[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 56169-56356]
[FR Doc No: 2015-21921]

Vol. 80

Thursday,

No. 180

September 17, 2015

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 11, 16, 117, et al.

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

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 16, 117, 500, 507, and 579

[Docket No. FDA-2011-N-0922]
RIN 0910-AG10

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is adding
regulations for the Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals.
These regulations will, for the first time, establish requirements for
the current good manufacturing practice (CGMP) for food for animals. In
addition, we are adding requirements for certain domestic and foreign
animal food facilities to establish and implement hazard analysis and
risk-based preventive controls for food for animals. We are taking this
action to provide greater assurance that animal food is safe and will
not cause illness or injury to humans and animals and to implement new
statutory provisions in the FDA Food Safety Modernization Act (FSMA).
The rule is intended to build an animal food safety system for the
future that makes modern science- and risk-based preventive controls
the norm across all sectors of the animal food system.

DATES: This rule is effective November 16, 2015, except for paragraph
(2) of the definition of ``qualified auditor'' in Sec.  507.3, and
Sec. Sec.  507.12(a)(1)(ii), 507.105(a)(2), 507.105(c),
507.110(d)(2)(ii), 507.130(d), 507.135(d), 507.175(c)(2), and
507.175(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.  507.3, Sec. Sec.  507.12(a)(1)(ii),
507.105(a)(2), 507.105(c), 507.110(d)(2)(ii), 507.130(d), 507.135(d),
507.175(c)(2), and 507.175(c)(13). Certain provisions have later
compliance dates as discussed in section LIII ``Effective and
Compliance Dates.''

FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
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 Animal Food Preventive
Controls Rule
    C. Summary of the Major Provisions of Proposed Rule for
Preventive Controls for Food for Animals
    D. Draft Risk Assessment
    E. Public Comments
II. Legal Authority
    A. Current Good Manufacturing Practice Regulations
    B. Hazard Analysis and Risk-Based Preventive Controls
III. General Comments on the Proposed Rule
IV. Definitions in the Section 415 Registration Regulations (21 CFR
Part 1, Subpart H)
    A. Definitions That Impact a Determination of Whether an
Establishment Is a ``Farm''
    B. Proposed Revisions to the Definition of Farm
    C. Proposed Revisions to Definitions of Harvesting, Holding,
Manufacturing/Processing, Mixed-Type Facility, and Packing
    D. Comments on Feed Mills Associated With Fully Vertically
Integrated Farming Operations
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. Subpart A: Comments on Proposed Sec.  507.1--Applicability and
Status
    A. Comments on Proposed Sec.  507.1(a)--Applicability
    B. Comments on Proposed Sec.  507.1(b)--Prohibited Act
    C. Comments on Proposed Sec.  507.1(c)--Specific CGMP
Requirements
    D. Comments on Proposed Sec.  507.1(d)--Human Food Facilities
That Manufacture Animal Food
VIII. Subpart A: Comments on Proposed Sec.  507.3--Definitions
    A. Definitions We Proposed To Establish in Part 507
    B. Comments Asking FDA To Establish Additional Definitions or
Otherwise Clarify Terms Not Defined in the Rule
    C. Additional Definitions To Clarify Terms Not Defined in the
Proposed Rule
IX. Subpart A: Comments on Qualifications of Individuals Who
Manufacture, Process, Pack, or Hold Animal Food
    A. Applicability and Qualifications of All Individuals Engaged
in Manufacturing, Processing, Packing, or Holding Animal Food (Final
Sec.  507.4(a), (b), and (d))
    B. Additional Requirements Applicable to Supervisory Personnel
(Final Sec.  507.4(c))
X. Subpart A: Comments on Proposed Sec.  507.5--Exemptions
    A. General Comments on the Proposed Exemptions
    B. Proposed Sec.  507.5(a)--Exemption for Facilities Not
Required To Register Under Section 415 Regulations
    C. Proposed Sec.  507.5(b)--Exemption Applicable to Food Subject
to 21 CFR part 113--Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers
    D. Proposed Sec.  507.5(c)--Exemption Applicable to Activities
Subject to Standards for Produce Safety in Section 419 of the FD&C
Act
    E. Proposed Sec.  507.5(d)--Exemption Applicable to a Qualified
Facility
    F. Proposed Sec.  507.5(e) and (f)--Exemptions Applicable to On-
Farm Low-Risk Activity/Animal Food Combinations Conducted by a Small
or Very Small Business
    G. Proposed Sec.  507.5(g)--Exemption Applicable to Facilities
Solely Engaged in Storage of Raw Agricultural Commodities Other Than
Fruits and Vegetables Intended for Further Distribution or
Processing
    H. Proposed Sec.  507.5(h)--Exemption Applicable to the Holding
or Transportation of One or More Raw Agricultural Commodities
    I. Comments Requesting Additional Exemptions
XI. Subpart A: Comments on Proposed Sec.  507.7--Requirements That
Apply to a Qualified Facility
    A. Comments on Submission of a Certification Statement
    B. General Comments on Requirements That Apply to a Qualified
Facility
    C. Proposed Sec.  507.7(a)--Documentation To Be Submitted
    D. Proposed Sec.  507.7(b)--Procedure for Submission
    E. Proposed Sec.  507.7(c)--Frequency of Determination and
Submission
    F. Proposed Sec.  507.7(d)--Notification to Consumers (Final
Sec.  507.7(e))
    G. Proposed Sec.  507.7(e)--Records (Final Sec.  507.7(f))
XII. Subpart A: Comments on Proposed Sec.  507.10--Applicability of
Part 507 to a Facility Solely Engaged in the Storage of Unexposed
Packaged Animal Food
XIII. Subpart A: Comments on Proposed Sec.  507.12--Applicability of
Part 507 to the Holding and Distribution of Human Food By-Products
for Use as Animal Food
XIV. Subpart B: General Comments on Proposed Subpart B--Current Good
Manufacturing Practice
XV. Subpart B: Comments on Proposed Sec.  507.14--Personnel
    A. Proposed Sec.  507.14(a)(1)--Personal Cleanliness (Final
Sec.  507.14(b)(1))

