Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Federal RegisterSep 17, 2015
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211
[Docket No. FDA-2011-N-0920]
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for “farms” and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system.
DATES:
This rule is effective November 16, 2015, except for the amendment to part 110 in instruction 13, which is effective September 17, 2018 and paragraph (2) of the definition of “qualified auditor” in § 117.3, and §§ 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) and 117.475(c)(13). FDA will publish a document in the
Federal Register
announcing the effective dates of paragraph (2) of the definition of “qualified auditor” in § 117.3, and §§ 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 117.475(c)(13). See section LVI for the compliance dates.
FOR FURTHER INFORMATION CONTACT:
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.
SUPPLEMENTARY INFORMATION:
Table of Contents
Executive Summary
Purpose and Coverage of the Rule
Summary of the Major Provisions of the Rule
Costs and Benefits
I. Background
A. FDA Food Safety Modernization Act
B. Stages in the Rulemaking for the Human Preventive Controls Rule
C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule
D. Draft Risk Assessment
E. Definition of “Retail Food Establishment”
F. Public Comments
II. Legal Authority
A. Changes to Current 21 CFR Part 1, Subparts H, I, and J
B. Changes to Current 21 CFR Part 110
C. Hazard Analysis and Risk-Based Preventive Controls
D. Comments on Legal Authority
III. General Comments on the Proposed Rule
IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)
A. Definitions That Impact a Determination of Whether an Establishment Is a “Farm”
B. Proposed Revisions to the Definition of Farm
C. Proposed New Definition of Harvesting
D. Proposed Revision to the Definition of Holding
E. Proposed Revision to the Definition of Manufacturing/Processing
F. Proposed New Definition of Mixed-Type Facility
G. Proposed Revision to the Definition of Packing
V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act
VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities
A. Section 103(c)(1)(C) of FSMA
B. Comments on Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition
C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-Type Facilities Under Section 421 of the FD&C Act
VII. Comments on Proposed General Revisions to Current Part 110 (Final Part 117)
A. Title of Part 117
B. Proposed Revisions for Consistency of Terms
C. Proposed Additions Regarding Allergen Cross-Contact
D. Proposed Revisions for Consistency With the Definition of “Food”
E. Proposed Revisions To Address Guidance in Current Part 110
F. Proposed Editorial Changes
G. General Comments on Current Part 110 (Final Part 117)
VIII. Subpart A: Comments on Proposed § 117.1—Applicability and Status
A. Comments on Proposed § 117.1(a)—Applicability
B. Comments on Proposed § 117.1(b)—Prohibited Act
C. Comments on Proposed § 117.1(c)—Specific CGMP Requirements
IX. Subpart A: Comments on Proposed § 117.3—Definitions
A. Redesignation
B. Definitions in Current Part 110 That We Proposed To Delete
C. Definitions That We Proposed To Establish in Part 117
D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule
E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule
X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food
A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food (Final § 117.4(a), (b), and (d))
B. Additional Requirements Applicable to Supervisory Personnel (Final § 117.4(c))
XI. Subpart A: Comments on Proposed § 117.5—Exemptions
A. General Comments on the Proposed Exemptions
B. Proposed § 117.5(a)—Exemption Applicable to a Qualified Facility
C. Proposed § 117.5(b) and (c)—Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products (21 CFR Part 123) or for Juice (21 CFR Part 120)
D. Proposed § 117.5(d)—Exemption Applicable to Food Subject to Part 113—Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers
E. Proposed § 117.5(e)—Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement
F. Proposed § 117.5(f)—Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act
G. Proposed §§ 117.5(g) and (h)—Exemptions Applicable to On-Farm Low-Risk Activity/Food Combinations Conducted by a Small or Very Small Business
H. Proposed § 117.5(i)—Exemption Related to Alcoholic Beverages
I. Proposed § 117.5(j)—Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and
Vegetables Intended for Further Distribution or Processing
J. Proposed § 117.5(k)—Exemption Applicable to Farms, Fishing Vessels, Activities of “Farm Mixed-Type Facilities” Within the Definition of “Farm,” the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities
K. Comments Requesting Additional Exemptions
XII. Subpart A: Comments on Proposed § 117.7—Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food
XIII. Subpart B: Comments on Proposed § 117.10—Personnel
A. Management Responsibility for Requirements Applicable to Personnel
B. Proposed § 117.10(a)—Disease Control
C. Proposed § 117.10(b)—Cleanliness
XIV. Subpart B: Comments on Proposed § 117.20—Plant and Grounds
A. Proposed § 117.20(a)—Grounds
B. Proposed § 117.20(b)—Plant Construction and Design
XV. Subpart B: Comments on Proposed § 117.35—Sanitary Operations
A. Proposed § 117.35(a)—General Maintenance
B. Proposed § 117.35(b)—Substances Used in Cleaning and Sanitizing; Storage of Toxic Materials
C. Proposed § 117.35(c)—Pest Control
D. Proposed § 117.35(d)—Sanitation of Food-Contact Surfaces
E. Proposed § 117.35(d)(1)—Food-Contact Surfaces Used for Manufacturing/Processing or Holding
F. Proposed § 117.35(d)(2)—Wet Cleaning
G. Proposed § 117.35(d)(3)—Single-Service Articles
H. Proposed § 117.35(e)—Sanitation of Non-Food-Contact Surfaces
I. Proposed § 117.35(f)—Storage and Handling of Cleaned Portable Equipment and Utensils
XVI. Subpart B: Comments on Proposed § 117.37—Sanitary Facilities and Controls
A. Proposed § 117.37(a)—Water Supply
B. Proposed § 117.37(b)—Plumbing
C. Proposed § 117.37(c)—Sewage Disposal
D. Proposed § 117.37(d)—Toilet Facilities
E. Proposed § 117.37(e)—Hand-Washing Facilities
XVII. Subpart B: Comments on Proposed § 117.40—Equipment and Utensils
A. Proposed § 117.40(a)—Design, Construction, Use, Installation, and Maintenance of Equipment and Utensils
B. Proposed § 117.40(b)—Seams on Food-Contact Surfaces
C. Proposed § 117.40(c)—Construction of Equipment
D. Proposed § 117.40(d)—Holding, Conveying, and Manufacturing Systems
