small or very small business, and that only conducts 
low-risk activity/food combinations for manufacturing, processing, 
packing, and holding foods that are not RACs, is exempt from the new 
requirements for hazard analysis and risk-based preventive controls. A 
farm mixed-type facility that does not satisfy these criteria for 
exemption, but is a very small business, is a qualified facility that 
is subject to modified requirements. All of these factors will reduce 
the burden on small farms.

[[Page 55924]]

    (Comment 17) Some comments express concern about contamination of 
produce and other food in open containers by sulfuric hydrogen being 
discharged from lead acid batteries that are used to operate forklifts.
    (Response 17) The long-standing CGMP provisions require that the 
food establishment must appropriately use equipment to avoid the 
adulteration of food with such contaminants (see Sec.  117.40(a)(2)).
    (Comment 18) Some comments assert that we do not address comments 
submitted by individuals.
    (Response 18) We address comments on the provisions of the rule 
regardless of who submits the comments. However, we group similar 
comments together, and do not discuss the specific text of each 
submitted comment letter when the point being made by one comment 
letter can be included in a general discussion of several comment 
letters that express similar points of view.
    (Comment 19) Some comments assert that we need specific standards 
and quantifiable guidelines for compressed air.
    (Response 19) We agree that specific standards and quantifiable 
guidelines for material such as compressed air could be useful to food 
establishments that use such material in the production of food. 
However, we disagree that such standards and guidelines need to be 
included in the rule. The rule is intended to establish procedures for 
the safe manufacturing, processing, packing, and holding of food, and 
for hazard analysis and risk-based preventive controls in the 
production of food, rather than to set standards for specific levels of 
contaminants in specific raw materials and other ingredients. If a 
facility believes that its use of compressed air should be addressed in 
its food safety plan, then it should do so.
    (Comment 20) Some comments ask us to address model laboratory 
standards and accreditation to ensure that laboratories are using sound 
and reliable test methods for detecting and identifying pathogens.
    (Response 20) We decline this request. A separate section of FSMA 
addresses ``Laboratory Accreditation For Analyses Of Foods'' (see 
section 202 of FSMA). This rule focuses on section 103 of FSMA (section 
418 of the FD&C Act).

IV. Comments on Proposed Revisions to the Definitions in the Section 
415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 
414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)

A. Definitions That Impact a Determination of Whether an Establishment 
Is a ``Farm''

    We previously described section 103(c) of FSMA (78 FR 3646 at 
3674). In brief, section 103(c) of FSMA directs us to conduct 
rulemaking to clarify the on-farm manufacturing, processing, packing, 
and holding activities that would trigger a requirement for a farm to 
register as a food facility and, thus, be subject to section 418 of the 
FD&C Act. We discussed the current legal and regulatory framework for 
farms under sections 415 and 418 of the FD&C Act, and explained how the 
status of a food as a RAC or a processed food affects the requirements 
applicable to a farm under sections 415 and 418 of the FD&C Act. We 
then articulated a comprehensive set of organizing principles that 
formed the basis for proposed revisions to the section 415 registration 
regulations. Because these definitions also are established in the 
section 414 recordkeeping regulations, these organizing principles also 
formed the basis for proposed revisions to definitions in the section 
414 recordkeeping regulations.
    Our previous description (78 FR 3646 at 3675-3676) of the current 
legal and regulatory framework that governs the determination of when 
an establishment is required to register as a food facility in 
accordance with the section 415 registration regulations focused on the 
framework that governs whether an establishment that grows and harvests 
crops or raises animals satisfies the definition of ``farm,'' because 
the facility registration requirements of section 415 of the FD&C Act 
do not apply to ``farms.'' Under that framework, a key factor in 
whether an establishment falls within the definition of ``farm,'' even 
with respect to crops it grows and harvests itself, is whether the 
activities conducted by the establishment fall within definitions of 
``harvesting,'' ``packing'' or ``holding'' (which are within the 
``farm'' definition). Another key factor is whether activities 
conducted by the establishment fall within the definition of 
manufacturing/processing (which have been outside the ``farm'' 
definition).
    We previously described comments regarding proposed revisions to 
the definitions of ``farm,'' ``harvesting,'' ``packing'' and 
``holding,'' as well as comments regarding the triggers for an activity 
to be considered manufacturing/processing (79 FR 58524 at 58530-58538). 
In the 2014 supplemental human preventive controls notice, we proposed 
additional revisions to the definitions of ``farm,'' ``harvesting,'' 
``packing,'' and ``holding'' to address these comments.
    Even after the revisions we proposed in the 2014 supplemental human 
preventive controls notice, some comments assert that the overall 
``farm'' definition still presents an unrealistic and incomplete 
understanding of how most farms in the United States are structured 
with regard to their physical location(s) and business models. Most of 
the comments suggest alternative or additional regulatory text (see, 
e.g., Comment 22, Comment 23, Comment 24, Comment 25, Comment 27, 
Comment 37, Comment 39, and Comment 50) or ask us to clarify how we 
will interpret the provisions (see, e.g., Comment 26, Comment 28, 
Comment 29, Comment 40, Comment 41, Comment 42, Comment 43, Comment 44, 
Comment 47, and Comment 48).
    As discussed in section I.A, there are several FSMA-required 
regulations that provide the framework for industry's implementation of 
preventive controls and enhance our ability to oversee their 
implementation for both domestic and imported food (see the seven 
foundational rules listed in table 1). Two of the proposed rules listed 
in table 1 (i.e., the 2013 proposed animal preventive controls rule and 
the 2013 proposed intentional adulteration rule) proposed to include a 
cross-reference to the ``farm'' definition in Sec.  1.227, and a third 
proposed rule (i.e., the 2013 proposed produce safety rule) proposed to 
establish the same ``farm'' definition as would be in Sec.  1.227. A 
fourth proposed rule (i.e., the 2013 proposed FSVP rule) did not 
propose to establish the ``farm'' definition (or a cross-reference to 
the ``farm'' definition in Sec.  1.227), but under its proposed 
definition of ``foreign supplier'' some foreign suppliers would be 
farms--i.e., establishments that harvest food that is exported to the 
United States. As a result, we received comments relevant to the 
``farm'' definition for all of these rules. The majority of the 
comments submitted to these other rulemakings addressed issues that 
were the same as, or similar to, the issues raised in the comments 
submitted to this rulemaking. One comment submitted to the proposed 
rulemaking for the forthcoming FSVP rule requested clarification 
regarding harvesting companies, and we are also providing

[[Page 55925]]

that clarification in this rulemaking. See Response 32.
    We proposed to redesignate all definitions in Sec.  1.227 in the 
section 415 registration regulations (i.e., current Sec.  1.227) to 
eliminate paragraph designations (such as (a) and (b)). We received no 
comments that disagreed with our proposed redesignations and are 
finalizing them as proposed.
    We proposed several technical amendments and conforming changes to 
the section 415 registration regulations and to the section 414 
recordkeeping regulations. No comments opposed the proposed technical 
amendments and conforming changes, except for comments noting that our 
proposed technical amendment to Sec.  1.361 was unnecessary because we 
had already made this change in a different rulemaking (see 77 FR 
10662, February 23, 2012). We are finalizing these technical amendments 
and conforming changes without change.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed definitions as shown in table 4, 
with editorial and conforming changes as shown in table 52. We also are 
establishing a new provision to allow off-farm establishments that 
package, pack, and hold RACs that are produce as will be defined in the 
produce safety rule to comply with the CGMPs in part 117, subpart B by 
complying with the applicable requirements for packing and holding that 
will be established in the final produce safety rule (see Sec.  117.8 
and Response 25). Because the new provision refers to provisions in a 
future produce safety rule, we will publish a document in the Federal 
Register announcing the effective date of Sec.  117.8 once we finalize 
the produce safety rule.

    Table 4--Revisions to the Proposed Definitions in the Section 415
 Registration Regulations and the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
                  Definition                            Revision
------------------------------------------------------------------------
Farm.........................................   A farm is an
                                                ``operation'' rather
                                                than an
                                                ``establishment.''
                                                There are two
                                                types of farms: (1)
                                                Primary production farm;
                                                and (2) secondary
                                                activities Farm.
Primary production farm......................   A primary
                                                production farm is
                                                ``under one management''
                                                rather than ``under one
                                                ownership.''
                                                Although a
                                                primary production farm
                                                continues to be ``in one
                                                general physical
                                                location,'' we have
                                                clarified that ``one
                                                general physical
                                                location'' is ``not
                                                necessarily
                                                contiguous.''
                                                A primary
                                                production farm is an
                                                operation devoted to the
                                                growing of crops, the
                                                harvesting of crops, the
                                                raising of animals
                                                (including seafood), or
                                                any combination of these
                                                activities. Although
                                                some primary production
                                                farms both grow and
                                                harvest crops, other
                                                primary production farms
                                                grow crops but do not
                                                harvest them, and other
                                                primary production farms
                                                harvest crops but do not
                                                grow them.
                                                Treatment to
                                                manipulate the ripening
                                                of RACs, and packaging
                                                and labeling the treated
                                                RACs, without additional
                                                manufacturing/
                                                processing, is within
                                                the ``farm'' definition.
                                                We added an
                                                example of drying/
                                                dehydrating RACs to
                                                create a distinct
                                                commodity that would
                                                fall within the ``farm''
                                                definition (i.e., drying/
                                                dehydrating grapes to
                                                produce raisins), as
                                                well as an example of
                                                additional manufacturing/
                                                processing that would
                                                cause an operation that
                                                dries/dehydrates RACs to
                                                create a distinct
                                                commodity to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                slicing).
                                                We added an
                                                example of additional
                                                manufacturing/processing
                                                that can cause an
                                                operation that packages
                                                and labels RACs to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                irradiation).
Secondary activities farm....................   A ``secondary
                                                activities farm'' is an
                                                operation, not located
                                                on a primary production
                                                farm, devoted to
                                                harvesting (such as
                                                hulling or shelling),
                                                packing, and/or holding
                                                of RACs, provided that
                                                the primary production
                                                farm(s) that grows,
                                                harvests, and/or raises
                                                the majority of the RACs
                                                harvested, packed, and/
                                                or held by the secondary
                                                activities farm owns, or
                                                jointly owns, a majority
                                                interest in the
                                                secondary activities
                                                farm.
                                                A secondary
                                                activities farm may also
                                                conduct those additional
                                                activities allowed on a
                                                primary production farm.
Harvesting...................................   We added
                                                additional examples of
                                                harvesting activities.
Holding......................................   We added
                                                additional examples of
                                                holding activities.
Manufacturing/Processing.....................   We added
                                                additional examples of
                                                manufacturing/processing
                                                activities.
------------------------------------------------------------------------

B. Proposed Revisions to the Definition of Farm

    We proposed to revise the ``farm'' definition to: (1) Provide for 
on-farm packing and holding of RACs to remain within the farm 
definition regardless of ownership of the RACs; (2) include, within the 
``farm'' definition, a description of packing activities that include 
packaging RACs grown or raised on a farm without additional 
manufacturing/processing; and (3) provide for drying/dehydrating RACs 
to create a distinct commodity (such as the on-farm drying of grapes to 
produce raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing, to remain within the farm 
definition. We also requested comment on whether we should retain, 
remove, or modify the phrase ``in one general physical location'' in 
the ``farm'' definition.
    (Comment 21) Most of the comments support our proposed revision to 
provide for on-farm packing and holding of RACs to remain within the 
farm definition regardless of ownership of the RACs. However, some 
comments oppose this proposed revision. Some comments ask us to require 
that a farm that packs, packs and sells, commingles lots, and holds 
produce grown on a farm under different ownership comply with the 
requirements of this rule for hazard analysis and risk-based preventive 
controls for six reasons: (1) Commingling. Contamination from one farm 
could find its way to another farm, leading to potential contamination 
of products from both farms, making it difficult to pinpoint the source 
of contamination in the event of a recall. (2) Recall Plan. It is 
critical for everyone in the produce supply chain to be ``recall 
ready,'' especially those packing, commingling lots, and selling 
produce grown on another farm under different ownership. (3) 
Traceability. It is important that produce be traceable from the 
specific farm where it was grown to the end-user, and from the end-user 
back to the farm where it was grown. (4) Exemptions. A covered farmer 
packing, packing and selling, commingling lots, or holding others' 
produce might be doing so from a farm that is exempt from the produce 
safety rule. (5) Supplier program. Under the

[[Page 55926]]

human preventive controls rule a farmer would be required to have a 
valid supplier program. (We note that a farmer might be a supplier to a 
facility that is subject to the human preventive controls rule, and 
could be subject to the facility's supplier program, but would not 
itself be required to ``have a valid supplier program.'') With this 
requirement, receiving facilities could purchase in confidence knowing 
that if the farm did pack others' produce it was produced in accordance 
with the rules required by FSMA. (6) Conflict with the National Organic 
Program (NOP). Under the NOP, a grower that purchases produce from 
another farm under different ownership, packs produce from another 
farm, or mixes produce is no longer considered a crop producer and must 
seek certification as a handler--an operation that has additional 
requirements to approve suppliers, segregate product, and maintain 
records necessary to demonstrate compliance. Comments assert that this 
NOP requirement is logical and is a practice that FDA should take into 
consideration.
    Other comments assert that allowing a farm to pack produce from 
another farm must account for the problem created by our proposal to 
exempt farm vehicles transporting RACs from the sanitary transportation 
rule. These comments argue that unless we revise that rule to prevent 
possible contamination during transport, we should develop guidance for 
farms packing produce that is transported from another farm, 
particularly where the commodity is high risk.
    (Response 21) The final ``farm'' definition continues to provide 
for on-farm packing and holding of RACs to remain within the farm 
definition regardless of ownership of the RACs. We have acknowledged 
that doing so would have consequences such as those described in these 
comments, as well as other consequences (see 79 FR 58524 at 58532). 
Although comments pointed out consequences that we had already 
considered, they did not point to any other consequences. Therefore, we 
affirm our tentative conclusion that impacts such as these, while not 
always optimal, are necessary to establish a sensible framework of 
risk-based regulations that both implement FSMA and reflect common farm 
activities. We intend to issue the final produce safety rule in the 
near future and respond to comments related to traceability of produce, 
including whether to include a requirement that a farm supplying 
produce to another farm that will pack or hold that produce should 
provide to the farm that receives the produce its name, complete 
business address, and description of the produce in any individual 
shipment, as well as respond to comments on whether it would be 
appropriate to also require the farm that receives the shipment 
maintain such record of information and, if so, for what specified 
period of time.
    In the 2014 proposed sanitary transportation rule, we explained our 
reasons for tentatively concluding that the sanitary transportation 
practices that would be required by that proposed rule are not 
necessary to prevent RACs from becoming adulterated during 
transportation by farms (79 FR 7006 at 7016, February 5, 2014). For 
example, we explained that we are not aware of instances in which 
insanitary conditions (e.g., improper temperature control, improper 
equipment construction, inadequate equipment cleaning) with regard to 
transportation operations conducted by farms involving the 
transportation of RACs have contributed to foodborne illness, 
regardless of whether the farms are conducting transportation 
operations for their own RACs or for others' RACs. We will consider 
comments we receive on our proposal to exempt farm vehicles 
transporting RACs from the sanitary transportation rule when we issue a 
final sanitary transportation rule. We will consider necessary guidance 
in light of the final sanitary transportation rule, but we note that 
good transportation practices are already included in our 1998 guidance 
for industry entitled ``Guide to Minimize Microbial Food Safety Hazards 
for Fresh Fruits and Vegetables'' (Ref. 13).
    (Comment 22) Some comments assert that farms are neither facilities 
nor establishments. These comments ask us to revise the ``farm'' 
definition to use a term more suited to the nature of farming.
    (Response 22) We consider a farm to be a type of ``establishment'' 
but have nonetheless revised the ``farm'' definition to refer to an 
``operation'' rather than an ``establishment'' as requested by these 
comments.
    (Comment 23) Many comments address the role of ``ownership'' in the 
``farm'' definition. Some of these comments emphasize that farming 
operations are complex, with complex business structures, and are often 
not held under sole ownership. Some comments describe the role of 
multiple business models (such as cooperatives, on-farm packinghouses 
under ownership by multiple growers, food aggregators, and food hubs) 
in modern farming and ask us to revise the ``farm'' definition to 
provide for such business models. Other comments emphasize ownership of 
the land on which crops are grown or animals are raised, noting that 
some farms are operated by ``tenant'' farmers who do not own the land 
used in the farm's operations. Some comments ask us to replace the 
concept of ownership with the concept of a responsible party, such as a 
``farm operator'' and to define a farm operator as ``the person or 
entity that has operational control over the farm and benefits in whole 
or in part from the farm's normal operation. A farm operator may be an 
owner, a tenant, a partner, or an employee.''
    Some comments ask us to remove the phrase ``under one ownership'' 
to allow sugar makers who share equipment and sugarhouses to qualify as 
a farm. Other comments ask us to clarify how renting or leasing storage 
rooms or facilities would affect the definition of a farm.
    (Response 23) We have revised the ``farm'' definition by replacing 
the phrase ``under one ownership'' with the phrase ``under one 
management.'' Although the original phrase ``under one ownership'' was 
not referring to a single owner, we agree that the ``farm'' definition 
should reflect modern business models (such as cooperatives, on-farm 
packinghouses under ownership by multiple growers, food aggregators, 
and food hubs) and use language that the modern farming community 
understands. We decline the request to define and introduce a new term, 
such as ``farm operator.'' The term ``management'' has a common meaning 
that captures the request of these comments and is suitable for the 
purposes of the farm definition. (Management. The person or persons 
controlling and directing the affairs of a business, institution, etc.) 
(Ref. 14).
    Under either the previous or the revised ``farm'' definition, 
leasing land to grow or store crops or raise animals does not impact 
whether an operation is within the ``farm'' definition. Under the 
previous definition, ``ownership'' focused on ownership of the business 
entity conducting farm operations, not ownership of the land. Leasing 
land is a business practice common to a variety of business types, not 
just farms. Likewise, leasing buildings to store RACs does not impact 
whether an operation is within the ``farm'' definition. See also 
Response 24 regarding comments on ``one general physical location.''
    To the extent that sugar makers who share equipment and sugarhouses 
only conduct activities that are within the ``farm'' definition, the 
revision from ``under one ownership'' to ``under one management'' 
should clarify that those operations would be within the ``farm''

[[Page 55927]]

definition. However, when sugar makers conduct operations outside the 
``farm'' definition, they are facilities that are required to register 
under the section 415 registration regulations, not ``farms'' that are 
exempt from that registration requirement. A sugar maker that is a 
small or very small farm mixed-type facility that only conducts the 
low-risk activity/food combinations listed in the exemptions in Sec.  
117.5(g) and (h) (such as making syrup and sugar (e.g., making maple 
syrup from maple sap)) is exempt from the requirements of this rule. 
However, a farm mixed-type facility that is not a small or very small 
business as those terms are defined in this rule, or that conducts 
activities in addition to the low-risk activity/food combinations 
listed in the exemptions in Sec.  117.5(g) and (h), is subject to the 
requirements for hazard analysis and risk-based preventive controls. 
Consistent with the discussion in Response 228, a farm mixed-type 
facility that must comply with the requirements for hazard analysis and 
risk-based preventive controls and makes sugar from sugarcane or sugar 
beets can consider the findings of the section 103(c)(1)(C) RA (i.e., 
that this is a low-risk activity/food combination) in determining 
whether there are any hazards requiring a preventive control. A 
facility that appropriately determines through its hazard analysis that 
there are no hazards requiring preventive controls would document that 
determination in its written hazard analysis but would not need to 
establish preventive controls and associated management components. For 
additional information about the section 103(c)(1)(C) RA and the 
exemptions for on-farm low-risk activity/food combinations for farm 
mixed-type facilities that are small or very small businesses, see 
sections VI and XI.G.
    (Comment 24) Many comments address the role of ``one general 
physical location'' in the ``farm'' definition and ask us to revise the 
``farm'' definition to acknowledge that farms may be composed of 
multiple parcels, buildings, or structures that may or may not be 
contiguous. Some comments point out that there are many farming 
operations that may fall under the same management and ownership, but 
are separated by either a strip of land, body of water, or another 
structure, particularly with respect to sites designated for packing 
and holding operations. Some comments assert that as long as an 
economic unit is operating a farm it should be irrelevant where the 
land is located, and state that this interpretation is consistent with 
a USDA definition of a ``farm operator.'' Some comments note that sugar 
makers rely on sap from existing stands of trees that are often not 
concentrated in a single area or even nearby the sugarhouse where the 
maple products are made. Some comments suggest that the term 
``reasonable distance'' could be used to better define ``general 
physical location.'' Some comments ask us to issue guidance that will 
clarify and further designate the boundaries of ``one general physical 
location.''
    Some comments note that the ``farm'' definition we proposed in the 
2014 supplemental human preventive controls notice correctly considers 
a farm operation to remain within the ``farm'' definition even if it 
packs and holds produce from another farm. However, these comments 
state that it is confusing that if the same two farms pack and hold 
produce together at an off-farm location, using the exact same 
practices, that packing location is considered a ``facility'' even 
though there is no difference in risk. Other comments state that both 
in-line and off-line egg production facilities should be considered 
farms. According to these comments, off-line egg production facilities 
receive eggs laid by hens at nearby farms, whereas in-line egg 
production facilities receive eggs laid by hens in henhouses adjacent 
to the plant and located on the same property.
    Some comments ask us to retain ``one general physical location'' in 
the ``farm'' definition because the word ``farm,'' and USDA's 
definition of ``farm,' are ``place-based.'' Other comments assert that 
if we delete the phrase ``in one general physical location'' then a 
fully integrated operation could be a single farm even though it was 
made up of numerous distinct farms possibly in several different 
states. Other comments ask us to retain ``one general physical 
location'' in the ``farm'' definition because different locations may 
have different food safety risks, different water sources, different 
personnel, and even different types of crops. Some comments assert that 
considering each unique and individually State-permitted dairy farm to 
be an individual ``farm'' regardless of common ownership or geographic 
proximity will prevent conflict and interference with the permitting 
and inspection activities of the Grade ``A'' program while maintaining 
food safety. Other comments state that regardless of whether we retain 
``one general physical location'' in the ``farm'' definition, we must 
interpret the term ``farm'' to cover a very limited geographic area and 
that separate locations that are not in close proximity to each other 
should not be considered the same ``farm.''
    (Response 24) We have revised the ``farm'' definition to specify 
that a farm is ``in one general (but not necessarily contiguous) 
physical location.'' We have concluded that adding ``not necessarily 
contiguous'' makes it clear that farming operations that are under one 
management but have some physical separation (e.g., with respect to the 
location of packing operations) can remain within the ``farm'' 
definition and that both in-line and off-line egg production facilities 
would be considered ``farms.''
    We agree that separate locations that are not in close proximity to 
each other should not be considered the same ``farm.'' As the comments 
point out, there already is a framework of State inspections for farms 
such as dairy farms, and we will need to work with our State regulatory 
partners to identify farms covered by the produce safety rule. However, 
even without the new phrase ``not necessarily contiguous,'' some 
situations would be complex. We intend to address these types of 
situations with our State food safety partners. (See Response 5.)
    We do not see that adding ``not necessarily contiguous'' creates a 
``farm'' definition that is not ``place-based,'' as was asserted by 
some comments, because the definition continues to specify ``in one 
general physical location.'' We also do not see that adding ``not 
necessarily contiguous'' presents any food safety concerns, as asserted 
by comments noting that different locations may have different food 
safety risks, different water sources, different personnel, and 
different types of crops. For example, a farm that will be covered by 
the forthcoming produce safety rule will be subject to standards for 
all of its water sources, all of its personnel, and all food subject to 
that rule. Likewise, we also do not believe that adding ``not 
necessarily contiguous'' affects a determination of whether a fully 
integrated operation could be a single farm.
    (Comment 25) Some comments ask us to consider revising the 
regulatory text to ensure that similar activities would be treated the 
same way under either the produce safety rule or the human preventive 
controls rule and be held to the same risk-based requirements. These 
comments point out some of the differences between the requirements 
that would be established under the proposed human preventive controls 
rule and the requirements that would be established under the proposed 
produce safety rule. For example, comments state that the proposed 
human

[[Page 55928]]

preventive controls rule, but not the proposed produce safety rule, 
would require off-farm packinghouses and off-farm cooling and storage 
facilities to have a written hazard analysis; written preventive 
controls; written procedures for monitoring and corrective actions; 
validation of process controls; a written recall plan; environmental 
monitoring and product testing requirements; and a written supplier 
program. As another example, comments state that off-farm packing and 
holding operations would be required to comply with the human 
preventive controls rule one year earlier than we proposed that similar 
sized on-farm packing and holding operations would be required to 
comply with the forthcoming produce safety rule.
    Some comments recommend options to achieve the goal of regulating 
on-farm and off-farm packinghouses the same way. These options include 
adding an exclusion to the ``farm'' definition in the produce safety 
rule; adding provisions to the human preventive controls rule to enable 
off-farm packinghouses to meet their obligation by complying with 
specified, applicable subparts of the produce safety rule; shortening 
the ``farm'' definition to simply state ``Farm means an establishment 
under one ownership devoted to the growing and/or harvesting of crops, 
the raising of animals (including seafood), or any or all of these 
activities;'' addressing off-farm establishments engaged solely in 
``low-risk'' farming and harvesting activities by adding low-risk 
activities such as hulling, shelling, and drying of tree nuts; 
expanding the scope of the produce safety rule to include registered 
facilities; and allowing modified requirements in the human preventive 
controls rule to allow off-farm packinghouses to be subject to 
requirements (and exemptions) of the produce safety rule within the 
framework of the human preventive controls rule.
    Some comments emphasize that farm activities are farm activities, 
regardless of where they happen. Some comments assert that 
establishments that are engaged solely in traditional harvesting, 
holding, or packing activities associated with a RAC that will be 
covered by the produce safety rule should be subject to the produce 
safety rule, rather than the human preventive controls rule, regardless 
of physical location, ownership, or legal ties to an operation devoted 
to the growing and harvesting of produce. Some comments assert that an 
off-farm operation that packs and holds RACs could be regulated in an 
identical fashion to an on-farm operation that packs and holds RACs 
without changing the section 415 requirement for registration by making 
them subject to the requirements of the produce safety rule for 
compliance purposes. Some comments ask us to provide an exemption from, 
or waiver for, the requirements of the human preventive controls rule 
if a business entity provides documentation that the entity is 
following the standards of the produce safety rule even though it is 
not on a farm. Other comments ask us to clarify that a farm can pack or 
hold RACs that have already undergone packing or holding activities by 
another farm.
    Some comments ask to revise the ``farm'' definition to include 
establishments solely engaged in ``packing'' and ``holding'' activities 
performed on RACs, regardless of whether the establishment grows crops. 
Other comments emphasize that any revisions to the ``farm'' definition 
must allow genuine farm operators to carry out harvesting, packing, and 
holding without opening loopholes for packing and processing 
businesses. Some comments ask us to revise the ``farm'' definition to 
provide for a multi-ownership operation provided that all of the 
partial owners are themselves farmers.
    Some comments ask us to provide that off-farm packing and holding 
operations that do not change the status of a RAC into a processed food 
should be able to comply with either the produce safety rule or with 
the CGMPs in subpart B of the human preventive controls rule. According 
to these comments, we could simply apply the same logic that we applied 
when providing that the packing and holding of RACs that have been 
dried/dehydrated to create a distinct commodity that is a processed 
food (i.e., no longer a RAC) may achieve compliance with the CGMP 
requirements by complying either with subpart B of the human preventive 
controls rule or by complying with the applicable requirements for 
packing and holding produce RACs in the produce safety rule (see Sec.  
117.5(k)(2)).
    (Response 25) We have revised the ``farm'' definition to provide 
for two types of farms: (1) A primary production farm and (2) a 
secondary activities farm (see Sec.  117.3). We use the term ``primary 
production farm'' to refer to the ``farm'' definition as proposed, with 
the revisions described in this final rule. We use the term ``secondary 
activities farm'' to mean an operation, not located on a primary 
production farm, devoted to harvesting (such as hulling or shelling), 
packing, and/or holding of RACs, provided that the primary production 
farm(s) that grows, harvests, and/or raises the majority of the RACs 
harvested, packed, and/or held by the secondary activities farm owns, 
or jointly owns, a majority interest in the secondary activities farm. 
A secondary activities farm may also conduct those additional 
activities allowed on a primary production farm. With the added 
definition of ``secondary activities farm,'' off-farm packinghouses 
that are managed by a business entity (such as a cooperative) that is 
different from the business entity growing crops (such as individual 
farms) can be within the ``farm'' definition. We are making these 
changes to reflect the current reality of what it means to be a farm. 
The changes will allow farms that use certain business models to 
harvest, pack, and/or hold produce to be able to comply with the 
produce safety rule for all of their operations. We believe that this 
flexibility allows for the requirements of the produce safety rule to 
apply to a wider array of activities than our original proposal without 
opening the ``farm'' definition to operations that have no connection 
to the growing of crops or the raising of animals--the core activities 
of a farm. By specifying that the farms that grow or raise the majority 
of the RACs harvested, packed, and/or held by the operation must own, 
or jointly own, a majority interest in the secondary activities farm, 
the revised ``farm'' definition does, as requested by comments, allow 
``farms'' to carry out harvesting, packing, and holding activities in 
the same way as the produce safety rule.
    We are, as requested by some comments, establishing a new provision 
to allow off-farm establishments that package, pack, and hold RACs that 
are produce as will be defined in the produce safety rule to comply 
with the CGMPs in part 117, subpart B by complying with the applicable 
requirements for packing and holding that will be established in the 
final produce safety rule (see Sec.  117.8). Because the new provision 
refers to provisions in a future produce safety rule, we will publish a 
document in the Federal Register announcing the effective date of that 
provision once we finalize the produce safety rule.
    However, the revised ``farm'' definition does not, as requested by 
some comments, establish the exact same regulatory framework for 
operations, such as certain packinghouses and hulling/shelling 
operations, that are within the ``farm'' definition as for operations 
that conduct similar activities but are outside the ``farm'' definition 
by allowing off-farm operations to be subject to the produce

[[Page 55929]]

safety rule rather than the requirements for hazard analysis and risk-
based preventive controls. We disagree that the statutory framework 
provides flexibility for entities such as packinghouses and hulling/
shelling operations that do not have a connection to a farm to be 
subject to the requirements of the produce safety rule for compliance 
purposes. (See the discussion at 79 FR 58524 at 58536.) We continue to 
believe that an off-farm packinghouse that is subject to this rule will 
be able to draw from the provisions of the produce safety rule in 
developing its food safety plan and establishing preventive control 
management components that are appropriate in light of the nature of 
the preventive controls and their role in the facility's food safety 
system. For example, as previously discussed (79 FR 58524 at 58536) we 
expect that the food safety plan for an off-farm packinghouse would 
focus on a few key preventive controls, including some that would have 
counterparts in the proposed produce safety rule, such as maintaining 
and monitoring the temperature of water used during packing (which 
would have counterparts under proposed Sec.  112.46(c) in the proposed 
produce safety rule). We also expect that an off-farm packinghouse 
would establish sanitation controls to address the cleanliness of food-
contact surfaces (including food-contact surfaces of utensils and 
equipment) and the prevention of cross-contamination from insanitary 
objects and from personnel to food, food-packaging material, and other 
food-contact surfaces. On-farm packinghouses would be subject to 
similar, but not identical, requirements (see e.g., proposed Sec.  
112.111(b) for cleanliness of food-contact surfaces and proposed Sec.  
112.113 for protection against contamination).
    We acknowledge that some of the provisions of the human preventive 
controls rule have no explicit counterparts in the proposed produce 
safety rule (e.g., the requirements for product testing and 
environmental monitoring as verification activities). As discussed in 
Response 525, we do not expect either product testing or environmental 
monitoring to be common in facilities that process, pack, or hold 
produce RACs.
    Finally, in response to comments that ask for a clarification that 
a farm can pack or hold RACs that have already undergone packing or 
holding activities by another farm, we presume that the commenter was 
asking about a case where the farm that did the previous packing and 
holding activities was not the farm on which the RACs were grown and 
harvested. The definition of ``farm'' allows packing and holding of 
one's own RACs and other's RACs, even if they have been previously 
packed or held by another farm that was not the farm on which the RACs 
were grown and harvested.
    (Comment 26) Some comments ask us to clarify whether the ``and'' 
between provisions that allow a farm to dry/dehydrate RACs to create a 
distinct commodity, and provisions that allow a farm to package and 
label RACs, means that an operation must do both of these activities to 
remain within the farm definition. These comments state that they do 
not think this is the intended (or logical) outcome, which is to 
provide that farms can do either or both activities and still be within 
the farm definition and ask us to consider editorial changes (such as 
replacing ``and'' with ``or,'' or adding a new paragraph that would 
encompass both activities).
    (Response 26) The rule does not require a farm to do both 
activities (i.e., drying/dehydrating RACs to create a distinct 
commodity, and packaging and labeling RACs) to remain within the farm 
definition.
    (Comment 27) Some comments ask us to add artificial ripening of 
RACs as an activity that is within the farm definition. Some comments 
assert that artificial ripening of RACs is not manufacturing/processing 
because artificial ripening does not transform a RAC into a processed 
food.
    (Response 27) We have revised the ``farm'' definition to specify 
that treatment to manipulate the ripening of RACs (such as by treating 
produce with ethylene gas), and packaging and labeling the treated 
RACs, without additional manufacturing/processing, are within the 
``farm'' definition. We agree that a treatment such as artificial 
ripening does not transform a RAC into a processed food but disagree 
that such a treatment is not manufacturing/processing. To make that 
clearer, we have added ``treating to manipulate ripening'' to the list 
of examples of manufacturing/processing in the definition of that term. 
As discussed during the rulemaking to establish the section 415 
registration regulations, artificial ripening constitutes 
manufacturing/processing because it involves treating, modifying, or 
manipulating food (68 FR 58894 at 58912, October 10, 2003). See also 
our previous statements about artificial ripening in this rulemaking 
(78 FR 3646 at 3683 and 79 FR 58524 at 58572).
    As previously discussed, the activities that transform a RAC into a 
processed food (and are sometimes therefore referred to as 
``processing'' in the context of a food's status as a RAC or processed 
food) are not coextensive with the activities described in our 
definition of ``manufacturing/processing'' (78 FR 3646 at 3679). When 
we first established the section 415 registration regulations, a key 
criterion in determining whether a business entity was a ``farm'' or a 
``facility'' was whether the operation conducted activities classified 
as ``manufacturing/processing.'' Indeed, in the 2013 proposed 
preventive controls rule we continued to rely on that key criterion in 
proposing revisions to the ``farm'' definition. However, as already 
discussed, some changes to the ``farm'' definition are necessary to 
establish a sensible framework of risk-based regulations that both 
implement FSMA and reflect common farm activities (see Response 21). 
One of these changes is to specify those manufacturing/processing 
activities that are within the ``farm'' definition, rather than attempt 
to re-classify an activity that arguably is manufacturing/processing as 
harvesting, packing, or holding in order to provide for the activity to 
remain within the ``farm'' definition.
    (Comment 28) Some comments disagree that we should provide for 
drying/dehydrating RACs to create a distinct commodity to be within the 
``farm'' definition because this activity is a manufacturing/processing 
activity and should be subject to the requirements for hazard analysis 
and risk-based preventive controls. Other comments agree that we should 
provide for this activity but assert that ``drying/dehydrating RACs to 
create a distinct commodity'' is confusing to the average reader and 
ask us to add examples of what this means. Some comments ask us to 
clarify whether this activity applies to specific situations, such as 
drying/baling of hops (because hops are a low-risk product and beer 
brewing should eliminate any pathogens on the hops), drying plums to 
create prunes, and concentrating maple sap into maple syrup, cream, and 
candy. Some comments assert that maple syrup should be considered a RAC 
because the process of producing maple syrup mirrors the regulatory 
text ``drying/dehydrating RACs to create a distinct commodity,'' 
because maple syrup can only be produced through the concentration of 
maple sap and the process of that concentration is akin to the 
harvesting of other raw products. Other comments assert that the 
processing of sap is more appropriately viewed as a harvesting activity 
(rather than food manufacturing).

[[Page 55930]]

    Other comments ask us to clarify the specific methods of drying/
dehydrating that we would consider to be within the ``farm'' 
definition--e.g., whether drying/dehydrating is constrained to in situ, 
with no heat or mechanical air circulation, because the example we 
discussed in the 2014 supplemental preventive controls notice was 
``natural condition raisins.'' These comments ask us to specify the 
allowable methods of drying to avoid confusion, and assert that there 
is no food safety reason to exclude use of heat or air, especially if 
sun and light are to be permitted. Other comments ask us to clarify 
what we mean by ``without additional manufacturing/processing.''
    (Response 28) We are retaining drying/dehydrating RACs to create a 
distinct commodity as an activity that is within the ``farm'' 
definition even though it is manufacturing/processing. As previously 
discussed, the processes (described in comments to the 2013 proposed 
human preventive controls rule) for drying grapes to ``natural 
condition raisins'' are akin to other harvesting activities 
traditionally conducted by farms on RACs grown and harvested on farms, 
because they are traditionally performed by farms for the purpose of 
removing RACs from the place they were grown or raised and preparing 
them for use as food (79 FR 58524 at 58533). As also previously 
discussed, the information provided by the comments to the 2013 
proposed human preventive controls rule included information that 
``natural condition raisins'' are produced with either sun-drying or 
artificial dehydration (79 FR 58524 at 58533). We did not intend to 
limit the processes for drying/dehydrating RACs to sun-drying, and the 
regulatory text includes no such limitation. We decline the request to 
specify specific methods of drying/dehydrating that would remain within 
the ``farm'' definition because doing so could imply that the list of 
methods was exhaustive and preclude use of new technology in the 
future.
    However, we are adding ``boiling'' and ``evaporating'' to the list 
of activities that we classify as manufacturing/processing to preclude 
interpretations, such as those expressed in some of these comments, 
that the processes to produce products such as maple syrup, maple 
cream, and maple candy are ``drying/dehydrating.'' In the 2013 proposed 
human preventive controls rule we included ``Boiling/evaporation of 
maple sap to make maple syrup'' as a low-risk manufacturing/processing 
activity/food combination in the exemption for small and very small 
businesses that only conduct specified on-farm low-risk activity/food 
combinations (proposed Sec.  117.5(h)), and we have retained--and 
broadened--that activity/food combination as an on-farm, low-risk 
manufacturing/processing activity/food combination in the final human 
preventive controls rule (see Sec.  117.5(h), which includes making 
sugar and syrup from fruits and vegetables (e.g., dates), grains (e.g., 
rice, sorghum), other grain products (e.g., malted grains such as 
barley), saps (e.g., agave, birch, maple, palm), sugar beets, and 
sugarcane). Processes such as ``boiling,'' ``concentrating,'' and 
``evaporating'' are not ``drying/dehydrating'' as the term ``drying/
dehydrating'' is used in this rule, and maple syrup is a processed 
food, not a RAC. See also the discussion in Response 23 regarding how a 
farm mixed-type facility that makes sugar from sugarcane or sugar beets 
can consider the findings of the section 103(c)(1)(C) RA (i.e., that 
this is a low-risk activity/food combination) in determining whether 
there are any hazards requiring a preventive control. A farm mixed-type 
facility that makes maple products from maple sap could follow the same 
approach.
    We have added ``slicing'' to the regulatory text as an example of 
additional manufacturing/processing that would be outside the ``farm'' 
definition. We also have added ``drying/dehydrating grapes to produce 
raisins'' to the regulatory text as an example of what we mean by 
``drying/dehydrating RACs to create a distinct commodity.'' Drying 
plums to produce prunes is another example of drying/dehydrating RACs 
to create a distinct commodity. Drying/baling hops is within the 
``farm'' definition, but as a ``holding'' activity because drying/
baling hops does not create a distinct commodity. As discussed in 
Response 39, we have revised the definition of ``holding'' to add 
drying/dehydrating RACs when the drying/dehydrating does not create a 
distinct commodity (such as drying/dehydrating hay or alfalfa) as an 
example of a holding activity.
    (Comment 29) Some comments agree that the activities of packaging 
and labeling RACs should remain within the ``farm'' definition but ask 
us to reclassify these activities so that they are not considered 
manufacturing/processing because they do not transform a RAC into a 
processed food or change the nature of the RAC. These comments ask us 
to add examples to regulatory text to explain what we mean by 
``packaging and labeling without additional manufacturing/processing.'' 
As an example, these comments ask whether a farm that packs produce 
grown by another farm, and washes the produce before packing it, would 
be conducting ``additional manufacturing/processing.''
    Other comments ask us to clarify whether packaged RACs are 
processed food because ``packaging'' is defined as a manufacturing/
processing operation. These comments also ask us to clarify whether a 
farm would be precluded from holding RACs packaged in retail form 
because the packaged RACs are processed food.
    (Response 29) See Response 27. We decline the request to reclassify 
packaging and labeling so that they would not be considered 
manufacturing/processing. Although we classify packaging and labeling 
as manufacturing/processing, packaging and labeling RACs do not 
transform the RACs into processed food, and we classify ``packaged 
RACs'' as RACs.
    We classify washing RACs as a harvesting or packing activity when 
done on RACs before or during packing or packaging, regardless of 
whether a farm is packing or packaging its own RACs or others' RACs. As 
requested by the comments, we have added an example of additional 
manufacturing/processing that would not be within the ``farm'' 
definition--i.e., irradiating--to both the ``farm definition'' and to 
the definition of ``manufacturing/processing.'' This example is 
different from the example we used in the preamble of the 2014 
supplemental human preventive controls notice to describe a limitation 
on activities within the ``farm definition''--i.e., ``modified 
atmosphere packaging'' (see 79 FR 58524 at 58532). We have decided to 
not restrict the specific types of packaging procedures that are within 
the ``farm'' definition because doing so could be confusing. Moreover, 
the specific safety concern that can be associated with modified 
atmosphere packaging (i.e., the production of Clostridium botulinum 
toxin), would be addressed by a proposed provision in the forthcoming 
produce safety rule, if that provision is finalized (see proposed Sec.  
112.115; 78 FR 3504 at 3589 and 3638). To clarify that ``modified 
atmosphere packaging'' is a type of ``packaging,'' we have revised the 
definition of ``manufacturing/processing'' to specify ``packaging 
(including modified atmosphere packaging)'' as an example of a 
manufacturing/processing activity.
    (Comment 30) Some comments assert that non-produce botanicals 
require treatments that do not create a new commodity and ask us to 
recognize these treatments as farm activities rather than 
manufacturing/processing activities. As examples, these comments

[[Page 55931]]

assert that activities such as cutting, slicing, drying, freezing, wet 
or dry heat treating to kill plant tissues, and aging or fermenting are 
all activities that are traditionally performed by farms on non-produce 
botanicals for the purpose of removing non-produce botanical RACs from 
the place where they were grown and preparing them for use as food. 
These comments also assert that we have been inconsistent in our 
activity classifications because we both state that ``heat treatment'' 
is a food processing activity and state that activities traditionally 
performed by farmers to prepare crops for use are farm activities. 
These comments express concern that farmers won't use heat treatments 
to control pests, based on a misunderstanding of what constitutes 
``food processing.''
    (Response 30) We note that these comments used the term ``non-
produce botanicals,'' which is not a term we have used or defined, and 
it is not clear to us what the commenters intended this term to 
represent. In this document, we are not addressing the question of 
whether certain ``botanicals'' are or are not ``produce.'' The term 
``produce'' was proposed to be defined in the forthcoming produce 
safety rule, and we intend to define it in that rule.
    However, we can address in this rule these commenters' questions 
about activity classification. Some of these activities are within the 
``farm'' definition. For example, drying/dehydrating a RAC without 
creating a distinct commodity is part of ``holding'' and drying/
dehydrating a RAC that creates a distinct commodity, without additional 
manufacturing/processing, is manufacturing/processing that is included 
within the ``farm'' definition. (See Response 28.) Cutting (or 
otherwise separating) the edible portion of the RAC from the crop plant 
and removing or trimming part of the RAC (e.g., foliage, husks, roots 
or stems) are harvesting activities. (See Response 37.) We have revised 
the definition of ``holding'' to include the example of ``fumigating 
food during storage.'' (See Response 39.) We decided to include this 
example of a holding activity based on previous discussions of how we 
classify fumigating as a type of pest control (see, e.g., 78 FR 3646 at 
3682 and 79 FR 28524 at 28571). Although we have not previously 
classified heat treatment for purposes of pest control, we agree that 
we should classify heat treatment for purposes of pest control the same 
way that we have classified fumigating for purposes of pest control--
i.e., as a holding activity. Regarding classification of the other 
activities listed in these comments, see Response 3.
    (Comment 31) Some comments assert that the ``farm'' definition is 
too limited and ask us to include standard farm activities such as 
culling, conveying, sorting, waxing, labeling, storing, packaging and 
shipping of raw, whole produce. These comments assert that these normal 
activities do not change the shape or structure of RACs, or alter the 
hazards, and should be covered under the produce safety rule rather 
than the human preventive controls rule.
    (Response 31) All of the activities described by these comments 
could be within the ``farm'' definition (see 79 FR 58524 at 58571-
58572), either because they are specified in the ``farm'' definition 
itself or because they are examples of activities within the definition 
of ``packing'' or holding.'' Packaging and labeling RACs, without 
additional manufacturing/processing, are specified in the regulatory 
text of the ``farm'' definition. Sorting and culling are included in 
the regulatory text of the definition of ``packing.'' Storing is simply 
another term for ``holding.'' We had already included ``weighing and 
conveying'' as an example of a low-risk packing or holding activity in 
the exemption applicable to on-farm low-risk activity/food combinations 
(Sec.  117.5(g)). To give more prominence to this packing activity, we 
have added it to the definition of ``packing'' as well.
    (Comment 32) One comment, submitted to Docket No. FDA-2011-N-0143 
for the FSVP rulemaking, notes that RACs often are harvested by a 
contract harvest company (Ref. 16). This comment asks us to clarify 
what is meant by ``establishment that harvests a food'' in the 
definition of ``foreign supplier'' and whether, in such circumstances, 
the supplier of the RAC would be the contract harvest company or the 
establishment that owns the crop and sells it to an importer.
    (Response 32) The 2014 supplemental human preventive controls 
notice had similar phrasing (``establishment that harvests the food'') 
in the definition of ``supplier.'' In the final rule the definition of 
``supplier'' has changed in relevant part to include the 
``establishment that grows the food,'' consistent with changes to the 
farm definition and as described in the following paragraphs.
    There are several different business models in which RACs are 
harvested by a contract harvester (Ref. 17). In one business model, a 
grower contracts with a harvester to perform harvesting on behalf of 
the grower. In another business model, a third-party handler enters 
into separate contracts with the grower and the harvester. In another 
business model, a grower sells its crop to an entity that contracts 
with a separate harvester to harvest the RACs and then packs the RACs. 
There are variations on these business models, such as when a grower 
sells its crop to an entity that both harvests and packs the RACs, 
without a contract with a separate harvester.
    Growing and harvesting operations are not under the same management 
in some of these business models. As discussed in Comment 23, comments 
emphasize that farming operations can have complex business structures, 
and ask us to revise the ``farm'' definition to provide for these 
business models. To explicitly include these business models in the 
``farm'' definition, we have revised the ``farm'' definition to mean an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. With this revision, an operation can 
be within the ``farm'' definition if it grows crops but does not 
harvest them or if it harvests crops but does not grow them.
    The ``farm'' definition established in the section 415 registration 
regulations in 2003 (68 FR 58894), and the proposed revisions to the 
``farm'' definition in the 2013 proposed human preventive controls rule 
and the 2014 supplemental human preventive controls notice, all 
describe a ``farm'' as an entity ``devoted to the growing and 
harvesting of crops'' (emphasis added). In light of the revision to the 
``farm'' definition and as discussed more fully in section IX.C.35, we 
have revised the ``supplier'' definition to include the establishment 
that ``grows the food'' rather than the establishment that ``harvests 
the food.'' With this change in the ``supplier'' definition, the 
supplier is the farm that grows the food regardless of the business 
model for harvesting the food.
    (Comment 33) Some comments ask us to modify the ``farm'' definition 
to exclude feed mills that provide feed to more than 5 other farms. 
These comments assert that egg farms are most likely to be company 
owned and the median number of farms owned by a company is under 8 and 
cite USDA as the source of this information. These comments assert that 
setting the limit at 5 would not automatically exempt feed mills 
operated by these large egg laying businesses from the animal 
preventive controls rule.
    (Response 33) We decline this request. The statutory exemption from

[[Page 55932]]

the section 415 registration regulations (and, thus, from the 
requirements for hazard analysis and risk-based preventive controls) 
for ``farms'' is based on the activities that an operation conducts 
rather than on the size of the operation.
    (Comment 34) Some comments assert that the hulling or dehydration 
of walnuts should not be considered processing and, thus, that an 
establishment that conducts hulling or dehydration activities on tree 
nuts such as walnuts should not be considered a facility subject to the 
requirements for hazard analysis and risk-based preventive controls. 
These comments also assert that all growers who hull and dry should 
operate under the same rules, regardless of whether or not they own 
their own crop. Some comments assert that the hulling and shelling 
operations in the nut industry are part of the harvesting operation in 
which the outer shells are removed. These comments state that 
regardless of whether activities are conducted on the farm in which 
they are grown or at an off-farm facility that provides hulling and 
shelling services, the food is a RAC, the activity is low-risk and does 
not transform the RAC into a processed food, and the product is 
delivered to a processing facility and is not distributed in commerce. 
The comments argue that for all these reasons and because hulling and 
shelling activities are not subject to subpart B, it is not appropriate 
to subject facilities that conduct such activities to subpart C. 
Comments request that hulling, shelling, and drying of tree nuts be 
considered ``on farm'' for the purposes of this rule. Other comments 
ask us to specify that the production of ``natural dried raisins,'' 
dried plums, and dried hops are within the ``farm'' definition.
    (Response 34) Hulling of tree nuts (such as walnuts, almonds, and 
pistachios) is a harvesting activity that is within the ``farm'' 
definition when conducted on a farm or the farm part of a farm mixed-
type facility. Drying/dehydrating RACs without creating a distinct 
commodity (such as drying walnuts and hops) is a holding activity that 
also is within the ``farm'' definition when conducted on a farm or farm 
mixed-type facility. As discussed in Response 25, we have revised the 
``farm'' definition to provide that an operation, not located on a 
primary production farm, devoted to harvesting (such as hulling or 
shelling), packing, and/or holding of RACs is within the ``farm'' 
definition (as a ``secondary activities farm''), provided that the 
primary production farm(s) that grows, harvests, and/or raises the 
majority of the RACs harvested, packed, and/or held by the secondary 
activities farm owns, or jointly owns, a majority interest in the 
secondary activities farm.
    Drying/dehydrating RACs (such as grapes and plums) to create a 
distinct commodity, and packaging and labeling such commodities, 
without additional manufacturing/processing is within the ``farm'' 
definition when conducted on a farm or farm mixed-type facility. (See 
Response 28.) However, additional manufacturing/processing activities 
(such as removing pits from dried plums) are outside the ``farm'' 
definition, and a farm or farm mixed-type facility that conducts such 
activities becomes a facility that is required to register and is 
subject to the requirements for hazard analysis and risk-based 
preventive controls for those activities outside the farm definition. 
The exception is when a farm is a small or very small business eligible 
for the exemptions in Sec.  117.5(g) and (h) for a farm mixed-type 
facility that only conducts low-risk activity/food combinations. Such a 
small or very small business must still register as a food facility, 
but will be exempt from the requirements for hazard analysis and risk-
based preventive controls. (See also the discussion in in the 2014 
supplemental human preventive controls notice (79 FR 58524 at 58533-
58534 and table 1 in the Appendix to the 2014 supplemental human 
preventive controls notice (79 FR 58524 at 58571-58572)).
    (Comment 35) Some comments assert that we have referred to raw milk 
as being ``inherently dangerous'' and should not consider any 
activities that result in the preparation of an inherently unsafe 
product for sale to consumers to be within the ``farm'' definition 
(i.e., production of raw milk for direct human consumption should not 
be considered ``harvesting'' or ``packing''). These comments ask us to 
re[hyphen]consider the definition of ``farm'' as it applies to the 
production of raw milk for human consumption. Specifically, these 
comments ask us to consider such activities to be outside the 
traditional business of a dairy farm and to subject businesses that 
conduct such activities to FSMA's requirements for hazard analysis and 
risk-based preventive controls requirements as a means of advancing 
public health.
    (Response 35) We decline this request. Producing milk is a 
traditional activity of a dairy farm, regardless of whether the milk 
produced by that dairy farm is pasteurized and introduced into 
interstate commerce in accordance with Sec.  1240.61 (Mandatory 
pasteurization for all milk and milk products in final package form 
intended for direct human consumption) or sold unpasteurized to 
consumers within a State consistent with applicable State laws and 
regulations. Distributing raw milk in interstate commerce would be 
unlawful, but would not form the basis for a decision that the business 
is ``not a farm.''
    (Comment 36) Some comments express concern that farmers who grow 
seed that is sold as animal feed must register as a food facility. 
These comments ask why sales of grain for animal feed are included in a 
rule that is focused on the safety of human food and ask us to exempt 
this category of farms and their sales of grain for animal feed from 
the registration rule.
    (Response 36) Establishments that satisfy the ``farm'' definition, 
including farms that grow seed that is sold as animal food, are not 
required to register as a food facility. These comments may mistakenly 
believe that we intended any food establishment that is required to 
register as a food facility to comply with the regulations we are 
establishing in part 117 regarding human food, regardless of whether 
the facility produces food for consumption by humans or food for 
consumption by animals. This is not the case. We simply proposed to 
revise definitions in the section 415 registration regulations relevant 
to the definition of ``facility'' in the same notice in which we 
proposed to modernize the current CGMPs for food and establish 
requirements for hazard analysis and risk-based preventive controls for 
human food, because section 103 of FSMA addresses the definitions in 
the section 415 registration regulations, as well as the requirements 
for hazard analysis and risk-based preventive controls. If a facility 
sells grain for use as animal food, and is not exempt from the section 
415 registration regulations, that facility would be subject to the 
animal preventive controls rule, not the human preventive controls rule 
that is the subject of this document.

C. Proposed New Definition of Harvesting

    We proposed to define ``Harvesting,'' as a new definition in 
Sec. Sec.  1.227 and 1.328, to apply to farms and farm mixed-type 
facilities and to mean activities that are traditionally performed by 
farms for the purpose of removing RACs from the place they were grown 
or raised and preparing them for use as food. We proposed that 
harvesting be limited to activities performed on RACs on a farm, and 
that harvesting does not include activities that transform a RAC into a 
processed

[[Page 55933]]

food. The proposed definition included examples of activities that 
would be harvesting. As noted in table 52 of this document, we have 
reorganized the listed examples of harvesting to present them in 
alphabetical order. We also have modified the proposal that harvesting 
be limited to activities performed on RACs on a farm to provide that 
harvesting can also be performed on processed foods created by drying/
dehydrating a RAC without additional manufacturing/processing, because 
processed foods created by drying/dehydrating RACs are within the 
``farm'' definition. See Response 28 and 79 FR 58524 at 58533 regarding 
drying/dehydrating RACs to create a distinct commodity.
    (Comment 37) Some comments ask us to provide more examples of 
harvesting activities, in the regulatory text and in guidance. Examples 
of the requested activities include braiding; bunching; cutting the 
edible portion of the crop from the plant; hydro-cooling; maintaining 
hydration of product; refrigerating; removing foliage; removing free 
water from (e.g., spinning); removing or trimming roots; trimming the 
tops of bunches of allium crops such as leeks, chives, or garlic and 
root crops such as carrots, beets, turnips, parsnips, etc. to prepare 
them for sale; and trimming the lower stems of harvested herb crops 
such as parsley, basil, or cilantro, or the lower stems of leafy 
greens. Other comments ask us to specify that harvesting also 
encompasses seed conditioning (i.e., cleaning the seed, including 
removal of leaves, stems, and husks to prepare for marketing), ripening 
(artificial or natural) of fruit, and waxing or coating of RACs.
    (Response 37) We have added or modified several examples of 
harvesting in the regulatory text (i.e., cutting (or otherwise 
separating) the edible portion of the RAC from the crop plant, removing 
or trimming part of the RAC (e.g., foliage, husks, roots or stems), 
field coring, and hulling). In table 1 in the Appendix to the 2014 
supplemental human preventive controls notice (79 FR 58524 at 58571-
58572), we provided a more extensive list of examples of harvesting 
activities, including examples that are not in the regulatory text. 
Although we have classified some of these activities in more than one 
way (see 79 FR 58524 at 58571-58572), in general these activities would 
fall within the ``farm'' definition when conducted on RACs that are not 
otherwise processed. For example, coating RACs with wax/oil/resin for 
the purpose of storage or transport can be a packing (not harvesting) 
activity, but waxing also has long been considered a manufacturing/
processing activity during the production of processed food (because it 
involves making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food) (see 78 FR 3646 at 
3679). Artificial ripening of fruit is manufacturing/processing (not 
harvesting), but is now within the ``farm'' definition (see Sec.  117.3 
and Response 27). Regarding classification of the other activities 
listed in these comments, see Response 3.
    (Comment 38) Some comments assert that fermenting cocoa beans and 
coffee beans should be classified as ``harvesting'' rather than 
``holding.''
    (Response 38) We agree that the process of fermenting cocoa beans 
and coffee beans begins as a ``harvesting'' activity, when the pods are 
harvested and the beans are removed; it continues as ``holding,'' while 
the harvested beans ferment. Thus, fermenting cocoa beans and coffee 
beans has elements of both ``harvesting'' and ``holding,'' which are 
both within the ``farm'' definition. It is not necessary to place the 
process of fermenting cocoa beans and coffee beans squarely in one 
activity or the other for the regulatory purpose of determining whether 
an operation is within the ``farm'' definition. See also Response 41.

D. Proposed Revision to the Definition of Holding

    We proposed to revise the definition of ``Holding'' in Sec. Sec.  
1.227 and 1.328 to add that holding also includes activities performed 
incidental to storage of a food, but does not include activities that 
transform a RAC into a processed food. Holding facilities could include 
warehouses, cold storage facilities, storage silos, grain elevators, 
and liquid storage tanks.
    (Comment 39) Some comments ask us to provide more examples of 
holding activities, in the regulatory text and in guidance. Examples of 
the requested activities include fumigating RACs; application of 
chemicals (including fungicides, sanitizers, and anti-oxidants); 
application of ripening agents; using wax as a carrier of fungicides or 
anti-oxidants applied before storage; and waxing or coating of RACs, 
including ``coating'' grain RACs with diatomaceous earth to control 
insects. According to these comments, these activities are incidental 
to storage and do not transform RACs into processed food.
    (Response 39) We have added or modified several examples of holding 
in the regulatory text (i.e., fumigating food during storage, and 
drying/dehydrating RACs when the drying/dehydrating does not create a 
distinct commodity (such as drying/dehydrating hay or alfalfa)). In 
table 1 in the Appendix to the 2014 supplemental human preventive 
controls notice (79 FR 58524 at 58571-58572), we provided a more 
extensive list of examples of holding activities, including examples 
that are not in the regulatory text. We have previously classified some 
of these activities in more than one way (see 79 FR 58524 at 58571-
58572) depending on when the activity occurs. For example, sorting, 
culling, and grading RACs can be either a holding activity or a packing 
activity. Drying/dehydrating RACs is holding when the drying/
dehydrating does not create a distinct commodity, but is manufacturing/
processing when the drying/dehydrating creates a distinct commodity 
(see Response 28). Regarding classification of the other activities 
listed in these comments, see Response 3.
    (Comment 40) Some comments ask us to clarify that mixing or 
blending intact RACs is considered ``holding'' regardless of whether 
the RACs are the same or different.
    (Response 40) We use the term ``blending'' when referring to RACs 
such as grain and when the RACs are the same. For example, we consider 
the activity of ``blending'' different lots of the same grain to meet a 
customer's quality specifications to be a practical necessity for 
product distribution and, thus, to be within the definition of 
``holding'' (see 79 FR 58524 at 58537). However, we use the term 
``mixing'' when the RACs are different. For example, we consider the 
activity of ``mixing'' corn and oats in the production of animal food 
to be manufacturing/processing, because mixing two different foods is 
``making food from one or more ingredients'' (which is our definition 
of ``manufacturing/processing''), and the animal food produced by 
mixing corn and oats is a processed food.
    We classify ``mixing'' intact RACs that does not create a processed 
food as incidental to, and therefore part of, ``packing'' or 
``holding'' as applicable.
    (Comment 41) Some comments ask us to clarify whether the expanded 
definition of holding that we proposed in the 2014 supplemental human 
preventive controls notice would mean that a warehouse that both stores 
cocoa beans and fumigates the cocoa beans to prevent pest infestation 
would be exempt from the requirements for hazard analysis and risk-
based preventive controls for a facility solely engaged in the storage 
of RACs (other than fruits and vegetables) for further distribution or 
processing (Sec.  117.5(j)).

[[Page 55934]]

    (Response 41) Fumigating RACs such as cocoa beans to prevent pest 
infestation would be within the definition of ``holding.'' Therefore, 
such fumigation would not prevent a facility that stores RACs (other 
than fruits and vegetables) from being eligible for the exemption in 
Sec.  117.5(j), provided that the facility does not conduct other 
activities not classified as ``holding.'' However, a threshold question 
for any facility solely engaged in the storage of RACs is whether the 
stored RACs are fruits or vegetables. We classify cocoa beans within 
the category of ``fruits and vegetables'' (78 FR 3646 at 3690) and, 
thus, a facility that stores cocoa beans is not eligible for the 
exemption in Sec.  117.5(j).
    (Comment 42) Some comments ask us to clarify whether there is a 
timeframe associated with holding and to better distinguish between 
``holding'' and ``storage.''
    (Response 42) There is no timeframe (maximum or minimum) associated 
with holding. The definition of holding states ``Holding means storage 
of food'' and, thus, there is no distinction between ``holding'' and 
``storing.''
    (Comment 43) Some comments ask us to clarify how the definition of 
holding relates to practices, such as fumigation, on almond hull 
stockpiles held on a farm, a farm mixed-type facility, or off-farm.
    (Response 43) Practices that are incidental to storage of food, 
such as fumigation of almond hull stockpiles, are holding, regardless 
of whether they are conducted on-farm, on a farm mixed-type facility, 
or off-farm.
    (Comment 44) Some comments ask us to clarify that value added 
activities (such as repacking and blast freezing) conducted in 
facilities such as warehouses would be considered holding when product 
is not exposed to the environment.
    (Response 44) We consider the activities described in these 
comments to be activities performed as a practical necessity for the 
distribution of the food and, thus, to be within the definition of 
holding.
    (Comment 45) Some express concern that the definition of holding 
would prevent a facility that samples food (such as sugar) for grading 
or quality control purposes from qualifying for the exemption for 
facilities engaged solely in holding unexposed packaged food because 
they would temporarily expose otherwise unexposed packaged food to the 
environment. These comments ask us to make clear that the requirements 
for hazard analysis and risk-based preventive controls only apply to 
the sampling activities and that engaging in sampling activities does 
not remove a warehouse's exemption altogether.
    (Response 45) We consider that sampling food in the manner 
described by this comment is a practical necessity for the distribution 
of the food within the definition of ``holding,'' and that the 
exemption still applies to a facility that conducts such sampling. 
Importantly, the sampling must be in done in accordance with CGMPs such 
that the exposure does not result in contamination of the food.

E. Proposed Revision to the Definition of Manufacturing/Processing

    We proposed to revise the definition of ``Manufacturing/
Processing'' in Sec. Sec.  1.227 and 1.328 by adding to the existing 
definition a criterion applicable to farms and farm mixed-type 
facilities. As noted in table 52, we have reorganized the listed 
examples of manufacturing/processing to present them in alphabetical 
order.
    (Comment 46) Some comments express concern that some activities 
included in the definition of ``manufacturing/processing'' overlap with 
activities (such as trimming, washing, and cooling) included in the 
definition of ``harvesting.''
    (Response 46) We acknowledge that there is some overlap in the 
activities that the regulatory text lists as examples of both 
``manufacturing/processing'' and ``harvesting,'' because some 
activities can occur during more than one operation (see also the 
discussion at 79 FR 58524 at 58538 and table 1 in the Appendix to the 
2014 supplemental human preventive controls notice (79 FR 58524 at 
58571-58572)). For example, ``cutting'' the core of the lettuce from 
the crop plant can occur on-farm in the field where the lettuce is 
harvested, and ``cutting'' the core of the lettuce from the rest of the 
harvested lettuce also can occur in a fresh-cut processing facility. An 
important consequence of the multiple revisions we have made to the 
``farm'' definition in this rulemaking is that there are fewer 
situations in which classification of a particular activity is the only 
trigger for an operation to be subject to the section 415 registration 
regulations. For example, the revised ``farm'' definition no longer 
classifies the packing and holding of others' RACs to be a 
manufacturing/processing activity that triggers the registration 
requirement. As another example, the revised ``farm'' definition 
specifies three manufacturing/processing activities that are within the 
``farm'' definition. We conclude that the overlap in the examples of 
activities listed in the definitions of ``harvesting'' and 
``manufacturing/processing'' does not create problems with determining 
the status of an operation as a ``farm'' or a ``facility'' and we are 
retaining examples in both definitions because doing so reflects 
current practices on farms and in manufacturing/processing facilities.
    (Comment 47) Some comments ask us to clarify that the traditional 
activities of a packing shed--cleaning and packing intact fruits and 
vegetables--do not constitute ``manufacturing/processing'' that would 
trigger the requirement to register as a facility.
    (Response 47) Packing activities are within the definition of 
``packing,'' and holding activities are within the definition of 
``holding,'' regardless of whether the packing or holding activities 
take place on-farm or off-farm. In other words, neither packing produce 
nor holding produce would be classified as manufacturing/processing 
merely because the business entity conducting the activity is a 
facility that is subject to the section 415 registration regulations. 
As discussed in Response 25, we have revised the ``farm'' definition to 
provide that an operation devoted to harvesting (such as hulling or 
shelling), packing, and/or holding of RACs is within the ``farm'' 
definition (as a ``secondary activities farm''), provided that the 
primary production farm(s) that grows, harvests, and/or raises the 
majority of the RACs harvested, packed, and/or held by the secondary 
activities farm owns, or jointly owns, a majority interest in the 
secondary activities farm. With this revision, some off-farm 
packinghouses that are managed by a business entity (such as a 
cooperative) that is different from the business entity growing crops 
(such as individual farms) can be within the ``farm'' definition, 
provided that the primary production farm(s) that grows, harvests, or 
raises the majority of the RACs harvested, packed, and/or held by the 
secondary activities farm owns, or jointly owns, a majority interest in 
the packing operation.
    (Comment 48) Some comments ask us to make clear, in our response to 
comments in the final rule, that any adjustments we make to the 
definition of manufacturing/processing in no way change the definitions 
of ``raw agricultural commodity,'' ``processing,'' and ``processed 
food,'' which were mutually agreed to by EPA and FDA (Ref. 15) to 
address regulatory responsibilities for antimicrobials applied to food, 
process water contacting food, or hard food-contact surfaces.
    (Response 48) The revisions we made to the ``farm'' definition, and 
to the classification of activities relevant to the

[[Page 55935]]

``farm'' definition, do not change the statutory definitions of ``raw 
agricultural commodity,'' and ``processed food,'' or impact our 
interpretation of the definition of ``processing,'' with respect to 
regulatory jurisdiction for antimicrobials applied to food, process 
water contacting food, or hard food-contact surfaces.

F. Proposed New Definition of Mixed-Type Facility

    We proposed to define ``Mixed-type facility,'' as a new definition 
in Sec. Sec.  1.227 and 1.328, to mean an establishment that engages in 
both activities that are exempt from registration under section 415 of 
the FD&C Act and activities that require the establishment to be 
registered. We specified in the regulatory text that an example of such 
a facility is a ``farm mixed-type facility,'' which is an establishment 
that grows and harvests crops or raises animals and may conduct other 
activities within the farm definition, but also conducts activities 
that require the establishment to be registered. As a conforming change 
associated with the revisions to the ``farm'' definition, we have 
revised the example of a ``farm mixed-type facility'' to specify that 
it is an establishment that is a farm, but also conducts activities 
outside the farm definition that require the establishment to be 
registered.
    (Comment 49) Some comments assert that there is no scientific basis 
for the definition of mixed-type facility.
    (Response 49) The proposed definition is not a science-based 
definition. It is a descriptive term that we are using to refer to 
certain food establishments. We used this same term during the 
rulemaking to establish the section 415 registration regulations (see 
response to comment 46, 68 FR 58894 at 58906, October 10, 2003).
    (Comment 50) Some comments ask us to revise the definition to add 
more details about activities that are inside the farm definition and 
activities that are outside the farm definition.
    (Response 50) We decline the request of these comments. Adding such 
details would detract from the focus of the definition--i.e., that it 
refers to a facility that conducts both activities that are inside the 
farm definition and activities that are outside the farm definition. We 
have included additional examples of ``harvesting,'' ``packing,'' and 
``holding'' activities in the regulatory text of the definitions for 
those terms (see Sec. Sec.  1.227, 1.328 and 117.3 and Response 31, 
Response 37 and Response 39). (See also Response 3.)
    (Comment 51) Some comments ask us to revise the definition to 
exclude those establishments that only conduct low-risk activities 
specified in the exemptions for on-farm, low-risk activity/food 
combinations (Sec.  117.5(g) and (h)).
    (Response 51) We decline this request. Whether a particular 
establishment that falls within the definition of ``mixed-type 
facility'' is subject to the requirements for hazard analysis and risk-
based preventive controls is governed by the exemptions established in 
this rule.

G. Proposed Revision to the Definition of Packing

    We proposed to revise the definition of ``Packing'' in Sec. Sec.  
1.227 and 1.328 by adding that packing includes activities performed 
incidental to packing a food, but does not include activities that 
transform a RAC into a processed food. We have revised the definition 
to clarify that packing includes ``re-packing.''
    (Comment 52) Some comments ask us to include minimal 
``manufacturing/processing'' of RACs in the definition of packing when 
the minimal ``manufacturing/processing'' does not transform the RAC 
into a processed food. The comments describe waxing of fresh fruit 
(such as apples) and vegetables as examples of activities that do not 
transform a RAC into a processed food.
    (Response 52) As already discussed, the activities that transform a 
RAC into a processed food (and are sometimes therefore referred to as 
``processing'' in the context of a food's status as a RAC or processed 
food) are not coextensive with the activities described in our 
definition of ``manufacturing/processing.'' (See Response 27.) Although 
waxing has long been considered a manufacturing/processing activity 
during the production of processed food (because it involves making 
food from one or more ingredients, or synthesizing, preparing, 
treating, modifying or manipulating food), we classify coating RACs 
with wax/oil/resin for the purpose of storage or transport as a packing 
activity. (See Response 37).
    (Comment 53) Some comments ask us to clarify the distinction 
between ``packing'' and ``packaging'' because the terms are different 
but seem to be used interchangeably. These comments express concern 
that ``placing food into containers'' on farms that have traditionally 
done so will be classified as ``manufacturing/processing'' and trigger 
the requirement to register as a food facility and ask us to reclassify 
``packaging'' within the definition of ``packing.'' Other comments ask 
us to remove the words ``other than packaging of food'' from the 
definition of ``packing.'' Some comments state that when a RAC is 
packed in the field and/or is placed into a clamshell container, as a 
practical matter it is considered to have been ``packed,'' not 
``packaged.''
    (Response 53) We acknowledge that farms traditionally refer to 
field packing, including placing RACs into clamshell containers that 
will serve as a consumer package, as ``packing,'' not ``packaging.'' 
Indeed, in the 2013 human preventive controls rule we proposed to 
revise the definition of ``packing'' to specify that, for farms and 
farm mixed-type facilities, ``packing'' includes ``packaging.'' 
However, in the 2014 supplemental human preventive controls notice we 
proposed a simpler approach to accommodate requests such as those in 
these comments, by simply specifying in the ``farm'' definition that 
packaging and labeling RACs, without additional manufacturing/
processing, is within the ``farm'' definition. We conclude that the 
distinctions between the terms ``packing'' and ``packaging'' do not 
create problems with determining the status of an operation as a 
``farm'' or a ``facility.'' Further, we note that we have given these 
terms identical meanings across multiple FDA regulations that are 
applicable to facilities.
    (Comment 54) Some comments refer to discussions at a ``listening 
session'' regarding harvesting several varieties of lettuce, washing 
them, and combining heads or bunches of the different varieties in one 
bag that is sealed with a knot or twist tie. During these discussions, 
this type of activity was classified as being within the ``farm'' 
definition. These comments ask how this activity can be classified as 
being within the ``farm'' definition when mixing and washing are listed 
as manufacturing/processing activities that trigger registration as a 
food facility and whether there is a discrepancy between what the rule 
requires and what they heard at the listening session. Other comments 
express the view that mixing RACs that have not been transformed into 
processed food (such as bagging mixed greens or different types of 
whole produce, such as potatoes, beets, and carrots) should not put a 
farm in the category of a mixed-type facility.
    (Response 54) Removing several varieties of lettuce from the place 
in which they were grown, washing them on the farm, and combining heads 
or bunches of the different varieties in one bag that is sealed with a 
knot or twist tie on the farm are all activities within the ``farm'' 
definition. We classify ``washing'' and ``mixing'' in more than one way 
depending on when the activity occurs, and the ``farm'' definition now 
specifies that

[[Page 55936]]

``packaging'' RACs (without additional manufacturing/processing, such 
as slicing) is a farm activity, even though it is a type of 
``manufacturing/processing.'' We have recognized ``washing'' as a 
harvesting activity since we first issued the section 415 registration 
regulations (68 FR 58894 at 58961, October 10, 2003), even though we 
also classify ``washing'' RACs as ``manufacturing/processing'' when 
done in a food processing facility (such as a fresh-cut processing 
facility). We classify ``mixing'' intact RACs that does not create a 
processed food as incidental to, and therefore part of, ``packing'' or 
``holding'' as applicable. Mixing heads or bunches of lettuce as 
described in the example does not create a processed food, because he 
mixing has not created a distinct commodity, but only a set of mixed 
RACs. On the other hand, mixing that creates a processed food is not 
``packing'' or ``holding.'' The definitions of both ``packing'' and 
``holding'' are limited so that they do not include activities that 
transform a RAC into processed food. Some kinds of mixing of RACs do 
create a distinct commodity (for example, mixing corn and oats to make 
animal food). In such cases, the mixing is manufacturing/processing and 
is not within the farm definition. Likewise, although we classify 
placing RACs in a plastic bag with a twist tie as ``packaging'' rather 
than ``packing'' when the plastic bag is the container that the 
consumer receives, we have provided for ''packaging'' RACs as an 
activity within the ``farm'' definition.

V. Comments on the Organizing Principles for How the Status of a Food 
as a Raw Agricultural Commodity or as a Processed Food Affects the 
Requirements Applicable to a Farm Under Sections 415 and 418 of the 
FD&C Act

    In the 2014 supplemental human preventive controls notice, we 
discussed comments on the organizing principles that formed the basis 
for proposed revisions to the section 415 registration regulations and 
the section 414 recordkeeping regulations (79 FR 58524 at 58538). We 
also explained how our proposed revisions to the ``farm'' definition 
would require us to reconsider those organizing principles (79 FR 58524 
at 58538).
    (Comment 55) Some comments assert that we should revise the 
organizing principles to reflect the realities and range of activities 
that farms conduct to prepare their crops for market and to make the 
organizing principles consistent with FSMA's risk-based mandate. These 
comments ask us to revise the organizing principles as follows: (1) The 
basic purpose of farms is to produce RACs and deliver them for sale to 
end-users or other buyers; (2) activities that involve RACs and that 
farms perform for the purposes of selling their own RACs, including 
growing them, harvesting them, preparing them for consumption in their 
raw and unprocessed state, and packing, sorting, grading, packaging, 
labeling, holding, transporting, marketing, and delivering them, should 
all be within the definition of ``farm;'' (3) even though farms 
traditionally also do a wide variety of activities that may be 
considered processing, for the purpose of these organizing principles, 
activities should be classified based on whether the activity 
transforms a RAC into a processed food (as defined by these rules); (4) 
manufacturing/processing, packing, or holding food--whether RACs or 
processed foods, from any source--for consumption on the farm should 
remain within the farm definition.
    (Response 55) We have revised the ``farm'' definition to refer to 
farms as ``operations'' rather than ``facilities'' or 
``establishments''; reflect modern business models (such as 
cooperatives, on-farm packinghouses under ownership by multiple 
growers, food aggregators, and some types of food hubs (e.g., those 
that consolidate and distribute RACs but do not conduct activities that 
transform the RACs into a processed food)); specify that a farm is in 
one general (but not necessarily contiguous) physical location; and 
provide that an operation devoted to harvesting (such as hulling or 
shelling), packing, and/or holding of RACs is within the ``farm'' 
definition as a secondary activities farm, provided that the primary 
production farm(s) that grows, harvests, and/or raises the majority of 
the RACs harvested, packed, and/or held by the secondary activities 
farm owns, or jointly owns, a majority interest in the secondary 
activities farm (e.g., an off-farm produce packinghouse owned by 
farmers or a farmer-owned tree nut hulling and drying operation). (See 
Response 22, Response 23, Response 24, and Response 25.) All of these 
changes to the ``farm'' definition do, as requested by these and other 
comments, reflect the realities and range of activities that farms 
conduct. See table 5 for organizing principles regarding classification 
of activities on-farm and off-farm in light of the changes to the 
``farm'' definition.

Table 5--Organizing Principles Regarding Classification of Activities On-
                            Farm and Off-Farm
------------------------------------------------------------------------
             No.                         Organizing principle
------------------------------------------------------------------------
1...........................  The basic purpose of farms is to produce
                               RACs, and RACs are the essential products
                               of farms.
2...........................  A farm is in one general (but not
                               necessarily contiguous) location.
3...........................  Farm operations include business models
                               such as cooperatives, on-farm
                               packinghouses under ownership by multiple
                               growers, food aggregators, and some types
                               of food hubs.
4...........................  Activities that involve RACs and that
                               farms traditionally do for the purposes
                               of growing RACs, removing them from the
                               growing areas, and preparing them for use
                               as a food RAC, and for packing, holding,
                               and transporting them, are all within the
                               ``farm'' definition.
5...........................  Activities are classified based in part
                               whether the activity transforms a RAC
                               into a processed food.
6...........................  A limited number of traditional operations
                               that farms do for the purpose of
                               preparing RACs for use as a food RAC, but
                               that are classified as ``manufacturing/
                               processing,'' are within the ``farm''
                               definition. These are: (1) Drying/
                               dehydrating RACs to create a distinct
                               commodity, and packaging and labeling
                               such commodities, without additional
                               manufacturing/processing; (2) treatment
                               to manipulate the ripening of RACs, and
                               packaging and labeling the treated RACs,
                               without additional manufacturing/
                               processing; and (3) packaging and
                               labeling RACs, when these activities do
                               not involve additional manufacturing/
                               processing.
7...........................  Manufacturing/processing, packing, or
                               holding food--whether RACs or processed
                               foods, from any source--for consumption
                               on the farm is within the farm
                               definition.
------------------------------------------------------------------------


[[Page 55937]]

VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c)(1)(C) of FSMA

    We previously described provisions of FSMA that direct us to 
conduct a science-based risk analysis to cover specific types of on-
farm packing, holding, and manufacturing/processing activities that 
would be outside the ``farm'' definition and, thus, subject to the 
requirements for hazard analysis and risk-based preventive controls 
(see section 103(c)(1)(C) of FSMA and 78 FR 3646 at 3674 and 3689-
3691). Consistent with this statutory direction, we developed the 
section 103(c)(1)(C) draft RA and made it available for public comment 
(Ref. 18 and 78 FR 3824). We are including the final risk assessment 
(the section 103(c)(1)(C) RA) in the docket established for this 
document (Ref. 4).
    We previously described provisions of FSMA that direct us to 
consider the results of the science-based risk analysis and exempt 
facilities that are small or very small businesses from the 
requirements for hazard analysis and risk-based preventive controls (or 
modify these requirements, as we determine appropriate), if such 
facilities are engaged only in specific types of on-farm activities 
that we determine to be low risk involving specific foods that we 
determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR 
3646 at 3675, 3691, and 3705-3707). Later in this document (see section 
XI.G), we discuss the provisions we are establishing in Sec.  117.5(g) 
and (h), based on the results of the section 103(c)(1)(C) RA, to exempt 
farm mixed-type facilities that are small or very small businesses from 
requirements for hazard analysis and risk-based preventive controls if 
the only activities that the business conducts that are subject to 
those requirements are low-risk activity/food combinations.
    We also previously described provisions of FSMA that direct us to: 
(1) Identify high risk-facilities and allocate resources to inspect 
facilities according to the known safety risks of the facilities (as 
determined by several factors) and immediately increase the frequency 
of inspection of all facilities (see the discussion of section 421 of 
the FD&C Act at 78 FR 3646 at 3654-3655); and (2) consider a possible 
exemption from or modification of requirements of section 421 of the 
FD&C Act as we deem appropriate (see the discussion of section 
103(c)(1)(D) of FSMA at 78 FR 3646 at 3658). We tentatively concluded 
that we should not exempt or modify the frequency requirements under 
section 421 based solely upon whether a facility only engages in low-
risk activity/food combinations and is a small or very small business 
and requested comment on this tentative conclusion.

B. Comments on Qualitative Risk Assessment of On-Farm Activities 
Outside of the Farm Definition

    (Comment 56) Some comments address the qualitative nature of the 
section 103(c)(1)(C) draft RA and assert that it is based on 
professional judgment rather than data. These comments ask us to update 
the section 103(c)(1)(C) draft RA when more data become available. Some 
comments assert that we should not rely on data from the Food 
Processing Sector Study (Ref. 19), but instead collect data from large-
scale surveys of actual farm mixed-type facilities and their 
activities. Other comments ask us to dedicate resources and enter into 
agreements with agencies/organizations to collect, analyze, and 
interpret data. Some comments ask us to consult with subject matter 
experts to ensure that the final risk assessment reflects sufficient 
geographic diversity.
    (Response 56) We have acknowledged the limitations of the section 
103(c)(1)(C) draft RA (Ref. 18; see section I.F in that document). 
Rather than limit public input to subject matter experts, we requested 
comment from all interested persons, and received a number of comments 
alerting us to activity/food combinations conducted on farms and farm 
mixed-type facilities, including comments from diverse geographic 
areas. We also received comments about activity/food combinations 
focused on botanicals that might be used in the production of dietary 
ingredients. We disagree that we need to conduct large scale surveys, 
or enter into agreements with agencies/organizations, to collect 
additional information in light of the previous opportunity for broad 
public input regarding the activity/food combinations conducted on 
farms and farm mixed-type facilities. (See also Response 139 regarding 
the Food Processing Sector Study.)
    (Comment 57) Some comments state that it is not clear how certain 
high- or moderate-risk practices (e.g., washing), which are necessary 
to move product from the field, will affect exemptions. These comments 
recommend that future risk assessments examine the impact of these 
practices by commodity and volume of intact fruits and vegetables 
marketed through small and very small farm mixed-type facilities. Other 
comments ask us to re-examine our data sources in assessing commodity-
specific risks, and assert that it is likely that many will be found to 
be low risk. Other comments suggest that the Centers for Disease 
Control and Prevention (CDC) expand its data analysis effort (Ref. 20) 
to separate out commodities to assess attribution of foodborne 
illnesses for additional commodities.
    (Response 57) Because of changes we made to the farm definition, 
practices such as washing that are necessary to move product from the 
field are within the farm definition and are not addressed in the 
section 103(c)(1)(C) RA. We disagree that we should re-examine our data 
sources in assessing commodity-specific risks. As we discussed in the 
section 103(c)(1)(C) draft RA, we focused on considering the risk of 
activity/food combinations rather than separately considering the risk 
of specific food categories because doing so would better enable us to 
focus on whether a specific manufacturing, processing, packing, or 
holding activity conducted on food by a farm mixed-type facility 
warranted an exemption from, or modified requirements for, the 
provisions of section 418 of the FD&C Act. The comments did not 
identify additional data sources to use in assessing commodity-specific 
risks. However, we did revise the section 103(c)(1)(C) draft RA by 
taking into consideration: (1) Comments submitted to Docket FDA-2012-N-
1258 on the section 103(c)(1)(C) Draft RA; (2) comments submitted to 
Docket FDA-2011-N-0920 on the proposed rule relevant to activities 
conducted on foods on farms; and (3) a revised Food Processing Sector 
Study on domestic establishments co-located on farms (Ref. 21). This 
led us to include additional activity/food combinations in our 
evaluation, and many were found to be low risk. With respect to CDC 
expanding its data analysis effort, the CDC publication cited by the 
comments (Ref. 20) is the most up-to-date publication available, and 
more finely grained data for additional commodities are not currently 
available.
    (Comment 58) Some comments assert that we should revise the section 
103(c)(1)(C) draft RA and then make it available for additional public 
comment before finalizing the rule.
    (Response 58) As we previously noted (78 FR 3824 at 3826, January 
16, 2013), we subjected the section 103(c)(1)(C) draft RA to peer 
review in accordance with the requirements of the Final Information 
Quality Bulletin for Peer Review (issued by the Office of Management 
and Budget to implement the Information Quality Act (Pub. L. 106-554)) 
before we made it available for broader public comment during a

[[Page 55938]]

time period that exceeded 10 months. The additional iterative process 
recommended by these comments is not necessary and would go beyond the 
processes we routinely apply for public input on a risk assessment.

C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-
Type Facilities Under Section 421 of the FD&C Act

1. Request for Comment on Data Submission Requirements
    We requested comment on whether we should establish data submission 
requirements that would allow us to identify types of facilities in 
order to exempt them from the inspection frequencies, or modify the 
inspection frequencies that apply to them, under section 421 of the 
FD&C Act. We provided examples of such data elements, including 
identification of a facility as a farm mixed-type facility, annual 
monetary value of sales, number of employees, and food category/
activity type. We also requested comment on any other criteria that may 
be appropriate for the purposes of allocating inspection resources to 
these facilities.
    Comments did not support these data submission requirements. We are 
not establishing any data submission requirements that would allow us 
to identify types of facilities in order to exempt them from the 
inspection frequencies, or modify the inspection frequencies that apply 
to them, under section 421 of the FD&C Act.
2. Request for Comment on an Exemption From the Requirements of Section 
421 of the FD&C Act
    We received no comments that disagreed with our tentative 
conclusion that we should not exempt or modify the inspection frequency 
requirements under section 421 based solely upon whether a facility 
only engages in low-risk activity/food combinations and is a small or 
very small business. We are not establishing any exemption from, or 
modification to, the inspection frequency requirements under section 
421 for facilities that only engage in low-risk activity/food 
combinations and are a small or very small business.

VII. Comments on Proposed General Revisions to Current Part 110 (Final 
Part 117)

    We proposed some general revisions to the CGMP requirements in part 
110, including revising the title; redesignating the provisions in part 
117; revising some terms for consistency within the rule; referring to 
the ``owner, operator, or agent in charge'' rather than to ``plant 
management'' or ``operator''; revising provisions directed to 
preventing contamination of food and food-contact substances so that 
they also are consistently directed to preventing contamination of 
food-packaging materials; revising several provisions to explicitly 
address allergen cross-contact, as well as contamination; referring to 
``raw materials and ingredients'' rather than ``raw materials and other 
ingredients''; deleting some non-binding provisions; and making some 
editorial revisions (78 FR 3646 at 3692 to 3693).
    Some comments support one or more of these proposed general 
revisions without change. For example, some comments agree that there 
is no meaningful distinction between ``manufacturing/processing,'' 
``packing,'' and ``holding'' as defined in the proposed revisions to 
Sec. Sec.  1.227 and 1.328 and those terms as they have been used in 
the long-standing CGMP requirements. These comments also agree that 
consistent use of these terms throughout proposed part 117, in 
reference to activities taking place in food facilities, 
establishments, or plants, would make the regulations more clear and 
have no substantive effect on the current requirements. Other comments 
support the proposed replacement of the term ``facility'' or 
``facilities'' in the CGMP requirements with the term ``establishment'' 
or ``plant'' whenever the term ``facility'' or ``facilities'' could be 
confused with the firms that are subject to the proposed requirements 
for hazard analysis and risk-based preventive controls. Other comments 
agree that it is appropriate to replace the word ``shall'' with the 
term ``must.'' Some comments that support the proposed provisions 
suggest alternative or additional regulatory text (see, e.g., Comment 
59, Comment 63, and Comment 65).
    We received no comments that disagreed with our proposed 
redesignations and are finalizing them as proposed. In the following 
sections, we discuss comments that ask us to clarify the proposed 
requirements or that disagree with, or suggest one or more changes to, 
the proposed requirements. After considering these comments, we have 
revised the proposed provisions as shown in table 6.

     Table 6--Outcome of the Proposed General Revisions to Part 110
------------------------------------------------------------------------
         Proposed revision                         Outcome
------------------------------------------------------------------------
Establish the title of part 117...  We have revised the title to read
                                     ``Current Good Manufacturing
                                     Practice, Hazard Analysis, and Risk-
                                     Based Preventive Controls for Human
                                     Food.''
Consistency of terms: Activities    We are establishing in part 117 the
 subject to part 117.                same definitions for the terms
                                     ``manufacturing/processing,''
                                     ``packing,'' and '' holding'' as we
                                     are establishing in the section 415
                                     registration regulations and the
                                     section 414 recordkeeping
                                     regulations.
Consistency of terms: Facility....  We have made the following changes
                                     to the proposed rule:
                                    1. We have revised the definition of
                                     ``plant'' to focus it on the
                                     building, structure, or parts
                                     thereof, used for or in connection
                                     with the manufacturing, processing,
                                     packing, or holding of human food.
                                    2. We have revised applicable
                                     provisions to use ``establishment''
                                     rather than ``plant'' when focusing
                                     on a business entity rather than on
                                     buildings or other structures.
                                    3. We have made conforming changes
                                     throughout the rule.
Consistency of terms: Owner,        We are: (1) Defining the term
 operator, or agent in charge.       ``you'' to mean, for purposes of
                                     part 117, the owner, operator, or
                                     agent in charge of a facility and
                                     (2) limiting use of the term
                                     ``you'' to provisions directed to
                                     ``facilities'' (i.e., provisions in
                                     subparts C, D, E, and G).
Consistency of terms: Food-         We received no comments that
 packaging materials.                disagreed with our proposal that
                                     provisions of current part 110
                                     directed to preventing
                                     contamination of food and food-
                                     contact substances consistently be
                                     directed to preventing
                                     contamination of food-packaging
                                     materials as well and are
                                     finalizing the applicable
                                     provisions as proposed.
Additions regarding allergen cross- The CGMPs that we are establishing
 contact.                            in subpart B explicitly address
                                     allergen cross-contact.

[[Page 55939]]

 
Revisions for consistency with the  We have retained the current phrase
 definition of ``food''.             ``raw materials and other
                                     ingredients'' (rather than the
                                     proposed phrase ``raw materials and
                                     ingredients'') throughout the rule
                                     to make it clear that raw materials
                                     are ingredients.
Revisions to delete some non-       We are deleting those nonbinding
 binding provisions.                 provisions of current part 110 that
                                     we proposed to delete. (For a list
                                     of these deleted provisions, see
                                     table 8 in the 2013 proposed human
                                     preventive controls rule, 78 FR
                                     3646 at 3714).
Revisions to re-establish some non- With one exception, we are, as
 binding provisions of part 110 as   proposed, re-establishing certain
 binding provisions in part 117.     non-binding provisions of part 110
                                     in part 117 as binding provisions.
                                     See table 11 in the 2013 proposed
                                     human preventive controls rule (78
                                     FR 3646 at 3728). The exception is
                                     one provision of Sec.
                                     110.80(b)(1) regarding inspecting
                                     containers of raw materials on
                                     receipt, which we are deleting
                                     rather than re-establishing it as a
                                     requirement.
Editorial changes.................  We are finalizing the proposed
                                     editorial changes regarding
                                     ``Federal Food, Drug, and Cosmetic
                                     Act,'' ``includes, but is not
                                     limited to,'' ``must,''
                                     ``adulteration,'' and ``when'' as
                                     proposed, except that we are
                                     retaining the term ``such as'' in
                                     place of the proposed term
                                     ``including'' in two provisions.
------------------------------------------------------------------------

A. Title of Part 117

    We proposed to re-establish the provisions of current part 110 in 
new part 117 and to establish the title of part 117 as ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' (78 FR 3646 at 3691). (Note that in the 2013 
proposed human preventive controls rule, we described this as revising 
the title of ``current subpart B.'' We should have described this as 
revising the title of current part 110.)
    (Comment 59) Some comments ask us to revise the title to read 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food.''
    (Response 59) We have revised the title of the rule as requested.

B. Proposed Revisions for Consistency of Terms

1. Activities Subject to Proposed Part 117
    We noted that we had previously described activities that may be 
considered ``manufacturing, processing, packing, or holding'' by 
establishing definitions for these terms in the section 415 
registration regulations and the section 414 recordkeeping regulations 
(78 FR 3646 at 3692). We proposed to revise these existing definitions 
(see sections IV.D, IV.E, and IV.G) and to incorporate the revised 
definitions in part 117. We tentatively concluded that there is no 
meaningful distinction between these terms as we would define them in 
the revised definitions and these terms as they had been used in the 
CGMPs. We also tentatively concluded that consistent use of these terms 
throughout part 117, in reference to activities taking place in food 
facilities, establishments, or plants, would make the regulations more 
clear and have no substantive effect on the current requirements (78 FR 
3646 at 3692). In the 2014 preventive controls supplemental notice, we 
proposed revisions to the definitions of ``holding'' and ``packing'' 
after considering comments submitted to the 2013 proposed human 
preventive controls rule.
    (Comment 60) Some comments ask us to clarify how we were 
``revising'' the definitions of the terms manufacturing, processing, 
packing, and holding because these terms had not been defined in the 
CGMPs in part 110.
    (Response 60) The comments are correct that these terms had not 
been defined in the CGMPs in part 110. We proposed to ``revise'' these 
definitions in the section 415 registration regulations and the section 
414 recordkeeping regulations and then establish in part 117 those 
revised definitions.
    (Comment 61) Some comments from the produce industry state that it 
is difficult to assess whether there is a meaningful distinction 
between ``packing'' and ``holding'' as would be defined in the proposed 
human preventive controls rule and as had been used in the CGMPs in 
part 110 because most harvesting and post-harvest handling activities 
of RACs had been excluded from the CGMP requirements under Sec.  
110.19.
    (Response 61) We assume that these comments are concerned about 
distinguishing ``packing'' from ``holding'' because some exemptions 
(e.g., the exemption in Sec.  117.5(k) from the CGMP requirements for 
holding RACs and the exemption in Sec.  117.5(j) from the requirements 
for hazard analysis and risk-based preventive controls) apply to 
``holding'' RACs. As previously discussed, we have previously 
classified several on-farm activities in more than one way (79 FR 58524 
at 58538 and 58571) depending on when the activity occurs. For example, 
sorting, culling, and grading RACs can occur during both packing and 
holding activities. However, we disagree that the full regulatory text 
of the definitions for ``packing'' and ``holding'' are not adequate to 
provide a meaningful distinction between the two terms. ``Packing'' 
means, in part, ``placing food into a container'' whereas holding 
means, in part ``storage of food.'' ``Placing food into a container'' 
is in no way similar to ``storage of food.''
    (Comment 62) Some comments disagree with our tentative conclusion 
that there is no meaningful distinction between ``manufacturing/
processing,'' ``packing,'' and ``holding'' as we would define them in 
the revised definitions and these terms as they had been used in the 
CGMPs. These comments ask us to define these terms differently in the 
human preventive controls rule. These comments state that although they 
do not object to the consistent use of these terms throughout part 117 
in reference to activities taking place in food facilities, 
establishments, or plants, they believe there are significant 
distinctions in these terms that need to be considered when finalizing 
the requirements of part 117.
    (Response 62) These comments provide neither specific suggestions 
for how we should define these terms for the purpose of the human 
preventive controls rule nor specific reasons for their assertion that 
there are significant distinctions in these terms that need to be 
considered when finalizing the requirements of part 117. Without more 
specific information, we assume that the changes we have made to the 
definitions of ``farm,'' ``holding,'' and ``packing'' adequately 
address these comments.
2. The Term ``Facility''
    We proposed to replace the term ``facility'' or ``facilities'' in 
current part 110 with the term ``establishment'' or ``plant'' in 
proposed part 117 whenever the term ``facility'' or ``facilities'' 
could be confused with the firms that are subject to the proposed 
requirements for hazard analysis and risk-based

[[Page 55940]]

preventive controls required by section 418 of the FD&C Act (78 FR 3646 
at 3692). However, we tentatively concluded that it would not be 
necessary to replace the use of the term ``facilities'' in current 
requirements directed to specific functional parts of a plant or 
establishment, such as ``toilet facilities'' and ``hand-washing 
facilities,'' because the use of the term ``facilities'' in these 
contexts would not create confusion.
    (Comment 63) Some comments state that it would not be helpful to 
use ``plant'' interchangeably with ``establishment'' when referring to 
a business that is not required to register. These comments ask us to 
consistently use one of these terms and to define a term that would 
mean ``a business that is not required to register'' to help 
distinguish such businesses from ``facilities.''
    (Response 63) We agree that it is appropriate to consistently use 
one term when referring to a business entity. However, we disagree that 
it is necessary to establish a definition for a business entity that is 
not required to register. A business that meets the definition of 
``facility'' is required to register; a business that is not required 
to register is simply a business that does not meet the definition of 
``facility.''
    To address these comments, we have revised provisions of the rule 
in three ways. First, we have revised the definition of ``plant'' to 
focus it on the building, structure, or parts thereof, used for or in 
connection with the manufacturing, processing, packing, or holding of 
human food, rather than on the ``building or establishment.'' Second, 
we have revised applicable provisions of part 117 to use 
``establishment'' rather than ``plant'' when focusing on a business 
entity rather than on buildings or other structures. Third, we have 
revised provisions that use the terms ``plant,'' ``establishment,'' or 
both to conform to the definition of ``plant'' and the described usage 
of ``establishment.'' For example, Sec.  117.10 establishes 
requirements for ``the management of the establishment'' rather than 
``plant management,'' because ``establishment'' is the term focusing on 
the business entity. As another example, Sec.  117.20(a)(1) establishes 
requirements for properly storing equipment, removing litter and waste, 
and cutting weeds or grass within the immediate vicinity of the 
``plant'' rather than within the immediate vicinity of the ``plant 
buildings or structures,'' because the defined term ``plant'' focuses 
on the buildings and structures, and it is not necessary to repeat 
``buildings and structures'' when the term ``plant'' is used.
3. Owner, Operator, or Agent in Charge
    In the 2013 proposed human preventive controls rule, we requested 
comment on whether there is any meaningful difference between the 
persons identified in current part 110 and the ``owner, operator, or 
agent in charge'' identified in section 418 of the FD&C Act. We also 
requested comment on whether it would be appropriate to refer to the 
``owner, operator, or agent in charge'' of a plant, establishment, or 
facility throughout proposed part 117 and, if so, whether the 
requirements would be clear if we revised the proposed rule to use 
pronouns (such as ``you'' and ``your'') within proposed part 117 (78 FR 
3646 at 3693). In the 2014 supplemental human preventive controls 
notice, we described comments on these issues and we tentatively 
concluded that we could simplify the regulations directed to the 
``owner, operator, or agent in charge of a facility'' in provisions in 
subparts C, D, and E by using pronouns, without creating confusion, if 
we (1) define the term ``you'' to mean, for purposes of part 117, the 
owner, operator, or agent in charge of a facility and (2) limit use of 
the term ``you'' to provisions in proposed subparts C, D, and E (79 FR 
58524 at 58556).
    We received no comments that disagreed with the proposed definition 
of ``you'' and are finalizing that proposed definition without change.
4. Food-Packaging Materials
    We proposed that provisions of current part 110 directed to 
preventing contamination of food and food-contact surfaces consistently 
be directed to preventing contamination of food-packaging materials as 
well (78 FR 3646 at 3693). We received no comments that disagreed with 
this proposal and are finalizing provisions directed to preventing 
contamination of food-packaging materials as proposed. For additional 
discussion regarding the term ``food-packaging materials,'' see Comment 
107.

C. Proposed Additions Regarding Allergen Cross-Contact

    We proposed to revise several CGMP provisions to explicitly address 
cross-contact (see 78 FR 3646 at 3693 and table 10 of the 2013 proposed 
human preventive controls rule, 78 FR 3646 at 3718-3719). In the 2014 
supplemental human preventive controls notice, we proposed to define 
and use the term ``allergen cross-contact'' rather than ``cross-
contact,'' and we are finalizing the definition of the term ``allergen 
cross-contact'' in this rule (see Sec.  117.3). As discussed in 
sections XIII-XXII, the CGMPs that we are establishing in subpart B 
explicitly address allergen cross-contact, with some revisions 
requested by comments.
    (Comment 64) Some comments ask us to clarify that allergen cross-
contact has a meaning that is distinct from ``contamination.''
    (Response 64) We previously noted that, in the past, inadvertent 
incorporation of an allergen into a food was referred to as 
``contamination'' or ``cross-contamination,'' but that more recently 
the term ``cross-contact'' (rather than ``contamination'' or ``cross-
contamination'') has been applied with respect to unintentional 
transfer of allergenic proteins from a food containing the proteins to 
one that does not, because an allergen is a normal component of food, 
and not itself a contaminant (78 FR 3646 at 3693). Given this shift in 
the scientific literature distinguishing ``cross-contact'' from 
``contamination'' and ``cross-contamination,'' we tentatively concluded 
that we should begin using the term ``cross-contact'' (now ``allergen 
cross-contact'') to describe inadvertent incorporation of an allergen 
into food, rather than the general term ``contamination,'' for purposes 
of clarity. In this final rule, we affirm that tentative conclusion.
    To further improve clarity, we reviewed the provisions of the rule 
directed to preventing both allergen cross-contact and preventing 
contamination and made editorial changes throughout. For example, Sec.  
117.10(b)(1) requires that hygienic practices must include wearing 
outer garments suitable to the operation in a manner that protects 
against allergen cross-contact and against the contamination of food, 
food-contact surfaces, or food-packaging materials. For additional 
provisions that include these editorial changes, see table 52.

D. Proposed Revisions for Consistency With the Definition of ``Food''

    We proposed to retain the definition for ``food'' as already 
defined in Sec.  110.3 (78 FR 3646 at 3693). Food means food as defined 
in section 201(f) of the FD&C Act and includes raw materials and 
ingredients. For consistency with the definition of food (which refers 
to ``raw materials and ingredients'' rather than ``raw materials and 
other ingredients''), we proposed to change the title of current Sec.  
110.80(a) (which would be proposed Sec.  117.80(b)) to ``Raw materials 
and ingredients'' rather than ``Raw materials and other ingredients.'' 
As a

[[Page 55941]]

companion change to this change in title, we proposed to substitute 
``ingredients'' for ``other ingredients'' throughout provisions in 
current Sec.  110.80 that refer to both raw materials and ingredients 
(78 FR 3646 at 3693-3694).
    (Comment 65) Some comments ask us to add a definition for ``raw 
materials.''
    (Response 65) We decline this request. During a previous rulemaking 
to revise the umbrella CGMPs, we explained that it is not possible to 
categorically distinguish raw materials and other ingredients because 
raw materials are ingredients, and both raw materials and ingredients 
are food within the meaning of the FD&C Act (51 FR 22458 at 22461, June 
19, 1986). We have broadly defined ``food'' in this rule to include 
both raw materials and ingredients.
    However, we have decided to retain the current phrase ``raw 
materials and other ingredients'' (rather than the proposed phrase 
``raw materials and ingredients'') throughout the rule to make it clear 
that raw materials are ingredients. See the regulatory text of 
Sec. Sec.  117.80(b), 117.80(c)(6), (7), and (9); and 
117.130(c)(2)(iii).
    (Comment 66) Some comments ask us to revise the current definition 
of food (see Comment 87, Comment 88, and Comment 89).
    (Response 66) See Response 87, Response 88, and Response 89 for our 
reasons for declining to revise the definition of ``food'' in this 
rule.

E. Proposed Revisions To Address Guidance in Current part 110

    We proposed to delete some non-binding provisions of current part 
110 (e.g., provisions using ``should'' or ``compliance may be achieved 
by'') (78 FR 3646 at 3694 and 3714-3717). We also requested comment on 
whether to revise other non-binding provisions to establish new 
requirements in proposed part 117 or to simply retain them as useful 
provisions of a comprehensive CGMP (78 FR 3646 at 3694 and 3728-3729).
    (Comment 67) Some comments ask us to retain the provisions we 
proposed to delete--e.g., because the information helps to clarify the 
intended effect of the regulations, suggests means of compliance with 
the requirements, and can educate small, new, or foreign companies. 
These comments assert that the benefits to both the regulated industry 
and to the general public of retaining the information we proposed to 
delete far outweigh any stylistic or other concerns. Likewise, some 
comments ask us to retain any non-binding provisions that we proposed 
to re-establish as requirements if, after considering comments, we do 
not finalize these provisions as requirements.
    (Response 67) We agree that the non-binding provisions we proposed 
to delete, or considered re-establishing as requirements, provide 
useful information for reasons such as those mentioned in the comments. 
However, these provisions are more appropriately included in guidance, 
and we are deleting those non-binding provisions of part 110 that we 
are not establishing as requirements. We intend to transfer some of the 
CGMP recommendations that are currently in part 110, but that will be 
deleted from part 117, to guidance with editorial changes and changes 
that reflect current technology and industry practices. For a list of 
non-binding provisions that we are deleting, see table 7 in this 
document and table 8 in the 2013 proposed human preventive controls 
rule (78 FR 3646 at 3714-3717). See Response 321 for a discussion of 
our reasons for deleting the recommendation listed in table 7 in this 
document.

 Table 7--Nonbinding Provisions That We Are Deleting in Addition to the
   Non-Binding Provisions Listed in Table 8 in the 2013 Proposed Human
                        Preventive Controls Rule
------------------------------------------------------------------------
      Designation in part 110                    Description
------------------------------------------------------------------------
Sec.   110.80(a)(1) (Processes and  Containers and carriers of raw
 controls--raw materials and         materials should be inspected on
 ingredients--final sentence).       receipt to ensure that their
                                     condition has not contributed to
                                     the contamination or deterioration
                                     of food.
------------------------------------------------------------------------

F. Proposed Editorial Changes

    We proposed to revise current part 110 to make five editorial 
changes: (1) Refer to the ``Federal Food, Drug, and Cosmetic Act'' 
rather than to ``the act''; (2) replace the term ``shall'' with the 
term ``must''; (3) replace the phrase ``includes, but is not limited 
to'' with ``includes''; (4) replace the phrase ``adulteration within 
the meaning of the act'' with the single term ``adulteration''; and (5) 
replace the term ``whenever'' with ``when.''
    We received no comments that disagreed with our proposed editorial 
changes regarding ``Federal Food, Drug, and Cosmetic Act,'' ``must,'' 
``adulteration,'' and ``when'' and are finalizing these editorial 
changes as proposed.
    (Comment 68) Some comments ask us to either retain ``includes, but 
is not limited to'' wherever the list which follows is not intended to 
be exhaustive, or replace ``includes, but is not limited to'' with 
``such as,'' to make clear that a following list is not complete.
    (Response 68) The word ``include'' means to have (someone or 
something) as part of a group or total; to contain (someone or 
something) in a group or as a part of something (Ref. 22). The word 
``includes'' does not need to be followed by ``but is not limited to'' 
to clearly communicate that a following list is not complete.
    We proposed that two provisions (proposed Sec.  117.80(c)(14) and 
(15)) replace the term ``such as'' with the term ``including'' (or 
variations of ``including''). In light of the comment's view that 
``such as'' would be clearer, we have retained the term ``such as'' in 
those provisions. We decline the request to more broadly revise the 
rule to replace ``includes'' with ``such as.'' In many cases the term 
``such as'' cannot replace ``includes'' when used as a verb. We note 
that several provisions of the rule do use ``such as'' when that term 
is grammatically appropriate, such as in parenthetical phrases (see, 
e.g., the definitions of ``holding'' and ``packing'' in Sec.  117.3).

G. General Comments on Current Part 110 (Final Part 117)

    We proposed specific revisions and deletions to our long-standing 
umbrella CGMP requirements to modernize them. We also proposed to 
redesignate some of these CGMP requirements. For example, we proposed 
to redesignate the provisions found in six sentences that precede 
current Sec.  110.80(a) by creating paragraph designations (a)(1) 
through (6) in new Sec.  117.80. As corresponding changes, we proposed 
to redesignate current Sec.  110.80(a) as Sec.  117.80(b) and to 
redesignate current Sec.  110.80(b) as Sec.  117.80(c).
    Several comments suggest specific modifications to the umbrella 
CGMPs beyond what we proposed to revise. In

[[Page 55942]]

this section and in sections XIII through XXII, we address these 
specific suggestions and have amended the regulatory text where 
warranted.
    (Comment 69) Some comments ask us to reorganize some of the current 
provisions to reduce redundancy, such as by combining provisions that 
address similar topics or deleting some provisions that the comments 
view as unnecessary in light of other provisions. For example, one 
comment suggests we move Sec.  117.80(b)(5) (storage of raw materials, 
other ingredients, and rework) to Sec.  117.80(a)(1) (general 
requirements) and another comment suggests we delete requirements in 
Sec.  117.80(b)(1) for storing raw materials and ingredients because 
they are redundant with the storage requirements in Sec.  117.80(b)(7).
    (Response 69) We decline these requests. We acknowledge that there 
is some redundancy in subpart B and that we could improve the logical 
structure of subpart B by moving some of the requirements as 
recommended by some comments. However, these provisions have been in 
effect for decades, either since 1969 (when the umbrella CGMPs were 
first established (34 FR 6977, April 26, 1969) or since 1986 (when we 
last revised the umbrella CGMPs (51 FR 22458, June 19, 1986), and the 
comments do not provide examples of how we have been interpreting these 
provisions in a way that does not accomplish the goal of the umbrella 
CGMPs. Furthermore, we disagree with some of the comments on whether 
some provisions are redundant. For example, we disagree that Sec.  
117.80(b)(1) is redundant with Sec.  117.80(b)(7) because Sec.  
117.80(b)(7) is narrowly directed to raw materials and other 
ingredients received in bulk and Sec.  117.80(b)(1) is more generally 
directed to all raw materials and other ingredients.
    Rather than reorganize and combine requirements, or delete 
requirements that some comments view as redundant with other 
requirements, we have focused on comments requesting specific changes 
to the current requirements to reflect current practices in the 
manufacturing, processing, packing, and holding of human food and to 
make these current requirements clearer (see sections XIII through 
XXII). Doing so is consistent with the goals of modernizing the 
umbrella CGMP requirements. However, we have declined many of these 
requests to make specific changes to particular CGMP provisions. In 
general, in evaluating the requested specific changes, we considered 
whether the comments described a problem with the current regulatory 
text, or instead focused on hypothetical problems that could occur in 
the future. Because most of these comments do not explain how the long-
standing regulatory text has created a problem, we have declined many 
of these requests.
    Likewise, in this document, we describe several editorial revisions 
that we made to improve the clarity of the CGMP requirements. However, 
we do not discuss comments that suggest editorial changes that simply 
suggest using different words in the regulatory text, but without 
explaining why the editorial revisions would improve the clarity of the 
provisions. These long-standing CGMPs have been in place and 
interpreted for decades, and we see no reason to revise them without a 
reason to do so.
    (Comment 70) Some comments ask us to specify that several of the 
CGMP requirements in subpart B only apply ``where the potential for 
contamination exists.'' (See table 8.) Other comments ask us to change 
some requirements to recommendations or to specify that they only apply 
``as appropriate.'' (See table 8.)

  Table 8--CGMP Requirements That Comments Ask Us To Apply ``Where the
       Potential for Contamination Exists'' or Ask Us To Change to
                             Recommendations
------------------------------------------------------------------------
   Examples of CGMP requirements that     Examples of CGMP requirements
  comments ask us to apply ``where the    that comments ask us to change
  potential for contamination exists''          to recommendations
------------------------------------------------------------------------
Sec.   117.20(a)--Management             Sec.   117.35(a)--General
 responsibility for maintaining grounds.  maintenance.
Sec.   117.20(b)--Suitability of plant   Sec.   117.35(b)(1)--Cleaning
 construction and design.                 Compounds and Sanitizing
                                          Agents.
Sec.   117.35(a)--General maintenance..  Sec.   117.35(b)(2)--
                                          Identification and Storage of
                                          Toxic Materials.
Sec.   117.35(c)--Pest control.........  Sec.   117.35(c)--Pest control.
Sec.   117.37--Sanitary facilities and   Sec.   117.35(d)--Sanitation of
 controls.                                food-contact surfaces.
Sec.   117.40(a)(1)--Design of plant     Sec.   117.40(a)(6)--
 equipment and utensils.                  Maintenance of food-contact
                                          surfaces.
Sec.   117.40(a)(3)--Installation and    Sec.   117.40(b)--Seams on food-
 maintenance of equipment.                contact surfaces.
Sec.   117.40(b)--Seams on food-contact  Sec.   117.40(c)--Construction
 surfaces.                                of equipment.
Sec.   117.40(c)--Construction of        Sec.   117.40(e)--Freezer and
 equipment.                               cold storage compartments.
Sec.   117.40(d)--Holding, conveying,
 and manufacturing systems.
Sec.   117.80(a)(1)--Adequate
 sanitation principles.
Sec.   117.80(a)(3)--Supervision of
 overall sanitation.
------------------------------------------------------------------------

    (Response 70) We decline these requests. These long-standing 
provisions apply generally to the plant, equipment and utensils in the 
plant, sanitary operations and sanitary facilities in a plant, and 
operations conducted in a plant. To suggest otherwise is inconsistent 
with the precepts of good manufacturing practices.
    For example, as required by Sec.  117.20(a), an establishment must 
have control of its grounds regardless of the specific food being 
produced, because litter, waste, weeds, and grass can all attract and 
harbor pests, and the first step for pest control in the plant is to 
avoid attracting pests. As required by Sec.  117.20(b), a plant 
requires suitable construction and design regardless of the specific 
potential for contamination at any particular location in the plant. 
Each of the seven more specific provisions governed by Sec.  117.20(b) 
adds the context that the requirements are directed to what is 
``adequate'' (e.g., adequate space, adequate precautions, and adequate 
cleaning), and the defined term ``adequate'' provides context that the 
purpose of the requirements for plant construction and design are 
related to public health. As required by Sec.  117.40, a plant requires 
clean and sanitary equipment regardless of the specific potential for 
contamination associated with a particular piece of equipment or the 
type of food being produced, because dirty equipment at one location in 
a plant can attract pests or become a harborage for environmental 
pathogens that can eventually lead to contamination in multiple 
locations in the plant. As required by Sec.  117.80(a)(10), a food 
plant requires adequate sanitation regardless of the specific potential 
for contamination, and the term ``adequate'' provides flexibility for 
how an

[[Page 55943]]

establishment designs and implements its sanitation program when the 
potential for contamination is low. As required by Sec.  117.80(a)(3), 
a plant requires adequate sanitation regardless of the specific 
potential for contamination, and someone must be in charge of 
sanitation to determine what needs to be done, where it needs to be 
done, and how often it needs to be done. The individual(s) who 
supervises the sanitation of the plant has flexibility in the design 
and implementation of a sanitation program when the potential for 
contamination is low.
    In addition, the CGMP requirements are flexible requirements that 
each establishment can adapt to its own operations, equipment, and food 
products. For example, Sec.  117.35(a) requires that buildings, 
fixtures, and other physical facilities of the plant must be maintained 
in a clean and sanitary condition and must be kept in repair adequate 
to prevent food from becoming adulterated. Cleaning and sanitizing of 
utensils and equipment must be conducted in a manner that protects 
against allergen cross-contact and against contamination of food, food-
contact surfaces, or food-packaging materials. The standards 
established by the requirement are to protect against contamination and 
allergen cross-contact, and the defined term ``adequate'' provides the 
context that the specific measures adopted by an establishment are 
related to public health.
    (Comment 71) Some comments ask us to change the phrase ``work-in-
process'' to ``in-process materials'' in several provisions throughout 
proposed subpart B because they believe ``in-process materials'' to be 
more familiar, straightforward, and commonly understood than ``work-in-
process.''
    (Response 71) ``Work-in-process'' is the common industry term used 
in widely disseminated industry publications (Ref. 23) (Ref. 24) and 
has been in use for more than 30 years in the umbrella CGMPs. In 
addition, we did not receive any comments objecting to the use of this 
term when we proposed to include it in previous revisions to the 
umbrella CGMPs (proposed rule 44 FR 33238 at 33247, June 8, 1979; final 
rule, 51 FR 22458, June 19, 1986). Therefore, we have retained the 
phrase ``work-in-process'' in the final rule.

VIII. Subpart A: Comments on Proposed Sec.  117.1--Applicability and 
Status

    We proposed to redesignate Sec.  110.5 as proposed Sec.  117.1, and 
to add a provision relevant to FSMA's statutory provisions for a 
prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 
331(uu)). Some comments support the proposed provisions without change. 
For example, one comment expresses the view that one strength of the 
long-standing CGMPs is their applicability to the broad spectrum of 
food manufacturing, from the manufacture of processed products and 
packaging of fresh produce to production of food additives and GRAS 
substances. (We note that some packaging of fresh produce (e.g., 
packaging of RACs on a farm) is not subject to the CGMPs.)
    Some comments that support the proposed provisions ask us to 
clarify how we will interpret the provisions (see, e.g., Comment 72).
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we are finalizing the provisions as proposed, with editorial 
and conforming changes as shown in table 52.

A. Comments on Proposed Sec.  117.1(a)--Applicability

    We proposed that the criteria and definitions in part 117 apply in 
determining whether a food is adulterated: (1) Within the meaning of 
section 402(a)(3) of the FD&C Act in that the food has been 
manufactured under such conditions that it is unfit for food; or (2) 
within the meaning of section 402(a)(4) of the FD&C Act in that the 
food has been prepared, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health. We also proposed that the 
criteria and definitions in part 117 also apply in determining whether 
a food is in violation of section 361 of the Public Health Service Act 
(42 U.S.C. 264).
    (Comment 72) Some comments ask us to clarify that part 117 does not 
apply to activities that are subject to the requirements for CGMPs, 
hazard analysis and risk-based preventive controls for animal food and 
feed by inserting ``intended for consumption by humans'' after ``food'' 
in Sec.  117.1(a).
    (Response 72) We decline this request. As discussed in Response 6, 
the applicability of these regulations to human food is specified in 
the regulatory text by the title of the rule and by its placement in 
Subchapter B, rather than Subchapter E, of 21 CFR.
    (Comment 73) Some comments assert that there is a clear difference 
between the criteria in proposed Sec.  117.1(a)(1) used to describe 
adulterated food and the referenced criteria in section 402(a)(3) of 
the FD&C Act, in that proposed Sec.  117.1(a)(1) describes 
manufacturing conditions whereas section 402(a)(3) of the FD&C Act 
describes actual adulterated product.
    (Response 73) We disagree with these comments. We interpret 
``otherwise unfit for food'' in this long-standing statement of 
applicability to be broader than physical properties of the food and to 
apply to the manufacturing conditions of the food.
    (Comment 74) Some comments note that FSMA granted FDA mandatory 
recall authority for adulterated food. These comments express concern 
that theoretically we could use a violation of the requirements for 
hazard analysis and risk-based preventive controls to determine that 
food is adulterated, thereby providing the basis for a mandatory recall 
of that food. These comments raise three issues regarding how we will 
apply Sec.  117.1(a), with consequences for a potential mandatory 
recall of food.
    First, these comments note that the regulatory text stating that 
the ``criteria and definitions'' apply in making a determination of 
adulteration appears to encompass the entirety of the rule. As a 
result, farms or facilities that violate any of the requirements in the 
proposed rule, including components not directly related to the safety 
of the food (such as recordkeeping requirements), could face a risk 
that we would deem their food adulterated.
    Second, these comments assert that the regulatory text suggests 
that we would not automatically consider a food adulterated as a result 
of a violation of the proposed rule, because it states that the 
criteria and definitions ``apply in determining'' whether a food will 
be considered adulterated, rather than that the food ``is'' 
adulterated.
    Third, these comments state that it is not clear how the exemption 
applicable to qualified facilities is included in the ``criteria and 
definitions'' used in making a determination of adulteration. These 
comments ask us to clarify that we will not just automatically assume 
that qualified facilities are selling adulterated food because they are 
by definition exempt from the requirements for hazard analysis and 
risk-based preventive controls.
    (Response 74) The comments are correct that the criteria and 
definitions ``apply in determining'' whether a food will be considered 
adulterated, rather than that the food ``is'' adulterated. In 
determining whether a food that is manufactured, processed, packed, or 
held in violation of part 117 (including a violation of the 
recordkeeping

[[Page 55944]]

requirement) is adulterated, we would consider the totality of the 
available data and information about the violation and the food before 
reaching a conclusion that the food is adulterated.
    Although this rule does not address the mandatory recall provisions 
of FSMA, the statutory provisions establish two basic criteria. (See 
section 423(a) of the FD&C Act (21 U.S.C. 350l).) First, we must 
determine that there is a ``reasonable probability'' that the food is 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act. A violation of part 117 would be 
relevant to determining whether a food is adulterated under section 
402. Second, we must determine that there is a reasonable possibility 
that the use of, or exposure to, that food will cause serious adverse 
health consequences or death to humans or animals. Not all food that is 
adulterated has a reasonable probability of causing serious adverse 
health consequences or death to humans or animals. For examples of food 
contamination with a reasonable probability of causing serious adverse 
health consequences or death to humans or animals, see the annual 
reports of the Reportable Food Registry (RFR) (Ref. 25) (Ref. 26) (Ref. 
27) (Ref. 28).
    A facility that is exempt from any requirement of part 117, 
including the requirements for hazard analysis and risk-based 
preventive controls, would not be in violation of part 117 if it did 
not comply with provisions that it is not subject to.

B. Comments on Proposed Sec.  117.1(b)--Prohibited Act

    We proposed that the operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States is a 
prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 
331(uu)) if the owner, operator, or agent in charge of such facility is 
required to comply with, and is not in compliance with, section 418 of 
the FD&C Act or subparts C, D, E, or F of part 117 (proposed Sec.  
117.1(b)).
    (Comment 75) Some comments from State regulatory agencies note that 
this new provision is not covered under the applicable State statute 
and that making any changes to the State statute can be a lengthy 
process that takes up to 3 years to complete.
    (Response 75) See Response 5 for a discussion of our approach to 
working with our food safety partners in the States.

C. Comments on Proposed Sec.  117.1(c)--Specific CGMP Requirements

    We proposed to redesignate Sec.  110.5(b) as proposed Sec.  
117.1(c) with no changes. We received no comments that disagreed with 
our proposal, and are finalizing the proposed provision without change.

IX. Subpart A: Comments on Proposed Sec.  117.3--Definitions

    We proposed to revise some definitions that had been established in 
part 110, redesignate and re-establish the remaining definitions in 
part 117 (except for the definition of ``shall,'' which we proposed to 
delete), and establish several new definitions in part 117. Some 
comments support one or more of these proposed definitions without 
change. For example, some comments state that they support the proposed 
definitions for the following terms with no suggested revisions: 
critical control point, facility, food allergen, food-contact surfaces, 
microorganism, mixed-type facility, monitor, plant, safe-moisture 
level, subsidiary, and validation. Some comments support our proposal, 
in the 2014 supplemental preventive controls notice, to use the phrase 
``chemical (including radiological)'' in the definition of ``hazard,'' 
noting that doing so is consistent with FSMA, current industry 
practice, and Codex and global HACCP standards. Some comments that 
support a proposed definition suggest alternative or additional 
regulatory text, such as adding examples to make the definition clearer 
(see, e.g., Comment 81 and Comment 87). Some comments that support a 
proposed definition ask us to clarify how we will interpret the 
definition (see, e.g., Comment 77 and Comment 87).
    In the following sections, we discuss comments that ask us to 
clarify the proposed definitions or that disagree with, or suggest one 
or more changes to, the proposed definitions. After considering these 
comments, we have revised the proposed requirements as shown in table 
9, with editorial and conforming changes as shown in table 52. We also 
have deleted the definition of ``should,'' because the final rule does 
not use that term.
    We also discuss definitions for additional terms (i.e., ``audit,'' 
``correction,'' ``defect action level,'' ``full-time equivalent 
employee,'' ``qualified facility exemption,'' ``raw agricultural 
commodity,'' ``supply-chain-applied control,'' ``written procedures for 
receiving raw materials and other ingredients,'' and ``unexposed 
packaged food'') that we are establishing in the final rule to simplify 
the regulatory text throughout the regulations and improve clarity. We 
also discuss a new name (i.e., ``preventive controls qualified 
individual'') for the definition of a term that we had proposed to name 
``qualified individual'' and are establishing a new definition for the 
term ``qualified individual.'' Finally, we discuss definitions that 
comments ask us to add, but that we did not add, to the final rule.

                       Table 9--Definitions That We Proposed To Establish in Sec.   117.3
----------------------------------------------------------------------------------------------------------------
                                                                                                Did we make any
                                                                          Did we receive any    changes to the
                                                                             comments that         proposed
                                  Current definition  If current, did we  disagreed with the   definition other
           Definition              (Sec.   110.3) or      propose any        definition we    than the editorial
                                    new definition?       revisions?          proposed to       and conforming
                                                                            include in part    changes listed in
                                                                                 117?              Table 52?
----------------------------------------------------------------------------------------------------------------
Acid foods or acidified foods...  Current...........  No................  No................  No.
Adequate........................  Current...........  No................  Yes...............  No.
Affiliate.......................  New...............  N/A...............  Yes...............  No.
Allergen cross-contact..........  New...............  N/A...............  Yes...............  No.
Audit...........................  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Batter..........................  Current...........  No................  No................  No.
Blanching.......................  Current...........  No................  No................  No.
Calendar day....................  New...............  N/A...............  No................  No.
Correction......................  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Critical control point..........  Current...........  Yes...............  Yes...............  No.
Defect action level.............  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Environmental pathogen..........  New...............  N/A...............  Yes...............  Yes.

[[Page 55945]]

 
Facility........................  New...............  N/A...............  Yes...............  No.
Farm............................  New...............  N/A...............  See discussion of   No.\1\
                                                                           Sec.   1.227 in
                                                                           section IV.B.
FDA.............................  New...............  N/A...............  No................  No.
Food............................  Current...........  No................  Yes...............  No.
Food allergen...................  New...............  N/A...............  Yes...............  No.
Food-contact surfaces...........  Current...........  Yes...............  No................  No.
Full-time equivalent employee...  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Harvesting......................  New...............  N/A...............  See discussion of   Yes.
                                                                           Sec.   1.227 in
                                                                           section IV.C.
Hazard..........................  New...............  N/A...............  Yes...............  Yes.
Holding.........................  New...............  N/A...............  See discussion of   Yes.
                                                                           Sec.   1.227 in
                                                                           section IV.D.
Known or reasonably foreseeable   New...............  N/A...............  Yes...............  Yes.
 hazard.
Lot.............................  Current...........  No................  Yes...............  Yes.
Manufacturing/processing........  New...............  N/A...............  See discussion of   Yes.
                                                                           Sec.   1.227 in
                                                                           section IV.E.
Microorganisms..................  Current...........  Yes...............  Yes...............  No.
Mixed-type facility.............  New...............  N/A...............  See discussion of   No.
                                                                           Sec.   1.227 in
                                                                           section IV.F.
Monitor.........................  New...............  N/A...............  Yes...............  Yes.
Packaging (when used as a verb).  New...............  N/A...............  Yes...............  The final rule
                                                                                               does not include
                                                                                               a definition of
                                                                                               packaging (when
                                                                                               used as a verb).
Packing.........................  New...............  N/A...............  See discussion of   No.
                                                                           Sec.   1.227 in
                                                                           section IV.G.
Pathogen........................  New...............  N/A...............  Yes...............  No.
Pest............................  Current...........  No................  Yes...............  No.
Plant...........................  Current...........  Yes...............  Yes...............  Replace the term
                                                                                               ``establishment''
                                                                                               with
                                                                                               ``structure''.
Preventive controls.............  New...............  N/A...............  Yes...............  No.
Preventive controls qualified     New...............  N/A...............  Yes...............  No, except to
 individual.                                                                                   change the name
                                                                                               of the term from
                                                                                               ``qualified
                                                                                               individual'' to
                                                                                               ``preventive
                                                                                               controls
                                                                                               qualified
                                                                                               individual''.
Qualified auditor...............  New...............  N/A...............  Yes...............  Yes.
Qualified end-user..............  New...............  N/A...............  Yes...............  Yes.
Qualified facility..............  New...............  N/A...............  Yes...............  No.
Qualified facility exemption....  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Qualified individual............  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Quality control operation.......  Current...........  No................  No................  No.
Raw agricultural commodity......  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Ready-to-eat (RTE) food.........  New...............  N/A...............  Yes...............  No.
Receiving facility..............  New...............  N/A...............  Yes...............  No.
Rework..........................  Current...........  No................  No................  No.
Safe-moisture level.............  Current...........  Yes...............  No................  No.
Sanitize........................  Current...........  Yes...............  Yes...............  Yes.
Should..........................  Current...........  No................  No................  Deleted the
                                                                                               definition.
Significant hazard..............  New...............  N/A...............  Yes...............  Yes, including
                                                                                               changing the term
                                                                                               to ``hazard
                                                                                               requiring a
                                                                                               preventive
                                                                                               control''.
Significantly minimize..........  New...............  N/A...............  Yes...............  No.
Small business..................  New...............  N/A...............  Yes...............  Yes.
Subsidiary......................  New...............  N/A...............  Yes...............  No.
Supplier........................  New...............  N/A...............  Yes...............  Yes.
Supply-chain -applied control...  New in the final    N/A...............  N/A...............  N/A.
                                   rule.
Unexposed packaged food.........  New in the final    N/A...............  N/A...............  N/A.
                                   rule.

[[Page 55946]]

 
Validation......................  New...............  N/A...............  Yes...............  Yes.
Verification....................  New...............  N/A...............  Yes...............  Yes.
Very small business.............  New...............  N/A...............  Yes...............  Yes.
Water activity..................  Current...........  No................  No................  No.
Written procedures for receiving  New in the final    N/A...............  N/A...............  N/A.
 raw materials and other           rule.
 ingredients.
You.............................  New...............  N/A...............  No................  No.
----------------------------------------------------------------------------------------------------------------
\1\ The ``farm'' definition in Sec.   117.3 is a cross-reference to the ``farm'' definition in the section 415
  registration regulations. Although we did revise the ``farm'' definition in the section 415 registration
  regulations (see section IV.B), the cross-reference we are establishing in Sec.   117.3 is unchanged.

A. Redesignation

    We proposed to redesignate all definitions in Sec.  110.3(a) 
through (r) as proposed Sec.  117.3, eliminate paragraph designations 
(such as (a), (b), and (c)), and add new definitions in alphabetical 
order. We received no comments that disagreed with our proposal, and 
are finalizing the proposed redesignations.

B. Definitions in Current Part 110 That We Proposed To Delete

    We proposed to delete the definition of ``shall'' and use ``must'' 
instead. We received no comments that disagreed with our proposal, and 
are deleting the definition of ``shall'' as proposed.

C. Definitions That We Proposed To Establish in Part 117

1. Adequate
    We proposed to define the term ``adequate'' to mean that which is 
needed to accomplish the intended purpose in keeping with good public 
health practice.
    (Comment 76) Some comments assert that the definition is vague and 
ask us to clarify what constitutes ``adequate'' for systems such as 
operating systems for waste treatment and disposal. Other comments ask 
us to develop guidance on thresholds and processes that qualify as 
``adequate.'' Other comments assert that the word ``adequate'' must be 
used in combination with the word ``reasonable'' to properly describe 
the intended measures and precautions. As an example, these comments 
assert that the definition of ``adequate'' could lead to excessive 
requirements when applied to the provisions for disease control and 
hygiene (Sec.  117.10).
    (Response 76) We disagree that this long-standing definition of the 
term ``adequate'' is vague. The comments do not provide any examples of 
how we have interpreted this definition in the past in a way that 
creates practical problems when applying CGMP requirements, including 
requirements directed to the management of waste or the provisions for 
disease control and hygiene. Our intent in using the term ``adequate'' 
is to provide flexibility for a food establishment to comply with the 
requirement in a way that is most suitable for its establishment. We 
decline the request to develop guidance to explicitly address 
``thresholds'' or to describe processes that qualify as adequate. The 
CGMPs established in this are broadly applicable procedures and 
practices rather than very specific procedures and practices where 
additional interpretation from FDA might be appropriate.
2. Affiliate and Subsidiary
    We proposed to define the term ``affiliate'' to mean any facility 
that controls, is controlled by, or is under common control with 
another facility. We proposed to define the term ``subsidiary'' to mean 
any company which is owned or controlled directly or indirectly by 
another company. These proposed definitions would incorporate the 
definition in sections 418(l)(4)(A) and (D) of the FD&C Act and would 
make the meanings of these terms clear when used in the proposed 
definition of ``qualified facility.''
    (Comment 77) Some comments ask us to clarify that a facility that 
has no material connection with another food processing operation would 
not be considered as an ``affiliate'' of that operation.
    (Response 77) It is not clear what the comments mean by ``no 
material connection with another food processing operation.'' To the 
extent that a facility does not control, is not controlled by, or is 
not under common control with another facility, we agree that the 
facility would not be considered an affiliate of that food processing 
operation.
    (Comment 78) Some comments assert that the definitions of 
``affiliate'' and ``subsidiary'' fail to account for the legal 
differences between a piece of property (i.e., a facility) and a 
business entity or person. These comments ask us to consider amending 
the proposed definition of ``qualified facility'' to clarify what sales 
to include in determining whether a facility so qualifies.
    (Response 78) See Response 118.
3. Allergen Cross-Contact
    We proposed to define the term ``allergen cross-contact'' to mean 
the unintentional incorporation of a food allergen into a food.
    (Comment 79) Some comments assert that the term ``incorporation'' 
used in the definition is a vague term that has entirely different 
meanings when used by different segments of the food industry (e.g., 
the term would mean something different to a produce wholesaler than to 
a cereal manufacturer). These comments ask us to provide either a 
clarification or a definition for the term ``incorporation.''
    (Response 79) By ``unintentional incorporation of a food allergen 
into food'' we mean that the food allergen would be in a food when the 
producer of the food did not intend it to be in the food--e.g., if a 
milk-based beverage contains soybeans in addition to milk. Several 
provisions of the rule require that a facility take steps to prevent 
such unintentional incorporation of a food allergen into food. See our 
previous discussion of the importance of preventing allergen cross-
contact (78 FR 3646 at 3693).
4. Critical Control Point
    We proposed to revise the definition for ``critical control point'' 
to mean a point, step, or procedure in a food process at which control 
can be applied and is essential to prevent or eliminate

[[Page 55947]]

a food safety hazard or reduce such hazard to an acceptable level.
    (Comment 80) Some comments ask us to specify that a critical 
control point is essential to reduce the presence of hazards such as 
microorganisms to ``minimize the risk of foodborne illness'' rather 
than to ``reduce such hazard to an acceptable level.'' These comments 
assert that this revision would be consistent with the approach in the 
proposed produce safety rule. Other comments disagree with the proposed 
definition because it does not define a term (i.e., acceptable level) 
used in the definition.
    (Response 80) We decline to modify the definition as requested by 
these comments. The proposed definition matches the statutory 
definition in section 418(o)(1) of the FD&C Act and is consistent with 
definitions in the NACMCF HACCP guidelines, the Codex HACCP Annex, and 
Federal HACCP regulations for seafood, juice, and meat and poultry (78 
FR 3646 at 3695). The proposed produce safety rule, which did not 
propose to define ``critical control point,'' focused on biological 
hazards. However, critical control points may be established to control 
chemical or physical hazards in addition to biological hazards. The 
standard suggested by the comments is not inconsistent with the 
definition we proposed for ``critical control point'' in the human 
preventive controls rule, because preventing or eliminating a food 
safety hazard or reducing such hazard to an acceptable level would 
minimize the risk of foodborne illness. However, the standard suggested 
by the comments was narrowly directed to biological hazards, because 
chemical and physical hazards generally cause injury rather than 
illness.
    We do not need to define every term used in the definition. By 
specifying that a point, step, or procedure in a food safety process 
would reduce a hazard to an ``acceptable level,'' the definition 
provides flexibility for a facility to determine an appropriate level 
in a particular circumstance. Consistent with the approach recommended 
in the proposed produce safety rule (78 FR 3504 at 3545), a facility 
could use current FDA guidance on microbiological hazards (e.g., Ref. 
29 and Ref. 30) to inform its decision on what constitutes an 
acceptable level. In those documents, we use the phrase ``adequately 
reduce'' to mean capable of reducing the presence of Salmonella to an 
extent sufficient to prevent illness. The extent of reduction 
sufficient to prevent illness usually is determined by the estimated 
extent to which Salmonella spp. may be present in the food combined 
with a safety factor to account for uncertainty in that estimate. For 
example, if it is estimated that there would be no more than 1000 
(i.e., 3 logs) Salmonella organisms in the food, and a safety factor of 
100 (i.e., 2 logs) is employed, a process adequate to reduce Salmonella 
spp. would be a process capable of reducing Salmonella spp. by 5 logs.
5. Environmental Pathogen
    We proposed to define the term ``environmental pathogen'' to mean a 
pathogen capable of surviving and persisting within the manufacturing, 
processing, packing, or holding environment such that food may be 
contaminated and may result in foodborne illness if that food is 
consumed without treatment to significantly minimize or prevent the 
environmental pathogen. We also proposed to specify that environmental 
pathogen does not include the spores of pathogenic sporeformers.
    (Comment 81) Some comments ask us to include Salmonella spp. and L. 
monocytogenes in the regulatory text as examples of environmental 
pathogens because of the likelihood that these environmental pathogens 
could contaminate ready-to-eat (RTE) food. Other comments ask us to 
provide a broader list (including Escherichia coli, Campylobacter, 
pathogenic Vibrio, Staphylococcus aureus, Clostridium botulinum, 
Shigella, Yersinia enterocolitica, and viruses such as rotoviruses and 
noroviruses) in the preamble to the final rule or in guidance, and to 
make clear that the list is not all-inclusive. Some comments emphasize 
the need for flexible language because any list of microorganisms might 
change over time, particularly as new environmental pathogens emerge.
    Some comments ask us to include the indicator organism Listeria 
spp. in the regulatory text, because analysis of Listeria spp. is 
faster than analysis of L. monocytogenes. Other comments ask us to 
include pathogens that have been associated with RACs, as reported by 
CDC.
    (Response 81) We agree that Salmonella spp. and L. monocytogenes 
are useful examples of environmental pathogens and have added these two 
examples to the proposed definition, which had not included examples. 
As the comments point out, adding these two examples to the definition 
does not mean that these two pathogens are the only environmental 
pathogens that a facility must consider in its hazard analysis. New 
environmental pathogens can emerge at any time, and other pathogens 
(e.g., Cronobacter spp.) can also be environmental pathogens (78 FR 
3646 at 3816).
    We have not included the indicator organism Listeria spp. as an 
example of an environmental pathogen, whether in the regulatory text, 
in the preamble of this document, or in guidance. Although we agree 
that Listeria spp. is an appropriate indicator organism when conducting 
verification testing for sanitation controls, the definition in 
question is for a pathogen, not for indicators of a pathogen. Other 
provisions of the rule are more appropriate to provide the context that 
a facility has flexibility for how to conduct verification testing for 
an environmental pathogen, including an option to test for an indicator 
organism. (See, e.g., Sec.  117.165(a)(2) and (3).)
    L. monocytogenes, Salmonella spp., and some of the other pathogens 
mentioned in the comments have been associated with RACs. To the extent 
that the comments are asking us to identify some environmental 
pathogens that have been associated with RACs, by identifying these 
pathogens in the regulatory text or in this preamble we have done so. 
However, it is important to note that the term ``environmental 
pathogen'' as defined in this rule is directed to pathogens in the food 
processing environment (such as the insanitary conditions in a facility 
that packed cantaloupes linked to an outbreak of listeriosis (78 FR 
3646 at 3814)), not to pathogens present in the growing environment for 
a RAC.
    (Comment 82) Some comments ask us to define ``environmental 
pathogen'' as a microorganism that is of public health significance and 
is capable of surviving and persisting within the manufacturing, 
processing, packing, and holding environment of the food being 
prepared.
    (Response 82) We decline this request. The definition of 
``environmental pathogen'' should not change depending on the food 
being prepared in a particular facility. As a practical matter, the 
facility will consider the manufacturing, processing, packing, and 
holding environment of the food being prepared when it conducts its 
hazard analysis (Sec.  117.130).
    (Comment 83) Some comments ask us to focus attention on the areas 
where environmental monitoring is particularly important by modifying 
the definition to address the risk of contamination to RTE food and to 
foods exposed to the environment after a lethality step. Other comments 
ask us to consider the number and types of different products produced, 
the complexity of processing procedures,

[[Page 55948]]

the amount of product produced, and whether an environmental sampling 
program is in place.
    (Response 83) We decline these requests, which are asking us to 
specify in a definition factors associated with developing an 
environmental monitoring program. The purpose of a definition is to 
simply explain what a term means, not to establish requirements, or 
provide guidance about requirements, that use the term.
    (Comment 84) Some comments ask us to clarify the meaning of the 
term ``persisting'' as used in the definition, such as whether it means 
that a sanitation process will not remove the microorganism.
    (Response 84) We use the term ``persisting'' to mean that a 
pathogen can become established if cleaning is not adequate. Once a 
pathogen becomes established, appropriate sanitation measures can 
remove the pathogen. However, sanitation procedures necessary to 
eliminate an environmental pathogen that has become established 
generally are more aggressive than routine sanitation procedures.
    (Comment 85) Some comments ask us to revise the definition to 
specify that the microorganisms are ``potentially'' of public health 
significance.
    (Response 85) We decline this request. The definition is only 
directed at those microorganisms that are of public health 
significance.
    (Comment 86) One comment asserts that the proposed definition of 
``environmental pathogen'' excludes the waterborne pathogens Cyclospora 
and Cryptosporidium and asks us to revise the definition so that these 
pathogens will be considered ``environmental pathogens'' for the 
purposes of the human preventive controls rule. The comment asserts 
that excluding these waterborne pathogens does not take into account 
the considerable food safety hazard of ``spores'' of ``pathogenic 
sporeformers'' that can be present in and delivered to a food 
processing facility by processing and ingredient water, both well water 
and surface water from either private or municipal supply, in both 
domestic and foreign facilities. The comment asks us to delete the 
statement that an environmental pathogen does not include the spores of 
pathogenic sporeformers so that, according to the comment, Cyclospora 
and Cryptosporidium would fall within the definition of ``environmental 
pathogen.''
    (Response 86) We disagree that the pathogens Cyclospora and 
Cryptosporidium should be considered ``environmental pathogens'' as we 
use that term in this rule. Our definition of ``environmental 
pathogen'' is directed to those pathogens that are capable of surviving 
and persisting within the manufacturing, processing, packing, or 
holding environment of a food establishment, not the water that is used 
in a food processing establishment. See the discussion of environmental 
pathogens in the food processing environment in section I.D of the 
Appendix to the 2013 proposed human preventive controls rule (78 FR 
3646 at 3813-3815, with corrected reference numbers at 78 FR 17142 at 
17144-17146). As discussed in that Appendix, the available data and 
information associate insanitary conditions in food facilities with 
contamination of a number of foods with Salmonella spp. and L. 
monocytogenes. Such contamination has led to recalls and to outbreaks 
of foodborne illness. As a result, the rule includes several provisions 
directed to those pathogens, such as Salmonella spp. and L. 
monocytogenes, that are capable of surviving and persisting within a 
food establishment (thereby serving as a source of contamination of the 
food establishment environment) and uses the defined term 
``environmental pathogens'' to describe those pathogens. These specific 
provisions do not apply to waterborne pathogens that do not survive and 
persist within a food establishment.
    By ``pathogenic sporeformers,'' we mean ``pathogenic sporeforming 
bacteria,'' and we are substituting the term ``pathogenic sporeforming 
bacteria'' for ``pathogenic sporeformers'' in the definition of 
``environmental pathogen'' to make that clearer. Both of the waterborne 
pathogens discussed by this comment are protozoan parasites, not 
bacteria (Ref. 31).
    The fact that waterborne organisms such as Cyclospora and 
Cryptosporidium are not ``environmental pathogens'' as that term is 
used in this rule does not mean that a facility has no responsibility 
to evaluate whether Cyclospora or Cryptosporidium are known or 
reasonably foreseeable hazards that require a preventive control. For 
example, when a fresh-cut produce processing facility receives produce 
from a geographic region where Cyclospora or Cryptosporidium have been 
associated with food safety problems, the facility likely would address 
the potential for contamination of incoming produce with Cyclospora or 
Cryptosporidium in its supply-chain program (see subpart G for the 
requirements of the supply-chain program).
6. Facility
    We proposed to define the term ``facility'' to mean a domestic 
facility or a foreign facility that is required to register under 
section 415 of the FD&C Act in accordance with the requirements of 21 
CFR part 1, subpart H. Comments directed to the meaning of the term 
``facility'' address its meaning as established in the section 415 
registration regulations, rather than this definition established in 
part 117. See Comment 4 and Response 4.
7. Farm
    We proposed to define the term ``farm'' by reference to the 
definition of that term in proposed Sec.  1.227 rather than by 
repeating the full text of the ``farm'' definition in part 117. See 
section IV.B for a discussion of the ``farm'' definition that we are 
establishing in Sec.  1.227.
8. Food
    We proposed to define the term ``food'' to mean food as defined in 
section 201(f) of the FD&C Act and to include raw materials and 
ingredients. Under section 201(f), the term ``food'' means: (1) 
Articles used for food or drink for man or other animals, (2) chewing 
gum, and (3) articles used for components of any such article.
    (Comment 87) Some comments ask us to include examples in the 
definition, particularly dietary supplements and dietary ingredients. 
These comments also ask us to clarify whether the definition applies to 
food for human consumption, animal consumption, or both.
    (Response 87) We decline the request to include examples in the 
definition. Dietary supplements and dietary ingredients are articles 
used for food or drink for man, as are many other articles. There are 
many examples of food and adding a limited list of examples could be 
confusing rather than helpful. Although the definition of food includes 
food for both human consumption and animal consumption, the provisions 
of the rule are clearly directed to food for human consumption (see 
Response 6 and Response 72).
    (Comment 88) Some comments ask us to consider fundamental and 
important differences between food additives and GRAS substances and 
finished food. These comments explain that food additives and GRAS 
substances may be synthesized using various chemical and biochemical 
processes, or may be extracted, hydrolyzed or otherwise modified from 
their natural sources, and result in food safety hazards that are quite 
different from finished food

[[Page 55949]]

preparations. These comments also explain that food additives and GRAS 
substances are often produced using processes that minimize microbial 
contamination hazards and are almost always used in food products that 
undergo further downstream processing. These comments assert that food 
additives and GRAS substances generally present a significantly lower 
public health hazard compared to finished food and should be regulated 
accordingly.
    (Response 88) Substances such as food additives and GRAS substances 
are food and are subject to the requirements of this rule. Both the 
CGMP requirements in subpart B and the requirements for hazard analysis 
and risk-based preventive controls in subparts C and G provide 
flexibility to address all types of food. (As discussed in section 
XLII, the final rule establishes the requirements for a supply-chain 
program in subpart G, rather than within subpart C as proposed. As a 
result, this document refers to subparts C and G when broadly referring 
to the requirements for preventive controls.) Some comments point out 
that one strength of the long-standing CGMPs is their applicability to 
the broad spectrum of food manufacturing, from the manufacture of 
processed products to production of food additives and GRAS substances 
(see section VIII). A manufacturer of a food additive or GRAS substance 
has flexibility to comply with the requirements of the rule based on 
the nature of the production processes and the outcome of the hazard 
analysis for that food substance. (See also Response 221.)
    (Comment 89) Some comments ask us to limit the definition of 
``food'' as it would apply to the new requirements for hazard analysis 
and risk-based preventive controls to only cover produce and processed 
foods covered by the rules, rather than all food (human and animal, 
produce and non-produce, low-risk and high-risk).
    (Response 89) We decline this request. It is not necessary to 
modify the definition of ``food'' to limit applicability of the rule to 
human food. (See Response 6.) The umbrella CGMPs that we are 
establishing in subpart B are long-standing provisions that establish 
basic requirements for the manufacturing, processing, packing, and 
holding of food to prevent adulteration and are not ``one-size-fits-
all.'' (See Response 221.) The new requirements for hazard analysis and 
risk-based preventive controls likewise are not ``one-size-fits-all,'' 
and facilities that are subject to the rule would consider the risk 
presented by the products as part of their hazard evaluation; a 
facility that appropriately determines through its hazard analysis that 
there are no hazards requiring preventive controls would document that 
determination in its written hazard analysis but would not need to 
establish preventive controls and associated management components. 
(See Response 222.)
9. Food Allergen
    We proposed to define the term ``food allergen'' to mean a major 
food allergen as defined in section 201(qq) of the FD&C Act.
    (Comment 90) Some comments ask us to narrow the definition of food 
allergen by specifying that a substance is only a food allergen when it 
is not disclosed on the product label.
    (Response 90) We decline this request, which appears to confuse the 
distinction between what a food allergen is and when a product would be 
misbranded under section 403(w) of the FD&C Act. The substances listed 
in section 201(qq) of the FD&C Act are food allergens; if any of those 
substances are not disclosed on the product label, then the product 
would be misbranded under section 403(w) of the FD&C Act.
    (Comment 91) Some comments ask us to expand the existing exemption 
for RACs from the definition of major food allergen in section 
403(w)(1) of the FD&C Act to include raw fish.
    (Response 91) This comment is unclear and appears to be confusing 
the definition of ``major food allergen'' in section 201(qq) of the 
FD&C Act with criteria for when a food shall be deemed to be misbranded 
under section 403(w) of the FD&C Act. Under section 403(w), a food 
shall be deemed misbranded if it is not a raw agricultural commodity 
and it is, or it contains an ingredient that bears or contains, a major 
food allergen, unless certain labeling requirements are met. Under 
section 201(r) of the FD&C Act, the term ``raw agricultural commodity'' 
means any food in its raw or natural state, including all fruits that 
are washed, colored, or otherwise treated in their unpeeled natural 
form prior to marketing. Fish are food and, thus, raw, unprocessed fish 
are RACs within the meaning of section 403(w). Thus, the misbranding 
provisions of section 403(w) would not apply to raw, unprocessed fish, 
because those misbranding provisions do not apply to RACs. However, the 
exemption in section 403(w) from the conditions under which a food 
shall be deemed to be misbranded do not establish an exemption for RACs 
in the definition of ``major food allergen'' in section 201(qq).
    To the extent that the comment is asking us to revise either the 
statutory definition of ``major food allergen'' in section 201(qq) of 
the FD&C Act, or to revise the criteria for when a food shall be deemed 
misbranded under section 403(w) of the FD&C Act, we do not have 
authority to do so.
    (Comment 92) Some comments ask us to include an example of an 
ingredient derived from an allergen in the definition.
    (Response 92) We decline this request. The definition of ``major 
food allergen'' in section 201(qq) of the FD&C Act is sufficient to 
define the term. Casein and whey protein, each of which are derived 
from milk, are examples of ingredients that would satisfy the 
definition of ``major food allergen'' in section 201(qq).
10. Harvesting
    We proposed to establish in Sec.  117.3 the same definition of 
``harvesting'' as we proposed to establish in Sec. Sec.  1.227 and 
1.328. See section IV.C for a discussion of comments we received to the 
proposed definition of ``harvesting'' in Sec. Sec.  1.227 and 1.328, 
and our responses to those comments.
11. Hazard
    We proposed to define the term ``hazard'' to mean any biological, 
chemical (including radiological), or physical agent that is reasonably 
likely to cause illness or injury in the absence of its control.
    (Comment 93) Some comments express concern that the rule would 
refer to four levels of ``hazard''--i.e., ``hazard,'' ``known or 
reasonably foreseeable hazard,'' ``significant hazard,'' and ``serious 
adverse health consequences or death to humans or animals'' hazard. 
These comments ask us to provide sufficient clarity to be able to 
distinguish between these types of hazards and to provide examples in 
guidance as to how these terms will be applied in determining 
compliance with the rule. Other comments express concern that the 
definitions do not establish a meaningful distinction between 
``hazard'' and ``significant hazards'' and do not sufficiently 
distinguish between the hazards identified in the first and second 
steps of the hazard analysis (first narrowing hazards to ``known or 
reasonably foreseeable hazards'' and then narrowing the ``known or 
reasonably foreseeable hazards'' to ``significant hazards'').
    (Response 93) The rule uses three of these terms (i.e., ``hazard,'' 
``known or reasonably foreseeable hazard,'' and the proposed term 
``significant hazard'') to

[[Page 55950]]

establish a tiered approach to the requirements for hazard analysis and 
risk-based preventive controls. The term ``hazard' is the broadest of 
these three terms--any biological, chemical (including radiological), 
or physical agent that is reasonably likely to cause illness or injury. 
To conduct its hazard analysis, a facility starts by first narrowing 
down the universe of all potential hazards to those that are ``known or 
reasonably foreseeable'' for each type of food manufactured, processed, 
packed, or held at its facility. The outcome of the facility's hazard 
analysis is a determination of ``significant hazards''--i.e., the 
subset of those known or reasonably foreseeable hazards that require a 
preventive control.
    To make this clearer, we have: (1) Revised the proposed definition 
of ``hazard''; (2) changed the term ``significant hazard'' to ``hazard 
requiring a preventive control''; and revised the definition of 
``hazard requiring a preventive control'' (formerly ``significant 
hazard''). See Response 94, Response 126, Response 127, Response 128, 
and Response 129.
    The rule does not define the term ``serious adverse health 
consequences or death to humans or animals'' hazard. However, the 
requirements for a supply-chain program refer to a hazard for which 
there is a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans (see 
Sec.  117.430(b)). For additional information on how we interpret 
``serious adverse health consequences or death to humans or animals,'' 
see our guidance regarding the Reportable Food Registry (Ref. 32) (Ref. 
33), which addresses statutory requirements regarding ``reportable 
foods.'' As explained in that guidance, a ``reportable food'' is an 
article of food (other than dietary supplements or infant formula) for 
which there is a reasonable probability that the use of, or exposure 
to, such article of food will cause serious adverse health consequences 
or death to humans or animals. The guidance includes examples of 
circumstances under which food might be reportable.
    (Comment 94) Some comments assert that the distinction between the 
definitions of ``hazard'' and ``significant hazard'' is not discernable 
because the proposed definition of ``hazard'' currently takes into 
account whether or not a ``hazard'' is or is not controlled. These 
comments ask us to delete the phrase ``in the absence of its control'' 
from the definition of ``hazard'' to clarify that hazards are simply 
the agents that are reasonably likely to cause illness or injury. 
Likewise, other comments assert that any hazard that is ``reasonably 
likely to cause illness or injury in the absence of its control'' will, 
if known or reasonably foreseeable, likely be controlled by any 
knowledgeable person.
    (Response 94) We have deleted the phrase ``in the absence of its 
control'' from the definition of ``hazard.'' As previously discussed, 
the phrase ``in the absence of its control'' is not included in the 
definition of ``hazard'' in the Codex HACCP Annex, our HACCP regulation 
for seafood, or the HACCP regulation for meat and poultry, although it 
is included in the NACMCF HACCP Guidelines and our HACCP regulation for 
juice (78 FR 3646 at 3697). We agree that deleting this phrase from the 
definition of ``hazard'' will more clearly distinguish between the 
terms ``hazard'' and ``hazard requiring a preventive control'' that we 
are establishing in this rule. We see no reason to propose an analogous 
change to the definition of ``hazard'' in our HACCP regulation for 
juice because that regulation only defines the single term ``hazard'' 
and, thus, the issue discussed in these comments does not apply.
    We also replaced the phrase ``that is reasonably likely to cause 
illness or injury'' with ``that has the potential to cause illness or 
injury'' to more clearly distinguish ``hazard'' from ``known or 
reasonably foreseeable hazard.'' This increases the alignment of the 
definition of ``hazard'' in this rule with the Codex definition of 
``hazard.''
    (Comment 95) Some comments ask us to add that the term hazard also 
means any agent that would cause a food to become adulterated under 
section 402 of the FD&C Act.
    (Response 95) The suggested addition is inconsistent with current 
national and international understanding of what constitutes a hazard 
(Ref. 34) (Ref. 35) because it would include agents such as filth, 
which would adulterate food within the meaning of section 402(a)(4) of 
the FD&C Act but would be unlikely to cause illness or injury (Ref. 
36).
12. Holding
    We proposed to establish in Sec.  117.3 the same definition of 
``holding'' as we proposed to establish in Sec. Sec.  1.227 and 1.328. 
See section IV.D for a discussion of comments we received to the 
proposed definition of ``holding'' in Sec. Sec.  1.227 and 1.328, and 
our responses to those comments.
13. Known or Reasonably Foreseeable Hazard
    We proposed to define the term ``known or reasonably foreseeable 
hazard'' to mean a biological, chemical (including radiological), or 
physical hazard that has the potential to be associated with the 
facility or the food.
    (Comment 96) Some comments support the definition as proposed, 
noting that it implies that the implementation of a preventive control 
is based both on the severity and likelihood of the hazard, can help to 
distinguish between the requirements of this rule and HACCP 
requirements, and provides for the proper consideration of both the 
food and the facility when determining whether a hazard is ``known or 
reasonably foreseeable.'' Other comments ask us to modify the 
definition to specify that the term means a hazard ``that is known to 
be, or has the potential to be,'' associated with the facility or the 
food'' to better align with the term as FDA proposed to define it in 
the proposed FSVP rule. (See 79 FR 58574 at 58595.)
    (Response 96) We have revised the definition as requested by the 
comments to better align with the proposed FSVP rule.
    (Comment 97) Some comments ask us to revise the definition so that 
it addresses a hazard that is known to be, or has the potential to be, 
associated with a food, the facility in which it is manufactured/
processed, or the location or type of farm on which it is grown or 
raised. These comments assert that the type of farm may affect those 
hazards that are known or reasonably foreseeable.
    (Response 97) We decline this request, which appears related to 
another difference between the definition proposed in this rule and the 
definition of this term in the proposed FSVP rule. The proposed FSVP 
rule would define ``known or reasonably foreseeable hazard'' as a 
hazard that is known to be, or has the potential to be, associated with 
a food or the facility ``in which it is manufactured/processed.'' (See 
79 FR 58574 at 58595.) In this rule, we do not need to specify that the 
applicable facility is the one ``in which the food is manufactured/
processed'' because this rule applies to the owner, operator, or agent 
in charge of the facility in which the food is manufactured, processed, 
packed, or held, and that applicability does not need to be repeated in 
each provision. To the extent that this comment is expressing concern 
about raw materials or other ingredients that a facility would receive 
from a farm, those concerns would be considered in the facility's 
hazard analysis, which would include a hazard evaluation that considers 
factors such as those related to the source of

[[Page 55951]]

raw materials and other ingredients (see Sec.  117.130(c)(2)(iii)).
    (Comment 98) Some comments ask us to include ``food allergens'' in 
the parenthetical where we list radiological hazards as a type of 
chemical hazard.
    (Response 98) We decline this request. As previously discussed, the 
definitions of ``hazard'' or ``food hazard'' in the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federal HACCP regulations for 
seafood, juice, and meat and poultry all define hazard with respect to 
biological, chemical, and physical agents, and we proposed to include 
radiological agents to implement section 418(b)(1)(A) of the FD&C Act 
(78 FR 3646 at 3697). We subsequently proposed to include radiological 
hazards as a subset of chemical hazards because comments recommended 
that we do so, and we believe that facilities in the past have 
considered radiological hazards as chemical hazards when conducting a 
hazard analysis for the development of HACCP plans (79 FR 58524 at 
58557).
    In this document, we affirm our proposal to implement section 
418(b)(1)(A) of the FD&C Act by specifically including radiological 
hazards in the definition of hazard. We acknowledge that food allergen 
hazards (together with pesticide and drug residues, natural toxins, 
decomposition, and unapproved food or color additives) also are a 
subset of chemical hazards but do not find it necessary to list all 
examples of chemical hazards in the definition of hazard, just as we do 
not find it necessary to list multiple examples of biological and 
physical hazards in the definition of hazard. The requirement to 
consider food allergen hazards in the hazard analysis is already 
explicit in the requirements for hazard identification (see Sec.  
117.130(b)(1)(ii)).
    (Comment 99) Some comments suggest using the phrase ``reasonably 
anticipated contaminants'' as a useful phrase that clearly defines all 
hazards, whether deliberate or accidental, that can cause adulteration 
in the food supply.
    (Response 99) We decline this request. We see no meaningful 
difference between ``reasonably expected'' and ``reasonably 
anticipated.'' We also see no benefit in specifying that a hazard is a 
``contaminant'' rather than an ``agent'' (which is the term used in the 
definition of ``hazard'').
14. Lot
    We proposed to define ``lot'' to mean the food produced during a 
period of time indicated by a specific code.
    (Comment 100) Some comments ask us to modify the proposed 
definition to make it more flexible and robust. These comments assert 
that the proposed definition appears to ignore other potential 
definitions, such as products with common characteristics (such as 
origin, variety, type of packing, packer, consignor, markings) and that 
multiple ``lots'' can be produced during the same time but with 
different lot designations. Other comments ask us to modify the 
proposed definition so that it is not limited by a period of time and 
suggest using an approach that would allow for a lot to be defined by 
either time or by a specific identifier. Other comments express the 
view that the individual operators should be able to define their lot 
designations and make these definitions available to FDA upon request. 
Other comments assert that the proposed definition is too prescriptive 
and inflexible in that timeframe is not necessarily the most logical 
way to identify a lot (e.g., for batch production). Some comments 
suggest specific changes to the text of the proposed definition, such 
as ``Lot means a body of food designated by the facility with common 
characteristics, e.g., origin, variety, type of packing, packer, 
consignor, markings or time of harvest, packing or processing, which is 
separable by such characteristics from other bodies of food.''
    (Response 100) As judged by these comments, the long-standing 
definition of ``lot'' has the potential to be misinterpreted to mean 
that the ``specific code'' must be based on time, such as a date. This 
is not the case. Although the term ``lot'' is associated with a period 
of time, an establishment has flexibility to determine the code, with 
or without any indication of time in the code. For example, a code 
could be based on a date, time of day, production characteristic (such 
as those mentioned in the comments), combination of date/time/
production characteristic, or any other method that works best for the 
establishment. To clarify that the rule does not require that time be 
``indicated'' by the code, and emphasize the establishment's 
flexibility to determine the code, we have revised ``period of time 
indicated by a specific code'' to ``period of time and identified by an 
establishment's specific code.''
    (Comment 101) Some comments ask us to clarify the purpose of the 
``specific code'' associated with the lot (i.e., that it should give 
insight into production history of the associated food) and to define a 
term such as ``lot code'' or ``production code.''
    (Response 101) The purpose of the specific code associated with a 
lot is to identify the food and associated production records--e.g., 
when investigating a food safety problem or conducting a recall. We 
decline the request to define a term such as ``lot code'' or 
``production code.'' The definition of ``lot'' is intended to provide 
flexibility for an establishment to determine the mechanism of 
assigning a code that is best suited to the food it produces.
    (Comment 102) Some comments ask us to clarify the factors that can 
affect the size of a ``lot.'' These comments assert that minimizing the 
size of a lot could be beneficial to an establishment if a recall is 
needed and express concern that our proposed definition may differ from 
that used by a specific establishment.
    (Response 102) The definition provides a company with flexibility 
to determine an appropriate size of a lot.
15. Manufacturing/Processing
    We proposed to establish in Sec.  117.3 the same definition of 
``manufacturing/processing'' as we proposed to establish in Sec. Sec.  
1.227 and 1.328. See section IV.E for a discussion of comments we 
received to the proposed definition of ``manufacturing/processing'' in 
Sec. Sec.  1.227 and 1.328, and our responses to those comments.
16. Microorganisms
    We proposed to define the term ``microorganisms'' to mean yeasts, 
molds, bacteria, viruses, protozoa, and microscopic parasites and 
include species having public health significance. We also proposed 
that the term ``undesirable microorganisms'' includes those 
microorganisms that are of public health significance, that subject 
food to decomposition, that indicate that food is contaminated with 
filth, or that otherwise may cause food to be adulterated.
    (Comment 103) Some comments express concern that the term 
``undesirable microorganisms'' includes microorganisms that subject 
food to decomposition. These comments assert that the definition would 
expand regulation beyond food safety and ask us to clarify that 
decomposition means a degradation of product that is only relevant when 
it affects the safety of the product, rather than simple spoilage, 
because the presence of microorganisms that can cause spoilage is an 
unavoidable condition of fresh produce.
    (Response 103) We have not modified the regulatory text of this 
long-standing definition of the term ``undesirable microorganisms'' 
regarding

[[Page 55952]]

microorganisms that subject food to decomposition. As we noted during 
the rulemaking to first establish this definition, the regulations are 
designed to prevent the growth of undesirable microorganisms, and the 
scope of the definition is not limited to pathogens because these 
regulations are also concerned with sanitation, decomposition, and 
filth (51 FR 22458 at 22460). The comments do not provide any examples 
of how we have interpreted this provision in the past in a way that 
creates practical problems to the fresh produce industry when applying 
CGMP requirements directed to preventing the growth of undesirable 
microorganisms.
    (Comment 104) Some comments ask us to specify that the term 
``undesirable microorganisms'' includes microorganisms that are 
resistant to drugs or antibiotics.
    (Response 104) We decline this request. The requirements of this 
rule directed to preventing contamination with microorganisms are 
intended to keep microorganisms out of food regardless of whether a 
particular strain of a specific microorganism (including a pathogen, a 
microorganism that subjects food to decomposition, and a microorganism 
that indicates that food is contaminated with filth) has the particular 
characteristic of being resistant to drugs or antibiotics.
    (Comment 105) Some comments ask us to provide lists of 
microorganisms that we consider indicative of ``contamination with 
filth'' and our rationale for such consideration.
    (Response 105) We decline this request, which is better suited for 
guidance. In other circumstances, we have discussed coliforms and fecal 
coliforms as indicators that food has been contaminated by 
manufacturing practices conducted under insanitary conditions (see, 
e.g., the discussion in the proposed rule to establish Current Good 
Manufacturing Practice, Quality Control Procedures, Quality Factors, 
Notification Requirements, and Records and Reports, for the Production 
of Infant Formula, 61 FR 36154 at 36171, July 9, 1996). As another 
example, ``Compliance Policy Guide Sec. 527.300 Dairy Products--
Microbial Contaminants and Alkaline Phosphatase Activity'' provides 
that dairy products may be considered adulterated within the meaning of 
section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), in that they 
have been prepared, packed, or held under insanitary conditions whereby 
they may have become contaminated with filth, when (nontoxigenic) E. 
coli is found at certain levels (Ref. 37).
17. Mixed-Type Facility
    We proposed to establish in Sec.  117.3 the same definition of 
``mixed-type facility'' as we proposed to establish in Sec. Sec.  1.227 
and 1.328. See section IV.F for a discussion of comments we received to 
the proposed definition of ``mixed-typed facility'' in Sec. Sec.  1.227 
and 1.328, and our responses to those comments.
18. Monitor
    We proposed to define the term ``monitor'' to mean to conduct a 
planned sequence of observations or measurements to assess whether a 
process, point, or procedure is under control and to produce an 
accurate record for use in verification.
    (Comment 106) Some comments assert that our proposed definition of 
monitoring is directed to the narrow circumstance of monitoring that 
would be applied to a CCP under the NACMCF HACCP guidelines and the 
Codex HACCP Annex. These comments also assert that, using such 
definitions, monitoring would not apply to control measures for which 
parameters cannot be established and that are not amenable to 
documentation. These comments suggest that we use a definition of 
monitoring consistent with that provided in ISO 22000:2005 (conducting 
a planned sequence of observations or measurements to assess whether 
control measures are operating as intended) to clarify that monitoring 
may be conducted where appropriate for preventive controls that are not 
CCPs. (ISO is an abbreviation for ``International Organization for 
Standardization.'' ISO develops and publishes international standards.) 
According to these comments, an advantage of this definition is that it 
also would clarify the difference between monitoring activities 
(observations conducted during the operation of a control measure to 
ensure that it is under control) and verification activities (to 
evaluate performance of a control measure).
    (Response 106) We have revised the definition of monitor to mean to 
conduct a planned sequence of observations or measurements to assess 
whether control measures are operating as intended. We agree that the 
revised definition, which reflects an international standard, more 
effectively communicates that monitoring also applies to controls that 
are not at CCPs and may apply to control measures for which parameters 
cannot be established. However, we disagree that this definition 
signals that it is not possible to obtain documentation when monitoring 
preventive controls that are not at CCPs, such as for controls that are 
not process controls and do not involve parameters and maximum or 
minimum values, or combinations of values, to which a parameter must be 
controlled to significantly minimize or prevent a hazard requiring a 
preventive control. For example, it is possible to monitor that a 
specific sanitation control activity has taken place, such as the 
cleaning of a piece of equipment to prevent allergen cross-contact.
    The requirement for documenting monitoring in records is 
established by the requirements for monitoring, not by the definition 
of monitor. As discussed in Response 468, we have made several 
revisions to the regulatory text, with associated editorial changes, to 
clarify that monitoring records may not always be necessary.
19. Packaging (When Used as a Verb)
    We proposed to establish in Sec.  117.3 the same definition of 
``packaging (when used as a verb)'' as we proposed to establish in 
Sec. Sec.  1.227 and 1.328.
    (Comment 107) Some comments express concern about establishing the 
definition of ``packaging (when used as a verb)'' in part 117. These 
comments ask us to clarify how this proposed definition relates to 
other uses of the word ``packaging'' in part 117, including use as an 
adjective in the common phrase ``food-packaging materials,'' and 
including some provisions directed to controlling allergen cross-
contact and contamination in ``food-packaging materials.'' Some 
comments ask us to establish definitions for terms such as ``food-
packaging materials'' or ``primary packaging'' to clarify the meaning 
of the term ``packaging'' as it has previously been used in part 110. 
Other comments ask us to clarify that provisions directed to preventing 
allergen cross-contact and contamination in ``food-packaging 
materials'' apply only to ``food-contact packaging,'' not ``secondary 
packaging.'' Some comments focus on the differences between the 
definition of the term ``packing'' and ``packaging'' with respect to 
activities conducted on RACs. Some comments ask us to clarify how the 
term ``packaging (when used as a noun)'' would apply when used in part 
117, even though we did not propose to establish a definition for 
``packaging (when used as a noun)'' in part 117.
    (Response 107) We have decided not to establish the definition 
``packaging (when used as a verb)'' in part 117. That definition was 
established in the section 415 registration regulations, in part, to 
identify those food establishments that would be subject to those 
regulations based, in part, on the activity of placing food into a 
container that directly

[[Page 55953]]

contacts the food and that the consumer receives. In addition, because 
the term ``packaging'' (when used as a noun) can be used in a very 
general way to refer to both the container that directly contacts the 
food and to the outer packaging of food that does not contact the food, 
the section 414 recordkeeping regulations established a definition of 
``packaging'' (when used as a noun) to narrowly refer to ``the outer 
packaging of food that bears the label and does not contact the food,'' 
because this narrow definition was also necessary for the purposes of 
those recordkeeping regulations.
    However, the term ``packaging'' has long been used as a noun in the 
CGMPs to generally refer to the container that directly contacts the 
food, rather than to the outer packaging of food that does not contact 
the food (as it means in the section 414 recordkeeping regulations). 
Thus, the very specific connotation for the term ``packaging'' (when 
used as a noun) that was established in the section 414 recordkeeping 
regulations does not apply, and is causing confusion. As the comments 
point out, our proposed definition of ``packaging (when used as a 
verb)'' is already causing confusion in the context of part 117. 
Therefore, for clarity and simplicity in part 117 we are not including 
in the final rule a definition of ``packaging (when used as a verb).'' 
A definition for ``packaging (when used as a verb)'' remains in the 
section 415 registration regulations, where a business can continue to 
use the definition for purposes of determining whether either or both 
of those regulations applies to its business.
    Part 117 establishes requirements for manufacturing, processing, 
packing, and holding human food. The definition of ``manufacturing/
processing'' we are establishing in this rule makes clear that 
``packaging'' (when used as a verb) is a manufacturing/processing 
activity and, thus, that requirements that apply to manufacturing or 
processing activities apply to packaging activities. Because part 117 
is not the regulation that describes whether a food establishment is 
subject to the section 415 registration regulations or the section 414 
recordkeeping regulations, it is not necessary for part 117 to do more.
    The comments that express concern about the distinction between 
``packing'' and ``packaging (when used as a verb)'' with respect to 
activities conducted on RACs no longer apply in light of the revised 
``farm'' definition that we are establishing in the section 415 
registration regulations. The revised ``farm'' definition provides for 
packaging RACs when packaging does not involve additional 
manufacturing/processing (such as cutting).
20. Packing
    We proposed to establish in Sec.  117.3 the same definition of 
``packing'' as we proposed to establish in Sec. Sec.  1.227 and 1.328. 
See section IV.G for a discussion of comments we received to the 
proposed definition of ``packing'' in Sec. Sec.  1.227 and 1.328, and 
our responses to those comments.
21. Pathogen
    We proposed to define the term ``pathogen'' to mean a microorganism 
of public health significance.
    (Comment 108) Some comments ask us to revise the definition to mean 
a ``microorganism of such severity and exposure that it would be deemed 
of public health significance'' because the significance of pathogens 
to public health depends on the organism's severity and the nature of 
exposure.
    (Response 108) We decline this request. Our purpose in defining the 
term pathogen was to simplify the regulations, including our long-
standing CGMP regulations, by substituting a single term (i.e., 
``pathogen'') for a more complex term (i.e., ``microorganism of public 
health significance'') throughout the regulations. These comments 
appear to be objecting to the use of the long-standing phrase 
``microorganism of public health significance,'' which has been in our 
CGMP regulations for decades, rather than to our proposal to define and 
use a simpler term in its place. These comments fail to explain how we 
have interpreted the current term ``microorganism of public health 
significance'' in a way that does not take into account factors such as 
the severity of illness and the route of exposure.
22. Pest
    We proposed to define the term ``pest'' to refer to any 
objectionable animals or insects including birds, rodents, flies, and 
larvae.
    (Comment 109) Some comments ask us to include reptiles in the 
definition due to a past instance of Salmonella linked to lizard feces 
in an RTE nut-manufacturing facility.
    (Response 109) We decline this request. This long-standing 
definition does not limit pests to those already included as examples. 
Reptiles are objectionable animals that are known to carry human 
pathogens and are considered pests.
    (Comment 110) Some comments ask us to clarify the meaning of the 
term ``objectionable.'' These comments state that, under the Canadian 
Pest Control Products Act, objectionable means that an animal does not 
belong in a food processing environment and suggest that we follow this 
meaning of ``objectionable.'' These comments also note that there may 
be circumstances where the presence of an animal is acceptable, such as 
the use of guide dogs.
    (Response 110) We decline this request. The meaning of the term 
``objectionable'' as described in these comments is consistent with our 
interpretation of this long-standing definition of ``pest,'' but we do 
not believe it is necessary to provide a definition. See the provisions 
for pest control (Sec.  117.35(c)), which allow the use of guard, 
guide, and pest-detecting dogs.
23. Plant
    We proposed to define the term ``plant'' to mean the building or 
establishment or parts thereof, used for or in connection with the 
manufacturing, processing, packing, or holding of human food. See 
Comment 63 for the comments on the definition of ``plant'' and Response 
63 for our response to those comments.
24. Preventive Controls
    We proposed to define the term ``preventive controls'' to mean 
those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would employ to significantly 
minimize or prevent the hazards identified under the hazard analysis 
that are consistent with the current scientific understanding of safe 
food manufacturing, processing, packing, or holding at the time of the 
analysis.
    (Comment 111) Some comments ask us to clarify the meaning of 
``current scientific understanding'' because scientific understanding 
can vary depending on the risk profile of a commodity.
    (Response 111) By ``current scientific understanding,'' we mean to 
emphasize that scientific information changes over time and a facility 
needs to keep current regarding safe handling and production practices 
such that the facility has the information necessary to apply 
appropriate handling and production practices.
25. Preventive Controls Qualified Individual
    We proposed to define the term ``qualified individual'' to mean a 
person who has successfully completed training in the development and 
application of risk-based preventive

[[Page 55954]]

controls at least equivalent to that received under a standardized 
curriculum recognized as adequate by the FDA or is otherwise qualified 
through job experience to develop and apply a food safety system. We 
have changed the proposed term ``qualified individual'' to ``preventive 
controls qualified individual'' because we are establishing a new 
definition for ``qualified individual,'' with a meaning distinct from 
``preventive controls qualified individual.'' To minimize the potential 
for confusion for when the term ``qualified individual'' refers to the 
proposed meaning of the term and when the term ``qualified individual'' 
refers to the meaning of that term as finalized in this rule, in the 
remainder of this document we use the new term ``preventive controls 
qualified individual'' whenever we mean ``a person who has successfully 
completed training in the development and application of risk-based 
preventive controls at least equivalent to that received under a 
standardized curriculum recognized as adequate by the FDA or is 
otherwise qualified through job experience to develop and apply a food 
safety system,'' even though the proposed rule used the term 
``qualified individual.'' Likewise, we use the new term ``preventive 
controls qualified individual'' for the proposed term ``qualified 
individual'' when describing the comments to the proposed rule, even 
though those comments use the term ``qualified individual.''
    In the following paragraphs, we discuss comments on this proposed 
definition. (See also our discussion (in section XXXVI) of the 
requirements applicable to the preventive controls qualified individual 
(Sec.  117.180(c)).)
    (Comment 112) Some comments assert that the proposed definition of 
preventive controls qualified individual is ambiguous.
    (Response 112) The comments provide no basis for asserting that 
this definition is ambiguous, such as difficulties in how we have 
interpreted similar regulatory text in enforcing our HACCP regulations 
for seafood and juice (Sec. Sec.  123.10 and 120.13(b), respectively). 
The proposed definition includes a performance standard (qualified to 
develop and apply a food safety system), two criteria for how a person 
can become qualified (specialized training or job experience), and a 
description of the type of applicable training (development and 
application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum). The proposed definition 
provides flexibility for how an individual can become qualified, but 
this flexibility does not make the definition ambiguous.
    (Comment 113) Some comments ask us to expand the definition so that 
it includes a team of preventive controls qualified individuals, not 
just a single person.
    (Response 113) We decline this request. The definition applies to 
each preventive controls qualified individual that a facility relies on 
to satisfy the requirements of the rule without limiting the number of 
such preventive controls qualified individuals. The requirements of the 
rule make clear that a facility may rely on more than preventive 
controls qualified individual (see, e.g., Sec.  117.180(a)).
    (Comment 114) One comment asks us to include ``trusted trader'' 
(i.e., a company or entity in the supply chain proven to be low risk) 
in the definition of preventive controls qualified individual.
    (Response 114) We decline this request. The concept of ``trusted 
trader'' applies to a facility's suppliers, not to individuals 
qualified to develop and apply a food safety system.
26. Qualified Auditor
    We proposed to define the term ``qualified auditor'' to mean a 
person who is a preventive controls qualified individual as defined in 
this part and has technical expertise obtained by a combination of 
training and experience appropriate to perform the auditing function as 
required by Sec.  117.180(c)(2). As discussed in Response 569, we have 
revised the definition to specify that ``qualified auditor'' means a 
person who is a ``qualified individual'' as that term is defined in 
this final rule, rather than a ``preventive controls qualified 
individual,'' because some auditors may be auditing businesses (such as 
produce farms) that are not subject to the requirements for hazard 
analysis and risk-based preventive controls, and it would not be 
necessary for such an auditor to be a ``preventive controls qualified 
individual.'' We also have clarified that the technical expertise is 
obtained through education, training, or experience (or a combination 
thereof) necessary to perform the auditing function to align the 
description of applicable education, training, and experience with the 
description of applicable education, training, and experience in the 
definition of ``qualified individual'' (see Sec.  117.3).
    (Comment 115) Some comments ask us to revise the definition of 
qualified auditor to include persons who have technical expertise 
obtained by a combination of training, experience, or education 
appropriate to perform audits. Some comments ask us to recognize that 
training and/or experience can make a person a qualified auditor; the 
comments state that people with experience performing audits likely 
have applicable training but might not have completed a specific 
regimen of courses. Some comments maintain that we should recognize the 
role of the education of a potential qualified auditor, as well as 
training and experience to meet the criteria.
    (Response 115) We agree that a qualified auditor might obtain the 
necessary auditing expertise in part through education, as well as 
through training and experience, and we have revised the definition of 
qualified auditor accordingly. However, we conclude that a person must 
have at least some actual experience in auditing to meet the definition 
of a qualified auditor, i.e., the necessary technical expertise cannot 
be obtained solely through education and/or training. Therefore, the 
revised definition retains the proposed criterion that a qualified 
auditor has technical expertise obtained by experience, as well as by 
education and training.
    (Comment 116) Some comments that support the proposed definition 
ask us to revise the definition to specify certain individuals who 
would be considered qualified auditors, such as FDA inspectors, 
properly trained Federal auditors, and State and private auditors 
operating under a contract with the Federal Government.
    (Response 116) We have revised the regulatory text to specify that 
examples of a qualified auditor include: (1) A government employee, 
including a foreign government employee and (2) an audit agent of a 
certification body that is accredited in accordance with regulations in 
part 1, subpart M (i.e., regulations in our forthcoming third-party 
certification rule implementing section 808 of the FD&C Act (21 U.S.C. 
348d)). Although we agree that it is useful to include examples of 
individuals who would have the appropriate qualifications, the example 
of an audit agent of a certification body that has been accredited in 
accordance with regulations in our forthcoming third-party 
certification rule adds context about the standard for such 
individuals. Because paragraph (2) of the new provision refers to 
provisions in a future third-party certification rule, we will publish 
a document in the Federal Register announcing the effective date of 
paragraph (2) once we finalize the third-party certification rule.

