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

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.

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 § 507.3, and §§ 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 § 507.3, §§ 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, 240-402-6246, email:

jenny.murphy@fda.hhs.gov

.

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 § 507.1—Applicability and Status

A. Comments on Proposed § 507.1(a)—Applicability

B. Comments on Proposed § 507.1(b)—Prohibited Act

C. Comments on Proposed § 507.1(c)—Specific CGMP Requirements

D. Comments on Proposed § 507.1(d)—Human Food Facilities That Manufacture Animal Food

VIII. Subpart A: Comments on Proposed § 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 § 507.4(a), (b), and (d))

B. Additional Requirements Applicable to Supervisory Personnel (Final § 507.4(c))

X. Subpart A: Comments on Proposed § 507.5—Exemptions

A. General Comments on the Proposed Exemptions

B. Proposed § 507.5(a)—Exemption for Facilities Not Required To Register Under Section 415 Regulations

C. Proposed § 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 § 507.5(c)—Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act

E. Proposed § 507.5(d)—Exemption Applicable to a Qualified Facility

F. Proposed § 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 § 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 § 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 § 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 § 507.7(a)—Documentation To Be Submitted

D. Proposed § 507.7(b)—Procedure for Submission

E. Proposed § 507.7(c)—Frequency of Determination and Submission

F. Proposed § 507.7(d)—Notification to Consumers (Final § 507.7(e))

G. Proposed § 507.7(e)—Records (Final § 507.7(f))

XII. Subpart A: Comments on Proposed § 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 § 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 § 507.14—Personnel