E. Proposed § 117.40(e)—Freezer and Cold Storage Compartments
F. Proposed § 117.40(f)—Accurate and Precise Instruments and Controls
G. Proposed § 117.40(g)—Compressed Air or Other Gases
XVIII. Subpart B: Comments on Proposed § 117.80(a)—General Processes and Controls
A. Proposed § 117.80(a)(1)—Adequate Sanitation Principles
B. Proposed § 117.80(a)(2)—Quality Control Operations
C. Proposed § 117.80(a)(3)—Supervision of Overall Sanitation
D. Proposed § 117.80(a)(4)—Production Procedures
E. Proposed § 117.80(a)(5)—Chemical, Microbial, or Extraneous-Material Testing Procedures
F. Proposed § 117.80(a)(6)—Contaminated Food
XIX. Subpart B: Comments on Proposed § 117.80(b)—Processes and Controls for Raw Materials and Other Ingredients
A. Proposed § 117.80(b)(1)—Inspection, Segregation and Handling of Raw Materials and Other Ingredients
B. Proposed § 117.80(b)(2)—Levels of Microorganisms in Raw Materials and Other Ingredients
C. Proposed § 117.80(b)(3)—Natural Toxins in Raw Materials and Other Ingredients
D. Proposed § 117.80(b)(4)—Pests, Undesirable Microorganisms and Extraneous Materials in Raw Materials and Other Ingredients
E. Proposed § 117.80(b)(5)—Holding Raw Materials, Other Ingredients, and Rework in Bulk
F. Proposed § 117.80(b)(7)—Liquid or Dry Raw Materials and Other Ingredients
G. Proposed § 117.80(b)(8)—Raw Materials and Other Ingredients That Are Food Allergens
XX. Subpart B: Comments on Proposed § 117.80(c)—Manufacturing Operations
A. Proposed § 117.80(c)(1)—Condition of Equipment, Utensils, and Finished Food Containers
B. Proposed § 117.80(c)(2)—Conditions and Controls for Food Manufacturing, Processing, Packing, and Holding
C. Proposed § 117.80(c)(3)—Food That Can Support the Rapid Growth of Undesirable Microorganisms
D. Proposed § 117.80(c)(4)—Measures To Destroy or Prevent the Growth of Undesirable Microorganisms
E. Proposed § 117.80(c)(5)—Work-in-Process and Rework
F. Proposed § 117.80(c)(6)—Finished Food
G. Proposed § 117.80(c)(7)—Equipment, Containers, and Utensils
H. Proposed § 117.80(c)(8)—Metal or Other Extraneous Material
I. Proposed § 117.80(c)(9)—Disposal of Adulterated Food, Raw Materials, and Other Ingredients
J. Proposed § 117.80(c)(10)—Performing Manufacturing Steps
K. Proposed § 117.80(c)(11)—Heat Blanching and Growth and Contamination by Thermophilic Microorganisms During Manufacturing Operations
L. Proposed § 117.80(c)(12)—Batters, Breading, Sauces, Gravies, Dressings, and Other Similar Preparations
M. Proposed § 117.80(c)(13)—Filling, Assembling, Packaging and Other Operations
N. Proposed § 117.80(c)(14)—Food That Relies on the Control of Water Activity for Preventing the Growth of Undesirable Microorganisms
O. Proposed § 117.80(c)(15)—Food That Relies on the Control of pH for Preventing the Growth of Undesirable Microorganisms
P. Proposed § 117.80(c)(16)—Requirements for Ice Used in Contact With Food
Q. Proposed Deletion of Current § 110.80(b)(17)—Food-Manufacturing Areas and Equipment
XXI. Subpart B: Comments on Proposed § 117.93—Warehousing and Distribution
XXII. Subpart B: Comments on Proposed § 117.110—Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard
XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and Risk-Based Preventive Controls
XXIV. Subpart C: Comments on Proposed § 117.126—Food Safety Plan
A. Proposed § 117.126(a)(1)—Requirement for a Food Safety Plan
B. Proposed § 117.126(a)(2)—Preparation of the Food Safety Plan by a Preventive Controls Qualified Individual
C. Proposed § 117.126(b)—Contents of a Food Safety Plan
D. Proposed § 117.126(c)—Records
E. Comments on Potential Requirements for Submission of a Facility Profile to FDA
XXV. Subpart C: Comments on Proposed § 117.130—Hazard Analysis
A. Proposed § 117.130(a)—Requirement for a Written Hazard Analysis
B. Proposed § 117.130(b)—Hazard Identification
C. Proposed § 117.130(c)—Evaluation of Whether a Hazard Requires a Preventive Control
XXVI. Subpart C: Comments on Proposed § 117.135—Preventive Controls
A. Proposed § 117.135(a)—Requirement To Identify and Implement Preventive Controls
B. Proposed § 117.135(b)—Requirement for Written Preventive Controls
C. Proposed § 117.135(c)(1)—Process Controls
D. Proposed § 117.135(c)(2)—Food Allergen Controls
E. Proposed § 117.135(c)(3)—Sanitation Controls
F. Proposed § 117.135(c)(4)—Supply-Chain Controls
G. Proposed § 117.135(c)(5)—Recall Plan
H. Proposed § 117.135(c)(6)—Other Controls
XXVII. Subpart C: Circumstances in Which the Owner, Operator, or Agent in Charge of a Manufacturing/Processing Facility Is Not Required To Implement a Preventive Control (Final §§ 117.136 and 117.137)
XXVIII. Subpart C: Comments on Proposed Requirements for a Recall Plan (Final § 117.139)
A. Proposed § 117.137(a)—Requirement for a Written Recall Plan (Final § 117.139(a))
B. Proposed § 117.137(b)—Procedures That Describe the Steps To Be Taken, and Assign Responsibility for Taking Those Steps (Final § 117.139(b))
XXIX. Comments on Proposed § 117.140—Preventive Control Management Components
A. Proposed § 117.140(a)—Flexible Requirements for Monitoring, Corrective Actions and Corrections, and Verification
B. Proposed § 117.140(b)—Applicability of Preventive Control Management Components to the Supply-Chain Program
C. Proposed § 117.140(c)—Recall Plan is Not Subject to Preventive Control Management Components
XXX. Subpart C: Comments on Proposed § 117.145—Monitoring
A. Our Tentative Conclusion To Require Monitoring of the Performance of Preventive Controls
B. Proposed § 117.145(a)—Flexibility in Requirements for Monitoring
C. Proposed § 117.145(b)—Records
XXXI. Subpart C: Comments on Proposed § 117.150—Corrective Actions and Corrections
A. Proposed § 117.150(a)(1)—Requirement To Establish and Implement Corrective Action Procedures
B. Proposed § 117.150(a)(2)—Content of Corrective Action Procedures
C. Proposed § 117.150(b)—Corrective Action in the Event of an Unanticipated Problem
D. Proposed § 117.150(c)—Corrections
E. Proposed § 117.150(d)—Records
XXXII. Subpart C: Comments on Proposed § 117.155—Verification
A. Flexibility in Requirements for Verification
B. Proposed § 117.155(a)—Verification Activities
C. Proposed § 117.155(b)—Documentation of Verification Activities
D. Comments on Potential Requirements Regarding Complaints
XXXIII. Subpart C: Comments on Proposed § 117.160—Validation
A. Flexibility in the Requirements To Validate Preventive Controls