[[Page 55955]]

27. Qualified End-user
    We proposed to define the term ``qualified end-user'' to mean, with 
respect to a food, the consumer of the food (where the term consumer 
does not include a business); or a restaurant or retail food 
establishment (as those terms are defined in Sec.  1.227) that: (1) Is 
located (a) in the same State as the qualified facility that sold the 
food to such restaurant or establishment; or (b) not more than 275 
miles from such facility; and (2) is purchasing the food for sale 
directly to consumers at such restaurant or retail food establishment. 
We have revised the definition of ``qualified end-user'' to add ``or 
the same Indian reservation'' to clarify for purposes of this rule so 
that ``in the same State'' under section 418(l)(4)(B)(ii)(I) of the 
FD&C Act includes both within a State and within the reservation of a 
Federally-Recognized Tribe.
    (Comment 117) Some comments object to the description of a 
qualified end-user as being not more than 275 miles from a facility 
that sold the food and assert that there is no scientific or risk-based 
reason to support the distance of 275 miles. Other comments ask us to 
clarify whether the criterion of not more than 275 miles from a 
facility that sold the food would provide for qualified end-users to be 
located across State lines and/or international borders relative to the 
facility that sold the food. Other comments ask us to revise the 
definition of ``restaurant or retail food establishment'' to include 
businesses such as supermarkets, supermarket distribution centers, food 
hubs, farm stands, farmers markets, and CSA.
    (Response 117) We have not revised the definition of ``qualified 
end-user,'' which reflects section 418(l)(4) of the FD&C Act, in 
response to these comments. As discussed in Response 581, we intend to 
focus on records demonstrating that a facility is a very small business 
(i.e., financial records demonstrating that a business averages less 
than a specified dollar threshold) rather than records demonstrating 
sales directly to qualified end-users. Likewise, we have not revised 
the definition of ``restaurant or retail food establishment'' to 
clarify whether particular businesses such as those mentioned in the 
comments would be considered as ``qualified end-users.'' Focusing on 
whether a facility is a very small business makes it unnecessary to 
determine whether an enterprise that receives the food is a retail food 
establishment. However, as discussed in section I.E, we have issued a 
separate proposed rule to amend the definition of ``retail food 
establishment'' in the section 415 registration regulations. We intend 
to issue a final rule to amend the definition of ``retail food 
establishment'' in the section 415 registration regulations in the near 
future. (See also Response 4.)
28. Qualified Facility
    We proposed to define ``qualified facility'' by incorporating the 
description of ``qualified facility'' in section 418(l)(1) of the FD&C 
Act with editorial changes to improve clarity. That definition includes 
two types of facilities: (1) A facility that is a very small business 
as defined in this rule; and (2) A facility to which certain statutory 
criteria apply regarding the average monetary value of food sold by the 
facility and the entities to whom the food was sold.
    Some comments discuss issues related to the definition of very 
small business. See Comment 154, Comment 156, Comment 157, and Comment 
158 and our associated responses.
    (Comment 118) Some comments assert that the definitions of 
``affiliate'' and ``subsidiary'' in the definition of ``qualified 
facility'' fail to account for the legal differences between a piece of 
property (i.e., a facility) and a business entity or person. These 
comments ask us to consider revising the proposed definition of 
``qualified facility'' to clarify what sales to include in determining 
whether a facility so qualifies.
    (Response 118) We have not revised the proposed definition of 
``qualified facility'' as requested by these comments. The sales to be 
included when a facility determines whether it meets the definition of 
a qualified facility are the sales of human food by a business entity, 
which includes the parent company and all its subsidiaries and 
affiliates. The total sales are applicable to each entity, whether it 
is the parent, the subsidiary, or the affiliate. We intend to address 
issues such as these in guidance as directed by section 
418(l)(2)(B)(ii) of the FD&C Act. (See also Comment 77 regarding the 
definitions of ``affiliate'' and ``subsidiary'' and our associated 
responses. See also Response 154 regarding the applicability of the 
monetary threshold of sales of human food plus the market value of 
human food manufactured, processed, packed, or held without sale (e.g., 
held for a fee).)
    (Comment 119) Some comments ask us to clarify who will determine 
whether a particular facility is a qualified facility.
    (Response 119) Any facility that determines that it satisfies the 
criteria for a ``qualified facility'' must notify FDA of that 
determination (see Sec.  117.201) and, thus, the first determination 
will be made by the facility itself. During inspection, the 
investigator could ask to see the records that support the facility's 
determination to verify the facility's determination.
    (Comment 120) Some comments address that part of the definition 
that discusses ``average annual monetary value of the food 
manufactured, processed, packed, or held at such facility, that is 
sold.'' These comments ask us to clarify whether the operative word in 
the clause is ``held'' or ``sold.''
    (Response 120) The operative word, for the purpose of calculating 
the average monetary value of that food, is ``sold.'' (See also 
Response 154 regarding the applicability of the monetary threshold of 
sales of human food plus the market value of human food manufactured, 
processed, packed, or held without sale (e.g., held for a fee).)
29. Ready-to-Eat Food (RTE Food)
    We proposed to define the term ``ready-to-eat food'' to mean any 
food that is normally eaten in its raw state or any other food, 
including processed food, for which it is reasonably foreseeable that 
the food would be eaten without further processing that will 
significantly minimize biological hazards.
    (Comment 121) Some comments ask us to substitute ``reasonably 
expected'' for ``reasonably foreseeable.''
    (Response 121) We decline this request. We see no substantive 
difference between ``reasonably expected'' and ``reasonably 
foreseeable.'' The term ``reasonably foreseeable'' is used in other 
provisions of the rule, including the defined term ``known or 
reasonably foreseeable hazard.''
    (Comment 122) Some comments ask us to clarify the distinction 
between a food that satisfies the definition of ``ready-to-eat'' and a 
food that satisfies the definition of a RAC. Some of these comments 
express concern that if tree fruits are classified as ``RTE food'' 
rather than as a RAC, we could force packers to do mandatory product 
testing.
    (Response 122) The terms RTE food and RAC are not mutually 
exclusive. Some RACs (such as lettuce, tomatoes, berries, and apples) 
are ready-to-eat, whereas other RACs (such as artichokes and potatoes) 
are not. The requirements for product testing as a verification 
activity are flexible requirements that depend on the facility, the 
food, and the

[[Page 55956]]

nature of the preventive control (see Sec.  117.165). See also Response 
525.
30. Receiving Facility
    We proposed to define the term ``receiving facility'' to mean a 
facility that is subject to subpart C of this part and that 
manufactures/processes a raw material or ingredient that it receives 
from a supplier.
    (Comment 123) Some comments ask us to modify the definition to 
specify that the receiving facility could receive the raw material or 
ingredient directly from a supplier or by means of an intermediary 
entity. These comments assert that without this added regulatory text 
the proposed definition implies that the material or ingredient must be 
received directly from the supplier.
    (Response 123) We decline this request. As discussed in Response 
658, the two parties that are critical to the supplier verification 
program are the receiving facility and the supplier, even if there are 
entities in the supply chain between the two. The definition of 
receiving facility does not preclude the participation of intermediary 
entities in the supply chain, and the rule does provide for such 
participation (see Response 657). However, the definition of receiving 
facility does highlight the fact that a receiving facility must have a 
link to a supplier.
    (Comment 124) Some comments that support the definition of 
receiving facility ask us to clarify that a cold storage facility is 
not by definition a receiving facility because it is not engaged in 
manufacturing/processing, but could be a supplier if temperature 
controls are needed to control a significant hazard.
    (Response 124) We agree that a cold storage facility is not likely 
to be a receiving facility if it is not engaged in manufacturing/
processing. However, it is the nature of the activity as manufacturing/
processing, rather than the use of a preventive control for purposes 
other than manufacturing/processing, that is relevant here. By 
definition, the supplier must also be engaged in manufacturing/
processing, raising animals, or growing food (see the definition of 
``supplier'' in Sec.  117.3). A cold storage facility has a 
responsibility to maintain foods that require temperature control for 
safety at an appropriate temperature, but generally does not engage in 
manufacturing/processing. However, a cold storage facility in the 
supply chain between the supplier and the receiving facility could 
participate in supplier verification activities (see Response 657).
31. Sanitize
    We proposed to define ``sanitize'' to mean to adequately treat 
cleaned food-contact surfaces by a process that is effective in 
destroying vegetative cells of microorganisms of public health 
significance, and in substantially reducing numbers of other 
undesirable microorganisms, but without adversely affecting the product 
or its safety for the consumer. We proposed to revise this otherwise 
long-standing definition by inserting the term ``cleaned'' before 
``food-contact surfaces'' because chemical sanitizers can be 
inactivated by organic material and, thus, are not effective unless 
used on clean surfaces (78 FR 3646 at 3697).
    (Comment 125) Some comments ask us to adopt a definition of 
``sanitize'' similar to that found in the Pasteurized Milk Ordinance 
(PMO), which recognizes that cleaning and sanitizing do not always have 
to be separate, sequential steps. These comments report that the 
definition in the PMO is ``the application of any effective method or 
substance to properly cleaned surfaces for the destruction of 
pathogens, and other microorganisms, as far as is practicable.'' Other 
comments agree with the proposed definition as it applies to chemical 
sanitizers, but disagree that clean surfaces are required for effective 
sanitizing for those systems that use steam and dry heat, such as those 
authorized by Appendix F of the PMO. These comments ask us to clarify 
that the ``cleaning'' should be appropriate to the specific food system 
and method used for sanitizing, and that cleaning should only be 
required when the sanitizing process alone would not be effective 
without a prior cleaning step.
    Some comments express concern about whether the proposed definition 
of ``sanitize'' would preclude the continued, routine use of dry 
cleaning methods with no sanitizing step. These comments note that 
adding routine aqueous-based cleaning and sanitizing procedures could 
create a public health risk in certain operations such as low-moisture 
food production. These comments also note that dry cleaning procedures 
can result in equipment that, while sanitary, is neither visibly clean 
nor suitable for aqueous chemical sanitizers.
    (Response 125) We consider that systems such as steam systems clean 
the surfaces, as well as sanitize them and, thus, satisfy the 
definition of ``sanitize.'' The definition of ``sanitize'' does not 
preclude the continued use of dry cleaning methods with no sanitizing 
step because the definition describes the meaning of the term 
``sanitize'' without establishing any requirement for when equipment 
must be sanitized.
    We have revised the definition so that it means adequately treating 
``surfaces'' rather than ``food-contact surfaces.'' Doing so is 
consistent with the definition of ``sanitize'' in the PMO. As a 
technical matter, adequately treating any surface--regardless of 
whether it is a food-contact surface--by a process that is effective in 
destroying vegetative cells of pathogens, and in substantially reducing 
numbers of other undesirable microorganisms, but without adversely 
affecting the product or its safety for the consumer, is ``sanitizing'' 
the surface. Clarifying this technical meaning of the term ``sanitize'' 
imposes no requirements to sanitize surfaces other than food-contact 
surfaces; the requirements for sanitizing surfaces are established by 
provisions such as Sec.  117.37(d), not by the definition of the term 
``sanitize.''
32. Significant Hazard (Hazard Requiring a Preventive Control)
    We proposed to define the term ``significant hazard'' to mean a 
known or reasonably foreseeable hazard for which a person knowledgeable 
about the safe manufacturing, processing, packing, or holding of food 
would, based on the outcome of a hazard analysis, establish controls to 
significantly minimize or prevent the hazard in a food. The rule would 
use the term ``significant hazard'' rather than ``hazard reasonably 
likely to occur'' to reduce the potential for a misinterpretation that 
all necessary preventive controls must be established at CCPs (79 FR 
58524 at 58526).
    (Comment 126) Comments support using a term other than ``hazard 
reasonably likely to occur'' and agree that using a term other than 
``hazard reasonably likely to occur'' throughout the rule will reduce 
the potential for a misinterpretation that all necessary preventive 
controls must be established at CCPs.
    Some comments support the regulatory text of the proposed 
definition of the term ``significant hazard.'' These comments state 
that the proposed regulatory text more closely aligns with the 
principles in FSMA (``reasonably foreseeable'' and ``significantly 
minimize or prevent'') and provides operators the flexibility to 
implement a range of preventive controls that are commensurate with the 
risk and probability posed by a specific hazard. Some comments agree 
that the proposed regulatory text can clarify the difference between 
HACCP rules and the human preventive controls rule.

[[Page 55957]]

Some comments state that the proposed regulatory text plainly reflects 
the concept that significant hazards are those hazards to be addressed 
through the very broad category of preventive controls, and the rule is 
explicit that preventive controls may be controls other than at CCPs. 
Some comments state that the definition reflects the risk-based nature 
(i.e., both the severity of a potential hazard and the probability that 
the hazard will occur) of the requirements and provides additional 
flexibility so that facilities can take into account the nature of the 
preventive control in determining when and how to establish and 
implement appropriate preventive control management components. Some 
comments support including the phrase ``based on the outcome of a 
hazard analysis'' in the definition because it ensures that 
identification of significant hazards will be risk based. Some comments 
ask us to preserve in the final definition two key aspects that grant 
the food industry the flexibility that it needs: (1) The logical 
conclusion that not all hazards will have the same impact or will even 
constitute ``significant hazards'' at all, depending on the facility's 
products and position in the supply chain; and (2) the fact that a 
``person knowledgeable about the safe manufacturing, processing, 
packing, or holding of food'' must be knowledgeable about the specific 
food produced at that facility and in that specific sector of the food 
industry.
    Some of the comments that support the regulatory text of the 
proposed definition nonetheless express concern about the term 
``significant hazard.'' Some of these comments express concern that a 
facility may not recognize hazards that need to be controlled because 
they do not rise to the commonly understood meaning of ``significant.'' 
Other comments express concern that the adjective ``significant'' is 
subject to many interpretations and suggest that the term ``hazard 
requiring control'' would be more straightforward, accurate, and 
suitable.
    Other comments express concern that the term ``significant hazard'' 
could cause confusion because it has implications in HACCP systems. For 
example, ``significant hazard'' is often used in the context of CCPs, 
and preventive controls are not necessarily established at CCPs. Some 
of these comments suggest that we eliminate the term and instead use 
the full regulatory text of the proposed definition in place of 
``significant hazard'' throughout the regulations. Other comments 
suggest using a term such as ``food safety hazard'' or ``actionable 
hazard'' instead of ``significant hazard'' to avoid a term that has 
HACCP implications. Other comments state that the term ``significant 
hazard'' has implications for facilities that follow the Codex HACCP 
Annex and express concern that foreign facilities would be especially 
likely to be confused by the term ``significant hazard.''
    Some comments ask us to ensure that the term ``significant hazard'' 
is used consistently and express the view that some regulatory text 
refers to a ``hazard'' or ``known or reasonably foreseeable hazard'' 
where ``significant hazard'' should instead be used. As discussed in 
Comment 93, some comments express concern that the rule would refer to 
multiple levels of hazard and ask us to provide sufficient clarity to 
be able to distinguish between these types of hazards.
    (Response 126) We have changed the term ``significant hazard'' to 
``hazard requiring a preventive control.'' The new term uses the 
explicit language of FSMA (i.e., ``preventive control''), is consistent 
with the specific suggestion of one comment (i.e., hazard requiring a 
control''), and is not commonly associated with HACCP systems. We 
decline the request to use the term ``food safety hazard'' because that 
term already is established in Federal HACCP regulations for seafood 
and meat/poultry, and the comments are particularly concerned about 
using a term that has implications for HACCP systems. We also decline 
the request to use the term ``actionable hazard,'' because the term 
``actionable'' is associated with violations at a food processing 
plant.
    We reviewed the full regulatory text of proposed subpart C and 
replaced ``significant hazard'' with ``hazard requiring a preventive 
control'' in most cases. See table 10 for the provisions where we made 
that change and for an explanation of those provisions where we 
replaced ``significant hazard'' with ``hazard'' or ``hazard requiring a 
process control.''

                           Table 10--Substitutions for the Term ``Significant Hazard''
----------------------------------------------------------------------------------------------------------------
                                                                                         Reason for substituting
                                                                  Term substituted for      a term other than
               Section                       Description         ``significant hazard''    ``hazard requiring a
                                                                                           preventive control''
----------------------------------------------------------------------------------------------------------------
117.130(a)(1)........................  Requirement to conduct   Hazard requiring a       N/A.\1\
                                        a hazard analysis.       preventive control.
117.135(a)(1)........................  Requirement to identify  Hazard requiring a       N/A.\1\
                                        and implement            preventive control.
                                        preventive controls.
117.135(c)(2)(ii)....................  Maximum and minimum      Hazard requiring a       The provision is
                                        values associated with   process control.         narrowly directed to a
                                        process controls.                                 specific category of
                                                                                          preventive controls--
                                                                                          i.e., process
                                                                                          controls.
117.139..............................  Recall plan............  Hazard requiring a       N/A.\1\
                                                                 preventive control.
117.160..............................  Validation.............  Hazard.................  Specifying that a
                                                                                          facility must validate
                                                                                          that the preventive
                                                                                          controls are adequate
                                                                                          to control ``the
                                                                                          hazard'' adequately
                                                                                          communicates the
                                                                                          requirement. In
                                                                                          contrast, specifying
                                                                                          that a facility must
                                                                                          validate that the
                                                                                          preventive controls
                                                                                          are adequate to
                                                                                          control the ``hazard
                                                                                          requiring a preventive
                                                                                          control'' would be
                                                                                          unnecessarily bulky
                                                                                          and awkward.

[[Page 55958]]

 
117.165(a)...........................  Activities for           Hazard.................  Specifying that a
                                        verification of                                   facility must verify
                                        implementation and                                that the preventive
                                        effectiveness of                                  controls are
                                        preventive controls.                              consistently
                                                                                          implemented and are
                                                                                          effectively and
                                                                                          significantly
                                                                                          minimizing or
                                                                                          preventing ``the
                                                                                          hazards'' adequately
                                                                                          communicates the
                                                                                          requirement. In
                                                                                          contrast, specifying
                                                                                          that a facility must
                                                                                          verify that the
                                                                                          preventive controls
                                                                                          are consistently
                                                                                          implemented and are
                                                                                          effectively and
                                                                                          significantly
                                                                                          minimizing or
                                                                                          preventing ``the
                                                                                          hazards requiring a
                                                                                          preventive control''
                                                                                          would be unnecessarily
                                                                                          bulky and awkward.
117.165(a)(3)........................  Requirement for          Hazard requiring a       N/A.\1\
                                        environmental            preventive control.
                                        monitoring to verify
                                        implementation and
                                        effectiveness of
                                        preventive controls.
----------------------------------------------------------------------------------------------------------------
\1\ N/A = Not applicable.

    We also reviewed the full regulatory text of proposed subpart C to 
evaluate whether there were any circumstances where the regulatory text 
should more appropriately refer to ``hazard requiring a preventive 
control'' rather than ``hazard'' or ``known or reasonably foreseeable 
hazard.'' The term ``known or reasonably foreseeable hazard'' appears 
only once, in the requirement for a facility to conduct a hazard 
analysis (Sec.  117.130(a)). We are retaining ``known or reasonably 
foreseeable hazard'' in that requirement because it is necessary to 
implement the tiered approach to the requirements for hazard analysis 
and risk-based preventive controls (see Response 93). To reinforce this 
tiered approach, and emphasize that the facility only conducts a hazard 
analysis for known or reasonably foreseeable hazards, we revised 
``hazard'' to ``known or reasonably foreseeable hazard'' in two 
additional provisions in the requirements for hazard identification 
(see the introductory regulatory text for Sec.  117.130(b)(1) and (2)).
    In our review of the full regulatory text of proposed subpart C, we 
did not identify any circumstances where we believe it is appropriate 
and necessary to specify ``hazard requiring a preventive control'' in 
place of ``hazard.'' It is not necessary for the regulatory text of 
requirements for preventive controls, the supply-chain program, the 
recall plan, corrective actions, and verification to specify ``hazard 
requiring a preventive control'' every time that the requirements use 
the term ``hazard'' because the context of the requirement establishes 
the applicability to ``hazards requiring a preventive control.'' 
Although we acknowledge that using ``hazard requiring a preventive 
control'' in place of ``hazard'' throughout applicable provisions of 
proposed subpart C would emphasize the tiered approach to the 
requirements for hazard analysis and risk-based preventive controls, 
doing so would make the regulatory text unnecessarily bulky and awkward 
and would be inconsistent with comments that ask us to make the 
regulatory text understandable (see Comment 13).
    (Comment 127) Some comments express concern that the proposed 
definition of ``significant hazard,'' which contains the phrase ``for 
which a person . . . would establish controls'' is problematic in that 
facilities are likely to have already established preventive controls 
for a variety of hazards that may not rise to the level of control 
management required for a ``significant hazard'' and would instead 
routinely be addressed in ``prerequisite programs.'' These comments 
express particular concern that identification of these hazards in and 
of themselves should not elevate control of these hazards to the 
category of being a ``significant hazard.'' Some comments ask us to 
allow facilities to continue to implement existing controls outside the 
framework of this rule (i.e., outside the framework that requires 
preventive control management components as appropriate to ensure the 
effectiveness of the preventive controls, taking into account the 
nature of the preventive control and its role in the food safety 
system) when a hazard addressed by the existing controls does not rise 
to the level of ``significant hazard.''
    Other comments express concern that the term ``significant hazard'' 
may create a disincentive for facilities to voluntarily implement 
preventive controls for hazards that only pose a remote risk or are 
very rarely encountered, because implementing preventive controls for 
hazards of very low probability and severity may be misinterpreted as 
requiring preventive controls applicable to a ``significant hazard'' 
even if the hazard does not meet the definition of ``significant 
hazard'' established in the rule. Some comments ask us to revise the 
definition to provide facilities with the flexibility and discretion to 
establish appropriate preventive controls for hazards that do not rise 
to the criteria of a ``significant hazard,'' as well as ensuring that 
preventive controls that address remote or very unlikely hazards not be 
subject to the preventive control management requirements for a 
``significant hazard.''
    (Response 127) We have revised the definition to specify that the 
term ``hazard requiring a preventive control'' applies when a 
knowledgeable person would, based on the outcome of a hazard analysis, 
``establish one or more preventive controls'' rather than ``establish 
controls.'' By narrowing ``controls'' to ``one or more preventive 
controls,'' we mean to signify that the proposed term ``significant 
hazard'' (which we now refer to as ``hazard requiring a preventive 
control'') only applies to those controls that the facility establishes 
to comply with the

[[Page 55959]]

requirements of subparts C and G for hazard analysis and risk-based 
preventive controls. A facility that establishes other controls (such 
as those that the comments describe as ``prerequisite programs,'' or 
controls directed to hazards of very low probability and severity) for 
hazards that are not, based on the outcome of the facility's hazard 
analysis, ``hazards requiring a preventive control'' would not need to 
establish preventive control management components for such controls. 
However, some controls previously established in ``prerequisite 
programs'' would be considered ``preventive controls.'' We provide some 
flexibility for facilities with respect to how they manage preventive 
controls, and the preventive control management components may be 
different for hazards that have been managed as ``prerequisite 
programs'' compared to those managed with CCPs. A facility that is 
concerned about the potential for an investigator to disagree during 
inspection that certain controls are not directed to ``hazards 
requiring a preventive control'' could, for example, include 
information relevant to its classification of those other controls in 
its hazard analysis, whether by merely listing the ``other controls'' 
or by providing a brief explanation why such controls are not 
``preventive controls'' as that term is defined in this rule.
    (Comment 128) Some comments assert that the proposed definition of 
``significant hazard'' is tautological because it essentially 
establishes a ``significant hazard'' to be a known or reasonably 
foreseeable hazard (i.e., the type of hazards identified in the first 
step of the analysis) for which preventive controls should be 
implemented. These comments assert that the proposed definition of 
``significant hazard'' would collapse the second step of hazard 
analysis into the first, which in turn would lead to the unintended 
consequence of facilities identifying the same hazards in the second 
step as in the first. Other comments ask us to revise the definition to 
clarify and distinguish the two steps of the hazard analysis by 
specifying within the definition that a significant hazard is a known 
or reasonably foreseeable hazard for which there is a reasonable 
probability, based on experience, illness data, scientific reports, or 
other information relevant to the food or the facility, that adverse 
health consequence or death will occur in the absence of its control. 
Some comments ask us to revise the definition to include evaluation of 
severity and probability, because these concepts are integral for 
making a proper determination of whether a hazard is significant. Other 
comments ask us to revise the definition to better reflect the risk-
based approach that preventive controls be implemented to control 
hazards that have a higher probability of resulting in public health 
consequence in the absence of control.
    (Response 128) We have revised the definition of ``significant 
hazard'' (which we now refer to as ``hazard requiring a preventive 
control'') to specify that the hazard analysis includes an assessment 
of the severity of the illness or injury if the hazard were to occur 
and the probability that the hazard will occur in the absence of 
preventive controls. By specifying that the determination of a 
``significant hazard'' is based on the outcome of a hazard analysis, 
the proposed definition did, as requested by the comments, include the 
risk-based nature of the determination. However, explicitly adding that 
the hazard analysis is based on probability and severity (i.e., risk) 
makes the risk-based nature of the determination clearer.
    We disagree that the proposed definition was tautological and would 
collapse the second step of hazard analysis into the first. As 
discussed in Response 93, a facility begins its hazard analysis by 
narrowing down the universe of all hazards to those that are ``known or 
reasonably foreseeable'' for each type of food manufactured, processed, 
packed, or held at its facility. The outcome of the facility's hazard 
analysis is a determination of a subset of those known or reasonably 
foreseeable hazards--i.e., those hazards requiring a preventive 
control. To the extent that these comments are asserting that the 
tautology was created by the phrase ``in the absence of its control'' 
in the proposed definition of ``hazard,'' we have deleted that phrase 
from the final definition of ``hazard'' (see Response 94).
    We decline the request to modify the definition to specify that a 
hazard requiring a preventive control is one for which there is a 
reasonable probability, based on experience, illness data, scientific 
reports, or other information relevant to the food or the facility, 
that adverse health consequence or death will occur in the absence of 
its control. The standard for harm in the definition of ``hazard'' is 
illness or injury. We disagree that the standard for harm in the 
definition of ``hazard requiring a preventive control'' should be 
different from (i.e., adverse health consequences), or greater than 
(i.e., death), the standard for harm in the definition of ``hazard.'' 
We also disagree that the definition of ``hazard requiring a preventive 
control'' needs to be modified to state that preventive controls are 
implemented to control hazards that have a higher probability of 
resulting in public health consequence in the absence of control. The 
definition already communicates the role of risk (i.e., severity and 
probability) in conducting the hazard analysis that identifies those 
hazards requiring a preventive control.
    We also decline the request to repeat in the definition of ``hazard 
requiring a preventive control'' the requirement for the types of 
information that a facility would consider in conducting its hazard 
analysis. The requirements for hazard analysis clearly specify that a 
facility must conduct its hazard analysis based on experience, illness 
data, scientific reports, and other information (see Sec.  117.130(a)).
    (Comment 129) Some comments that broadly address the overall 
framework for the new requirements for hazard analysis and risk-based 
preventive controls ask us to consistently refer to ``the nature of the 
preventive control'' (rather than simply to ``the preventive control'') 
when communicating the flexibility that a facility has in identifying 
preventive controls and associated preventive control management 
components. (See Comment 455). Other comments that broadly address the 
overall framework for the new requirements for hazard analysis and 
risk-based preventive controls ask us to emphasize that the 
requirements for preventive control management components convey not 
only that the application of a particular element is appropriate (i.e., 
capable of being applied), but also necessary for food safety. Some 
comments recommend that we do so by specifying that preventive control 
management components take into account the role of the preventive 
control in the food safety system. (See Comment 455.)
    (Response 129) We agree with these comments and have revised the 
definition of ``hazard requiring a preventive control'' to specify that 
preventive control management components are established as appropriate 
to ``the nature of the preventive control and its role in the 
facility's food safety system.'' (See also Response 455, where we 
describe additional provisions that we have revised to clarify that 
preventive control management components are established as appropriate 
to the nature of the preventive control and its role in the facility's 
food safety system.)
    (Comment 130) Some comments ask us to modify the definition of 
``significant hazard'' to specify that the

[[Page 55960]]

preventive control management components be established as appropriate 
to both the food and the intended use of the food.
    (Response 130) We decline this request. It is not necessary to 
repeat in the definition of ``hazard requiring a preventive control'' 
the requirement for the hazard evaluation to consider the intended use 
of the food. The requirements for hazard evaluation clearly specify 
that a facility must consider the intended or reasonably foreseeable 
use of the food (see Sec.  117.130(c)(2)(viii)).
    (Comment 131) Some comments assert that the problem is how to 
separate the hazards addressed by ``HACCP'' from those addressed by 
CGMPs. These comments suggest that control measures that are 
implemented for hazards from ingredients and food-contact packaging 
material, and from production and process, be called CCPs and that 
control measures that are implemented for hazards from personnel, 
equipment, and the plant be called preventive controls.
    (Response 131) The facility must control hazards through the 
application of CGMPs and preventive controls as appropriate to the 
hazard. Although some preventive controls will be established at CCPs, 
and ``CCP'' is a term commonly used in HACCP systems, this rule 
establishes requirements for hazard analysis and risk-based preventive 
controls, not ``HACCP,'' and this rule provides that preventive 
controls include controls at CCPs, if there are any CCPs, as well as 
controls, other than those at CCPs, that are also appropriate for food 
safety (see Sec.  117.135(a)(2)).
    Under the rule, some hazards may be addressed by CGMPs and others 
by preventive controls. For example, if a facility manufactures egg 
biscuit sandwiches, it could establish a preventive control, as a CCP, 
for cooking the eggs and establish CGMP controls to address the 
potential for personnel to contaminate the cooked egg and the egg 
biscuit sandwiches. As another example, a facility could control a 
physical hazard such as metal using screens and magnets under CGMPs and 
then use a metal detector as a preventive control. See also Response 
437, in which we give examples regarding when a facility might control 
food allergen hazards through a combination of CGMP controls and ``food 
allergen controls,'' which are a particular type of preventive control 
(see Sec.  117.135(c)(2)).
    (Comment 132) Some comments ask us to add examples throughout the 
regulatory text (e.g., in the requirements for hazard analysis, 
preventive controls, and recall plan) to reflect food allergens as a 
significant hazard.
    (Response 132) We decline this request. Food allergens are included 
as an example of a chemical hazard that a facility must consider when 
determining whether there are any known or reasonably foreseeable 
hazards requiring a preventive control (Sec.  117.130(b)(1)(ii)), and 
the rule specifically provides for food allergen controls where 
relevant. It is not necessary to include examples of food allergens as 
hazards requiring a preventive control throughout the regulatory text.
    (Comment 133) Some comments express concern that too much 
flexibility may make it harder for us to inspect conditions in a 
facility over time. These comments emphasize that we must not permit 
facilities to interpret the term ``significant hazard'' as allowing 
them to substitute inadequate sanitation programs--which may not 
require documentation of monitoring or verification measures--for 
necessary critical control points.
    (Response 133) We acknowledge that there can be a tension between 
the need for flexible requirements that must apply to diverse food 
processing facilities and the regulatory need to evaluate compliance 
with requirements. See Response 5 regarding our approach to enforcing 
the rule. Although preventive controls, such as sanitation controls, 
are not always directed to critical control points (see Sec.  
117.135(a)(2)(ii)), we agree that there could be circumstances where we 
would disagree with a facility about the measures it has in place 
regarding sanitation. We will address such circumstances on a case-by-
case basis.
    (Comment 134) Some comments express concern that the term 
``significant hazard'' may lead to misunderstanding by medium and 
smaller processors and ask how businesses with limited food safety 
experience will understand the difference between a food safety hazard 
that is ``reasonably likely to occur'' (and, thus, must be controlled 
by a full HACCP Plan) and a ``Significant Hazard'' that can be 
controlled by a preventive control plan.
    (Response 134) In most cases, it will not be necessary for a food 
processor to understand the difference between a hazard that is 
``reasonably likely to occur'' in the concept of HACCP requirements and 
a ``hazard requiring a preventive control'' in the context of this 
rule. Instead, a food processor must identify those regulations that 
apply to it. For example, a processor of juice products is subject to 
our HACCP regulations for juice, but is not subject to the requirements 
of this rule.
    (Comment 135) Some comments express concern about the potential for 
divergent interpretations of the definition by industry and regulators. 
Some comments state that a baseline understanding between industry and 
regulatory officials will need to be established as to what constitutes 
a ``significant hazard'' and what preventive controls will be deemed to 
be adequate to control such a hazard. Some comments ask us to provide 
guidance or allow ``inter-state compacts'' to provide guidelines on 
what constitutes significant hazards in major food industries. Other 
comments assert that the FSPCA provides the best forum to identify what 
constitutes ``significant hazards'' in food, and to develop timely and 
appropriate guidance and training for addressing such hazards. Other 
comments ask to engage with us early and often on the development of 
applicable guidance documents regarding what constitutes a 
``significant hazard'' for produce industry operations and provide an 
opportunity to explain and discuss current industry best practices and 
preventive controls to address identified significant hazards. Some 
comments ask us to develop an administrative procedure to adjudicate 
differences in professional opinion between a regulated firm and a 
Federal or State regulatory agency regarding hazard ``significance.''
    (Response 135) We agree that guidance will help create an 
understanding between industry and regulatory officials as to FDA 
recommendations for hazards that require preventive controls and 
appropriate preventive controls for those hazards. See Response 2 and 
Response 5. We decline the request to develop an administrative 
procedure to adjudicate differences in professional opinion between a 
regulated firm and a Federal or State regulatory agency regarding 
hazard ``significance.'' We note that existing procedures provide for 
an outside party to obtain internal agency review of a decision by an 
employee other than the Commissioner (see Sec.  10.75). The comments do 
not explain what they mean by ``inter-state compacts'' or provide any 
examples of ``inter-state compacts'' and, thus, it is not clear what, 
if any, role an ``inter-state compact'' could play in determining what 
constitutes a significant hazard in major food industries.
    (Comment 136) Some comments ask us to concur that ``temporal 
hazards'' in milk and dairy products (specifically,

[[Page 55961]]

aflatoxin, pesticides, and radiological contamination) do not represent 
``significant hazards'' that require monitoring and verification 
activities on an ongoing basis. These comments also ask us to 
acknowledge that in many cases the testing done by FDA and others is 
sufficient for protecting public health and that it is not necessary to 
require ongoing monitoring by individual dairy facilities to comply 
with the rule.
    (Response 136) We decline these requests because such a 
determination should be facility specific. However, we have revised the 
considerations for the hazard evaluation to clarify that in making the 
determination as to what hazards require preventive controls, the 
facility can consider factors such as the temporal nature of the hazard 
(see Sec.  117.130(c)(2)(x) and Response 407). In determining the 
appropriate preventive control management components, the facility can 
take into account the nature of the preventive control and its role in 
the facility's food safety system (see Sec.  117.140(a)).
    (Comment 137) One commenter asserts that municipal drinking water 
supplies can be variable such that they could be a hazard that is 
reasonably likely to occur and that relying on municipal water will 
compromise food safety. The commenter asks us to ``close the gap'' in 
Federal risk assessment policies by adding regulatory text to the 
proposed definition of ``significant hazard'' to specify that the 
hazards are based on the outcome of a hazard analysis that includes any 
water used by the facility, whatever its source. The commenter further 
asserts that FDA must require full scientific water risk analysis and 
written water safety plans and water treatment where necessary and that 
the written water safety plans must comply with FSMA standards for 
accurate and precise measurement instruments, monitoring, verification, 
and documentation. The commenter asserts that in lieu of a full 
assessment and testing, the plant could disinfect all incoming water to 
a preventive control standard, and track and document compliance. The 
commenter further asserts that its commercially available technology 
provides the most cost effective disinfection for a wide range of 
sporeformers, bacteria, viruses, algae and molds.
    In addition, the commenter asserts that food manufacturers who are 
not required to make a special effort to understand the status of their 
water supply through a required risk assessment process will not be 
aware of the need to institute preventive controls for their water 
supply. To support its position, the commenter makes assertions about 
the purpose of water standards established by the U.S. Environmental 
Protection Agency (EPA), the risk presented by water quality to the 
production of safe food, and the impact to food safety of EPA's 2013 
changes to the National Primary Drinking Water regulations (EPA's NPDW 
regulations; 41 CFR parts 141 and 142) regarding total coliforms (EPA's 
total coliform rule) (78 FR 10270, February 13, 2013).
    The commenter asserts that EPA's NPDW regulations hold public water 
suppliers to a standard that is protective of drinking water, not food 
manufacturing water. For example, the commenter describes EPA's NPDW 
regulations as requiring water suppliers to treat at least 95 percent 
of the water they distribute to the public to the treatment technique 
standard of the treatment they use and then argues that a user of the 
water would not necessarily know if it was getting some of the 
``allowable 5 percent off-spec water.'' The commenter also asserts that 
current standards in EPA's NPDW regulations are not universally 
achieved by all public water systems. The commenter also asserts that 
EPA's total coliforms rule further reduces the applicability of 
municipal water standards to food manufacturing (e.g., because it 
reduced the frequencies of water monitoring and public notices about 
water quality and instead shifted the regulatory scheme towards 
corrective action).
    According to the commenter 95,000 public water systems do not 
disinfect the water they provide to the public, and some studies have 
found infective viruses in drinking water samples in communities that 
did not disinfect their water. According to the commenter, water 
supplies close to aquifers that were not disinfected before 
distribution have recently had boil water advisories, demonstrating 
that problems with the water supply are reasonably likely to occur. The 
commenter questions whether the food manufacturing plants using that 
water had water safety back-up plans, stopped production, had 
monitoring measures in place to determine the impact of the unsafe 
water, or recalled product manufactured during the period when the 
municipal water systems had coliform positive tests but had not yet 
confirmed these tests and therefore had not yet issued the advisory. 
The commenter also asks whether the facilities relied on the 
traditional assumption that if they use municipal water their food 
safety risk analysis does not have to cover water, they do not need a 
written water safety plan, and they do not need to monitor the safety 
of their water.
    (Response 137) We decline the request to change the regulatory text 
to explicitly require that the hazard analysis address any water used 
by the facility, whatever its source. Many of the commenter's 
assertions address issues under the jurisdiction of EPA, such as 
``allowing'' ``5 percent off-spec water''; whether current standards 
are universally achieved by all public water systems; and whether it is 
appropriate to allow some water systems to not disinfect the water they 
supply. Such issues that are under the jurisdiction of EPA are outside 
the scope of this rulemaking. We consider that water standards directed 
to drinking water for household use would also be adequate for the 
production of food products and, thus, have no reason to question 
whether a facility can rely on the standards in EPA's NPDW regulations 
to satisfy the long-standing CGMP requirement that any water that 
contacts food, food-contact surfaces, or food-packaging materials must 
be safe and of adequate sanitary quality (Sec.  117.37(a)). For 
example, we consider that water standards that EPA concludes are 
appropriate for drinking water are also appropriate for the production 
of water-based beverages, which are mostly water. We also see no reason 
to specifically require that a facility that satisfies the CGMP 
requirement for water also address water quality in its hazard 
analysis. Further, if a facility chooses to address the safety of water 
in its hazard analysis (e.g., water used in washing fresh-cut produce), 
we consider it more likely that the facility would treat the water 
onsite, obtain the water supplier's records documenting the results of 
its water testing, or simply test the water on a periodic basis, rather 
than conduct a risk assessment for the water source.
    Under Sec.  117.37(a), we expect any food establishment--regardless 
of whether it is a facility subject to FSMA's requirements for hazard 
analysis and risk-based preventive controls--to be vigilant regarding 
public health advisories such as a ``boil water advisory'' and to take 
appropriate action in light of such advisories. It is not necessary for 
the regulatory text to specify each potential problem or to specify the 
actions a food establishment must take to address each potential 
problem.
33. Significantly Minimize
    We proposed to define the term ``significantly minimize'' to mean 
to reduce to an acceptable level, including to eliminate.

[[Page 55962]]

    (Comment 138) Some comments assert that the definition of 
``acceptable level'' for fresh produce is unclear because of the 
presence of spoilage microorganisms, which subject food to 
decomposition and reduce quality, but are not a public health concern. 
These comments ask us to revisit and change regulatory text that either 
does not clarify, or over-steps the intention of, the rule.
    (Response 138) We proposed to define ``significantly minimize'' to 
give context to the term used in FSMA to define ``preventive control.'' 
Thus, in this rule the term ``significantly minimize'' relates to 
hazards that will be addressed by preventive controls. The term 
``significantly minimize'' would not be relevant to spoilage 
microorganisms unless the facility determines, through its hazard 
analysis, that the spoilage microorganisms are a hazard requiring a 
preventive control. The standard of ``acceptable level'' is a flexible 
standard. By ``acceptable level,'' we mean a level that will not cause 
illness or injury or result in adulterated food.
34. Small Business
    We proposed to define the term ``small business'' to mean, for the 
purposes of part 117, a business employing fewer than 500 persons. As 
previously discussed, we conducted a Food Processing Sector Study as 
required by section 418(l)(5) of the FD&C Act (Ref. 19) and used the 
results of the study in defining the term ``small business'' (78 FR 
3646 at 3700 to 3701). We made the results of the Food Processing 
Sector Study available in Docket No. FDA-2011-N-0920 and requested 
public comment on that study.
    (Comment 139) Some comments express concern that the Food 
Processing Sector Study is not comprehensive. Some comments assert that 
FDA did not sufficiently collaborate with USDA, and that FDA 
significantly underestimated the number of mixed-use facilities, 
particularly by neglecting to count farms that perform the processing 
steps on RACs to become a processed food. Other comments assert that 
the Food Processing Sector Study is woefully inadequate and must be 
undertaken again to comply with the law.
    (Response 139) We previously acknowledged the limitations of the 
Food Processing Sector Study (78 FR 3646 at 3700-3701). We have revised 
and extended the results of our earlier study by expanding our data 
sources and by including representatives from USDA's Economic Research 
Service, USDA's Agricultural Marketing Service, and the American Farm 
Bureau to help oversee the revised study. The revised Food Processing 
Sector Study is available in the docket of this rule (Ref. 21).
    Our original analysis was based on the merger of Dun & Bradstreet 
data and FDA's Food Facility Registration data to help us estimate the 
number of manufacturing facilities that are also classified as farms. 
We have updated that data source and added data sources. To better 
account for farms that perform processing activities, we included 
Census of Agriculture (Ag Census) data both to provide a count of total 
U.S. farms and to estimate the number of farms conducting food 
processing activities, to the extent that the data identifies 
processing activities. We also included the Agricultural Resource 
Management Survey (ARMS) data because it included questions about some 
processing activities for select commodities.
    Both the Ag Census and ARMS are silent about many processing 
activities. Therefore, we also obtained estimates from commodity 
specialists at trade associations, USDA, and universities with in-depth 
knowledge of the processing activities for specific agricultural 
commodities. We also reached out to directors of promotion and 
marketing boards, and considered marketing agreements and marketing 
orders for various vegetables, fruits, and tree nuts to obtain 
information about the portion of farms that conduct food processing 
activities for use in this study.
    (Comment 140) Some comments ask us to explain how to calculate the 
number of full-time equivalent employees--e.g., with respect to 
temporary workers, seasonal workers, and part-time workers.
    (Response 140) As previously discussed, we proposed to establish 
the same definition for small business as that which has been 
established by the U.S. Small Business Administration (SBA) under 13 
CFR part 121 for most food manufacturers, and the limit of 500 
employees would include all employees of the business rather than be 
limited to the employees at a particular facility (78 FR 3646 at 3701). 
We will base the calculation on ``full-time equivalent employees'' and 
use the same approach to calculating full-time equivalent employees for 
the purpose of this rule as we used to calculate full-time equivalent 
employees in the section 414 recordkeeping regulations (see Sec.  
1.328). This approach is similar to the approach we used to calculate 
the small business exemption for nutrition labeling of food (21 CFR 
101.9(j)(18)(iv)(D)). Under this approach, the number of full-time 
equivalent employees is determined by dividing the total number of 
hours of salary or wages paid directly to employees of the business 
entity claiming the exemption and of all of its affiliates and 
subsidiaries by the number of hours of work in 1 year, 2,080 hours 
(i.e., 40 hours x 52 weeks).
    We received similar comments during the rulemaking to establish the 
section 414 recordkeeping regulations, and in response to those 
comments we established the definition of ``full-time equivalent 
employee'' in the definitions for that rule. As with the section 414 
recordkeeping regulations and the nutrition labeling regulations, the 
calculation for the number of employees affects exemptions (i.e., the 
exemptions for on-farm, low-risk activity/food combinations in Sec.  
117.5(g) and (h), which apply only to small and very small businesses), 
not just compliance dates. Therefore, we are establishing the 
definition of ``full-time equivalent employee'' in the definitions for 
this rule (Sec.  117.3) and modifying the definition of ``small 
business'' to use the term ``500 full-time equivalent employees'' 
rather than ``500 persons.''
    (Comment 141) Some comments ask us to base the definition of 
``small business'' on the amount of sales, rather than on the number of 
employees, for consistency with the definition of ``very small 
business.''
    (Response 141) We decline this request. As previously discussed, we 
based the definition of ``very small business'' on sales because the 
criterion of being a ``very small business'' plays a significant role 
in determining whether a facility is a ``qualified facility,'' and 
because the other principal criterion for being a ``qualified 
facility'' is based on sales (section 418(l)(1)(C) of the FD&C Act; see 
79 FR 58524 at 58556). In contrast, section 418(l) of the FD&C Act does 
not specify any particular criterion (whether sales or number of 
employees) for the definition of ``small business,'' other than direct 
us to consider the results of the Food Processing Sector Study. Basing 
the definition of ``small business'' on the number of employees is 
consistent with our approach to defining ``small business'' for our 
HACCP regulation for juice (Sec.  120.1(b)(1)), the section 414 
recordkeeping regulations (69 FR 71562, December 9, 2004), and our CGMP 
regulation for manufacturing, packaging, labeling, or holding 
operations for dietary supplements (72 FR 34752, June 25, 2007).
    (Comment 142) Some comments assert that the specified number of

[[Page 55963]]

employees (i.e., 500) has no relevance to food safety.
    (Response 142) The definition of ``small business'' is relevant to 
two aspects of this rule. First, it is relevant to the compliance date 
for the establishment, and provides an additional year for 
establishments satisfying the definition to comply with the rule. As 
discussed in the Final Regulatory Impact Analysis (FRIA) (Ref. 38), we 
estimate that the number of small businesses that will be eligible is 
45,936, accounting for 5.4 percent of the food supply. Although the 
purpose of the rule is to improve food safety, delaying the effective 
date for approximately 6 percent of the food supply will not 
significantly affect food safety in the long term.
    Second, the definition of ``small business'' is relevant to the 
statutory exemptions for on-farm, low-risk activity/food combinations 
for manufacturing/processing, packing, and holding food by farm mixed-
type facilities. These statutory exemptions, although expressly 
authorized only for small and very small businesses, encompass risk and 
are limited, because a small or very small farm mixed-type facility is 
only eligible for the exemption if the only activities that the 
facility conducts are the specified on-farm low-risk activity/food 
combinations.
    (Comment 143) Some comments assert that the specified number of 
employees (i.e., 500) may or may not be indicative of business size. As 
an example, the comment notes that harvest employees may operate under 
contract rather than be the grower's employees.
    (Response 143) If a farm mixed-type facility that is subject to 
this rule employs harvest employees under contract, the facility would 
include these employees in its calculation of full-time equivalent 
employees and would adjust for the temporary, seasonal nature of the 
increased number of employees when it calculates the 12 month average 
number of full-time equivalent employees. (See Response 140 for the 
calculation of full-time equivalents.)
    (Comment 144) Some comments assert that the human preventive 
controls rule and the produce safety rule should use the same 
definition of ``small business.''
    (Response 144) We tailored the definitions of ``small business'' to 
the characteristics of the sectors of industry subject to the two 
rules.
    (Comment 145) Some comments assert that the definition of a small 
business as less than 500 employees makes the very small business 
exemption irrelevant. These comments ask us to create a simple and 
broad small business exemption for any small business conducting ``low-
risk activities.''
    (Response 145) We disagree that the definition of a small business 
makes the very small business exemption irrelevant and decline the 
request to create a ``simple and broad small business exemption'' for 
any small business conducting ``low-risk activities.'' Although both 
small and very small businesses are eligible for the exemption for such 
businesses that only conduct specified low-risk activity/food 
combinations, other provisions apply solely to very small businesses. 
For example, the compliance date for a very small business is different 
from the compliance date for a small business, and a very small 
business (but not a small business) is eligible for modified 
requirements.
35. Supplier
    We proposed to define the term ``supplier'' to mean the 
establishment that manufactures/processes the food, raises the animal, 
or harvests the food that is provided to a receiving facility without 
further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition 
of labeling or similar activity of a de minimis nature.
    As discussed in Response 32, we have revised the ``farm'' 
definition to explicitly include business models in which one operation 
grows crops but does not harvest them, and another operation, not under 
the same management, harvests crops but does not grow them. As also 
discussed in Response 32, this revision represents a change from the 
existing and proposed ``farm'' definitions, which describe a ``farm'' 
as an entity ``devoted to the growing and harvesting of crops'' 
(emphasis added). We proposed the ``supplier'' definition in the 
context of a single business entity ``devoted to the growing and 
harvesting of crops'' (emphasis added). We used the term 
``harvesting,'' rather than ``growing,'' to reflect the last stage of 
production on a farm, except for packing.
    Because the proposed ``supplier'' definition contemplated that the 
same business entity that grows crops also harvests them, we have 
revised the ``supplier'' definition so that the grower remains the 
supplier when the harvester is under separate management. Specifically, 
``supplier'' is now defined to include an establishment that ``grows'' 
food rather than an establishment that ``harvests'' food. Doing so 
focuses the requirements for the supply-chain program (see subpart G) 
on the entity that produces the food, rather than on the entity that 
removes the food from the growing area, when the grower and the 
harvester are not under the same management. Doing so also simplifies 
the determination of who the supplier is in complex business models, 
such as when a ``handler'' arranges for harvest by another business 
entity.
    As discussed in Response 22, we consider a farm to be a type of 
``establishment'' even though we revised the ``farm'' definition to 
refer to an ``operation'' rather than an ``establishment'' within that 
definition.
    (Comment 146) Some comments assert that the definition of supplier 
is not workable because the status of warehouses and brokers is unclear 
in the definition. Other comments ask us to modify the definition to 
specify, in addition to the proposed definition, that the supplier 
could be an intermediary entity that takes responsibility on behalf of 
the receiving facility to ensure that the food meets the requirements 
of this part.
    (Response 146) As discussed in Response 657, we agree that the role 
of intermediaries in the supply chain is critical, and we have added 
options for entities other than the receiving facility to perform 
certain supplier verification activities, provided that the receiving 
facility reviews and assesses the documentation produced by the other 
entity and documents that review and assessment. However, this does not 
mean that these entities take on the role of the supplier. As discussed 
in Response 658 and Response 123, we believe it is important to 
supplier verification to retain the identities of two parties 
involved--the receiving facility and the supplier. Therefore, we are 
retaining our definition of supplier.
    (Comment 147) Some comments regarding RACs ask us to modify the 
definition of supplier in the case of commingled RACs, such that the 
supplier would be the person immediately back from the receiving 
facility in the supply chain provided that this entity (presumably a 
warehouse or aggregator) voluntarily complies with the requirements of 
subpart C of this part.
    (Response 147) We decline this request. As discussed in Response 
657, we recognize that doing supplier verification with commingled 
products will be a challenge. However, we believe it is important that 
there be a link between the receiving facility (which is manufacturing/
processing the

[[Page 55964]]

food) and the supplier (who controlled the hazard(s) in the food). We 
are allowing an entity such as an aggregator or distributor to perform 
some verification activities, so the outcome requested by these 
comments will be achieved while maintaining the identities of the two 
primary parties in the supplier verification relationship (see Response 
657).
    (Comment 148) One comment asks us to clarify who would be the 
supplier in a situation in which dairy farms are providing milk to a 
cooperative collecting milk.
    (Response 148) In this example, the dairy farms would be the 
suppliers because they are raising the animals.
    (Comment 149) One comment asks us to clarify that the proposed 
definition of supplier does not include sources of processing aids or 
chemicals required for post-harvest treatments and packing processes 
(including waxes, fungicides, detergents and sanitizers).
    (Response 149) As defined, the supplier is the establishment 
growing the food, not those establishments providing inputs (such as 
waxes, fungicides, detergents and sanitizers) to that entity.
36. Validation and Verification
    We proposed to define the term ``validation'' to mean that element 
of verification focused on collecting and evaluating scientific and 
technical information to determine whether the food safety plan, when 
properly implemented, will effectively control the identified hazards. 
We proposed to define the term ``verification'' to mean those 
activities, other than monitoring, that establish the validity of the 
food safety plan and that the system is operating according to the 
plan.
    (Comment 150) Some comments ask us to revise the definitions of 
``validation'' and ``verification'' to be consistent with the Codex 
definitions. (Codex defines ``validation'' to mean obtaining evidence 
that a control measure or combination of control measures, if properly 
implemented, is capable of controlling the hazard to a specified 
outcome. Codex defines ``verification'' to mean the application of 
methods, procedures, tests and other evaluations, in addition to 
monitoring, to determine whether a control measure is or has been 
operating as intended (Ref. 39).)
    Some comments ask us to more clearly distinguish between 
``validation'' and ``verification.'' Some comments assert that 
validation is not an element of verification as stated in our proposed 
definition and suggest that we clearly separate requirements for 
validation from requirements for verification--e.g., by moving the 
proposed requirements for verification to a distinct section in the 
regulatory text.
    (Response 150) We have explained how our proposed definitions for 
``validation'' and ``verification'' align with a variety of widely 
recognized definitions, including definitions established by Codex, the 
NACMCF HACCP guidelines, and Federal HACCP regulations for seafood, 
juice, and meat and poultry (78 FR 3646 at 3700). We disagree that 
validation is not an element of verification, but acknowledge it is not 
necessary to say so within the definition of ``validation.'' Although 
we have moved the details of the requirements for validation from its 
proposed location within the requirements for verification (i.e., 
proposed Sec.  117.155(a)) to a separate section (Sec.  117.160), we 
did so as an editorial change to improve clarity and readability rather 
than as a substantive change to signal that validation is not an 
element of verification (see table 8 in the 2014 supplemental human 
preventive controls notice, 79 FR 58524 at 58557).
    We agree that validation can apply to a specific control measure as 
specified in the Codex definition. We also agree that validation can 
apply to a combination of control measures as specified in the Codex 
definition. The food safety plan is one example of a combination of 
control measures.
    Although we likewise agree that verification can apply to a 
specific control measure as specified in the Codex definition, we 
disagree that to be consistent with the Codex definition we should 
adopt a definition that excludes the application of verification to the 
food safety plan. It is well established that some verification 
measures, such as testing for a pathogen, verify that multiple control 
measures operated as intended. (See, e.g., Codex's discussion of 
verification for uncooked fermented sausages (Ref. 39)).
    To more clearly distinguish between ``validation'' and 
``verification,'' the definition of ``validation'' we are establishing 
in this rule specifies that validation means obtaining and evaluating 
scientific evidence that a control measure, combination of control 
measures, or the food safety plan as a whole, when properly 
implemented, is capable of effectively controlling the identified 
hazards (emphasis added). We also made conforming changes associated 
with the revised definition of ``validation'' in the requirements for 
validation (see Sec.  117.160(b)(2)). The definition of 
``verification'' we are establishing in this rule specifies that 
verification means the application of methods, procedures, tests and 
other evaluations, in addition to monitoring, to determine whether a 
control measure or combination of control measures is or has been 
operating as intended and to establish the validity of the food safety 
plan as a whole (emphasis added). Consistent with the request of the 
comments, the definition of ``verification'' uses the Codex description 
of verification as the application of methods, procedures, tests and 
other evaluations, in addition to monitoring.
37. Very Small Business
    We proposed to define the term ``very small business'' to mean, for 
the purposes of proposed part 117, a business that has less than 
$1,000,000 in total annual sales of human food, adjusted for inflation. 
As discussed in the proposed rule, we conducted a Food Processing 
Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 19) 
and used the results of the study in defining the term ``very small 
business'' (78 FR 3646 at 3700 to 3702). We made the results of the 
Food Processing Sector Study available in Docket No. FDA-2011-N-0920 
and requested public comment on that study. As discussed in Response 
139, we have updated that study (Ref. 21).
    (Comment 151) Some comments support the proposed dollar threshold 
of $1,000,000, noting that it would provide sufficient flexibility to 
companies that receive the exemption to allow them to continue to 
operate. Some comments that support the proposed dollar threshold of 
$1,000,000 state that this threshold is consistent with Congress's 
mandate that the FSMA rules provide flexibility for all sizes and types 
of businesses and facilities, including small processing facilities co-
located on farms, and provide special considerations for small and very 
small businesses. These comments also state that our proposal to adopt 
the $1,000,000 threshold is appropriate in light of the two options 
Congress provided for facilities to qualify for modified requirements, 
and that although Congress directed us to consider the Food Processing 
Sector Study in establishing the very small business definition, it did 
not otherwise establish parameters for us to use in setting this 
definition, leaving it largely to our discretion. These comments argue 
that although Congress set out two options whereby facilities could 
qualify for modified requirements, Congress did not bind us to using 
both options. These comments express the view that when

[[Page 55965]]

Congress is silent on an issue, the agency may reasonably interpret its 
authority. These comments state that proposing the $1,000,000 threshold 
for a very small business is entirely reasonable given that businesses 
this size account for such a small percentage of the food supply, and 
given Congress's mandate that FDA establish flexible standards 
considering the effects of the rules on small and very small 
businesses.
    Other comments disagree with the proposed dollar threshold of 
$1,000,000. Some of these comments assert that the proposed dollar 
threshold of $1,000,000 would create a new category of exemption not 
contemplated by FSMA and will create confusion for both those who may 
be subject to the rule and those trying to enforce it. These comments 
ask us to instead adopt the $500,000 threshold we considered as 
``Option 2'' in the 2013 proposed preventive controls rule (78 FR 3646 
at 3702). Some comments assert that the proposed $1,000,000 threshold 
would expose a larger number of consumers to a heightened risk of 
contracting a foodborne illness.
    Other comments reiterate their previous assertions that any dollar 
threshold that exceeds $250,000 would be contrary to Congressional 
intent and conflict with section 418(l) of the FD&C Act. Some of these 
comments assert that adopting a $1,000,000 threshold would conflict 
with the statutory structure of the qualified facility program in a way 
that effectively nullifies a section of the law. Some of these comments 
assert that the discussion in the 2014 supplemental human preventive 
controls notice did not adequately address their comments submitted to 
the 2013 proposed human preventive controls rule because that 
discussion does not explain why we believe the proposed $1,000,000 
threshold is consistent with the statute's definitions of a qualified 
facility in section 418(l)(1) of the FD&C Act. These comments assert 
that the discussion in the 2014 supplemental human preventive controls 
notice clearly indicates that the definition is intended to abrogate 
the definition of a qualified facility under section 418(l)(1)(C) of 
the FD&C Act because the ``definition would . . . simplify a facility's 
determination of whether it is a qualified facility because the 
facility would only need to calculate its total sales of human food 
rather than determine how much food was sold to qualified 
end[hyphen]users.'' The comments assert that this discussion shows that 
we have made a deliberate decision to write qualified facilities under 
section 418(l)(1)(C) and the limitations on sales under section 
418(l)(4)(B) out of the law and state that an agency has no authority 
to repeal a well[hyphen]considered act of Congress by fiat in a 
rulemaking.
    (Response 151) We are establishing a $1,000,000 threshold for the 
definition of ``very small business.'' We disagree that a $1,000,000 
threshold would create a new category of exemption not contemplated by 
FSMA. Under section 418(l)(1)(A) and (B) of the FD&C Act, a very small 
business is a qualified facility; under the exemption authorized in 
section 418(l)(2) of the FD&C Act, a qualified facility is subject to 
modified requirements rather than the requirements for hazard analysis 
and risk-based preventive controls. We have acknowledged that a 
$1,000,000 threshold exempts a greater portion of the food supply than 
thresholds of either $250,000 or $500,000 (79 FR 58524 at 58555), but 
reaffirm that under the $1,000,000 threshold the businesses that would 
be exempt from the requirements for hazard analysis and risk-based 
preventive controls would represent a small portion of the potential 
risk of foodborne illness; businesses that fall within this definition 
of ``very small business,'' collectively, produce less than 0.6 percent 
of the food supply (Ref. 38). In addition, most of these facilities 
will be subject to the CGMP requirements in subpart B; the only 
exemption from those CGMP requirements is the exemption in Sec.  
117.5(k) (which applies to: (1) Farms; (2) certain fishing vessels; (3) 
establishments solely engaged in the holding and/or transportation of 
one or more RACs; (4) activities of ``farm mixed-type facilities'' that 
fall within the definition of ``farm''; and (5) establishments solely 
engaged in hulling, shelling, drying, packing, and/or holding nuts 
(without additional manufacturing/processing)).
    We disagree that a $1,000,000 threshold for the definition of 
``very small business'' will create confusion for both those who may be 
subject to the rule and those trying to enforce it; in contrast, it is 
our view that a $1,000,000 threshold will be less burdensome for both 
the qualified facilities and FDA. (See Response 581, where we explain 
that for compliance purposes we intend to focus on financial records 
demonstrating that a business averages less than the specified dollar 
threshold rather than records demonstrating that the average annual 
monetary value of the food manufactured, processed, packed, or held at 
such facility that is sold directly to qualified end-users during a 
three-year period exceeded the average annual monetary value of the 
food sold by the facility to all other purchasers.)
    We reaffirm our view, expressed in the 2014 supplemental human 
preventive controls notice, that section 418 of the FD&C Act does not 
limit how we may define ``very small business'' other than by requiring 
us to consider the Food Processing Sector Study, and we have done so. 
(See also Response 152.) Therefore, we disagree that adopting a 
$1,000,000 threshold would conflict with the statutory structure of the 
qualified facility program in a way that effectively nullifies an 
entire section of the law. We also disagree that our explanation in the 
2014 supplemental human preventive controls notice demonstrates that we 
have made a deliberate decision to write qualified facilities under 
section 418(l)(1)(C) of the FD&C Act, and the limitations on sales 
under section 418(l)(4)(B) of the FD&C Act, out of the law. Likewise, 
we disagree that we are in any way ``repealing'' a 
well[hyphen]considered act of Congress by fiat in a rulemaking.
    (Comment 152) Some comments that support a dollar threshold of 
$250,000 rather than $1,000,000 assert that the rationale we presented 
in the 2014 supplemental human preventive controls notice for a 
$1,000,000 threshold is inconsistent with the rationale we presented in 
our ``original draft'' of the 2013 proposed human preventive controls 
rule. These comments quote that ``original draft'' of the 2013 proposed 
human preventive controls rule as follows: ``FDA is proposing to define 
the term ``very small business'' to mean, for the purposes of part 110, 
a business that has less than $250,000 in total annual sales of foods, 
adjusted for inflation. We are proposing to define very small business 
using a dollar amount that is, for practical purposes, the same as the 
dollar amount of sales by a qualified facility to end users other than 
those that would satisfy the definition of ``qualified end users.'' The 
proposed definition is consistent with the findings of a study that we 
conducted as required by section 418(l)(5) of the FD&C Act.'' These 
comments note that we acknowledged, in the 2014 supplemental preventive 
controls notice, that section 418(n)(1)(B) of the FD&C Act requires us 
to consider the Food Processing Sector Study for the purpose of 
defining ``very small business'' (79 FR 58524 at 58555) and argue that 
it is difficult to see how the same study that supported defining a 
very small business as one that has less than $250,000 in total annual 
sales of food now supports a definition that puts that threshold at 
less than $1,000,000.

[[Page 55966]]

    (Response 152) These comments are citing a rationale in a draft 
version of the 2013 proposed human preventive controls rule, which we 
submitted to the Office of Management and Budget in 2011 (Ref. 40, p. 
259). In that draft, we proposed a single option for the definition of 
``very small business'' (i.e., less than $250,000) and explained the 
reasons for proposing that single option, including an explanation that 
the option was consistent with the findings of the Food Processing 
Sector Study. In contrast, in the published 2013 proposed human 
preventive controls rule that we issued for public comment we 
identified three options as part of a co-proposal for the definition of 
very small business, and provided a basis to support each option. For 
each option of the co-proposal, we made the same statement regarding 
the Food Processing Sector Study when we discussed the impact of the 
option on mixed-type facilities--i.e., that it is apparent that the 
number of co-located facilities is concentrated at the smaller end of 
the size spectrum. We see no conflict between a statement (made in the 
context of a single proposed option for the definition of ``very small 
business'') that a specific proposed definition was consistent with the 
findings of the Food Processing Sector Study and a statement (made in 
the context of three proposed options for the definition of ``very 
small business'') that it is apparent that the number of co-located 
facilities is concentrated at the smaller end of the size spectrum. 
(See also Response 139 regarding the Food Processing Sector Study.)
    (Comment 153) Some comments assert that the proposed $1,000,000 
threshold would be inconsistent with our explanation, in the 2014 
proposed sanitary transportation rule, of the definition of a ``non-
covered business'' as one having less than $500,000 in total annual 
sales. These comments note that we considered whether a less than $1 
million threshold should be applied but concluded: ``[W]e believe such 
an expansion would result in a greater risk of food becoming 
adulterated during transport due to insanitary food transportation 
practices.'' (Ref. 41) These comments assert that if we were to apply 
the same analysis we used in the 2014 proposed sanitary transportation 
rule to the human preventive controls rule, the threshold for a very 
small business would be below $500,000.
    (Response 153) The $500,000 threshold we proposed in the 2014 
proposed sanitary transportation rule would apply to ``non-covered 
businesses''--i.e., businesses that would be completely exempt from the 
requirements of the sanitary transportation rule. In contrast, the 
$1,000,000 threshold we are establishing in this rule applies to very 
small businesses that will be subject to modified requirements rather 
than be completely exempt. A very small business will have two options 
to comply with the modified requirements in the human preventive 
controls rule (the food safety practices option and the option to 
demonstrate compliance with other applicable non-Federal food safety 
law; see Sec.  117.201(a)(2) and the discussion in sections XXXVIII.C.2 
and XXXVIII.C.3). Regardless of which option a very small business 
chooses to comply with the modified requirements, we will inspect the 
business for compliance with the CGMPs and the modified requirements. 
In contrast, if the final sanitary transportation rule excludes a 
``non-covered business'' as would be defined in that rule, that 
business would be completely exempt rather than subject to modified 
requirements and, thus, would be not be inspected for compliance with 
any aspect of the sanitary transportation rule.
    (Comment 154) Some comments ask us to clarify how to classify the 
size of a business that does not take ownership of or directly sell 
food (e.g., warehouses and re-packing facilities) to determine status 
as a qualified facility.
    (Response 154) We have revised the definition to specify that the 
$1,000,000 threshold applies to sales of human food plus the market 
value of human food manufactured, processed, packed, or held without 
sale (e.g., held for a fee). When there are no sales of human food, 
market value of the human food manufactured, processed, packed, or held 
without sale is a reasonable approach to calculating the dollar 
threshold for very small business.
    (Comment 155) Some comments ask us to specify that the monetary 
threshold for the definition be based on average sales during a three-
year period on a rolling basis because otherwise firms may be subject 
to significant changes in status from year to year. These comments also 
ask us to clarify that the sales are to be evaluated retrospectively, 
not prospectively.
    (Response 155) We have revised the definition of very small 
business to specify that it is based on an average during the 3-year 
period preceding the applicable calendar year in sales of human food 
plus the market value of human food manufactured, processed, packed, or 
held without sale (e.g., held for a fee). The applicable calendar year 
is the year after the 3 calendar years used to determine whether a 
facility is a very small business. The most recent applicable calendar 
year is the current year. For example, on June 3, 2024, 2024 is the 
most recent applicable calendar year and is the applicable calendar 
year when the 3 calendar years used to determine whether a facility is 
a very small business are 2021-2023. The exception is when 3 calendar 
years of records are not available, such as when a facility begins 
business after the compliance date for very small businesses. In such 
situations the applicable calendar year refers to the year during which 
the calculation is made but is not preceded by 3 calendar years used to 
determine whether a facility is a very small business.
    As a companion change, we are explicitly requiring that a facility 
determine and document its status as a qualified facility on an annual 
basis by no later than July 1 of each calendar year (see Sec.  
117.201(c)(1)). Although this requirement was implicit in the proposed 
requirement that a facility must resubmit a notification to FDA if its 
status changes as a qualified facility (proposed Sec.  117.201(c)(2), 
which we are finalizing as Sec.  117.201(c)(3)), we are making this 
requirement explicit to clarify the responsibility of the facility to 
affirmatively determine its status when the calendar years that apply 
to the 3-year average change. The July 1 deadline for a facility to 
determine its status provides facilities with 6 months to make the 
determination after the end of the previous 3 calendar years.
    We also are establishing an earlier compliance date for the 
financial records that a facility maintains to support its status as a 
very small business that is eligible for the qualified facility 
exemption in Sec.  117.5(a). Specifically, the compliance date for a 
facility to retain records to support its status as a qualified 
facility is January 1, 2016. Even with this earlier compliance date for 
these records, we realize that although the calculation for ``very 
small business'' in the regulatory text is based on 3 calendar years, a 
facility will only be required to have 2 calendar years of records as 
of the general compliance date for very small businesses. Specifically, 
by September 17, 2018 a facility that begins retaining applicable 
financial records on January 1, 2016, would only have such records for 
2 previous calendar years. Therefore, it would be reasonable for a 
facility to make the calculation based on the 2 previous calendar 
years. If a facility has records for 3 previous calendar years, the 
facility could make the calculation based on the longer time period. 
During inspection in 2018, when a facility has

[[Page 55967]]

records for the preceding 2 calendar years, but not for the preceding 3 
previous calendar years, we will accept records for the preceding 2 
calendar years as adequate to support status as a qualified facility. 
We note that in some situations, a shorter time period is sufficient to 
determine that a facility is not a very small business. For example, a 
facility with sales exceeding $3,000,000 for the preceding calendar 
year cannot qualify as a very small business because no amount of sales 
from other years will reduce average sales below the threshold of 
$1,000,000.
    The available financial records for a facility that begins 
operations between January 1, 2017 and September 17, 2018 would not 
cover even 2 calendar years by September 17, 2018. During the first 3 
years of such a facility's operation, it would be reasonable for a 
facility to make the calculation based on records it has (i.e., for one 
or two preceding calendar years), and we will accept records for the 
preceding one or two years as adequate to support status as a qualified 
facility in these circumstances.
    When a facility does not begin operations until after January 1, 
2018, it would be reasonable for the facility to rely on a projected 
estimate of revenue (or market value) when it begins operations. We 
would evaluate the credibility of the projection considering factors 
such as the facility's number of FTEs. After the facility has records 
for one or two preceding years, it would be reasonable for the facility 
to make the calculation based on records it has (i.e., for one or two 
preceding calendar years) and we will accept records for the preceding 
one or two calendar years as adequate to support status as a qualified 
facility in these circumstances.
    (Comment 156) Some comments ask us to only include the total annual 
sales of food in the United States, adjusted for inflation, for foreign 
facilities that export food to the United States.
    (Response 156) We decline this request. The purpose of the 
definition of ``very small business'' is principally to enable such 
businesses to comply with modified requirements, because they have 
fewer resources to direct to full compliance with the rule. A foreign 
business that sells more than the threshold dollar amount of food has 
more resources than the businesses being excluded, even if less than 
that threshold dollar amount reflects sales to the United States. 
Likewise, a domestic business that sells more than the threshold dollar 
amount of food has more resources than the businesses being excluded, 
even if that domestic business exports some of its food and, as a 
result, less than that threshold dollar amount reflects sales within 
the United States.
    As discussed in Response 154, to address facilities such as those 
warehouses and re-packing facilities that do not take ownership or 
directly sell food we have revised the definition of ``very small 
business'' to specify that the $1,000,000 threshold applies to sales of 
human food plus the market value of human food manufactured, processed, 
packed, or held without sale (e.g., held for a fee). As with ``sales,'' 
facilities such as those warehouses and re-packing facilities that pack 
or hold more than the $1,000,000 threshold would have more resources 
than the facilities being excluded.
    (Comment 157) Some comments ask us to apply the rule to dairy farms 
with sales greater than $1 million annually of processed or packaged 
dairy products, rather than bulk sales of fluid milk. Other comments 
ask us to only include the annual monetary value of food covered by the 
preventive controls rule, rather than all human food. In particular, 
these comments argue that food covered by the produce safety rule 
should not be counted in the calculation of the sales of food for the 
purpose of defining very small business for the preventive controls 
rule. Some of these comments assert that basing the threshold on the 
monetary value of food covered by the preventive controls rule, rather 
than all human food, would be necessary to be consistent with the 
approach used in the proposed animal preventive controls rule, in which 
the sales threshold was based on sales of animal food (i.e., the 
product regulated by the rule).
    (Response 157) We decline these requests. As discussed in Response 
156, the purpose of the definition of ``very small business'' is 
principally to enable such businesses to comply with modified 
requirements, because they have fewer resources to direct to full 
compliance with the rule. Because of the exemptions in the human 
preventive controls rule (e.g., for processors of seafood, juice, low-
acid canned foods (LACF), and dietary supplements), basing the 
threshold on the monetary value of food covered by the preventive 
controls rule, rather than all human food, could lead to a situation 
where a very large food processor (such as a juice processor with more 
than $20,000,000 in annual sales) would not need to comply with the 
human preventive controls rule for milk- and soy-based beverages that 
it produces, if the annual sales of milk- and soy-based beverages is 
less than $1,000,000.
    We disagree that a threshold based on sales of human food, rather 
than food covered by the preventive controls rule, would be 
inconsistent with the threshold we proposed for the animal preventive 
controls rule. The threshold we proposed for the animal preventive 
controls rule was based on ``total annual sales of food for animals, 
adjusted for inflation,'' which is exactly parallel to our proposal to 
base the threshold on ``total annual sales of human food, adjusted for 
inflation.'' We proposed several exemptions to the animal preventive 
controls rule (see proposed Sec.  507.5 (proposed 21 CFR 507.5)) and, 
thus, not all food for animals will be subject to the animal preventive 
controls rule.
    (Comment 158) Some comments ask us to base the threshold on the 
total ``volume of product'' or ``amount of product'' handled or sold. 
These comments assert that an approach using product volume or amount 
would be more risk-based because it would correlate more closely to 
consumer exposures than dollar amounts, which can be skewed by product 
values.
    (Response 158) We use sales as a proxy for volume. We acknowledge 
that dollar amounts can be skewed by product values and, thus, sales 
are an imperfect proxy for volume. However, we are not aware of a more 
practical way to identify a threshold based on volume or amount of 
product that could be applied across all product sectors, and the 
comments provide no suggestions for how their recommendation could be 
carried out.
    (Comment 159) Some comments assert that our conclusion that our 
proposed definition of very small business is controlled by the two 
references in sections 418(l)(5) and 418(n)(1)(B) of the FD&C Act does 
not provide a reasonable justification for our decision. These comments 
assert that it is equally true that those two provisions would not 
prevent us from adopting one threshold (less than $250,000) for 
purposes of defining a qualified facility (and for a very small 
business conducting on[hyphen]farm low[hyphen]risk activity/food 
combinations) and another (less than $1 million) for setting compliance 
dates. These comments also assert that this is exactly the 
determination we made for our proposed animal preventive controls rule, 
where we proposed to define very small business, under the constraints 
of these same two references, as one with less than $2,500,000 in 
sales. To give full effect to the design of the qualified facility 
program while providing an adequate compliance deadline, these comments 
ask us to revise the definition of very small business to mean ``a 
business that has less than $250,000 in total annual

[[Page 55968]]

sales of human food, adjusted for inflation, except that for purposes 
of the effective dates in section 103(i) of the FDA Food Safety 
Modernization Act (21 U.S.C. 350g note) the term means less than 
$1,000,000 in total annual sales of human food.''
    (Response 159) These comments are unclear. We agree that we 
proposed to define very small business, for the purposes of the animal 
preventive controls rule, as one with less than $2,500,000 in sales (79 
FR 58476 at 58510), but disagree that we proposed to adopt one 
threshold for purposes of defining a qualified facility and another 
threshold for setting compliance dates. Regardless, we decline the 
request to adopt a threshold lower than $1,000,000 for purposes of 
defining a qualified facility, which appears to be the principal 
request of these comments (see Response 151).
    (Comment 160) Some comments support the proposed dollar threshold 
of $1,000,000, provided that we also make changes to the ``farm'' 
definition to encompass activities of food hubs performing low-risk 
packing and holding activities on RACs for distribution in local food 
markets. If we do not revise the ``farm'' definition to encompass such 
activities, these comments assert that a threshold dollar amount of 
$2,000,000 would be necessary to allay concerns that making food hubs 
subject to the requirements for hazard analysis and risk-based 
preventive controls would cause many food hubs to fail, and would 
prevent the start of new food hubs.
    (Response 160) See Response 23 and Response 25. Food hubs that pack 
and hold RACs are covered by the ``farm'' definition if the farm(s) 
that grow or raise the majority of the RACs packed and held by the food 
hub own, or jointly own, a majority interest in the food hub. Thus some 
food hubs will not be required to register as a food facility and, 
thus, will not be subject to the requirements for hazard analysis and 
risk-based preventive controls. Those food hubs that exceed the 
specified dollar threshold for a very small business and are not within 
the ``farm'' definition would be subject to the requirements for hazard 
analysis and risk-based preventive controls. However, the preventive 
controls that the food hub would establish and implement would depend 
on the food hub, the food, and the outcome of the facility's hazard 
analysis, and the preventive control management components that the 
food hub would establish and implement for its preventive controls 
would be established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the facility's food safety system. A facility 
that appropriately determines through its hazard analysis that there 
are no hazards requiring preventive controls would document that 
determination in its written hazard analysis but would not need to 
establish preventive controls and associated management components. 
(See Response 222).
    (Comment 161) Some comments express concern that establishing a 
threshold based on U.S. dollars would place domestic firms at a 
disadvantage relative to foreign firms whose sales are often 
denominated in currencies valued lower than the dollar and often 
reflect much lower costs for factors such as land, labor, and 
environmental compliance. These comments ask us to base the threshold 
on an alternate measure, such as number of employees, or to calculate 
the sales of foreign very small businesses using an appropriate measure 
of purchasing power parity, if there is a straightforward way to do so.
    (Response 161) We decline these requests. As previously discussed, 
we use dollar estimates to evaluate the percentage of all food produced 
in the United States that would not be covered by the rule (79 FR 58524 
at 58555). We acknowledge that the definition of ``small business'' is 
based on number of employees, and that two exemptions (i.e., the 
exemptions in Sec.  117.5(g) and (h) for on-farm, low-risk activity/
food combinations) apply to small businesses. However, the exemptions 
for on-farm, low-risk activity/food combinations are limited to a 
narrow sector of the food industry, whereas the exemption applicable to 
a very small business will apply to all sectors of the food industry.
    We do not know of a straightforward way to calculate the sales of 
foreign very small businesses using an appropriate measure of 
purchasing power parity and are basing the threshold only on U.S. 
dollars.
    (Comment 162) Some comments assert that the reach of potential harm 
from foods imported from very small businesses that would meet the 
proposed threshold of $1,000,000 may be greater because they are more 
likely to be ingredients, such as spices, and argue that small amounts 
of spice can contaminate a large volume of food and, thus, cause 
widespread illnesses. Other comments assert that it is very likely that 
more facilities in exporting countries will be exempt under the 
definition, thus putting those located in the United States at a 
disadvantage. These comments assert that the definition of ``very small 
business'' should reflect the probability and severity of potential 
hazards in order to align with the rest of the regulation and promote 
public health interests.
    (Response 162) We acknowledge that ingredients such as spices, 
which have been associated with outbreaks of foodborne illness and 
large recalls, can contaminate a large volume of food (78 FR 3646 at 
3665 and 3737). However, the suggestion that we define ``very small 
business'' in a way that reflects the probability and severity of 
potential hazards is neither practical nor aligned with a size-based 
nature of the term.
    The comments asserting that it is very likely that more facilities 
in exporting countries will be exempt under the definition, thus 
putting those located in the United States at a disadvantage, provided 
no basis for the assertion. As discussed in Response 156, we have 
declined the request to only include the total annual sales of food in 
the United States, adjusted for inflation, for foreign facilities that 
export food to the United States.
    (Comment 163) Some comments express concern that the Food 
Processing Sector Study is not comprehensive.
    (Response 163) See Response 139 regarding the Food Processing 
Sector Study.
38. You
    We proposed to define the term ``you'' for purposes of part 117, to 
mean the owner, operator, or agent in charge of a facility. We received 
no comments that disagreed with this proposed definition and are 
finalizing it as proposed.

D. Comments Asking FDA To Establish Additional Definitions or Otherwise 
Clarify Terms Not Defined in the Rule

1. Corrections
    (Comment 164) Some comments assert that clearly distinguishing 
between the terms ``corrective actions'' and ``corrections'' will be 
imperative for industry to comply with the rule and for regulators to 
enforce the rule. Some comments ask us to use the ISO definitions of 
``corrective actions'' and ``corrections.'' (According to ISO 
22000:2005 definition 3.13, a ``correction'' is action to eliminate a 
detected nonconformity; according to ISO 22000:2005 definition 3.14, 
corrective action is action to eliminate the cause of a detected 
nonconformity or other undesirable situation.) Other comments ask us to 
eliminate the term ``correction'' and instead revise the rule to 
clarify the type of situation in which ``corrective actions'' are 
neither

[[Page 55969]]

necessary nor appropriate. As an example, these comments suggest that 
the proposed provisions for corrections could refer to ``prompt actions 
taken in response to minor and isolated deviations that do not directly 
impact product safety.''
    Other comments agree with the concept of simple ``corrections'' but 
assert that the term ``corrections'' is unnecessary and could be 
confusing because different facilities may use the term differently. 
These comments explain that sometimes ``correction'' is used to refer 
to the action taken to fix a deviation, and may or may not be part of 
an overall corrective action taken to identify the root cause of the 
deviation and to prevent a similar occurrence. These comments suggest 
that the provisions explain that prompt actions taken to address minor 
and isolated deviations are not subject to the same requirements as 
corrective actions to address potentially systemic concerns, without 
defining the term ``corrections.''
    (Response 164) We are defining the term ``correction'' to mean an 
action to identify and correct a problem that occurred during the 
production of food, without other actions associated with a corrective 
action procedure (such as actions to reduce the likelihood that the 
problem will recur, evaluate all affected food for safety, and prevent 
affected food from entering commerce). We agree that clearly 
distinguishing between the terms ``corrective actions'' and 
``corrections'' will be important for both industry and regulators. We 
acknowledge that one way to distinguish between ``corrective actions'' 
and actions that we would consider ``corrections'' could be to avoid 
the term ``corrections'' and instead say what we mean each time the 
rule uses the term ``corrections.'' However, after reviewing the full 
regulatory text of proposed subpart C we concluded that it was not 
practical to do so, because the term ``corrections'' was used more 
often in a title or a cross-reference than in a provision where the 
full text of what we mean by the term ``corrections'' is necessary to 
communicate a requirement. Our definition of ``corrections'' focuses on 
the first step in a ``corrective action procedure'' (i.e., identify and 
correct the problem) and also specifies those aspects of a corrective 
action procedure that do not apply to a correction (i.e., actions to 
reduce the likelihood that the problem will recur, evaluate all 
affected food for safety, and prevent affected food from entering 
commerce). (A note to the ISO 22000:2005 definition of corrective 
action indicates that it includes cause analysis and is taken to 
prevent recurrence.) We believe that this definition will be adequate 
to distinguish ``corrective actions'' from ``corrections.''
    As an example, if a facility applies sanitation controls for an 
environmental pathogen such as L. monocytogenes and food residue is 
observed on ``clean'' equipment prior to production, corrections would 
involve re-cleaning and sanitizing the equipment before it is used. 
Because the observation of food residue was made prior to production of 
food, no food is affected, and no actions are needed with respect to 
food. Although there are actions that can be taken to prevent 
reoccurrence, such as re-training sanitation personnel, these types of 
actions are not always needed.
2. Defect Action Level
    (Comment 165) Some comments that address the proposed provisions 
regarding ``defect action levels'' (proposed Sec.  117.110) ask us to 
define that term so that its meaning will be clear.
    (Response 165) We have added a definition of the term ``defect 
action level'' to mean a level of a non-hazardous, naturally occurring, 
unavoidable defect at which FDA may regard a food product 
``adulterated'' and subject to enforcement action under section 
402(a)(3) of the FD&C Act. This definition derives from the definition 
in our long-standing ``Defect Levels Handbook'' (Ref. 36), which we 
continue to reference in the provisions established in this rule 
regarding defect action levels. This definition also derives from the 
long-standing provisions in Sec.  110.110, which referred to natural or 
unavoidable defects in food for human use that present no health hazard 
and noted that some foods contain natural or unavoidable defects that 
at low levels are not hazardous to health. These long-standing 
provisions also noted that we establish maximum levels for these 
defects in foods produced under current good manufacturing practice and 
use these levels in deciding whether to recommend regulatory action.
3. Food-Packaging Material
    (Comment 166) Some comments point out that the proposed human 
preventive controls rule would amend certain provisions requiring 
prevention of contamination and allergen cross-contact of food and 
food-contact surfaces to add ``food-packaging materials,'' a term which 
is not defined. These comments ask us to clarify that ``food-packaging 
materials'' is limited to packaging materials that are capable of 
contaminating food and does not include shipping containers such as 
cartons and crates that pose no risk of introducing contaminants or 
food allergens into food.
    (Response 166) For the purposes of the provisions that require 
protection against allergen cross-contact and against contamination of 
food, food-contact surfaces, and food-packaging materials, the term 
``food-packaging materials'' does not include shipping containers such 
as cartons and crates that pose no risk of introducing contaminants or 
food allergens into food. We are not adding a definition of ``food-
packaging materials'' to the definitions in Sec.  117.3 because the 
provisions requiring protection against contamination are long-standing 
provisions that have been applied in the manner requested by the 
comment and, thus, adding a definition is not necessary to address the 
comment's request.
4. Must
    (Comment 167) Some comments ask us to define the term ``must.''
    (Response 167) We decline this request. The term ``must'' has a 
common meaning, and it is not necessary to establish a specific meaning 
for this term specifically for this rule.
5. Parameter and Value as Used in the Requirements for Process Controls
    (Comment 168) Some comments ask us to define the terms 
``parameter'' and ``value'' used in the requirements for preventive 
controls (Sec.  117.135). These comments ask us to define ``parameter'' 
as a measurable attribute and ``value'' as a specific measurement.
    (Response 168) We decline this request. Both of these terms are 
used in the context of process controls and both have common meanings 
when associated with process controls. Therefore, it is not necessary 
for the rule to define them.
6. Raw Materials
    Some comments ask us to define ``raw materials'' (see Comment 65). 
As discussed in Response 65, we have declined to do so.
7. Qualified Facility Exemption
    (Comment 169) Some comments note that some of the terminology 
associated with the exemption for qualified facilities in the human 
preventive controls rule is different from terminology associated with 
an exemption in the proposed produce safety rule. These comments point 
out that the exemption in the proposed produce safety rule refers to 
``qualified exemptions'' (Sec.  112.5), whereas the

[[Page 55970]]

exemption in the proposed human preventive controls rule refers to 
``exemptions'' and ``qualified facilities'' (Sec.  117.5(a)). These 
comments ask us to harmonize the terminology associated with the 
exemption for qualified facilities in the human preventive controls 
rule with the terminology associated with ``qualified exemptions'' in 
the proposed produce safety rule.
    (Response 169) We have revised the human preventive controls rule 
in two ways to better harmonize the terminology associated with the 
exemption for qualified facilities in the human preventive controls 
rule with an analogous exemption in the proposed produce safety rule. 
First, we have added a definition for the term ``qualified facility 
exemption,'' to mean an exemption applicable to a qualified facility 
under Sec.  117.5(a) (see the regulatory text in Sec.  117.3). Second, 
we also have made conforming changes throughout the rule to use the 
term ``qualified facility exemption'' when it applies. (See table 52.) 
It is not practical to fully harmonize the relevant terminology in 
these two rules due to differences in the framework applicable to food 
businesses subject to section 418 of the FD&C Act compared to the 
framework applicable to farms subject to section 419 of the FD&C Act. 
For example, a farm is not a ``facility'' and, thus, it would be 
confusing to refer to the applicable exemption established in the final 
produce safety rule as a ``qualified facility exemption'' or to refer 
to the business entities that would be exempt from the final produce 
safety rule as ``qualified facilities.''
8. Unexposed Packaged Food
    As discussed in section XII, some comments ask us to clarify that 
modified requirements for packaged food that is not exposed to the 
environment only apply to such food that requires time/temperature 
control for safety (TCS food). To do so, we are defining the term 
``unexposed packaged food'' to mean packaged food that is not exposed 
to the environment and using this term throughout the rule. Doing so 
simplifies the regulatory text and makes it clearer.
    (Comment 170) Some comments note that certain fruits and vegetables 
must be stored and distributed in vented packaging to allow for proper 
air circulation and the escape of gases produced in the ripening 
process. These comments ask us to interpret ``not exposed to the 
environment'' in a way that would include produce packed in such vented 
crates. Some comments assert that ``exposed to the environment'' must 
be meaningful from a food-safety standpoint and that produce shipped in 
vented crates presents virtually no food-safety risk because its 
environmental exposure is minimal. Some comments state that they do not 
believe Congress intended the term ``not exposed to the environment'' 
to mean only airtight, sealed containers.
    (Response 170) We acknowledge that certain fruits and vegetables 
may need to be distributed in vented crates but disagree that such 
produce is ``packaged food not exposed to the environment.'' We 
consider ``packaged food not exposed to the environment'' and 
``unexposed packaged food'' to mean that the food is in a form that 
prevents any direct human contact with the food (78 FR 3646 at 3712). 
Although environmental exposure to produce packed in vented crates 
would be less than environmental exposure to produce packed in open 
crates, a vented crate can subject produce to contamination from 
condensate in aerosols carried by the air handling system, moisture 
dripping onto containers, particulates blown through the facility by 
the air handling system, fingers of handlers during handling of crates, 
objects that may be inadvertently inserted through the vents, pests 
that can access the produce through the vents, etc. We believe it is 
appropriate for facilities storing produce in vented crates to conduct 
a hazard analysis and evaluate whether there are hazards that would 
require a preventive control.
    (Comment 171) Some comments ask us to interpret ``not exposed to 
the environment'' to mean packaged with food grade material that is 
impermeable to outside bacteria or other contamination. These comments 
state that materials that prevent human contact with the food can 
nonetheless permit passage of contaminants and express concern about 
migration of chemicals, not approved as food-contact substances, from 
outer wrappers.
    (Response 171) We decline this request. A facility that packages 
``unexposed packaged food'' is responsible for complying with all 
applicable requirements for the production of the food, including 
requirements established under section 409 of the FD&C Act (21 U.S.C. 
348) regarding indirect food additives and food contact substances when 
packaging food. Likewise, a facility that packs ``unexposed packaged 
food'' in outer wrappers is responsible to ensure the safety of the 
food it packed, including ensuring that food is not contaminated from 
chemicals in the outer wrappers. The exemption applicable to 
``unexposed packaged food'' applies to the storage of such foods, not 
the manufacturing, processing, or packing of such foods. For practical 
purposes, food that is not exposed to the environment will be protected 
from outside bacteria by the packaging. See also the discussions in 
Response 170 and Response 232 regarding produce packed in ``vented 
crates,'' which is not ``unexposed packaged food.''

E. Additional Definitions To Clarify Terms Not Defined in the Proposed 
Rule

1. Audit
    As already noted, some comments ask us to make the various rules we 
are establishing to implement FSMA consistent with each other, and we 
have worked to align the provisions of this rule with the provisions of 
the FSVP rule to the extent practicable. (See Comment 9 and Response 
9.) To align these provisions, we are establishing in this final rule a 
definition of ``audit'' analogous to the definition of ``audit'' we 
proposed for the FSVP rule. For the purposes of this rule, ``audit'' 
means the systematic, independent, and documented examination (through 
observation, investigation, records review, discussions with employees 
of the audited entity, and, as appropriate, sampling and laboratory 
analysis) to assess a supplier's food safety processes and procedures.
2. Full-Time Equivalent Employee
    As discussed in Response 140, we have established a definition for 
``full-time equivalent employee'' as a term used to represent the 
number of employees of a business entity for the purpose of determining 
whether the business qualifies for the small business exemption. The 
number of full-time equivalent employees is determined by dividing the 
total number of hours of salary or wages paid directly to employees of 
the business entity and of all of its affiliates and subsidiaries by 
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 
weeks). If the result is not a whole number, round down to the next 
lowest whole number.
3. Raw Agricultural Commodity
    We have added a definition of the term ``raw agricultural 
commodity'' to have the meaning given in section 201(r) of the FD&C 
Act. We decided to define this term in the rule to simplify the 
provisions in part 117 that refer to raw agricultural commodities.
4. Supply-Chain-Applied Control
    We have added a definition of the term ``supply-chain-applied 
control'' to mean a preventive control for a hazard

[[Page 55971]]

in a raw material or other ingredient when the hazard in the raw 
material or other ingredient is controlled before its receipt. We 
decided to define this term in the rule to simplify the provisions in 
part 117, and in the discussions in this document, that refer to 
preventive controls applied by a supplier before receipt by a receiving 
facility.
5. Written Procedures for Receiving Raw Materials and Other Ingredients
    We have added a definition of the term ``written procedures for 
receiving raw materials and other ingredients'' to mean written 
procedures to ensure that raw materials and other ingredients are 
received only from suppliers approved by the receiving facility (or, 
when necessary and appropriate, on a temporary basis from unapproved 
suppliers whose raw materials or other ingredients are subjected to 
adequate verification activities before acceptance for use). We decided 
to define this term in the rule to simplify the provisions in part 117, 
and in this document, that refer to these procedures.
6. Qualified Individual
    As discussed in section X.A., we are clarifying in new Sec.  
117.4(b)(1) that each individual engaged in manufacturing, processing, 
packing, or holding food (including temporary and seasonal personnel) 
or in the supervision thereof must have the education, training, or 
experience (or a combination thereof) necessary to manufacture, 
process, pack, or hold clean and safe food as appropriate to the 
individual's assigned duties. To better align with the FSVP rule, we 
using the term ``qualified individual'' in new Sec.  117.4(b)(1) and 
are defining the term ``qualified individual'' to mean a person who has 
the education, training, or experience (or a combination thereof) 
necessary to manufacture, process, pack, or hold clean and safe food as 
appropriate to the individual's assigned duties. A qualified individual 
may be, but is not required to be, an employee of the establishment.

X. Subpart A: Comments on Qualifications of Individuals Who 
Manufacture, Process, Pack, or Hold Food

    In 2002, FDA convened a CGMP Modernization Working Group (CGMP 
Working Group) to determine whether part 110 is in need of further 
revision. In 2005, the CGMP Working Group issued a report (CGMP Working 
Group Report) summarizing the comments we received, as well as our key 
findings (78 FR 3646 at 3651). One of the specific areas identified in 
the CGMP Working Group Report that presented an opportunity to 
modernize the regulation was to ``require appropriate training for 
supervisors and workers to ensure that they have the necessary 
knowledge and expertise in food hygiene, food protection, employee 
health and personal hygiene to produce safe food products.'' (78 FR 
3646 at 3729)
    As previously discussed, FSMA recognizes the importance of both 
training and CGMPs in preventing hazards from occurring in foods in its 
definition of preventive controls, which identifies supervisor, 
manager, and employee hygiene training, and CGMPs under part 110, as 
some of the procedures, practices, and processes that may be included 
as preventive controls (see sections 418(o)(3)(B) and 418(o)(3)(F) of 
the FD&C Act, respectively) (78 FR 3646 at 3729).
    We proposed to re-establish part 110's recommendations for training 
as proposed Sec.  117.10(c) (FR 3646 at 3720). In addition, we 
requested comment on how best to revise part 110's current 
recommendations to implement section 418(o)(3) of the FD&C Act and the 
recommendations of the CGMP Working Group with respect to training (FR 
3646 at 3729). Specifically, we requested comment on whether we should 
merely replace the current recommendations for personnel education and 
experience with requirements or whether more detail would be 
appropriate. As examples of additional specificity, we requested 
comment on whether the rule should specify that each person engaged in 
food manufacturing, processing, packing, or holding (including 
temporary and seasonal personnel and supervisors) must receive training 
as appropriate to the person's duties; specify the frequency of 
training (e.g., upon hiring and periodically thereafter); specify that 
training include the principles of food hygiene and food safety, 
including the importance of employee health and personal hygiene, as 
applied at the facility; and specify that records document required 
training of personnel and, if so, specify minimum requirements for the 
documentation (e.g., the date of the training, the type of training, 
and the person(s) trained). We also requested comment on whether to 
establish some or all of the potential requirements for education and 
training in subpart B, subpart C, or both.
    In the following paragraphs, we discuss comments that respond to 
our requests for comment on potential requirements for education and 
training and for whether to establish any requirements in subpart B, 
subpart C, or both. After considering these comments, we are 
establishing requirements for the qualifications of individuals engaged 
in manufacturing, processing, packing, or holding food in new Sec.  
117.4 in subpart A, with associated recordkeeping requirements 
established in Sec.  117.9 in subpart A. The regulatory text makes 
clear that these requirements, established in subpart A, apply to 
individuals engaged in manufacturing, processing, packing, or holding 
food regardless of whether the individuals conduct these activities 
under the framework of the CGMPs established in subpart B or the 
framework for hazard analysis and risk-based preventive controls 
established in subparts C, D, E, and G. The regulatory text also makes 
clear that the qualification requirements apply to the recordkeeping 
requirements of subpart F. See table 11 for a description of these 
provisions.

       Table 11--Provisions for Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food
----------------------------------------------------------------------------------------------------------------
                                                Proposed section
       Final  section designation                 designation                         Description
----------------------------------------------------------------------------------------------------------------
117.4(a)(1).............................  N/A........................  Applicability to individuals who
                                                                        manufacture, process, pack, or hold food
                                                                        subject to subparts B and F.
117.4(a)(2).............................  N/A........................  Applicability to individuals who
                                                                        manufacture, process, pack, or hold food
                                                                        subject to subparts C, D, E, F, or G.
117.4(b)(1).............................  N/A........................  Each individual engaged in manufacturing,
                                                                        processing, packing, or holding food
                                                                        must have the education, training, or
                                                                        experience (or combination thereof)
                                                                        necessary to manufacture, process, pack,
                                                                        or hold clean and safe food as
                                                                        appropriate to the individual's assigned
                                                                        duties.
117.4(b)(2).............................  117.10(c)..................  Required training in the principles of
                                                                        food hygiene and food safety, including
                                                                        the importance of employee health and
                                                                        personal hygiene.
117.4(c)................................  117.10(d)..................  Additional qualifications of supervisory
                                                                        personnel.
117.4(d)................................  N/A........................  Records of required training.

[[Page 55972]]

 
117.9...................................  N/A........................  The required records are subject to the
                                                                        recordkeeping requirements of subpart F.
----------------------------------------------------------------------------------------------------------------

A. Applicability and Qualifications of All Individuals Engaged in 
Manufacturing, Processing, Packing, or Holding Food (Final Sec.  
117.4(a), (b), and (d))

    (Comment 172) Some comments support changing the current 
recommendations for training to requirements, e.g., by replacing 
``should'' with ``must.'' However, some of these comments also ask that 
the requirement allow sufficient flexibility for establishments to 
determine the scope and frequency of the training based on the 
establishment, types of products, and job responsibilities of the 
employee. Some of these comments assert that this position is 
consistent with the concept in the food safety plan of tailoring 
controls to the specific facility and operations, and also aligns with 
the Global Food Safety Initiative guidance document, which was based on 
the recommendations of the Codex Alimentarius Commission (Codex). Some 
of these comments ask that we specify ``as applicable to the plant 
operation'' and ``applicable to their assigned duties'' to allow 
establishments flexibility in establishing risk-based training 
requirements specific to their operations.
    Other comments prefer more detail and ask that we establish 
requirements addressing all of the recommendations of the CGMP Working 
Group. Some of these comments note that doing so would be consistent 
with the proposed training requirements for the produce safety rule.
    Other comments prefer that we continue to only provide 
recommendations for education and training and allow the food industry 
to determine the appropriate level of specific employee training that 
may be needed. These comments assert that overly prescriptive and 
binding requirements may not consider variables such as training course 
content, training provider, effectiveness of the course, and instructor 
and frequency of training per topic. In addition, comments assert that 
factors such as an employee's type and length of experience, nature of 
formal education, and the food product type and point in the food 
supply chain at which the employee works with the food product (close 
to the farm or close to the fork) will need to be considered. Other 
comments ask us to establish the recommendations of the CGMP Working 
Group in guidance rather than in the rule.
    Some comments recommend that employees be trained ``initially'' and 
``periodically thereafter'' but ask that we recognize the seasonal 
nature of a facility's workforce. Some comments ask that the training 
include the principles of food hygiene and food safety, including the 
importance of employee health and personal hygiene as applied at the 
facility.
    Some comments ask that training requirements be established in 
subpart B so that the requirements apply to all establishments that 
manufacture, process, pack, or hold food, including establishments that 
are not subject to FSMA's requirements for hazard analysis and risk-
based preventive controls. These comments assert that this broad 
training requirement would improve food safety overall. Some comments 
that recommend establishing the training requirement in subpart B 
assert that training is more appropriately considered a prerequisite 
program than a preventive control that would belong in subpart C.
    Other comments ask that the training and related recordkeeping 
requirements for the facility's preventive controls qualified 
individuals be established under subpart C because this is directly 
related to the facility's food safety plan. Other comments ask that 
training requirements be established in both subpart B and subpart C. 
Other comments assert that including requirements for education and 
training in both subparts B and C would be confusing.
    (Response 172) We are establishing a series of requirements for the 
qualifications of individuals engaged in manufacturing, processing, 
packing, or holding food in new Sec.  117.4. First, to clarify how 
these qualification requirements apply to establishments subject to 
subparts B and F, we are requiring that the management of an 
establishment ensure that all individuals who manufacture, process, 
pack, or hold food subject to subparts B and F are qualified to perform 
their assigned duties (Sec.  117.4(a)(1)). To clarify how these 
qualification requirements apply to facilities, we are requiring that 
the owner, operator, or agent in charge of a facility ensure that all 
individuals who manufacture, process, pack, or hold food subject to 
subparts C, D, E, F, or G are qualified to perform their assigned 
duties (Sec.  117.4(a)(2)).
    We are not requiring training specific to the person's assigned 
duties. Each establishment engaged in the manufacturing, processing, 
packing, and holding of food for human consumption would already have 
procedures in place to ensure that all individuals who manufacture, 
process, pack, or hold food know how to do their jobs. However, to 
emphasize that we expect all individuals who conduct such activities to 
know how to do their jobs, we are specifying that each individual 
engaged in manufacturing, processing, packing, or holding food 
(including temporary and seasonal personnel) or in the supervision 
thereof must have the education, training, or experience (or a 
combination thereof) necessary to manufacture, process, pack, or hold 
clean and safe food as appropriate to the individual's assigned duties 
(Sec.  117.4(b)(1)). To better align with the forthcoming FSVP rule, we 
are using the term ``qualified individual'' in new Sec.  117.4(b)(1) 
and are defining the term ``qualified individual'' to mean a person who 
has the education, training, or experience (or a combination thereof) 
necessary to manufacture, process, pack, or hold clean and safe food as 
appropriate to the individual's assigned duties. A qualified individual 
may be, but is not required to be, an employee of the establishment. 
See the discussion of the term ``preventive controls qualified 
individual'' in section IX.C.25, including a discussion of how we have 
changed the proposed term ``qualified individual'' to ``preventive 
controls qualified individual'' because we are establishing a new 
definition for ``qualified individual,'' with a meaning distinct from 
``preventive controls qualified individual.''
    We also are requiring that each individual engaged in 
manufacturing, processing, packing, or holding food (including 
temporary and seasonal personnel) or in the supervision thereof,

[[Page 55973]]

receive training in the principles of food hygiene and food safety, 
including the importance of employee health and personal hygiene, as 
appropriate to the food, the facility and the person's assigned duties 
(see Sec.  117.4(b)(2)). Records that document this required training 
must be established and maintained and are subject to the recordkeeping 
requirements of subpart F (Sec. Sec.  117.4(d) and 117.9). The rule 
does not specify the frequency of the required training. We expect that 
production employees will receive training before working in production 
operations. Based on a 2010 survey of the domestic food manufacturing 
industry, we expect that most facilities will also provide some form of 
refresher training (Ref. 54).
    We disagree that we should continue to only provide recommendations 
for education and training. Although the comments express concern about 
overly prescriptive requirements that may not consider variables that 
would affect an establishment's training program (such as training 
course content, training provider, effectiveness of the course and 
instructor and frequency of training per topic, an employee's type and 
length of experience, nature of formal education, and the food product 
type and point in the food supply chain at which the employee works 
with the food product), the training requirement we are establishing in 
the rule provides flexibility for each establishment to provide 
training, and determine the scope and frequency of the training, in a 
way that works best for the establishment.
    We agree that it is appropriate to establish training requirements 
so that the requirements apply to all establishments that manufacture, 
process, pack, or hold food, including establishments that are not 
subject to FSMA's requirements for hazard analysis and risk-based 
preventive controls, and we are establishing the qualification and 
training requirements in subpart A to clarify the applicability of 
these requirements to all establishments and facilities subject to part 
117. Although we agree that employees in facilities that are subject to 
the requirements for hazard analysis and risk-based preventive controls 
need to understand their responsibilities under the facility's food 
safety plan, we are setting forth a training requirement focused on the 
principles of food hygiene and food safety, including the importance of 
employee health and personal hygiene, as recommended in the report of 
the CGMP Working Group (Ref. 3). We consider training in the principles 
of food hygiene and food safety, including the importance of employee 
health and personal hygiene, to be fundamental to the concept of CGMPs. 
We agree that establishing a training requirement in both subpart B and 
subpart C could be confusing.
    (Comment 173) Some comments ask that training not be limited to a 
narrow class of processors. Other comments assert that anyone who works 
in the food industry should have mandatory training and re-training.
    (Response 173) The training applies to all individuals engaged in 
manufacturing, processing, packing, or holding food, consistent with 
the requests of these comments.
    (Comment 174) Some comments agree that training should be 
documented and assert that those records should show the date of 
training, a description of the training, and the name of the person 
trained. However, comments ask that we allow flexibility in the way 
these records are kept. Other comments assert that requiring that 
records document required training of personnel is burdensome, 
arbitrary, and capricious.
    (Response 174) The rule requires that records that document 
training required by Sec.  117.4(b)(2) be established and maintained 
without prescribing any content of those records. Although one approach 
to documenting training would be to provide the date of training, a 
description of the training, and the name of the person trained, the 
rule provides flexibility for each establishment to document its 
training in a way that works best for that establishment. We disagree 
that requiring records to document required training is burdensome, 
arbitrary, and capricious in light of the strong support in the 
comments regarding CGMP modernization for records documenting training 
and the flexibility provided by the rule for the content of training 
records.
    (Comment 175) Some comments that support mandatory training 
nonetheless caution us to be flexible towards the development and 
deployment of mandatory training, including issuance of certificates, 
so as not to create road blocks for third-party service providers. 
These comments state that education and training and/or capacity 
building is a growing, rapidly evolving, and well-developed third-party 
service industry today, and that food companies often deliver their 
training to other raw material suppliers and contract manufacturers. 
Some comments assert that the training and education programs should be 
developed and implemented in close cooperation with State agencies, 
public institutions, and stakeholder organizations.
    (Response 175) The requirements do not address issuance of 
certificates or any other provisions that could create road blocks for 
third-party providers. An establishment has flexibility to develop or 
otherwise provide training in cooperation with public and private 
organizations in a manner that suits its needs.
    (Comment 176) Some comments agree that any requirements should 
include training appropriate to the person's duties but emphasize that 
the decision as to what is appropriate to the person's assigned duties 
should be determined by the establishment.
    (Response 176) The requirement for employees to receive training in 
the principles of food hygiene and food safety, including the 
importance of employee health and personal hygiene, as appropriate to 
the person's assigned duties, provides flexibility for the 
establishment to provide training that is appropriate for its employees 
in light of each person's assigned duties. However, the rule does not 
require training specific to the person's assigned duties.
    (Comment 177) Some comments assert that the training requirement 
would be an unreasonable burden for small businesses and that companies 
may incur substantial cost for the time that workers would be in 
training rather than in production. Some comments ask us to provide 
non-specific training recommendations for smaller food processors that 
need flexibility to control the cost of training. Some comments assert 
that the training and education requirements must be accessible and 
flexible enough to allow employers to bring in temporary help when 
demand is high without causing a delay in hiring.
    Some comments assert that we must provide ongoing education, 
training, and outreach for previously regulated firms, newly regulated 
firms, regulators that will be responsible for implementing the rules, 
and educators who will help farmers and facilities understand and 
manage the new requirements. Some comments assert that training is 
needed to educate farmers, the food industry, and State and local 
authorities as well.
    (Response 177) All employees will need enough training to do their 
jobs and understand the importance of hygiene for food safety. The 
training offered does not need to be expensive (e.g., off-site training 
or off-the-shelf purchased training) and we expect that much of the 
training will be provided in-house by knowledgeable employees. As 
discussed in Response 2, the FSPCA is developing a preventive controls 
training curriculum. These training

[[Page 55974]]

materials will be available online, and we expect these training 
materials to be useful to small businesses to use for in-house 
training.
    (Comment 178) Some comments ask us to continue to work with foreign 
governments on access to training and education to ensure that the 
industry as a whole is moving towards better advancements in food 
safety practices, no matter the size, channels of distribution, or 
geographic location.
    (Response 178) As discussed in Response 717, we intend to work with 
the food industry, education organizations, USDA, the U.S. Agency for 
International Development, and foreign governments to develop tools and 
training programs to facilitate implementation of this rule.
    (Comment 179) Some comments assert that the preventive controls 
qualified individual should perform the trainings. Some comments assert 
that the preventive controls qualified individual should be responsible 
for determining the appropriate frequency and scope of training for 
each facility and employee, and the records necessary to document that 
appropriate training has been conducted.
    (Response 179) We decline these requests. Although we agree that 
the person delivering such training should be knowledgeable, we are 
providing flexibility for facilities to provide training as appropriate 
to the facility, including through on-line CGMP or other food safety 
courses.
    (Comment 180) Some comments ask that this rule provide FDA (and 
those States under contract) the ability to require certification of 
industry managers and training of employees if serious operational 
hazards are found and management and staff are unable to answer basic 
questions concerning hazards and controls in the facility.
    (Response 180) We decline this request. We address each compliance 
situation on a case-by-case basis.

B. Additional Requirements Applicable to Supervisory Personnel (Final 
Sec.  117.4(c))

    We received no comments that disagreed with our proposal to retain 
the requirement in part 110 that responsibility for ensuring compliance 
by all personnel with all requirements of this subpart must be clearly 
assigned to competent supervisory personnel. We are correcting ``all 
requirements of this subpart'' to ``all requirements of this part.'' As 
a conforming change for consistency with the provisions of Sec.  
117.4(b), we are replacing the phrase ``competent supervisory 
personnel'' with the phrase ``supervisory personnel who have the 
education, training, or experience (or a combination thereof) necessary 
to supervise the production of clean and safe food.''

XI. Subpart A: Comments on Proposed Sec.  117.5--Exemptions

    We proposed to establish a series of exemptions from the 
requirements for hazard analysis and risk-based preventive controls 
that would be established in subpart C, with modified requirements in 
some cases. We also proposed to redesignate Sec.  110.19(a) (a pre-
existing exemption from CGMP requirements applicable to establishments 
engaged solely in the harvesting, storage, or distribution of one or 
more RACs) as Sec.  117.5(k) and to revise this exemption to adjust and 
clarify what activities fall within this exemption based on experience 
and changes in related areas of the law since issuance of the CGMP 
regulation.
    Some comments support one or more of the proposed exemptions 
without change. For example, some comments note that the exemptions are 
specified in FSMA and, thus, reflect the intent of Congress. Some 
comments state that some exemptions (i.e., those for products already 
subject to our HACCP regulations for seafood and juice, or to 
regulations for the control of microbiological hazards for LACF) make 
sense because they are risk-based. Other comments that support one or 
more of the proposed exemptions ask us to clarify particulars 
associated with these exemptions (see, e.g., Comment 209, Comment 210, 
Comment 211, and Comment 212) or expand the scope of some of these 
exemptions (see, e.g., Comment 185, Comment 196, Comment 197, Comment 
208, and Comment 221). Other comments ask us to include additional 
exemptions in the rule (see section XI.K).
    In the remainder of this section, we discuss comments that ask us 
to clarify the proposed exemptions or that disagree with, or suggest 
one or more changes to, the proposed exemptions. We also discuss 
comments that ask us to include additional exemptions in the rule. 
After considering these comments, we have revised the proposed 
exemptions as shown in table 12 with editorial and conforming changes 
as shown in table 52. A key conforming change that affects all proposed 
exemptions from the requirements of subpart C is that the final 
exemptions are from the requirements of subpart G, as well as subpart 
C. As discussed in section XLII, the final rule establishes the 
requirements for a supply-chain program in subpart G, rather than 
within subpart C as proposed.

                                 Table 12--Revisions to the Proposed Exemptions
----------------------------------------------------------------------------------------------------------------
              Section                              Exemption                            Modification
----------------------------------------------------------------------------------------------------------------
117.5(g)...........................  From the requirements of subpart C      Made changes consequential
                                      for on-farm packing or holding of      to the revised ``farm'' definition--
                                      food by a small or very small          i.e., no longer identifying any
                                      business if the only packing and       packing or holding activities for
                                      holding activities subject to          any RACs.
                                      section 418 of the FD&C Act that the   Clarified that the modified
                                      business conducts are the specified    requirements do not apply to on-
                                      low-risk packing or holding activity/  farm packing or holding of food by
                                      food combinations.                     a very small business if the only
                                                                             packing and holding activities
                                                                             subject to section 418 of the FD&C
                                                                             Act that the business conducts are
                                                                             the listed low-risk packing or
                                                                             holding activity/food combinations.
                                                                             Updated food categories
                                                                             consistent with the food categories
                                                                             included in table 1 in the section
                                                                             103(c)(1)(C) RA.
                                                                             Added low-risk packing or
                                                                             holding activity/food combinations
                                                                             as a result of an updated risk
                                                                             assessment.
                                                                             Added a description of the
                                                                             food categories included in Sec.
                                                                             117.5(g) and (h).

[[Page 55975]]

 
117.5(h)...........................  From the requirements of subpart C      Made changes consequential
                                      for on-farm manufacturing/processing   to the revised ``farm'' definition--
                                      activities conducted by a small or     i.e.:
                                      very small business for distribution  --No longer distinguish between
                                      into commerce if the only              manufacturing/processing activities
                                      manufacturing/processing activities    conducted on a farm mixed-type
                                      subject to section 418 of the FD&C     facility's own RACs and
                                      Act that the business conducts are     manufacturing/processing activities
                                      the specified low-risk manufacturing/  conducted on food other than the
                                      processing activity/food               farm mixed-type facility's own
                                      combinations.                          RACs; and
                                                                            --Eliminated activities, conducted
                                                                             on others' RACs, that would no
                                                                             longer be classified as
                                                                             manufacturing/processing and
                                                                             instead would be classified as
                                                                             harvesting, packing, or holding.
                                                                             Clarified that the modified
                                                                             requirements do not apply to on-
                                                                             farm manufacturing/processing
                                                                             activities conducted by a very
                                                                             small business for distribution
                                                                             into commerce, if the only
                                                                             manufacturing/processing activities
                                                                             subject to section 418 of the FD&C
                                                                             Act that the business conducts are
                                                                             the listed low-risk manufacturing/
                                                                             processing activity/food
                                                                             combinations.
                                                                             Updated food categories
                                                                             consistent with the food categories
                                                                             included in table 1 in the section
                                                                             103(c)(1)(C) RA.
                                                                            Added low-risk manufacturing/
                                                                             processing activity/food
                                                                             combinations as a result of an
                                                                             updated risk assessment.
117.5(k)(1)(iii)...................  From the requirements of subpart B     Changed from an exemption for
                                      for the holding and transportation     specific activities (i.e., holding
                                      of RACs.                               and transportation of RACs) to
                                                                             establishments solely engaged in
                                                                             one or both of those activities.
117.5(k)(1)(v).....................  From the requirements of subpart B     Changed from an exemption for
                                      for certain activities conducted on    specific activities to
                                      nuts (without additional               establishments solely engaged in
                                      manufacturing/processing).             those activities.
----------------------------------------------------------------------------------------------------------------

A. General Comments on the Proposed Exemptions

    (Comment 181) Some comments ask us to provide the same flexibility 
for foreign small businesses as for domestic small businesses.
    (Response 181) The exemptions apply to both foreign small 
businesses and domestic small businesses.
    (Comment 182) Some comments note that proposed Sec.  117.10(c) 
recommends, but would not require, that the responsible individual at a 
food establishment have a background of education, experience or a 
combination of both to provide a level of competence necessary to 
produce clean and safe food. These comments ask us to make this a 
requirement, rather than a recommendation, for the responsible 
individual at any facility that is exempt from the requirements for 
hazard analysis and risk-based preventive controls. These comments also 
ask us to require presentation of the training information to us before 
an exemption is granted.
    (Response 182) We decline these requests. The statute does not 
require that we pre-qualify a facility for an exemption.
    (Comment 183) Some comments ask us to clarify whether an 
establishment that is exempt from the requirements for hazard analysis 
and risk-based preventive controls in subpart C remains subject to the 
CGMP requirements in subpart B.
    (Response 183) An establishment that is exempt from the 
requirements for hazard analysis and risk-based preventive controls in 
subparts C and G remains subject to the CGMP requirements in subpart B, 
unless that establishment is exempt from subpart B under Sec.  117.5(k) 
(which applies to: (1) Farms; (2) certain fishing vessels; (3) 
establishments solely engaged in the holding and/or transportation of 
one or more RACs; (4) activities of ``farm mixed-type facilities'' that 
fall within the definition of ``farm''; and (5) establishments solely 
engaged in hulling, shelling, drying, packing, and/or holding nuts 
(without additional manufacturing/processing)).

B. Proposed Sec.  117.5(a)--Exemption Applicable to a Qualified 
Facility

    We proposed that subpart C would not apply to a qualified facility, 
except as provided by subpart E (Withdrawal of an Exemption Applicable 
to a Qualified Facility), and that qualified facilities would be 
subject to the modified requirements in Sec.  117.201.
    (Comment 184) Some comments support the proposed exemption for a 
qualified facility and assert that all farms should be eligible for 
this exemption until it is shown that food obtained from these farms 
makes people sick. Other comments oppose this proposed exemption, 
asserting that it is not risk based and expressing concern that 
qualified facilities would cause significant food safety problems. Some 
comments ask us to strictly construct and narrowly apply the exemptions 
to as few businesses as possible.
    Some comments do not agree that qualified facilities should be 
subject to modified requirements because even the modified requirements 
are burdensome. Some comments assert that qualified facilities having 
an average annual value of food sold during the previous three-year 
period of $25,000 or less should be exempt from all requirements 
related to hazard analysis and risk-based preventive controls, 
including modified requirements.
    (Response 184) The exemption for qualified facilities, including 
the criteria for being a qualified facility and the applicability of 
modified requirements, is expressly directed by section 418(l) of the 
FD&C Act. In defining ``very small business'' to mean a business 
(including any subsidiaries and affiliates) averaging less than 
$1,000,000, adjusted for inflation, per year, during the 3-year period 
preceding the applicable calendar year in sales of human food plus the 
market value of human food manufactured, processed, packed, or held 
without sale (e.g., held for a fee), we constructed this exemption to 
apply

[[Page 55976]]

to businesses that, collectively, produce less than 0.6 percent of the 
food supply (Ref. 38). In addition, as discussed in Response 151, most 
of these facilities will be subject to the CGMP requirements in subpart 
B.
    (Comment 185) Some comments assert that a qualified facility should 
be exempt from the CGMP requirements of subpart B, as well as the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C.
    (Response 185) The exemption for qualified facilities is expressly 
directed by section 418(l) of the FD&C Act and is limited to an 
exemption from the requirements for hazard analysis and risk-based 
preventive controls in subparts C and G. The comments provide no basis 
for why new statutory requirements for hazard analysis and risk-based 
preventive controls should in any way impact the long-standing CGMPs 
requirements that apply to the manufacturing, packing, and holding of 
human food. CGMPs provide the basic requirements for ensuring 
production of safe and sanitary food. Following the CGMPs is essential 
to properly address public health risks from very small facilities that 
are provided an exemption from subparts C and G in order to minimize 
the burden on such facilities. (See also Response 221.)
    (Comment 186) Some comments ask us to clarify how the exemption 
applies to diversified farms that produce both exempt and non-exempt 
products.
    (Response 186) We assume that this comment is referring to a farm 
mixed-type facility that produces some products (such as juice or 
dietary supplements) that are exempt from the requirements for hazard 
analysis and risk-based preventive controls, as well as some products 
that are not exempt from these requirements. The exemption only applies 
to products that are not otherwise exempt from the requirements for 
hazard analysis and risk-based preventive controls. However, see the 
discussion in Response 157 with our response to comments requesting 
that we base the dollar threshold for the definition of very small 
business only on the annual monetary value of food covered by the 
preventive controls rule, rather than all human food; we declined that 
request.
    (Comment 187) Some comments ask us to provide that a qualified 
facility may voluntarily choose to comply with the requirements for 
hazard analysis and risk-based preventive controls.
    (Response 187) A qualified facility may voluntarily choose to 
comply with the requirements for hazard analysis and risk-based 
preventive controls without a specific provision authorizing it to do 
so.
    (Comment 188) Some comments ask us to specify in guidance that a 
qualified facility is not required to prepare and implement a food 
safety plan.
    (Response 188) We intend to recommend in guidance how a qualified 
facility could comply with the modified requirements in Sec.  117.201 
without satisfying all of the requirements in subparts C and G.

C. Proposed Sec.  117.5(b) and (c)--Exemptions Applicable to Food 
Subject to HACCP Requirements for Fish and Fishery Products (21 CFR 
Part 123) or for Juice (21 CFR Part 120)

    We proposed that subpart C would not apply with respect to 
activities that are subject to part 123 (21 CFR part 123) at a facility 
if the owner, operator, or agent in charge of the facility is required 
to comply with, and is in compliance with, part 123 with respect to 
such activities. We also proposed that subpart C would not apply with 
respect to activities that are subject to part 120 (21 CFR part 120) at 
a facility if the owner, operator, or agent in charge of the facility 
is required to comply with, and is in compliance with, part 120 with 
respect to such activities. We requested comment on the criteria that 
should be used to determine whether a facility is in compliance with 
part 123 or part 120 (78 FR 3646 at 3704).
    (Comment 189) Some comments ask us to clarify whether a seafood 
allergen that is identified as a hazard should be included in a seafood 
HACCP plan or in a facility's food safety plan. These comments also ask 
whether a food allergen that is identified as a hazard in juice subject 
to part 120 should be included in a juice HACCP plan or in a facility's 
food safety plan
    (Response 189) There is no specific requirement in the seafood 
HACCP regulation in part 123 that food allergen hazards be addressed in 
the seafood HACCP plan. However, Chapter 19 in our guidance entitled 
``Fish and Fishery Products Hazards and Controls Guidance (Fourth 
Edition)'' includes recommendations for the control of undeclared food 
allergens (Ref. 42). The juice HACCP regulation in part 120 requires 
that a juice processor consider the presence of undeclared ingredients 
that may be food allergens as part of its hazard analysis, and several 
sections in our guidance entitled ``Juice HACCP Hazards and Controls 
Guidance (First Edition)'' include recommendations for the control of 
food allergens (Ref. 43). Both seafood processors and juice processors 
would also address allergen hazards through application of CGMPs.
    Facilities that are exempt from the requirements of subparts C and 
G with respect to activities that are subject to part 120 or part 123 
are not required to prepare and implement a food safety plan in 
addition to their HACCP plans.
    (Comment 190) Some comments note that our HACCP regulations for 
juice and seafood do not require facilities subject to those 
regulations to address radiological hazards and ask how radiological 
hazards should be addressed for activities that are subject to part 120 
or part 123.
    (Response 190) A facility that conducts activities that are subject 
to part 120 or part 123 is not required to address radiological hazards 
in its HACCP plan if the facility is required to comply with, and is in 
compliance with, part 120 or part 123 with respect to such activities. 
However, under some circumstances radiological hazards might need to be 
considered. Moreover, the facility would be subject to the CGMP 
requirement that storage and transportation of food must be under 
conditions that will, among other things, protect against chemical 
(including radiological) contamination of food (Sec.  117.93).
    (Comment 191) Some comments state that what is needed to assess 
compliance with the applicable HACCP regulation is evidence of 
compliance with each specific requirement of the regulation, such as 
compliance with requirements for a written hazard analysis and 
Sanitation Standard Operating Procedures (SSOPs). Other comments ask us 
to provide guidance to industry and the regulatory community regarding 
the criteria that will be used to determine when a facility is ``in 
compliance with'' part 120 or part 123. Some comments note that any 
determination of compliance with one of our HACCP regulations would be 
product specific, and that we would only be able to assess compliance 
on the inspected product, not all of the products being produced at the 
facility. Some comments ask us to establish a transparent process to 
follow when determining when to nullify an exemption applicable to food 
subject to HACCP in part 120 or part 123. These comments made specific 
suggestions for such a process, including through a HACCP inspection of 
a domestic facility or a review of a facility's HACCP plan and 
corresponding HACCP records for a foreign facility. These comments 
assert that FDA actions such as issuing inspectional observations, 
issuing a Warning Letter, or making an imported product subject to 
detention without physical examination, should not be the basis for 
determining non-compliance

[[Page 55977]]

because in such situations a facility would have an opportunity to 
respond to FDA with its approach to correcting problems.
    Some comments assert that the key question for us to answer is when 
a situation will be so severe that it warrants requiring compliance 
with the human preventive controls rule rather than the applicable 
HACCP regulation. These comments raise questions about the practicality 
of requiring compliance with the human preventive controls rule for 
some products manufactured at a facility while continuing to require 
compliance with the applicable HACCP regulation for other products 
manufactured at that facility. These comments ask us to specify the 
added food safety protections that the human preventive controls rule 
can provide that cannot be obtained by compliance with the applicable 
HACCP regulation. These comments also ask us to consider the likelihood 
that a facility that cannot comply with the applicable HACCP regulation 
would be able to comply with the human preventive controls rule. Other 
comments ask whether we will modify existing guidance on compliance 
with applicable HACCP regulations to help facilities and inspectors 
understand what is needed for a facility to maintain its exemption.
    Some comments assert that the statutory intent for compliance would 
be satisfied by enforcement actions (such as administrative detention, 
registration suspension, or mandatory recall) that will either ensure 
compliance with the applicable HACCP regulation, or prohibit that 
facility from distributing food.
    (Response 191) We acknowledge the issues raised by these comments 
and agree that in many situations the appropriate action for us to take 
when a facility is out of compliance with an applicable HACCP 
regulation will be to employ existing enforcement tools to bring the 
facility into compliance with the applicable regulation. However, we 
also believe that there may be circumstances where an added food safety 
benefit could be achieved by requiring compliance with the human 
preventive controls rule when a facility does not comply with an 
applicable HACCP regulation. For example, the seafood HACCP regulation 
recommends--but does not require--that a seafood processor have and 
implement a written SSOP. In contrast, the human preventive controls 
rule requires that all preventive controls be written, and that 
preventive controls include, as appropriate to the facility and the 
food, sanitation controls, which include procedures, practices, and 
processes to ensure that the facility is maintained in a sanitary 
condition adequate to significantly minimize or prevent hazards such as 
environmental pathogens, biological hazards due to employee handling, 
and food allergen hazards (Sec.  117.135(c)(3)). A seafood processing 
facility that has ongoing sanitation problems and contamination with, 
for example, an environmental pathogen, but does not have a written 
SSOP, may be better able to address its sanitation problems by a 
combination of written sanitation controls and verification of those 
sanitation controls through environmental monitoring (Sec.  
117.165(a)(3)). Likewise, a juice processor that has ongoing problems 
with microbial contamination of fruit it receives for processing may be 
better able to address its supply of fruit by complying with the 
specific requirements of the human preventive controls rule for a 
supply-chain program (subpart G).
    We expect that situations in which enforcement actions to ensure 
compliance with an applicable HACCP regulation are insufficient to 
correct problems, and lead to a facility losing its exemption from the 
requirements of subparts C and G, will be rare and will depend on very 
specific circumstances. Therefore, at this time we do not anticipate 
issuing guidance on when violations of one of our HACCP regulations 
would cause us to require compliance with subparts C and G.
    (Comment 192) Some comments ask us to revise our HACCP regulations 
for seafood and juice to be consistent with subpart C to avoid the 
burden of having two systems within facilities that produce seafood or 
juice products, as well as other foods.
    (Response 192) We decline this request. Our HACCP regulations are 
already consistent with--though not identical to--subpart C. Further, 
it is not clear that such facilities would need two separate systems, 
given the similarities in requirements and flexibility we have provided 
for implementing preventive controls. The food safety plan for the 
products not subject to the HACCP regulations is likely to be very 
similar to that for the foods subject to the HACCP regulations (which 
includes monitoring of SSOPs). To the extent that subparts C and G 
contain additional requirements, a facility is free to perform similar 
actions for its products produced under a HACCP regulation.
    (Comment 193) Some comments ask us to exempt the production of 
fresh cider from the rule.
    (Response 193) Fresh cider is juice. A facility that produces fresh 
cider is eligible for the exemption for products subject to our HACCP 
regulation for juice.

D. Proposed Sec.  117.5(d)--Exemption Applicable to Food Subject to 
Part 113--Thermally Processed Low-Acid Foods Packaged in Hermetically 
Sealed Containers

    We proposed that subpart C would not apply with respect to 
activities that are subject to part 113 at a facility if the owner, 
operator, or agent in charge of the facility is required to comply 
with, and is in compliance with, part 113 with respect to such 
activities. We also proposed that this exemption would apply only with 
respect to the microbiological hazards that are regulated under part 
113. We requested comment on the criteria that should be used to 
determine whether a facility is in compliance with part 113 (78 FR 3646 
at 3704).
    (Comment 194) Some comments express concern that the partial 
exemption for products subject to part 113 could generate confusion for 
both regulators and regulated facilities. These comments also assert 
that the partial exemption for products subject to part 113 would 
generate duplicative recordkeeping requirements under the two rules.
    (Response 194) We acknowledge the potential for confusion and 
expect any confusion to decrease over time as both regulators and 
facilities gain experience with the new requirements. We also expect 
that in most instances a facility that is subject to part 113, and that 
evaluates potential microbiological hazards as part of its hazard 
analysis, would conclude that the potential hazards are controlled by 
the targeted requirements of part 113 and conclude there are no 
microbiological hazards that require preventive controls to 
significantly minimize or prevent the hazards.
    We disagree that the partial exemption for products subject to part 
113 would generate duplicative recordkeeping requirements. The 
requirements of part 113 to control biological hazards are different 
from the requirements of subparts C and G to conduct a hazard 
evaluation for chemical and physical hazards, and implement preventive 
controls and associated preventive control management components to 
address significant chemical and physical hazards. Likewise, the 
records associated with the control of biological hazards under part 
113 are not the same as the records associated with a hazard analysis, 
preventive controls, and associated preventive control management 
components for control of

[[Page 55978]]

chemical and physical hazards. However, to the extent that a facility 
appropriately determines that existing records required by part 113 can 
be used to demonstrate compliance with the requirements of subparts C 
and G, a facility may rely on those records (see Sec.  117.330).
    (Comment 195) Some comments ask us to provide guidance to industry 
and the regulatory community regarding the criteria that will be used 
to determine when a facility is ``in compliance with'' part 113.
    (Response 195) We discuss similar comments regarding the exemptions 
for products subject to one of our HACCP regulations in Response 191. 
As an example, an LACF manufacturing facility that has ongoing problems 
controlling biological hazards may be better able to address biological 
hazards by preparing and implementing a written food safety plan. As 
with facilities subject to our HACCP regulations, we expect that 
situations in which enforcement actions to ensure compliance with part 
113 are insufficient to correct problems, and lead to a facility losing 
its exemption from the requirements of subparts C and G, will be rare 
and will depend on very specific circumstances. Therefore, at this time 
we do not anticipate issuing guidance on when violations of part 113 
could lead to this outcome.

E. Proposed Sec.  117.5(e)--Exemption Applicable to a Facility That 
Manufactures, Processes, Packages, or Holds a Dietary Supplement

    We proposed that subpart C would not apply to any facility with 
regard to the manufacturing, processing, packing, or holding of a 
dietary supplement that is in compliance with the requirements of part 
111 (Current Good Manufacturing Practice in Manufacturing, Packing, 
Labeling, or Holding Operations for Dietary Supplements) and section 
761 (Serious Adverse Event Reporting for Dietary Supplements) of the 
FD&C Act. We requested comment on the criteria that should be used to 
determine whether a facility is in compliance with part 111 and section 
761 of the FD&C Act (78 FR 3646 at 3705). As noted in table 52, we 
corrected the exemption to match the title of part 111--i.e., ``Current 
Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or 
Holding Operations for Dietary Supplements.''
    (Comment 196) Some comments assert that the entire facility should 
be exempt from the requirements of subpart C if the facility implements 
the dietary supplement CGMP regulation even if the facility also makes 
food products that are not dietary supplements. Some comments assert 
that the exemption applicable to the manufacturing, processing, 
packing, or holding of a dietary supplement should also apply to the 
manufacturing, processing, packing, or holding of a dietary ingredient 
if the facility chooses to follow the dietary supplement CGMP 
regulation.
    (Response 196) The proposed exemption is directed by section 103(g) 
of FSMA. None of these comments explain how the desired expansion of 
the exemption is consistent with section 103(g), which limits the 
provision to ``the manufacturing, processing, packing, or holding of a 
dietary supplement'' (78 FR 3646 at 3705).
    (Comment 197) Some comments ask us to revise the exemption 
applicable to dietary supplements to add that subparts B and F do not 
apply to any facility with regard to the manufacturing, processing, 
packing, or holding of a dietary supplement that is in compliance with 
the requirements of part 111. These comments assert that it would be 
illogical to subject the dietary supplement industry to industry-
specific CGMPs (part 111), as well as a more general (and inherently 
less applicable) CGMP standard in part 117. These comments also assert 
that the intent of the CGMPs in part 117 is to regulate industries and 
industry segments that have not previously been regulated and that 
failing to acknowledge the regulations already applicable to dietary 
supplements would be duplicative, redundant, and provide no additional 
safety or public health protection.
    (Response 197) As discussed in the final rule establishing the 
dietary supplement CGMP regulation, we included in part 111 the 
existing requirements in part 110 that we believe are common to dietary 
supplement manufacturing (72 FR 34752 at 34764, June 25, 2007). We 
recognized that there may be operations related to the manufacturing of 
dietary supplements for which certain provisions in part 110 (now 
largely subpart B of part 117) apply, but that we did not determine to 
be common to most dietary supplement manufacturing operations (e.g., 
for dietary supplements that are dehydrated and rely on the control of 
moisture consistent with current Sec.  110.80(b)(14) (proposed Sec.  
117.80(c)(14)). As was the case when we issued the final rule to 
establish dietary supplement CGMPs and continues to be the case now, a 
manufacturer would be required to comply with the CGMP regulations in 
subpart B of part 117 in addition to the regulations in part 111, 
unless the regulations conflict. To the extent that the regulations 
conflict, the dietary supplement manufacturer would comply with the 
regulation in part 111.
    (Comment 198) Some comments ask us to clarify how the exemption 
applies to foods, other than dietary supplements, that may be held in a 
facility that conducts activities in compliance with the dietary 
supplement CGMP regulation.
    (Response 198) The exemption does not apply to foods, other than 
dietary supplements, that may be held in a facility that conducts 
activities in compliance with the dietary supplement CGMP regulation. 
The owner, operator, or agent in charge of a facility that produces 
both dietary supplements and foods that are not dietary supplements 
must comply with the requirements of this rule for hazard analysis and 
risk-based preventive controls, unless another exemption applies as 
specified in Sec.  117.5.
    (Comment 199) Some comments ask us to use information collected in 
the biennial food facility registration to help determine whether a 
facility is in compliance with part 111.
    (Response 199) We decline this request. It would be the 
observations and findings from an inspection, rather than information 
in a facility's registration, that could help us determine whether a 
facility is in compliance with part 111. Information collected during 
registration provides information on how we should inspect a facility, 
but has no bearing on whether the facility is complying with applicable 
regulations.

F. Proposed Sec.  117.5(f)--Exemption Applicable to Activities Subject 
to Standards for Produce Safety in Section 419 of the FD&C Act

    We proposed that subpart C would not apply to activities of a 
facility that are subject to section 419 (Standards for Produce Safety) 
of the FD&C Act (21 U.S.C. 350h). We received no comments that 
disagreed with this proposal and are finalizing it as proposed.

G. Proposed Sec. Sec.  117.5(g) and (h)--Exemptions Applicable to On-
Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very 
Small Business

    As discussed in section VI.A, consistent with the statutory 
direction in section 103(c) of FSMA, including conducting a qualitative 
risk assessment, we proposed three exemptions for on-farm activity/food 
combinations conducted by farm-mixed-type facilities that are small or 
very

[[Page 55979]]

small businesses (proposed Sec. Sec.  117.5(g), (h)(1), and (h)(2)).
1. General Comments on the Proposed Exemptions Applicable to On-Farm 
Low-Risk Activity/Food Combinations Conducted by a Small or Very Small 
Business
    (Comment 200) Some comments assert that conducting a low-risk 
activity/food combination should be sufficient to qualify any facility 
for exemption from subpart C, regardless of whether the activity is 
conducted on-farm or off-farm, or meets the economic threshold for a 
small or very small business.
    (Response 200) The statute provides specific direction for those 
facilities that can qualify for this exemption. (See sections 418(l) 
and 418(o)(2) of the FD&C Act.) See also Response 184 and Response 222.
    (Comment 201) Some comments ask why the activity/food combinations 
listed in proposed Sec.  117.5(g) are not consistent with the activity/
food combinations listed in proposed Sec.  117.5(h). Some comments 
state that the exemptions for farming activities are confusing.
    (Response 201) The items listed in Sec.  117.5(g) only specify the 
food or food category (rather than an activity/food combination) 
because the activities addressed in Sec.  117.5(g) are, in all cases, 
the same--i.e., packing and holding activities. In contrast, the items 
listed in Sec.  117.5(h) specify a particular activity (e.g., coating, 
mixing) in addition to a food or food category (e.g., peanuts and tree 
nuts) because there are multiple manufacturing/processing activities, 
each associated with a particular food or food category, listed in the 
provisions.
    Although these exemptions are more complex than other exemptions 
(e.g., because they are directed to specific activities conducted on 
specific foods or food categories), the final ``farm'' definition has 
simplified them to the extent practicable. For example, under the 
``farm'' definition in the 2013 proposed preventive controls rule, 
whether an activity was packing or manufacturing/processing depended, 
in part, on whether the RACs being packed were the farm's own RACs or 
others' RACs. In contrast, under the ``farm'' definition established in 
this rule, packing RACs is a ``packing'' activity, regardless of 
ownership of the RACs being packed.
    (Comment 202) Some comments note a distinction between the 
exemptions for on-farm low-risk activity/food combinations conducted by 
small and very small businesses and the exemption for qualified 
facilities. Specifically, a farm mixed-type facility that only conducts 
low-risk activity/food combinations (such as making certain jams or 
syrups) would be exempt from the requirements of subpart C, whereas an 
off-farm qualified facility making those same jams and syrups, while 
exempt from the requirements of subpart C, would nonetheless be subject 
to modified requirements in Sec.  117.201. These comments ask whether 
it would be better for a farm or farm mixed-type facility that 
satisfies criteria for a small or very small business, and also 
satisfies criteria for a qualified facility, to classify itself as a 
small or very small business or to classify itself as a qualified 
facility.
    (Response 202) In light of the final ``farm'' definition, these 
comments no longer apply with respect to activities within the farm 
definition.
    For activities conducted by a farm mixed-type facility, we 
acknowledge that the exemptions provided by Sec.  117.5(g) and (h) for 
on-farm low-risk activity/food combinations are different from the 
exemption provided by Sec.  117.5(a) for a qualified facility. A farm 
mixed-type facility that only conducts low-risk activity/food 
combinations listed in Sec.  117.5(g) and (h) is fully exempt from the 
requirements of subparts C and G, and is not subject to the modified 
requirements in Sec.  117.201, even if that farm mixed-type facility is 
also a very small business (and, thus, also is a qualified facility). 
To make this clear, we have revised proposed Sec.  117.5(g) to specify 
that Sec.  117.201 does not apply to on-farm packing or holding of food 
by a very small business if the only packing and holding activities 
subject to section 418 of the FD&C Act that the business conducts are 
the listed low-risk packing or holding activity/food combinations. 
Likewise, we have revised proposed Sec.  117.5(h) to specify that Sec.  
117.201 does not apply to on-farm manufacturing/processing activities 
conducted by a very small business for distribution into commerce, if 
the only manufacturing/processing activities subject to section 418 of 
the FD&C Act that the business conducts are the listed low-risk 
manufacturing/processing activity/food combinations.
    With these changes, a farm mixed-type facility that is a very small 
business and that only conducts the low-risk activity/food combinations 
listed in Sec.  117.5(g) and/or (h) may find it advantageous to 
classify itself as a very small business eligible for the exemption in 
Sec.  117.5(g) and/or (h) rather than as a qualified facility, which 
would be subject to the modified requirements in Sec.  117.201.
    (Comment 203) Some comments ask us to list activity/food 
combinations that are not low-risk activity/food combinations, or that 
should have modified requirement rather than be exempt (e.g., if the 
foods have been the subject of Class I recalls or outbreaks of 
foodborne illness).
    (Response 203) We decline this request. With few exceptions, the 
exemptions are established by specifying the activities that are not 
subject to the requirements for hazard analysis and risk-based 
preventive controls, rather than the activities that are subject to 
these requirements. When an exemption does specify activities that are 
subject to certain requirements of the rule, the specified activities 
are a narrow exception (see Sec.  117.5(k)). In the case of the 
exemptions for the low-risk activity/food combinations listed in Sec.  
117.5(g) and (h), the activity/food combinations that are subject to 
the requirements of subparts C and G are extensive and it is not 
feasible to identify and list all of them.
    In developing the low-risk activity/food combinations that are 
exempt from the requirements, we conducted a qualitative risk 
assessment (Ref. 4) that considered whether manufacturing, processing, 
packing, or holding activities conducted on a farm mixed-type facility 
had been implicated in food that has been the subject of a Class I 
recall or outbreak of foodborne illness. However, whether specific 
types of food had been the subject of a Class I recall or outbreak of 
foodborne illness was only one factor we considered. For example, we 
also considered factors that impact the frequency and levels of 
contamination of the food (Ref. 4). For additional discussion, see the 
section 103(c)(1)(C) RA (Ref. 4).
    (Comment 204) Some comments ask for a process to keep the list of 
low-risk activity/food combinations up to date, such as through 
guidance.
    (Response 204) We decline this request. The exemptions established 
in this rule are binding, whereas any list of additional activity/food 
combinations established in a guidance document would not be binding. 
We established the list of activity/food combinations included in these 
exemptions through an extensive public process, including a request for 
comments on the section 103(c)(1)(C) draft RA. From this time forward, 
the process available to a person who wishes us to consider an 
additional activity/food combination is to submit a citizen petition in 
accordance with 21 CFR 10.30.

[[Page 55980]]

2. Proposed Sec.  117.5(g)--Exemption Applicable to On-Farm Low-Risk 
Packing or Holding Activity/Food Combinations Conducted by a Small or 
Very Small Business
    We proposed that subpart C would not apply to on-farm packing or 
holding of food by a small or very small business if the only packing 
and holding activities subject to section 418 of the FD&C Act that the 
business conducts are low-risk packing or holding activity/food 
combinations on food not grown, raised, or consumed on that farm mixed-
type facility or another farm or farm mixed-type facility under the 
same ownership. As a consequential change in light of the final 
``farm'' definition, the final exemption no longer identifies any 
packing or holding activities for any RACs (whether the farm's own RACs 
or others' RACs), because an on-farm establishment would no longer be 
subject to the requirements for hazard analysis and risk-based 
preventive controls when it packs or holds RACs, regardless of whether 
it is packing and holding its own RACs or others' RACs.
    (Comment 205) Some comments ask us to expand the list of on-farm 
low-risk packing and holding activities to include packing and holding 
of food products not expressly covered by the proposed exemption. See 
the food products listed in table 13 and table 14.
    (Response 205) We considered these comments within the context of 
the section 103(c)(1)(C) RA. Table 1 in the section 103(c)(1)(C) draft 
RA listed activity/food combinations that we identified as likely to be 
conducted by farm mixed-type facilities using broad food categories 
such as ``grain'' and ``grain products.'' In light of comments such as 
those described in Comment 205, table 1 in the final section 
103(c)(1)(C) RA lists more types of food categories. The purpose of 
listing more types of food categories was to make it clearer when a 
particular food is encompassed within a particular activity/food 
combination. As one example, table 1 in the final section 103(c)(1)(C) 
RA lists food categories such as baked goods, milled grain products, 
and other grain products (e.g. dried pasta), in place of the original 
category ``grain products.'' As another example, table 1 in the section 
103(c)(1)(C) RA lists the broad term ``sap'' and provides examples of 
different types of sap to make clear that activity/food combinations 
regarding sap are broader than ``maple sap.''
    We have revised the final exemption to list food categories 
consistent with the food categories included in table 1 in the section 
103(c)(1)(C) RA and include those packing and holding activity/food 
combinations that the section 103(c)(1)(C) RA determines to be low-
risk. For additional details about the outcome of the section 
103(c)(1)(C) RA on the specific activity/food combinations described in 
the comments, see the section 103(c)(1)(C) RA (Ref. 4).
    We also revised the proposed exemption to add two sets of 
information that we believe will be useful to a farm mixed-type 
facility when evaluating whether the farm's packing activities satisfy 
the criteria for the exemption.
    First, we have added a new provision (Sec.  117.5(g)((1)) 
explaining that the exemption in Sec.  117.5(g) applies to packing or 
holding of processed foods on a farm mixed-type facility, except for 
processed foods produced by drying/dehydrating RACs to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins, and drying/dehydrating fresh herbs to produce dried herbs), 
and packaging and labeling such commodities, without additional 
manufacturing/processing (such as chopping and slicing), the packing 
and holding of which are within the ``farm'' definition in Sec.  1.227. 
Activities that are within the ``farm'' definition, when conducted on a 
farm mixed-type facility, are not subject to the requirements of 
subparts C and G of this part and therefore do not need to be specified 
in the exemption.
    Second, we have added a provision (Sec.  117.5(g)((2)) describing 
the food categories listed in the exemption. For example, this 
provision explains that ``milled grain products'' include processed 
food products such as flour, bran, and cornmeal.
    The first column in table 13 lists the food or food category that 
comments ask us to include in the exemption for on-farm, low-risk 
packing and holding activities. The second column lists the regulatory 
citation for the relevant exemption for on-farm packing and holding. 
Importantly, the full regulatory text of the exemption includes some 
limitations that were not specified in the comments, and table 13 
should not be viewed as equating the requests of the comments with the 
final regulatory text of the exemption. For example, Sec.  
117.5(g)(2)(ix) specifies that the food category ``baked goods'' 
includes processed food products such as breads, brownies, cakes, 
cookies, and crackers, but does not include products that require time/
temperature control for safety (such as cream-filled pastries). See 
Sec.  117.5(g)(2) for a description of those food categories listed in 
the exemption for on-farm, low-risk packing and holding activity/food 
combinations in table 13.

Table 13--Requested Food or Food Category and Relevant Exemption for On-
              Farm Low-Risk Packing and Holding Activities
------------------------------------------------------------------------
  Food or food category requested in
             the comments                 Relevant regulatory section
------------------------------------------------------------------------
 Barley malt syrup...........  Sec.   117.5(g)(3)(xix)--Sugar.
 Barley malt extract.........  Sec.   117.5(g)(3)(xx)--Syrups.
 Other concentrated grain      Sec.   117.5(g)(3)(xxii)--
 malt products in liquid or powder      Vinegar.
 form.                                 Sec.   117.5(g)(3)(xxiii)--Any
                                        other processed food that does
                                        not require time/temperature
                                        control for safety.
 Birch sap and syrup.........  Sec.   117.5(g)(3)(xix)--Sugar.
 Cane syrup..................  Sec.   117.5(g)(3)(xx)--Syrups.
 Coconut sap and sugar.......
 Date sugar..................
 Palm sap and sugar..........
 Sorghum juice and syrup.....
 Other concentrated natural
 sweetener having a water activity
 lower than 0.85 and made with an
 adequate microbial reduction step.
Chips................................  Sec.   117.5(g)(3)(xiii)--Other
                                        fruit and vegetable products.
 Crackers....................  Sec.   117.5(g)(3)(i)--Baked
                                        goods.
 Bread crumbs................
 Dry bread...................

[[Page 55981]]

 
Crude ``dietary ingredient             Sec.   117.5(g)(3)(xiii)--Other
 botanicals'' in cut, chopped, or       fruit and vegetable products.
 powdered form.                        Sec.   117.5(g)(3)(xv) Other herb
                                        and spice products.
 Dried cereal................  Sec.   117.5(g)(3)(xiv)--Other
                                        grain products.
 Dried pasta.................
Dried herbs and spices, chopped or     Sec.   117.5(g)(3)(xv)--Other
 ground.                                herb and spice products.
Dry legume products (e.g., chickpea    Sec.   117.5(g)(3)(xiii)--Other
 flour).                                fruit and vegetable products.
Dry, unsulfited, fruits and            Sec.   117.5(g)(3)(xiii)--Other
 vegetables in cut, chopped, sliced,    fruit and vegetable products.
 shredded, or other form.
Gums and resins......................  Sec.   117.5(g)(3)(vii)--Gums,
                                        latexes, and resins that are
                                        processed foods.
Herbal extracts (e.g., in solvents     Sec.   117.5(g)(3)(xv)--Other
 such as glycerin, alcohol and oil).    herb and spice products.
 Honey infused with dried      Sec.   117.5(g)(3)(xv)--Other
 herbs or spices.                       herb and spice products.
 Oil and/or vinegar infused
 with dried herbs or spices.
Jerky................................  Sec.   117.5(g)(3)(vi)--Game meat
                                        jerky.
Molasses and treacle.................  Sec.   117.5(g)(3)(xi)--Molasses
                                        and treacle.
Potato starch........................  Sec.   117.5(g)(3)(xiii)--Other
                                        fruit and vegetable products.
Popcorn..............................  Sec.   117.5(g)(3)(xiv)--Other
                                        grain products.
Salt, baking powder..................  Sec.   117.5(g)(3)(xxiii)--Any
                                        other processed food that does
                                        not require time/temperature
                                        control for safety.
Vitamins, minerals, and processed      Sec.   117.5(g)(3)(xxiii)--Any
 dietary ingredients (e.g., bone        other processed food that does
 meal) in powdered, granular, or        not require time/temperature
 other solid form.                      control for safety.
------------------------------------------------------------------------

    In table 14, we list those foods or food categories, requested by 
comments, that are not included in the exemption for on-farm, low-risk 
packing and holding activities, and explain why.