A. Proposed § 507.14(a)(1)—Personal Cleanliness (Final § 507.14(b)(1))

B. Proposed § 507.14(a)(2)—Hand Washing (Final § 507.14(b)(2))

C. Proposed § 507.14(a)(3)—Unsecured Jewelry and Other Objects (Final § 507.14(b)(3))

D. Proposed § 507.14(a)(4)—Storing Clothing and Personal Belongings (Final § 507.14(b)(4))

E. Proposed § 507.14(a)(5)—Taking Other Necessary Precautions (Final § 507.14(b)(5))

XVI. Subpart B: Comments on Proposed § 507.17—Plant and Grounds

A. Proposed § 507.17(a)—Grounds Surrounding an Animal Food Plant

B. Proposed § 507.17(b)(1)—Adequate Space Between Equipment, Walls, and Stored Materials

C. Proposed § 507.17(b)(2)—Dripping and Condensation

D. Proposed § 507.17(b)(3)—Ventilation

E. Proposed § 507.17(b)(4)—Lighting

F. Proposed § 507.17(b)(5)—Glass

G. Proposed § 507.17(b)(6)—Outdoor Storage

XVII. Subpart B: Comments on Proposed § 507.19—Sanitation

A. Proposed § 507.19(a)—Buildings

B. Proposed § 507.19(b)—Cleaning

C. Proposed § 507.19(b)(1)—Wet Cleaning

D. Proposed § 507.19(b)(2)—Wet Processing

E. Proposed § 507.19(c)—Cleaning Compounds and Sanitizing Agents

F. Proposed § 507.19(d)(1)—Toxic Materials

G. Proposed § 507.19(d)(2)—Identification, Use, and Storage of Toxic Materials

H. Proposed § 507.19(e)—Pest Control

I. Proposed § 507.19(f)—Trash and Garbage

XVIII. Subpart B: Comments on Proposed § 507.20—Water Supply and Plumbing

A. Proposed § 507.20(a)—Water Supply

B. Proposed § 507.20(b)—Plumbing

C. Proposed § 507.20(c)—Sewage

D. Proposed § 507.20(d)—Toilet Facilities

E. Proposed § 507.20(e)—Hand-Washing Facilities

XIX. Subpart B: Comments on Proposed § 507.22—Equipment and Utensils

A. Proposed § 507.22(a)(1)—Plant Equipment and Utensils

B. Proposed § 507.22(a)(2)—Design of Equipment and Utensils

C. Proposed § 507.22(a)(3)—Equipment Installation

D. Proposed § 507.22(a)(4)—Animal Food Contact Surfaces

E. Proposed § 507.22(a)(5)—Non-Animal Food Contact Equipment (Final § 507.22(a)(1))

F. Proposed § 507.22(b)—System Design and Construction

G. Proposed § 507.22(c)—Monitoring Cold Storage Temperatures

H. Proposed § 507.22(d)—Instruments

I. Proposed § 507.22(e)—Compressed Air

XX. Subpart B: Comments on Proposed § 507.25—Plant Operations

A. Proposed § 507.25(a)(1)—CGMPs

B. Proposed § 507.25(a)(2)—Identifying Contents of Containers

C. Proposed § 507.25(a)(3)—Labeling of Finished Product (Final § 507.27(b))

D. Proposed § 507.25(a)(4)—Animal Food Packaging Material (Final § 507.25(a)(3))

E. Proposed § 507.25(a)(5)—Responsibility for Overall Plant Cleanliness (Final § 507.25(a)(4))

F. Proposed § 507.25(a)(6)—Contamination Precautions (Final § 507.25(a)(5))

G. Proposed § 507.25(a)(7)—Testing Procedures (Final § 507.25(a)(6))

H. Proposed § 507.25(a)(8)—Contaminated Product (Final § 507.25(a)(7))

I. Proposed § 507.25(a)(9)—Protecting Against Contamination (Final § 507.25(a)(8))

J. Proposed § 507.25(b)(1)—Raw Materials and Ingredients

K. Proposed § 507.25(b)(1)(i)—Shipping Containers

L. Proposed § 507.25(b)(1)(ii)—Raw Materials

M. Proposed § 507.25(b)(1)(iii)—Raw Materials

N. Proposed § 507.25(b)(2)—Raw Materials Susceptible to Mycotoxins

O. Proposed § 507.25(b)(3)—Raw Materials and Rework (Final § 507.25(b)(1)(iii))

P. Proposed § 507.25(b)(4)—Frozen Raw Materials (Final § 507.25(b)(3))

Q. Proposed § 507.25(c)(1)—Appropriate Conditions for Animal Food

R. Proposed § 507.25(c)(2)—Control of Undesirable Microorganisms

S. Proposed § 507.25(c)(3)—Work-in-Process and Rework

T. Proposed § 507.25(c)(4)—Processing Steps

U. Proposed § 507.25(c)(5)—Processing Operations

V. Proposed § 507.25(c)(6)—Controlling Water Activity (aw)

W. Proposed § 507.25(c)(7)—Controlling pH

X. Proposed § 507.25(c)(8)—Ice

XXI. Subpart B: Comments on Proposed § 507.27—Holding and Distribution

A. Proposed § 507.27(a)—Holding and Distribution

B. Proposed § 507.27(a)(1)—Containers

C. Proposed § 507.27(a)(2)—Protection From Contamination

D. Proposed § 507.27(a)(3)—Labeling of Animal Food Held for Distribution (Final § 507.27(b))

E. Proposed § 507.27(b)—Shipping Containers (Final § 507.27(c))

F. Proposed § 507.27(c)—Returned Animal Food (Final § 507.27(d))

G. Proposed § 507.27(d)—Unpackaged Bulk Animal Food (Final § 507.27(e))

XXII. Subpart B: Comments on Proposed § 507.28—Holding and Distribution of Human Food By-Products for Use as Animal Food

A. Proposed § 507.28(a)—Contamination

B. Proposed § 507.28(a)(1)—Containers

C. Proposed § 507.28(a)(2)—Protection From Contamination

D. Proposed § 507.28(a)(3)—Labeling

E. Proposed § 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 § 507.31—Food Safety Plan

A. Proposed § 507.31(a)—Requirement for a Food Safety Plan

B. Proposed § 507.31(b)—Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual

C. Proposed § 507.31(c)—Contents of a Food Safety Plan

D. Proposed § 507.31(d)—Records

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

XXV. Subpart C: Comments on Proposed § 507.33—Hazard Analysis

A. Proposed § 507.33(a)—Requirement for a Written Hazard Analysis

B. Proposed § 507.33(b)—Hazard Identification

C. Proposed § 507.33(c) and (d)—Evaluation of Whether a Hazard Requires a Preventive Control

XXVI. Subpart C: Comments on Proposed § 507.36—Preventive Controls (Final § 507.34)

A. Proposed § 507.36(a)—Requirement To Identify and Implement Preventive Controls (Final § 507.34(a))

B. Proposed § 507.36(b)—Requirement for Written Preventive Controls (Final § 507.34(b))

C. Proposed § 507.36(c)(1)—Process Controls (Final § 507.34(c)(1))

D. Proposed § 507.36(c)(2)—Sanitation Controls (Final § 507.34(c)(2))

E. Proposed § 507.36(c)(3)—Supply-Chain Controls (Final § 507.34(c)(3))

F. Proposed § 507.36(c)(4)—Recall Plan (Final § 507.34(c)(4))

G. Proposed § 507.36(c)(5)—Other Controls (Final § 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 §§ 507.36 and 507.37)

XXVIII. Subpart C: Comments on Proposed § 507.38—Recall Plan

A. Proposed § 507.38(a)—Requirement for a Written Recall Plan

B. Proposed § 507.38(b)—Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps

XXIX. Comments on Proposed § 507.39—Preventive Control Management Components

A. Proposed § 507.39(a)—Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification

B. Proposed § 507.39(b)—Applicability of Preventive Control Management Components to Supply-Chain Program

C. Proposed § 507.39(c)—Recall Plan is Not Subject to Preventive Control Management Components

XXX. Subpart C: Comments on Proposed § 507.40—Monitoring

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

B. Proposed § 507.40(a) and (b)—Flexibility in Requirements for Monitoring

C. Proposed § 507.40(c)—Records

XXXI. Subpart C: Comments on Proposed § 507.42—Corrective Actions and Corrections

A. Proposed § 507.42(a)(1)(i)—Requirement To Establish and Implement Corrective Action Procedures

B. Proposed § 507.42(a)(2)—Content of Corrective Action Procedures

C. Proposed § 507.42(b)—Corrective Action in the Event of an Unanticipated Problem

D. Proposed § 507.42(c)—Corrections

E. Proposed § 507.42(d)—Records

XXXII. Subpart C: Comments on Proposed § 507.45—Verification

A. Flexibility in Requirements for Verification

B. Proposed § 507.45(a)—Verification Activities

C. Proposed § 507.45(b)—Documentation of Verification Activities

D. Comments on Potential Requirements Regarding Complaints

XXXIII. Subpart C: Comments on Proposed § 507.47—Validation

A. Flexibility in the Requirements To Validate Preventive Controls

B. Proposed § 507.47(b)(1)—When Validation Must Be Performed and Role of Preventive Controls Qualified Individual in Validation

C. Proposed § 507.47(b)(2)—What Validation Must Include

D. Proposed § 507.47(b)(3)—Preventive Controls for Which Validation Is Not Required

XXXIV. Subpart C: Comments on Proposed § 507.49—Verification of Implementation and Effectiveness

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

B. Proposed § 507.49(a)(1)—Calibration

C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed § 507.49(a)(2) and (b)(2)) and Environmental Monitoring (Proposed § 507.49(a)(3) and (b)(3))

D. Proposed § 507.49(a)(2)—Product Testing

E. Proposed § 507.49(a)(3)—Environmental Monitoring

F. Proposed § 507.49(a)(4)—Review of Records

G. Proposed § 507.49(b)—Written Procedures

XXXV. Subpart C: Comments on Proposed § 507.50—Reanalysis

A. Proposed § 507.50(a)—Circumstances Requiring Reanalysis

B. Proposed § 507.50(b)—Timeframe To Complete Reanalysis

C. Proposed § 507.50(c)—Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed

D. Proposed § 507.50(d) —Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual

E. Proposed § 507.50(e)—Reanalysis on the Initiative of FDA

XXXVI. Subpart C: Comments on Proposed § 507.51—Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Animal Food

A. Proposed § 507.51(a)—Modified Requirements for Unexposed Refrigerated Packaged Animal Food That Requires Time/Temperature Controls

B. Proposed § 507.51(b)—Records

XXXVII. Subpart C: Comments on Proposed § 507.53—Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor

A. Proposed § 507.53(a) and (b)—What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee

B. Proposed § 507.53(c)—Qualification Requirements

C. Proposed § 507.53(d)—Records

XXXVIII. Subpart C: Comments on Proposed § 507.55—Implementation Records

XXXIX. Subpart D: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption

A. Proposed § 507.60—Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption

B. Proposed § 507.62—Issuance of an Order To Withdraw a Qualified Facility Exemption

C. Proposed § 507.65—Contents of an Order To Withdraw a Qualified Facility Exemption

D. Proposed § 507.67—Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption

E. Proposed § 507.69—Procedure for Submitting an Appeal

F. Proposed § 507.71—Procedure for Requesting an Informal Hearing

G. Proposed § 507.73—Requirements Applicable to an Informal Hearing

H. Proposed § 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 § 507.105(a)(1) and (b))

B. Circumstances That Do Not Require a Written Supply-Chain Program (Final § 507.105(a)(2))

C. Exemption for Animal Food Supplied for Research or Evaluation (Final § 507.105(a)(3))

D. Additional Requirements for Non-Suppliers (Final § 507.105(c))

E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed § 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 § 507.110(a))