B. Proposed § 117.160(b)(1)—When Validation Must Be Performed and Role of the Preventive Controls Qualified Individual in Validation
C. Proposed § 117.160(b)(2)—What Validation Must Include
D. Proposed § 117.160(b)(3)—Preventive Controls for Which Validation Is Not Required
XXXIV. Subpart C: Comments on Proposed § 117.165—Verification of Implementation and Effectiveness
A. Flexibility in the Requirements To Conduct Activities To Verify Implementation and Effectiveness
B. Proposed § 117.165(a)(1)—Calibration
C. Comments Directed to Proposed Requirements for Both Product Testing (Proposed § 117.165(a)(2) and (b)(2)) and Environmental Monitoring (Proposed § 117.165(a)(3) and (b)(3))
D. Proposed § 117.165(a)(2)—Product Testing
E. Proposed § 117.165(a)(3)—Environmental Monitoring
F. Proposed § 117.165(a)(4)—Review of Records
G. Proposed § 117.165(b)—Written Procedures
XXXV. Subpart C: Comments on Proposed § 117.170—Reanalysis
A. Proposed § 117.170(a)—Circumstances Requiring Reanalysis
B. Proposed § 117.170(b)—Timeframe To Complete Reanalysis
C. Proposed § 117.170(c)—Requirement To Revise the Written Food Safety Plan or Document Why Revisions Are Not Needed
D. Proposed § 117.170(d)—Requirement for Oversight of Reanalysis by a Preventive Controls Qualified Individual
E. Proposed § 117.170(e)—Reanalysis on the Initiative of FDA
XXXVI. Subpart C: Comments on Proposed § 117.180—Requirements Applicable to a Preventive Controls Qualified Individual and a Qualified Auditor
A. Proposed § 117.180(a) and (b)—What a Preventive Controls Qualified Individual or Qualified Auditor Must Do or Oversee
B. Proposed § 117.180(c)—Qualification Requirements
C. Proposed § 117.180(d)—Records
XXXVII. Subpart C: Comments on Proposed § 117.190—Implementation Records
A. Proposed § 117.190(a)—List of Required Records
B. Proposed § 117.190(b)—Applicability of Subpart F
XXXVIII. Subpart D: Comments on Proposed § 117.201—Modified Requirements That Apply to a Qualified Facility
A. Comments on Submission of a Certification Statement
B. General Comments on Modified Requirements That Apply to a Qualified Facility
C. Proposed § 117.201(a)—Documentation To Be Submitted
D. Proposed § 117.201(b)—Procedure for Submission
E. Proposed § 117.201(c)—Frequency of Determination and Submission
F. Proposed § 117.201(d)—Notification to Consumers (Final § 117.201(e))
G. Proposed § 117.201(e)—Records (Final § 117.201(f))
XXXIX. Subpart D: Comments on Proposed § 117.206—Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Unexposed Packaged Food
A. Proposed § 117.206(a)—Modified Requirements for Unexposed Refrigerated Packaged Food That Requires Time/Temperature Controls
B. Proposed § 117.206(b)—Records
XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of a Qualified Facility Exemption
A. Proposed § 117.251—Circumstances That May Lead FDA To Withdraw a Qualified Facility Exemption
B. Proposed § 117.254—Issuance of an Order To Withdraw a Qualified Facility Exemption
C. Proposed § 117.257—Contents of an Order To Withdraw a Qualified Facility Exemption
D. Proposed § 117.260—Compliance With, or Appeal of, an Order To Withdraw a Qualified Facility Exemption
E. Proposed § 117.264—Procedure for Submitting an Appeal
F. Proposed § 117.267—Procedure for Requesting an Informal Hearing
G. Proposed § 117.270—Requirements Applicable to an Informal Hearing
H. Proposed § 117.287—Reinstatement of a Qualified Facility Exemption That Was Withdrawn
I. Conforming Amendment to 21 CFR part 16
J. Other Comments on the Withdrawal Provisions
XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements
A. Proposed § 117.301—Records Subject to the Requirements of Subpart F
B. Proposed § 117.305—General Requirements Applying to Records
C. Proposed § 117.310—Additional Requirements Applying to the Food Safety Plan
D. Proposed § 117.315—Requirements for Record Retention
E. Proposed § 117.320—Requirements for Official Review
F. Proposed § 117.325—Public Disclosure
G. Proposed § 117.330—Use of Existing Records
H. Final § 117.335—Special Requirements Applicable to a Written Assurance
I. Other Comments on the Recordkeeping Requirements of Subpart F
XLII. Subpart G: General Comments on Proposed Requirements for a Supply-Chain Program
XLIII. Subpart G: Comments on Requirement To Establish and Implement a Supply-Chain Program
A. Requirement for a Written Supply-Chain Program (Final § 117.405(a)(1) and (b))
B. Circumstances That Do Not Require a Written Supply-Chain Program (Final § 117.405(a)(2))
C. Exemption for Food Supplied for Research or Evaluation (Final § 117.405(a)(3))
D. Additional Requirements for Non-Suppliers (Final § 117.405(c))
E. Proposed General Requirements for the Supply-Chain Program That We Are Not Including in the Final Rule (Proposed § 117.136(a)(4) and (5))
XLIV. Subpart G: Comments on General Requirements Applicable to a Supply-Chain Program
A. Description of What the Supply-Chain Program Must Include (Final § 117.410(a))
B. Appropriate Supplier Verification Activities ((Final § 117.410(b))
C. Purpose of Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 117.410(c))
D. Factors That Must Be Considered When Approving Suppliers and Determining Appropriate Supplier Verification Activities for Raw Materials and Other Ingredients (Final § 117.410(d))
E. Supplier Non-Conformance (Final § 117.410(e))
XLV. Subpart G: New Requirement Specifying Responsibilities of the Receiving Facility (Final § 117.415)
XLVI. Subpart G: Comments on Using Approved Suppliers and Determining Appropriate Supplier Verification Activities
A. Using Approved Suppliers (Final § 117.420)
B. Determining Appropriate Verification Activities (Final § 117.425)
XLVII. Subpart G: Comments on Conducting Supplier Verification Activities for Raw Materials and Other Ingredients
A. Requirement to Conduct One or More Supplier Verification Activities (Final § 117.430(a))
B. Requirement for an Onsite Audit as a Verification Activity When a Hazard Has a Reasonable Probability of Resulting in Serious Adverse Health Consequences or Death to Humans (Final § 117.430(b))
C. Alternative Verification Activity When the Supplier Is a Qualified Facility (Final § 117.430(c))
D. Alternative Verification Activity When the Supplier Is a Produce Farm That Is Not a “Covered Farm” for the Purposes of the Future Produce Safety Rule (Final § 117.430(d))
E. Alternative Verification Activity When the Supplier Is a Shell Egg Producer That Has Less Than 3,000 Laying Hens (Final § 117.430(e))
F. Independence of Persons Who Conduct Supplier Verification Activities (Final § 117.430(f))