 Table 14--Why Certain Requested Food Categories Are Not Included in the
      Exemption for On-Farm Low-Risk Packing and Holding Activities
------------------------------------------------------------------------
 Food or food group requested in the   Why the food or food group is not
               comments                     listed in the exemption
------------------------------------------------------------------------
Barley malt and other grain malts....  Malting increases the potential
                                        for a hazard, e.g., growth of
                                        microbial pathogens such as
                                        Salmonella, during the
                                        germination process. (However,
                                        the risk is mitigated when
                                        malting is done in conjunction
                                        with making sugar, syrups or
                                        vinegar.)
Crude ``dietary ingredient             These are RACs, so packing and
 botanicals'' in whole, form.           holding them is within the farm
                                        definition.
Dates (RACs).........................  These are RACs, so packing and
                                        holding them is within the farm
                                        definition
Dried intact herbs and spices........  Although these are processed
                                        foods, packing and holding them
                                        is specifically included within
                                        the farm definition.
Dried legumes........................  Although these are processed
                                        foods, packing and holding them
                                        is specifically included within
                                        the farm definition.
Gums, resins, and exudates in solid,   Gums, resins and exudates
 powdered, granular, or paste form.     (including latexes such as
                                        chicle) are RACs, so packing and
                                        holding them is within the
                                        ``farm'' definition. These
                                        products are made into processed
                                        foods in some cases, such as by
                                        boiling or cutting. The
                                        powdered, granular and paste
                                        forms from further processing
                                        are considered in the risk
                                        assessment as ``any other
                                        processed food that does not
                                        require time/temperature control
                                        for safety.''
------------------------------------------------------------------------

3. Proposed Sec.  117.5(h)--Exemption Applicable to On-Farm Low-Risk 
Manufacturing/Processing Activity/Food Combinations Conducted by a 
Small or Very Small Business
    We proposed that subpart C would not apply to on-farm low-risk 
manufacturing/processing activities conducted by a small or very small 
business if the only manufacturing/processing activities subject to 
section 418 of the FD&C Act that the business conducts are those listed 
in the proposed exemption. The proposed exemption specified those 
activity/food combinations that would be exempt when conducted on a 
farm mixed-type facility's own RACs and those activity/food 
combinations that would be exempt when conducted on food other than the 
farm mixed-type facility's own RACs for distribution into commerce.
    As a consequential change in light of the final ``farm'' 
definition, the final exemption no longer distinguishes between 
manufacturing/processing activities conducted on a farm mixed-type 
facility's own RACs and manufacturing/processing activities conducted 
on food other than the farm mixed-type facility's own RACs. As another 
consequential change, the exemption has been revised to eliminate 
activities, conducted on others' RACs, which no longer are classified 
as manufacturing/processing and instead are classified as harvesting, 
packing, or holding. In addition, as discussed in Response 205 we have 
revised the final exemption to list food categories consistent with the 
food categories included in table 1 in the section 103(c)(1)(C) RA.
    We also revised the proposed exemption to add two sets of 
information that we believe will be useful to a farm mixed-type 
facility when evaluating whether the farm's manufacturing/processing 
activities satisfy the criteria for the exemption.

[[Page 55982]]

    First, we have added a new provision (Sec.  117.5(h)((1)) 
explaining that the exemption in Sec.  117.5(h) applies to 
manufacturing/processing of foods on a farm mixed-type facility, except 
for manufacturing/processing that is within the ``farm'' definition in 
Sec.  1.227. Drying/dehydrating RACs to create a distinct commodity 
(such as drying/dehydrating grapes to produce raisins, and drying/
dehydrating fresh herbs to produce dried herbs), and packaging and 
labeling such commodities, without additional manufacturing/processing 
(such as chopping and slicing), are within the ``farm'' definition in 
Sec.  1.227. In addition, treatment to manipulate the ripening of RACs 
(such as by treating produce with ethylene gas), and packaging and 
labeling the treated RACs, without additional manufacturing/processing, 
is within the ``farm'' definition. In addition, coating intact fruits 
and vegetables with wax, oil, or resin used for the purpose of storage 
or transportation is within the ``farm'' definition. Activities that 
are within the ``farm'' definition, when conducted on a farm mixed-type 
facility, are not subject to the requirements of subparts C and G of 
this part and therefore do not need to be specified in the exemption.
    Second, we have added a provision (Sec.  117.5(h)((2)) specifying 
that Sec.  117.5(g)(2) describes the food categories listed in the 
exemption.
    (Comment 206) Some comments ask us to include in the exemption a 
single list of low-risk manufacturing/processing activity/food 
combinations applicable to farm mixed-type facilities conducting 
activities on their own RACs and farm mixed-type facilities conducting 
activities on other's RACs.
    (Response 206) These comments no longer apply. As a consequence of 
the ``farm'' definition established by this rule, the exemption no 
longer distinguishes between manufacturing/processing activities 
conducted on a farm mixed-type facility's own RACs and manufacturing/
processing activities conducted on food other than the farm mixed-type 
facility's own RACs.
    (Comment 207) Some comments ask us to include additional activity/
food combinations in the exemption. See table 15 and table 16 for a 
list of the requested additional activity/food combinations.
    (Response 207) We evaluated each of the requested activity/food 
combinations within the qualitative risk assessment (Ref. 4), unless 
the activity/food combination was out of scope of this rule (for 
example, if the requested activity/food combination was directed to 
animal food rather than human food). See table 15 and table 16 for the 
outcome of our evaluation of these requests, based on the findings of 
the section 103(c)(1)(C) RA as to whether the requested activity/food 
combination satisfies the criteria in that risk assessment for a low-
risk activity/food combination. When we determined through the section 
103(c)(1)(C) RA that the requested activity/food combination did not 
satisfy the criteria for a low-risk activity/food combination, table 16 
explains why. See Sec.  117.5(g)(2) for a description of the food 
categories listed in the exemption for on-farm, low-risk manufacturing/
processing activity/food combinations in table 15 and table 16.
    The first column in table 15 lists the activity/food combination 
that comments ask us to include in the exemption for on-farm, low-risk 
manufacturing/processing activity/food combinations. The second column 
lists the regulatory citation for the relevant exemption for an on-farm 
manufacturing/processing activity/food combination. Importantly, the 
full regulatory text of the exemption includes some limitations that 
were not specified in the comments, and table 15 should not be viewed 
as equating the requests of the comments with the final regulatory text 
of the exemption. For example, Sec.  117.5(g)(2)(ix) specifies that the 
food category ``baked goods'' includes processed food products such as 
breads, brownies, cakes, cookies, and crackers, but does not include 
products that require time/temperature control for safety (such as 
cream-filled pastries).

  Table 15--Requested Activity/Food Combinations and Relevant Exemption
        for On-Farm Low-Risk Manufacturing/Processing Activities
------------------------------------------------------------------------
 Activity/food combination requested in   Regulatory section listing the
              the comments                          exemption
------------------------------------------------------------------------
Baking activities involving grain        Sec.   117.5(h)(3)(ix)--Making
 products.                                baked goods from milled grain
                                          products (e.g., breads and
                                          cookies).
Chopping, coring, cutting, peeling,      Sec.   117.5(h)(3)(ii)--
 pitting, shredding, and slicing..        Chopping, coring, cutting,
 Crackers, dry bread, bread       peeling, pitting, shredding,
 crumbs.                                  and slicing:
 Dry cereal, popcorn...........   Baked goods
 Gums, resins and exudates.....   Other grain products
 Jerky.........................   Gums/latexes/resins
                                          Game meat jerky.
Cooking low-moisture foods with dry      Sec.   117.5(h)(3)(xxv)--
 heat.                                    Roasting and toasting baked
                                          goods.
Drying/dehydrating cut fruits and        Sec.   117.5(h)(3)(iv)--Drying/
 vegetables that are immediately moved    dehydrating (that includes
 into a drying process.                   additional manufacturing or is
                                          performed on processed foods)
                                          other fruit and vegetable
                                          products with pH less than
                                          4.2, and other herb and spice
                                          products (e.g., chopped fresh
                                          herbs, including tea).
 Distilling mint...............  Sec.   117.5(h)(3)(v)--
 Extracting virgin olive oil...   Extracting (including by
 Extracting oils from seeds       pressing, by distilling, and
 (e.g., sunflower seeds, flax seeds).     by solvent extraction) from:
 Making liquid botanical          Dried/dehydrated herb
 extracts from dry botanical raw          and spice products
 material with solvents such as           Fresh herbs
 glycerin, ethanol, vinegar, honey.       Fruits and vegetables
                                          Grains
                                          Other herb and spice
                                          products.
Grinding/milling/cracking/crushing:....  Sec.   117.5(h)(3)(vii)--
 Crackers, dry bread, bread       Grinding/milling/cracking/
 crumbs.                                  crushing:
 Dry cereal, dry pasta, popcorn   Baked goods
 Dry legumes...................   Other grain products
                                          Dried/dehydrated fruit
                                          and vegetable products.
Mixing.................................  Sec.   117.5(h)(3)(xxii)--
 Honey infused with dried herbs   Mixing other herb and spice
 or spices.                               products.
 Oil and/or vinegar infused
 with dried herbs or spices.
Making maple cream, maple sugar, and     Sec.   117.5(h)(3)(x)--Making
 molded maple candy.                      candy.

[[Page 55983]]

 
Making molasses and treacle from         Sec.   117.5(h)(3)(xiv)--Making
 sugarcane and sugar beets.               molasses and treacle.
 Making apple syrup............  Sec.   117.5(h)(3)(xix)--Making
 Making syrups from sorghum,      sugar and syrup from:
 rice.                                    Fruits and vegetables
 Making syrups from malted        Grains
 barley.                                  Other grain products
 Making syrups such as birch      Saps.
 and walnut syrup.
Making vinegar, including infused and    Sec.   117.5(h)(3)(xxi)--Making
 flavored vinegars.                       vinegar from fruits and
                                          vegetables, other fruit and
                                          vegetable products, and other
                                          grain products.
                                         Sec.   117.5(h)(3)(xxii)--
                                          Mixing other herb and spice
                                          products.
Processing tea.........................  Sec.   117.5(h)(3)(iv)--Drying/
                                          dehydrating (that includes
                                          additional manufacturing or is
                                          performed on processed foods)
                                          other fruit and vegetable
                                          products with pH less than
                                          4.2, and other herb and spice
                                          products (e.g., chopped fresh
                                          herbs, including tea).
------------------------------------------------------------------------


   Table 16--Why Certain Requested Activity/Food Combinations Are Not
 Included in the Exemption for On-Farm Low-Risk Manufacturing/Processing
                               Activities
------------------------------------------------------------------------
  Food or food group requested in the     Why the food or food group is
                comments                   not listed in the exemption
------------------------------------------------------------------------
Acidifying, pickling, and fermenting     Acidifying, pickling, and
 low-acid fruits and vegetables made in   fermenting activities control
 compliance with CGMPs.                   microbial hazards and, thus,
                                          are not low-risk activities.
Cucumbers, garlic scapes, peppers, and   The production of low-acid
 other low-acid foods that are            processed foods must control
 preserved.                               the microbial hazard C.
                                          botulinum and, thus, is not a
                                          low-risk activity.
Drying/dehydrating tea leaves (e.g., by  Drying/dehydrating tea leaves
 withering).                              is within the ``farm''
                                          definition.
Fermentation of vegetables.............  Fermenting activities control
                                          microbial hazards and, thus,
                                          are not low-risk activities.
Food processing conducted in compliance  It is the risk associated with
 with relevant State regulation.          the activity/food combination,
                                          not the regulatory oversight
                                          by a State, that is relevant
                                          of this exemption.
Freezing fruit juices..................  Fruit juices are outside the
                                          scope of the RA based on the
                                          statutory framework of FSMA.
Low-acid fruits and vegetables           The production of low-acid
 manufactured in compliance with CGMPs    processed foods must control
 under the FD&C Act.                      the microbial hazard C.
                                          botulinum and, thus, is not a
                                          low-risk activity.
Making pickles and salsa...............  The processes for making
                                          pickles and salsa must control
                                          microbial hazards and, thus,
                                          are not low-risk activities.
Roasting grains for animal feed........  This activity involves the
                                          production of animal food,
                                          which is subject to the animal
                                          preventive controls rule
                                          rather than the human
                                          preventive controls rule.
------------------------------------------------------------------------

H. Proposed Sec.  117.5(i)--Exemptions Related to Alcoholic Beverages

    Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities) 
provides a rule of construction for certain facilities engaged in the 
manufacturing, processing, packing, or holding of alcoholic beverages 
and other food. In the proposed human preventive controls rule, we 
discussed our interpretation of section 116 of FSMA and requested 
comment on our interpretation. Based on our interpretation, we proposed 
that subpart C would not apply with respect to alcoholic beverages at 
facilities meeting two specified conditions (78 FR 3646 at 3707 to 
3709). We also proposed that subpart C would not apply with respect to 
food other than alcoholic beverages at facilities described in the 
exemption, provided such food is in prepackaged form that prevents 
direct human contact with the food and constitutes not more than 5 
percent of the overall sales of the facility.
    (Comment 208) Some comments ask us to include the production of 
spent grains, distillers' grains, grape pomace, and other by-products 
of the manufacturing process within the alcohol exemption. These 
comments argue that the mere act of separating and disposing of those 
by-products by sale or otherwise should not trigger an obligation to 
meet the requirements of subpart C.
    (Response 208) The exemption established under the rule of 
construction in section 116 of FSMA applies to alcoholic beverages, not 
to any other food (see section 116(c) of FSMA (21 U.S.C. 2206(c)), and 
we have revised the exemption to make the statutory applicability 
clearer (see table 52 and the regulatory text of Sec.  117.5(i)). As 
previously discussed (79 FR 58524 at 58558), the by-products described 
in these comments appear to be products that would be used in food for 
animals rather than in human food, and we addressed these by-products 
in the 2014 supplemental animal preventive controls notice (79 FR 58476 
at 58487-58489). (See also the discussion in section L regarding the 
specific CGMP provisions that will apply to these foods.)

I. Proposed Sec.  117.5(j)--Exemption Applicable to Facilities Solely 
Engaged in Storage of Raw Agricultural Commodities Other Than Fruits 
and Vegetables Intended for Further Distribution or Processing

    We proposed that subpart C would not apply to facilities that are 
solely engaged in the storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing. In the 
following paragraphs, we discuss comments that ask us to clarify how 
the proposed exemption would apply to specific circumstances.
    (Comment 209) Some comments ask whether this proposed exemption 
(proposed Sec.  117.5(j)) would apply to facilities such as peanut 
buying points or bean elevators and assert that such

[[Page 55984]]

commodities are analogous to grains and the activities conducted at 
such facilities are analogous to those performed by grain elevators.
    (Response 209) We classify peanuts and beans (such as kidney beans, 
lima beans, and pinto beans) within the category of ``fruits and 
vegetables''; we classify soybeans as grain (see the discussion of 
fruits and vegetables, 78 FR 3646 at 3690 and proposed Sec. Sec.  112.1 
and 112.2 in the proposed produce safety rule). The exemption for 
facilities solely engaged in storage of RACs intended for further 
distribution or processing does not apply to facilities that store 
fruit and vegetable RACs and, thus, does not apply to facilities such 
as peanut buying points and bean elevators. As discussed in Response 
25, we have revised the ``farm'' definition to provide that an 
operation devoted to harvesting (such as hulling or shelling), packing, 
and/or holding of RACs is within the ``farm'' definition as a secondary 
activities farm, provided that the primary production farm(s) that 
grows, harvests, and/or raises the majority of the RACs harvested, 
packed, and/or held by the secondary activities farm owns, or jointly 
owns, a majority interest in the secondary activities farm. With this 
revision, some operations dedicated to holding RACs, including fruit 
and vegetable RACs, will be within the ``farm'' definition.
    Peanut buying points and bean elevators that do not meet the 
revised farm definition are storing RACs that are ``fruits and 
vegetables'' and do not meet the criteria for exemption under Sec.  
117.5(j). However, we would not expect such facilities to need an 
extensive food safety plan. A facility that appropriately determines 
through its hazard analysis that there are no hazards requiring 
preventive controls would document that determination in its written 
hazard analysis but would not need to establish preventive controls and 
associated management components.
    (Comment 210) Some comments refer to our statement that there would 
not be significant public health benefit to be gained by subjecting 
facilities that solely store non-fruit and vegetable RACs intended for 
further distribution or processing to the requirements of subpart C (78 
FR 3646 at 3709) and assert that the same conclusion applies to those 
portions of oilseed processing facilities that are devoted solely to 
RAC storage. According to these comments, in the overwhelming majority 
of cases the inclusion of a separate RAC storage area in the same 
building as the oilseed processing area will not introduce additional 
risk either to the processing area or to the operations that take place 
there and that storage areas, whether standing alone as a separate 
facility or incorporated into a larger processing facility, store RACs 
safely. These comments ask us to recognize that storage activities may 
include grain drying to standardize moisture levels and preserve 
product quality. These comments also ask us to expand the exemption in 
Sec.  117.5(j) to also apply to distinct and physically separate 
storage areas that are used solely for storage of RACs (other than 
fruits and vegetables) intended for further distribution or processing.
    (Response 210) The activities included within the definition of 
holding include activities that are performed as a practical necessity 
for the distribution of RACs. In the 2014 supplemental human preventive 
controls notice, we explained that facilities that conduct operations 
similar to those conducted at grain elevators and silos, such as some 
facilities that hold oilseeds, may satisfy the criteria for exemption 
if activities other than storage are performed as a practical necessity 
for the distribution of RACs (see 79 FR 58524 at 58537 and the 
definition of ``holding'' in Sec.  117.3). Examples of holding 
activities include drying/dehydrating RACs when the drying/dehydrating 
does not create a distinct commodity (see Sec.  117.3). Thus, the 
specific example of drying grains to standardize moisture levels and 
preserve product quality would fall within the definition of holding as 
a practical necessity for the distribution of RACs. A facility that 
stores oilseeds, and dries them as a practical necessity for the 
distribution of RACs, would be covered by the exemption in Sec.  
117.5(j).
    However, we decline the request to modify the exemption in Sec.  
117.5(j) to also apply to distinct and physically separate storage 
areas that are used solely for storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing. To the 
extent that the comments are asking us to do so to provide for 
facilities that conduct activities as a practical necessity for the 
distribution of RACs to be eligible for the exemption, doing so is not 
necessary in light of the definition of holding. To the extent that the 
comments are asking us to do so to provide for facilities that conduct 
manufacturing/processing activities in addition to holding activities, 
we disagree that doing so would be consistent with the statutory 
direction in FSMA. As previously discussed, section 418(m) of the FD&C 
Act provides in relevant part that we may by regulation exempt or 
modify the requirements for compliance under section 418 of the FD&C 
Act with respect to facilities that are solely engaged in the storage 
of RACs (other than fruits and vegetables) intended for further 
distribution or processing (78 FR 3646 at 3709). The plain meaning of 
``solely'' is only, completely, entirely; without another or others; 
singly; alone (Ref. 44). Facilities that conduct manufacturing/
processing activities in addition to holding activities are not 
``solely'' engaged in the storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing. See also 
Response 233 regarding a similar request regarding the applicability of 
the requirements for hazard analysis and risk-based preventive controls 
to a facility solely engaged in the storage of unexposed packaged food.

J. Proposed Sec.  117.5(k)--Exemption Applicable to Farms, Fishing 
Vessels, Activities of ``Farm Mixed-Type Facilities'' Within the 
Definition of ``Farm,'' the Holding or Transportation of One or More 
Raw Agricultural Commodities, and Specified Activities Conducted on 
Specified Raw Agricultural Commodities

    We proposed to redesignate Sec.  110.19(a) as proposed Sec.  
117.5(k) and revise the exemption that had been in Sec.  110.19(a) to 
provide that subpart B would not apply to: (1) Farms; (2) fishing 
vessels that are not required to register as a food facility; (3) the 
holding or transportation of one or more RACs; (4) activities of ``farm 
mixed-type facilities'' that fall within the definition of ``farm''; 
and (5) hulling, shelling, and drying nuts (without manufacturing/
processing, such as roasting nuts).
    (Comment 211) Some comments ask us to clarify whether the proposed 
exemption for the holding or transportation of one or more RACs 
(proposed Sec.  117.5(k)) would apply to any food establishment, or 
only apply to farms and farm mixed-type facilities.
    (Response 211) The exemption applies to any food establishment.
    (Comment 212) Some comments ask us to clarify that CGMP 
requirements (such as requirements for the plant design to permit the 
taking of adequate precautions to protect food in outdoor bulk vessels 
(Sec.  117.20(b)(3)) and requirements for warehousing and distribution 
(Sec.  117.93) do not apply to the bulk outdoor storage of RACs for 
further processing.
    (Response 212) We are returning to the long-standing approach that 
the exemption applies to establishments ``solely engaged'' in specific 
activities. Under the exemption we are

[[Page 55985]]

establishing in Sec.  117.5(k)(1)(iii), those activities are holding 
and/or transportation of RACs. Under the exemption we are establishing 
in Sec.  117.5(k)(1)(v), those activities are hulling, shelling, 
drying, packing, and/or holding nuts. We explain why in the following 
paragraphs.
    These comments appear to interpret the proposed exemption in a way 
that goes beyond the long-standing ``RAC exemption'' in Sec.  110.19 
and is inconsistent with our intent in updating Sec.  110.19 to adjust 
and clarify what activities fall within this exemption based on 
experience and changes in related areas of the law since issuance of 
this exemption from the CGMPs (78 FR 3646 at 3710). The suggestion of 
these comments--i.e., that CGMPs should not apply to the holding of 
RACS in a facility that manufactures, processes, or packs RACs-would 
not make sense in some circumstances and would create difficulties for 
establishments (in determining how to comply with the CGMP 
requirements) and for regulators (in determining how to enforce the 
CGMP requirements). For example, it does not make sense for the part of 
a facility that holds RACs prior to processing to be exempt and the 
parts of the facility that are processing the RACs and storing them 
after processing to be covered. Likewise, it does not make sense for 
part of a transportation vehicle to be covered and part to be exempt.
    By revising these two proposed exemptions that derive from the 
``RAC exemption'' so that they apply only to establishments ``solely 
engaged'' in the storage and/or transportation of RACs, and to 
establishments ``solely engaged'' in the hulling, shelling, drying, 
packing, and/or holding of nuts, we are providing for a predictable 
framework for interpreting exemptions for facilities ``solely engaged'' 
in other activities. For example, as discussed in Comment 209, comments 
ask us to expand the exemption (in Sec.  117.5(j)) from the 
requirements for hazard analysis and risk-based preventive controls for 
facilities that are ``solely engaged'' in the storage of RACs (other 
than fruits and vegetables) intended for further distribution or 
processing to also apply to distinct and physically separate storage 
areas that are used solely for storage of such RACs. In our response, 
we noted that facilities that conduct manufacturing/processing 
activities in addition to holding activities are not ``solely engaged'' 
in the storage of such RACs (see Response 209). In addition, as 
discussed in Comment 233, comments ask us to apply the exemption (in 
Sec.  117.7) from the requirements for hazard analysis and risk-based 
preventive controls for facilities that are ``solely engaged'' in the 
storage of unexposed packaged food to storage areas of facilities that 
also engage in food processing activities--e.g., for distributors that 
are engaged in limited food processing, such as cutting vegetables or 
packing ready-to-eat foods. In our response, we noted that such 
distributors are not ``solely'' engaged in the storage of unexposed 
packaged food (see Response 233).
    The questions raised by these comments led us to reexamine the 
reasons we gave, in the 2013 proposed human preventive controls rule 
and the 2014 supplemental human preventive controls notice, for 
describing these exemption in terms of the activities conducted without 
specifying that the establishment is ``solely engaged'' in conducting 
these activities. For example, in the 2013 proposed human preventive 
controls rule we explained our assumption that if activities subject to 
the CGMPs take place in the same establishment, compliance with the 
CGMPs with respect to those activities should provide necessary 
protection. The comments led us to question that assumption. For 
example, with respect to the question posed by the comments about the 
outdoor bulk storage of RACs for further processing, it is not clear 
how conducting subsequent activities on the RACs in accordance with the 
CGMP requirements would protect the RACs during outdoor bulk storage. 
As discussed more fully in Response 660, processing fresh produce into 
fresh-cut products increases the risk of bacterial growth and 
contamination. RACs stored in bulk outdoors before being processed into 
fresh-cut produce must be stored in clean containers or vessels such 
that these do not contribute to contamination of the produce before it 
is processed. In addition, as already noted in this response, in 
interpreting the exemptions from subparts C and G for facilities that 
are solely engaged in the storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing (Sec.  
117.5(j)) and for facilities solely engaged in the storage of unexposed 
packaged food (Sec.  117.7), we do not consider that the exemption for 
these ``holding'' activities applies when holding is part of other 
operations conducted by the facility. For example, the exemption in 
Sec.  117.7 would not apply to a packaged food warehouse of a 
processing facility, even if the warehouse only stores unexposed 
packaged food.
    In the 2013 proposed human preventive controls rule we tentatively 
concluded that it would be reasonable to revise the RAC exemption in 
Sec.  110.19 so that it would exempt the specifically identified 
activities when performed on RACs, regardless of whether the 
establishment that conducts those activities also conducts other 
activities that do not qualify for the exemption, in part because the 
exemptions in section 418(j)(1) applied to ``activities'' (i.e., 
covered by parts 120, 123, and 113) (see 78 FR 3646 at 3710). However, 
section 418(j)(1) is premised on the existence of similar mandatory 
requirements for those specific foods. In contrast, there are no 
requirements similar to subpart B in some situations that would be 
exempt under an exemption broadly directed to the activities of holding 
and transportation. For example, there would be no other requirements 
similar to subpart B (e.g., for pest control) applicable to an off-farm 
establishment that stores apples in a controlled atmosphere storage 
facility or to an establishment that stores harvested dry beans. We now 
believe that a better comparison is to other exemptions in FSMA, such 
as the exemption in section 103(c)(1)(D)(i) of FSMA for facilities 
engaged only in specific types of on-farm manufacturing, processing, 
packing or holding activities, and the exemption in section 418(m) of 
the FD&C Act for facilities solely engaged in storage of RACs (other 
than fruits and vegetables) intended for further distribution or 
processing. It is reasonable to infer that one reason for the use of 
``solely'' in the statutory provisions in section 103(c)(1)(D)(i) of 
FSMA and in section 418(m) of the FD&C Act is to avoid some of the 
problems we have discussed in this response.
    In the 2013 proposed human preventive controls rule, we stated our 
belief that activities should be regulated the same way regardless of 
whether activities subject to the CGMP requirements take place in same 
establishment. However, as with the exemptions in section 
103(c)(1)(D)(i) of FSMA and section 418(m) of the FD&C Act, this is a 
situation where context matters. RACs that are the sole food in a 
warehouse are different from RACs being held in a manufacturing 
operation. As already noted in this response and as discussed more 
fully in Response 660, processing fresh produce into fresh-cut products 
increases the risk of bacterial growth and contamination, and produce 
being stored before processing into fresh-cut produce must be protected 
against contamination while being stored.
    The exemptions we are establishing in this rule for establishments 
solely engaged in the storage and/or

[[Page 55986]]

transportation of RACs, and for establishments solely engaged in 
hulling, shelling, drying, packing, and/or holding nuts (without 
additional manufacturing/processing, such as roasting nuts), remain 
consistent with our announced intent to adjust and clarify what 
activities fall within this exemption based, in part, on changes in 
related areas of the law since this exemption from the CGMP 
requirements was first issued. As discussed in section IV, we have made 
a number of changes to the ``farm'' definition, including changes that 
provide for an operation devoted to harvesting, packing, and/or holding 
of RACs to be a ``farm'' (i.e., a ``secondary activities farm'') (and, 
thus, be exempt from the CGMP requirements under Sec.  117.5(k)(1)(i)) 
even though the operation does not grow RACs (see Sec.  117.3). With 
this revised ``farm'' definition, some establishments that had relied 
on the ``RAC exemption'' in Sec.  110.19 to be exempt from CGMP 
requirements as establishments solely engaged in the ``storage'' of 
RACs, or because they were solely engaged in the harvesting (such as 
hulling and shelling) and storage (which includes drying) of nuts, will 
be exempt from the CGMP requirements because they are a ``farm.'' As a 
result, there are fewer operations that need to rely on exemptions that 
are an outgrowth of the long-standing RAC exemption in Sec.  110.19.

K. Comments Requesting Additional Exemptions

1. Introduction
    (Comment 213) We received comments requesting several additional 
exemptions from the requirements for hazard analysis and risk-based 
preventive controls in subpart C, the CGMP requirements of subpart B, 
or both. See the remainder of section XI.K for a description of the 
specific requests.
    (Response 213) Each year, about 48 million Americans (1 in 6) get 
sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, 
according to recent estimates from the Centers for Disease Control and 
Prevention (CDC) (Ref. 45). This is a significant public health burden 
that is largely preventable. We believe that improvements to our CGMP 
regulations, coupled with implementation of FSMA's directives to focus 
more on preventing food safety problems than on reacting to problems 
after they occur, can play an important role in reducing foodborne 
illness (other than foodborne illnesses that are the result of improper 
food handling practices in the home and food service settings, which 
would not be addressed by this rule). We did not propose any exemptions 
or exceptions from the requirements of subpart C other than those 
contained in section 103 of FSMA (78 FR 3646 at 3657). Likewise, we did 
not propose any additional exemptions from the CGMP requirements other 
than to adjust and clarify what activities fall within a long-standing 
exemption related to RACs based on experience and changes in related 
areas of the law since issuance of the CGMP regulation (78 FR 3646 at 
3709-3711).
    In the remainder of section XI.K, we respond to the specific 
requests for additional exemptions from the requirements of subparts C 
and G for hazard analysis and risk-based preventive controls. None of 
these specific requests describe (or otherwise provide) evidence 
demonstrating that the regulatory framework associated with the request 
would address all of the requirements of subparts C and G. Therefore, 
we have declined all of these requests. In some cases, a facility that 
is subject to other Federal, State, or local regulations that have some 
of the same requirements as subparts C and G will not have to repeat 
the same activity and will be able to use any existing records to 
demonstrate compliance and supplement those actions and records as 
necessary to demonstrate compliance with the remaining requirements of 
subparts C and G (see, e.g., 79 FR 58524 at 58542, Response 215, 
Response 216, Response 219, and the discussion of Sec.  117.330 in 
section XLI.G). In one case (for facilities subject to the PMO; see 
Response 214), we have extended the date for compliance with the 
requirements of subparts C and G in light of comments expressing an 
intent to revise the current requirements of a Federal/State 
cooperative program to incorporate the requirements of this rule. In 
other cases, a facility may determine and document through its hazard 
analysis that no preventive controls are necessary to prevent its food 
products from being adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act (see, e.g., Response 
222, Response 226, Response 229, and the discussion of Sec.  117.130 in 
section XXV). Such facilities, although not exempt, will have a reduced 
burden to comply with the rule, if the outcome of their hazard analysis 
is that there are no hazards requiring preventive controls.
    Likewise, in the remainder of section XI.K we respond to the 
specific requests for additional exemptions from the CGMP requirements 
of subpart B. None of these requests provide a basis for why the long-
standing CGMP provisions that establish basic requirements for the 
manufacturing, processing, packing, and holding of food to prevent 
adulteration should no longer apply to a particular type of food 
establishment and, thus, we have declined these requests.
2. Facilities That Comply With the Pasteurized Milk Ordinance
    (Comment 214) Some comments discuss facilities that comply with the 
Grade ``A'' PMO and are regulated under the National Conference on 
Interstate Milk Shipments (NCIMS) system (PMO facilities). NCIMS has 
been part of a cooperative program among the U.S. Public Health 
Service/FDA, the States and the dairy industry since 1950. Procedures 
for Governing the Cooperative Program of the NCIMS include procedures 
establishing milk sanitation standards, rating procedures, sampling 
procedures, laboratory procedures, laboratory evaluation and sample 
collector procedures. As previously discussed (78 FR 3646 at 3662), the 
PMO is a model regulation published and recommended by the U.S. Public 
Health Service/FDA for voluntary adoption by State dairy regulatory 
agencies to regulate the production, processing, storage and 
distribution of Grade ``A'' milk and milk products to help prevent 
milkborne disease. Appendix K--HACCP Program of the PMO--describes a 
voluntary, NCIMS HACCP Program alternative to the traditional 
inspection system. A milk plant, receiving station or transfer station 
may not participate in the voluntary NCIMS HACCP Program unless the 
regulatory agency responsible for the oversight of the facility agrees 
to participate with the dairy plant(s), receiving station(s) and 
transfer station(s) in the NCIMS HACCP Program. Currently all 50 
States, the District of Columbia, and Puerto Rico have adopted the PMO 
by reference or have codified the PMO or similar provisions in State 
regulations. At its biennial conferences, the NCIMS considers changes 
and modifications to the Grade ``A'' PMO to further enhance the safety 
of Grade ``A'' milk and milk products, including the administrative and 
technical details on how to obtain satisfactory compliance. Changes 
ultimately accepted by NCIMS voting delegates (representatives from 
States and territories) are forwarded to FDA for concurrence before 
they become effective.
    Some comments recommend that we make full use of the existing milk 
safety system of State regulatory oversight for Grade ``A'' milk and 
milk products provided through the NCIMS and the food safety 
requirements of the PMO. Some comments assert that we are

[[Page 55987]]

exceeding our authority by requiring PMO-regulated facilities to comply 
with both the PMO and the requirements of FSMA for hazard analysis and 
risk-based preventive controls.
    Some comments ask us to exempt PMO-regulated facilities (or the 
PMO-regulated part of a PMO facility that also produces food products 
not covered by the PMO) from the requirements of the rule for hazard 
analysis and risk-based preventive controls, or to otherwise determine 
that facilities operating in compliance with the PMO are also in 
compliance with those requirements. These comments suggest we could, as 
an interim step if we find it necessary, stay the application of these 
requirements to PMO-regulated facilities and work with the NCIMS 
cooperative program to enact any modifications to the PMO as may be 
needed to warrant an exemption or comparability determination. The 
comments characterize these changes as ``minor.''
    Some comments ask for clarification as to whether the human 
preventive controls rule would preempt the PMO if there are any 
conflicts or duplications between the human preventive controls rule 
and the PMO. Some comments ask us to explain our position concerning 
the interstate movement of milk and milk products and imported milk if 
the final rule does not recognize that PMO-regulated facilities are 
also in compliance with the requirements of the human preventive 
controls rule for hazard analysis and risk-based preventive controls. 
These comments ask: (1) Whether the final rule will become the de facto 
standard or the standard enforced by the FDA for the movement of milk 
in interstate commerce and for imported milk; (2) how the final rule 
will affect States that have adopted the PMO as their law/regulation 
for the production and processing of products such as fluid milk 
products and cottage cheese; and (3) how a final rule that does not 
recognize the PMO and the products made under the PMO will affect other 
Federal rules, policy, procedures, or practices that require compliance 
with the PMO.
    (Response 214) We agree that we should make use of the existing 
system of State regulatory oversight for Grade ``A'' milk and milk 
products provided through the NCIMS and the food safety requirements of 
the PMO. The NCIMS program has been effective from a regulatory 
standpoint, and has likely had a significant public health impact in 
reducing the incidence of foodborne illness attributable to milk and 
milk products. FDA is committed to the mission of the NCIMS and 
ensuring the continuance of an effective milk safety system with State 
regulatory oversight. However, the PMO does not address all of the 
requirements of subparts C and G, such as requirements relevant to the 
potential presence of environmental pathogens in the food processing 
environment (see, e.g., Sec. Sec.  117.130(c)(1)(ii) and 
117.150(a)(1)(ii)(B)). Such provisions could help to prevent food 
safety problems from the consumption of food produced by PMO facilities 
and play an important role in reducing foodborne illness. For example, 
in 2007, contamination of a PMO-regulated facility with the 
environmental pathogen L. monocytogenes was the cause of three deaths 
via listeriosis (Ref. 46). As another example, there have been large-
scale recalls as a result of contamination of dried milk with the 
environmental pathogen Salmonella (Ref. 47).
    In addition, the NCIMS HACCP Program is a voluntary program and, as 
of March 17, 2015, had been utilized by only 11 of approximately 625 
PMO facilities (Ref. 48). Further, the current NCIMS HACCP Program does 
not address all of the requirements of subparts C and G, such as 
environmental monitoring as a verification of sanitation controls for 
environmental pathogens and a supply-chain program for non-dairy 
ingredients (Ref. 49). The PMO also does not address food allergen 
controls, which are appropriate for those Grade ``A'' facilities that 
also handle food containing allergens other than milk. The comments do 
not provide a basis for why we should exempt PMO facilities from the 
rule in light of the differences between the requirements of this rule 
and the requirements of the PMO.
    NCIMS has initiated work to modify the PMO and that work is 
expected to include all of the requirements in a final human preventive 
controls rule. FDA has committed resources to work with the appropriate 
NCIMS Committees to make the necessary changes. However, the NCIMS 
process will not be complete in time for PMO facilities to meet the 
first two compliance dates for this rule (i.e., September 19, 2016 for 
businesses other than small and very small businesses, and September 
18, 2017 for small businesses), because the next scheduled Conference 
following the publication of this final rule would be April 2017. 
Therefore, to make use of the existing system of State regulatory 
oversight for Grade ``A'' milk and milk products provided through the 
NCIMS and the food safety requirements of the PMO, we are extending the 
compliance date for PMO-regulated facilities to comply with the 
requirements of subparts C and G to September 17, 2018. Doing so is 
consistent with the request of comments asking us to ``stay'' the 
application of the requirements for hazard analysis and risk-based 
preventive controls to PMO-regulated facilities and work with the NCIMS 
cooperative program to effect the necessary modifications to the PMO so 
that it will include all of the requirements in the human preventive 
controls rule. The extended compliance date is not equivalent to an 
exemption. Regardless of whether the PMO is modified to include the 
requirements of a final human preventive controls rule by the extended 
compliance date, PMO facilities must comply with the human preventive 
controls rule on September 17, 2018.
    The extended compliance date also is responsive to comments that 
identified complex implementation issues concerning the interstate 
movement of milk and milk products and imported milk. If the 
requirements of this rule for hazard analysis and risk-based preventive 
controls are incorporated into the PMO by the compliance date, such 
implementation issues will be moot, because a facility that complies 
with the revised PMO would also comply with this rule. As the 
compliance date approaches, it will be clearer as to whether any or all 
of the necessary revisions to the PMO will be in place by the 
compliance date for PMO facilities. If it appears that these revisions 
will not be in place by the compliance date for PMO facilities, we will 
take steps to address implementation issues specific to this Federal/
State cooperative program.
    In establishing a compliance date of September 17, 2018 for PMO 
facilities, we considered: (1) The extent of revisions that must be 
made to incorporate the requirements of this rule for hazard analysis 
and risk-based preventive controls into the PMO; (2) the process to 
revise the PMO; and (3) the date at which the necessary revisions to 
the PMO could begin to be made. We discuss each of these considerations 
in the following paragraphs.
    We disagree that the necessary revisions to incorporate the 
requirements of this rule for hazard analysis and risk-based preventive 
controls into the PMO are ``minor.'' There are gaps between the 
requirements of this rule and the current required and voluntary 
provisions of the PMO (Ref. 49), and gaps such as provisions directed 
to environmental

[[Page 55988]]

monitoring, supply-chain controls, and food allergen controls are not 
``minor.''
    With respect to process, NCIMS considers changes and modifications 
to the Grade ``A'' PMO at its biennial conferences, and proposals with 
the necessary changes must be voted on at such a biennial meeting. The 
next scheduled biennial conference is in the spring of 2017. Although 
it may be possible for NCIMS to convene a special conference in 2016 
for the purpose of voting on proposals to revise the PMO to make it 
comply with the requirements of this rule, practicalities such as the 
availability of funds for a special conference could interfere with any 
plans for a special conference. In addition, given that we do not view 
the necessary changes as ``minor,'' it could take more than one round 
of proposals for revising the PMO before a proposal receives the votes 
necessary to be adopted. Because the provisions of this rule will not 
be established until the date of publication of this final rule, any 
preliminary drafts of proposals to modify the PMO (e.g., to incorporate 
the provisions that we proposed in the 2014 supplemental preventive 
controls notice) before today's date may need revision to reflect the 
final provisions of the rule.
    In light of all these considerations, we are establishing September 
17, 2018 as the date for PMO facilities to comply with the requirements 
for hazard analysis and risk-based preventive controls in part 117, 
subparts C and G. The compliance date for PMO facilities to comply with 
the CGMP requirements of subpart B is also September 17, 2018, and PMO 
facilities will continue to comply with part 110 until that date. Under 
NCIMS procedures, changes agreed to by the voting delegates at the 2017 
NCIMS conference (and to which FDA concurs) would be effective within 
one year of the electronic publication of the NCIMS documents; or by 
official notification by FDA to the States and the dairy industry of 
``Actions from the 2017 NCIMS Conference;'' or by a previously 
determined effective date (e.g., September 17, 2018). We believe that 
the date of September 17, 2018 appropriately balances the need to 
realize the benefits of FSMA's requirements for hazard analysis and 
risk-based preventive controls with the practicalities associated with 
revising the PMO to incorporate the requirements of this rule.
3. Facilities That Have an Established HACCP Program
    (Comment 215) Some comments ask us to recognize operations that 
have an established HACCP Program implemented by a trained individual 
as meeting the requirements of the human preventive controls rule. Some 
of these comments note that the NCIMS HACCP Program describes a 
voluntary, NCIMS HACCP Program alternative to the traditional 
inspection system. Other comments discuss the EU Dairy HACCP Program 
and assert that the preventive controls system mandated by FSMA is a 
HACCP-like system but is not as robust as the EU Dairy HACCP Program. 
Other comments ask us to support and recognize industry-driven, 
mandatory programs that afford the same level of public health 
protection as the human preventive controls rule.
    Other comments note that facilities such as pizza manufacturing 
facilities are ``dual jurisdiction'' facilities, regulated and 
inspected by both FDA and USDA's Food Safety and Inspection Service 
(FSIS). These comments assert that such facilities already are 
operating under FSIS-approved HACCP plans, and their HACCP plans cover 
FDA-regulated products, as well as FSIS-regulated products. These 
comments acknowledge that there are differences between FSIS' HACCP 
regulation and FDA's proposed requirements for hazard analysis and 
risk-based preventive controls but nonetheless assert that requiring 
dual jurisdiction facilities to operate under two different food safety 
plans would result in unnecessary duplication of effort and confusion.
    (Response 215) Whether a particular HACCP program implemented by a 
trained individual would satisfy the requirements of the human 
preventive controls rule will depend on whether the particular HACCP 
program satisfies all of the requirements of the rule. (See Response 
213.) For operations that have implemented HACCP programs that are 
generally similar to the provisions of part 117, the burden of 
complying should be minimal in light of the provisions of Sec.  
117.330, which provides for use of existing records. As an example, if 
a facility has an existing HACCP plan (or multiple HACCP plans for 
different types of foods), supported by certain prerequisite programs 
that include food safety controls, the facility would not need to 
duplicate or re-write its existing HACCP plans or prerequisite 
programs, as long as the existing HACCP plans and prerequisite programs 
contain all of the required information and satisfy the requirements of 
subpart F, or are supplemented as necessary to include all of the 
required information and satisfy the requirements of subpart F (see 
Sec.  117.330(a)). Because the rule also provides that the required 
information does not need to be kept in one set of records, a facility 
may supplement existing records associated with its HACCP plans and 
prerequisite programs with other required components of a food safety 
plan (such as recall plan and, when applicable, a supply-chain program 
and written verification procedures for environmental monitoring) (see 
Sec.  117.330(b)). Moreover, the rule provides additional flexibility 
for a facility that relies on both existing records and newly 
established records to keep the records either separately or combined 
(see Sec.  117.330(b)).
    The flexibility provided by the provisions for use of existing 
records also enables a facility to comply with the requirement (in 
Sec.  117.310) for the owner, operator, or agent in charge of a 
facility to sign and date the facility's food safety plan, even when 
components of the food safety plan are kept separately. For example, 
when the food safety plan consists of one or more existing HACCP plans, 
one or more prerequisite programs that include food safety controls, a 
recall plan, a written supply-chain program, written verification 
procedures such as environmental monitoring, and any other components 
required by the rule, one approach for signing and dating the food 
safety plan could be to collect all these documents in a single 
location (e.g., a binder or folder) with a cover page containing the 
signature of the owner, operator, or agent in charge of the facility 
and the date on which the cover page was signed. However, because the 
food safety plan also could be a set of documents kept in different 
locations within the facility, a facility could sign and date a list of 
the relevant documents (e.g., as in a Table of Contents). (See also the 
discussion in Response 369 that a food safety plan may be prepared as a 
set of documents kept in different locations within the facility (e.g., 
based on where they will be used)).
4. Facilities That Are Subject to Requirements for Acidified Foods
    (Comment 216) Some comments ask us to exempt (or partially exempt) 
facilities that produce acidified foods from the requirements of 
subpart C, because acidified foods are subject to the specific food 
safety regulation in part 114 (21 CFR part 114) in addition to the CGMP 
requirements in subpart B. If we do not do so, these comments ask us to 
clarify whether a scheduled process established for an acidified food 
would be accepted as a process that had been validated as a preventive 
control for a microbiological hazard. Some of these comments mention 
specific acidified food products, such as salsa.

[[Page 55989]]

Other comments ask us to withdraw part 114 and regulate acidified foods 
under part 117 to avoid confusion, and then consider acidification as a 
preventive control.
    (Response 216) We agree that the specific CGMP requirements already 
established in part 114 play a key role in the safe production of 
acidified foods, but disagree that it would be appropriate to exempt 
facilities that are subject to part 114 from the requirements of 
subparts C and G. As the comments suggest, the long-standing 
requirements of part 114 could function as a type of preventive 
control. However, part 114 does not address all of the requirements of 
subparts C and G, such as the requirement to address chemical and 
physical hazards.
    We also disagree that we should withdraw part 114 and simply 
consider acidification as a preventive control under subparts C and G. 
The long-standing requirements of part 114 provide many details that do 
not fit within the framework of this rule, and we do not believe that 
it is in the best interest of public health to simply eliminate those 
details.
    A processor of acidified foods can consider its current scheduled 
processes, established in accordance with part 114, when conducting the 
hazard analysis required by this rule (Sec.  117.130). A processor of 
acidified foods could, through its hazard analysis, determine and 
document that the microbiological hazards associated with its products 
are addressed by preventive controls in its scheduled processes 
established under part 114. To the extent that the processor considers 
an existing scheduled process to be a preventive control as that term 
is defined in this rule, the processor would establish and implement 
preventive control management components (i.e., monitoring, corrective 
actions and corrections, and verification (including validation)) as 
appropriate to ensure the effectiveness of that preventive control, 
taking into account the nature of the preventive control. Again, a 
processor of acidified foods can consider its current procedures, 
established in accordance with part 114, when determining what 
preventive control management components to establish and implement. 
For example, a facility that previously validated a scheduled process 
can rely on its existing validation records and would not need to 
repeat the validation or make a new record. Processes issued by a 
process authority for acidified foods are generally accepted as 
validated processes. As another example, a facility can consider its 
current procedures for complying with the requirements of part 114, 
including frequent pH testing and recording of results, to exercise 
sufficient control so that the finished equilibrium pH values for 
acidified foods are not higher than 4.6 (Sec.  114.80(a)(2)), and to 
address deviations from scheduled processes (Sec.  114.89). A facility 
that produces acidified foods could demonstrate compliance with the 
requirements of subparts C and G of this rule by relying on the records 
it is currently required to establish and maintain (Sec.  114.100), as 
applicable, supplemented as necessary (see Sec.  117.330).
    (Comment 217) Some comments ask whether a qualified facility with 
activities that are subject to part 114 (Acidified Foods) would be 
exempt from the requirements of Subpart C.
    (Response 217) A qualified facility is exempt from the requirements 
of subparts C and G, and instead subject to the modified requirements 
in Sec.  117.201, for all foods that it produces, including acidified 
foods.
5. Egg Facilities
    (Comment 218) Some comments ask us to exempt shell egg facilities 
that are also regulated by USDA and by State shell egg grading programs 
from the requirements of both subpart B and subpart C or at least 
recognize these establishments as meeting the requirements for subpart 
B and Subpart C without further routine FDA inspection. Some comments 
ask us to exempt shell egg establishments subject to part 118 (21 CFR 
part 118) (Production, Storage, And Transportation Of Shell Eggs) from 
the requirements of subpart C because part 118 already requires shell 
egg establishments to take specific, concrete, steps to prevent the 
hazard Salmonella from contaminating eggs on the farm and from further 
growth during storage and transportation.
    (Response 218) Shell eggs are RACs. The on-farm production of shell 
eggs is exempt from both the CGMP requirements in subpart B (see the 
exemption for farms in Sec.  117.5(k)(1)(i)) and from the requirements 
for hazard analysis and risk-based preventive controls in subparts C 
and G (because a ``farm'' is exempt from the requirement to register as 
a food facility). Likewise, the packing of shell eggs by egg 
packinghouses that are within the ``farm'' definition established 
during this rulemaking are exempt from both the CGMP requirements in 
subpart B and the requirements for hazard analysis and risk-based 
preventive controls in subparts C and G, (see Response 25).
    Establishments that are solely engaged in the holding or 
transportation of shell eggs are exempt from the CGMP requirements in 
subpart B (see the exemption for establishments solely engaged in the 
holding or transportation of one or more RACs in Sec.  
117.5(k)(1)(iii)). Facilities that are required to register, but are 
solely engaged in the storage of shell eggs intended for further 
distribution or processing, are exempt from the requirements for hazard 
analysis and risk-based preventive controls in subparts C and G (see 
the exemption in Sec.  117.5(j)).
    Shell egg processing facilities that are regulated exclusively, 
throughout the entire facility, by USDA under the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.) are exempt from the section 415 
registration regulations and, thus, are not subject to the requirements 
of this rule for hazard analysis and risk-based preventive controls 
(subparts C and G).
6. Facilities That Produce Infant Formula
    (Comment 219) Some comments ask us to exempt the production of 
infant formula from the requirements of subpart C after we issue a 
final rule establishing requirements for CGMPs and quality control 
procedures for infant formula.
    (Response 219) We issued an interim final rule entitled ``Current 
Good Manufacturing Practices, Quality Control Procedures, Quality 
Factors, Notification Requirements, and Records and Reports, for Infant 
Formula'' on February 10, 2014 (79 FR 7934) and a final rule (the 
infant formula rule) adopting, with some modifications, that interim 
final rule on June 10, 2014 (79 FR 33057).
    We agree that the requirements of the infant formula rule play a 
key role in the safe production of infant formula, but disagree that it 
would be appropriate to exempt facilities that are subject to the 
infant formula rule from the requirements of subparts C and G. The 
infant formula rule does not address all of the requirements of 
subparts C and G, such as requirements relevant to the potential 
presence of environmental pathogens in the food processing environment 
(see, e.g., Sec. Sec.  117.130(c)(1)(ii) and 117.150(a)(1)(ii)(B)). As 
with products such as acidified foods (see Response 216), a 
manufacturer of infant formula could demonstrate compliance with the 
requirements of subparts C and G of this rule by relying on the records 
it is currently required to establish and maintain (Sec.  106.100), as 
applicable,

[[Page 55990]]

supplemented as necessary (see Sec.  117.330).
7. Small Businesses
    (Comment 220) Some comments ask us to provide more exemptions for 
small farms and small facilities.
    (Response 220) We decline this request. As discussed in Response 
213, the exemptions we are establishing are those provided by section 
103 of FSMA. Small farm that only conduct activities within the 
``farm'' definition are not subject to the human preventive controls 
rule. Small farms that also conduct activities outside the ``farm'' 
definition (such as manufacturing jams or jellies) (and, thus, are farm 
mixed-type facilities) are eligible for an exemption if the only such 
activities they conduct are the low-risk activity/food combinations 
specified in the exemptions in Sec.  117.5(g) and (h). Small farms that 
are subject to this rule as farm mixed-type facilities, and other small 
businesses, will have an extra year to comply with the rule. As 
discussed in Response 222, the new requirements for hazard analysis and 
risk-based preventive controls are flexible, and the preventive 
controls (if any) that a facility would establish and implement would 
depend on the outcome of the facility's hazard analysis and therefore 
would be tailored to the operation. These aspects of this rulemaking 
provide ample flexibility to small businesses.
8. Exemptions Based on Risk
    (Comment 221) Some comments ask us to exempt facilities identified 
as conducting low-risk activities from the CGMP requirements.
    (Response 221) We decline this request. The umbrella CGMPs that we 
are establishing in subpart B are long-standing provisions that 
establish basic requirements for the manufacturing, processing, 
packing, and holding of food to prevent adulteration. For example, food 
that is exposed must be protected against contamination from the 
plant's grounds, the design and construction of the plant, and sanitary 
operations regardless of whether the uncontaminated food could be 
``high-risk'' or ``low-risk''; contamination introduced during the 
production of food can adulterate any food. In addition, these umbrella 
CGMPs are not ``one-size-fits-all'' in that many provisions provide 
flexibility to tailor specific practices to the nature of the food and 
the activities being conducted. For example, many provisions establish 
a performance standard in which the measures taken must be ``adequate'' 
to comply with the rule, where adequate is defined as that which is 
needed to accomplish the intended purpose in keeping with good public 
health practice. As another example, provisions directed to raw 
materials require that they be washed or cleaned ``as necessary'' to 
remove soil or other contamination (see Sec.  117.80(b)(1)). Moreover, 
some comments point out that one strength of the long-standing CGMPs is 
their applicability to the broad spectrum of food manufacturing, from 
the manufacture of processed products and packaging of fresh produce to 
production of food additives and GRAS substances (see section VIII). 
(As already noted, some packaging of fresh produce (e.g., packaging of 
RACs on a farm) is not subject to the CGMPs.)
    (Comment 222) Some comments assert that we should not base the 
requirements for hazard analysis and risk-based preventive controls on 
the status of a business as a facility that is required to register 
under the section 415 registration regulations if there is no risk from 
consumption of food produced by that business. Some comments assert 
that a food safety plan should only be required for high-risk 
processing facilities because adhering to CGMPs is sufficient for low-
risk facilities. Some comments assert a food safety plan should be 
required for large businesses, but not for small and medium-size 
businesses, including small businesses that manufacture low-risk foods 
that are sterilized before being eaten and already undergo a 48-point 
inspection twice a year.
    Some comments ask us to adopt a commodity-specific approach to the 
exemptions and to only apply the requirements for hazard analysis and 
risk-based preventive controls to RACs that fall within the five 
highest-risk commodity groups and to any other specific commodities 
that we determine pose a comparable risk based on outbreak history and 
the commodity's characteristics.
    Other comments note that some States provide ``exemptions'' for 
``non-potentially-hazardous foods.'' These comments assert that there 
should be national agreement on what such foods are and, if such foods 
are truly low risk, there should not be onerous requirements regardless 
of the size of the business.
    (Response 222) We decline these requests to establish additional 
exemptions based on risk, other than the exemptions for on-farm low-
risk activity/food combinations provided by section 103(c)(1)(D) of 
FSMA (Sec.  117.5(g) and (h)). The applicability of the requirements of 
the human preventive controls rule to facilities that are required to 
register is required by the statute (see the definition of facility in 
section 418(o)(2) of the FD&C Act). Section 418(h) of the FD&C Act 
requires that a facility prepare and implement a food safety plan, 
unless an exemption applies. Neither FSMA nor this rule establishes a 
broad exemption for ``low-risk'' facilities, including ``low-risk'' 
facilities that are regularly inspected by State, local, or tribal 
government agencies. As discussed in Response 213, the exemptions we 
are establishing are those specifically authorized by the statute.
    The new requirements for hazard analysis and risk-based preventive 
controls are not ``one-size-fits-all,'' and facilities that are subject 
to the rule would consider the risk presented by the products as part 
of their hazard evaluation. (See Sec.  117.130(c)(1)(i), which requires 
that the hazard analysis include an evaluation of identified known or 
reasonably foreseeable hazards to assess the severity of the illness or 
injury if the hazard were to occur and the probability that the hazard 
will occur in the absence of preventive controls.) Although each 
facility subject to the rule must prepare and implement a food safety 
plan, the preventive controls that the facility would establish and 
implement would depend on the facility, the food, and the outcome of 
the facility's hazard analysis (Sec. Sec.  117.130 and 117.135(c)). In 
addition, the preventive control management components (i.e., 
monitoring, corrective actions and corrections, and verification) that 
a facility would establish and implement for its preventive controls 
would be established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the facility's food safety system (Sec.  
117.140(a)). A facility that appropriately determines through its 
hazard analysis that no preventive controls are necessary to prevent 
its food products from being adulterated under section 402 of the FD&C 
Act or misbranded under section 403(w) of the FD&C Act would document 
that determination in its written hazard analysis but would not need to 
establish preventive controls and associated preventive control 
management components for its products. A facility that is a very small 
business as that term is defined in this rule is exempt from the 
requirements of subparts C and G, including the requirement to prepare 
and implement a food safety plan, and is instead subject to the 
modified requirements in Sec.  117.201.

[[Page 55991]]

    We expect that there will be many circumstances in which a facility 
appropriately determines that certain biological, chemical, or physical 
hazards are not hazards requiring a preventive control that must be 
addressed in the food safety plan. There are several types of food 
products for which a facility may determine that there are no hazards 
requiring a preventive control. Such products could include, but are 
not limited to: many crackers, most bread, dried pasta, many cookies, 
many types of candy (hard candy, fudge, maple candy, taffy and toffee), 
honey, molasses, sugar, syrup, soft drinks, and jams, jellies, and 
preserves from acid fruits.
9. Hullers/Shellers
    (Comment 223) Some comments ask us to clarify whether an operation 
solely engaged in hulling/shelling would qualify for the exemption from 
the requirements for hazard analysis and risk-based preventive controls 
for facilities that solely are engaged in the storage of RACs (other 
than fruits and vegetables) intended for further distribution or 
processing (Sec.  117.5(j)). Other comments ask us to clarify whether 
an operation that is solely engaged in hulling/shelling and, thus, is 
exempt from the CGMP requirements of subpart B would also be exempt 
from the requirements for hazard analysis and risk-based preventive 
controls in subpart C. Some of these comments assert that it seems 
contrary to the principles of HACCP that a facility that is not 
required to implement CGMPs (which is a foundation of HACCP) would 
still need to develop a food safety plan. Some comments assert that 
requiring these operations to apply HACCP standards to what is an 
extension of harvesting is overkill, because the consumer is ultimately 
protected by processes at the handler (processor) level. Other comments 
assert that our clarification that operations that hull/shell/dry nuts 
are exempt from the CGMP requirements recognizes that hulling/shelling 
activities are low risk and do not alter the status of a RAC. Because 
the requirements for hazard analysis and risk-based preventive controls 
will be applied by those receiving product from the huller/sheller, it 
does not seem appropriate for an operation that is explicitly exempt 
from CGMP requirements to be required to conduct a hazard analysis, 
implement controls, conduct monitoring, etc.
    (Response 223) Under the revised ``farm'' definition, some hulling/
shelling operations will be within the ``farm'' definition (i.e., if 
the primary production farm(s) that grows, harvests, and/or raises the 
majority of the nuts owns, or jointly owns, a majority interest in the 
hulling/shelling operation). Because hulling/shelling is a harvesting 
activity, not a holding activity, those hulling/shelling operations 
that are not within the ``farm'' definition are not eligible for the 
exemption for facilities solely engaged in the storage of RACs (other 
than fruits and vegetables) intended for further distribution or 
processing (Sec.  117.5(j)). As discussed in Response 222, there is no 
exemption for ``low-risk operations.'' However, a facility that 
appropriately determines through its hazard analysis that there are no 
hazards requiring preventive controls would document that determination 
in its written hazard analysis but would not need to establish 
preventive controls and associated management components.
10. Fruit and Vegetable RACs
    (Comment 224) Some comments ask us to clarify the two exemptions 
applicable to RACs--i.e., the exemption from CGMP requirements for the 
holding or transportation of one or more RACs (Sec.  117.5(k)) and the 
exemption from the requirements for hazard analysis and risk-based 
preventive controls for facilities solely engaged in the storage of 
RACs (other than fruits and vegetables) intended for further 
distribution or processing (Sec.  117.5(j)). These comments ask whether 
an off-farm holding facility that strictly deals with fruit and 
vegetable RACs would be exempt from subpart B, but not subpart C.
    Some comments assert that operations that pack RACs other than 
fruits and vegetables intended for further distribution or processing 
should be exempt from both CGMP requirements and requirements for 
hazard analysis and risk-based preventive controls. These comments ask 
us to expand the exemption from CGMP requirements for the holding or 
transportation of one or more RACs to include the packing of RACs 
(other than fruits and vegetables). These comments also ask us to 
include packing RACs in the exemption from subpart C for facilities 
solely engaged in the storage of RACs (other than fruits and 
vegetables) intended for further distribution or processing.
    (Response 224) Under the revised ``farm'' definition, some 
operations that pack RACs will be within the ``farm'' definition (i.e., 
if the farms that grow or raise the majority of the RACs own, or 
jointly own, a majority interest in the packing operation). Packing 
operations that are within the ``farm'' definition are exempt from the 
CGMP requirements (Sec.  117.5(k)(1)). However, the packing of RACs is 
not otherwise exempt from either the CGMP requirements or the 
requirements for hazard analysis and risk-based preventive controls. As 
discussed in Response 221, the umbrella CGMPs that we are establishing 
in subpart B are long-standing provisions that establish basic 
requirements for the manufacturing, processing, packing, and holding of 
food to prevent adulteration.
    Packing operations that are within the ``farm'' definition are 
exempt from the requirements for hazard analysis and risk-based 
preventive controls (because ``farms'' are exempt from the section 415 
registration requirements for ``facilities''). As discussed more fully 
in Response 222, the new requirements for hazard analysis and risk-
based preventive controls are not ``one-size-fits-all.'' Although each 
facility subject to the rule must prepare and implement a food safety 
plan, the preventive controls that the facility would establish and 
implement would depend on the facility, the food, and the outcome of 
the facility's hazard analysis. In addition, the preventive control 
management components that a facility would establish and implement for 
its preventive controls would be established as appropriate to ensure 
the effectiveness of the preventive controls, taking into account the 
nature of the preventive control and its role in the facility's food 
safety system.
11. Enclosed Outdoor Vessels
    (Comment 225) Some comments ask us to exempt enclosed outdoor 
vessels from the specific CGMP provisions (such as requirements for the 
plant design to permit the taking of adequate precautions to protect 
food in outdoor bulk vessels (Sec.  117.20(b)(3)) and requirements for 
warehousing and distribution (Sec.  117.93)) if they are properly 
``risk assessed'' and covered by appropriate procedures for preventing 
contamination, and system verification is implemented.
    (Response 225) We decline this request. The long-standing CGMP 
requirements are comprehensive, interrelated provisions intended to 
prevent the adulteration of food. Specifying particular provisions that 
would not apply if a food establishment appropriately implements other 
provisions would be contrary to this comprehensive approach to food 
safety, in addition to being both impractical and difficult to 
administer. If a food establishment has appropriately determined that 
its procedures for preventing contamination adequately address the 
requirements for the safe storage of food in enclosed outdoor

[[Page 55992]]

vessels, it should have no difficulty demonstrating that during 
inspection.
12. Supermarket Distribution Centers
    (Comment 226) Some comments ask us to exempt supermarket 
distribution centers from the requirements of subpart C and instead 
require them to have written CGMPs. If this request is not accepted, 
then these comments ask us to either exempt supermarket distribution 
centers from the requirements of subpart C for those packaged foods not 
exposed to the environment (with modified requirements for unexposed, 
refrigerated, packaged TCS foods), or specify that there are no 
significant hazards for such a facility to address in a food safety 
plan.
    (Response 226) A supermarket distribution center must register as a 
food facility because it holds food for human consumption and does not 
satisfy any of the criteria for entities that are not required to 
register (see Sec.  1.226). As discussed in Response 222, the 
preventive controls that a facility would establish and implement would 
depend on the facility, the food, and the outcome of the facility's 
hazard analysis, and any preventive control management components 
associated with a facility's preventive controls would be established 
as appropriate to ensure the effectiveness of the preventive controls, 
taking into account the nature of the preventive control and its role 
in the facility's food safety system. In the case of a facility that is 
a supermarket distribution center, the facility would, as part of its 
evaluation, determine whether any preventive controls are necessary for 
unexposed, non-refrigerated packaged foods. The facility might 
determine that the modified requirements in Sec.  117.206 for 
unexposed, refrigerated, packaged TCS foods are appropriate to apply to 
such foods that it holds. If so, the facility could establish its food 
safety plan by building on the provisions established in Sec.  117.206.
13. Local and Regional Facilities Such as Kitchen Incubators, Food 
Hubs, and Grower Marketing Cooperatives
    (Comment 227) Some comments ask us to provide flexibility to local 
and regional facilities that do not qualify for an exemption from 
subpart C (e.g., ``kitchen incubators'' and farm mixed-type facilities 
that are subject to State or local laws). Some comments ask us to 
exempt (or partially exempt) food hubs, grower marketing cooperatives, 
``produce auctions,'' and similar entities. Some comments ask us not to 
cover facilities with less than $25,000 in annual sales (similar to a 
provision being considered under the 2013 proposed produce safety rule) 
or to establish a higher sales limit (i.e., $100,000) applicable to 
both the human preventive controls rule and the produce safety rule.
    (Response 227) We decline the requests to exempt (or partially 
exempt) the business models described in these comments. (See Response 
213.) None of these requests describe or provide evidence that the 
regulatory framework associated with the business model would address 
all of the requirements of subparts C and G. Many of the types of 
facilities listed have multiple business models that conduct different 
types of activities. For example, USDA defines a regional food hub as 
``a business or organization that actively manages the aggregation, 
distribution, and marketing of source-identified food products 
primarily from local and regional producers to strengthen their ability 
to satisfy wholesale, retail, and institutional demand.'' (Ref. 50). 
Some food hubs have facilities at which they conduct activities, 
including dry and cold storage, grading, packing, labeling, and light 
processing (trimming, cutting, and freezing), whereas other food hubs 
never physically handle the product sold but instead rely on farmers 
and contract trucking firms to provide aggregation and transportation 
services (Ref. 50). Some food hubs have a farm-to-business model (e.g., 
selling to food cooperatives, grocery stores, institutional foodservice 
companies, and restaurants), while others have a farm-to-consumer model 
(i.e., selling directly to the consumer, e.g., through a CSA), and some 
are hybrids that do both (Ref. 50). Some food hubs combine produce 
distribution with food processing operations (shared commercial 
processing space, or ``incubator kitchens''). Thus, some of these 
operations could be exempt. For example, some of these operations may 
fall within the revised ``farm'' definition (e.g., if the farms that 
grow or raise the majority of the RACs own, or jointly own, a majority 
interest in a food hub or a grower marketing cooperative and the food 
hub or grower marketing cooperative does not conduct any activities 
outside of the ``farm'' definition). Other operations could be exempt 
if they fall within the definition of ``retail food establishment'' 
(see Response 4). With respect to produce auction houses, to the extent 
that these operations are simply a location for buyers and sellers to 
meet and to sell and transfer produce and the food is not stored, we do 
not consider such facilities to be holding food and would not expect 
them to register; therefore these operations would not be subject to 
the requirements of subparts C and G for hazard analysis and risk-based 
preventive controls.
    We also decline the request not to cover facilities with less than 
$25,000 or $100,000 in annual sales. (See the discussion in Response 
220, in which we declined the request to provide more exemptions for 
small farm mixed-type facilities and other small facilities). However, 
if a local or regional facility such as those described in the comments 
is a very small business, the facility would be subject to modified 
requirements (Sec.  117.201) rather than to the full requirements for 
hazard analysis and risk-based preventive controls. When such an 
operation is not a farm, a retail food establishment, or a very small 
business, the preventive controls that a facility would establish and 
implement would depend on the facility, the food, and the outcome of 
the facility's hazard analysis, and any preventive control management 
components associated with a facility's preventive controls would be 
established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the facility's food safety system. (See 
Response 222.)
14. Production of Raw Sugar
    (Comment 228) Some comments ask us to exempt the production of raw 
sugar that is destined for refining from the requirements in subpart C 
for hazard analysis and risk-based preventive controls.
    (Response 228) Making sugar from sugarcane or sugar beets is a low-
risk activity/food combination (see Sec.  117.5(h)), and the statutory 
exemption in Sec.  117.5(h) would apply to a small or very small 
business that makes sugar on-farm if the only other activities it 
conducts outside the farm definition are the low-risk activity/food 
combinations in Sec.  117.5(g) and (h).
    We decline the request to extend this exemption to a small or very 
small business that makes sugar off-farm or to a business that is not a 
small or very small business (see Response 213). As discussed in 
Response 222, the preventive controls that such businesses would 
establish and implement would depend on the facility, the food, and the 
outcome of the facility's hazard analysis, and any preventive control 
management components associated with a facility's preventive controls 
would be established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account

[[Page 55993]]

the nature of the preventive control and its role in the facility's 
food safety system. An off-farm facility that makes sugar from 
sugarcane or sugar beets can consider the findings of the section 
103(c)(1)(C) RA (i.e., that this is a low-risk activity/food 
combination) in determining whether there are any hazards requiring a 
preventive control. A facility that appropriately determines through 
its hazard analysis that there are no hazards requiring preventive 
controls would document that determination in its written hazard 
analysis but would not need to establish preventive controls and 
associated management components.
15. Biological Hazards in Olive Oil
    (Comment 229) Some comments ask us to establish an exemption for 
the consideration of biological hazards such as Salmonella and 
pathogenic E. coli in olive oil.
    (Response 229) We decline this request. The rule requires the 
facility to conduct a hazard analysis to determine hazards requiring a 
preventive control. If the facility appropriately determines through 
its hazard analysis that biological hazards such as Salmonella and 
pathogenic E. coli are not hazards requiring a preventive control in 
its product, then these hazards would not be addressed in the 
facility's food safety plan.
    We expect that there will be many circumstances in which a facility 
appropriately determines that certain biological, chemical, or physical 
hazards are not hazards requiring a preventive control that must be 
addressed in the food safety plan. The provisions of the rule that 
allow a facility to appropriately determine that a particular hazard is 
not a hazard requiring a preventive control in certain food products 
are not equivalent to an exemption from the rule. For example, a 
facility that appropriately determines that there are no hazards 
requiring a preventive control associated with its food products must 
document that determination in its written hazard analysis (Sec.  
117.130(a)(2)); however, no preventive controls, including supplier 
verification activities, and associated management components would be 
required in such a situation. As discussed in Response 222, there are 
several types of food products for which a facility may determine that 
there are no hazards requiring a preventive control.

XII. Subpart A: Comments on Proposed Sec.  117.7--Applicability of Part 
117 to a Facility Solely Engaged in the Storage of Unexposed Packaged 
Food

    We proposed that subpart C would not apply to a facility solely 
engaged in the storage of packaged food that is not exposed to the 
environment (proposed Sec.  117.7(a)). We also proposed that a facility 
solely engaged in the storage of packaged food that is not exposed to 
the environment would be subject to the modified requirements that 
would be established in Sec.  117.206 of subpart D (proposed Sec.  
117.7(b)).
    Some comments support these proposed provisions without change. For 
example, one comment expresses the view that the safety of these 
products would be ensured during the manufacturing process by companies 
that comply with the stringent requirements of the proposed rule, and 
no new hazards will be introduced to the food at these facilities. 
Other comments that support the proposed provisions ask us to clarify 
some aspects of the provisions (see, e.g., Comment 230) or to clarify 
how the provisions will apply in particular circumstances (see, e.g., 
Comment 231 and Comment 232). Other comments that support the proposed 
provisions ask us to broaden them (see, e.g., Comment 233, Comment 234, 
and Comment 235).
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
17, with editorial and conforming changes as shown in table 52. A key 
conforming change that affects Sec.  117.7 is that the final exemption 
is from the requirements of subpart G, as well as subpart C. As 
discussed in section XLII, the final rule establishes the requirements 
for a supply-chain program in subpart G, rather than within subpart C 
as proposed.

 Table 17-- Revisions to the Proposed Applicability of Subparts C and D
 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.7(b)......................  Applicability of   Clarification that
                                 subpart D.         subpart D only
                                                    applies to those
                                                    unexposed packaged
                                                    foods that require
                                                    time/temperature
                                                    control to
                                                    significantly
                                                    minimize or prevent
                                                    the growth of, or
                                                    toxin production by,
                                                    pathogens.
------------------------------------------------------------------------

    (Comment 230) Some comments ask us to clarify the interplay between 
the proposed exemption (proposed Sec.  117.7) and the proposed modified 
requirements (proposed Sec.  117.206) to better reflect that the 
modified requirements would apply only to TCS foods. Some comments ask 
us to clarify that if a facility stores both TCS food and non-TCS food 
(i.e., unexposed packaged food that does not require time/temperature 
control for safety), then the modified requirements only apply for the 
portion of the facility that holds the TCS foods.
    (Response 230) We have revised Sec.  117.7(b) to clarify that a 
facility solely engaged in the storage of unexposed packaged food, 
including unexposed packaged food that requires time/temperature 
control to significantly minimize or prevent the growth of, or toxin 
production by, pathogens is subject to the modified requirements in 
Sec.  117.206 of subpart D for any unexposed packaged food that 
requires time/temperature control to significantly minimize or prevent 
the growth of, or toxin production by, pathogens.
    (Comment 231) Some comments ask us to revise the regulatory text to 
be explicit that frozen unexposed packaged food is not a TCS food 
subject to modified requirements.
    (Response 231) We decline this request. In the 2013 proposed human 
preventive controls rule, we tentatively concluded that it would be 
rare for a frozen food to be a TCS food (78 FR 3646 at 3774), and we 
affirm that conclusion in this document. However, specifying in the 
regulatory text that a frozen food is not a TCS food would require us 
to conclude that a frozen food would ``never'' (rather than ``rarely'') 
be a TCS food, and we lack information to support ``never.''
    (Comment 232) Some comments assert that a hazard analysis of the 
risks associated with storage of produce in vented crates would reveal 
no significant hazards and, thus, that even

[[Page 55994]]

if we do not agree that produce packaged in vented crates satisfies the 
criterion ``not exposed to the environment,'' we should exercise 
enforcement discretion for produce packaged in vented crates.
    (Response 232) As discussed in Response 170, produce stored in 
vented crates is not ``unexposed packaged food.'' Although 
environmental exposure to produce packed in vented crates would be less 
than environmental exposure to produce packed in open crates, a vented 
crate can subject produce to contamination. Thus, we disagree that we 
should not enforce the provisions of the rule for such produce. A 
facility that stores produce packed in vented crates must conduct a 
hazard analysis and evaluate whether there are any hazards requiring a 
preventive control. However, as discussed in Response 222, the 
preventive controls that the facility would establish and implement 
would depend on the facility, the food, and the outcome of the 
facility's hazard analysis, and any preventive control management 
components associated with a facility's preventive controls would be 
established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the facility's food safety system. A facility 
that appropriately determines through its hazard analysis that there 
are no hazards requiring a preventive control associated with its food 
products would document that determination in its written hazard 
analysis (Sec.  117.130(a)(2)) but would not need to establish 
preventive controls and associated preventive control management 
components for its products.
    (Comment 233) Some comments ask us to apply the exemption to 
storage areas of facilities that also engage in food processing 
activities--e.g., for distributors that are engaged in limited food 
processing, such as cutting vegetables or packing RTE foods. These 
comments assert that the intent of the term ``solely'' is to make clear 
that a facility that conducts an activity subject to the exemption does 
not escape responsibility for complying with the requirements for 
hazard analysis and risk-based preventive controls when conducting 
activities that are not exempt. In the comment's example, a facility 
that cuts vegetables or packs RTE foods would prepare and implement a 
food safety plan for cutting vegetables and packing RTE foods, but 
would not conduct a hazard analysis to determine whether there are 
significant hazards for storing unexposed packaged food.
    (Response 233) We disagree with the comment's interpretation of the 
term ``solely.'' The plain meaning of ``solely'' is only, completely, 
entirely; without another or others; singly; alone (Ref. 44). The 
facility described in the comment is not ``solely'' engaged in the 
storage of unexposed packaged food.
    Such a facility must conduct a hazard analysis that addresses all 
activities conducted by the facility. As discussed in Response 222, the 
preventive controls that the facility would establish and implement 
would depend on the facility, the food, and the outcome of the 
facility's hazard analysis, and any preventive control management 
components associated with a facility's preventive controls would be 
established as appropriate to ensure the effectiveness of the 
preventive controls, taking into account the nature of the preventive 
control and its role in the facility's food safety system. A facility 
that stores unexposed packaged food that is not a TCS food could, for 
example, determine that no preventive controls and associated 
management components would be necessary for those foods. A facility 
that stores unexposed refrigerated packaged TCS food could, for 
example, determine that preventive controls and management components 
patterned after the modified requirements in Sec.  117.206 are adequate 
to address hazards requiring a preventive control associated with that 
food.
    (Comment 234) Some comments ask us to allow a facility to designate 
a storage area as a separate facility for purposes of compliance with 
the requirements for hazard analysis and risk-based preventive 
controls. In the comments' view, an area solely engaged in the storage 
of unexposed packaged food could fall within the exemption in Sec.  
117.7 even though other areas would be subject to the requirements for 
hazard analysis and risk-based preventive controls.
    Some comments contrast our proposed approach to applying the 
statutory provision for facilities ``solely engaged in . . . storage'' 
with our proposed approach to applying section 418 of the FD&C Act to 
farm mixed-type facilities and facilities that conduct activities 
subject to one of our HACCP regulations. These comments point out that, 
for farm mixed-type facilities, we determined that section 418 applies 
only with respect to the activities that trigger registration (78 FR 
3646 at 3705). Likewise, these comments point out that for facilities 
that conduct activities subject to our HACCP regulations for seafood or 
juice, we determined that the facilities can be exempt from the 
requirements of section 418 with respect to the activities subject to 
those regulations but not with respect to other activities (78 FR 3646 
at 3704).
    (Response 234) We disagree that a designated storage area in an 
establishment that conducts manufacturing, processing, or packing in 
addition to storage can fall within the exemption for facilities 
``solely engaged in . . . storage.'' The statute provides authority for 
us to exempt or modify the requirements for compliance with respect to 
``facilities'' that are solely engaged in the storage of packaged foods 
that are not exposed to the environment (section 418(m) of the FD&C 
Act). The statute defines ``facility'' as a domestic facility or a 
foreign facility that is required to register under section 415 of the 
FD&C Act (section 418(o)(2) of the FD&C Act). The section 415 
registration regulations define facility as ``any establishment, 
structure, or structures under one ownership at one general physical 
location . . .'' The comment's interpretation that we could view 
``areas'' of registered facilities to be ``facilities that are solely 
engaged in . . . the storage of packaged foods that are not exposed to 
the environment'' is inconsistent with the statutory and regulatory 
framework under sections 415 and 418 of the FD&C Act.
    See also the discussion in Response 233 regarding how a facility 
that both stores unexposed packaged food and conducts activities such 
as food processing or packing could address the requirements for hazard 
analysis and risk-based preventive controls for the storage activities 
conducted by the facility.
    (Comment 235) Some comments ask us to consider an alternative to 
the exemption for unexposed packaged foods when a facility conducts 
manufacturing, processing, packing, or holding activities in addition 
to storing unexposed packaged food. Specifically, these comments ask us 
to recognize that the minimal risks of storing unexposed packaged foods 
can be addressed through a combination of compliance with the modified 
requirements for TCS foods (if applicable) and the CGMPs in subpart B 
and state that doing so would be consistent with our discussion in the 
2013 proposed human preventive controls rule.
    (Response 235) These comments appear to suggest the outcome of a 
facility's hazard analysis for storing unexposed packaged food--i.e., 
that the only hazards requiring a preventive control are the potential 
for growth of pathogens in refrigerated unexposed packaged foods and 
that the preventive controls and preventive control

[[Page 55995]]

management components specified in the modified requirements for TCS 
food are adequate to address such hazards. It is the responsibility of 
the facility's preventive controls qualified individual to identify the 
hazards requiring a preventive control associated with the facility and 
the food it stores, as well as the appropriate preventive controls and 
preventive control management components. However, we agree that in 
some cases the approach suggested in these comments would be 
appropriate.
    (Comment 236) Some comments assert that it is difficult to identify 
TCS foods and that the benefits of undertaking that work are unclear 
when existing CGMP requirements protect public health. These comments 
ask us to work with industry and professional organizations to develop 
guidance on when the modified requirements apply. Other comments ask us 
to specify that specific foods such as yogurt are not TCS foods and 
provide scientific information to support their request.
    (Response 236) This document does not include guidance on whether 
specific foods, such as yogurt, are TCS foods. Information on whether 
specific foods are TCS foods is already widely available--e.g., in 
Annex 3, Chapter 1 (Purpose and Definitions) of the Food Code (Ref. 51) 
and in a report prepared for us under contract by the Institute of Food 
Technologists (Ref. 52). A facility solely engaged in storage of 
unexposed packaged food can consult the Food Code or work with the 
manufacturer of the food to identify TCS food. Alternatively, such a 
facility could simply treat any refrigerated food as a TCS food.
    Although we agree with comments that in general yogurt would not be 
a TCS food, whether a particular yogurt is a TCS food would depend on 
what is added to the yogurt. For example, in 1989 an outbreak of 
foodborne botulism in the United Kingdom from the consumption of yogurt 
containing added hazelnut conserve (puree) caused 27 illnesses and one 
death (Ref. 53). The hazelnut puree had not been adequately processed 
to prevent toxin production by C. botulinum. Even though this 
particular outbreak was not related to the question of whether yogurt 
is a TCS food, it demonstrates the importance of having a preventive 
controls qualified individual consider all hazards associated with a 
product to determine whether there are hazards requiring a preventive 
control, including temperature control.

XIII. Subpart B: Comments on Proposed Sec.  117.10--Personnel

    We proposed to re-establish the provisions of Sec.  110.10 in new 
Sec.  117.10 with some revisions to modernize them. Some comments agree 
with one or more of these proposed provisions without change. For 
example, some comments state that the proposed provisions for disease 
control are already widely practiced across the produce industry and 
are part of most food safety guidance and standards. Some comments that 
support the proposed revisions suggest alternative or additional 
regulatory text (see, e.g., Comment 243 and Comment 244) or ask us to 
clarify how we will interpret the revised provision (see, e.g., Comment 
239). Other comments that support provisions that we proposed to re-
establish in part 117 without change ask us to revise or clarify those 
provisions (see, e.g., Comment 237, Comment 238, Comment 240, and 
Comment 241).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we proposed to re-establish in Sec.  117.10 with no 
changes. After considering these comments, we have revised the proposed 
provisions as shown in table 18, with editorial and conforming changes 
as shown in table 52.

                                         Table 18--Personnel Provisions
----------------------------------------------------------------------------------------------------------------
                                           Did we propose
                                        revisions  or request   Did we get comments that     Did we modify the
              Provision                 comment on  potential      disagreed with the       proposed regulatory
                                             revisions?            proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.10--Management             No......................  Yes.....................  Yes.
 Responsibility.
Sec.   117.10(a)--Disease Control...  No......................  Yes.....................  Yes.
Sec.   117.10(b)--Cleanliness.......  Yes.....................  No......................  No.
Sec.   117.10(b)(1)--Outer Garments.  Yes.....................  Yes.....................  No.
Sec.   117.10(b)(2)--Personal         No......................  No......................  No.
 Cleanliness.
Sec.   117.10(b)(3)--Washing Hands..  No......................  No......................  No.
Sec.   117.10(b)(4)--Unsecured        Yes.....................  Yes.....................  No.
 Jewelry and Other Objects.
Sec.   117.10(b)(5)--Gloves.........  Yes.....................  Yes.....................  No.
Sec.   117.10(b)(6)--Hair Restraints  No......................  No......................  No.
Sec.   117.10(b)(7)--Clothing and     Yes.....................  Yes.....................  No.
 Other Personal Belongings.
Sec.   117.10(b)(8)--Eating Food,     Yes.....................  Yes.....................  Yes.
 Drinking Beverages, and Using
 Tobacco.
Sec.   117.10(b)(9)--Any Other        Yes.....................  Yes.....................  No.
 Necessary Precautions.
Sec.   117.10(c)--Education and       Yes.....................  Yes.....................  Shifted to Sec.
 Training.                                                                                 117.4 as a
                                                                                           requirement rather
                                                                                           than a
                                                                                           recommendation.
Sec.   117.10(d)--Supervision.......  Yes.....................  No......................  Shifted to Sec.
                                                                                           117.4.
----------------------------------------------------------------------------------------------------------------

A. Management Responsibility for Requirements Applicable to Personnel

    We proposed no revisions to the requirement that plant management 
must take all reasonable measures and precautions to ensure compliance 
with the provisions for disease control, cleanliness, and training.
    (Comment 237) Some comments ask us to remove ``all'' because it is 
too extreme and prescriptive. These comments ask us to instead specify 
that the intended measures and precautions must be ``adequate.''
    (Response 237) We have revised the regulatory text to delete 
``all.'' We disagree that the term ``all'' in this long-standing 
provision is too extreme and prescriptive, but find that the term 
``all'' is not necessary to communicate the intent of the requirement. 
We decline the request to add ``adequate.'' The intent of the 
requirement is to communicate our expectation that these

[[Page 55996]]

measures and precautions are reasonable. Other, more specific 
provisions that management must address specify that particular 
measures and precautions must be ``adequate'' (see Sec.  117.10(b)(2), 
(3), and (4)).

B. Proposed Sec.  117.10(a)--Disease Control

    We proposed no revisions to the requirement that any person who, by 
medical examination or supervisory observation, is shown to have, or 
appears to have, an illness, open lesion, including boils, sores, or 
infected wounds, or any other abnormal source of microbial 
contamination by which there is a reasonable possibility of food, food-
contact surfaces, or food-packaging materials becoming contaminated, 
must be excluded from any operations which may be expected to result in 
such contamination until the condition is corrected. Personnel must be 
instructed to report such health conditions to their supervisors.
    (Comment 238) Some comments ask us to provide flexibility to not 
exclude from operations personnel who have an open lesion (such as 
boils, sores or any other infected wounds) that is covered completely 
using appropriate first aid materials.
    (Response 238) We have revised the regulatory text to reflect 
flexibility such as that provided in FDA's Food Code (Ref. 51). Under 
the Food Code, workers need not be excluded if an open lesion on hands 
and wrists, or on exposed portions of arms, is protected by an 
impermeable cover, and workers need not be excluded if an open lesion 
on other parts of the body is covered by a dry, durable, tight-fitting 
bandage.

C. Proposed Sec.  117.10(b)--Cleanliness

1. Proposed Sec.  117.10(b)(1)--Outer Garments
    We proposed that the methods for maintaining cleanliness include 
wearing outer garments suitable to the operation in a manner that 
protects against the contamination of food, food-contact surfaces, or 
food-packaging materials and to protect against the cross-contact of 
food.
    (Comment 239) Some comments ask us to clarify whether the newly 
proposed requirement to prevent allergen cross-contact would require a 
line worker to change outer garments when switching between individual 
food-production lines if separate major allergens are present on the 
food production lines.
    (Response 239) The provision does not prescribe the specific 
methods by which wearing outer garments must protect against allergen 
cross-contact and, thus, the establishment has flexibility to take 
appropriate steps to satisfy the requirements in the context of the 
establishment and the food it produces. Requiring a line worker to 
change outer garments when switching between individual food-production 
lines could be an appropriate precaution for some establishments. When 
a facility that is subject to the requirements for hazard analysis and 
risk-based preventive controls determines that it is necessary to 
require a line worker to change outer garments to prevent allergen 
cross-contact between food-production lines, the facility could decide 
to establish such a procedure as a food allergen control under Sec.  
117.135(c)(2).
2. Proposed Sec.  117.10(b)(4)--Unsecured Jewelry and Other Objects
    We proposed to require that the methods for maintaining cleanliness 
include removing all unsecured jewelry and other objects that might 
fall into food, equipment, or containers, and removing hand jewelry 
that cannot be adequately sanitized during periods in which food is 
manipulated by hand. If such hand jewelry cannot be removed, it may be 
covered by material which can be maintained in an intact, clean, and 
sanitary condition and which effectively protects against the 
contamination by these objects of the food, food-contact surfaces, or 
food-packaging materials.
    (Comment 240) Some comments ask us to modify the requirements to 
provide that they only apply as appropriate to each operation and 
recommend that jewelry be removed when the company's hazard analysis 
determines that it is a hazard. These comments acknowledge that jewelry 
is a physical hazard in some instances, but assert that objects such as 
jewelry are not a physical hazard for operations conducted on many 
medium- to large-sized RACs (e.g., melons, apples, oranges, potatoes).
    (Response 240) We decline this request. We included this long-
standing provision of the umbrella CGMPs during our last revision of 
the food CGMPs based on public comments during that rulemaking (51 FR 
22458 at 22463). The provision provides flexibility for an 
establishment to do what is appropriate in the context of its own 
operations--e.g., by limiting some requirements to ``unsecured'' 
jewelry and by providing options to cover hand jewelry during periods 
in which food is manipulated by hand. Although a facility could decide 
to also establish preventive controls for jewelry as a physical hazard 
following a hazard analysis, such preventive controls would be distinct 
from the more general CGMP requirements in this provision.
3. Proposed Sec.  117.10(b)(5)--Gloves
    We proposed that the methods for maintaining cleanliness include 
maintaining gloves, if they are used in food handling, in an intact, 
clean, and sanitary condition. We also proposed to delete a 
recommendation that gloves should be of an impermeable material. 
Although some comments ask us to retain this nonbinding recommendation, 
as discussed in Response 67 we are deleting those non-binding 
recommendations of part 110 that we are not establishing as 
requirements.
4. Proposed Sec.  117.10(b)(7)--Clothing and Other Personal Belongings
    We proposed to require that the methods for maintaining cleanliness 
include storing clothing or other personal belongings in areas other 
than where food is exposed or where equipment or utensils are washed.
    (Comment 241) Some comments ask us to specify that the requirements 
only apply to ``extra'' clothing. These comments express concern that 
the requirement otherwise might be interpreted to mean that no personal 
clothing is allowed in these areas (e.g., that employees are permitted 
to wear only company[hyphen]issued uniforms).
    (Response 241) We decline this request. This long-standing 
provision of the umbrella GMPs has been in place for decades. The 
comments do not provide any examples of how we have interpreted this 
provision in the past to mean that employees must wear company-issued 
uniforms.
5. Proposed Sec.  117.10(b)(8)--Eating Food, Drinking Beverages, and 
Using Tobacco
    We proposed to require that the methods for maintaining cleanliness 
include confining the following to areas other than where food may be 
exposed or where equipment or utensils are washed: eating food, 
drinking beverages, or using tobacco.
    (Comment 242) Some comments note that the provision would no longer 
require that chewing gum be confined to areas other than where food may 
be exposed or where equipment or utensils are washed. These comments 
ask us whether this omission was intentional, or whether we are simply 
considering that requirements applicable to ``chewing gum'' are covered 
by those for ``eating food.'' Some comments state that it would not be 
immediately obvious to many laypersons as to whether the chewing of gum 
is included in ``eating food.''

[[Page 55997]]

    (Response 242) We agree that removing the phrase ``chewing gum'' 
from this provision could make it unclear that this long-standing 
requirement regarding chewing gum still applies and we have revised the 
proposed regulatory text to retain the express requirement regarding 
chewing gum. As the comments point out, the statute includes chewing 
gum in its definition of ``food'' (see section 201(f) of the FD&C Act). 
However, in this long-standing provision, the term ``chewing gum'' is 
used to mean ``the act of chewing'' rather than to refer to the gum 
itself.
    (Comment 243) Some comments regarding processes conducted on RACs 
ask us to modify the regulatory text to distinguish ``drinking 
beverages'' from ``drinking water.'' These comments note that this 
provision is of concern to their industry because drinking water needs 
to be readily available to workers.
    (Response 243) We decline this request. We acknowledge that workers 
may need ready access to drinking water when conducting activities on 
RACs, particularly in an environment that is largely outdoors (such as 
in an off-farm packinghouse that has a roof but is otherwise largely 
unenclosed). However, this provision does not apply to on-farm 
activities such as harvesting of RACs. During packing activities 
covered by this rule, workers must move away from the packing 
operations to get a drink. The establishment can make drinking water 
available in a designated area that is nearby, and provide multiple 
designated areas when appropriate to make drinking water readily 
available to all workers.
6. Proposed Sec.  117.10(b)(9)--Any Other Necessary Precautions
    We proposed that the methods for maintaining cleanliness include 
taking any other necessary precautions to protect against contamination 
of food, food-contact surfaces, or food-packaging materials with 
microorganisms or foreign substances (including perspiration, hair, 
cosmetics, tobacco, chemicals, and medicines applied to the skin) and 
to protect against cross-contact of food.
    (Comment 244) Some comments ask us to specify that the provision 
applies to ``medicines or other products'' applied to the skin.
    (Response 244) We decline this request. The comment does not 
explain what ``other products'' applied to the skin are not already 
covered by ``cosmetics'' and ``medicines.'' For example, powders and 
lotions applied as ``make-up'' generally would be cosmetics and 
products such as sunscreen generally are classified as over-the-counter 
medicines.

XIV. Subpart B: Comments on Proposed Sec.  117.20--Plant and Grounds

    We proposed to re-establish the provisions of Sec.  110.20 in new 
Sec.  117.20 with some revisions to modernize them. Some comments agree 
with one or more of these proposed revisions without change. Some 
comments that support the proposed revisions suggest alternative or 
additional regulatory text (see, e.g., Comment 251 and Comment 256) or 
ask us to clarify how we will interpret the revised provision (see, 
e.g., Comment 253). Other comments that support provisions that we 
proposed to re-establish in part 117 without change ask us to revise or 
clarify those provisions (see, e.g., Comment 246, Comment 247, Comment 
248, Comment 250, and Comment 254).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we proposed to re-establish in Sec.  117.20 with no 
changes. After considering these comments, we have revised the proposed 
provisions as shown in table 19, with editorial and conforming changes 
as shown in table 52.

                                   Table 19--Provisions for Plant and Grounds
----------------------------------------------------------------------------------------------------------------
                                      Did we propose revisions    Did we get comments       Did we  modify the
              Provision                 or request  comment on  that disagreed with the    proposed regulatory
                                        potential  revisions?     proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.20(a)--Grounds...........  No......................  Yes....................  No.
Sec.   117.20(a)(1)--Equipment,       No......................  Yes....................  No.
 Litter, Waste, Weeds, and Grass.
Sec.   117.20(a)(2)--Roads, Yards,    No......................  No.....................  No.
 and Parking Lots.
Sec.   117.20(a)(3)--Draining Areas.  No......................  No.....................  No.
Sec.   117.20(a)(4)--Operating        No......................  Yes....................  Yes.
 Systems for Waste Treatment and
 Disposal.
Sec.   117.20(a)(5)--Grounds Not      Yes.....................  Yes....................  Yes.
 Under the Operator's Control.
Sec.   117.20(b)--Plant Construction  Yes.....................  Yes....................  No.
 and Design.
Sec.   117.20(b)(1)--Space for        No......................  Yes....................  Yes.
 Equipment and Materials.
Sec.   117.20(b)(2)--Food Safety      Yes.....................  Yes....................  Yes.
 Controls, Operating Practices, or
 Design.
Sec.   117.20(b)(3)--Outdoor Bulk     Yes.....................  Yes....................  Yes.
 Vessels.
Sec.   117.20(b)(4)--Plant            Yes.....................  No.....................  No.
 Construction.
Sec.   117.20(b)(5)--Lighting.......  No......................  Yes....................  Yes.
Sec.   117.20(b)(6)--Ventilation....  Yes.....................  Yes....................  Yes.
Sec.   117.20(b)(7)--Screening or     No......................  Yes....................  No.
 Other Protection.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.20(a)--Grounds

1. Proposed Sec.  117.20(a)--Management Responsibility for Maintaining 
Grounds
    We proposed no revisions to the requirement that the grounds about 
a food plant under the control of the operator must be kept in a 
condition that will protect against the contamination of food.
    (Comment 245) Some comments ask us to specify that the requirements 
do not apply to test/pilot kitchens.
    (Response 245) We decline this request. An establishment must have 
control of the grounds under its control regardless of the specific 
food or amount of food being produced, because litter, waste, weeds, 
and grass can all attract and harbor pests, and the first step for pest 
control in the plant is to avoid attracting pests.

[[Page 55998]]

2. Proposed Sec.  117.20(a)(1)--Equipment, Litter, Waste, Weeds, and 
Grass
    We proposed no revisions to the requirement that the methods for 
adequate maintenance of grounds include properly storing equipment, 
removing litter and waste, and cutting weeds or grass within the 
immediate vicinity of the plant buildings or structures that may 
constitute an attractant, breeding place, or harborage for pests.
    (Comment 246) Some comments ask us to specify ``immediately 
adjacent to'' rather than ``the immediate vicinity.'' These comments 
also ask us to provide guidance on the importance of pollinator habitat 
so that inspectors will view such areas within the greater context of 
the farm and not immediately see that the farm is out of compliance.
    (Response 246) We decline the request to modify the regulatory text 
of this long-standing provision. We note that a ``farm'' is not subject 
to the CGMP requirements of subpart B (see Sec.  117.5(k)). We do not 
see that the suggested modification would provide any specific 
information to investigators who are inspecting a food establishment 
(such as a farm mixed-type facility or packing shed) that has 
pollinator habitat near plant buildings or structures. We expect that 
investigators will adapt their inspection programs to account for such 
circumstances and food establishments will take steps to prevent weeds 
or grass in a pollinator habitat from leading to problems with pests in 
the plant.
3. Proposed Sec.  117.20(a)(4)--Operating Systems for Waste Treatment 
and Disposal
    We proposed no revisions to the requirement that the methods for 
adequate maintenance of grounds must include operating systems for 
waste treatment and disposal in an adequate manner so that they do not 
constitute a source of contamination in areas where food is exposed. If 
the plant grounds are bordered by grounds not under the operator's 
control and not maintained in the manner described in Sec.  
117.20(a)(1) through (a)(3), care must be exercised in the plant by 
inspection, extermination, or other means to exclude pests, dirt, and 
filth that may be a source of food contamination.
    (Comment 247) Some comments assert that the term ``adequate'' has 
been added to this provision and is ambiguous when used to describe the 
way in which ``operating systems for waste treatment and disposal'' 
must be managed, even though that term is defined in the rule. These 
comments ask us to clarify what constitutes ``adequate'' for the 
purpose of this provision, such as whether it requires compliance with 
local plumbing codes.
    (Response 247) The term ``adequate'' has been in Sec.  110.20(a) 
and (a)(4) since 1986 (51 FR 22477). This long-standing provision 
addresses matters under FDA's jurisdiction rather than local plumbing 
codes. An example of waste disposal under FDA's jurisdiction is an 
operating system for water disposal. Such an operating system would be 
inadequate if it allowed water to accumulate on the facility grounds 
and become an attractant for pests.
    (Comment 248) Some comments ask us to clarify how the requirements 
in Sec.  117.20(a) would apply to potential problems associated with 
neighboring grounds. Other comments note that we proposed to address 
potential problems with neighboring grounds within the final sentence 
of this provision (proposed Sec.  117.20(a)(4)) and suggest editorial 
changes to more clearly identify the requirements regarding grounds 
under the control of a neighboring entity.
    (Response 248) These provisions do not require an establishment to 
take action on its neighbor's property to protect against 
contamination, but do require an establishment to be aware of any 
problems that may affect its own grounds. For example, if a neighbor's 
grass is long, the establishment is not required to mow the neighbor's 
grass, but if the long grass in the neighbor's property provides a 
breeding ground for pests, the establishment needs to be aware of this 
potential for contamination and may need to take mitigating actions 
(e.g., enhanced pest control in the bordering areas).
    We have clarified the proposed requirements by redesignating the 
final sentence of proposed Sec.  117.20(a)(4) as Sec.  117.20(a)(5) and 
specifying that the requirements of newly designated Sec.  117.20(a)(5) 
apply if the plant grounds are bordered by grounds not under the 
operator's control and not maintained in the manner described in Sec.  
117.20(a)(1) through (a)(4) (rather than in Sec.  117.20(a)(1) through 
(a)(3)).

B. Proposed Sec.  117.20(b)--Plant Construction and Design

1. Proposed Sec.  117.20(b)--Suitability of Plant Construction and 
Design
    We proposed that the plant buildings and structure must be suitable 
in size, construction, and design to facilitate maintenance and 
sanitary operations for food-production purposes (i.e., manufacturing, 
processing, packing, and holding).
    (Comment 249) Some comments ask us to specify that the requirements 
for suitability of plant construction and design apply only where the 
potential for contamination exists.
    (Response 249) We decline this request. A plant requires suitable 
construction and design regardless of the specific potential for 
contamination at any particular location in the plant. Each of the 
seven more specific provisions governed by Sec.  117.20(b) adds the 
context that the requirements are directed to what is ``adequate'' 
(e.g., adequate space, adequate precautions, and adequate cleaning). 
The defined term ``adequate'' provides context that the purpose of the 
requirements for plant construction and design are related to public 
health.
2. Proposed Sec.  117.20(b)(1)--Placement of Equipment and Storage of 
Materials
    We proposed no revisions to the requirement that the plant must 
provide sufficient space for such placement of equipment and storage of 
materials as is necessary for the maintenance of sanitary operations 
and the production of safe food.
    (Comment 250) Some comments assert that the phrase ``maintenance of 
sanitary operations'' is unclear because it does not clearly 
communicate that maintenance of equipment and the facility is necessary 
for the production of safe food. These comments ask us to revise the 
provision to specify that the plant must provide sufficient space for 
such placement of equipment and storage of materials as is necessary 
for maintenance, sanitary operations, and the production of safe food.
    (Response 250) We agree that the suggested revision adds clarity 
and have modified the provision as requested. The revised requirement 
is consistent with the governing paragraph in Sec.  117.20(b), which 
clearly addresses both maintenance and sanitary operations.
3. Proposed Sec.  117.20(b)(2)--Reduce Potential for Contamination and 
Allergen Cross-Contact Through Adequate Food Safety Controls and 
Operating Practices or Effective Design
    We proposed that the plant must permit the taking of proper 
precautions to reduce the potential for contamination of food, food-
contact surfaces, or food-packaging materials with microorganisms, 
chemicals, filth, and other extraneous material, and to reduce the 
potential for cross-contact. The potential for cross-contact and 
contamination may be reduced by adequate food safety controls and 
operating practices or effective design,

[[Page 55999]]

including the separation of operations in which cross-contact and 
contamination are likely to occur, by one or more of the following 
means: Location, time, partition, air flow, enclosed systems, or other 
effective means.
    (Comment 251) Some comments ask us to specify both air flow systems 
and dust control systems as examples of separation of operations in 
which allergen cross-contact and contamination are likely to occur.
    (Response 251) We agree that both air flow systems and dust control 
systems are appropriate examples of separation of operations and have 
added these examples as requested.
4. Proposed Sec.  117.20(b)(3)--Food in Outdoor Bulk Vessels
    We proposed that the plant must permit the taking of proper 
precautions to protect food in outdoor bulk vessels by any effective 
means, including using protective coverings, controlling areas over and 
around the vessels to eliminate harborages for pests, checking on a 
regular basis for pests and pest infestation, and skimming fermentation 
vessels.
    (Comment 252) Some comments express concern about applying these 
provisions to the transport of large RACs such as watermelons and 
assert that there would be no food safety advantage to doing so after 
the RACs had spent the growing season in an uncovered environment.
    (Response 252) The comments are mistaken about these requirements, 
which relate to installed bulk vessels such as outdoor tanks, silos, 
etc. Moreover, this section addresses the construction and design of 
the plant, not transportation. To make this clearer, we have revised 
the provision to specify that it applies to ``installed outdoor bulk 
vessels.''
    (Comment 253) Some comments ask us to clarify that the requirements 
do not apply to open containers of RACs that are subject to further 
processing. Other comments assert that lugs, totes, corrugated bins, 
and harvest containers used to hold fruit are not bulk vessels that are 
subject to the provision. The comments explain that these containers 
are designed and built to be open at the top, with air holes on the 
sides and bottom that provide an adequate air flow to the fruit.
    (Response 253) The requirement applies to installed bulk vessels, 
not containers (including lugs, totes, corrugated bins, and harvest 
containers generally) that are delivered to a food establishment for 
packing or processing. (See discussion in Response 252.) Thus, the 
provision does not preclude the use of such containers. Although the 
provision specifies the use of protective coverings, it does so only as 
an example of an effective means of precautions to protect food held in 
outdoor vessels. Other specified examples of precautions to protect 
food held in outdoor bulk vessels include controlling areas over and 
around the vessels to eliminate harborages for pests, and checking on a 
regular basis for pests and pest infestation. Such measures to protect 
against pests are appropriate when food such as fruit is held in 
outdoor containers. (See also Response 327.)
    We agree that the measures taken by the establishment are those 
applicable to public health protection. To make this clearer, we have 
revised the provision to refer to ``adequate precautions'' rather than 
``proper precautions,'' because the defined term ``adequate'' focuses 
on public health.
5. Proposed Sec.  117.20(b)(5)--Lighting
    We proposed no revisions to the requirement that the plant must 
provide adequate lighting in hand-washing areas, dressing and locker 
rooms, and toilet rooms and in all areas where food is examined, 
processed, or stored and where equipment or utensils are cleaned; and 
provide safety-type light bulbs, fixtures, skylights, or other glass 
suspended over exposed food in any step of preparation or otherwise 
protect against food contamination in case of glass breakage.
    (Comment 254) Some comments ask us to add that the plant must 
provide adequate lighting in areas where food is packed and to 
substitute the term ``shatter-resistant'' for the term ``safety-type.''
    (Response 254) We have revised the provision to specify that it 
applies to areas in the plant where food is examined, manufactured, 
processed, packed, or held. Doing so makes the terms in this provision 
consistent with terms used throughout the CGMPs (78 FR 3646 at 3692). 
We also have substituted the term ``shatter-resistant'' for the term 
``safety-type.'' ``Shatter-resistant'' is a more modern term describing 
the safety features that are specified in the provision.
6. Proposed Sec.  117.20(b)(6)--Ventilation
    We proposed that a plant must provide adequate ventilation or 
control equipment to minimize odors and vapors in areas where they may 
contaminate food; and locate and operate fans and other air-blowing 
equipment in a manner that minimizes the potential for contaminating 
food-contact surfaces and for cross-contact.
    (Comment 255) Some comments ask us to specify ``where necessary'' 
to modify ``adequate.''
    (Response 255) We decline this request because ``where necessary'' 
is captured by ``is needed'' in the long-standing definition of 
``adequate.''
    (Comment 256) Some comments ask us to specify that the provision 
requires minimizing dust and that the applicable areas include areas 
where dust could cause allergen cross-contact.
    (Response 256) We agree that it is important to minimize dust 
(e.g., dust from milk powder that could be a source of allergen cross-
contact) and have modified the provision as requested.
7. Proposed Sec.  117.20(b)(7)--Screening
    We proposed no revisions to the requirement that the plant must 
provide, where necessary, adequate screening or other protection 
against pests.
    (Comment 257) Some comments ask us to add examples of adequate 
screening, such as by window screens, door sweeps, gap sealant, or 
other appropriate measures.
    (Response 257) We decline this request. Although the examples 
suggested by the comment appear to be acceptable, examples of screening 
are not necessary in this long-standing requirement.

XV. Subpart B: Comments on Proposed Sec.  117.35--Sanitary Operations

    We proposed to re-establish the provisions of Sec.  110.35 in new 
Sec.  117.35 with some revisions to modernize them. Some comments agree 
with one or more of these proposed provisions without change. Some 
comments that support the proposed revisions suggest alternative or 
additional regulatory text (see, e.g., Comment 258, Comment 261, 
Comment 263, Comment 269, Comment 272, and Comment 273) or ask us to 
clarify how we will interpret the revised provision (see, e.g., Comment 
260, Comment 267, Comment 268, and Comment 270). We also proposed to 
delete current Sec.  110.35(d)(5) (requirements for sanitizing agents) 
because it would be redundant with another proposed provision (proposed 
Sec.  117.35(b)(1)). We received no comments that disagreed with this 
proposed deletion and are not re-establishing current Sec.  
110.35(d)(5) in part 117.
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions. After considering these 
comments, we have revised the proposed provisions as

[[Page 56000]]

shown in table 20, with editorial and conforming changes as shown in 
table 52.

                                  Table 20--Provisions for Sanitary Operations
----------------------------------------------------------------------------------------------------------------
                                      Did we propose revisions    Did we get comments       Did we  modify the
              Provision                 or request  comment on  that disagreed with the    proposed regulatory
                                        potential  revisions?     proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.35(a)--General             Yes.....................  Yes....................  Yes.
 Maintenance.
Sec.   117.35(b)(1)--Substances Used  Yes.....................  Yes....................  Yes.
 in Cleaning and Sanitizing.
Sec.   117.35(b)(2)--Storage of       Yes.....................  Yes....................  No.
 Toxic Materials.
Sec.   117.35(c)--Pest Control......  Yes.....................  Yes....................  Yes.
Sec.   117.35(d)--Sanitation of Food- Yes.....................  Yes....................  No.
 Contact Surfaces.
Sec.   117.35(d)(1)--Food-Contact     Yes.....................  Yes....................  Yes.
 Surfaces Used for Manufacturing/
 Processing or Holding.
Sec.   117.35(d)(2)--Wet Cleaning...  Yes.....................  Yes....................  Yes.
Sec.   117.35(d)(3)--Single-Service   Yes.....................  Yes....................  Yes.
 Articles.
Sec.   117.35(e)--Sanitation of Non-  Yes.....................  Yes....................  Yes.
 Food-Contact Surfaces.
Sec.   117.35(f)--Storage and         Yes.....................  Yes....................  No.
 Handling of Cleaned Portable
 Equipment and Utensils.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.35(a)--General Maintenance

    We proposed that buildings, fixtures, and other physical facilities 
of the plant must be maintained in a sanitary condition and must be 
kept in repair sufficient to prevent food from becoming adulterated. 
Cleaning and sanitizing of utensils and equipment must be conducted in 
a manner that protects against cross-contact and contamination of food, 
food-contact surfaces, or food packaging materials.
    (Comment 258) Some comments ask us to specify that buildings, 
fixtures, and other physical facilities of the plant must be maintained 
in a ``clean'' condition in addition to a ``sanitary'' condition.
    (Response 258) We have revised the requirement as requested. Doing 
so is consistent with other provisions of subpart B that specify clean 
and sanitary conditions (e.g., the personnel cleanliness provisions in 
Sec.  117.10(b)(4) and (5)), including the requirements for sanitary 
operations (see the requirements for substances used in cleaning and 
sanitizing in Sec.  117.35(b)(1) and the requirements for sanitation of 
food-contact surfaces in Sec.  117.35(d)).
    (Comment 259) Some comments ask us to qualify the level of 
sanitation required for different areas of the plant because the degree 
of sanitation required for a warehouse or utility room is different 
from the degree of sanitation required for a processing room.
    (Response 259) We decline this request. The requirement is a long-
standing provision that has been used in this context for decades. The 
comments do not provide any examples of how we have interpreted this 
provision in the past in a manner that does not acknowledge the 
appropriate degree of sanitation required in different areas of a 
plant. Importantly, however, the fact that the degree of sanitation may 
be different does not mean that it could be appropriate, for example, 
for pests to be present in areas, like utility rooms, that may not need 
the same degree of sanitation as a processing room.
    (Comment 260) Some comments assert that by its nature, the 
operations of some facilities generate dust and debris. For example, 
although equipment such as conveyors and screens used for hulling and 
shelling almonds can be cleaned before use, as soon as operations begin 
dust will accumulate on the surfaces of the equipment. Some comments 
ask us to clarify that the intent of the CGMP requirements for sanitary 
operations is to ensure that equipment is clean prior to use, with the 
understanding that once operations commence, dust will accumulate and 
that the presence of this type of dust and debris does not necessarily 
mean that sanitation is not being regularly conducted.
    (Response 260) We agree that the intent of the CGMP requirements 
for sanitary operations is to ensure that equipment is clean prior to 
use. However, the fact that dust and debris can accumulate during some 
production operations does not excuse the establishment from taking 
appropriate steps to prevent food from becoming contaminated. The 
timing and extent of such steps would depend on the nature of the food 
and the production operation.

B. Proposed Sec.  117.35(b)--Substances Used in Cleaning and 
Sanitizing; Storage of Toxic Materials

1. Proposed Sec.  117.35(b)(1)--Cleaning Compounds and Sanitizing 
Agents
    We proposed that cleaning compounds and sanitizing agents used in 
cleaning and sanitizing procedures must be free from undesirable 
microorganisms and must be safe and adequate under the conditions of 
use. We also proposed that mechanisms to comply with provisions related 
to cleaning compounds and sanitizing agents must be safe and effective 
and provided examples of ways to achieve such compliance (78 FR 3646 at 
3721). Only the toxic materials listed in this provision may be used or 
stored in a plant where food is processed or exposed.
    (Comment 261) Some comments ask us to specify that ``Cleaning and 
sanitizing agents used on food-contact surfaces must contain only 
ingredients which are generally recognized as safe or are approved in 
Sec.  178.1010 for use in cleaning and sanitizing food-contact 
surfaces'' because this information will be useful to processors who 
may be unaware of the specific kinds of substances approved for food-
contact surfaces. Other comments ask us to specify that residual levels 
of cleaning and sanitizing agents which are generally recognized as 
safe or are approved for use on food-contact surfaces are permissible.
    (Response 261) We decline these requests. Requirements such as 
those applicable to substances added to food or substances used in 
cleaning and sanitizing food-contact surfaces are available elsewhere 
in our regulations and it is neither practical nor necessary

[[Page 56001]]

to use the CGMP requirements of part 117 as a means to communicate some 
or all of these other requirements. For example, the manufacturer of a 
food product must also comply with food labeling regulations ranging 
from declaration of ingredients (Sec.  101.4) to health claims (part 
101, subpart E).
2. Proposed Sec.  117.35(b)(2)--Identification and Storage of Toxic 
Materials
    We proposed that toxic cleaning compounds, sanitizing agents, and 
pesticide chemicals must be identified, held, and stored in a manner 
that protects against contamination of food, food-contact surfaces, or 
food-packaging materials. We also proposed to remove a recommendation 
for following all relevant regulations promulgated by other Federal, 
State, and local government agencies for the application, use, or 
holding of toxic cleaning compounds, sanitizing agents, and pesticides.
    (Comment 262) Some comments ask us to specify that we require that 
the compounds, agents, and pesticides be used according to the 
manufacturer's instructions.
    (Response 262) We decline this request. Such a recommendation is 
more properly addressed by the applicable Federal, State, and local 
government agencies. See the discussion at 78 FR 3646 at 3721.

C. Proposed Sec.  117.35(c)--Pest Control

    We proposed that pests must not be allowed in any area of a food 
plant. Guard or guide dogs may be allowed in some areas of a plant if 
the presence of the dogs is unlikely to result in contamination of 
food, food-contact surfaces, or food-packaging materials. Effective 
measures must be taken to exclude pests from the manufacturing, 
processing, packing, and holding areas and to protect against the 
contamination of food on the premises by pests. The use of insecticides 
or rodenticides is permitted only under precautions and restrictions 
that will protect against the contamination of food, food-contact 
surfaces, and food-packaging materials.
    (Comment 263) Some comments ask us to specify ``pest-detection'' 
dogs in addition to guard and guide dogs because the use of animals to 
detect pests is widespread in the professional pest management industry 
for concealed and difficult to find pests. Comments assert that like 
guard and guide dogs, detection dogs are well trained and should be 
permissible in areas of the plant where the presence of the dog is 
unlikely to result in contamination of the food, food-contact surfaces 
or food-packaging materials.
    Other comments ask us to specify that pests must not be allowed in 
any area of a food plant ``where appropriate'' or ``where the potential 
for contamination exists.'' Other comments assert that animals should 
be excluded from all areas that are used by production or packaging 
employees or that communicate with food processing, packing, or storage 
areas. Some comments ask us to clarify whether this provision includes 
administrative offices, cafeterias, and other rooms that are not 
directly involved in the processing, packing, or holding of food 
because the provision applies to ``any area of a food plant.''
    (Response 263) We have revised the regulatory text to account for 
``pest-detection dogs.'' However, we have not otherwise modified the 
regulatory text of this long-standing provision as a result of these 
comments. Areas of the food plant (such as a cafeteria) that are not 
directly involved with production may nonetheless be a source of 
contamination (e.g., if there are pests in that area). We have long 
provided that specified types of dogs may be allowed in some areas of a 
plant provided that the presence of the dogs is unlikely to result in 
contamination, and the comments provide no basis for why this qualified 
exception is no longer appropriate.
    (Comment 264) Some comments ask us to specify that insecticides and 
rodenticides are types of pesticides and that the use of these 
substances is permitted in accordance with the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) label precautions and 
restrictions.
    (Response 264) We have revised the regulatory text to specify the 
``use of pesticides'' rather than the ``use of insecticides and 
rodenticides ``to use the broader term ``pesticides.'' We also modified 
the regulatory text to clarify that the restrictions on use of 
pesticides is when the pesticides are used ``to control pests.'' We 
made this modification because we are aware that some food processing 
processes (such as fumigating almonds) involve treating food with 
substances that are classified as ``pesticides.'' Without this 
modification, the provision could mistakenly appear to prevent 
establishments from conducting such processes.
    We decline to modify the text to account for FIFRA label 
precautions and restrictions. See (Response 262).
    (Comment 265) Some comments express concern that the phrases ``must 
not be allowed'' and ``exclude'' suggest that it is always possible to 
prevent all types of pests. Some comments assert that it is not always 
possible to prevent all types of pests, especially on farms and in 
areas where pests are prevalent because of the presence of conditions 
over which the food manufacturer has no control. Some comments assert 
that a food establishment should be required to take all reasonable 
measures to exclude pests, but an outright ``exclude'' is unrealistic.
    (Response 265) The requirements apply to activities conducted in a 
plant and do not apply to activities that are within the ``farm'' 
definition, such as harvesting RACs and on-farm packing of RACs. We 
disagree that effective measures cannot be taken to exclude pests from 
a plant that is fully enclosed. When a plant is only partially enclosed 
(e.g., a partially enclosed area that processes seafood taken off a 
fishing vessel, or a partially enclosed building on an off-farm 
establishment that packs RACs), we would interpret the provision in a 
manner consistent with the provisions of previous guidance, such as our 
2005 ``Guide to Produce Farm Investigations'' and the final provisions 
of the produce safety rule. We are not modifying the requirement to 
incorporate this interpretation because pest control in buildings that 
are only partially enclosed will be a concern for only a small 
percentage of establishments subject to subpart B.

D. Proposed Sec.  117.35(d)--Sanitation of Food-Contact Surfaces

    We proposed that all food-contact surfaces, including utensils and 
food-contact surfaces of equipment, must be cleaned as frequently as 
necessary to protect against cross-contact and contamination of food.
    (Comment 266) Some comments ask us to specify that all food-contact 
surfaces must also be sanitized.
    (Response 266) We decline this request. These long-standing 
requirements identify specific circumstances when food-contact surfaces 
must be sanitized (see Sec.  117.35(d)(2), which specifies 
circumstances when food-contact surfaces must be sanitized when used in 
wet processing operations). The comment provided no basis for why food-
contact surfaces must be sanitized when they will be used in 
manufacturing/processing or holding low-moisture food or why food-
contact surfaces must be sanitized when used in wet processing 
operations other than the circumstances specified in Sec.  
117.35(d)(2). There are some situations in which food-contact surfaces 
do not need to be sanitized. For example, raw

[[Page 56002]]

materials and other ingredients for processing may be held in clean 
containers prior to processing with steps lethal to microorganisms; 
sanitizing such containers is not necessary for the production of safe 
food.
    (Comment 267) Some comments ask us to clarify that we are not 
requiring an absolutely allergen-free environment, but rather that the 
expectation is that the manufacturer will take steps to identify 
potential sources of allergen cross-contact and implement preventive 
measures. Some comments ask us to also clarify that dedicated lines or 
equipment are not required for effective preventive control of food 
allergens. Some comments discuss practical difficulties that arise when 
balancing the need to control microorganisms such as Salmonella in 
chocolate and low-moisture confectionary products (through procedures 
such as dry cleaning) with the control of allergens (which may be 
controlled better when wet cleaning procedures are used).
    (Response 267) See also the discussion of food allergen controls in 
Response 429. This rule does not establish a particular standard for 
preventing allergen cross-contact. In general, when we do establish a 
standard we avoid ``absolute'' standards such as the ``absolutely 
allergen-free'' standard mentioned by the comment. Likewise, the rule 
does not require the use of dedicated lines or equipment for effective 
prevention of allergen cross-contact. As the comments suggest, the 
intent of the requirement is for the manufacturer to take steps to 
identify potential sources of allergen cross-contact and implement 
preventive measures.
    (Comment 268) Some comments ask us to clarify that the use of 
advisory label statements is appropriate when allergen cross-contact 
has been reduced to the greatest extent possible, but cannot be 
eliminated with certainty.
    (Response 268) See Response 434 for a discussion about the use of 
advisory label statements.

E. Proposed Sec.  117.35(d)(1)--Food-Contact Surfaces Used for 
Manufacturing/Processing or Holding

    We proposed that food-contact surfaces used for manufacturing/
processing or holding low-moisture food must be in a clean, dry, 
sanitary condition at the time of use. When the surfaces are wet-
cleaned, they must, when necessary, be sanitized and thoroughly dried 
before subsequent use.
    (Comment 269) Some comments ask us to specify ``packing'' for 
clarity and completeness.
    (Response 269) We have revised the provision to specify that it 
applies to food-contact surfaces used for manufacturing, processing, 
packing, or holding low-moisture food. Doing so makes the terms in this 
provision consistent with terms used throughout the CGMPs (78 FR 3646 
at 3692).
    (Comment 270) Some comments ask us to clarify that the proposed 
requirement to maintain food-contact surfaces in a sanitary condition 
is not a requirement to sanitize all product contact surfaces. These 
comments also ask us to specifically allow the continued use of 
cleaning methods based on a risk assessment, including dry cleaning 
with no sanitizing step. Some comments ask us to clarify that 
``sanitary condition'' is not synonymous with ``sanitized'' from an 
antimicrobial standpoint.
    (Response 270) See Response 266. This provision does not require 
that all product contact surfaces be sanitized and, thus, it is not 
necessary to specify that dry cleaning methods with no sanitizing step 
are acceptable in certain circumstances. We do not consider ``sanitary 
condition'' to be synonymous with ``sanitized.'' We consider ``sanitary 
condition'' to be a state of cleanliness. Terms such as ``sanitize'' 
and ``sanitizing'' are associated with the reduction of microorganisms.
    (Comment 271) Some comments ask us to specify different 
requirements for food-contact surfaces used during different stages of 
manufacturing/processing or holding. These comments explain that the 
provision does not accommodate initial processing steps prior to 
moisture removal where food-contact surfaces will be exposed to moist 
(non-dry) conditions. These comments also explain that the provision 
also does not recognize that food-contact surfaces may not appear to be 
``sanitary'' when raw materials handled at initial processing steps 
have not yet undergone subsequent processes designed to eliminate 
microorganisms of public health concern. Some comments ask us to 
specify that food-contact surfaces only need to be clean and sanitary 
``before use and after any interruption during which the food-contact 
surfaces may have become contaminated.'' Comments also ask us to 
specify that ``finished product low-moisture food-contact surfaces must 
be maintained in a clean, dry, and sanitary condition.''
    (Response 271) We decline these requests. This long-standing 
provision has been used in this context for decades. The full 
requirements for sanitation of food-contact surfaces (Sec.  117.35(d), 
(d)(1), and (d)(2)) address both processing of low-moisture foods and 
wet processing. It is not practical to describe all variations of 
complex manufacturing scenarios that may involve both wet processing 
and low-moisture foods. Instead, we expect both industry and regulators 
to appropriately apply the specific requirements associated with the 
sanitary condition of food-contact surfaces during such complex 
manufacturing scenarios. The comments do not provide any examples of 
how we have interpreted this provision in the past in a way that does 
not accommodate manufacturing processes such as those it describes.
    (Comment 272) Some comments ask us to specify that food-contact 
surfaces used for manufacturing/processing or holding low-moisture food 
be in a clean, dry, sanitary condition ``prior to use or the start of 
production'' instead of ``at time of use'' to more accurately reflect 
the reality of food processing. Some comments express concern that 
properly cleaned and sanitized food-contact surfaces begin to 
accumulate small dust particles on the surface of conveyors, sizing 
screens, and other equipment surfaces as soon as operations commence. 
These comments assert that it is unrealistic to keep the equipment in a 
clean, dry, sanitary condition during the entire operation.
    (Response 272) We have revised the regulatory text to specify that 
the requirement applies ``before use.'' We agree that ``before use'' 
more accurately describes the intent of the requirement.

F. Proposed Sec.  117.35(d)(2)--Wet Cleaning

    We proposed that in wet processing, when cleaning is necessary to 
protect against cross-contact and the introduction of microorganisms 
into food, all food-contact surfaces must be cleaned and sanitized 
before use and after any interruption during which the food-contact 
surfaces may have become contaminated. Where equipment and utensils are 
used in a continuous production operation, the utensils and food-
contact surfaces of the equipment must be cleaned and sanitized as 
necessary.
    (Comment 273) Some comments ask us to specify that this requirement 
applies when cleaning is necessary to protect against allergen cross-
contact or the introduction of microorganisms into food, not only when 
both conditions are satisfied.
    (Response 273) We have revised the regulatory text to specify 
``necessary to protect against allergen cross-contact or the 
introduction of microorganisms into food.''

[[Page 56003]]

G. Proposed Sec.  117.35(d)(3)--Single-Service Articles

    We proposed that single-service articles (such as utensils intended 
for one-time use, paper cups, and paper towels) should be stored in 
appropriate containers and must be handled, dispensed, used, and 
disposed of in a manner that protects against cross-contact and 
contamination of food, food-contact surfaces, or food-packaging 
materials. We also requested comment on whether to require, rather than 
recommend, that single-service articles be stored in appropriate 
containers (78 FR 3646 at 3721).
    (Comment 274) Comments are mixed regarding whether to require, 
rather than recommend, that single-service articles be stored in 
appropriate containers. Some comments ask us to keep this provision as 
a recommendation, whereas other comments ask us to change this 
recommendation to a requirement. One comment asking us to retain the 
provision as a recommendation asserts that these practices have never 
resulted in a food safety risk.
    Other comments ask us to specify that ``single-service articles 
must be handled in a manner that protects against allergen cross-
contact and contamination of food.'' These comments assert that the 
proposed use of ``must'' and ``appropriate'' in the same sentence will 
lead to inconsistency in determining what is ``appropriate'' for each 
individual situation. In addition, the comments assert that the common 
definition of ``handling'' encompasses ``appropriate storage, 
dispensing, usage, and disposal.''
    (Response 274) We have decided to establish this provision as a 
requirement rather than as a recommendation. Articles used in the 
manufacturing, processing, packing, or holding of food must not cause 
allergen cross-contact or contamination of food, food-contact surfaces, 
or food-packaging materials, regardless of whether the articles are 
single-service or would be used multiple times.
    We have revised the regulatory text to accept some, but not all, of 
the suggestions in these comments. We deleted ``in appropriate 
containers'' so as not to prescribe a specific mechanism for complying 
with the requirement. We also deleted ``dispensed'' and ``used'' 
because we agree that these terms are captured by the term ``handled.'' 
We have not deleted ``stored'' because other provisions of these long-
standing CGMPs refer to both storage and handling (see Sec.  117.35(f)) 
and, thus, we have not previously considered that the term ``handling'' 
includes ``storage'' in this context. See the regulatory text for the 
final provision containing all of these modifications.

H. Proposed Sec.  117.35(e)--Sanitation of Non-Food-Contact Surfaces

    We proposed that non-food-contact surfaces of equipment used in the 
operation of a food plant should be cleaned in a manner and as 
frequently as necessary to protect against cross-contact and 
contamination of food, food-contact surfaces, and food-packaging 
materials. We also requested comment on whether to establish these 
recommendations as requirements (78 FR 3646 at 3722).
    (Comment 275) Some comments ask us to change this recommendation to 
a requirement to prevent the creation of insanitary conditions and the 
adulteration of product.
    (Response 275) We have revised the regulatory text to establish 
this recommendation as a requirement.
    (Comment 276) Some comments assert that it is impractical to 
sanitize all non-food-contact surfaces in a farm mixed-type facility 
and that this provision should only apply to those areas where a RAC is 
being transformed into a processed food.
    (Response 276) These comments appear to misinterpret the proposed 
provision, which does not require sanitizing any non-food-contact 
surfaces, but rather requires cleaning the non-food-contact surfaces of 
equipment. (See also Response 278.)
    (Comment 277) Some comments ask us to specify that this provision 
applies to non-food-contact surfaces of equipment used ``where food is 
exposed or in the food production sections.''
    (Response 277) We decline these requests. The provision clearly 
addresses equipment used in the operation of a food plant, which 
includes food storage in addition to food production. Non-food-contact 
surfaces can become harborages for environmental pathogens (Ref. 55). 
Specifying that non-food-contact surfaces be cleaned as frequently as 
necessary to protect against allergen cross-contact and against 
contamination provides flexibility for industry and regulators to 
interpret this long-standing provision as appropriate to the 
establishment and the food being processed.
    (Comment 278) Some comments ask us to specify that non-food-contact 
surfaces be sanitized or ``sanitized where appropriate.'' Other 
comments assert that sanitizing of high touch areas in the non-
processing areas of a food facility will help prevent transmission of 
public health pathogens into food processing areas. Some comments 
assert that sanitizing non-food-contact surfaces could also assist with 
minimizing risks from possible pathogen transfer to food-contact 
surfaces.
    (Response 278) We decline these requests. We acknowledge that there 
could be some benefit to sanitizing non-food-contact surfaces with 
substances that would reduce pathogens but disagree that treating non-
food-contact surfaces with substances that would reduce pathogens is 
necessary if the surfaces are kept clean. The provision does not 
preclude an establishment from sanitizing non-food-contact surfaces in 
addition to cleaning them, if the establishment determines that doing 
so is necessary or prudent for its operations. See also Response 125.
    (Comment 279) Some comments ask us not to designate the frequency 
for cleaning of non-food-contact surfaces because doing so would create 
an unnecessary burden for smaller facilities.
    (Response 279) The provision does not specify the frequency for 
cleaning of non-food-contact surfaces. Instead, it specifies that the 
surfaces be cleaned ``as frequently as necessary.''

I. Proposed Sec.  117.35(f)--Storage and Handling of Cleaned Portable 
Equipment and Utensils

    We proposed that cleaned and sanitized portable equipment with 
food-contact surfaces and utensils should be stored in a location and 
manner that protects food-contact surfaces from cross-contact and 
contamination. We also requested comment on whether to establish this 
provision as a requirement rather than a recommendation (78 FR 3646 at 
3722).
    (Comment 280) Comments are mixed regarding whether to require, 
rather than recommend, provisions for cleaned and sanitized portable 
equipment with food-contact surfaces and utensils. Some comments ask us 
to keep this provision a recommendation, whereas other comments ask us 
to change this recommendation to a requirement. Some comments agree 
that it is important that these food-contact surfaces are clean and 
sanitary when used, but because storage of equipment and utensils could 
be for an extended period of time, the comments ask us to specify that 
this requirement applies before the subsequent use of the equipment and 
utensils.
    (Response 280) The intent of the provision is to emphasize that 
equipment that is cleaned and sanitized at one location has the 
potential to

[[Page 56004]]

become contaminated or be subject to allergen cross-contact before or 
during movement to a location in which the equipment is used. Examples 
of such equipment are portable mixing kettles, tables, and slicers. We 
are establishing the provision as a requirement because of the 
importance of ensuring that food-contact surfaces are clean and 
sanitary at time of use.
    (Comment 281) Some comments assert that the manner in which this 
equipment is stored includes the location and therefore such wording is 
redundant. These comments ask us to modify the language to remove 
``location.''
    (Response 281) We acknowledge that ``manner'' in which the 
equipment is stored could be interpreted to include ``location'' but 
disagree that this interpretation would be universal. The storage 
location can affect the potential for the equipment to become 
contaminated or subject to allergen cross-contact, and we are retaining 
it in the rule.
    (Comment 282) Some comments state that they support the proposed 
revision for ``all new equipment installations being away from the 
wall,'' but request a waiver for equipment installed before this rule 
is issued. These comments ask for a clear definition of ``portable 
equipment'' because some large, stationary pieces of equipment may have 
wheels.
    (Response 282) The provision is directed to the storage of 
equipment that does not remain stationary in a given establishment, 
regardless of whether the equipment is designed in such a way so that 
it could readily be moved in that establishment or another 
establishment. These comments appear to misinterpret the proposed 
provision, which does not specify that equipment be installed away from 
a wall. (See also Response 296.)
    (Comment 283) Some comments ask us to clarify this provision to 
adapt industry practices for transport of watermelons because it is 
unrealistic and impractical to clean the carpet or replace the 
cardboard lining the harvest buses that transport watermelons on a 
regular basis. Other comments ask that the use of wooden totes to 
transport nuts from the field to the wash and dryer operators remains 
an option for this industry.
    (Response 283) These comments appear to have misinterpreted this 
provision, which relates to the storage and handling of cleaned 
portable equipment and utensils used within an establishment rather 
than to vehicles or equipment used to transport food to a location 
other than the establishment.

XVI. Subpart B: Comments on Proposed Sec.  117.37--Sanitary Facilities 
and Controls

    We proposed to re-establish the provisions of Sec.  110.37 in new 
Sec.  117.37 with some revisions to modernize them. Some comments agree 
with one or more of these proposed provisions without change. Some 
comments that support the proposed provisions suggest alternative or 
additional regulatory text (see, e.g., Comment 285 and Comment 286). 
Other comments that support the proposed provisions ask us to revise or 
clarify current provisions that we proposed to re-establish in part 117 
without change (see, e.g., Comment 290).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we proposed to re-establish in Sec.  117.37 with no 
changes. After considering these comments, we have revised the proposed 
provisions as shown in table 21, with editorial and conforming changes 
as shown in table 52.

                            Table 21--Provisions for Sanitary Facilities and Controls
----------------------------------------------------------------------------------------------------------------
                                  Did we propose revisions   Did we get comments that
           Provision               or request comment on        disagreed with the         Did we modify the
                                   potential  revisions?       proposed provision?     proposed regulatory text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.37(a)--Water Supply.  Yes......................  Yes......................  No.
Sec.   117.37(b)--Plumbing.....  No.......................  No.......................  No.
Sec.   117.37 (b)(1), (2), and   No.......................  No.......................  No.
 (3).
Sec.   117.37(b)(4)--Adequate    No.......................  Yes......................  No.
 floor drainage.
Sec.   117.37(b)(5)--Backflow..  Yes......................  No.......................  No.
Sec.   117.37(c)-- Sewage        No.......................  Yes......................  Yes.
 Disposal.
Sec.   117.37(d)--Toilet         Yes......................  Yes......................  No.
 Facilities.
Sec.   117.37(e)--Hand-Washing   Yes......................  Yes......................  No.
 Facilities.
Sec.   117.37(f) --Rubbish and   Yes......................  No.......................  No.
 Offal Disposal.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.37(a)--Water Supply

    We proposed that the water supply must be sufficient for the 
operations intended and must be derived from an adequate source. Any 
water that contacts food, food-contact surfaces, or food-packaging 
materials must be safe and of adequate sanitary quality. Running water 
at a suitable temperature, and under pressure as needed, must be 
provided in all areas where required for the processing of food, for 
the cleaning of equipment, utensils, and food-packaging materials, or 
for employee sanitary facilities.
    (Comment 284) Some comments express concern that because the 
provision does not define specific microbial limits, it is possible 
that a packer or processor that is subject to the CGMPs for human food 
could have more flexibility in interpreting and following water quality 
expectations than a farm that will be subject to the produce safety 
rule.
    (Response 284) We expect that most facilities subject to this rule 
will have access to a public water supply that would not, under the 
provisions of the proposed produce safety rule, require testing to 
demonstrate that it complies with defined microbial standards. When 
facilities that pack or process produce subject to the produce safety 
rule use untreated ground water or surface water to wash produce, the 
measures described in the proposed produce safety rule are appropriate 
measures to demonstrate that water used in packing and processing of 
produce is safe and of adequate sanitary quality when the produce does 
not undergo any processing to reduce pathogens.
    (Comment 285) Some comments ask us to modify the requirement that 
water must be safe and of adequate sanitary quality by specifying that 
the standard

[[Page 56005]]

for water quality is ``as defined in 40 CFR part 141.'' These comments 
also ask us to specify that compliance with this requirement may be 
verified by any effective means, such as examination of the supplier's 
specifications or test reports; purchase of the water under a 
supplier's guarantee or certification; or analyzing the water.
    (Response 285) We decline these requests. The CGMP provisions apply 
to diverse establishments, including some establishments that do not 
have access to water that satisfies the drinking water requirements of 
40 CFR part 141. For example, seafood processing vessels may need to 
use seawater to clean areas of the ship used for food processing. This 
long-standing provision has been in place since the umbrella CGMPs were 
first established and the comments do not provide any examples of food 
safety problems that would have been addressed by the proposed change. 
Moreover, the CGMP Working Group report (Ref. 3) did not identify the 
water quality standard as something that needed to be changed.
    (Comment 286) Some comments ask us to specify that running water be 
provided only ``at appropriate locations.''
    (Response 286) We decline this request. We agree that running water 
must be provided only ``at appropriate locations.'' However, in the 
context of this provision ``appropriate locations'' means ``in all 
areas where required for the processing of food, for the cleaning of 
equipment, utensils, and food-packaging materials, or for employee 
sanitary facilities'' as has been specified for decades.

B. Proposed Sec.  117.37(b)--Plumbing

    We proposed that plumbing must be of adequate size and design and 
adequately installed and maintained to: (1) Carry sufficient quantities 
of water to required locations throughout the plant; (2) properly 
convey sewage and liquid disposable waste from the plant; (3) avoid 
constituting a source of contamination to food, water supplies, 
equipment, or utensils or creating an unsanitary condition; (4) provide 
adequate floor drainage in all areas where floors are subject to 
flooding-type cleaning or where normal operations release or discharge 
water or other liquid waste on the floor; and (5) provide that there is 
not backflow from, or cross-connection between, piping systems that 
discharge waste water or sewage and piping systems that carry water for 
food or food manufacturing.
    (Comment 287) Some comments assert that requirements for adequate 
floor drainage are overly prescriptive and do not allow for any 
standing water subsequent to washing and sanitizing activities.
    (Response 287) This provision does not prohibit standing water--
e.g., during vegetable or other wet processing operations. However, 
floors should provide for drainage, e.g., be sloped towards drains, and 
standing water should be minimized to the extent possible to reduce the 
potential for contamination of food and food-contact surfaces. This is 
a long-standing provision and the comment does not provide any 
information as to how this has been interpreted in the past to not 
allow for standing water during processing or subsequent to washing and 
sanitizing activities.

C. Proposed Sec.  117.37(c)--Sewage Disposal

    We proposed that sewage disposal must be made into an adequate 
sewerage system or disposed of through other adequate means.
    (Comment 288) Some comments ask us to specify that sewage ``must be 
disposed.''
    (Response 288) We have revised the regulatory text to consistently 
use the verb ``dispose'' rather than to use a noun (i.e., ``disposal'') 
in the first clause.

D. Proposed Sec.  117.37(d)--Toilet Facilities

    We proposed to replace the existing CGMP requirements for toilets 
(i.e., that each plant provide its employees with adequate, readily 
accessible toilet facilities, along with recommendations for how to 
comply with these requirements) with a requirement that each plant must 
provide its employees with adequate, readily accessible toilet 
facilities. We proposed that toilet facilities must be kept clean and 
must not be a potential source of contamination of food, food-contact, 
or food-packaging materials. We also proposed to delete the guidance on 
how to comply with the requirements.
    (Comment 289) Some comments ask us to retain the guidance we 
proposed to delete. Some comments ask us to retain some of the guidance 
and make some of it optional to allow for flexibility based on the 
design of the facility. Some comments provide specific editorial 
suggestions to include the guidance in this provision.
    (Response 289) We decline these requests. As noted in the final 
rule establishing CGMPs for dietary supplements (72 FR 34752 at 34817), 
it is unnecessary to require specific features because an establishment 
may be able to achieve compliance through other means better suited to 
its operations.

E. Proposed Sec.  117.37(e)--Hand-Washing Facilities

    We proposed to replace the existing CGMP requirements for hand-
washing facilities (i.e., that hand-washing facilities must be adequate 
and convenient and be furnished with running water at a suitable 
temperature, along with recommendations for how to comply with these 
requirements) with a requirement that each plant must provide hand-
washing facilities designed to ensure that an employee's hands are not 
a source of contamination of food, food-contact surfaces, or food-
packaging materials, by providing facilities that are adequate, 
convenient, and furnish running water at a suitable temperature. We 
also proposed to delete the guidance on how to comply with the 
requirements.
    (Comment 290) Some comments ask us to clarify the meaning of 
``suitable temperature'' in this provision.
    (Response 290) By ``suitable temperature,'' we mean a temperature 
that does not discourage employees from adequately washing hands, or 
from washing hands at all, because the water is either too cold or too 
hot.
    (Comment 291) Some comments ask that we specify that hot water 
should be provided so that this provision is more consistent with 
similar rules for most State and local jurisdictions that interpret 
``suitable temperature'' as ``hot.'' Some comments ask whether we are 
deleting a current requirement for hot water to be provided at a hand-
wash station.
    (Response 291) We are not deleting a current requirement for hot 
water to be provided at a hand-wash station. The comments may be 
mistaking our CGMP requirements with the provisions of our Food Code, 
which specify that a hand-washing sink shall be equipped to provide 
water at a temperature of at least 38 degrees C (110 degrees F) through 
a mixing valve or combination faucet (See section 5-202.12 of the Food 
Code) (Ref. 51).
    We decline the request to modify the regulatory text so that it 
requires that ``hot water'' be provided. This long-standing requirement 
for a ``suitable temperature,'' without specifying a requirement for 
``hot water,'' means that the water should be neither too hot nor too 
cold to discourage personnel from washing their hands. We continue to 
believe that it is not necessary to specify a particular temperature or 
to use the subjective term ``hot.''

[[Page 56006]]

XVII. Subpart B: Comments on Proposed Sec.  117.40--Equipment and 
Utensils

    We proposed to re-establish the provisions of Sec.  110.40 in new 
Sec.  117.40 with some revisions to modernize them. Some comments agree 
with one or more of these proposed provisions without change. Some 
comments that support the proposed provisions suggest alternative or 
additional regulatory text (see, e.g., Comment 301, Comment 305, and 
Comment 307) or ask us to clarify how we will interpret the provision 
(see, e.g., Comment 308). Other comments that support the proposed 
provisions ask us to revise or clarify current provisions that we 
proposed to re-establish in part 117 without change (see, e.g., Comment 
292, Comment 300, and Comment 310).
    We also proposed to reorganize provisions found in current Sec.  
110.40(a) by creating paragraph designations (a)(1) through (a)(6) with 
associated editorial changes. We received no comments that disagreed 
with this proposed redesignation and are finalizing it as proposed.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we proposed to re-establish in Sec.  117.40 with no 
changes. After considering these comments, we have revised the proposed 
provisions as shown in table 22, with editorial and conforming changes 
as shown in table 52.

                                 Table 22--Provisions for Equipment and Utensils
----------------------------------------------------------------------------------------------------------------
                                  Did we propose revisions   Did we get comments that
           Provision               or request comment on        disagreed with the         Did we modify the
                                   potential  revisions?       proposed provision?     proposed regulatory text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.40(a)(1)--Design of   No.......................  Yes......................  No.
 Plant Equipment and Utensils.
Sec.   117.40(a)(2)--Design      No.......................  Yes......................  Yes.
 Construction, and Use of
 Equipment and Utensils.
Sec.   117.40(a)(3)--            Yes......................  Yes......................  Yes.
 Installation and Maintenance
 of Equipment.
Sec.   117.40(a)(4)--Corrosion-  No.......................  Yes......................  No.
 Resistant Food-Contact
 Surfaces.
Sec.   117.40(a)(5)--Food-       No.......................  Yes......................  Yes.
 Contact Surfaces and Nontoxic
 Materials.
Sec.   117.40(a)(6)--            Yes......................  Yes......................  No.
 Maintenance of Food-Contact
 Surfaces.
Sec.   117.40(b)--Seams on Food- Yes......................  Yes......................  No.
 Contact Surfaces.
Sec.   117.40(c)--Construction   No.......................  Yes......................  Yes.
 of Equipment.
Sec.   117.40(d)--Holding,       No.......................  Yes......................  Yes.
 Conveying, and Manufacturing
 Systems.
Sec.   117.40(e)--Freezer and    Yes......................  Yes......................  No.
 Cold Storage Compartments.
Sec.   117.40(f)--Accurate and   Yes......................  Yes......................  No.
 Precise Instruments and
 Controls.
Sec.   117.40(g)--Compressed     No.......................  Yes......................  No.
 Air or Other Gases.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.40(a)--Design, Construction, Use, Installation, 
and Maintenance of Equipment and Utensils

1. Proposed Sec.  117.40(a)(1)--Design of Plant Equipment and Utensils
    We proposed no revisions to the requirement that all plant 
equipment and utensils must be so designed and of such material and 
workmanship as to be adequately cleanable, and must be properly 
maintained.
    (Comment 292) Some comments ask us to specify that this provision 
only applies to equipment and utensils used for, or in connection with, 
food manufacturing, processing, packing, or holding and appropriate to 
the stage of production it is used in. These comments assert that ``all 
plant equipment and utensils'' is too broad and that the requirements 
for cleanliness of the equipment and utensils differ at various stages 
of production. Other comments ask us to specify ``as needed to protect 
against allergen cross-contact and contamination.''
    (Response 292) We agree that it is not necessary to apply the 
provision to all plant equipment and utensils, regardless of what the 
equipment is and whether it has any role in the production of food. For 
example, we agree that it is not necessary to apply the requirement to 
equipment such as welding equipment used in an establishment's machine 
shop. Accordingly, we have made the following modifications to the 
provision: (1) Specify that the provision applies to all plant 
equipment and utensils ``used in manufacturing, processing, packing, or 
holding food''; (2) specify that equipment and utensils must be 
``adequately'' maintained, rather than ``properly'' maintained, to 
emphasize the public health goal of the requirement; and (3) specify 
that the purpose of the requirement is to protect against allergen 
cross-contact and contamination.
2. Proposed Sec.  117.40(a)(2)--Design, Construction, and Use of 
Equipment and Utensils
    We proposed no revisions to the requirement that the design, 
construction, and use of equipment and utensils must preclude the 
adulteration of food with lubricants, fuel, metal fragments, 
contaminated water, or any other contaminants.
    (Comment 293) Some comments suggest editorial changes to the 
provision to improve clarity.
    (Response 293) We agree that the suggested changes improve the 
clarity of the provision and have incorporated them into the regulatory 
text.
3. Proposed Sec.  117.40(a)(3)--Installation and Maintenance of 
Equipment
    We requested comment on whether to establish the current 
recommendation that all equipment be so installed and maintained as to 
facilitate the cleaning of the equipment and of all adjacent spaces as 
a requirement (78 FR 3646 at 3723).
    (Comment 294) Some comments assert that we should establish this 
recommendation as a requirement in light of recent findings of the 
pathogen L. monocytogenes in environmental swab samples taken from food 
processing plants.
    (Response 294) We agree with these comments that an additional 
reason to establish this recommendation as a requirement, in addition 
to the reasons we provided in the 2013 proposed preventive controls 
rule (78 FR 3646 at 3728), is that it could facilitate cleaning for 
environmental pathogens. We have revised the regulatory text to change 
``should'' to ``must.''
    (Comment 295) Some comments suggest that we make editorial changes, 
for clarity and completeness, to read ``so as to facilitate the 
cleaning and maintenance'' rather than ``so installed

[[Page 56007]]

and maintained as to facilitate the cleaning.''
    (Response 295) We agree that the suggested changes improve the 
clarity of the provision and have incorporated them into the regulatory 
text.
    (Comment 296) Some comments support the proposed revision for ``all 
new equipment installations being away from the wall,'' but ask that we 
provide a waiver for equipment that has been installed prior to the 
issuance of this rulemaking.
    (Response 296) These comments appear to misinterpret the proposed 
provision, which does not specify that equipment be installed away from 
a wall. The requirement is to install equipment so as to facilitate 
both cleaning and maintenance. This provision has been a long-standing 
recommendation. Moreover, if the existing equipment is installed in a 
way that it cannot be cleaned, it would not have been in compliance 
with existing CGMP requirements for the design and construction of the 
plant (Sec.  110.20). For example, the current CGMPs have long required 
that the design and construction of the plant must provide sufficient 
space for such placement of equipment and storage of materials as is 
necessary for the maintenance of sanitary operations and the production 
of safe food (Sec.  110.20(a)(1)).
4. Proposed Sec.  117.40(a)(4)--Corrosion-Resistant Food-Contact 
Surfaces
    We proposed no revisions to the requirement that food-contact 
surfaces must be corrosion-resistant when in contact with food.
    (Comment 297) Some comments ask us to specify that the requirement 
only applies where appropriate for food safety. Other comments ask us 
to specify that the food-contact surfaces be corrosion-resistant as 
appropriate to the type of food and other substances with which they 
come in contact.
    (Response 297) We decline these requests. We disagree with the 
implication that the condition of some food-contact surfaces would not 
be relevant to food safety. We also disagree that it would be 
acceptable for some food products to be in contact with surfaces 
susceptible to corrosion, regardless of the nature of the food product.
5. Proposed Sec.  117.40(a)(5)--Food-Contact Surfaces and Nontoxic 
Materials
    We proposed no revisions to the requirement that food-contact 
surfaces must be made of nontoxic materials and designed to withstand 
the environment of their intended use and the action of food, and, if 
applicable, cleaning compounds and sanitizing agents.
    (Comment 298) Some comments assert that food-contact surfaces or 
utensils could be dedicated to allergens only or non-allergens only.
    (Response 298) We agree that dedicating food-contact surfaces and 
utensils is one way to comply with various requirements of this rule to 
prevent allergen cross-contact, but disagree that we should require 
this particular mechanism to prevent allergen cross-contact. Other 
mechanisms can prevent allergen cross-contact, such as adequately 
cleaning equipment and surfaces between uses.
    (Comment 299) Some comments ask us to specify that food-contact 
surfaces must be made of food-grade materials and suitably durable.
    (Response 299) We decline these requests. Food-grade materials must 
be non-toxic. The comment provides no examples of circumstances in 
which the long-standing criterion of ``nontoxic'' is inadequate. We 
agree that ``suitably durable'' could be interpreted to capture the 
general intent of the current text that specifies ``designed to 
withstand the environment of their intended use and the action of food, 
and, if applicable, cleaning compounds and sanitizing agents,'' but 
disagree that this interpretation would be universal and are retaining 
the long-standing regulatory text.
    (Comment 300) Some comments ask us to specify that food-contact 
surfaces must be designed to withstand cleaning procedures.
    (Response 300) We have revised the regulatory text to include 
cleaning procedures. For example, food-contact surfaces must be 
designed to withstand the actions of scrubbing utensils that could 
scratch or pit the equipment, creating cracks and crevices that could 
be difficult to clean and lead to a niche where environmental pathogens 
could lodge and potentially contaminate food produced using the 
equipment.
6. Proposed Sec.  117.40(a)(6))--Maintenance of Food-Contact Surfaces
    We proposed that food-contact surfaces must be maintained to 
protect food from cross-contact and from being contaminated by any 
source, including unlawful indirect food additives. As an inadvertent 
error, we specified that this requirement would be designated as Sec.  
117.40(a)(5); we intended to specify that it be designated Sec.  
117.40(a)(6).
    (Comment 301) Some comments ask us to specify that this requirement 
also applies to equipment and utensils but does not apply to single-use 
items.
    (Response 301) We decline these requests. As proposed, the 
requirement applies to all food-contact surfaces, including those on 
equipment and utensils; it is not necessary to separately specify that 
the requirement applies to equipment and utensils. We are not 
specifying that single-use food-contact surfaces do not need to be 
maintained. Using equipment or utensils that have single-use food-
contact surfaces may be one way to satisfy the requirements of the 
provision, although single use items may still need to be protected 
from allergen cross-contact and from contamination, e.g., by protective 
packaging.
    (Comment 302) Some comments ask us to require that the surfaces 
also be appropriately cleaned and sanitized.
    (Response 302) We decline this request. Cleaning and sanitizing of 
food-contact surfaces is covered by Sec.  117.35(d) and does not need 
to be repeated here.
    (Comment 303) Some comments ask us to strike the phrase ``including 
unlawful indirect food additives.'' These comments assert that the 
wording would be equally effective without the phrase and that striking 
it would result in a stronger and more absolute requirement.
    (Response 303) We decline this request. Although some persons might 
realize that the provision requires them to protect against unlawful 
indirect food additives, such an interpretation may not be universal.

B. Proposed Sec.  117.40(b)--Seams on Food-Contact Surfaces

    We proposed that seams on food-contact surfaces must be smoothly 
bonded or maintained so as to minimize accumulation of food particles, 
dirt, and organic matter, and thus minimize the opportunity for growth 
of microorganisms and cross-contact.
    (Comment 304) Some comments assert that this provision should not 
apply to all establishments--e.g., that it seems directed towards 
bakeries but inapplicable to establishments that pack produce.
    (Response 304) The provision requires an establishment to minimize 
accumulation of food particles, dirt, and organic matter in seams on 
food-contact surfaces to minimize the opportunity for growth of 
microorganisms and allergen cross-contact and provides flexibility for 
how to comply with the requirement (i.e., through smoothly bonded seams 
or through maintenance). Minimizing the accumulation of food particles, 
dirt, and organic matter in seams on food-contact surfaces is 
appropriate for all establishments that produce food.

[[Page 56008]]

C. Proposed Sec.  117.40(c)--Construction of Equipment

    We proposed that equipment that is in the manufacturing or food-
handling area and that does not come into contact with food must be so 
constructed that it can be kept in a clean condition.
    (Comment 305) Some comments ask us to specify ``areas where food is 
manufactured, processed, or packed'' and clarify that the equipment 
must be constructed so that it can be kept ``appropriately clean and 
sanitary.''
    (Response 305) We have revised the provision to specify that it 
applies to areas in the plant where food is manufactured, processed, 
packed, or held. Doing so makes the terms in this provision consistent 
with terms used throughout the CGMPs (78 FR 3646 at 3692). Consistent 
with (Response 258, we also have modified the provision to specify that 
the equipment must be constructed so that it can be kept ``clean and 
sanitary.''
    (Comment 306) Some comments ask us to consider inserting technical 
language to address systems used for sanitizing in food processing 
environments to ensure they meet generally accepted design principles 
for food grade equipment. Some comments ask us to specify that the 
equipment must be constructed of materials that will not get corroded 
by cleaning chemicals and that welded joints must be of non-corrosive 
materials and ``dressed'' to eliminate porous surfaces and occlusions.
    (Response 306) We decline these requests. It is not necessary to 
specify every type of equipment that could be used in a food processing 
environment or every situation that must be addressed to satisfy the 
specific requirements of this provision and the more general 
requirements of Sec.  117.40(a).

D. Proposed Sec.  117.40(d)--Holding, Conveying, and Manufacturing 
Systems

    We proposed no revisions to the requirement that holding, 
conveying, and manufacturing systems, including gravimetric, pneumatic, 
closed, and automated systems, must be of a design and construction 
that enables them to be maintained in an appropriate sanitary 
condition.
    (Comment 307) Some comments ask us to specify that these systems 
also need to be maintained in an appropriately clean condition in 
addition to a sanitary condition.
    (Response 307) Consistent with Response 258, we have revised the 
provision to specify that the equipment must be constructed so that it 
can be kept ``clean and sanitary.''

E. Proposed Sec.  117.40(e)--Freezer and Cold Storage Compartments

    We proposed that each freezer and cold storage compartment used to 
store and hold food capable of supporting growth of microorganisms must 
be fitted with an indicating thermometer, temperature measuring device, 
or temperature-recording device so installed as to show the temperature 
accurately within the compartment. We also proposed to delete the 
recommendation that each freezer and cold storage compartment used to 
store and hold food capable of supporting growth of microorganisms be 
fitted with an automatic control for regulating temperature or with an 
automatic alarm system to indicate a significant temperature change in 
a manual operation.
    (Comment 308) Some comments ask us to clarify that this requirement 
is only for foods that require temperature control for food safety, and 
does not apply to any intact fruits or vegetables that are only held at 
specific temperatures for quality and shelf-life purposes. Some 
comments ask us to change this requirement to a recommendation for the 
same reason. Some comments assert that temperature control for intact 
fruits and vegetables is likely not always necessary or even desirable 
(e.g., to avoid chill damage).
    (Response 308) We decline this request. The requirement applies to 
refrigerated storage when the establishment has placed food in a 
refrigerated storage compartment, whether for food safety or for food 
quality (e.g., to prevent the growth of spoilage microorganisms). The 
provision, which is an existing requirement in Sec.  110.40, does not 
specify which foods must be refrigerated or what the refrigeration 
temperature must be. However, once the establishment has determined 
that refrigerated storage is appropriate, either for food safety or 
food quality, it is appropriate to require that the establishment have 
evidence that it is refrigerating the food as it has decided to do.

F. Proposed Sec.  117.40(f)--Accurate and Precise Instruments and 
Controls

    We proposed that instruments and controls used for measuring, 
regulating, or recording temperatures, pH, acidity, water activity, or 
other conditions that control or prevent the growth of undesirable 
microorganisms in food must be accurate and precise and adequately 
maintained, and adequate in number for their designated uses.
    (Comment 309) Some comments ask us to specify ``calibrated'' for 
clarity, accuracy, and completeness. Some comments assert that proper 
calibration of such equipment is essential to ensure food safety, and 
does not entail so large a cost as to preclude even small companies 
from compliance.
    (Response 309) We decline this request. The request of this comment 
is already addressed by our proposal to revise this long-standing 
provision to require that these types of instruments be accurate, as 
well as precise. As discussed in Comment 519 and Response 519, some 
types of instruments generally are subject to accuracy checks rather 
than to calibration.

G. Proposed Sec.  117.40(g)--Compressed Air or Other Gases

    We proposed no revisions to the requirement that compressed air or 
other gases mechanically introduced into food or used to clean food-
contact surfaces or equipment must be treated in such a way that food 
is not contaminated with unlawful indirect food additives.
    (Comment 310) Some comments ask us to specify that compressed air 
or other gases must be ``filtered or otherwise treated'' for clarity.
    (Response 310) We decline this request. We agree that filtration is 
a common treatment to prevent contamination, but disagree that it is 
necessary to modify this long-standing requirement to add this 
particular example of a treatment to prevent contamination with 
unlawful indirect food additives. As written, the provision provides 
flexibility for an establishment to determine the appropriate treatment 
for compressed air or other gases in a manner that works best for its 
plant.
    (Comment 311) Some comments ask us to strike the phrase ``with 
unlawful indirect food additives.'' These comments assert that the 
wording would be equally effective without the phrase and that striking 
it would result in a stronger and more absolute requirement.
    (Response 311) We decline this request. Although some persons might 
realize that the provision requires them to protect against unlawful 
indirect food additives, such an interpretation may not be universal.

XVIII. Subpart B: Comments on Proposed Sec.  117.80(a)--General 
Processes and Controls

    We proposed to re-establish the provisions of Sec.  110.80 in new 
Sec.  117.80(a) with some revisions to modernize them and with some

[[Page 56009]]

redesignations. Some comments support one or more of these proposed 
provisions without change. Some comments that support the proposed 
provisions suggest alternative or additional regulatory text (see, 
e.g., Comment 316) or ask us to clarify how we will interpret the 
provision (see, e.g., Comment 317). Other comments that support the 
proposed provisions ask us to revise or clarify current provisions that 
we proposed to re-establish in part 117 without change (see, e.g., 
Comment 312 and Comment 320).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we did not propose to revise. After considering these 
comments, we have revised the proposed provisions as shown in table 23, 
with editorial and conforming changes as shown in table 52.

                             Table 23--Provisions for General Processes and Controls
----------------------------------------------------------------------------------------------------------------
                                  Did we propose revisions   Did we get comments that
           Provision               or request comment on        disagreed with the         Did we modify the
                                   potential  revisions?       proposed provision?     proposed regulatory text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.80(a)(1 )--Adequate   No.......................  Yes......................  No.
 sanitation principles.
Sec.   117.80(a)(2)--Quality     No.......................  Yes......................  No.
 control operations.
Sec.   117.80(a)(3)--            No.......................  Yes......................  No.
 Supervising overall sanitation.
Sec.   117.80(a)(4)--Production  Yes......................  Yes......................  Yes.
 procedures.
Sec.   117.80(a)(5)--Chemical,   Yes......................  Yes......................  No.
 microbial, or extraneous-
 material testing procedures.
Sec.   117.80(a)(6)--            No.......................  Yes......................  No.
 Contaminated food.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.80(a)(1)--Adequate Sanitation Principles

    We proposed no revisions to the requirements of current Sec.  
110.80 (proposed Sec.  117.80(a)(1)) that all operations in the 
manufacturing, processing, packing, and holding of food (including 
operations directed to receiving, inspecting, transporting, and 
segregating) be conducted in accordance with adequate sanitation 
principles.
    (Comment 312) Some comments ask us to clarity ``adequate sanitation 
principles.'' Some of these comments express concern that facilities 
receiving raw produce that will be further cleaned or processed will be 
unable to meet this requirement and assert that this requirement will 
not provide additional public health benefits.
    (Response 312) These comments fail to explain how we have 
interpreted the provision in a way that has been problematic such that 
clarification is necessary. The term ``adequate'' is a long-standing 
term that we defined in its current form when we first established the 
umbrella CGMPs in 1969 (34 FR 6977 at 6978). Furthermore, during a 
previous rulemaking to revise the umbrella CGMPs and establish current 
Sec.  110.80 we explained that the phrase ``adequate sanitation 
principles'' must be broad so that industry can easily adapt sanitation 
principles to its existing procedures (51 FR 22458 at 22461).
    (Comment 313) Some comments ask us to specify that operations be 
conducted in accordance with adequate sanitation principles ``specific 
to the operation'' to provide for extended time intervals between 
sanitation procedures. These comments explain that in the case of low-
moisture almonds, sanitation intervals may be extended in order to 
minimize addition of water into the facility.
    (Response 313) We decline this request. By specifying that 
sanitation principles must be ``adequate,'' the provision already 
provides flexibility such as that requested by these comments. In 
addition, the rule does not specify any time intervals for conducting 
sanitation operations and, thus, the provision needs no qualification 
to provide flexibility for an establishment to adopt a frequency of 
sanitation procedures consistent with its operations.

B. Proposed Sec.  117.80(a)(2)--Quality Control Operations

    We proposed no revisions to the requirements of current Sec.  
110.80 (proposed Sec.  117.80(a)(2)) that appropriate quality control 
operations be employed to ensure that food is suitable for human 
consumption and that food-packaging materials are safe and suitable.
    (Comment 314) Some comments assert that specifying that food-
packaging materials must be ``safe and suitable'' is confusing because 
the definition for ``safe and suitable'' at Sec.  130.3(d) defines the 
phrase with respect to ingredients.
    (Response 314) The requirement is a long-standing provision that 
has been used in this context for decades. When we first proposed this 
provision during a previous rulemaking to revise the umbrella CGMPs, we 
included this exact phrase and did not receive any comments regarding 
its use (44 FR 33238 at 33246). Furthermore, as evidence that industry 
commonly understands the use of the term ``suitable'' in the context of 
CGMP requirements in addition to requirements applicable to ingredients 
used in standardized foods, we note that we substituted the term 
``suitable'' for ``fit'' in another provision (Sec.  110.80(a)(1)) in 
response to comments from industry stating that ``suitable'' was a more 
familiar term than ``fit'' (51 FR 22458 at 22470).

C. Proposed Sec.  117.80(a)(3)--Supervision of Overall Sanitation

    We proposed no revisions to the requirements of current Sec.  
110.80 (proposed Sec.  117.80(a)(3)) that overall sanitation of the 
plant be under the supervision of one or more competent individuals 
assigned responsibility for this function.
    (Comment 315) Some comments ask us to revise this provision to 
specify that it applies to overall cleaning of the plant, as well as 
overall sanitation of the plant.
    (Response 315) We decline this request. Sanitation is a general 
term that already encompasses cleaning (and, as appropriate, 
sanitizing).

D. Proposed Sec.  117.80(a)(4)--Production Procedures

    We proposed that all reasonable precautions must be taken to ensure 
that production procedures do not contribute to cross-contact and 
contamination from any source.
    (Comment 316) Some comments assert that the phrase ``all reasonable 
precautions'' is too extreme and prescriptive and suggest that 
``adequate'' would be more appropriate than ``all'' to

[[Page 56010]]

describe the intended measures and precautions.
    (Response 316) We agree that ``adequate'' is more appropriate than 
``all'' and have substituted the word ``adequate'' for ``all 
reasonable'' in the final rule.

E. Proposed Sec.  117.80(a)(5)--Chemical, Microbial, or Extraneous-
Material Testing Procedures

    We proposed that chemical, microbial, or extraneous-material 
testing procedures must be used where necessary to identify sanitation 
failures or possible cross-contact and food contamination.
    (Comment 317) Some comments ask whether the word ``must'' in the 
provision means that testing will always be required, including for 
food allergens. Other comments assert that testing should only be used 
when there is reason to suspect a specific problem has occurred and 
when methods are available.
    (Response 317) Testing is not always required. The provision 
provides flexibility for an establishment to test when appropriate, 
such as when a facility determines that it is necessary to use rapid 
ATP (adenosine triphosphate) swabs as an indicator of microbial or food 
residue contamination to verify cleaning of a line prior to running a 
different product (Ref. 56). Facilities commonly conduct tests on food 
for microorganisms that indicate sanitation failures, such as testing 
for total plate count, generic E. coli, total coliforms, etc. (Ref. 
57). When the number of such organisms exceeds expectation, sanitation 
or other failures are suspected and the facility can take actions to 
determine the source of the problem.
    (Comment 318) Some comments oppose any implication that food 
manufacturers are required to develop test methods or analytical 
standards, or search out methods that are not readily available, for 
this or any other purpose.
    (Response 318) The provision does not require food manufacturers to 
develop test methods or analytical standards, or search out methods 
that are not readily available.
    (Comment 319) Some comments suggest that testing as part of an 
environmental monitoring program should be risk-based and include 
allergens, but should not be required for finished product.
    (Response 319) The provision does not use the term ``environmental 
monitoring,'' which is a term that has come to be associated with 
monitoring for environmental pathogens rather than for other substances 
that may contaminate the food processing environment. Likewise, the 
provision does not establish requirements for environmental monitoring 
for finished product. As discussed in Response 317, the provision 
provides flexibility for an establishment to test when testing is 
appropriate, such as when the facility determines testing would be 
useful to verify adherence to CGMPs or when there is a problem such as 
allergen cross-contact.