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

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

    B. Proposed Sec.  507.202--General Requirements Applying to
Records
    C. Proposed Sec.  507.206--Additional Requirements Applying to
the Food Safety Plan
    D. Proposed Sec.  507.208--Requirements for Record Retention
    E. Proposed Sec.  507.212--Use of Existing Records
    F. Final Sec.  507.215--Special Requirements Applicable to a
Written Assurance
XLIX. Comments by Foreign Governments and Foreign Businesses
L. Editorial and Conforming Changes
LI. Comments on FSMA's Rulemaking Provisions
    A. Comments on Section 418(m) of the FDA&C Act Regarding
Modified Requirements for Facilities Solely Engaged in the
Production of Food for Animals Other Than Man
    B. Comments on Requirements in Section 418(n)(3) of the FD&C Act
Regarding Content
LII. Comments on Proposed Conforming Amendments
LIII. Effective and Compliance Dates
    A. Effective and Compliance Dates for Part 507
    B. Effective Dates for Conforming Amendments
    C. Delayed Effective Dates for Provisions That Refer to the
Forthcoming Rules for Produce Safety and Third-Party Certification
LIV. Compliance and Enforcement
LV. Executive Order 13175
LVI. Economic Analysis of Impacts
LVII. Analysis of Environmental Impact
LVIII. Paperwork Reduction Act of 1995
LIX. Federalism
LX. References

Executive Summary

Purpose and Coverage of the Rule

    This rule is part of FDA's implementation of FSMA, which intends to
better protect public (human and animal) health by, among other things,
adopting a modern, preventive, and risk-based approach to food safety
regulation. This rule establishes new requirements for the production
of animal food by registered food facilities in two ways.
    First, this rule creates new CGMP regulations that specifically
address the manufacturing, processing, packing, and holding of food for
animals. These requirements apply to establishments that are required
to register with FDA as a food ``facility.'' Second, this rule creates
new requirements for certain domestic and foreign facilities to
establish and implement hazard analysis and risk-based preventive
controls for food for animals. As with the CGMPs, these requirements
apply to establishments that are required to register with FDA as a
food facility. This portion of the rule requires registered animal 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.
    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 (human and animal) health.

Summary of the Major Provisions of the Rule

    The final rule establishes CGMP provisions to ensure the safety and
suitability of animal food. Specifically, the rule establishes
requirements in the following areas:
     Personnel;
     Plant and grounds;
     Sanitation;
     Water supply and plumbing;
     Equipment and utensils;
     Plant operations;
     Holding and distribution; and
     Holding and distribution of human food by-products for use
as animal food.
    We have added flexibility and clarity to the CGMPs in response to
comments. These CGMPs establish baseline standards for producing safe
animal food that take into consideration the unique aspects of the
animal food industry and provide flexibility for the wide diversity in
types of animal food facilities. In addition, the CGMPs in this final
regulation allow human food facilities subject to and in compliance
with CGMPs for human food and in compliance with all applicable FDA
human food safety requirements to only follow the specific CGMPs for
the holding and distribution of human food by-products for use as
animal food, as long as they do not further process the by-product.
Under this final rule, all other requirements of part 507, including
the hazard analysis, preventive controls and supply-chain program
provisions, would not apply to these by-products of human food
production.
    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 animal food manufactured,
processed, packed, or held at the facility to determine whether 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 animal 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 animal 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
animal 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 an
animal 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 animal 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 animal 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., 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 animal 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 raw agricultural commodities that are rarely consumed
unprocessed, such as soybeans.
    A facility must reanalyze the food safety plan as a whole at least
once every 3 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 an
animal 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 E (Supply-Chain Program).
    Each facility subject to the rule must have a recall plan for an
animal 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 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 sales of     required to:
 <$500,000 and at least half the sales    Notify FDA about its
 to consumers or local retailers or       status and either:
 restaurants (within the same state or   [cir] Notify FDA that it is
 within 275 miles); or                    addressing hazards through
 Very small business, which the   preventive controls and
 rule defines as a business (including    monitoring; or
 any subsidiaries or affiliates)         [cir] Notify FDA that it
 averaging less than $2,500,000,          complies with applicable non-
 adjusted for inflation, per year,        Federal food safety
 during the 3-year period preceding the   regulations, and notify
 applicable calendar year in sales of     consumers of the name and
 animal food plus the market value of     complete business address of
 animal food manufactured, processed,     the facility where the animal
 packed, or held without sale (e.g.,      food was manufactured or
 held for a fee or supplied to a farm     processed.
 without sale)                            The notification is in
                                          the form of an attestation,
                                          and must be submitted every 2
                                          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
                                          are exempt from the
                                          requirements for hazard
                                          analysis and risk-based
                                          preventive controls.
-or-
 Low-risk, on-farm activities    We define the low-risk, on-farm
 performed by a very small business       activities that qualify for
 (dollar threshold of $2,500,000, as      the exemption, including the
 described previously).                   specific animal foods to which
                                          they relate (such as re-
                                          packing roughage products, or
                                          cracking grains).
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.
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) (21       safety.
 U.S.C. 350h).
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 unexposed packaged animal     the storage of unexposed
 food that does not require time/         packaged animal food that
 temperature control to significantly     requires time/temperature
 minimize or prevent the growth of, or    control to significantly
 toxin production by, pathogens.          minimize or prevent the growth
                                          of, or toxin production by,
                                          pathogens.
------------------------------------------------------------------------