XLVIII. Subpart G: Comments on Onsite Audit
A. Requirements Applicable to an Onsite Audit (Final § 117.435(a) and (b))
B. Substitution of Inspection by FDA or an Officially Recognized or Equivalent Food Safety Authority
C. Onsite Audit by a Third-Party Auditor Accredited for the Purposes of Section 808 of the FD&C Act
XLIX. Subpart G: Comments on Records Documenting the Supply-Chain Program
A. Applicability of the Recordkeeping Requirements of Subpart F (Final § 117.475(a))
B. Requirement To Review Records of the Supply-Chain Program (Final § 117.475(b))
C. Documentation Demonstrating Use of the Written Procedures for Receiving Raw Materials and Other Ingredients (Final § 117.475(c)(5))
D. Documentation of the Conduct of an Onsite Audit (Final § 117.475(c)(7))
E. Documentation of Sampling and Testing (Final § 117.475(c)(8))
F. Documentation of Other Appropriate Supplier Verification Activity (Final § 117.475(c)(10))
G. Documentation of an Alternative Verification Activity for a Supplier That Is a Farm That Is Not a “Covered Farm” for the Purposes of the Future Produce Safety Rule (Final § 117.475(c)(13))
L. Holding Human Food By-Products Intended for Use in Animal Food
LI. Comments by Foreign Governments and Foreign Businesses
LII. Editorial and Conforming Changes
LIII. Comments on FSMA's Rulemaking Provisions
A. Comments on Requirements in Section 418(n)(3) of the FD&C Act Regarding Content
B. Comments on Requirements in Section 418(n)(5) of the FD&C Act Regarding Review of Hazard Analysis and Preventive Controls Programs in Existence on the Date of Enactment of FSMA
LIV. Comments on Proposed Removal of 21 CFR part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
LV. Comments on Proposed Conforming Amendments
LVI. Effective and Compliance Dates
A. Effective and Compliance Dates for Part 117
B. Effective and Compliance Dates for Revisions to Part 1
C. Effective Dates for Conforming Amendments
D. Delayed Effective Dates for Provisions That Refer to the Forthcoming Rules for Produce Safety and Third-Party Certification
LVII. Compliance and Enforcement
LVIII. Executive Order 13175
LIX. Economic Analysis of Impacts
LX. Analysis of Environmental Impact
LXI. Paperwork Reduction Act of 1995
LXII. Federalism
LXIII. References
Executive Summary
Purpose and Coverage of the Rule
This rule is part of FDA's implementation of the FDA Food Safety Modernization Act (FSMA), which intends to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. This rule creates certain new requirements for the production of human food by registered food facilities, and revises previous requirements, in three key ways.
First, this rule creates new requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. In general, these requirements apply to establishments that are required to register with FDA as a food “facility.” This portion of the rule requires registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards, unless an exemption applies. Facilities must also monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions.
Second, this rule modernizes FDA's long-standing current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food. We have updated, revised, and otherwise clarified certain requirements within the CGMP regulations, which were last updated in 1986.
Third, this rule clarifies the scope of the exemption for “farms” in FDA's current food facility registration regulations and makes corresponding revisions to FDA's current regulations for the establishment, maintenance, and availability of records. These revisions affect who is subject to the existing regulations for registration and recordkeeping, as well as the new requirements for hazard analysis and risk-based preventive controls requirements established here.
This final rule is the result of significant stakeholder engagement, beginning before the proposed rule. In response to extensive stakeholder input on the proposed rule, we revised key provisions in a supplemental notice of proposed rulemaking. After the supplemental notice of proposed rulemaking, we conducted even more outreach to the stakeholder community to ensure that the risk-based, preventive requirements in this final rule are practical and protective of public health.
Summary of the Major Provisions of the Rule
The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the rule establishes requirements for:
• A written food safety plan;
• Hazard analysis;
• Preventive controls;
• Monitoring;
• Corrective actions and corrections;
• Verification;
• Supply-chain program;
• Recall plan; and
• Associated records.
We have added flexibility and clarity to these provisions in response to comments. Although there are similarities between these requirements of FSMA and the requirements of food safety systems known as Hazard Analysis and Critical Control Point (HACCP) systems, not every provision in FSMA is identical to the provisions of HACCP systems, and we have revised much of our terminology to distinguish FSMA's requirements for hazard analysis and risk-based preventive controls from HACCP requirements. A facility subject to the rule must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether
there are any hazards requiring preventive controls. The first step of a hazard analysis is hazard identification, which must consider known or reasonably foreseeable hazards, including biological, chemical, and physical hazards. The hazard analysis must consider hazards that may be present in the food because they occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain. We continue to believe that hazards that may be intentionally introduced for economic gain will need preventive controls in rare circumstances, usually in cases where there has been a pattern of economically motivated adulteration in the past. Economically motivated adulteration that affects product integrity or quality, for example, but not food safety, is out of the scope of this rule.
A facility subject to the rule must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. The rule establishes preventive control management components (monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls. One way we have clarified the risk-based flexibility of these requirements is by clearly stating in the final rule that a facility must take into account the nature of the preventive control and the facility's food safety system when considering which activities are appropriate for that facility.