B. Appropriate Supplier Verification Activities ((Final § 507.110(b))

C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 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 § 507.110(d))

E. Supplier Non-Conformance (Final § 507.110(e))

XLIII. Subpart E: New Requirement Specifying the Responsibilities of the Receiving Facility (Final § 507.115)

XLIV. Subpart E: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification Activities

A. Using Approved Suppliers (Final § 507.120)

B. Determining Appropriate Verification Activities (Final § 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 § 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 § 507.130(b))

C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final § 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 § 507.130(d))

E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final § 507.130(e))

F. Independence of Persons Who Conduct Supplier Verification Activities (Final § 507.130(f))

XLVI. Subpart E: Comments on Onsite Audit

A. Requirements Applicable to an Onsite Audit (Final § 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 § 507.175(a))

B. Requirement To Review Records of the Supply-Chain Program (Final § 507.175(b))

C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final § 507.175(c)(5))

D. Documentation of the Conduct of an Onsite Audit (Final § 507.175(c)(7))

E. Documentation of Sampling and Testing (Final § 507.175(c)(8))

F. Documentation of Other Appropriate Supplier Verification Activity (Final § 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 § 507.175(c)(13))

XLVIII. Subpart F: Comments on Proposed New Recordkeeping Requirements

A. Proposed § 507.200—Records Subject to the Requirements of Subpart F and Requirements for Official Review

B. Proposed § 507.202—General Requirements Applying to Records

C. Proposed § 507.206—Additional Requirements Applying to the Food Safety Plan

D. Proposed § 507.208—Requirements for Record Retention

E. Proposed § 507.212—Use of Existing Records

F. Final § 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 risk-based preventive controls

Notes

“Qualified Facility” as defined by FSMA:

Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or

• Very small business, which the rule defines as a business (including any subsidiaries or affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (

e.g.

, held for a fee or supplied to a farm without sale)

Modified requirements apply—

i.e.

, a qualified facility is required to:

• Notify FDA about its status and either:

○ Notify FDA that it is addressing hazards through preventive controls and monitoring; or

○ Notify FDA that it complies with applicable non-Federal food safety regulations, and notify consumers of the name and complete business address of the facility where the animal food was manufactured or processed.

• 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 performed by small business (<500 full-time equivalent employees)

Small and very small on-farm businesses conducting only the specified low-risk activities are exempt from the requirements for hazard analysis and risk-based preventive controls.

-or-

• Low-risk, on-farm activities performed by a very small business (dollar threshold of $2,500,000, as described previously)

We define the low-risk, on-farm activities that qualify for the exemption, including the specific animal foods to which they relate (such as re-packing roughage products, or cracking grains).

Activities that are subject to the “low-acid canned food” requirements of part 113 (21 CFR part 113)

• The exemption applies only with respect to microbiological hazards regulated under part 113.

• The facility must be in compliance with part 113.

Activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety) (21 U.S.C. 350h)

These activities will be established in FDA's forthcoming rule for produce safety.

Facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing

A facility that stores raw agricultural commodities that are fruits and vegetables is not exempt.

A facility solely engaged in the storage of unexposed packaged animal food that does not require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens

Modified requirements apply for the storage of unexposed packaged animal food that requires time/temperature control to significantly 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]

One-time

Annual

Total

annualized

cost at 7%

1

Total

annualized

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 Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

2013 proposed rule for preventive controls for animal food

78 FR 64736, October 29, 2013.

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

2013 proposed rule for preventive controls for human food

78 FR 3646, January 16, 2013.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

2013 proposed produce safety rule

78 FR 3504, January 16, 2013.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

2013 proposed FSVP rule

78 FR 45730, July 29, 2013.

Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications

2013 proposed third-party certification rule

78 FR 45782, July 29, 2013.

Focused Mitigation Strategies To Protect Food Against Intentional Adulteration

2013 proposed intentional adulteration rule (human food only)

78 FR 78014, December 24, 2013.

Sanitary Transportation of Human and Animal Food

2014 proposed sanitary transportation rule

79 FR 7006, February 5, 2014.

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 Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

2014 supplemental notice

79 FR 58476, September 29, 2014.

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

2014 supplemental human preventive controls notice

79 FR 58524, September 29, 2014.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

2014 supplemental produce safety notice

79 FR 58434, September 29, 2014.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

2014 supplemental FSVP notice

79 FR 58574, September 29, 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 (§ 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 (§ 10.115(g)) (21 CFR 10.115(g)). The public may submit comments on any guidance document at any time (§ 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, § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 1.227 are not required to register under section 415 of the FD&C Act, § 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 § 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 only engages in low-risk activity/animal food combinations and is a small or very small business. We are not establishing any exemption from, or modification to, the frequency requirements under section 421 for facilities that only engage in low-risk activity/animal food combinations and are a small or very small business.

VII. Subpart A: Comments on Proposed § 507.1—Applicability and Status

We proposed in § 507.1 to establish the significance of this part in determinations of whether animal food is adulterated. We also proposed a provision relevant to FSMA's statutory provisions for a prohibited act under section 301(uu) of the FD&C Act. We proposed that animal food covered by specific CGMPs would also be subject to those requirements. For facilities required to comply with CGMPs and preventive controls for both the proposed preventive controls rule for animal food and the proposed preventive controls rule for human food, we proposed that the facility must comply with either rule for the animal food, as long as the food safety plan addresses hazards unique to animal food. Some comments support the proposed provisions without change. Some comments that support the proposed provisions ask us to clarify how we will interpret the provisions.

In the following paragraphs, we discuss comments that ask us to clarify the proposed requirements, disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed requirements along with editorial and conforming changes as shown in table 31.

A. Comments on Proposed § 507.1(a)—Applicability

We proposed that the criteria and definitions in part 507 apply in determining whether a food is adulterated: (1) Within the meaning of section 402(a)(3) of the FD&C Act in that the food has been manufactured under such conditions that it is unfit for food; or (2) Within the meaning of section 402(a)(4) of the FD&C Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. We also proposed that the criteria and definitions in part 507 also apply in determining whether an animal food is in violation of section 361 of the PHS Act.