    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 (human and
animal) 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.

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 identified as
requiring a preventive control. It also includes requirements for
facilities to institute risk-based environmental monitoring, product
testing, and a supply-chain program as appropriate to the animal 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 costs
are estimated at $139.0 to $170.7 million per year (over 10 years at a
7 percent discount rate), and $135.6 to $166.7 million per year (over
10 years at a 3 percent discount rate). The total annualized benefits
to pets are estimated at $10.1-$138.0 million.

                                       Estimated Total Costs and Benefits
                                                   [Millions]
----------------------------------------------------------------------------------------------------------------
                                                                           Total  annualized   Total  annualized
                                       One-time             Annual          cost at 7% \1\      cost at 3% \1\
----------------------------------------------------------------------------------------------------------------
Total Costs.....................    $135.6 to $160.1    $119.7 to $147.9    $139.0 to $170.7    $135.6 to $166.7
Total Benefits to Pets..........             \2\ N/A     $10.1 to $138.0     $10.1 to $138.0     $10.1 to $138.0
----------------------------------------------------------------------------------------------------------------
\1\ Total annualized cost equal to annualized one-time cost plus annual cost.
\2\ N/A = Not applicable

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

I. Background

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 (human and animal) 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 animal
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 rule  78 FR 64736,
 Practice and Hazard Analysis      for preventive      October 29, 2013.
 and Risk-Based Preventive         controls for
 Controls for Food for Animals.    animal food.

Current Good Manufacturing        2013 proposed rule  78 FR 3646,
 Practice and Hazard Analysis      for preventive      January 16, 2013.
 and Risk-Based Preventive         controls for
 Controls for Human Food.          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.
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.
Focused Mitigation Strategies To  2013 proposed       78 FR 78014,
 Protect Food Against              intentional         December 24,
 Intentional Adulteration.         adulteration rule   2013.
                                   (human food only).
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 58476,
 Practice and Hazard Analysis      notice.             September 29,
 and Risk-Based Preventive                             2014.
 Controls for Food for Animals.
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.
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
(Refs. 1 and 2). As a result of this stakeholder dialogue, FDA decided
to issue the four supplemental notices of proposed rulemaking to share
our 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 Animal Food Preventive Controls
Rule

    With regard to this rulemaking, we published proposed provisions in
the 2013 proposed animal food preventive controls rule and we published
new and re-proposed provisions in the 2014 supplemental notice. In the
2014 supplemental 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 animal food
preventive controls rule'' to refer to the complete proposed regulatory
text, including both the proposed provisions we published in the 2013
proposed animal food preventive controls rule and the new and re-
proposed provisions we published in the 2014 supplemental notice. We
use the narrow terms ``2013 proposed preventive controls rule for
animal food'' and ``2014 supplemental notice'' to refer to specific
text published in the Federal Register of October 29, 2013 (78 FR
64736) and September 29, 2014 (79 FR 58476), respectively. We use the
terms ``final preventive controls rule for animal food'' and ``this
rule'' to refer to the regulations we are establishing as a result of
this rulemaking.

C. Summary of the Major Provisions of Proposed Rule for Preventive
Controls for Food for Animals

    As part of our implementation of new statutory provisions in FSMA,
we proposed to add, in newly established part 507, regulations for
CGMPs. In addition, we proposed to add requirements for certain
domestic and foreign facilities to establish and implement hazard
analysis and risk-based preventive controls for food for animals. As
directed by FSMA (see section 418 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 350g)), these new provisions would
apply to domestic and foreign facilities that are required to register
under section 415 of the FD&C Act (21 U.S.C. 350d) and our regulation
for Registration of Food Facilities (21 CFR part 1, subpart H; the
section 415 registration regulations). As directed by FSMA (see section
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 supplier program, and hazards that may be
intentionally introduced for purposes of economic gain.
    We proposed to establish the requirements for CGMPs, for hazard
analysis and risk-based preventive controls, and related requirements
in new 21 CFR 507 as shown in table 3:

               Table 3--Proposed Subparts in New Part 507
------------------------------------------------------------------------
              Subpart                               Title
------------------------------------------------------------------------
A.................................  General Provisions.
B.................................  Current Good Manufacturing Practice.
C.................................  Hazard Analysis and Risk-Based
                                     Preventive Controls.
D.................................  Withdrawal of an Exemption
                                     Applicable to a Qualified Facility.
E.................................  Reserved.
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
of Risk of Activity/Animal Food Combinations for Activities (Outside
the Farm Definition) Conducted in a Facility Co-Located on a Farm''
(the section 103(c)(1)(C) draft risk assessment (RA)) (78 FR 64428,
October 29, 2013). The purpose of the section 103(c)(1)(C) draft RA was
to provide a science-based risk analysis of those activity/animal 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. 3).