We have also added flexibility and made risk-based modifications for specific preventive control management components. For example, the final rule allows flexibility for the specific records required to document monitoring of refrigeration controls during storage of a food that requires time/temperature control for safety. These records can be either affirmative records demonstrating temperature is controlled or “exception records” demonstrating loss of temperature control. As another example, the rule includes tailored, less burdensome requirements for corrections. A correction is defined in this rule as an action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce). The final rule clarifies that corrections must be taken in a timely manner and must be recorded when appropriate, but they do not, for example, need to be included in a written plan or accompanied by a reanalysis of the written food safety plan.
As a third example, the final rule provides flexibility for which verification activities must occur. In general, a facility is required to conduct verification activities, as appropriate to the nature of the preventive control and its role in the facility's food safety system, including validation, verification of monitoring, verification of corrective actions, verification of implementation and effectiveness, and reanalysis. Validation is not required for all controls. For example, the rule specifies that validation is not required for certain types of preventive controls (
i.e.,
food allergen controls, sanitation controls, supply-chain controls, and the recall plan) and provides flexibility for the facility to not validate other preventive controls with a written justification based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility's food safety system. Product testing and environmental monitoring are listed as possible verification activities, but, like other preventive control management components in general, they are only required as appropriate to the food, facility, the nature of the preventive control, and the preventive control's role in the facility's food safety system. In many cases, neither product testing nor environmental monitoring will be appropriate. For example, there would be little or no benefit to product testing or environmental monitoring in facilities that pack or hold produce raw agricultural commodities that are rarely consumed raw, such as potatoes.
A facility must reanalyze the food safety plan as a whole at least once every three years. The final rule provides the flexibility for a facility to only reanalyze the applicable portion of the food safety plan under certain other circumstances, such as when a facility becomes aware of new information about potential hazards associated with a food.
The final rule also adds flexibility to the preventive controls requirements and recognizes the reality of modern distribution chains by not requiring a manufacturing/processing facility to implement a preventive control in certain circumstances when the hazard requiring a preventive control will be controlled by another entity in the distribution chain. For example, if a facility's customer (or another entity in the distribution chain) will control the hazard, then that facility can rely on its customer to provide written assurance that the identified hazard will be controlled by an entity in the distribution chain, with flexibility for how the customer provides that written assurance depending on whether the customer, or an entity subsequent to the customer, will control the hazard. We have identified four specific circumstances in which a manufacturing/processing facility can rely on another entity in the distribution chain to control a hazard, with practical solutions explained further in section XXVII. We also have provided flexibility for a facility to establish, document, and implement an alternative system that ensures adequate control, at a later distribution step, of the hazards in the food product distributed by a manufacturing/processing facility such that the facility would not need to implement a preventive control.
We revised the proposed provisions for a supplier program to add flexibility, recognizing that the receiving facility and the supplier may be separated by several entities in a supply chain. We are allowing entities such as distributors, brokers, and aggregators to determine, conduct, and document appropriate supplier verification activities as a service to the receiving facility, provided that the receiving facility reviews and assesses applicable documentation provided by the other entity and documents that review and assessment. However, because the approval of suppliers is ultimately the responsibility of the receiving facility, the rule specifies that only a receiving facility can approve suppliers. To improve clarity and readability we redesignated the proposed provisions into eight distinct sections of regulatory text in a newly established subpart G (Supply-Chain Program).
Each facility subject to the rule must have a recall plan for a food with a hazard requiring a preventive control.
Many activities required by the final rule must be conducted (or overseen) by a preventive controls qualified individual, a new term we are coining here. A preventive controls qualified individual is a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.
The rule establishes several exemptions (including modified requirements in some cases) from the requirements for hazard analysis and risk-based preventive controls. All of
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 and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee)
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 food was manufactured or processed.
• The notification is in the form of an attestation, and must be submitted every two years, during the same timeframe as the facility is required to update its facility registration.
• Low-risk, on-farm activities performed by small business (<500 full-time equivalent employees)
-or-
• Low-risk, on-farm activities performed by a very small business (dollar threshold of $1,000,000, as described previously)
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.
We define the low-risk, on-farm activities that qualify for the exemption, including the specific foods to which they relate (such as making jams, jellies, and preserves from acid fruits, and making milled grain products such as cornmeal).
Activities that are subject to the seafood HACCP requirements of part 123 (21 CFR part 123)
The facility must be in compliance with part 123.
Activities that are subject to the juice HACCP requirements of part 120 (21 CFR part 120)
The facility must be in compliance with part 120.
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.
The manufacturing, processing, packaging, or holding of a dietary supplement that is subject to the CGMP requirements of part 111 (21 CFR part 111)
• The facility must be in compliance with part 111.
• The facility must be in compliance with requirements for serious adverse event reporting for dietary supplements.
Activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety)
These activities will be established in FDA's forthcoming rule for produce safety.
Alcoholic beverages at a facility that is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States
The exemption also applies to food other than alcoholic beverages at such a facility, provided that the food is in prepackaged form and constitutes not more than 5 percent of the overall sales of the facility.
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 packaged food that is not exposed to the environment
Modified requirements apply for the storage of unexposed packaged food that must be refrigerated for safety.
The rule includes procedures for withdrawing a qualified facility exemption, in the event of an active investigation of a foodborne illness outbreak that is directly linked to the facility, or if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on relevant conditions or conduct associated with the qualified facility. The final rule provides procedures for a facility to appeal an order to withdraw a qualified facility exemption, for a facility to request an informal hearing, for the conduct of an informal hearing, for an appeal, for revoking an order to withdraw a qualified facility exemption, and for reinstating an exemption that was withdrawn.
The rule finalizes recordkeeping provisions associated with the new provisions for hazard analysis and risk-based preventive controls. These records allow facilities to show, and FDA to determine, compliance with the new requirements. To meet these requirements, a facility may use existing records as appropriate.
In addition to finalizing new requirements for hazard analysis and risk-based preventive controls as required by FSMA, the rule does two more key things. First, it modernizes the existing CGMPs. Second, it revises the “farm” definition.