F. Proposed Sec.  117.80(a)(6)--Contaminated Food

    We proposed no revisions to the requirements of current Sec.  
110.80 (proposed Sec.  117.80(a)(6)) that all food that has become 
contaminated to the extent that it is adulterated be rejected, or if 
permissible, treated or processed to eliminate the contamination.
    (Comment 320) Some comments assert that the use of the phrase ``if 
permissible'' is vague and confusing and should be replaced by a 
statement of precisely what is impermissible.
    (Response 320) We acknowledge that the phrase ``if permissible'' 
does not communicate the circumstances under which it is permissible to 
treat or process a food to eliminate contamination. Rather than add 
such circumstances to the rule, we have replaced the phrase ``if 
permissible'' with ``if appropriate.'' In the following paragraphs, we 
discuss examples of when treatment or processing to eliminate 
contamination would or would not be appropriate.
    Some RACs, such as cocoa beans, can become adulterated with insects 
or filth but may be fumigated or cleaned in accordance with an 
application for reconditioning submitted to FDA to bring the product 
into compliance. Acid or acidified canned goods with microbial 
contamination due to a container defect may be reconditioned by sorting 
out the defective containers to ensure that containers released into 
commerce are intact and the product is not contaminated. Tree nuts with 
signs of mold growth can be reconditioned using methods that separate 
the moldy nuts from those that are not contaminated. Tree nuts found to 
be contaminated with Salmonella may be treated by processes such as 
steam or propylene oxide when such treatments have been validated to 
provide an adequate reduction of Salmonella. A heat-treated food 
contaminated from the environment, such as a heat-treated, dried 
protein product, can sometimes be rehydrated, and a food establishment 
could repeat the processing to reduce pathogens. Other products, such 
as many types of produce, are not normally processed to reduce 
pathogens, and product quality may be impacted by such treatments. Even 
though processing techniques such as irradiation have the potential to 
reduce pathogens, irradiation is a food additive that requires 
approval. For example, as of January 15, 2015, irradiation had been 
approved for control of foodborne pathogens and extension of shelf-life 
in fresh iceberg lettuce and fresh spinach, but not in other fresh 
leafy greens. Using irradiation for a purpose that has not been 
approved (such as for the irradiation of fresh leafy greens other than 
fresh iceberg lettuce and fresh spinach) would render the food 
adulterated under section 402(a)(2)(C)(i) of the FD&C Act and, thus, it 
would not be appropriate to treat or process fresh leafy greens other 
than fresh iceberg lettuce and fresh spinach using irradiation.

XIX. Subpart B: Comments on Proposed Sec.  117.80(b)--Processes and 
Controls for Raw Materials and Other Ingredients

    We proposed to re-establish the provisions of Sec.  110.80(a) in 
new Sec.  117.80(b) with some revisions to modernize them. Some 
comments support one or more of these proposed provisions without 
change. For example, some comments support a new provision that would 
require raw materials and ingredients that are food allergens, and 
rework that contains food allergens, to be identified and held in a 
manner that prevents allergen cross-contact. Some comments that support 
the proposed provisions suggest alternative or additional regulatory 
text (see, e.g., Comment 324, Comment 325, Comment 328, and Comment 
329) or ask us to clarify how we will interpret the provision (see, 
e.g., Comment 323 and Comment 327).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we did not propose to revise. After considering these 
comments, we have revised the proposed provisions as shown in table 24, 
with editorial and conforming changes as shown in table 52.

[[Page 56011]]



             Table 24--Provisions for Processes and Controls for Raw Materials and Other Ingredients
----------------------------------------------------------------------------------------------------------------
                                  Did we propose revisions   Did we get comments that
           Provision               or request comment on        disagreed with the         Did we modify the
                                   potential  revisions?       proposed provision?     proposed regulatory text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.80(b)(1)--            Yes......................  Yes......................  Yes.
 Inspection, storage, and
 handling of raw materials and
 other ingredients.
Sec.   117.80(b)(2)--Levels of   Yes......................  Yes......................  No.
 microorganisms in raw
 materials and other
 ingredients.
Sec.   117.80(b)(3)--Natural     Yes......................  Yes......................  No.
 toxins in raw materials and
 other ingredients.
Sec.   117.80(b)(4)--Pests,      Yes......................  Yes......................  No.
 undesirable microorganisms,
 and extraneous material in raw
 materials and other
 ingredients.
Sec.   117.80(b)(5)--Holding     Yes......................  Yes......................  No.
 raw materials, other
 ingredients, and rework in
 bulk.
Sec.   117.80(b)(6)--Frozen raw  No.......................  No.......................  No.
 materials and other
 ingredients.
Sec.   117.80(b)(7)--Liquid and  Yes......................  Yes......................  No.
 dry raw materials and other
 ingredients.
Sec.   117.80(b)(8)--Raw         Yes......................  Yes......................  No.
 materials and other
 ingredients that are food
 allergens.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.80(b)(1)--Inspection, Segregation and Handling of 
Raw Materials and Other Ingredients

    We proposed that raw materials and ingredients must be inspected 
and segregated or otherwise handled as necessary to ascertain that they 
are clean and suitable for processing into food and must be stored 
under conditions that will protect against cross-contact and 
contamination and minimize deterioration. Raw materials must be washed 
or cleaned as necessary to remove soil or other contamination. Water 
used for washing, rinsing, or conveying food must be safe and of 
adequate sanitary quality. Water may be reused for washing, rinsing, or 
conveying food if it does not increase the level of contamination of 
the food or cause cross-contact.
    We also proposed to continue to recommend that containers and 
carriers of raw materials be inspected on receipt to ensure that their 
condition has not contributed to cross-contact, contamination, or 
deterioration. However, we also requested comment on whether to 
establish this recommendation as a requirement (78 FR 3646 at 3724).
    (Comment 321) Some comments express concern about revising current 
Sec.  110.80(a)(1) to require, rather than recommend, that containers 
and carriers of raw materials be inspected on receipt. Some comments 
focus on practical problems associated with inspecting bins containing 
RACs such as produce. These comments explain that produce bins received 
by a packing establishment are too large to be handled directly and 
instead are delivered by a fork lift followed by automated travel 
through the establishment.
    (Response 321) We agree that circumstances such as those described 
in these comments make it appropriate to continue to recommend, but not 
require, that containers and carriers of raw materials be inspected on 
receipt to ensure that their condition has not contributed to allergen 
cross-contact, contamination, or deterioration. Therefore, we are not 
re-establishing this nonbinding recommendation as a requirement. 
Instead, as discussed in Response 67, we have deleted this non-binding 
provision from the rule.

B. Proposed Sec.  117.80(b)(2)--Levels of Microorganisms in Raw 
Materials and Other Ingredients

    We proposed that raw materials and ingredients must either not 
contain levels of microorganisms that may render the food injurious to 
health of humans, or they must be pasteurized or otherwise treated 
during manufacturing operations so that they no longer contain levels 
that would cause the product to be adulterated. We also proposed to 
delete guidance regarding how to comply with this requirement.
    (Comment 322) Some comments ask us to supply the list of 
microorganisms that may render the food injurious to the health of 
humans. Some comments assert that we would have to establish acceptable 
pathogen concentration limits in order for industry to comply with this 
provision.
    (Response 322) We are not providing a list of microorganisms that 
may render the food injurious to the health of humans. CGMPs establish 
procedural requirements, not declarations of foods that are 
adulterated. It is not necessary for us to establish acceptable 
pathogen concentration limits in order for industry to comply with this 
provision. Moreover, several Compliance Policy Guides (CPGs) provide 
guidance to our investigators about agency policies that apply when 
food is contaminated with microorganisms, and these CPGs are available 
to industry (Ref. 58) (Ref. 59) (Ref. 60) (Ref. 61) (Ref. 62).
    (Comment 323) Some comments express concern about the requirement 
for pasteurization, explaining that fresh produce cannot be 
pasteurized.
    (Response 323) The proposed provision would not require 
pasteurization of products such as produce. The proposed provision 
clearly states that pasteurization or other treatment is only required 
when raw materials and other ingredients contain levels of 
microorganisms that may render the food injurious to health of humans. 
However, when products such as produce contain levels of microorganisms 
that may render the food injurious to health of humans, and the 
products cannot be pasteurized or otherwise treated so that they no 
longer contain levels that would cause the product to be adulterated, 
other provisions require that the product be rejected and disposed of 
in a manner that protects against the contamination of other food (see, 
e.g., Sec. Sec.  117.80(a)(6) and 117.80(c)(9)).
    (Comment 324) Some comments assert that this requirement is overly 
broad and should only apply to RTE food. These comments express the 
view that we should not focus on the issue of microbiological 
contamination in foods that are early in the supply chain (other than 
produce that will be consumed without adequate processing or cooking). 
Some comments suggest adding a statement to be provided in commercial 
documentation accompanying the sale of produce not covered by the 
proposed produce safety rule to alert potential purchasers to the 
hazard that may exist and allow them to determine whether the food 
offered for sale is suitable for their particular needs or whether the 
food requires commercial formulation, processing, or both to adequately 
reduce microorganisms.
    (Response 324) It is not necessary to narrow this requirement to 
RTE food to

[[Page 56012]]

provide for use of raw materials and other ingredients that are early 
in the supply chain. The requirement already clearly provides for 
pasteurization or other treatment during manufacturing operations so 
that the processed product would no longer contain levels that would 
cause the product to be adulterated. See also our previous discussion 
of the importance of this provision during a previous rulemaking to 
revise the umbrella CGMPs (51 FR 22458 at 22470).
    We decline the request to require a statement in commercial 
documentation when produce is not covered by the produce safety rule. 
As discussed in section XXVII, we are providing for a narrow use of 
commercial documentation, when a manufacturer/processor that has 
identified a hazard requiring a preventive control does not establish a 
preventive control because it: (1) Relies on its customer to ensure 
that an identified hazard will be controlled and (2) discloses, in 
documents accompanying the food, in accordance with the practice of the 
trade, that the food is ``not processed to control [identified 
hazard]'' (See Sec.  117.136(a)(2), (3), and (4)). That use of 
commercial documentation reflects the outcome of a hazard analysis--in 
particular, an outcome in which the manufacturer/processor determines 
that a hazard requires a preventive control. The vast majority of the 
produce that we proposed would not be subject to the requirements of 
the forthcoming produce safety rule would either be produce that is 
going to commercial processing that adequately reduces the presence of 
microorganisms of public health significance or produce that is rarely 
consumed raw. Thus, there would be no benefit to alert potential 
purchasers to a hazard because such produce has been determined to be 
low-risk, based on the findings of a qualitative assessment of risk 
(e.g., for produce rarely consumed raw) or because it will not go 
directly to the consumer but to commercial processing to adequately 
reduce pathogens. We see no reason to also establish a broad CGMP 
requirement that would apply regardless of the outcome of a hazard 
analysis.

C. Proposed Sec.  117.80(b)(3)--Natural Toxins in Raw Materials and 
Other Ingredients

    We proposed that raw materials and ingredients susceptible to 
contamination with aflatoxin or other natural toxins comply with 
current FDA regulations for poisonous or deleterious substances before 
these materials or ingredients are incorporated into finished food. We 
also proposed to delete guidance regarding how to comply with this 
requirement and to delete a requirement for compliance with action 
levels, which are not binding.
    (Comment 325) Some comments ask us to delete ``aflatoxin'' from the 
provision because it is redundant with ``other natural toxin.''
    (Response 325) We decline this request. Aflatoxin is an important 
natural toxin that is an example illustrating what we mean when we 
refer to ``natural toxins.'' An illustrative example does not create a 
redundancy.

D. Proposed Sec.  117.80(b)(4)--Pests, Undesirable Microorganisms and 
Extraneous Materials in Raw Materials and Other Ingredients

    We proposed that raw materials, ingredients, and rework susceptible 
to contamination with pests, undesirable microorganisms, or extraneous 
material must comply with applicable FDA regulations for natural or 
unavoidable defects if a manufacturer wishes to use the materials in 
manufacturing food. We also proposed to delete guidance regarding how 
to comply with this requirement and to delete the requirement for 
compliance with action levels, which are not binding.
    (Comment 326) Some comments ask us to qualify that the requirement 
does not apply if the manufacturing process includes steps that serve 
to decontaminate the food.
    (Response 326) We decline this request. We have defined ``defect 
action level'' to mean a level of a non-hazardous, naturally occurring, 
unavoidable defect at which FDA may regard a food product 
``adulterated'' and subject to enforcement action under section 
402(a)(3) of the FD&C Act (see Sec.  117.3). It is not uncommon for an 
establishment to receive raw materials (such as RACs) that contain 
extraneous material that is removed before production. For example, 
some methods of harvesting vegetable RACs (e.g., pulling up most of the 
plant material in the field) result in inclusion of extraneous material 
that is removed during initial cleaning steps at processing facilities. 
It is not necessary to revise this long-standing requirement to provide 
for such common procedures. Moreover, in general we use the term 
``decontaminate'' to refer to an action taken when the substance is a 
hazardous substance (such as a pathogen) rather than to a non-hazardous 
substance.

E. Proposed Sec.  117.80(b)(5)--Holding Raw Materials, Other 
Ingredients, and Rework in Bulk

    We proposed that raw materials, ingredients, and rework must be 
held in bulk, or in containers designed and constructed so as to 
protect against cross-contact and contamination and must be held at 
such temperature and relative humidity and in such a manner as to 
prevent the food from becoming adulterated. Material scheduled for 
rework must be identified as such.
    (Comment 327) Some comments express concern that this requirement 
would make the use of wooden bins in the produce industry problematic 
and ask us to clarify whether it is our intent to prohibit use of 
wooden bins. Some comments ask us to clarify whether the provision 
would preclude using or storing containers (such as trailers and 
gondolas used in the produce industry) outdoors because such containers 
cannot be covered.
    (Response 327) We do not intend to interpret this provision in such 
a way that would prohibit the use of wooden bins in the produce 
industry or preclude using and storing containers such as trailers and 
gondolas outside. Importantly, these CGMP requirements are long-
standing provisions that we have not interpreted as prohibiting wooden 
containers in the produce industry. See also our ``Guide to Produce 
Farm Investigations'' (Ref. 63), which applies during investigations 
when an outbreak and traceback investigation implicates a farm and 
related operations, or as a follow-up to a produce sample that tests 
positive for contamination with a pathogen.
    (Comment 328) Some comments ask us to add ``in-process'' materials 
to the provision.
    (Response 328) We decline this request, which is already covered by 
Sec.  117.80(c)(7). We note that the requirements directed to raw 
materials and other ingredients are established in Sec.  117.80(b), 
whereas the requirements directed to in-process materials are 
established in Sec.  117.80(c).

F. Proposed Sec.  117.80(b)(7)--Liquid or Dry Raw Materials and Other 
Ingredients

    We proposed that liquid or dry raw materials and ingredients 
received and stored in bulk form must be held in a manner that protects 
against cross-contact and contamination.
    (Comment 329) Some comments ask us to revise the proposed provision 
to clarify that liquid or dry raw materials and ingredients received 
and stored in bulk form must be held in a manner that

[[Page 56013]]

protects against deterioration, as well as in a manner that protects 
against allergen cross-contact and contamination.
    (Response 329) We decline this request. The rule already requires 
that raw materials and ingredients be stored under conditions that will 
minimize deterioration (see Sec.  117.80(b)(1)).

G. Proposed Sec.  117.80(b)(8)--Raw Materials and Other Ingredients 
That Are Food Allergens

    We proposed to establish a new requirement that raw materials and 
ingredients that are food allergens, and rework that contains food 
allergens, be identified and held in a manner that prevents cross-
contact.
    (Comment 330) Some comments ask us to exempt finished, packaged 
product that is later reworked from the proposed requirement.
    (Response 330) We decline this request. A product that is in 
finished, packaged form, including label information that identifies 
any food allergen, would be in compliance with the requirement and need 
not be exempted. However, when a product is packaged, but not yet 
labeled, it is necessary to identify the product in a way (other than a 
product label) that would prevent allergen cross-contact while the 
packaged product is being held. For example, shelves holding the 
product before labeling operations could have a sign such as ``Contains 
peanuts.''
    (Comment 331) Some comments ask us to modify the proposed 
requirement to specify that it applies to raw materials and ingredients 
that ``are or contain'' food allergens and that it applies to in-
process material, as well as to raw materials and ingredients and to 
rework. These comments explain that such modifications would provide 
clarity and completeness.
    (Response 331) We decline these requests. The rule defines ``food 
allergen'' to mean a major food allergen as defined in section 201(qq) 
of the FD&C Act, and section 201(qq) of the FD&C Act already specifies 
that a major food allergen is a food that is one of several specified 
foods and food groups, or contains protein derived from one of these 
foods or food groups (78 FR 3646 at 3697). Thus, the request that the 
provisions be directed to raw materials and other ingredients that 
``are or contain'' food allergens is already addressed in the 
definition of food allergen. Requirements applicable to in-process 
material are addressed in Sec.  117.80(c)(5).

XX. Subpart B: Comments on Proposed Sec.  117.80(c)--Manufacturing 
Operations

    We proposed that current Sec.  110.80(b) would become proposed 
Sec.  117.80(c). We also proposed revisions to all provisions that 
would be established in Sec.  117.80(c) except for the provisions that 
would be established in Sec.  117.80(c)(1) and (c)(16).
    Some comments support one or more of these proposed provisions 
without change. For example, some comments support provisions directed 
to control of, or preventing contamination with, undesirable 
microorganisms during manufacturing, storage, and handling. Other 
comments that support the proposed provisions suggest alternative 
regulatory text (see, e.g., Comment 334) or ask us to clarify how we 
will interpret the provision (see, e.g., Comment 345 and Comment 346). 
Other comments that support the proposed provisions ask us to revise or 
clarify provisions that we proposed to re-establish in part 117 without 
change (see, e.g., Comment 333).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we did not propose to revise. After considering these 
comments, we have revised the proposed provisions as shown in table 25, 
with editorial and conforming changes as shown in table 52.

                  Table 25--Provisions for Processes and Controls for Manufacturing Operations
----------------------------------------------------------------------------------------------------------------
                                            Did we propose
                                         revisions or request     Did we get comments       Did we modify the
              Provision                  comment on potential   that disagreed with the    proposed regulatory
                                              revisions?          proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.80(c)(1)--Condition of      No.....................  Yes....................  Yes.
 equipment, utensils, and finished
 food containers.
Sec.   117.80(c)(2)--Conditions and    Yes....................  Yes....................  Yes.
 controls for food manufacturing,
 processing, packing, and holding.
Sec.   117.80(c)(3)--Food that can     Yes....................  Yes....................  No.
 support the rapid growth of
 undesirable microorganisms.
Sec.   117.80(c)(4)--Measures to       Yes....................  Yes....................  No.
 destroy or prevent the growth of
 undesirable microorganisms.
Sec.   117.80(c)(5)--Work-in-Process   Yes....................  Yes....................  No.
 and Rework.
Sec.   117.80(c)(6)--Finished food...  Yes....................  Yes....................  No.
Sec.   117.80(c)(7)--Equipment,        Yes....................  Yes....................  No.
 containers, and utensils.
Sec.   117.80(c)(8)--Metal and other   Yes....................  Yes....................  Yes.
 extraneous material.
Sec.   117.80(c)(9)--Disposal of       Yes....................  Yes....................  Yes.
 adulterated food, raw materials, and
 other ingredients.
Sec.   117.80(c)(10)--Manufacturing    Yes....................  No.....................  Yes.
 operations.
Sec.   117.80(c)(11)--Heat blanching,  Yes....................  Yes....................  Yes.
 and growth and contamination by
 thermophilic microorganisms, during
 manufacturing operations.
Sec.   117.80(c)(12)--Batters,         Yes....................  Yes....................  Yes.
 breading, sauces, gravies,
 dressings, and other similar
 preparations.
Sec.   117.80(c)(13)--Filling,         Yes....................  Yes....................  No.
 Assembling, Packaging and Other
 Operations.
Sec.   117.80(c)(14)--Food that        Yes....................  Yes....................  Yes.
 relies on the control of water
 activity for preventing the growth
 of undesirable microorganisms.
Sec.   117.80(c)(15)--Food that        Yes....................  Yes....................  Yes.
 relies on the control of pH for
 preventing the growth of undesirable
 microorganisms.
Sec.   117.80(c)(16)--Requirements     No.....................  Yes....................  Yes.
 for ice used in contact with food.

[[Page 56014]]

 
Sec.   117.80(c)(17)--Food-            Yes (proposed to         Yes....................  No (deleted as
 manufacturing areas and equipment.     delete).                                          proposed).
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.80(c)(1)--Condition of Equipment, Utensils, and 
Finished Food Containers

    We proposed no revisions to the requirements of current Sec.  
110.80(b)(1) (proposed Sec.  117.80(c)(1)) that equipment and utensils 
and finished food containers be maintained in an acceptable condition 
through appropriate cleaning and sanitizing, as necessary. Insofar as 
necessary, equipment must be taken apart for thorough cleaning.
    (Comment 332) Some comments assert that this provision precludes 
the use of wooden bins, because wooden bins cannot be sanitized.
    (Response 332) This requirement is a long-standing provision that 
provides flexibility for an establishment to sanitize when appropriate 
by specifying that equipment, utensils, and food containers be 
sanitized ``as necessary.'' For example, equipment food-contact 
surfaces are usually sanitized after cleaning to minimize the potential 
for contaminating food with undesirable microorganisms that accumulate 
during processing and grow in food residues on the equipment. When 
containers such as wooden bins cannot be sanitized, the establishment 
is responsible for taking appropriate steps to adequately clean and 
maintain the containers to minimize the potential for contaminating 
food with undesirable microorganisms. To clarify that the standard 
governing the condition of the equipment, utensils, and finished food 
containers is the same public health standard that applies to other 
provisions in Sec.  117.80, we have revised the provision to specify 
that containers be kept in ``adequate'' condition rather than 
``acceptable'' condition.
    (Comment 333) Some comments ask us to delete the term ``finished'' 
from ``finished food containers'' so that the requirements applicable 
to the condition of equipment, utensils, and food containers will be 
more complete.
    (Response 333) We agree that the requirements should apply to all 
food containers used during manufacturing operations, not just to 
``finished food containers.'' We note that we received comments about 
the most appropriate adjective to describe the food containers subject 
to this requirement during the rulemaking to establish this provision 
in part 110. (See the discussion at 51 FR 22458 at 22471, in which we 
responded to comments asking us to change ``finished product container 
to ``bulk product container'' by explaining that finished product 
containers includes bulk product containers.) Rather than perpetuate 
questions as to how we are interpreting ``finished,'' we have deleted 
this adjective.

B. Proposed Sec.  117.80(c)(2)--Conditions and Controls for Food 
Manufacturing, Processing, Packing, and Holding

    We proposed that all food manufacturing, processing, packing, and 
holding must be conducted under such conditions and controls as are 
necessary to minimize the potential for the growth of microorganisms or 
for the contamination of food. We also proposed to delete guidance 
regarding how to comply with this requirement.
    (Comment 334) Some comments ask us to add ``in-process materials 
and rework,'' ``cross-contact,'' and ``or deterioration'' for clarity 
and completeness.
    (Response 334) We agree that adding ``allergen cross-contact'' is 
necessary for completeness and have revised the proposed provision to 
include it. We also agree that the provision needs to address 
deterioration; doing so is consistent with the requirements applicable 
to raw materials and other ingredients (see Sec.  117.80(b)(1)). We 
decline the request to add ``in-process materials and rework'' to this 
provision because in-process materials and rework are already covered 
by the phrase ``all food.''

C. Proposed Sec.  117.80(c)(3)--Food That Can Support the Rapid Growth 
of Undesirable Microorganisms

    We proposed that all food that can support the rapid growth of 
undesirable microorganisms must be held at temperatures that will 
prevent the food from becoming adulterated during manufacturing, 
processing, packing, and holding. We also proposed to delete 
recommendations for how to comply with this requirement.
    (Comment 335) Some comments ask us to keep requirements for 
specific temperatures for holding hot food and cold food because there 
is a direct correlation between temperature abuse and growth of 
pathogenic bacteria.
    (Response 335) We agree that temperature abuse can lead to growth 
of pathogenic bacteria. Importantly, the temperatures that have been in 
current Sec.  110.80(b)(3) were recommendations rather than 
requirements. As discussed in Response 67, we have deleted non-binding 
provisions from the rule and intend to issue guidance that will include 
much of the guidance that we have deleted from the umbrella CGMPs. As 
noted in the 2013 proposed human preventive controls rule (see table 8, 
78 FR 3646 at 3715), the temperatures needed for safe holding may vary 
and the diversity of food to which the provision applies makes it 
inappropriate to specify these temperatures in regulation. There is 
information available currently on appropriate temperatures for a 
variety of foods (e.g., in the Food Code (Ref. 51) and the PMO (Ref. 
64)). Moreover, a continued approach to specific temperatures for 
holding hot food and cold food through non-binding guidance is 
particularly appropriate because we can reasonably expect ongoing 
scientific advances that would alter our thinking on appropriate 
temperatures to hold hot food and cold food.
    (Comment 336) Some comments ask us to require that food that can 
support the rapid growth of undesirable microorganisms be held at 
temperatures or ``in another manner'' that will prevent the food from 
becoming adulterated. These comments assert that current or future 
technology may provide other means of preventing microbial growth 
besides temperature controls--e.g., through use of pressure or in 
another as[hyphen]yet[hyphen]unforeseen manner.
    (Response 336) We agree that current or future technology may 
provide other means of preventing microbial growth besides temperature 
controls. However, we disagree that it is necessary to modify the 
requirement to provide for preventing microbial growth by means other 
than temperature control, because the provision does not identify 
specific temperatures that must be used to prevent the food from 
becoming adulterated. If, for example, a food that currently requires 
refrigeration to

[[Page 56015]]

prevent adulteration becomes shelf-stable as a result of new 
technology, the provision as written would allow the food to be held at 
room temperature rather than under refrigeration.

D. Proposed Sec.  117.80(c)(4))--Measures To Destroy or Prevent the 
Growth of Undesirable Microorganisms

    We proposed that measures such as sterilizing, irradiating, 
pasteurizing, cooking, freezing, refrigerating, controlling pH, or 
controlling water activity that are taken to destroy or prevent the 
growth of undesirable microorganisms must be adequate under the 
conditions of manufacture, handling, and distribution to prevent food 
from being adulterated.
    (Comment 337) Some comments express concern that the measures 
listed could be interpreted as an exhaustive list of processing methods 
and, thus, hinder the development of new technologies. These comments 
suggest adding ``or other measures'' at the end of the list.
    (Response 337) The phrase ``such as'' indicates that these are 
examples of processing methods and that the list is not all inclusive. 
We believe that the list of examples and wording of the provision 
adequately express the intent behind this provision and allow the use 
of other measures without the suggested addition.

E. Proposed Sec.  117.80(c)(5)--Work-in-Process and Rework

    We proposed that work-in-process and rework must be handled in a 
manner that protects against cross-contact, contamination, and growth 
of undesirable microorganisms.
    (Comment 338) Comments that address this proposed requirement ask 
us to use the term ``in-process materials'' rather than ``work-in-
process.''
    (Response 338) As discussed in Response 71, we decline this 
request.

F. Proposed Sec.  117.80(c)(6)--Finished Food

    We proposed that effective measures must be taken to protect 
finished food from cross-contact and contamination by raw materials, 
ingredients, or refuse. When raw materials, ingredients, or refuse are 
unprotected, they must not be handled simultaneously in a receiving, 
loading, or shipping area if that handling could result in cross-
contact or contaminated food. Food transported by conveyor must be 
protected against cross-contact and contamination as necessary.
    (Comment 339) Some comments ask us to specify that raw materials, 
ingredients, or refuse that are unprotected not be handled 
simultaneously in ``the same area'' rather than in ``a receiving, 
loading, or shipping area.'' The comments assert that this would be 
clearer.
    (Response 339) We decline this request. We narrowly directed the 
provision to address the potential for allergen cross-contact and for 
contamination by unprotected raw materials, ingredients, and refuse 
when finished food is in a receiving, loading, or shipping area. 
Broadening the provision to prohibit handling raw materials, 
ingredients, or refuse in the same area as finished food would imply 
that raw materials, ingredients, or refuse will never be handled in the 
production area where they may be needed or generated during 
production.
    (Comment 340) Some comments ask us to revise the provision to add 
``in-process'' food and ``cleaning and sanitizing agents, and other 
chemicals'' for clarity and completeness.
    (Response 340) We decline this request. Work-in-process foods are 
covered separately in Sec.  117.80(c)(5), and cleaning and sanitizing 
agents are addressed in the requirements for sanitary operations (see 
Sec.  117.35(b)(2)).

G. Proposed Sec.  117.80(c)(7)--Equipment, Containers, and Utensils

    We proposed that equipment, containers, and utensils used to 
convey, hold, or store raw materials, work-in-process, rework, or food 
must be constructed, handled, and maintained during manufacturing, 
processing, packing, and holding in a manner that protects against 
cross-contact and contamination.
    (Comment 341) Some comments ask us to specify that the equipment, 
containers, and utensils also must be cleaned and sanitized during 
manufacturing, processing, packing, and holding in a manner that 
protects against cross[hyphen]contact and against contamination.
    (Response 341) We decline this request. Cleaning and sanitizing are 
addressed in the requirements for sanitary operations (see Sec.  
117.35(a)) and do not need to be addressed again in the requirements 
for manufacturing operations.
    (Comment 342) Some comments ask us to add the phrase ``where 
appropriate for food safety'' at the beginning of the provision because 
food gases are manufactured, held, and distributed in a closed 
pressurized system and are therefore not exposed to personnel or 
environmental conditions where there is an impact on food safety.
    (Response 342) We decline this request. The closed pressurized 
system described by the comment appears to satisfy the requirements of 
the provision, as would other systems commonly used in the food 
industry. The purpose of the provision is to set the standard; it is 
not necessary to add that no specific actions are necessary for those 
systems that inherently comply with the requirement.

H. Proposed Sec.  117.80(c)(8)--Metal or Other Extraneous Material

    We proposed that effective measures must be taken to protect 
against the inclusion of metal or other extraneous material in food and 
to delete guidance regarding how to comply with this requirement.
    (Comment 343) Some comments assert that it could be more effective 
from the perspective of food safety to use a risk-based approach to 
implementing protective measures against the inclusion of metal or 
other extraneous material in food. These comments assert that the risk 
of inclusion of metal is higher in cut fruits or vegetables than in 
fresh whole fruits or vegetables and, thus, the measures used to 
protect against the inclusion of metal should be different in cut 
fruits or vegetables than in fresh whole fruits or vegetables.
    (Response 343) We agree that the measures used to protect against 
the inclusion of metal likely will be different for cut fruits or 
vegetables than for fresh whole fruits or vegetables and that a risk-
based approach can be helpful in determining how to comply with the 
requirement. To emphasize the utility of a risk-based approach, we have 
revised the provision to require ``adequate'' measures rather than 
``effective'' measures; as defined in the rule (see Sec.  117.3), the 
term ``adequate'' means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.

I. Proposed Sec.  117.80(c)(9)--Disposal of Adulterated Food, Raw 
Materials, and Other Ingredients

    We proposed that food, raw materials, and ingredients that are 
adulterated must be disposed of in a manner that protects against the 
contamination of other food or, if the adulterated food is capable of 
being reconditioned, it must be reconditioned using a method that has 
been proven to be effective. We also proposed an editorial change to 
make clear that reconditioning, rather than disposal, is an option and 
to delete a provision that could be viewed as providing an option to 
simply

[[Page 56016]]

reexamine adulterated food and subsequently find it not to be 
adulterated.
    (Comment 344) Some comments ask us to retain the provision to 
reexamine adulterated food and subsequently find it not to be 
adulterated. These comments explain that there are processes that can 
remove contaminants such as pesticides and heavy metals from foods such 
as botanical extracts. Although laboratory studies or 
small[hyphen]scale pilot batches may give an indication that the 
reconditioning is likely to be effective, they cannot always guarantee 
the treatment will be equally effective when scaled up to 
commercial[hyphen]scale production batches. Because these methods have 
not been ``proven to be effective,'' the appropriate approach to 
determining whether the reconditioned food is no longer adulterated is 
reexamination after the reconditioning is complete.
    (Response 344) We agree with these comments and have revised the 
provision to make clearer that reexamination can only be used to 
subsequently find that the food is not adulterated after the food has 
been reconditioned. See the regulatory text of Sec.  117.80(c)(9).
    (Comment 345) Some comments ask us to clarify that the provision 
only applies if the food has actually been found to be adulterated. The 
comments assert that the provision should not apply where product has 
been placed ``on hold'' due to an equipment failure (e.g., if product 
is put on hold due to an inoperative metal detector until the 
establishment can retest for potential metal contaminants).
    (Response 345) The provision only applies if the food is 
adulterated. In the example described in these comments, if the food is 
not adulterated, the establishment would not need to dispose of, or 
recondition, the product.
    (Comment 346) Some comments ask us to clarify that the provision 
does not apply to grains subject to the review inspection provisions 
provided for by 7 CFR 800.125 and 800.135.
    (Response 346) In many cases, grains subject to the review 
inspection provisions provided for by 7 CFR 800.125 and 800.135 are 
RACs that are being held or transported by an establishment solely 
engaged in holding or transporting RACs and subpart B (including Sec.  
117.80(c)(8)) would not apply to the grains (see Sec.  117.5(k)). In 
addition, as noted in Response 345, this provision only applies to food 
that is adulterated.

J. Proposed Sec.  117.80(c)(10)--Performing Manufacturing Steps

    We proposed that steps such as washing, peeling, trimming, cutting, 
sorting and inspecting, mashing, dewatering, cooling, shredding, 
extruding, drying, whipping, defatting, and forming must be performed 
so as to protect food against cross-contact and contamination. We 
proposed that food should be protected from contaminants that may drip, 
drain, or be drawn into food and requested comment on whether to 
establish the recommendation regarding physical protection of food from 
contaminants that may drip, drain, or be drawn into the food as a 
requirement (78 FR 3646 at 3726). We also proposed to delete two 
recommendations regarding adequate cleaning and sanitizing of food-
contact surfaces and regarding the use of time and temperature 
controls.
    (Comment 347) Some comments agree that we should require, rather 
than recommend, that food be protected from contaminants that may drip, 
drain, or be drawn into food. Other comments express concern that 
turning the current recommendation into a requirement could lead to a 
de facto requirement for closed systems to be used in food production. 
Some comments ask us to specify that the requirements only apply where 
food is exposed.
    (Response 347) We agree that we should require, rather than 
recommend, that food be protected from contaminants that may drip, 
drain, or be drawn into food. We have not revised the regulatory text 
to specify that the requirements only apply where food is exposed, 
because such protections would only be needed if foods are exposed to 
such conditions. Such a requirement would not lead to a de facto 
requirement for a closed system, because this is not the only way to 
protect food from such contaminants. For example, covers can be used on 
kettles and tanks, and shields can be placed over conveyor lines.

K. Proposed Sec.  117.80(c)(11)--Heat Blanching and Growth and 
Contamination by Thermophilic Microorganisms During Manufacturing 
Operations

    We proposed that heat blanching, when required in the preparation 
of food, should be effected by heating the food to the required 
temperature, holding it at this temperature for the required time, and 
then either rapidly cooling the food or passing it to subsequent 
manufacturing without delay. We proposed that thermophilic growth and 
contamination in blanchers should be minimized by the use of adequate 
operating temperature and by periodic cleaning and requested comment on 
whether to establish these two recommendations as requirements (78 FR 
3646 at 3726).
    (Comment 348) Some comments support establishing the 
recommendations in this provision as requirements. Other comments 
oppose doing so and assert that these detailed steps may not be 
important to protect the public health.
    (Response 348) We disagree that the use of adequate operating 
temperature and periodic cleaning are not important to protect public 
health. Improper cooling can lead to growth of pathogenic sporeforming 
bacteria if product remains too long at temperatures that support their 
multiplication. In addition, growth of thermophiles, while not a public 
health issue, can lead to product spoilage, and, thus, adulteration. We 
are establishing these two recommendations as requirements in the 
regulatory text, along with associated editorial changes.

L. Proposed Sec.  117.80(c)(12)--Batters, Breading, Sauces, Gravies, 
Dressings, and Other Similar Preparations

    We proposed that batters, breading, sauces, gravies, dressings, and 
other similar preparations must be treated or maintained in such a 
manner that they are protected against cross-contact and contamination. 
We also proposed to clarify that these steps require protection against 
cross-contact and to delete the recommendations for how to comply with 
this requirement.
    (Comment 349) Some comments agree that we should delete the 
provided examples of mechanisms to achieve compliance.
    (Response 349) We have deleted the examples as proposed.
    (Comment 350) Some comments ask us to modify the provision to 
clarify that it applies to preparations that are held and used 
repeatedly over time and to add ``dipping solutions'' as another 
example of such a preparation.
    (Response 350) We agree that the provision applies to preparations 
that are held and used repeatedly over time and that ``dipping 
solutions'' is a useful example to add. We have revised the regulatory 
text as requested by these comments.
    (Comment 351) Some comments ask us to add that another purpose of 
the requirement is to minimize the potential for the growth of 
undesirable microorganisms.
    (Response 351) This request would promote consistency in the 
requirements throughout Sec.  117.80 and

[[Page 56017]]

we have revised the regulatory text accordingly.

M. Proposed Sec.  117.80(c)(13)--Filling, Assembling, Packaging and 
Other Operations

    We proposed that filling, assembling, packaging, and other 
operations must be performed in such a way that the food is protected 
against cross-contact, contamination, and growth of undesirable 
microorganisms. We also proposed to delete the recommendations for 
achieving compliance with this requirement.
    (Comment 352) Some comments ask us to specify that the requirement 
applies only to finished food to differentiate it from other provisions 
in Sec.  117.80 and assert that without the modification the provision 
would be redundant.
    (Response 352) The specific requirements of Sec.  117.80(c)(13) are 
not redundant with other provisions in Sec.  117.80. The long-standing 
provisions of Sec.  117.80 first address general requirements (Sec.  
117.80(a)) and then address more specific requirements applicable to 
raw materials and other ingredients (Sec.  117.80(b)) and manufacturing 
operations (Sec.  117.80(c)). Although the comment does not define 
``finished food,'' we consider that term to apply to a packaged and 
labeled food product; filling, assembling, and packaging operations 
would be conducted on in-process food to create a finished product. 
Regardless of whether the appropriate term would be ``finished'' or 
``in-process food,'' the comment provides no reason for why this long-
standing provision is not clear without specifying the production stage 
of a food product that is subject to filling, assembling, and packaging 
operations.

N. Proposed Sec.  117.80(c)(14)--Food That Relies on the Control of 
Water Activity for Preventing the Growth of Undesirable Microorganisms

    We proposed that food, including dry mixes, nuts, intermediate 
moisture food, and dehydrated food, that relies on the control of water 
activity for preventing the growth of undesirable microorganisms must 
be processed to, and maintained at, a safe moisture level. We also 
proposed to delete the recommendations for achieving compliance with 
this requirement.
    (Comment 353) Some comments assert that moisture level is not an 
adequate food safety control measure. The comments ask us to revise the 
requirement to reflect that it is the proper maintenance of water 
activity, rather than moisture level, that will prevent growth of 
undesirable microorganisms.
    (Response 353) The rule defines safe moisture level as a level of 
moisture low enough to prevent the growth of undesirable microorganisms 
in the finished product and notes that the safe moisture level is 
related to water activity (Sec.  117.3). Although in most cases water 
activity is the most suitable measurement to predict food safety, 
moisture content is frequently used to assess the stability of grains 
and nuts with respect to prevention of growth and mycotoxin production 
by molds. We are retaining the term ``safe moisture level'' as a 
broader term that takes into account the fact that measuring moisture 
level and measuring water activity are both common industry practice 
and, depending on the food, can be measures that are appropriate to 
assess safety. The comments provide no basis for the assertion that 
this long-standing provision is not an adequate food safety measure.
    (Comment 354) Some comments assert that water activity may not be 
the only factor responsible for preventing the growth of undesirable 
microorganisms in dry products and ask us to modify the regulatory text 
to take into account other synergistic barriers for microbial growth 
and toxin formation.
    (Response 354) We agree with these comments and have revised the 
regulatory text to clarify that such products rely ``principally'' on 
the control of water activity.
    (Comment 355) Some comments assert that nuts should be 
``maintained'' at an appropriate moisture level rather than ``processed 
to'' an appropriate moisture level.
    (Response 355) We acknowledge that some products need only be 
``maintained'' at a safe moisture level and may not need to be 
processed to achieve that level. However, we disagree that it is 
necessary to modify this long-standing requirement to specify this 
distinction. The comments do not provide examples of how we have been 
interpreting this provision in a way that does not accommodate the 
differences in products.
    (Comment 356) Some comments ask us to more closely adhere to the 
current regulatory text (i.e., food, such as dry mixes . . .) rather 
than the proposed regulatory text (i.e., food, including dry mixes . . 
.).
    (Response 356) The final rule retains the long-standing language 
``such as'' as requested by the comments. (See also the discussion in 
Response 68.)

O. Proposed Sec.  117.80(c)(15)--Food That Relies on the Control of pH 
for Preventing the Growth of Undesirable Microorganisms

    We proposed that food, including acid and acidified food, that 
relies principally on the control of pH for preventing the growth of 
undesirable microorganisms must be monitored and maintained at a pH of 
4.6 or below. We also proposed to delete the recommendations for how to 
comply with this requirement.
    (Comment 357) Some comments ask us to use the term ``equilibrated 
pH'' or ``finished equilibrium pH'' for consistency with part 114. Some 
comments ask us to add a definition for ``equilibrated pH'' in Sec.  
117.3.
    (Response 357) We decline these requests. It is not necessary for 
this long-standing provision in the umbrella food CGMPs to use 
specialty terms used in the more specific CGMPs that apply to acidified 
foods in order to make clear that the operative pH for the safety of 
such foods is 4.6 or below.
    (Comment 358) Some comments ask us to more closely adhere to the 
current language (i.e., food such as acid and acidified food . . .) 
rather than the proposed language (i.e., food, including acid food and 
acidified food . . .) to make it clear that the list is not intended to 
be complete.
    (Response 358) The final rule retains the long-standing language 
``such as'' as requested by the comments. (See also the discussion in 
Response 68.)

P. Proposed Sec.  117.80(c)(16)--Requirements for Ice Used in Contact 
With Food

    We proposed no revisions to the requirements of current Sec.  
110.80(b)(16) (proposed Sec.  117.80(c)(16)) that when ice is used in 
contact with food, it must be made from water that is safe and of 
adequate sanitary quality, and must be used only if it has been 
manufactured in accordance with current good manufacturing practice.
    (Comment 359) Some comments ask us to replace the requirement that 
water must be safe and of adequate sanitary quality with a cross-
reference to the water quality requirements of Sec.  117.37(a).
    (Response 359) We acknowledge that cross-referencing the water 
quality requirements established in Sec.  117.37(a), without describing 
those requirements, would accurately convey the requirements for ice 
used in contact with food. However, we believe there is value added by 
continuing to emphasize the water quality standard within the 
requirements for ice used in contact

[[Page 56018]]

with food. We have added a cross-reference to Sec.  117.37(a) but have 
not deleted ``safe and of adequate sanitary quality.''

Q. Proposed Deletion of Current Sec.  110.80(b)(17)--Food-Manufacturing 
Areas and Equipment

    We proposed to delete the current recommendation that food-
manufacturing areas and equipment used for manufacturing human food not 
be used to manufacture nonhuman food-grade animal feed or inedible 
products, unless there is no reasonable possibility for the 
contamination of the human food. We tentatively concluded that this 
recommendation would be more appropriate in guidance, which could 
include examples of situations where there is no reasonable possibility 
for the contamination of the human food.
    (Comment 360) Some comments ask us to retain this provision for 
clarity and as a means to educate small, foreign, and new food 
processors.
    (Response 360) We decline this request. The focus of the provision 
is to emphasize the importance of manufacturing food in a way that 
prevents contamination. Other provisions (such as Sec. Sec.  117.10(b), 
117.20(a), 117.35(a), 117.40(a)(1), 117.80(a), and 117.93) already 
require that an establishment prevent contamination from any source. 
(See also the discussion in Response 67 about our decision to delete 
those non-binding provisions of part 110 that we are not establishing 
as requirements.)

XXI. Subpart B: Comments on Proposed Sec.  117.93--Warehousing and 
Distribution

    Current Sec.  110.93 requires that storage and transportation of 
finished food be under conditions that will protect food against 
physical, chemical, and microbial contamination, as well as against 
deterioration of the food and the container. We proposed a series of 
revisions to these current requirements--i.e., to apply the 
requirements to ``food'' rather than to ``finished food''; clarify that 
storage and transportation of food must be under conditions that will 
protect against allergen cross-contact in addition to protecting 
against contamination of food; add radiological hazards as an 
additional category of contaminants; and require protection against 
``biological,'' rather than ``microbial'' contamination. With all of 
these revisions, we proposed that storage and transportation of food 
must be under conditions that will protect against cross-contact and 
biological, chemical, physical, and radiological contamination of food, 
as well as against deterioration of the food and the container.
    Some comments support one or more of these proposed revisions 
without change. For example, some comments support adding radiological 
hazards as an additional category of contaminants to the list of 
contaminants which may be encountered in warehousing and distribution 
because food may be subject to contamination with radiological hazards. 
Other comments that support the proposed provisions suggest alternative 
regulatory text (see, e.g., Comment 361) or ask us to clarify how we 
will interpret the provision (see, e.g., Comment 363).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provision or that disagree with, or suggest one or 
more changes to, the proposed provision. After considering these 
comments, we are finalizing the provision as proposed (see table 26), 
with editorial and conforming changes as shown in table 52.

                              Table 26--Provisions for Warehousing and Distribution
----------------------------------------------------------------------------------------------------------------
                                            Did we propose
                                         revisions or request     Did we get comments       Did we modify the
              Provision                  comment on potential   that disagreed with the    proposed regulatory
                                              revisions?          proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
117.93--Warehousing and distribution.  Yes....................  Yes....................  No.
----------------------------------------------------------------------------------------------------------------

    (Comment 361) Some comments express concern that produce will spoil 
and deteriorate even under the best conditions. These comments ask us 
to modify the proposed requirements to address these concerns, such as 
by specifying that the conditions will ``reasonably protect'' or by 
revising ``will protect'' to ``will minimize to acceptable levels.''
    (Response 361) We decline this request. In some cases, this 
provision will not apply to produce (i.e., when the produce is a RAC 
subject to the exemption for an establishment solely engaged in the 
holding or transportation of one or more RACs; see Sec.  117.5(k)). 
When the produce is not subject to the RAC exemption (e.g., when the 
produce is being handled in a fresh-cut processing facility), requiring 
storage and transportation of produce under the conditions specified in 
the provision is appropriate. The comments provide no basis that we 
have been enforcing this long-standing provision in a manner that does 
not acknowledge practical issues associated with the short shelf life 
of produce in such facilities and, thus, that modifications such as 
those suggested by the comments are necessary.
    (Comment 362) Some comments assert that regulations directed to 
radiological hazards will act as a double regulation to hinder amicable 
trade activities and will increase economic burden to manufacturers. As 
discussed in Comment 410, these same comments ask us to provide that a 
facility subject to the requirements for hazard analysis and risk-based 
preventive controls may rely on existing systems in place to manage 
radiological risks, such as steps taken by government officials to 
inspect ingredients obtained from a geographic region that has been the 
subject of a nuclear accident.
    (Response 362) See Response 410 for a discussion of how a facility 
may consider existing systems in place to manage radiological risks, 
but still has responsibilities to establish and implement preventive 
controls to address a radiological hazard when circumstances warrant. 
The comment provides no basis for its assertion that regulations 
directed to radiological hazards will act as a double regulation to 
hinder amicable trade activities and will increase economic burden to 
manufacturers.
    (Comment 363) Some comments support our proposal to specify that 
the requirements apply to ``food'' rather than to ``finished food,'' 
provided that doing so does not affect common and safe practices for 
the transportation of RACs, such as transporting raw produce from the 
field, or from packinghouses, in open top containers such as field 
boxes, totes and gondola trucks.
    (Response 363) As discussed in the 2013 proposed human preventive 
controls rule, we proposed to apply the CGMP requirements for storage 
and transportation to ``food'' rather than ``finished food'' to ensure 
food safety throughout the food chain, regardless of whether a food 
product is a raw material or ingredient or in its finished state (78

[[Page 56019]]

FR 3646 at 3727). We intend this revision to clarify that the CGMP 
provisions for warehousing and distribution apply to raw materials and 
ingredients, including RACs. When a food establishment that stores and 
transports RACs is subject to the CGMP provisions, common and safe 
storage and transportation practices such as those described in our 
1998 guidance entitled ``Guide to Minimize Microbial Food Safety 
Hazards for Fresh Fruits and Vegetables (Ref. 13) would be appropriate.
    (Comment 364) As noted in Response 324, under the proposed produce 
safety rule a farm that produces covered produce that is distributed 
for commercial processing would be required to maintain documentation 
of the identity of the recipient of the commercial processor. Some 
comments appear to assume that a farm might distribute such products 
with information disclosing that such produce was not grown in 
compliance with part 112, should not be consumed raw, and/or requires 
commercial processing. These comments ask us to add a provision that no 
food whose labels, labeling, or commercial documentation accompanying 
the sale contain any of the following notices may be sold or otherwise 
distributed to any user except a commercial processor: Not grown in 
compliance with part 112; Not for fresh or raw consumption; May require 
commercial formulation, processing, or both to adequately reduce 
microorganisms.
    (Response 364) We decline to add such a provision to the CGMP 
requirements for distribution of food. As noted in Response 324, we do 
not see a benefit to labeling produce as indicated because we believe 
that the vast majority of such produce is low risk. However, as also 
noted in Response 324, we are providing for a narrow use of commercial 
documentation, which would include produce, when a manufacturer/
processor that has identified a hazard requiring a preventive control 
does not establish a preventive control because it: (1) Relies on its 
customer to ensure that an identified hazard will be controlled and (2) 
discloses, in documents accompanying the food, in accordance with the 
practice of the trade, that the food is ``not processed to control 
[identified hazard]'' (See Sec.  117.136(a)(2), (3), and (4)).

XXII. Subpart B: Comments on Proposed Sec.  117.110 (Natural or 
Unavoidable Defects in Food for Human Use That Present No Health 
Hazards)

    We proposed to revise the current provisions directed to natural or 
unavoidable defects in food for human use that present no health 
hazard. Some comments support one or more of these proposed provisions 
without change. Other comments that support the proposed provisions 
suggest alternative or additional regulatory text (see, e.g., Comment 
365, Comment 367, and Comment 368).
    In the following sections, we discuss comments that ask us to 
clarify the proposed provisions or that disagree with, or suggest one 
or more changes to, the proposed provisions, including comments on 
provisions that we did not propose to revise. After considering these 
comments, we have revised the proposed provisions as shown in table 27, 
with editorial and conforming changes as shown in table 52.

                                  Table 27--Provisions for Defect Action Levels
----------------------------------------------------------------------------------------------------------------
                                            Did we propose
                                         revisions or request     Did we get comments       Did we modify the
              Provision                  comment on potential   that disagreed with the    proposed regulatory
                                              revisions?          proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
117.110(a) and (b)--Description of     No.....................  Yes....................  Yes.
 defect action levels.
117.110(c)--Quality control            Yes....................  Yes....................  No.
 operations that reduce natural or
 unavoidable defects to the lowest
 level currently feasible.
117.110(d)--Mixing adulterated food    Yes....................  Yes....................  Yes.
 with food that is not adulterated.
117.110(e)--How to obtain the booklet  Yes (proposed to         Yes....................  Yes (provided Internet
 ``Defect Action Levels''.              delete).                                          address).
----------------------------------------------------------------------------------------------------------------

    We proposed that some foods, even when produced under current good 
manufacturing practice, contain natural or unavoidable defects that at 
low levels are not hazardous to health. The proposed provisions specify 
that FDA establishes maximum levels for these defects in foods produced 
under current good manufacturing practice and uses these levels in 
deciding whether to recommend regulatory action. The proposed 
provisions also specify that defect action levels are established for 
foods when it is necessary and feasible to do so, and that these levels 
are subject to change upon the development of new technology or the 
availability of new information (proposed Sec.  117.110(a) and (b)).
    We also proposed that compliance with defect action levels does not 
excuse violation of the requirement in section 402(a)(4) of the FD&C 
Act that food not be prepared, packed, or held under unsanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health, or the 
requirements in part 117 that food manufacturers, processers, packers, 
and holders must observe current good manufacturing practice. Evidence 
indicating that such a violation exists causes the food to be 
adulterated, even though the amounts of natural or unavoidable defects 
are lower than the currently established defect action levels. The 
manufacturer, processor, packer and holder of food must at all times 
utilize quality control operations that reduce natural or unavoidable 
defects to the lowest level currently feasible (proposed Sec.  
117.110(c)).
    We also proposed that the mixing of a food containing defects at 
levels that render that food adulterated with another lot of food is 
not permitted and renders the final food adulterated, regardless of the 
defect level of the final food. (Proposed Sec.  117.110(d)).
    We proposed to delete current Sec.  110.110(e), which specifies 
that a Defect Levels Handbook (a compilation of the current defect 
action levels for natural or unavoidable defects in food for human use 
that present no health hazard) may be obtained upon request from the 
Center for Food Safety and Applied Nutrition.
    (Comment 365) Some comments assert that the word ``defects'' may 
cause confusion in industry, because the term ``defects'' is commonly 
used to describe quality or physical type attributes that do not pose a 
risk to

[[Page 56020]]

public health. These comments ask us to consider using another term, 
such as ``contaminant,'' in place of the term ``defect.''
    (Response 365) We decline this request. The specific term requested 
by the comments (i.e., contaminant) often carries the connotation of 
hazardous to health. However, we have added a definition of the term 
``defect action level'' to the rule (see Response 165 and Sec.  117.3). 
The defined term makes clear that the term does not refer to quality or 
physical type attributes such as those described in the comments. We 
also have deleted the first two full paragraphs of the proposed 
provision (proposed Sec.  117.110(a) and (b)), which are no longer 
necessary to provide context about the regulatory impact of the term 
``defect action level,'' because the new definition of ``defect action 
level'' explains that a defect action level is a level of a non-
hazardous, naturally occurring, unavoidable defect at which FDA may 
regard a food product ``adulterated'' and subject to enforcement action 
under section 402(a)(3) of the FD&C Act.
    (Comment 366) Some comments assert that a facility subject to this 
provision will implement both CGMPs and a food safety plan as guiding 
``quality control operations'' appropriate for this purpose. These 
comments also assert that reducing natural or unavoidable defects to 
``the lowest level currently feasible'' does not require a facility to 
exceed CGMPs or go beyond preventive controls identified through a 
hazard analysis. In the view of these comments, doing so would run 
contrary to the risk-based principles that underlie FSMA and leading 
food safety programs by requiring that all hazards be managed equally 
without considering the outcomes of the hazard analysis. These comments 
assert that successful, responsible food safety programs allocate 
resources to hazards commensurate with their potential impact to the 
public health.
    (Response 366) We agree that reducing natural or unavoidable 
defects to ``the lowest level currently feasible'' does not require a 
facility to exceed CGMPs or go beyond preventive controls identified 
through a hazard analysis.
    (Comment 367) Some comments assert that the word ``reduce'' in 
Sec.  117.110 (c) may not be appropriate for all facilities. As an 
example, the comments explain that a brownskin almond facility that 
solely sizes and sorts product before packaging may not have processes 
to reduce microbial contaminants. Instead, that facility may rely upon 
custom processors to reduce the level of microbial contamination. In 
such a case, these comments note that it would be more accurate for the 
provision to specify using quality control operations that ensure the 
lowest level currently feasible for natural or unavoidable defects.
    (Response 367) We have not revised the provision to account for 
circumstances such as those described in these comments. We acknowledge 
that the production of some food products requires that food pass 
through multiple facilities before the finished food is distributed 
into commerce, and that a specific pathogen reduction step may occur at 
only one of the applicable facilities. The comments do not provide any 
examples of how we have interpreted this long-standing provision in the 
past in a way that creates practical problems when applying the 
provision to facilities such as those described in the comments.
    (Comment 368) Some comments ask us to retain the provision, in 
Sec.  110.110(e), specifying that the Defect Levels Handbook may be 
obtained upon request from the Center for Food Safety and Applied 
Nutrition. These comments also ask us to add an FDA Web site where the 
handbook may be obtained.
    (Response 368) We have added a reference to the Defect Levels 
Handbook (Ref. 36) to the provisions as examples of defect action 
levels that may render food adulterated, including an address on the 
FDA Web site where this handbook may be obtained.

XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and 
Risk-Based Preventive Controls

    In the 2014 supplemental human preventive controls notice, we 
proposed a series of changes to proposed subpart C and reopened the 
comment period specifically with respect to these changes. The proposed 
changes included: (1) Eliminating the term ``hazard reasonably likely 
to occur'' throughout proposed subpart C (and, thus, deleting the 
definition we had proposed for this term); (2) adding a new defined 
term, ``significant hazard,'' and, in general, using this new term 
instead of ``hazard reasonably likely to occur'' throughout the re-
proposed regulations; (3) defining ``known or reasonably foreseeable 
hazard'' in place of ``reasonably foreseeable hazard'' and clarifying 
that the new term means a hazard ``that has the potential to be 
associated with the facility or the food'' rather than ``a potential . 
. . hazard that may be associated with the facility or the food''; and 
(4) providing additional flexibility to address concerns about re-
writing existing plans or programs to conform with the requirement of 
the human preventive controls rule.
    We received many comments on the overall framework for hazard 
analysis and risk-based preventive controls. We discuss each of these 
comments in the discussion of the specific regulatory text applicable 
to each comment. We show highlights of the changes we made after 
considering these comments in table 28.

  Table 28--Revisions to the Overall Framework for Hazard Analysis and
                     Risk-Based Preventive Controls
------------------------------------------------------------------------
             Section                  Description          Revision
------------------------------------------------------------------------
117.3...........................  Definition of       Revise the
                                   ``significant       proposed term
                                   hazard''.           ``significant
                                                       hazard'' to
                                                       ``hazard
                                                       requiring a
                                                       preventive
                                                       control'' and
                                                       revise the
                                                       definition to
                                                       emphasize the
                                                       role of risk in
                                                       determining
                                                       whether a hazard
                                                       requires a
                                                       preventive
                                                       control.
117.3...........................  Definition of       Define the term
                                   ``corrections''.    ``correction'' to
                                                       distinguish
                                                       ``corrections''
                                                       from ``corrective
                                                       actions.''
117.135(c)(1), 117.140(a),        Flexibility in      Clarify that
 117.145, 117.155(a),              preventive          preventive
 117.160(a), 117.165(a),           controls and        control
 117.165(b).                       preventive          management
                                   control             components depend
                                   management          on the role of a
                                   components for      preventive
                                   monitoring,         control in the
                                   corrective          facility's food
                                   actions and         safety system, as
                                   corrections, and    well as the
                                   verification.       nature of the
                                                       preventive
                                                       control.
117.130(b)(1), 117.130(b)(2)....  Hazard              Emphasize that the
                                   identification.     hazard
                                                       identification
                                                       focuses on known
                                                       or reasonably
                                                       foreseeable
                                                       hazards (rather
                                                       than on all
                                                       hazards).

[[Page 56021]]

 
117.145(c)......................  Monitoring records  Provide for the
                                                       use of
                                                       ``exception
                                                       records'' for
                                                       monitoring
                                                       preventive
                                                       controls.
117.150(a)......................  Corrective action   Clarify that
                                   procedures.         corrective action
                                                       procedures depend
                                                       on the nature of
                                                       the hazard.
117.150(c)......................  Corrections.......  Provide for
                                                       additional
                                                       circumstances
                                                       when corrections,
                                                       rather than
                                                       corrective
                                                       actions, are
                                                       warranted.
117.160(c)......................  Preventive          Clarify that a
                                   controls that do    list of
                                   not require         preventive
                                   validation.         controls that do
                                                       not require
                                                       validation is not
                                                       an exhaustive
                                                       list.
117.165(a)(5)...................  Activities to       Clarify that there
                                   verify              could be
                                   implementation      alternative
                                   and effectiveness.  verification
                                                       activities of
                                                       implementation
                                                       and effectiveness
                                                       other than those
                                                       that we specify
                                                       in the rule.
117.165(b)......................  Written procedures  Clarify that
                                   for verification    written
                                   of implementation   procedures for
                                   and effectiveness.  verification of
                                                       implementation
                                                       and effectiveness
                                                       are established
                                                       and implemented
                                                       as appropriate to
                                                       the role of the
                                                       preventive
                                                       control in the
                                                       facility's food
                                                       safety system, as
                                                       well as
                                                       appropriate to
                                                       the facility, the
                                                       food, and the
                                                       nature of the
                                                       preventive
                                                       control.
117.170(b)......................  Reanalysis........  Provide for
                                                       reanalysis of an
                                                       applicable
                                                       portion of the
                                                       food safety plan
                                                       (rather than the
                                                       complete food
                                                       safety plan) in
                                                       specified
                                                       circumstances.
------------------------------------------------------------------------

XXIV. Subpart C: Comments on Proposed Sec.  117.126--Food Safety Plan

    We proposed requirements for a food safety plan. Some comments 
support the proposed requirements without change. Some comments that 
support the proposed provisions suggest alternative or additional 
regulatory text (see, e.g., Comment 377 and Comment 381) or ask us to 
clarify how we will interpret the provision (see, e.g., Comment 370).
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we are finalizing the provisions as proposed, with editorial 
and conforming changes as shown in table 52.
    We proposed that the food safety plan be under the oversight of one 
or more ``qualified individuals.'' As discussed in section IX.C.25, we 
have changed the proposed term ``qualified individual'' to ``preventive 
controls qualified individual'' because we are establishing a new 
definition for ``qualified individual,'' with a meaning distinct from 
``preventive controls qualified individual.'' To minimize the potential 
for confusion for when the term ``qualified individual'' refers to the 
proposed meaning of the term and when the term ``qualified individual'' 
refers to the meaning of that term as finalized in this rule, in the 
remainder of this document we substitute the new term ``preventive 
controls qualified individual'' for the proposed term ``qualified 
individual,'' even though the proposed rule used the term ``qualified 
individual.'' Likewise, we substitute the new term ``preventive 
controls qualified individual'' for the proposed term ``qualified 
individual'' when describing the comments to the proposed rule, even 
though those comments use the term ``qualified individual.''
    We proposed that several other provisions of subpart C be under the 
oversight of a ``qualified individual'' (now ``preventive controls 
qualified individual''), and also proposed requirements that would 
apply to the ``qualified individual'' (now ``preventive controls 
qualified individual''). See, e.g., Sec. Sec.  117.160, 117.165, 
117.170, 117.180, 117.190, and 117.206). As discussed in the preceding 
paragraph, in the remainder of this document, we substitute the new 
term ``preventive controls qualified individual'' for the proposed term 
``qualified individual,'' when describing these proposed provisions and 
the comments to these proposed provisions.

A. Proposed Sec.  117.126(a)(1)--Requirement for a Food Safety Plan

    We proposed that you must prepare, or have prepared, and implement 
a written food safety plan.
    (Comment 369) Some comments ask us to emphasize that ``written'' 
means ``any type of recordable and reproducible format'' (e.g., as 
paper or electronic documents). Some comments ask us to specify that 
the components of the food safety plan need not be in a single document 
or stored in one place.
    (Response 369) A ``written'' food safety plan can be either a paper 
document or an electronic document, as provided by Sec.  117.305(a). 
The final rule specifies that required information (which would include 
the food safety plan) does not need to be kept in one set of records 
(see Sec.  117.330 (b)), and a food safety plan may be prepared as a 
set of documents kept in different locations within the facility (e.g., 
based on where they will be used), provided that each set of documents 
is onsite. As provided in the recordkeeping provisions, electronic 
records are considered to be onsite if they are accessible from an 
onsite location.
    (Comment 370) Some comments agree with our previous statements that 
facilities should be able to group food types or production method 
types if hazards, control measures, parameters, and required 
procedures, such as monitoring, are identical (78 FR 3646 at 3730). 
These comments note that exceptions should be carefully delineated and 
followed as appropriate. Some comments ask us to clarify that we will 
allow food safety plans to share common provisions where there are 
uniform systems in place. Some comments ask us to clarify whether one 
plan is required for the facility or for each crop/food item 
individually.
    (Response 370) We are requiring that a facility have a written food 
safety plan that covers all the foods that it manufactures, processes, 
packs, or holds. We recognize that, to the extent that the controls are 
the same, there may be common controls that broadly apply to some or 
all of a facility's food products. However, any product- or process-
specific differences must be carefully delineated and observed in 
practice.
    In some facilities with limited types of products, the written food 
safety plan may contain a single set of procedures that addresses all 
of the products produced. For example, a facility

[[Page 56022]]

making fruit-flavored beverages may be able to address all of its 
beverages in the same set of procedures. For other facilities, there 
may not be a practical way to group the products and the written food 
safety plan may need to contain more than one set of procedures to 
address all of its products. For example, a facility that makes both 
RTE entrees and entrees that are not RTE may choose to group the RTE 
entrees in one set of procedures, but have a separate set of procedures 
for the entrees that are not RTE. However, to the extent that some of 
the written procedures in the food safety plan are the same for both 
RTE entrees and entrees that are not RTE, the facility need not 
duplicate those procedures in its written food safety plan. For 
example, a facility that uses an electronic food safety plan could 
store written procedures in multiple folders in the electronic system, 
and the food safety plan for individual products (or groups of 
products) could simply hyperlink to the written procedures applicable 
to each product. Likewise, a facility that uses a paper-based food 
safety plan could store written procedures in a binder or file cabinet, 
with written cross-references to procedures that apply to more than one 
product.
    (Comment 371) Some comments ask us to provide that the food safety 
plan be handled at the corporate level rather than the facility level 
if a corporation owns many facilities.
    (Response 371) A corporation may designate an individual at the 
corporate level as the owner, operator, or agent in charge of a 
particular facility. In addition, an employee of the corporation, 
whether at headquarters or at another facility owned by the 
corporation, may provide input into a particular facility's food safety 
plan. As previously discussed, the food safety plan needs to be 
facility specific (see the discussion of the facility-based nature of 
the food safety plan in the 2013 proposed human preventive controls 
rule, 78 FR 3646 at 3732). For example, even if a corporation makes 
similar products at two separate facilities, it is unlikely that the 
two facilities have exactly the same equipment and layout. Procedural 
instructions must be tailored to the equipment being used, and the 
layout of a facility may affect its approach to preventive controls 
such as food allergen controls.
    (Comment 372) Some comments ask us to provide for facilities that 
have HACCP plans to build off their existing HACCP programs. As an 
example, these comments state that we could allow facilities to use 
terms like ``critical limits'' for process controls rather than require 
these foundational documents to be rewritten simply to change 
terminology.
    (Response 372) A facility that has a HACCP plan (or other food 
safety plan) in place before this rule becomes effective can build off 
its existing program and can rely on existing records, supplemented as 
necessary to include all of the required information and satisfy the 
requirements of this rule (see Sec.  117.330). The rule does not 
preclude the use of terms like ``critical limits'' that are associated 
with HACCP systems.
    (Comment 373) Some comments ask us to provide templates that 
facilities can use as models to develop their food safety plans. Some 
comments ask us to accept Good Agricultural Practices (GAPs) food 
safety plan formats and/or HACCP plans. Some comments provide specific 
templates for us to consider.
    (Response 373) We decline the request to provide templates for 
facilities to use to develop their food safety plans. The rule does not 
specify the format of a food safety plan, and a facility has 
flexibility to format its food safety plan in a way that works best for 
the facility, provided that the plan includes all required information. 
In general, internationally recognized food safety plan formats would 
be acceptable, although modification and supplementation may be 
necessary to comply with all requirements of the rule (see Sec.  
117.330 on the use and adaptation of existing records). Training 
materials being developed by the FSPCA may be useful in developing food 
safety plans (see Response 2).
    We note that activities of farm mixed-type facilities that are 
within the ``farm'' definition (e.g., packing and holding RACs) are not 
subject to the human preventive controls rule. However, to the extent 
that some components of GAPs-based food safety plans are relevant to a 
facility (e.g., for an off-farm packinghouse), the facility has 
flexibility to format its plan in a way that is consistent with GAPs-
based food safety plans.
    (Comment 374) Some comments ask us to clarify that a food safety 
plan is not required when a facility is exempt as a qualified facility 
(Sec.  117.5(a)) or as a facility solely engaged in the storage of 
packaged food that is not exposed to the environment (Sec.  117.7).
    (Response 374) A qualified facility is exempt from the requirements 
of subparts C and G, including the requirement to prepare and implement 
a food safety plan, and is instead subject to the modified requirements 
in Sec.  117.201. Likewise, a facility solely engaged in the storage of 
packaged food that is not exposed to the environment is exempt from the 
requirements of subparts C and G, including the requirement to prepare 
and implement a food safety plan, and is instead subject to the 
modified requirements in Sec.  117.206.
    (Comment 375) Some comments ask us to clarify that a food safety 
plan is not required for facilities that store unexposed, refrigerated, 
packaged TCS foods.
    (Response 375) We agree that a facility ``solely engaged'' in the 
storage of unexposed, refrigerated, packaged TCS food is exempt from 
the requirements of subparts C and G, including the requirement to 
prepare and implement a food safety plan, and is instead is subject to 
the modified requirements in Sec.  117.206 (see Sec.  117.7). However, 
if a facility engages in other activities in addition to the storage of 
unexposed, refrigerated, packaged TCS foods, the exemption does not 
apply. In such a case, the facility must prepare and implement a food 
safety plan. However, the modified requirements of Sec.  117.206 can be 
informative with respect to what the food safety plan could include 
regarding the storage of unexposed, refrigerated, packaged TCS food.
    (Comment 376) Some comments ask us to explain why a written food 
safety plan is necessary, because adoption of a HACCP system is only 
voluntary under the Codex General Principles of Food Hygiene.
    (Response 376) The requirement to prepare and implement a written 
food safety plan is required by U.S. law (i.e., by section 418(h) of 
the FD&C Act). In contrast, Codex standards are recommendations for 
voluntary application by members and, thus, Codex provisions are only 
mandatory if the standard is adopted by a country in its national 
legislation.

B. Proposed Sec.  117.126(a)(2)--Preparation of the Food Safety Plan by 
a Preventive Controls Qualified Individual

    We proposed that the food safety plan must be prepared, or its 
preparation overseen, by one or more preventive controls qualified 
individuals.
    (Comment 377) Some comments ask us to provide for a group of 
preventive controls qualified individuals to prepare, or oversee the 
preparation of, a food safety plan.
    (Response 377) The proposed regulatory text included in the 2014 
supplemental human preventive controls notice provides for the food 
safety plan to be prepared, or its

[[Page 56023]]

preparation overseen, by one or more preventive controls qualified 
individuals, and we are finalizing that provision as proposed.
    (Comment 378) Some comments ask us to specify that oversight of the 
food safety plan is voluntary rather than required.
    (Response 378) We decline this request. The food safety plan is the 
foundation for a preventive approach to producing safe food. As 
previously discussed, the food safety plan must be designed to 
identify, and to significantly minimize or prevent, hazards for the 
purpose of preventing illness or injury (78 FR 3646 at 3731). The 
comments fail to explain how a facility could ensure the proper design 
of an effective food safety plan without oversight by an individual who 
satisfies the minimum requirements for a preventive controls qualified 
individual (see the discussion of the requirements for a preventive 
controls qualified individual in section XXXVI).
    (Comment 379) Some comments assert that oversight of the food 
safety plan by a preventive controls qualified individual should not be 
required for products subject to the PMO because the production of such 
products is subject to the NCIMS process.
    (Response 379) As discussed in Response 214, we agree we should 
make use of the existing system of oversight provided for by NCIMS, 
which has been part of a cooperative program among the U.S. Public 
Health Service/FDA, the States, and the dairy industry since 1950, and 
we have provided an extended compliance date in order that the PMO be 
revised for consistency with this rule. Under a revised PMO, Grade 
``A'' facilities would need a preventive controls qualified individual 
to make decisions about hazards and verification procedures such as 
environmental monitoring specific to a facility and to review food 
safety records.
    (Comment 380) Some comments express concern about the cost 
associated with oversight of the food safety plan by a preventive 
controls qualified individual, regardless of whether the preventive 
controls qualified individual is employed by the facility or is a third 
party. These comments focus on the burden that this oversight would 
place on farms and small businesses, and note that the food industry is 
a ``low margin'' industry. Some comments ask us to provide for an 
officer or employee of a State agricultural agency to provide oversight 
of the food safety plan, because such persons have the most specialized 
knowledge concerning that State, it is more efficient for State 
officials to travel to nearby farms, and farmers feel more comfortable 
working with State employees.
    (Response 380) A farm is not subject to this rule for activities 
within the ``farm'' definition. A farm mixed-type facility that is a 
small or very small business and only conducts the low-risk activity/
food combinations specified in Sec.  117.5(g) and (h) is exempt from 
the requirements of subparts C and G, including the requirement for 
oversight of the food safety plan by a preventive controls qualified 
individual. Furthermore, a farm mixed-type facility that is a very 
small business, but does not satisfy the criteria for the exemptions 
specified in Sec.  117.5(g) and (h), is a qualified facility that is 
exempt from the requirements of subparts C and G, and is instead 
subject to modified requirements that do not require oversight of a 
food safety plan by a preventive controls qualified individual. 
Moreover, we expect that some training materials and courses will be 
available online, thereby helping to mitigate costs, both associated 
with training of a preventive controls qualified individual and loss of 
production manpower during training.
    We disagree that it would be appropriate for an officer or employee 
of a State agricultural agency to provide oversight of the food safety 
plan. The food safety plan and its oversight are the responsibility of 
the facility, not State government officials. The role of an officer or 
employee of a State agricultural agency would be in determining whether 
the applicable facility is in compliance with the rule, such as during 
inspection. State extension agents may be available to assist small 
businesses, even if those agents are not the designated preventive 
controls qualified individual for the facility, provided that such 
agents do not also have any role in determining whether the applicable 
facility is in compliance with the rule.
    We acknowledge that oversight of a food safety plan by a preventive 
controls qualified individual is a cost associated with the rule, and 
we have accounted for that cost in the FRIA for this rule (Ref. 38). To 
minimize the burden on the smallest businesses, the definition of 
``very small business'' establishes a $1,000,000 threshold, adjusted 
for inflation, during the 3-year period preceding the applicable 
calendar year. As already noted, a facility that satisfies the 
definition of very small business is exempt from the requirements of 
subparts C and G and instead is subject to modified requirements (see 
Sec.  117.201), which do not require a food safety plan that is 
prepared or overseen by a preventive controls qualified individual.

C. Proposed Sec.  117.126(b)--Contents of a Food Safety Plan

    We proposed that the written food safety plan must include the 
written hazard analysis, preventive controls (including the supplier 
program and the recall plan), procedures for monitoring the 
implementation of the preventive controls, corrective action 
procedures, and verification procedures. As discussed in more detail in 
section XLII, we have revised the phrase ``supplier program'' to 
``supply-chain program'' throughout the regulatory text. In the 
remainder of this document, we use the phrase ``supply-chain program'' 
in section headings and when referring to the provisions of the final 
rule. We continue to use the term ``supplier program'' when describing 
the proposed provisions and the comments regarding the proposed 
provisions.
    (Comment 381) Some comments ask us to specify that sanitation 
controls must be in the food safety plan. Some comments ask us to 
require equipment standards in the food safety plan, noting that it is 
not possible to clean and sanitize equipment that is not designed and 
constructed to be cleanable by meeting specific standards.
    (Response 381) Sanitation controls are one type of preventive 
control. As appropriate to the facility and the food (e.g., to control 
hazards such as environmental pathogens), sanitation controls for 
cleanliness of food-contact surfaces and prevention of allergen cross-
contact and cross contamination would be required to be in the food 
safety plan (Sec.  117.135(c)(3)).
    We are not adding a requirement to include equipment standards in 
the food safety plan. The CGMPs established in subpart B already 
require that all plant equipment and utensils be so designed and of 
such material and workmanship so to be adequately cleanable (Sec.  
117.40(a)(1)). It is not practical to specify equipment standards in 
the CGMPs due to the wide range of equipment used by the food industry, 
including equipment subject to ongoing development and improvement.
    (Comment 382) Some comments ask us to recognize that existing HACCP 
plans, such as those developed in accordance with the EU 2004 Food 
Hygiene law and GFSI-compliant food safety plans, can satisfy the 
requirements for what must be in a food safety plan.
    (Response 382) To the extent that an existing HACCP plan or GFSI-
compliant food safety plan includes all required information, a 
facility can use such

[[Page 56024]]

plans to meet the requirements of this rule. We expect that many 
existing plans will need only minor supplementation to fully comply 
with these requirements. Relying on existing records, with 
supplementation as necessary to demonstrate compliance with the 
requirements of the human preventive controls rule, is acceptable (see 
Sec.  117.330).
    (Comment 383) Some comments ask us to explain the differences 
between the food safety plan being established to implement FSMA and 
HACCP plans established under current requirements or guidelines for 
HACCP systems. These comments ask us to provide exporters with 
background information and specific examples of differences, including 
how firms are directed to set their critical control points and 
critical limits.
    (Response 383) Table 29 compares the provisions of the food safety 
plan required by this rule to the provisions of HACCP plans in some 
current requirements or guidelines for HACCP systems. See also the 
discussion in the 2013 proposed human preventive controls rule (78 FR 
3646 at 3730-3732) and our memorandum comparing the provisions of this 
rule to various existing domestic and international HACCP-based 
standards (Ref. 65). This rule does not specify how a facility would 
identify any applicable CCPs or critical limits. Importantly, this rule 
explicitly provides that preventive controls include controls other 
than those at CCPs that are also appropriate for food safety (Sec.  
117.135(a)(2)(ii)). See also Response 2, in which we discuss both 
future guidance and a preventive controls training curriculum being 
developed by the FSPCA. We expect that both of these resources will 
help facilities, including foreign facilities, understand the 
requirements for a food safety plan.

                            Table 29--A Comparing the Food Safety Plan to HACCP Plans
----------------------------------------------------------------------------------------------------------------
                                                                                            Federal HACCP  rules
                                                    NACMCF HACCP                            for juice,  seafood,
     Requirements              PC Rule               Guidelines        Codex HACCP  Annex       and meat  and
                                                                                                   poultry
----------------------------------------------------------------------------------------------------------------
Written plan..........  Yes..................  Yes..................  Yes.................  Yes.
Who is responsible for  The owner, operator    A HACCP team may need  Individual            The processor.
 preparing the plan?     or agent in charge     assistance from        businesses, with
                         of a facility must     outside experts        advice when
                         prepare, or have       knowledgeable in the   necessary from
                         prepared, and          hazards associated     other sources.
                         implement a written    with the product and
                         food safety plan.      process.
                         The food safety plan
                         must be prepared, or
                         its preparation
                         overseen, by one or
                         more preventive
                         controls qualified
                         individuals.
What does the plan       Written        Written        Written       Written
 contain?                hazard analysis.       hazard analysis.       hazard analysis.      hazard analysis.
                         Written        Must include   Must          Must list
                         preventive controls.   the hazard, the        include CCPs and      all food safety
                         Written        CCPs, and critical     critical limits.      hazards that are
                         supply-chain program.  limits.                Must          reasonably likely
                         Written        Must include   include monitoring    to occur, CCPs, and
                         recall plan.           monitoring             procedures.           critical limits.
                         Written        procedures.            Must          Must list
                         procedures for         Must include   include corrective    monitoring
                         monitoring the         corrective actions.    actions.              procedures.
                         implementation of      Must include   Must          Must
                         the preventive         verification           include               include corrective
                         controls.              procedures.            verification          action procedures.
                         Written        Must include   procedures.           Must
                         corrective action      recordkeeping          Must          include
                         procedures.            procedures.            include records.      verification
                         Written                                                     procedures;
                         verification                                                        Must
                         procedures.                                                         include
                                                                                             recordkeeping
                                                                                             procedures.
Is oversight required   Yes..................  Yes..................  Yes.................  Yes.
 by a person qualified
 by training and
 experience?
----------------------------------------------------------------------------------------------------------------

D. Proposed Sec.  117.126(c)--Records

    We proposed that the food safety plan is a record that is subject 
to the recordkeeping requirements of subpart F. We received no comments 
that disagreed with this proposed requirement and are finalizing it as 
proposed.

E. Comments on Potential Requirements for Submission of a Facility 
Profile to FDA

    We requested comment on whether to require submission to FDA of a 
subset of the information that would be in a food safety plan (78 FR 
3646 at 3768). This information, which could be referred to as a 
``facility profile,'' could be submitted through an electronic form 
using a menu selection approach at the same time as facility 
registration, and could be updated biennially simultaneously with the 
required biennial update of the food facility registration. We 
described potential benefits to having a facility's food safety plan in 
advance of an inspection, such as aiding in the efficient oversight of 
preventive controls by allowing us to better target inspectional 
activities to facilities that produce foods that have an increased 
potential for contamination (particularly contamination with biological 
hazards). We noted that facilities could benefit from our advance

[[Page 56025]]

preparation through interaction with better-informed investigators and 
potentially reduced inspection time. We requested comment on the 
utility and necessity of such an approach and on the specific types of 
information that would be useful in developing a facility profile. We 
also requested comment on any additional benefits that might be 
obtained from using such an approach and any potential concerns with 
this approach.
    We noted that we had previously announced an opportunity for public 
comment on the proposed collection of additional food facility profile 
information on a voluntary basis from firms that complete the FDA food 
facility registration process (Federal Register of May 11, 2012, 77 FR 
27779). In contrast to the voluntary submission of food facility 
profile information described in that notice, in the 2013 proposed 
human preventive controls rule we requested comment on whether the 
submission of such information should be required.
    (Comment 384) Some comments state that submission of a facility 
profile would be useful and support requiring such a submission. 
However, most of the comments that addressed our request for comments 
on such a submission express concern. Some comments assert that 
requiring submission of a facility profile is outside of FDA's 
statutory authority under FSMA. Other comments assert that submitting a 
facility profile would not advance food safety goals or have a 
commensurate benefit to food safety. Some comments express concern 
about protection of confidential information. Other comments express 
concern that we would misinterpret the submitted information in the 
absence of discussion with the facility. Some comments assert that 
receiving and evaluating the submitted information would be too time-
consuming for FDA, whereas other comments assert that submitting the 
information would be too time-consuming for the facility. Some comments 
state that a subset of the information that would be submitted could be 
found in the Establishment Inspection Reports. Some comments assert 
that we could use information already available through the Reportable 
Food Registry to identify facilities that have needed to address a 
serious food safety violation and target our inspectional resources to 
those facilities. Some comments state that a facility profile is a not 
a static document and would be very difficult to keep up-to-date.
    (Response 384) We have decided that we will not establish a 
requirement for submission of a facility profile. We will explore other 
mechanisms to achieve the goals we described in the 2013 proposed human 
preventive controls rule.

XXV. Subpart C: Comments on Proposed Sec.  117.130--Hazard Analysis

    We proposed requirements for hazard analysis, including hazard 
identification and hazard evaluation. Some comments support the 
proposed requirements without change. For example, some comments 
support our proposal for the hazard analysis to address ``known or 
reasonably foreseeable hazards'' because this is consistent with Codex. 
Other comments agree that the hazard analysis should address both the 
severity of the potential hazard and the probability that the hazard 
will be present in a food product. Other comments state that testing 
for environmental pathogens may be impractical in certain situations 
for facilities in chemical plants that also produce food additives and 
that the proposed requirements for hazard evaluation make it clear that 
in such facilities environmental monitoring would not be required. Some 
comments that support the proposed provisions suggest alternative or 
additional regulatory text (see, e.g., Comment 385, Comment 395, 
Comment 406, and Comment 407) or ask us to clarify how we will 
interpret the provision (see, e.g., Comment 418).
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
30, with editorial and conforming changes as shown in table 52.

  Table 30--Revisions to the Proposed Requirements for Hazard Analysis
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.130(a)(1).................  Requirement for a  Specify that a
                                 hazard analysis.   facility must
                                                    ``conduct a hazard
                                                    analysis'' to
                                                    identify and
                                                    evaluate known or
                                                    reasonably
                                                    foreseeable hazards,
                                                    rather than merely
                                                    specify that a
                                                    facility must
                                                    ``identify and
                                                    evaluate'' known or
                                                    reasonably
                                                    foreseeable hazards.
117.130(a)(2).................  Requirement for    Clarify that the
                                 the hazard         hazard analysis must
                                 analysis to be     be written,
                                 written.           regardless of its
                                                    outcome.
117.130(b)(1) and (b)(2)......  Hazard             Emphasize that the
                                 identification.    hazard
                                                    identification
                                                    focuses on known or
                                                    reasonably
                                                    foreseeable hazards
                                                    (rather than on all
                                                    hazards).
117.130(b)(1)(iii)............  Hazard             Add examples of
                                 identification.    physical hazards.
117.130(c)(1)(ii).............  Hazard evaluation  Provide that hazard
                                                    evaluation does not
                                                    need to include an
                                                    evaluation of
                                                    environmental
                                                    pathogens whenever
                                                    RTE food is exposed
                                                    to the environment
                                                    prior to packaging
                                                    if the packaged food
                                                    includes a control
                                                    measure (such as a
                                                    formulation lethal
                                                    to the pathogen)
                                                    that would
                                                    significantly
                                                    minimize the
                                                    pathogen.
117.130(c)(2)(x)..............  Hazard evaluation  Provide an example of
                                                    ``other relevant
                                                    factor'' that the
                                                    hazard evaluation
                                                    must consider (the
                                                    example is the
                                                    temporal (e.g.,
                                                    weather-related)
                                                    nature of some of
                                                    some hazards (e.g.,
                                                    levels of some
                                                    natural toxins)).
------------------------------------------------------------------------

A. Proposed Sec.  117.130(a)--Requirement for a Written Hazard Analysis

    We proposed that you must identify and evaluate, based on 
experience, illness data, scientific reports, and other information, 
known or reasonably foreseeable hazards for each type of food 
manufactured, processed, packed, or held at your facility to determine 
whether there are significant hazards. We also proposed that the hazard 
analysis must be written. As discussed in Response 126, we have revised 
the term ``significant hazard'' to ``hazard requiring a preventive 
control.''

[[Page 56026]]

    (Comment 385) Some comments ask us to specify that the rule 
requires a written hazard analysis even if the hazard analysis 
concludes that no hazards exist.
    (Response 385) As proposed, the regulatory text would require a 
written hazard analysis even if the hazard analysis concludes that no 
hazards exist. To make this clearer, we have made two revisions to the 
regulatory text. First, we have revised the regulatory text to specify 
that a facility must ``conduct a hazard analysis'' to identify and 
evaluate known or reasonably foreseeable hazards, rather than merely 
specify that a facility must ``identify and evaluate'' known or 
reasonably foreseeable hazards. Second, we have revised the regulatory 
text to specify that the hazard analysis must be written regardless of 
its outcome.
    (Comment 386) Some comments assert that a facility should not be 
able to conclude that no hazard exists in its production process and 
that any such conclusion reached should be a ``red flag'' to FDA 
investigators.
    (Response 386) The purpose of a hazard analysis is to identify and 
evaluate known or reasonably foreseeable hazards to determine whether 
there are any hazards requiring a preventive control. If a facility 
appropriately determines, under the oversight of a preventive controls 
qualified individual, that no such hazards exist, then that is the 
outcome of its hazard analysis, and the facility must document that 
outcome in its written hazard analysis. (See also Response 222, 
Response 226, Response 229, Response 232, Response 397, Response 721, 
and Response 726.)
    However, we agree that our investigators should take appropriate 
steps to evaluate a facility's hazard analysis when the outcome is that 
there are no hazards requiring a preventive control. We expect that our 
investigators would both review the facility's written hazard analysis 
and discuss the outcome with the facility. During the initial stages of 
implementation, we also expect that our investigators will ask subject 
matter experts in our Center for Food Safety and Applied Nutrition 
(CFSAN) to review such a hazard analysis. Over time, as our 
investigators gain experience with appropriate determinations that 
there are no hazards requiring a preventive control, we expect that 
there will be fewer circumstances in which our investigators would 
consult CFSAN about such an outcome.
    (Comment 387) Some comments ask us to require facilities to provide 
supporting documentation in the hazard analysis and assert that such a 
requirement would be consistent with the requirements of the FSIS HACCP 
regulation for meat and poultry.
    (Response 387) We made no changes to the regulatory text to 
specifically require that a facility ``provide supporting 
documentation'' in its hazard analysis. A facility has flexibility to 
determine the appropriate content of its written hazard analysis, 
provided that the written hazard analysis complies with the 
requirements for hazard identification and hazard evaluation (see Sec.  
117.130(b) and (c)). A facility must be able to justify its hazard 
analysis decisions, even if the supporting documentation is not 
specifically included with the hazard analysis. For example, a facility 
that relies on one or more scientific publications to support its 
hazard analysis might include a bibliography listing the relevant 
publications, but not include a copy of the listed publications. 
Differences in the regulatory text of this rule compared to the FSIS 
HACCP regulation for meat and poultry reflect the flexible framework 
provided by FSMA but do not create a conflict.
    (Comment 388) Some comments ask us to modify the provision to 
specify that the hazard analysis identify and evaluate known or 
reasonably foreseeable hazards for each type of food manufactured, 
processed, packed, or held at the facility, including hazards in the 
raw materials and ingredients used in the food (emphasis added).
    (Response 388) We decline this request. Other provisions in the 
requirements for hazard analysis specify that the hazard evaluation 
must consider raw materials and ingredients (see Sec.  
117.130(c)(2)(iii)). It is not necessary to repeat the specific 
requirements associated with the hazard evaluation in the provision 
that directs each facility to conduct a hazard analysis.
    (Comment 389) Some comments ask us to modify the provision to use 
``or'' instead of ``and'' in the clause ``based on experience, illness 
data, scientific reports, and other information'' because it is not 
necessary to evaluate all of the specified criteria in all cases.
    (Response 389) We decline this request. We agree that in some cases 
some of the specified types of information may not be available. For 
example, if a food product has not been associated with foodborne 
illness, there would be no illness data. However, modifying the 
provision as suggested by the comments would establish a regulatory 
requirement in which a facility could pick and choose which information 
to evaluate, irrespective of whether the information is available.
    (Comment 390) Some comments point out that the Codex HACCP Annex 
includes ``mileposts'' for the identification of hazards, recommending 
that the HACCP Annex apply to ``all of the hazards that may be 
reasonably expected to occur at each step from primary production, 
processing, manufacture, and distribution until the point of 
consumption.'' These comments ask us to include such ``mileposts'' in 
the requirements to conduct a hazard analysis to put the regulations in 
better alignment with the Codex HACCP Annex and underscore the fact 
that food producers cannot anticipate or be responsible for customer 
behavior that is contrary to general principles of food safety.
    (Response 390) By ``mileposts'' for hazard identification, we 
assume that the comments are referring to the steps included in the 
Codex HACCP Annex regarding the recommendation to list all potential 
hazards associated with each step, conduct a hazard analysis, and 
consider any measures to control identified hazards. These steps 
include consideration of: (1) The likely occurrence of hazards and 
severity of their adverse health effects; (2) the qualitative and/or 
quantitative evaluation of the presence of hazards; (3) survival or 
multiplication of microorganisms of concern; (4) production or 
persistence in foods of toxins, chemicals or physical agents; and (5) 
conditions leading to these factors (Ref. 34).
    We agree that a hazard analysis should address known or reasonably 
foreseeable hazards at each step from primary production, processing, 
manufacture, and distribution until the point of consumption. For 
example, a facility that produces cut or shredded RTE carrots might 
consider pathogens such as Salmonella that can occur at primary 
production; metal from the slicers or shredders, and L. monocytogenes 
as an environmental pathogen, during manufacturing/processing; and 
refrigeration until the end of the shelf life to prevent the growth of 
pathogenic sporeforming bacteria.
    However, to the extent that these comments are asserting that a 
facility can ignore consumer behavior that the facility considers 
contrary to principles of food safety, we disagree. For example, a 
facility could not conclude that it need not identify and evaluate 
known or reasonably foreseeable hazards because the facility intends to 
provide cooking instructions on the label of a packaged food. Consumer 
research indicates that

[[Page 56027]]

consumer cooking practices are not uniform and that many consumers do 
not follow some cooking instructions, such as those on frozen foods or 
directions specifying that a product should be cooked until it reaches 
a certain temperature (Ref. 66) (Ref. 67).
    (Comment 391) Some comments ask us to require that the hazard 
analysis be re-evaluated every three years and updated as needed.
    (Response 391) The written hazard analysis is one component of the 
food safety plan, and the food safety plan is subject to reanalysis at 
least every three years (see Sec.  117.170).
    (Comment 392) Some comments state that the standard for hazard 
analysis in the human preventive controls rule should both align with 
the re-proposed requirements for hazard analysis set forth in the 
supplemental FSVP notice and be consistent with the statutory standard 
for hazard analysis in section 418(b)(1) of the FD&C Act.
    (Response 392) We have aligned the requirements of the human 
preventive controls rule and the proposed FSVP rule to the extent 
practicable, consistent with the applicable statutory requirements.
    (Comment 393) Some comments ask us to endorse a template, format, 
or style to be used for a hazard analysis to ensure these analyses are 
conducted consistently across the food industry and that auditors are 
consistent in their evaluation.
    (Response 393) We decline this request. See Response 373.

B. Proposed Sec.  117.130(b)--Hazard Identification

    We proposed that the hazard identification must consider hazards 
that include biological, chemical, and physical hazards. We proposed to 
list examples of biological hazards (i.e., microbiological hazards such 
as parasites, environmental pathogens, and other pathogens) and 
chemical hazards (i.e., radiological hazards and substances such as 
pesticide and drug residues, natural toxins, decomposition, unapproved 
food or color additives, and food allergens). In the preamble (78 FR 
3646 at 3734)], we provided examples of physical hazards (i.e., stones, 
glass, or metal fragments that could inadvertently be introduced into 
food) but did not propose to include these examples in the regulatory 
text.
    We also proposed that the hazard identification must consider 
hazards that may be present in the food if they occur naturally, may be 
unintentionally introduced, or may be intentionally introduced for 
purposes of economic gain.
    (Comment 394) As discussed in Comment 126, some comments express 
concern that the rule would refer to multiple levels of hazards (i.e., 
``hazards,'' ``known or reasonably foreseeable hazards,'' and 
``significant hazards'' (which we now refer to as ``hazards requiring a 
preventive control'') and ask us to provide sufficient clarity to be 
able to distinguish between these types of hazards.
    (Response 394) As discussed in Response 126, we have revised the 
requirements for hazard identification to emphasize that the hazard 
identification focuses on known or reasonably foreseeable hazards 
(rather than on all hazards).
    (Comment 395) Some comments ask us to include examples of physical 
hazards in the regulatory text.
    (Response 395) We have added stones, glass, and metal fragments as 
examples of physical hazards in the regulatory text. This is consistent 
with the regulatory text for biological and chemical hazards, even 
though the hazards listed in section 418(b)(1) of the FD&C Act include 
examples of chemical and biological hazards but do not include examples 
of physical hazards.
    (Comment 396) Some comments ask us to separately list some hazards 
(such as parasites and drug residues) rather than include them as 
examples of biological hazards and chemical hazards.
    (Response 396) We decline this request. Although section 
418(b)(1)(A) of the FD&C Act lists such items separately, we believe it 
is clearer to acknowledge that some of the hazards listed in the 
statute are in fact a subset of the broader categories of biological 
and chemical hazards.
    (Comment 397) Some comments ask us to rephrase the requirement for 
hazard identification to specify ``The hazard analysis must identify 
hazards'' rather than ``The hazard identification must consider 
hazards.''
    (Response 397) We decline this request. The provision is directed 
to the first step of a hazard analysis--i.e., hazard identification--
rather than to the overall hazard analysis (which is addressed in Sec.  
117.130(a)). The purpose of the hazard identification is to consider 
the types of hazards listed in the provision as a step in determining 
whether there are any hazards requiring a preventive control; the 
suggestion of the comments implies that such hazards will always be 
identified. As discussed in Response 386, the outcome of a hazard 
analysis for a food product could be that there are no hazards 
requiring a preventive control.
    (Comment 398) Some comments ask us to broaden the examples listed 
for chemical hazards to include ``allergens and ingredients associated 
with food sensitivities.''
    (Response 398) We decline this request. Although the presence of an 
undeclared ingredient associated with a food sensitivity (such as the 
color additive Yellow #5) can be considered a chemical hazard for the 
sensitive population, it is neither practical nor necessary for the 
list of examples of chemical hazards in the regulatory text to be 
exhaustive.
    (Comment 399) Some comments assert that we should not require all 
food safety plans to specifically address the likelihood of 
radiological hazards.
    (Response 399) The rule only requires that a facility consider 
whether radiological hazards are known or reasonably foreseeable, and 
we have described situations where radiological hazards could be 
considered to be known or reasonably foreseeable (78 FR 3646 at 3667). 
A facility that appropriately determines that no radiological hazards 
are known or reasonably foreseeable would document that determination 
in its written hazard analysis but would not need to establish 
preventive controls and associated preventive control management 
components to address radiological hazards.
    (Comment 400) Some comments addressing radiological hazards ask us 
to clarify that radiological hazards are an example of chemical 
hazards; clarify the requirements by identifying specific radiological 
hazards and including them in the regulatory text; develop a baseline 
for acceptable levels and specific monitoring recommendations for each 
product; defer compliance on the control of radiological hazards until 
more comprehensive information is available to industry and regulators 
on how best to control for and assess compliance in controlling the 
hazard; clarify whether irradiation of produce for phytosanitary 
purposes must be considered as a potential radiological hazard; confirm 
that a facility is required to assess only two types of radiological 
hazards (production water and accidental contamination from accidental 
release from a nuclear facility); and clarify whether we will require 
consideration of radiological hazards by processors subject to our 
HACCP regulations for seafood and juice.
    (Response 400) The regulatory text specifies that radiological 
hazards are an example of chemical hazards. We decline the requests to 
identify specific radiological hazards, include them in

[[Page 56028]]

the regulatory text, and develop a baseline for acceptable levels, with 
specific monitoring recommendations for each product type. As discussed 
in the 2013 proposed human preventive controls rule (78 FR 3646 at 
3667), radiological contamination of foods is a rare event. The most 
relevant information that would lead a food facility to consider and 
evaluate a specific radiological hazard to determine whether it is a 
hazard requiring a preventive control would be publicly disseminated 
information following a particular event, such as contamination arising 
from accidental release from a nuclear facility or from damage to a 
nuclear facility from a natural disaster. We already have issued 
guidance on levels of concern for radionuclides that could be a known 
or reasonably foreseeably hazard in certain circumstances, such as 
after an accident at a nuclear facility (Ref. 68). In light of this 
current guidance, we see no reason to provide additional guidance to 
address hypothetical circumstances or to defer compliance until more 
information is available.
    A facility does not need to consider sources of radiation used in 
accordance with a food additive regulation in its hazard analysis. Such 
sources are safe for their intended use. As with any other equipment 
and substances used in the manufacture of food, a facility must comply 
with all applicable safety requirements established either under the 
terms of a food additive regulation or by an authority such as the 
Occupational Safety and Health Administration. Although production 
water and accidental contamination from accidental release from a 
nuclear facility would be the two most likely sources of radiological 
hazards that a facility would need to address, we are not limiting the 
facility's responsibilities to these two sources. We cannot anticipate 
the future.
    We have not taken action to revise either our HACCP regulations for 
seafood and juice or our current guidance on hazards and controls for 
seafood and juice (Ref. 42) (Ref. 43) to require or recommend that 
processors of those products address radiological hazards in their food 
safety plans. However, in the event of a situation such as an accident 
at a nearby nuclear facility, it would be prudent for such processors 
to consider whether the potential for contamination with radiological 
hazards would warrant modification of their food safety plans.
    (Comment 401) Some comments assert that predictable intentional 
hazards should be in the food safety plan but unexpected intentional 
hazards should be part of a food defense plan.
    (Response 401) This rule only requires a facility to consider 
intentionally introduced hazards when such hazards are introduced for 
purposes of economic gain. Hazards that may be intentionally introduced 
by acts of terrorism are the subject of the 2013 proposed intentional 
adulteration rule (78 FR 78014, December 24, 2013).
    (Comment 402) Some comments disagree that the human preventive 
controls rule should address hazards that are intentionally introduced 
for purposes of economic gain (economically motivated adulteration). 
Some of these comments assert that economically motivated adulteration 
is not a good fit for the hazard analysis and preventive controls 
framework because it is, in all but the rarest of circumstances, an 
issue of product integrity and quality, whereas food safety systems are 
designed and built to prevent or mitigate food safety hazards. Some 
comments state that traditional food safety hazards are primarily both 
identified and addressed at the facility level, but economically 
motivated adulteration is typically handled by the corporate parent 
company, where supply chain management programs are typically located. 
These comments also assert that food safety-related economically 
motivated adulteration is extremely rare and that predicting 
economically motivated adulteration to prevent it is extremely 
difficult. Some comments assert there will be no measurable benefit to 
food safety by imposing requirements to consider economically motivated 
adulteration as part of a food safety plan and that doing so will 
consume limited resources without a corresponding increase in consumer 
protection. Other comments assert that there is no need to require a 
facility to identify hazards intentionally introduced for purposes of 
economic gain because the misbranding and adulteration provisions of 
the FD&C Act already sufficiently provide safeguards against economic 
gain.
    (Response 402) We agree with the comments stating that the 
requirement to consider hazards intentionally introduced for purposes 
of economic gain is narrow. Such hazards will be identified in rare 
circumstances, usually in cases where there has been a pattern of 
economically motivated adulteration in the past. In addition, we define 
hazards to only include those agents that have the potential to cause 
illness or injury. Economically motivated adulteration that affects 
product integrity or quality, for example, but not food safety, is out 
of the scope of this rule. We continue to believe that there is benefit 
in taking this preventive approach to economically motivated 
adulteration, and not solely on enforcing the preexisting misbranding 
and adulteration provisions of the FD&C Act after a violation occurs.
    As discussed in sections XLII through XLIX, we are finalizing 
supply-chain program provisions. It is consistent with the framework of 
this rule for a facility to address hazards requiring a preventive 
control that may be intentionally introduced for purposes of economic 
gain through the facility's supply-chain program.
    (Comment 403) Some comments express concern about identifying 
hazards that may be intentionally introduced for purposes of economic 
gain because there are potentially an unlimited number of unknown or 
yet-to-be-identified hazards that could be intentionally introduced for 
purposes of economic gain by an unscrupulous supplier. These comments 
disagree with our attempt to narrow the field of potential scenarios 
for economically motivated adulteration to circumstances where there 
has been a pattern of such adulteration in the past.
    Some comments assert that our attempt to narrow the field of 
potential scenarios for economically motivated adulteration is both too 
broad and too narrow at the same time. These comments assert that our 
attempt is too broad, because we expect facilities to consider patterns 
of adulteration from the past ``even though the past occurrences may 
not be associated with the specific supplier or the specific food 
product'' and a requirement to consider every potential product and 
potential supplier makes the task open ended. These comments further 
assert that our attempt is too narrow, because a focus on patterns of 
adulteration in the past is unlikely to reveal potential future 
instances of economically motivated adulteration and because those 
intending to defraud purchasers for economic gain are trying to avoid 
detection. According to these comments, once a food safety-related 
instance of economically motivated adulteration is uncovered, 
perpetrators quickly move to carry out their fraudulent activities in a 
different way. Some comments assert that there are alternative ways to 
control hazards that may be intentionally introduced for purposes of 
economic gain without specific regulatory requirements, such as by 
having an effective supplier approval program with appropriate 
qualification and verification activities; through business-to-business 
relations, expectations, and contracts; and through

[[Page 56029]]

a vulnerability assessment and control plan tailored specifically to 
economically motivated adulteration.
    (Response 403) We disagree that the requirement is too broad. A 
facility must conduct a hazard analysis for each type of food 
manufactured, processed, packed, or held at the facility. There is no 
requirement to consider every potential product or potential supplier. 
We also disagree that the requirement is too narrow. Some individuals 
intending to defraud purchasers for economic gain will develop entirely 
novel ways of adulterating food to suit their purposes. We agree that 
these circumstances may not lend themselves to the preventive approach 
required here. We encourage, but do not mandate, that facilities adopt 
other measures they deem appropriate to mitigate the risks of 
economically motivated adulteration that this rulemaking does not 
address. Still, the repeated economically motivated adulteration of 
spices with toxic colorants demonstrates that patterns of economically 
motivated adulteration can emerge and should be considered as part of a 
food safety plan (see the examples in the 2014 supplemental human 
preventive controls notice, 79 FR 58524 at 58550-58551).
    (Comment 404) Some comments ask us to limit the requirement to 
identify hazards that may be introduced for purposes of economic gain 
to only those hazards that pose a risk to public health for which there 
has been a pattern in the past. Some comments assert that in those few 
instances where a hazard was intentionally introduced the underlying 
intention was to defraud rather than to cause harm, and the food safety 
hazard was an unintended consequence. Some comments ask us to focus the 
hazard identification solely on inbound products, because it is obvious 
that hazards introduced by the facility itself will not be prevented 
through a hazard analysis. Some comments ask us to narrow the scope of 
the requirement by specifying that facilities focus on three 
situations: (1) Situations in which there has been a pattern of similar 
adulteration in the past; (2) foods or ingredients for which quality 
assurance methods may not sufficiently characterize the food or 
ingredient to assure its identity, and; (3) foods or ingredients for 
which there are substitutes that are likely to be harmful that would be 
considered obvious to one skilled in food science.
    (Response 404) We decline to make the changes suggested in these 
comments, because they are unnecessary. Because of our definition of 
hazard, the requirement is already limited to economically motivated 
adulteration that has the potential to cause illness or injury. Under 
the final rule, a facility does not need to identify a hazard related 
to economically motivated adulteration when there is no risk to public 
health or when the economically motivated adulteration is not known or 
reasonably foreseeable.
    We agree that the three circumstances suggested by the comments are 
an appropriate focus for facilities who seek guidance on how to 
approach the requirements, but decline the request to specify these 
limitations of the scope in the regulatory text. As already noted, some 
comments assert that our attempt to narrow the field of potential 
scenarios for economically motivated adulteration is both too broad and 
too narrow at the same time (see Comment 403). Although we continue to 
believe that the instances in which a facility will identify a hazard 
intentionally introduced for economic gain will be rare, we also 
consider that limiting the scope of the requirement in the regulatory 
text would be both pre-judging the future and inconsistent with the 
public health objectives of this rule.
    (Comment 405) Some comments ask us to allow implementation of the 
major provisions in FSMA before establishing requirements to address 
economically motivated adulteration. These comments assert that 
economically motivated adulteration requires a completely different 
paradigm than unintentional adulteration. In addition, because 
economically motivated adulteration is typically addressed through 
product specifications, supplier relationships, and good business 
practices, implementation of these other provisions of the human 
preventive controls rule are likely to have a positive effect on 
preventing economically motivated adulteration.
    (Response 405) We disagree that economically motivated adulteration 
requires a completely different paradigm than unintentional 
adulteration. Hazards intentionally introduced for economic gain are 
addressed here with the same preventive framework as every other 
hazard. As such, we do not see a compelling reason to delay 
implementation of the requirements to address economically motivated 
adulteration.

C. Proposed Sec.  117.130(c)--Evaluation of Whether a Hazard Requires a 
Preventive Control

    We proposed that the hazard analysis must include an evaluation of 
the identified hazards to assess the severity of the illness or injury 
if the hazard were to occur and the probability that the hazard will 
occur in the absence of preventive controls; and environmental 
pathogens whenever an RTE food is exposed to the environment prior to 
packaging and the packaged food does not receive a treatment that would 
significantly minimize the pathogen (proposed Sec.  117.130(c)(1)). We 
also proposed that the hazard evaluation must consider the effect of 
the following on the safety of the finished food for the intended 
consumer: (1) The formulation of the food; (2) the condition, function, 
and design of the facility and equipment; (3) raw materials and 
ingredients; (4) transportation practices; (5) manufacturing/processing 
procedures; (6) packaging activities and labeling activities; (7) 
storage and distribution; (8) intended or reasonably foreseeable use; 
(9) sanitation, including employee hygiene; and (10) any other relevant 
factors (proposed Sec.  117.130(c)(2)).
    (Comment 406) Some comments ask us to revise the requirement to 
include an evaluation of environmental pathogens to avoid the 
implication that an intervention is needed when there may be other 
controls (such as pH or formulation) that would significantly minimize 
or prevent the pathogen. These comments suggest that we revise the 
provision to require that a hazard evaluation include an evaluation of 
environmental pathogens whenever an RTE food is exposed to the 
environment prior to packaging and the packaged food does not receive a 
treatment ``or otherwise include a control measure'' that would 
significantly minimize the pathogen.
    (Response 406) We have revised the provision on the hazard 
evaluation for environmental pathogens to specify that the packaged 
food does not receive a treatment or otherwise include a control 
measure (such as a formulation lethal to the pathogen) that would 
significantly minimize the pathogen. We agree that controls such as 
formulation can function as a ``kill step'' and that the provision 
should make clear that such controls can be used in lieu of 
``treatment.''
    (Comment 407) Some comments ask us to clarify what we meant by 
``other relevant factors'' and note that natural disasters (which we 
previously discussed) (78 FR 3646 at 3738) are ``usually exceptional 
events'' that are best managed in a facility crisis management plan. 
Other comments ask us to specify that the hazard evaluation must 
consider any relevant geographic, temporal, agricultural, or other 
factors that may affect the severity or probability of the hazard.

[[Page 56030]]

    (Response 407) We included ``other relevant factors'' to emphasize 
that the list of factors in the provision is not an exhaustive list and 
that a facility is responsible to consider those factors that play a 
role in its determination of whether a potential hazard is a hazard 
requiring a preventive control, regardless of whether those factors are 
listed in the provision. A facility that already addresses 
circumstances such as natural disasters in other plans may consider the 
applicable part of those plans to be part of its food safety plan (see 
Sec.  117.330).
    We agree that geographic, temporal, and agricultural factors are 
examples of ``other relevant factors.'' For example, hazards such as 
aflatoxin are subject to a weather-dependent effect in that aflatoxin 
levels in some RACs are more of a problem in some years than in others. 
We have added the temporal nature of some hazards associated with some 
RACs as an example of ``other relevant factors'' to consider (see Sec.  
117.130(c)(2)(x)).
    (Comment 408) Some comments assert that it is unnecessary to 
establish a specific provision that identifies environmental pathogens 
as a hazard that is required to be evaluated.
    (Response 408) We are retaining the provision, which we proposed to 
highlight the importance of environmental pathogens in some facilities 
and to make clear that sanitation controls, with appropriate 
verification, may be necessary in addition to sanitation measures that 
the facility establishes as a matter of CGMP.
    (Comment 409) Some comments assert that it can be difficult to 
determine ``the severity of the illness or injury if the hazard were to 
occur'' for a food that is not RTE food, especially for raw materials 
and ingredients.
    (Response 409) We acknowledge that determining the severity of the 
illness or injury if the hazard were to occur can be more difficult for 
some foods than for other foods. However, recent outbreaks and large-
scale recalls demonstrate the potential for some raw materials and 
other ingredients to cause serious illness or injury (78 FR 3646 at 
3656 and 3737). For reasons such as these, the rule requires that a 
facility identify and evaluate multiple sources of information (i.e., 
experience, illness data, scientific reports, and other information) 
and also requires that the food safety plan (which includes the written 
hazard analysis) be prepared, or its preparation overseen, by one or 
more preventive controls qualified individuals (see Sec.  
117.126(a)(2)).
    (Comment 410) Some comments ask us to provide that a facility may 
rely on existing systems in place to manage radiological risks, such as 
steps taken by government officials to inspect ingredients obtained 
from a geographic region that has been the subject of a nuclear 
accident.
    (Response 410) A facility may consider all available resources in 
appropriately determining whether a known or reasonably foreseeable 
radiological hazard is a hazard requiring a preventive control and in 
appropriately determining what preventive controls, and associated 
preventive control management components, to establish and implement in 
light of a radiological hazard that is a hazard requiring a preventive 
control. However, existing systems in place to manage radiological 
risks, such as after a nuclear accident, do not absolve a facility of 
its responsibilities to establish and implement preventive controls to 
address a radiological hazard when circumstances warrant.
    (Comment 411) Some comments assert that there would be no need to 
evaluate an environmental pathogen if the finished food is inherently 
incapable of supporting pathogen survival (e.g., in acid or acidified 
foods). These comments ask us to modify the requirement to narrow the 
circumstances when it would apply to whenever an RTE food is ``capable 
of supporting pathogen growth to, or survival at, infectious levels.''
    (Response 411) The suggestion of the comments pre-judges the 
outcome of the hazard analysis for a wide variety of food products. A 
facility can consider factors such as whether the formulation of a food 
would not support the growth of the pathogen to increased numbers, or 
would cause pathogens to die off over time, in determining whether an 
environmental pathogen is a hazard requiring a preventive control. 
Importantly, for many pathogens the mere presence of the pathogen 
presents a risk of illness, and the time necessary for pathogens in the 
food to die off due to the formulation of the food varies. Thus, a 
facility that appropriately determines that an environmental pathogen 
is not a hazard requiring a preventive control due to factors such as 
formulation of a food would need to document the basis for its 
determination in its written hazard analysis.
    (Comment 412) Some comments ask us to include a definition for 
``exposed to the environment'' to avoid confusion. These comments state 
their understanding that this phrase means that the product is in a 
form that is exposed and/or subject to direct human contact.
    (Response 412) We decline this request. It is not necessary to 
define every term and phrase included in the rule. See the Appendix to 
the 2013 proposed preventive controls rule for examples of food 
products that are, or are not, exposed to the environment (78 FR 3646 
at 3819). In the context of doing a hazard analysis, the facility must 
appropriately determine whether contamination of RTE foods with 
pathogenic organisms from the production environment can occur; to make 
such an appropriate determination does not require a definition of 
``exposed to the environment.''
    (Comment 413) Some comments assert that the proposed requirement to 
consider the effect of ``intended or reasonably foreseeable use'' on 
the safety of the finished food for the intended consumer is too open-
ended and vague to provide clear direction to industry and regulators 
pertaining to compliance obligations. These comments ask us to 
substitute ``expected use'' for ``intended or reasonably foreseeable 
use.''
    (Response 413) We decline this request. We agree that the term 
``expected use'' has potential to communicate both intended use and 
reasonably foreseeable use but disagree that this interpretation would 
be universal. We are retaining ``intended or reasonably foreseeable 
use'' to be explicit that a facility must consider what is reasonably 
foreseeable in addition to what is intended. (See also Response 121.)
    (Comment 414) Some comments express concern about the potential for 
a hazard evaluation to overlook food allergens and assert that food 
allergens must be designated as significant hazards whenever they 
occur. Other comments assert that a determination of whether a food 
allergen is a significant hazard should consider protein levels in 
ingredients. Other comments assert that food allergens are not a 
problem in produce, except for tree nuts.
    (Response 414) The hazard identification must consider chemical 
hazards, including food allergens (Sec.  117.130(b)(1)(ii)). Thus, food 
allergens cannot be overlooked. Whether the protein level of a food 
allergen in ingredients is a factor that must be considered in the 
hazard evaluation would be determined by the preventive controls 
qualified individual who must conduct or oversee the hazard analysis. 
We agree that most produce does not satisfy the definition of food 
allergen, but the evaluation of whether a food allergen hazard exists 
in any particular food still must be considered by the preventive 
controls qualified individual

[[Page 56031]]

who must conduct or oversee the hazard analysis.
    (Comment 415) Some comments ask us to specify that the hazard 
evaluation be more specific about issues relevant to raw materials and 
ingredients, including how raw materials are selected and shipped, how 
suppliers are evaluated, and how shipments are inspected on receipt.
    (Response 415) We decline this request. When a hazard requiring a 
preventive control in a raw material or other ingredient is controlled 
before receipt, the receiving facility would address such specifics in 
the supply-chain program that would be required as a preventive control 
(see subpart G). In addition, the rule already specifies that the 
hazard evaluation must consider the effect of raw materials and other 
ingredients on the finished food (Sec.  117.130(c)(2)(iii)).
    (Comment 416) Some comments ask us to specify that a hazard 
evaluation consider the history of the class of product causing 
outbreaks from a particular pathogen.
    (Response 416) We decline this request. The rule already specifies 
that the hazard analysis must be based on experience, illness data, 
scientific reports, and other information (see Sec.  117.130(a)).
    (Comment 417) Some comments assert that a facility that exports 
fresh fruit to the United States should not be required to consider 
storage and distribution of the food because storage and distribution 
are parts of the supply chain that are not known or controlled by the 
supplier. These comments also assert that records showing where the 
facility sent the food should suffice when a facility exports fresh 
fruit to the United States. Likewise, some comments assert that a 
facility that exports fresh fruit to the United States should not be 
required to consider intended or foreseeable use because the facility 
could not necessarily ascertain the intended or foreseeable use.
    (Response 417) Each facility is part of a complex food supply chain 
and a supplier must consider how its food products are likely to be 
stored, distributed, and used. For example, entities that transport a 
food product generally rely on the shipper (in this case, the facility 
exporting the fruit) to provide information relevant to the safe 
handling of the food during transport. As another example, a facility 
exporting fruit could simply assume that its food product will be 
consumed without any processing to reduce any pathogens that may be on 
the fruit, unless it knows that its food product is destined for a 
commercial processing facility that makes processed fruit products 
using processes to adequately control pathogens.
    (Comment 418) Some comments note our previous discussion about 
conducting a hazard evaluation for pathogens, including addressing 
whether a specific product has been documented to be contaminated with 
such pathogens (78 FR 3646 at 3737). These comments ask us to clarify 
what we mean by ``documented,'' particularly in the context of a single 
incident.
    (Response 418) We expect a facility to take appropriate steps to 
remain aware of current reports of food contamination. For example, 
such reports are often disseminated through press releases that we post 
on our Web site when firms send them to us, and a facility can 
subscribe to our service that alerts interested persons to recalls, 
market withdrawals, and other safety alerts (Ref. 69). In appropriately 
determining whether a pathogen is a hazard requiring a preventive 
control, the facility would consider factors such as the severity of 
the hazard and the probability that the hazard would occur in the 
absence of preventive controls. Whether a single incident warrants 
consideration of a pathogen as a hazard requiring a preventive control 
may depend on the incident.
    (Comment 419) Some comments ask us to specify that the hazard 
analysis consider the impact of a pathogen on high-risk populations.
    (Response 419) We decline this request. The rule requires that a 
hazard evaluation consider the severity of the illness or injury if the 
hazard were to occur. This evaluation would consider the expected 
population of consumers and the severity of consequences when the 
expected population is exposed to a pathogen that is a known or 
reasonably foreseeable hazard in the food.
    (Comment 420) Some comments assert that the proposed requirements 
for hazard evaluation could be interpreted in many ways. For example, a 
facility could conclude that the presence of a hand sink or boot dip 
prior to entering the processing area will reduce the likelihood of 
environmental pathogens and that environmental pathogens are not a 
significant hazard, whereas a regulator could interpret this provision 
to mean that a facility must always consider an environmental pathogen 
to be a significant hazard when the criteria in the provision are met, 
unless the facility can provide evidence to the contrary.
    (Response 420) We agree that the requirements for hazard evaluation 
are subject to alternative interpretations. This is often the case, 
particularly when a regulation is new. The provision specifies that a 
facility must evaluate whether an environmental pathogen is a hazard 
requiring a preventive control in particular circumstances--i.e., 
whenever an RTE food is exposed to the environment prior to packaging 
and the packaged food does not receive a treatment or otherwise include 
a control measure (such as a formulation lethal to the pathogen) that 
would significantly minimize the pathogen. The written hazard analysis 
must be prepared (or its preparation overseen by) a preventive controls 
qualified individual (see Sec.  117.126(a)(2) and (b)(1)). The 
preventive controls qualified individual for a facility that determines 
that an environmental pathogen is not a hazard requiring a preventive 
control in such circumstances must document that determination, and a 
regulator would consider the adequacy of the facility's documented 
determination before reaching a conclusion as to whether the facility 
had failed to satisfy the requirements. However, the use of a hand sink 
or boot dip prior to entering the processing area to reduce the 
likelihood of environmental pathogens may also be considered to be part 
of the sanitation controls for the environmental pathogen.
    (Comment 421) Some comments assert that the hazard assessment must 
document that the benefits of using a particular chemical outweigh the 
potential risks, such as the risks of the chemical causing antibiotic 
resistance. Other comments ask us to consider the factors listed in the 
provision for potential benefits, as well as risks.
    (Response 421) A hazard is an agent that is reasonably likely to 
cause illness or injury in the absence of its control (Sec.  117.3). As 
previously discussed, the focus of the requirement on risk (i.e., the 
severity of the hazard and the likelihood that it will occur) is 
consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and 
Federal HACCP regulations for seafood, juice, and meat and poultry (78 
FR 3646 at 3735). None of these national or international guidelines or 
regulations suggest that a risk-benefit analysis is part of a hazard 
analysis.
    Moreover, these comments appear to be directed to a determination 
by a facility of which raw materials or other ingredients to 
intentionally add to a food product rather than to biological, 
chemical, or physical hazards that, for example, occur naturally in the 
raw materials or other ingredients or may be unintentionally 
introduced. Any raw material or other ingredient that a facility adds 
to a food product must be lawful. This rule does not address the

[[Page 56032]]

criteria for determining whether a particular raw material or other 
ingredient is lawful under the applicable statutory provisions (e.g., 
under section 409 of the FD&C Act regarding food additives).
    (Comment 422) Some comments object to the use of sucrose fatty acid 
esters as an example (in our previous discussion, 78 FR 3646 at 3737) 
for distinguishing between raw materials and ingredients because 
sucrose fatty acid esters are an obscure product and the example does 
not clearly distinguish between the two terms.
    (Response 422) As discussed in Response 65, we have decided to 
return to the phrase ``raw materials and other ingredients'' (rather 
than the proposed phrase ``raw materials and ingredients'') throughout 
the rule to make it clear that raw materials are ingredients. As a 
result, it is not necessary to provide a more broadly applicable 
example to distinguish between the terms.
    (Comment 423) Some comments ask us to clarify how the requirements 
of this rule apply to transportation practices and assert that a 
facility receiving product should not be responsible for hazards in 
foods that are not being transported under its custody. Other comments 
assert that we should require all entities across the supply chain to 
identify food transportation as a critical control point under the 
facility's hazard analysis.
    (Response 423) We address specifics about the responsibilities of 
shipping facilities and receiving facilities in the 2014 proposed 
sanitary transportation rule (79 FR 7006). We will address comments 
regarding the responsibilities of shippers and receivers in the final 
sanitary transportation rule. For the purpose of the hazard analysis, 
whether a particular facility would identify food transportation as a 
critical control point through its hazard analysis would depend on the 
circumstances, such as whether the food is a TCS food. We expect a 
facility that identifies temperature control, including during 
transportation, as a preventive control (whether or not as a CCP), to 
communicate the need for appropriate temperature control to the person 
transporting the food.
    (Comment 424) Some comments ask us to clarify our previous 
statements (78 FR 3646 at 3737) regarding whether and how label 
information, such as cooking instructions, may be a factor to consider 
in a hazard evaluation.
    (Response 424) See Response 390 regarding consumer research about 
consumer cooking practices.

XXVI. Subpart C: Comments on Proposed Sec.  117.135--Preventive 
Controls

    We proposed requirements to identify and implement preventive 
controls to provide assurances that significant hazards will be 
significantly minimized or prevented and the food manufactured, 
processed, packed, or held by the facility will not be adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of 
the FD&C Act. Some comments support the proposed requirements without 
change. For example, some comments agree that preventive controls must 
be written and include process controls, food allergen controls, 
sanitation controls, a recall plan, and other controls as appropriate 
and necessary. Some comments that support the proposed provisions 
suggest alternative or additional regulatory text (see, e.g., Comment 
428, Comment 431, Comment 432, and Comment 439) or ask us to clarify 
how we will interpret the provision (see, e.g., Comment 425, Comment 
437, and Comment 440).
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we have revised the proposed requirements as shown in table 
31, with editorial and conforming changes as shown in table 52.

                    Table 31--Revisions to the Proposed Requirements for Preventive Controls
----------------------------------------------------------------------------------------------------------------
                 Section                          Description                           Revision
----------------------------------------------------------------------------------------------------------------
117.135(c)(1)...........................  Process controls...........  Clarify that the requirements for process
                                                                        controls depend on the role of the
                                                                        process control in the food safety
                                                                        system.
117.135(c)(2)(i)........................  Food allergen controls.....  Specify that food be protected from
                                                                        allergen cross-contact during handling,
                                                                        as well as during storage.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.135(a)--Requirement To Identify and Implement 
Preventive Controls

    We proposed that you must identify and implement preventive 
controls, including at critical control points, if any, to provide 
assurances that significant hazards will be significantly minimized or 
prevented and the food manufactured, processed, packed, or held by your 
facility will not be adulterated under section 402 of the FD&C Act or 
misbranded under section 403(w) of the FD&C Act. We also proposed that 
these preventive controls include controls at CCPs, if there are any 
CCPs, and controls, other than those at CCPs, that are also appropriate 
for food safety.
    Some comments support the flexibility provided to facilities to 
implement preventive controls that are appropriate to the facility and 
the food. Other comments support the clarification, in the 2014 
supplemental human preventive controls rule, that not all preventive 
controls are established at CCPs and that some food safety plans will 
have not CCPs. We are finalizing the provision as proposed with the 
editorial and conforming changes in table 52.

B. Proposed Sec.  117.135(b)--Requirement for Written Preventive 
Controls

    We proposed that preventive controls must be written.
    (Comment 425) Some comments from the almond industry explain that 
USDA's regulations for a mandatory program for reduction of Salmonella 
on almonds require almond handlers (facilities) to subject almonds to a 
process that delivers a minimum 4-log destruction of Salmonella. The 
process can be applied by the almond handler (facility) or off-site at 
a ``custom processor.'' These comments agree that preventive controls 
should be written, but ask us to clarify whether documentation of 
treatment by its ``custom processor'' would be accepted as a ``written 
preventive control'' when the ``custom processor'' controls the hazard.
    (Response 425) The question posed by these comments highlights the 
difference between the records required in the food safety plan and the 
records documenting the implementation of the food safety plan. The 
``written preventive controls'' are part of the food safety plan, 
whereas the records

[[Page 56033]]

documenting treatment are implementation records. Implementation 
records documenting treatment, whether by a facility or its ``custom 
processor,'' would not satisfy the requirements for written preventive 
controls. However, specifying that the preventive control for a 
specific hazard is a particular treatment by a ``custom processor,'' 
along with information that describes the treatment, would satisfy the 
requirement for written preventive controls.

C. Proposed Sec.  117.135(c)(1)--Process Controls

    We proposed that preventive controls include process controls as 
appropriate to the facility and the food. Process controls include 
procedures, practices, and processes to ensure the control of 
parameters during operations such as heat processing, acidifying, 
irradiating, and refrigerating foods. Process controls must include, as 
appropriate to the applicable control, parameters associated with the 
control of the hazard, and the maximum or minimum value, or combination 
of values, to which any biological, chemical, or physical parameter 
must be controlled to significantly minimize or prevent a significant 
hazard.
    (Comment 426) Some comments state that assigning a parameter and 
associated minimum and maximum values for some process controls (such 
as refrigeration (including freezing), baking, or water activity) may 
be possible, but not be necessary for food safety. These comments ask 
us to require minimum and maximum values to be assessed against the 
applicable food safety need, or otherwise make clear that the 
implications of not controlling minimum and maximum values must be 
assessed in light of the circumstances. Other comments express concern 
that ``as appropriate to the applicable control'' could be interpreted 
as suggesting that if it is merely feasible to establish parameters for 
a process control, they must be established. Other comments express 
concern that the proposed requirement suggests that if a parameter is 
not ``controlled,'' a regulator could conclude that the facility is not 
in compliance with the rule because it necessarily has not 
significantly minimized or prevented a significant hazard.
    One comment provides two examples of refrigeration controls to 
explain its view that the management components for refrigeration 
controls will vary depending on the role of refrigeration within the 
facility's overall food safety system. (See Comment 455.) This comment 
also provides an example to make a point that water activity may not be 
necessary for food safety even when maximum or minimum values are 
assigned. In this example, a parameter for water activity could be set 
at less than 0.85 based on the control of Staphylococcus aureus, but 
such a parameter would not be necessary for food safety for a product 
such as a dry seasoning blend that has a water activity of 0.2-0.3. 
This comment also notes that when there are many different controls 
working together to minimize or prevent one hazard simultaneously (such 
as a formulation that uses a combination of moisture, pH, titratable 
acidity, and salt level), noncompliance with any one parameter will not 
necessarily result in an unsafe product.
    (Response 426) See Response 455. We have revised the regulatory 
text to specify that process controls must include parameters and 
minimum or maximum values as appropriate to both the nature of the 
applicable control and its role in the facility's food safety system.
    (Comment 427) Some comments ask us to delete the phrase ``to 
significantly minimize or prevent a significant hazard.''
    (Response 427) We decline this request. ``Significantly minimize or 
prevent a significant hazard'' (which we have revised to 
``significantly minimize or prevent a hazard requiring a preventive 
control'') is the standard for controlling the hazards. Although the 
phrase could be viewed as redundant with the standard in the 
requirement to identify and implement preventive controls (Sec.  
117.135(a)(1)), repeating that standard in the requirements for 
parameters and the minimum or maximum values associated with control of 
the hazard emphasizes the standard, which is appropriate for process 
controls.

D. Proposed Sec.  117.135(c)(2)--Food Allergen Controls

    We proposed that preventive controls include, as appropriate to the 
facility and the food, food allergen controls that include those 
procedures, practices, and processes employed for ensuring protection 
of food from allergen cross-contact, including during storage and use, 
and for labeling the finished food, including ensuring that the 
finished food is not misbranded under section 403(w) of the FD&C Act.
    (Comment 428) Some comments ask us to specify that food be 
protected from allergen cross-contact during handling, as well as 
during storage.
    (Response 428) We have revised the provision as requested by the 
comments.
    (Comment 429) Some comments assert that food allergen controls 
should be based on hazard analysis and risk. Other comments provide 
examples of existing industry guidance that addresses food allergen 
controls. Some comments note that food allergen controls are addressed 
in the PMO (e.g., Appendix K, the voluntary HACCP program).
    Other comments assert that establishing food allergen controls at 
this time is premature or that food allergen controls need to be 
balanced with pathogen controls. Some comments ask us to clarify 
whether the standard that would be established for food allergen 
controls is ``absolutely allergen free.''
    (Response 429) We have acknowledged that it is premature to require 
validation of food allergen controls (see 78 FR 3646 at 3755 and 
Response 515). However, we disagree that requiring a facility to 
establish food allergen controls as a preventive control is premature 
at this time, as evidenced by the existing industry guidance, and 
requirements of programs such as Appendix K of the PMO, submitted by 
comments. We agree that whether a facility appropriately determines 
that food allergen controls are necessary will be based on the outcome 
of the hazard analysis (see the requirements for hazard analysis in 
Sec.  117.130(a) and (c)). A facility that already has established food 
allergen controls based on recommendations in industry guidelines or 
requirements of programs such as the voluntary HACCP program of the PMO 
can incorporate those established food allergen controls into its own, 
facility-specific food safety plan, and rely on its existing records 
for those food allergen controls to demonstrate compliance with the 
requirements of this rule (see Sec.  117.330). Whether a facility needs 
to establish food allergen controls in addition to pathogen controls 
depends on the outcome of the facility's hazard analysis; a facility 
that determines that both allergens and pathogens are hazards requiring 
a preventive control in the manufacturing, processing, packing, or 
holding of a food product must address both hazards.
    The requirements for food allergen controls do not establish a 
particular standard. In general, when we do establish a standard we 
avoid ``absolute'' standards such as the ``absolutely allergen free'' 
standard mentioned by the comment.
    We appreciate receiving examples of food allergen control guides.
    (Comment 430) Some comments ask us to revise the proposed 
requirement from ``food allergen controls must

[[Page 56034]]

include'' to ``food allergen controls include.''
    (Response 430) In the 2014 supplemental human preventive controls 
notice, we proposed a series of revisions to the overall framework of 
the requirements for hazard analysis and risk-based preventive 
controls, including revisions to the requirements for preventive 
controls to emphasize that the preventive controls that a facility must 
establish and implement are those appropriate to the facility and the 
food (79 FR 58524 at 58541-58543). With respect to food allergen 
controls, we proposed to first specify what food allergen controls 
``include'' (i.e., procedures, practices, and processes to control food 
allergens), as requested by these comments. However, we also proposed 
to continue to specify minimum requirements for what food allergen 
controls must include when a facility determines that a food allergen 
is a hazard requiring a preventive control--i.e., those procedures, 
practices, and processes employed for ensuring protection of food from 
allergen cross-contact and for labeling the finished food.
    To the extent that these comments are asking us to clarify the 
distinction between a description of what constitutes a food allergen 
control and the minimum requirements for what food allergen controls 
must include when a facility determines that a food allergen is a 
hazard requiring a preventive control, the regulatory text we proposed 
in the 2014 supplemental human preventive controls notice modified the 
regulatory text as requested. However, to the extent that these 
comments are asking us to modify the provision so that it no longer 
establishes the minimum requirements for what food allergen controls 
must include when a facility determines that a food allergen is a 
hazard requiring a preventive control, we disagree. The listed minimum 
requirements are consistent with long-standing approaches to the 
control of food allergens and provide flexibility for a facility to 
identify and implement those procedures, practices, and processes most 
suited to the control of food allergen hazards in light of the facility 
and its food products (Ref. 70) (Ref. 71); see also the discussion at 
78 FR 3646 at 3741.
    (Comment 431) Some comments ask us to revise the requirement that 
food allergen controls must include labeling controls by adding the 
phrase ``to ensure that major food allergens are properly disclosed.''
    (Response 431) We decline this request. The provision requires that 
the procedures, practices, and processes employed for labeling the 
finished food include those for ensuring that the finished food is not 
misbranded under section 403(w) of the FD&C Act. Requiring that 
labeling procedures, practices, and processes ensure that major food 
allergens are properly disclosed would be redundant with the proposed 
requirement that they ensure that the finished food is not misbranded 
under section 403(w).
    (Comment 432) Some comments ask us to revise the requirement that 
food allergen controls must include labeling controls by adding the 
phrase ``as appropriate'' because section 201(qq)(2)(A) of the FD&C Act 
excludes highly refined oils from the definition of ``major food 
allergen.''
    (Response 432) We decline this request because qualifying that the 
requirement applies ``as appropriate'' is not necessary to achieve the 
outcome requested by the rule comments. If a food ingredient, such as a 
highly refined oil, is not a major food allergen, it is not subject to 
the requirements for food allergen controls.
    (Comment 433) Some comments assert that quantification or 
measurement of specific parameters is not appropriate for some food 
allergen controls.
    (Response 433) We agree with these comments. In the 2014 
supplemental human preventive controls notice, we clarified that the 
requirements for parameters and maximum and minimum values apply to 
process controls.
    (Comment 434) Some comments ask us to establish thresholds for food 
allergens. Other comments assert that we should not have a ``zero-
tolerance'' approach to food allergens. Some comments ask us to require 
advisory labeling (such as a label statement that a food that does not 
contain an allergen ingredient was processed in a facility that also 
processes foods that do have specific allergen ingredients) if we do 
not establish a ``zero-tolerance'' policy for food allergen controls. 
Other comments assert we should allow advisory labeling in light of 
difficulties in developing food allergen controls.
    (Response 434) In 2008, we announced a public hearing on the use of 
advisory labeling of allergens in foods as part of a long-term strategy 
to help manufacturers use allergen advisory labeling that is truthful 
and not misleading, conveys a clear and uniform message, and adequately 
informs food-allergic consumers and their caregivers (73 FR 46302, 
October 8, 2008). In that document, we explained our concerns with food 
allergens, including food allergens inadvertently incorporated into 
manufactured foods, due to the number of reports concerning consumers 
who have experienced adverse reactions following exposure to an 
allergenic substance in a food. We also described our previous actions 
targeting food manufacturers, including: (1) A notice to manufacturers 
entitled ``Label Declaration of Allergenic Substances in Foods'' in 
1996 (Ref. 72); (2) an FDA/state partnership to increase industry's 
understanding of food allergens and to identify effective manufacturing 
controls (Ref. 73); and (3) a statement of policy, to our staff, 
regarding food allergens (Ref. 74).
    In 2012, we requested comments relevant to conducting a risk 
assessment to establish regulatory thresholds for major food allergens 
as defined in FALCPA (77 FR 74485, December 14, 2012). We noted that 
regulatory thresholds would help industry to conduct allergen hazard 
analyses and develop standards for evaluating the effectiveness of 
allergen preventive controls.
    However, establishing regulatory policy or requirements, such as a 
long-term strategy regarding use of allergen advisory labeling, or a 
specific threshold for a food allergen or a ``zero-tolerance'' policy, 
is outside the scope of this rule. The provisions of this rule, whether 
the CGMPs in subpart B or the requirements for hazard analysis and 
risk-based preventive controls in subparts C and G, are directed to 
procedures, practices, and processes for the safe manufacturing, 
processing, packing, and holding of food rather than to special 
labeling policies or specific levels of substances (such as food 
allergens) that would render food adulterated or misbranded.
    (Comment 435) Some comments assert that food allergen controls need 
not be required in specific situations, such as during the storage and 
transport of coffee and the storage of packaged foods not exposed to 
the environment.
    (Response 435) Whether food allergen controls are necessary in any 
particular circumstance depends on the outcome of the facility's hazard 
analysis. Although coffee is not a food allergen, whether coffee 
requires food allergen controls during storage and transport depends on 
factors such as how the coffee is stored and transported and whether 
there is potential for allergen cross-contact. Although we agree that 
the potential for allergen cross-contact during the storage of packaged 
foods not exposed to the environment is low, it is the responsibility 
of the preventive controls qualified individual who conducts or 
oversees the hazard analysis

[[Page 56035]]

to make an appropriate determination for an individual facility.
    (Comment 436) Some comments assert that implementation of food 
allergen controls poses particular challenges in the context of milling 
operations. As an example, these comments explain that most milling 
operations do not handle soy. However, allergen cross-contact between 
grains and soy can occur at various points in the chain of production 
and transport, such that grains arriving at a milling facility might 
already contain low levels of soy. These comments also assert that the 
presence in a desired grain of low levels of soy or of other grains is 
consistent with U.S. Grain Standards. For example, the Grain 
Inspection, Packers and Stockyards Administration (GIPSA) definition of 
corn allows for the presence of between 2 percent and 7 percent foreign 
material, depending on the grade of corn, and the presence of up to 10 
percent of other grains for which standards have been set. Although 
millers use equipment that helps to separate the desired grain from soy 
or other grains, these comments assert that complete elimination of soy 
and other grains is not practicable even under CGMP. These comments ask 
us to acknowledge that complete elimination of allergen cross-contact 
is not feasible in certain operations even under CGMP and that the 
intermittent presence of undeclared allergens is possible in certain 
foods, notwithstanding the observance of CGMP.
    (Response 436) We acknowledge that GIPSA standards may allow for 
the presence of foreign material, and that foreign material could be a 
food allergen such as soy. However, such standards are not 
determinative as to whether hazards requiring a preventive control will 
be significantly minimized or prevented and the food manufactured, 
processed, packed, or held by a facility will not be adulterated under 
section 402 of the FD&C Act or misbranded under section 403(w) of the 
FD&C Act. Thus, as the comments point out, grains that arrive at a 
facility for milling may contain levels of a food allergen that a 
milling operation would not be able to eliminate. In circumstances such 
as these, supply-chain controls directed to the supplier's cleaning 
procedures, in addition to separation techniques applied at milling, 
may be necessary to enable the milling operation to satisfy its 
responsibilities under this rule. For example, a supplier that uses 
storage bins to hold soybeans at some times and corn at other times 
could agree to additional ``cleaning'' of bins previously used to store 
soybeans by ``scouring'' the bin with corn before using the bin to hold 
corn intended for human consumption. The corn used for scouring would 
be handled appropriately--e.g., by diverting to use in animal food, 
because food allergens are not hazards requiring a preventive control 
in food for animals. Doing so would reduce the potential for residual 
soybeans to be present in the next lot of corn, sold for human 
consumption.
    (Comment 437) Some comments ask us to clarify when a facility would 
be expected to establish food allergen controls rather than rely on the 
CGMP requirements (in subpart B) to prevent allergen cross-contact, 
particularly for oilseed processors who only need to address soy 
allergens.
    (Response 437) Food allergen controls are applicable to facilities 
that handle any of the foods that are food allergens. Any facility that 
handles a single food allergen, such as a processor only handling 
soybeans to make soybean oil, may simply need to ensure that the 
products it ships into commerce are labeled with the food allergen. (If 
the oils are highly refined and do not contain soy proteins, the 
facility may need to prevent cross-contact with less highly refined 
oils that may contain soy proteins.) If the facility only produces 
foods that contain the single food allergen, there would not be any 
foods for which cross-contact could occur. For facilities that handle 
more than one allergen-containing food or both foods that contain a 
specific food allergen along with foods that do not contain that food 
allergen (such as a facility that roasts almonds, macadamia nuts, and 
cashews), the facility could establish preventive controls to ensure 
that common equipment is cleaned between each type of nut. The facility 
could use CGMPs to ensure that the different nuts are stored separately 
before and after roasting to prevent cross-contact.
    (Comment 438) Some comments ask us to confirm that FSMA does not 
change prior agency guidance on the reasonable steps that should be 
taken to prevent allergens from being unintentionally incorporated into 
the food and the limited use of allergen advisory statements where the 
risk of allergen cross-contact cannot be eliminated through CGMPs.
    (Response 438) Prior agency guidance on the reasonable steps that 
should be taken to prevent allergens from being unintentionally 
incorporated into the food and the limited use of allergen advisory 
statements is still applicable. (See also the discussion in Response 
434.)

E. Proposed Sec.  117.135(c)(3)--Sanitation Controls

    We proposed that preventive controls include, as appropriate to the 
facility and the food, sanitation controls that include procedures, 
practices, and processes to ensure that the facility is maintained in a 
sanitary condition adequate to significantly minimize or prevent 
hazards such as environmental pathogens, biological hazards due to 
employee handling, and food allergen hazards. We also proposed that 
sanitation controls must include procedures, practices, and processes 
for the cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment, and procedures for the prevention 
of allergen cross-contact and cross-contamination from insanitary 
objects and from personnel to food, food packaging material, and other 
food-contact surfaces and from raw product to processed product.
    (Comment 439) Some comments ask us to use the term ``primary 
packaging material'' rather than ``food packaging material.''
    (Response 439) We decline this request. See Response 166, in which 
we discuss what we mean by ``food packaging material'' (e.g., we do not 
intend the term ``food-packaging materials'' to include shipping 
containers such as cartons and crates that pose no risk of introducing 
contaminants or food allergens into food).
    (Comment 440) Some comments ask us to clarify whether the 
requirements for sanitation controls apply to all food facilities or 
only to those that make RTE products.
    (Response 440) The requirements for sanitation controls apply to 
all food facilities, not just those that make RTE products. The 
facility must determine through its hazard analysis when sanitation 
controls are necessary to address a hazard requiring a preventive 
control. It is reasonable to assume that sanitation controls will be 
more common in facilities that make RTE products than in facilities 
that make non-RTE products.
    (Comment 441) Some comments assert that sanitation controls are not 
necessary to prevent any hazards in distribution facilities where food-
contact surfaces are not present. Other comments assert that sanitation 
controls should be required in all cases (rather than ``as 
appropriate'') given their central importance.
    (Response 441) Under the framework established by FSMA--and 
implemented in this rule--each facility determines through its hazard 
analysis

[[Page 56036]]

when sanitation controls are necessary to control a hazard requiring a 
preventive control. The rule neither establishes circumstances (such as 
in distribution centers) where sanitation controls are not necessary 
nor pre-judges whether sanitation controls are necessary in specific 
circumstances. Although we do not expect that facilities such as 
distribution centers would determine through their hazard analysis that 
sanitation controls are required, we do expect all food establishments 
that are subject to the CGMP requirements established in subpart B to 
fully comply with applicable requirements for sanitation.

F. Proposed Sec.  117.135(c)(4)--Supply-Chain Controls

    We proposed that supplier controls include the supplier program. 
See the discussion of comments on the supplier program, now in subpart 
G, in sections XLII through XLIX. As discussed in more detail in 
section XLII, we have revised the phrase ``supplier program'' to 
``supply-chain program'' throughout the regulatory text. As a companion 
change, we have revised Sec.  117.135(c)(4) to refer to ``supply-chain 
controls'' rather than ``supplier controls.''

G. Proposed Sec.  117.135(c)(5)--Recall Plan

    We proposed that preventive controls include, as appropriate, a 
recall plan as would be required by proposed Sec.  117.137. See the 
discussion of comments on the recall plan (final Sec.  117.139) in 
section XXVIII.

H. Proposed Sec.  117.135(c)(6)--Other Controls

    We proposed that preventive controls include any other procedures, 
practices, and processes necessary to satisfy the requirements of Sec.  
117.135(a). Examples of other controls include hygiene training and 
other current good manufacturing practices.
    (Comment 442) Some comments ask us to specify that preventive 
controls include controls on raw materials and other ingredients.
    (Response 442) The final rule specifies that preventive controls 
include supply-chain controls as appropriate to the facility and the 
food. The request of these comments is addressed by the requirements 
for the supply-chain program (see Sec.  117.135(c)(4) and subpart G).
    (Comment 443) Some comments refer to our discussion that an example 
of an ``other'' preventive control could include temperature control 
for a TCS refrigerated food, and our discussion that although many 
refrigerated foods only require refrigeration for food quality, some 
refrigerated foods do require refrigeration for food safety (78 FR 3646 
at 3744). These comments ask us to be clearer about foods that require 
refrigeration for food quality rather than for food safety.
    (Response 443) Additional information about foods that do not 
require refrigeration for food safety is available in the Food Code 
(Ref. 51) (see, e.g., the definition of TCS food and the examples of 
foods that are not TCS foods in section 1-2 of the Food Code).

XXVII. Subpart C: Circumstances in Which the Owner, Operator, or Agent 
in Charge of a Manufacturing/Processing Facility Is Not Required To 
Implement a Preventive Control (Final Sec. Sec.  117.136 and 117.137)

    In the 2014 supplemental human preventive controls notice, we 
provided an opportunity for public comment on potential requirements 
for a supplier program as a preventive control, including comments on 
when a supplier program would not be required. As discussed in more 
detail in section XLII, we have revised the phrase ``supplier program'' 
to ``supply-chain program'' throughout the regulatory text. As 
summarized in table 32 and discussed more fully in the following 
paragraphs, after considering comments on when a supplier program would 
not be required, we are establishing two new provisions. Although both 
provisions have an effect on the required supply-chain program, they 
would be implemented outside the framework of a supply-chain program.

     Table 32--Summary of Applicable Provisions Regarding When the Owner, Operator, or Agent in Charge of a
               Manufacturing/Processing Facility Is Not Required to Implement a Preventive Control
----------------------------------------------------------------------------------------------------------------
                                     Proposed section
    Final section designation           designation                  Description                   Revision
----------------------------------------------------------------------------------------------------------------
117.136(a)(1)....................  N/A.................  A manufacturer/processor is not     N/A.
                                                          required to implement a
                                                          preventive control if it
                                                          determines and documents that the
                                                          type of food (e.g., RACs such as
                                                          cocoa beans, coffee beans, and
                                                          grains) could not be consumed
                                                          without application of an
                                                          appropriate control.
117.136(a)(2)....................  117.136(a)(1)(ii)(C)  A manufacturer/processor is not     Includes a
                                                          required to implement a             requirement for
                                                          preventive control if it relies     documentation that
                                                          on its customer who is subject to   the food is ``not
                                                          the requirements for hazard         processed to
                                                          analysis and risk-based             control
                                                          preventive controls in subpart C    [identified
                                                          to ensure that the identified       hazard].''
                                                          hazard will be significantly
                                                          minimized or prevented and both
                                                          (1) discloses in documents
                                                          accompanying the food that the
                                                          food is ``not processed to
                                                          control [identified hazard]'' and
                                                          (2) annually obtains from its
                                                          customer written assurance that
                                                          the customer has established and
                                                          is following procedures that will
                                                          significantly minimize or prevent
                                                          the identified hazard.
117.136(a)(3)....................  N/A.................  A manufacturer/processor is not     N/A.
                                                          required to implement a
                                                          preventive control if it relies
                                                          on its customer who is not
                                                          subject to the requirements for
                                                          hazard analysis and risk-based
                                                          preventive controls in subpart C
                                                          to provide assurance it is
                                                          manufacturing, processing, or
                                                          preparing the food in accordance
                                                          with applicable food safety
                                                          requirements and it: (1)
                                                          Discloses in documents
                                                          accompanying the food, in
                                                          accordance with the practice of
                                                          the trade, that the food is ``not
                                                          processed to control [identified
                                                          hazard]''; and (2) annually
                                                          obtains from its customer written
                                                          assurance that it is
                                                          manufacturing, processing, or
                                                          preparing the food in accordance
                                                          with applicable food safety
                                                          requirements.

[[Page 56037]]

 
117.136(a)(4)....................  117.136(a)(1)(ii)(C)  A manufacturer/processor is not      Addresses
                                                          required to implement a             the circumstance
                                                          preventive control if it relies     where an entity
                                                          on its customer to ensure that      (other than the
                                                          the food will be processed to       facility's
                                                          control the identified hazard by    customer) in the
                                                          an entity in the distribution       distribution chain
                                                          chain subsequent to the customer    controls the
                                                          and both: (1) Discloses in          hazard.
                                                          documents accompanying the food     Includes a
                                                          that the food is ``not processed    requirement for
                                                          to control [identified hazard]''    documentation that
                                                          and (2) annually obtains from its   the food is ``not
                                                          customer written assurance that     processed to
                                                          the customer will both disclose     control
                                                          the information that the food is    [identified
                                                          ``not processed to control          hazard].''
                                                          [identified hazard]'' and will
                                                          only sell to another entity that
                                                          agrees, in writing, it will
                                                          follow procedures that will
                                                          significantly minimize or prevent
                                                          the identified hazard (if the
                                                          entity is subject to the
                                                          requirements for hazard analysis
                                                          and risk-based preventive
                                                          controls in subpart C) or
                                                          manufacture, process, or prepare
                                                          the food in accordance with
                                                          applicable food safety
                                                          requirements (if the entity is
                                                          not subject to the requirements
                                                          for hazard analysis and risk-
                                                          based preventive controls in
                                                          subpart C), or obtain a similar
                                                          written assurance from the
                                                          entity's customer.
117.136(a)(5)....................  N/A.................  A manufacturer/processor is not     N/A.
                                                          required to implement a
                                                          preventive control if it has
                                                          established, documented, and
                                                          implemented a system that ensures
                                                          control, at a subsequent
                                                          distribution step, of the hazards
                                                          in the food product it
                                                          distributes and documents the
                                                          implementation of that system.
117.136(b).......................  117.136(g)(3).......  Records documenting the applicable  Includes a
                                                          circumstances in Sec.               requirement for
                                                          117.136(a).                         documentation of
                                                                                              the additional
                                                                                              circumstances in
                                                                                              which a
                                                                                              manufacturer/
                                                                                              processor is not
                                                                                              required to
                                                                                              implement a
                                                                                              preventive
                                                                                              control.
117.137..........................  N/A.................  A facility that provides a written  N/A.
                                                          assurance under Sec.
                                                          117.136(a)(2), (3), or (4) must
                                                          act consistently with the
                                                          assurance and document its
                                                          actions taken to satisfy the
                                                          written assurance.
----------------------------------------------------------------------------------------------------------------

    The first provision allows a manufacturer/processor to not 
implement a preventive control if the manufacturer/processor determines 
and documents that the type of food (e.g., RACs such as cocoa beans, 
coffee beans, and grains) could not be consumed without application of 
the appropriate control (see Sec.  117.136(a)(1)). We describe comments 
leading to this provision, and our response to those comments, in 
Comment 444 and Response 444, respectively. Although we are 
establishing these provisions outside the framework of the supply-chain 
program, these provisions continue to play a role in the requirements 
for a supply-chain program, because they also provide an exception to 
the requirements for a manufacturer/processor to establish and 
implement a supply-chain program.
    The second provision relates to comments we received on a proposed 
exception to the requirement for a manufacturer/processor to establish 
and implement a supplier program (proposed Sec.  117.136(a)(1)(ii)(C)). 
(See Comment 445.) Under proposed Sec.  117.136(a)(1)(ii)(C), a 
receiving facility would not have been required to have a supplier 
program if it relied on its customer to control the hazard and annually 
obtained from its customer written assurance that the customer has 
established and is following procedures (identified in the written 
assurance) that will significantly minimize or prevent the hazard. As 
discussed in Response 445, we are replacing this provision with several 
provisions that apply when a manufacturer/processor identifies a hazard 
requiring a preventive control (``identified hazard''), does not 
control the identified hazard, but can demonstrate and document that 
the identified hazard will be controlled by an entity in its 
distribution chain. A manufacturer/processor that satisfies the 
criteria in these provisions will not be required to implement a 
preventive control for the identified hazard. Under these provisions, 
the combination of three requirements will provide adequate assurance 
that the food will be processed to control the identified hazard before 
it reaches consumers. These requirements are: (1) Documentation 
provided by the manufacturer/processor to its direct customer that the 
food is ``not processed to control [identified hazard]''; (2) written 
assurance from customers regarding appropriate procedures to ensure 
that the food will receive further processing to control the identified 
hazards; and (3) provisions relating to accountability for written 
assurances. (In these provisions, ``customer'' means a commercial 
customer, not a consumer.)
    (Comment 444) Some comments express concern about the ability for 
distributors/cooperatives to identify the individual farms that 
harvested the produce when such farms are more than one step back in 
the food chain from the distributor/cooperative. Some comments assert 
that receiving facilities should not be required to verify suppliers 
with which they do not have a direct commercial relationship. These 
comments note that, in the case of the cocoa bean supply chain, the 
processing facility likely has no direct relationship with the 
thousands of farms involved in the growing and harvesting of the beans. 
Some comments ask for an exemption from supplier verification 
activities for foods such as cocoa beans because,

[[Page 56038]]

although cocoa processors do not currently rely on farms to control 
hazards, and would therefore not need to verify farms, it is 
problematic to have a requirement that potentially could necessitate 
traceback to farms.
    (Response 444) We are establishing a provision, applicable to both 
the supply chain and the distribution chain of a manufacturer/
processor, for a circumstance when a manufacturer/processor does not 
need to implement a preventive control. The specific food product 
identified by some of the comments (i.e., cocoa beans) is part of a 
class of food products (principally RACs) that could simply not be 
eaten without processing that would control the hazards requiring a 
preventive control. Other RACs in this class of food products are 
coffee beans, grains, and some RACs that are rarely consumed raw. 
Therefore, we are providing that a manufacturer/processor does not need 
to implement a preventive control if it determines and documents that 
the type of food (e.g., RACs such as cocoa beans, coffee beans, and 
grains) could not be consumed without application of the appropriate 
control (see Sec.  117.136(a)(1)). The regulatory text does not specify 
RACs ``rarely consumed raw'' because ``rarely consumed raw'' is not the 
same as ``could not be consumed without application of the appropriate 
control.'' However, depending on the facility, the RAC, and the food 
produced by the manufacturer/processor, there may be some circumstances 
where a manufacturer/processor could determine that a particular RAC 
that passes through its facility satisfies the criterion ``could not be 
consumed without application of the appropriate control.''
    In other cases, a facility that conducts a manufacturing/processing 
activity on produce rarely consumed raw may satisfy the criteria in 
other new provisions (Sec.  117.136(a)(2), (3), and (4)) in which it 
relies on its customer to provide assurance that the food will be 
processed to control the identified hazard. In still other cases, such 
a facility may have determined through its hazard analysis that there 
are no hazards requiring a preventive control, and will not consider 
whether one of the circumstances in new Sec.  117.136 apply.
    As a consequential addition, new Sec.  117.136(b) specifies the 
records that a manufacturer/processor would need to satisfy the 
documentation requirements established in new Sec.  117.136(a)(1), and 
we have added new Sec.  117.136(b) to the list of implementation 
records (Sec.  117.190) that are subject to the recordkeeping 
requirements of subpart F.
    See also Comment 657, in which we discuss comments asking us to add 
flexibility to the requirements for a supply-chain program such that 
any entity other than the receiving facility can perform supplier 
verification activities. As discussed in Response 657, the rule 
provides additional flexibility in the supply-chain program with regard 
to who can perform certain activities (see Sec.  117.415).
    (Comment 445) Some comments ask us to delete the criterion for 
control of the hazard by the receiving facility's customer, with annual 
written assurance that the customer had established and was following 
procedures (identified in the written assurance) that would 
significantly minimize or prevent the hazard. The stated reasons 
varied. For example, some comments state that a receiving facility may 
have so many customers that it is not possible to obtain written 
assurance annually from all customers. Other comments express concern 
that a customer may be unwilling to describe confidential trade secrets 
in order to identify in writing the procedures the customer has 
established and is following to control the hazard. Other comments 
express concern about ``legal issues'' when a receiving facility needs 
to assess the adequacy of the customers' procedures for controlling a 
hazard because under current business practices a vendor can provide 
assurance to a buyer (its customer), but buyers do not typically 
provide such assurance to vendors. Some comments express concern that 
written assurance does not guarantee that the customer is actually 
doing anything to significantly minimize or prevent the hazard.
    Some comments ask us to provide an alternative that would allow the 
receiving facility to provide documentation to its customer about a 
hazard that needs a preventive control at a processing facility later 
in the distribution chain rather than obtain written assurance that its 
customer will control a hazard. If written assurance must be required, 
these comments ask us to allow the written assurance provided by the 
customer to state that the customer would evaluate the hazard and if 
necessary establish and follow procedures to significantly minimize or 
prevent the hazard.
    Some comments state the receiving facility may not know the 
identity of all its ultimate customers, particularly if the receiving 
facility sells its products to a distributor who then sells to other 
entities. Some comments ask us to provide flexibility for facilities to 
determine whether annual updates of written assurance are necessary. 
Other comments ask us to specify that a receiving facility need not 
establish and implement a supplier program for raw materials and 
ingredients that are RACs intended for further processing.
    Some comments assert that the presence of low levels of pathogens 
on a raw product that will be subject to a lethal process further 
downstream does not pose a risk to the consumer, and should not be 
considered a significant hazard (i.e., a hazard requiring a preventive 
control). These comments also assert that if we maintain that 
Salmonella contamination is a significant hazard for each member of the 
supply chain, then we should allow the preventive control to be applied 
in a subsequent step at another facility. Other comments ask us to 
clarify that a facility would not need to develop preventive controls 
where it produces raw materials or ingredients that are subject to 
subsequent processing that will address known or reasonably foreseeable 
hazards.
    (Response 445) We are establishing several provisions, specifically 
applicable to the distribution chain of a manufacturer/processor, for 
circumstances when a manufacturer/processor does not need to implement 
a preventive control (Sec. Sec.  117.136(a)(2), (a)(3), (a)(4) and 
(a)(5), (b)(2), (b)(3), (b)(4), and (b)(5), 117.137, and 117.335). See 
Response 444 for another new provision that applies to the supply chain 
in addition to the distribution chain (Sec.  117.136(a)(1)).
    Under the first of these provisions (Sec.  117.136(a)(2)), a 
manufacturer/processor is not required to implement a preventive 
control if it relies on its customer (who is subject to the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C) to ensure that the identified hazard will be significantly 
minimized or prevented and: (1) Discloses in documents accompanying the 
food, in accordance with the practice of the trade, that the food is 
``not processed to control [identified hazard]''; and (2) annually 
obtains from its customer written assurance, subject to the 
requirements of Sec.  117.137, that the customer has established and is 
following procedures (identified in the written assurance) that will 
significantly minimize or prevent the hazard. The manufacturer/
processor would include the specific hazard requiring a preventive 
control (e.g., Salmonella) where the statement says ``[identified 
hazard].'' A facility that provides the written assurance must act 
consistently with the assurance and document its

[[Page 56039]]

actions taken to satisfy the written assurance (see new Sec.  117.137). 
The documents could be bills of lading or other papers that accompany 
the food, or labels on the containers of the food.
    Under the second of these provisions, (Sec.  117.136(a)(3)), a 
manufacturer/processor is not required to implement a preventive 
control if it relies on its customer (who is not subject to the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C) to provide assurance it is manufacturing, processing, or 
preparing the food in accordance with applicable food safety 
requirements and it: (1) Discloses in documents accompanying the food, 
in accordance with the practice of the trade, that the food is ``not 
processed to control [identified hazard]''; and (2) annually obtains 
from its customer written assurance that it is manufacturing, 
processing, or preparing the food in accordance with applicable food 
safety requirements. By ``customer who is not required to implement 
preventive controls under part 117'' we mean entities such as qualified 
facilities and retail food establishments.
    Under the third of these provisions (Sec.  117.136(a)(4)), a 
manufacturer/processor is not required to implement a preventive 
control if it relies on its customer to provide assurance that the food 
will be processed to control the identified hazard by an entity in the 
distribution chain subsequent to the customer and: (1) Discloses in 
documents accompanying the food, in accordance with the practice of the 
trade, that the food is ``not processed to control [identified 
hazard]''; and (2) annually obtains from its customer written 
assurance, subject to the requirements of Sec.  117.137, that the 
customer will disclose in documents accompanying the food, in 
accordance with the practice of the trade, that the food is ``not 
processed to control [identified hazard]''. The manufacturer/processor 
also must obtain written assurance that its customer will only sell to 
another entity that agrees, in writing, it will: (1) Follow procedures 
(identified in a written assurance) that will significantly minimize or 
prevent the hazard (if the entity is subject to the requirements for 
hazard analysis and risk-based preventive controls in subpart C), or 
manufacture, process, or prepare the food in accordance with applicable 
food safety requirements (if the entity is not subject to the 
requirements for hazard analysis and risk-based preventive controls in 
subpart C); or (2) obtain a similar written assurance from the entity's 
customer.
    Under the fourth of these provisions (Sec.  117.136(a)(5)), a 
manufacturer/processor is not required to implement a preventive 
control if it has established, documented, and implemented a system 
that ensures control, at a subsequent distribution step, of the hazards 
in the food product it distributes and documents the implementation of 
that system. Comments did not provide examples of such a system, but we 
do not want to preclude the development of such systems.
    We have added several other requirements related to these new 
provisions that we are specifically establishing as circumstances in 
which a manufacturer/processor need not implement a preventive control. 
As already noted in this response, new Sec.  117.137 requires that a 
facility that provides a written assurance must act consistently with 
the assurance and document its actions taken to satisfy the written 
assurance. In addition, new Sec.  117.136(b)(2), (3), (4), and (5) 
specify the records that a manufacturer/processor would need to satisfy 
the documentation requirements established in new Sec.  117.136(a)(2), 
(3), (4), and (5), and new Sec.  117.335 establishes requirements 
applicable to the written assurance between a manufacturer/processor 
and its customer. Taken together, the provisions of Sec. Sec.  117.137 
and 117.335 establish legal responsibilities for a facility that 
provides a written assurance under Sec.  117.136(a)(2), (3), or (4), 
even if that facility is not a manufacturer/processor.
    The point of these provisions is to ensure that hazards that a 
manufacturer/processor has determined, through its hazard analysis, 
require a preventive control, but are not controlled in the supply 
chain before the manufacturer/processor or by the manufacturer/
processor, are in fact controlled by a subsequent entity in the 
distribution chain. With the assurance from the first manufacturer/
processor's customer that the hazards will be controlled after the food 
product leaves the manufacturer/processor, it is not necessary for the 
first manufacturer/processor to implement the applicable preventive 
control. We continue to believe that annual written assurance from a 
manufacturer/processor's direct customer is an appropriate mechanism to 
ensure that its customer is aware of the identified hazard and is 
taking steps to ensure that the food is processed to control the 
identified hazard. We do not believe that a manufacturers/processor 
will need all of the details of its customer's process to satisfy the 
requirement to state in writing the procedures the customer has 
established and is following to control the hazard. For example, the 
customer could merely state that its manufacturing processes include a 
lethality step for microbial pathogens of concern.
    We agree that it is appropriate to require that the manufacturer/
processor provide documentation to its customer indicating that the 
food must be processed to control an identified hazard. Such 
documentation will be a means of clear communication from the 
manufacturer/processor to its customer. When the hazard will not be 
controlled by the customer, the customer will still have documentation 
that can be passed on to the entity that is expected to process the 
food to control the identified hazard, so that it will be very clear to 
that entity that the identified hazard still needs to be controlled.
    (Comment 446) Some comments ask us to delete the proposed 
requirement to maintain the written assurance as a record.
    (Response 446) We decline this request. As already discussed in 
this section, it is the combination of requirements (i.e., for 
documentation that the food is ``not processed to control [identified 
hazard]''; assurance from customers regarding appropriate procedures to 
ensure that the food will receive further processing to control the 
identified hazards; and provisions relating to accountability for 
written assurances) that will provide adequate assurance that the food 
will be processed to control the identified hazard before it reaches 
consumers. Records documenting the written assurances are a key 
component of the provisions.

XXVIII. Subpart C: Comments on Proposed Requirements for a Recall Plan 
(Final Sec.  117.139)

    We proposed that you must establish a written recall plan for food 
with a significant hazard and that the recall plan must include certain 
procedures. Some comments support the proposed requirements without 
change. For example, some comments express the view that a written 
recall plan is critical in the event of a system breakdown where 
adulterated foods have been distributed. Some comments that support the 
proposed requirements note that many model plans are available to 
industry. Other comments state that the proposed requirements for a 
recall plan mirror guidelines in many fresh produce commodity-specific 
food safety guidelines and seem appropriate for all types of facilities 
handling fresh produce. Some comments that support the proposed 
provisions suggest

[[Page 56040]]

alternative or additional regulatory text (see, e.g., Comment 447, 
Comment 452, Comment 453, and Comment 454).
    In the following paragraphs, we discuss comments that ask us to 
clarify the proposed requirements or that disagree with, or suggest one 
or more changes to, the proposed requirements. After considering these 
comments, we are finalizing the requirements as proposed with the 
conforming revision to use the term ``hazard requiring a preventive 
control'' rather than ``significant hazard.'' See Response 126 and 
table 52. We also are redesignating the requirements as Sec.  117.139. 
As discussed in section XXVII, we are establishing a provision applying 
to certain assurances in Sec.  117.137.