(Comment 15) Some comments note that FSMA granted FDA mandatory recall authority for adulterated food. These comments express concern that theoretically we could use a violation of the requirements for hazard analysis and risk-based preventive controls to determine that food is adulterated, thereby providing the basis for a mandatory recall of that food. These comments raise three issues relevant to how we will apply § 507.1(a), with consequences for a potential mandatory recall of food.

First, these comments note that the regulatory text stating that the “criteria and definitions” apply in making a determination of adulteration appears to encompass the entirety of the rule. As a result, farms or facilities that violate any of the requirements in the proposed rules, including components not directly related to the safety of the food (such as recordkeeping requirements), could face a risk that we would deem their food adulterated.

Second, these comments assert that the regulatory text suggests that we

would not automatically consider a food adulterated as a result of a violation of the proposed rule, because it states that the criteria and definitions “apply in determining” whether a food will be considered adulterated, rather than that the food “is” adulterated.

Third, these comments state that it is not clear how the exemption applicable to qualified facilities is included in the “criteria and definitions” used in making a determination of adulteration. These comments ask us to clarify that we will not just automatically assume that qualified facilities are selling adulterated food because they are by definition exempt from the requirements for hazard analysis and risk-based preventive controls.

(Response 15) The comments are correct that the criteria and definitions “apply in determining” whether an animal food will be considered adulterated, rather than that the animal food “is” adulterated. In determining whether an animal food that is manufactured, processed, packed, or held in violation of part 507 (including a violation of the recordkeeping requirement) is adulterated, we would consider the totality of the available data and information about the violation and the animal food before reaching a conclusion that the animal food is adulterated.

Although this rule does not address the mandatory recall provisions of FSMA, the statutory provisions establish two basic criteria. (See section 423(a) of the FD&C Act (21 U.S.C. 3501).) First, we must determine that there is a “reasonable probability” that the animal food is adulterated under section 402 of the FD&C Act. A violation of part 507 would be relevant to determining whether an animal food is adulterated under section 402 of the FD&C Act. Second, we must determine that there is a reasonable possibility that the use of, or exposure to, that animal food will cause serious adverse health consequences or death to humans or animals. Not all animal food that is adulterated has a reasonable probability of causing serious adverse health consequences or death to humans or animals. For examples of animal food contamination with a reasonable probability of causing serious adverse health consequences or death to humans or animals, see the annual reports of the Reportable Food Registry (RFR) (Refs. 13, 14, 15, and 16).

A facility that is exempt from any requirement of part 507, including the requirements for hazard analysis and risk-based preventive controls, would not be in violation of part 507 if it did not comply with provisions that it is not subject to.

B. Comments on Proposed § 507.1(b)—Prohibited Act

We proposed that the operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States is a prohibited act under section 301(uu) of the FD&C Act if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the FD&C Act or subparts C, D, or F of part 507 and § 507.7 (proposed § 507.1(b)).

(Comment 16) Some comments from State regulatory Agencies note that this new provision is not covered under the applicable state statute and that making any changes to the state statute can be a lengthy process that takes up to 3 years to complete.

(Response 16) See Response 2 for a discussion of our approach to working with our food safety partners in the States.

C. Comments on Proposed § 507.1(c)—Specific CGMP Requirements

We proposed § 507.1(c) would establish that animal food covered by specific current good manufacturing practice regulations also be subject to the requirement of those regulations. We received no comments that disagreed with our proposal, and are finalizing the proposed provision without change.

D. Comments on Proposed § 507.1(d)—Human Food Facilities That Manufacture Animal Food

We proposed in § 507.1(d) that a facility that would be required to comply with subpart B of part 507 and would be required to comply with subpart B of proposed part 117 for human food, may choose to comply with part 117 for the animal food. We also proposed that a facility that would be required to comply with subpart C of part 507 and would be required to comply with subpart C of proposed part 117 for human food, may choose to comply with part 117 for the animal food as long as the food safety plan also addressed hazards that are reasonably likely to occur in the animal food. We also proposed that when applying the requirements of part 117 to animal food, the term “food” in part 117 would include animal food.

Based on comments received in the 2014 supplemental notice, we proposed in § 507.12 that human food by-products held by the human food processor for distribution for use as animal food without additional manufacturing/processing by the human food processor would only need to comply with proposed § 507.28 in part 507 and proposed § 117.95 in part 117 (79 58476 at 58487 to 58489). (See section XIII for a discussion of comments received on proposed § 507.12.) We are finalizing the proposed provisions in 507.1(d) with the exceptions in § 507.12.

For further discussion of comments on applicability and status, see section VIII in the final rule for preventive controls for human food published elsewhere in this issue of the

Federal Register

.

VIII. Subpart A: Comments on Proposed § 507.3—Definitions

We proposed definitions in the preventive controls rule for animal food to be consistent with the proposed preventive controls rule for human food with some minor differences and clarifications applicable to animal food (

e.g.,

adding “animal” before “food”). Some comments support one or more of these proposed definitions without change. For example, some comments state that they support the proposed definitions for “microorganism” and “subsidiary” with no suggested revisions. Some comments support our proposal in the 2014 supplemental notice to use the phrase “chemical (including radiological)” in the definition of “hazard,” noting that doing so is consistent with FSMA, current industry practice, and Codex and global HACCP standards. Some comments that support a proposed definition suggest alternative or additional regulatory text, such as adding examples to make the definition clearer. Some comments that support a proposed definition ask us to clarify how we will interpret the definition. Comments generally ask that we maintain consistency of terms among the FSMA rules to avoid confusion and ensure regulatory compliance.

We did not receive comment on the following terms and therefore, are finalizing them as proposed: “calendar day,” “FDA,” “pest,” “water activity,” and “you.”

We removed some proposed definitions because the final rule does not use them. The proposed definitions that are removed in this final rule are “batter,” “blanching,” “packaging,” “quality control operation,” “safe moisture level,” “should,” and “significant hazard.”

In the following sections, we discuss comments that ask us to clarify proposed definitions or that disagree with, or suggest one or more changes to, a proposed definition. After considering these comments, we have revised the proposed requirements with editorial

and conforming changes as shown in table 31.