The rule makes several revisions to the CGMPs to update and clarify them. For example, the final CGMPs do not include nonbinding provisions, because it is no longer FDA's practice to include guidance in the regulatory text. The rule finalizes some of the previously nonbinding provisions in the CGMPs as binding requirements, including a requirement for education and training, but deletes other nonbinding provisions. We have revised some key terms for consistency and clarity. And we have clarified FDA's long-standing position that the CGMPs address allergen cross-contact by making that explicit in the regulatory text. Finally, the rule revises a long-standing exemption from the CGMP requirements regarding specific activities conducted on raw agricultural commodities to reflect the contemporary regulatory framework associated with the “farm” definition. In addition, elsewhere in this issue of the
Federal
Register
, in a final rule that establishes requirements for hazard analysis and risk-based preventive controls for food for animals, FDA is establishing an additional revision to the human food CGMPs to address comments about the practice of human food manufacturers sending by-products to local farmers or animal food manufacturers for use as animal food. Because we proposed these requirements as part of the rulemaking for the animal preventive controls rule, we are finalizing these provisions in the final animal preventive controls rule rather than in this rule.
Finally, the rule clarifies the “farm” definition that is central to the determination of whether certain entities must register as a food facility and, thus, become subject to the new requirements for hazard analysis and risk-based preventive controls. The final “farm” definition reflects current farming practices, differentiates between two types of farm operations (
i.e.,
a “primary production farm” and a “secondary activities farm”), and allows for a consistent—although not identical—regulatory approach across similar operations, to the extent possible. In general, a “primary production farm” is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. A farm packs and holds raw agricultural commodities and may conduct certain manufacturing/processing activities (
i.e.,
drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling). The term farm also now includes a “secondary activities farm,” which is an operation, not located on a primary production farm, devoted to the key farming operations of harvesting, packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grow, harvest, and/or raise the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm.
Costs and Benefits
This final regulation requires domestic and foreign facilities to adopt a food safety plan, perform a hazard analysis, and to institute preventive controls for the mitigation of those hazards. It also includes requirements for facilities to institute risk-based environmental monitoring, product testing, and a supply-chain program as appropriate to the food, the facility, and the nature of the preventive controls, as well as a requirement to institute controls to help prevent hazards associated with economically motivated adulteration. The total annualized domestic costs are estimated to be approximately $381 million per year, estimated with a 3 percent discount rate, and $382 million per year, estimated at 7 percent when discounted over 10 years. We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion. Our break-even analysis shows that for the rule to be cost effective, it would have to prevent $382 million worth of foodborne illness; approximately 17 percent of the total annual illnesses, or approximately 157,000 illnesses when using a discount rate of 7 percent. For the rule to be cost effective using a discount rate of 3 percent, it would have to prevent $381 million worth of foodborne illness (about 17 percent or 156,000 illnesses).
Costs and Health Benefits
[$ millions]
PCHF Provision
One-time cost
first yr compliance period
One-time cost
second yr compliance period
(small
businesses
<500 FTE's)
One-time cost
third yr compliance period
(very small
businesses
<$1 million)
Annual cost
(annually
recurring
costs)
Total annualized
cost at 7%
Total Annualized
cost at 3%
Learn about Rule
$6
$96
$21
$0
$16
$14
Total Costs Subparts A & D
17
148
88
15
43
41
Total Costs Subparts C & G
9
183
0
340
323
326
Total Domestic Costs
32
427
109
355
382
381
Total Foreign Costs
68
915
234
760
820
817
Total Costs
100
1,342
344
1,115
1,202
1,198
Total Health Benefits
Not Quantified. Break-even occurs when 157,000 illnesses are prevented per year (based on domestic costs discounted at 7 percent).
Table of Abbreviations and Acronyms
Abbreviation/acronym
What it means
Bioterrorism Act
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188).
CFSAN
Center for Food Safety and Applied Nutrition.
CGMP
Current Good Manufacturing Practice.
Codex
Codex Alimentarius Commission.
Codex Validation Guidelines.
Codex Guidelines for the Validation of Food Safety Control Measures.
CSA
Community Supported Agriculture.
CPG
Compliance Policy Guide.
EO
Executive Order.
EPA
U.S. Environmental Protection Agency.
EU
European Union.
FDA.
U.S Food and Drug Administration.
FD&C Act
Federal Food, Drug, and Cosmetic Act.
FSIS
Food Safety and Inspection Service of the U.S. Department of Agriculture.
FSIS Validation Guidelines
FSIS' Compliance Guidelines on HACCP Systems Validation.
FSMA
FDA Food Safety Modernization Act.
FSPCA
Food Safety Preventive Controls Alliance.
GFSI
Global Food Safety Initiative.
HACCP
Hazard Analysis and Critical Control Point.
HIPAA
Health Insurance Portability and Accountability Act of 1996.
Infant formula rule
Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula, June 10, 2014 (79 FR 33057).
ISO
International Organization for Standardization.
LACF
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (commonly called “Low-Acid Canned Foods”).
N/A
Not Applicable.
NCIMS
National Conference on Interstate Milk Shipments.
NIFA
National Institute of Food and Agriculture.
NOP
National Organic Program.
OMB
Office of Management and Budget.
PHS Act
Public Health Service Act.
PMO
Pasteurized Milk Ordinance.
PMO facilities
Facilities that comply with the PMO and are regulated under the NCIMS system.
PFP
Partnership for Food Protection.
PRA
Paperwork Reduction Act.
PSA
Produce Safety Alliance.
RAC
Raw agricultural commodity.
RFR
Reportable Food Registry.
Section 103(c)(1)(C) draft RA
Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm.
Section 103(c)(1)(C) RA
Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (Final).
SBA
Small Business Administration.
SECG
Small Entity Compliance Guide.
TCS food
Time/Temperature Control for Safety Food.
USDA
U.S. Department of Agriculture.
I. Background
A. FDA Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities. A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food. To that end, we proposed the seven foundational rules listed in table 1 and requested comments on all aspects of these proposed rules.
Table 1—Published Foundational Rules for Implementation of FSMA
Title
Abbreviation
Publication
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
2013 proposed human preventive controls rule
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
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
2013 proposed animal preventive controls rule
78 FR 64736, October 29, 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
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 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
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
2014 supplemental animal preventive controls notice
79 FR 58476, 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 (Ref. 1) (Ref. 2). As a result of this stakeholder dialogue, FDA decided to issue the four supplemental notices of proposed rulemaking to share our current thinking on key issues and get additional stakeholder input on those issues. As we move forward into the next phase of FSMA implementation, we intend to continue this dialogue and collaboration with our stakeholders, through guidance, education, training, and assistance, to ensure that everyone understands and engages in their role in food safety. FDA believes these seven foundational final rules, when implemented, will fulfill the paradigm shift toward prevention that was envisioned in FSMA and be a major step forward for food safety that will protect consumers into the future.