A. Proposed Sec.  117.137(a)--Requirement for a Written Recall Plan 
(Final Sec.  117.139(a))

    We proposed that you must establish a written recall plan for food 
with a significant hazard.
    (Comment 447) Some comments ask us to require a written recall plan 
for all food (rather than just for food with a significant hazard) and 
to establish the requirements for a written recall plan as CGMP 
requirements in subpart B rather than as part of the requirements for 
hazard analysis and risk-based preventive controls in subpart C. These 
comments assert that all products can be subject to a recall. These 
comments contrast recall plans with other preventive controls in that 
recall plans are often specific to a firm or facility, but rarely are 
specific to particular foods. In addition, these comments note that a 
recall may be administered and managed at the corporate office rather 
than at the specific manufacturing facility that produced the food.
    Some comments note the requirements for a written recall plan are 
sufficiently different from other provisions in subpart C that we 
proposed to specify that the recall plan would not be subject to the 
preventive control management requirements for monitoring, corrective 
actions, and verification (see Sec.  117.140(c)). Some comments note 
that facilities that are exempt from the requirements of subpart C, but 
remain subject to the CGMP requirements, would not be required to have 
a recall plan unless we establish the requirements in subpart B.
    Some comments note that our authority to require recall plans is 
not limited to section 418 of the FD&C Act and that we can use other 
legal authority to impose a requirement for recall plans in subpart B. 
Some comments note that FSMA specifically amended the FD&C Act to 
provide us with the authority to mandate a food recall (section 423 of 
the FD&C Act). These comments assert that it would be reasonable for us 
to conclude that in order to efficiently carry out section 423 of the 
FD&C Act we should issue requirements governing the conduct of recalls, 
because section 423 of the FD&C Act requires that we provide a firm 
with an opportunity to voluntarily recall a product before issuing an 
order to the firm to cease distribution and recall a product.
    (Response 447) We decline the request to establish requirements for 
a written recall plan as a CGMP requirement in subpart B and are 
establishing the requirements as a preventive control in subpart C as 
proposed. We acknowledge that a recall plan would be useful to all food 
establishments, and we encourage all food establishments to have a 
recall plan. However, the report issued by the CGMP Modernization 
Working Group did not identify the lack of a written recall plan as 
something that needed to be changed (Ref. 3). (See 78 FR 3646 at 3651 
for a discussion of the CGMP Modernization Working Group and the 
process leading to its report.) However, going forward we intend to 
monitor whether the lack of a broader requirement for a recall plan 
leads to problems when food establishments that are not subject to the 
requirements of subpart C are faced with recall situations. As we gain 
experience with the impact of the new requirement for a recall plan on 
those facilities subject to subpart C, we can reassess at a later date 
whether to conduct rulemaking to broaden the requirement to apply to 
all food establishments subject to the CGMP requirements in subpart B. 
For now, food establishments that are not subject to subpart C can 
continue to follow our long-standing recall policy in part 7.
    Consistent with the overall framework of FSMA, a recall plan (like 
other preventive controls) is only required when the facility has 
identified a hazard requiring a preventive control. A facility could 
establish a recall plan that applies to other foods it manufactures. We 
recognize that recalls may be managed by the corporate office of a firm 
rather than at the specific manufacturing facility that produced the 
food. Nothing in the rule precludes this approach. In such cases the 
corporate recall policy would be reflected in a facility's recall plan. 
(See also (Response 371.) In addition, a facility that identifies one 
or more hazards requiring a preventive control in multiple food 
products could use the same recall plan for all applicable food 
products.
    The rule specifies that the requirements for preventive control 
management components (i.e., monitoring, corrective actions and 
corrections, and verification) apply as appropriate to ensure the 
effectiveness of the preventive control, taking into account the nature 
of the preventive control (Sec.  117.140(a)). As previously discussed, 
the preventive control management components are directed at food that 
remains at the facility, whereas the recall plan addresses food that 
has left the facility (78 FR 3646 at 3745). Our determination that the 
nature of the recall plan does not require these preventive control 
management components demonstrates the flexibility provided by FSMA and 
this rule, not that the recall plan must be considered a CGMP rather 
than a preventive control.
    We have not yet made a determination of whether we should issue 
requirements governing the conduct of recalls, rather than rely on the 
guidelines in part 7, in order to fully implement section 423 of the 
FD&C Act. However, we have issued draft guidance entitled ``Draft 
Guidance for Industry: Questions and Answers Regarding Mandatory Food 
Recalls'' which, when finalized, would address topics such as the 
criteria for a mandatory recall and the process that FDA must follow 
for a mandatory recall (Ref. 75).
    (Comment 448) Some comments assert that the requirements for a 
recall plan should only apply to RTE food.
    (Response 448) These comments are suggesting that the rule 
predetermine the outcome of the hazard analysis at all facilities. The 
framework provided by FSMA and established in this rule makes it the 
responsibility of each facility to appropriately determine the hazards 
requiring a preventive control, and establish preventive controls as 
appropriate to the facility and the food.
    (Comment 449) Some comments ask us to cross-reference the 
provisions of part 7 (21 CFR part 7) rather than establish requirements 
that these comments assert would be duplicative with the provisions of 
part 7. These comments ask us to address any more substantive 
requirements than are already in part 7 as part of a review of part 7. 
These comments assert that part 117 should require a written recall 
plan, but not require a ``written recall plan for the food,'' to be 
consistent with the approach of part 7.
    (Response 449) We decline these requests. Part 7 addresses 
enforcement policy, and the provisions for recalls in subpart C of part 
7 are ``Guidance on Policy, Procedures, and Industry 
Responsibilities.'' These recall

[[Page 56041]]

provisions do not establish requirements and are not binding on 
industry. They also are broadly directed to recalls for all FDA-
regulated products, not just food. As already discussed (see Response 
447), nothing in this rule would prevent a facility that establishes a 
recall plan for a particular food from using that recall plan for any 
food product that the facility decides to recall.

B. Proposed Sec.  117.137(b)--Procedures That Describe the Steps To Be 
Taken, and Assign Responsibility for Taking Those Steps (117.139(b))

    We proposed that the recall plan must include procedures that 
describe the steps to be taken, and assign responsibility for taking 
those steps, to perform the following actions as appropriate to the 
facility: (1) Directly notify the direct consignees of the food being 
recalled, including how to return or dispose of the affected food; (2) 
notify the public about any hazard presented by the food when 
appropriate to protect the public health; (3) conduct effectiveness 
checks to verify that the recall is carried out; and (4) appropriately 
dispose of recalled food (e.g., through reprocessing, reworking, 
diverting to a use that does not present a safety concern, or 
destroying the food). We requested comment on whether: (1) The proposed 
procedures are appropriate for all types of facilities; (2) we should 
require a recall plan to include procedures and assignment of 
responsibility for notifying FDA of recalls subject to the plan; and 
(3) we should include a requirement for a mock recall as a verification 
activity.
    (Comment 450) Some comments ask us to modify the proposed 
requirements for a recall plan to clearly differentiate between 
manufacturers and distributors. These comments note that distributors 
are often not the initial recalling firm and ask us to clarify that the 
manufacturer, rather than the distributor, is the responsible party for 
notifying the public. Other comments ask us to modify and simplify the 
details of the recall plan for smaller businesses based on product, 
distribution, and other factors.
    (Response 450) In the 2014 supplemental human preventive controls 
notice, we revised the proposed requirements for a recall plan by 
specifying that the procedures in the recall plan are ``as appropriate 
to the facility.'' As a result, the rule explicitly provides 
flexibility for a recall plan to be different based on characteristics 
such as size of the facility or the role of the facility in the food 
supply chain. For example, the rule provides flexibility for a small 
business to simply specify that it will telephone its customers. 
Although we decline the request to specify that the manufacturer, 
rather than the distributor, is the responsible party for notifying the 
public, the rule provides flexibility for a distributor to establish, 
through its business relationships with manufacturers, that this would 
be the procedure established in the distributor's recall plan.
    (Comment 451) Some comments ask us to delete the proposed 
requirement that the recall plan include procedures for a facility to 
notify the public about any hazard presented by the food when 
appropriate to protect public health. These comments assert that such a 
requirement would be highly subjective and create a nebulous regulatory 
burden that could subject facilities to unnecessary regulatory 
oversight and enforcement actions.
    (Response 451) We decline this request. Our guidance for a recall 
strategy has long recommended issuing a public warning to alert the 
public that a product being recalled presents a serious hazard to 
health in urgent situations where other means for preventing use of the 
recalled product appear inadequate (Sec.  7.42(b)(2)). Operationally, 
such notification to the public is so common that our current home page 
on our Internet site (Ref. 76) gives prominence to recall information, 
and we have established a free email subscription service for updates 
on recalls (Ref. 77). Consistent with the long-standing recall policy 
in part 7, subpart C, the proposed requirement qualifies that the 
notification to the public is ``when appropriate to protect public 
health.''
    (Comment 452) Some comments ask us to specify that food recall 
plans include a minimum data requirement about the food product in 
question. These comments assert that information such as lot, batch, 
product size, and production date are critical in sorting defective 
products from non[hyphen]defective ones.
    (Response 452) The procedures that must be established in a recall 
plan are those that describe the steps that will be taken to notify 
entities that a product must be removed from commerce, to verify that 
product is removed, and to appropriately dispose of the product. 
Information (such as lot, batch, product size, and production date) is 
necessary to be able to carry out the steps that must be included in 
the procedures and can be a useful component of the procedures that a 
facility includes in its recall plan, because a facility would need to 
obtain such information about the specific product being recalled when 
conducting a recall. However, we decline the request to specify what a 
facility must include in its procedures because facilities may use 
different approaches in how they carry out recalls and the information 
they need to do so. For example, not all facilities use that same data 
for identifying the product that may be impacted by a recall.
    (Comment 453) Some comments ask us to specify that the procedures 
require facilities to notify us about a recall to ensure that all 
suppliers, retailers, and consumers will have adequate notification of 
the recall action. Other comments agree that it is important for 
facilities to involve us in a recall situation as soon as possible, but 
assert that the best way to address such a notification is through the 
existing RFR system. These comments assert that additional procedures 
or means to notify us would involve unnecessary additional steps and be 
duplicative, with no improvement to the public health. Some comments 
ask us to specify that the appropriate State regulatory agency with 
inspection jurisdiction be notified in the event of a recall.
    (Response 453) We agree with comments that it is important to 
notify us about a recall and that doing so can help to ensure that 
suppliers, retailers, and consumers will have adequate notification of 
the recall action. We also agree that the existing procedures to notify 
us through the RFR system can accomplish this goal when a food presents 
a risk of serious adverse health consequences or death and that it 
therefore is not necessary to duplicate the notification procedures 
already established in the RFR system in part 117. However, we 
encourage facilities to include in their recall plan any procedures 
they have to comply with the RFR or to include a cross-reference to 
those procedures. Doing so may save time, which is critical during a 
recall. When the recalled food does not present a risk of serious 
adverse health consequences or death (and, thus, there is no report to 
the RFR), our guidance entitled ``Guidance for Industry: Product 
Recalls, Including Removals and Corrections'' recommends that recalling 
firms notify the local FDA District Recall Coordinator as soon as a 
decision is made that a recall is appropriate and prior to the issuance 
of press or written notification to customers (Ref. 78). Including this 
guidance with the facility's recall procedures may also save time.
    Likewise, we agree with comments that it is important to notify 
appropriate State regulatory agencies about a recall. However, 
procedures are available for

[[Page 56042]]

State regulatory agencies to rapidly receive information from us about 
food recalls. For example, State regulatory agencies can receive 
automatic notification about food recalls that we post on our Web site 
(Ref. 79). We note that whatever methods are used to dispose of 
adulterated food should comply with State and local requirements.
    (Comment 454) Some comments ask us to add a requirement for mock 
recalls on a regular basis, such as annually. Some of these comments 
state that mock recalls would familiarize the staff and communications 
network(s) with the recall process and would improve the facility's 
capacity to conduct effective and efficient recalls in the event of a 
contamination event. Other comments assert that mock recalls would be 
the only way to determine the effectiveness of a recall program. Some 
comments note that mock recalls would be particularly critical for 
manufacturers that have limited experience in actual recalls. Other 
comments note that information from mock recalls could support 
development of guidance on best practices for recalls. Some comments 
recommend that any requirement for a mock recall as a verification 
measure include sufficient flexibility to accommodate diverse 
procedures and mechanisms.
    Some comments acknowledge that a mock recall could be an important 
element of a recall plan but recommend that mock recalls remain 
voluntary, such as by including mock recalls as an example of how 
verification may be accomplished. Other comments note that the current 
recall procedures in part 7 do not recommend mock recalls. Some 
comments assert that a requirement to include a mock recall as a 
verification activity would be an excessive and inappropriate burden. 
Some comments note that retail facilities execute multiple recalls each 
week and that adding the requirement to perform a mock recall would be 
an unnecessary burden on the retail industry. Likewise, some comments 
note that foodservice distributors are experts in conducting recall 
activities, because they are routinely affected by manufacturer 
recalls.
    Some comments ask us to clarify the ``metrics'' for a mock recall, 
particularly with respect to the consequences of failing to meet an 
appropriate metric if a mock recall is conducted as a verification 
activity.
    (Response 454) We agree that a mock recall would familiarize the 
facility with the recall process, could improve the facility's capacity 
to conduct effective and efficient recalls during a contamination 
event, may be particularly helpful for manufacturers that have limited 
experience in actual recalls, and could support the development of 
guidance on best practices for recalls, and we encourage facilities to 
conduct one or more mock recalls to accomplish these goals. However, as 
previously discussed, a recall plan would address food that had left 
the facility, whereas the proposed requirements for monitoring, 
corrective actions, and verification would all be directed at food 
while it remains at the facility. Comments are mixed regarding whether 
the rule should require a mock recall as a verification activity for 
the recall plan, and we have decided to not require a facility to 
conduct a mock recall as a verification activity for its recall plan so 
that the focus of the monitoring, corrective actions, and verification 
in the rule remains focused on food being produced rather than on food 
that is distributed in commerce. A facility that voluntarily conducts a 
mock recall would establish metrics appropriate to its plan and take 
action (such as modifications to its procedures, or additional training 
for its employees) if it is not satisfied with the results of the mock 
recall.
    We note that retail companies are not subject to this rule and, 
thus, are not subject to the requirement to have a written recall plan.

XXIX. Comments on Proposed Sec.  117.140--Preventive Control Management 
Components

    We proposed preventive control management components as appropriate 
to ensure the effectiveness of the preventive controls, taking into 
account the nature of the preventive control. Most of the comments that 
support the proposed provisions suggest alternative or additional 
regulatory text (see, e.g., Comment 455).
    In the following sections, we discuss comments that disagree with, 
or suggest one or more changes to, the proposed requirements. After 
considering these comments, we have revised the proposed requirements 
as shown in table 33, with editorial and conforming changes as shown in 
table 52.

 Table 33--Revisions to the Proposed Requirements for Preventive Control
                          Management Components
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.140.......................  Flexible           Provide that
                                 requirements for   preventive control
                                 preventive         management
                                 control            components take into
                                 management         account both the
                                 components.        nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
------------------------------------------------------------------------

A. Proposed Sec.  117.140(a)--Flexible Requirements for Monitoring, 
Corrective Actions and Corrections, and Verification

    We proposed that, with some exceptions, the preventive controls 
would be subject to three preventive control management components as 
appropriate to ensure the effectiveness of the preventive controls, 
taking into account the nature of the preventive control: monitoring, 
corrective actions and corrections, and verification.
    (Comment 455) Some comments support our proposal to provide 
flexibility in the oversight and management of preventive controls, 
including the explicit provision that preventive control management 
components take into account the nature of the preventive control. Some 
of these comments state that the provisions for the preventive control 
management components will allow facilities to tailor their food safety 
plans to their specific facility, product, and process and ensure that 
the regulatory requirements are risk-based. Other comments state that 
the proposed approach acknowledges the safety benefits derived from the 
use of prerequisite programs, such as CGMPs, and provides for a 
framework whereby appropriate decisions may be reached regarding 
hazards that require management controls that may include monitoring, 
corrections or corrective actions, verification, and records. Other 
comments state that the provisions will allow businesses to allocate 
resources to spend the most time and resources controlling and 
monitoring those hazards that pose the greatest risk to public health.
    However, many of these comments also ask us to convey not only that 
the application of a particular management component be appropriate 
(i.e., capable

[[Page 56043]]

of being applied), but also that it be necessary for food safety (i.e., 
to meet the overall FSMA food safety goals or to ensure a particular 
control is effective) by specifying that the preventive control 
management components take into account both the nature of the 
preventive control and its role within the facility's overall food 
safety system. Some of these comments ask us to make companion changes 
reflecting that the preventive control management components take into 
account both the nature of the preventive control and its role within 
the facility's overall food safety system throughout applicable 
provisions of the rule, such as the definition of ``significant 
hazard'' (which we now refer to as ``hazard requiring a preventive 
control'') and in the requirements for preventive controls, monitoring, 
corrective actions and corrections, and verification. Some comments ask 
us to consistently refer to ``the nature of the preventive control'' 
(rather than simply to ``the preventive control'') when communicating 
the flexibility that a facility has in identifying preventive controls 
and associated preventive control management components.
    One comment provides two examples of refrigeration controls to 
explain its view that the management components for refrigeration 
controls will vary depending on the role of refrigeration within the 
facility's overall food safety system. In the first example, a facility 
that manages the process of cooling a cream cheese as a CCP would 
validate its refrigeration control, establish time and temperature 
parameters that must be met, monitor those parameters and confirm their 
use through verification, and, if the parameters were not met, then 
follow a specific corrective action procedure to address the situation. 
In contrast, after the initial cooling process for the hot-filled 
product, the facility would manage refrigerated storage differently. 
The facility would not keep validation data to support the specific 
temperature chosen because the temperatures needed to keep food safe 
are widely known and accepted. Although the facility may choose to 
establish temperature parameters, the facility typically would not 
apply such values as hard and fast limits in the same way as it would 
for a CCP (e.g., because a 5 degree increase over the upper end of the 
temperature range for a short time would not be meaningful to food 
safety). The facility may choose not to monitor temperature 
continuously and, even if the facility does monitor temperature 
continuously it would only generate ``exception records'' when the 
temperature exceeds a specific value. The facility also would find it 
unnecessary to verify its ongoing monitoring.
    (Response 455) We agree that preventive control management 
components should take into account both the nature of the preventive 
control and its role in the facility's food safety system and have 
modified the regulatory text of Sec.  117.140 to incorporate this 
suggestion. We reviewed the full regulatory text of proposed subpart C 
and made similar modifications to the regulatory text for the 
definition of ``hazard requiring a preventive control'' (Sec.  117.3); 
process controls (Sec.  117.135(c)(1)); monitoring (Sec.  117.145); 
verification (Sec.  117.155); validation (Sec.  117.160); and 
verification of implementation and effectiveness (Sec.  117.165).
    (Comment 456) Some comments assert that the flexibility explicitly 
provided in the regulatory text could result in some facilities taking 
a broad approach to significant hazards and other facilities taking a 
more detailed approach. These comments express concern that inspectors 
will view the detailed approach (e.g., with more preventive controls) 
as the standard to judge compliance with the rule. Other comments 
express concern that identifying a large number of preventive controls 
could also undermine the value of HACCP programs because treating too 
many controls as CCPs will pull resources from those controls that are 
truly critical.
    (Response 456) We agree that facilities are likely to take 
different approaches to complying with the rule. A facility-specific 
approach is consistent with FSMA, which places responsibility for 
hazard analysis and risk-based preventive controls on the owner, 
operator, or agent in charge of the facility (section 418(a) of the 
FD&C Act). We agree that having too many CCPs could dilute their 
significance, but not every hazard will require a CCP to be controlled. 
See table 6 in the 2014 supplemental preventive controls rule for two 
examples of preventive controls that would not be CCPs (79 FR 58524 at 
58542).
    During the initial stages of implementation, we expect that our 
investigators will ask subject matter experts in CFSAN to review the 
outcome of the facility's hazard analysis, the preventive controls 
established by the facility, and the associated preventive control 
management components that the facility has established and 
implemented. Over time, as our investigators gain experience, we expect 
that there will be fewer circumstances in which our investigators would 
consult CFSAN about such an outcome. See also Response 5.
    (Comment 457) Some comments express concern with the number of 
provisions that will impact certain types of operations. As an example, 
these comments assert that a fresh-cut produce facility potentially 
could be required to implement supplier verification, environmental 
monitoring, and product testing, whereas a peanut butter producer may 
not be required to implement any of those three provisions. According 
to these comments, supplier verification most likely would not be 
required if the manufacturing operation of the peanut butter 
manufacturer includes a kill step to significantly minimize Salmonella, 
because the ``significant hazard'' would be addressed at the receiving 
facility. These comments interpret our previous discussions about 
product testing, in the 2013 proposed preventive controls rule, as 
evidence that such a peanut butter manufacturer also would likely not 
conduct product testing. If the peanut butter product is hot-filled 
into jars, there would be no RTE food exposed to the environment and, 
thus, the facility's hazard analysis would not be required to consider 
the potential for contamination with environmental pathogens.
    (Response 457) We acknowledge that some facilities will need to do 
more than others, because the rule is flexible and risk-based. 
Importantly, the rule does not require every fresh-cut produce 
operation to conduct environmental monitoring, even though it does 
require each fresh-cut produce operation to consider whether it is 
necessary.
    We disagree that the flexibility provided in the regulatory text 
would lead a peanut butter manufacturer to conclude that there would be 
no RTE food exposed to the environment when peanut butter is hot-filled 
into jars. In the production of peanut butter, the kill step (i.e., 
roasting) happens before the rest of the manufacturing process, and the 
roasted peanuts are exposed to the environment before the filling step. 
At the filling step, the temperature is hot enough to fill the jars but 
is not hot enough to act as a kill step to significantly minimize any 
pathogens that contaminated the peanuts after they were roasted. As a 
result, in contrast to the interpretation of the comments, the peanut 
butter production described by the comments does involve RTE food 
exposed to the environment, and the facility's hazard analysis must 
consider the potential for contamination with environmental pathogens. 
However,

[[Page 56044]]

when a peanut butter manufacturer concludes that it requires sanitation 
controls for environmental pathogens, it is more likely that the peanut 
butter manufacturer would conduct environmental monitoring (rather than 
product testing) as a verification of its sanitation controls. (The 
peanut butter manufacturer may also conclude that product testing is a 
useful tool to verify its overall food safety system.) Likewise, a 
facility that buys peanut butter for use in an RTE food would need to 
consider whether it needs supply-chain controls for the manufacturer 
that performed the kill step for Salmonella and whether it needs 
sanitation controls for environmental pathogens and environmental 
monitoring as verification of its sanitation controls.
    (Comment 458) Some comments state that USDA's regulations (in 7 CFR 
205.201(a)(3)) for the NOP include regulatory text to ``ensure the 
effectiveness'' of measures in that program and that this regulatory 
text is similar to regulatory text in the requirements for preventive 
control management components. These comments assert that this type of 
regulatory text has created compliance challenges and ask us to consult 
with USDA about its experience with implementing effectiveness language 
associated with monitoring practices and procedures and ensure that the 
final rule uses regulatory text that will be clearly understood and 
readily implementable by those subject to its provisions.
    (Response 458) Under the USDA regulation cited by these comments, 
an organic production or handling system plan must include a 
description of the monitoring practices and procedures to be performed 
and maintained, including the frequency with which they will be 
performed, to ``verify that the plan is effectively implemented.'' We 
have not consulted with USDA regarding its experience in evaluating 
compliance with this requirement because we addressed the issue likely 
to cause these compliance challenges for monitoring practices and 
procedures in an organic production or handling system plan when we 
established our requirements for monitoring preventive controls. 
Specifically, we require that a facility monitor the preventive 
controls with adequate frequency to ``provide assurance that they are 
consistently performed,'' not to ``verify that the plan is effectively 
implemented.'' Our requirements more clearly distinguish the purpose of 
monitoring and verification activities. See our previous discussion of 
the relationship between monitoring and verification, and our tentative 
conclusion to require monitoring of the performance of the preventive 
controls (78 FR 3646 at 3747). We are affirming that conclusion in this 
rule (see Response 461).
    (Comment 459) Some comments assert that regulations issued under 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
would prevent a facility from monitoring employee health if it 
establishes a Good Worker Hygiene Program as a preventive control.
    (Response 459) The basis of these comments is unclear. We do not 
expect that activities associated with monitoring of employee health 
would include activities that would be contrary to provisions of the 
Health Insurance Portability and Accountability Act of 1996. Employee 
health could be addressed through long-standing CGMP provisions (see 
Sec.  117.10(a) and (b)). Specifically, with respect to disease control 
there could be supervisory observation of illness or conditions such as 
an open lesion, with appropriate action to exclude the worker from 
operations in which there is a reasonable possibility of food, food-
contact surfaces, or food-packaging materials becoming contaminated 
(Sec.  117.10(a)). Generally, the regulations described in this comment 
(commonly referred to as ``the Privacy Rule'') apply to disclosures 
made by a health care provider, not to the questions of an employer 
(Ref. 80). See 45 CFR 160.103, which defines a ``covered entity'' as a 
health plan; a health care clearinghouse; and a health care provider 
who transmits any health information in electronic form in connection 
with a transaction covered by the Privacy Rule. The Privacy Rule does 
not prevent a supervisor, human resources worker or others from asking 
an employee for a doctor's note or other information about health if 
the employer needs the information to administer sick leave, workers' 
compensation, wellness programs, or health insurance (45 CFR 
164.512(b)(1)(v)).

B. Proposed Sec.  117.140(b)--Applicability of Preventive Control 
Management Components to the Supply-Chain Program

    We proposed that the supplier program (which we now refer to as 
``supply-chain program'') is subject to the following preventive 
control management components as appropriate to ensure the 
effectiveness of the supplier program, taking into account the nature 
of the hazard controlled before receipt of the raw material or 
ingredient: (1) Corrective actions and corrections, taking into account 
the nature of any supplier non-conformance; (2) review of records; and 
(3) reanalysis. We address comments on the supply-chain program in 
sections XLII through XLIX. We are finalizing the applicability of 
preventive control management components to the supply-chain program as 
proposed.

C. Proposed Sec.  117.140(c)--Recall Plan Is Not Subject to Preventive 
Control Management Components

    We proposed that the recall plan would not be subject to the 
preventive control management components.
    (Comment 460) As discussed in Comment 447, some comments ask us to 
establish requirements for a written recall plan as a CGMP requirement 
in subpart B rather than as a preventive control in subpart C. As a 
companion change, some of these comments ask us to delete our proposed 
provision that the recall plan would not be subject to the preventive 
control management components.
    (Response 460) As discussed in Response 447, we are establishing 
the requirements as a preventive control in subpart C as proposed. 
Therefore, we are finalizing the provision that the recall plan not be 
subject to the preventive control management components.

XXX. Subpart C: Comments on Proposed Sec.  117.145--Monitoring

    We proposed to establish requirements for monitoring the preventive 
controls. We also discussed our tentative conclusion that the language 
of section 418 of the FD&C Act regarding monitoring is ambiguous and 
that it would be appropriate to require monitoring of the 
``performance'' of preventive controls.
    Some comments agree with our tentative conclusion regarding the 
ambiguous nature of section 418. For example, some comments state that 
our interpretation seems appropriate because requiring monitoring of 
the ``effectiveness'' of the preventive controls would be redundant 
with required verification activities. In addition, requiring 
monitoring of the performance of preventive controls is consistent with 
applicable domestic and internationally recognized standards.
    Some comments support the proposed provisions without change. For 
example, some comments note that the proposed requirement for written 
procedures for monitoring is similar to globally recognized food safety 
standards and current industry practices and is a proactive measure to 
help facilities prevent problems. Some comments that support the 
proposed

[[Page 56045]]

provisions suggest alternative or additional regulatory text (see, 
e.g., Comment 466 and Comment 467) or ask us to clarify how we will 
interpret the provision (see, e.g., Comment 465 and Comment 468).
    In the following paragraphs, we discuss comments that disagree with 
our tentative conclusion or with the proposed requirements, or ask us 
to clarify the proposed requirements or suggest one or more changes to 
the proposed requirements. After considering these comments, we are 
affirming our tentative conclusion that the language of section 418 of 
the FD&C Act regarding monitoring is ambiguous and that it would be 
appropriate to require monitoring of the ``performance'' of preventive 
controls. We also have revised the proposed requirements as shown in 
table 34, with editorial and conforming changes as shown in table 52.

     Table 34--Revisions to the Proposed Requirements for Monitoring
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.145.......................  Flexibility in     Provide that
                                 requirements for   monitoring take into
                                 monitoring.        account both the
                                                    nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
117.145(c)(1).................  Records of         Provide that records
                                 monitoring.        of refrigeration
                                                    temperature during
                                                    storage of food that
                                                    requires time/
                                                    temperature control
                                                    to significantly
                                                    minimize or prevent
                                                    the growth of, or
                                                    toxin production by,
                                                    pathogens may be
                                                    affirmative records
                                                    demonstrating
                                                    temperature is
                                                    controlled or
                                                    exception records
                                                    demonstrating loss
                                                    of temperature
                                                    control.
117.145(c)(2).................  Records of         Provide for exception
                                 monitoring.        records for
                                                    monitoring of
                                                    preventive controls
                                                    other than
                                                    refrigeration.
------------------------------------------------------------------------

A. Our Tentative Conclusion To Require Monitoring of the Performance of 
Preventive Controls

    (Comment 461) Some comments disagree with our tentative conclusion 
that it would be appropriate to require monitoring of the 
``performance'' of preventive controls and assert that the concept of 
``performance evaluation'' is too complex to be included in the rule.
    (Response 461) These comments may have misinterpreted what we meant 
by ``monitoring performance of preventive controls.'' We used the term 
``performance'' to mean ``the execution or accomplishment of an action, 
operation, or process undertaken or ordered'' (78 FR 3646 at 3747). We 
acknowledge that the definition of ``monitoring'' that we are 
establishing in this rule includes that the purpose of observations or 
measurements conducted as part of monitoring is to ``assess'' whether 
control measures are operating as intended. However, we provided 
examples showing that this assessment is a straightforward 
determination of whether a process is operating as intended and is not 
a complex evaluation as asserted by the comments. (See, e.g., the 
discussion of monitoring the temperature of a process for roasting 
nuts, 78 FR 3646 at 3746-3747.)
    (Comment 462) Some comments that support monitoring the performance 
of preventive controls assert that our proposed definition of 
``monitoring'' (proposed Sec.  117.3), and our preamble discussions of 
``monitoring,'' have the potential to confuse ``monitoring the 
performance of preventive controls'' with verification activities that 
address ongoing implementation of control measures.
    (Response 462) See Response 106, in which we discuss comments on 
the definition of monitoring and describe the changes we have made to 
that definition to address concerns about the potential to confuse 
``monitoring the performance of preventive controls'' with verification 
activities that address ongoing implementation of control measures.
    (Comment 463) Some comments assert that authority should be 
explicitly granted to the States to conduct food safety monitoring and 
that we should maintain our responsibilities for product tracing.
    (Response 463) These comments misinterpret the provisions of 
section 418 of the FD&C Act and this rule. Section 418 places the 
responsibility for establishing and implementing a food safety system 
(including hazard analysis, risk-based preventive controls, preventive 
control management components (including monitoring, corrective action 
procedures, and verification), and recordkeeping) on the owner, 
operator, or agent in charge of a facility, not on FDA or any other 
regulatory authority. This requirement for monitoring within the 
framework of hazard analysis and risk-based preventive controls is 
distinct from regulatory oversight of food safety, such as during 
inspections and investigations of outbreaks of foodborne illness, which 
generally involve product tracing. We agree that it is important to 
coordinate regulatory oversight of food safety with the States and 
other food safety partners. As discussed in Response 5, we are working 
through the PFP 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).
    (Comment 464) Some comments express concern about monitoring for 
radiological hazards. Some comments claim hardships for fruit 
packinghouses required to analyze and monitor radiological hazards. 
Some comments object to comprehensive monitoring for radiological 
hazards and note that the Codex Principles of Food Hygiene (Ref. 81) do 
not address radiological hazards. Some comments from foreign entities 
request an exemption from the requirements to monitor radiological 
hazards because their government already monitors the food supply for 
radiological safety at a national level.
    (Response 464) These comments misinterpret the proposed 
requirements for monitoring. In this rule, ``monitoring'' means to 
conduct a planned sequence of observations or measurements to assess 
whether control measures are operating as intended, such as measuring 
temperature during a process in which temperature is critical to 
controlling a hazard. The comments seem to be referring to a situation 
in which a receiving facility would find it appropriate to test 
incoming raw materials or other ingredients to ensure that they are not 
contaminated with a radiological hazard. In such a circumstance, 
testing the incoming materials would not be monitoring, but rather 
would be a preventive control (different from its usual role in 
verification). Regardless, whether a facility would need to conduct 
such testing (e.g., after an accident at a nuclear facility near one of 
the facility's suppliers) would be determined based on the outcome of 
its hazard analysis.

[[Page 56046]]

As part of its hazard analysis, a facility that identifies a 
radiological hazard as a hazard requiring a preventive control, and 
determines that testing raw materials and other ingredients is an 
appropriate preventive control, could consider the extent to which any 
testing conducted by its government on raw materials and other 
ingredients reduces the need for, or extent of, its own testing.

B. Proposed Sec.  117.145(a)--Flexibility in Requirements for 
Monitoring

    We proposed that, as appropriate to the preventive control, you 
must establish and implement written procedures, including the 
frequency with which they are to be performed, for monitoring the 
preventive controls, and monitor the preventive controls with adequate 
frequency to provide assurance that they are consistently performed.
    (Comment 465) Some comments assert that some food allergen controls 
are not ``monitored'' in the sense that HACCP controls are monitored. 
Some comments support a ``visibly clean'' standard for monitoring for 
food allergens.
    (Response 465) To the extent that these comments are asserting that 
the types of monitoring activities that a facility would establish 
likely would be different for food allergen controls than for a control 
at a CCP for a product subject to a HACCP plan, we agree. Under the 
rule, a facility has flexibility to establish preventive control 
management components, including monitoring, as appropriate to the 
preventive control, and the nature of any monitoring activity will 
depend on the nature of the preventive control and its role in the 
facility's food safety system. In addition, a facility could determine, 
for example, that it will visually observe food allergen controls as a 
verification activity and not establish a separate ``monitoring'' 
activity within the meaning of Sec.  117.145. For example, a facility 
that uses several food allergens as ingredients could store each of the 
food allergens in a separate area of the facility, and then ``visually 
observe'' that the various food allergens are in their assigned storage 
areas. We agree that ``visibly clean'' can be a minimum standard that a 
facility could apply during verification of food allergen controls by 
visual observation.
    (Comment 466) Some comments ask us to require continuous monitoring 
of preventive controls because the NACMCF HACCP guidelines recommend 
continuous monitoring of controls where possible.
    (Response 466) We decline this request. The NACMCF HACCP guidelines 
characterize continuous monitoring as the ideal situation and 
specifically note that continuous monitoring is always preferred ``when 
feasible.'' The NACMCF HACCP guidelines also note that continuous 
monitoring is possible with many types of physical and chemical 
methods. However, as we previously discussed, both the NACMCF HACCP 
guidelines and the Codex HACCP Annex acknowledge that continuous 
monitoring may not be possible, or even necessary, in all cases (78 FR 
3646 at 3748).
    (Comment 467) Some comments agree that frequency and areas to be 
tested and monitored need to be determined based on each product and 
facility and ask us to allow each individual facility to determine the 
frequency and areas to be monitored based on a completed risk 
assessment. Some comments ask us to specify that the frequency of 
monitoring preventive controls must have a scientific basis.
    (Response 467) It is unclear whether the comment agreeing that 
monitoring frequency and areas to be tested need to be determined based 
on each product and facility was directed to the monitoring provision 
or to environmental monitoring. Regardless, by requiring written 
procedures for monitoring, and specifying that the procedures include 
the frequency with which the procedures are to be performed, the rule 
provides that each facility must determine the frequency of monitoring, 
as well as details such as the areas to be monitored. However, we 
decline the request to specify that these procedures be based on a 
completed ``risk assessment.'' The rule requires the facility to 
conduct a hazard analysis, which determines whether there are any 
hazards requiring a preventive control, and the facility would 
establish preventive controls for such hazards as appropriate to the 
facility and the food. The facility must consider factors associated 
with risk (i.e., 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) in evaluating whether any potential 
hazard is a hazard requiring a preventive control (Sec.  117.130(c)). 
Risk could be relevant to a facility's identification of appropriate 
preventive controls for a particular hazard requiring a preventive 
control. However, it is the nature of the preventive control, rather 
than the risk associated with the hazard, that is more relevant to the 
frequency of monitoring and the areas to be monitored. Accordingly, the 
rule specifies that the facility establish written procedures and 
conducts monitoring as appropriate to the preventive control, rather 
than based on risk associated with the hazard. (See, e.g., the 
discussion of monitoring the temperature of a process for roasting 
nuts, 78 FR 3646 at 3746-3747.)
    We decline the request to specify that the frequency of monitoring 
preventive controls must have a scientific basis. Monitoring should 
take place with sufficient frequency to detect a problem in the 
performance of a preventive control. The importance of the preventive 
control to the safety of the food can be one factor in setting a 
frequency. We acknowledge that scientific information may be 
appropriate in determining the frequency of monitoring in some cases. 
For example, the frequency may be statistically based, such as with 
statistical process control. However, in some cases factors other than 
scientific information may be appropriate in determining the frequency 
of monitoring. For example, historical information on the consistency 
of the control measure can be a factor in determining frequency. When 
variability of the process is low, the frequency may be less than with 
a process that has more variability. As another example, a process that 
is operated at a point close to a food safety parameter limit may be 
monitored more frequently than one where there is a large safety margin 
built into the process.

C. Proposed Sec.  117.145(b)--Records

    We proposed that all monitoring of preventive controls must be 
documented in records that are subject to verification and records 
review.
    (Comment 468) Some comments point out that table 6 in the 2014 
supplemental human preventive controls notice includes an example of a 
monitoring activity that generally would not require monitoring records 
(i.e., monitoring for foreign material with x-rays) (see 79 FR 58524 at 
58542). These comments assert that this example is in conflict with the 
proposed regulatory text and ask us to modify the regulatory text to 
provide the flexibility we acknowledged in the 2014 supplemental human 
preventive controls notice. Other comments ask us to specify that 
monitoring must be documented as appropriate to the nature of the 
preventive control.
    Some comments ask us to recognize the acceptability of monitoring 
systems that exclusively provide exception reports. These comments 
describe exception reporting as a structure where

[[Page 56047]]

automated systems are designed to alert operators and management on an 
exception basis--i.e., only when a deviation from food safety parameter 
limits are observed by the system. These comments assert that, in many 
cases, monitoring of preventive controls can be done by automated 
systems that provide exception reporting in a much more efficient 
manner than if performed by operators and that automated monitoring 
allows for increased sampling frequency (often continuous) and 
reduction of human error. The comments provide an example of a 
refrigeration temperature control that notifies on exception (e.g., 
high temperature alarm) and may only record temperatures that exceed 
the specified temperature (without recording temperatures that meet 
control requirements). These comments acknowledge that such systems 
must be validated and periodically verified to ensure they are working 
properly. These comments ask us to clarify in the preamble to the final 
rule that monitoring systems can work affirmatively or by exception and 
that both types of systems and their related documentation are 
acceptable.
    (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. We agree that the exception 
reporting described in these comments, including validation and 
periodic verification to ensure that the system is working properly, 
would be an acceptable monitoring system in the circumstances provided 
in the comments--i.e., for monitoring refrigeration temperature. 
Therefore, we have revised the regulatory text to provide that records 
of refrigeration temperature during storage of food that requires time/
temperature control to significantly minimize or prevent the growth of, 
or toxin production by, pathogens may be affirmative records 
demonstrating temperature is controlled or exception records 
demonstrating loss of temperature control. Although the comments 
specifically requested that we clarify our view on exception records in 
the preamble, we believe that clarifying the regulatory text will be 
more useful, both to facilities and to regulatory agencies that conduct 
inspections for compliance with the rule. If a facility uses 
``exception records,'' the facility must have evidence that the system 
is working as intended, such as a record that the system has been 
challenged by increasing the temperature to a point at which an 
``exception record'' is generated. (See also Response 602 and Response 
610.)
    We also have revised the regulatory text to provide that exception 
records may be adequate in circumstances other than monitoring of 
refrigeration temperature. For example, in table 6 of the 2014 
supplemental human preventive controls notice the example we provided 
of a monitoring activity that generally would not require monitoring 
records is monitoring for foreign material with x-rays. We believe that 
an x-ray system that monitors for foreign material with x-rays would 
result in a record only when the system detects foreign material.

XXXI. Subpart C: Comments on Proposed Sec.  117.150--Corrective Actions 
and Corrections

    We proposed to establish requirements for corrective actions and 
corrections. Some comments support the proposed requirements without 
change. For example, some comments assert that there is virtually no 
reason to have a food safety plan unless there are proper corrective 
actions in place so the product can be properly disposed of. Some 
comments agree that there should be written procedures for corrective 
actions and note the importance of identifying and evaluating the 
problem, correcting it, and documenting the corrective action. Some 
comments express the view that the proposed requirement for clear 
corrective action in the event of an unanticipated problem, and 
documenting all corrective actions, contributes to a comprehensive 
safety plan. Some comments that support the proposed provisions suggest 
alternative or additional regulatory text (see, e.g., Comment 469, 
Comment 470, Comment 479, Comment 480, and Comment 485).
    In the following paragraphs, 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 35, with editorial and conforming 
changes as shown in table 52.

 Table 35--Revisions to the Proposed Requirements for Corrective Actions
                             and Corrections
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.150(a)....................  Corrective action  Clarify that
                                 procedures.        corrective action
                                                    procedures depend on
                                                    the nature of the
                                                    hazard, as well as
                                                    the nature of the
                                                    preventive control.
117.150(a)(1).................  Corrective action  Clarify that the
                                 procedures.        specified list of
                                                    corrective action
                                                    procedures is not
                                                    intended to be
                                                    exhaustive.
117.150(b)....................  Corrective action  Specify that the
                                 in the event of    requirement applies
                                 an unanticipated   when ``a corrective
                                 food safety        action procedure''
                                 problem.           (rather than ``a
                                                    specific corrective
                                                    action procedure'')
                                                    has not been
                                                    established.
117.150(b)(1)(ii).............  Corrective action  Specify that the
                                 in the event of    requirement applies
                                 an unanticipated   when a preventive
                                 food safety        control, combination
                                 problem.           of preventive
                                                    controls, or the
                                                    food safety plan as
                                                    a whole is found to
                                                    be ineffective
                                                    (rather than just
                                                    when a single
                                                    preventive control
                                                    has been found to be
                                                    ineffective).
117.150(c)(2).................  Corrections......  Provide for
                                                    additional
                                                    circumstances when
                                                    corrections, rather
                                                    than corrective
                                                    actions, are
                                                    warranted.
------------------------------------------------------------------------

A. Proposed Sec.  117.150(a)(1)--Requirement To Establish and Implement 
Corrective Action Procedures

    We proposed that, with some exceptions, as appropriate to the 
preventive control you must establish and implement written corrective 
action procedures that must be taken if preventive controls are not 
properly implemented. The corrective action procedures must include 
procedures to address, as appropriate, the presence of a pathogen or 
appropriate indicator organism in an RTE product detected as a result 
of product testing, as well as the presence of an environmental 
pathogen or appropriate indicator organism detected through 
environmental monitoring.
    (Comment 469) Some comments note that we proposed to list two 
circumstances that require written corrective active procedures (i.e., 
product testing and environmental

[[Page 56048]]

monitoring) and that it is not clear whether this list is intended to 
be exhaustive or not (i.e., whether written corrective action 
procedures are required in only these two circumstances, or whether 
there may be other circumstances that require written corrective action 
procedures). These comments ask us to insert ``but are not limited to'' 
after ``must include'' if we intend that the list is not exhaustive. 
Likewise, other comments state our proposal to specifically require 
corrective action procedures may result in a misunderstanding by some 
facilities about the need to take corrective actions in circumstances 
other than in response to testing results, other non-conformances, or 
other types of verification activities. These comments assert that it 
would be better for food safety if the regulatory requirements took a 
more principled approach and generally required corrective action 
procedures, with the importance of corrective action procedures for 
testing programs addressed through guidance. If, however, we conclude 
that specific requirements for corrective action procedures for testing 
programs are necessary, these comments ask us to clarify that the 
nature and extent of any corrective actions should be proportional to 
the nature of the test findings.
    (Response 469) We have revised the regulatory text, with associated 
editorial revisions and redesignations, to clarify that the specified 
list of corrective action procedures is not intended to be exhaustive 
(i.e., not limited to the two corrective action procedures that we 
specified in the proposed human preventive controls rule). The approach 
we used in the modified regulatory text (i.e., ``You must establish and 
implement written corrective action procedures . . ., including 
procedures to address, as appropriate . . .'' is similar to the 
approach used in several other provisions of the rule. (See, e.g., 
requirements for allergen controls (Sec.  117.135(c)(2)); sanitation 
controls (Sec.  117.135(c)(3)(i)); and monitoring (Sec.  117.145(a).) 
We decline the suggestion to modify the regulatory text by adding ``but 
is not limited to'' after ``includes.'' 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. (See Response 68.) We agree that 
the nature and extent of any corrective actions in response to the 
findings of testing programs should be proportional to nature of the 
test findings. (See Response 470.)
    (Comment 470) Some comments state that the nature and extent of the 
corrective actions should be proportional to the nature of the testing 
results. These comments ask us to require that a facility establish and 
implement corrective action procedures that must be taken if preventive 
controls are not properly implemented as appropriate to the nature of 
the hazard, the nature of the control measure, and the extent of the 
deviation.
    (Response 470) We have revised the regulatory text to specify that 
the corrective action procedures are established and implemented based 
on the nature of the hazard in addition to the nature of the preventive 
control. We agree that the nature of the hazard plays a key role in the 
corrective actions that a facility would take. Although a facility's 
corrective action procedures likely would specify actions to take based 
on the extent of the deviation, we consider this a detail that does not 
need to be specified in the rule.
    (Comment 471) Some comments ask us to revise the provisions to 
clarify that corrective action procedures are not always necessary when 
testing detects the presence of a pathogen or indicator organism. These 
comments assert that the extent of the corrective actions should be 
proportional to the nature of the testing results themselves because 
the level of contamination matters for those microorganisms with 
thresholds that need to be taken into account and because the location 
of contamination in the food processing environment matters (e.g., the 
zone in the facility where the contamination is detected). (For 
information about zones associated with environmental monitoring, see 
78 FR 3646 at 3816.)
    (Response 471) We decline this request. These comments appear to be 
confusing the requirement to establish and implement corrective action 
procedures with the content of the corrective action procedures. These 
comments also appear to assume that a requirement to have corrective 
action procedures (which describe the steps to be taken to ensure that 
appropriate action is taken to identify and correct a problem and, when 
necessary, to reduce the likelihood that the problem will recur; that 
all affected food is evaluated for safety; and that all affected food 
is prevented from entering into commerce when appropriate) pre-
determines the outcome of following the corrective action procedures. 
This is not the case. If, as the comments assert, a facility concludes, 
for example, that the nature of some test results do not warrant steps 
to reduce the likelihood that the problem will recur and that affected 
food is safe and lawful (or, in the case of finding a pathogen in some 
zones in the facility, that no food is affected), then that is what its 
corrective action procedures would say. The reason to have corrective 
action procedures is to consider the likely scenarios in advance, with 
appropriate input from the facility's food safety team and preventive 
controls qualified individual, rather than react to these scenarios on 
an ad hoc basis.
    (Comment 472) Some comments ask us to require that corrective 
actions include an analysis to determine the root cause of a problem, 
not only identify it. These comments also ask us to require follow-up 
actions to ensure the corrective action was effective and assert that 
although the requirements address the need to reanalyze the food safety 
plan they do not appear to specifically address a review of the 
corrective action.
    (Response 472) The requests of these comments do not require any 
revisions to the regulatory text. The rule does not use the term ``root 
cause'' but it does require the facility to take appropriate action, 
when necessary, to reduce the likelihood that the problem will recur 
(see Sec.  117.150(a)(2)(ii)). Root cause analysis is simply part of a 
common approach to complying with this requirement. (Knowing the root 
cause is key to reducing the likelihood that a problem will happen 
again.) The rule also requires a review of records of corrective 
actions, but does so as a verification activity rather than as part of 
the corrective action procedures (see Sec.  117.165(a)(4)).
    (Comment 473) Some comments ask us to revise the proposed rule to 
address corrective actions in a more general way and then outline areas 
where specific corrective action procedures would be helpful, such as 
for testing programs, in guidance.
    (Response 473) The proposed provisions do not prescribe the outcome 
of the corrective action procedures, but merely direct the facility to 
the types of actions that the procedures must address. In essence, the 
proposed provisions already do, as the comments request, address 
corrective actions in a general way.
    (Comment 474) Some comments ask us to specify that the requirements 
also apply when a preventive control is found to be ineffective.
    (Response 474) We have not revised the regulatory text as requested 
by these comments. The appropriate action when a preventive control is 
found to be ineffective is to reanalyze the food safety plan and to 
establish and implement a preventive control that is effective, not 
follow a corrective action procedure. A corrective action

[[Page 56049]]

procedure is intended to address a problem that happens when following 
the procedures in a food safety plan that previously was verified to be 
valid, not to fix problems on an ongoing basis when a preventive 
control is ineffective (and, thus, the food safety plan is not valid). 
We agree that some of the steps that apply to corrective actions may 
need to be taken, such as evaluating affected food for safety and 
ensuring that adulterated food does not enter commerce. This is 
addressed by the provisions for corrective actions in the event of an 
unanticipated problem (Sec.  117.150(b)(1)(ii)), which require specific 
corrective actions to be taken (Sec.  117.150(b)(2)).

B. Proposed Sec.  117.150(a)(2)--Content of Corrective Action 
Procedures

    We proposed that corrective action procedures must describe the 
steps to be taken to ensure that: (1) Appropriate action is taken to 
identify and correct a problem that has occurred with implementation of 
a preventive control; (2) appropriate action is taken to reduce the 
likelihood that the problem will recur; (3) all affected food is 
evaluated for safety; and (4) all affected food is prevented from 
entering into commerce, if you cannot ensure that the affected food is 
not adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act.
    (Comment 475) Some comments assert that the corrective action 
procedures should not consider food to be ``affected'' if it is 
immediately subjected to an additional (or repeat) preventive control 
after determining that the initial preventive control was not properly 
implemented. These comments discuss an example in which there is a 
temperature deviation below accepted parameter limits for a given 
process, and the incorrectly processed product is re-processed 
correctly, and assert that it would be illogical to consider the food 
to be ``affected'' in this circumstance. Other comments ask us to 
modify the requirements to specify that they apply to all affected food 
``if any.''
    (Response 475) We decline the request to modify the regulatory text 
to specify that the requirements apply to all affected food ``if any.'' 
Food is ``affected'' if a preventive control is not properly 
implemented during its production. However, the rule does not pre-
determine the consequences when food is ``affected.'' Instead, the rule 
requires the facility to evaluate the affected food for safety. If, as 
in the example described by the comments, the facility re-applies the 
preventive control such that the food is safe and is not adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of 
the FD&C Act, there would be no need to take steps to prevent that food 
from entering commerce.
    (Comment 476) Some comments assert that the proposed regulatory 
text could be misunderstood as a requirement to establish a new 
preventive control after implementing a corrective action procedure. 
These comments also assert that it would be inappropriate to assume 
that corrective action procedures always correct a problem with the 
implementation of a new or additional preventive control.
    (Response 476) We received these comments before we issued the 2014 
supplemental human preventive controls notice. The proposed regulatory 
text in the 2014 supplemental human preventive controls notice 
addresses the issues identified in these comments by clearly separating 
the requirement to take appropriate action to identify and correct a 
problem that has occurred from the requirement to take appropriate 
action, when necessary, to reduce the likelihood that the problem will 
recur.
    (Comment 477) Some comments ask us to provide that requirements for 
corrective actions be principle-based (e.g., containment of affected 
product, control restored to operation before commencing production) 
rather than prescriptive.
    (Response 477) The requirements for corrective actions established 
by this rule are principle-based in that they require the facility to 
describe the steps that it will take rather than prescribe the steps 
that it will take.
    (Comment 478) Some comments ask us to revise the provision to make 
re-sampling and/or re-testing one of the first steps in a corrective 
action procedure to take into account human error. These comments 
assert that mishandling during sampling, transport, and testing can 
contribute to a false positive result and that if the results of a 
follow-up test are negative, then the previous test could be considered 
an anomaly that could be ignored.
    (Response 478) We decline this request. We disagree that an 
appropriate approach to positive findings of a test for contamination 
is to re-sample and re-test and to consider positive findings to be an 
anomaly if subsequent test results are negative. Many food products are 
not homogeneous and contamination is localized. Even for homogeneous 
food products (such as fluids), the problem could be the sensitivity of 
the method if the level of contamination is low. See our guidance 
entitled ``Guidance for Industry: Testing for Salmonella Species in 
Human Foods and Direct-Human-Contact Animal Foods'' (Ref. 82).

C. Proposed Sec.  117.150(b)--Corrective Action in the Event of an 
Unanticipated Problem

    With some exceptions, we proposed that you must take corrective 
action to identify and correct a problem, reduce the likelihood that 
the problem will recur, evaluate all affected food for safety, and, as 
necessary, prevent affected food from entering commerce as would be 
done following a corrective action procedure if any of the following 
circumstances apply: (1) A preventive control is not properly 
implemented and a specific corrective action has not been established; 
(2) a preventive control is found to be ineffective; or (3) a review of 
records finds that the records are not complete, the activities 
conducted did not occur in accordance with the food safety plan, or 
appropriate decisions were not made about corrective actions. We also 
proposed that if any of these circumstances apply, when appropriate you 
must reanalyze the food safety plan to determine whether modification 
of the food safety plan is required.
    (Comment 479) Some comments ask us to delete the proposed 
requirement that a facility must reanalyze the food safety plan in the 
event of an unanticipated problem. These comments argue that FSMA does 
not specify reanalysis in the event of an unanticipated problem. In 
addition, these comments assert that the proposed requirement for 
reanalysis in the event of an unanticipated problem would be redundant 
with the proposed requirements for reanalysis as a verification 
activity (proposed Sec.  117.170) and would not add value for food 
safety. These comments also assert that the term ``problem'' is 
ambiguous and ask us to replace ``problem'' with ``food safety issue'' 
if we retain the provision in the final rule.
    (Response 479) We acknowledge that section 418 of the FD&C Act does 
not explicitly specify that a facility must reanalyze its food safety 
plan in the event of an unanticipated problem. However, as previously 
discussed, requiring reanalysis of the food safety plan after an 
unanticipated problem 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 3752). In the 2014 
supplemental human preventive controls notice, we clarified that 
reanalysis would be conducted ``when appropriate.'' For example, if a 
problem

[[Page 56050]]

occurs because personnel did not understand the procedures or carry out 
the procedures correctly, additional training for applicable personnel 
may be warranted, but there likely would be no need to reanalyze the 
food safety plan.
    We disagree that the term ``problem'' is ambiguous. The term 
``problem'' signifies that something is wrong, whereas the term 
suggested by the comments (i.e., ``issue'') may or may not signify that 
something is wrong. The analogous provisions in the NACMCF HACCP 
guidelines (Ref. 34), the Codex HACCP Annex (Ref. 35), and Federal 
HACCP regulations for seafood, juice, and meat and poultry is 
``deviation.'' We avoided the term ``deviation'' because ``deviation'' 
has the potential to signify that the requirements of this rule for 
corrective actions only apply when a preventive control is at a CCP, 
which is not the case. We agree that the requirements are directed to 
problems related to food safety, and in the 2014 supplemental human 
preventive controls notice we modified the title of the requirement to 
be ``Corrective action in the event of an unanticipated food safety 
problem.'' However, we continue to use the simpler term ``problem'' in 
the remainder of the regulatory text. Specifying that the nature of the 
problem is ``food safety'' in the title is sufficient to focus the 
requirement on food safety.
    We agree that there is a relationship between the requirements for 
corrective actions in the event of an unanticipated food safety problem 
and the requirements for reanalysis. To reduce redundant regulatory 
text, in the 2014 supplemental human preventive controls notice we 
proposed to modify the regulatory text of the requirements for 
reanalysis to specify that reanalysis is required when appropriate 
after an unanticipated food safety problem, and we are establishing 
that modified provision in this final rule. Importantly, the provisions 
for reanalysis continue to require reanalysis when a preventive control 
is found to be ineffective. We are not aware of any circumstances in 
which it would not be appropriate to reanalyze the food safety plan if 
a preventive control is found to be ineffective.
    (Comment 480) Some comments assert that the word ``specific'' is 
not appropriate as a modifier for ``corrective action procedure'' 
because many preventive controls will have corrective action procedures 
that allow flexibility based on the nature of the hazard and control. 
These comments also state that the term ``specific'' in this context is 
more appropriate for a CCP control in a HACCP system.
    (Response 480) We have revised the regulatory text to delete the 
word ``specific.''
    (Comment 481) Some comments ask us to emphasize that reanalysis is 
required only when a combination of two events occurs (i.e., a 
preventive control is not properly implemented, and the facility has 
not established a corrective action procedure).
    (Response 481) In the 2014 supplemental human preventive controls 
notice, we proposed revisions to the regulatory text to clearly specify 
the circumstances requiring reanalysis. One such circumstance is when a 
preventive control is not properly implemented and a corrective action 
procedure has not been established (Sec.  117.150(b)(1)(i)). The final 
provision includes the revisions included in the 2014 supplemental 
human preventive controls notice and is consistent with the request of 
these comments.
    (Comment 482) Some comments ask us to add that corrective actions 
in the event of an unanticipated problem also apply when a preventive 
control is ``missing.''
    (Response 482) We have revised the regulatory text to require 
corrective actions whenever a preventive control, combination of 
preventive controls, or the food safety plan as a whole, is 
ineffective. (See Sec.  117.150(b)(1)(ii).) In assessing what the 
comment might mean by a preventive control that is ``missing,'' we 
concluded that an unanticipated problem could, in some cases, mean that 
a combination of preventive controls, or the facility's food safety 
plan as a whole (rather than a single preventive control), simply was 
not effective. If this is the case, reanalysis would be appropriate, 
and we also have modified the requirements for reanalysis to specify 
that a facility must reanalyze its food safety plan whenever it finds 
that a preventive control, combination of preventive controls, or the 
food safety plan as a whole is ineffective. (See also Response 556.)
    (Comment 483) Some comments assert that fresh and fresh-cut produce 
operations are unlikely to prevent recurrence of occasional detections 
of human pathogens (particularly L. monocytogenes, which is a soil 
microorganism whose normal habitat is in the field) because there is no 
``kill step'' for pathogens and because the source of contamination may 
not be identified. These comments point out that we recognize that 
preventive controls may only be able to ``significantly minimize'' 
significant hazards and assert that our acknowledgement that preventive 
controls may not always be able to prevent significant hazards is 
inconsistent with an expectation to prevent recurrence.
    (Response 483) We disagree that our acknowledgement that preventive 
controls may not always be able to prevent significant hazards is 
inconsistent with an expectation to prevent recurrence. Even when a 
preventive control is not always able to prevent a hazard requiring a 
preventive control, it can reduce the likelihood that the hazard will 
adulterate the food within the meaning of section 402 of the FD&C Act 
or misbrand the food within the meaning of section 403(w) of the FD&C 
Act. For example, a facility processing fresh-cut produce can reduce 
the likelihood of contamination of incoming fresh produce with L. 
monocytogenes through enhanced supply-chain controls for incoming fresh 
produce, along with appropriate sanitation controls. As discussed in 
Response 470, we have revised the regulatory text to specify that the 
corrective action procedures are established and implemented based on 
the nature of the hazard in addition to the nature of the preventive 
control, because the nature of the hazard plays a key role in the 
corrective actions that a facility would take. When a preventive 
control is not able to prevent a hazard, the facility must focus on 
minimizing the hazard.
    (Comment 484) Some comments ask us to replace the term 
``reanalyze'' with the term ``reassess.''
    (Response 484) We decline this request. See Response 551.

D. Proposed Sec.  117.150(c)--Corrections

    We proposed that you do not need to comply with the requirements 
for corrective actions and corrections for conditions and practices 
that are not consistent with specified food allergen controls or 
sanitation controls if you take action, in a timely manner, to correct 
such conditions and practices.
    (Comment 485) Some comments support our proposal to provide for 
corrections, rather than corrective actions, for sanitation controls 
and some food allergen controls in some circumstances. Other comments 
assert that situations in which ``corrections'' can be applied are not 
limited to sanitation and food allergen controls and could include 
actions to address other preventive controls such as preventive 
maintenance controls or CGMPs. As discussed in Comment 164, some 
comments emphasize the importance of distinguishing between the terms 
``correction'' and ``corrective action.''

[[Page 56051]]

    (Response 485) We have revised the regulatory text, with associated 
editorial revisions and redesignations, to provide for corrections, 
rather than corrective actions and corrective action procedures, for 
minor and isolated problems that do not directly impact product safety. 
As discussed in Response 164, we also have defined 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).

E. Proposed Sec.  117.150(d)--Records

    We proposed that all corrective actions (and, when appropriate, 
corrections) must be documented in records and that these records are 
subject to the verification requirements in Sec. Sec.  117.155(a)(3) 
and 117.165(a)(4)(i). We received no comments that disagreed with this 
proposed requirement and are finalizing it as proposed.

XXXII. Subpart C: Comments on Proposed Sec.  117.155--Verification

    In the 2013 proposed human preventive controls rule, we proposed 
verification activities that would include validation, verification of 
monitoring, verification of corrective actions, verification of 
implementation and effectiveness, written procedures, reanalysis, and 
documentation of all verification activities. We also requested comment 
on whether we should specify the verification activities that must be 
conducted for verification of monitoring (78 FR 3646 at 3756) and for 
verification of corrective actions (78 FR 3646 at 3756), and if so, 
what verification activities should be required.
    To improve clarity and readability, in the 2014 supplemental human 
preventive controls notice we proposed to move the more extensive 
verification requirements for validation, implementation and 
effectiveness, and reanalysis from the single proposed section 
(proposed Sec.  117.150) to separate sections (proposed Sec. Sec.  
117.160, 117,165, and 117.170, respectively). In addition, to address 
comments that asked us to provide more flexibility to facilities, 
including flexibility in determining whether and how to conduct 
verification activities, in the 2014 supplemental human preventive 
controls notice we proposed that the verification activities be 
performed ``as appropriate to the preventive control.''
    In this section, we discuss the proposed requirements for 
verification of monitoring, verification of corrective actions, and 
documentation of verification activities. See sections XXXIII through 
XXXV for comments on the proposed requirements for validation, 
verification of implementation and effectiveness, written procedures, 
and reanalysis. See table 37, table 38, and table 39 for a summary of 
the revisions to those proposed requirements.
    Some comments support the proposed requirements for verification of 
monitoring, verification of corrective actions, and documentation of 
verification activities without change. For example, comments support 
the documentation of verification activities (see section XXXII.C). In 
the following paragraphs, we discuss comments on the flexibility 
provided for a facility to conduct verification activities as 
appropriate to the nature of the preventive control. We also discuss 
comments that address our request for comment on whether we should 
revise the regulatory text to specify the verification activities that 
must be conducted for verification of monitoring and for verification 
of corrective actions, or express concern that the requirements as 
proposed are too prescriptive. After considering these comments, we 
have revised the verification requirements described in Sec.  117.155 
as shown in table 36.

    Table 36--Revisions to the Proposed Requirements for Verification
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.155.......................  Flexibility to     Provide that
                                 conduct            verification
                                 verification       activities take into
                                 activities.        account both the
                                                    nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
------------------------------------------------------------------------

A. Flexibility in Requirements for Verification

    (Comment 486) Some comments support the flexibility provided by use 
of the phrase ``as appropriate to the preventive control'' in the 
requirement that verification activities must include, as appropriate 
to the preventive control, specified verification activities (i.e., 
validation, verification that monitoring is being conducted, 
verification that appropriate decisions about corrective actions are 
being made, verification of implementation and effectiveness, and 
reanalysis). These comments emphasize that verification activities must 
be tailored to the preventive control and assert that the use of the 
word ``must'' is potentially confusing in light of this flexibility--
e.g., because not all preventive controls must be validated for food 
safety, and those preventive controls that do not need monitoring would 
not need verification of monitoring. Other comments ask us to allow 
facilities flexibility to verify that preventive controls are effective 
in the manner prescribed by FSMA--i.e., such controls should be deemed 
to be effective by an appropriate means as determined and supported by 
the facility within its food safety plan.
    (Response 486) The provisions for preventive control management 
components make clear that all preventive control management 
components, including verification, are required as appropriate to 
ensure the effectiveness of the preventive control, taking into account 
the nature of the preventive control and its role in the facility's 
food safety system (see Sec.  117.140). Likewise, the provisions for 
each of the preventive control management components (i.e., monitoring, 
corrective actions and corrections, and verification) individually 
provide flexibility, either by specifying that the provisions apply as 
appropriate to the nature of the preventive control and its role in the 
facility's food safety system (i.e., for monitoring and verification) 
or both the nature of the preventive control and the nature of the 
hazard (i.e., for corrective actions and corrections). The word 
``must'' specifies the type of activities that a facility can use to 
satisfy the requirements for a particular preventive control management 
component.
    We are retaining the term ``must.'' However, we agree that the rule 
should provide flexibility for additional verification of 
implementation and effectiveness. To provide that additional 
flexibility, we have revised the specific requirements for verification 
of implementation and effectiveness to provide for other activities 
appropriate

[[Page 56052]]

for verification of implementation and effectiveness (see Sec.  
117.165(a)(5)). As a conforming revision, we have revised the 
requirement for review of records to include a review of records of 
``other verification activities'' within a reasonable time after the 
records are created (see Sec.  117.165(a)(4)(ii)).

B. Proposed Sec.  117.155(a)--Verification Activities

1. Proposed Sec.  117.155(a)(1)--Validation
    We proposed that verification activities must include, as 
appropriate to the preventive control, validation in accordance with 
Sec.  117.160. See section XXXIII for comments on validation as a 
verification activity.
2. Proposed Sec.  117.155(a)(2)--Verification of Monitoring
    We proposed that verification activities must include, as 
appropriate to the preventive control, verification that monitoring is 
being conducted in accordance with Sec.  117.145. We requested comment 
on whether we should specify the verification activities that must be 
conducted for monitoring, and, if so, what verification activities 
should be required.
    (Comment 487) Comments that address our request for comment on 
whether we should specify the verification activities that must be 
conducted for monitoring ask us to not do so because this prescriptive 
approach would be too limiting. These comments ask us to instead 
provide flexibility for the facility to determine the appropriate 
verification activities.
    (Response 487) We agree that we should provide flexibility for the 
facility to determine these verification activities, and are not 
specifying the verification activities that must be conducted for 
monitoring.
    (Comment 488) Some comments express concern that the proposed 
requirements for verification of monitoring would bring food CGMPs to 
the same level as pharmaceutical CGMPs. These comments assert that our 
example of how verification of monitoring could be conducted when a 
metal detector is a preventive control is impractical (FR 3646 at 
3756). These comments explain that a quality control officer is not 
likely to go out onto the plant floor every shift to verify the 
operator's metal detector readings but would instead document the metal 
detector readings, which would be captured as part of the batch record 
review. These comments suggest that a more appropriate description of 
what a facility would do when a metal detector is a preventive control 
would be to ``check'' whether the metal detector is rejecting test 
pieces of metal.
    (Response 488) We are establishing the requirements for 
verification of monitoring as part of a system for hazard analysis and 
risk-based preventive controls, not as a matter of CGMP. As previously 
discussed (78 FR 3646 at 3756), verification of monitoring is 
consistent with the FSIS HACCP regulation for meat and poultry, which 
requires direct observations of monitoring activities as an ongoing 
verification activity (9 CFR 417.4(a)(2)(ii)). We disagree that our 
example of how verification of monitoring could be conducted when a 
metal detector is a preventive control is impractical; observation of 
the operator conducting the check with test pieces by a supervisor, or 
having a quality assurance person run a test, is not uncommon. However, 
in the 2014 supplemental human preventive controls notice, we clarified 
that verification that monitoring is being conducted is required as 
appropriate to the preventive control. With this added flexibility, a 
facility could, for example, determine that it would satisfy the 
requirement for verification of monitoring by reviewing records under 
Sec.  117.165(a)(4). Doing so would be consistent with the NACMCF HACCP 
guidelines (Ref. 35), the Codex HACCP guidelines (Ref. 34), and FDA's 
HACCP regulations for seafood and juice, which all address verification 
of monitoring through the review of records (78 FR 3646 at 3756).
3. Proposed Sec.  117.155(a)(3)--Verification of Corrective Actions
    We proposed that verification activities must include, as 
appropriate to the preventive control, verification that appropriate 
decisions about corrective actions are being made in accordance with 
Sec.  117.150. We requested comment on whether this section should 
specify the verification activities that must be conducted for 
corrective actions, and if so, what verification activities should be 
required.
    (Comment 489) Some comments ask us not to specify the verification 
activities that must be conducted for corrective actions because this 
approach would be too limiting. These comments ask us to instead 
provide flexibility for the facility to determine the appropriate 
verification activities.
    (Response 489) We agree that we should provide flexibility for the 
facility to determine the appropriate verification activities for 
corrective actions, and are not specifying the verification activities 
that must be conducted for corrective actions.
4. Proposed Sec.  117.155(a)(4)--Verification of Implementation and 
Effectiveness
    We proposed that verification activities must include, as 
appropriate to the preventive control, verification of implementation 
and effectiveness in accordance with Sec.  117.165. See section XXXIV 
for comments on verification of implementation and effectiveness.
5. Proposed Sec.  117.155(a)(5)--Reanalysis
    We proposed that verification activities must include, as 
appropriate to the preventive control, reanalysis in accordance with 
Sec.  117.170. See section XXXV for comments on reanalysis as a 
verification activity.

C. Proposed Sec.  117.155(b)--Documentation of Verification Activities

    We proposed that all verification activities must be documented in 
records. We received no comments that disagreed with this proposed 
requirement and are finalizing it as proposed.

D. Comments on Potential Requirements Regarding Complaints

    We requested comment on whether and how a facility's review of 
complaints, including complaints from consumers, customers, or other 
parties, should be required as a component of its activities to verify 
that its preventive controls are effectively minimizing the occurrence 
of hazards (78 FR 3646 at 3768).
    (Comment 490) Some comments ask us to require review of consumer 
complaints as a verification activity and note that our HACCP 
regulations for seafood and juice require that verification activities 
include a review of consumer complaints to determine whether they 
relate to the performance of the HACCP plan or reveal the existence of 
unidentified CCPs. Some comments note circumstances in which consumer 
complaints have identified food safety problems that resulted in a 
company report to the RFR.
    Some comments state that the frequency and type of complaints a 
facility receives is a very good indicator of the underlying issues 
associated with food production, reviewing these records would provide 
valuable insight into the type of issues that should be investigated, 
and this type of verification activity could be therefore be extremely 
effective with little to no cost because the facility would already be 
performing this type of activity. Some comments state that many

[[Page 56053]]

foodborne outbreaks have been identified through complaints and a 
review of complaints is a critical component of a food safety system.
    Other comments state that a food safety review of complaints is a 
prudent part of a food safety program but that the value of such a 
review is in providing information and feedback for continuous 
improvement of the food safety management system rather than as a 
verification of preventive controls. These comments caution against use 
of consumer complaints as a regulatory requirement for verification of 
the food safety plan because most complaints relate to product quality. 
If such a requirement is nonetheless established in the final rule, 
these comments recommend that the rule only require follow-up and 
documentation for the rare occurrences where consumer complaints relate 
to food safety issues.
    Other comments ask us not to require review of complaints as a 
verification activity. Some of these comments assert that complaints 
rarely relate to food safety or yield information that leads to 
discovery of a food safety issue. Some comments assert that requiring 
review of consumer complaints could result in unnecessary time and 
effort being spent on an activity with a limited correlation to food 
safety. Other comments assert that complaints would be acted upon 
immediately for business reasons, and that waiting to react to 
complaints until conducting a review of records as a verification 
activity would be too late. Other comments assert that complaints are 
sensitive business information. Other comments assert that some 
consumer complaints are false or emotional (rather than factual) and 
have no place in development of preventive controls. Some comments 
assert that FSMA does not expressly direct us to require review of 
complaints. Some comments assert that review of complaints is not a 
precise scientific process, and that consumer comments are often open 
to different interpretations.
    (Response 490) We are not establishing a requirement for a review 
of complaints as a verification activity. We agree that review of 
complaints is more likely to be useful in providing information and 
feedback for continuous improvement of the food safety system rather 
than as a verification of preventive controls. However, we encourage 
facilities to do such a review, as they occasionally do uncover food 
safety issues such as an undeclared allergen.

XXXIII. Subpart C: Comments on Proposed Sec.  117.160--Validation

    We proposed to establish requirements for validation of preventive 
controls. Some comments support the proposed requirements without 
change. For example, some comments agree that validation must be 
performed by (or overseen by) a preventive controls qualified 
individual and that some preventive controls (e.g., food allergen 
controls, sanitation controls, and recall plans) do not require 
validation. Some comments that support the proposed provisions suggest 
alternative or additional regulatory text (see, e.g., Comment 491, 
Comment 500, Comment 501, Comment 503, and Comment 513) or ask us to 
clarify how we will interpret the provision (see, e.g., Comment 499, 
Comment 502, and Comment 508).
    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 
37, with editorial and conforming changes as shown in table 52.

     Table 37--Revisions to the Proposed Requirements for Validation
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.160(a)....................  Flexibility for    Provide that
                                 validating         validation be
                                 preventive         conducted as
                                 controls.          appropriate to both
                                                    the nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system.
117.160(b)(1).................  Circumstances      Provide that, when
                                 requiring          necessary to
                                 validation.        demonstrate the
                                                    control measures can
                                                    be implemented as
                                                    designed, validation
                                                    may be performed:
                                                    (1) Within 90 days
                                                    after production of
                                                    the applicable food
                                                    first begins; or (2)
                                                    within a reasonable
                                                    timeframe, provided
                                                    that the preventive
                                                    controls qualified
                                                    individual prepares
                                                    (or oversees the
                                                    preparation of) a
                                                    written
                                                    justification.
117.160(b)(1).................  Circumstances      Add an additional
                                 requiring          circumstance
                                 validation.        requiring
                                                    validation--i.e.,
                                                    whenever a change to
                                                    a control measure or
                                                    combination of
                                                    control measures
                                                    could impact whether
                                                    the control measure
                                                    or combination of
                                                    control measures,
                                                    when properly
                                                    implemented, will
                                                    effectively control
                                                    the hazards
                                                    requiring a
                                                    preventive control.
117.160(c)....................  Preventive         Clarify that a list
                                 controls that do   of preventive
                                 not require        controls that do not
                                 validation.        require validation
                                                    is not an exhaustive
                                                    list.
------------------------------------------------------------------------

A. Flexibility in the Requirements To Validate Preventive Controls

    With some exceptions (see discussion of proposed Sec.  
117.160(b)(3) in section XXXIII.D), we proposed that you must validate 
that the preventive controls identified and implemented in accordance 
with proposed Sec.  117.135 to control the significant hazards are 
adequate to do so (proposed Sec.  117.160(a)).
    (Comment 491) Some comments assert that the regulatory text is in 
conflict with the preamble discussion in the 2014 supplemental human 
preventive controls notice because the regulatory text (i.e., 
``[e]xcept as provided by . . .'') narrowly provides exceptions only 
for validation of food allergen controls, sanitation controls, supplier 
controls, and the recall plan, whereas the preamble discussion provides 
other examples of preventive controls that would not require validation 
(i.e., zoning, training, preventive maintenance, and refrigerated 
storage). These comments also assert that although the regulatory text 
specifies that validation requirements apply ``as appropriate to the 
nature of the preventive control,'' that phrase could be interpreted to 
mean that only the validation act itself can be tailored and that the 
facility does not have the flexibility to conclude that validation 
isn't necessary.
    Some comments assert that the proposed regulatory text would 
prevent us from requiring validation of specific allergen or sanitation 
controls where it may be prudent to do so, either now or in the future 
as a result of a newly

[[Page 56054]]

identified hazard, establishment of regulatory allergen threshold(s), 
or the development of a tool, such as a test method, that would enable 
validation of the control for the specific hazard.
    (Response 491) We have deleted ``except as provided by paragraph 
(b)(3) of this section'' from proposed Sec.  117.160(a) to remove the 
limitation seen by the comments on the exceptions to the requirement 
for validation of preventive controls. We also have revised the 
regulatory text of Sec.  117.160(c) to provide that a facility does not 
need to validate other preventive controls, if the preventive controls 
qualified individual prepares (or oversees the preparation of) a 
written justification that validation is not applicable 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. 
We specified that the determination that validation is not required 
must be made by the preventive controls qualified individual to 
emphasize that specialized experience is necessary to evaluate whether 
validation is required. We made a conforming revision to the list of 
responsibilities of the preventive controls qualified individual (see 
Sec.  117.180(a)).
    (Comment 492) Some comments ask us to separate requirements for 
validation from requirements for verification because verification and 
validation are two different concepts and combining them is confusing. 
Some comments point out that while section 418(f)(1) of the FD&C Act 
explicitly requires verification, it does not require validation. Some 
of these comments assert that our proposed requirements for validation 
exceed the mandate of FSMA while others argue that the lack of explicit 
language in section 418 of the FD&C Act gives us legal flexibility in 
determining whether and how to require validation.
    (Response 492) Our approach is consistent with section 418 of the 
FD&C Act. Section 418(f)(1) of the FD&C Act requires verification of 
the preventive controls, and validation is an element of verification 
(see both the NACMCF HACCP guidelines (Ref. 35) and our HACCP 
regulation for juice (Sec.  120.3(p)). We agree that the purpose of 
validation is different from the purpose of other verification 
activities, and we have revised the definitions of both terms to make 
this clearer. Although we are establishing a separate regulatory 
section for the validation requirements, we did so to improve clarity 
and readability rather than as a substantive change relevant to the 
issues discussed in these comments (See Response 150).
    (Comment 493) Some comments assert that validation is more 
appropriate for a HACCP regulation and that requiring the validation of 
all preventive controls does not reflect the flexibility mandated by 
section 418(n)(3)(A) of FSMA. Other comments assert that effective 
preventive measures may be identified in the future that are not 
amenable to validation and it would be counterproductive for them not 
to be employed in food safety plans because they cannot meet the 
validation requirements. These comments explain that certain control 
measures are not suitable for validation activities due to the nature 
of the activity or previous validation by another entity (e.g., a 
supplier).
    (Response 493) The 2013 proposed human preventive controls rule 
would not have required the validation of all preventive controls. For 
example, we specifically proposed that the validation of preventive 
controls need not address food allergen controls, sanitation controls, 
and the recall plan. To emphasize that a facility has flexibility in 
appropriately determining which other preventive controls require 
validation, in the 2014 supplemental human preventive controls notice 
we revised the proposed regulatory text to require validation ``as 
appropriate to the nature of the preventive control.'' See (Response 
491 for additional revisions we have made to the regulatory text to 
provide flexibility for a facility to determine that validation is not 
necessary.
    (Comment 494) Some comments ask us to allow validation of the whole 
system instead of individual controls.
    (Response 494) See the discussion of the definition of validation 
in Response 150. Under the definition, validation can be directed to a 
control measure, combination of control measures, or the food safety 
plan as a whole.
    (Comment 495) Some comments ask us to align validation requirements 
with the relative risk of operations.
    (Response 495) Validation requirements apply only to preventive 
controls that are established and implemented based on the outcome of a 
hazard analysis, which requires consideration of risk. We also require 
validation as appropriate to the nature of the preventive control and 
its role in the facility's food safety system. This provides 
flexibility with respect to validation and allows consideration of 
risk.
    (Comment 496) Some comments ask whether we will endorse 
certification under GFSI as satisfying the requirements for validation.
    (Response 496) GFSI was established to support improvements in food 
safety management systems to ensure confidence in the delivery of safe 
food to consumers worldwide (Ref. 83). GFSI has developed a guidance 
document that specifies a process by which food safety schemes may gain 
recognition by GFSI, the requirements to be put in place for a food 
safety scheme seeking recognition by GFSI, and the key elements for 
production of safe food or feed, or for service provision (e.g., 
contract sanitation services or food transportation), in relation to 
food safety (Ref. 83). We have no plans to endorse certification under 
GFSI (or any other standard setting organization) as satisfying the 
requirements for validation. However, to the extent that scientific and 
technical information available from GFSI or another standard setting 
organization provides evidence that a control measure, combination of 
control measures, or the food safety plan as a whole is capable of 
effectively controlling the identified hazards, a facility may use such 
information to satisfy the validation requirements of the rule.
    (Comment 497) Some comments ask us to provide guidance and 
clarification on topics relevant to validation, such as commodity-
specific guidance to help facilities understand what preventive 
controls are capable of being validated and to design testing to ensure 
validation conditions always exceed conditions during production. Some 
comments ask us to clarify our expectations for a validated process and 
on conducting studies for validation purposes, particularly for 
preventive controls applied to fresh and fresh-cut produce (such as 
reduction of pathogens in wash water for fresh-cut leafy greens with 
the use of sanitizers, which the comments characterize as 
scientifically difficult and time consuming). Some comments ask us to 
provide resources for validation, noting that some preventive controls 
will be difficult to validate and that no scientific research or data 
are available for certain controls. Some comments ask us to delay 
enforcement for the validation requirements until a readily accessible 
repository of validated processes, and scientific and technical 
information, can be created to assist stakeholders in complying with 
the validation requirements.
    (Response 497) We intend that the guidance we are developing will 
address topics such as those recommended in the comments. (See Response 
2.) In addition, there is a ``wash water validation group'' with 
members from government (including

[[Page 56055]]

FDA, USDA and CDC) and industry (including producers, chemical 
suppliers, and equipment suppliers) developing information on how to 
validate the efficacy of antimicrobial chemicals in wash water for 
fresh-cut produce processes to demonstrate that the antimicrobials in 
the washing process are effective for minimizing the risk of cross-
contamination. The FSPCA and the Produce Safety Alliance (PSA) are 
developing information for training, which may be useful to facilities, 
including facilities that process produce. We are not requiring 
facilities to comply with the rule, including the validation 
requirements, for 1, 2, or 3 years depending on the size of the 
facility. We expect that segments of the food industry will work 
together and with the FSPCA and the PSA to develop scientific and 
technical information that can be used as evidence to validate a 
variety of preventive controls, and that this information will be 
helpful to facilities.
    (Comment 498) Some comments ask us to develop a mechanism for 
industry to make sure their approach and studies meet the requirements 
of the rule, such as certification of process authorities or the 
establishment of a liaison between FDA and industry to ensure 
validation protocols are in compliance.
    (Response 498) As discussed in Response 2, we are developing 
several guidance documents within FDA, including guidance on 
validation. In addition, as part of a collaborative effort with the 
FSPCA we are obtaining technical information useful for developing 
commodity/industry sector-specific guidelines for preventive controls 
and outreach to industry, and we intend that effort to include guidance 
on approaches to satisfy the validation requirements of the rule. We do 
not intend to develop a mechanism for certification of process 
authorities or establish a liaison between FDA and industry to ensure 
validation protocols are in compliance. The guidance we are developing 
on validation should help industry determine whether their validation 
approaches are likely to be acceptable to us.

B. Proposed Sec.  117.160(b)(1)--When Validation Must Be Performed and 
Role of the Preventive Controls Qualified Individual in Validation

    We proposed that validation of the preventive controls must be 
performed by (or overseen by) a preventive controls qualified 
individual prior to implementation of the food safety plan (or, when 
necessary, during the first 6 weeks of production) and whenever a 
reanalysis of the food safety plan reveals the need to do so.
    (Comment 499) Some comments ask us to clarify whether an individual 
attending food safety training by an entity such as a cooperative 
extension or a State department of agriculture could be a ``preventive 
controls qualified individual'' for the purpose of performing or 
overseeing the validation of preventive controls.
    (Response 499) See the discussion in section XXXVI.B.1 for 
additional information about training applicable to a preventive 
controls qualified individual. We have not specified additional 
requirements for a preventive controls qualified individual with 
respect to validation. A person may be a preventive controls qualified 
individual through job experience, as well as training. Food safety 
training provided by an entity such as a cooperative extension 
specialist or a State department of agriculture could be appropriate 
training for many of the functions of the preventive controls qualified 
individual if the training is consistent with the standardized 
curriculum being developed by the FSPCA.
    (Comment 500) Some comments that discuss the distinction between 
validation and verification ask us to align with the distinction made 
in FSIS' Compliance Guidelines on HACCP Systems Validation (FSIS 
Validation Guidelines) (Ref. 84). As discussed in those guidelines, 
there are two distinct elements to validation: design and execution. 
The design element addresses the scientific or technical support for 
the system design, and the execution element addresses the initial, 
practical, in-plant demonstration that the system can perform as 
expected.
    (Response 500) As discussed in Response 150, the definition of 
validation focuses on whether a control measure, combination of control 
measures, or the food safety plan as a whole is capable of controlling 
the identified hazards and, thus, captures the design element of 
validation. We have revised the validation requirements to clarify that 
it may be necessary to perform validation during production to 
demonstrate the control measures can be implemented as designed.
    (Comment 501) Some comments question whether 6 weeks is enough time 
to perform all applicable validation studies that would address the 
execution element of validation. Some comments ask us to explain the 
basis for the proposed 6-week timeframe. Some comments ask us to align 
with the 90-day timeframe in the FSIS Validation Guidelines (Ref. 84). 
Some comments note that food additives may only be produced a few times 
per year at plants that also produce industrial, cosmetic, and 
excipient grade products, and that this production schedule may make it 
impractical to meet the proposed 6-week timeframe. Some comments note 
that the seasonal nature of production of some food products may make 
it impractical to perform all required validations within 6 weeks. Some 
comments suggest that validation be performed within a specified number 
of production batches, such as 10 production batches. Some comments 
emphasize the need for flexibility and ask us to both adopt a 90-day 
timeframe and provide for a longer timeframe with a written 
justification, or provide for ongoing evidence of process validation. 
Some comments ask us to specify that validation be performed within a 
reasonable time as justified by the preventive controls qualified 
individual. Some comments ask for more time for small businesses to 
perform validation studies.
    (Response 501) We note that the 90-day timeframe for validation is 
established in FSIS' regulations at 9 CFR 304.3(b) and (c) and 9 CFR 
381.22(b) and (c) (Conditions for receiving inspection for meat and 
meat products and poultry and poultry products, respectively). The FSIS 
Validation Guidelines are a companion to those regulations. We have 
revised the regulatory text, with associated editorial changes, to make 
two changes to the proposed 6-week timeframe for validation of 
preventive controls. First, we have adopted the 90-day timeframe 
already established in FSIS' regulations by specifying that when 
necessary to demonstrate the control measures can be implemented as 
designed, validation may be performed within 90 days after production 
of the applicable food first begins. Although we had proposed a 6-week 
timeframe based on the 3 to 6-week timeframe suggested in the Codex 
Guidelines for the Validation of Food Safety Control Measures (Ref. 39) 
(Codex Validation Guidelines), we agree that practical limitations 
associated with the production of some food products may make it 
difficult to perform validation within 6 weeks. The 90-day timeframe in 
FSIS' regulations, and incorporated into the FSIS Validation 
Guidelines, reflects more than 15 years of experience with validating 
HACCP systems for meat and poultry. Although we have provided for 
validation to be performed within 90 days after production of the 
applicable food first begins, we do not believe it

[[Page 56056]]

would take a full 90 days of production to determine whether the 
facility can provide assurances that a control measure is working as 
intended to control the hazard.
    Second, we have provided for validation within a reasonable 
timeframe, provided that the preventive controls qualified individual 
prepares (or oversees the preparation of) a written justification for a 
timeframe that exceeds 90 days after production of the applicable food 
first begins. We acknowledge that practical limitations such as those 
described in the comments could prevent a facility from performing the 
validation within 90 days after production of the applicable food first 
begins. A timeframe that exceeds 90 days after production of the 
applicable food first begins will be the exception rather than the norm 
and we are requiring that the preventive controls qualified individual 
provide (or oversee the preparation of) a written justification for 
such a timeframe. We made a conforming revision to the list of 
responsibilities of the preventive controls qualified individual (see 
Sec.  117.180(a)).
    (Comment 502) Some comments ask us to clarify that the time period 
when validation is performed would be considered as production time 
rather than ``down time.'' These comments explain that many farms with 
on-farm processing activities conduct those activities sporadically for 
a brief period. For a processing activity that may be conducted for 
only 2 or 3 days within a six week period, the facility may not have 
enough production run time to validate controls.
    (Response 502) As discussed in Response 501, we have provided for 
validation within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 days after 
production of the applicable food first begins. A facility would design 
a preventive control that is valid based on scientific and technical 
information and then determine that the control can be applied in the 
facility. It is unlikely that this will require a full 90 days of 
production, and we see no reason for a facility to significantly extend 
the validation time--e.g., to a year or more--because it only produces 
for 2-3 days every 6 weeks.
    (Comment 503) Some comments ask us to add another circumstance when 
validation would be required--i.e., whenever a change is made to the 
control being applied.
    (Response 503) We have revised the regulatory text to require 
validation whenever a change to a control measure or combination of 
control measures could impact whether the control measure or 
combination of control measures, when properly implemented, will 
effectively control the hazards requiring a preventive control. Under 
this provision, a facility would re-validate a preventive control if, 
for example, a different type of equipment is used to deliver a heat 
process, because it would be necessary to determine that the new 
equipment can consistently achieve the required temperature and time of 
the process. However, a facility would not need to re-validate a 
preventive control if, for example, a thermal process is changed by 
increasing the time or temperature, because a less stringent thermal 
process would already have been validated.
    (Comment 504) Some comments ask us to require validation both 
before production and 6 weeks after production begins.
    (Response 504) We decline this request. A facility has flexibility 
to perform validation as appropriate to the nature of the preventive 
controls, whether before production (e.g., by obtaining and evaluating 
generally available scientific and technical information or by 
conducting studies), after production begins (to demonstrate the 
control measures can be implemented as designed during full-scale 
production), or both.
    (Comment 505) Some comments assert that qualified third parties 
should conduct all process validations.
    (Response 505) The critical factor is that the validation be 
performed (or overseen) by an individual who has the appropriate 
training and experience to validate the control measures. This 
preventive controls qualified individual could be a third party or an 
employee of the facility. Employees of the facility have a vested 
interest in ensuring that the controls are effective, including by 
appropriately validating the controls, just as a ``disinterested'' 
third party would have.

C. Proposed Sec.  117.160(b)(2)--What Validation Must Include

    We proposed that the validation of preventive controls must include 
collecting and evaluating scientific and technical information (or, 
when such information is not available or is inadequate, conducting 
studies) to determine whether the preventive controls, when properly 
implemented, will effectively control the significant hazards.
    (Comment 506) As discussed in Comment 150, some comments ask us to 
revise the definition of ``validation'' to be consistent with the Codex 
definitions.
    (Response 506) The Codex definition of validation is ``Obtaining 
evidence that a control measure or combination of control measures, if 
properly implemented, is capable of controlling the hazard to a 
specified outcome.'' 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, which more closely aligns with the Codex definition. As a 
conforming change for consistency with the revisions we made to the 
definition, we have revised the proposed requirements for validation of 
preventive controls to specify that validation of preventive controls 
must include obtaining and evaluating scientific and technical evidence 
(or, when such evidence is not available or is inadequate, conducting 
studies) to determine whether the preventive controls, when properly 
implemented, will effectively control the hazards. (See also Response 
150.)
    (Comment 507) Some comments assert that our discussion of 
validation refers to ``scientific proof'' for the validation of a 
processing step and ask us to define what is and is not considered 
scientific proof for validation.
    (Response 507) We used terms such as ``scientific and technical 
information'' and ``scientific and technical basis'' rather than 
``scientific proof'' when discussing validation. For information about 
what we mean by ``scientific and technical information,'' see 78 FR 
3646 at 3753-3754.
    (Comment 508) Some comments ask us to clarify expectations of 
validations for basic sanitary processes.
    (Response 508) The requirements for validation only apply to 
preventive controls. To the extent that the comment is referring to 
sanitary practices governed by CGMPs (such as in Sec. Sec.  117.35 and 
117.37), the validation requirements would not apply. To the extent 
that the comment is referring to sanitation controls established as a 
preventive control, those sanitation controls are excluded from the 
validation requirements (see Sec.  117.160(a)(3)(ii)).
    (Comment 509) Some comments ask that we not require further 
validation of well-accepted preventive controls, such

[[Page 56057]]

as refrigeration temperature and roasting coffee.
    (Response 509) A facility may rely on generally available 
scientific and technical information to demonstrate the adequacy of 
controls such as refrigeration and roasting processes for coffee, but 
must obtain that information and establish it as a record (see Sec.  
117.155(b)).
    (Comment 510) Some comments express concern that specific methods 
are not available to enable validation. Some comments express concern 
that the requirement to ``conduct studies'' might be intended, or could 
be interpreted, to mean that firms are required to develop or validate 
analytical methods (either in general or for specific food matrices). 
These comments assert that any such requirement would incur extreme 
costs and burdens without delivering commensurate public health 
benefits.
    (Response 510) We do not intend the requirement to ``conduct 
studies'' to mean that firms are required to develop or validate 
analytical methods.
    (Comment 511) Some comments ask us to clarify that dry pasta 
facilities would not be required to validate that their extrusion or 
drying process provides a 5-log reduction for Salmonella. These 
comments assert that a ``kill step'' is not necessary for foods such as 
dry pasta because consumers cook the product before consumption and 
that validation would be costly, time-consuming, and impractical.
    (Response 511) The rule does not require any specific performance 
standards, such as the 5-log reduction standard in our HACCP regulation 
for juice (see Sec.  120.24). A dry pasta facility that evaluates 
Salmonella as a known or reasonably foreseeable hazard may determine 
that the nature of the dry pasta product (and, thus, its reasonably 
foreseeable use) makes it unlikely that it would be consumed without a 
``kill step'' (i.e., cooking sufficient to adequately reduce 
Salmonella) by the consumer and the facility could conclude that its 
extrusion or drying process is not a preventive control. In contrast, 
when the nature of the product (such as refrigerated cookie dough) is 
such that its reasonably foreseeable use includes consumption without 
cooking (or without cooking sufficient to adequately reduce Salmonella) 
by the consumer, it would not be appropriate to rely on cooking by the 
consumer to control a known or reasonably foreseeable biological 
hazard.
    (Comment 512) Some comments recommend validation via indirect 
methods such as scientific publications, government documents, 
predictive modeling, and other technical information from equipment 
manufacturers and other sources. These comments assert that the 
development of validation data is not appropriate for a number of 
preventive controls in fresh-cut operations (e.g., temperature control, 
employee hygiene practices, and product separation protocols). Other 
comments assert that there are a variety of circumstances in which the 
collection and evaluation of scientific and technical information is 
not necessary (e.g., the use of sieving or metal detectors to control 
physical hazards).
    (Response 512) See Response 491 and Response 493. We agree that not 
all preventive controls require validation, and the facility has 
flexibility to take into account the nature of the preventive control 
when determining whether to perform validation. The regulatory text, 
which provides for scientific and technical evidence that a control 
measure is capable of effectively controlling the identified hazards, 
provides for the use of ``indirect methods'' as recommended by the 
comments. However, even when sources such as scientific publications 
are the basis for validation, studies may be needed to demonstrate that 
the process used can be implemented in the facility to control the 
hazard. For example, scientific publications may support use of a 
specific concentration of sanitizer in produce wash water to prevent 
cross-contamination. The facility would still need to demonstrate it 
can consistently maintain that concentration under operating 
conditions.

D. Proposed Sec.  117.160(b)(3)--Preventive Controls for Which 
Validation Is Not Required

    We proposed that validation need not address food allergen 
controls, sanitation controls, the recall plan and the supplier program 
(which we now refer to as the ``supply-chain program'').
    (Comment 513) Some comments ask us to eliminate the specific list 
of controls that are excluded from the validation requirement and 
instead revise the regulatory text to provide the facility with 
flexibility to determine when validation is appropriate. (See also 
Comment 491.)
    (Response 513) As discussed in Response 491, we have deleted 
``except as provided by paragraph (b)(3) of this section'' from 
proposed Sec.  117.160(a) to remove the limitation seen by the comments 
on the exceptions to the requirement for validation of preventive 
controls. We also have revised the regulatory text of Sec.  117.160(c) 
to provide that a facility does not need to validate other preventive 
controls, if the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification that validation is 
not applicable 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. We see no reason to also eliminate the list of 
those controls for which we have already determined that validation is 
not necessary, and require each facility to develop its own rationale 
for concluding that validation is not necessary based on the nature of 
these preventive controls. The rule would not prevent a facility from 
validating one of these preventive controls, such as a food allergen 
control, if it chooses to do so. (See also Response 514.)
    (Comment 514) Some comments assert that the proposed regulatory 
text would prevent us from requiring validation of specific allergen or 
sanitation controls where it may be prudent to do so, either now or in 
the future as a result of a newly identified hazard, establishment of 
regulatory allergen threshold(s), or the development of a tool, such as 
a test method, that would enable validation of the control for the 
specific hazard. Other comments assert that validation of food allergen 
controls for some food allergens is possible now and that we should not 
preclude future requirements as it becomes possible to validate food 
allergen controls for other allergens in the future. Other comments 
state that a preventive controls qualified individual should determine 
appropriate validation for food allergen controls. Other comments state 
that scientific studies are not needed to validate food allergen 
controls because monitoring is sufficient.
    (Response 514) This rule establishes requirements that will apply 
when the rule becomes effective. It does not address the potential for 
additional requirements that we could establish, through additional 
rulemaking, in the future. The rule does not preclude a facility from 
validating any of its food allergen controls, and we encourage 
facilities to validate food allergen controls as appropriate to the 
facility, the food, and the specific food allergen control. However, if 
a facility decides to validate any of its food allergen controls, the 
rule does not require that such validation be conducted or overseen by 
a preventive controls qualified individual.
    As previously discussed, we agree that food allergen controls 
generally are not evaluated through scientific studies and that 
monitoring (e.g., by visual observation) that these activities do not

[[Page 56058]]

result in allergen cross-contact provides sufficient assurance that the 
controls are functioning as intended to prevent the hazard of 
undeclared food allergens in the food due to allergen cross-contact (78 
FR 3646 at 3755).
    (Comment 515) Some comments assert that validation of food allergen 
controls and sanitation controls is already possible through sample 
swabs and, thus, that reliance strictly on visual observation for 
potential allergen cross-contact and sanitation controls does not 
appear to be appropriate.
    (Response 515) As discussed in Response 150, validation is directed 
to determining whether a control measure, when properly implemented, is 
capable of effectively controlling a hazard. Procedures such as sample 
swabs (e.g., of equipment used for food containing an allergen to 
determine if the allergen protein is present after cleaning, and of 
equipment following a dry cleaning procedure to determine microbial 
load) are generally directed to verifying that a control measure is 
functioning as intended rather than whether the control measure is 
capable of effectively controlling the hazard. However, they can also 
be part of a validation study to determine whether a sanitation 
procedure effectively removes a food allergen from equipment surfaces 
if a facility decides to validate such procedures.

XXXIV. Subpart C: Comments on Proposed Sec.  117.165--Verification of 
Implementation and Effectiveness

    We proposed that you must verify that the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the significant hazards. We proposed that to 
do so you must conduct specified activities (i.e., calibration, product 
testing, environmental monitoring, and review of records) as 
appropriate to the facility, the food, and the nature of the preventive 
control. We also proposed that you must establish and implement written 
procedures for the frequency of calibrating process monitoring 
instruments and verification instruments, product testing, and 
environmental monitoring.
    Some comments that support the proposed provisions suggest 
alternative or additional regulatory text (see, e.g., Comment 516, 
Comment 519, Comment 539, Comment 540, Comment 544, and Comment 545) or 
ask us to clarify how we will interpret the provision (see, e.g., 
Comment 522, Comment 523, Comment 528, and Comment 536). 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 
38.

  Table 38--Revisions to the Proposed Requirements for Verification of
                    Implementation and Effectiveness
------------------------------------------------------------------------
           Section                 Description            Revision
------------------------------------------------------------------------
117.165(a)..................  Flexibility in the    Provide that
                               requirement to        activities for
                               conduct activities    verification of
                               to verify             implementation and
                               implementation and    effectiveness take
                               effectiveness.        into account both
                                                     the nature of the
                                                     preventive control
                                                     and its role in the
                                                     facility's food
                                                     safety system.
117.165(a)(1)...............  Verification of       Provide for accuracy
                               implementation and    checks in addition
                               effectiveness for     to calibration.
                               process monitoring
                               instruments and
                               verification
                               instruments.
117.165(a)(4)(i)............  Timeframe for review  Provide for records
                               of records of         review within 7
                               monitoring and        working days after
                               corrective action     the records are
                               records.              created, or within
                                                     or within a
                                                     reasonable
                                                     timeframe, provided
                                                     that the preventive
                                                     controls qualified
                                                     individual prepares
                                                     (or oversees the
                                                     preparation of) a
                                                     written
                                                     justification.
117.165(a)(5)...............  Other activities      Clarify that there
                               appropriate for       could be
                               verification of       alternative
                               implementation and    verification
                               effectiveness.        activities of
                                                     implementation and
                                                     effectiveness other
                                                     than those that we
                                                     specify in the
                                                     rule.
117.165(b)..................  Written procedures    Clarify that written
                               for verification of   procedures for
                               implementation and    verification of
                               effectiveness.        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.
117.165(b)(1)...............  Written procedures    Require written
                               for verification of   procedures for
                               implementation and    accuracy checks in
                               effectiveness for     addition to
                               process monitoring    calibration.
                               instruments and
                               verification
                               instruments.
------------------------------------------------------------------------

A. Flexibility in the Requirement To Conduct Activities To Verify 
Implementation and Effectiveness

    We proposed that you must verify that the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the significant hazards by conducting 
specified activities as appropriate to the facility, the food, and the 
nature of the preventive control. We proposed to specify the following 
verification activities: (1) Calibration; (2) product testing; (3) 
environmental monitoring; and (4) review of records.
    In the following paragraphs, we discuss comments generally directed 
to the need for a facility to have flexibility to apply these 
requirements (particularly the requirements for product testing and 
environmental monitoring) in a manner that works best for the facility 
in light of its food products and the nature of the preventive controls 
that would be verified. In sections XXXIV.B through XXXIV.F, we discuss 
the requirements for calibration, product testing, environmental 
monitoring, and review of records more specifically.
    (Comment 516) Some comments express support for the flexibility 
provided by specifying that verification activities must be conducted 
``as appropriate to the facility, the food, and the nature of the 
preventive control.'' Some comments state that the proposed provision 
means that, based on risk, a fresh fruit packing operation could decide 
whether or not to do product testing and, when applicable, the type of 
test and the testing frequency. Some comments agree with the proposed

[[Page 56059]]

provisions because they address product testing through flexible 
written procedures that consider both testing and corrective action 
plans rather than through mandatory or prescribed requirements. Other 
comments agree with the proposed provisions because they require 
facilities to develop and use testing programs that are tailored to 
their facility, equipment, processes, products, and other specific 
circumstances and do not prescribe specific requirements for testing, 
such as finished product testing. Some comments state that product 
testing may not be effective in identifying the acceptability of a 
specific ingredient or finished product lot on any given day, but it 
can help assess and verify the effectiveness of a food safety plan as a 
whole and the facility's capability to consistently deliver against it.
    Some comments assert that the preamble discussion in the 2014 
supplemental human preventive controls notice is in conflict with the 
proposed regulatory text and ask us to modify the regulatory text to 
provide the flexibility we signaled in that supplemental notice. These 
comments express concern that the term ``must'' (i.e., ``you must 
conduct activities that include the following'') could be interpreted 
to mean that activities listed in the regulatory text (in particular, 
product testing and environmental monitoring) are always required in 
some form. Some comments ask us to clarify whether product testing and 
environmental monitoring are required or optional. Other comments 
assert that facilities should have the flexibility to determine whether 
to conduct product testing and environmental monitoring based on a risk 
assessment. Some comments assert that there are circumstances (such as 
in warehouses and distribution centers; in the production of gases used 
in food; in operations that hull and shell nuts; and in the production 
of refined vegetable oils) where these tests would not be necessary. 
Some comments assert that a determination to conduct environmental 
monitoring should be on a case-by-case basis and that other 
verification activities may be used (such as process verifications or 
testing of intermediates) to verify implementation and effectiveness. 
Some comments assert that there would be no reason to conduct 
environmental monitoring in the shell egg processing plant, given the 
testing in henhouses required by part 118. Other comments ask us to 
exempt operations when their hazard analysis appropriately concludes 
that there is no foreseeable risk.
    See also Comment 486.
    (Response 516) The provisions for verification provide flexibility 
by specifying that they apply as appropriate to the nature of the 
preventive control and its role in the facility's food safety system. 
As noted by some comments, the provisions address testing through 
flexible written procedures that allow facilities to develop and use 
testing programs that are tailored to their facility, equipment, 
processes, products, and other specific circumstances. We agree that an 
appropriate outcome of the hazard analysis for some facilities will be 
that product testing and environmental monitoring are not required; it 
is not necessary to grant an ``exemption'' to allow a facility to 
achieve this outcome. For example, environmental monitoring would be 
required to verify effectiveness of sanitation controls when 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 because such environmental 
monitoring is appropriate to the facility (one manufacturing RTE 
foods), the food (an RTE food exposed to the environment), and the 
nature of the preventive control (sanitation controls). Foods such as 
peanut butter, soft cheeses, dried dairy products for use in RTE foods, 
and roasted nuts are among the products for which manufacturing 
operations would need to have an environmental monitoring program when 
such foods are exposed to the environment. In an FDA memorandum on 
environmental monitoring, we discuss several outbreaks of foodborne 
illness attributed to contamination from the environment (Ref. 55). 
These examples illustrate the severe consequences that can occur when 
environmental pathogens contaminate a product as a result of inadequate 
preventive controls and how environmental monitoring can be used to 
verify the adequacy of the preventive controls.
    We discuss product testing for microbial pathogens in another FDA 
memorandum, including the use of pathogens and indicator organisms and 
microbial testing of foods for process control and for problem solving 
(Ref. 85). The circumstances in which product testing would be required 
are dependent on a variety of factors, as described in that memorandum 
and in the Appendix to the 2013 proposed human preventive controls rule 
(78 FR 3646 at 3818-3820, with reference numbers corrected in 78 FR 
17142 at 17149-17151). As with environmental monitoring, product 
testing must be conducted as appropriate to the facility, the food, and 
the nature of the preventive control. For example, a raw material or 
other ingredient added to an RTE food after a pathogen ``kill step'' 
must be tested before use when the raw material or other ingredient has 
been associated with a pathogen and has not been treated to 
significantly minimize or prevent that pathogen (e.g., spices added to 
snack chips, a food that has been previously involved in an outbreak of 
foodborne illness). Product testing would be required because it is 
appropriate to the facility (one making an RTE food), the food (spiced 
snack chips), and the nature of the preventive control (there is no 
control applied to the spices added to the snack chips).
    When process control testing for an indicator organism, or 
environmental monitoring for an indicator organism, indicates an RTE 
food is reasonably likely to be contaminated with a pathogen, that food 
must be tested for the pathogen. For example, if environmental 
monitoring reveals food-contact surfaces that are used in the 
production of soft cheese are contaminated with Listeria spp. and 
additional environmental monitoring following corrective actions 
indicates food-contact surfaces are still contaminated with Listeria 
spp., product testing would be required because it is appropriate to 
the facility (one making an RTE food), the food (soft cheese, which 
supports the growth of L. monocytogenes), test results from 
environmental monitoring (which show the presence of an indicator 
organism for L. monocytogenes on food-contact surfaces in the food 
processing environment), and the nature of the preventive control 
(sanitation controls to prevent contamination by environmental 
pathogens, which appear to be inadequate).
    The word ``must'' specifies the type of activities that a facility 
can use to satisfy the requirements for a particular preventive control 
management component, and we are retaining the term ``must.'' However, 
we agree that the rule should provide flexibility for additional 
verification of implementation and effectiveness. To provide that 
additional flexibility, we have revised the specific requirements for 
verification of implementation and effectiveness to provide for other 
activities appropriate for verification of implementation and 
effectiveness (see Sec.  117.165(a)(5)). (See also Response 486.)
    (Comment 517) Many comments ask us to issue guidance, rather than

[[Page 56060]]

requirements, for product testing and environmental monitoring based on 
concerns such as the following: The value of environmental monitoring 
will be reduced if it becomes a minimum regulatory requirement; in many 
cases environmental pathogens can be eliminated by proper preparation 
by the consumer; there are well-known limitations to product testing 
and negative results from product testing can create a false sense of 
security; product testing is not preventive, would put industry into a 
reactive mode, and would pull valuable resources from activities 
focused on preventing contamination; there is limited technology 
available to test fresh produce, and limited time available due to the 
perishable nature of the commodity; any regulatory requirement will 
soon be outdated as products change and science improves; neither 
product testing nor environmental monitoring are required by HACCP 
systems; product testing would vastly increase the cost of the rule and 
will drive many businesses out of business without necessarily 
improving food safety; and requirements for product testing would 
require the States to direct resources to respond to non-compliant 
product testing results, and such resources would be better directed to 
environmental monitoring.
    Some of these comments emphasize the need for flexibility so that 
product testing and environmental monitoring are options that are 
available to the facility rather than requirements for all facilities. 
Other comments assert that guidance provides greater opportunity for 
industry innovation and stakeholder participation to determine the 
appropriate use of verification measures, and avoids a ``one-size-fits-
all'' approach to regulations. Some of these comments state that we 
should encourage environmental monitoring to be conducted ``through 
facility specific food safety plans,'' which would provide the 
flexibility necessary to monitor risks associated with exposures of RTE 
foods. Other comments state that operators should be given the 
necessary flexibility to implement any requirements in the most 
effective and efficient manner using a risk-based approach and taking 
into account the specific conditions of their facilities and 
operations. Some comments express concern that including a requirement 
makes it difficult for businesses to justify a conclusion that testing 
is not necessary.
    Some comments ask us to solicit drafts of proposed guidance 
documents from the sustainable agriculture and local/regional food 
system community; publish a list of possible topics for future guidance 
each year; seek input in advance from the sustainable agriculture and 
local/regional food system community before preparing draft guidance 
(including public meetings, workshops, and formation of an advisory 
committee); hold public meetings on draft guidance after publication; 
and present draft guidance to an advisory committee including 
representatives from the sustainable agriculture and local/regional 
food system community.
    (Response 517) We are retaining the requirements for product 
testing and environmental monitoring in the rule, with the revisions, 
already discussed, to provide that verification activities depend on 
the role of the preventive control in the facility's food safety system 
(see Response 455); corrective action procedures depend on the nature 
of the hazard (see Response 470); and written procedures for product 
testing and environmental monitoring are established and implemented as 
appropriate to the role of the preventive control in the facility's 
food safety system (see Response 455). These revisions clarify in the 
regulatory text the flexibility that we discussed in the 2014 
supplemental human preventive controls notice (79 FR 58524 at 58543-
58545). Some of the comments that ask us to issue guidance rather than 
requirements appear to believe that only guidance can provide 
sufficient flexibility for product testing and environmental 
monitoring. This is not the case. See Response 516.
    We disagree that environmental monitoring will be become a minimum 
regulatory requirement in all cases; the decision to conduct 
environmental monitoring is made by the facility and some comments 
discuss specific examples of when environmental monitoring or product 
testing would not be warranted (see Comment 516). We acknowledge that 
in some cases environmental pathogens can be eliminated by proper 
preparation by the consumer, but this rule will not change consumer 
behavior (see, e.g., our discussion of a prepackaged, refrigerated 
cookie dough that was implicated in an E. coli O157:H7 outbreak that 
caused 76 confirmed cases of illness, including 35 hospitalizations (78 
FR 3646 at 3665)). Also, as noted in Response 390, we note that many 
consumers do not follow some cooking instructions. Moreover, the fact 
that consumer preparation would be capable of eliminating an 
environmental pathogen is not a reason to not take reasonable measures 
to prevent contamination from the environment and to verify that such 
measures are effective through environmental monitoring.
    We have acknowledged limitations of product testing (78 FR 3646 at 
3819-3820) and agree that a facility should consider such limitations 
when determining whether to conduct product testing and keep such 
limitations in mind when obtaining negative results from product 
testing. We also agree that product testing is not preventive. However, 
the mere facts that there are limitations, and that product testing is 
itself not a preventive measure, do not eliminate all benefits of 
product testing; we agree with comments (described in Comment 516) that 
although product testing may not be effective in identifying the 
acceptability of a specific ingredient or finished product lot on any 
given day, it can help assess and verify the effectiveness of a food 
safety plan as a whole and the facility's capability to consistently 
deliver against it. We agree that there is limited technology available 
to test fresh produce and expect testing of fresh produce by a facility 
as a verification of its food safety plan as a whole would be the 
exception rather than the norm.
    We disagree that regulatory requirements for product testing and 
environmental monitoring will soon be outdated as products change and 
science improves; the rule requires reanalysis of the food safety plan 
as a whole at least every 3 years, and requires reanalysis of the food 
safety plan as a whole, or the applicable preventive control, in light 
of new information (see Sec.  117.170(a) and (b)(2)). We disagree that 
the lack of specific provisions for product testing and environmental 
monitoring in HACCP systems should preclude us from establishing 
requirements for product testing and environmental monitoring in this 
rule; as previously discussed, not every provision in section 418 of 
the FD&C Act is identical to HACCP as described in current literature 
(78 FR 3646 at 3660). Moreover, the HACCP systems have provisions for 
verification activities, as we consider these to be. We agree that 
there are some costs to product testing, but the rule provides 
flexibility for the facility to determine when product testing is 
appropriate. We acknowledge that the States will be required, in many 
cases, to follow up on positive findings obtained during product 
testing but disagree that this is a reason to eliminate the proposed 
requirements. The States would only be directing resources when the 
findings indicate contamination of food, and doing so will protect 
public health.

[[Page 56061]]

    We will follow the procedures in Sec.  10.115 for issuing guidance 
documents. Under Sec.  10.115(f), members of the public can suggest 
areas for guidance document development and submit drafts of proposed 
guidance documents for FDA to consider. Under Sec.  10.115(g), after we 
prepare a draft guidance we may hold public meetings or workshops, or 
present the draft guidance document to an advisory committee for 
review; doing so is not common and is determined on a case-by-case 
basis.
    (Comment 518) Some comments ask us to consider the volume of 
product produced in establishing the verification testing requirements 
because volume-based testing is a way to address the burden that 
testing requirements may create for small facilities.
    (Response 518) We decline this request. Although a facility would 
establish the frequency of testing if it determines, through its hazard 
analysis, that product testing or environmental monitoring is 
warranted, volume does not play a role in most statistical sampling 
plans. See the discussion of statistical sampling plans in the Appendix 
to the 2013 proposed human preventive controls rule (78 FR 3646 at 
3819-3820).

B. Proposed Sec.  117.165(a)(1)--Calibration

    We proposed to require calibration of process monitoring 
instruments and verification instruments.
    (Comment 519) Some comments distinguish ``calibration'' from an 
accuracy check, which the comments describe as a test to confirm that a 
particular equipment or measurement device is accurate. These comments 
assert that calibration may not be possible for certain equipment or 
measurement devices, and the appropriate corrective action may be 
replacement or application of corrective values. These comments ask us 
to specify that an accuracy check may be used as a verification 
activity in lieu of calibration.
    (Response 519) We have revised the proposed requirements to require 
calibration of process monitoring instruments and verification 
instruments, or checking them for accuracy. However, if the outcome of 
an accuracy check is that a process monitoring instrument or 
verification instrument is not accurate, the facility must follow up by 
calibrating the device, rather than by applying corrective values, when 
it is practical to do so and replace the device when it is not 
practical to calibrate it.

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))

    We proposed that to verify that the preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the significant hazards you must conduct 
activities that include product testing and environmental monitoring, 
as appropriate to the facility, the food, and the nature of the 
preventive control (Sec.  117.165(a)(2) and (a)(3)). We also proposed 
that you must establish and implement written procedures for product 
testing and for environmental monitoring.
    (Comment 520) Some comments ask us to revise the regulatory text to 
be explicit that there are circumstances when product testing and 
environmental monitoring would not be necessary.
    (Response 520) We decline this request. We discussed examples 
relevant to this request in memoranda that we placed in the docket for 
this rule as references to the 2014 supplemental human preventive 
controls notice (Ref. 55) (Ref. 85). However, the actual decision as to 
whether product testing and environmental monitoring are warranted 
depend on the actual facility and its food product, as well as the 
nature of the preventive control and its role in the facility's food 
safety system, and a slight variation on circumstances that would lead 
one facility to conclude that such testing programs were not required 
could lead a different facility to the opposite conclusion.
    (Comment 521) Some comments discuss topics for us to include in 
guidance on procedures for product testing and environmental 
monitoring, such as which pathogens to test for; the range of products 
that should be tested; circumstances that warrant testing; what a 
facility would document and what factors the facility would consider 
before determining that product testing is not appropriate for its food 
product; frequency of sampling and number of samples to be collected; 
actions to take after a positive result; available test methods; 
reporting requirements for results; compliance strategies; and criteria 
for laboratories conducting the testing.
    (Response 521) The memoranda that we placed in the docket for this 
rule as references to the 2014 supplemental human preventive controls 
notice (Ref. 55) (Ref. 85) address many of these topics.
    (Comment 522) Some comments ask us to clarify that tests can be 
performed by third-party facilities or laboratories, as well as by the 
facility itself. Some comments ask us to clarify that we will accept 
test results in the same format as the format used for other purposes, 
such as third-party certification services.
    (Response 522) The rule places no restrictions on who conducts 
testing. However, facilities have a responsibility to choose testing 
laboratories that will produce reliable and accurate test results. (See 
Response 524.) The rule does not specify the format of test results, 
provided that the record documenting testing satisfies the 
recordkeeping requirements of subpart F.
    (Comment 523) Some comments express concern about requirements for 
product testing and environmental monitoring in light of section 202 of 
FSMA (section 422 of the FD&C Act). (Section 422 of the FD&C Act 
addresses laboratory accreditation for the analyses of foods, including 
use of accredited laboratories in certain circumstances and including 
requirements for accredited laboratories to report the results of 
laboratory testing to FDA in certain circumstances.) These comments 
express concern that requirements for facilities to submit results of 
environmental monitoring to us will create an additional disincentive 
to looking for pathogens established in the facility. These comments 
assert that the results of environmental monitoring tests should be 
available to us for inspection but not submitted to us if product has 
not been distributed and that submitting the results of routine tests 
would be burdensome without benefit. These comments ask us to clarify 
whether facilities or laboratories would be required to submit the 
results of environmental monitoring tests to us. Likewise, some 
comments ask us to clarify whether product testing (including testing 
of raw materials or other ingredients as part of supplier controls) is 
subject to the requirements of section 422 of the FD&C Act for using 
accredited laboratories and for reporting test results to us. Other 
comments ask us to establish standards and procedures for certifying 
laboratories that would perform the tests. These comments assert that 
these standards and procedures are needed to ensure the credibility of 
the testing and to provide direction for facilities that establish in-
house testing facilities. Other comments urge us to establish 
regulations implementing section 422 of the FD&C Act because they would 
complement the requirements of the human preventive controls rule and 
because

[[Page 56062]]

model laboratory standards that address quality controls, proficiency 
testing, training, and education of laboratory personnel offer the 
protections necessary for ensuring reliable, accurate test results. 
Other comments assert that if laboratories are not accredited or 
samples are not collected in a sanitary manner, there is no guarantee 
the results will be scientifically valid.
    (Response 523) Section 422 of the FD&C Act would require, in 
relevant part, that food testing be conducted by an accredited 
laboratory (and the results of such testing be sent directly to FDA) 
whenever such testing is conducted in response to a specific testing 
requirement established under the FD&C Act or its implementing 
regulations, when applied to address an identified or suspected food 
safety problem, or to support admission of a food under an Import Alert 
that requires food testing. Although another rulemaking will address 
the requirements of section 422 of the FD&C Act, our current thinking 
is that routine product testing and environmental monitoring conducted 
as a verification activity is not being applied to address an 
identified or suspected food safety problem that requires food testing 
and would not be subject to requirements to use an accredited 
laboratory that would submit the results to FDA. We will review the 
results of environmental monitoring and product testing, if any, during 
inspections.
    The primary concern expressed in these comments was with respect to 
laboratories reporting results to FDA and not with use of accredited 
laboratories. The rule requires a facility to establish and implement 
written procedures for product testing and environmental monitoring and 
that the procedures for such testing be scientifically valid. One way 
to comply with the requirement that testing procedures be 
scientifically valid is to use an accredited laboratory.
    (Comment 524) Some comments ask us to expand the proposed 
requirement to identify the laboratory conducting the testing to also 
specify whether that laboratory is accredited and uses the appropriate 
standards (such as quality control, proficiency testing, and trained 
laboratory staff). These comments assert that such information would be 
useful to facilities.
    (Response 524) We decline this request. These comments appear to be 
asking us to establish in the human preventive controls rule 
requirements related to section 422 of the FD&C Act. Doing so in 
advance of regulations implementing section 422 of the FD&C Act is 
premature. However, facilities have a responsibility to choose testing 
labs that will produce reliable and accurate test results even if the 
rule does not require the facility to specify whether the laboratory is 
accredited.
    (Comment 525) Some comments express concern about how the 
requirements for product testing will apply to the produce industry. 
For example, some comments assert that product testing on intact RACs 
is not an effective way to ensure food safety and assume that product 
testing would apply only to foods we consider to pose a greater risk, 
like fresh fruits and vegetables consumed raw. Some comments assert 
that product testing would be an excessive and unnecessary cost on 
farms and in low-risk facilities that pack and hold RACs. Other 
comments strongly object to mandatory product testing for fresh and 
fresh-cut produce. These comments assert that the results of product 
testing are unlikely to provide useful information for RACs and support 
application of GAPs and CGMPs rather than product testing. Some 
comments express concern that the fresh-cut produce industry will be 
dramatically changed if every lot of product needs to be tested and 
that such testing would certainly add expense without making the food 
any safer. Other comments assert that produce contamination occurs at 
so low a frequency that product testing for produce (including tree 
nuts) is not economically feasible through any scientifically valid 
sampling protocol. These comments also assert that ``test and hold'' 
would require building additional cooling operations in all facilities 
and that, because of short shelf life, testing of produce would 
negatively impact quality and marketing. Other comments assert that 
industry data have shown a sporadic and limited finding of pathogens in 
product and statistical sampling profiles do not provide sufficient 
evidence that product testing is an effective use of time and money. 
Other comments assert that facilities handling produce RACs are a 
unique type of facility and repeat previous requests that we allow all 
produce operations handling RACs to be covered by the produce safety 
rule, rather than the human preventive controls rule, to ensure that 
such facilities will not be expending resources on testing that could 
be better directed to implementation of preventive controls.
    Likewise, some comments express concern about how the requirements 
for environmental monitoring will apply to the produce industry. For 
example, some comments express concern that off-farm packinghouses 
would be subject to environmental monitoring because certain produce 
RACs are classified as RTE foods. Other comments reiterate requests 
that we not interpret produce held in vented crates to be ``exposed to 
the environment,'' so that facilities that only hold food could qualify 
for the exemption for facilities solely engaged in the storage of 
unexposed packaged food. These comments assert that holding produce in 
vented crates presents a low risk of contamination from environmental 
pathogens and that environmental pathogens do not qualify as a hazard 
requiring preventive controls. Some comments assert that neither 
product testing nor environmental monitoring would be warranted for 
facilities that hull and dry walnuts because at this stage walnuts are 
not a finished commercial commodity or an RTE food.
    Some comments that express concern about the requirements for 
environmental monitoring focus on the environmental pathogen L. 
monocytogenes. Some of these comments assert that fresh produce poses a 
unique challenge in that L. monocytogenes is routinely found in the 
outdoor environment and its occasional transient detection on raw 
produce in low numbers does not necessarily indicate poor practices, 
that a contamination event has occurred due to insanitary conditions, 
or that such occasional transient detection presents an elevated public 
health risk. These comments assert that the occasional detection of 
transient L. monocytogenes in low numbers on food-contact surfaces 
where produce is handled is to be expected and must be considered and 
addressed in the drafting of environmental monitoring procedures for 
produce facilities. Other comments state that not all produce 
operations will be susceptible to harborage of L. monocytogenes. Other 
comments state that they will not support mandatory environmental 
monitoring for facilities that handle RACs until we amend our policies 
regarding the regulatory consequences of a single detection of 
potentially transient and low levels of L. monocytogenes on a food-
contact surface.
    (Response 525) We acknowledge the limitations of product testing 
for produce RACs and fresh-cut produce. As discussed in Response 517, 
the product testing that this rule requires as a verification activity 
is to help assess and verify the effectiveness of a food safety plan 
and the facility's capability to consistently deliver against it, not 
as a ``hold and test'' procedure to establish the acceptability of 
every lot or batch. We do not expect either product testing or 
environmental monitoring to be

[[Page 56063]]

common in facilities that process, pack, or hold produce RACs. We agree 
that there would be little or no benefit to product testing or 
environmental monitoring in facilities that pack or hold produce RACs 
that are rarely consumed raw, such as potatoes. We expect that many 
facilities that process, pack, or hold produce RACs that are RTE foods 
may conclude, as a result of their hazard analysis, that neither 
product testing nor environmental monitoring is warranted. We also 
expect that many facilities that process, pack, or hold produce RACs 
that are RTE foods will conclude that the limitations of product 
testing when applied to produce reduce the value of product testing for 
their products and would direct their resources to food safety 
practices and verification measures other than product testing. In 
addition, we expect that some facilities will see benefits in 
conducting environmental monitoring as a verification measure and would 
direct resources to such activities.
    We disagree that produce held in vented crates is not exposed to 
the environment (see Response 170), but agree that holding produce in 
vented crates presents a low risk of contamination from environmental 
pathogens. We do not expect that facilities that store produce in 
vented crates would conclude, as a result of their hazard analysis, 
that environmental pathogens are a hazard requiring preventive controls 
during storage activities. See Response 25 for a discussion of how this 
final rule broadens the number of packinghouses that will be governed 
by the provisions of the produce safety rule. See the discussions, in 
the 2014 supplemental human preventive controls notice (79 FR at 58535-
536) and in Response 25, of the similarities and differences for off-
farm packing and holding compared to on-farm packing and holding. We 
note that some of the comments express concern related to operations 
that, as a result of changes in the farm definition, may fall within 
that definition (e.g., some walnut hullers and dryers) and would not be 
subject to the requirements of this rule.
    We agree that not all produce facilities are susceptible to 
harborage with L. monocytogenes. For example, harborage with L. 
monocytogenes is more likely to be a potential hazard in certain wet 
packing operations (e.g., wet packing operations for cantaloupes) (Ref. 
86). Comments that we previously received about our draft guidance 
entitled ``Guidance for Industry: Control of Listeria monocytogenes in 
Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance'' (Ref. 87) 
have raised issues, similar to the issues described in these comments, 
regarding the detection of L. monocytogenes on food-contact surfaces, 
and we intend to re-issue that draft guidance for public comment in the 
near future.
    The memoranda that we prepared on product testing and environmental 
monitoring for the 2014 supplemental human preventive controls notice 
(Ref. 55) (Ref. 85) include some examples relevant to facilities that 
process, pack, or hold produce. In light of the questions we have 
received regarding similarities and differences for off-farm packing 
and holding compared to on-farm packing and holding, we are considering 
developing a separate guidance on this topic.
    (Comment 526) Some comments express concern about the cost of 
testing and suggest creation of a one-time grant program for very small 
businesses that would assist them in developing their initial food 
safety plans and testing programs.
    (Response 526) Very small businesses are qualified facilities that 
are subject to modified requirements, which do not require testing or 
development of a food safety plan. We intend that the guidance we are 
developing will be helpful to all sizes of businesses that are subject 
to the requirements for product testing and environmental monitoring. 
(See Response 2.)

D. Proposed Sec.  117.165(a)(2)--Product Testing

    (Comment 527) Some comments ask us to require finished product 
testing for food products designated as high-risk, particularly when 
the product supports pathogen growth during its shelf life. Other 
comments suggest that finished product or ingredient testing should be 
implemented as appropriate in situations where a risk has been 
identified and an effective preventive control cannot be implemented. 
Other comments ask us to require product testing if an environmental 
pathogen is identified as a significant hazard.
    (Response 527) We decline these requests. A facility's decision to 
conduct product testing, and to establish the frequency of such 
testing, will reflect a risk-based approach consistent with its hazard 
analysis. Consequently, we expect that facilities that produce foods 
that have frequently been associated with outbreaks of foodborne 
illness, or produce food for which an effective preventive control 
cannot be implemented, would establish product testing programs more 
often than facilities that do not produce such foods.
    A facility that identifies an environmental pathogen as a hazard 
requiring a preventive control such as sanitation controls would 
conduct environmental monitoring. Such a facility would decide what, if 
any, role product testing would play as a verification activity, or as 
part of a corrective action as a result of positive findings from 
environmental monitoring, based on the facility, the food, the nature 
of the preventive control, and the role of the preventive control in 
the facility's food safety system.
    (Comment 528) Some comments ask us to clarify (or specify) when 
product testing would be directed at raw materials and other 
ingredients and when product testing would be directed at finished 
product. Some comments favor testing raw materials and other 
ingredients as part of ``product testing,'' whereas other comments 
state that testing raw materials and other ingredients should be 
considered part of a supplier program rather than verification of 
implementation and effectiveness. Other comments state that it is 
unclear what preventive control step would be verified by product 
testing and what types of facilities would be required to perform 
product testing. One comment from a supplier of produce states that 
testing its product (i.e., produce testing) is not an adequate measure 
of its cleaning and sanitation program and asks us to clarify that 
product testing is not on final product and that final product testing 
is not required.
    (Response 528) We use the term ``product testing'' to mean testing 
any food product, whether raw materials or other ingredients, in-
process foods, or finished products (Ref. 85) and, thus, product 
testing can be directed to any of these food products. For example, 
testing raw materials and other ingredients could be verification of a 
supplier; testing in-process material after a kill step could be 
verification of process control; testing finished product could be 
verification of the food safety plan as a whole, and capture a problem 
introduced during manufacture, including from contaminated raw 
materials and other ingredients. Product testing generally is not the 
most effective means of measuring the adequacy of cleaning and 
sanitation programs, but such testing is common to track a facility's 
overall hygienic production measures.
    (Comment 529) Some comments assert that a facility that implements 
supplier verification and environmental monitoring (or other measures) 
should not be required to perform product

[[Page 56064]]

testing in addition to the other controls and verification measures.
    (Response 529) The facility determines whether product testing is 
necessary as appropriate to the facility, the food, and the nature of 
the preventive control and its role in the facility's food safety 
system. The factors mentioned by the comment are examples of factors 
that a facility would consider in making its determination.
    (Comment 530) Some comments ask us to revise the requirement for 
product testing to clarify that product testing applies to significant 
hazards.
    (Response 530) We decline this request. Product testing is a 
verification activity for a preventive control, and a preventive 
control is established for a ``significant hazard'' (which we now refer 
to as ``hazard requiring a preventive control''). It is not necessary 
to repeat, for each type of verification activity, that the activity 
applies to hazards requiring a preventive control.
    (Comment 531) Some comments assert that the real point of product 
testing is to test all lots or batches. These comments explain that 
they would be required to retest every lot of product in order to pass 
an analysis of the product on to its customers, even if testing had 
already been performed by their vendors (i.e., suppliers), because each 
of their customers receives a proprietary blend. These comments further 
explain that it is not economically or physically possible to retest 
small lots of product already tested by their vendors, and that the 
risk has already been mitigated by its vendors.
    (Response 531) The situation described by these comments appears to 
be a supplier-customer relationship in that the customer--not this 
rule--has established a requirement for a certificate of analysis for 
every lot of received product. As discussed in Response 517, the 
product testing that this rule requires as a verification activity is 
to help assess and verify the effectiveness of a food safety plan and 
the facility's capability to consistently deliver against it, not to 
establish the acceptability of every lot or batch.
    (Comment 532) Some comments assert that we should set out a 
consultation process by which identification of hazards, situations, or 
product types that may require finished product testing is undertaken 
(noting that there may be significant international differences) before 
establishing requirements for product testing in the rule. These 
comments also assert that before product testing is mandated as a 
potential control step, as opposed to as part of a general verification 
program, Competent Authorities are obligated to demonstrate that it 
will directly deliver demonstrable food safety benefits. According to 
these comments, other than for specific pathogens, random, intermittent 
finished product testing should primarily be used as a measure of 
process control, not for acceptance testing; product testing should 
normally be viewed as a monitoring and review tool, not as a product 
conformance verification tool. Testing programs for product conformance 
verification should be the exception rather than the rule. Other 
comments suggest seeking advice from either the National Advisory 
Committee on Microbiological Criteria for Foods or the FDA Food 
Advisory Committee on establishing statistically based product testing 
programs for process control.
    (Response 532) These comments appear to have misunderstood the 
proposed requirements for product testing. Consistent with the views 
expressed by these comments, we proposed requirements for product 
testing as a verification measure of the food safety plan as a whole, 
not for product conformance or lot acceptance. We do not intend to 
initiate the consultation process described by these comments; however, 
we may consider requesting the assistance of advisory committees on 
process control testing in the future.

E. Proposed Sec.  117.165(a)(3)--Environmental Monitoring

    We proposed to require environmental monitoring, for an 
environmental pathogen or for an appropriate indicator organism, if 
contamination of a ready-to-eat food with an environmental pathogen is 
a significant hazard, by collecting and testing environmental samples.
    (Comment 533) Some comments assert that requirements for 
environmental monitoring as a verification activity would be 
unnecessary in light of proposed revisions to some CGMP requirements, 
such as: (1) A requirement to use chemical, microbial, or extraneous-
material testing procedures where necessary to identify sanitation 
failures or possible allergen cross-contact and food contamination 
(Sec.  117.80(a)(5)); (2) a requirement for raw materials and 
ingredients to either not contain levels of microorganisms that may 
render the food injurious to the health of humans, or to be pasteurized 
or otherwise treated during manufacturing operations so that they no 
longer contain levels that would cause the product to be adulterated 
(Sec.  117.80(b)(2)); and (3) a requirement for all food manufacturing, 
processing, packing, and holding to 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 (Sec.  
117.80(c)(2)).
    (Response 533) Environmental monitoring would be a verification 
activity to ensure that sanitation controls are being implemented and 
are effective. The CGMP testing requirement cited by the comments 
neither explicitly requires environmental monitoring, nor describes the 
circumstances in which environmental monitoring would be needed. The 
cited CGMP requirement for raw materials and ingredients would not 
negate the need for environmental monitoring to verify that sanitation 
controls are preventing environmental pathogens from becoming 
established in a ``niche'' or harborage site (78 FR 3646 at 3814). The 
cited CGMP requirement to minimize the potential for the growth of 
microorganisms or for the contamination of food does not specify that a 
food establishment verify that it is meeting this requirement through 
environmental monitoring.
    (Comment 534) Some comments ask us to specify that environmental 
monitoring of pathogens be executed according to a risk analysis.
    (Response 534) We decline this request. See the discussion in 
Response 467, which explains how risk applies to the facility's hazard 
analysis and the determination by the facility to establish preventive 
controls for hazards requiring a preventive control as appropriate to 
the facility and the food. In contrast, the requirements for 
environmental monitoring are a verification activity that a facility 
would conduct to verify that one or more preventive controls are 
consistently implemented and are effectively and significantly 
minimizing or preventing the hazards requiring a preventive control and 
would be established as appropriate to the facility, the food, and the 
nature of the preventive control rather than according to a risk 
analysis.
    (Comment 535) Some comments ask us to expand the requirements for 
environmental monitoring. For example, comments ask us to broadly 
require environmental monitoring in the following circumstances: as a 
component of every food safety program; in any facility in which there 
is a risk of contamination by an environmental pathogen, not just 
facilities that make RTE food; whenever there is a risk of 
environmental contamination if a likelihood exists that a person may 
consume the food raw; for spores of pathogenic sporeforming

[[Page 56065]]

bacteria if there is a possibility the spores could germinate and 
multiply in a packaged food or under storage or preparation conditions 
in the home; and for unintended food allergens.
    (Response 535) We decline these requests. We are requiring a 
facility to evaluate 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 
(such as a formulation lethal to the pathogen) that would significantly 
minimize the pathogen (Sec.  117.130(c)(1)(ii)). This risk-based 
requirement is a minimum requirement; a facility can do more if its 
preventive controls qualified individual determines that doing so would 
be appropriate.
    The definition of RTE food does include food for which it is 
reasonably foreseeable that the food will be eaten without further 
processing that would significantly minimize biological hazards (Sec.  
117.3)). The definition of environmental pathogen (Sec.  117.3) 
excludes the spores of pathogenic sporeforming bacteria, and we decline 
the request to require environmental monitoring (by revising the 
definition of environmental pathogen) for such spores if there is a 
possibility the spores could germinate and multiply in a packaged food 
or under storage or preparation conditions in the home. As previously 
discussed, pathogenic sporeforming bacteria are normally present in 
foods and unless the foods are subjected to conditions that allow 
multiplication, they present minimal risk of causing illness. Because 
pathogenic sporeforming bacteria are so commonly present in food, a 
more appropriate approach to the risks presented by pathogenic 
sporeforming bacteria would be to focus on their potential presence in 
raw materials and other ingredients and implement appropriate measures 
to prevent their growth (e.g., formulation, refrigeration) rather than 
to monitor for them in the food processing environment.
    We decline the request to expand the requirement to all foods, not 
just RTE foods. Although facilities are required to apply CGMPs to 
prevent contamination of foods that are not RTE, these foods will 
receive a treatment that will significantly minimize or prevent 
environmental pathogens at a later stage.
    Environmental monitoring is directed at microbiological hazards, 
not chemical hazards such as food allergens. The rule requires a 
facility to evaluate known or reasonably foreseeable food allergen 
hazards and to establish food allergen controls when the outcome of the 
hazard analysis is that a food allergen hazard is a hazard requiring a 
preventive control (Sec.  117.130(b)(1)(ii) and (c)). A facility that 
determines that a food allergen hazard requires preventive controls 
could, for example, establish sanitation controls for food allergens 
and a swabbing program to verify those sanitation controls. Even though 
the facility would take swabs from the food processing environment, 
such swabs would not be considered ``environmental monitoring'' as that 
term is used in this rule.
    (Comment 536) Some comments ask us to clarify whether the 
requirement for environmental monitoring ``if contamination of an RTE 
food with an environmental pathogen is a significant hazard'' refers to 
all RTE foods.
    (Response 536) The requirements for environmental monitoring are 
addressed to RTE foods (including RACs, as well as processed foods) 
that are exposed to the environment unless the packaged RTE food 
receives a treatment or otherwise includes a control measure (such as a 
formulation lethal to the pathogen) that would significantly minimize 
the pathogen. See Sec.  117.130(c)(1)(ii) and the discussion in 
Response 406. See also Comment 525 and Response 525 for a discussion of 
environmental monitoring as it could apply to the produce industry.
    (Comment 537) Some comments suggest that a mechanism to reduce 
costs could be to clarify that environmental testing should only be 
done on food-contact surfaces.
    (Response 537) We disagree that it would be appropriate to focus 
environmental monitoring only on food-contact surfaces. It is well-
established that successful environmental monitoring programs look to 
eliminate environmental pathogens from non-food-contact surfaces as a 
means to keep the pathogens from contaminating food-contact surfaces 
and thereby contaminating food.

F. Proposed Sec.  117.165(a)(4)--Review of Records

    We proposed to require review of specified records by (or under the 
oversight of) a preventive controls qualified individual, to ensure 
that the records are complete, the activities reflected in the records 
occurred in accordance with the food safety plan, the preventive 
controls are effective, and appropriate decisions were made about 
corrective actions. We proposed to require review of records of 
monitoring and corrective action records within a week after the 
records are made, and review of records of calibration, product 
testing, environmental monitoring, and supplier verification activities 
within a reasonable time after the records are made.
    (Comment 538) Some comments assert that it is not necessary for a 
preventive controls qualified individual to conduct or oversee review 
of records as a verification activity, noting that review of records in 
another food safety regulation (i.e., the LACF requirements in part 
113) can be done by persons adequately trained in recordkeeping and 
review of records.
    (Response 538) The rule does not preclude review of records by 
persons other than the preventive controls qualified individual, 
provided that the preventive controls qualified individual provides 
oversight for that review. Oversight by a preventive controls qualified 
individual is necessary because the review of records is critical to 
assessing the facility's application of the preventive controls system 
and, thus, is fundamental to ensuring its successful operation (78 FR 
3646 at 3757-58). Oversight by a preventive controls qualified 
individual is consistent with requirements of Federal HACCP regulations 
for seafood, juice, and meat and poultry, and with NACMCF HACCP 
guidelines (Ref. 35) (78 FR 3646 at 3757-58).
    (Comment 539) Some comments ask us to provide for a timeframe 
longer than one week (such as 7 working days) for review of records of 
monitoring and corrective actions. Some comments ask us to provide the 
same flexibility for review of records of monitoring and corrective 
actions as we proposed for review of records of calibration, product 
testing, environmental monitoring, and supplier verification activities 
(``within a reasonable time'' after the records are made)--e.g., 
because some preventive controls may be monitored less frequently than 
is typical in a traditional HACCP plan dominated with CCPs. Some 
comments note that corrective actions may not be fully implemented 
within 7 days and ask us to provide for review of these records within 
a week or other timeframe determined to be appropriate to ensure that 
potentially hazardous goods do not enter commerce. Some comments ask us 
to retain the one week timeframe for review of records associated with 
perishable foods, but to extend the timeframe to one month for 
nonperishable foods.
    Some comments state that some food processors that operate on a 
batch production basis (rather than a continuous production basis) 
review all records related to a particular batch all at once just 
before release of the batch

[[Page 56066]]

for distribution. These comments assert that it would be inefficient, 
unnecessary, and needlessly complicated to require management to review 
a few production records in advance of the normal complete records 
review, particularly when laboratory testing conducted on the batch by 
an outside laboratory takes several weeks to complete.
    (Response 539) We have revised the proposed requirement to require 
review of records of monitoring and corrective actions within 7 working 
days after the records are made or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7 working days. A timeframe that exceeds 7 working days 
will be the exception rather than the norm. For example, reviewing 
records before release of product may be considered adequate by a 
facility, although this may be later than one week after the records 
were created. A facility may determine that all records for a lot of 
product will be reviewed after product testing or environmental 
monitoring records relevant to that lot of product are available, which 
may be more than a week after monitoring records were created. We made 
a conforming change to the list of responsibilities of the preventive 
controls qualified individual to address the requirement for the 
preventive controls qualified individual to provide (or oversee the 
preparation of) a written justification for such a timeframe (see Sec.  
117.180(a)).
    We are not requiring that a facility review records of monitoring 
and corrective actions before release of product or that the timeframe 
for the review depend on the shelf life of the food. The purpose of 
reviewing records is not to determine whether to release product. 
Instead, the purpose of reviewing records is to ensure that the records 
are complete, the activities reflected in the records occurred in 
accordance with the food safety plan, the preventive controls are 
effective, and appropriate decisions were made about corrective 
actions. However, a facility will have flexibility to review records of 
monitoring and corrective actions within a timeframe that exceeds 7 
working days, such as before product release, provided that the 
facility provides a written justification for doing so. As discussed in 
Response 542, depending on the nature of the record, a facility that 
reviews these types of records in a timeframe that exceeds 7 working 
days, and finds a problem, may be faced with recall decisions for a 
relatively large number of affected lots of product.
    (Comment 540) Some comments ask us to revise the provisions for 
review of records by more generally referring to records of 
``verification testing (e.g., product testing and/or environmental 
monitoring as applicable).''
    (Response 540) We have revised the regulatory text to refer to 
records of ``testing (e.g., product testing, environmental 
monitoring).''
    (Comment 541) Some comments refer to our request for comment on 
whether the regulatory text should specify the verification activities 
that must be conducted for corrective actions (see the discussion in 
Comment 489 and Response 489). These comments assert that if we do not 
further specify verification activities for corrective actions then we 
should eliminate the proposed requirement to review records of 
corrective actions.
    (Response 541) Records are necessary to document all verification 
activities (see Sec.  117.155(b)). The fact that the rule provides 
flexibility for the facility to appropriately determine the 
verification activities for corrective actions, rather than prescribes 
these verification activities, has no bearing on the requirement to 
document the verification activities.
    (Comment 542) Some comments state that records of calibration 
activities are reviewed at the time the calibration is performed. These 
comments assert that in most cases a formal scheduled review of 
calibration records is not required to ensure the effectiveness of the 
control and that records review of calibrations should be based upon 
the nature of the control being calibrated.
    (Response 542) The purpose of reviewing records as a verification 
activity is to ensure that the records are complete, the activities 
reflected in the records occurred in accordance with the food safety 
plan, the preventive controls are effective, and appropriate decisions 
were made about corrective actions. Although records may be reviewed at 
the time they are made, the review of records as a verification 
activity includes oversight by a preventive controls qualified 
individual (see Response 538). Because the timeframe for review of 
calibration records is ``within a reasonable time after the records are 
created,'' the facility has flexibility over the frequency of 
conducting this review. However, depending on the nature of the control 
for which the instrument is being calibrated, a facility that reviews 
calibration records infrequently, and finds a problem with calibration 
of process monitoring instruments and verification instruments, may be 
faced with recall decisions for a relatively large number of affected 
lots of product.
    (Comment 543) Some comments emphasize the importance of calibrating 
those instruments and monitoring devices that are critical to the 
preventive control, and reviewing the associated records, before 
validation of a lethality step and as frequently as necessary 
thereafter. These comments question whether requiring review of 
calibration records ``within a reasonable time'' will be adequate.
    (Response 543) We agree that instruments and monitoring devices 
that are critical to a preventive control should be calibrated, and 
calibration records should be reviewed, before conducting studies to 
validate a lethality step. However, the provision is directed at 
verification of implementation and effectiveness of preventive controls 
on an ongoing basis. This rule does not prescribe specific steps that a 
facility must take before conducting validation studies.
    A facility has flexibility to appropriately determine the frequency 
of reviewing calibration records based on the facility, the food, and 
the nature of the preventive control. We agree that it would be prudent 
to review calibration records of those instruments and monitoring 
devices that are critical to the preventive control more frequently 
than of those instruments and monitoring devices that are not critical 
to the preventive control. As discussed in Response 542, depending on 
the nature of the control for which the instrument is being calibrated, 
a facility that reviews calibration records infrequently, and finds a 
problem with calibration of process monitoring instruments and 
verification instruments, may be faced with recall decisions for a 
relatively large number of affected lots of product.

G. Proposed Sec.  117.165(b)--Written Procedures

1. Proposed Sec.  117.165(b)(1)--Frequency of Calibration
    We proposed that you must establish and implement written 
procedures for the frequency of calibrating process monitoring 
instruments and verification instruments.
    (Comment 544) As discussed in Comment 519, some comments ask us to 
specify that an accuracy check may be used as a verification activity 
in lieu of calibration. These comments also ask us to specify that 
written procedures address the frequency of accuracy checks, as well as 
calibration.

[[Page 56067]]

    (Response 544) Consistent with Response 519, we have revised the 
proposed requirement to specify that written procedures address the 
frequency of accuracy checks, as well as calibration.
2. Proposed Sec.  117.165(b)(2) and (b)(3)--Product Testing and 
Environmental Monitoring
    We proposed that you must establish and implement written 
procedures for product testing. We proposed that procedures for product 
testing must: (1) Be scientifically valid; (2) identify the test 
microorganism(s); (3) specify the procedures for identifying samples, 
including their relationship to specific lots of product; (4) include 
the procedures for sampling, including the number of samples and the 
sampling frequency; (5) identify the test(s) conducted, including the 
analytical method(s) used; (6) identify the laboratory conducting the 
testing; and (7) include the corrective action procedures required by 
Sec.  117.150(a)(1).
    Likewise, we proposed that you must establish and implement written 
procedures for environmental monitoring. Procedures for environmental 
monitoring must: (1) Be scientifically valid; (2) identify the test 
microorganism(s); (3) identify the locations from which the samples 
will be collected and the number of sites to be tested during routine 
environmental monitoring; (4) identify the timing and frequency for 
collecting and testing samples; (5) identify the test(s) conducted, 
including the analytical method(s) used; (6) identify the laboratory 
conducting the testing; and (7) include the corrective action 
procedures required by Sec.  117.150(a)(1).
    (Comment 545) Some comments express concern that the word ``valid'' 
in the phrase ``scientifically valid'' could be construed to mean 
``validated'' because not all testing protocols can be validated within 
the traditional meaning of the term. These comments state their belief 
that what we intend is for these testing programs to be ``technically 
sound.'' Other comments express concern that ``scientifically valid'' 
may be interpreted to mean that firms are required to develop or 
validate analytical methods (either in general or for specific food 
matrices).
    (Response 545) We are retaining the term ``scientifically valid'' 
in these provisions. We disagree that we would interpret 
``scientifically valid'' to mean that facilities are required to 
develop or validate analytical methods. We discussed our interpretation 
of the term ``scientifically valid'' in the Appendix to the 2013 
proposed preventive controls rule (78 FR 3646 at 3812 to 3813), and 
noted that this interpretation was consistent with our previous 
discussion of the term ``scientifically valid'' (in place of 
``validated'') in the rulemaking to establish CGMP requirements for 
dietary supplements (68 FR 12158 at 12198, March 13, 2003). While 
validated methods are considered ``scientifically valid,'' methods that 
have not gone through formal validation processes but have been 
published in scientific journals, for example, may also be 
``scientifically valid.'' We do expect methods used for testing to be 
adequate for their intended use.
    We have had several years interpreting the term ``scientifically 
valid'' in the context of the requirement, in the dietary supplement 
CGMPs, that the manufacturer must ensure that the tests and 
examinations that it uses to determine whether the specifications are 
met are appropriate, scientifically valid methods (Sec.  111.75(h)(1)). 
Although we agree that methods that are ``scientifically valid'' would 
also be ``technically sound,'' we disagree that the hypothetical 
concern that we would construe ``scientifically valid'' to mean 
``validated'' warrants changing ``scientifically valid'' to a new term 
(such as ``technically sound'') in light of our previous statements 
regarding this term and experience in the context of CGMP requirements. 
See the final rule establishing the dietary supplement CGMPs for 
additional discussion on the terms ``validated'' and ``scientifically 
valid'' (72 FR 34752 at 34853).
    (Comment 546) Some comments support the proposed requirements for 
written procedures for environmental monitoring, including providing 
flexibility to use indicator organisms and to design the timing, 
location, and frequency of environmental monitoring programs in a risk-
based manner, and in not prescribing specific locations (e.g., food-
contact surfaces or ``zone 1'') or sample quantities for testing. Other 
comments ask us to add details to the written procedures for product 
testing and environmental monitoring regarding when and where sampling 
is required and the number of samples to take. Some comments ask us to 
make sure the most current ``sampling planning science'' is used for 
environmental monitoring by specifying that procedures for 
environmental monitoring must employ ``sample quality criteria 
objectives.'' Other comments assert that the product testing procedure 
requirements are inadequate and ask us to require that procedures for 
product testing specify the procedures for identifying samples 
(including their relationship to specific lots of product); describe 
how sampling was conducted (to establish that the sample obtained 
adequately represents the lot of product the sample is intended to 
represent); and include the procedures for sample quality control from 
field to lab. Other comments assert that the frequency of environmental 
monitoring and product testing is unclear and express concern that 
frequent swabbing and frequent testing could cause cheeses to be held 
past their optimum ripeness if they are fresh or soft ripened.
    (Response 546) We decline the request to prescribe additional 
details, such as those described in these comments, in the requirements 
for written procedures for product testing and environmental 
monitoring. As with other procedures required by the rule, those 
relating to environmental monitoring and product testing must be 
adequate for their intended purpose. Further, procedures will not be 
identical in all circumstances. For example, a facility that produces 
products with a short shelf life may choose a different frequency of 
swabbing and testing than a facility that produces products with a long 
shelf life.
    (Comment 547) Some comments ask us to provide more flexibility in 
product testing by not requiring establishments to provide written 
procedures for product testing and corrective action procedures.
    (Response 547) These comments are unclear. By requiring that a 
facility establish its own procedures, the rule provides facilities 
with flexibility to develop a product testing program that works best 
for its facility and its products. We are retaining the requirements 
for written procedures for product testing, as well as for corrective 
action procedures.
    (Comment 548) Some comments ask us to add a provision requiring 
that all positive results must result in corrective action being taken.
    (Response 548) We decline this request. The rule requires that a 
facility must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented, including procedures to address, as appropriate, the 
presence of a pathogen or appropriate indicator organism in an RTE 
product detected as a result of product testing and the presence of an 
environmental pathogen or appropriate indicator organism detected 
through environmental monitoring (see Sec.  117.150(a)(1)). However, 
the rule does not pre-determine what corrective actions a facility must 
take when presented with positive results from product testing or 
environmental

[[Page 56068]]

monitoring. The corrective action procedures that a facility would 
develop, and the actual corrective actions that the facility would 
take, will depend on the nature of the hazard and the nature of the 
preventive control, as well as information relevant to the positive 
result (e.g., pathogen or indicator organism, product or environment, 
food-contact surface or non-food-contact surface).

XXXV. Subpart C: Comments on Proposed Sec.  117.170--Reanalysis

    We proposed to establish requirements for reanalysis of the food 
safety plan. Some comments support the proposed requirements without 
change. For example, comments agree that a preventive controls 
qualified individual must perform (or oversee) the reanalysis (see 
section XXXV.D). Some comments that support the proposed provisions 
suggest alternative or additional regulatory text (see, e.g., Comment 
549, Comment 550, Comment 552, Comment 553, Comment 557, and Comment 
558).
    In the following paragraphs, 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 39, with editorial and conforming 
changes as shown in table 52.

     Table 39--Revisions to the Proposed Requirements for Reanalysis
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.170(b)....................  Circumstances      Provide for
                                 that require       reanalysis of an
                                 reanalysis.        applicable portion
                                                    of the food safety
                                                    plan (rather than
                                                    the complete food
                                                    safety plan) in
                                                    specified
                                                    circumstances.
117.170(b)(4).................  Circumstances      Require reanalysis of
                                 that require       the food safety plan
                                 reanalysis.        as a whole, or the
                                                    applicable portion
                                                    of the food safety
                                                    plan, whenever a
                                                    preventive control,
                                                    combination of
                                                    preventive controls,
                                                    or the food safety
                                                    plan as a whole is
                                                    found to be
                                                    ineffective.
117.170(c)....................  Timeframe to       Clarify that the
                                 complete the       requirement applies
                                 reanalysis.        to completing the
                                                    reanalysis and
                                                    validating any
                                                    additional
                                                    preventive controls
                                                    (as appropriate to
                                                    the nature of the
                                                    preventive control
                                                    and its role in the
                                                    facility's food
                                                    safety system),
                                                    rather than to
                                                    completing the
                                                    reanalysis and
                                                    implementing any
                                                    additional
                                                    preventive controls
                                                    (emphasis added).
------------------------------------------------------------------------

A. Proposed Sec.  117.170(a)--Circumstances Requiring Reanalysis

    We proposed that you must conduct a reanalysis of the food safety 
plan: (1) At least once every 3 years; (2) whenever a significant 
change in the activities conducted at your facility creates a 
reasonable potential for a new hazard or creates a significant increase 
in a previously identified hazard; (3) whenever you become aware of new 
information about potential hazards associated with the food; (4) 
whenever appropriate after an unanticipated food safety problem; and 
(5) whenever you find that a preventive control is ineffective.
    (Comment 549) Some comments assert that the need to reanalyze the 
food safety plan will depend on the nature of the preventive control 
and its role in the food safety system. These comments also assert that 
if a specific preventive control is found to be ineffective, only the 
applicable portion of the food safety plan would need to be reanalyzed.
    (Response 549) We agree and have revised the regulatory text, with 
associated editorial changes and redesignation, to separate the 
requirement to reanalyze the food safety plan as a whole every 3 years 
from all other circumstances when reanalysis is required ``for cause.'' 
When reanalysis is ``for cause,'' the regulatory text provides that 
reanalysis is of the food safety plan as a whole, or the applicable 
portion of the food safety plan.
    (Comment 550) Some comments ask us to recognize other terminologies 
already used by some facilities (e.g., ``reassess'').
    (Response 550) We have acknowledged that the terminology used in 
relation to the concept of ``reanalysis'' varies in current regulations 
and guidelines for systems such as HACCP (78 FR 3646 at 3759). A 
facility may choose to use a term such as ``reassessment'' in its 
records--e.g., if it relies on existing records that use the term 
``reassessment'' to satisfy some or all of the requirements of this 
rule for reanalysis. However, the human preventive controls rule will 
use a single term (i.e., reanalyze) to minimize the potential for 
confusion about whether different terms have a different meaning for 
the purposes of the rule.
    (Comment 551) Some comments ask us to define ``reanalysis'' to mean 
``a reassessment of the validity of a preventive control or food safety 
plan to control a hazard. Reanalysis may include a system review and, 
where necessary, activities to revalidate a control measure or 
combination of control measures.''
    (Response 551) We decline this request. Reanalysis goes beyond 
assessing the validity of a preventive control or food safety plan to 
control a hazard. Reanalysis can also include assessing whether all 
hazards have been identified, whether established procedures are 
practical and effective, and other factors.
    (Comment 552) Some comments ask us to require reanalysis on an 
annual basis, noting that annual reanalysis is required by Federal 
HACCP regulations for seafood, juice, and meat and poultry.
    (Response 552) We decline this request. We proposed to require 
reanalysis at least once every 3 years as a minimum requirement in the 
event that there is no other circumstance warranting reanalysis (see 
proposed Sec.  117.170(a)(1)). That 3-year minimum is consistent with 
the statute (see section 418(i) of the FD&C Act). As a practical 
matter, we expect that reanalysis will occur more frequently as a 
result of changes in the activities conducted at a facility (see final 
Sec.  117.170(b)(1) through (4)).
    (Comment 553) Some comments suggest editorial changes to improve 
the readability of the requirement to conduct reanalysis when there is 
a change in a preventive control.
    (Response 553) We are including these editorial changes in the 
regulatory text, which now reads whenever ``a significant change in the 
activities conducted at your facility creates a reasonable potential . 
. .''
    (Comment 554) Some comments assert that the proposed requirement to 
conduct reanalysis whenever you become aware of new information about 
potential hazards associated with the food does not align with FSMA 
statutory language, is ambiguous, and would establish vague compliance 
obligations.

[[Page 56069]]

    (Response 554) We disagree. See our previous discussion regarding 
the emergence of the pathogen L. monocytogenes in the mid-1980's and 
the first outbreak of foodborne illness in the United States, in 2006-
2007, caused by consumption of peanut butter contaminated with 
Salmonella (78 FR 3646 at 3759). Although we acknowledge that the 
proposed requirement is not explicit in section 418(i) of the FD&C Act, 
we disagree it is not in alignment with FSMA as a whole. FSMA directs 
the owner, operator, or agent in charge of a facility to evaluate the 
hazards that could affect food manufactured, processed, packed, or held 
by such facility and identify and implement preventive controls to 
significantly minimize or prevent the occurrence of those hazards (see 
section 418(a) of the FD&C Act). In other words, FSMA focuses on a 
system to prevent food safety problems rather than a system to react to 
problems after they occur. Requiring that a facility reanalyze its food 
safety plan, or the applicable portion of the food safety plan, in 
response to information such as the emergence of a new foodborne 
pathogen, or an outbreak of foodborne illness from consumption of a 
food product not previously associated with foodborne illness from a 
well-known pathogen, aligns very well with the statutory direction in 
FSMA.
    (Comment 555) Some comments ask us to specify that reanalysis is 
required when a preventive control ``fails to be'' properly implemented 
rather than when a preventive control ``is not'' properly implemented.
    (Response 555) We decline this request. We see no meaningful 
difference between ``fails to be'' and ``is not'' in this context, 
except that ``fails to be'' could lead to questions about the meaning 
of the term ``fails'' in this context.
    (Comment 556) Some comments ask us to add a requirement to conduct 
reanalysis whenever a preventive control is found to be ``missing'' in 
addition to whenever a preventive control is found to be 
``ineffective.''
    (Response 556) We have revised the regulatory text to require 
reanalysis whenever a preventive control, a combination of preventive 
controls, or the food safety plan as a whole, is ineffective. (See 
Sec.  117.170(b)(4).) A ``missing'' preventive control could be 
discovered during verification to establish the validity of the food 
safety plan as a whole or as a result of an unanticipated problem. (See 
Response 482.) If circumstances lead a facility to conclude that an 
additional (or different) preventive control is necessary, the facility 
would include that preventive control in its food safety plan along 
with associated preventive control management components, including 
verification to establish the validity of the food safety plan.

B. Proposed Sec.  117.170(b)--Timeframe To Complete Reanalysis

    We proposed that you must complete the reanalysis and implement any 
additional preventive controls needed to address the hazard identified, 
if any, before the change in activities at the facility is operative 
or, when necessary, during the first 6 weeks of production. We have 
clarified that the requirement is to complete the reanalysis and 
validate (rather than implement) any additional preventive controls as 
appropriate to the nature of the preventive control and its role in the 
facility's food safety system.
    (Comment 557) As discussed in Comment 501, some comments question 
whether 6 weeks is enough time to perform all applicable validation 
studies that would address the execution element of validation. 
Likewise, some comments question whether 6 weeks is enough time to 
complete reanalysis.
    (Response 557) Consistent with revisions we have made to the 
timeframe to complete validation (see Response 501), we have revised 
the timeframe to complete the reanalysis and validate, as appropriate 
to the nature of the preventive control and its role in the facility's 
food safety system, any additional preventive controls to be within 90 
days after production of the applicable food first begins or within a 
reasonable timeframe, provided that the preventive controls qualified 
individual provides (or oversees the preparation of) a written 
justification for a timeframe that exceeds 90 days after production of 
the applicable food first begins. We made a conforming change to the 
list of responsibilities of the preventive controls qualified 
individual (see Sec.  117.180(a)).
    (Comment 558) Some comments state that the phrase ``before the 
change in activities at the facility is operative'' is ambiguous in 
that it is unclear if the phrase is referencing the initial change in 
activities that triggered the reanalysis or a change in activities 
subsequent to the reanalysis. These comments ask us to clarify the 
requirement by substituting the phrase ``before the relevant process is 
operative.''
    (Response 558) We agree that there was ambiguity in this phrase, 
because changes in activities could result in the need for reanalysis 
and reanalysis could result in the need for changes in activities, both 
of which can result in a new preventive control. We have made several 
revisions to the regulatory text, with associated editorial changes, to 
clarify the requirements for reanalysis. First, we have clarified that 
reanalysis can be routine (at least every 3 years) or ``for cause'' 
(i.e., a significant change that creates the potential for a new hazard 
or an increase in a previously identified hazard; when you become aware 
of new information about potential hazards associated with the food; 
when there is an unanticipated food safety problem; or whenever a 
preventive control, combination of preventive controls or the food 
safety plan as a whole is ineffective). Second, we have specified that 
the reanalysis ``for cause'' may be for the entire food safety plan or 
only for an applicable portion.
    In addition, as discussed in Response 557, we have clarified that 
the reanalysis and the validation, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
of any additional preventive controls needed to address an identified 
hazard would need to be completed before any change in activities 
(including any change in preventive controls) is operative. When 
additional time is necessary, we have provided for a timeframe within 
90 days after production of the applicable food first begins or within 
a reasonable timeframe, provided that the preventive controls qualified 
individual provides (or oversees the preparation of) a written 
justification for a timeframe that exceeds 90 days after production of 
the applicable food first begins. In other words, if you decide to make 
a change, you should conduct a reanalysis before you make that change 
if there is potential for that change to create or increase a hazard; a 
reanalysis that results in changes to preventive controls should be 
completed and the preventive controls validated, as appropriate to the 
nature of the preventive control and its role in the facility's food 
safety system, before changes in activities to produce food using a new 
preventive control are put into operation. However, we acknowledge that 
it may be necessary to produce product to demonstrate a revised 
preventive control can be implemented appropriately, and provide for an 
extended timeframe to make this assessment.

C. Proposed Sec.  117.170(c)--Requirement To Revise the Written Food 
Safety Plan or Document Why Revisions Are Not Needed

    We proposed that you must revise the written food safety plan if a 
significant change is made or document the basis

[[Page 56070]]

for the conclusion that no revisions are needed. We received no 
comments that disagreed with this proposed requirement and are 
finalizing it as proposed.

D. Proposed Sec.  117.170(d) --Requirement for Oversight of Reanalysis 
by a Preventive Controls Qualified Individual

    We proposed that a preventive controls qualified individual must 
perform (or oversee) the reanalysis. We received no comments that 
disagreed with this proposed requirement and are finalizing it as 
proposed. See section XXXVI.B.1 for comments on the qualifications for 
a preventive controls qualified individual who would perform or oversee 
the reanalysis.

E. Proposed Sec.  117.170(e)--Reanalysis on the Initiative of FDA

    We proposed that you must conduct a reanalysis of the food safety 
plan when FDA determines it is necessary to respond to new hazards and 
developments in scientific understanding.
    (Comment 559) Some comments ask us to issue formal, written 
communications about new hazards and developments in scientific 
understanding. These comments express concern that communications of 
this type could be inconsistent if they are communicated by individual 
investigators. Other comments ask us to specify in the regulatory text 
that it is the Commissioner of Food and Drugs who makes the 
determination that it is necessary to conduct a reanalysis of the food 
safety plan.
    (Response 559) We agree that a communication from FDA about the 
need to reanalyze the food safety plan should be issued in a formal 
written manner but disagree that it is necessary to specify that it is 
the Commissioner of Food and Drugs who makes the determination that it 
is necessary to conduct a reanalysis of the food safety plan. The 
comment provides no basis for precluding such a determination by an 
organizational component (such as CFSAN or a component of FDA's Office 
of Regulatory Affairs) that has operational responsibility for food 
safety and subject matter experts to advise the managers in those 
organizational components.

XXXVI. Subpart C: Comments on Proposed Sec.  117.180--Requirements 
Applicable to a Preventive Controls Qualified Individual and a 
Qualified Auditor

    We proposed to establish requirements for the qualifications of a 
preventive controls qualified individual and a qualified auditor. 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 563 and Comment 568) or 
ask us to clarify how we will interpret the provisions (see, e.g., 
Comment 560, Comment 564, and Comment 571).
    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 conforming 
changes as shown in table 52.

A. Proposed Sec.  117.180(a) and (b)--What a Preventive Controls 
Qualified Individual or Qualified Auditor Must Do or Oversee

    We proposed to list the functions that must be performed by one or 
more preventive controls qualified individuals (i.e., preparation of 
the food safety plan; validation of the preventive controls; review of 
records for implementation and effectiveness of preventive controls and 
appropriateness of corrective actions; and reanalysis of the food 
safety plan) or by a qualified auditor (i.e., conduct an onsite audit). 
We proposed to list these functions for simplicity (i.e., to make it 
easy to see all of the requirements in a single place). We specified 
that this list of functions already proposed to be established in 
applicable sections of the rule did not in itself impose any additional 
requirements.
    (Comment 560) Some comments ask us to clarify whether the 
preventive controls qualified individual must be on the premises during 
operating hours. Other comments ask us to clarify that the preventive 
controls qualified individual is not responsible for performing 
laboratory testing, because the preventive controls qualified 
individual may not be appropriately educated and trained for laboratory 
testing.
    (Response 560) The rule does not require that the preventive 
controls qualified individual be onsite during operating hours. The 
rule also does not require that the preventive controls qualified 
individual be responsible for performing laboratory testing, although 
review of testing records (e.g., records of product testing or 
environmental testing) must be conducted or overseen by a preventive 
controls qualified individual.
    (Comment 561) Some comments ask us to consider the implication of 
having the preventive controls qualified individual serve as the 
process authority, serve as the auditor, and offer final sign off on a 
validation and corrective actions, and suggest that a third party may 
be necessary to ensure that uniform standards are applied.
    (Response 561) To the extent that the comment suggests that the 
functions of the preventive controls qualified individual create a 
conflict of interest, we disagree. The rule focuses on the need for 
applicable training and experience to perform certain functions. The 
preventive controls qualified individual must develop (or oversee the 
development of) the food safety plan that controls the identified 
hazards and then ensure through review of records that the plan is 
being implemented as designed. The rule does not require that a 
facility engage a third party to provide oversight of any individual, 
including a preventive controls qualified individual, but does not 
preclude a facility from doing so if it chooses.