E. Public Comments

    We received more than 2400 public submissions on the 2013 proposed
preventive controls rule for animal food, and more than 140 public
submissions on the 2014 preventive controls supplement notice, each
containing one or more comments. We received submissions from diverse
members of the public, including animal 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; pet owners,
consumer groups; Congress, Federal, State, local, and foreign
Government Agencies; and other organizations. Some submissions included
signatures and statements from multiple individuals. Comments address
virtually every provision of the proposed animal 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
preventive controls rule for animal food.
    Some comments address issues that are outside the scope of this
rule. For example, some comments ask for more inspections of pet food
facilities. Other comments express concern about the use of
bioengineered animal food ingredients, and ask that animal foods
containing such ingredients not be used in pet food. Other comments
have concerns with FDA's general obligations for the outcome of
regulations it issues and implements, general concerns with FDA's
regulation and oversight of industry, concerns about banning specific
products or imports from specific countries, testing procedures at the
borders, and concerns about animal food marketing. 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 FSMA, the FD&C Act, and the Public Health Service Act
(the PHS Act). After considering comments received in response to the
2013 proposed rule and the 2014 supplemental notice, we made changes in
the final rule. The legal authorities relied on for the final rule are
generally the same as in the proposed rule unless otherwise described.

A. Current Good Manufacturing Practice Regulations

    The CGMP regulations finalized in this document establish current
good manufacturing practice requirements for the manufacturing,
processing, packing and holding of animal food. FDA's legal authority
to require current good manufacturing practice derives from sections
402(a)(3) and (4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3) and
(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 CGMP regulations we are establishing
are necessary to prevent animal 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 establishing
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
CGMP regulations are necessary to prevent the spread of communicable
disease.
    The CGMP regulations finalized in this document include limited
labeling requirements. These requirements are partly to help prevent
accidental co-mingling or mix-ups of products at the facility, which
could result in contaminated animal food. Thus, FDA's legal authority
for these requirements derives from its authority to require current
good manufacturing practice. The labeling requirements also are
intended to enable animal producers and owners, and facilities
receiving the animal food for further manufacture, to use the animal
food appropriately. Accordingly, the requirements are supported by
section 403(a)(1) of the FD&C Act, which states that a food is
misbranded if its labeling is false or misleading in any particular,
and by section 403(i) of the FD&C Act, which states that a food is
misbranded unless

its label bears the common or usual name of the food or its
ingredients.

B. 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). . . .'' In
addition to the general requirements in section 418(a) of the FD&C Act,
sections 418(b) to (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) to (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 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)); and 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). In sections X,
XI, XII, and XXXVI we discuss provisions that implement these
exemptions and modified requirements.
    In the supplemental notice, we included potential requirements for
a supplier program, environmental monitoring, and product testing. We
are including provisions for such activities in the final 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 animal 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. An animal 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 animal 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 animal
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 FD&C 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, E and F 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) (21 CFR
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, E and F, under sections 402(a)(3) and (4),
and 701(a) of the FD&C Act to the extent such requirements are
necessary to prevent animal food from being held under insanitary
conditions whereby it may become contaminated with filth or rendered
injurious to health, or being unfit for food. 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.