B. Stages in the Rulemaking for the Human Preventive Controls Rule
With regard to this rulemaking, we published proposed provisions in the 2013 proposed human preventive controls rule and we published new and re-proposed provisions in the 2014 supplemental human preventive controls notice. In the 2014 supplemental human preventive controls notice, we reopened the comment period only with respect to specific proposed provisions. In addition, we emphasized that the re-proposed provisions we included in the regulatory text were based on a preliminary review of the comments.
In this document, we use the broad term “proposed human preventive controls rule” to refer to the complete proposed regulatory text, including both the proposed provisions we published in the 2013 proposed human preventive controls rule and the new and re-proposed provisions we published in the 2014 supplemental human preventive controls notice. We use the narrow terms “2013 proposed human preventive controls rule” and “2014 supplemental human preventive controls notice” to refer to specific text published in the
Federal Register
of January 16, 2013 (78 FR 3646) and September 29, 2014 (79 FR 58524), respectively. We use the terms “final human preventive controls rule” and “this rule” to refer to the regulations we are establishing as a result of this rulemaking.
We issued a notice correcting several typographical and stylistic errors in the 2013 proposed human preventive controls rule and a mistake in the date of a reference (78 FR 17142, March 20, 2013). In that correction notice, we republished the Appendix in its entirety (78 FR 17142 at 17143 through 17155; the corrected Appendix) because all the references to the Appendix as published in the 2013 proposed human preventive controls rule (78 FR 3646 at 3812 through 3824) had been numbered incorrectly. We also extended the comment periods for the 2013 proposed human preventive controls rule, its information collection provisions, and a related risk assessment (see section I.D) in response to several requests that we do so.
C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule
As part of our announced initiative (Ref. 3) to revisit the CGMP requirements since they were last revised in 1986, we proposed to amend our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (currently established in part 110 (21 CFR part 110)) to: (1) Modernize it; (2) adjust and clarify what activities fall within the long-standing exemption from the CGMP requirements for establishments engaged solely in the harvesting, storage, or distribution of one or more raw agricultural commodities (RACs) based on experience and changes in related areas
of the law since issuance of the CGMP regulation; (3) delete some non-binding provisions of current part 110; and (4) re-establish the provisions of current part 110 in new part 117 (21 CFR part 117). We also requested comment on: (1) Additional proposed revisions or clarifications to our CGMP regulations, including whether to further implement opportunities for CGMP modernization, such as on how best to revise the current provisions for training; and (2) whether to revise some non-binding provisions to establish new requirements in proposed part 117, or to simply retain them as useful provisions of a comprehensive CGMP.
As part of our implementation of new statutory provisions in FSMA, we also proposed to add, in newly established part 117, requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for human food. As directed by FSMA (see section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), these new provisions would apply to domestic and foreign facilities that are required to register under section 415 of the FD&C Act and our regulation for Registration of Food Facilities (21 CFR part 1, subpart H; the section 415 registration regulations). As directed by FSMA (see sections 418(l) and (m) of the FD&C Act), we proposed to establish modified requirements for certain facilities. We requested comment on all aspects of the proposed requirements, including an opportunity for public comment on potential requirements for product testing, environmental monitoring, a supply-chain program, and hazards that may be intentionally introduced for purposes of economic gain.
As directed by section 103 of FSMA, we proposed to clarify the scope of the exemption from the section 415 registration regulations for “farms” by revising the “farm” definition and by adding or modifying the definitions for certain activities (
i.e.,
for “harvesting,” “holding,” “manufacturing/processing,” and “packing” activities) that govern, in part, whether a business that is devoted to the growing of crops, the raising of animals, or both is within the “farm” definition. We also proposed to add or revise these definitions in our current regulation (implementing section 414 of the FD&C Act) for Establishment and Maintenance of Records for Foods (21 CFR part 1, subpart J; the section 414 recordkeeping regulations), which also have an exemption for “farms.”
We proposed to establish the requirements for CGMPs, for hazard analysis and risk-based preventive controls, and related requirements in new part 117 as shown in table 3:
Table 3—Proposed Subparts in New Part 117
Subpart
Title
A
General Provisions.
B
Current Good Manufacturing Practice.
C
Hazard Analysis and Risk-Based Preventive Controls.
D
Modified Requirements.
E
Withdrawal of an Exemption Applicable to a Qualified Facility.
F
Requirements Applying to Records That Must Be Established and Maintained.
D. Draft Risk Assessment
We issued for public comment a “Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” (the section 103(c)(1)(C) draft RA) (78 FR 3824, January 16, 2013). The purpose of the section 103(c)(1)(C) draft RA was to provide a science-based risk analysis of those activity/food combinations that would be considered low risk when conducted in a facility co-located on a farm. We used the tentative conclusions of the section 103(c)(1)(C) draft RA to propose to exempt food facilities that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities from the requirements for hazard analysis and risk-based preventive controls. We are including the final risk assessment (the section 103(c)(1)(C) RA) in the docket established for this document (Ref. 4).
E. Definition of “Retail Food Establishment”
An establishment that meets the definition of “retail food establishment” is exempt from the requirements of the section 415 registration regulations and, thus, from FSMA's requirements for hazard analysis and risk-based preventive controls. Section 102(c) of FSMA requires that we revise the definition of “retail food establishment” in § 1.227 to clarify its intent. We are addressing the requirements of section 102(c) of FSMA in a separate rulemaking and issued a separate proposed rule to amend the definition of “retail food establishment” in the section 415 registration regulations and the section 414 recordkeeping regulations (80 FR 19160, April 9, 2015). We intend to issue a final rule to amend the definition of “retail food establishment” in the section 415 registration regulations in the near future.
F. Public Comments
We received more than 8,000 public submissions on the 2013 proposed human preventive controls rule, and more than 1,300 public submissions on the 2014 preventive controls supplemental notice, each containing one or more comments. We received submissions from diverse members of the public, including food facilities (including facilities co-located on a farm); farms; cooperatives; coalitions; trade organizations; consulting firms; law firms; academia; public health organizations; public advocacy groups; consumers; consumer groups; Congress; Federal, State, local, and tribal Government Agencies; and other organizations. Some submissions included signatures and statements from multiple individuals. Comments address virtually every provision of the proposed human preventive controls rule. In the remainder of this document, we describe these comments, respond to them, and explain any revisions we made to the proposed human preventive controls rule.