We also discuss definitions for additional terms (

i.e.,

“audit,” “correction,” “full-time equivalent employee,” “hazard requiring a preventive control,” “qualified facility exemption,” “raw agricultural commodity,” “supply-chain-applied control,” “unexposed packaged animal food,” and “written procedures for receiving raw materials and other ingredients”) that we are establishing in the final rule to simplify the regulatory text throughout the regulations and improve clarity. We also discuss a new name (

i.e.,

“preventive controls qualified individual”) for the definition of a term that we had proposed to name “qualified individual,” and are establishing a new definition for the term “qualified individual.” Finally, we also discuss definitions that comments ask us to add, but that we did not add, to the final rule.

A. Definitions We Proposed To Establish in Part 507

1. Adequate

We proposed to define the term “adequate” to mean that which is needed to accomplish the intended purpose in keeping with good public health practice.

(Comment 17) Some comments express concern that there is no standard or definition for “good public health practice” and, for animal food establishments, the term “good public health practice” creates more uncertainty than it removes. The comments request that we remove from the definition the term “good public health practice.” Other comments ask us to develop guidance on thresholds and processes that qualify as “adequate.” Other comments assert that the word “adequate” must be used in combination with the word “reasonable” to properly describe the intended measures and precautions.

(Response 17) We disagree that there is no standard for “good public health practice.” However, we have revised the definition to add after public “(human and animal)” to clarify it includes both. Our intent in using the term “adequate” is to provide flexibility for an animal food establishment to comply with the requirement in a way that is most suitable for its establishment. We decline the request to develop guidance to explicitly address “thresholds” or to describe processes that qualify as adequate. The CGMPs and preventive controls requirements established in this rule are broadly applicable procedures and practices rather than very specific procedures and practices where additional interpretation from FDA might be appropriate.

2. Affiliate and Subsidiary

We proposed to define the term “affiliate” to mean any facility that controls, is controlled by, or is under common control with another facility. We proposed to define the term “subsidiary” to mean any company which is owned or controlled directly or indirectly by another company. These proposed definitions would incorporate the definition in section 418(l)(4)(A) and (D) of the FD&C Act and would make the meanings of these terms clear when used in the proposed definition of “qualified facility.”

(Comment 18) Some comments ask us to clarify that a facility that has no material connection with another food processing operation would not be considered as an “affiliate” of that operation.

(Response 18) It is not clear what the comments mean by “no material connection with another food processing operation.” To the extent that a facility does not control, is not controlled by, or is not under common control with another facility, we agree that the facility would not be considered an affiliate of that food processing operation.

(Comment 19) Some comments assert that the definitions of “affiliate” and “subsidiary” fail to account for the legal differences between a piece of property (

i.e.,

a facility) and a business entity or person. These comments ask us to consider amending the proposed definition of “qualified facility” to clarify what sales to include in determining whether a facility so qualifies.

(Response 19) See Response 57.

3. Animal Food

We proposed to define the term “animal food” to mean food for animals other than man that includes pet food, animal feed, and raw materials and ingredients.

(Comment 20) Several comments voice concerns about including within the definition of animal food the term “raw materials.” The main concern is whether firms producing raw materials for animal food must register and create animal food safety plans. The comments fear firms would dispose of the raw material products due to the high cost of developing and maintaining safety plans, and disposal of those raw material products would have a significant economic impact due to a considerable increase in the cost of animal food in the United States.

(Response 20) We decline to change the definition. We do not expect that the inclusion of the term “raw materials” in the definition for animal food will change current practices, noting that a facility producing raw materials for animal food is already required to register. The definition of “animal food” is intended to clarify that the rule refers to “food for animals” and not “food derived from animals.”

4. Critical Control Point

We proposed to define the term “critical control point” (CCP) to mean a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.

(Comment 21) Some comments oppose the use of “critical control point” in the rule because the term is confusing and not understood by the relevant industry in the context of FSMA and the required preventive controls. The comments suggest critical control point is a HACCP term and not appropriate for use in this rule where the scope is defined differently by the statute.

(Response 21) We decline to modify or remove the definition as these comments request because we believe the term is helpful to industry. The proposed definition matches the statutory definition in section 418(o)(1) of the FD&C Act and is consistent with definitions in the Federal HACCP regulations for seafood, juice, and meat and poultry (parts 123 and 120 (21 CFR part 123 and 120) and 9 CFR part 417 respectively). By specifying that a point, step, or procedure in an animal food safety process would reduce a hazard to an “acceptable level,” the definition provides flexibility for a facility to determine an appropriate level in a particular circumstance.

(Comment 22) Some comments request that we define the term “control point.” The comments suggest defining this term as a point, step, or procedure in the production of an animal food at which a control may be applied.

(Response 22) We decline this request. We define “critical control point” as a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. Also, “control point” is not a term used in the regulatory text of the rule and therefore does not need to be defined.

5. Environmental Pathogen

We proposed to define the term “environmental pathogen” to mean a

pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food for animals may be contaminated and may result in foodborne illness if that animal food is not treated to significantly minimize or prevent the environmental pathogen. We also proposed to specify that environmental pathogen does not include the spores of pathogenic sporeformers. By “pathogenic sporeformers,” we mean “pathogenic sporeforming bacteria,” and we are substituting the term “pathogenic sporeforming bacteria” for “pathogenic sporeformers” in the definition of “environmental pathogen” to make that clearer.

(Comment 23) Some comments ask us to include

Salmonella

spp. and

Listeria monocytogenes

in the regulatory text as examples of environmental pathogens. Other comments believe the definition is too broad because it would include any pathogen that is capable of surviving or persisting in the environment, and the definition should be limited to the pathogenic bacteria that are more appropriate for protecting animal food safety.

(Response 23) We agree that

Salmonella

spp. and

L. monocytogenes

are useful examples of environmental pathogens and have added these two examples to the proposed definition, which had not included examples. Adding these two examples to the definition does not mean that these two pathogens are the only environmental pathogens that a facility must consider in its hazard analysis. New environmental pathogens can emerge at any time, and other pathogens can also be environmental pathogens.

Salmonella

spp in pet food have been involved in foodborne illness outbreaks in humans (78 FR 64736 at 64747). In addition, there have been recalls of pet food found to contain L. monocytogenes, though no human or animal illnesses were associated with these recalls to date (Refs. 17 and 18).

(Comment 24) Some comments ask us to clarify the meaning of the term “persisting” as used in the definition, such as whether it means that a sanitation process will not remove the microorganism.