III. General Comments on the Proposed Rule

    (Comment 1) 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.
Some of these comments request that the guidance be available as soon
as possible and before the rule becomes effective. Some comments
request guidance specific to small businesses. Several comments suggest
FDA revisit some current compliance policy guidances in light of FSMA
and the proposed rules.
    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 hazards should be addressed in food safety plan. Other
comments ask us to engage universities and extension in education and
training efforts.
    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 1) We are developing several guidance documents,
including general guidance on hazard analysis and preventive controls,
as well as guidance for complying with the CGMP requirements of subpart
B (Ref. 4). 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)). In addition, we intend to review
current guidance documents and make a determination whether they need
to be withdrawn or revised based on this final rule.
    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. 5). 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. 5). This will allow us to respond in a timely and
consistent way to industry questions on preventive controls technical
and compliance issues (Ref. 5).
    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 (Refs. 5 and 6).
The Alliance includes members from FDA, State food protection Agencies,
the food (human and animal) 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. 7). Such efforts will help ensure widespread voluntary compliance
by encouraging greater understanding and adoption of established food
safety standards, guidance, and protocols.
    (Comment 2) 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. 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 2) 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. 8). 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. 9).
    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. 10). 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. 10).
    (Comment 3) Some comments ask us to reevaluate the proposed animal
food 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 and ask us why we
proposed to create a separate inspection framework for FSMA, without
integrating that inspection framework with existing programs.
    (Response 3) We decline this request. As previously discussed, we
are establishing this rule as required by section 103 of FSMA (78 FR
64736 at 64743 through 64745 and 64817 through 64818). 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 2 regarding implementation of a
national Integrated Food Safety System.)
    (Comment 4) Some comments ask us to make the various rules we are
establishing to implement FSMA consistent with each other. One comment
specifically asks us to harmonize the human and animal food preventive
controls final rules to avoid confusion by firms that produce both
human and animal food.
    (Response 4) 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.,
packing, holding, and manufacturing/processing) in this rule, the human
food 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 Foreign Supplier Verification Program (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. Except in the circumstance where an
importer is also a manufacturer/processor, an importer must conduct a
hazard analysis as part of the foreign supplier verification
requirements, whereas a facility that is a manufacturer/processor must
conduct a hazard analysis to determine whether the requirements of the
animal food preventive controls rule apply to it. As another example,
section 805 of the FD&C Act does not provide an exemption for small or
very small entities, whereas section 418 of the FD&C Act provides an
exemption for ``qualified facilities,'' which include very small
businesses.
    To the extent possible, we have attempted to harmonize the animal
food preventive controls final rule with the human food preventive
controls final rule. The CGMP (subpart B) requirements address the
manufacturing, processing, packing, and holding practices at animal
food plants, but are similar to those for human food, where
appropriate. Furthermore, Sec.  507.1(d) contains provisions for a
human food facility that also manufactures, processes, packs, or holds
animal food. This is intended to reduce confusion and increase
flexibility for facilities that produce both human and animal food.
    (Comment 5) 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 5) We intend to enforce this rule in a consistent manner
to ensure that imported and domestically produced animal 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 animal
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 (human and
animal) 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 animal 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 animal food destined
for the United States. Mandating that a finished animal food is
manufactured under general methods applicable to all animal foods
(e.g., good manufacturing practices) is a widely accepted regulatory
practice and fundamentally different than mandating that animal food be
produced in a certain way. We note that other countries have adopted
animal food safety regulations that mandate certain principles and
conditions be applied to animal food manufacturing. 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 for human and
animal food, we provided an extensive background discussing the
scientific evidence upon which this rule is based (78 FR 3646 at 3659
through 3667, January 16, 2013 and 78 FR 64736 at 64745, October 29,
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 64736 at 64834
through 64836).
    (Comment 6) Many comments from pet owners are generally supportive
of the rule; however, some request additional regulations and oversight
for pet food. Many comments state that pet food should meet the same
standards as human food. Some comments request that pet food be
required to be tested for safety.
    (Response 6) The CGMP requirements in subpart B are intended to
serve as baseline standards for producing safe animal food across all
types of animal food facilities, including pet food facilities. For
discussion of the relevance of the CGMP requirements to pet food, see
Response 163. Many pet food facilities (as well as facilities producing
other animal food) will be subject to the preventive controls
requirements of subpart C. These provisions require the pet food
manufacturer to identify and evaluate

potential hazards for the pet food to determine whether a preventive
control is required (see Sec.  507.33). These could be hazards to the
pet consuming the pet food or the person handling the pet food (e.g.,
Salmonella). The preventive controls provisions also include
requirements for product testing for pathogens or other hazards and
environmental monitoring for pathogens under certain circumstances (see
Sec.  507.49), in order to help ensure the safety of the pet (animal)
food. Currently, low-acid canned animal food in a hermetically sealed
container (such as canned pet food) is subject to the requirements of
Sec.  500.23 (21 CFR 500.23) and part 113 to control microbiological
hazards.
    (Comment 7) Some comments request communication and coordination
with state regulators throughout the FSMA implementation phase. Some
comments specifically request training of FDA staff and regulatory
partners to inspect animal food facilities because there are
differences between animal food and human food facilities. Some
comments request that inspectors receive training on the broad range of
animal food manufacturing. At least one comment requests we establish a
national advisory committee to provide ongoing input throughout FSMA
implementation and enforcement. Some comments request that we provide
methods for communication with State and other regulatory partners,
including possibly a call center or other direct-contact resource for
regulators and industry to obtain information on FSMA.
    (Response 7) As discussed in Response 1, we are working in
collaboration with the FSPCA to develop training materials and programs
to be used by industry and regulators. The training will be specific to
human or animal food and will include information on developing a food
safety plan tailored to each facility's unique hazards. We will
consider these and other recommendations for the content of such
training as part of that collaborative effort.
    As discussed in Responses 1 and 2, we are working through two
working groups (FSCPA and PFP) that involve State and local regulators
in order to implement this final rule. We will continue to work through
these groups, as well as use other methods of communication and
coordination (e.g., arranged teleconference meetings with the States
(i.e., 50-State calls) to collaborate with State and local regulatory
officials to implement this final rule. We will consider these
recommendations as we communicate with State and local regulatory
partners during the implementation of this final rule.
    (Comment 8) Some comments request that this final rule have a
provision similar to the proposed produce safety rule that allows a
state or foreign country to request a variance from the rule's
requirements due to procedures, processes, and practices that ensure a
product is not adulterated.
    (Response 8) We are implementing these regulations according to the
statutory direction of FSMA. A variance request and review process is
specified for produce in section 419(c)(2) of the FD&C Act; however,
there are no similar provisions in FSMA directing FDA to create a
variance process for facilities subject to the preventive controls
regulations and we therefore are declining to do so.
    (Comment 9) Some comments ask us to take a ``BASE'' approach to
implementing FSMA. These comments describe this approach as follows: B
stands for borders, a critical area where FDA should be focusing its
attention and resources; A stands for audits, recognizing that FDA will
need to actively audit states and foreign suppliers; S stands for
standard, representing the standards FDA will set by which firms will
be audited; and E stands for education, ensuring that all stakeholders
know their roles and responsibilities required by the rules.
    (Response 9) While we do not intend to follow the BASE approach
described in the comment, we expect that some of our implementation
efforts will be similar to the approach described. For discussion of
our implementation planning, see Responses 1 and 2. To the extent this
comment is referring to animal food from foreign suppliers presented
for import, this is a subject of the forthcoming FSVP rule.
    (Comment 10) Some comments requested exceptions or reduced
requirements that were not previously proposed. One comment requests a
narrower scope of requirements for facilities involved in the
production of chemicals used as food additives or in accordance with
generally recognized as safe (GRAS) standards.
    (Response 10) We decline these requests. The CGMPs in subpart B and
preventive controls in subpart C are written to serve as baseline
standards for producing safe animal food across all types of animal
food facilities, including those producing food additives or other
ingredients.