B. Proposed Sec.  117.180(c)--Qualification Requirements

1. Proposed Sec.  180(c)(1)--Preventive Controls Qualified Individual
    We proposed that to be a preventive controls qualified individual, 
the individual must have 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 FDA or be otherwise qualified through job experience to 
develop and apply a food safety system. We also proposed that this 
individual may be, but is not required to be, an employee of the 
facility.
    (Comment 562) Some comments ask us to work with industry to 
establish a national training curriculum and standards for knowledge 
requirements before the final rule is issued. Comments recommend that 
curriculum and training requirements be consistent with already 
existing standards, including Better Process Control School, 
International HACCP, GFSI, Seafood HACCP, and those trainings offered 
by Cooperative Extension or State Agriculture departments. Some 
comments ask us to allow flexibility for industry to continue current 
training programs without receiving express approval from the FSPCA. 
Other comments ask that a standardized curriculum for training a 
preventive controls qualified individual be harmonized with the GFSI 
requirement.
    (Response 562) As discussed in Response 2, the FSPCA is 
establishing a

[[Page 56071]]

standardized curriculum. The curriculum will focus on the specific 
requirements of the human preventive controls rule. Training providers 
do not need approval from the FSPCA to use the curriculum.
    (Comment 563) Some comments ask who will assess the qualifications 
of a particular preventive controls qualified individual or determine 
whether particular individuals are in fact ``qualified.'' Some comments 
ask us to use an outcome-based demonstration of competency. Some 
comments ask us to specify that all work experience must be comparable 
or that a preventive controls qualified individual must pass a 
proficiency test. Some comments ask us to establish minimum standards 
for competency. Some comments ask us to clarify what job experiences 
would be sufficient. Some comments ask how we will verify that reported 
training and experience are true.
    (Response 563) We are not establishing minimum standards for 
competency and do not intend routinely to directly assess the 
qualifications of persons who function as the preventive controls 
qualified individual, whether by their training or by their job 
experience. Instead, we intend to focus our inspections on the adequacy 
of the food safety plan. As necessary and appropriate, we will consider 
whether deficiencies we identify in the food safety plan suggest that 
the preventive controls qualified individual may not have adequate 
training or experience to carry out the assigned functions, including 
whether reported training and experience is accurately represented.
    (Comment 564) Some comments ask us to provide for competency 
requirements to be met through on-the-job experience in lieu of 
traditional classroom training. Some comments ask us to clarify what we 
mean by training that is ``at least equivalent'' to that received under 
a standardized curriculum recognized as adequate by FDA. Some comments 
ask us to clarify whether individuals who have successfully completed 
training in the development and application of risk-based preventive 
controls through programs delivered and recognized under the 
International HACCP Alliance would be considered to have completed 
training ``equivalent'' to that recognized by FDA for the development 
and application of risk-based preventive controls.
    (Response 564) The requirements do provide for qualification 
through appropriate job experience, such as experience with 
successfully implementing HACCP systems or other preventive-based food 
safety systems. It is the responsibility of the owner, operator, or 
agent in charge of the facility to determine whether any individual who 
prepares (or oversees the preparation of) the food safety plan has 
appropriate qualifications to do so, whether by on-the-job experience 
or by training.
    There are some differences in the requirements of the human 
preventive controls rule compared to the requirements of HACCP 
regulations for seafood, juice, and meat and poultry such that training 
provided by the International HACCP Alliance may not be equivalent. 
Such an individual may need to obtain supplemental training specific to 
the rule. Alternatively, a person who has received the International 
HACCP Alliance training and has implemented a HACCP plan may be 
qualified through job experience.
    (Comment 565) Some comments ask us to emphasize that a standardized 
curriculum in the development and application of risk-based preventive 
controls may not provide a preventive controls qualified individual 
with sufficient expertise to design and conduct robust, scientific 
validation studies to support the adequacy of control measures.
    (Response 565) We acknowledge that a single training course may not 
provide adequate training for every function of the preventive controls 
qualified individual for the foods produced by a facility. In some 
cases an individual may gain the full complement of knowledge and 
experience through multiple, specific training courses; in other cases 
an individual may gain the full complement of knowledge and experience 
through job experience or through a combination of training and job 
experience.
    (Comment 566) Some comments ask us not to establish requirements 
that are overly strict because there is a finite supply of food safety 
experts in the country and many facilities will need multiple 
preventive controls qualified individuals.
    (Response 566) We disagree that the requirements applicable to the 
preventive controls qualified individual should be designed to match 
any current limitations in the number of individuals who have the 
knowledge and skill to prepare (or oversee the preparation of) a food 
safety plan. We expect that market forces will act to increase the 
number of preventive controls qualified individuals to match the demand 
generated by this rule. In addition, as discussed in section LVI.A, we 
are staggering the compliance dates for the rule, so that only those 
businesses that are not small or very small businesses will need to 
comply with the rule within one year, and very small businesses are not 
required to develop a food safety plan or conduct other activities that 
require oversight by a preventive controls qualified individual.
    (Comment 567) Some comments ask us to develop training that 
emphasizes the need for appropriate equipment standards.
    (Response 567) The training will focus on the specific requirements 
of the human preventive controls rule, which does not establish 
requirements for equipment standards.
    (Comment 568) Some comments ask us to provide that the standardized 
curriculum can be recognized as adequate by the competent authority for 
food safety in each country rather than by FDA. One comment cited a 
requirement in one country for training that is consistent with Codex 
HACCP.
    (Response 568) We decline this request. The standardized curriculum 
will be available to training providers, and we expect market forces 
will result in the development in foreign countries of training 
consistent with the standardized training curriculum. As noted 
previously (see Response 564), HACCP-based training may not be 
equivalent to the standardized curriculum because of the specific 
requirements of this rule. However, we believe that the flexibility 
provided by the alternative that a preventive controls qualified 
individual may be otherwise qualified through job experience to develop 
and apply a food safety system provides an approach to address the 
circumstances in a foreign country with respect to preventive controls 
qualified individuals until the training is available. In addition we 
will work with partners around the world--including the Alliances, 
regulatory counterparts, and multinational organizations--to promote 
training to the global community of food suppliers. We intend to meet 
both the letter and the spirit of our obligation to the World Trade 
Organization to facilitate training on the new regulations, 
particularly in developing nations.
2. Proposed Sec.  117.180(c)(2)--Qualified Auditor
    We proposed that to be a qualified auditor, a preventive controls 
qualified individual must have technical expertise obtained by a 
combination of training and experience appropriate to perform the 
auditing function.
    (Comment 569) Some comments object to the proposed requirement that 
a qualified auditor must be a preventive

[[Page 56072]]

controls qualified individual with certain technical auditing 
expertise. One comment asserts that a qualified auditor should not be 
required to have the broader skills of a preventive controls qualified 
individual.
    (Response 569) We have revised the definition of ``qualified 
auditor,'' and the requirements applicable to a ``qualified auditor,'' 
such that a ``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.''
    (Comment 570) Some comments ask us to consider specifying training 
for qualified auditors. These comments also ask us to consider certain 
industry documents in any guidance we may issue regarding qualified 
auditors.
    (Response 570) At this time, we are not planning to specify a 
training curriculum for qualified auditors. If we develop guidance 
related to qualified auditors, we will consider industry documents that 
are already available.

C. Proposed Sec.  117.180(d)--Records

    We proposed that all applicable training must be documented in 
records, including the date of the training, the type of training, and 
the person(s) trained. For clarity, we have revised the requirement to 
specify the type of training that must be documented--i.e., applicable 
training in the development and application of risk-based preventive 
controls (see 78 FR 3646 at 3762).
    (Comment 571) Some comments ask us to explain how job experience 
should be documented in records to prove qualifications.
    (Response 571) The rule does not require documentation of job 
experience. A facility has flexibility to determine whether and how to 
document the job experience of a preventive controls qualified 
individual. For example, a facility could ask a preventive controls 
qualified individual to provide a resume documenting applicable 
experience. As discussed in Response 563, we intend to focus our 
inspections on the adequacy of the food safety plan. As necessary and 
appropriate, we will consider whether deficiencies we identify in the 
food safety plan suggest that the preventive controls qualified 
individual may not have adequate experience to carry out the assigned 
functions.

XXXVII. Subpart C: Comments on Proposed Sec.  117.190--Implementation 
Records

    We proposed to list all records documenting implementation of the 
food safety plan in Sec.  117.190(a). We noted that proposed Sec.  
117.190(a) would not establish any new requirements but merely make it 
obvious at a glance what implementation records are required under 
proposed part 117, subpart C. We received no comments that disagreed 
with this proposed provision and are finalizing it as proposed.
    We proposed that the records that you must establish and maintain 
are subject to the requirements of proposed subpart F (Requirements 
Applying to Records that Must be Established and Maintained). (Proposed 
subpart F would establish requirements that would apply to all records 
that would be required by the various proposed provisions of proposed 
part 117.) We received no comments that disagreed with this proposed 
provision and are finalizing it as proposed.

XXXVIII. Subpart D: Comments on Proposed Sec.  117.201--Modified 
Requirements That Apply to a Qualified Facility

    As previously discussed (78 FR 3646 at 3769), sections 418(l)(2)(A) 
and (B) of the FD&C Act provide that a qualified facility must submit 
two types of documentation to us. The first type of required 
documentation relates to food safety practices at the facility, with 
two options for satisfying this documentation requirement. Under the 
first option, the qualified facility may choose to submit documentation 
that demonstrates that it has identified potential hazards associated 
with the food being produced, is implementing preventive controls to 
address the hazards, and is monitoring the preventive controls to 
ensure that such controls are effective. Alternatively, under the 
second option, the qualified facility may choose to submit 
documentation (which may include licenses, inspection reports, 
certificates, permits, credentials, certification by an appropriate 
agency (such as a State department of agriculture), or other evidence 
of oversight), that the facility is in compliance with State, local, 
county, or other applicable non-Federal food safety law. The second 
type of required documentation relates to whether the facility 
satisfies the definition of a qualified facility.
    If a qualified facility does not prepare documentation 
demonstrating that it has identified potential hazards associated with 
the food being produced, is implementing preventive controls to address 
the hazards, and is monitoring the preventive controls to ensure that 
such controls are effective, it must provide notification to consumers 
of certain facility information by one of two procedures, depending on 
whether a food packaging label is required on the food.
    Consistent with the statutory direction of section 418(l) of the 
FD&C Act, we proposed the following modified requirements for qualified 
facilities: (1) Submission of certain documentation (proposed Sec.  
117.201(a)); (2) procedures for submission of the documentation 
(proposed Sec.  117.201(b)); (3) the frequency of the submissions 
(proposed Sec.  117.201(c)); (4) notification to consumers in certain 
circumstances (proposed Sec.  117.201(d)); and (5) applicable records 
that a qualified facility must maintain.
    In the 2013 proposed human preventive controls rule, we tentatively 
concluded that a certified statement would be acceptable for the 
purposes of satisfying the submission requirements of proposed Sec.  
117.201(a). We also requested comment on the efficiency and 
practicality of submitting the required documentation using the 
existing mechanism for registration of food facilities, with added 
features to enable a facility to identify whether or not the facility 
is a qualified facility.
    Some comments support one or more of the proposed requirements 
without change. For example, some comments state that our proposed 
interpretation of the statutory term ``business address'' is consistent 
with our use of the term ``business address'' in our regulations 
regarding information that must be included in a prior notice for 
imported food (21 CFR 1.281). Some comments that support the proposed 
provisions suggest alternative or additional regulatory text (see, 
e.g., Comment 587 through Comment 589, Comment 591 through Comment 593, 
and Comment 596 through Comment 598) or ask us to clarify how we will 
interpret the provision (see, e.g., Comment 572 and Comment 579 through 
Comment 585).
    In this section, 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. We also address comments 
discussing our tentative conclusion regarding the submission of 
certified statements to FDA, including submitting certified statements 
using the existing mechanism for registration of food facilities. After 
considering these comments, we have revised the proposed requirements 
as shown in

[[Page 56073]]

table 40, with editorial and conforming changes as shown in table 52.
    As discussed in Response 155, we have revised the definition of 
very small business to specify that it is based on an average (of sales 
plus market value of human food held without sale) during the 3-year 
period preceding the applicable calendar year and, as a companion 
change, we are explicitly requiring that a facility determine and 
document its status as a qualified facility on an annual basis (see 
Sec.  117.201(c)(1)).

               Table 40--Revisions to the Proposed Modified Requirements for Qualified Facilities
----------------------------------------------------------------------------------------------------------------
                 Section                          Description                           Revision
----------------------------------------------------------------------------------------------------------------
117.201(a)..............................  Documentation to be           Specify that the submitted
                                           submitted.                   documentation is an ``attestation.''
                                                                        Add ``tribal'' as an example of
                                                                        applicable non-Federal food safety law.
117.201(b)..............................  Procedure for submission...  Update details regarding the electronic
                                                                        and paper submission of a form specific
                                                                        to the attestation requirement.
117.201(c)..............................  Frequency of determination    New requirement to determine and
                                           and submission.              document status as a qualified facility
                                                                        on an annual basis no later than July 1
                                                                        of each calendar year.
                                                                        Specify that a facility that
                                                                        begins manufacturing, processing,
                                                                        packing or holding food after September
                                                                        17, 2018 must submit the attestation
                                                                        before beginning such operations.
                                                                        Specify that a facility must
                                                                        notify FDA of a change in status from
                                                                        ``not a qualified facility'' to
                                                                        ``qualified facility'' by July 31 of the
                                                                        applicable calendar year.
                                                                        Specify that when the status of
                                                                        a facility changes from ``qualified
                                                                        facility'' to ``not a qualified
                                                                        facility'' based on the annual
                                                                        determination, the facility must notify
                                                                        FDA of that change in status using Form
                                                                        3942a by July 31 of the applicable
                                                                        calendar year.
                                                                        Specify that the required
                                                                        biennial submissions of the attestations
                                                                        must be made during a timeframe that
                                                                        will coincide with the required biennial
                                                                        updates to facility registration.
117.201(d)..............................  Timeframe for compliance     When the status of a facility changes
                                           with the requirements of     from ``qualified facility'' to ``not a
                                           subparts C and G.            qualified facility,'' the facility must
                                                                        comply with subparts C and G no later
                                                                        than December 31 of the applicable
                                                                        calendar year unless otherwise agreed to
                                                                        by FDA and the facility.
117.201(e)..............................  Notification to consumers..  Conforming changes associated with the
                                                                        term ``attestation.''
117.201(f)..............................  Records....................  Conforming changes associated with the
                                                                        term ``attestation.''
----------------------------------------------------------------------------------------------------------------

A. Comments on Submission of a Certification Statement

    (Comment 572) Some comments ask us to clarify the distinction 
between the documentation that would be submitted to FDA and the 
records that a qualified facility relies on to support the submitted 
documentation.
    Some comments agree with our tentative conclusion to use certified 
statements to satisfy the proposed submission requirements, noting that 
it would save time and money and reduce the paperwork burden on 
qualified facilities. Some comments ask us to revise the proposed 
requirements to make this use of certified statements explicit in the 
regulatory text.
    Other comments disagree with our tentative conclusion to use 
certified statements to satisfy the submission requirements. These 
comments focus on the importance of actual copies of documents in 
determining compliance with the documentation requirements and assert 
that proof of qualification requires more than a checked box in an on-
line registration database. Some comments ask us to require that a 
qualified facility affirm that it has the original documents on file 
and available for FDA inspection. Other comments assert that requiring 
qualified facilities to submit copies of the actual documentation would 
enable us to easily review food safety plans or inspection reports and 
to target our compliance and enforcement activities to those qualified 
facilities that pose a greater risk because of inadequate prevention 
measures or deficient inspections.
    (Response 572) We are affirming our tentative decision that we will 
not require a qualified facility to submit to FDA, as part of its 
attestation, the underlying documentation that establishes its 
compliance. We agree that the underlying records are needed to 
determine compliance with the documentation requirements and that a 
qualified facility must retain the documents it is relying on to 
support its attestation and make them available to us during 
inspection. We also agree that the regulatory text needs to be explicit 
regarding the required documentation and that we need to clearly 
distinguish between the documentation that would be submitted to FDA 
and the records that a qualified facility relies on to support the 
submitted documentation. Therefore, we have made the following three 
revisions to the proposed regulatory text.
    First, we have revised proposed Sec.  117.201(a) to specify that 
the submitted documentation is an ``attestation.'' Second, we have 
revised proposed Sec.  117.201(b) to update details regarding the 
electronic and paper submission of a form specific to this attestation 
requirement. Third, we have revised proposed Sec.  117.201(e) (final 
Sec.  117.201(f)) to specify that you must maintain those records 
relied upon to support the ``attestations'' that are required by Sec.  
117.201(a).
    We acknowledge that requiring submission of the actual 
documentation would enable us to easily review food safety plans or 
inspection reports and to target our compliance activities based on 
information that we see in those food safety plans or inspection 
reports. However, as discussed in Response 384, we are not requiring 
that other facilities submit a ``facility profile'' that would allow us 
to more broadly review food safety plans and target our compliance 
activities based on information that we see in those food safety plans 
and will instead explore other mechanisms to achieve the goals we 
described in the 2013 proposed human preventive controls rule for a 
facility profile.

B. General Comments on Modified Requirements That Apply to a Qualified 
Facility

    (Comment 573) Some comments assert that the proposed modified 
requirements would create a costly burden for qualified facilities 
(e.g.,

[[Page 56074]]

registering and making submissions to FDA) that would not be imposed on 
other types of exempted facilities. Some of these comments question 
whether the exemption for qualified facilities is meaningful in light 
of the significant burden imposed by the proposed modified 
requirements. Some comments contrast the proposed modified requirement 
for qualified facilities to submit documentation to FDA with proposed 
requirements for all other facilities to simply establish and maintain 
applicable records.
    (Response 573) The submission requirements that we are establishing 
in this rule for qualified facilities reflect the statutory framework 
for qualified facilities (section 418(l)(2)(B) of the FD&C Act). 
Although the submission requirements only apply to qualified 
facilities, the reporting burden associated with submission of an 
attestation is much lower than the recordkeeping burden for facilities 
that are subject to the requirements for hazard analysis and risk-based 
preventive controls (see section LXI).
    (Comment 574) Some comments ask us to minimize setting different 
standards even though the modified requirements reflect express 
statutory provisions.
    (Response 574) These comments appear to be referring to the 
statutory provisions of section 418(n)(3)(C) of the FD&C Act, which 
specify that the regulations we establish to implement section 418 of 
the FD&C Act acknowledge differences in risk and minimize, as 
appropriate, the number of separate standards that apply to separate 
foods. We disagree that the statutory provisions of section 
418(n)(3)(C) are directly relevant to the submission requirements of 
this rule for qualified facilities. The requirements for qualified 
facilities, but not other facilities, to submit documentation to FDA 
reflect different regulatory requirements. The different regulatory 
requirements are directed at different facilities, and do not set 
separate standards for particular foods. Regardless, even if the 
statutory provisions of section 418(n)(3)(C) were relevant to the 
submission requirements of qualified facilities, provisions of this 
rule that reflect express statutory provisions would not conflict with 
the statutory direction in section 418(n)(3)(C).
    (Comment 575) Some comments ask us to implement the same labeling 
requirements that we proposed to establish for farms that would be 
eligible for a ``qualified exemption'' in the proposed produce safety 
rule, noting that such labeling requirements would allow us to trace 
food produced by the facility back through the supply chain if there is 
a problem.
    (Response 575) The rule does include a labeling requirement 
analogous to the applicable labeling requirement in the proposed 
produce safety rule (see Sec.  117.201(e)). However, that labeling 
requirement only applies to one of the two options that a qualified 
facility has for satisfying the submission requirements (see Sec.  
117.201(a)(2) and (e)). Specifically, a labeling requirement applies if 
the qualified facility chooses to attest that it is in compliance with 
applicable non-Federal food safety laws (Sec.  117.201(a)(2)(ii) and 
(e)). However, the labeling requirement does not apply if the qualified 
facility chooses to attest that it has identified the potential hazards 
associated with the food being produced, is implementing preventive 
controls to address the hazards, and is monitoring the performance of 
the preventive controls to ensure that such controls are effective 
(Sec.  117.201(a)(2)(i)). The difference between the requirements of 
the human preventive controls rule and the proposed produce safety rule 
reflect differences in the distinct statutory provisions governing the 
two rules.
    (Comment 576) Some comments emphasize that the modified 
requirements need to ensure adequate protection of public health and 
state that we should maintain and exercise oversight of qualified 
facilities. Some comments ask that we provide enough specificity so 
that qualified facilities know and understand their food safety 
responsibilities towards consumers.
    (Response 576) A facility that satisfies criteria to be a qualified 
facility continues to be responsible to produce food that will not be 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403 of the FD&C Act. Such a facility is also subject to the 
requirements of section 421 of the FD&C Act regarding frequency of 
inspection of all facilities and to the new administrative tools 
provided by FSMA, such as for suspension of registration (section 415 
of the FD&C Act) and for mandatory recall (section 423 of the FD&C 
Act). As discussed in Response 151, we expect that most qualified 
facilities will be subject to the CGMP requirements of subpart B. As we 
do now, we will continue to inspect these facilities for compliance 
with those CGMP requirements.
    (Comment 577) Some comments ask which exemption a farm mixed-type 
facility should follow if it satisfies criteria for a qualified 
facility (Sec.  117.5(a)), as well as criteria for a very small 
business that only conducts on-farm low-risk activity/food combinations 
(specified in Sec.  117.5(g) and (h)).
    (Response 577) We describe these comments in more detail in Comment 
202. As discussed in Response 202, 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 (h) may find it advantageous 
to classify itself as a very small business eligible for the exemption 
in Sec.  117.5(g) and (h) (which is not subject to the modified 
requirements in Sec.  117.201) rather than as a qualified facility 
(which is subject to the modified requirements in Sec.  117.201).
    (Comment 578) Some comments express concern about State access to 
the records that a qualified facility maintains to support its 
attestations, particularly when a State would conduct an inspection for 
compliance with part 117 under contract to FDA. These comments express 
concern about the time and resources necessary to verify the status of 
a facility as a qualified facility and note that previous mechanisms 
whereby we provide information to States in advance of inspection have 
been slow. These comments also express concern that if the State must 
verify the ``qualified facility'' status of all firms, including those 
that are not FDA contracts, this could delay their ability to conduct 
timely inspections and increase inspection time, reducing the number of 
inspections conducted.
    (Response 578) We are sensitive to the time required for various 
inspection activities and intend to communicate with States regarding 
our expectations for how to verify whether a facility is a qualified 
facility.
    (Comment 579) Some comments point out that the proposed procedures 
for submission are silent on the process and timeframe for our review 
and approval of the submitted documentation and ask us to clarify this 
process and timeframe. Other comments ask us to clarify the 
consequences to a facility if its submission is found to be 
insufficient.
    (Response 579) We will not be approving the submitted attestations. 
Instead, we intend to use the information to determine whether the 
facility should be inspected for compliance with the requirements for 
hazard analysis and risk-based preventive controls, or for compliance 
with the modified requirements. During the inspection, we would ask to 
see the records that the facility maintains to support any submitted 
attestations.
    (Comment 580) Some comments ask us to clarify whether a foreign 
facility would need to submit documentation of

[[Page 56075]]

its status as qualified facility. These comments note that a foreign 
facility also would be required to provide information to an importer 
and assert that submitting information to both FDA and an importer 
would be a duplication of effort. These comments ask us to allow a 
foreign facility that is a qualified facility to submit information to 
either FDA or the importer, rather than to both FDA and the importer.
    (Response 580) We decline this request. Documentation submitted to 
an importer would not reach FDA and, thus, could not satisfy the 
requirements of this rule. As discussed in Response 572, we are 
requiring submission of an attestation, on a form that can be submitted 
either electronically or on paper, rather than submission of the 
underlying information.

C. Proposed Sec.  117.201(a)--Documentation To Be Submitted

1. Proposed Sec.  117.201(a)(1)--Documentation That the Facility Is a 
Qualified Facility
    We proposed that a qualified facility must submit documentation 
that the facility is a qualified facility. We also proposed that for 
the purpose of determining whether a facility satisfies the definition 
of a qualified facility, the baseline year for calculating the 
adjustment for inflation is 2011. As discussed in Response 572, we have 
revised the provision to specify that the documentation that must be 
submitted is an attestation.
    (Comment 581) Some comments ask us to clarify the documentation 
required to certify that an operation is a qualified facility. Some 
comments ask us to explicitly state that the documentation must include 
financial and sales records of the business and its subsidiaries or 
affiliates. Some comments ask us to clarify the types of records that 
would be required to be submitted by foreign establishments to support 
the classification of a foreign establishment as a ``qualified 
facility.''
    (Response 581) The submission to FDA will be an attestation rather 
than the records that the qualified facility relies on to support the 
attestation; however, you must maintain those records relied upon to 
support the ``attestations'' (see Sec.  117.201(f)). As previously 
discussed, consistent with section 418(l)(2)(B)(ii) of the FD&C Act we 
intend to issue guidance on the records that a facility could retain to 
demonstrate that it is a qualified facility (78 FR 3646 at 3770). 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 the $1,000,000 threshold adjusted for inflation, 
during the 3-year period preceding the applicable calendar year) 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 expect that financial records 
demonstrating that a business is a very small business will be less 
burdensome for a qualified facility to maintain and require fewer 
resources for FDA to review.
    (Comment 582) Some comments ask whether documentation demonstrating 
that a facility is a qualified facility must be prepared by a 
``preventive controls qualified individual'' as that term is defined in 
Sec.  117.3.
    (Response 582) The rule does not require that documentation 
demonstrating that a facility is a qualified facility be prepared by a 
``preventive controls qualified individual.''
    (Comment 583) Some comments ask how the adjustment for inflation 
will be calculated and how regulators such as the States will get this 
information.
    (Response 583) We intend to use the Federal calculation for the 
Gross Domestic Product price deflator, as provided by the Bureau of 
Economic Analysis, to adjust for inflation. We will make the inflation-
adjusted dollar value to the baseline very small business sales cut-
offs (e.g., $1,000,000 in 2011) available on our Internet site. We will 
update the values for the very small business exemptions and 
qualifications annually using this calculation.
2. Proposed Sec.  117.201(a)(2)(i)--First Option for Documentation: 
Food Safety Practices
    We proposed two options for satisfying the statutory documentation 
requirement in section 418(l)(2)(B)(i) of the FD&C Act. Under the first 
option (the food safety practices option), a qualified facility could 
submit documentation demonstrating that it has identified the potential 
hazards associated with the food being produced, is implementing 
preventive controls to address the hazards, and is monitoring the 
performance of the preventive controls to ensure that such controls are 
effective. As discussed in Response 572, we have revised the provision 
to specify that the submission is an attestation.
    (Comment 584) Some comments assert that the rule is vague about 
what the applicable documentation should include and how exhaustive it 
should be. Some comments ask whether documentation (such as a food 
safety plan) must address all operations at the establishment or only 
those that trigger the registration of the establishment as a facility. 
Some comments ask us to clarify the difference between having 
documentation to support food safety practices and attesting that the 
facility has such documentation. Other comments ask whether a qualified 
facility would need to have records documenting a risk analysis and 
monitoring.
    (Response 584) If a qualified facility submits an attestation 
regarding its food safety practices, the documentation that the 
facility maintains for review during inspection must specify that the 
facility has identified the potential hazards associated with the food 
being produced, is implementing preventive controls to address the 
hazards, and is monitoring the performance of the preventive controls 
to ensure that such controls are effective (see Sec.  
117.201(a)(2)(i)). For example, a qualified facility that produces one 
or more nut butters might have documentation specifying that it has 
determined that Salmonella is a hazard requiring a preventive control, 
describing the roasting process that will control Salmonella, 
describing sanitation controls to prevent contamination of the nut 
butters with Salmonella, and describing an environmental monitoring 
program to verify that its sanitation controls are effective. Likewise, 
a qualified facility that prepares cooked soups that require 
refrigeration for safety might have documentation specifying that it 
has determined that Salmonella is a hazard requiring a preventive 
control and supporting the temperature and time used in a thermal 
process to kill Salmonella, with temperature controls for safety and 
procedures for monitoring the temperature controls. A qualified 
facility that makes pickles might have documentation specifying that 
the hazard requiring a preventive control is C. botulinum, specifying 
the final equilibrium pH (of the pickled cucumbers) that is controlling 
the hazard, and demonstrating its monitoring of the pH during the 
production process.
    As discussed in Response 572, a qualified facility that chooses the 
food safety practices option for complying with the submission 
requirements of this rule will attest to that by checking a statement 
on a form. In contrast, a food safety plan (or other documentation) 
that the qualified

[[Page 56076]]

facility relies on to support the attestation will be a record subject 
to the recordkeeping requirements of subpart F.
    (Comment 585) Some comments ask us to clarify whether the 
submission requirement addresses compliance with the CGMP requirements 
of subpart B.
    (Response 585) The submission requirement does not address 
compliance with the CGMP requirements of subpart B.
3. Proposed Sec.  117.201(a)(2)(ii)--Second Option for Documentation: 
Compliance With Other Applicable Non-Federal Food Safety Law
    Under the second option for satisfying the statutory documentation 
requirement, a qualified facility could submit documentation that it is 
in compliance with State, local, county, or other applicable non-
Federal food safety law, including relevant laws and regulations of 
foreign countries. As discussed in Response 572, we have revised the 
provision to specify that the submission is an attestation. We also 
have revised the provision to add ``tribal'' as an example of 
applicable non-Federal food safety law to clarify for purposes of this 
rule that a qualified facility could submit an attestation that it is 
in compliance with tribal food safety law.
    (Comment 586) Some comments object to the proposed provision. These 
comments point out that State and local requirements are inconsistent 
and assert that such requirements are not sufficiently rigorous to 
substitute for the FSMA requirement to conduct a hazard analysis and 
establish and execute a documented food safety plan.
    (Response 586) The provision reflects the express statutory 
direction of section 418(l)(2)(B)(i)(II) of the FD&C Act. See Response 
576.
    (Comment 587) Some comments ask us to specify that a qualified 
facility must document its compliance with the food safety laws of the 
State where its products are sold.
    (Response 587) We decline this request. We interpret section 
418(l)(2)(B)(i)(II) of the FD&C Act to apply to the State where a 
qualified facility is located. This is consistent with how States 
conduct inspections.
    (Comment 588) Some comments ask us to specify that a qualified 
facility must document compliance with all applicable non-Federal food 
safety laws.
    (Response 588) We decline this request. Section 418(l)(2)(B)(i)(II) 
of the FD&C Act refers to compliance with ``State, local, county or 
other applicable non-Federal food safety law'' (emphasis added).
    (Comment 589) Some comments ask us to revise the proposed provision 
to make clear that a facility could submit an applicable attestation if 
the facility is subject to a State or local ``cottage food'' law (laws 
allowing sale of certain food from home kitchens). These comments 
explain that some cottage food laws do not require State or local 
authorities to inspect a facility or otherwise document that the 
facility is in compliance with the cottage food law. In addition, under 
some of these cottage food laws a facility would not have documentation 
such as a license to support its compliance with food safety 
requirements. Some of these comments ask us to revise the proposed 
provision to specify that a facility could rely on a copy of the 
relevant State law or regulation and a letter from the facility stating 
that it complies with that law or regulation, or certification by an 
appropriate agency (such as a State department of agriculture).
    (Response 589) As discussed in Response 572, we have revised the 
regulatory text.to provide for qualified facilities to submit an 
attestation that the facility is in compliance with State, local, 
county, or other applicable non-Federal food safety law. During an 
inspection, we expect the facility to be able to show us how the 
facility is complying with the applicable food safety regulation 
(including relevant licenses, inspection reports, certificates, 
permits, credentials, or certifications), and producing safe food.
    (Comment 590) Some comments ask us to provide resources to the 
States to implement the proposed provision. These comments also ask us 
to develop and implement a strategic plan to provide resources (e.g., 
training, guidance) to State and local inspection agencies in advance 
of the anticipated increased burden on State and local inspection 
programs that will be created by the provision.
    (Response 590) We do not believe that specific training for State 
or other government counterparts is necessary for the purposes of 
inspecting a qualified facility that attested to having documentation 
from a non-Federal regulatory authority. The State or other government 
counterpart would merely examine applicable documentation (such as a 
license, inspection report, certificate, permit, credentials, or 
certification by an appropriate agency (such as a State department of 
agriculture), which is specified in the provision. After inspecting 
such documentation, the State or other government counterpart would 
focus on inspection for compliance with CGMPs, as it has done in the 
past.

D. Proposed Sec.  117.201(b)--Procedure for Submission

    We proposed that the documentation must be submitted to FDA either 
electronically or by mail. As discussed in Response 572, we have 
revised the regulatory text to update details regarding the electronic 
and paper submission of a specific form. We are developing paper and 
electronic versions of Form FDA 3942a, which is an information 
collection provision that is subject to review by OMB under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We intend to 
make the paper Form FDA 3942a available in the near future and invite 
comments consistent with procedures for approval of the form by OMB.
    (Comment 591) Some comments recommend that any interface for 
electronic submission of certification statements post adequate notice 
of requirements the facility must meet and warnings detailing potential 
penalties (e.g., for fraudulent submission).
    (Response 591) We intend that the electronic submission system will 
operate in a manner similar to the existing electronic submission 
system for registration of food facilities, including a certification 
statement advising the person signing the form that, under 18 U.S.C. 
1001, anyone who makes a materially false, fictitious, or fraudulent 
statement to the U.S. Government is subject to criminal penalties. We 
intend to include a similar certification statement on paper forms that 
will be available for qualified facilities that choose to submit by 
paper rather than through the electronic system. The electronic and 
paper submission forms will focus on the attestation statements rather 
than on other requirements that the facility is subject to. The Small 
Entity Compliance Guide that we will issue in accordance with section 
212 of the Small Business Regulatory Enforcement Fairness Act (Public 
L. 104-121) will be better suited to helping qualified facilities 
understand the requirements of the rule than information presented on a 
submission form.

E. Proposed Sec.  117.201(c)--Frequency of Determination and Submission

    We proposed that the documentation must be: (1) Submitted to FDA 
initially within 90 days of the applicable compliance date; and (2) 
resubmitted at least every 2 years, or whenever there is a material 
change to the information applicable to determining the status of a 
facility.
    (Comment 592) Some comments assert that the proposed timeframe of 
90

[[Page 56077]]

days to submit the required documentation would not provide sufficient 
time to gather and submit the required documentation and ask us to 
extend the timeframe--e.g., to 120 or 180 days.
    (Response 592) We are retaining the proposed timeframe for the 
initial submission (within 90 days of the applicable compliance date). 
The only documentation that the qualified facility will need to submit 
is an attestation, which does not need to be gathered. Importantly, 
however, documentation supporting the attestation must be available for 
inspection by September 17, 2018. As discussed in Response 155 the 
compliance date for a facility to retain records to support its status 
as a qualified facility is January 1, 2016. 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)).
    In addition, we have revised proposed Sec.  117.201(c)(1) (which we 
are finalizing as Sec.  117.201(c)(2)(i)(A), (B), and (C)) to specify 
the timeframe for the initial submission for three distinct 
circumstances: (1) By December 17, 2018, for a facility that begins 
manufacturing, processing, packing or holding food before September 17, 
2018; (2) Before beginning operations, for a facility that begins 
manufacturing, processing, packing or holding food after September 17, 
2018; or (3) By July 31 of the applicable calendar year, when the 
status of a facility changes from ``not a qualified facility'' to 
``qualified facility'' based on the annual determination required by 
paragraph (c)(1) of this section. See the discussion in Response 155 
regarding the approach we intend to take in a number of circumstances 
that could lead to a facility having records to support its status as a 
qualified facility for fewer than 3 preceding calendar years.
    We have revised the provision to specify that the required biennial 
submissions of the attestations must be made during a timeframe that 
will coincide with the required biennial updates to facility 
registration (See section 102 of FSMA)--i.e., during the period 
beginning on October 1 and ending on December 31, beginning in 2020. In 
determining that 2020 would be the first year for the required biennial 
submissions of the attestations, we first considered that the first 
submission of an attestation would be approximately December 2018 for 
qualified facilities that are operating as of the date of this final 
rule (i.e., approximately 90 days after the date of publication of this 
rule). For qualified facilities that do not begin operations until 
after December 2018, the first biennial submission will be required in 
a timeframe less than two years, but once the qualified facility has 
made its first submission the subsequent biennial submissions will all 
be at two-year intervals. Coordinating the biennial submissions of the 
required attestations with the biennial registration will reduce the 
cumulative economic impact on the food industry of complying with two 
separate requirements because qualified facilities that choose to 
submit electronically will be able to submit electronically while 
accessing the same electronic portal used for facility registration. 
This approach is consistent with our approach to food labeling 
requirements, where we establish a Uniform Compliance Date (see, e.g., 
79 FR 73201, December 10, 2014).
    (Comment 593) Some comments ask us to include an option within the 
system to notify us when a facility's status as a ``qualified 
facility'' changes--e.g., because its business expands or changes.
    (Response 593) Notifying us when there is a change in the 
facility's status from ``qualified facility'' to ``not a qualified 
facility'' is a requirement rather than an option. We included this 
requirement in the proposed rule, and are establishing it in this final 
rule. We made editorial changes to the provision to make this clearer.
    We also established a series of dates associated with the 
facility's change in status from ``qualified facility'' to ``not a 
qualified facility.'' First, we are specifying that when the status of 
a facility changes from ``qualified facility'' to ``not a qualified 
facility'' based on the required annual determination, the facility 
must notify FDA of that change in status using Form 3942a by July 31 of 
the applicable calendar year (see Sec.  117.201(c)(3)). We have 
provided the facility with flexibility to wait until July 1 of a given 
calendar year to determine whether its status changes (see Sec.  
117.201(c)(1)); 30 days is an adequate timeframe to submit the form 
notifying us of the change in status.
    Second, we are specifying that when the status of a facility 
changes from ``qualified facility'' to ``not a qualified facility,'' 
the facility must comply with subparts C and G no later than December 
31 of the applicable calendar year unless otherwise agreed to by FDA 
and the facility (see Sec.  117.201(d)). In essence, this provision can 
provide a facility with up to a full year to comply with the full 
requirements for hazard analysis and risk-based preventive controls 
when the facility determines its change in status early in the calendar 
year. A facility that does not determine that change in status until 
the required date of July 1 would still have 6 months to comply with 
the full requirements for hazard analysis and risk-based preventive 
controls. As we have done in the case of a qualified exemption being 
withdrawn (see Sec.  117.257(d)(1)), we are providing flexibility for a 
facility to comply in an alternative timeframe if agreed to by FDA and 
the facility.
    (Comment 594) Some comments ask us to specify that the required 
attestations be submitted annually rather than every 2 years. These 
comments assert that annual submission would be consistent with the 
statutory provisions that determine eligibility for status as a 
qualified facility based on sales, which will vary each year. These 
comments also assert that using the current mechanism for registration 
of food facilities would not be burdensome and would provide us with 
assurances that only facilities that satisfy criteria to be a qualified 
facility will operate under the modified requirements, thereby 
minimizing risk to public health.
    Other comments ask us to specify that the required attestations be 
submitted every 5 years rather than every 2 years. These comments 
assert that doing so would be consistent with the statutory direction 
of section 201 of FSMA (Targeting of Inspection Resources) for non-high 
risk food facilities. These comments also assert that we did not 
provide specific reasons for the proposed 2 year timeframe and that re-
submitting the attestations every two years will increase cost in time 
and labor.
    (Response 594) We decline both of these requests. The rule already 
requires resubmission whenever there is a material change to the 
information that changes the status of a facility as a qualified 
facility. Therefore, if the facility's sales change its status, so that 
it is no longer a qualified facility, the rule requires that facility 
to notify us when its status changes. (Note that the definition of very 
small business established in this rule is based on an average (of 
sales plus market value of human food held without sale) during the 3-
year period preceding the applicable calendar year, rather than on 
annual sales plus market value. See Response 155.) A biennial 
submission is adequate to otherwise require a qualified facility to 
affirmatively attest that it continues to satisfy the criteria for 
being a qualified facility. A biennial submission is not overly 
burdensome, because a facility can coordinate its biennial submission 
with its biennial update to its facility registration. The suggested 5-
year submission based on

[[Page 56078]]

the targeted inspection frequency for non-high risk food facilities 
implies that all qualified facilities produce such foods, which is not 
the case.

F. Proposed Sec.  117.201(d)--Notification to Consumers (Final Sec.  
117.201(e))

    We proposed that a qualified facility that does not submit 
documentation of its food safety practices must provide notification to 
consumers as to the name and complete business address of the facility 
where the food was manufactured or processed (including the street 
address or P.O. box, city, state, and zip code for domestic facilities, 
and comparable full address information for foreign facilities).
    (Comment 595) Some comments assert that the proposed requirement 
exceeds what is already present for food in packaged form (21 CFR 
101.5), and that these differences will create confusion for regulators 
and producers alike, with added costs but no food safety benefits. Some 
comments assert that the proposed requirement will likely cause 
consumer confusion at point of purchase and may discourage retail and 
food service buyers from receiving products from qualified facilities. 
Some comments ask us to specify that when a food packaging label is 
required, the required information must appear prominently and 
conspicuously on the label in compliance with Sec.  101.5.
    (Response 595) We decline these requests. The requirement for 
notification to consumers is mandated by section 418(l)(7)(A) of the 
FD&C Act. The labeling requirements applicable to packaged foods (Sec.  
101.5) are established under a different statutory provision than the 
labeling requirements applicable to qualified facilities (i.e., under 
section 403(e) of the FD&C Act (21 U.S.C. 343(e)) rather than section 
418(l)(7) of the FD&C Act). The comments provide no explanation of the 
basis for their assertion that these differences will create confusion 
for consumers at point of purchase or discourage retail and food 
service buyers from receiving products from qualified facilities. As 
previously discussed (78 FR 3646 at 3771), the use of the term 
``business address'' in section 418(l)(7) of the FD&C Act contrasts 
with Congress' use of a different term, ``place of business,'' in 
section 403(e) of the FD&C Act. These comments do not address the 
reasons we previously discussed for our tentative conclusion that the 
use of the term ``business address'' in section 418(l)(7) demonstrates 
Congress' intent to require the facility's full address, including the 
street address or P.O. box, to appear on labels or other required 
notifications when the facility has opted to not submit documentation 
directed to food safety practices. In this document, we are affirming 
that tentative conclusion. As discussed in section LVI.A, we are 
establishing January 1, 2020, as the date when a qualified facility 
that is subject to the notification requirements of Sec.  117.201(e)(1) 
must notify consumers of the complete business address of the facility 
where the food was manufactured or processed.

G. Proposed Sec.  117.201(e)--Records (Final Sec.  117.201(f))

    We proposed that a qualified facility must maintain those records 
relied upon to support the required documentation. We also proposed 
that the records that a qualified facility must maintain would be 
subject to the requirements that would be established in subpart F of 
this rule. As discussed in Response 572, after considering comments we 
have revised the rule to specify that a qualified facility must 
maintain those records relied upon to support the required attestations 
(rather than the required documentation).
    (Comment 596) Some comments ask us to explicitly specify that we 
have access to documents that establish a facility as a qualified 
facility. Some comments assert that a facility may reasonably assume 
that records such as financial records would not be available to us 
because such records are excluded from the records that we have access 
to under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act), as provided by Sec.  
1.362.
    (Response 596) The rule explicitly specifies that we have access to 
records that are required by the rule (see Sec.  117.320). If a 
facility relies on financial records to demonstrate its status as a 
qualified facility, we will have access to those financial records. The 
exemption referred to by the comments for financial records (Sec.  
1.362) is narrowly targeted to records required by the section 414 
recordkeeping regulations and does not apply to records required by 
this human preventive controls rule.
    (Comment 597) Some comments ask us to revise the rule to define 
documentation as the actual records or true copies of the actual 
records.
    (Response 597) The rule explicitly specifies that the records a 
qualified facility relies on to support the required attestations must 
be actual records, true copies, or electronic records. However, it does 
so by requiring that the records that a qualified facility must 
maintain are subject to the requirements in subpart F (see Sec.  
117.305(a)), which specifies that these requirements apply to all 
records required by this rule, rather than by specifying these 
requirements within the provisions directed to modified requirements 
for qualified facilities.
    (Comment 598) Some comments ask us to include a new section in 
subpart F to cover additional requirements applying to the records that 
a qualified facility must keep and make available to FDA upon request. 
These comments assert that such a section is necessary to ensure that 
qualified facilities understand their obligations. These comments also 
assert that clarity is needed in light of the nature of the financial 
records that would be required to support the facility's status as a 
qualified facility.
    (Response 598) We decline this request. As discussed in Response 
581, consistent with section 418(l)(2)(B)(ii) of the FD&C Act we intend 
to issue guidance on the records that a facility could retain to 
demonstrate that it is a qualified facility rather than specify these 
records in the human preventive controls rule. Section 117.201(f) 
already specifies that a qualified facility must maintain those records 
relied upon to support the required attestations. There is no need to 
repeat this requirement in subpart F, which establishes general 
requirements for all records required by the rule but does not specify 
those records required to demonstrate compliance with particular 
requirements of the rule.

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

    We proposed that if your facility is solely engaged in the storage 
of unexposed packaged food, you must conduct certain activities for any 
such refrigerated packaged food that requires time/temperature control 
to significantly minimize or prevent the growth of, or toxin production 
by, microorganisms of public health significance. We requested comment 
on the proposed list of modified requirements. Some comments that 
support the proposed provisions suggest alternative or additional 
regulatory text (see, e.g., Comment 599, Comment 600, Comment 604, 
Comment 606, Comment 608, and Comment 610) or ask us to clarify how we 
will interpret the provision (see, e.g., Comment 601 and Comment 602).
    In this section, we discuss comments that ask us to clarify the 
proposed

[[Page 56079]]

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 41.

Table 41--Revisions to the Proposed Modified Requirements for Unexposed,
                       Refrigerated, Packaged Food
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.206(a)....................  Circumstances      Clarify that the
                                 that make a        requirements apply
                                 facility subject   to a temperature
                                 to the modified    control area in a
                                 requirements for   facility that holds
                                 unexposed,         TCS food rather than
                                 refrigerated       to each product in
                                 packaged food.     the holding
                                                    facility.
117.206(a)(3).................  Modified           Clarify that
                                 requirements for   corrective actions
                                 corrective         need only be taken
                                 actions.           when a loss of
                                                    temperature control
                                                    may impact the
                                                    safety of the TCS
                                                    food.
117.206(a)(4)(i)..............  Modified           Provide additional
                                 requirements for   flexibility for
                                 verification of    accuracy checks, in
                                 temperature        addition to
                                 controls.          calibration, to
                                                    verify that
                                                    temperature controls
                                                    are consistently
                                                    implemented.
117.206(a)(4)(iii)............  Modified           Provide additional
                                 requirements for   flexibility for
                                 verification of    reviewing records of
                                 temperature        monitoring and
                                 controls.          corrective actions
                                                    either within a week
                                                    after the records
                                                    are made or within a
                                                    reasonable
                                                    timeframe.
117.206(a)(5)(i)..............  Records            Provide additional
                                 documenting the    flexibility for
                                 monitoring of      records documenting
                                 temperature        the monitoring of
                                 controls.          temperature controls
                                                    to be kept either as
                                                    affirmative records
                                                    demonstrating
                                                    temperature is
                                                    controlled or as
                                                    exception records
                                                    demonstrating loss
                                                    of temperature
                                                    control.
117.206(a)(5)(ii).............  Records            Conforming change
                                 documenting        associated with the
                                 corrective         modified
                                 actions.           requirements for
                                                    corrective actions
                                                    to clarify that
                                                    records of
                                                    corrective actions
                                                    are required when
                                                    there is a loss of
                                                    temperature control
                                                    that may impact the
                                                    safety of the TCS
                                                    food.
------------------------------------------------------------------------

A. Proposed Sec.  117.206(a)--Modified Requirements for Unexposed 
Refrigerated Packaged Food That Requires Time/Temperature Controls

1. Proposed Sec.  117.206(a)(1)--Establish and Implement Temperature 
Controls
    We proposed that if your facility is subject to the modified 
requirements, you must establish and implement temperature controls 
adequate to significantly minimize or prevent the growth of, or toxin 
production by, microorganisms of public health significance.
    We also tentatively concluded that it would be rare for a facility 
solely engaged in the storage of unexposed packaged food to not have 
information regarding whether a refrigerated packaged food is a TCS 
food and, if so, what specific temperature controls are necessary for 
safe storage of the food. We requested comment on this tentative 
conclusion.
    (Comment 599) Some comments ask us to clarify that the requirement 
to establish and implement temperature controls applies to temperature 
control areas in a facility rather than to each product in a facility.
    (Response 599) We agree that the requirement to establish and 
implement temperature controls applies to temperature control areas in 
a facility rather than to each product in a facility. To make this 
clearer, we have revised the proposed requirement to clarify that the 
facility must conduct activities as appropriate to ensure the 
effectiveness of the temperature controls rather than conduct 
activities ``for any such refrigerated packaged food.''
    (Comment 600) Some comments disagree with our tentative conclusion 
that it would be rare for a facility solely engaged in the storage of 
unexposed packaged food to not have information regarding whether a 
refrigerated packaged food is a TCS food and, if so, what specific 
temperature controls are necessary for safe storage of the food. These 
comments ask us to specify that the responsibility for determining 
whether a food is a TCS food falls to the manufacturer of the food 
rather than the warehouse storing the food, because the warehouse 
merely provides a service. Other comments note that the food product 
owners determine the optimal conditions for storage of their products 
based on their own hazard analysis and preventive controls, and that 
the food product owners can simply communicate those requirements to 
the warehouses that will store the products.
    (Response 600) In this type of circumstance, it is appropriate for 
the manufacturer of the food to share the responsibility with the 
warehouse for proper storage of the food. The various provisions of 
section 418 of the FD&C act explicitly place the responsibility for 
complying with the requirements for hazard analysis and risk-based 
preventive controls, including modified requirements, on the owner, 
operator, or agent in charge of a facility and, thus, a facility that 
is a warehouse is responsible for its own food safety plan. Regardless, 
the manufacturer also has responsibilities under section 418 of the 
FD&C Act to determine the storage conditions necessary for food safety 
and to take steps to ensure that the food is stored under conditions 
that will ensure its safety.
    It is not necessary to specify this joint responsibility for 
determining storage conditions in the rule, because the rule already 
clearly specifies that its provisions apply to persons who manufacture/
process food, as well as to persons who hold food. Both the warehouse 
and the manufacturer have flexibility in determining how to comply with 
the rule, including the specific mechanism whereby the warehouse would 
receive information about storage of a food product from the 
manufacturer or owner of the product. Moreover, a citizen petition 
submitted to FDA [Docket No. FDA-2011-P-0561], in requesting an 
exemption or modified requirements for facilities solely engaged in the 
storage of unexposed packaged foods, asserts that such facilities work 
closely with food manufacturers to understand the conditions and 
controls needed to ensure the quality of the foods they store and 
distribute and that manufacturers appropriately instruct the warehouses 
to ensure packaged products are being properly stored (78 FR 3646 at 
3712).
    (Comment 601) Some comments ask us to clarify which facility--the 
shipping facility or the receiving facility--will be responsible for 
ensuring that temperature control is maintained during transportation 
of TCS foods.

[[Page 56080]]

    (Response 601) See Response 423, which notes our intention to 
address comments regarding the responsibilities of shippers and 
receivers in the final sanitary transportation rule.
2. Proposed Sec.  117.206(a)(2)--Monitor the Temperature Controls
    We proposed that if your facility is subject to the modified 
requirements, you must monitor the temperature controls with sufficient 
frequency to provide assurance they are consistently performed. We 
requested comment on whether there would be a benefit to requiring a 
facility to develop written procedures for monitoring temperature.
    (Comment 602) Some comments ask us to explain in the preamble of 
the final rule that we will accept monitoring systems that provide 
exception reports to satisfy the modified requirements. The comments 
describe exception reporting as a structure where automated systems are 
designed to alert operators and management when the monitoring system 
observes a deviation from an established limit. These comments assert 
that monitoring of preventive controls by automated systems can be more 
efficient than monitoring by personnel, and can eliminate human error.
    (Response 602) See also Response 468 and Response 610. We have 
revised the recordkeeping provisions of these modified requirements to 
provide that the temperature monitoring records for the modified 
requirements may be kept either as affirmative records demonstrating 
temperature is controlled or as exception records demonstrating loss of 
temperature control. Although the comments explicitly ask us to provide 
a clarification in the preamble of this rule, we decided the 
clarification within the regulatory text would be clearer to facilities 
that are subject to the requirements, as well as to investigators who 
will be inspecting facilities for compliance with the rule.
    (Comment 603) Some comments state that written procedures for 
monitoring temperature are not necessary. One reason provided by the 
comments is that the required records (specified in proposed Sec.  
117.206 (a)(5)) would provide sufficient information on the type and 
frequency of monitoring. Another reason is that the specific activities 
we proposed to ensure the effectiveness of the temperature controls 
already address activities that a facility would include in a written 
procedure.
    (Response 603) We agree with the comments that the rule does not 
need to require that a facility develop written procedures for 
monitoring temperature.
3. Proposed Sec.  117.206(a)(3)--Requirement to Take Corrective Actions
    We proposed that if your facility is subject to the modified 
requirements, you must take appropriate corrective actions if there is 
a problem with the temperature controls for a TCS food.
    (Comment 604) Some comments ask us to narrow the term ``temperature 
controls'' to more specifically focus it on temperature controls that 
are relevant to food safety because some problems with the controls may 
not impact the product temperature (and, thus, would not impact food 
safety).
    (Response 604) We have revised the proposed requirement (and the 
applicable recordkeeping requirement) to specify that corrective 
actions are necessary only when there is a loss of temperature control 
that may impact the safety of a TCS food.
    (Comment 605) Some comments assert that the responsibility for 
determining any corrective actions for a TCS food when there is a loss 
of temperature control falls to the manufacturer of the food rather 
than to the warehouse. These comments also assert that a warehouse is a 
third party who is not legally empowered to make independent decisions 
about when and where to ship the product, or not to ship it at all. 
These comments ask us to clarify that the responsibility of a warehouse 
for ``preventing'' affected food entering commerce ends when the 
product is returned to the manufacturer or processor.
    (Response 605) Returning affected food to the manufacturer/
processor or owner of the food is one way to satisfy the requirement to 
prevent food from entering commerce if the owner, operator, or agent in 
charge of a warehouse cannot ensure the affected food is not 
adulterated under section 402 of the FD&C Act, either on its own or 
after consultation with the manufacturer or processor of the food. It 
is not necessary to specify this specific action on the part of a 
warehouse in the regulatory text.
4. Proposed Sec.  117.206(a)(4)--Requirement To Verify Consistent 
Implementation of Temperature Controls
    We proposed that if your facility is subject to the modified 
requirements, you must verify that temperature controls are 
consistently implemented by: (1) Calibrating temperature monitoring and 
recording devices; (2) reviewing records of calibration within a 
reasonable time after the records are made; and (3) reviewing records 
of monitoring and corrective actions taken to correct a problem with 
the control of temperature within a week after the records are made.
    (Comment 606) Some comments assert that the proposed requirement to 
``calibrate'' devices that monitor and record temperature is 
inconsistent with the requirement to test such devices for accuracy in 
the LACF regulations in part 113. These comments assert that ``accuracy 
check'' is a more appropriate term to use in the modified requirements 
because many instruments that monitor or record temperature have very 
low drift values and may seldom require calibration.
    (Response 606) We have revised the proposed requirements to require 
verification that temperature controls are consistently implemented by 
calibrating temperature monitoring and recording devices or checking 
them for accuracy. However, if the outcome of an accuracy check is that 
a temperature monitoring or recording device is not accurate, the 
facility must follow up by calibrating or replacing the device. See 
also Comment 519 and Response 519.
    (Comment 607) Some comments assert that reviewing records of 
calibration or accuracy checks is only needed if a designated tolerance 
is exceeded.
    (Response 607) Although we recognize that in most instances an out-
of-calibration device will be identified and corrected at the time a 
calibration or accuracy check is performed, this is not always the 
case. The purpose of reviewing records of calibration or accuracy 
checks is to identify a problem that may have been missed or may not 
have been corrected rather than to react to a problem after the problem 
is identified. The records review is also a verification that the 
temperature controls were consistently implemented and that corrective 
actions were taken if needed.
    (Comment 608) Some comments ask us to modify the frequency of 
checking monitoring records to specify that it be done with a frequency 
to demonstrate control rather than within a week after the records are 
made.
    (Response 608) Consistent with Response 539, we have revised the 
proposed requirement to require review of records of monitoring (as 
well as records of corrective actions taken to correct a problem with 
the control of temperature) within 7 working days after the records are 
created or within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 7 working days.

[[Page 56081]]

    (Comment 609) Some comments assert that the proposed verification 
and review activities are too prescriptive because they require reviews 
that are not necessary. However, these comments also assert that the 
proposed verification activities are too vague because they do not 
specify the reasons for reviewing the records. These comments ask us to 
focus the regulatory text on achieving the overall objective of the 
review (i.e., ensuring the adequacy of the control) and to provide 
examples of meaningful review activities in guidance.
    (Response 609) We disagree that the proposed verification 
activities would require reviews that are not necessary. As noted in 
Response 607, the purpose of the records review is both to identify a 
problem with a temperature monitoring device that may not have been 
detected or corrected, and to verify that the temperature controls were 
consistently implemented and that corrective actions were taken if 
needed. The requirement is consistent with requirement for records 
review in subpart C (Sec.  117.165(a)(4)), which specifies records 
review as a verification activity to ensure that the records are 
complete, the activities reflected in the records occurred in 
accordance with the food safety plan, the preventive controls are 
effective, and appropriate decisions were made about corrective 
actions.
5. Proposed Sec.  117.206(a)(5)--Establish and Maintain Records
    We proposed that if your facility is subject to the modified 
requirements, you must establish and maintain records that document 
monitoring, corrective actions, and verification activities.
    (Comment 610) Some comments state that temperature controls in 
refrigerated warehouses are extremely reliable and therefore extensive 
recordkeeping and record review are not value-added. These comments ask 
us to revise the proposed provision to require a record only if a 
deviation in the environmental temperature from the prescribed limits 
was noted.
    (Response 610) See also Response 468 and Response 602. We have 
revised the regulatory text to provide that temperature monitoring 
records may be kept either as affirmative records demonstrating 
temperature is controlled or as exception records demonstrating loss of 
temperature control. The revised provision is consistent with the more 
general requirement for monitoring records of refrigeration temperature 
during storage of TCS food (see Sec.  117.145(c)(2)).

B. Proposed Sec.  117.206(b)--Records

    We proposed that the records that a facility must establish and 
maintain for the proposed modified requirements are subject to the 
requirements that would be established in proposed subpart F. We 
received no comments that disagreed with our proposal, and are 
finalizing proposed Sec.  117.206(b) without change.

XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of a 
Qualified Facility Exemption

    In the 2013 proposed human preventive controls rule, we proposed to 
establish procedural requirements that would govern our withdrawal of 
an exemption for a qualified facility (proposed subpart E; the 
withdrawal provisions). In the 2014 supplemental human preventive 
controls notice, we discussed several comments we received on these 
withdrawal provisions, and proposed modifications and additions to 
them. Some of the re-proposed provisions would modify the provisions 
that we included in the 2013 proposed human preventive controls rule 
(such as the timeframe for compliance with an order withdrawing an 
exemption), whereas others would be new provisions (such as a procedure 
to reinstate an exemption that had been withdrawn). In this section of 
this document we discuss comments that we received on the withdrawal 
provisions in the 2013 proposed human preventive controls rule, but did 
not address in the 2014 supplemental human preventive controls notice. 
We also discuss comments that we received on the re-proposed withdrawal 
provisions in the 2014 supplemental human preventive controls notice.
    Most of the comments that support the proposed provisions suggest 
alternative or additional regulatory text (see, e.g., Comment 612 
through Comment 614, Comment 620 through Comment 626, Comment 628, 
Comment 629, and Comment 631 through Comment 633) or ask us to clarify 
how we will interpret the provision (see, e.g., Comment 617).
    For several provisions, we received no comments that disagreed with 
our proposal, and are finalizing the provisions without change. These 
provisions are Sec.  117.274 (Presiding officer for an appeal and for 
an informal hearing); Sec.  117.277 (Timeframe for issuing a decision 
on an appeal); Sec.  117.280 (Revocation of an order to withdraw a 
qualified facility exemption); and Sec.  117.284 (Final agency action).
    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 
42, with editorial and conforming changes as shown in table 52.

   Table 42--Revisions to the Proposed Provisions for Withdrawal of a
                      Qualified Facility Exemption
------------------------------------------------------------------------
           Section                 Description            Revision
------------------------------------------------------------------------
117.251(b)(2)...............  Timeframe for a       Allow 15 calendar
                               qualified facility    days, rather than
                               to respond to a       10 calendar days,
                               notification from     for the facility to
                               FDA about             respond.
                               circumstances that
                               may lead FDA to
                               withdraw the
                               facility's
                               exemption.
117.257(c)..................  Contents of an order  Editorial changes to
                               to withdraw a         clarify that the
                               qualified facility    order will specify
                               exemption.            which of two
                                                     circumstances that
                                                     may lead FDA to
                                                     withdraw a
                                                     qualified facility
                                                     exemption apply, or
                                                     whether both of
                                                     these two
                                                     circumstances
                                                     apply.
117.257(d)(1)...............  Contents of an order  Specify that the
                               to withdraw a         timeframe for the
                               qualified facility    qualified facility
                               exemption.            to comply with the
                                                     order is 120
                                                     calendar days after
                                                     the date of receipt
                                                     of the order, or
                                                     within a reasonable
                                                     timeframe, agreed
                                                     to by FDA, based on
                                                     a written
                                                     justification,
                                                     submitted to FDA,
                                                     for a timeframe
                                                     that exceeds 120
                                                     calendar days from
                                                     the date of receipt
                                                     of the order.
117.257(e)..................  Contents of an order  Include a statement
                               to withdraw a         informing the
                               qualified facility    facility that it
                               exemption.            may ask us to
                                                     reinstate an
                                                     exemption that was
                                                     withdrawn by
                                                     following the
                                                     procedures in Sec.
                                                      117.287.

[[Page 56082]]

 
117.257(d)(2)...............  Timeframe for a       Allow 15 calendar
                               qualified facility    days, rather than
                               to appeal an order    10 calendar days,
                               withdrawing the       for the facility to
                               facility's            appeal the order.
                               exemption.
117.260.....................  Compliance with, or   Specifies that a
                               appeal of, an order   qualified facility
                               to withdraw a         that loses its
                               qualified facility    exemption would no
                               exemption.            longer need to
                                                     comply with the
                                                     modified
                                                     requirements that
                                                     apply to qualified
                                                     facilities that
                                                     have an active
                                                     exemption.
117.260(a)(1) and (c)(1)....  Compliance with, or   Specify that the
                               appeal of, an order   timeframe for the
                               to withdraw a         qualified facility
                               qualified facility    to comply with the
                               exemption.            order is 120
                                                     calendar days after
                                                     the date of receipt
                                                     of the order, or
                                                     within a reasonable
                                                     timeframe, agreed
                                                     to by FDA, based on
                                                     a written
                                                     justification,
                                                     submitted to FDA,
                                                     for a timeframe
                                                     that exceeds 120
                                                     calendar days from
                                                     the date of receipt
                                                     of the order.
------------------------------------------------------------------------

A. Proposed Sec.  117.251--Circumstances That May Lead FDA To Withdraw 
a Qualified Facility Exemption

    We proposed that we may withdraw the exemption that would apply to 
a qualified facility in the event of an active investigation of a 
foodborne illness outbreak that is directly linked to the qualified 
facility, or if we determine that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conditions or conduct associated with a qualified facility that are 
material to the safety of the food manufactured, processed, packed, or 
held at such facility. We also proposed that before we issue an order 
to withdraw an exemption, we: (1) May consider one or more other 
actions to protect the public health or mitigate a foodborne illness 
outbreak; (2) must notify you, in writing, of circumstances that may 
lead us to withdraw the exemption, and provide an opportunity for you 
to respond in writing, within 10 calendar days of the date of receipt 
of the notification, to our notification; and (3) must consider your 
actions to address the circumstances that may lead us to withdraw the 
exemption.
    (Comment 611) Some comments agree with the proposed provisions 
regarding certain actions we may take, and other actions we must take, 
before issuing an order to withdraw a qualified facility exemption. For 
example, some comments agree that other regulatory actions should be 
considered before withdrawing a qualified facility exemption, and some 
comments agree that it is appropriate to assess corrective actions 
taken by a qualified facility in response to a food safety problem when 
considering whether to withdraw its exemption. Other comments agree 
that these provisions are reasonable and will provide qualified 
facilities due process and greater clarity on the withdrawal process, 
but suggest that we could issue guidance rather than include these 
provisions in the rule to allow us greater flexibility should we have 
to act quickly to protect the public health.
    Other comments disagree with these proposed provisions and ask us 
to delete them from the final rule. These comments assert that FSMA 
does not require us to describe the actions that we may take prior to 
withdrawing a qualified facility exemption and that it is not necessary 
to do so because it is customary for us to work with a food facility to 
address problems before taking enforcement actions. These comments also 
express concern that listing possible regulatory actions before we 
would issue an order to withdraw a qualified facility exemption could 
create an expectation that we will always exercise such regulatory 
actions before issuing the order. These comments also express concern 
that being bound by these provisions could prevent us from acting 
quickly to protect public health.
    (Response 611) We are retaining the provisions regarding certain 
actions we may take, and other actions we must take, before issuing an 
order to withdraw a qualified facility exemption. We agree that it is 
customary for us to work with a food facility to address problems 
before taking enforcement actions but disagree that specifying this 
customary practice in the rule would prevent us from acting quickly to 
protect public health. As previously discussed, we consider that 
issuing an order to withdraw an exemption would be a rare event, in 
part because alternative actions such as those described in these 
provisions may provide a more expeditious approach to correcting a 
problem than withdrawing an exemption (79 FR 58524 at 58553). We also 
disagree that the rule binds us to take alternative regulatory action 
before issuing an order to withdraw a qualified facility exemption, 
other than to notify the facility in writing of circumstances that may 
lead us to withdraw the exemption, provide an opportunity for the 
facility to respond in writing, and consider the actions taken by the 
facility to address the circumstances we describe. The rule clearly 
specifies that regulatory actions such as a warning letter, recall, 
administrative detention, suspension of registration, refusal of food 
offered for import, seizure, and injunction are actions that we ``may'' 
(not ``must'') take before issuing an order to withdraw a qualified 
facility exemption. Providing the facility with an opportunity to 
correct the problems before we take steps to withdraw an exemption has 
the potential to save agency resources associated with preparing an 
order, responding to an appeal of the order and request for a hearing, 
and administering a hearing. Directing resources to help a facility 
correct problems, rather than to administer a withdrawal process that 
could be resolved by the time of a hearing, is appropriate public 
health policy.
    (Comment 612) Some comments ask us to specify that the notification 
of circumstances that may lead FDA to withdraw the exemption must 
include facts specific to the situation and information about how the 
facility can remedy the situation.
    (Response 612) By specifying that we must notify the facility of 
circumstances that may lead us to withdraw an exemption, we mean that 
we would include facts specific to the situation. It is the 
responsibility of the facility, not FDA, to remedy the situation.
    (Comment 613) Some comments ask us to state affirmatively that we 
must not withdraw the exemption if the facility has satisfactorily 
addressed the problematic conditions or conduct at the facility. These 
comments assert that,

[[Page 56083]]

without this affirmative statement, the requirement that we ``consider 
the actions taken by the facility'' remains unclear.
    (Response 613) We decline this request. If the facility has 
satisfactorily addressed the problematic conditions or conduct, there 
would be no problematic circumstances for us to describe in the order 
withdrawing the qualified facility exemption.
    (Comment 614) Some comments ask us to provide additional time for a 
qualified facility to respond, in writing, to a notification of 
circumstances that may lead us to withdraw its exemption. Comments 
suggest timeframes of 60, 90, and 120 days as a reasonable or 
appropriate period of time for a qualified facility to compile 
information and documentation of facts and to respond to a notification 
of circumstances that may cause us to withdraw its exemption. Some of 
these comments express concern that the proposed deadline is too short, 
and that the short timeframe violates the intent of the exemption. Some 
comments ask us to establish graduated response times, with less 
response time allowed for more serious food safety concerns.
    (Response 614) We have revised the provision to provide for 15 
calendar days, rather than 10 calendar days, for a facility to respond 
in writing to our notification. The 15-day timeframe is the same as the 
timeframe for responding to a warning letter. Circumstances that could 
lead us to withdraw a qualified facility exemption require prompt 
action on the part of a facility, just as circumstances that lead us to 
issue a warning letter require prompt action.
    (Comment 615) Some comments ask us to clarify how an exemption can 
be revoked (and restored) on diversified farms that produce both exempt 
and non-exempt products.
    (Response 615) 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. Neither withdrawing nor 
reinstating a qualified facility exemption would have any impact on 
products that are not subject to the requirements for hazard analysis 
and risk-based preventive controls. In contrast, administrative 
procedures such as injunction and suspension of registration likely 
would apply to all food production by the facility.
    (Comment 616) Some comments ask us to consistently use either 
``calendar days'' or ``working days'' throughout the provisions 
directed to withdrawal of an exemption. Some comments ask us to use 
``business days'' rather than ``calendar days'' or ``working days.''
    (Response 616) We have expressed the timeframes for all of the 
withdrawal provisions in calendar days.
    (Comment 617) Some comments ask us to clarify that the decision to 
withdraw a qualified exemption is an individualized determination and 
will not be applied to a class of farmers by stating this clearly in 
the preamble.
    (Response 617) The decision to withdraw a qualified exemption is an 
individualized determination and will not be applied to a class of 
facilities or farmers.
    (Comment 618) Some comments assert that the timeframes for 
responding to a notification that an exemption may be withdrawn should 
be the same regardless of whether the notification is sent to a 
qualified facility subject to the human preventive controls rule or a 
farm subject to the produce safety rule. These comments state that many 
small farms do value-added processing and will be subject to both 
rules.
    (Response 618) Although the produce safety rule is not yet final, 
we intend to make the administrative procedures associated with 
withdrawal of an exemption consistent to the extent practicable, 
including the timeframe for responding to a notification.
    (Comment 619) Some comments ask us to expand the scope of the 
withdrawal provisions to include facilities that would satisfy criteria 
for an exemption from the requirements for hazard analysis and risk-
based preventive controls for low-risk activity/food combinations 
(i.e., the exemptions in proposed Sec.  117.5(g) and (h)).
    (Response 619) We decline this request. Section 418 of the FD&C Act 
does not provide for withdrawal of the exemptions established in Sec.  
117.5(g) and (h). The withdrawal provision in section 418(l)(3) of the 
FD&C Act is limited to qualified facilities.

B. Proposed Sec.  117.254--Issuance of an Order To Withdraw a Qualified 
Facility Exemption

    We proposed procedures for the steps we would take to issue an 
order to withdraw an exemption applicable to a qualified facility, 
including procedures that would: (1) Emphasize that a senior FDA 
official (such as an FDA District Director, the Director of the Office 
of Compliance in the Center for Food Safety and Applied Nutrition, or a 
more senior FDA official) must approve an order to withdraw the 
exemption before the order is issued; (2) provide that any officer or 
qualified employee of FDA may issue the order after it has been 
approved; (3) specify that we would issue the order to the owner, 
operator, or agent in charge of the facility; and (4) require that the 
order be in writing and be signed and dated by the officer or qualified 
employee of FDA who is issuing the order.
    (Comment 620) Some comments ask us to include in the procedures 
timeframes for: (1) Submitting an order after an initial determination 
that criteria for withdrawing an exemption are met; (2) approval or 
denial by the FDA District Director; (3) issuing the withdrawal (with 
automatic revocation of order if FDA does not issue the order within 
the specified timeframe); and (4) delivery of the order to the owner, 
operator, or agent in charge of the facility. Other comments recommend 
that the procedures for issuing an order specify that we send the order 
in a way that ensures its receipt, such as through certified mail with 
confirmation of delivery to ensure the facility operator receives the 
order.
    (Response 620) We are not establishing timeframes for the steps we 
take before a facility receives an order for withdrawal of an 
exemption. The timeframes surrounding our internal process for 
developing an order have no bearing on the time that a facility will 
need to respond to the order or on the information it will need to do 
so. We agree that it is appropriate to specify timeframes for the 
procedural steps that follow a facility's receipt of an order, and the 
withdrawal procedures include such timeframes.
    We are not specifying that we send an order in a way that ensures 
its receipt. Although certified mail with confirmation of delivery is 
one way to ensure receipt, other methods are available, including 
delivery through private carriers that provide mechanisms to document 
receipt. In light of the provision (which we included in the 2014 
supplemental human preventive controls notice) linking the timeframes 
for a facility to comply with, or appeal, an order to the date of 
receipt of the order (rather than to the date of the order), it will be 
up to us to deliver the order in a way that provides us with evidence 
of receipt.

C. Proposed Sec.  117.257--Contents of an Order To Withdraw a Qualified 
Facility Exemption

    We proposed specific information that would be included in an order 
to withdraw an exemption, including: (1) The date of the order and the 
name, address, and location of the qualified

[[Page 56084]]

facility; (2) a brief, general statement of the reasons for the order, 
including information relevant to the circumstances that led us to 
issue the order; (3) a statement that the facility must either comply 
with subpart C within 120 calendar days of receipt, or appeal the order 
within 10 calendar days of receipt; (4) the text of section 418(l) of 
the FD&C Act and of the withdrawal provisions in part 117, subpart E; 
(5) information about an informal hearing on an appeal of the order; 
and (6) contact information for appropriate senior FDA officials, as 
well as the name and the title of the FDA representative who approved 
the order.
    (Comment 621) Some comments recommend that the order specify which 
of the two circumstances that could lead us to issue the order apply.
    (Response 621) We have made editorial changes to the regulatory 
text to make it more clear that the provision requires us to specify 
which circumstance applies (i.e., an active investigation of foodborne 
illness, or conduct or conditions associated with the qualified 
facility), or whether both of these two circumstances apply. See the 
revised regulatory text for Sec.  117.257(c).
    (Comment 622) Some comments ask us to add more specific 
requirements for the content of an order to withdraw an exemption, 
including specific evidence about the circumstances leading to the 
order. The comments maintain that doing so would help the facility 
respond with particularity to the facts and issues contained in the 
order if the facility appeals the order. The comments also recommend 
that the order include the evidence on which the order is based 
including, as applicable, evidence linking the active investigation of 
a foodborne illness outbreak directly to the facility or measurable 
evidence (collected using generally accepted scientific standards) 
indicating the presence in the facility of pathogens that pose an 
imminent threat to public health, or conduct or conditions that are 
material to the safety of food. The comments also recommend that the 
order include, when applicable, a statement explaining how altering the 
conduct or conditions would prevent or mitigate a foodborne illness 
outbreak.
    (Response 622) We agree that the order must provide sufficient 
information to enable a facility to respond with particularity to 
specific evidence about the circumstances leading to the order. 
However, we disagree that the order must do so by including the 
specific information recommended by the comments, and we have not 
revised the proposed withdrawal provisions to incorporate the 
suggestions of these comments. The comments appear to be more focused 
on whether the circumstances that lead us to issue an order meet an 
evidentiary standard than on explaining the problem so that a facility 
can both understand the problem and respond with particularity to the 
facts and issues contained in the order. The withdrawal provisions that 
we are establishing in this provision require the order to include a 
brief, general statement of the reasons for the order, including 
information relevant to: (1) An active investigation of a foodborne 
illness outbreak that is directly linked to the facility; or (2) 
conditions or conduct associated with a qualified facility that are 
material to the safety of the food manufactured, processed, packed, or 
held at the facility. The requirements that we are establishing in this 
provision would enable a qualified facility to both understand the 
problem and respond to it. In addition, because other requirements in 
these withdrawal provisions specify that we must notify a qualified 
facility of circumstances that may lead us to withdraw its exemption 
before we issue the actual order, the order withdrawing the exemption 
would be the second time that the facility hears about the problems 
(see Sec.  117.251(b)(2)). We intend that the process of responding to 
the notification that we must send before issuing an order to withdraw 
an exemption, including discussing the problems with FDA as warranted, 
would provide additional information to the facility to enable the 
facility to both understand the problem and respond to it.
    (Comment 623) Some comments ask us to provide 15 ``business days'' 
from date of receipt of the order, rather than the proposed 10 calendar 
days from date of receipt of the order, for the facility to appeal the 
order.
    (Response 623) We have revised the provision to provide for 15 
calendar days, rather than 15 business days, for a facility to appeal 
the order. We also have made conforming changes to establish the same 
15 calendar timeframe in all provisions that specify the timeframe to 
appeal the order (i.e., Sec. Sec.  117.260(a)(2), 117.264(a)(1), and 
117.267(a)(2)). We also extended the timeframe for the hearing to be 
held to be within 15 calendar days, rather than the proposed 10 
calendar days, after the date the appeal is filed to provide more time 
for the facility to prepare for the hearing (see Sec.  117.270(a)). The 
timeframe for the hearing to be held continues to provide for an 
alternative timeframe agreed upon in writing by both the facility and 
FDA; a facility that would have preferred the proposed timeframe of 10 
calendar days could request that the hearing be held more quickly than 
15 calendar days.
    The 15-day timeframe is the same as the timeframe for responding to 
a warning letter. As discussed in Response 614, circumstances that 
could lead us to withdraw a qualified facility exemption require prompt 
action on the part of a facility, just as circumstances that lead us to 
issue a warning letter require prompt action.
    (Comment 624) Some comments support the proposed timeframe of 120 
calendar days for a qualified facility whose exemption has been 
withdrawn to comply with the human preventive controls rule, but ask us 
to make the timeframe for complying with a FSMA rule the same 
regardless of whether the exemption is withdrawn from a qualified 
facility subject to the human preventive controls rule or from a farm 
subject to the produce safety rule. Other comments ask us to extend the 
timeframe to come into compliance--e.g., to 1 or 2 years. Some of these 
comments suggest that qualified facilities should have 120 days to 
develop a plan of action, but 2 years to fully comply. Some of the 
comments argue that large farms and manufacturers are given a year to 
come into compliance, and that requiring small and very small 
businesses to comply in a shorter time period would effectively drive 
them out of business. Other comments ask us to consider provisions that 
would require compliance with only those portions of the rule that 
formed the basis for the revocation.
    (Response 624) We continue to believe that the 120-day timeframe is 
adequate, but we have added flexibility such that a facility may 
request, with a justification in writing to FDA, a reasonable timeframe 
for compliance that exceeds 120 calendar days from the receipt of the 
order. FDA must grant the request for the facility to receive the 
extended timeframe. We are not generally extending the timeframe 
because circumstances that could lead us to withdraw a qualified 
facility exemption require prompt action on the part of a facility. A 
qualified facility that receives an order to withdraw its exemption 
would have received advance notification of the circumstances leading 
to the order and would have had an opportunity to correct the problems 
rather than have us proceed to issue the order (see Sec.  117.251(b)). 
If the facility requests a hearing, more than 40 days could elapse 
between the date that the facility receives the order and the date that 
the

[[Page 56085]]

presiding officer for the hearing confirms the order to withdraw the 
exemption. Given that the circumstances that would lead us to issue the 
order involve either: (1) An active investigation of a foodborne 
illness outbreak that is directly linked to the qualified facility; or 
(2) a determination that withdrawal of the exemption is necessary to 
protect the public health and prevent or mitigate a foodborne illness 
outbreak based on conditions or conduct associated with the qualified 
facility that are material to the safety of the food manufactured, 
processed, packed, or held at the facility, a delay of 1 to 2 years to 
comply with the rule is not warranted. We also do not believe that it 
would be appropriate to require a facility to come into compliance with 
only those provisions that formed the basis of the revocation. The 
provisions of subparts C and G are interrelated and operate as a system 
and therefore are not optimized through piecemeal implementation. 
However, FDA may consider staggered implementation as an option in 
granting a request for an extension of the timeframe to comply with an 
order to withdraw the exemption for a qualified facility.
    As already discussed, 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. (See Response 222.)
    Although the produce safety rule is not yet final, we intend to 
make the administrative procedures associated with withdrawal of an 
exemption consistent to the extent practicable, including the timeframe 
to comply with the applicable rule if an exemption is withdrawn.
    (Comment 625) Some comments ask us include in the order a statement 
that a facility may request that FDA reinstate an exemption that was 
withdrawn by following the procedures in Sec.  117.287.
    (Response 625) We have revised the requirements for the contents of 
an order as requested by these comments.

D. Proposed Sec.  117.260--Compliance With, or Appeal of, an Order To 
Withdraw a Qualified Facility Exemption

    We proposed that: (1) You must either comply with applicable 
requirements of part 117 within 120 calendar days of receipt, or appeal 
the order within 10 calendar days of receipt; (2) submission of an 
appeal, including submission of a request for an informal hearing, will 
not operate to delay or stay any administrative action unless the 
Commissioner of FDA, as a matter of discretion, determines that delay 
or a stay is in the public interest; and (3) if you appeal the order, 
and we confirm the order, you must comply with applicable requirements 
of part 117 within 120 calendar days of confirmation of receipt of the 
order.
    (Comment 626) Some comments ask us to specify that a qualified 
facility that loses its exemption from the requirements for hazard 
analysis and risk-based preventive controls would no longer need to 
comply with the modified requirements that apply to qualified 
facilities that have an active exemption.
    (Response 626) A qualified facility that loses its exemption from 
the requirements for hazard analysis and risk-based preventive controls 
would no longer need to comply with the modified requirements that 
apply to qualified facilities that have an active exemption. To make 
this clearer, the final withdrawal procedures now include this 
information (see the regulatory text for Sec.  117.260(c)).

E. Proposed Sec.  117.264--Procedure for Submitting an Appeal

    We proposed that: (1) To appeal an order, you must submit a written 
appeal to FDA within 10 calendar days of receipt and respond with 
particularity to the facts and issues contained in the order, including 
any supporting documentation upon which you rely; and (2) in your 
written appeal, you may include a written request for an informal 
hearing.
    (Comment 627) Some comments ask us to rely on records kept in the 
normal course of business for documentation that will be sufficient to 
respond to an order to withdraw a qualified facility's exemption, 
rather than requiring a facility to ``respond with particularity to the 
facts and issues contained in the order, including any supporting 
documentation upon which the owner, operator or agent in charge of the 
facility relies.'' These comments assert that we should not require a 
facility that submits a written appeal to provide documents and records 
that they are not required to keep.
    (Response 627) We decline this request. In a withdrawal action, FDA 
is providing a qualified facility multiple opportunities to persuade 
FDA that withdrawal is not appropriate. If the facility relies on 
documentation as part of its response, it is reasonable to require that 
this documentation be provided to FDA.

F. Proposed Sec.  117.267--Procedure for Requesting an Informal Hearing

    We proposed that if you appeal the order: (1) You may request an 
informal hearing, and must do so together with your written appeal 
(within 10 calendar days of the date of receipt of the order; and (2) a 
request for an informal hearing may be denied, in whole or in part, if 
the presiding officer determines that no genuine and substantial issue 
of material fact has been raised by the material submitted; you would 
receive written notice of the presiding officer's determination, 
explaining the reason for the denial.
    (Comment 628) Some comments ask us to guarantee a hearing so that a 
qualified facility can present its case in person before having its 
exemption revoked.
    (Response 628) We decline this request. We agree that a qualified 
facility has a right to appeal an order to withdraw an exemption, and 
we have provided for a right to appeal.

G. Proposed Sec.  117.270--Requirements Applicable to an Informal 
Hearing

    We proposed that if you request an informal hearing, and we grant 
the request: (1) The hearing will be held within 10 calendar days after 
the date the appeal is filed or, if applicable, within a timeframe 
agreed upon in writing by you and by us; (2) the presiding officer may 
require that the hearing be completed within 1 calendar day; and (3) we 
must conduct the hearing in accordance with part 16 (21 CFR part 16), 
with some specified modifications, including that no party shall have 
the right, under Sec.  16.119, to petition FDA for reconsideration or a 
stay of the presiding officer's final decision.
    (Comment 629) Some comments object to our proposal that no party 
shall have the right, under Sec.  16.119, to petition FDA for 
reconsideration or a stay of the presiding officer's final decision. 
These comments assert that our justification (i.e., that the 
circumstances that would lead to a withdrawal merit prompt action and 
that a facility has the opportunity for judicial review in accordance 
with 21

[[Page 56086]]

CFR 10.45) is not a sufficient argument for justifying the removal of 
the option to file a motion for reconsideration or stay. These comments 
ask us to revise proposed Sec.  117.270(c)(6) to specify that the 
qualified facility shall have the right to file a motion for 
reconsideration or stay.
    (Response 629) We decline this request. In the 2014 supplemental 
human preventive controls notice, we proposed an additional mechanism 
for a qualified facility to present its view that its exemption should 
not be withdrawn--i.e., by providing advance written notification to a 
qualified facility if we are considering withdrawing an exemption and 
providing an opportunity for the facility to respond before we issue an 
order to withdraw an exemption. We also proposed to provide an 
opportunity for reinstatement of an exemption that had been withdrawn. 
We believe the multiple opportunities now available to a facility 
provide adequate opportunities for a facility's views to be considered, 
and further mechanisms are not warranted.

H. Proposed Sec.  117.287--Reinstatement of a Qualified Facility 
Exemption That Was Withdrawn

    We proposed four provisions for reinstating a withdrawn qualified 
facility exemption. First, we proposed that if the FDA District 
Director in whose district your facility is located (or, in the case of 
a foreign facility, the Director of the Office of Compliance in the 
Center for Food Safety and Applied Nutrition) determines that a 
facility has adequately resolved problems with the conditions and 
conduct that are material to the safety of the food manufactured, 
processed, packed, or held at the facility and that continued 
withdrawal of the exemption is not necessary to protect public health 
and prevent or mitigate a foodborne illness outbreak, the FDA District 
Director in whose district your facility is located (or in the case of 
a foreign facility, the Director of the Office of Compliance in the 
Center for Food Safety and Applied Nutrition) will, on his own 
initiative or on the request of a facility, reinstate the exemption 
(proposed Sec.  117.287(a)).
    Second, we proposed that you may ask FDA to reinstate an exemption 
that has been withdrawn by following specific steps (Sec.  
117.287(b)(1) and (2)). Third, we proposed that if your exemption was 
withdrawn in the event of an active investigation of a foodborne 
illness outbreak that is directly linked to your facility and FDA later 
determines, after finishing the active investigation of a foodborne 
illness outbreak, that the outbreak is not directly linked to your 
facility, FDA will reinstate your qualified facility exemption and will 
notify you in writing that your exempt status has been reinstated.
    We proposed that if your exemption was withdrawn both in the event 
of an active investigation of a foodborne illness outbreak that is 
directly linked to your facility and because FDA had determined that it 
is necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak based on conditions or conduct associated 
with your facility that are material to the safety of the food 
manufactured, processed, packed, or held at such facility, and FDA 
later determines, after finishing the active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
your facility, FDA will inform you of this finding, and you may ask FDA 
to reinstate your qualified facility exemption.
    (Comment 630) Some comments agree with our tentative conclusion 
that the absence of a specific provision in section 418 of the FD&C Act 
for the reinstatement of an exemption that is withdrawn does not 
preclude us from providing for such a process (79 FR 58524 at 58553). 
Other comments disagree with that tentative conclusion and assert that 
Congress crafted the withdrawal provision as a ``one strike, you're 
out'' provision. These comments also assert that including the 
withdrawal provision as a ``one strike, you're out'' provision was an 
essential part of the legislative agreement that allowed for adoption 
of the qualified facility exemption. These comments also assert that 
reinstatement would undermine the intent of the withdrawal provision 
because it would reduce the incentive for small food processors to 
ensure that the products they sell are as safe as possible. These 
comments also assert that a recognized principle of statutory 
interpretation provides that exemptions to statutes should be strictly 
construed, particularly when the statute addresses public health and 
safety, and that we are giving the exemption an impermissibly broad 
construction.
    Some comments ask why we believe that a business deserves a 
``second bite of the apple'' in light of the understanding (under 
proposed Sec.  117.251(b) and (c)) that we will first seek to correct 
problems before considering withdrawal. These comments also question at 
what point a facility would apply for reinstatement, and ask why we 
would allow a facility that has already come into compliance with 
FSMA's requirement to implement preventive controls to abandon those 
controls in favor of reinstating its exempt status. These comments ask 
us to eliminate the proposed provisions allowing for reinstatement.
    Some comments do not support the proposed reinstatement provisions 
when a food facility has been directly linked to a foodborne illness 
outbreak. Some comments support the proposed reinstatement provisions 
only when we determine, after finishing an active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
the facility that had its exemption withdrawn.
    (Response 630) We disagree that the proposed reinstatement 
provisions would give the exemption an impermissibly broad 
construction. The express statutory language of section 418(l) of the 
FD&C Act does not support the comments' assertion that the withdrawal 
provision is a ``one strike, you're out'' provision. We also disagree 
that reinstatement would undermine the intent of the withdrawal 
provision because it would reduce the incentive for small food 
processors to ensure that the products they sell are as safe as 
possible. We expect that the withdrawal provision itself provides a big 
incentive for small food processors to ensure that the products they 
sell are as safe as possible because of the business disruption that 
would occur if they are subject to withdrawal of the exemption. We 
proposed that a facility would need to present data and information to 
demonstrate that it has adequately resolved the problems with the 
conditions or conduct that are material to the safety of the food 
manufactured, processed, packed, or held at the facility, such that 
continued withdrawal of the exemption is not necessary to protect 
public health and prevent or mitigate a foodborne illness outbreak.
    We disagree that we should categorically refuse to consider 
reinstating a qualified facility exemption if we had withdrawn the 
exemption because a food facility had been directly linked to a 
foodborne illness outbreak. First, if information later comes to light 
to raise considerable doubt that a qualified facility had, indeed, been 
directly linked to a foodborne illness outbreak, and conditions and 
conduct at the facility do not otherwise warrant withdrawing the 
facility's exemption, it would be appropriate for us to reinstate the 
facility's exemption. Second, we would only reinstate the exemption if 
we determined that a facility has adequately resolved any problems with 
the conditions and conduct that are material to the safety of the food 
manufactured, processed, packed, or

[[Page 56087]]

held at the facility and that continued withdrawal of the exemption is 
not necessary to protect public health and prevent or mitigate a 
foodborne illness outbreak.
    (Comment 631) Some comments that support the reinstatement of a 
withdrawn exemption ask us to establish a timeframe within which FDA 
will reinstate an exemption. Some comments ask us to specify in the 
regulatory text that the reinstatement would occur in a reasonable 
period of time, both in circumstances where FDA has decided on its own 
initiative to reinstate the exemption and in circumstances where a 
facility submits a request for reinstatement. Some comments suggest 10 
days is a reasonable period of time within which FDA should reinstate 
an exemption.
    (Response 631) We decline the requests to establish a timeframe for 
reinstatement in the regulatory text. If we determine on our own 
initiative to reinstate an exemption (e.g., because we later determine, 
after finishing the active investigation of a foodborne illness 
outbreak, that the outbreak is not directly linked to the facility), 
our determination would be effective immediately. If we receive a 
request to reinstate a withdrawn exemption, we intend to respond in a 
reasonable timeframe consistent with available resources. In some 
cases, we may respond that we need more information in order to 
evaluate your request.
    (Comment 632) Some comments ask that the process for reinstatement 
include at least one level of administrative appeal if we deny a 
facility's request for reinstatement.
    (Response 632) We have not revised the regulatory text to provide 
for an administrative appeal if we deny a facility's request for 
reinstatement. Existing procedures allow a facility to ask for a 
meeting with applicable FDA officials (see 21 CFR 10.65(c)) and appeal 
our decision if we deny the request (see 21 CFR 10.75).
    (Comment 633) Some comments ask us to establish a 1-year 
probationary period before the withdrawn qualified facility exemption 
could be fully reinstated.
    (Response 633) We decline this request. We intend to act on a 
request for reinstatement based on the merits of the data and 
information presented in the request, not after a pre-determined 
timeframe.

I. Conforming Amendment to 21 CFR Part 16

    We proposed to amend Sec.  16.1(b)(2) to include part 117, subpart 
E, relating to the withdrawal of an exemption applicable to a qualified 
facility, in the list of regulatory provisions under which regulatory 
hearings are available. We received no comments that disagreed with 
this proposed provision, and are finalizing it as proposed.

J. Other Comments on the Withdrawal Provisions

    (Comment 634) Several comments ask us to provide clarification 
through guidance, issued for public comment, on a variety of topics 
associated with the withdrawal provisions.
    (Response 634) We will consider the need for guidance in the 
future. At this time, we consider that withdrawing an exemption would 
be both rare and dependent upon the circumstances. We need to direct 
our resources to developing guidance on issues that would apply more 
broadly, and more generally, than the withdrawal provisions.
    (Comment 635) Some comments ask detailed questions about how we 
would coordinate the withdrawal process with the States.
    (Response 635) In general, we work with our State partners and 
other government counterparts in dealing with enforcement actions, 
including coordinating actions or deferring to each other when one 
department has authority to swiftly act to protect the consumer. In the 
specific case of this rule, we are working through the PFP to develop 
and implement a national Integrated Food Safety System consistent with 
FSMA's emphasis on establishing partnerships for achieving compliance 
(see Response 5 and section 209(b) of FSMA).
    (Comment 636) Some comments ask us to add provisions regarding 
notification of the appropriate State regulatory agency when a 
qualified facility exemption is withdrawn and reinstated.
    (Response 636) We decline this request. As previously noted, we are 
sensitive to the time required for various inspection activities and 
intend to communicate with States regarding our expectations for how to 
verify whether a facility is a qualified facility. The status of a 
facility as a qualified facility principally affects the requirements 
that it is subject to, and will be most useful to FDA and our food 
safety partners when preparing for inspection. At this time we do not 
intend to establish a system notifying the applicable State authorities 
at a point in time when the status of a facility as a qualified 
facility changes, whether as a result of withdrawal or reinstatement of 
a qualified facility exemption or because the facility's business has 
grown to the point where it exceeds the financial threshold for very 
small business. See also Response 635.

XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements

    We proposed to establish in subpart F requirements that would apply 
to all records that would be required by the various provisions of 
proposed part 117, including general requirements related to the 
content and form of records; additional requirements specific to the 
food safety plan; requirements for record retention; requirements for 
official review of records by FDA; and public disclosure.
    Some comments support the proposed requirements without change. For 
example, some comments state that the proposed 2-year retention period 
is consistent with the majority of food safety guidelines currently 
being used in the fresh produce industry. Some comments that support 
the proposed provisions suggest alternative or additional regulatory 
text (see, e.g., Comment 639, Comment 642, and Comment 644 through 
Comment 646) or ask us to clarify how we will interpret the provision 
(see, e.g., Comment 643 and Comment 650).
    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 
43, with editorial and conforming changes as shown in table 52.

     Table 43--Revisions to the Proposed Recordkeeping Requirements
------------------------------------------------------------------------
           Section                 Description            Revision
------------------------------------------------------------------------
117.305(c)..................  General requirements  Provide that the
                               applying to records.  time of an activity
                                                     being documented
                                                     only include the
                                                     time of the
                                                     activity when
                                                     appropriate.
117.305(g)..................  General requirements  Specify that
                               applying to records.  electronic records
                                                     are exempt from the
                                                     requirements of 21
                                                     CFR part 11.

[[Page 56088]]

 
117.315(a)(2)...............  Requirements for      Specify that records
                               record retention.     that a facility
                                                     relies on during
                                                     the 3-year period
                                                     preceding the
                                                     applicable calendar
                                                     year to support its
                                                     status as a
                                                     qualified facility
                                                     must be retained at
                                                     the facility for as
                                                     long as necessary
                                                     to support the
                                                     status of a
                                                     facility as a
                                                     qualified facility
                                                     during the
                                                     applicable calendar
                                                     year.
117.315(c)..................  Requirements for      Provide for offsite
                               record retention.     storage of all
                                                     records other than
                                                     the food safety
                                                     plan, provided that
                                                     the offsite records
                                                     can be retrieved
                                                     and provided onsite
                                                     within 24 hours of
                                                     request for
                                                     official review.
117.315(d)..................  Requirements for      Provide that the
                               record retention.     food safety plan
                                                     may be transferred
                                                     to some other
                                                     reasonably
                                                     accessible location
                                                     if the plant or
                                                     facility is closed
                                                     for a prolonged
                                                     period, provided
                                                     that it is returned
                                                     to the plant or
                                                     facility within 24
                                                     hours of request
                                                     for official
                                                     review.
117.320.....................  Requirements for      Clarify that FDA may
                               official review.      copy records upon
                                                     oral or written
                                                     request by a duly
                                                     authorized
                                                     representative of
                                                     the Secretary of
                                                     Health and Human
                                                     Services.
117.325.....................  Requirements for      Specify that the
                               public disclosure.    requirement applies
                                                     to records
                                                     ``obtained by
                                                     FDA''.
117.335.....................  Special requirements   Establish
                               applicable to a       requirements
                               written assurance.    applicable to all
                                                     written assurances
                                                     required by the
                                                     rule.
                                                     Establish
                                                     additional
                                                     requirements
                                                     applicable to
                                                     written assurances
                                                     that are required
                                                     when a food product
                                                     distributed by
                                                     manufacturer/
                                                     processor requires
                                                     further processing
                                                     for food safety by
                                                     a subsequent
                                                     manufacturer.
------------------------------------------------------------------------

A. Proposed Sec.  117.301--Records Subject to the Requirements of 
Subpart F

    We proposed that all records required by part 117 would be subject 
to all requirements of subpart F, except that certain specific 
requirements (proposed Sec.  117.310) would apply only to the written 
food safety plan. We also proposed that certain proposed requirements 
(e.g., for records to contain the actual values and observations 
obtained during monitoring and, as appropriate, during verification 
activities) would not apply to the records that would be kept by 
qualified facilities.
    (Comment 637) Some comments disagree with the proposal to exempt 
the records that would be kept by qualified facilities from 
requirements to keep accurate, detailed records. The comments note that 
the proposed exemption would apply to qualified facilities regardless 
of whether they operate under the first option for documentation (i.e., 
food safety practices) or under the second option for documentation 
(i.e., compliance with non-Federal food safety laws). These comments 
assert that the proposed detailed recordkeeping requirements should 
apply to records relating to monitoring food safety practices and ask 
us to revise the proposed requirements so that this exemption would 
apply only to those qualified facilities that operate under non-Federal 
food safety laws.
    (Response 637) We decline this request. We based the proposed 
exemption on a statutory provision that a qualified facility is not 
subject to certain requirements, including the statutory recordkeeping 
requirements (see section 418(l)(2) of the FD&C Act). Although the 
modified requirements that apply to a qualified facility require 
submission of certain attestations to FDA (see Sec.  117.201(a) and 
(b)), and these attestations must be supported by documentation (see 
Sec.  117.201(f)), the rule does not require that records kept by a 
qualified facility to support its attestations be the same type of 
records that would be kept by a facility subject to subparts C and G. 
For example, if the facility attests that it has identified the 
potential hazards associated with the food being produced, implemented 
preventive controls to address the hazards, and is monitoring the 
performance of the preventive controls, the qualified facility might 
support its attestation by having a standard operating procedure for 
monitoring preventive controls rather than detailed records of actual 
monitoring.

B. Proposed Sec.  117.305--General Requirements Applying to Records

    We proposed that the records must: (1) Be kept as original records, 
true copies, or electronic records (and that electronic records must be 
kept in accordance with part 11 (21 CFR part 11)); (2) contain the 
actual values and observations obtained during monitoring and, as 
appropriate, during verification activities; (3) be accurate, 
indelible, and legible; (4) be created concurrently with performance of 
the activity documented; (5) be as detailed as necessary to provide 
history of work performed; and (6) include the name and location of the 
plant or facility, the date and time of the activity documented, the 
signature or initials of the person performing the activity, and, where 
appropriate, the identity of the product and the production code, if 
any.
    We have revised the provision to require information adequate to 
identify the plant or facility (e.g., the name, and when necessary, the 
location of the plant or facility) rather than to always require both 
the name and location of the plant or facility (see Sec.  
117.305(f)(1)). In some cases, the name of the plant or facility will 
be adequate to identify it--e.g., when a plant or facility is not part 
of a larger corporation that has facilities at more than one location. 
In other cases, the name of the plant or facility may not, by itself, 
be adequate to identify the plant or facility--e.g., when a plant or 
facility is part of a larger corporation with more than one location 
and the ``name'' of each plant or facility is the same.
    (Comment 638) Some comments assert that compliance with part 11 for 
the secure operation of many systems

[[Page 56089]]

currently in use is unnecessary and would create the need to redesign 
and recreate existing systems, thus leading to considerable cost and 
complexity. These comments identify the requirement for hardware and 
software to be validated as a key cost concern and assert that 
validation activities would be difficult to maintain and would not 
deliver added value. As an example, these comments explain that an 
expectation for validation of electronic recordkeeping software and 
hardware would be particularly problematic because software patches and 
security updates are distributed on a nearly weekly basis, and express 
the view that validation procedures are most appropriately applied 
before use of a new system and after major software changes or updates. 
These comments also assert that it would be costly, burdensome, and 
require specialized resources to modify or replace existing electronic 
systems to comply with part 11. These comments provide an example in 
which a facility needed more than nine months to upgrade one system 
alone to comply with part 11, and note that it would not be unusual for 
companies to employ multiple systems, so the burden and cost would 
exponentially increase. These comments ask us to instead require 
facilities that use electronic records to use a secure system that 
ensures records are trustworthy, reliable, and generally equivalent to 
paper records and handwritten signatures executed on paper.
    Other comments express concern about the financial burden for small 
facilities such as farm mixed-type facilities and ask us to either 
modify requirements for farm mixed-type facilities, very small 
businesses, and small businesses or provide that such facilities be 
fully exempt from part 11 requirements for electronic records. Other 
comments state that, as with the recordkeeping requirements under the 
Bioterrorism Act, such requirements are disproportionate to the 
regulatory need. Other comments state that many operators that use 
electronic data records in the produce industry use open software and 
would not meet part 11 requirements.
    Some comments state that major advances in software technology have 
been made since part 11 published in 1997, and such advances must be 
carefully considered in evaluating any potential expansion or new 
applications of part 11. These comments also state that we already are 
in the process of reevaluating part 11 for the regulations for which it 
currently applies, citing industry guidance issued more than 10 years 
ago in which we acknowledged that part 11 is unworkable in many 
respects and decided to exercise enforcement discretion for part of the 
regulations and announced plans to reexamine part 11 as a whole.
    Some comments recommend that we develop guidance, with input from 
key stakeholders, to describe the kinds of systems and steps that can 
be used to assure records meet the required standard. This guidance 
should clearly establish that specific security needs will depend on 
the circumstances, including the system at issue, its intended use, the 
criticality of the preventive control or other food safety measure it 
is used to manage, and other relevant factors. For example, these 
comments explain that a quality system used to manage CCP documentation 
would have greater security needs than a review of a Certificate of 
Analysis for a non-sensitive ingredient.
    (Response 638) In light of the substantial burden that could be 
created by the need to redesign large numbers of already existing 
electronic records and recordkeeping, we are providing in new Sec.  
117.305(g) that records that are established or maintained to satisfy 
the requirements of part 117 and that meet the definition of electronic 
records in Sec.  11.3(b)(6) are exempt from the requirements of part 
11. As we did in the section 414 recordkeeping regulations, we also are 
specifying that records that satisfy the requirements of part 117, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to part 11. The rule provides that a 
facility may rely on existing records to satisfy the requirements of 
this rule, and this rule does not change the status under part 11 of 
any such records if those records are currently subject to part 11. As 
we did in the rulemaking to establish the section 414 recordkeeping 
regulations, we are establishing a conforming change in part 11 to 
specify in new Sec.  11.1(i) that part 11 does not apply to records 
required to be established or maintained under part 117, and that 
records that satisfy the requirements of part 117, but that also are 
required under other applicable statutory provisions or regulations, 
remain subject to part 11.
    Although we are not specifying that part 11 applies, facilities 
should take appropriate measures to ensure that records are 
trustworthy, reliable, and generally equivalent to paper records and 
handwritten signatures executed on paper.
    (Comment 639) Some comments assert that certain production and 
associated activities are not time-sensitive and would not require 
documentation of the time the activity is performed. These comments ask 
us to modify the proposed requirements so that the records would only 
require the time of the activity documented where appropriate for food 
safety.
    (Response 639) We agree that certain activities (e.g., record 
review and verification activities) are not time-sensitive and, thus, 
would not need to include the time that the activity was performed. The 
final rule provides flexibility for the facility to determine when to 
document the time by specifying that the time be documented ``when 
appropriate'' (see Sec.  117.305(f)(2)).
    (Comment 640) Some comments assert that concurrent record creation 
will prove difficult in many food-processing environments. These 
comments ask us to modify the proposed requirement that records be 
created concurrently with the performance of the activity documented to 
qualify that the requirement only applies where feasible, and that the 
records could be created as soon as possible thereafter under 
circumstances where concurrent record creation is not feasible.
    (Response 640) We decline this request. The comments did not 
provide any examples of activities where concurrent record creation in 
food manufacturing, processing, packing, or holding environments would 
prove difficult, and we are not aware of any such example. For example, 
we are not aware of any difficulty complying with long-standing similar 
requirements associated with our HACCP regulations for seafood and 
juice (see Sec. Sec.  123.9(a)(4) and 120.12(b)(4), respectively).
    (Comment 641) Some comments express concern about ``apparent 
mandates'' that we will require records to be kept in the English 
language and assert that the language of food factory documents should 
not be dictated as a precondition for food exports. These comments ask 
us to limit the documents that must written in English to reduce 
translation and records duplication. These comments also ask us to 
focus the requirements for English language on those documents that 
must be submitted to FDA.
    (Response 641) We did not propose to require that any ``factory 
records'' (such as the written food safety plan (Sec.  117.126) and the 
implementation records listed in Sec.  117.190) be kept in the English 
language. Consistent with other regulations for submissions to FDA 
(such as for registration of a food facility), the form we will use for 
a qualified facility to submit its required

[[Page 56090]]

attestations (Sec.  117.201(b) and (c)) will be in the English 
language.

C. Proposed Sec.  117.310--Additional Requirements Applying to the Food 
Safety Plan

    We proposed that the food safety plan must be signed and dated by 
the owner, operator, or agent in charge of the facility upon initial 
completion and upon any modification.
    (Comment 642) Some comments state that the provision would exclude 
the preventive controls qualified individual from signing and dating 
the food safety plan unless the preventive controls qualified 
individual is the owner, operator, or agent in charge of the facility. 
These comments ask us to revise the rule to allow the preventive 
controls qualified individual to sign and date the food safety plan 
(e.g., because it is the preventive controls qualified individual who 
prepares (or oversees the preparation of) the food safety plan). Some 
comments ask us to require that any preventive controls qualified 
individuals who prepare (or oversee the preparation of) specific 
sections of the food safety plan sign and date the applicable sections.
    (Response 642) We decline these requests. The statute expressly 
directs the owner, operator, or agent in charge of a facility to 
prepare the food safety plan (see section 418(h) of the FD&C Act). As 
previously discussed, such a signature would provide direct evidence of 
the owner, operator or agent's acceptance of the plan and commitment to 
implementation of the plan (78 FR 3646 at 3782). A facility has 
flexibility to require the signature of one or more preventive controls 
qualified individuals who prepared, or oversaw the preparation of, its 
food safety plan in addition to the minimum signature requirement 
specified in the rule. Likewise, a facility also has flexibility to 
require the signature of one or more members of its food safety team 
who contributed to the preparation of the food safety plan, even if 
those individuals are not serving as the preventive controls qualified 
individual for the facility. (See also Response 377.)

D. Proposed Sec.  117.315--Requirements for Record Retention

    We proposed that: (1) All required records must be retained at the 
plant or facility for at least 2 years after the date they were 
prepared; (2) records relating to the general adequacy of equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained at the facility for at least 
2 years after their use is discontinued; (3) except for the food safety 
plan, offsite storage of records is permitted after 6 months following 
the date that the records were made if such records can be retrieved 
and provided onsite within 24 hours of request for official review; and 
(4) if the plant or facility is closed for a prolonged period, the 
records may be transferred to some other reasonably accessible location 
but must be returned to the plant or facility within 24 hours for 
official review upon request.
    (Comment 643) Some comments ask us to clarify that the 2-year 
record retention requirement only applies to records created after the 
compliance date for the final rule.
    (Response 643) The retention requirements only apply to records 
created after the applicable compliance date for the final rule. See 
Response 155 and section LVI.A, which explain that the compliance date 
for a facility to retain records to support its status as a qualified 
facility is January 1, 2016. See also Response 646, which explains that 
we have revised the record retention provisions to specify that records 
that a facility relies on during the 3-year period preceding the 
applicable calendar year to support its status as a qualified facility 
must be retained at the facility as long as necessary to support the 
status of a facility as a qualified facility during the applicable 
calendar year.
    (Comment 644) Some comments ask us to delete the proposed 
requirement to keep records on site for 6 months or 2 years (depending 
on the record) and assert that it should suffice to require that 
records be available within 24 hours of request or within a reasonable 
period of time. Some comments assert that a facility should be able to 
keep records in the location where they are created, which may be at 
corporate headquarters. Comments also assert that specifying the 
location for record storage will increase costs but will not contribute 
to improvements in public health. Some comments ask us to permit off-
site storage for all records more than 6 months old, in contrast to the 
2-year retention period we proposed for records relating to the general 
adequacy of equipment or processes being used by a facility, including 
the results of scientific studies and evaluations.
    (Response 644) We have revised the provisions to provide for 
offsite storage of all records (except the food safety plan), provided 
that the records can be retrieved and made available to us within 24 
hours of request for official review. We expect that many records will 
be electronic records that are accessible from an onsite location and, 
thus, would be classified as being onsite (see Sec.  117.315(c)). As a 
companion change, we have revised the proposed provision directed to 
the special circumstance of storing records when a facility is closed 
for prolonged periods of time so that it only relates to the offsite 
storage of the food safety plan in such circumstances (see Sec.  
117.315(d)).
    (Comment 645) Some comments assert that a two year retention period 
for records is much longer than needed for a product with a short shelf 
life (such as milk) and may not be long enough for products with very 
long shelf lives (such as oils). These comments ask us to establish a 
retention period that is risk-based and related to the shelf life of 
the product rather than ``one-size-fits-all.'' As an example, these 
comments suggest that we could set the retention requirement as 2 years 
past the date of manufacture or 1 year past an ``expiration'' date, 
whichever is longer. These comments also suggest that documentation on 
raw materials could be maintained for two years after final product lot 
is manufactured.
    (Response 645) We decline these requests. The proposed 2-year 
retention period is authorized by the statute (see section 418(g) of 
the FD&C Act). Moreover, the reasons discussed by the comments for 
linking the retention period to shelf life are more relevant to the 
record retention requirements for the purpose of tracking potentially 
contaminated food (21 CFR part 1, subpart J; see Sec.  1.360) than to 
the record retention requirements for the purpose of evaluating 
compliance with this rule.
    (Comment 646) Some comments ask us to require that qualified 
facilities keep financial and sales records for 3 or 4 years, because a 
qualified facility must document that the average value of food it sold 
during the prior 3 years did not exceed $500,000 annually.
    (Response 646) We have revised the record retention provisions to 
specify that records that a facility relies on during the 3-year period 
preceding the applicable calendar year to support its status as a 
qualified facility must be retained at the facility as long as 
necessary to support the status of a facility as a qualified facility 
during the applicable calendar year. As discussed in Response 155, the 
definition of very small business established in this rule is based on 
an average (of sales plus market value of human food held without sale) 
during the 3-year period preceding the applicable calendar year. Thus, 
both of the criteria for the qualified facility exemption are based on 
financial records associated with the preceding 3-year period. The 
actual retention time necessary to support the status of a qualified 
facility during the

[[Page 56091]]

applicable calendar year could be as long as 4 years. For example, if 
we inspect a facility on May 1, 2024, the facility would have retained 
the records from 2021-2023 for 3 years and 4 months. If we inspect the 
facility on December 28, 2024, the facility would have retained the 
records from 2021-2023 for nearly 4 years.

E. Proposed Sec.  117.320--Requirements for Official Review

    We proposed that all records required by proposed part 117 be made 
promptly available to a duly authorized representative of the Secretary 
of HHS upon oral or written request. We asked for comment on whether we 
should require a facility to send records to us rather than make the 
records available for review at a facility's place of business and, if 
so, whether we should require that the records be submitted 
electronically.
    (Comment 647) Some comments assert that we should not copy 
documents as part of routine investigations so as to prevent critical 
documents from release under the Freedom of Information Act (FOIA). 
These comments are particularly concerned that our ability to copy 
verification records (such as testing records) and potentially release 
these records under the FOIA would discourage facilities from testing 
as a verification activity. These comments also express concern that 
some facilities would include in their food safety plans elements, not 
required by the proposed rule, that address food defense as well food 
safety, and that disclosure of such a food safety plan without proper 
redaction could provide useful information to persons seeking to defeat 
the facility's food defense strategies. In addition, these comments 
express concern that the task of reviewing all of these records and 
redacting trade secrets and confidential information would further set 
back FDA's already overburdened FOIA offices and create even longer 
delays in responding to FOIA requests.
    As discussed in Comment 649, some comments suggest that we revise 
the proposed public disclosure requirements (proposed Sec.  117.325) to 
be analogous to the public disclosure requirements in our HACCP 
regulations for seafood and juice (see Sec. Sec.  123.9(d) and 
120.12(f), respectively).
    (Response 647) We have revised the proposed requirement to specify 
that all required records must be made promptly available ``for 
official review and copying'' to increase the alignment of the 
recordkeeping requirements of this rule with those of our HACCP 
regulations for seafood and juice. The issues raised by these comments 
are similar to some of the issues raised by comments during the 
rulemaking to establish our HACCP regulations for seafood (see the 
discussion at 60 FR 65096 at 65137-65140, December 18, 1995) and our 
regulations in part 118 for the prevention of Salmonella Enteritidis in 
shell eggs. We intend to copy records on a case-by-case basis as 
necessary and appropriate. We may consider it necessary to copy records 
when, for example, our investigators may need assistance in reviewing a 
certain record from relevant experts in headquarters. If we are unable 
to copy the records, we would have to rely solely on our investigators' 
notes and reports when drawing conclusions. In addition, copying 
records will facilitate follow-up regulatory actions. We primarily 
intend to copy records such as the results of product testing or 
environmental monitoring when we conduct an inspection for cause--e.g., 
as a result of an outbreak investigation, violative sample results, or 
follow up to a consumer complaint. See Response 650 for a discussion of 
how the FOIA would apply to records, such as records of testing as a 
verification activity, that we copy during an inspection and maintain 
in our system.
    See also Response 649 for a discussion of how the public disclosure 
requirements of this rule align with those of our HACCP regulations for 
seafood and juice.
    (Comment 648) Some comments strongly oppose any requirement for 
submission of records to FDA remotely and assert that there is no basis 
in FSMA for such a requirement. Some comments express concern about our 
ability to protect confidential information (such as supplier and 
customer records received by a facility under the protection of 
confidentially agreements) that is transmitted electronically (e.g., 
the information might be released through computer hacking or leaks). 
Some comments note that inadvertent disclosure of information related 
to specific products, hazards, and preventive controls implemented at 
food facilities could both prove harmful from a commercial or 
competitive standpoint and expose existing vulnerabilities in the U.S. 
food supply, thus potentially rendering food facilities susceptible to 
malicious attack.
    Some comments oppose the concept of a ``desk audit'' whereby our 
investigators conduct their inspections from a remote office without 
actually visiting the facility and assert that our access to company 
records must be conducted on-site in the course of an authorized 
inspection so that we may understand the full context of what the 
records show. Some comments point out that there would be challenges 
associated with credential validation when we asked for records to be 
sent remotely, such as in an email request. Some comments ask that we 
modify the proposed requirement to specify that records would only be 
made available to us during a facility inspection.
    (Response 648) We have decided not to establish any requirements 
for a facility to send records to us. We will review records when we 
are onsite in the course of an authorized inspection, and copy records 
as necessary and appropriate. (See also Response 647.)
    We are not modifying the proposed requirement to specify that 
records would only be made available to us during a facility inspection 
because it is not necessary to do so. The regulatory text specifying 
that the records be made available to a duly authorized representative 
of the Secretary of Health and Human Services provides the context that 
the records would be made available during inspection.

F. Proposed Sec.  117.325--Public Disclosure

    We proposed that records required by proposed part 117 are subject 
to the disclosure requirements under part 20 (21 CFR part 20).
    (Comment 649) Some comments assert that the proposed requirements 
governing public disclosure are not aligned with other risk-based 
preventive controls programs, such as HACCP programs. These comments 
argue that the proposed requirements should be realigned with other 
risk-based preventive controls programs to preserve the privacy of 
information maintained in required records unless that information has 
been otherwise made publicly available. Some comments suggest that we 
revise the proposed requirements to be analogous to the public 
disclosure requirements in our HACCP regulations for seafood and juice 
(see Sec. Sec.  123.9(d) and 120.12(f), respectively). One comment 
acknowledged our statements that the proposed requirements governing 
public disclosure are consistent with, but framed differently than, the 
disclosure provisions of our HACCP regulations for seafood and juice 
(79 3646 at 3783), but nonetheless asks us to provide a more detailed 
explanation of how our proposed approach is consistent with the 
disclosure provisions in our HACCP regulations for seafood and juice.
    (Response 649) We disagree that the proposed provisions governing 
public disclosure are not aligned with the

[[Page 56092]]

public disclosure provisions of our HACCP regulations for seafood and 
juice. Our regulations in part 20 regarding public information apply to 
all agency records, regardless of whether a particular recordkeeping 
requirement says so. In the case of the recordkeeping requirements for 
our HACCP regulations for seafood and juice, we framed the provisions 
regarding public disclosure by providing specific details about how 
particular provisions in part 20 (i.e., Sec.  20.61 (Trade secrets and 
commercial or financial information which is privileged or 
confidential) and Sec.  20.81 (Data and information previously 
disclosed to the public)) would apply to the applicable records, 
because we recognized that such details were of particular interest to 
the regulated industries. In the case of the recordkeeping requirements 
for this rule, we framed the provisions regarding public disclosure by 
more broadly referring to all the requirements of part 20, consistent 
with our more recent approach for framing the provisions regarding 
public disclosure in the rule ``Prevention of Salmonella Enteritidis in 
Shell Eggs During Production, Storage, and Transportation'' (part 118; 
see Sec.  118.10(f)). For example, provisions such as Sec.  20.20 
(Policy on disclosure of Food and Drug Administration records) apply to 
all records that we have in our system, including HACCP records, even 
though the HACCP regulations do not specify that this is the case.
    As discussed in Response 647, to increase the alignment between 
this rule and our HACCP regulations for seafood and juice, we have 
revised the proposed requirement regarding our access to records to 
specify that all required records must be made promptly available ``for 
official review and copying.''
    (Comment 650) Some comments ask us to clarify that the disclosure 
requirements of part 20 include protections for trade secrets and 
privileged or confidential commercial information and financial 
information. Other comments ask us to clarify that written food safety 
plans and associated records are not subject to public disclosure 
because they represent trade secret or confidential commercial 
information. Other comments ask us to clarify how the disclosure 
requirements of part 20 would apply to verification records (such as 
testing records).
    (Response 650) The questions raised in these comments are similar 
to some of the questions raised during the rulemaking to establish our 
HACCP regulation for seafood (see the discussion at 60 FR 65096 at 
65137-65140). Our experience in conducting CGMP inspections in 
processing plants, our experience with enforcing our HACCP regulations 
for seafood and juice, and our understanding from the FRIA for this 
rule make it clear that food safety plans will take each facility some 
time and money to develop. Thus, we conclude that food safety plans 
generally will meet the definition of trade secret, including the 
court's definition in Public Citizen Health Research Group v. FDA, 704 
F.2d 1280 (D.C. Cir. 1983). Plans that incorporate unique regimens or 
parameters to achieve product safety, which are the result of 
considerable research and effort, will surely meet this definition.
    Moreover, there is value in a plan to a company that produces it 
for no other reason than that it took work to write. The equity in such 
a product is not readily given away to competitors. We expect that 
plant configurations will be unique to individual processors, or at 
least have unique features, as was the case in the seafood industry 
(Ref. 88). While generic plans will have great utility in many 
circumstances, they serve primarily as starting points for processors 
to develop their own plans. Facilities will still need to expend time 
and money to tailor a generic plan to their individual circumstances.
    We would establish the status of verification records, such as the 
results of product testing and environmental monitoring, as available 
for, or protected from, public disclosure on a case-by-case basis. As 
discussed in Response 647, we primarily intend to copy such records 
when we conduct an inspection for cause. We also intend to copy such 
records if the preliminary assessment by our investigator during a 
routine inspection is that regulatory follow-up may be appropriate 
(e.g., if these records demonstrate that an environmental pathogen has 
become established in a niche environment in a food processing plant).
    (Comment 651) Some comments assert that our regulations in 
Sec. Sec.  20.47 and 20.48 require us to consult with the entity 
providing information prior to disclosing such information. These 
comments ask us to provide a small business compliance guide that would 
allow smaller entities to understand our procedures for publicly 
disclosing information, including information maintained in records 
required by this rule, to allow opportunity for redaction of 
``confidential'' information prior to disclosure.
    (Response 651) We disagree with the comments' interpretation of 
Sec. Sec.  20.47 and 20.48. Section 20.47 requires consultation with 
the person providing data or information only when the confidentiality 
of data or information is uncertain. During any such consultation FDA 
would provide any necessary information to the person who provided the 
data or information at issue.
    (Comment 652) Some comments ask us to modify the proposed 
requirement to clarify that it is ``records required by this part and 
provided to the Agency,'' rather than ``records obtained by the 
Agency'' that are subject to public disclosure.
    (Response 652) We agree that it is appropriate to specify that the 
disclosure requirements of this rule apply to information that we 
maintain as a record (see the description of ``record'' in Sec.  
20.20(e)). (See also the discussion (in the proposed rule to establish 
our seafood HACCP regulation, 59 FR 4142 at 4160, January 28, 1994) 
that there are significant legal and practical questions as to whether 
FDA has the authority to require disclosure of industry records that 
are not in FDA's possession.) However, we see no meaningful distinction 
between records ``provided to FDA'' and records ``obtained by FDA,'' 
and have revised the provision to specify that records obtained by FDA 
in accordance with this part are subject to the disclosure requirements 
under part 20. The revised regulatory text makes clear that the 
requirements of Part 20 attach to those documents obtained by FDA. To 
the extent that these comments are addressing the difference between 
records provided during inspection and records submitted to us, as 
already discussed we have decided not to require submission of certain 
records to us (see Response 648).

G. Proposed Sec.  117.330--Use of Existing Records

    We proposed that existing records (e.g., records that are kept to 
comply with other Federal, State, or local regulations, or for any 
other reason) do not need to be duplicated if they contain all of the 
required information and satisfy the requirements of subpart F. 
Existing records may be supplemented as necessary to include all of the 
required information and satisfy the requirements of subpart F. We also 
proposed that the information required by part 117 does not need to be 
kept in one set of records. If existing records contain some of the 
required information, any new information required by part 117 may be 
kept either separately or combined with the existing records.
    Comments that address this proposed requirement support it. For 
example, some comments state that this provision would provide 
flexibility to facilities to

[[Page 56093]]

comply with the record requirements in an efficient manner. Other 
comments state that this provision would prevent companies from having 
to duplicate records or create new records solely to satisfy 
recordkeeping requirements.
    (Comment 653) Some comments state that food safety plan records are 
a ``web of related documents'' that may be used in other programs and 
cannot be collected or ``reduced to a binder.''
    (Response 653) We agree that food safety plan records could be 
considered a ``web of related documents''--i.e., a set of records that 
could include documents used in other programs. We also agree that the 
food safety plan records need not be collected in a single location or 
``reduced to a binder.'' See the discussion in Response 215 about how a 
food safety plan could consist of one or more existing HACCP plans, one 
or more prerequisite programs that include food safety controls, and 
other components required by the rule, and be dated and signed even if 
its components are not kept in a single location.
    Likewise, the records documenting implementation of the plan could 
be a ``web of related documents.'' For example, a facility that 
collects samples of product and sends them to a laboratory for testing 
would have records documenting its collection of samples, as well as 
records documenting the laboratory's test results. Consistent with the 
requirements of the rule for written procedures for product testing 
(Sec.  117.165(b)(2)) and the general recordkeeping requirements of 
subpart F (Sec.  117.305), the sampling records would contain 
information such as the name and location of the facility, the date 
when the samples were collected, the signature or initials of the 
person collecting the samples, and the identity and lot code of the 
sampled product. Likewise, the laboratory report would contain 
information identifying the laboratory, the product tested (and 
associated lot code), the test analyte, the test(s) conducted 
(including the analytical method(s) used), the date of the test(s), the 
test results, and the signature or initials of the person who conducted 
the test. Alternatively, it would be acceptable to have the signature 
or initials of the person who approved the release of the test results 
from the laboratory. Together, these records contain all the required 
information to associate them with a facility, a specific lot of 
product, and the results of laboratory testing on that product.
    Although the provisions for use of existing records provide 
flexibility, there are some limitations. For example, monitoring 
records must be created concurrently with the monitoring activity and 
contain the signature or initials of the person conducting the 
monitoring. If the facility has an existing form that it uses to 
document the monitoring activity, and that form does not provide (or 
have space to add) information adequate to identify the plant or 
facility (e.g., the name and, when necessary, the location of the 
facility), and does have (or have space to add) a place for the 
signature of the person performing the activity, we expect the facility 
to modify the form rather than use the existing form. The provisions 
for ``supplementing'' existing records do not extend to providing 
information identifying the facility, or signatures, on separate pages.
    (Comment 654) Some comments state that our review of records should 
be limited to issues under our jurisdiction, regardless of the other 
information that may be contained in the record. Other comments ask us 
to ensure that inspectors are adequately trained on how to review 
facility records for the requisite information across multiple sets of 
documents, as needed.
    (Response 654) Section 418(h) of the FD&C Act requires that the 
written plan that documents and describes the procedures used by the 
facility to comply with the requirements of section 418, together with 
the documentation of monitoring of preventive controls, instances of 
nonconformance material to food safety, the results of testing and 
other means of verification, instances when corrective actions were 
implemented, and the efficacy of preventive controls and corrective 
actions, be made available to FDA. Our inspectors will be trained to 
focus on the written food safety plan and the records documenting 
implementation of the plan during inspections. Our inspectors have 
experience in the review of records that a food business establishes 
and maintains for more than one purpose--e.g., during the review of 
records kept under the section 414 recordkeeping regulations during the 
investigation of an outbreak of foodborne illness.

H. Final Sec.  117.335--Special Requirements Applicable to a Written 
Assurance

    As discussed in section XXVII, new Sec.  117.335 establishes 
requirements applicable to the written assurance a manufacturer/
processor obtains from its customer. New Sec.  117.335(a) applies to 
all written assurances required by the rule--i.e., the assurance must 
contain the effective date; printed names and signatures of authorized 
officials; and the applicable assurance.
    The provisions of Sec.  117.335(b), together with another new 
provision (Sec.  117.137), establish legal responsibilities under the 
rule for a facility that provides a written assurance regarding a food 
product that a manufacturer/processor distributes without application 
of a preventive control that is needed to control a hazard. This 
responsibility exists even for a facility that is not itself a 
manufacturer/processor, such as for a facility that is a distributor. 
We are establishing legal responsibilities for the facilities that 
provide these written assurances because following these assurances is 
critical to ensuring that required preventive controls are applied to 
the food by an entity in the distribution chain before the food reaches 
consumers.

I. Other Comments on the Recordkeeping Requirements of Subpart F

    (Comment 655) Some comments assert that the extensive recordkeeping 
requirements of every aspect of farm and food production would be 
crushing to small and mid-sized businesses. These comments ask us to 
replace the proposed recordkeeping requirements with a brief farm plan 
that outlines perceived risks and how the farmer plans to address those 
risks.
    (Response 655) We decline this request, which is largely moot in 
light of the changes we have made to the ``farm'' definition and to the 
classification of activities on-farm and off-farm (see the discussion 
in section IV of this document and table 1 in the Appendix to the 2014 
supplemental human preventive controls notice (79 FR 58524 at 58571-
58572)). None of the activities within the ``farm'' definition (i.e., 
packing and holding RACs, and certain processing activities (such as 
drying grapes to produce raisins, and packaging RACs such as 
strawberries, without additional manufacturing/processing), will be 
subject to this rule if performed on a farm.

XLII. Subpart G: General Comments on Proposed Requirements for a 
Supply-Chain Program

    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. The supplier program 
for a receiving facility would be limited to those raw materials and 
other ingredients for which the receiving facility has identified a 
significant hazard (which we now refer

[[Page 56094]]

to as ``hazard requiring a preventive control''). Under the definitions 
established in this rule, ``supplier'' means the establishment that 
manufactures/processes the food, raises the animal, or grows 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; ``receiving facility'' means a 
facility that is subject to subparts C and G and that manufactures/
processes a raw material or other ingredient that it receives from a 
supplier (see Sec.  117.3).
    We previously explained our understanding that, particularly for 
RACs, there may be multiple establishments, including cooperatives, 
packinghouses, and distributors, between a receiving facility and the 
establishment that would be considered the supplier, which would make 
supplier verification very challenging under certain circumstances (79 
FR 58524 at 58548). We requested comment on what verification 
activities would be appropriate for receiving facilities to conduct 
when a raw material or ingredient passes through more than one facility 
that would not be required to verify control of hazards if supplier 
programs are limited to manufacturers/processors. We discussed an 
example in which a receiving facility is a fresh-cut processing 
facility that receives produce from a distributor, who receives produce 
from a cooperative, and neither the distributor nor the cooperative is 
required to establish supplier controls for the farms where the hazards 
are being controlled, and we asked what supplier controls should be 
applied for the produce coming from the farms. We requested comment on 
whether and how the requirements for supplier verification should 
address such situations. We also requested comment regarding whether 
(and, if so, how) the final human preventive controls rule should 
address the potential for gaps in supplier controls when a hazard is 
controlled at Point A in the supply chain (e.g., by Supplier A, a 
farm), and Point B in the supply chain is a facility (such as Warehouse 
B, Distributor B, or Packing Shed B) that only packs or holds food, but 
does not manufacture/process food (and therefore would not be required 
to have a supplier program) before passing it on to Point C in the 
supply chain, which also would not be required to have a supplier 
program (e.g., Retail Food Establishment C or Consumer C). We discussed 
an example in which Packing Shed B distributes produce it packs after 
receiving the produce from Farm A directly to retail facilities (which 
would not be subject to the requirements of the human preventive 
controls rule); under the proposed suppler control program no supplier 
controls would be applied to Farm A. We requested comment on whether 
verification activities should be required in circumstances in which a 
RAC such as fresh produce will not be sent to any facilities that would 
be required to have preventive controls before reaching consumers.
    In the remainder of this section, we discuss comments that address 
our request for comment on complex supply-chain scenarios such as those 
described in the 2014 supplemental human preventive controls notice. We 
also describe our reasons for revising the proposed requirements for a 
supplier program to provide additional flexibility for an entity other 
than the receiving facility to determine, conduct, and document the 
appropriate supplier verification activities. When an entity other than 
the receiving facility determines, conducts, or both determines and 
conducts the appropriate supplier verification activities, the 
receiving facility must review and assess that entity's applicable 
documentation, and document the receiving facility's review and 
assessment. Providing this additional flexibility required a series of 
changes to multiple proposed provisions. To improve clarity and 
readability we redesignated proposed Sec.  117.136 into eight distinct 
sections of regulatory text in a newly established subpart G (Supply-
Chain Program), with editorial changes associated with the new 
structure of the redesignated regulations. See table 44 for the section 
numbers and titles in subpart G. See table 45 for an overview of the 
major revisions to the proposed requirements for a supplier program. 
See sections XLIII through XLIX for a discussion of the specific 
provisions of the final requirements for a supplier program, and table 
46, table 47, table 48, table 49, table 50, and table 51 for more 
detailed summaries of revisions to these specific provisions. Because 
table 45 is an overview, the changes identified in table 45 appear 
again in table 46, table 47, table 48, table 49, table 50, and table 
51. Because the editorial changes associated with the redesignation are 
extensive, we do not list them in table 52.
    The title of subpart G is ``Supply-Chain Program'' rather than 
``Supplier Program.'' As shown in table 45 and discussed in more detail 
in section XLIII.D, we have added one requirement applicable to non-
suppliers. ``Supply-chain program'' is a more appropriate term to 
reflect a subpart that includes a requirement applicable to non-
suppliers in addition to the requirements applicable to suppliers. 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.

 Table 44--Redesignation of the Requirements for a Supply-Chain Program
                              in Subpart G
                         [Supply-chain program]
------------------------------------------------------------------------
               Section                            Description
------------------------------------------------------------------------
117.405..............................  Requirement to establish and
                                        implement a supply-chain
                                        program.
117.410..............................  General requirements applicable
                                        to a supply-chain program.
117.415..............................  Responsibilities of the receiving
                                        facility.
117.420..............................  Using approved suppliers.
117.425..............................  Determining appropriate supplier
                                        verification activities
                                        (including determining the
                                        frequency of conducting the
                                        activity).
117.430..............................  Conducting supplier verification
                                        activities for raw materials and
                                        other ingredients.
117.435..............................  Onsite audit.
117.475..............................  Records documenting the supply-
                                        chain program.
------------------------------------------------------------------------


[[Page 56095]]


             Table 45--Overview of Revisions to the Proposed Requirements for a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
   Final section designation     Proposed section designation        Description                Revision
----------------------------------------------------------------------------------------------------------------
Throughout....................  Throughout....................  The type of            Refer to ``supply-chain-
                                                                 preventive control     applied control'' rather
                                                                 applicable to the      than ``preventive
                                                                 supply-chain program.  control'' or variations
                                                                                        such as ``hazard
                                                                                        requiring a preventive
                                                                                        control when the hazard
                                                                                        is controlled before
                                                                                        receipt of the raw
                                                                                        material or other
                                                                                        ingredient.''
117.136(a)(2).................  117.136(a)(1)(ii).............  A supply-chain         Shifted to be in
(in subpart C)................                                   program is not         provisions outside the
                                                                 required when the      framework of the supply-
                                                                 hazard will be         chain program in subpart
                                                                 controlled by the      G.
                                                                 receiving facility's
                                                                 customer in the
                                                                 distribution chain.
117.405(a)(2).................  N/A...........................  Circumstances that do  The receiving facility
                                                                 not require a supply-  does not need a supply-
                                                                 chain program.         chain program when the
                                                                                        receiving facility is an
                                                                                        importer, is in
                                                                                        compliance with the
                                                                                        forthcoming FSVP
                                                                                        requirements, and has
                                                                                        documentation of
                                                                                        verification activities
                                                                                        conducted under the
                                                                                        forthcoming FSVP
                                                                                        program.
117.405(a)(3).................  N/A...........................  Exemption from the     Exemption for food
                                                                 requirements for a     supplied for research or
                                                                 supply-chain program.  evaluation.
117.405(c)....................  N/A...........................  Requirements           When a supply-chain-
                                                                 applicable to non-     applied control is
                                                                 suppliers.             applied by an entity
                                                                                        other than the receiving
                                                                                        facility's supplier
                                                                                        (e.g., when a non-
                                                                                        supplier applies
                                                                                        controls to certain
                                                                                        produce (i.e., produce
                                                                                        that will be subject to
                                                                                        the forthcoming produce
                                                                                        safety rule), because
                                                                                        growing, harvesting, and
                                                                                        packing activities are
                                                                                        under different
                                                                                        management), the
                                                                                        receiving facility must
                                                                                        (1) verify the supply-
                                                                                        chain-applied control;
                                                                                        or (2) obtain
                                                                                        documentation of an
                                                                                        appropriate verification
                                                                                        activity from another
                                                                                        entity, review and
                                                                                        assess the entity's
                                                                                        applicable
                                                                                        documentation, and
                                                                                        document that review and
                                                                                        assessment.
117.410(c)....................  117.136(a)(3)(ii).............  Purpose of the supply- Specify only that the
                                                                 chain program.         supply-chain program
                                                                                        must provide assurance
                                                                                        that a hazard requiring
                                                                                        a supply-chain-applied
                                                                                        control has been
                                                                                        significantly minimized
                                                                                        or prevented.
117.410(d)....................  117.136(b)....................  Factors that must be    Clarification
                                                                 considered in          that these factors must
                                                                 determining            be considered in
                                                                 appropriate supplier   approving suppliers, as
                                                                 verification           well as in determining
                                                                 activities.            appropriate supplier
                                                                                        verification activities.
                                                                                        Flexibility in
                                                                                        the factors that must be
                                                                                        considered if a supplier
                                                                                        is a qualified facility,
                                                                                        a produce farm that will
                                                                                        not be subject to the
                                                                                        forthcoming produce
                                                                                        safety rule on the basis
                                                                                        of size and/or direct
                                                                                        farm marketing, or a
                                                                                        shell egg producer that
                                                                                        is not subject to the
                                                                                        requirements of 21 CFR
                                                                                        part 118 (production,
                                                                                        storage, and
                                                                                        transportation of shell
                                                                                        eggs) because it has
                                                                                        less than 3,000 laying
                                                                                        hens.
117.415(a)....................  N/A...........................  Responsibilities of    Provide flexibility for
                                                                 the receiving          an entity other than the
                                                                 facility.              receiving facility to
                                                                                        determine, conduct, and
                                                                                        document supplier
                                                                                        verification activities,
                                                                                        provided that the
                                                                                        receiving facility
                                                                                        reviews and assesses
                                                                                        applicable documentation
                                                                                        from that entity and
                                                                                        documents the receiving
                                                                                        facility's review and
                                                                                        assessment.
117.415(b)....................  N/A...........................  Responsibilities of    Specify documentation
                                                                 the receiving          that a receiving
                                                                 facility.              facility may not accept
                                                                                        from a supplier to
                                                                                        satisfy the receiving
                                                                                        facility's
                                                                                        responsibilities for its
                                                                                        supply-chain program.
117.420(a)....................  117.136(a)(3)(i)..............  Approval of suppliers  Explicit requirement for
                                                                                        a receiving facility to
                                                                                        approve its suppliers.
117.420(b)....................  117.136(a)(3)(i)..............  Approval of suppliers  Explicit requirement for
                                                                                        a receiving facility to
                                                                                        establish and follow
                                                                                        written procedures for
                                                                                        receiving raw materials
                                                                                        and other ingredients.
117.430(e)....................  N/A...........................  Alternative supplier   Provide for an
                                                                 verification           alternative supplier
                                                                 activity.              verification activity
                                                                                        when the supplier is a
                                                                                        shell egg producer with
                                                                                        less than 3,000 laying
                                                                                        hens.
117.430(f)....................  N/A...........................  Independence of the    Specify that there must
                                                                 supplier.              not be any financial
                                                                                        conflicts of interests
                                                                                        that influence the
                                                                                        results of the
                                                                                        verification activities
                                                                                        listed in Sec.
                                                                                        117.410(b) and payment
                                                                                        must not be related to
                                                                                        the results of the
                                                                                        activity.
117.435(c)(1).................  117.136(e)....................  Substitution of an     Provide additional
                                                                 inspection for an      flexibility for domestic
                                                                 audit.                 inspection by
                                                                                        representatives of other
                                                                                        Federal agencies (such
                                                                                        as USDA), or by
                                                                                        representatives of
                                                                                        State, local, tribal, or
                                                                                        territorial agencies.
117.475.......................  117.136(g)....................  Records documenting    List additional records
                                                                 the supply-chain       associated with the
                                                                 program.               revised provisions.
----------------------------------------------------------------------------------------------------------------

    (Comment 656) Several comments ask us to issue guidance rather than 
establish requirements for a supplier program in the rule. Some 
comments assert that the benefits of a supplier verification program do 
not outweigh

[[Page 56096]]

the costs, that we did not consider the effects of such a requirement 
on farms and small businesses, and that FSMA does not actually contain 
a requirement for a supplier verification program. Conversely, other 
comments support including a mandatory supplier program in the rule for 
hazards that are controlled in raw materials and other ingredients 
before receipt by the receiving facility, although many comments assert 
that a supplier verification program should be viewed as a verification 
activity rather than a preventive control. Some comments assert that a 
mandatory domestic supplier program is necessary to provide parity with 
the requirements of the FSVP rule authorized by FSMA, while other 
comments assert that FSMA's authorization of foreign supplier 
verification should not be used to justify a domestic supplier program. 
Some of these comments single out our request for comment, in the 
proposed FSVP rule, on whether to allow an entity that would be both an 
importer (under the FSVP rule) and a receiving facility (under the 
human preventive controls rule) to be deemed in compliance with the 
FSVP rule if it was in compliance with the supplier verification 
provisions of the human preventive controls rule, and agree with such 
an approach (78 FR 47730 at 45748).
    (Response 656) We agree that it is necessary to include a mandatory 
supply-chain program in the rule to ensure the safety of food where 
hazards are controlled in raw materials and other ingredients before 
receipt by a receiving facility, and we are finalizing such a 
requirement in this rule. The statute specifically identifies supplier 
verification activities as a preventive control (see section 418(o)(3) 
of the FD&C Act). Further, we believe a supply-chain program is a 
measure that a person knowledgeable about food safety would establish 
and implement in order to significantly minimize or prevent hazards 
requiring a preventive control in an incoming raw material or other 
ingredient.
    Supplier verification is sufficiently important for the control of 
hazards in both domestic and imported foods that FSMA contains 
provisions for both domestic and foreign supplier verification 
(sections 418(o)(3) and 805 of the FD&C Act). Because we have aligned 
the provisions for supplier verification in the FSVP rule with the 
provisions for a supply-chain program in this rule, we are allowing 
importers and receiving facilities to take advantage of that fact in 
considering compliance with both part 117 and our forthcoming FSVP 
regulations that we proposed to establish in part 1, subpart L, so that 
they do not have to duplicate verification activities (see Sec.  
117.405(a)(2)).
    (Comment 657) Some comments that addressed questions we asked in 
the 2013 proposed human preventive controls rule and the 2014 
supplemental human preventive controls notice recommend that we add 
flexibility to the requirements for a supplier program such that any 
entity in the supply chain between the supplier and the receiving 
facility can perform supplier verification activities. Some comments 
ask us to allow a receiving facility to have a supplier program 
established for it by another entity. Other comments assert that it 
would be too burdensome for a receiving facility to consider any 
information related to the supplier's supplier or to go further back in 
the supply chain beyond the entity that is one back from the receiving 
facility. Other comments assert that we should eliminate any 
requirements for a supplier program from the rule because a supplier 
program involving more entities than just the receiving facility and 
the supplier would become too complex. Some comments express concern 
that we would be creating ``an environment where our supply chain is 
required to be disclosed to our customers via product testing, audits 
and supplier verification,'' asserting that this would discourage 
customers from buying from entities such as re-packers when they could 
go to the source. Some comments state that we have not taken into 
account the low-risk nature of specific industries such as those that 
re-pack already processed foods. Other comments ask us to confirm that 
distributors and warehouses are not included in the requirements for a 
supplier program because they would not likely meet the definition of a 
receiving facility or a supplier.
    (Response 657) We agree with comments recommending additional 
flexibility in the supply-chain program with regard to who can perform 
certain activities and have added this flexibility to the final rule 
(see Sec.  117.415). Because the receiving facility and the supplier 
may be separated by several entities in a supply chain, we are allowing 
such entities (e.g., distributors, brokers, aggregators) to determine, 
conduct, and document 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 
(see Sec. Sec.  117.415(a)(1) and 117.420(a) and Response 658).
    We disagree that complex supply chains make a supply-chain program 
too difficult and that a receiving facility cannot be expected to reach 
further back in a supply chain than the entity immediately before it in 
the supply chain. Supply-chain programs are currently used by 
facilities as a standard business practice and we understand that some 
of those supply chains are complex, with entities between the receiving 
facility and the supplier. We acknowledge that complex supply chains 
present a challenge because information will need to flow through 
several entities to allow the link between the receiving facility and 
the supplier. However, we believe a supply-chain program is a critical 
preventive control for receiving facilities that will rely on suppliers 
to control hazards in raw materials and other ingredients. Although 
distributors, brokers, and other entities in the supply chain between a 
receiving facility and its supplier are not required to have a role in 
supplier verification, they have the option to determine, conduct, and 
document supplier verification activities as a service to the receiving 
facility if they so choose. If these entities choose not to participate 
in supplier verification, the receiving facility will need to reach 
back in the supply chain past them. In such situations, it may be 
necessary for the entities between the receiving facility and the 
supplier to provide the identity of the supplier to the receiving 
facility, if that identity is not available on the raw material or 
other ingredient or otherwise apparent. In such cases, the role that 
distributors, brokers, aggregators, and similar entities would play in 
supplier verification would be minimal. We cannot determine whether 
having to provide the identity of the supplier to the receiving 
facility would change buying practices. However, we believe that 
manufacturers consider a number of factors in determining who they will 
purchase from, including the services provided, and that there will 
continue to be a role for aggregators, re-packers, brokers, and others. 
We have provided flexibility for these entities to play a role in 
supplier verification if the receiving facility and the business entity 
determine there is a benefit to do so.
    See also the discussion in section XLV regarding the specific 
provisions of Sec.  117.415. Although comments focus on flexibility for 
an entity in the supply chain between the supplier and the

[[Page 56097]]

receiving facility to perform supplier verification activities, and 
such entities are the most likely entities to be the entities 
determining, conducting, and documenting supplier verification 
activities, the flexibility provided by the rule is not limited to such 
entities.
    (Comment 658) Some comments ask us to establish a general 
requirement for a supplier program without specifying roles and 
responsibilities for the various entities involved. Other comments ask 
us to define ``supplier'' as the entity with which the receiving 
facility has a commercial relationship.
    (Response 658) We disagree that we should establish a general 
requirement for a supply-chain program without specifying roles and 
responsibilities for the various entities involved. Although we have 
added flexibility to provide that an entity other than the receiving 
facility may determine, conduct, and document supplier verification 
activities (see Sec.  117.415), we continue to believe it is important 
to clearly define two roles in the supply chain that share the primary 
responsibility in the supplier verification process--i.e., the 
receiving facility and the supplier. In all cases where we have added 
flexibility for participation by an entity other than the receiving 
facility, the responsibility for the supply-chain program is clearly 
lodged with the receiving facility, and linked to the supplier (see 
Sec.  117.415). To emphasize the responsibility of the receiving 
facility and its link to the supplier, the final rule clearly states 
that the receiving facility must approve its suppliers before receiving 
raw materials and other ingredients (see Sec.  117.420(a)).
    For the supply-chain program to be meaningful and robust, there 
must be an exchange of information between these two entities--the 
entity receiving the food and the entity that controlled the hazard--
even when an entity other than the receiving facility participates by 
determining, conducting, and documenting some supplier verification 
activities. The ultimate responsibility for supplier verification rests 
with the receiving facility through its determination in approving 
suppliers and in reviewing and assessing applicable documentation 
provided by another entity. Therefore, we also disagree that the 
definition of ``supplier'' should be revised to be the next entity back 
in a supply chain (e.g., the entity with which a receiving facility has 
a commercial relationship). The entity with which a receiving facility 
has a commercial relationship might be a distributor, broker, or 
aggregator. A distributor, broker, or aggregator does not control an 
identified hazard and, therefore, cannot assume the same role as an 
establishment that manufactures/processes the food, raises the animal, 
or grows the food.
    (Comment 659) Some comments ask us to provide flexibility in the 
content of the supplier program. Some comments assert that specifying 
the content of the supplier program would result in duplicative 
requirements on suppliers, who must first comply with certain 
regulations and then demonstrate that compliance in order to comply 
with a different regulation.
    (Response 659) We disagree that a requirement for a supply-chain 
program in which compliance with an underlying regulation is 
demonstrated is duplicative with the need to comply with the underlying 
regulation. The requirement for a supply-chain program is not mandating 
that the facility or farm comply twice with the human preventive 
controls rule or the produce safety rule; it is merely requiring that 
the compliance by the facility or the farm with the applicable 
regulation be verified to ensure that hazards requiring a preventive 
control are being controlled.
    We are continuing to specify the basic content of a supply-chain 
program--i.e., using approved suppliers; determining appropriate 
supplier verification activities; conducting supplier verification 
activities; and establishing records documenting these activities (see 
Sec.  117.410(a)). However, the rule provides flexibility in the choice 
of supplier verification activities and how often such activities must 
be performed. (See Sec. Sec.  117.410(b)(4) and 117.430(b)(2), (c), 
(d), and (e)). In addition, the rule provides for an alternative 
supplier verification activity for certain entities (see Sec.  
117.430(c), (d), and (e)) regarding alternative supplier verification 
activities for qualified facilities, certain produce farms, and certain 
shell egg producers, respectively).
    (Comment 660) As already noted in this section, in the 2014 
supplemental human preventive controls notice we asked for comment on 
whether verification activities should be required in circumstances in 
which a RAC such as fresh produce will not be sent to any facilities 
that would be required to have preventive controls before reaching 
consumers. In response, we received comments both in support of, and in 
opposition to, a requirement that verification activities be conducted 
in circumstances in which produce would go directly from an 
establishment that would not be required to have supplier controls 
(e.g., farm, warehouse, distributor) to another establishment not 
required to have supplier controls (e.g., retail food establishment) or 
to a consumer. Some comments assert that any firm that sells directly 
to retail food establishments or consumers should have a supplier 
program in place, while other comments assert that this is not 
necessary, particularly in the case of RACs.
    Some comments maintain that the produce safety rule will provide 
adequate assurances of safety for covered produce and that covering 
such products with the supplier verification requirements of the human 
food preventive controls rule would be subjecting this produce to 
duplicative requirements. These comments recommend that, if some 
verification is required in these ``gaps'' on which we asked for 
comment, entities in these categories be allowed to voluntarily apply 
certain supplier verification best practices rather than be subject to 
the supplier program requirements of this rule.
    (Response 660) As previously discussed (79 FR 58524 at 58548), 
fresh produce often goes directly from the farm to a distributor and 
then on to retail food establishments and/or consumers. We are not 
requiring any of the entities in this supply chain to do supplier 
verification under part 117, so the farm's compliance with the produce 
safety rule, if applicable, will not be verified unless done 
voluntarily. In contrast, we are requiring that a manufacturer/
processor that uses covered produce to make a processed product such as 
fresh-cut produce establish and implement a supply-chain program. As we 
have previously discussed, processing fresh produce into fresh-cut 
products increases the risk of bacterial growth and contamination (Ref. 
89). This has the potential to increase the exposure to pathogens, 
because contamination of a few pieces of raw produce can be spread to 
many servings of processed fresh-cut produce. Disturbing the physical 
barriers of produce (e.g., by cutting the produce) and inadequate 
temperature control of fresh-cut produce can enhance bacterial growth 
(including growth of pathogens, if present). The increased risk 
presented by processing of fresh produce makes it appropriate to 
subject this processed food to the full requirements of the human 
preventive controls rule in addition to the requirements of the 
forthcoming produce safety rule for the RACs that are used to make this 
processed food.

XLIII. Subpart G: Comments on Requirement To Establish and Implement a 
Supply-Chain Program

    We proposed that the receiving facility must establish and 
implement a

[[Page 56098]]

risk-based supplier program for those raw materials and ingredients for 
which the receiving facility has identified a significant hazard when 
the hazard is controlled before receipt of the raw material or 
ingredient (proposed Sec.  117.136(a)). We also proposed circumstances 
when a receiving facility would not be required to have a supplier 
program.
    In the following sections, we discuss comments that ask us to 
clarify the proposed requirement to establish and implement a written 
supplier program or that disagree with, or suggest one or more changes 
to, the proposed requirements. After considering these comments, we 
have revised the regulatory text as shown in table 46.

       Table 46--Revisions to the Proposed Requirements To Establish and Implement a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
    Final section  designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
N/A...............................  117.136(a)(2)(i).....  A supplier program is not   Deleted as unnecessary.
                                                            required when there are
                                                            no hazards requiring a
                                                            preventive control.
N/A...............................  117.136(a)(2)(i).....  A supplier program is not   Deleted as unnecessary.
                                                            required when the
                                                            preventive controls at
                                                            the receiving facility
                                                            are adequate to
                                                            significantly minimize or
                                                            prevent each of the
                                                            hazards requiring a
                                                            preventive control.
117.136(a)(2).....................  117.136(a)(2)(iii)...  A supplier program is not   Shifted to be in
                                                            required when the hazard    provisions outside the
                                                            will be controlled by the   framework of the supply-
                                                            receiving facility's        chain program in subpart
                                                            customer in the             G.
                                                            distribution chain.
117.405(a)(2).....................  N/A..................  Circumstances that do not   A receiving facility is
                                                            require a supply-chain      an importer, is in
                                                            program even though the     compliance with the
                                                            receiving facility's        forthcoming FSVP
                                                            hazard analysis             requirements, and has
                                                            determines that a hazard    documentation of
                                                            requires a supply-chain-    verification activities
                                                            applied control.            conducted under the
                                                                                        forthcoming FSVP
                                                                                        program.
117.405(a)(3).....................  N/A..................  Exemption from the          Exemption for food
                                                            requirements for a supply-  supplied for research or
                                                            chain program.              evaluation.
117.405(c)........................  N/A..................  Requirements applicable to  When a supply-chain-
                                                            non-suppliers.              applied control is
                                                                                        applied by an entity
                                                                                        other than the receiving
                                                                                        facility's supplier
                                                                                        (e.g., when a non-
                                                                                        supplier applies
                                                                                        controls to certain
                                                                                        produce (i.e., produce
                                                                                        that will be subject to
                                                                                        the forthcoming produce
                                                                                        safety rule), because
                                                                                        growing, harvesting, and
                                                                                        packing activities are
                                                                                        under different
                                                                                        management), the
                                                                                        receiving facility must
                                                                                        (1) verify the supply-
                                                                                        chain-applied control;
                                                                                        or (2) obtain
                                                                                        documentation of an
                                                                                        appropriate verification
                                                                                        activity from another
                                                                                        entity, review and
                                                                                        assess the entity's
                                                                                        applicable
                                                                                        documentation, and
                                                                                        document that review and
                                                                                        assessment.
----------------------------------------------------------------------------------------------------------------

A. Requirement for a Written Supply-Chain Program (Final Sec.  
117.405(a)(1) and (b))

    We proposed that the receiving facility must establish and 
implement a risk-based supplier program for those raw materials and 
ingredients for which the receiving facility has identified a 
significant hazard when the hazard is controlled before receipt of the 
raw material or ingredient. We also proposed that the supplier program 
must be written. (See proposed Sec.  117.136(a)(1)(i) and (2).) To 
improve clarity, we have revised the revision to substitute the phrase 
``hazard requiring a supply-chain-applied control'' for the phrase 
``significant hazard when the hazard is controlled before receipt of 
the raw material or ingredient.'' We have added a definition for the 
term ``supply-chain-applied control'' to mean a preventive control for 
a hazard in a raw material or other ingredient when the hazard in the 
raw material or other ingredient is controlled before its receipt (see 
Sec.  117.3) and use the more specific term ``supply-chain-applied 
control,'' rather than the broader term ``preventive control,'' 
throughout the provisions for a supply-chain program.
    (Comment 661) As discussed in Comment 656, several comments ask us 
to issue guidance rather than establish requirements for a supplier 
program in the rule.
    (Response 661) See Response 656 for a discussion of our reasons for 
declining this request and establishing requirements for a supply-chain 
program in the rule.
    (Comment 662) Some comments ask us to revise the regulatory text to 
remove the condition that all hazards be foreseeable so that the 
supplier program can address economically motivated adulteration.
    (Response 662) This comment is unclear. The requirement for a 
supply-chain program applies when the outcome of a hazard analysis is 
that a known or reasonably foreseeable hazard requires a preventive 
control, and the hazard would be controlled by the receiving facility's 
supplier. The requirement applies regardless of whether the hazard 
requiring a preventive control is, or is not, a hazard that would be 
introduced into a food for the purposes of economic gain.
    (Comment 663) Some comments ask us to specify that a Certificate of 
Analysis or other documentation of the existence and/or level of a 
hazard could be provided to the receiving facility to indicate the 
potential for an actual existence of a hazard so that the receiving 
facility could evaluate whether the hazard requires a preventive 
control. One comment explains that chemical contaminants such as lead 
are not controlled through easily described ``procedures'' but are 
instead controlled through factors such

[[Page 56099]]

as product formulation (e.g., controlling the levels of contaminants in 
each ingredient depending on the proportion of the ingredient in the 
finished food) and serving size. These comments explain that chemical 
contaminants such as lead may require control in one context (e.g., if 
children are the target consumers) but not in another context (e.g., if 
adults are the target consumers and the product is unlikely to be 
consumed by children). This comment expresses concern about whether 
customers would be willing to provide the receiving facility with 
confidential information about the customer's own hazard analysis with 
respect to sensitive topics (e.g., how much lead it has decided to 
allow in its finished products, or how its product formulation controls 
the level of lead in its finished food). Furthermore, in such cases the 
receiving facility will not even know whether the chemical contaminant 
constitutes an actual ``hazard'' for the purposes of the customer's 
finished food. This comment also asserts that a Certificate of Analysis 
provided to a receiving facility constitutes ``control before receipt 
of the raw material or ingredient.''
    (Response 663) We do not understand the concern of this comment. A 
receiving facility and a supplier do not need to share all of the 
details of product formulation for a receiving facility to communicate 
its requirements to a supplier. In the example provided by the comment, 
the receiving facility could provide the supplier with a written 
specification for a contaminant such as lead, and the supplier could 
demonstrate that it satisfied the receiving facility's specification by 
providing a Certificate of Analysis showing the results of laboratory 
testing for lead. Neither the written specification provided by the 
receiving facility, nor the Certificate of Analysis provided by the 
supplier, would disclose confidential information about the 
formulations or procedures of either entity.
    This comment also appears to misunderstand the applicability of the 
supply-chain program. The rule requires a supply-chain program when the 
receiving facility has identified, through its hazard analysis, that 
there is a hazard requiring a supply-chain-applied control. In the 
circumstances described by the comment, a Certificate of Analysis or 
other documentation of test results from the supplier to the receiving 
facility could demonstrate that the supplier has controlled the hazard 
to the receiving facility's specifications, but would not overturn the 
outcome of the receiving facility's hazard analysis that there is a 
hazard requiring a preventive control, and that the appropriate control 
is applied by the supplier. On the contrary, the Certificate of 
Analysis simply demonstrates that the supply-chain-applied control 
functioned as intended.
    (Comment 664) One comment asks us to specify in the regulatory text 
that the supplier program must be written ``if required'' because there 
are specified circumstances when a supplier program is not required.
    (Response 664) We decline this request. Although the rule provides 
circumstances when a supply-chain program is not required (see Sec.  
117.405(a)(2)), it is not necessary to specify, for all other 
provisions of the supply-chain program, that the provision only applies 
``if required.''

B. Circumstances That Do Not Require a Written Supply-Chain Program 
(Final Sec.  117.405(a)(2))

    We proposed that the receiving facility is not required to 
establish and implement a supplier program for raw materials and 
ingredients for which there are no significant hazards; the preventive 
controls at the receiving facility are adequate to significantly 
minimize or prevent each of the significant hazards; or the receiving 
facility relies on its customer to control the hazard and annually 
obtains 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. (See 
proposed Sec.  117.136(a)(1)(ii)(A), (B), and (C).)
    We are deleting the proposed provision that a supplier program is 
not required for raw materials and ingredients for which there are no 
``significant hazards'' (which we now refer to as ``hazards requiring a 
preventive control'') because it is unnecessary. The supply-chain 
program is required when a hazard identified in the receiving 
facility's hazard analysis identifies a hazard requiring a supply-
chain-applied control; it is not necessary to also state the converse. 
Likewise, we are deleting the proposed provision that a supplier 
program is not required if the preventive controls at the receiving 
facility are adequate to significantly minimize or prevent each of the 
significant hazards. In such a case, the outcome of the hazard analysis 
would not be that the hazard requires a supply-chain-applied control.
    As discussed in section XXVII, after considering comments, we are 
shifting the provision in which the receiving facility relies on its 
customer to control the hazard from the requirements for a supply-chain 
program to a series of provisions that apply when a manufacturer/
processor identifies a hazard requiring a preventive control, but can 
demonstrate and document that the hazard will be controlled by an 
entity in its distribution chain (see Sec. Sec.  117.136 and 117.137). 
However, as discussed in Response 665 and section XLIII.C, we also are 
establishing two additional circumstances when a supply-chain program 
is not required (see Sec.  117.405(a)(2) and (3)).
    (Comment 665) As noted in Comment 656, some comments single out our 
request for comment, in the proposed FSVP rule, on whether to allow an 
entity that would be both an importer (under the FSVP rule) and a 
receiving facility (under the human preventive controls rule) to be 
deemed in compliance with the FSVP rule if it was in compliance with 
the supplier verification provisions of the human preventive controls 
rule, and agree with such an approach (78 FR 47730 at 45748).
    (Response 665) As noted in Response 656, we have aligned the 
provisions for supplier verification in the FSVP rule with the 
provisions for a supply-chain program in this rule, and we are allowing 
importers that are receiving facilities to take advantage of that fact 
in considering compliance with our forthcoming FSVP regulations that we 
proposed to establish in part 1, subpart L, so that they do not have to 
duplicate verification activities (see Sec.  117.405(a)(2)).
    (Comment 666) Some comments support the specified criteria for when 
a receiving facility would not be required to establish and implement a 
supplier program. Other comments express concern that these criteria 
suggest no supplier verification is needed at all in some circumstances 
despite supplier verification activities being potentially informative 
about a particular supplier. These comments ask us to establish some 
general requirement to perform verification activities for all 
suppliers.
    (Response 666) We decline this request because it is neither risk-
based nor consistent with the nature and purpose of the supply-chain 
program, which is to provide assurance that a hazard requiring a 
supply-chain-applied control has been significantly minimized or 
prevented (see the regulatory text of Sec.  117.410(c)). We agree that 
some degree of verification of all suppliers may prove useful to a 
receiving facility for various purposes, and the rule would not prevent 
a receiving facility from establishing a

[[Page 56100]]

supply-chain program for all of its suppliers regardless of risk and 
regardless of whether the applicable hazard in a raw material or other 
ingredient is controlled before its receipt.
    (Comment 667) Some comments ask us to specify that a ``kill step'' 
would be an adequate indicator to significantly minimize or prevent 
significant hazards identified by the receiving facility when the 
receiving facility controls the hazard.
    (Response 667) These comments appear to misunderstand the 
applicability of the supply-chain program. The rule requires a supply-
chain program when the receiving facility has identified, through its 
hazard analysis, that there is a hazard requiring a preventive control 
and the receiving facility's manufacturing/processing will not control 
the hazard. In the circumstances described by the comment, the 
receiving facility is controlling the hazard and a supply-chain program 
for the raw material or other ingredient is not required. It is not 
necessary to specify the types of controls that the receiving facility 
may use to control the hazard.
    (Comment 668) Some comments ask us to specify that a receiving 
facility need not establish and implement a supplier program for raw 
materials and ingredients if those raw materials or ingredients were 
received from an affiliated party within the same corporate or 
controlling entity.
    (Response 668) We decline this request. With the revisions we have 
made to the proposed requirements for a supplier program, the supply-
chain program that we are establishing in this rule provides ample 
opportunities for an affiliated party within the same corporate or 
controlling entity to establish and implement a supply-chain program 
that is suited to its relationship to these entities. For example, as 
discussed in Response 687, a receiving facility might be able to 
determine and document a justification for a supplier verification 
activity other than an annual audit when a supplier is an affiliated 
party based on the receiving facility's knowledge of the corporate 
policies regarding food safety practices (see Sec.  117.430(b)(2)). In 
addition, as discussed in Response 690, we have agreed that the 
corporate parent of a facility can be active in developing and 
implementing the facility's food safety plan (see section XXIV.A). If, 
for example, a corporate headquarters establishes and implements a 
supply-chain program for use company-wide, a receiving facility could 
rely on supplier verification activities conducted by its corporate 
headquarters, with applicable documentation available during 
inspection.

C. Exemption for Food Supplied for Research or Evaluation (Final Sec.  
117.405(a)(3))

    We are establishing an exemption from the requirement for a 
receiving facility to establish and implement a supply-chain program 
when it receives food for the purposes of research or evaluation, 
provided that certain conditions are met (see Sec.  117.405(a)(3)). 
Those conditions are that the food: (1) Is not intended for retail sale 
and is not sold or distributed to the public; (2) is labeled with the 
statement ``Food for research or evaluation use''; (3) is supplied in a 
small quantity that is consistent with a research, analysis, or quality 
assurance purpose, the food is used only for this purpose, and any 
unused quantity is properly disposed of; and (4) is accompanied with 
documents, in accordance with the practice of the trade, stating that 
the food will be used for research or evaluation purposes and cannot be 
sold or distributed to the public. The exemption is analogous to an 
exemption we proposed for the FSVP rule under section 805(f) of the 
FD&C Act. (See proposed Sec.  1.501(c), 78 FR 45730 at 45745). We 
believe it is not necessary to conduct supplier verification activities 
when food is obtained in this limited circumstance.

D. Additional Requirements for Non-Suppliers (Final Sec.  117.405(c))

    As discussed in section IV.B, the final rule includes several 
revisions to the ``farm'' definition in response to comments. For 
example, 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. In 
response to these comments, we have added a new definition for a 
``secondary activities farm,'' which provides for practices such as 
packing by cooperatives and packinghouses under the ownership of 
multiple growers to remain within the ``farm'' definition (See Response 
25). Another change to the ``farm'' definition accommodates 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 (see Response 32). As discussed in Response 32, 
this revision is a change from the ``farm'' definition established in 
the section 415 registration regulations in 2003, and the proposed 
revisions to the ``farm'' definition in the 2013 proposed human 
preventive controls rule and the 2014 supplemental human preventive 
controls notice, which all describe a ``farm'' as an entity ``devoted 
to the growing and harvesting of crops'' (emphasis added).
    We proposed the requirements for a supplier program in the context 
of a single business entity ``devoted to the growing and harvesting of 
crops'' (emphasis added), in which packing operations were often done 
by that same business entity. The final ``farm'' definition 
accommodates business models where growing, harvesting, and packing 
operations will be done by different business entities. Harvesting and 
packing operations include some supply-chain-applied controls, such as 
controls on worker hygiene, quality of water used during harvesting and 
packing operations, and establishing and following water-change 
schedules for recirculated water, even though the harvesting and 
packing operations do not fall within the definition of ``supplier.''
    A receiving facility has an obligation to 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 under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act (see section 418(c) of the FD&C Act and 
Sec.  117.135(a)). That obligation includes responsibilities for raw 
materials and other ingredients when a supply-chain-applied control is 
applied by an entity other than the receiving facility's supplier. An 
example of such a situation is when produce that will be covered by the 
forthcoming produce safety rule is grown, harvested, and packed under 
different management. To clarify the receiving facility's 
responsibilities when a supply-chain-applied control is applied by a 
non-supplier, we are establishing a requirement specifying that when a 
supply-chain-applied control is applied by an entity other than the 
receiving facility's supplier (e.g., when a non-supplier applies 
controls to certain produce (i.e., produce that will be subject to the 
forthcoming produce safety rule), because growing, harvesting, and 
packing activities are under different management), the receiving 
facility must: (1) Verify the supply-chain-applied control; or (2) 
obtain documentation of an appropriate verification activity from 
another entity, review and assess the entity's applicable 
documentation, and document that review and assessment. See

[[Page 56101]]

Sec.  117.405(c). Because Sec.  117.405(c) 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.
    We do not expect the receiving facility to follow all of the 
requirements of subpart G applicable to ``suppliers'' when verifying 
control by a ``non-supplier,'' as required by Sec.  117.405(c). 
Instead, we expect the receiving facility will take steps such as a 
review of the non-supplier's applicable food safety records. For 
example, if a receiving facility receives produce from a supply chain 
that includes a separate grower, harvester, and packer, the grower is 
the supplier and the requirements of subpart G applicable to 
``suppliers'' apply to the grower. To verify controls applied by the 
harvester, the receiving facility could review the harvester's records, 
such as records of training for harvest workers and records of 
agricultural water quality used in harvest operations. To verify 
controls applied by the packer, the receiving facility could review the 
packer's records, such as records of agricultural water quality used in 
packing operations. As discussed in Response 657, we are allowing 
entities such as distributors, brokers, and aggregators to determine, 
conduct, and document verification activities that apply to suppliers 
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. Likewise, under 
Sec.  117.405(c)(2) a receiving facility could obtain documentation of 
review of applicable records maintained by the harvester or packer from 
another entity, review and assess the entity's applicable 
documentation, and document that review and assessment.