(Response 24) We use the term “persisting” to mean that a pathogen can get established if cleaning is not adequate. Once a pathogen gets established, appropriate sanitation measures can remove the pathogen. However, sanitation procedures necessary to eliminate an environmental pathogen that has become established generally are more aggressive than routine sanitation procedures.

6. Facility

We proposed to define the term “facility” to mean a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act in accordance with the requirements of part 1, subpart H. Comments directed to the meaning of the term “facility” address its meaning as established in the section 415 registration regulations, rather than this definition established in part 507.

For a discussion of comments on definitions in part 1, see section IV of the final rule for preventive controls for human food published elsewhere in this issue of the

Federal Register

.

7. Farm

We proposed to define the term “farm” by reference to the definition of that term in § 1.227(b) rather than by repeating the full text of the “farm” definition in part 507. For a discussion of comments to the farm definition and of the “farm” definition that we are establishing in § 1.227, see section IV of the final rule for preventive controls for human food published elsewhere in this issue of the

Federal Register

.

8. Food

We proposed to define the term “food” to mean food as defined in section 201(f) of the FD&C Act and to include raw materials and ingredients. Under section 201(f), the term “food” means: (1) Articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

(Comment 25) Some comments ask us to include examples in the definition. These comments also ask us to clarify whether the definition applies to food for human consumption, animal consumption, or both.

(Response 25) We decline the request to include examples in the definition. There are many examples of food and adding a limited list of examples could be confusing rather than helpful. Although the definition of food includes food for both human consumption and animal consumption, the provisions of the rule are clearly directed to food for animal consumption.

(Comment 26) Some comments ask us to consider fundamental and important differences between food additives and GRAS substances and finished food. These comments explain that food additives and GRAS substances may be synthesized using various chemical and biochemical processes, or may be extracted, hydrolyzed or otherwise modified from their natural sources, and result in food safety hazards that are quite different from finished food preparations. These comments also explain that food additives and GRAS substances are often produced using processes that minimize microbial contamination hazards and are almost always used in food products that undergo further downstream processing. These comments assert that food additives and GRAS substances generally present a significantly lower public health hazard compared to finished food and should be regulated accordingly.

(Response 26) Substances such as food additives and GRAS substances are food and are subject to the requirements of this rule. Both the CGMP requirements in subpart B and the requirements for hazard analysis and risk-based preventive controls in subparts C and E provide flexibility to address all types of food. (As discussed in section XL, the final rule establishes the requirements for a supply-chain program in subpart E, rather than within subpart C as proposed. As a result, this document refers to subparts C and E when broadly referring to the requirements for preventive controls.) A manufacturer of a food additive or GRAS substance has flexibility to comply with the requirements of the rule based on the nature of the production processes and the outcome of the hazard analysis for that animal food substance.

9. Food-Contact Surfaces

We proposed to define “food-contact surfaces” to mean those surfaces that contact animal food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food-contact surfaces” include food-contact surfaces of utensils and equipment.

(Comment 27) Several comments state that the terms “drainage” and “utensils” are not widely used or understood within animal feed and pet food industry and that the definition for “food-contact surfaces” should be revised by deleting “drainage, or other,” and by replacing “utensils” with “tools.”

(Response 27) We decline these requests. See our discussion of the term “utensils” in Response 169. We believe the term “drainage” is commonly understood.

10. Harvesting

We proposed to define the term “harvesting” to apply to farms and farm

mixed-type facilities and to mean activities that are traditionally performed by farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as food. We proposed that harvesting be limited to activities performed on RACs on a farm, and that harvesting does not include activities that transform a RAC into a processed food. The proposed definition included examples of activities that would be harvesting.

In this final rule, we added or modified several examples of harvesting (see Response 28). As noted in table 31, we have reorganized the listed examples of harvesting to present them in alphabetical order.

We are defining the term “harvesting” to apply to farms and farm mixed-type facilities and to mean activities that are traditionally performed on farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as animal food. The definition includes examples of activities that are harvesting, as described in this section. Harvesting is also limited to activities performed on RACs, or on processed foods created by drying/dehydrating a RAC without additional manufacturing/processing, on a farm.

(Comment 28) Some comments ask us to provide more examples of harvesting activities, in the regulatory text and in guidance. Examples of the requested activities include braiding; bunching; cutting the edible portion of the crop from the plant; hydro-cooling; maintaining hydration of product; refrigerating; removing foliage; removing free water from (

e.g.

spinning); removing or trimming roots; trimming the tops of bunches of allium crops such as leeks, chives, or garlic and root crops such as carrots, beets, turnips, parsnips, etc. to prepare them for sale; and trimming the lower stems of harvested herb crops such as parsley, basil, or cilantro, or the lower stems of leafy greens. Other comments ask us to specify that harvesting also encompasses seed conditioning (

i.e.,

cleaning the seed, including removal of leaves, stems, and husks to prepare for marketing), ripening (artificial or natural) of fruit, and waxing or coating of RACs.

(Response 28) We have added or modified several examples of harvesting in the regulatory text (

i.e.,

cutting (or otherwise separating) the edible portion of the RAC from the crop plant, removing or trimming part of the RAC (

e.g.,

foliage, husks, roots or stems) and field coring and hulling). In table 1 in the Appendix to the 2014 supplemental notice (79 FR 58476 at 58520 through 58521), we provided a more extensive list of examples of harvesting activities, including examples that are not in the regulatory text. We have classified some of these activities in more than one way (see 79 FR 58476 at 58520 through 58521). For example, trimming of outer leaves from RACs can be a harvesting activity, as well as a manufacturing/processing activity. Artificial ripening of fruit is manufacturing/processing (not harvesting), but is now within the “farm” definition.

(Comment 29) Some comments ask us to periodically review the list of harvesting activities to ensure that it reflects current practices.

(Response 29) If particular activities present questions in the future about whether the activity is a harvesting activity within the “farm” definition, or a manufacturing/processing activity that is outside the “farm” definition, we will consider issuing guidance or updating any existing guidance to clarify our recommended classification of the activity.

(Comment 30) Some comments note that the proposed definition for “harvesting” seems to be much more inclusive than FDA's original proposed regulation, but is significantly more restrictive than the current regulation in part 1 because it excludes future technological developments. The comment further notes as technology and harvesting techniques advance, the risk of tying the definition to traditional activities will have a negative effect on agriculture's ability to adapt. Furthermore, harvesting is merely the first step in transforming a RAC into processed food.

(Response 30) The comment did not make a specific request or provide any suggestions as to how future technological developments should be handled; therefore, we are finalizing the definition with the changes previously described.