IV. Definitions in the Section 415 Registration Regulations (21 CFR
Part 1, Subpart H)

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

    The 2013 proposed rule for human food preventive controls contained
a description (78 FR 3646 at 3675 through 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. That description 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).
    In the 2014 supplemental human preventive controls notice, comments
were described 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 through 58538).
Additional revisions were proposed 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 America are structured with regard
to their physical location(s) and business models. See table 4 for
revised definitions that are being finalized in the human food
preventive controls for the section 415 registration regulations and
the section 414 recordkeeping regulations.
    In section IV of the final rule for preventive controls for human
food, published elsewhere in this issue of the Federal Register,
comments on the proposed changes to the section 415

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

    Table 4--Revisions to the Proposed Definitions in the Section 415
 Registration Regulations and the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
                  Definition                            Revision
------------------------------------------------------------------------
Farm.........................................   A farm is an
                                                ``operation'' rather
                                                than an
                                                ``establishment.``
                                                There are two
                                                types of farms: (1)
                                                Primary production farm;
                                                and (2) secondary
                                                activities farm.
Primary production farm......................   A primary
                                                production farm is
                                                ``under one management''
                                                rather than ``under one
                                                ownership.''
                                                Although a
                                                primary production farm
                                                continues to be ``in one
                                                general physical
                                                location,'' we have
                                                clarified that ``one
                                                general physical
                                                location is ``not
                                                necessarily
                                                contiguous.''
                                                A primary
                                                production farm is an
                                                operation devoted to the
                                                growing of crops, the
                                                harvesting of crops, the
                                                raising of animals
                                                (including seafood), or
                                                any combination of these
                                                activities. Although
                                                some primary 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 raw agricultural
                                                commodities (RACs), and
                                                packaging and labeling
                                                the treated RACs,
                                                without additional
                                                manufacturing/
                                                processing, is within
                                                the ``farm'' definition.
                                                We added an
                                                example of drying/
                                                dehydrating RACs to
                                                create a distinct
                                                commodity that would
                                                fall within the ``farm''
                                                definition (i.e., drying/
                                                dehydrating grapes to
                                                produce raisins), as
                                                well as an example of
                                                additional manufacturing/
                                                processing that would
                                                cause an operation that
                                                dries/dehydrates RACs to
                                                create a distinct
                                                commodity to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                slicing).
                                                We added an
                                                example of additional
                                                manufacturing/processing
                                                that can cause an
                                                operation that packages
                                                and labels RACs to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                irradiation).
Secondary activities farm....................   A ``secondary
                                                activities farm'' is an
                                                operation, not located
                                                on a primary production
                                                farm, devoted to
                                                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

    In the human food proposed preventive controls rule, 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. See
section IV.B of the final rule for preventive controls for human food,
published elsewhere in this issue of the Federal Register, for a full
discussion of comments and responses on the proposed revisions to the
farm definition.
    In the final rule for preventive controls for human food, published
elsewhere in this issue of the Federal Register, we have revised the
definition of farm to replace the term ``under one ownership'' with the
term ``under one management.'' As discussed in section IV.B of the
final rule for preventive controls for human food, although the
original phrase ``under one ownership'' was not referring to a single
owner, 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. The term ``under one
management'' refers to the control structure of the business, that is,
the management of the business entity that is the farm operation. Thus,
for example, a primary production farm that hires another company as a
contract harvester to perform harvesting services on the primary
production farm's behalf is not ``under one management'' with the
primary production farm just because the primary production farm is
directing the contractor's activities performed on the primary
production farm's behalf. The primary production farm and the contract
harvester have separate and independent management structures because
they are separate and independent businesses. (See Response 25 in the
final rule for preventive controls for human food). As another example,
if a poultry processing company contracts with a primary production
farm to raise chickens on the poultry processor's behalf, the poultry
processor and the primary production farm are not ``under one
management,'' even if their contract strictly controls almost all
aspects of the raising of the poultry. The poultry processor and the
primary production farm have separate and independent management
structures because they are separate and independent businesses.
    In the final rule for preventive controls for human food, we also
revised the farm definition to add a new category: A ``secondary
activities farm.'' (See Response 25 in the final rule for preventive
controls for human food). An important limitation on the types of
operations that fit within this category is that they must be majority
owned (or majority jointly owned) by the primary production farm(s)
that grows, harvests, and/or raises the majority of the RACs the
secondary activities farm harvests, packs, and/or holds. Thus, both
product and majority ownership must link a secondary activities farm to
a primary production farm(s).
    For example, a primary production farm may own a majority interest
in a separate business that holds RACs and processes them into animal
food (e.g., a feed mill). If the majority of the RACs held by the feed
mill come from the primary production farm that owns the feed mill's
majority interest, the feed