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))

    We proposed that when supplier verification activities are required 
for more than one type of hazard in a food, the receiving facility must 
conduct the verification activity or activities appropriate for each of 
those hazards. We also proposed that for some hazards, in some 
situations it will be necessary to conduct more than one verification 
activity and/or to increase the frequency of one or more verification 
activities to provide adequate assurances that the hazard is 
significantly minimized or prevented. We have concluded that these 
provisions are largely self-evident and need not be included in the 
regulatory text. Therefore, we are not finalizing these proposed 
provisions. We will consider whether it will add value to discuss the 
principles in these proposed provisions in guidance that we intend to 
develop for the supply-chain program.

XLIV. Subpart G: Comments on General Requirements Applicable to a 
Supply-Chain Program

    We proposed several requirements generally applicable to the 
supplier program (such as factors to consider in determining 
appropriate supplier verification activities (proposed Sec.  
117.136(b)), as well as several requirements more narrowly targeted to 
specific aspects of the supplier program (such as requirements 
applicable to onsite audits). As part of the redesignation of proposed 
Sec.  117.136 into subpart G, with eight distinct sections, we are 
establishing the more general requirements in Sec.  117.410 (see table 
47).
    Most comments that support the proposed provisions suggest 
alternative or additional regulatory text (see, e.g., Comment 671, 
Comment 672, Comment 675, Comment 676, and Comment 678). 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 regulatory text as shown in table 47.

          Table 47--Revisions to the Proposed General Requirements Applicable to a Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
   Final section designation     Proposed section designation        Description                Revision
----------------------------------------------------------------------------------------------------------------
117.410(a)....................  117.136(a)(3).................  What the supply-chain  Add that the supply-chain
                                                                 program must include.  program includes, when
                                                                                        applicable, verifying a
                                                                                        supply-chain-applied
                                                                                        control applied by an
                                                                                        entity other than the
                                                                                        receiving facility's
                                                                                        supplier and documenting
                                                                                        that verification, or
                                                                                        obtaining documentation
                                                                                        of an appropriate
                                                                                        verification activity
                                                                                        from another entity,
                                                                                        reviewing and assessing
                                                                                        that documentation, and
                                                                                        documenting the review
                                                                                        and assessment.
117.410(b)....................  117.136(c)(1).................  Appropriate supplier   N/A.
                                                                 verification
                                                                 activities.
117.410(c)....................  117.136(a)(3)(ii).............  Purpose of supplier    Specify only that the
                                                                 verification           supply-chain program
                                                                 activities for raw     must provide assurance
                                                                 materials and other    that a hazard requiring
                                                                 ingredients.           a supply-chain-applied
                                                                                        control has been
                                                                                        significantly minimized
                                                                                        or prevented.
117.410(d)....................  117.136(b)....................  Factors that must be   Clarify that the factors
                                                                 considered when        apply in approving
                                                                 approving suppliers    suppliers, as well as in
                                                                 and determining        determining appropriate
                                                                 appropriate supplier   supplier verification
                                                                 verification           activities.
                                                                 activities for raw
                                                                 materials and other
                                                                 ingredients.
117.410(d)....................  117.136(b)....................  Factors that must be    Specify that
                                                                 considered when        three of the factors
                                                                 approving suppliers    relate to ``supplier
                                                                 and determining        performance.''
                                                                 appropriate supplier   Specify ``The
                                                                 verification           entity or entities that
                                                                 activities for raw     will be applying
                                                                 materials and other    controls for the hazards
                                                                 ingredients;           requiring a supply-chain-
                                                                 Supplier performance.  applied control'' rather
                                                                                        than ``Where the
                                                                                        preventive controls for
                                                                                        those hazards are
                                                                                        applied for the raw
                                                                                        material and
                                                                                        ingredients--such as at
                                                                                        the supplier or the
                                                                                        supplier's supplier.''
                                                                                        Add ``other FDA
                                                                                        compliance actions
                                                                                        related to food safety''
                                                                                        as an example of
                                                                                        information relevant to
                                                                                        the supplier's
                                                                                        compliance with
                                                                                        applicable FDA food
                                                                                        safety regulations

[[Page 56102]]

 
                                                                                        Clarify that
                                                                                        consideration of
                                                                                        supplier performance
                                                                                        includes, when
                                                                                        applicable, relevant
                                                                                        laws and regulations of
                                                                                        a country whose food
                                                                                        safety system FDA has
                                                                                        officially recognized as
                                                                                        comparable or has
                                                                                        determined to be
                                                                                        equivalent to that of
                                                                                        the United States and
                                                                                        information relevant to
                                                                                        the supplier's
                                                                                        compliance with those
                                                                                        laws and regulations
                                                                                        Provide
                                                                                        flexibility in the
                                                                                        factors that must be
                                                                                        considered if a supplier
                                                                                        is a qualified facility,
                                                                                        a produce farm that will
                                                                                        not be subject to the
                                                                                        forthcoming produce
                                                                                        safety rule on the basis
                                                                                        of size and/or direct
                                                                                        farm marketing, or a
                                                                                        shell egg producer that
                                                                                        is not subject to the
                                                                                        requirements of 21 CFR
                                                                                        part 118 (production,
                                                                                        storage, and
                                                                                        transportation of shell
                                                                                        eggs) because it has
                                                                                        less than 3,000 laying
                                                                                        hens
117.410(e)....................  117.136(f)....................  Supplier non-          N/A.
                                                                 conformance.
----------------------------------------------------------------------------------------------------------------

A. Description of What the Supply-Chain Program Must Include (Final 
Sec.  117.410(a))

    We proposed to require that a supplier program include verification 
activities, as appropriate to the hazard, and documentation of these 
activities, to ensure raw materials and ingredients are received only 
from suppliers approved for control of the hazard(s) in that raw 
material or ingredient (or, when necessary and appropriate, on a 
temporary basis from unapproved suppliers) (proposed Sec.  
117.136(a)(3)(i)). We also proposed to require that a supplier program 
include verification activities, as appropriate to the hazard, and 
documentation of these activities. We also proposed requirements 
applicable to the determination and documentation of appropriate 
supplier verification activities (proposed Sec.  117.136(b)). We also 
proposed specific documentation requirements for records associated 
with the supplier program (proposed Sec.  117.136(g)).
    The final rule specifies that the supply-chain program must 
include: (1) Using approved suppliers; (2) determining appropriate 
supplier verification activities (including determining the frequency 
of conducting the activity); (3) conducting supplier verification 
activities; and (4) documenting supplier verification activities. For 
clarity, Sec.  117.410(a) states this general requirement for the 
supply-chain program and Sec. Sec.  117.420, 117.425, 117.430, 117.435, 
and 117.475 provide the specific requirements for using approved 
suppliers, determining appropriate supplier verification activities, 
conducting verification activities, specific requirements for onsite 
audits, and records, respectively. See the discussion of the specific 
requirements of Sec. Sec.  117.420, 117.425, 117.430, 117.435, and 
117.475 in sections XLVI, XLVII, XLVIII, and XLIX, respectively.
    As discussed in section XLIII.D, the final rule establishes a 
verification requirement when a supply-chain-applied control is applied 
by an entity other than the receiving facility's supplier (see Sec.  
117.405(c)). For clarity, Sec.  117.410(a) states this general 
requirement for the supply-chain program in Sec.  117.405(a)(5), and 
Sec.  117.405(c) provides the specific requirements that apply when a 
supply-chain-applied control is applied by an entity other than the 
receiving facility's supplier.

B. Appropriate Supplier Verification Activities ((Final Sec.  
117.410(b))

    We proposed to require that appropriate supplier verification 
activities include: (1) Onsite audits; (2) sampling and testing of the 
raw material or ingredient, which may be conducted by either the 
supplier or receiving facility; (3) review by the receiving facility of 
the supplier's relevant food safety records; or (4) other appropriate 
supplier verification activities based on the risk associated with the 
ingredient and the supplier (proposed Sec.  117.136(c)(1)).
    (Comment 669) Some comments support the inclusion of onsite audits 
as an appropriate supplier verification activity. However, other 
comments oppose it, and ask us to remove the onsite audit requirement 
from the supplier verification program, stating that Congress 
prohibited FDA from requiring third parties to verify or audit 
compliance with the rules. These comments express concern that the 
supplier verification program effectively imposes an ``entire second 
layer of regulation'' on produce farms that are supplying ingredients 
to processors, and claim this is an unnecessary burden that is not 
authorized by FSMA.
    (Response 669) We are retaining onsite audits as an appropriate 
supplier verification activity. As noted in our memorandum on supplier 
programs, onsite audits are commonly used by industry in the 
verification of supplier performance (Ref. 83). Onsite audits provide 
the opportunity to review the food safety plan and written procedures 
and to observe the implementation of food safety procedures, as well as 
to review the records related to the past application of control 
measures, including laboratory test results. Audits also provide the 
opportunity to interview employees to assess their understanding of the 
food safety measures for which they are responsible. Thus, an audit can 
provide for a more comprehensive assessment of food safety 
implementation by a facility, and often is used in approving food 
suppliers. Comments that oppose including onsite audits as a 
verification activity are concerned that farms will be required to have 
audits to verify that they are in compliance with produce safety 
standards or facilities will be required to have audits to verify 
preventive controls. These comments apparently refer to the provision 
in section 419(c)(1)(E) of the FD&C Act that the regulation issuing 
standards for the safety of produce ``not require a business to hire a 
consultant or other third party to identify, implement, certify 
compliance with these procedures, processes and practices,'' or the 
provision in section 418(n)(3)(D) of the FD&C Act that the preventive 
controls regulation ``not require a facility to hire a consultant or 
other third party to identify, implement, certify or audit [preventive] 
controls.'' The regulations proposed under section 419 of the FD&C Act 
do not impose such

[[Page 56103]]

requirements. The requirements for supplier verification in this rule 
(under section 418 of the FD&C Act) provide for audits as one supplier 
verification activity. Although the rule does specify an annual onsite 
audit as the appropriate supplier verification activity when a hazard 
in a raw material or other ingredient will be controlled by the 
supplier and is one for which there is a reasonable probability that 
exposure to the hazard will result in serious adverse health 
consequences or death to humans, the receiving facility is not required 
to hire a third party to conduct the audit. Any qualified auditor, 
other than the supplier, may conduct the audit, including an employee 
of the receiving facility or another entity, such as an entity in the 
supply chain between the supplier and the receiving facility. The rule 
also provides that a receiving facility may determine and document that 
other verification activities and/or less frequent onsite auditing of 
the supplier provide adequate assurance that the hazards are controlled 
(see Sec.  117.430(b)(1) and (2)). Audits already conducted on a 
supplier's facility or operation for other business purposes may meet 
the requirement for supplier verification. In addition, the rule 
provides alternative requirements for verification of suppliers that 
are farms that are not a covered farm under part 112 in accordance with 
Sec.  112.4(a), or in accordance with Sec. Sec.  112.4(b) and 112.5 
(see Sec.  117.430(d)). Finally, we have also provided that inspections 
may substitute for an audit under specified circumstances (see Sec.  
117.435(c)).
    While we realize that some farms may receive audits under the 
supplier verification provisions of part 117, we note that farms that 
might receive an audit because they are suppliers to a receiving 
facility produce a limited subset of the total produce production that 
comes from farms. These are products such as leafy greens for fresh-cut 
processing operations and fruits and vegetables that are going into 
ready-to-eat products like deli salads. These are products for which 
there is a history of outbreaks and, therefore, good reason to do 
appropriate supplier verification activities.
    (Comment 670) Some comments support the inclusion of sampling and 
testing of the raw material or other ingredient as an appropriate 
supplier verification activity, and note that verification testing is 
more effective when conducted by the supplier than the receiving 
facility because the supplier can control the lot of product tested. 
However, other comments oppose it, stating that sampling and testing is 
not useful for products with short shelf life, such as fresh produce.
    (Response 670) We are retaining sampling and testing as an 
appropriate supplier verification activity. As noted in our memorandum 
on supplier programs, sampling and testing are commonly used by 
industry in the verification of supplier performance (Ref. 83). We have 
previously discussed factors that impact the utility and frequency of 
raw material/ingredient testing (see the Appendix published in the 2013 
proposed human preventive controls rule (78 FR 3646 at 3818-3820); 
republished in its entirety with corrected reference numbers on March 
20, 2013, 78 FR 17142 at 17149-17151). We agree that there are benefits 
in having sampling and testing conducted by the supplier, because the 
supplier can then take appropriate action with respect to the findings, 
including not shipping contaminated product. However, because 
contamination with microbial pathogens is likely to be non-homogeneous 
and the numbers of pathogens are likely to be low, a negative does not 
guarantee the absence of contamination. This should be taken into 
account when deciding which verification activity (or activities) is 
appropriate. Because of the limitations of sampling and testing, the 
controls the supplier has in place to minimize contamination, and the 
management of those controls, are key in determining when sampling and 
testing is appropriate as a verification activity. For short shelf life 
products, where holding product pending test results can negatively 
impact product shelf life, an onsite audit to verify control of hazards 
may be more appropriate than sampling and testing.
    (Comment 671) Some comments ask us to specify in the regulatory 
text that sampling and testing can be conducted by or on behalf of the 
supplier or the receiving facility.
    (Response 671) The provisions of Sec.  117.415 specify the 
responsibilities of the receiving facility, and allow a receiving 
facility to conduct all supplier verification activities, including 
sampling and testing. These provisions also provide that a supplier, or 
an entity other than the receiving facility (such as an entity in the 
supply chain between the supplier and the receiving facility), can 
conduct sampling and testing, provided that the receiving facility 
reviews and assesses the documentation provided by the supplier. The 
rule places no restrictions on when a receiving facility, a supplier, 
or an entity other than the receiving facility could have a business 
relationship with a third party (such as a contract laboratory) to 
conduct sampling and testing.
    (Comment 672) Some comments suggest that, for a facility regularly 
undergoing audits, reviewing a ``supplier's relevant food safety 
records'' should allow for the receiving facility to review 
documentation related to pre-existing audits. These comments ask us to 
revise the provision to add ``including, but not limited to, records 
related to audits previously performed on the supplier's facility.''
    (Response 672) We decline this request. The comment misinterprets 
what we mean by a ``supplier's relevant food safety records.'' The rule 
provides for onsite audits as a verification activity, as well as 
reviewing a ``supplier's relevant food safety records.'' When an annual 
audit is determined to be an appropriate verification activity (see 
Sec.  117.430(b)(1)), the audit would be reviewed by the receiving 
facility, but a review of this audit is not what we meant by a 
``supplier's relevant food safety records.'' As described in our 
memorandum on supplier programs, food safety records are records 
documenting that the food safety procedures that have been established 
to control hazards are being followed and are adequately controlling 
such hazards (Ref. 83). Thus, a receiving facility may obtain 
documentation of a supplier's control measures for a particular lot of 
a raw material or ingredient provided to the receiving facility, such 
as the records created when a process control measure was applied. The 
food safety records may also include supplier records that show that 
the supplier's supplier has controlled a hazard. Such records may 
include audits, for example, when the supplier's supplier controls the 
hazard and the supplier's records include records of an audit conducted 
with respect to the hazard control activities of the supplier's 
supplier. To emphasize that the review of a supplier's relevant food 
safety records can include records other than records of audits, we 
have revised the documentation requirements applicable to review of a 
supplier's food safety records to specify that the documentation must 
include the general nature of the records reviewed (see Sec.  
117.475(c)(9)). By ``general nature of the records reviewed,'' we mean 
information such as ``records of process controls.''
    (Comment 673) Some comments support the inclusion of other 
appropriate supplier verification activities based on the risks 
associated with the ingredient and the supplier, because it provides 
flexibility for

[[Page 56104]]

facilities to design risk-based programs that are appropriate for their 
operations. Comments suggest other verification activities may include 
receiving raw materials and other ingredients from a supplier without a 
full audit report if the supplier maintains certification to a standard 
recognized by GFSI; providing for documentary verification (such as 
fact-specific questionnaires and representations exchanged between the 
supplier and the receiving facility); and confirming that a facility, 
especially a small manufacturing facility, is licensed by the 
appropriate State or local regulatory authority.
    (Response 673) We are retaining this provision to allow other 
appropriate supplier verification activities based on supplier 
performance and the risk associated with the raw material or other 
ingredient. We have revised the regulatory text to refer to ``supplier 
performance and the risk associated with the raw material or other 
ingredient'' because ``supplier performance'' is more appropriate than 
``risk associated with the supplier.'' We use the term ``risk'' as 
defined by the Codex Alimentarius Commission to be ``a function of the 
probability of an adverse health effect and the severity of that 
effect, consequential to a hazard(s) in food'' (Ref. 90). As discussed 
in section XLIV.D, the considerations for supplier performance, which 
can be related to the probability of a hazard in the raw material or 
ingredient and the severity of adverse health effects that can result, 
are broader than this.
    We agree that a supplier's certification to a GFSI scheme that 
considers FDA food safety regulations can be a consideration in the 
determination of the type and frequency of the verification activity 
conducted. Similarly, fact-specific questionnaires and representations 
exchanged between the supplier and the receiving facility can be a 
consideration in the determination of the type and frequency of the 
verification activity conducted. Confirming that a facility is licensed 
by the appropriate State or local regulatory authority should not serve 
as the only verification that a supplier is controlling the hazard, 
because the requirements for a license and the degree of inspectional 
oversight could vary greatly. We do provide for modified supplier 
verification activities for qualified facilities, which are very small 
businesses (Sec.  117.430(c)).

C. Purpose of Supplier Verification Activities for Raw Materials and 
Other Ingredients (Final Sec.  117.410(c))

    We proposed to require that a supplier program include verification 
activities, as appropriate to the hazard, and documentation of these 
activities, to verify that: (1) The hazard is significantly minimized 
or prevented; (2) the incoming raw material or ingredient is not 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act; and (3) the incoming raw material or 
ingredient is produced in compliance with the requirements of 
applicable FDA food safety regulations (proposed Sec.  
117.136(a)(3)(ii)). We have revised the provision to specify that the 
supply-chain program must provide assurance that a hazard requiring a 
supply-chain-applied control has been significantly minimized or 
prevented. If the supply-chain program provides assurance that a hazard 
requiring a supply-chain-applied control has been significantly 
minimized or prevented, it is not necessary to also specify that the 
incoming raw material or ingredient is not adulterated under section 
402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. 
We also have deleted the requirement that the verification activities 
must verify that the incoming raw material or ingredient is produced in 
compliance with the requirements of applicable FDA food safety 
regulations and instead focused that requirement as a factor that must 
be considered in approving suppliers and determining the appropriate 
supplier verification activities and the frequency with which they are 
conducted rather than as one of the stated purposes of the supply-chain 
program. See the regulatory text of Sec.  117.410(d)(i)(iii)(B).
    (Comment 674) Some comments ask us to revise this provision to 
state that the receiving facility's use of the incoming raw material or 
ingredient will not cause the finished food to be adulterated under 
section 402 of the FD&C Act or misbranded under section 403(w) of the 
FD&C Act. These comments assert that FSMA does not mandate, nor is it 
reasonable to expect, that incoming raw materials and ingredients will 
not be adulterated under section 402, and that it is acceptable for a 
receiving facility to control the ``adulterating hazard,'' even if it 
relies on the supplier to control other hazards.
    (Response 674) We decline this request. We acknowledge that in some 
circumstances a receiving facility may rely on the supplier to control 
certain hazards, while controlling other hazards itself. For example, a 
receiving facility that produces peanut-derived products could rely on 
its supplier for the control of the chemical hazard aflatoxin, but 
control the biological hazard Salmonella through its own roasting 
process. However, the supply-chain program applies to hazards requiring 
a supply-chain-applied control, and the supply-chain program must 
provide assurance that a hazard requiring a supply-chain-applied 
control has been significantly minimized or prevented. In the example 
where the receiving facility is relying on the supplier to control 
aflatoxin, the provision would require the receiving facility to verify 
that the hazard (aflatoxin) has been significantly minimized or 
prevented by the supplier.

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))

    We proposed that in determining and documenting the appropriate 
verification activities, the receiving facility must consider the 
following: (1) The hazard analysis, including the nature of the hazard, 
applicable to the raw material and ingredients; (2) where the 
preventive controls for those hazards are applied for the raw material 
and ingredients--such as at the supplier or the supplier's supplier; 
(3) the supplier's procedures, processes, and practices related to the 
safety of the raw material and ingredients; (4) applicable FDA food 
safety regulations and information relevant to the supplier's 
compliance with those regulations, including an FDA warning letter or 
import alert relating to the safety of the food; (5) the supplier's 
food safety performance history relevant to the raw materials or 
ingredients that the receiving facility receives from the supplier, 
including available information about results from testing raw 
materials or ingredients for hazards, audit results relating to the 
safety of the food, and responsiveness of the supplier in correcting 
problems; and (6) any other factors as appropriate and necessary, such 
as storage and transportation practices (proposed Sec.  117.136(b)).
    As discussed in Response 657, Response 658, and section XLVI.A, we 
have revised the regulatory text regarding use of approved suppliers to 
more explicitly state that the receiving facility must approve 
suppliers. The factors that must be considered in determining the 
appropriate supplier verification activities are equally relevant to 
approving suppliers, and the final rule requires that these factors 
must be considered in approving suppliers, as well as in determining 
appropriate supplier verification activities. For clarity and 
consistency with terms used throughout the final

[[Page 56105]]

provisions for a supply-chain program, the final rule specifies ``the 
entity or entities that will be applying controls for the hazards 
requiring a supply-chain-applied control'' rather than ``Where the 
preventive controls for those hazards are applied for the raw material 
and ingredients--such as at the supplier or the supplier's supplier.''
    As discussed in Response 673, we are using the term ``supplier 
performance,'' rather than ``risk of supplier,'' when discussing 
factors associated with suppliers. The final rule groups three of the 
proposed factors as ``supplier performance.'' As a companion change to 
emphasize that ``supplier performance'' applies to all three of these 
factors, we refer to the supplier's ``food safety history'' rather than 
``food safety performance history.''
    We also have revised the regulatory text to clarify that 
consideration of supplier performance includes, when applicable, 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States and information relevant to the 
supplier's compliance with those laws and regulations. We made this 
change because the final rule includes several provisions that 
acknowledge that some food establishments, including food 
establishments that are ``suppliers'' as that term is defined in this 
rule, operate in a foreign country. (See, e.g., the definition of 
``qualified auditor'' in Sec.  117.3 and Sec. Sec.  117.201(a)(2)(ii), 
117.201(e), 117.405(a)(2), 117.430(c), 117.435(c)(1)(ii), 
117.435(c)(2), and 117.475(c)(15)). Some of these provisions (e.g., 
Sec. Sec.  117.405(a)(2), 117.430(c), 117.435(c)(1)(ii), 117.435(c)(2), 
and 117.475(c)(15)) are in the requirements for a supply-chain program. 
When the supplier is in a foreign country whose food safety system FDA 
has officially recognized as comparable or determined to be equivalent 
to that of the United States, a receiving facility may substitute the 
written results of an inspection by the applicable food safety 
authority for an audit, provided that certain conditions are met (see 
Sec.  117.435(c)(1)(ii) and (2)).
    The final rule provides flexibility for alternative verification 
requirements for certain entities (see Sec.  117.430(c), (d), and (e)). 
We have revised the factors that must be considered regarding supplier 
performance to reflect the flexibility the rule provides for conducting 
supplier verification activities for these entities (see Sec.  
117.410(d)(2)).
    (Comment 675) Some comments support the flexibility for receiving 
facilities to determine the appropriate supplier verification 
activities and frequency with which to conduct these activities. Some 
comments state that not all of the factors that we proposed a receiving 
facility consider are relevant for the process of selecting the 
verification activity. These comments suggest changing the regulatory 
text to require a receiving facility to consider ``both food and 
supplier related risks, including the following, as appropriate'' and 
then listing the factors as proposed. Other comments suggested similar 
changes to the regulatory text.
    (Response 675) We disagree that some of the factors that we 
proposed a receiving facility must consider are not relevant to 
determining the appropriate verification activity. Every factor might 
not be determinative in all cases, and our requirement merely to 
consider each factor does not assume so. However, any one of these 
factors could be crucial depending on the food, the hazard, and the 
nature of the preventive control. We continue to consider it 
appropriate to require receiving facilities to consider each of these 
factors in making their determinations about the appropriate 
verification activities.
    (Comment 676) Some comments ask us to clarify that the phrase ``the 
nature of the hazard'' means the nature of the hazard requiring 
control.
    (Response 676) We have revised the regulatory text to specify ``the 
nature of the hazard controlled before receipt of the raw material or 
other ingredient.'' The revised regulatory text is consistent with 
regulatory text in the provisions for the preventive control management 
components (see Sec.  117.140(b), which specifies ``taking into account 
the nature of the hazard controlled before receipt of the raw material 
or other ingredient'').
    (Comment 677) Some comments agree that a receiving facility must 
consider where the preventive controls for hazards are applied for the 
raw materials and ingredients, such as at the supplier or the 
supplier's supplier. Other comments assert that this consideration 
should not be used to determine if supplier oversight is needed. Other 
comments state that it may be hard to review the procedures used by a 
supplier's supplier and beyond and ask us to provide clear flexibility 
regarding requirements for the content and performance of a receiving 
facility's supplier program.
    (Response 677) The purpose of the requirement to consider where the 
hazard is controlled is to assist a receiving facility in determining 
what supplier verification activities are appropriate, not to determine 
whether supplier oversight is needed. Once a receiving facility has 
already determined that a hazard requiring a preventive control is 
controlled before receipt of a raw material or other ingredient, 
supplier oversight is needed.
    We recognize that there is need for additional flexibility 
regarding conducting supplier verification activities. As discussed in 
Response 657, we are providing significant additional flexibility to 
address this situation in the final rule.
    (Comment 678) Some comments object to the proposed requirement to 
consider applicable FDA food safety regulations and information 
relevant to the supplier's compliance with those regulations, including 
an FDA warning letter or import alert relating to the safety of the 
food. These comments assert that it is difficult for a receiving 
facility to know a supplier's compliance status, because it is not easy 
to obtain this kind of information in a timely fashion. Some comments 
ask us to develop an online database to house this information to help 
make it easier to find. Some comments ask us to replace the broad 
requirement to consider applicable FDA food safety regulations and 
information relevant to the supplier's compliance with those 
regulations with a narrower requirement to only consider any FDA 
warning letter or import alert relating to the safety of the food.
    (Response 678) We are retaining the broad requirement to consider 
applicable FDA food safety regulations and information relevant to the 
supplier's compliance with those regulations. Such information is 
relevant to supplier performance regardless of whether there is an 
applicable warning letter or import alert. For example, if a receiving 
facility purchases canned green beans to use in making vegetable soup, 
it is appropriate for the receiving facility to verify that its 
supplier is producing the canned green beans in accordance with part 
113.
    We currently have a searchable online database for warning letters 
(Ref. 91) and another searchable online database for import alerts 
(Ref. 92). Both of these databases are available to the public from our 
homepage at http://www.fda.gov. We also publicize actions to suspend a 
facility's registration, such as in our 2012 suspension of registration 
due to Salmonella contamination of nut butter and nut products 
manufactured, processed, packed, and held by the facility (Ref. 93). 
Under the requirement to consider supplier performance with respect to 
applicable food safety

[[Page 56106]]

regulations, a receiving facility cannot ignore published information 
relating to a supplier's compliance with applicable FDA food safety 
regulations in determining the appropriate verification activities, 
such as publicized information regarding suspension of registration. To 
emphasize this point, we have revised the regulatory text to specify 
that the applicable information includes ``other FDA compliance actions 
related to food safety.'' We also have revised the regulatory text to 
specify that the compliance relates to an FDA warning letter or import 
alert relating to the ``safety of food,'' rather than the ``safety of 
the food,'' to provide flexibility for a receiving facility to identify 
information that may raise a question about a supplier's compliance 
history in a more general way, rather than only with respect to a 
particular food.
    (Comment 679) Some comments state we should only require 
consideration of the supplier's food safety performance history 
relevant to the hazards requiring control in the raw materials or 
ingredients that the receiving facility receives from the supplier.
    (Response 679) Consideration of the supplier's food safety history 
relevant to the raw materials or other ingredients that the receiving 
facility receives from the supplier will be focused on the hazard that 
the supplier is controlling because that is the food safety information 
the receiving facility will consider to be most relevant and for which 
the receiving facility would develop a history. The information could 
indicate that certain verification activities may be more appropriate 
than others for verifying the control of the hazard at that particular 
supplier or provide information useful in determining a frequency for 
the verification activity. However, we decline to revise the provision 
to specify that consideration should be limited to the hazards 
requiring control. Even though this is the most relevant information, a 
facility may become aware of information with respect to a raw material 
or other ingredient provided to another customer of the supplier that 
may suggest the need to conduct a different verification activity. For 
example, if the receiving facility is obtaining a cheese product from a 
supplier that is controlling pathogens such as L. monocytogenes and 
Salmonella, and becomes aware that cheeses from this supplier have been 
associated with an undeclared allergen due to improper labeling, the 
receiving facility would determine that it should implement 
verification activities related to label control to prevent undeclared 
allergens.
    (Comment 680) Some comments ask us to replace the phrase ``examples 
of factors that a receiving facility may determine are appropriate and 
necessary are storage and transportation'' with ``such as storage and 
transportation.''
    (Response 680) We have made this editorial change.

E. Supplier Non-Conformance (Final Sec.  117.410(e))

    We proposed that if the owner, operator, or agent in charge of a 
receiving facility determines through auditing, verification testing, 
relevant consumer, customer or other complaints, or otherwise that the 
supplier is not controlling hazards that the receiving facility has 
identified as significant, the receiving facility must take and 
document prompt action in accordance with Sec.  117.150 to ensure that 
raw materials or ingredients from the supplier do not cause food that 
is manufactured or processed by the receiving facility to be 
adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act (proposed Sec.  117.136(f)).
    (Comment 681) Some comments object to the use of the word 
``significant'' in this proposed provision, recommending that we 
replace it with ``requiring control by the supplier.'' These comments 
reason that these activities are only necessary if the receiving 
facility is relying on the supplier to control the specific hazards.
    (Response 681) We have revised the regulatory text to state ``a 
hazard requiring a supply-chain-applied control'' rather than 
``significant.''

XLV. Subpart G: New Requirement Specifying the Responsibilities of the 
Receiving Facility (Final Sec.  117.415)

    As discussed in Response 657, after considering comments we are 
providing flexibility for an entity other than the receiving facility 
to determine, conduct, and document the appropriate supplier 
verification activities, provided that the receiving facility reviews 
and assesses the entity's applicable documentation, and documents the 
receiving facility's review and assessment. We are specifying that 
flexibility in Sec.  117.415. We have titled this section 
``Responsibilities of the receiving facility'' to emphasize the 
responsibility of the receiving facility for its supply-chain program. 
(See Response 657 and Response 658.) Although comments focus on 
flexibility for an entity in the supply chain between the supplier and 
the receiving facility to perform supplier verification activities, and 
such entities are the most likely entities to be the entities 
determining, conducting, and documenting supplier verification 
activities, the flexibility provided by the rule is not limited to such 
entities.
    The rule does, however, set some bounds on the flexibility for 
determining, conducting, and documenting appropriate supplier 
verification activities. For example, as discussed in Response 657 and 
Response 658, only the receiving facility can approve its suppliers. As 
another example, although it would not be appropriate for a supplier to 
determine the appropriate supplier verification activities for itself, 
we had proposed that it would be appropriate for a supplier to conduct 
sampling and testing of raw materials and ingredients as a supplier 
verification activity (proposed Sec.  117.136(c)(1)(ii)), and we are 
retaining that provision in the final rule (see Sec.  117.415(a)(4)). 
Likewise, it is common industry practice for a supplier to arrange for 
an audit by a third party (Ref. 83), and the new flexibility provision 
does not prohibit a receiving facility from relying on an audit 
provided by its supplier when the audit of the supplier was conducted 
by a third-party qualified auditor in accordance with the requirements 
of the rule applicable to audits (Sec.  117.435). See Sec.  117.415 for 
the full text of this new flexibility provision.

XLVI. Subpart G: Comments on Using Approved Suppliers and Determining 
Appropriate Supplier Verification Activities

    We proposed requirements for the use of approved suppliers 
(proposed Sec.  117.136(a)(3)(i)) and for determining and documenting 
appropriate supplier verification activities (proposed Sec.  
117.136(b)). See table 48 for a description of the final provisions and 
the changes we have made to clarify the requirements.

[[Page 56107]]



  Table 48--Revisions to the Proposed Requirements for Approving Suppliers and for Determining and Documenting
                                  Appropriate Supplier Verification Activities
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
     Final section designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
117.420(a)........................  117.136(a)(3)(i).....  The receiving facility      Explicit statement of
                                                            must approve suppliers      this requirement.
                                                            and document that
                                                            approval.
117.420(b)(1).....................  117.136(a)(3)(i).....  Written procedures for      Explicit requirement for
                                                            receiving raw materials     written procedures.
                                                            and other ingredients
                                                            must be established and
                                                            followed.
117.420(b)(2).....................  .....................  The purpose of the written  N/A.
                                                            procedures is to ensure
                                                            that raw materials and
                                                            other ingredients are
                                                            received only from
                                                            approved suppliers (or,
                                                            when necessary and
                                                            appropriate, on a
                                                            temporary basis from
                                                            unapproved suppliers
                                                            whose raw materials or
                                                            other ingredients the
                                                            receiving facility
                                                            subjects to adequate
                                                            verification activities
                                                            before acceptance for
                                                            use).
117.420(b)(3).....................  117.136(a)(3)(i).....  Use of the written          Conforming change
                                                            procedures for receiving    associated with the
                                                            raw materials and other     explicit requirement to
                                                            ingredients must be         establish and follow
                                                            documented.                 written procedures.
117.425...........................  117.136(b)...........  Requirement to determine    N/A.
                                                            and document appropriate
                                                            supplier verification
                                                            activities.
----------------------------------------------------------------------------------------------------------------

A. Using Approved Suppliers (Final Sec.  117.420)

    We proposed to require that a supplier program include verification 
activities, as appropriate to the hazard, and documentation of these 
activities, to ensure raw materials and ingredients are received only 
from suppliers approved for control of the hazard(s) in that raw 
material or ingredient (or, when necessary and appropriate, on a 
temporary basis from unapproved suppliers whose raw materials or 
ingredients the receiving facility subjects to adequate verification 
activities before acceptance for use) (proposed Sec.  117.136(a)(i)).
    This proposed requirement included an implicit requirement that a 
facility must approve suppliers. For clarity, we make that requirement, 
and documentation of that approval, explicit in the final rule. (See 
Sec.  117.420(a)).
    The rule continues to require that a receiving facility ensure raw 
materials and other ingredients are received only from suppliers 
approved for control of the hazard(s) in that raw material or other 
ingredient (or, when necessary and appropriate, on a temporary basis 
from unapproved suppliers whose raw materials or other ingredients are 
subject to adequate verification activities before acceptance for use), 
but we revised the provision to specify that the receiving facility 
must do so by establishing and following written procedures, and 
require documentation that these procedures were followed. To simplify 
the provisions, we also established a definition for 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), and use that term throughout subpart G. For example, a facility 
could design a checklist for employees to use when raw materials and 
other ingredients are delivered to the facility. We decided to specify 
use of written procedures for receiving raw materials and other 
ingredients in light of the flexibility the final rule provides for an 
entity other than the receiving facility (such as an entity in the 
supply chain between the supplier) to conduct this activity (see Sec.  
117.415(a)(2)). Although we agree that such an entity can do this as a 
service to the receiving facility, a written procedure is appropriate 
to ensure a robust and meaningful verification. As a companion change, 
we revised the associated documentation requirement to specify 
documentation of use of the written procedures.
    (Comment 682) Some comments support the requirement to approve 
suppliers. Other comments ask us to provide guidance for use of 
unapproved suppliers on a temporary basis, because the use of 
unapproved suppliers could be a high risk situation. Other comments 
emphasize that if the final supplier approval process is significantly 
changed compared to the proposed supplier approval process, industry 
must have enough time to plan and develop supplier verification plans 
and a process for unapproved sources.
    (Response 682) We will consider including guidance for use of 
unapproved suppliers on a temporary basis in guidance that we intend to 
issue regarding the supply-chain program. We do not believe that the 
final requirements regarding the use of approved suppliers will require 
increased implementation time. The principal change is to allow 
flexibility for entities in the supply chain other than the receiving 
facility to establish written procedures for receiving raw materials 
and other ingredients and document that written procedures for 
receiving raw materials and other ingredients are being followed.

B. Determining Appropriate Verification Activities (Final Sec.  
117.425)

    The rule requires that a supply-chain program include determining 
appropriate supplier verification activities (including determining the 
frequency of conducting the activity) (see Sec.  117.410(a)(2)). 
Comments that addressed the proposed provision for determining 
appropriate verification activities (which provides flexibility to the 
facility to determine the appropriate verification activities) did not 
disagree with it. (See Comment 675.) The rule also requires that 
certain factors must be considered in determining appropriate 
verification activities (Sec.  117.410(d)). We discuss those factors, 
and comments that addressed those factors, in section XLIV.D. Both of 
these provisions (i.e., Sec.  117.410(a)(2) and Sec.  117.410(d)) 
derive from the proposed requirement regarding factors that must be

[[Page 56108]]

considered in determining appropriate supplier verification activities 
(proposed Sec.  117.136(b)). To give prominence to both the 
responsibility and the flexibility to determine appropriate supplier 
verification activities, and emphasize the factors that must be 
considered in addressing this responsibility, new Sec.  117.425 
specifies that appropriate supplier verification activities (including 
the frequency of conducting the activity) must be determined in 
accordance with the requirements of Sec.  117.410(d).

XLVII. Subpart G: Comments on Conducting Supplier Verification 
Activities for Raw Materials and Other Ingredients

    We proposed requirements applicable to conducting supplier 
verification activities (proposed Sec.  117.136(c)). Most comments that 
support the proposed provisions suggest alternative or additional 
regulatory text (see, e.g., Comment 688, Comment 690, and Comment 695) 
or ask us to clarify how we will interpret the provision (see, e.g., 
Comment 684 and Comment 685). 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 49.

    Table 49--Revisions to the Proposed Requirements for Conducting Supplier Verification Activities for Raw
                                         Materials and Other Ingredients
----------------------------------------------------------------------------------------------------------------
                                       Proposed section
     Final section designation           designation               Description                  Revision
----------------------------------------------------------------------------------------------------------------
117.430(a)........................  117.136(c)(1)........  Requirement to conduct one  Add reference to an
                                                            or more appropriate         additional provision
                                                            supplier verification       that provides for
                                                            activities.                 alternative supplier
                                                                                        verification activities
                                                                                        for shell egg producers
                                                                                        that have less than
                                                                                        3,000 laying hens.
117.430(b)(1).....................  117.136(c)(2)(i).....  Requirement to conduct an   N/A.
                                                            onsite audit as the
                                                            supplier verification
                                                            activity when the hazard
                                                            being controlled by the
                                                            supplier is one for which
                                                            there is a reasonable
                                                            probability that exposure
                                                            to the hazard will result
                                                            in serious adverse health
                                                            consequences or death to
                                                            humans.
117.430(b)(2).....................  117.136(c)(2)(ii)....  Exception to the            N/A.
                                                            requirement to conduct an
                                                            annual onsite audit with
                                                            a written determination.
117.430(c)........................  117.136(c)(3)........  Alternative supplier         Modify the
                                                            verification activity       regulatory text to
                                                            when the supplier is a      better align with the
                                                            qualified facility.         responsibilities of a
                                                                                        qualified facility to
                                                                                        submit an attestation to
                                                                                        FDA about its food
                                                                                        safety practices or its
                                                                                        compliance with State,
                                                                                        local, county, tribal,
                                                                                        or other applicable non-
                                                                                        Federal food safety law,
                                                                                        including relevant laws
                                                                                        and regulations of
                                                                                        foreign countries.
                                                                                        Clarify that the
                                                                                        date for a receiving
                                                                                        facility to obtain
                                                                                        written assurance that a
                                                                                        supplier is a qualified
                                                                                        facility is before first
                                                                                        approving the supplier
                                                                                        for an applicable
                                                                                        calendar year, and on an
                                                                                        annual basis thereafter,
                                                                                        by December 31 of each
                                                                                        calendar year for the
                                                                                        following calendar year.
                                                                                        Provide for
                                                                                        written assurance that,
                                                                                        when applicable, the
                                                                                        supplier is producing
                                                                                        the raw material or
                                                                                        other ingredient in
                                                                                        compliance with relevant
                                                                                        laws and regulations of
                                                                                        a country whose food
                                                                                        safety system FDA has
                                                                                        officially recognized as
                                                                                        comparable or has
                                                                                        determined to be
                                                                                        equivalent to that of
                                                                                        the United States.
117.430(d)........................  117.136(c)(3)........  Alternative supplier         Clarify that the
                                                            verification activity       applicable farms are
                                                            when the supplier is a      ``not covered farms''
                                                            farm that is not a          rather than ``not
                                                            ``covered farm'' under      subject to part 112''
                                                            part 112 in accordance      because some of these
                                                            with Sec.   112.4(a) or     farms are subject to
                                                            in accordance with Sec.     modified requirements in
                                                            Sec.   112.4(b) and 112.5.  Sec.   112.6.
                                                                                        Clarify that the
                                                                                        date for a receiving
                                                                                        facility to obtain
                                                                                        written assurance from
                                                                                        the farm about its
                                                                                        status is before first
                                                                                        approving the supplier
                                                                                        for an applicable
                                                                                        calendar year, and on an
                                                                                        annual basis thereafter,
                                                                                        by December 31 of each
                                                                                        calendar year for the
                                                                                        following calendar year.

[[Page 56109]]

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

A. Requirement To Conduct One or More Supplier Verification Activities 
(Final Sec.  117.430(a))

    With two exceptions, we proposed that the receiving facility must 
conduct and document one or more specified supplier verification 
activities for each supplier before using the raw material or 
ingredient and periodically thereafter (proposed Sec.  117.136(c)(1)). 
See section XLIV.B for a discussion of comments regarding the 
appropriate verification activities (i.e., onsite audits, sampling and 
testing, records review, and other appropriate supplier verification 
activities based on supplier performance and the risk associated with 
the raw material or other ingredient). See sections XLVII.C and XLVII.D 
for a discussion of the proposed exceptions to this requirement to 
conduct and document verification activities. As discussed in section 
XLVII.E, the final rule provides for an additional circumstance in 
which an alternative supplier verification activity may be conducted--
i.e., when the supplier is a shell egg producer that has fewer than 
3,000 laying hens.

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))

    We proposed that when a hazard in a raw material or ingredient will 
be controlled by the supplier and is one for which there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans, the receiving 
facility must have documentation of an onsite audit of the supplier 
before using the raw material or ingredient from the supplier and at 
least annually thereafter. We also proposed that this requirement does 
not apply if the receiving facility documents its determination that 
other verification activities and/or less frequent onsite auditing of 
the supplier provide adequate assurance that the hazards are 
controlled. (Proposed Sec.  117.136(c)(2)).
    (Comment 683) Some comments support the provision for audits when 
there is a reasonable probability that exposure to the hazard will 
result in serious adverse health consequences or death to humans. Some 
of these comments state that audits should be the default verification 
activity in order to eliminate facilities choosing the lowest cost 
option regardless of whether it was best for food safety. Other 
comments state that audits would be the best option for facilities that 
cannot visit each supplier annually and that onsite inspection can 
identify problems in ways that paperwork reviews cannot.
    However, other comments oppose this requirement. Some of these 
comments express concern that this requirement does not allow the 
necessary flexibility for a facility to tailor an effective supplier 
program based upon risk. Other comments state that annual audits are 
neither the preferred nor the most effective verification measure and 
express concern that the provision sets a precedent that annual audits 
are the preferred or most effective verification measure and that other 
verification activities often can help paint a more accurate picture of 
a supplier over time. Other comments express concern that audits only 
give a ``snapshot'' of a supplier's performance at a given time and ask 
that we not overemphasize audits.
    (Response 683) We are retaining this provision as proposed. As we 
indicated in the Appendix of our 2013 proposed preventive controls 
rule, an increasing number of establishments are requiring, as a 
condition of doing business, that their suppliers become certified to 
food safety management schemes that involve third-party audits (78 FR 
3646 at 3818-3820); republished in its entirety with corrected 
reference numbers on March 20, 2013, 78 FR 17142 at 17149-17151). An 
online survey of retail suppliers noted that such certification 
enhanced their ability to produce safe food (Ref. 94). We agree that 
onsite audits can identify problems in ways that paperwork reviews 
cannot. Because an audit involves more than simply observing the 
facility producing a food product, we believe it is more than just a 
``snapshot'' of the supplier's programs. As discussed in Response 669, 
onsite audits can include observations, records review and employee 
interviews.
    The requirement to conduct an annual audit in specified 
circumstances is risk-based because the specified circumstances are 
limited to situations where there is a reasonable probability that 
exposure to the hazard in the raw material or other ingredient will 
result in serious adverse health consequences or death to humans. The 
food safety controls applied by suppliers of such raw materials or 
other ingredients are more important than for other types of hazards 
because of the serious adverse health consequences that can occur if 
the hazards are not controlled. Annual audits are required of 
certification schemes that are benchmarked to the Global Food Safety 
Initiative Guidance Document for GFSI recognition (Ref. 95). We 
disagree that this requirement does not provide flexibility in choosing 
verification activities; in recognition that other verification 
activities can help paint a more accurate picture of a supplier over 
time, we have provided for alternative verification activities or audit 
frequencies if the receiving facility documents its determination that 
other verification activities and/or less frequent onsite auditing of 
the supplier provide adequate assurance that the

[[Page 56110]]

hazards are controlled (see Sec.  117.430(b)(2)).
    (Comment 684) Some comments ask us to define those products that 
may trigger the requirement for an audit, especially with respect to 
farms. These comments question how to assess whether a hazard could 
result in serious adverse health consequences or death to humans.
    (Response 684) We decline this request. Any list of such products 
would be extensive and it is unlikely we could capture all the 
circumstances in which this could apply. Hazards for which there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans are those for 
which a recall of a violative product posing such a hazard is 
designated as ``Class 1'' under 21 CFR 7.3(m)(1). Examples of such 
hazards that, in some circumstances, have resulted in serious adverse 
health consequences or death to humans include pathogens or their 
toxins in RTE foods and undeclared food allergens. Foods (other than 
dietary supplements or infant formula) containing 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 or 
animals are considered reportable foods; examples of foods FDA has 
considered to present a reasonable probability of serious adverse 
health consequences or death can be found in our Guidance for Industry: 
Questions and Answers Regarding the Reportable Food Registry as 
Established by the Food and Drug Administration Amendments Act of 2007 
(Ref. 32) and (Ref. 33).
    (Comment 685) Some comments ask us to clarify the role of third-
party audits and the GAP program and ask us to allow GAPs to be a 
voluntary mechanism to satisfy buyer demands for food safety 
certification.
    (Response 685) Although the rule would not require a receiving 
facility to hire a third party to conduct an audit, onsite audits can 
include third-party audits. There are likely to be benefits for 
suppliers to have a third-party audit, because the same audit may be 
acceptable by multiple receiving facilities as an appropriate supplier 
verification activity. For farms, GAPs audits may be viewed as an 
appropriate supplier verification activity. GAPs audits and other 
third-party audits would need to comply with the requirements of this 
rule applicable to onsite audits (see Sec.  117.435).
    (Comment 686) Some comments assert that we should delete this 
provision entirely, stating that this requirement for an audit is 
``outside the scope of FSMA.'' Other comments state that manufacturing 
or processing facilities should not require suppliers that are produce 
farms to conduct annual onsite audits in three specified circumstances: 
(1) If the farm is not subject to the produce safety standards (e.g., 
the produce is not eaten raw, or the farm is not covered because total 
annual sales exclude it, because these farms are so small as to pose 
minimal risk to the food supply and audits would be cost-prohibitive 
for them); (2) if the farm is subject to the produce safety standards 
(because these farms are already regulated); and (3) if the farm has 
been GAP certified (because this would mean they were undergoing 
duplicative requirements).
    (Response 686) When a supplier farm is not subject to the produce 
safety standards because of low sales revenue, we have provided for 
modified verification requirements (see Sec.  117.430(d)). For produce 
not subject to the produce safety standards because they are rarely 
consumed raw, we would not expect receiving facilities to identify 
hazards requiring a preventive control that would be controlled before 
receipt of the raw material or ingredient; thus such produce would not 
be subject to the supply-chain program.
    We disagree that a farm should not be subject to the requirements 
of the supply-chain program in this rule simply because it is subject 
to the produce safety rule. The produce subject to the produce safety 
rule may contain hazards that could result in serious adverse health 
consequences or death to humans; unless such produce will receive a 
treatment that significantly minimizes these hazards, the controls for 
the hazards are those applied by the farm. GAP certification involves 
an audit of the farm; as noted in Response 685, GAPs audits that comply 
with the requirements of this rule may be viewed as an appropriate 
verification activity, and the certification audit could serve two 
purposes.
    We disagree that a requirement for an audit is ``outside the scope 
of FSMA.'' See the discussion in Response 669 regarding the provision 
in section 419(c)(1)(E) of the FD&C Act that the regulation issuing 
standards for the safety of produce ``not require a business to hire a 
consultant or other third party to identify, implement, certify 
compliance with the procedures, processes and practices'' and the 
provision in section 418(n)(3)(D) of the FD&C Act that the preventive 
controls regulation ``not require a facility to hire a consultant or 
other third party to identify, implement, certify or audit preventive 
controls.'' As noted in that response, a facility is not required to 
hire a third party to conduct an audit.
    (Comment 687) Some comments support the flexibility to not conduct 
an annual onsite audit if the receiving facility documents its 
determination that other verification activities and/or less frequent 
onsite auditing of the supplier provide adequate assurance that the 
hazards are controlled. Other comments question how a facility would 
prove that alternative measures are equally effective as an annual 
audit, when it is not known how effective an annual audit is. Other 
comments assert that the provision is meaningless because a farm or 
facility would not take the legal risk of verifying it has received 
``adequate assurance,'' because this would be subject to an FDA 
inspector's interpretation.
    (Response 687) This provision requires a facility to use a 
verification activity that provides adequate assurance that a hazard is 
controlled, not to determine how effective an audit is and assess 
whether alternative measures are equally effective.
    As an example of using an alternative approach to an annual onsite 
audit, consider the situation in which a receiving facility is part of 
a larger corporation, is making trail mix, and obtains roasted peanuts 
from a supplier that is a subsidiary of the corporation and is 
operating under the same food safety system as the receiving facility. 
The receiving facility could determine that the food safety 
requirements established by the parent company and applied at the 
subsidiary provide the needed assurance that Salmonella in raw peanuts 
is adequately controlled. The facility could support its decision by 
documenting this determination, including the procedures in effect at 
the supplier and the activities used by the corporation to verify that 
the subsidiary operates in accordance with corporate food safety 
policies and practices to ensure that hazards are adequately 
controlled.
    We disagree that the provision is meaningless because a farm or 
facility would see a legal risk in using an alternative to annual 
onsite audits as a supplier verification activity. First, a farm would 
be a supplier and would not be the entity that would determine whether 
an onsite audit or some other supplier verification activity is 
appropriate. As established in Sec.  117.415, determining the 
appropriate supplier verification activity would be the responsibility 
of a receiving facility, and although appropriate supplier verification 
activities could be

[[Page 56111]]

determined by another entity in the receiving facility's supply chain 
as a service, the supplier verification activities could not be 
determined by the supplier itself. Second, although there is always a 
potential for differences in interpretation between an FDA inspector 
and an inspected firm, we are establishing 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. For example, FDA 
intends to deploy specialized investigators, backed up by technical 
experts, to assess the soundness and performance of a facility's food 
safety system (Ref. 12). In addition, a central element of FDA's 
strategy to gain industry compliance is to help make available to 
farmers, food processors, and importers--especially small businesses--
the education and technical assistance they need to understand and 
implement FSMA's new prevention-oriented standards (Ref. 6). The new 
inspection paradigm and the assistance and training for industry should 
help minimize different interpretations between industry and 
regulators.
    (Comment 688) Some comments ask us to require facilities to notify 
us when they determine that an alternative to an audit is an 
appropriate supplier verification activity and be able to justify and 
document how an alternative verification activity provides the same 
level of assurance as an onsite audit.
    (Response 688) We decline this request. We will assess a facility's 
supplier verification activities during a facility inspection, 
including the documentation that an alternative verification activity 
provides the same level of assurance as an onsite audit.
    (Comment 689) Some comments ask us to specify the type of 
documentation required for our investigators to determine when the 
activities are ``in compliance with the law and sufficient to protect 
public health.''
    (Response 689) We decline this request. The facility's approach to 
the determination, and the applicable documentation required to support 
that determination, would depend on the circumstances. For example, in 
Response 687 we discuss a possible approach in a situation in which a 
receiving facility is part of a corporation and obtains an ingredient 
from a supplier that is a subsidiary of the corporation and is 
operating under the same food safety system as the receiving facility. 
Another situation could be when a receiving facility has many years of 
experience with the same supplier, but the approach and documentation 
in that situation likely would be different from an approach and 
documentation used when the supplier and the receiving facility are 
part of the same corporation.
    (Comment 690) Some comments ask that we not limit the determination 
for a supplier verification activity other than an onsite audit to a 
determination by the receiving facility. These comments explain that 
the corporate parent of a facility can be the entity that makes this 
determination. These comments suggest that we can account for the role 
of the corporation by specifying that a facility documents ``the 
determination'' (rather than ``its'' determination).
    (Response 690) We have agreed that the corporate parent of a 
facility can be active in developing and implementing the facility's 
food safety plan (see section XXIV.A). However, the specific suggestion 
of these comments is not necessary to achieve the outcome requested by 
the comments because of editorial changes we made to provide for 
entities other than the receiving facility to determine and conduct the 
appropriate supplier verification activities.

C. Alternative Verification Activity When the Supplier Is a Qualified 
Facility (Final Sec.  117.430(c))

    We proposed that if a supplier is a qualified facility the 
receiving facility need not comply with the specified verification 
requirements if the receiving facility: (1) Documents, at the end of 
each calendar year, that the supplier is a qualified facility; and (2) 
obtains written assurance, at least every 2 years, that the supplier is 
producing the raw material or ingredient in compliance with applicable 
FDA food safety regulations and that the raw material or ingredient is 
not adulterated under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act. The written assurance must include a 
brief description of the processes and procedures that the supplier is 
following to ensure the safety of the food.
    This rule has several provisions that require written assurances. 
We have established specific elements that each of these written 
assurances must include--i.e., the effective date; printed names and 
signatures of authorized officials; and the applicable assurance (see 
Sec.  117.335).
    We have revised the provision to clarify that the receiving 
facility must have written assurance that a facility is a qualified 
facility: (1) Before first approving the supplier for an applicable 
calendar year; and (2) by December 31 of each calendar year (rather 
than ``at the end of the calendar year'') and that the written 
assurance is regarding the status of the qualified facility for the 
following calendar year. By specifying ``by December 31,'' a receiving 
facility can work with each applicable supplier to determine the 
specific date within a calendar year for that supplier to annually 
notify the receiving facility about its status. See also Response 155, 
Response 592, and Response 593, the requirements in Sec.  117.201(a) 
for an annual determination of the status of a facility as a qualified 
facility, and the requirements in Sec.  117.201(d) that apply when the 
status of a facility changes from ``qualified facility'' to ``not a 
qualified facility.'' A receiving facility and its suppliers have 
flexibility to approach the potential for the status of a facility to 
shift between ``qualified facility'' and ``not a qualified facility'' 
(or vice versa) in a way that works best for their specific business 
relationship.
    As discussed in section XLIV.D, we have revised the requirements 
for considering supplier performance to provide that the receiving 
facility may, when applicable, consider relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States, and information relevant to the supplier's compliance with 
those laws and regulations, rather than consider applicable FDA food 
safety regulations and information relevant to the supplier's 
compliance with applicable FDA food safety regulations. We have made a 
conforming change to the alternative verification activities for a 
qualified facility (see the regulatory text of Sec.  117.430(c)(2)).
    (Comment 691) Some comments support this alternative supplier 
verification activity because it provides flexibility. Other comments 
ask us to revise the provision so that it only requires that the 
supplier document its status as a qualified facility. Still other 
comments ask us to remove all provisions on qualified facilities 
because they view these provisions as effectively adding a second layer 
of regulations on produce farms, and claim this is not authorized by 
FSMA. Other comments ask us to delete the requirement that the written 
assurance include a brief description of the processes and procedures 
that the supplier is following to ensure the safety of the food.
    (Response 691) We have revised the provisions for an alternative 
verification activity for a qualified facility to better

[[Page 56112]]

align with the responsibilities of a qualified facility to submit an 
attestation to FDA about its food safety practices (Sec.  
117.201(b)(2)(i)) or its compliance with State, local, county, tribal, 
or other applicable non-Federal food safety law, including relevant 
laws and regulations of foreign countries (Sec.  117.201(b)(2)(ii)) 
(see the regulatory text of Sec.  117.430(c)). Importantly, a qualified 
facility is still subject to CGMPs and the FD&C Act, and if the 
qualified facility is a supplier controlling a hazard it is reasonable 
for a receiving facility to expect the qualified facility to provide to 
the receiving facility an assurance that reflects an attestation the 
facility has made to FDA. As modified, one possibility is for a 
qualified facility to provide a receiving facility with a brief 
description of the preventive controls it is implementing to control 
the applicable hazard, consistent with an attestation of its food 
safety practices in accordance with Sec.  117.201(a)(2)(i). For 
example, the qualified facility could state that its manufacturing 
processes include a lethality step for microbial pathogens of concern. 
As required by Sec.  117.201(f), a qualified facility that submits an 
attestation to FDA about its food safety practices would have 
documentation of those practices to support its attestation to FDA and, 
thus, would have documentation to support its written assurance to the 
receiving facility. Although a qualified facility that submits an 
attestation to FDA about its food safety practices also would have 
documentation of monitoring the performance of the preventive controls 
to ensure that such controls are effective as required by Sec.  
117.201(a)(2)(i), we are not requiring the qualified facility to 
describe its monitoring of the performance of preventive controls to 
ensure that they are effective. Alternatively, a qualified facility 
could provide a receiving facility with a statement that the facility 
is in compliance with State, local, county, tribal, or other applicable 
non-Federal food safety law, including relevant laws and regulations of 
foreign countries.
    We disagree that the alternative verification activity for produce 
farms would add a second layer of regulations on produce farms and are 
retaining this provision. See Response 693.
    (Comment 692) Some comments ask us to remove the requirement that 
the written assurance be obtained at least every 2 years. Other 
comments ask us to revise the purpose of the written assurance from 
``the raw material or ingredient is not adulterated'' to ``the 
receiving facility's use of the raw material or ingredient will not 
cause the finished food to be adulterated.''
    (Response 692) We decline these requests. A supplier verification 
activity needs to consider supplier performance on an ongoing basis. 
Procedures and practices evolve over time, and it is appropriate for a 
receiving facility that is obtaining written assurance from a supplier 
as an alternative verification activity to be aware of both procedures 
and practices that have changed, as well as procedures and practices 
that have stayed the same. The specified timeframe for updating the 
written assurance--i.e., at least every two years--is reasonable.
    A supplier can only provide assurance about raw materials and other 
ingredients that it supplies to the receiving facility, not about the 
food product that the receiving facility will produce using the 
supplier's raw material or other ingredients.

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))

    We proposed that if a supplier is a farm that is not subject to the 
requirements that we have proposed to be established in the produce 
safety rule in accordance with proposed Sec.  112.4 regarding the raw 
material or ingredient that the receiving facility receives from the 
farm, the receiving facility does not need to comply with the 
verification requirements if the receiving facility: (1) Documents, at 
the end of each calendar year, that the raw material or ingredient 
provided by the supplier is not subject to the produce safety rule; and 
(2) obtains written assurance, at least every 2 years, that the 
supplier is producing the raw material or ingredient in compliance with 
applicable FDA food safety regulations and that the raw material or 
ingredient is not adulterated under section 402 of the FD&C Act. See 
also Sec.  117.335, which establishes specific elements that this 
written assurance must include--i.e., the effective date; printed names 
and signatures of authorized officials; and the applicable assurance.
    Produce farms that are not ``covered farms'' under Sec.  112.4 of 
the forthcoming produce safety rule have less than $25,000 in annual 
sales averaged over the previous 3-year period, or satisfy the 
requirements for a qualified exemption in Sec.  112.5 and associated 
modified requirements in Sec.  112.6 based on average monetary value of 
all food sold (less than $500,000) and direct farm marketing (during 
the previous 3-year period, the average annual monetary value of food 
sold directly to qualified end users exceeded the average annual 
monetary value of the food sold to all other buyers). In the 2014 
supplemental human preventive controls notice, we erroneously referred 
to these farms as farms ``not subject to the requirements in part 
112.'' While produce farms that make less than $25,000 are not subject 
to the requirements in part 112, produce farms that satisfy the 
requirements for a qualified exemption are not subject to the full 
requirements of part 112, but they do have certain modified 
requirements that they must meet, as described in Sec.  112.6. We have 
corrected the description of these farms in Sec.  117.430(d).
    We have revised the provision to clarify that the receiving 
facility must have documentation that the raw material or other 
ingredient provided by the supplier is not subject to part 112 in 
accordance with Sec.  112.4(a), or in accordance with Sec. Sec.  
112.4(b) and 112.5: (1) Before first approving the supplier for an 
applicable calendar year; and (2) by December 31 of each calendar year 
(rather than ``at the end of the calendar year'') and that the 
documentation is regarding the status of supplier for the following 
calendar year. By specifying ``by December 31,'' a receiving facility 
can work with each applicable supplier to determine the specific date 
within a calendar year for that supplier to annually notify the 
receiving facility about its status. See also the discussion in section 
XLVII.C regarding a similar revision we made when the supplier is a 
qualified facility.
    (Comment 693) Some comments support the proposed alternative 
supplier verification activity. Other comments support applying the 
proposed alternative supplier verification activity more broadly--i.e., 
to any farm that will not be subject to part 112 (e.g., a farm that 
grows wheat), stating that both small and large non-produce farms 
should have the same option as farms that are exempted under Sec.  
112.4. Some comments ask us to revise the alternative verification 
requirements to apply to raw materials from farms that do not grow and 
harvest ``produce'' as we proposed to define it in Sec.  112.3(c) so 
that the alternative verification requirements would apply to grain. 
Some comments assert that it is not possible to receive ``written 
assurances'' of compliance from growers of grain because there is no 
safety standard for grain growers, and that any such documents would be 
essentially meaningless.
    Some comments ask us to revise the requirement to obtain written 
assurance so that it does not apply to ``food not subject to the 
requirements of part 112 of this chapter pursuant to part 112.2.''

[[Page 56113]]

Other comments assert that a documentation requirement for commodities 
that will be exempt from the produce safety rule would increase 
recordkeeping burdens without added benefit because produce that will 
be exempt from the produce safety rule is low-risk.
    Some comments assert that farms should not have to provide written 
assurances because the requirement is ambiguous. These comments assert 
that exempt farmers are small-scale producers who are subject primarily 
to state and local laws and this provision would require them to 
provide written assurances that they are complying with unspecified 
Federal regulations. The comments claim that, without seeking legal 
counsel, many exempt farmers would be unable to provide such 
assurances, limiting the ability of these farmers to market their 
products to non-exempt facilities (the overwhelming majority of the 
food market).
    (Response 693) We have revised the provision to specify that the 
written assurance from the farm must state that the farm acknowledges 
that its food is subject to section 402 of the FD&C Act (or, when 
applicable, that its food is subject to relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States). Any business that introduces food into interstate commerce is 
subject the prohibited acts provisions in section 301 of the FD&C Act, 
and is accountable if it produces food that is adulterated.
    As discussed in Response 444, new Sec.  117.136(a) allows a 
manufacturer/processor to not 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. We believe most receiving 
facilities will take advantage of this provision, and not establish 
supply-chain controls under the supply-chain program in subpart G for a 
number of RACs.
    This alternative supplier verification activity is intended to 
minimize the burden on suppliers that are small farms. The amount of 
food produced by such farms is small, and the exposure to food from 
such farms therefore is low. We disagree that a written assurance from 
such a farm would be meaningless. Any business that distributes food in 
interstate commerce is subject to the FD&C Act, and must produce food 
that is in compliance with the FD&C Act, regardless of whether FDA has 
established a specific regulation governing the production of the food.
    (Comment 694) Some comments ask us to delete this alternative 
supplier verification activity because they see it as a contradiction 
to the traceability provisions of the Bioterrorism Act and FSMA, 
because ``traceback'' is only required for ``one step back'' or for a 
single supplier for a particular shipment of food.
    (Response 694) The supply-chain program that is being established 
in this rule is a preventive control for the ongoing production of safe 
food, not a ``traceback'' provision, established under the Bioterrorism 
Act, to help address credible threats relating to food that is 
reasonably believed to be adulterated and to present a threat of 
serious adverse health consequences or death to humans or animals.
    (Comment 695) Some comments ask us to specify 3 options for 
verification if a supplier is a farm subject to the requirements of 
part 112: (1) Documentation at the end of each calendar year that the 
raw material or ingredient provided by the supplier is subject to part 
112; (2) written assurance, at least every 2 years, that the supplier 
is producing the raw material or ingredient in compliance with 
applicable FDA food safety regulations and that the raw material or 
ingredient is not adulterated under the FD&C Act; or (3) evidence that 
the supplier is certified to a recognized third-party GAP/GHP/GMP/HACCP 
audit scheme. (We note that we are assuming that ``GHP'' is an 
abbreviation for ``Good Hygienic Practice.'')
    (Response 695) We decline this request. Documenting that a raw 
material or other ingredient is subject to the produce safety rule has 
no bearing on whether the farm is complying with that rule to control 
the hazards. With respect to all farms subject to the requirements of 
part 112 providing a written assurance, as discussed in Response 693, 
the amount of food produced by the small farms that could provide 
written assurance to a receiving facility is small, and the exposure to 
food from such farms therefore is low. We disagree that it is 
appropriate to extend this alternative supplier verification activity 
to larger farms because such farms provide a larger volume of produce.
    A farm that has been subject to an audit that complies with the 
requirements of this rule can provide the results of the audit.

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))

    We are establishing an additional alternative supplier verification 
activity when a supplier is a shell egg producer that is not subject to 
the requirements of part 118 because it has less than 3,000 laying 
hens. See the regulatory text of Sec.  117.430(e). The provision is 
analogous to the alternative supplier verification activity when a 
supplier is a farm that meets the criteria in Sec.  117.430(d) and 
would account for a very small amount of eggs in the food supply. See 
also Sec.  117.335, which establishes specific elements that the 
required written assurance must include--i.e., the effective date; 
printed names and signatures of authorized officials; and the 
applicable assurance.

F. Independence of Persons Who Conduct Supplier Verification Activities 
(Final Sec.  117.430(f))

    In the 2014 supplemental preventive controls notice, we requested 
comment on whether we should include in the final preventive controls 
rule requirements to address conflicts of interest for individuals 
conducting verification activities and, if so, the scope of such 
requirements.
    (Comment 696) Some comments ask that conflict of interest 
provisions not be written too broadly, and be limited to circumstances 
where the individual employee carrying out the verification activities 
has a direct personal financial interest in or financial ties to the 
supplier (e.g., owns a substantial amount of stock in the supplier or 
is personally paid directly by the supplier). Comments state that it 
would not be uncommon for a receiving facility to have a shared 
financial interest in the supplier (e.g., partial ownership of one by 
the other or both being owned by the same parent company). Thus, 
employees that have an indirect financial interest (e.g., owning stock 
in a supplier because they own stock in their own company, which in 
turn owns an interest in the supplier) should not be disqualified from 
performing verification activities. Comments also indicate that a 
laboratory analyst performing ingredient testing should not be 
precluded from testing ingredients from a supplier in which the analyst 
has a potential conflict of interest, as long as the analyst is not 
aware of the identity of the supplier at the time the test is 
performed.
    (Response 696) We are establishing a requirement that there must 
not be any financial conflicts of interests that

[[Page 56114]]

influence the results of the verification activities listed in Sec.  
117.410(b) and payment must not be related to the results of the 
activity. This does not prohibit employees of a supplier from 
performing the functions specified in Sec.  117.415 in accordance with 
Sec.  117.415. For example, this provision would not prohibit an 
employee of a supplier from conducting sampling and testing so that the 
supplier could provide the results in documentation provided to the 
receiving facility. The provisions would not prevent a person who is 
employed by a receiving facility from having an indirect financial 
interest in a supplier (e.g., if a company in which the employee owns 
stock owns an interest in the supplier).
    (Comment 697) Comments ask that we not preclude a supplier from 
hiring an outside party to perform onsite audits, food certifications, 
or sampling and testing.
    (Response 697) We have specified that the requirements do not 
prohibit a receiving facility from relying on an audit provided by its 
supplier when the audit of the supplier was conducted by a third-party 
qualified auditor (see Sec.  117.415(c)). We also have specified that a 
supplier may conduct and document sampling and testing of raw materials 
and other ingredients, for the hazard controlled by the supplier, as a 
supplier verification activity for a particular lot of product and 
provide the documentation to the receiving facility (see Sec.  
117.415(a)(4)). This acknowledges that it is common for suppliers to 
include Certificates of Analysis for tests conducted on specific lots 
of product along with the shipment to the receiving facility.

XLVIII. Subpart G: Comments on Onsite Audit

    We proposed requirements that would apply to an onsite audit. Most 
comments that support the proposed provisions suggest alternative or 
additional regulatory text (see, e.g., Comment 698, Comment 701, and 
Comment 702) or ask us to clarify how we will interpret the provision 
(see, e.g., Comment 703 and Comment 704). 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 50.

                       Table 50--Revisions to the Proposed Requirements for Onsite Audits
----------------------------------------------------------------------------------------------------------------
   Final section designation     Proposed section designation        Description                Revision
----------------------------------------------------------------------------------------------------------------
117.435(a)....................  117.136(d)(1).................  An onsite audit of a   N/A.
                                                                 supplier must be
                                                                 performed by a
                                                                 qualified auditor.
117.435(b)....................  117.136(d)(2).................  An onsite audit must   Clarify that, when
                                                                 consider applicable    applicable, an onsite
                                                                 FDA regulations.       audit may consider
                                                                                        relevant laws and
                                                                                        regulations of a country
                                                                                        whose food safety system
                                                                                        FDA has officially
                                                                                        recognized as comparable
                                                                                        or has determined to be
                                                                                        equivalent to that of
                                                                                        the United States.
117.435(c)(1)(i)..............  117.136(e)(1).................  Substitution of        Broaden the list of
                                                                 inspection for         applicable inspections
                                                                 domestic suppliers.    to include inspections
                                                                                        by representatives of
                                                                                        other Federal agencies
                                                                                        (such as the United
                                                                                        States Department of
                                                                                        Agriculture), or by
                                                                                        representatives of
                                                                                        State, local, tribal, or
                                                                                        territorial agencies.
117.435(c)(1)(ii) and           117.136(e)(2).................  Substitution of        N/A.
 117.435(c)(2).                                                  inspection for
                                                                 foreign suppliers.
117.435(d)....................  N/A...........................  Use of a third-party   If the onsite audit is
                                                                 auditor that has       solely conducted to meet
                                                                 been accredited in     the requirements of the
                                                                 accordance with        human preventive
                                                                 regulations that       controls rule by an
                                                                 will be established    audit agent of a
                                                                 in the forthcoming     certification body that
                                                                 third-party            is accredited in
                                                                 certification rule.    accordance with
                                                                                        regulations that will be
                                                                                        established in part 1,
                                                                                        subpart M, the audit is
                                                                                        not subject to the
                                                                                        requirements in those
                                                                                        regulations.
----------------------------------------------------------------------------------------------------------------

A. Requirements Applicable to an Onsite Audit (Final Sec.  117.435(a) 
and (b))

    We proposed that an onsite audit of a supplier must be performed by 
a qualified auditor. If the raw material or ingredient at the supplier 
is subject to one or more FDA food safety regulations, an onsite audit 
must consider such regulations and include a review of the supplier's 
written plan (e.g., HACCP plan or other food safety plan), if any, 
including its implementation, for the hazard being audited (proposed 
Sec.  117.136(d)). We have revised ``including its implementation'' to 
``and its implementation'' to emphasize that implementation of the plan 
is distinct from the plan itself (e.g., Sec.  117.126(c) establishes 
the recordkeeping requirement for the food safety ``plan,'' and Sec.  
117.190 lists implementation records).
    As discussed in section XLIV.D, we have revised the requirements 
for considering supplier performance to provide that the receiving 
facility may, when applicable, consider relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States, and information relevant to the supplier's compliance with 
those laws and regulations, rather than consider applicable FDA food 
safety regulations and information relevant to the supplier's 
compliance with applicable FDA food safety regulations. We have made a 
conforming change to the requirements for an onsite audit to clarify 
that an onsite audit may consider relevant laws and regulations of a 
country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States.
    (Comment 698) Comments support a requirement that an onsite audit 
be performed by a qualified auditor, provided that we finalize 
provisions (in proposed Sec.  117.136(e)) whereby an inspection by 
certain authorities could substitute for an audit. Some comments ask us 
to specify that the rule permits the use of audits conducted by private 
third-party food safety auditing firms. Other comments ask us to 
provide a list of recognized private third-party food safety schemes 
and consider making third-party food safety certification to a 
recognized audit scheme mandatory for all food operations that grow, 
pack, hold, and manufacture/process food for

[[Page 56115]]

wholesale markets. Other comments ask us to further specify that FDA 
will audit all food facilities no less than once every 5 years to 
verify that private third-party audits are consistent with FDA audits 
and findings.
    (Response 698) See our discussion in section XLVIII.B of the final 
provisions governing substitution of inspection for an audit. We agree 
that onsite audits may be conducted by third parties but disagree that 
it is necessary to specify this in the rule. Nothing in this rule 
prevents a facility from hiring a third party to conduct audits.
    We decline the requests to provide a list of recognized private 
third-party food safety schemes or to make third-party food safety 
certification to a recognized audit scheme mandatory for all food 
operations that grow, pack, hold, and manufacture/process food for 
wholesale markets. The rule provides flexibility regarding use of 
third-party auditors and the information is easily obtained from other 
sources. Likewise, we decline the request to specify that FDA will 
``audit'' all food facilities no less than once every 5 years to verify 
that private third-party audits are consistent with FDA audits and 
findings. We will inspect food facilities for compliance with this 
rule, not to verify the findings of a third-party audit, with a 
frequency consistent with our responsibilities under the FD&C Act.
    (Comment 699) Some comments express concern about the multiple 
audits that facilities are subject to each year and ask us to encourage 
those subject to the rule to accept an audit performed by any of the 
``bona fide authorities'' where it is warranted. Other comments note 
that food manufacturers conduct their own audits and have developed 
extensive expertise in doing so, and oppose any supplier verification 
requirement that would affect those audits. Other comments ask us to 
allow audits such as GFSI benchmark schemes to satisfy supplier 
verification requirements to avoid adding a new audit to audits 
currently being conducted. Some comments express concern that requiring 
a new audit in addition to audits already being conducted could lead to 
auditor shortages and unnecessary additional costs.
    (Response 699) We expect that a facility will adopt an approach to 
audits that works best for the facility and minimizes the number of 
audits conducted for the same facility. An employee of a receiving 
facility may perform an audit, provided that the employee satisfies the 
criteria established in the rule for qualified auditors. Under Sec.  
117.3 and Sec.  117.180, a qualified auditor is a qualified individual 
(as defined in Sec.  117.3) and has technical expertise obtained 
through education, training or experience (or a combination thereof) 
necessary to perform the auditing function. See Response 700, in which 
we discuss auditor qualifications with respect to the GFSI's auditor 
competency model, noting that the provisions for auditor competency for 
GFSI are consistent with our definition of a qualified auditor. GFSI 
schemes that consider FDA food safety regulations and include a review 
of the supplier's written HACCP plan (or other food safety plan), if 
any, and its implementation, with respect to the hazard being 
controlled are likely to satisfy the requirements for an onsite audit. 
We expect that audits being conducted for other purposes will also be 
used to satisfy supplier verification audit requirements and such 
audits will be adjusted as needed to conform to the requirements of 
this rule.
    (Comment 700) Some comments assert that GFSI-benchmarked audits and 
other similarly accredited audits should be considered equivalent to 
onsite audits.
    (Response 700) See our description of GFSI in Response 496. The 
GFSI guidance document requires audit scheme owners to have a clearly 
defined and documented audit frequency program, which must ensure a 
minimum audit frequency of one audit per year of an organization's 
facility (Ref. 83), and a GFSI-compliant food safety scheme must 
include procedures for conducting internal audits (Ref. 95). To be used 
to satisfy the requirements of this rule, a GFSI-benchmarked audit, as 
with any audit, must address all requirements of this rule, including 
the requirement to consider applicable FDA food safety regulations and 
include a review of the supplier's written plan (e.g., HACCP plan or 
other food safety plan), if any.
    As discussed in our memorandum on supplier programs (Ref. 83), the 
GFSI guidance document also specifies that the person who performs the 
audit needs to be qualified to do so. As described in ``GFSI Food 
Safety Auditor Competencies,'' the GFSI's auditor competency model 
lists three main components for auditor competencies: (1) Auditing 
skills and knowledge; (2) technical skills and knowledge; and (3) 
behavior and systems thinking (Ref. 96). Within each main component, 
GFSI provides details of specific tasks and the required auditor 
knowledge and skills to perform the specific tasks (Ref. 96). The 
provisions for auditor competency are consistent with our definition of 
a qualified auditor.
    (Comment 701) Some comments ask us to delete the proposed 
requirement for a review of the supplier's written plan as part of an 
audit because review of the supplier's food safety plan should be part 
of an overall supplier verification program when the supplier is 
controlling a hazard that could cause serious adverse health 
consequences or death, but should not be tied to an audit. These 
comments state that receiving facilities may choose to use an 
unannounced audit program where the auditor spends time focusing on the 
actual conditions on the production floor, with a review of the 
supplier's food safety plan being done as a separate verification 
activity.
    (Response 701) We decline this request. We agree that review of an 
applicable food safety plan should be part of an overall supplier 
verification program and that the review of the food safety plan may be 
conducted separately from the observation of actual conditions on the 
production floor, provided that both are conducted within the annual 
timeframe. However, we believe it important that the audit address 
whether the food safety plan is being implemented as designed, and 
other comments to this rule support that view. For example, as 
discussed in Comment 648 regarding our inspection of a food facility, 
some comments assert that our access to company records must be 
conducted onsite in the course of an authorized inspection so that we 
may understand the full context of what the records show. Thus, the 
onsite observations and the food safety plan review cannot be entirely 
separated, as the comment seems to suggest.
    We note that the requirement to include a review of the supplier's 
food safety plan only applies when the supplier has a food safety plan. 
For example, we did not propose a requirement for a farm that would be 
subject to the forthcoming produce safety rule to have a food safety 
plan.

B. Substitution of Inspection by FDA or an Officially Recognized or 
Equivalent Food Safety Authority

    We proposed that instead of an onsite audit, a receiving facility 
may rely on the results of an inspection of the supplier by FDA or, for 
a foreign supplier, by FDA or the food safety authority of a country 
whose food safety system FDA has officially recognized as comparable or 
has determined to be equivalent to that of the United States, provided 
that the inspection was conducted within 1 year of the date that the 
onsite audit would have been required to be conducted. For inspections 
conducted by the food

[[Page 56116]]

safety authority of a country whose food safety system FDA has 
officially recognized as comparable or determined to be equivalent to 
that of the United States, the food that is the subject of the onsite 
audit must be within the scope of the official recognition or 
equivalence determination, and the foreign supplier must be in, and 
under the regulatory oversight of, such country (proposed Sec.  
117.136(e)).
    (Comment 702) Some comments ask us to allow State or local 
inspection reports, as well as FDA inspection reports, to substitute 
for an onsite audit for small and very small facilities. Other comments 
ask us to create a ``safe harbor'' provision in which a supplier 
providing a copy of permits obtained from the most recent inspection 
done by Federal, State, or local health authorities satisfies the 
supplier verification requirement; if there are no permits, review of 
relevant records and/or sampling of raw material based on scale of 
production should be adequate.
    (Response 702) We have revised the regulatory text to provide for 
an appropriate inspection of the supplier for compliance with 
applicable FDA food safety regulations by FDA, by representatives of 
other Federal agencies (such as USDA), or by representatives of State, 
local, tribal, or territorial agencies. We are specifying that the 
inspection must be ``appropriate'' and be conducted for compliance 
``with applicable FDA regulations'' to make clear that the inspection 
must be sufficiently relevant to an onsite audit to credibly substitute 
for an onsite audit. For example, inspection by USDA to determine 
whether a farm satisfies the requirements of the produce safety rule 
could constitute an appropriate inspection that could substitute for an 
audit, but an inspection by USDA to determine whether a farm satisfies 
the requirements of the National Organic Program could not.
    We have not provided for substitution of a ``permit obtained from 
the most recent inspection'' for an onsite audit. We do not see how a 
``permit'' could shed light on whether a business is complying with 
specific applicable FDA regulations. We have provided for an 
alternative verification activity to the annual onsite audit (such as a 
review of relevant records and/or sampling of raw material) with a 
written justification (see Sec.  117.430(b)). The rule would not 
preclude an appropriate review of records, or sampling and testing of 
raw materials, by other Federal agencies, or by representatives of 
State, local, tribal, or territorial agencies, provided that the 
receiving facility satisfies the requirements for an adequate written 
justification.
    (Comment 703) Some comments ask us to clarify what we mean by 
``food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or has determined to be equivalent 
to that of the United States.'' These comments also ask whether a 
specific country qualifies and whether HACCP certificates issued by a 
specific foreign government agency would replace an onsite audit.
    (Response 703) A country whose food safety system FDA has 
officially recognized as ``comparable'' to that of the United States 
would be one for which there is a signed systems recognition 
arrangement or other agreement between FDA and the country establishing 
official recognition of the foreign food safety system. Information on 
FDA systems recognition can be found on the FDA Web site (Ref. 97). As 
of March 2015, FDA only has a signed systems recognition agreement with 
New Zealand, but agreements with other countries are under development. 
We would not accept a HACCP certificate issued by a foreign government 
as a substitute for an onsite audit, but a receiving facility could 
consider whether such a certificate could be part of its justification 
for conducting another supplier verification activity in lieu of an 
annual onsite audit, or for conducting an audit on a less frequent 
basis than annually.
    (Comment 704) Some comments ask us to clarify that the applicable 
standards will be those applied by the food safety authority of a 
country with a food safety system recognized as comparable or 
equivalent rather than having to achieve compliance with the applicable 
U.S. FDA food safety regulations.
    (Response 704) The applicable standards will be those applied by 
the food safety authority of a country with a food safety system 
recognized as comparable or equivalent to that of the United States.

C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of 
Section 808 of the FD&C Act

    We have proposed to establish regulations (in part 1, subpart M) to 
provide for accreditation of third-party auditors/certification bodies 
to conduct food safety audits of foreign food entities, including 
registered foreign food facilities, and to issue food and facility 
certifications (78 FR 45782, July 29, 2013). The purpose of the 
proposed third-party certification rule is to help us ensure the 
competence and independence of third-party auditors/certification 
bodies who conduct foreign food safety audits and to help ensure the 
reliability of food and facility certifications, issued by third-party 
auditors/certification bodies, that we will use in making certain 
decisions relating to imported food, such as food certifications 
required by FDA as a condition of granting admission to a food 
determined to pose a safety risk.
    (Comment 705) Comments support use of third-party auditors, but 
emphasize that such auditors need not be accredited under the 
requirements to be established under our forthcoming third-party 
certification rule.
    (Response 705) We agree that a third-party auditor who conducts an 
audit as a supplier verification activity to satisfy the requirements 
of this rule need not be accredited under our forthcoming third-party 
certification rule. In addition, we see no reason that any requirements 
of our forthcoming third-party certification rule should apply to an 
audit merely because it was conducted by a person who had been 
accredited under that rule. To make this clear, we have added a 
provision to specify that if an onsite audit is solely conducted to 
meet the requirements of this rule by an audit agent of a certification 
body that is accredited in accordance with regulations in part 1, 
subpart M, the audit is not subject to the requirements in those 
regulations. See Sec.  117.435(d). Because Sec.  117.435(d) refers to 
provisions in a future third-party certification rule, we will publish 
a document in the Federal Register announcing the effective date of 
Sec.  117.435(d) once we finalize the third-party certification rule.

XLIX. Subpart G: Comments on Records Documenting the Supply-Chain 
Program

    We proposed to require documentation of verification activities in 
records, including minimum requirements for records documenting an 
audit, records of sampling and testing, and records documenting a 
review by the receiving facility of the supplier's relevant food safety 
records. We also proposed that the receiving facility must review such 
records in accordance with the requirements applicable to review of 
records as a verification activity (i.e., in accordance with Sec.  
117.165(a)(4)).
    We did not receive comments on the documentation requirements 
associated with a written supplier program, determination of 
appropriate supplier verification activities, review of records, 
supplier verification activities other than an annual onsite audit when 
the

[[Page 56117]]

hazard being controlled by the supplier is one for which there is a 
reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death to humans, alternative 
supplier verification activity when the supplier is a qualified 
facility, substitution of inspection for an audit, or supplier 
nonconformance (proposed Sec.  117.136(g)(1), (2), (7), (9), (10), 
(12), and (13), respectively). We are finalizing these documentation 
requirements with editorial and conforming changes associated with the 
final requirements of the supply-chain program.
    The supply-chain program includes two provisions that are explicit 
requirements of the final human preventive controls rule, but had been 
implicit requirements of the proposed human preventive controls rule. 
The first of these provisions is the explicit requirement that the 
receiving facility must approve suppliers in accordance with the 
requirements of Sec.  117.410(d), and document that approval, before 
receiving raw materials and other ingredients from those suppliers (see 
Sec.  117.420(a)). The second of these requirements is that written 
procedures for receiving raw materials and other ingredients must be 
established and followed (see Sec.  117.420(b)(1)). We are including in 
Sec.  117.475 the documentation associated with these requirements (see 
Sec.  117.475(c)(3) and (4)).
    The supply-chain program includes four provisions that were not in 
the proposed human preventive controls rule: (1) A receiving facility 
that is an importer can comply with the foreign supplier verification 
requirements in the FSVP rule rather than conduct supplier verification 
activities for that raw material or other ingredient under this rule 
(Sec.  117.405(a)(2)); (2) a receiving facility may use an alternative 
verification activity for a supplier that is a shell egg producer that 
is not subject to the requirements established in part 118 because it 
has less than 3,000 laying hens (Sec.  117.430(e)); (3) when 
applicable, a receiving facility must verify a supply-chain-applied 
control applied by an entity other than the receiving facility's 
supplier (Sec.  117.405(c); and (4) entities other than the receiving 
facility may determine, conduct, and document certain specified 
supplier verification activities, provided that the receiving facility 
reviews and assesses the other entity's applicable documentation, and 
documents its review and assessment (Sec.  117.415). We are 
establishing the associated documentation requirements in Sec.  
117.475(c)(2), (14), (17), and (18), respectively.
    In the following sections, we discuss comments on the proposed 
records for the supplier program. After considering these comments, we 
have revised the proposed requirements as shown in table 51.

            Table 51--Revisions to the Proposed Requirements for Records for the Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
                                                                                                  Did we revise
                                                                                                       the
                                                                                                  documentation
                                                                                                   requirement
                                                                                                   other than
                                                                            Did we receive        editorial and
Final section designation       Proposed section         Description    comments regarding the     conforming
                                  designation                            proposed requirement?       changes
                                                                                                 associated with
                                                                                                    the final
                                                                                                requirements for
                                                                                                the supply-chain
                                                                                                    program?
----------------------------------------------------------------------------------------------------------------
117.475(a)...............  N/A......................  The records       N/A...................  Consequential
                                                       documenting the                           change
                                                       supply-chain                              associated with
                                                       program are                               establishing
                                                       subject to the                            the
                                                       requirements of                           requirements
                                                       subpart F.                                for a supplier
                                                                                                 in subpart G
                                                                                                 rather than
                                                                                                 subpart C.
117.475(b)...............  117.136(g)...............  The receiving     Yes...................  No.
                                                       facility must
                                                       review the
                                                       records in
                                                       accordance with
                                                       Sec.
                                                       117.165(a)(4).
117.475(c)(1)............  117.136(g)(1)............  The written       No....................  N/A.
                                                       supply-chain
                                                       program.
117.136(b)(2)............  117.136(g)(3)............  Annual written    Yes...................  Shifted to be in
                                                       assurance from                            provisions
                                                       a receiving                               outside the
                                                       facility's                                framework of
                                                       customer.                                 the supply-
                                                                                                 chain program
                                                                                                 in subpart G.
117.475(c)(2)............  N/A......................  Documentation     N/A...................  N/A.
                                                       obtained from
                                                       an importer.
117.475(c)(3)............  117.136(g)(1)............  Documentation of  No....................  No.
                                                       the approval of
                                                       a supplier.
117.475(c)(4)............  117.136(g)(1)............  Written           No....................  No.
                                                       procedures for
                                                       receiving raw
                                                       materials and
                                                       other
                                                       ingredients.
117.475(c)(5)............  117.136(g)(4)............  Documentation     Yes...................  Yes.
                                                       demonstrating
                                                       use of the
                                                       written
                                                       procedures for
                                                       receiving raw
                                                       materials and
                                                       other
                                                       ingredients.
117.475(c)(6)............  117.136(g)(2)............  Documentation of  No....................  No.
                                                       the
                                                       determination
                                                       of the
                                                       appropriate
                                                       supplier
                                                       verification
                                                       activities for
                                                       raw materials
                                                       and other
                                                       ingredients.
117.475(c)(7)............  117.136(g)(5)............  Documentation of  Yes...................  Added a
                                                       the conduct of                            requirement for
                                                       an onsite audit.                          the
                                                                                                 documentation
                                                                                                 to include the
                                                                                                 name of the
                                                                                                 supplier
                                                                                                 subject to the
                                                                                                 onsite audit.
117.475(c)(8)............  117.136(g)(6)............  Documentation of  Yes...................  Specify that the
                                                       sampling and                              documentation
                                                       testing                                   include the
                                                       conducted as a                            date(s) on
                                                       supplier                                  which the
                                                       verification                              test(s) were
                                                       activity.                                 conducted and
                                                                                                 the date of the
                                                                                                 report.
117.475(c)(9)............  117.136(g)(7)............  Documentation of  No....................  Specify that the
                                                       the review of                             documentation
                                                       the supplier's                            must include
                                                       relevant food                             the general
                                                       safety records.                           nature of the
                                                                                                 records
                                                                                                 reviewed and
                                                                                                 conclusions of
                                                                                                 the review.

[[Page 56118]]

 
117.475(c)(10)...........  117.136(g)(8)............  Documentation of  Yes...................  Specify that the
                                                       other                                     other
                                                       appropriate                               appropriate
                                                       supplier                                  supplier
                                                       verification                              verification
                                                       activities.                               activities are
                                                                                                 based on
                                                                                                 supplier
                                                                                                 performance and
                                                                                                 the risk
                                                                                                 associated with
                                                                                                 the raw
                                                                                                 material or
                                                                                                 other
                                                                                                 ingredient.
117.475(c)(11)...........  117.136(g)(9)............  Documentation of  No....................  No.
                                                       any
                                                       determination
                                                       that
                                                       verification
                                                       activities
                                                       other than an
                                                       onsite audit,
                                                       and/or less
                                                       frequent onsite
                                                       auditing of a
                                                       supplier,
                                                       provide
                                                       adequate
                                                       assurance that
                                                       the hazards are
                                                       controlled when
                                                       a hazard in a
                                                       raw material or
                                                       other
                                                       ingredient will
                                                       be controlled
                                                       by the supplier
                                                       and is one for
                                                       which there is
                                                       a reasonable
                                                       probability
                                                       that exposure
                                                       to the hazard
                                                       will result in
                                                       serious adverse
                                                       health
                                                       consequences or
                                                       death to humans.
117.475(c)(12)...........  117.136(g)(10)...........  Documentation of  No....................  Provide for
                                                       an alternative                            documentation,
                                                       verification                              when
                                                       activity for a                            applicable, of
                                                       supplier that                             a written
                                                       is a qualified                            assurance that
                                                       facility.                                 the supplier is
                                                                                                 producing the
                                                                                                 raw material or
                                                                                                 other
                                                                                                 ingredient in
                                                                                                 compliance with
                                                                                                 relevant laws
                                                                                                 and regulations
                                                                                                 of a country
                                                                                                 whose food
                                                                                                 safety system
                                                                                                 FDA has
                                                                                                 officially
                                                                                                 recognized as
                                                                                                 comparable or
                                                                                                 has determined
                                                                                                 to be
                                                                                                 equivalent to
                                                                                                 that of the
                                                                                                 United States.
117.475(c)(13)...........  117.136(g)(11)...........  Documentation of  Yes...................  No.
                                                       an alternative
                                                       verification
                                                       activity for a
                                                       supplier that
                                                       is a farm that
                                                       supplies a raw
                                                       material or
                                                       other
                                                       ingredient that
                                                       would not be a
                                                       covered farm
                                                       subject to the
                                                       forthcoming
                                                       produce safety
                                                       rule.
117.475(c)(14)...........  N/A......................  Documentation of  N/A...................  N/A.
                                                       an alternative
                                                       verification
                                                       activity for a
                                                       supplier that
                                                       is a shell egg
                                                       producer that
                                                       is not subject
                                                       to the
                                                       requirements
                                                       established in
                                                       part 118
                                                       because it has
                                                       less than 3,000
                                                       laying hens.
117.475(c)(15)...........  117.136(g)(12)...........  The written       No....................  No.
                                                       results of an
                                                       appropriate
                                                       inspection of
                                                       the supplier
                                                       for compliance
                                                       with applicable
                                                       FDA food safety
                                                       regulations by
                                                       FDA, by
                                                       representatives
                                                       of other
                                                       Federal
                                                       agencies (such
                                                       as USDA), or by
                                                       representatives
                                                       from State,
                                                       local, tribal,
                                                       or territorial
                                                       agencies, or
                                                       the food safety
                                                       authority of
                                                       another country
                                                       when the
                                                       results of such
                                                       an inspection
                                                       is substituted
                                                       for an onsite
                                                       audit.
117.475(c)(16)...........  117.136(g)(13)...........  Documentation of  No....................  No.
                                                       actions taken
                                                       with respect to
                                                       supplier non-
                                                       conformance.
117.475(c)(17)...........  N/A......................  Documentation of  N/A...................  N/A.
                                                       verification of
                                                       a supply-chain-
                                                       applied control
                                                       applied by an
                                                       entity other
                                                       than the
                                                       receiving
                                                       facility's
                                                       supplier.
117.475(c)(18)...........  N/A......................  When applicable,  N/A...................  N/A.
                                                       documentation
                                                       of the
                                                       receiving
                                                       facility's
                                                       review and
                                                       assessment of
                                                       documentation
                                                       of a supplier
                                                       verification
                                                       activity
                                                       provided by a
                                                       supplier or by
                                                       an entity other
                                                       than the
                                                       receiving
                                                       facility.
----------------------------------------------------------------------------------------------------------------


[[Page 56119]]

A. Applicability of the Recordkeeping Requirements of Subpart F

    We have added new Sec.  117.475(a) to specify that the records 
documenting the supply-chain program in subpart G are subject to the 
requirements of subpart F. Under the proposed human preventive controls 
rule, the documentation requirements would have been in subpart C, and 
the applicability of subpart F was specified in Sec.  117.190 in 
subpart C. The new provision specifying the applicability of subpart F 
to the records associated with the supply-chain program is a 
consequential change associated with establishing the requirements for 
a supply-chain program in subpart G, rather than in subpart C.

B. Requirement To Review Records of the Supply-Chain Program (Final 
Sec.  117.475(b))

    We proposed that a receiving facility must review records 
documenting the supplier program in accordance with the requirements 
applicable to review of records as a verification activity (i.e., in 
accordance with Sec.  117.165(a)(4)). (Proposed Sec.  117.136(g))
    (Comment 706) Some comments ask us to provide consideration for 
records associated with the supplier program to be administered and 
maintained at corporate headquarters rather than at individual 
facilities, because this is common industry practice.
    (Response 706) We are aware that certain programs are administered, 
and records are maintained, at corporate headquarters rather than at 
individual facilities. The rule provides that offsite storage of 
records is permitted if such records can be retrieved and provided 
onsite within 24 hours of request for official review and electronic 
records are considered to be onsite if they are accessible from an 
onsite location (see Sec.  117.315(c)). We expect that the facility 
would be able to access information and records relevant to the supply-
chain program within 24 hours (e.g., electronically) when the records 
are maintained at corporate headquarters. As necessary and appropriate, 
we intend to work with facilities on a case-by-case basis to determine 
the best way to review records associated with the supply-chain program 
when the supply-chain program is administered at the corporate level.
    (Comment 707) Some comments ask us to clarify in the regulatory 
text that the required records are ``as appropriate to the supplier 
program.''
    (Response 707) We have revised the regulatory text to specify that 
the required records are ``as applicable to its supply-chain program'' 
(see Sec.  117.475(c)).

C. Documentation Demonstrating Use of the Written Procedures for 
Receiving Raw Materials and Other Ingredients (Final Sec.  
117.475(c)(5))

    We proposed to require documentation demonstrating that products 
are received only from approved suppliers (proposed Sec.  
117.136(g)(4)).
    (Comment 708) Some comments support the proposed requirement with 
no changes. Other comments ask us to specify ``raw materials and 
ingredients'' rather than ``products'' in the regulatory text.
    (Response 708) We have revised the regulatory text to specify ``raw 
materials and other ingredients'' with associated conforming changes.

D. Documentation of the Conduct of an Onsite Audit (Final Sec.  
117.475(c)(7))

    We proposed to require documentation of an onsite audit. This 
documentation must include: (1) Documentation of audit procedures; (2) 
the dates the audit was conducted; (3) the conclusions of the audit; 
(4) corrective actions taken in response to significant deficiencies 
identified during the audit; and (5) documentation that the audit was 
conducted by a qualified auditor. For clarity, we have revised the 
regulatory text to specify documentation of the ``conduct'' of an audit 
and added a requirement for the documentation to include the name of 
the supplier subject to the onsite audit.
    (Comment 709) Some comments ask us to maintain the confidentiality 
of audit reports and exempt such audit reports from disclosure under 
the FOIA.
    (Response 709) These comments are similar to comments we received 
related to disclosure of other records required by this part (See 
Comment 647 and Comment 650). We would establish the status of supply-
chain program records, such as audit reports, as available for, or 
protected from, public disclosure on a case-by-case basis. As discussed 
in Response 647, we primarily intend to copy such records when we 
conduct an inspection for cause or if the preliminary assessment by our 
investigator during a routine inspection is that regulatory follow-up 
may be appropriate (e.g., if the report indicates that a significant 
food safety problem was noted). See Response 650 for a discussion of 
situations in which records would, or would not, be protected from 
disclosure.
    (Comment 710) Some comments express concern about maintaining 
documentation of the conclusions of an audit and documentation of 
corrective actions taken in response to significant deficiencies 
identified during the audit. These comments explain that FDA's access 
to such documentation during inspection might discourage suppliers from 
allowing unannounced audits. These comments ask us to delete these 
proposed requirements. If the requirement regarding documentation of 
corrective actions remains in the final rule, these comments ask us to 
limit such documentation to situations in which the identified 
deficiencies posed a risk to public health.
    (Response 710) We are retaining these documentation requirements as 
proposed. These comments appear to be suggesting that documentation 
requirements be established based on whether a business entity would 
want us to see information during inspection rather than on the utility 
and value of the documentation. We expect that receiving facilities, in 
general, maintain documentation of the conclusions of audits that they 
have conducted or arranged to have conducted. A receiving facility must 
approve all of its suppliers, and documentation of corrective actions 
taken in response to significant deficiencies identified during an 
audit has value to a receiving facility in determining whether to 
approve a supplier before first receiving any raw materials or other 
ingredients and then on an ongoing basis.
    The rule does not require that onsite audits be unannounced, 
although we acknowledge that some receiving facilities may see value in 
unannounced audits. We decline the request to require a receiving 
facility to maintain documentation of corrective actions only if the 
identified deficiencies posed a risk to public health. If, for example, 
a supplier's facility has filthy conditions or the raw materials and 
other ingredients it supplies are contaminated with filth, a receiving 
facility may find it inappropriate to approve that supplier. Even 
though filth often does not pose a risk to public health, a food may be 
deemed to be adulterated under section 402(a)(4) of the FD&C Act if it 
has been prepared, packed, or held under insanitary conditions whereby 
it may have become contaminated with filth.

E. Documentation of Sampling and Testing (Final Sec.  117.475(c)(8))

    We proposed to require records of sampling and testing. These 
records must include: (1) Identification of the raw material or 
ingredient tested (including lot number, as appropriate) and the number 
of samples tested; (2) identification of the test(s) conducted,

[[Page 56120]]

including the analytical method(s) used; (3) the date(s) on which the 
test(s) were conducted; (4) the results of the testing; (5) corrective 
actions taken in response to detection of hazards; and (6) information 
identifying the laboratory conducting the testing.
    (Comment 711) Some comments ask us to not apply the requirement to 
maintain records related to sampling and testing to the receipt of RACs 
because sampling and testing of RACs is neither common nor effective 
for detecting biological or chemical hazards, especially in raw, intact 
produce.
    (Response 711) We decline this request. These comments appear to 
suggest that documentation requirements be established based on the 
frequency and utility of sampling and testing a particular commodity 
rather than on a determination by a receiving facility that sampling 
and testing is an appropriate supplier verification activity for a 
particular supplier. We disagree with such a suggestion. A receiving 
facility that has determined that sampling and testing is an 
appropriate supplier verification activity needs to maintain records of 
those results as it would for any other supplier verification activity. 
To the extent that these comments are concerned that the supply-chain 
program requires sampling and testing of RACs, we emphasize that this 
is not the case. See also Response 525 for a discussion of the 
usefulness of sampling and testing as a verification measure for RACs.
    (Comment 712) Some comments ask us to allow documentation of 
testing to include the date the test results were reported as an 
alternative to the date(s) on which the test(s) were conducted.
    (Response 712) We have revised the provision to require ``The 
date(s) on which the test(s) were conducted and the date of the 
report.'' We agree that the date on which the test results are reported 
can be important, but it should not be a replacement for the date of 
the test.
    (Comment 713) Some comments ask us to add ``if necessary'' to the 
end of the proposed requirement for documentation of corrective actions 
taken in response to detection of hazards.
    (Response 713) We decline this request. The documentation is always 
necessary if corrective actions are taken. The provision is about 
maintaining documentation when corrective actions are taken, not about 
the fact that corrective actions may not always be needed.

F. Documentation of Other Appropriate Supplier Verification Activity 
(Final Sec.  117.475(c)(10))

    We proposed to require records of other appropriate verification 
activities based on the risk associated with the ingredient. For 
clarity and consistency, we have revised the proposed requirement to 
specify ``documentation'' of the other appropriate supplier 
verification activity rather than ``records'' of the activity. As a 
conforming change associated with using the term ``supplier 
performance,'' rather than ``risk of supplier,'' when discussing 
factors associated with suppliers (see Response 673), the final 
requirement specifies that the other appropriate supplier verification 
activities are based on the supplier performance and the risk 
associated with the raw material or other ingredient.
    (Comment 714) Some comments ask us to also specify that an 
``other'' appropriate supplier verification activity be based on the 
risk associated with raw materials and suppliers.
    (Response 714) We have revised the regulatory text to specify 
``Documentation of other appropriate supplier verification activities 
based on the supplier performance and the risk associated with the raw 
material or other ingredient.'' The revised regulatory text of the 
documentation tracks the regulatory text of this ``other'' appropriate 
supplier verification activity (see Sec.  117.410(b)(4)). As discussed 
in Response 673, ``supplier performance'' is more appropriate than 
``risk associated with the supplier.''

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))

    We proposed to require 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, including: (1) The 
documentation that the raw material or ingredient provided by the 
supplier is not subject to the produce safety rule; and (2) the written 
assurance that the supplier is producing the raw material or ingredient 
in compliance with applicable FDA food safety regulations and that the 
raw material or ingredient is not adulterated under section 402 of the 
FD&C Act. We have revised the documentation to reflect the final 
requirements of Sec.  117.430(d)--i.e., to require: (1) Written 
assurance that the supplier is not a covered farm under part 112 in 
accordance with Sec.  112.4(a), or in accordance with Sec. Sec.  
112.4(b) and 112.5, before approving the supplier and on an annual 
basis thereafter; and (2) the written assurance that the farm 
acknowledges that its food is subject to section 402 of the FD&C Act 
(or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States).
    (Comment 715) Some comments ask us to delete this documentation 
requirement because RACs except fruits and vegetables should be exempt 
from supplier verification.
    (Response 715) See Response 693. This alternative supplier 
verification activity is intended to minimize the burden on suppliers 
that are small farms.
    (Comment 716) Some comments ask us to include a cross-reference to 
the applicable requirement.
    (Response 716) We have not added this cross-reference. We agree 
that adding the cross-reference has the potential to be helpful, but it 
also has the potential to clutter the regulatory text. We considered it 
would be more useful to specify what the documentation needs to be 
rather than to specify the cross-reference to the applicable 
alternative supplier verification activity.

L. Holding Human Food By-Products Intended for Use in Animal Food

    In the 2014 supplemental animal preventive controls notice, we 
discussed proposed revisions 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 (79 FR 58524 at 58558). We explained that we were proposing 
these revisions as part of the rulemaking for the animal preventive 
controls rule. (See the discussion of these proposed revisions in the 
animal preventive controls rule.) Because we proposed these revisions 
as part of the rulemaking for the animal preventive controls rule, we 
also are finalizing these provisions as part of that rulemaking. See 
the final animal preventive controls rule, published elsewhere in this 
issue of the Federal Register, for our response to comments on these 
proposed revisions to the human food CGMPs. The final provisions, being 
established in Sec.  117.95 (Holding and distribution of human food by-
products for use as animal food), require that:
    (1) Human food by-products held for distribution as animal food 
without

[[Page 56121]]

additional manufacturing or processing by the human food processor, as 
identified in Sec.  507.12, must be held under conditions that will 
protect against contamination, including the following:
     Containers and equipment used to convey or hold human food 
by-products for use as animal food before distribution must be 
designed, constructed of appropriate material, cleaned as necessary, 
and maintained to protect against the contamination of human food by-
products for use as animal food;
     Human food by-products for use as animal food held for 
distribution must be held in a way to protect against contamination 
from sources such as trash; and
     During holding, human food by-products for use as animal 
food must be accurately identified.
    (2) Labeling that identifies the by-product by the common or usual 
name must be affixed to or accompany human food by-products for use as 
animal food when distributed.
    (3) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute human food by-products for use as animal 
food must be examined prior to use to protect against contamination of 
the human food by-products for use as animal food from the container or 
vehicle when the facility is responsible for transporting the human 
food by-products for use as animal food itself or arranges with a third 
party to transport the human food by-products for use as animal food.

LI. Comments by Foreign Governments and Foreign Businesses

    We received several comments from foreign governments and foreign 
businesses covering a wide range of issues. Many of those comments were 
similar to comments made on certain topics by domestic stakeholders, so 
we are addressing those comments in other sections throughout this 
preamble. In this section, we are responding to comments that are 
primarily focused on international issues, such as the obligations of 
the United States under the World Trade Organization Agreement (WTO).
    (Comment 717) Some comments by foreign government representatives 
ask us to provide ``special and differential treatment'' along with 
technical assistance to help exporters from developing countries meet 
the requirements of the rule. For special and differential treatment, 
the comments propose extended periods of time for the implementation of 
the rule by producers in developing countries, and flexibility in 
implementation for small businesses in those countries. For technical 
assistance, the comments request training and other forms of assistance 
to help producers understand and implement the regulation.
    (Response 717) The concept of special and differential treatment is 
incorporated in the WTO Agreements. Article 10.2 of the WTO SPS 
Agreement states: ``Where the appropriate level of sanitary or 
phytosanitary protection allows scope for the phased introduction . . . 
longer time-frames for compliance should be accorded on products of 
interest to developing country Members so as to maintain opportunities 
for their exports.''
    In 2001, at the WTO Ministerial Conference in Doha, WTO Members 
issued a Ministerial Decision that interpreted the special and 
differential obligations of the SPS Agreement (Ref. 98). The 
Ministerial Decision defined ``longer time-frame for compliance'' to 
normally mean a period of not less than 6 months.
    We recognize that businesses of all sizes may need more time to 
comply with the new requirements established under this rule. As 
discussed in section LVI.A, the first compliance date for businesses 
other than small and very small businesses will be one year after this 
final rule is published in the Federal Register. Recognizing that 
smaller businesses may need more time to comply with the requirements, 
FDA is allowing two years for small businesses and three years for very 
small businesses to comply. We anticipate that these extended 
implementation periods for small businesses and very small businesses 
will apply to a number of businesses in developing countries. Because 
all of these time periods are longer than the 6 month minimum defined 
in the WTO Ministerial Decision, we believe these implementation 
periods are sufficient to address the needs of businesses in developing 
countries, particularly for small and very small businesses in such 
countries.
    In addition to the extended time periods for compliance for small 
and very small businesses, we have also established modified 
requirements for very small businesses, which we define as 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). These modified requirements for 
very small businesses are less burdensome and are described in Sec.  
117.201 of this regulation.
    In addition to the 1 to 3 year time periods for compliance for all 
firms, and modified requirements for very small businesses, we intend 
to work with the food industry, education organizations, USDA, the 
United States Agency for International Development, and foreign 
governments to develop tools and training programs to facilitate 
implementation of this rule.
    (Comment 718) Some comments assert that the food safety systems of 
the European Union and other countries afford a similar level of food 
safety protection and must therefore be recognized by FDA as equivalent 
under the WTO SPS Agreement. These comments urge FDA to accept the 
HACCP plans and other steps taken to comply with European food safety 
laws as being sufficient to comply with this rule.
    (Response 718) The concept of ``equivalence'' for food safety 
regulatory measures is contained in Article 4 of the World Trade 
Organization Agreement on the Application of Sanitary and Phytosanitary 
Measures (the ``SPS Agreement'') (Ref. 99). That article provides that 
WTO Member countries ``shall accept the sanitary or phytosanitary 
measures of other Members as equivalent, even if these measures differ 
from their own or from those used by other Members trading in the same 
product, if the exporting Member objectively demonstrates to the 
importing Member that its measures achieve the importing Member's 
appropriate level of sanitary or phytosanitary protection.'' This 
provision of the SPS Agreement envisions a process in which the 
exporting country provides evidence to the food safety regulator in the 
importing country in order to ``objectively demonstrate'' that the food 
safety system in the exporting country meets the level of food safety 
protection established by the importing country. To date, FDA has 
considered equivalence as most appropriately applied to the assessment 
of a foreign government's specific programs for specific types of 
foods, such as shellfish and dairy products. In that context, the 
equivalence assessment provides a very detailed comparison of each 
measure that a country applies in controlling risks associated with the 
particular commodity under review. FDA continues to have latitude to 
engage in equivalence determinations for market access and as required 
by our regulations for certain commodities. For example, FDA has active 
equivalence

[[Page 56122]]

deliberations underway on Grade ``A'' dairy and will continue to engage 
in equivalence activities as needed.
    In contrast to the assessment of equivalence for the regulation of 
specific foods based upon a detailed review of an individual food 
safety measure or group of measures applied to a specific food, FDA has 
established a process of assessing foreign food safety systems to 
identify systems that offer a comparable level of public health 
protection as the U.S. food safety system for FDA regulated foods. We 
refer to that process as ``systems recognition,'' which we discuss in 
Response 719.
    (Comment 719) Some comments urge FDA to include a provision in this 
rule that would reflect a determination made by FDA in the ``systems 
recognition'' process so that FDA's compliance framework, including 
audit and inspection activities, take into account the effectiveness of 
the regulatory or administrative control of food safety systems. These 
comments ask us to include a provision in this rule establishing that 
an affirmative systems recognition determination by FDA for an 
exporting country would be a sufficient basis to exempt exporting 
producers from that country from their obligation to comply with the 
requirements of this rule. Another comment urges FDA to utilize the 
systems recognition process to recognize the effectiveness of the EU 
system in order to avoid unnecessary or duplicative requirements and 
controls on food imports from the European Union.
    (Response 719) We agree, in part, with this comment. Since 2010, 
FDA has been developing a program of ``systems recognition'' to explore 
ways to leverage the work of food safety authorities in countries that 
have food safety systems that are comparable to that of FDA. Systems 
recognition assessment provides a tool for identifying countries where 
FDA can establish closer regulatory partnerships, including leveraging 
the work conducted by FDA and foreign food safety authorities.
    We agree that the systems recognition program can allow FDA to take 
into account the effectiveness of a foreign food safety regulatory 
system as we develop a compliance framework for imported foods from a 
country for which we have made an affirmative determination of 
comparability via the systems recognition program. While we decline to 
add an exemption for food imported from a country with affirmative 
systems recognition determination by FDA, we note that the systems 
recognition program is based upon the concept that foreign food 
producers can meet U.S. food safety requirements by providing 
assurances that these foods are produced according to the food safety 
standards of a country that FDA has found to be comparable or 
equivalent to that of the United States. Therefore, foreign producers 
of foods that are subject to a systems recognition agreement can show 
that their products are meeting FDA's requirements for imported foods 
by virtue of the fact that they are meeting their domestic food safety 
standards. Several provisions of the supply-chain program specifically 
provide for consideration of relevant laws and regulations of a country 
whose food safety system FDA has officially recognized as comparable or 
has determined to be equivalent to that of the United States (see 
Sec. Sec.  117.410(d)(1)(iii)(B); 117.430(c)(2), (d)(2), and (e)(2); 
and 117.435(b) and (c)(1)(ii).
    We also note that we intend to publish a final FSVP rule in the 
near future. There, we intend to establish modified requirements for 
food imported from a foreign supplier in, and under the regulatory 
oversight of, a country whose food safety system FDA has officially 
recognized as ``comparable'' to that of the United States.
    Section 117.405(a)(2) of this rule provides the option for a 
receiving facility that is an importer to comply with the supplier 
verification requirements in this rule or with the foreign supplier 
verification program requirements that we will establish in part 1, 
subpart L for a raw material or other ingredient. We intend that the 
final FSVP rule will contain a similar provision (derived from proposed 
Sec.  1.502), so that only one supplier verification procedure needs to 
be undertaken in order to comply with both rules when the specified 
conditions are met.

LII. Editorial and Conforming Changes

    The revised regulatory text includes several changes that we have 
made to make the requirements more clear and improve readability. The 
revised regulatory text also includes several conforming changes that 
we have made when a change to one provision affects other provisions. 
We summarize the principal editorial and conforming changes in table 
52.

          Table 52--Principal Editorial and Conforming Changes
------------------------------------------------------------------------
  Designation in the revised
   regulatory text (Sec.   )         Revision           Explanation
------------------------------------------------------------------------
 1.227................  Alphabetize the    Make it easier to
 1.328................   examples of        compare the examples
 117.3................   harvesting         of harvesting
                                 activities in      activities to the
                                 the definition     examples of
                                 of                 manufacturing/
                                 ``harvesting''.    processing
                                                    activities in the
                                                    definition of
                                                    ``manufacturing/
                                                    processing.''
 1.227................  Alphabetize the    Make it easier to
 1.328................   examples of        compare the examples
 117.3................   manufacturing/     of manufacturing/
                                 processing         processing
                                 activities in      activities to the
                                 the definition     examples of
                                 of                 harvesting
                                 ``manufacturing/   activities in the
                                 processing''.      definition of
                                                    ``harvesting.''
 11.1(i)..............  Specify that part  Conforming change
                                 11 does not        associated with the
                                 apply to records   recordkeeping
                                 required to be     requirements in Sec.
                                 established or       117.305, which
                                 maintained under   provide that part 11
                                 part 117, and      does not apply to
                                 that records       records required to
                                 that satisfy the   be established or
                                 requirements of    maintained under
                                 part 117, but      part 117.
                                 that also are
                                 required under
                                 other applicable
                                 statutory
                                 provisions or
                                 regulations,
                                 remain subject
                                 to part 11.
Throughout part 117...........             Conforming change
                                 Substitute the     associated with our
                                 term               proposal, in the
                                 ``adequate'' for   2014 supplemental
                                 the term           human preventive
                                 ``sufficient''.    controls notice, to
                                            make this
                                 Substitute the     substitution so that
                                 term               the rule
                                 ``inadequate''     consistently uses
                                 for the term       the term
                                 ``insufficient''.  ``adequate.''

[[Page 56123]]

 
Throughout part 117...........  Substitute the     Conforming change
                                 term               associated with the
                                 ``pathogen'' for   definition of
                                 the term           ``pathogen.''
                                 ``microorganism
                                 of public health
                                 significance''.
Throughout part 117...........  Substitute the     Conforming change
                                 term ``allergen    associated with the
                                 cross-contact''    definition of
                                 for the term       ``allergen cross-
                                 ``cross-           contact.''
                                 contact''.
Throughout part 117...........  Substitute the     Conforming change
                                 term               associated with
                                 ``preventive       adding the term
                                 controls           ``preventive
                                 qualified          controls qualified
                                 individual'' for   individual.''
                                 the term
                                 ``qualified
                                 individual''.
Throughout part 117...........  Substitute the     Conforming change
                                 term ``unexposed   associated with the
                                 packaged food''    definition of
                                 for the phrase     ``unexposed packaged
                                 ``packaged food    food.''
                                 that is not
                                 exposed to the
                                 environment''.
Throughout part 117...........  Substitute the     Conforming change
                                 phrase             associated with the
                                 ``chemical         definition of
                                 (including         ``hazard.''
                                 radiological)
                                 hazards'' for
                                 phrases such as
                                 ``chemical and
                                 radiological
                                 hazards''.
Throughout part 117...........  Substitute the     Conforming change
                                 term ``hazard      associated with the
                                 requiring a        proposed definition
                                 preventive         of ``significant
                                 control'' for      hazard'' (which we
                                 the term           now refer to as
                                 ``significant      ``hazard requiring a
                                 hazard''.          preventive
                                                    control.'')
Throughout part 117...........  Shorten ``raw      Conforming change
                                 agricultural       associated with the
                                 commodity as       new definition of
                                 defined in         ``raw agricultural
                                 section 201(r)     commodity.''
                                 of the Federal
                                 Food, Drug, and
                                 Cosmetic Act''
                                 to ``raw
                                 agricultural
                                 commodity''.
117.1(a)......................  Redesignate        Improve clarity.
                                 subparagraphs to
                                 distinguish
                                 between applying
                                 the provisions
                                 in determining
                                 whether food is
                                 adulterated and
                                 applying the
                                 provisions in
                                 determining
                                 whether there is
                                 a violation of
                                 the PHS Act.
117.3.........................  Substitute         Improve clarity.
                                 ``apply'' for
                                 ``are
                                 applicable'' in
                                 the introductory
                                 paragraph.
117.3.........................  Editorial changes  Improve clarity.
                                 to verb tense in
                                 the definition
                                 of ``ready-to-
                                 eat food''.
117.3.........................  Specify that the   Give prominence to
                                 definition of      this aspect of the
                                 ``very small       definition of ``very
                                 business''         small business.''
                                 includes any       The relevance of
                                 subsidiaries and   subsidiaries and
                                 affiliates of      affiliates to the
                                 the business.      definition of ``very
                                                    small business'' is
                                                    established in the
                                                    definition of
                                                    ``qualified
                                                    facility,'' but
                                                    including it again
                                                    in the definition of
                                                    ``very small
                                                    business'' will help
                                                    to ensure that it is
                                                    considered when
                                                    determining whether
                                                    the business is
                                                    within the dollar
                                                    threshold
                                                    established in the
                                                    definition of ``very
                                                    small business.''
117.3, 117.5, 117.7(a),         Substitute         Conforming change
 117.257(d)(1).                  ``subparts C and   associated with the
                                 G'' for            redesignation of the
                                 ``subpart C''.     requirements for a
                                                    supply-chain program
                                                    in new subpart G.
117.5(e)......................  Substitute         Correction to use the
                                 ``packaging''      same term as is used
                                 for ``packing''.   in part 111 for
                                                    CGMPs for dietary
                                                    supplements.
117.5(i)......................  Substitute         Improve clarity.
                                 ``Subparts C and
                                 G of this part
                                 do not apply
                                 with respect to
                                 food that is not
                                 an alcoholic
                                 beverage'' for
                                 ``Subparts C and
                                 G of this part
                                 do not apply
                                 with respect to
                                 food other than
                                 an alcoholic
                                 beverage''
                                 (emphasis added).
117.5(k)(2)...................  Specify that the   Clarification. The
                                 provision          provision only
                                 applies to those   applies to those
                                 RACs that are      produce RACs that
                                 produce as will    will have applicable
                                 be defined in      requirements in the
                                 the final          produce safety rule.
                                 produce safety
                                 rule.
 117.10(b), (b)(1),     Editorial changes  Improve clarity.
 and (b)(9).                     to clearly
 117.20(b)(2) and        distinguish
 (b)(6).                         requirements
 117.35(a), (d),         directed to
 (d)(2), (d)(3), (e), and (f).   allergen cross-
                                 contact from
                                 requirements
                                 directed to
                                 contamination.
 117.40(a)(6) and (b)
 117.80(a)(4) and
 (a)(6)
 117.80(b)(1), (b)(5),
 and (b)(7)
 117.80(c)(6), (c)(7),
 (c)(10), and (c)(12)

[[Page 56124]]

 
 117.93
 117.10...............  Conforming         The definition of
                                 changes            ``plant'' focuses on
                                 associated with    the building,
                                 the definition     structure, or parts
                                 of ``plant''.      thereof, used for or
                                                    in connection with
                                                    the manufacturing,
                                                    processing, packing,
                                                    or holding of human
                                                    food. The term
                                                    ``establishment''
                                                    focuses on a
                                                    business entity
                                                    rather than on
                                                    buildings or other
                                                    structures.
 117.20(a)
 117.37(d)
 117.305(f)
117.35(b).....................  Refer to ``letter  This long-standing
                                 of guarantee''     CGMP provision is
                                 rather than        not limited to
                                 ``supplier's       documents from a
                                 guarantee''.       ``supplier'' as that
                                                    term is defined in
                                                    this rule.
117.37(d).....................  Refer to           Editorial change.
                                 ``employees''
                                 rather than
                                 ``its
                                 employees''.
 117.80(b)(1) through   Changes to         Return to long-
 (8).                            consistently       standing terminology
 117.80(c)(7) and        refer to raw       in the CGMPs
 (c)(9).                         materials and      previously
                                 ``other            established in part
                                 ingredients''.     110.
117.80(c)(7)..................  Refer to ``other   Raw materials and
                                 food'' rather      other ingredients,
                                 than ``food'' in   work-in-process, and
                                 the phrase ``raw   rework are all types
                                 materials and      of food.
                                 other
                                 ingredients,
                                 work-in-process,
                                 rework, or
                                 food''.
117.126(b)(3), 117.135(c)(4),   Refer to ``supply- Conforming change
 117.140(b), 117.160(c)(4),      chain program''    associated with the
 117.190(a)(5).                  rather than        title of final
                                 ``supplier         subpart G (proposed
                                 program''.         Sec.   117.136).
 117.160(b)(2)........  Conforming         Improve clarity;
 117.170(b)(4)........   changes            consistency with the
                                 associated with    requirements for
                                 the definition     validation.
                                 of
                                 ``validation''.
117.165(a)(4)(ii).............  Refer to ``supply- Consequential change
                                 chain              as a result of the
                                 verification       requirement in Sec.
                                 activities,'' as    117.405(c) for
                                 well as            verification of an
                                 ``supplier         entity that is in
                                 verification       the supply-chain but
                                 activities''.      is not a supplier.
117.165(b)(1).................  Changes to         Conforming change
                                 require written    associated with the
                                 procedures for     requirements to
                                 method and         calibrate process
                                 frequency of       monitoring
                                 accuracy checks    instruments and
                                 for process        verification
                                 monitoring         instruments (or
                                 instruments and    check them for
                                 verification       accuracy).
                                 instruments.
117.170(c)(2).................  Conforming         Consistency with the
                                 changes            requirements for
                                 associated with    validating
                                 the timeframe      preventive controls.
                                 for validating
                                 preventive
                                 controls.
117.170(d)....................  Editorial changes  Improve clarity.
                                 to the
                                 requirement to
                                 revise the
                                 written food
                                 safety plan or
                                 document why
                                 revisions are
                                 not needed.
117.180(a)(3).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for
                                 individual in      validation of a
                                 determining an     preventive control.
                                 alternative
                                 timeframe for
                                 validation.
117.180(a)(4).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine that
                                 qualified          validation of a
                                 individual in      preventive control
                                 determining that   is not required.
                                 validation is
                                 not required.
117.180(a)(6).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for review
                                 individual in      of records of
                                 determining an     monitoring and
                                 alternative        corrective actions.
                                 timeframe for
                                 review of
                                 records of
                                 monitoring and
                                 corrective
                                 actions.
117.180(a)(8).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for
                                 individual in      completing
                                 determining an     reanalysis.
                                 alternative
                                 timeframe for
                                 completing
                                 reanalysis.
117.80(b)(3)..................  Delete             ``Current'' is
                                 ``current'' from   unnecessary.
                                 ``current FDA
                                 regulations''.

[[Page 56125]]

 
117.201(a)(2)(ii).............  Editorial change   Improve clarity.
                                 to place the
                                 clause
                                 ``including
                                 through
                                 licenses,
                                 inspection
                                 reports,
                                 certificates,
                                 permits,
                                 credentials,
                                 certification by
                                 an appropriate
                                 agency (such as
                                 a State
                                 department of
                                 agriculture), or
                                 other evidence
                                 of oversight''
                                 at the end of
                                 the provision,
                                 rather than in a
                                 parenthetical at
                                 the beginning of
                                 the provision.
117.206(a)(2).................  Editorial change   Improve clarity.
                                 to specify
                                 ``provide
                                 assurance that
                                 the temperature
                                 controls are
                                 consistently
                                 performed''
                                 rather than
                                 ``provide
                                 assurance that
                                 they are
                                 consistently
                                 performed''.
 117.206(a)(4)(ii)....  Substitute the     Consistency with
 117.206(a)(4)(iii)...   phrase ``records   other recordkeeping
                                 are created''      requirements of the
                                 for the phrase     rule.
                                 ``records are
                                 made''.
117.206(a)(4)(iii)............  Change ``within a  Conforming change
                                 week'' to          associated with
                                 ``within 7         review of records of
                                 working days''.    monitoring and
                                                    corrective action
                                                    records.
Subpart E (title).............  Substitute the     Conforming change
 117.251..............   term ``qualified   associated with the
 117.254..............   facility           definition of
 117.257..............   exemption'' for    ``qualified facility
 117.260..............   the phrase         exemption.''
 117.264..............   ``exemption
 117.280..............   applicable to a
 117.251..............   qualified
                                 facility'' or
                                 the phrase
                                 ``exemption
                                 applicable to a
                                 qualified
                                 facility under
                                 Sec.
                                 117.5(a)''.
117.251(b)(1).................  Change ``import    Align with statutory
                                 alert'' to         language regarding
                                 ``refusal of       imports rather than
                                 food offered for   with specific
                                 import''.          procedures that FDA
                                                    uses for refusing
                                                    admission to foods
                                                    offered for import.
117.254(a)....................  Change ``FDA       The provision refers
                                 official senior    to two ``Directors''
                                 to such            and the clause
                                 Director'' to      applies to either
                                 ``FDA official     Director.
                                 senior to either
                                 such Director''.
117.257(c)(2).................  Refer to           Consistency with
                                 ``conditions or    regulatory text in
                                 conduct'' rather   Sec.
                                 than ``conduct     117.251(a)(2).
                                 or conditions''.
 117.260(a)(2)........  Change ``within    Conforming change to
 117.264(a)(1)........   10 calendar        reflect a timeframe
 117.267(a)(2)........   days'' to          of 15 calendar days,
 117.270(a)...........   ``within 15        rather than 10
                                 calendar days''.   calendar days, in
                                                    the order
                                                    withdrawing a
                                                    qualified facility
                                                    exemption.
 117.287(a)...........  Specify ``any      Clarify that
 117.287(b)(2)........   problems with      reinstatement of a
                                 the conditions     qualified exemption
                                 and conduct''      that was withdrawn
                                 rather than        requires resolution
                                 ``problems with    of any problems,
                                 the conditions     regardless of
                                 and conduct'' or   whether the problems
                                 ``problems with    related to
                                 the conditions     conditions, conduct,
                                 or conduct''.      or both conditions
                                                    and conduct.
117.305.......................  Refer to ``lot     Consistency with the
                                 code'' rather      definition of
                                 than               ``lot.''
                                 ``production
                                 code''.
117.310.......................  Editorial changes  Improve clarity.
                                 to present the
                                 requirement in
                                 active voice.
------------------------------------------------------------------------

LIII. Comments on FSMA's Rulemaking Provisions

A. Comments on Requirements in Section 418(n)(3) of the FD&C Act 
Regarding Content

    FSMA specifies that this rule acknowledge differences in risk and 
minimize, as appropriate, the number of separate standards that apply 
to separate foods (section 418(n)(3)(C) of the FD&C Act). As previously 
discussed, we consider that the proposed human preventive controls rule 
strikes what we consider to be an appropriate balance between 
acknowledging differences in risk and minimizing the number of separate 
standards applied to separate foods (78 FR 3646 at 3785).
    (Comment 720) Some comments agree that the proposed human 
preventive controls rule reflects a risk-based approach and our 
recognition that a ``one -size-fits-all'' approach is not appropriate 
in the application of hazard analysis and risk-based preventive 
controls across the entire domestic and international food industry. 
These comments ask us to retain this flexibility in the final rule by 
describing the required and expected results of the program, but not 
going as far as prescribing the process and methodology taken to get 
there. Other comments emphasize that the final rule must provide 
sufficient flexibility to allow facilities to adopt practices that are 
practical and effective for their specific, individual operations.
    (Response 720) The final rule directs the owner, operator, or agent 
in charge of a facility to establish and implement

[[Page 56126]]

a food safety plan that includes a written hazard analysis, preventive 
controls that the facility identifies to control hazards requiring a 
preventive control, and establish and implement appropriate preventive 
control management components 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. As requested 
by the comments, the rule does not prescribe the process and 
methodology to ``get there.''
    (Comment 721) Some comments ask us to adopt a commodity-specific 
approach to RACs when activities conducted on RACs are subject to the 
human preventive controls rule. The requested commodity-specific 
approach would exempt (or, at a minimum, defer regulation of) ``low-
risk commodities (such as table grapes)'' from the human preventive 
controls rule. These comments note that we have acknowledged that just 
five commodity groups (leafy greens, tomatoes, herbs, melons, and 
sprouts) accounted for 77 percent of all produce-related outbreaks, 54 
percent of produce-related illnesses, and 56 percent of produce-related 
hospitalizations between 1996 and 2010 (78 FR 3504 at 3525). These 
comments assert that the principal benefits of the FSMA rules will come 
from regulating these crops and that we cannot claim to have 
acknowledged differences in risk if we adopt a ``one-size-fits-all'' 
strategy. These comments ask us to apply the human preventive controls 
rule only to RACs that fall within the five highest-risk commodity 
groups and to any other specific commodities that we have determined 
pose a comparable risk based on outbreak history and the commodity's 
characteristics.
    Other comments asserting that the rule is ``one-size-fits-all'' 
likewise ask us to apply the human preventive controls rule only to the 
highest risk commodities but do not narrowly direct their request to 
RACs. Some of these comments state that regulations must be scale- and 
supply-chain appropriate to be effective and assert that a ``one-size-
fits-all'' approach will put small and mid-sized farms and processors 
out of business, undermining public health goals, such as increased 
production of, availability of, and access to healthy foods, as well as 
economic opportunity, equity, and job-creation goals.
    (Response 721) We decline these requests to apply the human 
preventive controls rule only to foods determined to be of the highest 
risk and disagree that the rule is ``one-size-fits-all.'' For example, 
several provisions of the rule expressly qualify that the requirements 
apply as appropriate to the facility, the food, the nature of the 
preventive control and its role in the facility's food safety system, 
the nature of the hazard, or a combination of these factors (see, e.g., 
Sec.  117.135(c), (c)(1), and (c)(3); Sec.  117.140(a) and (b); Sec.  
117.150(a); Sec.  117.160(a); Sec.  117.165(a) and (b)); and Sec.  
117.410(d)(1)). The exemptions we are establishing are provided by 
section 103 of FSMA. As discussed in Response 222, 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 that there are no hazards requiring a preventive control 
associated with its food products 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. (See also Response 16.)
    (Comment 722) Some comments interpret the statutory direction in 
section 418(n)(3)(C) of the FD&C Act to mean that Congress granted us 
authority to provide flexibility for businesses of all sizes and types 
(i.e., not just small businesses), as well as to acknowledge 
differences in risk. These comments assert that section 418(n)(3)(C) 
grants us authority to exempt distribution centers from the 
requirements for hazard analysis and risk-based preventive controls 
because: (1) Distribution centers are very low-risk facilities and (2) 
requiring distribution centers to comply with those requirements would 
not be practicable.
    (Response 722) We disagree with these comments. See Response 221 
for our response to comments that ask us to establish exemptions based 
on the risk presented by a food product and Response 226 for our 
response to comments that request an exemption for facilities such as 
supermarket distribution centers. The rule establishes an exemption for 
facilities solely engaged in the storage of unexposed packaged food 
(see Sec.  117.7(a)), except that there are modified requirements for 
such establishments engaged in the storage of TCS foods (see Sec.  
117.7(b) and 117.206).
    (Comment 723) Some comments state that Grade ``A'' dairy products 
are already effectively regulated under the PMO, and assert that 
subjecting these products to the human preventive controls rule would 
apply two separate standards, doubling rather than minimizing the 
number of separate standards that apply to separate foods. These 
comments ask us to instead acknowledge the reduced risk profile of 
foods produced in accordance with the PMO and allow dairy products to 
continue to be regulated under one standard, the PMO. These comments 
also assert that exempting PMO-regulated facilities from the rule would 
allow us to better tailor our requirements to those foods not currently 
manufactured under such regulatory programs, which would also minimize 
the need to develop separate guidance and standards for this segment of 
the dairy industry.
    (Response 723) See Response 214 for a discussion of our approach to 
PMO-regulated facilities.
    (Comment 724) Some comments assert that the rule addresses 
differences in risk based on the number of people affected in the event 
of contaminated product being sold rather than on the types of hazards 
identified for a particular food and the ability to address those 
hazards via preventive practices, because the rule bases modified 
requirements on company revenues, customer type (restaurant and retail 
establishments), and customer location (275 mile radius). These 
comments assert that the proposed modified requirements do not properly 
address food safety risk through prevention and ask us to establish 
risk-based standards that require preventive practices to address 
identified hazards for a particular food and process for all companies 
manufacturing, processing, packing, and holding food.
    Other comments assert that the statutory direction to require 
hazard analysis and risk-based preventive controls for all facilities 
that are required to register as a food facility under the section 415 
registration regulations does not take into consideration the 
significant differences in risk profiles of fresh produce facilities 
and food processing and manufacturing facilities. These comments 
further assert that the section 415 registration regulations are not 
risk-based but simply served to keep a catalogue of facilities 
supplying the U.S. food supply and that it is not logical or 
appropriate that a fresh produce facility that packs RACs should be 
subject to the same regulatory controls as food manufacturing 
facilities such as those that produce canned foods or infant formula.
    (Response 724) We disagree with these comments. See Response 222, 
in which we respond to comments asserting that a food safety plan 
should only be required for high-risk processing facilities. 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

[[Page 56127]]

presented by the products as part of their hazard evaluation.

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

    FSMA directs us to review regulatory hazard analysis and preventive 
control programs in existence on the date of its enactment, including 
the PMO, to ensure that the regulations we establish are consistent, to 
the extent practicable, with applicable domestic and internationally-
recognized standards in existence on that date. (See section 418(n)(5) 
of the FD&C Act.) Consistent with that statutory direction, we 
previously compared the key features of our proposed requirements to 
implement section 418 of the FD&C Act to certain domestic and 
international food safety standards (Ref. 100) (78 FR 3646 at 3785 to 
3788).
    In the following paragraphs, we discuss comments specifically 
directed to the statutory direction in section 418(n)(5) of the FD&C 
Act. For examples of other comments related to the consistency of the 
proposed human preventive controls rule with applicable domestic and 
internationally-recognized standards, see Comment 8, Comment 215, 
Comment 372, Comment 718, and Comment 719.
    (Comment 725) Some comments assert that a proper harmonization is 
needed with international standards and ask us to harmonize the FSMA 
requirements for the food safety plan with international and domestic 
HACCP programs. These comments also ask us to explain any differences 
between the FSMA food safety plan and the existing HACCP programs and 
ask us to provide exporters with background information and specific 
examples of differences, including how firms are directed to set their 
CCPs and critical limits.
    (Response 725) As previously discussed (Ref. 102 and 78 FR 3646 at 
3785 to 3788), we believe the human preventive controls rule is 
consistent with existing food safety programs. We have updated our 2012 
memorandum entitled ``Comparison of Proposed Subpart C (Hazard Analysis 
and Risk-Based Preventive Controls) to Various Existing Domestic and 
International HACCP-Based Standards'' (Ref. 102) to reflect the 
provisions of the final human preventive controls rule (rather than the 
proposed human preventive controls rule) (Ref. 65). The comparative 
format of the updated memorandum provides the background information 
and specific examples of differences requested by these comments.
    However, neither this rule nor our updated memorandum (Ref. 65) 
provide firms with direction on how to set their CCPs and critical 
limits. A facility has flexibility to establish and implement 
appropriate preventive controls, including controls at CCPs and 
including any critical limits that the facility determines are 
necessary to provide assurances that 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 under section 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act.
    (Comment 726) Some comments ask whether we concluded, in light of 
the statutory direction in section 418(n)(5) of the FD&C Act, that the 
CGMP requirements in combination with the standards of identity for 
cheese in part 133 do not provide adequate public health controls 
within the cheese manufacturing industry. According to these comments, 
under regulations in part 133 many cheeses have an option to use 
unpasteurized milk, provided the cheese manufactured from unpasteurized 
milk is aged for at least 60 days at not less than 35 degrees F. These 
comments ask whether the 60 day aging process will be recognized as a 
preventive control.
    (Response 726) Section 418(n)(5) of the FD&C Act directs us to 
review ``regulatory hazard analysis and preventive control programs'' 
in existence on the date of its enactment. We have not considered 
provisions in the standards of identity (whether in part 133 or in 
other standards of identity) in our analysis directed by section 
418(n)(5) of the FD&C Act, because standards of identity are not hazard 
analysis and preventive controls programs. We establish food standards, 
such as the standards in part 133 (Cheeses and Related Cheese Products) 
under section 401 of the FD&C Act (21 U.S.C. 341) to promote honesty 
and fair dealing in the interest of consumers. In contrast to this role 
of food standards, hazard analysis and preventive control programs 
(e.g., HACCP) involve a systematic approach to the identification and 
assessment of the risk (likelihood of occurrence and severity) of 
hazards from a particular food or food production process or practice 
and the control of those hazards (78 FR 3646 at 3659).
    We acknowledge that part 133 requires an aging period, such as at 
least 60 days at not less than 35 degrees F, for cheese manufactured 
from unpasteurized milk, and that this aging period was presumed to act 
as a control measure to reduce the risk that pathogens would be present 
when the cheese was consumed. We recently issued a request for comments 
and for scientific data and information that would assist us in 
identifying and evaluating intervention measures that might have an 
effect on the presence of bacterial pathogens in cheeses manufactured 
from unpasteurized milk (80 FR 46023, August 3, 2015). It is premature 
to determine what role, if any, an aging process could play in a food 
safety plan for the manufacture of cheese from unpasteurized milk.
    (Comment 727) Some comments assert that we did not make the 
required comparison of the proposed human preventive controls rule to 
the PMO available for review.
    (Response 727) The required comparison of the proposed human 
preventive controls rule to the PMO is available in the docket for this 
rulemaking (Docket FDA-2011-N-0920) (see Reference 193 to the proposed 
human preventive controls rule). We stated that it was available during 
the discussion of section 418(n)(5) of the FD&C Act (36 FR 3646 at 
3786). For this final rule, we have both updated this comparison (Ref. 
65) and prepared a separate comparison of the final provisions of this 
rule to the PMO (Ref. 49).

LIV. Comments on Proposed Removal of 21 CFR Part 110--Current Good 
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

    We proposed to remove current part 110 after the compliance date 
for all businesses to be in compliance with the requirements of new 
part 117. We received no comments that disagreed with this proposal. As 
discussed in section LVI.A, businesses will be required to comply with 
new part 117 1, 2, or 3 years after September 17, 2015, depending on 
the size of the business. Thus, part 110 will be removed on September 
17, 2018.

LV. Comments on Proposed Conforming Amendments

    We proposed a series of conforming amendments to current 
regulations (in Sec. Sec.  106.100(j) and (n), 114.5, 120.3, 120.5, 
120.6(b), 123.3, 123.5(a), 123.11(b), 129.1, 179.25(a), and 211.1(c)) 
that refer to the requirements of part 110. With the proposed 
conforming changes, these current regulations would refer to part 117, 
as well as part 110. We also proposed that when part

[[Page 56128]]

110 is removed, all references to part 110 be removed from our 
regulations.
    We received no comments that disagreed with the proposed conforming 
changes. Therefore, at this time we are amending each of these current 
regulations so that they refer to part 117, as well as part 110. When 
part 110 is removed, we will issue conforming amendments to remove all 
references to part 110 from our regulations.

LVI. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 117

    We proposed that any final rule based on proposed part 117 become 
effective 60 days after its date of publication in the Federal 
Register, with staggered compliance dates (78 FR 3646 at 3673). 
Businesses other than small and very small businesses would have 1 year 
from the date of publication of the final rule to comply with the rule, 
whereas small businesses would have 2 years and very small businesses 
would have 3 years to comply with the rule. We proposed that these 
staggered compliance dates would apply to the modernized CGMPs that 
would be established in subpart B of part 117, as well as the new 
requirements for hazard analysis and risk-based preventive controls (78 
FR 3646 at 3674). The staggered compliance dates for compliance with 
the modernized CGMPs would apply to all food establishments, including 
those establishments that are subject to the CGMPs in subpart B, but 
exempt from the new requirements for hazard analysis and risk-based 
preventive controls in subparts C and G. For the purpose of determining 
its compliance date, the definitions of ``small business'' and ``very 
small business'' established in this rule apply, regardless of whether 
a food establishment is subject to requirements of another rule (such 
as our HACCP regulation for juice in part 120) that may have a 
different definition for ``small business'' and ``very small 
business.''
    Most of the comments support staggering the compliance dates. For 
example, one comment states that the rule would substantially prevent 
wide-ranging harm associated with contaminated processed foods, but at 
a reasonable cost to the food industry, with ample exclusions and 
extended compliance dates for small facilities. However, some of the 
comments that support staggering the compliance dates suggest extending 
the compliance dates for some sizes of business (see, e.g., Comment 
728, Comment 730, and Comment 731).
    In the following sections, we discuss comments that suggest 
extensions to the proposed compliance dates or ask us to clarify how 
the compliance dates will apply. After considering these comments, we 
are establishing the effective and compliance dates as proposed, except 
for the following three changes. First, we are extending the compliance 
date for PMO-regulated facilities to comply with the requirements of 
subparts C and G to September 17, 2018 (See Response 214). Second, we 
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. (See Response 155.) Third, we are establishing separate 
compliance dates for the supply-chain program provisions. As discussed 
in Response 729, a receiving facility's compliance date with the 
supply-chain program provisions of this rulemaking is the later of: (1) 
March 17, 2017; (2) for a receiving facility that is a small business, 
September 18, 2017; and (3) when the supplier of a raw material or 
other ingredient will be subject to the human preventive controls rule 
or the produce safety rule, 6 months after the receiving facility's 
supplier of that raw material or other ingredient is required to comply 
with the applicable rule. See table 53 and table 54 for a summary of 
these compliance dates.

 Table 53--Compliance Dates for the Requirements of Part 117 Other Than
               the Requirements for a Supply-Chain Program
                               [Subpart G]
------------------------------------------------------------------------
            Size of business                     Compliance date
------------------------------------------------------------------------
Qualified facility (including very       September 17, 2018, except that
 small business) as defined in Sec.       the compliance date for a
 117.3.                                   facility to retain records to
                                          support its status as a
                                          qualified facility is January
                                          1, 2016.
Small business as defined in Sec.        September 18, 2017.
 117.3.
Businesses subject to the Pasteurized    September 17, 2018.
 Milk Ordinance.
All other businesses...................  September 19, 2016.
------------------------------------------------------------------------


   Table 54--Compliance Dates for the Requirements of the Supply-Chain
                                 Program
                               [Subpart G]
------------------------------------------------------------------------
               Situation                         Compliance date
------------------------------------------------------------------------
A receiving facility is a small          September 18, 2017.
 business and its supplier will not be
 subject to the human preventive
 controls rule or the produce safety
 rule.
A receiving facility is a small          The later of: September 18,
 business and its supplier is subject     2017 or 6 months after the
 to the human preventive controls rule    receiving facility's supplier
 or the produce safety rule.              of that raw material or other
                                          ingredient is required to
                                          comply with the applicable
                                          rule.
A receiving facility is not a small      March 17, 2017.
 business or a very small business and
 its supplier will not be subject to
 the human preventive controls rule or
 the produce safety rule.
A receiving facility is not a small      6 months after the receiving
 business or a very small business and    facility's supplier of that
 its supplier will be subject to the      raw material or other
 human preventive controls rule or the    ingredient is required to
 produce safety rule.                     comply with the applicable
                                          rule.
------------------------------------------------------------------------


[[Page 56129]]

    We also are establishing two additional compliance dates applicable 
to qualified facilities. First, we are establishing December 17, 2018 
as the compliance date for (1) the initial submission of the 
attestation by a facility that it is a qualified facility (see Sec.  
117.201(a)(1)) and (2) the attestation by a qualified facility about 
its food safety practices (see Sec.  117.201(a)(2)(i)) or that it is in 
compliance with non-Federal food safety law (see Sec.  
117.201(a)(2)(ii)).
    Second, we are establishing January 1, 2020, as the compliance date 
for the notification requirement of Sec.  117.201(e)(1). A qualified 
facility that submits an attestation that it is in compliance with 
applicable non-Federal food safety law must notify consumers as to the 
name and complete business address of the facility where the food was 
manufactured or processed (see Sec.  117.201(e)). If a food packaging 
label is required, the required notification must appear prominently 
and conspicuously on the label of the food (see Sec.  117.201(e)(1)). 
This notification requirement may require some qualified facilities to 
update the labels of their packaged food products.
    For many labeling requirements, the timeframe for a food 
establishment to comply with new or revised labeling requirements is 
governed by a uniform compliance date (see, e.g., 79 FR 73201, December 
10, 2014 and 77 FR 70885, November 28, 2012). Use of a uniform 
compliance date provides for an orderly and economical industry 
adjustment to new labeling requirements by allowing sufficient lead 
time to plan for the use of existing label inventories and the 
development of new labeling materials. This policy serves consumers' 
interests as well because the cost of multiple short-term label 
revisions that would otherwise occur would likely be passed on to 
consumers in the form of higher prices. We generally announce a uniform 
compliance date during November or December of even-numbered calendar 
years, and establish the uniform compliance date to be January 1 of an 
upcoming even-numbered calendar year. For example, in December, 2014, 
we issued a final rule establishing January 1, 2018, as the uniform 
compliance date for food labeling regulations that are issued between 
January 1, 2015, and December 31, 2016 (79 FR 73201). Likewise, in 
November, 2012, we issued a final rule establishing January 1, 2016, as 
the uniform compliance date for food labeling regulations that are 
issued between January 1, 2013, and December 31, 2014 (77 FR 70885, 
November 28, 2012). These uniform compliance dates provide a minimum of 
1 year between the date when a food labeling regulation is issued and 
the date when a food establishment must comply with that regulation. 
Following this pattern, we intend that the next uniform compliance date 
will be January 1, 2020 for food labeling regulations that are issued 
between January 1, 2017 and December 31, 2018. A qualified facility 
that submits an attestation that it is in compliance with non-Federal 
food safety law would become subject to the notification requirement 
during this timeframe--i.e., by December 31, 2018.
    The compliance date that we are establishing for the notification 
requirement of Sec.  117.201(e) (i.e., January 1, 2020) is consistent 
with the approach of a uniform compliance date and will provide a 
qualified facility that chooses to submit an attestation about 
compliance with non-Federal food safety law with more than 1 year from 
the applicable general compliance date to comply with the notification 
requirement. This compliance date also will provide such a qualified 
facility with more than 4 years to comply with the notification 
requirement relative to the date of publication of this rule.
    (Comment 728) Some comments assert that one year is not a 
sufficient amount of time for any size firm to comply with the human 
preventive controls rule based on experiences with the implementation 
of our HACCP regulation for seafood. These comments assert that HACCP 
required a ``cultural change'' for many seafood processors. The 
comments acknowledge that the knowledge of HACCP and food safety 
systems has advanced throughout the food industry in the nearly 20 
years since we established our HACCP regulation for seafood but 
nonetheless assert that firms will need to modify previously developed 
food safety plans in order to comply with the rule. The comments also 
assert that training cannot realistically begin until both the final 
rule and associated guidance are published and that the experiences 
with implementing our HACCP regulation for seafood should be magnified 
for the human preventive controls rule because the universe of food 
processors needing to comply will be much larger, both in the United 
States and throughout the world. These comments ask us to establish a 
2-year compliance period for the largest firms to allow time for the 
training programs and guidance documents to be developed.
    (Response 728) We decline this request. As the comments 
acknowledge, approximately 20 years have elapsed since we issued the 
final rule establishing our HACCP regulation for seafood, and 
requirements such as conducting a hazard analysis and implementing 
appropriate preventive controls, with associated preventive control 
management components, are no longer novel. We agree that the details 
of the final requirements could not be known until publication of this 
final rule, and that the guidance we are developing can help businesses 
develop or modify their food safety plans and training programs. 
However, the statutory direction in section 418 of the FD&C Act is 
extensive and, thus, signaled the general nature of the requirements as 
early as January 4, 2011, when FSMA was signed into law. In addition, 
we conducted extensive stakeholder outreach during the 10-month comment 
period for the 2013 proposed human preventive controls rule (79 FR 
58524 at 58528). We also provided public notice about proposed changes 
to the farm-related definitions that affect the determination of 
whether a business is subject to the rule, the framework for hazard 
analysis and risk-based preventive controls, and about specific 
potential requirements for environmental monitoring, product testing, 
and a supplier program, in the 2014 supplemental human preventive 
controls notice, and conducted outreach activities to discuss the new 
or revised proposed provisions in that supplemental notice (see section 
I.A and Ref. 1 and Ref. 2). In light of the broad awareness of 
preventive programs such as HACCP, the statutory direction in FSMA, and 
extensive outreach associated with this rulemaking, we disagree that 
the largest businesses will need more than one year to fully adapt 
their programs to the specific requirements of the final rule. Although 
a business may find it useful to revise certain aspects of its food 
safety plan, or enhance its training materials, after we issue 
implementation guidance such as that discussed in Response 2, such 
revisions would serve to enhance the company's food safety plan rather 
than be a necessary resource before a food safety plan could be 
developed and implemented or before employees could be trained in their 
specific duties associated with implementing the plan.
    Moreover, for our HACCP regulation for seafood we established a 
single compliance date regardless of the size of the business, and 
announced our intention to monitor the progress of the industry after 
publication of the final rule. If we determined that the compliance 
date for that regulation was placing a significant and unreasonable 
burden on the industry, particularly on small businesses, we were 
willing to

[[Page 56130]]

consider an extension for as much as one additional year or some form 
of additional technical assistance (Federal Register of December 18, 
1995, 60 FR 65096 at 65169). Approximately 5 years later, we issued the 
final rule for our HACCP regulation for juice (January 19, 2001, 66 FR 
6138), in which we staggered the compliance dates based on business 
size and provided only one year for the largest businesses to comply. 
The staggered compliance dates that we proposed for the human 
preventive controls rule based on business size are consistent with the 
approach we took for the HACCP regulation for juice, given increased 
awareness of hazard analysis and the application of risk-based 
preventive controls in the years after we issued the final rule for 
seafood HACCP.
    (Comment 729) Some comments point out that there are staggered 
compliance deadlines for small and very small businesses under both the 
human preventive controls rule and the produce safety rule. These 
comments express concern that to the extent a receiving facility 
subject to the human preventive controls rule is required to comply 
with the rule sooner than a current or prospective supplier, that 
receiving facility is in effect creating pressure for that supplier to 
come into compliance on a timetable inconsistent with that established 
in the rules. The ``adequacy'' of the receiving facility's verification 
activities becomes potentially even more problematic to demonstrate to 
FDA inspectors.
    (Response 729) We are establishing separate compliance dates for 
the supply-chain program provisions. While this adds complexity, we are 
doing this for two main reasons. First, we are aligning, to the extent 
feasible, the compliance dates of the supply-chain program provisions 
of this rule with the compliance dates of the forthcoming FSVP rule, 
which we intend to publish in the near future. This will provide 
greater consistency across the programs, particularly with respect to 
the verification of domestic and imported raw materials and 
ingredients. For the FSVP rule, we proposed a minimum compliance period 
of 18 months.
    Second, to address the concerns expressed in these comments we want 
to minimize the likelihood that a receiving facility will be required 
to comply with the supply-chain program provisions of this rulemaking 
before its supplier is required to comply with applicable new food 
safety regulations implementing FSMA. Our goal is to avoid a situation 
in which a receiving facility would be required to develop a supply-
chain program for a food from a particular supplier and then be 
required to revise this supply-chain program shortly thereafter once 
the supplier is subject to an applicable new food safety regulation--
specifically, the human preventive controls rule or the forthcoming 
produce safety rule.
    Therefore, a receiving facility's compliance date with the supply-
chain program provisions of this rulemaking is the later of: (1) March 
17, 2017; (2) for a receiving facility that is a small business, 
September 18, 2017; and (3) when the supplier of a raw material or 
other ingredient will be subject to the human preventive controls rule 
or the produce safety rule, six months after the receiving facility's 
supplier of that raw material or other ingredient is required to comply 
with the applicable rule.
    (Comment 730) One comment from a State department of agriculture 
asserts that the farm-related definitions in the 2013 proposed human 
preventive controls rule would cover a large sector of agricultural 
operations that would not be able to comply due to cost and would need 
a longer compliance schedule.
    (Response 730) We believe that the revised definitions that we 
proposed in the 2014 supplemental human preventive controls notice for 
``farm,'' and for on-farm manufacturing, processing, packing, and 
holding activities that trigger a requirement for an establishment that 
is also a farm to register as a food facility, largely address these 
comments. Many activities that farms conduct on RACs, and that would 
have triggered a requirement to register under the definitions 
established in the section 415 registration regulations in 2003 (68 FR 
58894), will not trigger a requirement to register under the 
definitions we are establishing in this final rule.
    We are aware of the impact that food safety rulemakings may have on 
small and very small businesses, and in the 2001 final rule to 
establish our HACCP regulation for juice we began the practice of 
reducing the burden on these businesses by staggering the compliance 
dates and giving small and very small businesses additional time to 
comply with food safety regulations. Since that time, we have continued 
this practice of staggering compliance dates in rulemakings such as 
establishing CGMPs for dietary supplements (June 25, 2007, 72 FR 34752) 
and preventing Salmonella Enteritidis in Shell Eggs During Production, 
Storage, and Transportation (July 9, 2009, 74 FR 33030 at 33034). We 
believe that the staggered compliance dates in this final rule provide 
adequate time for businesses of all sizes to comply with the rule, and 
that the additional compliance time provided for small and very small 
businesses sufficiently minimizes the burden on those businesses. (See 
also Response 731.)
    (Comment 731) Some comments assert that differences between the 
proposed compliance dates for different sizes of businesses subject to 
the human preventive controls rule and the proposed compliance dates 
for different sizes of businesses subject to the produce safety rule 
will create confusion within industry and State and local regulators. 
These comments also express concern that certain farms will be subject 
to both rules at the same time, and that compliance with each rule will 
require significant investment of both resources and time, both to 
understand and to implement the various provisions. These comments ask 
us to consider a process to permit very small and small farms (as 
defined under the proposed produce safety rule) that are also mixed-
type facilities subject to the human preventive controls rule to apply 
for a one-time compliance period extension of twelve months by 
notifying FDA in writing. These comments assert that only a small 
percentage of businesses will be eligible for such a one-time extension 
and that the extension will enable a farmer to plan accordingly, first 
implementing the produce safety rule and then implementing the human 
preventive controls rule.
    (Response 731) We decline this request. See Response 730 regarding 
the impact of the revised farm-related definitions on businesses that 
conduct on-farm activities. A small or very small business that only 
conducts the on-farm low-risk activity/food combinations we have 
specified as exempt (see Sec.  117.5(g) and (h)) is exempt from all 
requirements for hazard analysis and risk-based preventive controls. A 
very small business that conducts on-farm activity/food combinations in 
addition to those low-risk activity/food combinations would be subject 
to an exemption as a qualified facility and is subject only to the 
modified requirements we are establishing in Sec.  117.201.
    A small business that would not be exempt because it conducts other 
activities in addition to those low-risk activity/food combinations 
that would qualify the business for an exemption will have 2 years to 
comply with the human preventive controls rule. We acknowledge that 
complying with both the human preventive controls rule and the produce 
safety rule involves significant new requirements, but we have provided 
extended compliance periods and done substantial outreach.

[[Page 56131]]

    (Comment 732) Some comments ask us to clarify when a very small 
business would need to comply with the rule if the business starts up 
after the rule goes into effect. For example, if a very small business 
starts up six months after the date of the final rule, would that 
business have 2.5 years to comply, or would it need to comply 
immediately?
    (Response 732) A very small business that is operating as of the 
date of publication of the final rule, or begins operating any time 
before the compliance date for very small businesses, must comply with 
the rule by the compliance date for very small businesses. That date is 
fixed in time and is not a moving date based on market entry. A very 
small business that begins operation any time after the compliance date 
for very small businesses must comply with the rule when it begins 
operation, and should plan accordingly.

B. Effective and Compliance Dates for Revisions to Part 1

    This rule includes revisions to the ``farm definition,'' and to 
activities related to the ``farm definition,'' in Sec. Sec.  1.227 and 
1.328. This rule also includes technical amendments to Sec. Sec.  
1.241, 1.276, and 1.361. We did not discuss effective and compliance 
dates for these revisions to part 1 in either the 2013 proposed human 
preventive controls rule or the 2014 supplemental human preventive 
controls notice. See table 55 for the effective dates and compliance 
dates that we are establishing in this final rule. As with the 
requirements we are establishing in part 117, the revisions to part 1 
become effective 60 days after the date of publication of this rule 
(i.e., November 16, 2015). The compliance dates for the technical 
amendments to Sec. Sec.  1.241, 1.276, and 1.361 are the same as the 
effective dates. Two of these technical amendments change the citation 
to the FD&C Act from ``the act'' to ``the Federal Food, Drug, and 
Cosmetic Act''; the third technical amendment updates a cross-reference 
to the definition of ``manufacturer'' in regulations for the prior 
notice of imported food.
    The principal impact of the substantive revisions to the 
definitions in the section 415 registration regulations and the section 
414 recordkeeping regulations is whether the revised definitions affect 
the classification of a business as an entity that is subject to these 
regulations. We believe that some businesses that were subject to one 
or both of these regulations will no longer be subject to either of 
these regulations because the activities that these businesses conduct 
are now within the ``farm'' definition and, thus, exempt from those 
regulations. During the 60 day period between the publication of this 
rule and its effective date, FDA does not intend to prioritize 
enforcing the section 415 registration regulations and the section 414 
recordkeeping regulations for businesses that will no longer be subject 
to either or both of those regulations once the revisions are 
effective.
    However, we cannot predetermine whether some businesses that 
previously were not subject to the section 415 registration 
regulations, the section 414 recordkeeping regulations, or both will 
not become subject to one or both of those regulations. The approach we 
are taking to the compliance date for the revisions to these 
regulations is the same as the approach we took when we first 
established these regulations. First, for the section 415 registration 
regulations, the compliance date is the same date as the effective 
date. Such establishments must register as a food facility by November 
16, 2015. (See 68 FR 58894, which establishes an effective date for the 
section 415 registration regulations but does not establish a different 
date for compliance with those regulations.) An establishment that is 
required to register as a food facility by November 16, 2015 will be 
required to comply with the requirements in part 117 as described in 
section LVI.A.
    For the section 414 recordkeeping regulations, we are requiring 
that establishments that become subject to these requirements for the 
first time as a result of the revisions that become effective November 
16, 2015 comply with the requirements using the same criteria as we 
applied when we first established this regulation as shown in table 55. 
(See 69 FR 71562, December 9, 2004.)

Table 55--Compliance Dates for the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
             Size of business                      Compliance date
------------------------------------------------------------------------
10 or fewer full-time equivalent employees  September 18, 2017.
Businesses employing fewer than 500, but    March 17, 2017.
 more than 10 full-time equivalent
 employees
All other businesses                        September 19, 2016.
------------------------------------------------------------------------

C. Effective Dates for Conforming Amendments

    The conforming amendments to regulations in parts 106, 114, 120, 
123, 129, 179, and 211 are technical amendments that add a cross-
reference to part 117 where the current regulation refers to part 110. 
The conforming amendment to part 11 adds a reference to the scope of 
part 11 that the records required under part 117 are not subject to 
part 11. The conforming amendment to part 16 adds a reference to the 
scope of part 16 for new procedures in part 117, subpart E that provide 
a person with an opportunity for a hearing under part 16. These 
conforming amendments are effective on November 16, 2015, the same date 
as the effective date of part 117. We are not establishing compliance 
dates for these conforming amendments. As a practical matter, 
compliance dates will be determined by the dates for compliance with 
part 117.

D. Delayed Effective Dates for Provisions That Refer to the Forthcoming 
Rules for Produce Safety and Third-Party Certification

    The following provisions refer to provisions we intend to establish 
in the near future in part 112 (Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption): Sec. Sec.  
117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), and 
117.475(c)(13). In addition, paragraph (2) of the definition of 
``qualified auditor'' in Sec.  117.3, and Sec.  117.435(d) refers to 
provisions we intend to establish in the near future in part 1, subpart 
M (Accredited Third-Party Food Safety Audits and Food or Facility 
Certification). In addition, Sec. Sec.  117.405(a)(2) and 117.475(c)(2) 
refer to provisions we intend to establish in the near future in part 
1, subpart L (Foreign Supplier Verification Programs for Food 
Importers). We 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(c), 117.410(d)(2)(ii), 117.430(d), 117.405(a)(2), 
117.435(d), 117.475(c)(2) and 117.475(c)(13).

LVII. Compliance and Enforcement

    Gaining industry compliance with the provisions of this rule is as 
important as establishing the provisions. 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

[[Page 56132]]

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 FSPCA to develop 
training materials and establish training and technical assistance 
programs (Ref. 5) and (Ref. 7). The FSPCA 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 NIFA of 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.
    With regard to inspections, we will conduct regular inspections of 
domestic facilities to ensure that facilities subject to this rule are 
adequately implementing the required preventive controls and supply-
chain program, pursuant to our inspection authority under section 704 
of the FD&C Act. Our inspections will verify that such facilities are 
implementing systems that effectively prevent food contamination, and 
in particular, that they comply with the rule by implementing 
preventive controls, including supply-chain programs, to provide 
assurances that any hazard requiring a preventive control or supply-
chain applied control has been significantly minimized or prevented.
    In order to effectively carry out this new paradigm of food safety 
prevention, we will need to reorient and retrain our staff. To this 
end, we are seeking additional funding, including for the training of 
more than 2,000 FDA inspectors, compliance officers, and other staff 
involved in food safety activities (Ref. 12).
    We also plan to leverage the resources of State, local, tribal, and 
territorial governments to conduct domestic verification activities. We 
are working with officials from these governments through the PFP to 
develop and implement a national Integrated Food Safety System, which 
will focus on establishing partnerships for achieving compliance (see 
section 209(b) of FSMA), and which will allow us to utilize the 
thousands of State, local, and tribal inspectors available to help with 
the domestic verification process.
    Consistent with FSMA, we will use our current resources, new 
resources that we obtain, and our partnerships to conduct regular 
inspections of covered facilities, focusing on those facilities that 
pose the highest risk to food safety. Section 201 of FSMA mandates that 
FDA inspect domestic high-risk facilities no less than once every 3 
years. We are currently meeting this mandate, and even exceeding it 
with respect to certain domestic high-risk facilities. Once the FSMA 
rulemakings come into effect, we intend to build on this track record 
and to have an FDA or State inspection of domestic high-risk human food 
facilities on an annual basis to ensure hazards have been significantly 
minimized or prevented in compliance with this rule.

LVIII. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with 
tribal government officials. A Tribal Summary Impact Statement has been 
prepared that includes a summary of Tribal officials' concerns and how 
FDA has addressed them (Ref. 101). Persons with access to the Internet 
may obtain the Tribal Summary Impact Statement at http://www.fda.gov/pchfrule or at http://www.regulations.gov. Copies of the Tribal Summary 
Impact Statement also may be obtained by contacting the person listed 
under FOR FURTHER INFORMATION CONTACT.

LIX. Economic Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because facilities with less than 20 employees (both 
qualified and non-qualified facilities) will bear a large portion of 
the costs, the Agency concludes that the final rule will have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects this final 
rule to result in a 1-year expenditure that will exceed this amount.

LX. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment (Ref. 102) (Ref. 103). Therefore, 
neither an environmental assessment nor an environmental impact 
statement is required.