11. Hazard

We proposed to define the term “hazard” to mean any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury in humans or animals in the absence of its control.

(Comment 31) Some comments express concern that the rule would refer to four levels of “hazard,”

i.e.,

“hazard,” “known or reasonably foreseeable hazard,” “significant hazard,” and “serious adverse health consequences or death to humans or animals” hazard. These comments ask us to provide sufficient clarity to be able to distinguish between these types of hazards and to provide examples in guidance as to how these terms will be applied in determining compliance with the rule. Other comments express concern that the definitions do not establish a meaningful distinction between “hazard” and “significant hazards” and do not sufficiently distinguish between the hazards identified in the first and second steps of the hazard analysis (first narrowing hazards to “known or reasonably foreseeable hazards” and then narrowing the “known or reasonably foreseeable hazards” to “significant hazards”).

(Response 31) The rule uses three of these terms (

i.e.,

“hazard,” “known or reasonably foreseeable hazard,” and the proposed term “significant hazard”) to establish a tiered approach to the requirements for hazard analysis and risk-based preventive controls. The term “hazard” is the broadest of these three terms—any biological, chemical (including radiological), or physical agent has the potential to cause illness or injury. To conduct its hazard analysis, a facility starts by first narrowing down the universe of all potential hazards to those that are “known or reasonably foreseeable” for each type of food for animals manufactured, processed, packed, or held at its facility. The outcome of the facility's hazard analysis is a determination of “significant hazards,”

i.e.,

the subset of those known or reasonably foreseeable hazards that require a preventive control.

To make this clearer, we have: (1) Revised the proposed definitions of “hazard” and (2) changed the term “significant hazard” to “hazard requiring a preventive control” (formerly “significant hazard”). See Responses 32 and 62.

The rule does not define the term “serious adverse health consequences or death to humans or animals” hazard. However, the requirements for a supply-chain program refer to a hazard for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (see § 507.130(b)). For additional information on how we interpret “serious adverse health consequences or death to humans or animals,” see our guidance regarding the RFR (Refs. 19 and 20), which addresses statutory requirements regarding “reportable foods.” As explained in that guidance, a “reportable food” is an article of food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or

death to humans or animals. The guidance includes examples of circumstances under which food might be reportable.

(Comment 32) Some comments assert that the distinction between the definitions of “hazard” and “significant hazard” is not discernable because the proposed definition of “hazard” currently takes into account whether or not a “hazard” is or is not controlled. These comments ask us to delete the phrase “in the absence of its control” from the definition of “hazard” to clarify that hazards are simply the agents that are reasonably likely to cause illness or injury. Likewise, other comments assert that any hazard that is “reasonably likely to cause illness or injury in the absence of its control” will, if known or reasonably foreseeable, likely be controlled by any knowledgeable person.

(Response 32) We have deleted the phrase “in the absence of its control” from the definition of “hazard.” We agree that deleting this phrase from the definition of “hazard” will more clearly distinguish between the terms “hazard” and “hazard requiring a preventive control” that we are establishing in this rule.

We also replaced the phrase “that is reasonably likely to cause illness or injury” with “that has the potential to cause illness or injury” to more clearly distinguish “hazard” from “known or reasonably foreseeable hazard.” This increases the alignment of the definition of “hazard” in this rule with the Codex definition of “hazard.”

(Comment 33) Some comments ask us to include “in the intended species” in the definition of “hazard.”

(Response 33) We decline this request. During the hazard analysis the facility must identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards requiring a preventive control (§ 507.33(a)). During the hazard evaluation, the facility must consider the effect of the intended or reasonably foreseeable use on the safety of the finished animal food for the intended animal (§ 507.33(d)(8)).

12. Holding

We proposed to define “holding” to mean storage of food, including activities performed incidental to storage of a food (

e.g.,

activities performed for the safe or effective storage of that food and activities performed as a practical necessity for the distribution of that food (such as blending of the same RAC and breaking down pallets)), but not including activities that transform a RAC into a processed food. We proposed that holding facilities could include warehouses, cold-storage facilities, storage silos, grain elevators, and liquid-storage tanks.

(Comment 34) Some comments ask us to provide more examples of holding activities, in the regulatory text and in guidance. Examples of the requested activities include fumigating RACs; application of chemicals (including fungicides, sanitizers, and anti-oxidants); and “coating” grain RACs with diatomaceous earth to control insects. According to these comments, these activities are incidental to storage and do not transform RACs into processed food. Other comments wanted examples of holding of human-food by-products destined for animal food (for example wet pasta that dries naturally while being held).

(Response 34) We have added or modified several examples of holding in the regulatory text (

i.e.,

fumigating animal food during storage, and drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). In table 1 in the Appendix to the 2014 supplemental notice (79 FR 58476 at 58520 through 58521), we provided a more extensive list of examples of holding activities, including examples that are not in the regulatory text. We have previously classified some of these activities in more than one way (see 79 FR 58476 at 58520 through 58521) depending on when the activity occurs. For example, sorting, culling, and grading RACs can be either a holding activity or a packing activity. Drying/dehydrating RACs is holding when the drying/dehydrating does not create a distinct commodity, but is manufacturing/processing when the drying/dehydrating creates a distinct commodity (see section IV). Holding of certain human food by-products for use as animal food is discussed in sections XIII and XXII.

(Comment 35) Some comments ask us to clarify that mixing or blending intact RACs is considered “holding” regardless of whether the RACs are the same or different.

(Response 35) We use the term “blending” when referring to RACs such as grain and when the RACs are the same. For example, we consider the activity of “blending” different lots of the same grain to meet a customer's quality specifications to be a practical necessity for product distribution and, thus, to be within the definition of “holding” (see 79 FR 58476 at 58483). However, we use the term “mixing” when the RACs are different. For example, we consider the activity of “mixing” corn and oats in the production of animal food to be manufacturing/processing, because mixing two different foods is “making food from one or more ingredients” (which is our definition of “manufacturing/processing”) and the animal food produced by mixing corn and oats is a processed food.

We classify “mixing” intact RACs that does not create a processed animal food as incidental to, and therefore part of, “packing” or “holding” as applicable. For example, mixing heads or bunches of lettuce does not create a processed food, because the mixing has not created a distinct commodity, but only a set of mixed RACs. On the other hand, mixing that creates a processed animal food is not “packing” or “holding.” The definitions of both “packing” and “holding” are limited so that they do not include activities that transform a RAC into processed animal food. Some kinds of mixing of RACs does create a distinct commodity (for example, mixing corn and oats to make animal food). In such cases, the mixing is manufacturing/processing and is not within the farm definition.