mill is a secondary activities farm and may manufacture/process animal
food within the farm definition, but only to the extent that the animal
food manufactured is consumed at the feed mill or on another farm whose
``one management'' is the same management as the feed mill. However, if
the feed mill in this example manufactures/processes animal food that
is consumed on farms that are not under the same management as the feed
mill, that manufacturing/processing is outside the farm definition, the
feed mill is subject to registration under section 415 of the FD&C Act,
and its manufacturing/processing of animal food for consumption on
farms not under the same management is subject to the requirements of
this rule.
    To further clarify, a feed mill that is not majority owned by a
primary production farm(s) cannot be a secondary activities farm. Also,
a feed mill that does not receive more than half of the RACs it holds
from primary production farm(s) that own a majority interest in the
feed mill cannot be a secondary activities farm. For example, a feed
mill owned by a poultry processing company will be required to register
as a food facility, unless the feed mill otherwise meets the definition
of ``farm.'' When a feed mill is owned by a company such as a poultry
processor, it is not majority owned by the primary production farm(s)
that supply the majority of the RACs it holds, and therefore the feed
mill cannot be a secondary activities farm.

C. Proposed Revisions to Definitions of Harvesting, Holding,
Manufacturing/Processing, Mixed-Type Facility, and Packing

    See section VIII. for a discussion of comments and responses and
revisions to the definitions in part 507 of harvesting, holding,
manufacturing/processing, mixed-type facility, and packing. For a
discussion of comments and responses to these definitions in the
section 415 registration regulations and the section 414 recordkeeping
regulations, see section IV.C through IV.G of the final rule for
preventive controls for human food, published elsewhere in this issue
of the Federal Register.

D. Comments on Feed Mills Associated With Fully Vertically Integrated
Farming Operations

    In the 2014 supplemental notice for animal food, we requested
comment on whether feed mills that are part of fully vertically
integrated farming operations, including cooperatives that fit this
model, that meet the farm definition should be required to register
under section 415 of the FD&C Act (and thus would be subject to the
rule). For comments that supported applying the final preventive
controls rule to feed mills that are part of fully vertically
integrated farming operations, we requested input on how the farm
definition should be modified. If they were required to register, we
also requested comment on whether there should be exemptions from
registration under section 415 based on size, such as number of animals
being fed or the amount of animal food being fed (based on tonnage,
monetary value, or some other factor). Lastly, since there would be no
total annual sales figure for the animal food produced by these feed
mills, we requested comment on how to value the animal food being fed
to animals for purposes of determining whether the feed mill would be a
qualified facility (proposed Sec.  507.7) and in particular a very
small business.
    (Comment 11) Some comments generally agree with our recognition
that there are different types of farm models for raising animals but
request additional clarification on what we mean by a fully vertically
integrated farming operation and the depth of integration within an
operation.
    (Response 11) Feed mills that are part of fully vertically
integrated farming operations, or certain cooperative farming
operations that meet the definition of a farm (see Sec.  1.227, as
revised by the final rule for preventive controls for human food
published elsewhere in this Federal Register), are not subject to this
final rule because they are not required to register under section 415
of the FD&C Act (see Sec.  507.5(a)). Because expanding on the
characteristics of a fully integrated farming operation is beyond the
scope of this rule, we decline to further clarify the fully vertically
integrated farming operation farming model discussed in the 2014
supplemental notice.
    (Comment 12) Some comments do not support modifying the farm
definition to subject feed mills that are part of fully vertically
integrated farming operations to the requirements of this final rule.
These comments state that these feed mills are currently making safe
animal food and that some are following industry best practices that
would meet or exceed the requirements of our proposed CGMPs. Some
comments also state that these feed mills are producing a narrower
range of animal food when compared to independent feed mills because
these integrated feed mills typically provide animal food to a single
species and therefore utilize fewer ingredients, resulting in less
chance of harmful error. Some comments note that for large farming
operations, feeding of the animals is overseen by dedicated
individuals, such as a nutritionist, which ensures an extra layer of
oversight for the safety of animal food.
    Some comments express concern that feed mills associated with
contract farming operations (contract feed mills) will be treated
differently because, as proposed in the 2013 proposed rule, they would
need to comply with the rule unlike the feed mills that are part of
fully vertically integrated farming operations. These comments
recommend modifications to the farm definition to incorporate the
contract feed mills into the farm definition, resulting in the contract
feed mills no longer being required to register under section 415 and
therefore no longer being subject to the requirements of this rule.
Some comments (including ones that support and ones that oppose
modifying the farm definition) generally agree there is no evidence
that the safety of animal food varies depending on whether a feed mill
is associated with vertically integrated or contract farming. These
comments also state that the farm definition as proposed has the
potential to create disparity in regulatory requirements that feed
mills must follow based solely on the type of farming model with which
they are associated (i.e., some will be subject to CGMP and preventive
controls requirements, while some will be subject to neither).
    Some comments support modifying the farm definition to subject feed
mills that are part of fully vertically integrated farming operations
to the requirements of this final rule, and some of those comments also
support providing an exclusion if it is limited to small on-farm animal
food mixers. Other comments contend that some of the feed mills that
are part of fully vertically integrated farming operations produce
large volumes of animal food that feed a substantial portion of the
U.S. food-producing animal population and that these feed mills should
be subject to the final rule to ensure continual production of safe
animal food. Some comments state concern that the feed mills that are
part of fully vertically integrated farming operations could introduce
food safety hazards into the human food supply because they are not
being adequately controlled due to the feed mills' exemption from this
rule.
    Comments that support modifying the farm definition to subject feed
mills that are part of fully vertically integrated farming operations
to the requirements of this final rule recommend that any exemption
from this final rule