LXI. Paperwork Reduction Act of 1995

    This rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act (PRA) of 
1995 (44 U.S.C. 3501-3520). A description of these provisions is given 
in the following paragraphs with an estimate of the annual 
recordkeeping and reporting burdens. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Current Good Manufacturing Practice, Hazard Analysis and 
Risk-Based Preventive Controls for Human Food.
    Description: The Food and Drug Administration (FDA) is proposing to 
amend its regulation for Current Good Manufacturing Practice in

[[Page 56133]]

Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it 
and to add requirements for domestic and foreign facilities that are 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to establish and implement hazard analysis 
and risk-based preventive controls for human food. FDA is taking this 
action as part of its announced initiative to revisit the CGMPs since 
they were last revised in 1986 and to implement new statutory 
provisions in section 418 of the FD&C Act.
    Description of Respondents: Section 418 of the FD&C Act is 
applicable to the owner, operator or agent in charge of a food facility 
required to register under section 415 of the FD&C Act. Generally, a 
facility is required to register if it manufactures, processes, packs, 
or holds food for consumption in the United States. There are 83,819 
such facilities; 37,134 of these facilities are considered 
``qualified'' facilities and have reduced requirements in regards to 
this rule-making.
    In the following paragraphs, we describe and respond to the 
comments that we received for the PRA for both our 2013 proposed human 
preventive controls rule and our 2014 supplemental human preventive 
controls notice. We numbered each comment to help distinguish between 
different comments. The number assigned to each comment is purely for 
organizational purposes and does not signify the comment's value, 
importance, or the order in which it was received.
    (Comment 733) Comments stated that we overestimated the 
recordkeeping burden because we assume the burden is evenly distributed 
across all facilities beginning in the first year. However, facilities 
that are not small or very small have one year from the effective date 
of the rule to come into compliance. For small facilities, compliance 
is delayed for 2 years and very small facilities will have 3 years. The 
agency's 7 year horizon for discounting burdens would need to be 
staggered to account for the delayed compliance dates in order to 
arrive at a consistent annualized burden of the records collection.
    (Response 733) We clarify that our estimate for the recordkeeping 
burden for the first year is for the first full year that all 
facilities are responsible for the requirements for the rule. We note 
that the FRIA (Ref. 38) now uses a 10 year horizon for discounting 
burdens.
    (Comment 734) Comments support our estimate that many facilities 
already keep the records required by section 418 of the FD&C Act and 
the proposed human preventive controls rule as good business practice. 
Comments believe that preventive food safety systems are the norm for 
the food industry. Comments believe this is demonstrated by what they 
cite as 57 percent of the industry already operating under HACCP 
programs. Not accounting for the effects of widespread adoption of 
HACCP may result in an overestimate. The reason a majority of food 
facilities have already implemented HACCP or a HACCP[hyphen]like 
systems is that preventive systems are the best, most 
cost[hyphen]effective means of insuring against recall costs and 
potential criminal liability for releasing adulterated product into 
commerce. If the industry standard is prevention, then the baseline for 
calculating PRA burdens should be adjusted to account for that.
    (Response 734) We concur that we do not account for those 
facilities that are in the process of adopting our requirements 
independently. We do address the impact of a likely trend toward 
adopting our requirements in the uncertainty analysis of our FRIA (Ref. 
38).
    (Comment 735) Comments assert that knowledge transferred from 
facilities already applying HACCP will be available to small and very 
small facilities during the delayed implementation period. Delayed 
implementation periods usually contemplate that smaller businesses will 
benefit from increased availability of advanced technology and 
knowledge that can lower the costs of compliance. Related comments 
suggest that the PRA does not appear to have considered that during the 
three[hyphen]year implementation period standardized templates and 
software for hazard analyses and food safety plans may become available 
for food facilities. The availability of templates and software would 
reduce the time needed for small and very small facilities to prepare 
mandatory documents.
    (Response 735) We concur that delayed implementation periods will 
benefit smaller businesses from the increased availability of advanced 
technology and knowledge that can lower the costs of compliance. We 
allowed the staggered compliance period for this very reason. We 
revised our estimate of the costs to learn about the requirements of 
rule in the main analysis. In our revised analysis, we estimate that 
facilities with fewer than 20 employees will devote 5 hours to learning 
about their requirements, rather than 10 hours. For facilities with 20 
to 99 employees, one individual at the level of an operations manager 
will take about 10 hours to review and assess the requirements or to 
learn about the requirements for their facility rather than 15 hours.
    (Comment 736) Comments suggest that the PRA review does not account 
for reduced training costs for small and very small facilities derived 
from the availability for hire of trained employees. The average 
turnover rate in manufacturing in 2010 was 15 percent, suggesting some 
small businesses will be able to hire qualified individuals rather than 
training current employees.
    (Response 736) We agree that some new employees will already be 
trained but we believe that we accounted for those that are already 
trained by only including burden hours for employees at facilities that 
disclosed to our survey that they did not conduct training. In 
addition, we estimated a turnover rate of 10 percent, which indicates 
that fewer new employees would require training than proposed by the 
comments, indicating that we did not overestimate the burden hours.
    (Comment 737) Comments assert that we underestimated the 
recordkeeping burden of the proposed information collection, that our 
methodology and assumptions are wrong or that it is not possible to 
adequately assess the accuracy of our recordkeeping burden estimates. 
Comments further dispute our assessment that creation of a single food 
safety plan will require 110 hours and that one plan will be required 
per facility. In the experience of the comments' member organization, 
it takes considerably longer, with a median of over 200 hours per 
facility. Additionally, many plants currently have more than one HACCP 
plan in place. Large plants have multiple products, raw materials, 
processes, and equipment. Comments report that one large plant has 34 
plans in place that took approximately 860 hours to develop and another 
large plant has 25 plans in place that took approximately 1385 hours to 
develop.
    (Response 737) We concur that establishments might have more than 
one HACCP plan in place and we acknowledge that large establishments 
might require considerably more than 110 hours to develop a food safety 
plan. Our estimate is based on the average time to create a food safety 
plan for establishments of all sizes, so our estimate includes very 
small facilities that are likely to require considerably less than 110 
hours, too.
    (Comment 738) Comments assert that it is not clear if our 
assessment includes the considerable pre-work time that is required as 
an input to development of a HACCP plan. Pre-work includes activities 
such as employee training,

[[Page 56134]]

assembling the food safety plan team (which may require outside 
experts, and specific company experts like microbiologists, 
procurement, research and development, etc.), creating the processing 
and product profile, and creating a flow diagram. Some estimated that 
approximately 150-300 hours of pre-work are needed per facility before 
the actual HACCP plan is prepared.
    (Response 738) Our analysis for the PRA includes pre-work time to 
the extent that pre-work time includes preparing the documents that are 
required in accordance with the rule. The preparation of records for 
the validation of process controls might be considered pre-work and 
would be considered in our estimate. We disagree that all of the pre-
work mentioned by the comments should be included in our estimate of 
the burden hours.
    (Comment 739) Comments believe that a robust food safety plan 
should be developed by a multidisciplinary group of professionals with 
a broad skill set. These comments believe that it is unclear what wage 
rate we used in our estimate of the operating and maintenance costs 
associated with implementing and maintaining a food safety plan or if 
those estimates consider the range of wages applicable to the broad 
team involved in plan development.
    (Response 739) We concur that a multidisciplinary group of 
professionals is likely to be involved in the plan development. Our 
estimate is based on an average wage rate for the type of professional 
that would be likely to develop the specific document. We included our 
estimate for the average wage rate that we used for each type of 
document in our description.
    (Comment 740) Comments suggest that our estimate that facilities 
will keep records of 730 monitoring activities and that each record can 
be made in about three minutes (36.5 hours total per year per 
facility), severely underestimates both the number of activities and 
the time required.
    (Response 740) Comments did not provide supporting evidence. In the 
absence of a better substantiated estimate, we decline to revise our 
estimate.
    (Comment 741) Comments assert that we severely underestimated the 
number of monitoring records. Comments claim that several of their 
members reported over 50,000 monitoring events in their facilities 
annually. They provided as an example that if one production line has 
two metal detectors and one barcode scanner, there would be three 
records per shift, with three shifts per day. Assuming 300 days of 
operation per year, this one line would have 2700 records per year. 
Most plants have multiple lines and conduct monitoring beyond metal 
detectors and bar code scanners. A large plant may have well over 730 
monitoring events per day--not per year as FDA estimates.
    (Response 741) We concur that a large establishment might have 
significantly more monitoring events. Our analysis is based on the 
average of all establishments, including very small establishments that 
are unlikely to so many events. In the absence of substantiated 
evidence for the large average number of monitoring events, we decline 
to revise our estimate.
    (Comment 742) Comments let us know that it is unclear what 
activities are included in our time estimate. Comments claim that the 
amount of time required to produce a record will vary depending on 
whether the estimate only includes documenting time to create the 
record or whether it also includes the underlying task of monitoring 
and follow-up tasks like filing. Furthermore, the number of monitoring 
events could be significantly higher than the estimate if all 
preventive controls are subject to similar monitoring requirements as 
critical control points. Thus, although some tasks may take only three 
minutes to monitor, our members suggest that six minutes per monitoring 
event may be a more accurate estimate of the information collection 
burden.
    (Response 742) We concur with the comments that time will vary by 
what's included in the task. The PRA requires that we include in our 
burden estimate the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information. We believe our estimate 
of 3 minutes, as an average over time, accurately reflects the entire 
requirement for recordkeeping, including the initial time to create, 
maintain and file the records. Many, if not most, records can be 
created, maintained and filed in batch to reduce time, especially when 
done electronically, so we decline to revise our estimate of 3 minutes, 
in the absence of more evidence.
    (Comment 743) Comments claim that our estimated burden for 
corrective action records assumes that 18,291 facilities subject to 
preventive controls will have two corrective actions to document, which 
will take one hour each to record. Our assessment does not explain the 
basis for estimating that only 18,291 facilities will engage in 
corrective actions. Because occasional deviations from expected values 
are an unavoidable part of any manufacturing environment, it should be 
expected that all facilities subject to preventive controls regulations 
will have corrective actions to document annually. Comments claim that 
our time estimate also appears to be low. Comments report that their 
member's facilities typically engage in between 10 and 60 corrective 
actions per year for critical control point deviations, which is 
considerably higher than our proposed estimate of two actions per year. 
Although it may take only one hour to manage the record involved with 
the corrective action, additional time would be required to investigate 
the underlying issue and implement the corrective action. We expect it 
can take between two and four hours to investigate a single corrective 
action and come up with a solution.
    (Response 743) We revised our estimate for the number of 
establishments that would be subject to the requirements to 16,285 
based on the most recent number of facilities registered with FDA and 
that are subject to subparts C and G. We address elsewhere our reason 
for not requiring all facilities to be subject to subparts C and G. We 
recognize that some facilities will conduct more than our estimate of 
two corrective actions per year. Our estimate is based on actions that 
must be made to correct a problem that has occurred with the 
implementation of a preventive control; or that might affect the safety 
of the food. Many corrective actions might occur to address product 
quality problems, unrelated to food safety. Further, our estimate for 
the PRA is necessarily only related to the recordkeeping burden, and 
should not include the additional time that would be required to 
investigate the underlying issue and implement the corrective action.
    (Comment 744) Comments noted that our estimate for keeping 
verification records assumes facilities will keep records of 244 
verification events and that each record can be made in about three 
minutes (12.2 hours total per year per facility). Comments claim that 
our assessment does not explain whether this estimate considers the 
broad scope of activities included in the definition of 
``verification'' in the proposed rule (proposed Sec.  117.150), 
although it should. The proposed regulatory definition of verification 
not only includes verification of monitoring, corrective actions, and 
implementation and effectiveness (e.g., calibration), but also includes 
validation and reanalysis. Validation and reanalysis of a food safety 
plan are extensive activities that take tens, if not hundreds, of hours 
to conduct. The estimate does not appear

[[Page 56135]]

to account for these activities. The comments note that even when 
considering just the traditional activities considered as verification 
under HACCP, their members' experience shows that our current 
verification estimate is too low. They received a wide range of 
estimates of the number of verification events conducted annually--from 
about 200 to over 14,000 events per year. Similarly, their members 
report that it takes them between 8 minutes and 2 hours per 
verification event. It is unclear whether our estimate includes only 
the time to handle the record or also the time to conduct the 
verification. The comments suggest this missing information in our 
estimate may explain the range of responses in our survey. Comments 
claim that the time to conduct the verification should be included.
    (Response 744) We concur that our estimates should assess the full 
scope of activities associated with recordkeeping. Our analysis did 
neglect to include the recordkeeping activities for the validation of 
process controls, which are an essential part of verification. We added 
our estimate for the burden of validation and we revised our 
description about the recordkeeping burden for the food safety plan to 
state that our estimate does include the burden of reanalysis of the 
food safety plan. For the purposes of the PRA, our estimate of the 
burden of recordkeeping is only for the time of recordkeeping, not the 
full verification activity. We decline to revise our estimate based on 
the comment because insufficient evidence was presented about just the 
time for recordkeeping.
    (Comment 745) Comments noted that we estimate that 47,484 food 
manufacturers will need to document the training of their preventive 
controls qualified individual, which will take 15 minutes per facility. 
(We note that the proposed rule defined and used the term ``qualified 
individual, but the term in the final rule is ``preventive controls 
qualified individual, and we use the term ``preventive controls 
qualified individual'' in describing these comments on this topic.) 
They are unclear why we estimate that only 47,484 food manufacturers 
and not all registered facilities subject to preventive controls would 
be required to have a preventive controls qualified individual and to 
document that person's training. Comments state that their members 
found that we are accurate in our assumption, although our estimate for 
the documentation may take 30 minutes in some situations. Comments also 
suggest that many facilities may need to document more than one 
preventive controls qualified individual. Comments provide as an 
example, that a thermal process authority outside of the plant may be a 
qualified individual in terms of confirming the process has a validated 
kill step, while the same facility will likely have a qualified 
individual responsible for approving the food safety plan. This 
situation would increase the time burden beyond estimate.
    (Response 745) Our estimate of 47,484 establishments that will need 
to document the training of their preventive controls qualified 
individual was based on our estimate of the number of facilities that 
are subject to subparts C and G of the rule. We updated our estimate to 
46,685 based on our most recent count of facilities registered with 
FDA. Our estimate is based on the requirement that only one preventive 
controls qualified individual is necessary to perform the requirements 
of the provisions that require a preventive controls qualified 
individual. Moreover, some preventive controls qualified individuals 
may be qualified by experience and there would not be a need for 
documentation of training.
    (Comment 746) Comments note that our estimate for submitting a new 
domestic food facility profile will take 15 minutes. Comments believe 
that we grossly underestimate the amount of time retailers will need to 
respond to the form. Comments believe that the typical distribution 
center carries 26 of the 27 product categories listed in the Draft 
Form. Providing detail on the potential hazards and preventive controls 
implemented for each product will take retailers a total of 20-30 or 
more hours per facility. Most chain retailers have multiple facilities. 
A national retailer will easily have a dozen or more distribution 
centers. The largest food retailers will have several dozen. It is 
conceivable that hundreds of hazard and preventive control entries will 
be required to be made for each distribution center to respond to the 
Draft Form if such facilities are required to input information on 
hazards they do not control. The typical distribution center carries 
more than 13,000 different SKUs of FDA-regulated foods. Completing the 
form itself will require several hours due to all of the entries. 
Compiling the information for each facility will take 20-30 hours. 
Under the PRA, comments believe that we are required to consider not 
only the time it takes to complete the form, but also the time it takes 
to compile the information. Comments believe that we must revise our 
estimate of the burden imposed by the information collection request 
(ICR).
    (Response 746) We requested comment on whether to require 
submission to FDA of a subset of the information that would be in a 
food safety plan. After considering comments, we decided that we will 
not establish a requirement for submission of a facility profile. To 
the extent that this comment is addressing the form used for 
registering a food facility with FDA, such a comment is outside the 
scope of this rule-making. Moreover, an establishment that meets the 
definition of a retail food establishment is not a facility required to 
register.
    (Comment 747) Comments believe that our ICR contains redundant 
collections. Comments believe that our existing Food Facility 
Registration Module requests information on facility type and products 
handled, while our ICR seeks the same information. Commenters believe 
that we should minimize redundancies to the greatest extent possible 
and use the information that we already have. As such, we should not be 
requesting information on facility type, products handled and, if it 
decides to as we recommend, types of storage, through this ICR. All of 
these data points are already collected by the existing Food Facility 
Registration Module.
    (Response 747) The ICR associated with this rule-making is not 
redundant. The ICR associated with food facility registration with FDA 
is a separate rule-making and a separate burden. This PRA contains the 
ICR for completing all the requirements for a food facility to develop 
a hazard analysis and preventive controls; not register their facility. 
See Response 746.
    (Comment 748) Comments suggest that our estimated time and costs to 
comply with the requirement to label products from certain qualified 
facilities do not come under the PRA because the address requirement is 
a disclosure, and not an information collection.
    (Response 748) We concur that the requirement to add a qualified 
facility address to the product label is a third-party disclosure 
burden, and because it is a disclosure burden, is subject to the PRA. 
We revised our estimate for the hour burden for each of these 
disclosures to be 15 minutes as shown in table 69 of the PRA, to 
reflect that this will not be a coordinated label change for most 
qualified facilities so most will not be updating their labels anyway.

Information Collection Burden Estimate

    FDA estimates the burden for this information collection as 
follows:

[[Page 56136]]

Recordkeeping Burden

    We estimate that about 46,685 facilities subject to subparts C and 
G Hazard Analysis and Risk-Based Preventive Controls will need to 
create a food safety plan (Sec.  117.175(a)(1)) which is a compilation 
of many written food safety procedures. We total the hour burdens as 
presented throughout the FRIA (Ref. 38) to then create an average hour 
burden for each facility to create or complete a food safety plan. We 
estimate that creation of the food safety plan will require 110 hours. 
The total hour burden on an annual basis is 46,685 facilities x 110 
hours = 5,135,350 hours. There are no capital costs or operating and 
maintenance costs associated with this collection of information.
    We estimate the burden for disclosing to a customer, in documents 
to accompany foods that require further processing, that the food has 
not been processed to control a specified hazard (Sec.  117.136), is 15 
minutes per record. We estimate that 16,285 establishments will each 
make one of these disclosures for a total recordkeeping burden of 4,071 
hours.
    The burden for keeping monitoring records (Sec.  117.175(a)(2)) 
follows the same pattern as that for the food safety plan. We estimate 
that there are 8,143 facilities subject to subparts C and G Hazard 
Analysis and Risk-Based Preventive Controls that will need to keep 
additional records of the monitoring that they do of different 
activities within their food facilities. Based on estimates of 
monitoring created, when appropriate, throughout the FRIA, we estimate 
that each of the 8,143 facilities will keep records of 730 monitoring 
activities and that each record can be made in about 3 minutes (0.05 
hours) for a total hour burden of 297,220.
    For the burden for corrective action records (Sec.  117.175(a)(3) 
we estimate that twice per year 16,285 facilities subject to subparts C 
and G Hazard Analysis and Risk-Based Preventive Controls will have 
corrective actions to document. The documentation of those corrective 
actions is expected to take one hour for each record for a total hour 
burden of 32,570.
    We estimate that there are 8,143 facilities subject to subparts C 
and G Hazard Analysis and Risk-Based Preventive Controls that will need 
to keep additional records of verification activities. Based on 
estimates of verification records created, when appropriate, throughout 
the FRIA, we estimate that 8,143 facilities will keep records of 244 
verification activities and that each record can be made in about 3 
minutes (0.05 hours) for a total hour burden of 101,675.
    The burden for keeping validation records (Sec.  117.160) follows 
the same pattern as that for verification records. We estimate that 
there are 3,677 facilities subject to subparts C and G Hazard Analysis 
and Risk-Based Preventive Controls that will need to keep additional 
records of the validation of their process control activities within 
their food facilities. Based on estimates of the establishments that 
will require validation, when appropriate, throughout the FRIA, we 
estimate that each of the 3,677 facilities will keep records of six 
validation activities for a total of 22,062 records. We estimate that 
each record can be made in about 15 minutes (0.25 hours) for a total 
hour burden of 5,515.
    The burden for keeping supplier records is for the use of approved 
suppliers and for establishments to document their audits Sec.  
117.475(c)(7), the sampling and testing of their ingredients Sec.  
117.475(c)(8), and the review of their supplier's relevant food safety 
records Sec.  117.475(c)(9), among up to 18 possible supplier related 
records. Our estimate follows the same pattern as that for other 
records. We estimate that there are 16,285 facilities subject to 
subparts C and G Hazard Analysis and Risk-Based Preventive Controls 
that will need to keep as many as 18 additional records for an average 
of 10 records of their approved suppliers and review records. Based on 
estimates throughout the FRIA, we estimate that each of the 16,285 
establishments will maintain these records and that the total time for 
this recordkeeping will be about 4 hours for a total hour burden of 
651,400.
    We estimate that 46,685 establishments subject to subparts C and G 
Hazard Analysis and Risk-Based Preventive Controls will need to 
document the training of their preventive controls qualified 
individuals (Sec.  117.180(d)). We estimate that this will require 15 
minutes (0.25 hours) per facility total for a total hour burden of 
11,671.
    Under Sec.  117.206(a)(5) facilities are required to keep records 
documenting (1) the monitoring of temperature controls for refrigerated 
packaged food, (2) the corrective actions taken when there is a problem 
with the control of temperature for refrigerated packaged food, and (3) 
the verification activities relating to the temperature control of 
refrigerated packaged food. We believe that the keeping of such records 
is already common industry practice and will not constitute an 
additional paperwork burden.
    Table 56 shows the estimated annual recordkeeping burden associated 
with this rule. There are no capital costs or operating and maintenance 
costs associated with this collection of information.

                                 Table 56--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
   21 CFR Part 1, Subpart 117      recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
117.126 (c) and 117.170(d) food           46,685               1          46,685          110          5,135,350
 safety plan and reanalysis.....
117.136 assurance records.......          16,285               1          16,285            0.25           4,070
117.145 (c) monitoring records..           8,143             730       5,944,390            0.05         297,220
117.150 (d) corrective actions            16,285               2          32,570            1             32,570
 and corrections records........
117.155(b) verification records.           8,143             244       1,986,892            0.05         101,675
117.160 validation records......           3,677               6          22,062             .25           5,515
117.475(c)(7), 117.475(c)(8),             16,285               1          16,285            4            651,400
 and 117.475(c)(9) among up to
 18 supplier records............
117.180(d) Records that document          46,685               1          46,685             .25          11,671
 applicable training for the
 preventive controls qualified
 individual.....................
                                 -------------------------------------------------------------------------------
    Total annual burden hours...  ..............  ..............  ..............  ..............       6,239,471
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information


[[Page 56137]]

Reporting Burden

    Table 57 shows the estimated annual reporting burden associated 
with this rule.
    Qualified facilities must report their status as such a facility 
every 2 years; status will likely be reported electronically through a 
web portal maintained by FDA. This requirement will cause the 37,134 
qualified facilities to spend 0.5 hour every 2 years reporting to FDA 
their status as a qualified facility for a total annual hour burden of 
about 9,283 hours (37,134 facilities x 0.5 responses annually x 0.5 
hours per response).

                                   Table 57--Estimated Annual Reporting Burden
                                         [Very small business <$1 m] \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
21 CFR Section (or FDA Form No.)     Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
117.201(e) Qualified facility...          37,134             0.5          18,567             0.5           9,283
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total burden hours..........  ..............  ..............  ..............  ..............           9,283
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Third Party Disclosure Burden

    Under Sec.  117.201(e) qualified facilities must add the address of 
the facility where the food is manufactured to their label. We estimate 
the hour burden of this disclosure is 15 minutes per disclosure. This 
requirement will cause the 37,134 qualified facilities to spend 0.25 
hours adding their address to their new labels for a total hour burden 
of about 9,283 hours (37,134 facilities x 0.25 hours per response).

                                Table 58--Estimated Third-Party Disclosure Burden
                                         [Very small business <$1 m] \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
  20 CFR section  (or FDA Form       Number of       Number of         Total        burden per
              No.)                  respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
117.201(e) Qualified facility...          37,134               1          37,134            0.25           9,283
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total burden hours..........  ..............  ..............  ..............  ..............           9,283
----------------------------------------------------------------------------------------------------------------

LXII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

LXIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
These references are also available electronically at http://www.regulatons.gov. We have verified the Web site addresses, but we are 
not responsible for any subsequent changes to Web sites after this 
document publishes in the Federal Register.

1. FDA Memorandum, ``FDA Memorandum to Dockets on Records of 
Outreach,'' 2013. See Reference 7 to the 2014 supplemental human 
preventive controls notice.
2. FDA Memorandum, ``Memoranda of Outreach,'' 2015.
3. FDA, ``Food CGMP Modernization--A Focus on Food Safety,'' (http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm207458.htm), November 
2, 2005. Accessed and printed on March 20, 2015. See Reference 1 to 
the 2013 proposed human preventive controls rule.
4. FDA, ``Qualitative Risk Assessment: Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2015.
5. FDA, ``Technical Staffing and Guidance Development at FDA,'' 
(http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM436592.pdf), 2015. Accessed and printed on March 22, 2015.
6. FDA, ``Education and Technical Assistance for Industry,'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM436593.pdf), 
March 5, 2015. Accessed and printed on March 26, 2015.
7. FDA, ``Food Safety Preventive Controls Alliance,'' (http://www.fda.gov/food/guidanceregulation/fsma/ucm284406.htm), 2015. 
Accessed and printed on August 29, 2015.
8. FDA, ``FDA Announces Competitive Grant Program With NIFA to Fund 
Food Safety Training, Education and Technical Assistance,'' (http://www.fda.gov/food/newsevents/constituentupdates/ucm430492.htm), 
January 15, 2015. Accessed and printed on March 27, 2015.
9. FDA, ``Guidance for Industry: Questions and Answers Regarding 
Food Facility Registration (Sixth Edition),'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf), 2014. Accessed and 
printed on June 2, 2015.
10. Partnership for Food Protection National Workplan Workgroup, 
``Model for Local Federal/State Planning and Coordination of Field 
Operations and Training: a Partnership for Food Protection ``Best 
Practice,'' (http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM373333.pdf), 
October, 2013. Accessed and printed on May 19, 2014.
11. FDA, ``Operational Strategy for Implementing the FDA Food Safety 
Modernization Act (FSMA),'' (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm), May 2, 2014. Accessed and 
printed on May 19, 2014.

[[Page 56138]]

12. FDA, ``Inspection Modernization and Training: Key Investments 
for Implementing the FDA Food Safety Modernization Act (FSMA),'' 
(http://www.fda.gov/food/guidanceregulation/fsma/ucm432576.htm), 
2015.
13. FDA, ``Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards for Fresh Fruits and Vegetables,'' 1998.
14. Dictionary.com, ``Definition of ``Management'','' (http://dictionary.reference.com/browse/management), 2015. Accessed and 
printed on February 26, 2015.
15. FDA, ``Guidance for Industry: Antimicrobial Food Additives,'' 
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm077256.htm), July, 1999. 
Accessed and printed on October 17, 2011. See Reference 118 to the 
2013 proposed human preventive controls rule.
16. Produce Marketing Association, ``Foreign Supplier Verification 
Programs for Importers of Food for Humans and Animals (Docket No. 
FDA-2011-N-0143),'' ID FDA-2011-N-0143-018, 2014.
17. USDA Agricultural Marketing Service, Memorandum for the Record, 
``Documenting April 2015 Conversation Relative to Contract 
Harvesting Scenarios,'' 2015.
18. FDA, ``Draft Qualitative Risk Assessment: Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2012. See Reference 115 to the 
2013 proposed human preventive controls rule.
19. Muth, M. K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator, 
``Food Processing Sector Study,'' 2011. See Reference 34 to the 2014 
supplemental human preventive controls notice.
20. Painter, J. A., R. M. Hoekstra, T. Ayers, R. V. Tauxe, C. R. 
Braden, F. J. Angulo, and P. M. Griffin, ``Attribution of Foodborne 
Illnesses, Hospitalizations, and Deaths to Food Commodities by Using 
Outbreak Data, United States, 1998-2008,'' Emerging Infectious 
Diseases, 19:407-415, 2013.
21. Capogrossi, K., L. Calvin, M. Coglaiti, D. Hinman, S. Karns, A. 
Lasher, T. Minor, M.K. Muth, V. Nigh, P. Vardon, C. Viator and C. 
Zhen, ``Food Processing Sector Study, (Contract HHSF-223-2011-
10005B, Task Order 20), Final Report,'' 2015.
22. Merriam-webster.com, ``Definition of ``Include'','' (http://www.merriam-webster.com/dictionary/include), 2015. Accessed and 
printed on June 3, 2014.
23. Grocery Manufacturers Association, ``Food Supply Chain 
Handbook,'' (http://www.gmaonline.org/downloads/technical-guidance-and-tools/GMA_SupplyChain2.pdf), April 16, 2008. Accessed and 
printed on March 13, 2015. See Appendix Reference 92 to the 2013 
proposed human preventive controls rule.
24. Grocery Manufacturers Association, ``Industry Handbook for Safe 
Processing of Nuts,'' (http://www.gmaonline.org/downloads/technical-guidance-and-tools/Industry_Handbook_for_Safe_Processing_of_Nuts_1st_Edition_22Feb10.pdf
), February 22, 2010. Accessed and printed on March 13, 2015.
25. FDA, ``The Reportable Food Registry: A New Approach to Targeting 
Inspection Resources and Identifying Patterns of Adulteration--First 
Annual Report: September 8, 2009--September 7, 2010,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM291297.pdf), 
January, 2011. Accessed and printed on February 24, 2014. See 
Reference 60 to the 2013 proposed human preventive controls rule.
26. FDA, ``The Reportable Food Registry: Targeting Inspection 
Resources and Identifying Patterns of Adulteration--Second Annual 
Report: September 8, 2010--September 7, 2011,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/UCM301013.pdf), April 19, 2012. 
Accessed and printed on February 24, 2014. See Reference 61 to the 
2013 proposed human preventive controls rule.
27. FDA, ``The Reportable Food Registry: Targeting Inspection 
Resources and Identifying Patterns of Adulteration--Third Annual 
Report: September 8, 2011-September 7, 2012,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM349856.pdf), May 1, 
2013. Accessed and printed on February 24, 2014.
28. FDA, ``The Reportable Food Registry: Targeting Inspection 
Resources and Identifying Patterns of Adulteration--Fourth Annual 
Report: September 8, 2012-September 7, 2013,'' (http://www.fda.gov/downloads/Food/ComplianceEnforcement/RFR/UCM395684.pdf), May 5, 
2014. Accessed and printed on September 26, 2014.
29. FDA, ``Guidance for Industry: Measures to Address the Risk for 
Contamination by Salmonella Species in Food Containing a Peanut-
Derived Product as an Ingredient,'' 2009. See Reference 6 to the 
2013 proposed human preventive controls rule.
30. FDA, ``Guidance for Industry: Measures to Address the Risk for 
Contamination by Salmonella Species in Food Containing a Pistachio-
Derived Product as an Ingredient,'' 2011. See Reference 156 to the 
2013 proposed human preventive controls rule.
31. FDA, ``Bad Bug Book: Foodborne Pathogenic Microorganisms and 
Natural Toxins Handbook. Second Edition,'' 2012. See Reference 49 to 
the 2013 proposed human preventive controls rule.
32. FDA, ``Draft Guidance for Industry: Questions and Answers 
Regarding the Reportable Food Registry As Established by the Food 
and Drug Administration Amendments Act of 2007 (Edition 2),'' 
(http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM213214.pdf), May, 2010. Accessed and printed on March 27, 2015.
33. FDA, ``Guidance for Industry: Questions and Answers Regarding 
the Reportable Food Registry As Established by the Food and Drug 
Administration Amendments Act of 2007,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm180761.htm), September, 2009. Accessed and printed on March 13, 
2015.
34. Codex Alimentarius Commission, ``Hazard Analysis And Critical 
Control Point (HACCP) System And Guidelines For Its Application. 
Annex to CAC/RCP 1-1969 (Rev. 4--2003),'' (http://www.codexalimentarius.org/download/standards/23/CXP_001e.pdf), 2003. 
Accessed and printed on December 12, 2011. See Reference 35 to the 
2013 proposed human preventive controls rule.
35. National Advisory Committee on Microbiological Criteria for 
Foods, ``Hazard Analysis and Critical Control Point Principles and 
Application Guidelines,'' Journal of Food Protection, 61:1246-1259, 
1998. See Reference 34 to the 2013 proposed human preventive 
controls rule.
36. FDA, ``The Food Defect Action Levels: Levels of Natural or 
Unavoidable Defects in Foods That Present No Health Hazards for 
Humans,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/SanitationTransportation/ucm056174.htm), February, 2005. Accessed and printed on October 14, 
2011. See Reference 141 to the 2013 proposed human preventive 
controls rule.
37. FDA, ``CPG Sec. 527.300 Dairy Products--Microbial Contaminants 
and Alkaline Phosphatase Activity,'' (http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM192468.pdf), December, 2009. Accessed and printed on March 25, 
2015. See Reference 7 to the 2013 proposed human preventive controls 
rule.
38. FDA, ``Part 117. FSMA Final Rulemaking for Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: Final Regulatory Impact Analysis, Final 
Regulatory Flexibility Analysis, Final Unfunded Mandates Reform Act 
Analysis, and Final Paperwork Reduction Act Analysis,'' 2015.
39. Codex Alimentarius Commission, ``Guidelines for the Validation 
of Food Safety Control Measures, CAC/GL 69-2008,'' 
(www.codexalimentarius.org/input/download/standards/11022/CXG_069e.pdf), 2008. Accessed and printed on August 29, 2011. See 
Reference 127 to the 2013 proposed human preventive controls rule.
40. FDA, ``NPRM Human Preventive Controls Rule Submitted to OMB,'' 
2011. See Tab A in ``OMB Review of Proposed Rule re Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls For Human Food, January 16, 2013--Memorandum'' in

[[Page 56139]]

Docket No. FDA-2011-N-0920, No. FDA-2011-N-0920-0014.
41. FDA, ``Preliminary Regulatory Impact Analysis for the Proposed 
Sanitary Transportation of Human and Animal Food Rule,'' 2014.
42. FDA, ``Fish and Fishery Products Hazards and Controls Guidance, 
Fourth Edition,'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM251970.pdf), 2011. See Reference 3 to the 2013 
proposed human preventive controls rule.
43. FDA, ``Guidance for Industry: Juice HACCP Hazards and Controls 
Guidance First Edition; Final Guidance,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm), March 3, 2004. Accessed and printed on March 20, 
2015. See Reference 4 to the 2013 proposed human preventive controls 
rule.
44. Dictionary.com, ``Definition of ``Solely'','' (http://dictionary.reference.com/browse/solely), June 11, 2014. Accessed and 
printed on June 11, 2014.
45. Scallan, E., R. M. Hoekstra, F. J. Angulo, R. V. Tauxe, M.-A. 
Widdowson, S. L. Roy, J. L. Jones, and P. M. Griffin, ``Foodborne 
Illness Acquired in the United States--Major Pathogens,'' Emerging 
Infectious Diseases, 17, 2011. See Reference 45 to the 2013 proposed 
human preventive controls rule.
46. Stiles, T., ``Post-Pasteurization Contamination of Milk by 
Listeria Monocytogenes in Massachusetts,'' (http://www.aphl.org/conferences/proceedings/Documents/2008_12th_Annual_PulseNet_Update_Meeting/7-StilesListeriainMass.pdf), December 27, 2008. Accessed and printed 
on March 20, 2015.
47. FDA, ``Company Recalls Various Products Due to Potential 
Salmonella Contamination,'' (http://www.fda.gov/safety/recalls/archiverecalls/2009/ucm169471.htm), June 28, 2009. Accessed and 
printed on September 9, 2011. See Reference 155 to the 2013 proposed 
human preventive controls rule.
48. FDA Memorandum, ``Grade ``A'' Pasteurized Milk Ordinance (PMO) 
description and comparison to the requirements of the Preventive 
Controls for Human Food Rule,'' 2015.
49. FDA Memorandum, ``Comparison of the Requirements for Hazard 
Analysis and Risk-Based Preventive Controls in 21 CFR 117 and the 
Requirements of the Grade ``A'' Pasteurized Milk Ordinance (PMO),'' 
2015.
50. USDA Agricultural Marketing Service, ``Regional Food Hub 
Resource Guide,'' (http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097957), April, 2012. Accessed and printed 
on March 26, 2015.
51. FDA, ``Food Code,'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM374510.pdf), 
2013. Accessed and printed on December 9, 2014.
52. Institute of Food Technologists, ``Evaluation and Definition of 
Potentially Hazardous Foods,'' (http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm094141.htm), 
December 31, 2005. Accessed and printed on December 14, 2011. See 
Reference 140 to the 2013 proposed human preventive controls rule.
53. O'Mahony, M., E. Mitchell, R. J. Gilbert, D. N. Hutchinson, N. 
T. Begg, J. C. Rodhouse, and J. E. Morris, ``An Outbreak of 
Foodborne Botulisum Associated With Contaminated Hazelnut Yoghurt,'' 
Epidemiol.Infect, 104:389-395, 1990.
54. Serkaya, A., C. Fenton, N. Ackerley, A. Berlind, J. Bryant, and 
C. Marsden, ``2010 Nationwide Survey of Food Industry Safety 
Practices,'' 2011.
55. FDA Memorandum, ``Environmental Monitoring,'' 2014. See 
Reference 23 to the 2014 supplemental human preventive controls 
notice.
56. Evancho, G. M., W. H. Sveum, L. J. Moberg, and J. F. Frank, 
``Microbiological Monitoring of the Food Processing Environment,'' 
In: Compendium of Methods for the Microbiological Examination of 
Foods, edited by F. P. Downes and K. Ito, 4th edition, Washington, 
DC, Chapter 3, pp. 25-35, American Public Health Association, 2001. 
See Appendix Reference 63 to the 2013 proposed human preventive 
controls rule.
57. Kornacki, J. and J. Johnson, ``Enterobacteriaceae, Coliforms, 
and Escherichia Coli As Quality and Safety Indicators,'' In: 
Compendium of Methods for the Microbiological Examination of Foods, 
4th Edition, Washington, DC, Chapter 8, pp. 69-82, American Public 
Health Association, 2001.
58. FDA, ``CPG Sec. 570.550 Reconditioning--Tree Nuts Contaminated 
With E. Coli,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074602.htm), December 9, 1988. 
Accessed and printed on March 24, 2015.
59. FDA, ``CPG Sec. 540.275 Crabmeat--Fresh and Frozen--Adulteration 
With Filth, Involving the Presence of the Organism Escherichia Coli; 
Draft Guidance,'' (http://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm426995.pdf), 
December 16, 2014. Accessed and printed on March 24, 2015.
60. FDA, ``CPG Sec. 555.300 Foods, Except Dairy Products--
Adulteration With Salmonella,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074553.htm), 
March, 1995. Accessed and printed on September 21, 2007. See 
Reference 8 to the 2013 proposed human preventive controls rule.
61. FDA, ``CPG Sec. 560.600 Clams, Mussels, Oysters, Fresh or 
Frozen--Adulteration With by Bacteriological Contamination,'' 
(http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074574.htm), November 29, 2005. 
Accessed and printed on March 24, 2015.
62. FDA, ``CPG Sec. 570.450 Tree Nuts--Adulteration With Filth, 
Involving the Presence of the Organism Escherichia Coli,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074600.htm), November 29, 2005. Accessed and printed on March 24, 
2015.
63. FDA, ``Guide to Produce Farm Investigations,'' (http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074962.htm), 
November, 2005. Accessed and printed on October 17, 2011. See 
Reference 132 to the 2013 proposed human preventive controls rule.
64. FDA, ``Pasteurized Milk Ordinance, 2011 Revision,'' (http://www.fda.gov/downloads/food/guidanceregulation/ucm291757.pdf), 2011. 
Accessed and printed on April 2, 2015. See Reference 37 to the 2013 
proposed human preventive controls rule.
65. FDA Memorandum, ``Comparison of Requirements for Hazard Analysis 
and Risk-Based Preventive Controls in 21 CFR part 117 to Various 
Existing Domestic and International HACCP-Based Standards,'' 2015.
66. Byrd-Bredbenner, C., J. Berning, J. Martin-Biggers, and V. 
Quick, ``Food Safety in Home Kitchens: A Synthesis of the 
Literature,'' International Journal of Environmental Research and 
Public Health, 10, 2013.
67. Lando, A. and E. Carlton, ``2010 Food Safety Survey: Topline 
Frequency Report,'' (http://www.fda.gov/downloads/Food/FoodScienceResearch/ConsumerBehaviorResearch/UCM407008.pdf), 2010. 
Accessed and printed on March 26, 2015.
68. FDA, ``CPG Sec. 560.750 Radionucleotides in Imported Foods--
Levels of Concern,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074576.htm), November 29, 2005. 
Accessed and printed on October 14, 2011. See Reference 151 to the 
2013 proposed human preventive controls rule.
69. FDA, ``FDA Recalls Web site,'' (http://www.fda.gov/Safety/Recalls/default.htm), June 4, 2014. Accessed and printed on March 
13, 2015.
70. Food Allergy Research & Resource Group and the University of 
Nebraska, Lincoln, ``Components of an Effective Allergen Control 
Plan,'' (http://farrp.unl.edu/c/document_library/get_file?uuid=3fcc9e7c-9430-4988-99a0-96248e5a28f7&groupId=2103626), 
2011. Accessed and printed on October 17, 2011. See Reference 123 to 
the 2013 proposed human preventive controls rule.
71. Jackson, L. S., F. M. Al-taher, M. Moorman, J. W. DeVries, R. 
Tippett, K. M. J. Swanson, T.-J. Fu, R. Salter, G. Dunaif, S. Estes, 
S. Albillos, and S. M. Gendel, ``Cleaning and Other Control and 
Validation Strategies to Prevent

[[Page 56140]]

Allergen Cross-Contact in Food-Processing Operations,'' Journal of 
Food Protection, 71:445-458, 2008. See Reference 124 to the 2013 
proposed human preventive controls rule.
72. FDA, ``FDA Allergy Warning Letter,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106546.htm), June 10, 1996. Accessed and printed on October 17, 
2011. See Reference 120 to the 2013 proposed human preventive 
controls rule.
73. FDA, ``Food Allergen Partnership,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106779.htm), January, 2001. Accessed and printed on September 17, 
2014.
74. FDA, ``CPG, Sec. 555.250 Statement of Policy for Labeling and 
Preventing Cross-Contact of Common Food Allergens,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074552.htm), November 29, 2005. Accessed and printed on September 
12, 2014.
75. FDA, ``Draft Guidance for Industry: Questions and Answers 
Regarding Mandatory Food Recalls,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm445428.htm), May, 2015. Accessed and printed on May 21, 2015.
76. FDA, ``FDA Homepage,'' (http://www.fda.gov/), March 25, 2015. 
Accessed and printed on March 25, 2015.
77. FDA, ``Recalls, Market Withdrawals, & Safety Alerts (FDA Email 
Sign-up Web page),'' (https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_48), 2015. Accessed and printed 
on June 3, 2015.
78. FDA, ``Guidance for Industry: Product Recalls, Including 
Removals and Corrections,'' (http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm), November 3, 2003. Accessed and 
printed on February 19, 2015.
79. FoodSafety.gov, ``Get Food Safety Widget,'' (http://www.foodsafety.gov/recalls/widget/index.html), March 27, 2015. 
Accessed and printed on March 13, 2015.
80. U.S. Department of Health and Human Services, ``Employers and 
Health Information in the Workplace HIPAA Privacy Rule,'' (http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/employers.html), 2015. Accessed and printed on April 2, 2015.
81. Codex Alimentarius Commission, ``Recommended International Code 
of Practice: General Principles of Food Hygiene CAC/RCP1-1969, Rev. 
4-2003,'' (https://www.idfa.org/docs/default-source/resource-library/391_cxp_001e.pdf?sfvrsn=0; http://www.codexalimentarius.org/download/standards/23/CXP_001e.pdf), 2003. Accessed and printed on 
October 27, 2009. See Reference 44 to the 2013 proposed human 
preventive controls rule.
82. FDA, ``Guidance for Industry: Testing for Salmonella in Human 
Foods and Direct-Human-Contact Animal Foods,'' (http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/salmonella/ucm295271.htm), March, 2012. Accessed and printed on 
February 20, 2015.
83. FDA Memorandum, ``Supplier Programs,'' 2014. See Reference 24 to 
the 2014 supplemental human preventive controls notice.
84. USDA Food Safety and Inspection Service, ``FSIS Compliance 
Guideline HACCP Systems Validation,'' (http://www.fsis.usda.gov/wps/wcm/connect/a70bb780-e1ff-4a35-9a9a-3fb40c8fe584/HACCP_Systems_Validation.pdf?MOD=AJPERES), 2015. Accessed and 
printed on July10, 2015.
85. FDA Memorandum, ``Product Testing,'' 2014. See Reference 18 to 
the 2014 supplemental human preventive controls notice.
86. FDA, ``Draft Qualitative Assessment of Risk to Public Health 
From on-Farm Contamination of Produce,'' 2014.
87. FDA, ``Guidance for Industry: Control of Listeria Monocytogenes 
in Refrigerated or Frozen Ready-to-Eat Foods (Draft Guidance),'' 
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodProcessingHACCP/ucm073110.htm), February, 2008. Accessed and printed on September 
13, 2011. See Reference 126 to the 2013 proposed human preventive 
controls rule.
88. FDA Memorandum, ``Unique Configuration of HACCP Plans,'' 1995.
89. FDA, ``Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards of Fresh-cut Fruits and Vegetables,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm064458.htm), February, 
2008. Accessed and printed on June 1, 2015.
90. Codex Alimentarius Commission, ``Codex Alimentarius Commission 
Procedural Manual, 23rd Edition,'' (ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_23e.pdf), 2015. Accessed and printed 
on March 26, 2015.
91. FDA, ``Inspections, Compliance, Enforcement, and Criminal 
Investigations: Warning Letters,'' (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm), March 26, 2015. 
Accessed and printed on March 26, 2015.
92. FDA, ``Import Alerts,'' (http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm), 2015. Accessed and printed 
on March 26, 2015.
93. FDA, ``Letter to Sunland Inc. Concerning Suspension of Food 
Facility Registration; Notice of Opportunity for Hearing,'' (http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/cfsanfoiaelectronicreadingroom/ucm329370.htm), November 26, 2012. 
Accessed and printed on March 26, 2015.
94. Crandall, P., EJ Van Loo, CA O'Bryan, A Mauromoustakos, F 
Yiannas, N Dyenson, and I Berdik. 2012. Companies' opinions and 
acceptance of Global Food Safety Initiative benchmarks after 
implementation. J. Food Protection. 75: 1660-1672.
95. Global Food Safety Initiative, ``GFSI Guidance Document, Version 
6.3,'' (http://www.mygfsi.com/images/mygfsi/gfsifiles/gfsi_guidance/GFSI_Guidance_Document_Over.pdf), 2013. Accessed and printed on June 
2, 2015.
96. Global Food Safety Initiative & The Consumer Goods Forum, ``GFSI 
Food Safety Auditor Competencies, Edition 1,'' (http://www.mygfsi.com/images/mygfsi/gfsifiles/information-kit/GFSI_Food_Safety_Auditor_Competencies_-_Edition_1_October_2013.pdf), 
2013. Accessed and printed on April 2, 2015.
97. FDA, ``Information for Foreign Governments: Frequently Asked 
Questions on Systems Recognition,'' (http://www.fda.gov/Food/InternationalInteragencyCoordination/ucm367400.htm), September 5, 
2013. Accessed and printed on March 26, 2015.
98. World Trade Organization, ``WTO Ministerial Conference: 
Implementation-Related Issues and Concerns,'' (https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.pdf), 
November 20, 2001. Accessed and printed on March 17, 2015.
99. World Trade Organization, ``The WTO Agreement on the Application 
of Sanitary and Phytosanitary Measures (SPS Agreement),'' (https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm), April 15, 1994. 
Accessed and printed on March 17, 2015.
100. FDA, ``Comparison of Proposed Subpart C (Hazard Analysis and 
Risk-Based Preventive Controls) to Various Existing Domestic and 
International HACCP-Based Standards,'' 2012. See Reference 193 to 
the 2013 proposed human preventive controls rule.
101. FDA, ``Tribal Summary Impact Statement,'' 2015.
102. FDA, ``Memorandum on the Modernization of Food Current Good 
Manufacturing Practices (CGMP) As Required by the Food Safety 
Modernization Act of 2011,'' 2011. See Reference 36 to the 2014 
supplemental human preventive controls notice.
103. FDA, ``Memorandum on the Re-Proposal of Select Provisions of 
the Proposed Rule: Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Human Food,'' 2014. 
See Reference 35 to the 2014 supplemental human preventive controls 
notice.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

[[Page 56141]]

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 106

    Food grades and standards, Infants and children, Nutrition, 
Reporting and recordkeeping requirements.

21 CFR Part 110

    Food packaging, Foods.

21 CFR Part 114

    Food packaging, Foods, Reporting and recordkeeping requirements.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 120

    Foods, Fruit juices, Imports, Reporting and recordkeeping 
requirements, Vegetable juices.

21 CFR Part 123

    Fish, Fishery products, Imports, Reporting and recordkeeping 
requirements, Seafood.

21 CFR Part 129

    Beverages, Bottled water, Food packaging, Reporting and 
recordkeeping requirements.

21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.

21 CFR Part 211

    Drugs, Labeling, Laboratories, Packaging and containers, 
Prescription drugs, Reporting and recordkeeping requirements, 
Warehouses.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
chapter I is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as 
follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.


0
2. Revise Sec.  1.227 to read as follows:


Sec.  1.227  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act apply to such terms when used in this subpart. In 
addition, for the purposes of this subpart:
    Calendar day means every day shown on the calendar.
    Facility means any establishment, structure, or structures under 
one ownership at one general physical location, or, in the case of a 
mobile facility, traveling to multiple locations, that manufactures/
processes, packs, or holds food for consumption in the United States. 
Transport vehicles are not facilities if they hold food only in the 
usual course of business as carriers. A facility may consist of one or 
more contiguous structures, and a single building may house more than 
one distinct facility if the facilities are under separate ownership. 
The private residence of an individual is not a facility. Nonbottled 
water drinking water collection and distribution establishments and 
their structures are not facilities.
    (1) Domestic facility means any facility located in any State or 
Territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico that manufactures/processes, packs, or 
holds food for consumption in the United States.
    (2) Foreign facility means a facility other than a domestic 
facility that manufactures/processes, packs, or holds food for 
consumption in the United States.
    Farm means:
    (1) Primary production farm. 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. The term ``farm'' includes operations 
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (2) 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 
raw agricultural commodities, provided that the primary production 
farm(s) that grows, harvests, and/or raises 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 as described in paragraphs (1)(ii) and (iii) of this definition.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act:
    (1) Except for purposes of this subpart, it does not include:
    (i) Food contact substances as defined in section 409(h)(6) of the 
Federal Food, Drug, and Cosmetic Act; or
    (ii) Pesticides as defined in 7 U.S.C. 136(u).
    (2) Examples of food include: Fruits, vegetables, fish, dairy 
products, eggs, raw agricultural commodities for use as food or as 
components of food, animal feed (including pet food), food and feed 
ingredients, food and feed additives, dietary supplements and dietary 
ingredients, infant formula, beverages (including alcoholic beverages 
and bottled water), live food animals, bakery goods, snack foods, 
candy, and canned foods.
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally

[[Page 56142]]

performed on farms for the purpose of removing raw agricultural 
commodities from the place they were grown or raised and preparing them 
for use as food. Harvesting is limited to activities performed on raw 
agricultural commodities, or on processed foods created by drying/
dehydrating a raw agricultural commodity without additional 
manufacturing/processing, on a farm. Harvesting does not include 
activities that transform a raw agricultural commodity into a processed 
food as defined in section 201(gg) of the Federal Food, Drug, and 
Cosmetic Act. Examples of harvesting include cutting (or otherwise 
separating) the edible portion of the raw agricultural commodity from 
the crop plant and removing or trimming part of the raw agricultural 
commodity (e.g., foliage, husks, roots or stems). Examples of 
harvesting also include cooling, field coring, filtering, gathering, 
hulling, removing stems and husks from, shelling, sifting, threshing, 
trimming of outer leaves of, and washing raw agricultural commodities 
grown on a farm.
    Holding means storage of food and also includes activities 
performed incidental to storage of a food (e.g., activities performed 
for the safe or effective storage of that food, such as fumigating food 
during storage, and drying/dehydrating raw agricultural commodities 
when the drying/dehydrating does not create a distinct commodity (such 
as drying/dehydrating hay or alfalfa)). Holding also includes 
activities performed as a practical necessity for the distribution of 
that food (such as blending of the same raw agricultural commodity and 
breaking down pallets), but does not include activities that transform 
a raw agricultural commodity into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding 
facilities could include warehouses, cold storage facilities, storage 
silos, grain elevators, and liquid storage tanks.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, irradiating, labeling, milling, mixing, packaging 
(including modified atmosphere packaging), pasteurizing, peeling, 
rendering, treating to manipulate ripening, trimming, washing, or 
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Nonprofit food establishment means a charitable entity that 
prepares or serves food directly to the consumer or otherwise provides 
food or meals for consumption by humans or animals in the United 
States. The term includes central food banks, soup kitchens, and 
nonprofit food delivery services. To be considered a nonprofit food 
establishment, the establishment must meet the terms of section 
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging 
the food and also includes re-packing and activities performed 
incidental to packing or re-packing a food (e.g., activities performed 
for the safe or effective packing or re-packing of that food (such as 
sorting, culling, grading, and weighing or conveying incidental to 
packing or re-packing), but does not include activities that transform 
a raw agricultural commodity, as defined in section 201(r) of the 
Federal Food, Drug, and Cosmetic Act, into a processed food as defined 
in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Restaurant means a facility that prepares and sells food directly 
to consumers for immediate consumption. ``Restaurant'' does not include 
facilities that provide food to interstate conveyances, central 
kitchens, and other similar facilities that do not prepare and serve 
food directly to consumers.
    (1) Entities in which food is provided to humans, such as 
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food 
stands, saloons, taverns, bars, lounges, catering facilities, hospital 
kitchens, day care kitchens, and nursing home kitchens are restaurants; 
and
    (2) Pet shelters, kennels, and veterinary facilities in which food 
is provided to animals are restaurants.
    Retail food establishment means an establishment that sells food 
products directly to consumers as its primary function. A retail food 
establishment may manufacture/process, pack, or hold food if the 
establishment's primary function is to sell from that establishment 
food, including food that it manufactures/processes, packs, or holds, 
directly to consumers. A retail food establishment's primary function 
is to sell food directly to consumers if the annual monetary value of 
sales of food products directly to consumers exceeds the annual 
monetary value of sales of food products to all other buyers. The term 
``consumers'' does not include businesses. A ``retail food 
establishment'' includes grocery stores, convenience stores, and 
vending machine locations.
    Trade name means the name or names under which the facility 
conducts business, or additional names by which the facility is known. 
A trade name is associated with a facility, and a brand name is 
associated with a product.
    U.S. agent means a person (as defined in section 201(e) of the 
Federal Food, Drug, and Cosmetic Act residing or maintaining a place of 
business in the United States whom a foreign facility designates as its 
agent for purposes of this subpart. A U.S. agent cannot be in the form 
of a mailbox, answering machine or service, or other place where an 
individual acting as the foreign facility's agent is not physically 
present.
    (1) The U.S. agent acts as a communications link between the Food 
and Drug Administration (FDA) and the foreign facility for both 
emergency and routine communications. The U.S. agent will be the person 
FDA contacts when an emergency occurs, unless the registration 
specifies under Sec.  1.233(e) another emergency contact.
    (2) FDA will treat representations by the U.S. agent as those of 
the foreign facility, and will consider information or documents 
provided to the U.S. agent the equivalent of providing the information 
or documents to the foreign facility.
    (3) Having a single U.S. agent for the purposes of this subpart 
does not preclude facilities from having multiple agents (such as 
foreign suppliers) for other business purposes. A firm's commercial 
business in the United States need not be conducted through the U.S. 
agent designated for purposes of this subpart.

[[Page 56143]]

    You or registrant means the owner, operator, or agent in charge of 
a facility that manufactures/processes, packs, or holds food for 
consumption in the United States.

0
3. In Sec.  1.241, revise paragraph (a) to read as follows:


Sec.  1.241  What are the consequences of failing to register, update, 
or cancel your registration?

    (a) Section 301 of the Federal Food, Drug, and Cosmetic Act 
prohibits the doing of certain acts or causing such acts to be done. 
Under section 302 of the Federal Food, Drug, and Cosmetic Act, the 
United States can bring a civil action in Federal court to enjoin a 
person who commits a prohibited act. Under section 303 of the Federal 
Food, Drug, and Cosmetic Act, the United States can bring a criminal 
action in Federal court to prosecute a person who is responsible for 
the commission of a prohibited act. Under section 306 of the Federal 
Food, Drug, and Cosmetic Act, FDA can seek debarment of any person who 
has been convicted of a felony relating to importation of food into the 
United States. Failure of an owner, operator, or agent in charge of a 
domestic or foreign facility to register its facility, to update 
required elements of its facility's registration, or to cancel its 
registration in accordance with the requirements of this subpart is a 
prohibited act under section 301(dd) of the Federal Food, Drug, and 
Cosmetic Act.
* * * * *

0
4. In Sec.  1.276, revise paragraph (b)(9) to read as follows:


Sec.  1.276  What definitions apply to this subpart?

* * * * *
    (b) * * *
    (9) Manufacturer means the last facility, as that word is defined 
in Sec.  1.227, that manufactured/processed the food. A facility is 
considered the last facility even if the food undergoes further 
manufacturing/processing that consists of adding labeling or any 
similar activity of a de minimis nature. If the food undergoes further 
manufacturing/processing that exceeds an activity of a de minimis 
nature, then the subsequent facility that performed the additional 
manufacturing/processing is considered the manufacturer.
* * * * *

0
5. In Sec.  1.328, remove the definitions for ``Act'' and 
``Packaging''; add definitions in alphabetically order for 
``Harvesting'', ``Mixed-type facility'', ``Packaging (when used as a 
noun)'', ``Packaging (when used as a verb)'', and ``Packing''; and 
revise the definitions for ``Farm'', ``Food'', ``Holding'', and 
``Manufacturing/processing'' to read as follows:


Sec.  1.328  What definitions apply to this subpart?

* * * * *
    Farm means:
    (1) Primary production farm. 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. The term ``farm'' includes operations 
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (2) 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 
raw agricultural commodities, provided that the primary production 
farm(s) that grows, harvests, and/or raises 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 as described in paragraphs (1)(ii) and (iii) of this definition.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act. Examples of food include, but are not limited 
to fruits; vegetables; fish; dairy products; eggs; raw agricultural 
commodities for use as food or as components of food; animal feed, 
including pet food; food and feed ingredients and additives, including 
substances that migrate into food from the finished container and other 
articles that contact food; dietary supplements and dietary 
ingredients; infant formula; beverages, including alcoholic beverages 
and bottled water; live food animals; bakery goods; snack foods; candy; 
and canned foods.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, removing stems and husks from, 
shelling, sifting, threshing, trimming of outer leaves of, and washing 
raw agricultural commodities grown on a farm.
    Holding means storage of food and also includes activities 
performed incidental to storage of a food (e.g., activities performed 
for the safe or effective storage of that food, such as fumigating food 
during storage, and drying/dehydrating raw agricultural

[[Page 56144]]

commodities when the drying/dehydrating does not create a distinct 
commodity (such as drying/dehydrating hay or alfalfa)). Holding also 
includes activities performed as a practical necessity for the 
distribution of that food (such as blending of the same raw 
agricultural commodity and breaking down pallets), but does not include 
activities that transform a raw agricultural commodity into a processed 
food as defined in section 201(gg) of the Federal Food, Drug, and 
Cosmetic Act. Holding facilities could include warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid storage tanks.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding, 
homogenizing, irradiating, labeling, milling, mixing, packaging 
(including modified atmosphere packaging), pasteurizing, peeling, 
rendering, treating to manipulate ripening, trimming, washing, or 
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
* * * * *
    Packaging (when used as a noun) means the outer packaging of food 
that bears the label and does not contact the food. Packaging does not 
include food contact substances as they are defined in section 
409(h)(6) of the Federal Food, Drug, and Cosmetic Act.
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging 
the food and also includes re-packing and activities performed 
incidental to packing or re-packing a food (e.g., activities performed 
for the safe or effective packing or re-packing of that food (such as 
sorting, culling, grading, and weighing or conveying incidental to 
packing or re-packing)), but does not include activities that transform 
a raw agricultural commodity, as defined in section 201(r) of the 
Federal Food, Drug, and Cosmetic Act, into a processed food as defined 
in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *

0
6. Revise Sec.  1.363 to read as follows:


Sec.  1.363  What are the consequences of failing to establish or 
maintain records or make them available to FDA as required by this 
subpart?

    (a) The failure to establish or maintain records as required by 
section 414(b) of the Federal Food, Drug, and Cosmetic Act and this 
regulation or the refusal to permit access to or verification or 
copying of any such required record is a prohibited act under section 
301 of the Federal Food, Drug, and Cosmetic Act.
    (b) The failure of a nontransporter immediate previous source or a 
nontransporter immediate subsequent recipient who enters an agreement 
under Sec.  1.352(e) to establish, maintain, or establish and maintain, 
records required under Sec.  1.352(a), (b), (c), or (d), or the refusal 
to permit access to or verification or copying of any such required 
record, is a prohibited act under section 301 of the Federal Food, 
Drug, and Cosmetic Act.
    (c) The failure of any person to make records or other information 
available to FDA as required by section 414 or 704(a) of the Federal 
Food, Drug, and Cosmetic Act and this regulation is a prohibited act 
under section 301 of the Federal Food, Drug, and Cosmetic Act.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
7. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
0
8. In Sec.  11.1, add and reserve paragraphs (g) and (h) and add 
paragraph (i) to read as follows:


Sec.  11.1  Scope.

* * * * *
    (i) This part does not apply to records required to be established 
or maintained by part 117 of this chapter. Records that satisfy the 
requirements of part 117 of this chapter, but that also are required 
under other applicable statutory provisions or regulations, remain 
subject to this part.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
9. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.


0
10. In Sec.  16.1(b)(2), add the following entry in numerical order to 
read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  117.251 through 117.287 (part 117, subpart E of this 
chapter), relating to withdrawal of a qualified facility exemption.
* * * * *

PART 106--INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD 
MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY 
FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS

0
11. The authority citation for 21 CFR part 106 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 350a, 371.


0
12. In Sec.  106.100, revise paragraph (n) to read as follows:


Sec.  106.100  Records.

* * * * *
    (n) Production control, product testing, testing results, 
complaints, and distribution records necessary to verify compliance 
with parts 106, 107, 109, 110, 113, and 117 of this chapter, or with 
other appropriate regulations, shall be retained for 1 year after the 
expiration of the shelf life of the infant formula or 3 years from the 
date of manufacture, whichever is greater.
* * * * *

PART 110--[Removed and Reserved]

0
13. Remove and reserve part 110, effective September 17, 2018.

PART 114--ACIDIFIED FOODS

0
14. The authority citation for 21 CFR part 114 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.


0
15. Revise Sec.  114.5 to read as follows:

[[Page 56145]]

Sec.  114.5  Current good manufacturing practice.

    The criteria in Sec. Sec.  114.10, 114.80, 114.83, 114.89, and 
114.100, as well as the criteria in parts 110 and 117 of this chapter, 
apply in determining whether an article of acidified food is 
adulterated:
    (a) Within the meaning of section 402(a)(3) of the Federal Food, 
Drug, and Cosmetic Act in that it has been manufactured under such 
conditions that it is unfit for food; or
    (b) Within the meaning of section 402(a)(4) of the Federal Food, 
Drug, and Cosmetic Act in that 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.

0
16. Add part 117 to read as follows:

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

Subpart A--General Provisions
Sec.
117.1 Applicability and status.
117.3 Definitions.
117.4 Qualifications of individuals who manufacture, process, pack, 
or hold food.
117.5 Exemptions.
117.7 Applicability of subparts C, D, and G of this part to a 
facility solely engaged in the storage of unexposed packaged food.
117.8 Applicability of subpart B of this part to the off-farm 
packing and holding of raw agricultural commodities
117.9 Records required for this subpart.
Subpart B--Current Good Manufacturing Practice
117.10 Personnel.
117.20 Plant and grounds.
117.35 Sanitary operations.
117.37 Sanitary facilities and controls.
117.40 Equipment and utensils.
117.80 Processes and controls.
117.93 Warehousing and distribution.
117.110 Defect action levels.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
117.126 Food safety plan.
117.130 Hazard analysis.
117.135 Preventive controls.
117.136 Circumstances in which the owner, operator, or agent in 
charge of a manufacturing/processing facility is not required to 
implement a preventive control.
117.137 Provision of assurances required under Sec.  117.136(a)(2), 
(3), and (4).
117.139 Recall plan.
117.140 Preventive control management components.
117.145 Monitoring.
117.150 Corrective actions and corrections.
117.155 Verification.
117.160 Validation.
117.165 Verification of implementation and effectiveness.
117.170 Reanalysis.
117.180 Requirements applicable to a preventive controls qualified 
individual and a qualified auditor.
117.190 Implementation records required for this subpart.
Subpart D--Modified Requirements
117.201 Modified requirements that apply to a qualified facility.
117.206 Modified requirements that apply to a facility solely 
engaged in the storage of unexposed packaged food.
Subpart E--Withdrawal of a Qualified Facility Exemption
117.251 Circumstances that may lead FDA to withdraw a qualified 
facility exemption.
117.254 Issuance of an order to withdraw a qualified facility 
exemption.
117.257 Contents of an order to withdraw a qualified facility 
exemption.
117.260 Compliance with, or appeal of, an order to withdraw a 
qualified facility exemption.
117.264 Procedure for submitting an appeal.
117.267 Procedure for requesting an informal hearing.
117.270 Requirements applicable to an informal hearing.
117.274 Presiding officer for an appeal and for an informal hearing.
117.277 Timeframe for issuing a decision on an appeal.
117.280 Revocation of an order to withdraw a qualified facility 
exemption.
117.284 Final agency action.
117.287 Reinstatement of a qualified facility exemption that was 
withdrawn.
Subpart F--Requirements Applying to Records That Must Be Established 
and Maintained
117.301 Records subject to the requirements of this subpart.
117.305 General requirements applying to records.
117.310 Additional requirements applying to the food safety plan.
117.315 Requirements for record retention.
117.320 Requirements for official review.
117.325 Public disclosure.
117.330 Use of existing records.
117.335 Special requirements applicable to a written assurance.
Subpart G--Supply-Chain Program
117.405 Requirement to establish and implement a supply-chain 
program.
117.410 General requirements applicable to a supply-chain program.
117.415 Responsibilities of the receiving facility.
117.420 Using approved suppliers.
117.425 Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity).
117.430 Conducting supplier verification activities for raw 
materials and other ingredients.
117.435 Onsite audit.
117.475 Records documenting the supply-chain program.

    Authority:  21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.

Subpart A--General Provisions


Sec.  117.1  Applicability and status.

    (a) The criteria and definitions in this part apply in determining 
whether a food is:
    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act 
in that the food has been manufactured under such conditions that it is 
unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic 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; and
    (2) In violation of section 361 of the Public Health Service Act 
(42 U.S.C. 264).
    (b) 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 required to comply 
with, and is not in compliance with, section 418 of the Federal Food, 
Drug, and Cosmetic Act or subpart C, D, E, or F of this part is a 
prohibited act under section 301(uu) of the Federal Food, Drug, and 
Cosmetic Act.
    (c) Food covered by specific current good manufacturing practice 
regulations also is subject to the requirements of those regulations.


Sec.  117.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
    Acid foods or acidified foods means foods that have an equilibrium 
pH of 4.6 or below.
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Affiliate means any facility that controls, is controlled by, or is 
under common control with another facility.
    Allergen cross-contact means the unintentional incorporation of a 
food allergen into a food.
    Audit means the systematic, independent, and documented examination 
(through observation,

[[Page 56146]]

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.
    Batter means a semifluid substance, usually composed of flour and 
other ingredients, into which principal components of food are dipped 
or with which they are coated, or which may be used directly to form 
bakery foods.
    Blanching, except for tree nuts and peanuts, means a prepackaging 
heat treatment of foodstuffs for an adequate time and at an adequate 
temperature to partially or completely inactivate the naturally 
occurring enzymes and to effect other physical or biochemical changes 
in the food.
    Calendar day means every day shown on the calendar.
    Correction means 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).
    Critical control point means a point, step, or procedure in a food 
process at which control can be applied and is essential to prevent or 
eliminate a food safety hazard or reduce such hazard to an acceptable 
level.
    Defect action level means 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 Federal Food, Drug, and Cosmetic Act.
    Environmental pathogen means 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 the environmental pathogen. Examples of 
environmental pathogens for the purposes of this part include Listeria 
monocytogenes and Salmonella spp. but do not include the spores of 
pathogenic sporeforming bacteria.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of part 1, subpart H 
of this chapter.
    Farm means farm as defined in Sec.  1.227 of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food allergen means a major food allergen as defined in section 
201(qq) of the Federal Food, Drug, and Cosmetic Act.
    Food-contact surfaces are those surfaces that contact human food 
and those surfaces from which drainage, or other transfer, onto the 
food or onto surfaces that contact the food ordinarily occurs during 
the normal course of operations. ``Food-contact surfaces'' includes 
utensils and food-contact surfaces of equipment.
    Full-time equivalent employee is 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.
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, removing stems and husks from, 
shelling, sifting, threshing, trimming of outer leaves of, and washing 
raw agricultural commodities grown on a farm.
    Hazard means any biological, chemical (including radiological), or 
physical agent that has the potential to cause illness or injury.
    Hazard requiring a preventive control means 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 (which 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), establish one or more preventive controls to significantly 
minimize or prevent the hazard in a food and components to manage those 
controls (such as monitoring, corrections or corrective actions, 
verification, and records) as appropriate to the food, the facility, 
and the nature of the preventive control and its role in the facility's 
food safety system.
    Holding means storage of food and also includes activities 
performed incidental to storage of a food (e.g., activities performed 
for the safe or effective storage of that food, such as fumigating food 
during storage, and drying/dehydrating raw agricultural commodities 
when the drying/dehydrating does not create a distinct commodity (such 
as drying/dehydrating hay or alfalfa)). Holding also includes 
activities performed as a practical necessity for the distribution of 
that food (such as blending of the same raw agricultural commodity and 
breaking down pallets), but does not include activities that transform 
a raw agricultural commodity into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding 
facilities could include warehouses, cold storage facilities, storage 
silos, grain elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological, chemical 
(including radiological), or physical hazard that is known to be, or 
has the potential to be, associated with the facility or the food.
    Lot means the food produced during a period of time and identified 
by an establishment's specific code.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as 
drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, formulating, freezing, grinding,

[[Page 56147]]

homogenizing, irradiating, labeling, milling, mixing, packaging 
(including modified atmosphere packaging), pasteurizing, peeling, 
rendering, treating to manipulate ripening, trimming, washing, or 
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, 
and microscopic parasites and includes species that are pathogens. The 
term ``undesirable microorganisms'' 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.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether control measures are operating as 
intended.
    Packing means placing food into a container other than packaging 
the food and also includes re-packing and activities performed 
incidental to packing or re-packing a food (e.g., activities performed 
for the safe or effective packing or re-packing of that food (such as 
sorting, culling, grading, and weighing or conveying incidental to 
packing or re-packing), but does not include activities that transform 
a raw agricultural commodity into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Pathogen means a microorganism of public health significance.
    Pest refers to any objectionable animals or insects including 
birds, rodents, flies, and larvae.
    Plant means the building or structure or parts thereof, used for or 
in connection with the manufacturing, processing, packing, or holding 
of human food.
    Preventive controls means 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.
    Preventive controls qualified individual means a qualified 
individual 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 FDA or is otherwise qualified through job experience to develop and 
apply a food safety system.
    Qualified auditor means a person who is a qualified individual as 
defined in this part and has technical expertise obtained through 
education, training, or experience (or a combination thereof) necessary 
to perform the auditing function as required by Sec.  117.180(c)(2). 
Examples of potential qualified auditors 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 of this chapter.
    Qualified end-user, with respect to a food, means 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 of this chapter) that:
    (1) Is located;
    (i) In the same State or the same Indian reservation as the 
qualified facility that sold the food to such restaurant or 
establishment; or
    (ii) 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.
    Qualified facility means (when including the sales by any 
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of 
any entity of which the facility is a subsidiary or affiliate) a 
facility that is a very small business as defined in this part, or a 
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar 
year, the average annual monetary value of the food manufactured, 
processed, packed or held at such facility that is sold directly to 
qualified end-users (as defined in this part) during such period 
exceeded the average annual monetary value of the food sold by such 
facility to all other purchasers; and
    (2) The average annual monetary value of all food sold during the 
3-year period preceding the applicable calendar year was less than 
$500,000, adjusted for inflation.
    Qualified facility exemption means an exemption applicable to a 
qualified facility under Sec.  117.5(a).
    Qualified individual means 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.
    Quality control operation means a planned and systematic procedure 
for taking all actions necessary to prevent food from being 
adulterated.
    Raw agricultural commodity has the meaning given in section 201(r) 
of the Federal Food, Drug, and Cosmetic Act.
    Ready-to-eat food (RTE food) means any food that is normally eaten 
in its raw state or any other food, including a processed food, for 
which it is reasonably foreseeable that the food will be eaten without 
further processing that would significantly minimize biological 
hazards.
    Receiving facility means a facility that is subject to subparts C 
and G of this part and that manufactures/processes a raw material or 
other ingredient that it receives from a supplier.
    Rework means clean, unadulterated food that has been removed from 
processing for reasons other than insanitary conditions or that has 
been successfully reconditioned by reprocessing and that is suitable 
for use as food.
    Safe-moisture level is a level of moisture low enough to prevent 
the growth of undesirable microorganisms in the finished product under 
the intended conditions of manufacturing, processing, packing, and 
holding. The safe moisture level for a food is related to its water 
activity (aw). An aw will be considered safe for 
a food if adequate data are available that demonstrate that the food at 
or below the given aw will not support the growth of 
undesirable microorganisms.
    Sanitize means to adequately treat cleaned surfaces 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.
    Significantly minimize means to reduce to an acceptable level, 
including to eliminate.

[[Page 56148]]

    Small business means, for purposes of this part, a business 
employing fewer than 500 full-time equivalent employees.
    Subsidiary means any company which is owned or controlled directly 
or indirectly by another company.
    Supplier means the establishment that manufactures/processes the 
food, raises the animal, or grows 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.
    Supply-chain-applied control means a preventive control for a 
hazard in a raw material or other ingredient when the hazard in the raw 
material or other ingredient is controlled before its receipt.
    Unexposed packaged food means packaged food that is not exposed to 
the environment.
    Validation means obtaining and evaluating scientific and technical 
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.
    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.
    Very small business means, for purposes of this part, 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).
    Water activity (aw) is a measure of the free moisture in 
a food and is the quotient of the water vapor pressure of the substance 
divided by the vapor pressure of pure water at the same temperature.
    Written procedures for receiving raw materials and other 
ingredients means 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).
    You means, for purposes of this part, the owner, operator, or agent 
in charge of a facility.


Sec.  117.4  Qualifications of individuals who manufacture, process, 
pack, or hold food.

    (a) Applicability. (1) The management of an establishment must 
ensure that all individuals who manufacture, process, pack, or hold 
food subject to subparts B and F of this part are qualified to perform 
their assigned duties.
    (2) The owner, operator, or agent in charge of a facility must 
ensure that all individuals who manufacture, process, pack, or hold 
food subject to subpart C, D, E, F, or G of this part are qualified to 
perform their assigned duties.
    (b) Qualifications of all individuals engaged in manufacturing, 
processing, packing, or holding food. Each individual engaged in 
manufacturing, processing, packing, or holding food (including 
temporary and seasonal personnel) or in the supervision thereof must:
    (1) Be a qualified individual as that term is defined in Sec.  
117.3--i.e., 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; 
and
    (2) 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 individual's 
assigned duties.
    (c) Additional qualifications of supervisory personnel. 
Responsibility for ensuring compliance by individuals with the 
requirements of this part must be clearly assigned to supervisory 
personnel who have the education, training, or experience (or a 
combination thereof) necessary to supervise the production of clean and 
safe food.
    (d) Records. Records that document training required by paragraph 
(b)(2) of this section must be established and maintained.


Sec.  117.5  Exemptions.

    (a) Except as provided by subpart E of this part, subparts C and G 
of this part does not apply to a qualified facility. Qualified 
facilities are subject to the modified requirements in Sec.  117.201.
    (b) Subparts C and G of this part do not apply with respect to 
activities that are subject to part 123 of this chapter (Fish and 
Fishery Products) at a facility if you are required to comply with, and 
are in compliance with, part 123 of this chapter with respect to such 
activities.
    (c) Subparts C and G of this part do not apply with respect to 
activities that are subject to part 120 of this chapter (Hazard 
Analysis and Critical Control Point (HACCP) Systems) at a facility if 
you are required to comply with, and are in compliance with, part 120 
of this chapter with respect to such activities.
    (d)(1) Subparts C and G of this part do not apply with respect to 
activities that are subject to part 113 of this chapter (Thermally 
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at 
a facility if you are required to comply with, and are in compliance 
with, part 113 of this chapter with respect to such activities.
    (2) The exemption in paragraph (d)(1) of this section is applicable 
only with respect to the microbiological hazards that are regulated 
under part 113 of this chapter.
    (e) Subparts C and G do not apply to any facility with regard to 
the manufacturing, processing, packaging, or holding of a dietary 
supplement that is in compliance with the requirements of part 111 of 
this chapter (Current Good Manufacturing Practice in Manufacturing, 
Packaging, Labeling, or Holding Operations for Dietary Supplements) and 
section 761 of the Federal Food, Drug, and Cosmetic Act (Serious 
Adverse Event Reporting for Dietary Supplements).
    (f) Subparts C and G of this part do not apply to activities of a 
facility that are subject to section 419 of the Federal Food, Drug, and 
Cosmetic Act (Standards for Produce Safety).
    (g)(1) The exemption in paragraph (g)(3) of this section applies to 
packing or holding of processed foods on a farm mixed-type facility, 
except for processed foods produced by drying/dehydrating raw 
agricultural commodities 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 of this chapter. 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.
    (2) For the purposes of paragraphs (g)(3) and (h)(3) of this 
section, the following terms describe the foods associated with the 
activity/food combinations. Several foods that are fruits or vegetables 
are separately considered for the purposes of these activity/food 
combinations (i.e., coffee

[[Page 56149]]

beans, cocoa beans, fresh herbs, peanuts, sugarcane, sugar beets, tree 
nuts, seeds for direct consumption) to appropriately address specific 
hazards associated with these foods and/or processing activities 
conducted on these foods.
    (i) Dried/dehydrated fruit and vegetable products includes only 
those processed food products such as raisins and dried legumes made 
without additional manufacturing/processing beyond drying/dehydrating, 
packaging, and/or labeling.
    (ii) Other fruit and vegetable products includes those processed 
food products that have undergone one or more of the following 
processes: acidification, boiling, canning, coating with things other 
than wax/oil/resin, cooking, cutting, chopping, grinding, peeling, 
shredding, slicing, or trimming. Examples include flours made from 
legumes (such as chickpea flour), pickles, and snack chips made from 
potatoes or plantains. Examples also include dried fruit and vegetable 
products made with additional manufacturing/processing (such as dried 
apple slices; pitted, dried plums, cherries, and apricots; and sulfited 
raisins). This category does not include dried/dehydrated fruit and 
vegetable products made without additional manufacturing/processing as 
described in paragraph (g)(2)(i) of this section. This category also 
does not include products that require time/temperature control for 
safety (such as fresh-cut fruits and vegetables).
    (iii) Peanut and tree nut products includes processed food products 
such as roasted peanuts and tree nuts, seasoned peanuts and tree nuts, 
and peanut and tree nut flours.
    (iv) Processed seeds for direct consumption include processed food 
products such as roasted pumpkin seeds, roasted sunflower seeds, and 
roasted flax seeds.
    (v) Dried/dehydrated herb and spice products includes only 
processed food products such as dried intact herbs made without 
additional manufacturing/processing beyond drying/dehydrating, 
packaging, and/or labeling.
    (vi) Other herb and spice products includes those processed food 
products such as chopped fresh herbs, chopped or ground dried herbs 
(including tea), herbal extracts (e.g., essential oils, extracts 
containing more than 20 percent ethanol, extracts containing more than 
35 percent glycerin), dried herb- or spice-infused honey, and dried 
herb- or spice-infused oils and/or vinegars. This category does not 
include dried/dehydrated herb and spice products made without 
additional manufacturing/processing beyond drying/dehydrating, 
packaging, and/or labeling as described in paragraph (g)(2)(v) of this 
section. This category also does not include products that require 
time/temperature control for safety, such as fresh herb-infused oils.
    (vii) Grains include barley, dent- or flint-corn, sorghum, oats, 
rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil 
extraction (such as cotton seed, flax seed, rapeseed, soybeans, and 
sunflower seed).
    (viii) Milled grain products include processed food products such 
as flour, bran, and corn meal.
    (ix) Baked goods include processed food products such as breads, 
brownies, cakes, cookies, and crackers. This category does not include 
products that require time/temperature control for safety, such as 
cream-filled pastries.
    (x) Other grain products include processed food products such as 
dried cereal, dried pasta, oat flakes, and popcorn. This category does 
not include milled grain products as described in paragraph 
(g)(2)(viii) of this section or baked goods as described in paragraph 
(g)(2)(ix) of this section.
    (3) Subparts C and G of this part do not apply to on-farm packing 
or holding of food by a small or very small business, and 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 Federal Food, Drug, and Cosmetic Act that the business 
conducts are the following low-risk packing or holding activity/food 
combinations--i.e., packing (or re-packing) (including weighing or 
conveying incidental to packing or re-packing); sorting, culling, or 
grading incidental to packing or storing; and storing (ambient, cold 
and controlled atmosphere) of:
    (i) Baked goods (e.g., bread and cookies);
    (ii) Candy (e.g., hard candy, fudge, maple candy, maple cream, nut 
brittles, taffy, and toffee);
    (iii) Cocoa beans (roasted);
    (iv) Cocoa products;
    (v) Coffee beans (roasted);
    (vi) Game meat jerky;
    (vii) Gums, latexes, and resins that are processed foods;
    (viii) Honey (pasteurized);
    (ix) Jams, jellies, and preserves;
    (x) Milled grain products (e.g., flour, bran, and corn meal);
    (xi) Molasses and treacle;
    (xii) Oils (e.g., olive oil and sunflower seed oil);
    (xiii) Other fruit and vegetable products (e.g., flours made from 
legumes; pitted, dried fruits; sliced, dried apples; snack chips);
    (xiv) Other grain products (e.g., dried pasta, oat flakes, and 
popcorn);
    (xv) Other herb and spice products (e.g., chopped or ground dried 
herbs, herbal extracts);
    (xvi) Peanut and tree nut products (e.g., roasted peanuts and tree 
nut flours);
    (xvii) Processed seeds for direct consumption (e.g., roasted 
pumpkin seeds);
    (xviii) Soft drinks and carbonated water;
    (xix) Sugar;
    (xx) Syrups (e.g., maple syrup and agave syrup);
    (xxi) Trail mix and granola;
    (xxii) Vinegar; and
    (xxiii) Any other processed food that does not require time/
temperature control for safety (e..g., vitamins, minerals, and dietary 
ingredients (e.g., bone meal) in powdered, granular, or other solid 
form).
    (h)(1) The exemption in paragraph (h)(3) of this section 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 of this chapter. Drying/dehydrating raw agricultural 
commodities 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 of this 
chapter. In addition, treatment to manipulate ripening of raw 
agricultural commodities (such as by treating produce with ethylene 
gas), and packaging and labeling the treated raw agricultural 
commodities, 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.
    (2) The terms in paragraph (g)(2) of this section describe certain 
foods associated with the activity/food combinations in paragraph 
(h)(3) of this section.
    (3) Subparts C and G of this part do not apply to on-farm 
manufacturing/processing activities conducted by a small or very small 
business for

[[Page 56150]]

distribution into commerce, and 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 Federal Food, Drug, and 
Cosmetic Act that the business conducts are the following low-risk 
manufacturing/processing activity/food combinations:
    (i) Boiling gums, latexes, and resins;
    (ii) Chopping, coring, cutting, peeling, pitting, shredding, and 
slicing acid fruits and vegetables that have a pH less than 4.2 (e.g., 
cutting lemons and limes), baked goods (e.g., slicing bread), dried/
dehydrated fruit and vegetable products (e.g., pitting dried plums), 
dried herbs and other spices (e.g., chopping intact, dried basil), game 
meat jerky, gums/latexes/resins, other grain products (e.g., shredding 
dried cereal), peanuts and tree nuts, and peanut and tree nut products 
(e.g., chopping roasted peanuts);
    (iii) Coating dried/dehydrated fruit and vegetable products (e.g., 
coating raisins with chocolate), other fruit and vegetable products 
except for non-dried, non-intact fruits and vegetables (e.g., coating 
dried plum pieces, dried pitted cherries, and dried pitted apricots 
with chocolate are low-risk activity/food combinations but coating 
apples on a stick with caramel is not a low-risk activity/food 
combination), other grain products (e.g., adding caramel to popcorn or 
adding seasonings to popcorn provided that the seasonings have been 
treated to significantly minimize pathogens, peanuts and tree nuts 
(e.g., adding seasonings provided that the seasonings have been treated 
to significantly minimize pathogens), and peanut and tree nut products 
(e.g., adding seasonings provided that the seasonings have been treated 
to significantly minimize pathogens));
    (iv) Drying/dehydrating (that includes additional manufacturing or 
is performed on processed foods) other fruit and vegetable products 
with pH less than 4.2 (e.g., drying cut fruit and vegetables with pH 
less than 4.2), and other herb and spice products (e.g., drying chopped 
fresh herbs, including tea);
    (v) Extracting (including by pressing, by distilling, and by 
solvent extraction) from dried/dehydrated herb and spice products 
(e.g., dried mint), fresh herbs (e.g., fresh mint), fruits and 
vegetables (e.g., olives, avocados), grains (e.g., oilseeds), and other 
herb and spice products (e.g., chopped fresh mint, chopped dried mint);
    (vi) Freezing acid fruits and vegetables with pH less than 4.2 and 
other fruit and vegetable products with pH less than 4.2 (e.g., cut 
fruits and vegetables);
    (vii) Grinding/cracking/crushing/milling baked goods (e.g., 
crackers), cocoa beans (roasted), coffee beans (roasted), dried/
dehydrated fruit and vegetable products (e.g., raisins and dried 
legumes), dried/dehydrated herb and spice products (e.g., intact dried 
basil), grains (e.g., oats, rice, rye, wheat), other fruit and 
vegetable products (e.g., dried, pitted dates), other grain products 
(e.g., dried cereal), other herb and spice products (e.g., chopped 
dried herbs), peanuts and tree nuts, and peanut and tree nut products 
(e.g., roasted peanuts);
    (viii) Labeling baked goods that do not contain food allergens, 
candy that does not contain food allergens, cocoa beans (roasted), 
cocoa products that do not contain food allergens), coffee beans 
(roasted), game meat jerky, gums/latexes/resins that are processed 
foods, honey (pasteurized), jams/jellies/preserves, milled grain 
products that do not contain food allergens (e.g., corn meal) or that 
are single-ingredient foods (e.g., wheat flour, wheat bran), molasses 
and treacle, oils, other fruit and vegetable products that do not 
contain food allergens (e.g., snack chips made from potatoes or 
plantains), other grain products that do not contain food allergens 
(e.g., popcorn), other herb and spice products (e.g., chopped or ground 
dried herbs), peanut or tree nut products, (provided that they are 
single-ingredient, or are in forms in which the consumer can reasonably 
be expected to recognize the food allergen(s) without label 
declaration, or both (e.g., roasted or seasoned whole nuts, single-
ingredient peanut or tree nut flours)), processed seeds for direct 
consumption, soft drinks and carbonated water, sugar, syrups, trail mix 
and granola (other than those containing milk chocolate and provided 
that peanuts and/or tree nuts are in forms in which the consumer can 
reasonably be expected to recognize the food allergen(s) without label 
declaration), vinegar, and any other processed food that does not 
require time/temperature control for safety and that does not contain 
food allergens (e.g., vitamins, minerals, and dietary ingredients 
(e.g., bone meal) in powdered, granular, or other solid form);
    (ix) Making baked goods from milled grain products (e.g., breads 
and cookies);
    (x) Making candy from peanuts and tree nuts (e.g., nut brittles), 
sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple 
cream);
    (xi) Making cocoa products from roasted cocoa beans;
    (xii) Making dried pasta from grains;
    (xiii) Making jams, jellies, and preserves from acid fruits and 
vegetables with a pH of 4.6 or below;
    (xiv) Making molasses and treacle from sugar beets and sugarcane;
    (xv) Making oat flakes from grains;
    (xvi) Making popcorn from grains;
    (xvii) Making snack chips from fruits and vegetables (e.g., making 
plantain and potato chips);
    (xviii) Making soft drinks and carbonated water from sugar, syrups, 
and water;
    (xix) Making sugars and syrups 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;
    (xx) Making trail mix and granola from cocoa products (e.g., 
chocolate), dried/dehydrated fruit and vegetable products (e.g., 
raisins), other fruit and vegetable products (e.g., chopped dried 
fruits), other grain products (e.g., oat flakes), peanut and tree nut 
products, and processed seeds for direct consumption, provided that 
peanuts, tree nuts, and processed seeds are treated to significantly 
minimize pathogens;
    (xxi) Making vinegar from fruits and vegetables, other fruit and 
vegetable products (e.g., fruit wines, apple cider), and other grain 
products (e.g., malt);
    (xxii) Mixing baked goods (e.g., types of cookies), candy (e.g., 
varieties of taffy), cocoa beans (roasted), coffee beans (roasted), 
dried/dehydrated fruit and vegetable products (e.g., dried blueberries, 
dried currants, and raisins), dried/dehydrated herb and spice products 
(e.g., dried, intact basil and dried, intact oregano), honey 
(pasteurized), milled grain products (e.g., flour, bran, and corn 
meal), other fruit and vegetable products (e.g., dried, sliced apples 
and dried, sliced peaches), other grain products (e.g., different types 
of dried pasta), other herb and spice products (e.g., chopped or ground 
dried herbs, dried herb- or spice-infused honey, and dried herb- or 
spice-infused oils and/or vinegars), peanut and tree nut products, 
sugar, syrups, vinegar, and any other processed food that does not 
require time/temperature control for safety (e.g., vitamins, minerals, 
and dietary ingredients (e.g., bone meal) in powdered, granular, or 
other solid form);
    (xxiii) Packaging baked goods (e.g., bread and cookies), candy, 
cocoa beans (roasted), cocoa products, coffee beans (roasted), game 
meat jerky, gums/latexes/resins that are processed foods, honey 
(pasteurized), jams/jellies/preserves, milled grain products (e.g.,

[[Page 56151]]

flour, bran, corn meal), molasses and treacle, oils, other fruit and 
vegetable products (e.g., pitted, dried fruits; sliced, dried apples; 
snack chips), other grain products (e.g., popcorn), other herb and 
spice products (e.g., chopped or ground dried herbs), peanut and tree 
nut products, processed seeds for direct consumption, soft drinks and 
carbonated water, sugar, syrups, trail mix and granola, vinegar, and 
any other processed food that does not require time/temperature control 
for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., 
bone meal) in powdered, granular, or other solid form);
    (xxiv) Pasteurizing honey;
    (xxv) Roasting and toasting baked goods (e.g., toasting bread for 
croutons);
    (xxvi) Salting other grain products (e.g., soy nuts), peanut and 
tree nut products, and processed seeds for direct consumption; and
    (xxvii) Sifting milled grain products (e.g., flour, bran, corn 
meal), other fruit and vegetable products (e.g., chickpea flour), and 
peanut and tree nut products (e.g., peanut flour, almond flour).
    (i)(1) Subparts C and G of this part do not apply with respect to 
alcoholic beverages at a facility that meets the following two 
conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et 
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 
(26 U.S.C. 5001 et seq.) the facility is required to obtain a permit 
from, register with, or obtain approval of a notice or application from 
the Secretary of the Treasury as a condition of doing business in the 
United States, or is a foreign facility of a type that would require 
such a permit, registration, or approval if it were a domestic 
facility; and
    (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act 
the facility is required to register as a facility because it is 
engaged in manufacturing, processing, packing, or holding one or more 
alcoholic beverages.
    (2) Subparts C and G of this part do not apply with respect to food 
that is not an alcoholic beverage at a facility described in paragraph 
(i)(1) of this section, provided such food:
    (i) Is in prepackaged form that prevents any direct human contact 
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of 
the facility, as determined by the Secretary of the Treasury.
    (j) Subparts C and G of this part do not apply to facilities that 
are solely engaged in the storage of raw agricultural commodities 
(other than fruits and vegetables) intended for further distribution or 
processing.
    (k)(1) Except as provided by paragraph (k)(2) of this section, 
subpart B of this part does not apply to any of the following:
    (i) ``Farms'' (as defined in Sec.  1.227 of this chapter);
    (ii) Fishing vessels that are not subject to the registration 
requirements of part 1, subpart H of this chapter in accordance with 
Sec.  1.226(f) of this chapter;
    (iii) Establishments solely engaged in the holding and/or 
transportation of one or more raw agricultural commodities;
    (iv) Activities of ``farm mixed-type facilities'' (as defined in 
Sec.  1.227 of this chapter) that fall within the definition of 
``farm''; or
    (v) Establishments solely engaged in hulling, shelling, drying, 
packing, and/or holding nuts (without additional manufacturing/
processing, such as roasting nuts).
    (2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates 
raw agricultural commodities that are produce as defined in part 112 of 
this chapter to create a distinct commodity, subpart B of this part 
applies to the packaging, packing, and holding of the dried 
commodities. Compliance with this requirement may be achieved by 
complying with subpart B of this part or with the applicable 
requirements for packing and holding in part 112 of this chapter.


Sec.  117.7  Applicability of subparts C, D, and G of this part to a 
facility solely engaged in the storage of unexposed packaged food.

    (a) Applicability of subparts C and G. Subparts C and G of this 
part do not apply to a facility solely engaged in the storage of 
unexposed packaged food.
    (b) Applicability of subpart D. 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 for any unexposed packaged 
food that requires time/temperature control to significantly minimize 
or prevent the growth of, or toxin production by, pathogens.


Sec.  117.8  Applicability of subpart B of this part to the off-farm 
packing and holding of raw agricultural commodities.

    Subpart B of this part applies to the off-farm packaging, packing, 
and holding of raw agricultural commodities. Compliance with this 
requirement for raw agricultural commodities that are produce as 
defined in part 112 of this chapter may be achieved by complying with 
subpart B of this part or with the applicable requirements for packing 
and holding in part 112 of this chapter.


Sec.  117.9  Records required for this subpart.

    (a) Records that document training required by Sec.  117.4(b)(2) 
must be established and maintained.
    (b) The records that must be established and maintained are subject 
to the requirements of subpart F of this part.

Subpart B--Current Good Manufacturing Practice


Sec.  117.10  Personnel.

    The management of the establishment must take reasonable measures 
and precautions to ensure the following:
    (a) Disease control. 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, unless conditions such as open lesions, 
boils, and infected wounds are adequately covered (e.g., by an 
impermeable cover). Personnel must be instructed to report such health 
conditions to their supervisors.
    (b) Cleanliness. All persons working in direct contact with food, 
food-contact surfaces, and food-packaging materials must conform to 
hygienic practices while on duty to the extent necessary to protect 
against allergen cross-contact and against contamination of food. The 
methods for maintaining cleanliness include:
    (1) 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.
    (2) Maintaining adequate personal cleanliness.
    (3) Washing hands thoroughly (and sanitizing if necessary to 
protect against contamination with undesirable microorganisms) in an 
adequate hand-washing facility before starting work, after each absence 
from the work station, and at any other time when the hands may have 
become soiled or contaminated.

[[Page 56152]]

    (4) 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.
    (5) Maintaining gloves, if they are used in food handling, in an 
intact, clean, and sanitary condition.
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
headbands, caps, beard covers, or other effective hair restraints.
    (7) Storing clothing or other personal belongings in areas other 
than where food is exposed or where equipment or utensils are washed.
    (8) Confining the following to areas other than where food may be 
exposed or where equipment or utensils are washed: eating food, chewing 
gum, drinking beverages, or using tobacco.
    (9) Taking any other necessary precautions to protect against 
allergen cross-contact and 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).


Sec.  117.20  Plant and grounds.

    (a) Grounds. 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. The methods for adequate maintenance of grounds 
must include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant that 
may constitute an attractant, breeding place, or harborage for pests.
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where food is exposed.
    (3) Adequately draining areas that may contribute contamination to 
food by seepage, foot-borne filth, or providing a breeding place for 
pests.
    (4) 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.
    (5) If the plant grounds are bordered by grounds not under the 
operator's control and not maintained in the manner described in 
paragraphs (a)(1) through (4) of this section, 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.
    (b) Plant construction and design. The plant 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). The plant must:
    (1) Provide adequate space for such placement of equipment and 
storage of materials as is necessary for maintenance, sanitary 
operations, and the production of safe food.
    (2) Permit the taking of adequate precautions to reduce the 
potential for allergen cross-contact and for contamination of food, 
food-contact surfaces, or food-packaging materials with microorganisms, 
chemicals, filth, and other extraneous material. The potential for 
allergen cross-contact and for contamination may be reduced by adequate 
food safety controls and operating practices or effective design, 
including the separation of operations in which allergen cross-contact 
and contamination are likely to occur, by one or more of the following 
means: location, time, partition, air flow systems, dust control 
systems, enclosed systems, or other effective means.
    (3) Permit the taking of adequate precautions to protect food in 
installed outdoor bulk vessels by any effective means, including:
    (i) Using protective coverings.
    (ii) Controlling areas over and around the vessels to eliminate 
harborages for pests.
    (iii) Checking on a regular basis for pests and pest infestation.
    (iv) Skimming fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and 
ceilings may be adequately cleaned and kept clean and kept in good 
repair; that drip or condensate from fixtures, ducts and pipes does not 
contaminate food, food-contact surfaces, or food-packaging materials; 
and that aisles or working spaces are provided between equipment and 
walls and are adequately unobstructed and of adequate width to permit 
employees to perform their duties and to protect against contaminating 
food, food-contact surfaces, or food-packaging materials with clothing 
or personal contact.
    (5) Provide adequate lighting in hand-washing areas, dressing and 
locker rooms, and toilet rooms and in all areas where food is examined, 
manufactured, processed, packed, or held and where equipment or 
utensils are cleaned; and provide shatter-resistant 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.
    (6) Provide adequate ventilation or control equipment to minimize 
dust, odors and vapors (including steam and noxious fumes) in areas 
where they may cause allergen cross-contact or contaminate food; and 
locate and operate fans and other air-blowing equipment in a manner 
that minimizes the potential for allergen cross-contact and for 
contaminating food, food-packaging materials, and food-contact 
surfaces.
    (7) Provide, where necessary, adequate screening or other 
protection against pests.


Sec.  117.35  Sanitary operations.

    (a) General maintenance. 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.
    (b) Substances used in cleaning and sanitizing; storage of toxic 
materials. (1) 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. Compliance with this requirement must be verified by any effective 
means, including purchase of these substances under a letter of 
guarantee or certification or examination of these substances for 
contamination. Only the following toxic materials may be used or stored 
in a plant where food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) 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.
    (c) Pest control. Pests must not be allowed in any area of a food 
plant.

[[Page 56153]]

Guard, guide, or pest-detecting 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 
pesticides to control pests in the plant is permitted only under 
precautions and restrictions that will protect against the 
contamination of food, food-contact surfaces, and food-packaging 
materials.
    (d) Sanitation of food-contact surfaces. All food-contact surfaces, 
including utensils and food-contact surfaces of equipment, must be 
cleaned as frequently as necessary to protect against allergen cross-
contact and against contamination of food.
    (1) Food-contact surfaces used for manufacturing/processing, 
packing, or holding low-moisture food must be in a clean, dry, sanitary 
condition before use. When the surfaces are wet-cleaned, they must, 
when necessary, be sanitized and thoroughly dried before subsequent 
use.
    (2) In wet processing, when cleaning is necessary to protect 
against allergen cross-contact or 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.
    (3) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) must be stored, handled, and 
disposed of in a manner that protects against allergen cross-contact 
and against contamination of food, food-contact surfaces, or food-
packaging materials.
    (e) Sanitation of non-food-contact surfaces. Non-food-contact 
surfaces of equipment used in the operation of a food plant must be 
cleaned in a manner and as frequently as necessary to protect against 
allergen cross-contact and against contamination of food, food-contact 
surfaces, and food-packaging materials.
    (f) Storage and handling of cleaned portable equipment and 
utensils. Cleaned and sanitized portable equipment with food-contact 
surfaces and utensils must be stored in a location and manner that 
protects food-contact surfaces from allergen cross-contact and from 
contamination.


Sec.  117.37  Sanitary facilities and controls.

    Each plant must be equipped with adequate sanitary facilities and 
accommodations including:
    (a) Water supply. The water supply must be adequate 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.
    (b) Plumbing. Plumbing must be of adequate size and design and 
adequately installed and maintained to:
    (1) Carry adequate 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.
    (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.
    (c) Sewage disposal. Sewage must be disposed of into an adequate 
sewerage system or disposed of through other adequate means.
    (d) Toilet facilities. Each plant must provide employees with 
adequate, readily accessible toilet facilities. Toilet facilities must 
be kept clean and must not be a potential source of contamination of 
food, food-contact surfaces, or food-packaging materials.
    (e) Hand-washing facilities. 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.
    (f) Rubbish and offal disposal. Rubbish and any offal must be so 
conveyed, stored, and disposed of as to minimize the development of 
odor, minimize the potential for the waste becoming an attractant and 
harborage or breeding place for pests, and protect against 
contamination of food, food-contact surfaces, food-packaging materials, 
water supplies, and ground surfaces.


Sec.  117.40  Equipment and utensils.

    (a)(1) All plant equipment and utensils used in manufacturing, 
processing, packing, or holding food must be so designed and of such 
material and workmanship as to be adequately cleanable, and must be 
adequately maintained to protect against allergen cross-contact and 
contamination.
    (2) Equipment and utensils must be designed, constructed, and used 
appropriately to avoid the adulteration of food with lubricants, fuel, 
metal fragments, contaminated water, or any other contaminants.
    (3) Equipment must be installed so as to facilitate the cleaning 
and maintenance of the equipment and of adjacent spaces.
    (4) Food-contact surfaces must be corrosion-resistant when in 
contact with food.
    (5) 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, sanitizing 
agents, and cleaning procedures.
    (6) Food-contact surfaces must be maintained to protect food from 
allergen cross-contact and from being contaminated by any source, 
including unlawful indirect food additives.
    (b) 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 allergen cross-contact.
    (c) Equipment that is in areas where food is manufactured, 
processed, packed, or held and that does not come into contact with 
food must be so constructed that it can be kept in a clean and sanitary 
condition.
    (d) 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 clean and sanitary condition.
    (e) 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

[[Page 56154]]

the temperature accurately within the compartment.
    (f) 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.
    (g) 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.


Sec.  117.80  Processes and controls.

    (a) General. (1) All operations in the manufacturing, processing, 
packing, and holding of food (including operations directed to 
receiving, inspecting, transporting, and segregating) must be conducted 
in accordance with adequate sanitation principles.
    (2) Appropriate quality control operations must be employed to 
ensure that food is suitable for human consumption and that food-
packaging materials are safe and suitable.
    (3) Overall sanitation of the plant must be under the supervision 
of one or more competent individuals assigned responsibility for this 
function.
    (4) Adequate precautions must be taken to ensure that production 
procedures do not contribute to allergen cross-contact and to 
contamination from any source.
    (5) Chemical, microbial, or extraneous-material testing procedures 
must be used where necessary to identify sanitation failures or 
possible allergen cross-contact and food contamination.
    (6) All food that has become contaminated to the extent that it is 
adulterated must be rejected, or if appropriate, treated or processed 
to eliminate the contamination.
    (b) Raw materials and other ingredients. (1) Raw materials and 
other 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 allergen cross-contact and against 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 cause allergen cross-contact or increase 
the level of contamination of the food.
    (2) Raw materials and other ingredients must either not contain 
levels of microorganisms that may render the food injurious to the 
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.
    (3) Raw materials and other ingredients susceptible to 
contamination with aflatoxin or other natural toxins must comply with 
FDA regulations for poisonous or deleterious substances before these 
raw materials or other ingredients are incorporated into finished food.
    (4) Raw materials, other 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.
    (5) Raw materials, other ingredients, and rework must be held in 
bulk, or in containers designed and constructed so as to protect 
against allergen cross-contact and against 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.
    (6) Frozen raw materials and other ingredients must be kept frozen. 
If thawing is required prior to use, it must be done in a manner that 
prevents the raw materials and other ingredients from becoming 
adulterated.
    (7) Liquid or dry raw materials and other ingredients received and 
stored in bulk form must be held in a manner that protects against 
allergen cross-contact and against contamination.
    (8) Raw materials and other ingredients that are food allergens, 
and rework that contains food allergens, must be identified and held in 
a manner that prevents allergen cross-contact.
    (c) Manufacturing operations. (1) Equipment and utensils and food 
containers must be maintained in an adequate condition through 
appropriate cleaning and sanitizing, as necessary. Insofar as 
necessary, equipment must be taken apart for thorough cleaning.
    (2) 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, allergen 
cross-contact, contamination of food, and deterioration of food.
    (3) 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.
    (4) Measures such as sterilizing, irradiating, pasteurizing, 
cooking, freezing, refrigerating, controlling pH, or controlling 
aw 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.
    (5) Work-in-process and rework must be handled in a manner that 
protects against allergen cross-contact, contamination, and growth of 
undesirable microorganisms.
    (6) Effective measures must be taken to protect finished food from 
allergen cross-contact and from contamination by raw materials, other 
ingredients, or refuse. When raw materials, other ingredients, or 
refuse are unprotected, they must not be handled simultaneously in a 
receiving, loading, or shipping area if that handling could result in 
allergen cross-contact or contaminated food. Food transported by 
conveyor must be protected against allergen cross-contact and against 
contamination as necessary.
    (7) Equipment, containers, and utensils used to convey, hold, or 
store raw materials and other ingredients, work-in-process, rework, or 
other food must be constructed, handled, and maintained during 
manufacturing, processing, packing, and holding in a manner that 
protects against allergen cross-contact and against contamination.
    (8) Adequate measures must be taken to protect against the 
inclusion of metal or other extraneous material in food.
    (9) Food, raw materials, and other ingredients that are 
adulterated:
    (i) Must be disposed of in a manner that protects against the 
contamination of other food; or
    (ii) If the adulterated food is capable of being reconditioned, it 
must be:
    (A) Reconditioned (if appropriate) using a method that has been 
proven to be effective; or
    (B) Reconditioned (if appropriate) and reexamined and subsequently 
found not to be adulterated within the meaning of the Federal Food, 
Drug, and Cosmetic Act before being incorporated into other food.
    (10) 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

[[Page 56155]]

against allergen cross-contact and against contamination. Food must be 
protected from contaminants that may drip, drain, or be drawn into the 
food.
    (11) Heat blanching, when required in the preparation of food 
capable of supporting microbial growth, must 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. Growth and contamination 
by thermophilic microorganisms in blanchers must be minimized by the 
use of adequate operating temperatures and by periodic cleaning and 
sanitizing as necessary.
    (12) Batters, breading, sauces, gravies, dressings, dipping 
solutions, and other similar preparations that are held and used 
repeatedly over time must be treated or maintained in such a manner 
that they are protected against allergen cross-contact and against 
contamination, and minimizing the potential for the growth of 
undesirable microorganisms.
    (13) Filling, assembling, packaging, and other operations must be 
performed in such a way that the food is protected against allergen 
cross-contact, contamination and growth of undesirable microorganisms.
    (14) Food, such as dry mixes, nuts, intermediate moisture food, and 
dehydrated food, that relies principally on the control of 
aw for preventing the growth of undesirable microorganisms 
must be processed to and maintained at a safe moisture level.
    (15) Food, such as 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.
    (16) When ice is used in contact with food, it must be made from 
water that is safe and of adequate sanitary quality in accordance with 
Sec.  117.37(a), and must be used only if it has been manufactured in 
accordance with current good manufacturing practice as outlined in this 
part.


Sec.  117.93  Warehousing and distribution.

    Storage and transportation of food must be under conditions that 
will protect against allergen cross-contact and against biological, 
chemical (including radiological), and physical contamination of food, 
as well as against deterioration of the food and the container.


Sec.  117.110  Defect action levels.

    (a) 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.
    (b) 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. For examples of defect action levels that may render 
food adulterated, see the Defect Levels Handbook, which is accessible 
at http://www.fda.gov/pchfrule and at http://www.fda.gov.

Subpart C--Hazard Analysis and Risk-Based Preventive Controls


Sec.  117.126  Food safety plan.

    (a) Requirement for a food safety plan. (1) You must prepare, or 
have prepared, and implement a written food safety plan.
    (2) The food safety plan must be prepared, or its preparation 
overseen, by one or more preventive controls qualified individuals.
    (b) Contents of a food safety plan. The written food safety plan 
must include:
    (1) The written hazard analysis as required by Sec.  117.130(a)(2);
    (2) The written preventive controls as required by Sec.  
117.135(b);
    (3) The written supply-chain program as required by subpart G of 
this part;
    (4) The written recall plan as required by Sec.  117.139(a); and
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec.  117.145(a)(1);
    (6) The written corrective action procedures as required by Sec.  
117.150(a)(1); and
    (7) The written verification procedures as required by Sec.  
117.165(b).
    (c) Records. The food safety plan required by this section is a 
record that is subject to the requirements of subpart F of this part.


Sec.  117.130  Hazard analysis.

    (a) Requirement for a hazard analysis. (1) You must conduct a 
hazard analysis to 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 any 
hazards requiring a preventive control.
    (2) The hazard analysis must be written regardless of its outcome.
    (b) Hazard identification. The hazard identification must consider:
    (1) Known or reasonably foreseeable hazards that include:
    (i) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances 
such as pesticide and drug residues, natural toxins, decomposition, 
unapproved food or color additives, and food allergens; and
    (iii) Physical hazards (such as stones, glass, and metal 
fragments); and
    (2) Known or reasonably foreseeable hazards that may be present in 
the food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of 
economic gain.
    (c) Hazard evaluation. (1)(i) The hazard analysis must include an 
evaluation of the hazards identified in paragraph (b) of this section 
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.
    (ii) The hazard evaluation required by paragraph (c)(1)(i) of this 
section must include an evaluation of environmental pathogens whenever 
a ready-to-eat 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.
    (2) The hazard evaluation must consider the effect of the following 
on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the facility and 
equipment;
    (iii) Raw materials and other ingredients;
    (iv) Transportation practices;
    (v) Manufacturing/processing procedures;
    (vi) Packaging activities and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors, such as the temporal (e.g., 
weather-related) nature of some hazards (e.g., levels of some natural 
toxins).


Sec.  117.135  Preventive controls.

    (a)(1) You must identify and implement preventive controls to 
provide assurances that any hazards requiring a preventive control will 
be

[[Page 56156]]

significantly minimized or prevented and the food manufactured, 
processed, packed, or held by your facility will not be adulterated 
under section 402 of the Federal Food, Drug, and Cosmetic Act or 
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic 
Act.
    (2) Preventive controls required by paragraph (a)(1) of this 
section include:
    (i) Controls at critical control points (CCPs), if there are any 
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate 
for food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and 
the food:
    (1) Process controls. 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 nature of the applicable control and its role in the facility's 
food safety system:
    (i) Parameters associated with the control of the hazard; and
    (ii) 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 hazard requiring a 
process control.
    (2) Food allergen controls. Food allergen controls include 
procedures, practices, and processes to control food allergens. Food 
allergen controls must include those procedures, practices, and 
processes employed for:
    (i) Ensuring protection of food from allergen cross-contact, 
including during storage, handling, and use; and
    (ii) Labeling the finished food, including ensuring that the 
finished food is not misbranded under section 403(w) of the Federal 
Food, Drug, and Cosmetic Act.
    (3) Sanitation controls. Sanitation controls 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. Sanitation controls must 
include, as appropriate to the facility and the food, procedures, 
practices, and processes for the:
    (i) Cleanliness of food-contact surfaces, including food-contact 
surfaces of utensils and equipment;
    (ii) 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.
    (4) Supply-chain controls. Supply-chain controls include the 
supply-chain program as required by subpart G of this part.
    (5) Recall plan. Recall plan as required by Sec.  117.139.
    (6) Other controls. Preventive controls include any other 
procedures, practices, and processes necessary to satisfy the 
requirements of paragraph (a) of this section. Examples of other 
controls include hygiene training and other current good manufacturing 
practices.


Sec.  117.136  Circumstances in which the owner, operator, or agent in 
charge of a manufacturing/processing facility is not required to 
implement a preventive control.

    (a) Circumstances. If you are a manufacturer/processor, you are not 
required to implement a preventive control when you identify a hazard 
requiring a preventive control (identified hazard) and any of the 
following circumstances apply:
    (1) You determine and document that the type of food (e.g., raw 
agricultural commodities such as cocoa beans, coffee beans, and grains) 
could not be consumed without application of an appropriate control.
    (2) You rely on your customer who is subject to the requirements 
for hazard analysis and risk-based preventive controls in this subpart 
C to ensure that the identified hazard will be significantly minimized 
or prevented and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your 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 identified hazard.
    (3) You rely on your customer who is not subject to the 
requirements for hazard analysis and risk-based preventive controls in 
this subpart to provide assurance it is manufacturing, processing, or 
preparing the food in accordance with applicable food safety 
requirements and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it 
is manufacturing, processing, or preparing the food in accordance with 
applicable food safety requirements.
    (4) You rely on your 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 you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec.  117.137, that your customer:
    (A) 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]''; and
    (B) 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 identified hazard (if the entity 
is subject to the requirements for hazard analysis and risk-based 
preventive controls in this subpart) 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 this subpart); or
    (2) Obtain a similar written assurance from the entity's customer, 
subject to the requirements of Sec.  117.137, as in paragraphs 
(a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5) You have established, documented, and implemented a system that 
ensures control, at a subsequent distribution step, of the hazards in 
the food product you distribute and you document the implementation of 
that system.
    (b) Records. You must document any circumstance, specified in 
paragraph (a) of this section, that applies to you, including:
    (1) A determination, in accordance with paragraph (a) of this 
section, that the type of food could not be consumed without 
application of an appropriate control;
    (2) The annual written assurance from your customer in accordance 
with paragraph (a)(2) of this section;
    (3) The annual written assurance from your customer in accordance 
with paragraph (a)(3) of this section;
    (4) The annual written assurance from your customer in accordance 
with paragraph (a)(4) of this section; and
    (5) Your system, in accordance with paragraph (a)(5) of this 
section, that

[[Page 56157]]

ensures control, at a subsequent distribution step, of the hazards in 
the food product you distribute.


Sec.  117.137  Provision of assurances required under Sec.  
117.136(a)(2), (3), and (4).

    A facility that provides a written 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.


Sec.  117.139  Recall plan.

    For food with a hazard requiring a preventive control:
    (a) You must establish a written recall plan for the food.
    (b) The written 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 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.


Sec.  117.140  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
the preventive controls required under Sec.  117.135 are subject to the 
following 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 
facility's food safety system:
    (1) Monitoring in accordance with Sec.  117.145;
    (2) Corrective actions and corrections in accordance with Sec.  
117.150; and
    (3) Verification in accordance with Sec.  117.155.
    (b) The supply-chain program established in subpart G of this part 
is subject to the following preventive control management components as 
appropriate to ensure the effectiveness of the supply-chain program, 
taking into account the nature of the hazard controlled before receipt 
of the raw material or other ingredient:
    (1) Corrective actions and corrections in accordance with Sec.  
117.150, taking into account the nature of any supplier non-
conformance;
    (2) Review of records in accordance with Sec.  117.165(a)(4); and
    (3) Reanalysis in accordance with Sec.  117.170.
    (c) The recall plan established in Sec.  117.139 is not subject to 
the requirements of paragraph (a) of this section.


Sec.  117.145  Monitoring.

    As appropriate to the nature of the preventive control and its role 
in the facility's food safety system:
    (a) Written procedures. You must establish and implement written 
procedures, including the frequency with which they are to be 
performed, for monitoring the preventive control; and.
    (b) Monitoring. You must monitor the preventive controls with 
adequate frequency to provide assurance that they are consistently 
performed.
    (c) Records. (1) Requirement to document monitoring. You must 
document the monitoring of preventive controls in accordance with this 
section in records that are subject to verification in accordance with 
Sec.  117.155(a)(2) and records review in accordance with Sec.  
117.165(a)(4)(i).
    (2) Exception records. (i) Records of refrigeration temperature 
during storage of food that requires time/temperature control to 
significantly minimize or prevent the growth of, or toxin production 
by, pathogens may be affirmative records demonstrating temperature is 
controlled or exception records demonstrating loss of temperature 
control.
    (ii) Exception records may be adequate in circumstances other than 
monitoring of refrigeration temperature.


Sec.  117.150  Corrective actions and corrections.

    (a) Corrective action procedures. As appropriate to the nature of 
the hazard and the nature of the preventive control, except as provided 
by paragraph (c) of this section:
    (1) You must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented, including procedures to address, as appropriate:
    (i) The presence of a pathogen or appropriate indicator organism in 
a ready-to-eat product detected as a result of product testing 
conducted in accordance with Sec.  117.165(a)(2); and
    (ii) The presence of an environmental pathogen or appropriate 
indicator organism detected through the environmental monitoring 
conducted in accordance with Sec.  117.165(a)(3).
    (2) The corrective action procedures must describe the steps to be 
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem 
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken, when necessary, to reduce the 
likelihood that the problem will recur;
    (iii) All affected food is evaluated for safety; and
    (iv) All affected food is prevented from entering into commerce, if 
you cannot ensure that the affected food is not adulterated under 
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded 
under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
    (b) Corrective action in the event of an unanticipated food safety 
problem. (1) Except as provided by paragraph (c) of this section, you 
are subject to the requirements of paragraphs (b)(2) of this section if 
any of the following circumstances apply:
    (i) A preventive control is not properly implemented and a 
corrective action procedure has not been established;
    (ii) A preventive control, combination of preventive controls, or 
the food safety plan as a whole is found to be ineffective; or
    (iii) A review of records in accordance with Sec.  117.165(a)(4) 
finds that the records are not complete, the activities conducted did 
not occur in accordance with the food safety plan, or appropriate 
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this 
section apply, you must:
    (i) Take corrective action to identify and correct the problem, 
reduce the likelihood that the problem will recur, evaluate all 
affected food for safety, and, as necessary, prevent affected food from 
entering commerce as would be done following a corrective action 
procedure under paragraphs (a)(2)(i) through (iv) of this section; and
    (ii) When appropriate, reanalyze the food safety plan in accordance 
with Sec.  117.170 to determine whether modification of the food safety 
plan is required.
    (c) Corrections. You do not need to comply with the requirements of 
paragraphs (a) and (b) of this section if:
    (1) You take action, in a timely manner, to identify and correct 
conditions and practices that are not consistent with the food allergen 
controls in Sec.  117.135(c)(2)(i) or the sanitation controls in Sec.  
117.135(c)(3)(i) or (ii); or
    (2) You take action, in a timely manner, to identify and correct a 
minor

[[Page 56158]]

and isolated problem that does not directly impact product safety.
    (d) Records. All corrective actions (and, when appropriate, 
corrections) taken in accordance with this section must be documented 
in records. These records are subject to verification in accordance 
with Sec.  117.155(a)(3) and records review in accordance with Sec.  
117.165(a)(4)(i).


Sec.  117.155  Verification.

    (a) Verification activities. Verification activities must include, 
as appropriate to the nature of the preventive control and its role in 
the facility's food safety system:
    (1) Validation in accordance with Sec.  117.160.
    (2) Verification that monitoring is being conducted as required by 
Sec.  117.140 (and in accordance with Sec.  117.145).
    (3) Verification that appropriate decisions about corrective 
actions are being made as required by Sec.  117.140 (and in accordance 
with Sec.  117.150).
    (4) Verification of implementation and effectiveness in accordance 
with Sec.  117.165; and
    (5) Reanalysis in accordance with Sec.  117.170.
    (b) Documentation. All verification activities conducted in 
accordance with this section must be documented in records.


Sec.  117.160  Validation.

    (a) You must validate that the preventive controls identified and 
implemented in accordance with Sec.  117.135 are adequate to control 
the hazard as appropriate to the nature of the preventive control and 
its role in the facility's food safety system.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a preventive controls 
qualified individual:
    (i)(A) Prior to implementation of the food safety plan; or
    (B) When necessary to demonstrate the control measures can be 
implemented as designed:
    (1) Within 90 calendar days after production of the applicable food 
first begins; or
    (2) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 calendar days 
after production of the applicable food first begins;
    (ii) Whenever a change to a control measure or combination of 
control measures could impact whether the control measure or 
combination of control measures, when properly implemented, will 
effectively control the hazards; and
    (iii) Whenever a reanalysis of the food safety plan reveals the 
need to do so;
    (2) Must include obtaining and evaluating scientific and technical 
evidence (or, when such evidence is not available or is inadequate, 
conducting studies) to determine whether the preventive controls, when 
properly implemented, will effectively control the hazards; and
    (c) You do not need to validate:
    (1) The food allergen controls in Sec.  117.135(c)(2);
    (2) The sanitation controls in Sec.  117.135(c)(3);
    (3) The recall plan in Sec.  117.139;
    (4) The supply-chain program in subpart G of this part; and
    (5) Other preventive controls, if the preventive controls qualified 
individual prepares (or oversees the preparation of) a written 
justification that validation is not applicable 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.


Sec.  117.165  Verification of implementation and effectiveness.

    (a) Verification activities. You must verify that the preventive 
controls are consistently implemented and are effectively and 
significantly minimizing or preventing the hazards. To do so you must 
conduct activities that include the following, as appropriate to the 
facility, the food, and the nature of the preventive control and its 
role in the facility's food safety system:
    (1) Calibration of process monitoring instruments and verification 
instruments (or checking them for accuracy);
    (2) Product testing, for a pathogen (or appropriate indicator 
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for 
an appropriate indicator organism, if contamination of a ready-to-eat 
food with an environmental pathogen is a hazard requiring a preventive 
control, by collecting and testing environmental samples; and
    (4) Review of the following records within the specified 
timeframes, by (or under the oversight of) a preventive controls 
qualified individual, to ensure that the records are complete, the 
activities reflected in the records occurred in accordance with the 
food safety plan, the preventive controls are effective, and 
appropriate decisions were made about corrective actions:
    (i) Records of monitoring and corrective action records within 7 
working days after the records are created or within a reasonable 
timeframe, provided that the preventive controls qualified individual 
prepares (or oversees the preparation of) a written justification for a 
timeframe that exceeds 7 working days; and
    (ii) Records of calibration, testing (e.g., product testing, 
environmental monitoring), supplier and supply-chain verification 
activities, and other verification activities within a reasonable time 
after the records are created; and
    (5) Other activities appropriate for verification of implementation 
and effectiveness.
    (b) Written procedures. As appropriate to the facility, the food, 
the nature of the preventive control, and the role of the preventive 
control in the facility's food safety system, you must establish and 
implement written procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring 
instruments and verification instruments (or checking them for 
accuracy) as required by paragraph (a)(1) of this section.
    (2) Product testing as required by paragraph (a)(2) of this 
section. Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including 
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of 
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.  
117.150(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of 
this section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected 
and the number of sites to be tested during routine environmental 
monitoring. The number and location of sampling sites must be adequate 
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing 
samples. The timing and frequency for collecting and testing samples 
must be adequate to determine whether preventive controls are 
effective;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;

[[Page 56159]]

    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.  
117.150(a)(1).


Sec.  117.170  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan as a 
whole at least once every 3 years;
    (b) You must conduct a reanalysis of the food safety plan as a 
whole, or the applicable portion of the food safety plan:
    (1) Whenever a significant change in the activities conducted at 
your facility creates a reasonable potential for a new hazard or 
creates a significant increase in a previously identified hazard;
    (2) Whenever you become aware of new information about potential 
hazards associated with the food;
    (3) Whenever appropriate after an unanticipated food safety problem 
in accordance with Sec.  117.150(b); and
    (4) Whenever you find that a preventive control, combination of 
preventive controls, or the food safety plan as a whole is ineffective.
    (c) You must complete the reanalysis required by paragraphs (a) and 
(b) of this section and validate, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
any additional preventive controls needed to address the hazard 
identified:
    (1) Before any change in activities (including any change in 
preventive control) at the facility is operative; or
    (2) When necessary to demonstrate the control measures can be 
implemented as designed:
    (i) Within 90 calendar days after production of the applicable food 
first begins; or
    (ii) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90-calendar days 
after production of the applicable food first begins.
    (d) You must revise the written food safety plan if a significant 
change in the activities conducted at your facility creates a 
reasonable potential for a new hazard or a significant increase in a 
previously identified hazard or document the basis for the conclusion 
that no revisions are needed.
    (e) A preventive controls qualified individual must perform (or 
oversee) the reanalysis.
    (f) You must conduct a reanalysis of the food safety plan when FDA 
determines it is necessary to respond to new hazards and developments 
in scientific understanding.


Sec.  117.180  Requirements applicable to a preventive controls 
qualified individual and a qualified auditor.

    (a) One or more preventive controls qualified individuals must do 
or oversee the following:
    (1) Preparation of the food safety plan (Sec.  117.126(a)(2));
    (2) Validation of the preventive controls (Sec.  117.160(b)(1));
    (3) Written justification for validation to be performed in a 
timeframe that exceeds the first 90 calendar days of production of the 
applicable food;
    (4) Determination that validation is not required (Sec.  
117.160(c)(5));
    (5) Review of records (Sec.  117.165(a)(4));
    (6) Written justification for review of records of monitoring and 
corrective actions within a timeframe that exceeds 7 working days;
    (7) Reanalysis of the food safety plan (Sec.  117.170(d)); and
    (8) Determination that reanalysis can be completed, and additional 
preventive controls validated, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
in a timeframe that exceeds the first 90 calendar days of production of 
the applicable food.
    (b) A qualified auditor must conduct an onsite audit (Sec.  
117.435(a)).
    (c)(1) To be a preventive controls qualified individual, the 
individual must have 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 FDA or be otherwise qualified through job experience to develop and 
apply a food safety system. Job experience may qualify an individual to 
perform these functions if such experience has provided an individual 
with knowledge at least equivalent to that provided through the 
standardized curriculum. This individual may be, but is not required to 
be, an employee of the facility.
    (2) To be a qualified auditor, a qualified individual must have 
technical expertise obtained through education, training, or experience 
(or a combination thereof) necessary to perform the auditing function.
    (d) All applicable training in the development and application of 
risk-based preventive controls must be documented in records, including 
the date of the training, the type of training, and the person(s) 
trained.


Sec.  117.190  Implementation records required for this subpart.

    (a) You must establish and maintain the following records 
documenting implementation of the food safety plan:
    (1) Documentation, as required by Sec.  117.136(b), of the basis 
for not establishing a preventive control in accordance with Sec.  
117.136(a);
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable, 
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification 
instruments;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (5) Records that document the supply-chain program; and
    (6) Records that document applicable training for the preventive 
controls qualified individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to 
the requirements of subpart F of this part.

Subpart D--Modified Requirements


Sec.  117.201  Modified requirements that apply to a qualified 
facility.

    (a) Attestations to be submitted. A qualified facility must submit 
the following attestations to FDA:
    (1) An attestation that the facility is a qualified facility as 
defined in Sec.  117.3. For the purpose of determining whether a 
facility satisfies the definition of qualified facility, the baseline 
year for calculating the adjustment for inflation is 2011; and
    (2)(i) An attestation that you have identified the potential 
hazards associated with the food being produced, are implementing 
preventive controls to address the hazards, and are monitoring the 
performance of the preventive controls to ensure that such controls are 
effective; or
    (ii) An attestation that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries, including 
an attestation based on licenses, inspection reports, certificates, 
permits, credentials, certification by an appropriate agency (such as a 
State department of agriculture), or other evidence of oversight.
    (b) Procedure for submission. The attestations required by 
paragraph (a) of this section must be submitted to FDA by one of the 
following means:
    (1) Electronic submission. To submit electronically, go to http://
www.fda.gov/

[[Page 56160]]

furls and follow the instructions. This Web site is available from 
wherever the Internet is accessible, including libraries, copy centers, 
schools, and Internet cafes. FDA encourages electronic submission.
    (2) Submission by mail. (i) You must use Form FDA 3942a. You may 
obtain a copy of this form by any of the following mechanisms:
    (A) Download it from http://www.fda.gov/pchfrule;
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5100 
Paint Branch Parkway, College Park, MD 20550; or
    (C) Request a copy of this form by phone at 1-800-216-7331 or 301-
575-0156.
    (ii) Send a paper Form FDA 3942a to the U.S. Food and Drug 
Administration (HFS-681), 5100 Paint Branch Parkway, College Park, MD 
20550. We recommend that you submit a paper copy only if your facility 
does not have reasonable access to the Internet.
    (c) Frequency of determination of status and submission. (1) A 
facility must determine and document its status as a qualified facility 
on an annual basis no later than July 1 of each calendar year.
    (2) The attestations required by paragraph (a) of this section must 
be:
    (i) Submitted to FDA initially:
    (A) By December 17, 2018, for a facility that begins manufacturing, 
processing, packing, or holding food before September 17, 2018;
    (B) Before beginning operations, for a facility that begins 
manufacturing, processing, packing, or holding food after September 17, 
2018; or
    (C) By July 31 of the applicable calendar year, when the status of 
a facility changes from ``not a qualified facility'' to ``qualified 
facility'' based on the annual determination required by paragraph 
(c)(1) of this section; and
    (ii) Beginning in 2020, submitted to FDA every 2 years during the 
period beginning on October 1 and ending on December 31.
    (3) When the status of a facility changes from ``qualified 
facility'' to ``not a qualified facility'' based on the annual 
determination required by paragraph (c)(1) of this section, the 
facility must notify FDA of that change in status using Form 3942a by 
July 31 of the applicable calendar year.
    (d) Timeframe for compliance with subparts C and G of this part 
when the facility status changes to ``not a qualified facility.'' When 
the status of a facility changes from ``qualified facility'' to ``not a 
qualified facility,'' the facility must comply with subparts C and G of 
this part no later than December 31 of the applicable calendar year 
unless otherwise agreed to by FDA and the facility.
    (e) Notification to consumers. A qualified facility that does not 
submit attestations under paragraph (a)(2)(i) of this section must 
provide notification to consumers as to the name and complete business 
address of the facility where the food was manufactured or processed 
(including the street address or P.O. box, city, state, and zip code 
for domestic facilities, and comparable full address information for 
foreign facilities), as follows:
    (1) If a food packaging label is required, the notification 
required by paragraph (e) of this section must appear prominently and 
conspicuously on the label of the food.
    (2) If a food packaging label is not required, the notification 
required by paragraph (e) of this section must appear prominently and 
conspicuously, at the point of purchase, on a label, poster, sign, 
placard, or documents delivered contemporaneously with the food in the 
normal course of business, or in an electronic notice, in the case of 
Internet sales.
    (f) Records. (1) A qualified facility must maintain those records 
relied upon to support the attestations that are required by paragraph 
(a) of this section.
    (2) The records that a qualified facility must maintain are subject 
to the requirements of subpart F of this part.


Sec.  117.206  Modified requirements that apply to a facility solely 
engaged in the storage of unexposed packaged food.

    (a) If a facility that is solely engaged in the storage of 
unexposed packaged food stores any such refrigerated packaged food that 
requires time/temperature control to significantly minimize or prevent 
the growth of, or toxin production by pathogens, the facility must 
conduct the following activities as appropriate to ensure the 
effectiveness of the temperature controls:
    (1) Establish and implement temperature controls adequate to 
significantly minimize or prevent the growth of, or toxin production 
by, pathogens;
    (2) Monitor the temperature controls with adequate frequency to 
provide assurance that the temperature controls are consistently 
performed;
    (3) If there is a loss of temperature control that may impact the 
safety of such refrigerated packaged food, take appropriate corrective 
actions to:
    (i) Correct the problem and reduce the likelihood that the problem 
will recur;
    (ii) Evaluate all affected food for safety; and
    (iii) Prevent the food from entering commerce, if you cannot ensure 
the affected food is not adulterated under section 402 of the Federal 
Food, Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented 
by:
    (i) Calibrating temperature monitoring and recording devices (or 
checking them for accuracy);
    (ii) Reviewing records of calibration within a reasonable time 
after the records are created; and
    (iii) Reviewing records of monitoring and corrective actions taken 
to correct a problem with the control of temperature within 7 working 
days after the records are created or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7 working days;
    (5) Establish and maintain the following records:
    (i) Records (whether affirmative records demonstrating temperature 
is controlled or exception records demonstrating loss of temperature 
control) documenting the monitoring of temperature controls for any 
such refrigerated packaged food;
    (ii) Records of corrective actions taken when there is a loss of 
temperature control that may impact the safety of any such refrigerated 
packaged food; and
    (iii) Records documenting verification activities.
    (b) The records that a facility must establish and maintain under 
paragraph (a)(5) of this section are subject to the requirements of 
subpart F of this part.

Subpart E--Withdrawal of a Qualified Facility Exemption


Sec.  117.251  Circumstances that may lead FDA to withdraw a qualified 
facility exemption.

    (a) FDA may withdraw a qualified facility exemption under Sec.  
117.5(a):
    (1) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public 
health and prevent or mitigate a foodborne illness outbreak based on 
conditions or conduct associated with the qualified facility that are 
material to the safety of the food manufactured, processed, packed, or 
held at such facility.
    (b) Before FDA issues an order to withdraw a qualified facility 
exemption, FDA:
    (1) May consider one or more other actions to protect the public 
health or

[[Page 56161]]

mitigate a foodborne illness outbreak, including a warning letter, 
recall, administrative detention, suspension of registration, refusal 
of food offered for import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the 
facility, in writing, of circumstances that may lead FDA to withdraw 
the exemption, and provide an opportunity for the owner, operator, or 
agent in charge of the facility to respond in writing, within 15 
calendar days of the date of receipt of the notification, to FDA's 
notification; and
    (3) Must consider the actions taken by the facility to address the 
circumstances that may lead FDA to withdraw the exemption.


Sec.  117.254  Issuance of an order to withdraw a qualified facility 
exemption.

    (a) An FDA District Director in whose district the qualified 
facility is located (or, in the case of a foreign facility, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition), or an FDA official senior to either such Director, 
must approve an order to withdraw the exemption before the order is 
issued.
    (b) Any officer or qualified employee of FDA may issue an order to 
withdraw the exemption after it has been approved in accordance with 
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.


Sec.  117.257  Contents of an order to withdraw a qualified facility 
exemption.

    An order to withdraw a qualified facility exemption under Sec.  
117.5(a) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to one or both of the following 
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the facility; or
    (2) Conditions or conduct associated with a qualified facility that 
are material to the safety of the food manufactured, processed, packed, 
or held at such facility.
    (d) A statement that the facility must either:
    (1) Comply with subparts C and G of this part on the date that is 
120 calendar days after the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  117.264.
    (e) A statement that a facility may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec.  
117.287.
    (f) The text of section 418(l) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this 
chapter, with certain exceptions described in Sec.  117.270;
    (h) The mailing address, telephone number, email address, and 
facsimile number of the FDA district office and the name of the FDA 
District Director in whose district the facility is located (or, in the 
case of a foreign facility, the same information for the Director of 
the Office of Compliance in the Center for Food Safety and Applied 
Nutrition); and
    (i) The name and the title of the FDA representative who approved 
the order.


Sec.  117.260  Compliance with, or appeal of, an order to withdraw a 
qualified facility exemption.

    (a) If you receive an order under Sec.  117.254 to withdraw a 
qualified facility exemption, you must either:
    (1) Comply with applicable requirements of this part within 120 
calendar days of the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec.  117.264.
    (b) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner of Food and Drugs, as a matter of discretion, determines 
that delay or a stay is in the public interest.
    (c) If you appeal the order, and FDA confirms the order:
    (1) You must comply with applicable requirements of this part 
within 120 calendar days of the date of receipt of the order, or within 
a reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; and
    (2) You are no longer subject to the modified requirements in Sec.  
117.201.


Sec.  117.264  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw a qualified facility exemption, 
you must:
    (1) Submit the appeal in writing to the FDA District Director in 
whose district the facility is located (or, in the case of a foreign 
facility, the Director of the Office of Compliance in the Center for 
Food Safety and Applied Nutrition), at the mailing address, email 
address, or facsimile number identified in the order within 15 calendar 
days of the date of receipt of confirmation of the order;
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which you rely.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec.  117.5(a), you may include a written request for an 
informal hearing as provided in Sec.  117.267.


Sec.  117.267  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
your written appeal submitted in accordance with Sec.  117.264 within 
15 calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, written notice of the determination will be given to you 
explaining the reason for the denial.


Sec.  117.270  Requirements applicable to an informal hearing.

    If you request an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon 
in writing by you and FDA.
    (b) The presiding officer may require that a hearing conducted 
under this subpart be completed within 1-calendar day, as appropriate.

[[Page 56162]]

    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec.  117.254 and 
117.257, rather than the notice under Sec.  16.22(a) of this chapter, 
provides notice of opportunity for a hearing under this section and is 
part of the administrative record of the regulatory hearing under Sec.  
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA District Director (or, in the case of a foreign facility, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition) as provided in the order withdrawing an exemption.
    (3) Section 117.274, rather than Sec.  16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a 
written report of the hearing. All written material presented at the 
hearing will be attached to the report. The presiding officer must 
include as part of the report of the hearing a finding on the 
credibility of witnesses (other than expert witnesses) whenever 
credibility is a material issue, and must include a proposed decision, 
with a statement of reasons. The hearing participant may review and 
comment on the presiding officer's report within 2-calendar days of 
issuance of the report. The presiding officer will then issue the final 
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report 
of the hearing and any comments on the report by the hearing 
participant under Sec.  117.270(c)(4) are part of the administrative 
record.
    (6) No party shall have the right, under Sec.  16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under a regulation in accordance with part 16 of 
this chapter, except that Sec.  16.95(b) of this chapter does not apply 
to a hearing under this subpart. With respect to a regulatory hearing 
under this subpart, the administrative record of the hearing specified 
in Sec. Sec.  16.80(a)(1) through (3) and (a)(5) of this chapter and 
117.270(c)(5) constitutes the exclusive record for the presiding 
officer's final decision. For purposes of judicial review under Sec.  
10.45 of this chapter, the record of the administrative proceeding 
consists of the record of the hearing and the presiding officer's final 
decision.


Sec.  117.274  Presiding officer for an appeal and for an informal 
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an FDA Regional Food and Drug Director or another FDA official 
senior to an FDA District Director.


Sec.  117.277  Timeframe for issuing a decision on an appeal.

    (a) If you appeal the order without requesting a hearing, the 
presiding officer must issue a written report that includes a final 
decision confirming or revoking the withdrawal by the 10th calendar day 
after the appeal is filed.
    (b) If you appeal the order and request an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is 
held, the presiding officer must provide a 2-calendar day opportunity 
for the hearing participants to review and submit comments on the 
report of the hearing under Sec.  117.270(c)(4), and must issue a final 
decision within 10-calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.


Sec.  117.280  Revocation of an order to withdraw a qualified facility 
exemption.

    An order to withdraw a qualified facility exemption is revoked if:
    (a) You appeal the order and request an informal hearing, FDA 
grants the request for an informal hearing, and the presiding officer 
does not confirm the order within the 10-calendar days after the 
hearing, or issues a decision revoking the order within that time; or
    (b) You appeal the order and request an informal hearing, FDA 
denies the request for an informal hearing, and FDA does not confirm 
the order within the 10-calendar days after the appeal is filed, or 
issues a decision revoking the order within that time; or
    (c) You appeal the order without requesting an informal hearing, 
and FDA does not confirm the order within the 10-calendar days after 
the appeal is filed, or issues a decision revoking the order within 
that time.


Sec.  117.284  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.


Sec.  117.287  Reinstatement of a qualified facility exemption that was 
withdrawn.

    (a) If the FDA District Director in whose district your facility is 
located (or, in the case of a foreign facility, the Director of the 
Office of Compliance in the Center for Food Safety and Applied 
Nutrition) determines that a facility has adequately resolved any 
problems with the conditions and conduct that are material to the 
safety of the food manufactured, processed, packed, or held at the 
facility and that continued withdrawal of the exemption is not 
necessary to protect public health and prevent or mitigate a foodborne 
illness outbreak, the FDA District Director in whose district your 
facility is located (or, in the case of a foreign facility, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition) will, on his own initiative or on the request of a 
facility, reinstate the exemption.
    (b) You may ask FDA to reinstate an exemption that has been 
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in 
whose district your facility is located (or, in the case of a foreign 
facility, the Director of the Office of Compliance in the Center for 
Food Safety and Applied Nutrition); and
    (2) Present data and information to demonstrate that you have 
adequately resolved any problems with the conditions and conduct that 
are material to the safety of the food manufactured, processed, packed, 
or held at your facility, such that continued withdrawal of the 
exemption is not necessary to protect public health and prevent or 
mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  117.251(a)(1) and 
FDA later determines, after finishing the active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
your facility, FDA will reinstate your exemption under Sec.  117.5(a), 
and FDA will notify you in writing that your exempt status has been 
reinstated.
    (d) If your exemption was withdrawn under both Sec.  117.251(a)(1) 
and (2) and FDA later determines, after finishing the active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to your facility, FDA will inform you of this finding, 
and you may ask FDA to reinstate your exemption under Sec.  117.5(a) in 
accordance with the requirements of paragraph (b) of this section.

[[Page 56163]]

Subpart F--Requirements Applying to Records That Must Be 
Established and Maintained


Sec.  117.301  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
all records required by this part are subject to all requirements of 
this subpart.
    (b) The requirements of Sec.  117.310 apply only to the written 
food safety plan.
    (c) The requirements of Sec.  117.305(b), (d), (e), and (f) do not 
apply to the records required by Sec.  117.201.


Sec.  117.305  General requirements applying to records.

    Records must:
    (a) Be kept as original records, true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records), or electronic records;
    (b) Contain the actual values and observations obtained during 
monitoring and, as appropriate, during verification activities;
    (c) Be accurate, indelible, and legible;
    (d) Be created concurrently with performance of the activity 
documented;
    (e) Be as detailed as necessary to provide history of work 
performed; and
    (f) Include:
    (1) Information adequate to identify the plant or facility (e.g., 
the name, and when necessary, the location of the plant or facility);
    (2) The date and, when appropriate, the time of the activity 
documented;
    (3) The signature or initials of the person performing the 
activity; and
    (4) Where appropriate, the identity of the product and the lot 
code, if any.
    (g) Records that are established or maintained to satisfy the 
requirements of this part and that meet the definition of electronic 
records in Sec.  11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.


Sec.  117.310  Additional requirements applying to the food safety 
plan.

    The owner, operator, or agent in charge of the facility must sign 
and date the food safety plan:
    (a) Upon initial completion; and
    (b) Upon any modification.


Sec.  117.315  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the 
plant or facility for at least 2 years after the date they were 
prepared.
    (2) Records that a facility relies on during the 3-year period 
preceding the applicable calendar year to support its status as a 
qualified facility must be retained at the facility as long as 
necessary to support the status of a facility as a qualified facility 
during the applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained by the facility for at least 
2 years after their use is discontinued (e.g., because the facility has 
updated the written food safety plan (Sec.  117.126) or records that 
document validation of the written food safety plan (Sec.  
117.155(b)));
    (c) Except for the food safety plan, offsite storage of records is 
permitted if such records can be retrieved and provided onsite within 
24 hours of request for official review. The food safety plan must 
remain onsite. Electronic records are considered to be onsite if they 
are accessible from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the 
food safety plan may be transferred to some other reasonably accessible 
location but must be returned to the plant or facility within 24 hours 
for official review upon request.


Sec.  117.320  Requirements for official review.

    All records required by this part must be made promptly available 
to a duly authorized representative of the Secretary of Health and 
Human Services for official review and copying upon oral or written 
request.


Sec.  117.325  Public disclosure.

    Records obtained by FDA in accordance with this part are subject to 
the disclosure requirements under part 20 of this chapter.


Sec.  117.330  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this subpart. Existing 
records may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this subpart.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part may be kept 
either separately or combined with the existing records.


Sec.  117.335  Special requirements applicable to a written assurance.

    (a) Any written assurance required by this part must contain the 
following elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) The applicable assurance under:
    (i) Section 117.136(a)(2);
    (ii) Section 117.136(a)(3);
    (iii) Section 117.136(a)(4);
    (iv) Section 117.430(c)(2);
    (v) Section 117.430(d)(2); or
    (vi) Section 117.430(e)(2);
    (b) A written assurance required under Sec.  117.136(a)(2), (3), or 
(4) must include:
    (1) Acknowledgement that the facility that provides the written 
assurance assumes legal responsibility to act consistently with the 
assurance and document its actions taken to satisfy the written 
assurance; and
    (2) Provision that if the assurance is terminated in writing by 
either entity, responsibility for compliance with the applicable 
provisions of this part reverts to the manufacturer/processor as of the 
date of termination.

Subpart G--Supply-Chain Program


Sec.  117.405  Requirement to establish and implement a supply-chain 
program.

    (a)(1) Except as provided by paragraphs (a)(2) and (3) of this 
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other 
ingredients for which the receiving facility has identified a hazard 
requiring a supply-chain-applied control.
    (2) A receiving facility that is an importer, is in compliance with 
the foreign supplier verification program requirements under part 1, 
subpart L of this chapter, and has documentation of verification 
activities conducted under Sec.  1.506(e) of this chapter (which 
provides assurance that the hazards requiring a supply-chain-applied 
control for the raw material or other ingredient have been 
significantly minimized or prevented) need not conduct supplier 
verification activities for that raw material or other ingredient.
    (3) The requirements in this subpart do not apply to food that is 
supplied for research or evaluation use, provided that such food:
    (i) Is not intended for retail sale and is not sold or distributed 
to the public;
    (ii) Is labeled with the statement ``Food for research or 
evaluation use'';
    (iii) Is supplied in a small quantity that is consistent with a 
research, analysis, or quality assurance purpose,

[[Page 56164]]

the food is used only for this purpose, and any unused quantity is 
properly disposed of; and
    (iv) Is accompanied with documents, in accordance with the practice 
of the trade, stating that the food will be used for research or 
evaluation purposes and cannot be sold or distributed to the public.
    (b) The supply-chain program must be written.
    (c) When a supply-chain-applied control is applied by an entity 
other than the receiving facility's supplier (e.g., when a non-supplier 
applies controls to certain produce (i.e., produce covered by part 112 
of this chapter)), because growing, harvesting, and packing activities 
are under different management), the receiving facility must:
    (1) Verify the supply-chain-applied control; or
    (2) Obtain documentation of an appropriate verification activity 
from another entity, review and assess the entity's applicable 
documentation, and document that review and assessment.


Sec.  117.410  General requirements applicable to a supply-chain 
program.

    (a) The supply-chain program must include:
    (1) Using approved suppliers as required by Sec.  117.420;
    (2) Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity) as 
required by Sec.  117.425;
    (3) Conducting supplier verification activities as required by 
Sec. Sec.  117.430 and 117.435;
    (4) Documenting supplier verification activities as required by 
Sec.  117.475; and
    (5) When applicable, verifying a supply-chain-applied control 
applied by an entity other than the receiving facility's supplier and 
documenting that verification as required by Sec.  117.475, or 
obtaining documentation of an appropriate verification activity from 
another entity, reviewing and assessing that documentation, and 
documenting the review and assessment as required by Sec.  117.475.
    (b) The following are appropriate supplier verification activities 
for raw materials and other ingredients:
    (1) Onsite audits;
    (2) Sampling and testing of the raw material or other ingredient;
    (3) Review of the supplier's relevant food safety records; and
    (4) Other appropriate supplier verification activities based on 
supplier performance and the risk associated with the raw material or 
other ingredient.
    (c) The supply-chain program must provide assurance that a hazard 
requiring a supply-chain-applied control has been significantly 
minimized or prevented.
    (d)(1) Except as provided by paragraph (d)(2) of this section, in 
approving suppliers and determining the appropriate supplier 
verification activities and the frequency with which they are 
conducted, the following must be considered:
    (i) The hazard analysis of the food, including the nature of the 
hazard controlled before receipt of the raw material or other 
ingredient, applicable to the raw material and other ingredients;
    (ii) The entity or entities that will be applying controls for the 
hazards requiring a supply-chain-applied control;
    (iii) Supplier performance, including:
    (A) The supplier's procedures, processes, and practices related to 
the safety of the raw material and other ingredients;
    (B) Applicable FDA food safety regulations and information relevant 
to the supplier's compliance with those regulations, including an FDA 
warning letter or import alert relating to the safety of food and other 
FDA compliance actions related to food safety (or, when applicable, 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States, and information relevant to 
the supplier's compliance with those laws and regulations); and
    (C) The supplier's food safety history relevant to the raw 
materials or other ingredients that the receiving facility receives 
from the supplier, including available information about results from 
testing raw materials or other ingredients for hazards, audit results 
relating to the safety of the food, and responsiveness of the supplier 
in correcting problems; and
    (iv) Any other factors as appropriate and necessary, such as 
storage and transportation practices.
    (2) Considering supplier performance can be limited to the 
supplier's compliance history as required by paragraph (d)(1)(iii)(B) 
of this section, if the supplier is:
    (i) A qualified facility as defined by Sec.  117.3;
    (ii) A farm that grows produce and is not a covered farm under part 
112 of this chapter in accordance with Sec.  112.4(a), or in accordance 
with Sec. Sec.  112.4(b) and 112.5; or
    (iii) A shell egg producer that is not subject to the requirements 
of part 118 of this chapter because it has less than 3,000 laying hens.
    (e) If the owner, operator, or agent in charge of a receiving 
facility determines through auditing, verification testing, document 
review, relevant consumer, customer or other complaints, or otherwise 
that the supplier is not controlling hazards that the receiving 
facility has identified as requiring a supply-chain-applied control, 
the receiving facility must take and document prompt action in 
accordance with Sec.  117.150 to ensure that raw materials or other 
ingredients from the supplier do not cause food that is manufactured or 
processed by the receiving facility to be adulterated under section 402 
of the Federal Food, Drug, and Cosmetic Act or misbranded under section 
403(w) of the Federal Food, Drug, and Cosmetic Act.


Sec.  117.415  Responsibilities of the receiving facility.

    (a)(1) The receiving facility must approve suppliers.
    (2) Except as provided by paragraphs (a)(3) and (4) of this 
section, the receiving facility must determine and conduct appropriate 
supplier verification activities, and satisfy all documentation 
requirements of this subpart.
    (3) An entity other than the receiving facility may do any of the 
following, provided that the receiving facility reviews and assesses 
the entity's applicable documentation, and documents that review and 
assessment:
    (i) Establish written procedures for receiving raw materials and 
other ingredients by the entity;
    (ii) Document that written procedures for receiving raw materials 
and other ingredients are being followed by the entity; and
    (iii) Determine, conduct, or both determine and conduct the 
appropriate supplier verification activities, with appropriate 
documentation.
    (4) The supplier may conduct and document sampling and testing of 
raw materials and other ingredients, for the hazard controlled by the 
supplier, as a supplier verification activity for a particular lot of 
product and provide such documentation to the receiving facility, 
provided that the receiving facility reviews and assesses that 
documentation, and documents that review and assessment.
    (b) For the purposes of this subpart, a receiving facility may not 
accept any of the following as a supplier verification activity:
    (1) A determination by its supplier of the appropriate supplier 
verification activities for that supplier;

[[Page 56165]]

    (2) An audit conducted by its supplier;
    (3) A review by its supplier of that supplier's own relevant food 
safety records; or
    (4) The conduct by its supplier of other appropriate supplier 
verification activities for that supplier within the meaning of Sec.  
117.410(b)(4).
    (c) The requirements of this section do not prohibit a receiving 
facility from relying on an audit provided by its supplier when the 
audit of the supplier was conducted by a third-party qualified auditor 
in accordance with Sec. Sec.  117.430(f) and 117.435.


Sec.  117.420  Using approved suppliers.

    (a) Approval of suppliers. The receiving facility must approve 
suppliers in accordance with the requirements of Sec.  117.410(d), and 
document that approval, before receiving raw materials and other 
ingredients received from those suppliers;
    (b) Written procedures for receiving raw materials and other 
ingredients. (1) Written procedures for receiving raw materials and 
other ingredients must be established and followed;
    (2) The written procedures for receiving raw materials and other 
ingredients must ensure that raw materials and other ingredients are 
received only from approved suppliers (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); and
    (3) Use of the written procedures for receiving raw materials and 
other ingredients must be documented.


Sec.  117.425  Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity).

    Appropriate supplier verification activities (including the 
frequency of conducting the activity) must be determined in accordance 
with the requirements of Sec.  117.410(d).


Sec.  117.430  Conducting supplier verification activities for raw 
materials and other ingredients.

    (a) Except as provided by paragraph (c), (d), or (e) of this 
section, one or more of the supplier verification activities specified 
in Sec.  117.410(b), as determined under Sec.  117.410(d), must be 
conducted for each supplier before using the raw material or other 
ingredient from that supplier and periodically thereafter.
    (b)(1) Except as provided by paragraph (b)(2) of this section, when 
a hazard in a raw material or other ingredient will be controlled by 
the supplier and is one for which there is a reasonable probability 
that exposure to the hazard will result in serious adverse health 
consequences or death to humans:
    (i) The appropriate supplier verification activity is an onsite 
audit of the supplier; and
    (ii) The audit must be conducted before using the raw material or 
other ingredient from the supplier and at least annually thereafter.
    (2) The requirements of paragraph (b)(1) of this section do not 
apply if there is a written determination that other verification 
activities and/or less frequent onsite auditing of the supplier provide 
adequate assurance that the hazards are controlled.
    (c) If a supplier is a qualified facility as defined by Sec.  
117.3, the receiving facility does not need to comply with paragraphs 
(a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the supplier is a qualified 
facility as defined by Sec.  117.3:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
supplier is producing the raw material or other ingredient in 
compliance with applicable FDA food safety regulations (or, when 
applicable, relevant laws and regulations of a country whose food 
safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States). The written 
assurance must include either:
    (i) A brief description of the preventive controls that the 
supplier is implementing to control the applicable hazard in the food; 
or
    (ii) A statement that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries.
    (d) If a supplier is a farm that grows produce and is not a covered 
farm under part 112 of this chapter in accordance with Sec.  112.4(a), 
or in accordance with Sec. Sec.  112.4(b) and 112.5, the receiving 
facility does not need to comply with paragraphs (a) and (b) of this 
section for produce that the receiving facility receives from the farm 
as a raw material or other ingredient if the receiving facility:
    (1) Obtains written assurance that the raw material or other 
ingredient provided by the supplier is not subject to part 112 of this 
chapter in accordance with Sec.  112.4(a), or in accordance with 
Sec. Sec.  112.4(b) and 112.5:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
farm acknowledges that its food is subject to section 402 of the 
Federal Food, Drug, and Cosmetic Act (or, when applicable, that its 
food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States).
    (e) If a supplier is a shell egg producer that is not subject to 
the requirements of part 118 of this chapter because it has less than 
3,000 laying hens, the receiving facility does not need to comply with 
paragraphs (a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the shell eggs produced by the 
supplier are not subject to part 118 because the shell egg producer has 
less than 3,000 laying hens:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
shell egg producer acknowledges that its food is subject to section 402 
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that 
its food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States).
    (f) There must not be any financial conflicts of interests that 
influence the results of the verification activities listed in Sec.  
117.410(b) and payment must not be related to the results of the 
activity.


Sec.  117.435  Onsite audit.

    (a) An onsite audit of a supplier must be performed by a qualified 
auditor.
    (b) If the raw material or other ingredient at the supplier is 
subject to one or more FDA food safety regulations, an onsite audit 
must consider such regulations and include a review of the supplier's 
written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) 
plan or other food safety plan), if any, and its implementation, for 
the hazard being controlled (or, when applicable, an onsite audit may 
consider relevant laws

[[Page 56166]]

and regulations of a country whose food safety system FDA has 
officially recognized as comparable or has determined to be equivalent 
to that of the United States).
    (c)(1) The following may be substituted for an onsite audit, 
provided that the inspection was conducted within 1 year of the date 
that the onsite audit would have been required to be conducted:
    (i) The written results of an appropriate inspection of the 
supplier for compliance with applicable FDA food safety regulations by 
FDA, by representatives of other Federal Agencies (such as the United 
States Department of Agriculture), or by representatives of State, 
local, tribal, or territorial agencies; or
    (ii) For a foreign supplier, the written results of an inspection 
by FDA or the food safety authority of a country whose food safety 
system FDA has officially recognized as comparable or has determined to 
be equivalent to that of the United States.
    (2) For inspections conducted by the food safety authority of a 
country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent, the food that is the subject 
of the onsite audit must be within the scope of the official 
recognition or equivalence determination, and the foreign supplier must 
be in, and under the regulatory oversight of, such country.
    (d) If the onsite audit is solely conducted to meet the 
requirements of this subpart by an audit agent of a certification body 
that is accredited in accordance with regulations in part 1, subpart M 
of this chapter, the audit is not subject to the requirements in those 
regulations.


Sec.  117.475  Records documenting the supply-chain program.

    (a) The records documenting the supply-chain program are subject to 
the requirements of subpart F of this part.
    (b) The receiving facility must review the records listed in 
paragraph (c) of this section in accordance with Sec.  117.165(a)(4).
    (c) The receiving facility must document the following in records 
as applicable to its supply-chain program:
    (1) The written supply-chain program;
    (2) Documentation that a receiving facility that is an importer is 
in compliance with the foreign supplier verification program 
requirements under part 1, subpart L of this chapter, including 
documentation of verification activities conducted under Sec.  1.506(e) 
of this chapter;
    (3) Documentation of the approval of a supplier;
    (4) Written procedures for receiving raw materials and other 
ingredients;
    (5) Documentation demonstrating use of the written procedures for 
receiving raw materials and other ingredients;
    (6) Documentation of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (7) Documentation of the conduct of an onsite audit. This 
documentation must include:
    (i) The name of the supplier subject to the onsite audit;
    (ii) Documentation of audit procedures;
    (iii) The dates the audit was conducted;
    (iv) The conclusions of the audit;
    (v) Corrective actions taken in response to significant 
deficiencies identified during the audit; and
    (vi) Documentation that the audit was conducted by a qualified 
auditor;
    (8) Documentation of sampling and testing conducted as a supplier 
verification activity. This documentation must include:
    (i) Identification of the raw material or other ingredient tested 
(including lot number, as appropriate) and the number of samples 
tested;
    (ii) Identification of the test(s) conducted, including the 
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted and the date 
of the report;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards; 
and
    (vi) Information identifying the laboratory conducting the testing;
    (9) Documentation of the review of the supplier's relevant food 
safety records. This documentation must include:
    (i) The name of the supplier whose records were reviewed;
    (ii) The date(s) of review;
    (iii) The general nature of the records reviewed;
    (iv) The conclusions of the review; and
    (v) Corrective actions taken in response to significant 
deficiencies identified during the review;
    (10) Documentation of other appropriate supplier verification 
activities based on the supplier performance and the risk associated 
with the raw material or other ingredient;
    (11) Documentation of any determination that verification 
activities other than an onsite audit, and/or less frequent onsite 
auditing of a supplier, provide adequate assurance that the hazards are 
controlled when a hazard in a raw material or other ingredient will be 
controlled by the supplier and is one for which there is a reasonable 
probability that exposure to the hazard will result in serious adverse 
health consequences or death to humans;
    (12) The following documentation of an alternative verification 
activity for a supplier that is a qualified facility:
    (i) The written assurance that the supplier is a qualified facility 
as defined by Sec.  117.3, before approving the supplier and on an 
annual basis thereafter; and
    (ii) The written assurance that the supplier is producing the raw 
material or other ingredient in compliance with applicable FDA food 
safety regulations (or, when applicable, relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States);
    (13) The following documentation of an alternative verification 
activity for a supplier that is a farm that supplies a raw material or 
other ingredient and is not a covered farm under part 112 of this 
chapter:
    (i) The written assurance that supplier is not a covered farm under 
part 112 of this chapter in accordance with Sec.  112.4(a), or in 
accordance with Sec. Sec.  112.4(b) and 112.5, before approving the 
supplier and on an annual basis thereafter; and
    (ii) The written assurance that the farm acknowledges that its food 
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act 
(or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States);
    (14) The following documentation of an alternative verification 
activity for a supplier that is a shell egg producer that is not 
subject to the requirements established in part 118 of this chapter 
because it has less than 3,000 laying hens:
    (i) The written assurance that the shell eggs provided by the 
supplier are not subject to part 118 of this chapter because the 
supplier has less than 3,000 laying hens, before approving the supplier 
and on an annual basis thereafter; and
    (ii) The written assurance that the shell egg producer acknowledges 
that its food is subject to section 402 of the Federal Food, Drug, and 
Cosmetic Act (or, when applicable, that its food is subject to relevant 
laws and regulations

[[Page 56167]]

of a country whose safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States);
    (15) The written results of an appropriate inspection of the 
supplier for compliance with applicable FDA food safety regulations by 
FDA, by representatives of other Federal Agencies (such as the United 
States Department of Agriculture), or by representatives from State, 
local, tribal, or territorial agencies, or the food safety authority of 
another country when the results of such an inspection is substituted 
for an onsite audit;
    (16) Documentation of actions taken with respect to supplier non-
conformance;
    (17) Documentation of verification of a supply-chain-applied 
control applied by an entity other than the receiving facility's 
supplier; and
    (18) When applicable, documentation of the receiving facility's 
review and assessment of:
    (i) Applicable documentation from an entity other than the 
receiving facility that written procedures for receiving raw materials 
and other ingredients are being followed;
    (ii) Applicable documentation, from an entity other than the 
receiving facility, of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (iii) Applicable documentation, from an entity other than the 
receiving facility, of conducting the appropriate supplier verification 
activities for raw materials and other ingredients;
    (iv) Applicable documentation, from its supplier, of:
    (A) The results of sampling and testing conducted by the supplier; 
or
    (B) The results of an audit conducted by a third-party qualified 
auditor in accordance with Sec. Sec.  117.430(f) and 117.435; and
    (v) Applicable documentation, from an entity other than the 
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving 
facility's supplier.

PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) 
SYSTEMS

0
17. The authority citation for 21 CFR part 120 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 
381, 393; 42 U.S.C. 241, 242l, 264.


0
18. In Sec.  120.3, revise the first sentence of the introductory text 
to read as follows:


Sec.  120.3  Definitions.

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act, Sec.  101.9(j)(18)(vi) of this chapter, and parts 110 
and 117 of this chapter are applicable to such terms when used in this 
part, except that the definitions and terms in parts 110 and 117 do not 
govern such terms where such terms are redefined in this part and 
except that the terms facility, hazard, and manufacturing/processing in 
parts 110 and 117 do not govern such terms where used in this part. * * 
*
* * * * *

0
19. Revise Sec.  120.5 to read as follows:


Sec.  120.5  Current good manufacturing practice.

    Except as provided by Sec.  117.5(c), parts 110 and 117 of this 
chapter apply in determining whether the facilities, methods, 
practices, and controls used to process juice are safe, and whether the 
food has been processed under sanitary conditions.

0
20. In Sec.  120.6, revise the first sentence of paragraph (b) to read 
as follows:


Sec.  120.6  Sanitation standard operating procedures.

* * * * *
    (b) Monitoring. The processor shall monitor the conditions and 
practices during processing with sufficient frequency to ensure, at a 
minimum, conformance with those conditions and practices specified in 
part 110 of this chapter and in subpart B of part 117 of this chapter 
that are appropriate both to the plant and to the food being processed. 
* * *
* * * * *

PART 123--FISH AND FISHERY PRODUCTS

0
21. The authority citation for 21 CFR part 123 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 
381, 393; 42 U.S.C. 241, 2411, 264.


0
22. In Sec.  123.3, revise the first sentence of the introductory text 
to read as follows:


Sec.  123.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) and in parts 110 and 117 
of this chapter are applicable to such terms when used in this part, 
except that the definitions and terms in parts 110 and 117 do not 
govern such terms where such terms are redefined in this part and 
except that the terms facility, hazard, and manufacturing/processing in 
parts 110 and 117 do not govern such terms where used in this part. * * 
*
* * * * *

0
23. In Sec.  123.5, revise paragraph (a) to read as follows:


Sec.  123.5  Current good manufacturing practice.

    (a) Except as provided by Sec.  117.5(b), parts 110 and 117 of this 
chapter apply in determining whether the facilities, methods, 
practices, and controls used to process fish and fishery products are 
safe, and whether these products have been processed under sanitary 
conditions.
* * * * *

0
24. In Sec.  123.11, revise the introductory text of paragraph (b) to 
read as follows:


Sec.  123.11  Sanitation control procedures.

* * * * *
    (b) Sanitation monitoring. Each processor shall monitor the 
conditions and practices during processing with sufficient frequency to 
ensure, at a minimum, conformance with those conditions and practices 
specified in part 110 of this chapter and in subpart B of part 117 of 
this chapter that are both appropriate to the plant and the food being 
processed and relate to the following:
* * * * *

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

0
25. The authority citation for 21 CFR part 129 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.


0
26. Revise Sec.  129.1 to read as follows:


Sec.  129.1  Current good manufacturing practice.

    The applicable criteria in parts 110 and 117 of this chapter, as 
well as the criteria in Sec. Sec.  129.20, 129.35, 129.37, 129.40, and 
129.80 shall apply in determining whether the facilities, methods, 
practices, and controls used in the processing, bottling, holding, and 
shipping of bottled drinking water are in conformance with or are 
operated or administered in conformity with good manufacturing practice 
to assure that bottled drinking water is safe and that it has been 
processed, bottled, held, and transported under sanitary conditions.

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

0
27. The authority citation for 21 CFR part 179 continues to read as 
follows:


[[Page 56168]]


    Authority:  21 U.S.C. 321, 342, 343, 348, 373, 374.


0
28. In Sec.  179.25, revise paragraph (a) to read as follows:


Sec.  179.25  General provisions for food irradiation.

* * * * *
    (a) Any firm that treats foods with ionizing radiation shall comply 
with the requirements of parts 110 and 117 of this chapter and other 
applicable regulations.
* * * * *

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED 
PHARMACEUTICALS

0
29. The authority citation for 21 CFR part 211 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 
U.S.C. 216, 262, 263a, 264.


0
30. In Sec.  211.1, revise the last sentence in paragraph (c) to read 
as follows:


Sec.  211.1  Scope.

* * * * *
    (c) * * * Therefore, until further notice, regulations under parts 
110 and 117 of this chapter, and where applicable, parts 113 through 
129 of this chapter, shall be applied in determining whether these OTC 
drug products that are also foods are manufactured, processed, packed, 
or held under current good manufacturing practice.

    Dated: August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21920 Filed 9-10-15; 8:45 am]
 BILLING CODE 4164-01-P