(Comment 36) Some comments ask us to clarify whether the expanded definition of holding that we proposed in the 2014 supplemental human preventive controls notice would mean that a warehouse that both stores and fumigates a RAC to prevent pest infestation would be exempt from the requirements for hazard analysis and risk-based preventive controls for a facility solely engaged in the storage of RACs (other than fruits and vegetables) for further distribution or processing (§ 507.5).

(Response 36) Fumigating RACs to prevent pest infestation would be within the definition of “holding” and therefore would not prevent a facility that stores RACs (other than fruits and vegetables) from being eligible for the exemption in § 507.5(g), provided that the facility does not conduct other activities not classified as “holding.” However, a threshold question for any facility solely engaged in the storage of RACs is whether the stored RACs are fruits or vegetables.

(Comment 37) Some comments ask us to clarify whether there is a timeframe associated with holding and to better distinguish between “holding” and “storage.”

(Response 37) There is no timeframe (maximum or minimum) associated with holding. The definition of holding

states “Holding means storage of food” and, thus, there is no distinction between “holding” and “storing.”

(Comment 38) Some comments ask us to clarify how the definition of holding relates to practices, such as fumigation, on almond hull stockpiles held on a farm, a farm mixed-type facility or off-farm.

(Response 38) Practices that are incidental to storage of food, such as fumigation of almond hull stockpiles, are holding, regardless of whether they are conducted on-farm, on a farm mixed-type facility, or off-farm.

(Comment 39) Some comments ask us to clarify that value added activities (such as repacking and blast freezing) conducted in facilities such as warehouses would be considered holding when product is not exposed to the environment.

(Response 39) We consider the activities described in these comments to be activities performed as a practical necessity for the distribution of the food and, thus, to be within the definition of holding.

(Comment 40) Several comments do not support the proposed definition of “holding” stating that the definition would exempt grain receiving and storage facilities that are the primary suppliers of the main ingredient in many animal foods including distiller's products. Some comments ask us to clarify what is a practical necessity.

(Response 40) Section 418(m) of the FD&C Act provides us with the authority to exempt certain facilities from the requirements of section 418, or to modify those requirements. We proposed to use this authority to exempt facilities that solely engage in the storage (holding) of RACs (other than fruits and vegetables) intended for further distribution or processing. We tentatively concluded that there would not be significant public (human and animal) health benefit to be gained by having these facilities subject to the requirements of subpart C. Outbreaks of illness associated with feeding RACs to animals have not been traced back to storage facilities solely engaged in the storage of RACs, therefore we think it is appropriate to exempt them from the requirements of subparts C and E of the final rule. Such facilities remain subject to the requirements of section 402 of the FD&C Act that the animal food being held is not adulterated.

The revised definition of “holding” encompasses activities performed as a practical necessity for the distribution of RACs, such as blending of the same RAC and breaking down pallets. Sampling for grading or quality control purposes, repacking, and drying grains and oilseeds would also be considered performed as a practical necessity for the distribution of animal food within the definition of “holding.”

13. Known or Reasonably Foreseeable Hazard

We proposed to define the term “known or reasonably foreseeable hazard” to mean a biological, chemical (including radiological), or physical hazard that has the potential to be associated with the facility or the food.

(Comment 41) Some comments support the definition as proposed, noting that it implies that the implementation of a preventive control be based both on the severity and likelihood of the hazard, can help to distinguish between the requirements of this rule and HACCP requirements, and provides for the proper consideration of both the food and the facility when determining whether a hazard is “known or reasonably foreseeable.” Other comments ask us to modify the definition to specify that the term means a hazard “that is known to be, or has the potential to be, associated with the facility or the food” to better align with the term as FDA proposed to define it in the proposed FSVP rule. (See 79 FR 58574 at 58595.)

(Response 41) We have revised the definition as requested by the comments to better align with the proposed FSVP rule.

(Comment 42) Some comments ask us to revise the definition so that it addresses a hazard that is known to be, or has the potential to be, associated with a food, the facility in which it is manufactured/processed, or the location or type of farm on which it is grown or raised. These comments assert that the type of farm may affect those hazards that are known or reasonably foreseeable.

(Response 42) We decline this request, which appears related to another difference between the definition proposed in this rule and the definition of this term in the proposed FSVP rule. The proposed FSVP rule would define “known or reasonably foreseeable hazard” as a hazard that is known to be, or has the potential to be, associated with a food or the facility “in which it is manufactured/processed.” (See 79 FR 58574 at 58595.) In this rule, we do not need to specify that the applicable facility is the one “in which the food is manufactured/processed” because this rule applies to the owner, operator, or agent in charge of the facility in which the food is manufactured, processed, packed, or held, and that applicability does not need to be repeated in each provision. To the extent that this comment is expressing concern about raw materials or other ingredients that a facility would receive from a farm, those concerns would be considered in the facility's hazard analysis, which would include a hazard evaluation that considers factors such as those related to the source of raw materials and other ingredients (see § 507.33(d)(3)).

14. Lot

We proposed to define “lot” to mean the food produced during a period of time indicated by a specific code.

(Comment 43) Some comments state that many animal food processors operate on a batch-production basis rather than a continuous-production basis and request that we take this into account with respect to the definition of “lot.” Other comments suggest replacing “lot” with “lot identifier” where “lot identifier” means a unique identifier for each lot, batch or production run that enables the manufacturer to trace accurately the complete manufacturing and distribution history of the product. Other comments ask us to modify the proposed definition so that it is not limited by a period of time and suggest using an approach that would allow for a lot to be defined by either time or by a specific identifier. Other comments express the view that the individual operators should be able to define their lot designations and make these definitions available to FDA upon request.

(Response 43) Although the term “lot” is associated with a period of time, an establishment has flexibility to determine the code, with or without any indication of time in the code. For example, a code could be based on a date, time of day, production characteristic (such as origin, variety, and type of packing), combination of date/time/production characteristic, or any other method that works best for the establishment. To clarify that the rule does not require that time be “indicated” by the code, and emphasize the establishment's flexibility to determine the code, we have revised “period of time indicated by a specific code” to “period of time and identified by an establishment's specific code.”

15. Manufacturing/Processing

We proposed to define “manufacturing/processing” to mean making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. We proposed that examples of manufacturing/processing activities would be cutting, peeling, trimming,

washing, waxing, eviscerating, rendering, cook

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