applicable to farms be limited based on the volume of the animal feed
produced or animal equivalency units.
    (Response 12) The farm definition in 21 CFR part 1 has been
modified based on other comments received to both the 2014 supplemental
notice for human food preventive controls and to the 2014 supplemental
notice for animal food preventive controls (see section IV.B of the
final rule for preventive controls for human food published elsewhere
in this issue of the Federal Register). However, feed mills that are
part of fully vertically integrated farming operations still meet the
definition of farm. As a result, they are not required to register as a
food facility under section 415 and are not subject to the requirements
of this rule including CGMPs (subpart B) and Hazard Analysis and Risk-
Based Preventive Controls (subpart C), and supply-chain program
(subpart E). We remain concerned that this leaves a gap in the
protection of public (human and animal) health because these feed mill
operations manufacture significant amounts of animal food. While some
of these feed mills may be voluntarily implementing some type of animal
food safety measures, not all feed mills that are part of vertically
integrated farming operations do. In addition, the voluntary measures
adopted by some feed mills may not meet the standards of the food
safety requirements in this rule. Moreover, we do not and cannot
enforce compliance with purely voluntary practices. Finally, we
recognize that other feed mills not part of a ``farm'' as defined in
part 1 will have to comply with the requirements of this rule (unless
they qualify for an exemption). As we have previously stated, we do not
have evidence that the safety of animal food varies depending on
whether a feed mill is part of vertically integrated or contract
farming. Therefore, we intend to publish a proposed rule that would
require some feed mill operations that currently are part of a farm to
comply with the CGMPs (subpart B) of this rule.
    The animal food CGMP requirements help ensure that animal food is
protected from contamination during manufacturing, processing, packing,
and holding (see sections XIV to XXII for further discussion of the
animal food CGMP). By implementing these CGMPs, we believe that feed
mills not currently covered by this rule would be able to provide a
baseline level of animal food safety, thus further protecting the
public (human and animal) health. We will continue to review the
comments received from the 2014 supplemental proposed rule and other
available data in considering a proposed rule for feed mills that are
part of fully vertically integrated farming operations that are not
required to register under section 415, but produce a large volume of
animal food. One reason we are not finalizing new food safety
requirements for feed mills that are part of fully integrated farming
operations in this rulemaking is that we need more information to help
guide the scope of the requirements. As part of the future rulemaking
process we will seek input on the best way to subject vertically
integrated feed mills that produce large volumes of animal food to food
safety requirements while avoiding overburdening on-farm feed mixers
that produce a small amount of food for a small number of animals. The
proposed rulemaking would not change the applicability of subpart C,
``Hazard Analysis and Risk-Based Preventive Controls,'' for feed mills
that are part of a farm. Because farms meeting the definition of Sec.
1.227 are not required to register under section 415 of the FD&C Act,
Sec.  507.5(a) exempts them from compliance with subpart C, as required
by FSMA.

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 notice (79 FR 58476 at 58482), we referred
to the 2014 supplemental human preventive controls notice that
discussed comments on the organizing principles that formed the basis
for proposed revisions to section 415 registration regulations and the
section 414 recordkeeping regulations (79 FR 58524 at 58538). We also
explained how its proposed revisions to the ``farm'' definition would
require FDA to reconsider those organizing principles (79 FR 58524 at
58538).
    For discussion of comments, see section V of the final rule for
preventive controls for human food, published elsewhere in this issue
of the Federal Register.

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 64736 at 64751 and 64752
through 64754). Consistent with this statutory direction, we developed
the section 103(c)(1)(C) draft RA and made it available for public
comment (Ref. 11 and 78 FR 64428). We are including the final risk
assessment (the section 103(c)(1)(C) RA) in the docket established for
this document (Ref. 3).
    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 animal foods that
we determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR
64736 at 64751, 64753 through 64754, and 64763 through 64764). In
section X.F, we discuss the provisions we are establishing in Sec.
507.5(e) and (f), 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/animal
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 64736 at 64754) 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 64736 at 64744). 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/animal 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 13) 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. 12), but instead
collect data from large-scale surveys of actual farm mixed-type
facilities and their activities. Other comments ask us to collect,
analyze, and interpret data about the levels of hazards from animal
food samples taken from small and very small mixed-type facilities and
use consumption to estimate the likelihood of exposure to hazards in
animal food from such facilities. Some comments ask us to consult with
subject matter experts to ensure that the final risk assessment
reflects sufficient geographic diversity.
    (Response 13) We have acknowledged the limitations of the section
103(c)(1)(C) draft RA (Ref. 11 and 78 FR 64428; 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 about activity/animal food combinations conducted on farms and
farm mixed-type facilities, including comments from diverse geographic
areas comprising both areas where farms and farm mixed-type facilities
tend to be small and where they tend to be large. 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/
animal food combinations conducted on farms and farm mixed-type
facilities.
    (Comment 14) 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 14) 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 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 animal 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 frequency
requirements under section 421 based solely upon whether a facility