Some comments address issues that are outside the scope of this rule. For example, some comments express concern over pesticides being used on local crops being harmful to the honeybee population. Other comments address the requirements of the proposed produce safety rule, such as standards for water quality. Other comments express concern about the use of bioengineered food ingredients, and ask that foods containing such ingredients be labeled so that consumers can identify such foods and choose whether to consume them. Other comments assert that the rules should address social issues. We do not discuss such comments in this document.
II. Legal Authority
The proposed rule contained an explanation of its legal basis under authorities in the FDA Food Safety Modernization Act, the FD&C Act, and the Public Health Service Act. After considering comments received in response to the 2013 proposed human preventive controls rule and 2014 supplemental human preventive controls notice, FDA made changes in the final rule. The legal authorities relied on for the final rule are the same as in the proposed rule unless otherwise described in the sections that follow.
A. Changes to Current 21 CFR Part 1, Subparts H, I, and J
Sections 103(c)(2)(A) and (B) of FSMA require that the Secretary adopt final rules for purposes of section 415 of the FD&C Act (Registration of Food Facilities) with respect to “activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership” and “activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.” In section IV, we discuss our revision of the section 415 registration regulations (21 CFR part 1, subpart H) to clarify the types of activities that are included as part of the definition of the term “facility” under section 415 of the FD&C Act and the scope of the exemption for “farms” provided by section 415 of the FD&C Act. The final rule also makes corresponding changes in part 1, subpart I (Prior Notice of Imported Food) and in part 1, subpart J (Establishment, Maintenance, and Availability of Records). FDA's legal authority to modify these regulations is derived from section 103(c) of FSMA and sections 414, 415, 381(m) and 371(a) of the FD&C Act (21 U.S.C. 350c, 350d, 801(m), and 701(a)).
B. Changes to Current 21 CFR Part 110
The changes to the current CGMP regulation finalized in this document clarify the existing requirements of the regulation and update existing requirements to reflect changes in the food industry and in scientific understanding of food safety since issuance of the current regulation. FDA's legal authority to require Current Good Manufacturing Practices derives from sections 402(a)(3), (a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The revisions we are making to the current CGMP regulation are necessary to prevent food from containing filthy, putrid, or decomposed substances, being otherwise unfit for food, or being prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
In addition to the FD&C Act, FDA's legal authority for the changes to current CGMP requirements derives from the PHS Act to the extent such measures are related to communicable disease. Authority under the PHS Act is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State” (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary.) The revisions we are making to the current CGMP regulation are necessary to prevent the spread of communicable disease.
C. Hazard Analysis and Risk-Based Preventive Controls
Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418, which mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary issue regulations “to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls. . . .” Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms “small business” and “very small business,” taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Further, section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit “[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].”
In addition to rulemaking requirements, section 418 contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is to “prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 [of the FD&C Act] or misbranded under section 403(w) [of the FD&C Act]. . . .” In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include hazard analysis (section 418(b)), preventive controls (section 418(c)), monitoring (section 418(d)), corrective actions (section 418(e)), verification (section 418(f)), recordkeeping (section 418(g)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)).
Section 103(c)(2)(C) of FSMA requires that the Secretary adopt a final rule with respect to the requirements under sections 418 and 421 of the FD&C Act from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities. Sections 418(j)-(m) of the FD&C Act and sections 103(c)(1)(D) and (g) of FSMA provide authority for certain exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to seafood and juice HACCP, and low-acid canned food (section 418(j)); activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety) (section 418(k)); qualified facilities (section 418(l)); facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment (section 418(m)); facilities engaged only in certain low-risk on-farm activities on certain foods conducted by small or very small businesses (section 103(c)(1)(D) of FSMA), and dietary supplements (section 103(g) of FSMA). In sections XI, XII, XXXVIII, and XXXIX, we discuss provisions that implement these exemptions and modified requirements.
In the 2014 supplemental human preventive controls notice, we included potential requirements for a supplier program, environmental monitoring, and product testing. We are including provisions for such activities in the final
rule. Section 418(o)(3) of the FD&C Act provides supplier verification activities and an environmental monitoring program as examples of preventive controls. Section 418(f)(4) of the FD&C Act provides for the use of environmental and product testing programs as part of required verification that the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards.
In certain circumstances, the final rule does not require a manufacturing/processing facility to implement a preventive control for a hazard requiring a preventive control. Instead, the facility is permitted to rely on a subsequent entity in the distribution chain to significantly minimize or prevent the hazard. In such a circumstance, a facility must disclose in documents accompanying the food, that the food is “not processed to control [identified hazard].” This requirement is supported by sections 418 and 701(a) of the FD&C Act (21 U.S.C. 350g and 371(a)). The requirement that facilities apply preventive controls to significantly minimize or prevent hazards is fundamental to the public health benefits of the rule. To accommodate the realities of modern food production, the rule allows a facility to rely on a subsequent entity in the distribution chain rather than requiring that facility to apply the control. A food may pass through multiple entities in the distribution chain before it reaches consumers. Further, ordinarily it is not apparent from visual examination of the food whether a hazard requiring a preventive control has been addressed. Consequently, without labeling, a facility might not know that a facility upstream in the supply chain has not applied a preventive control and is relying on a downstream entity to do so. Therefore, the agency concludes that information that food has not been processed to control an identified hazard is necessary for a facility to fulfil its obligation under section 418 when a facility is relying on a subsequent entity to control the hazard. The agency also concludes that such labeling is necessary for the efficient enforcement of the Act because the labelling is critical for FDA to hold facilities responsible for their obligations under this regulatory scheme. Further, when the hazard can cause a communicable disease, FDA concludes that the requirement is necessary to prevent the spread of communicable disease from one state into another state and relies on sections 311, 361, and 368 of the PHS Act.
FDA concludes that the provisions in subpart C and related requirements in subparts A, D, F, and G should be applicable to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (§ 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility from the requirements because food from such a facility is not in interstate commerce. Further, the prohibited act provision associated with section 418 (section 301(uu) of the FD&C Act) does not require interstate commerce for a violation.
FDA also is issuing the provisions in subpart C and related requirements in Subparts A, D, F, and G, under sections 402(a)(3), 402(a)(4), 403(w), and 701(a) of the FD&C Act to the extent such requirements are necessary to prevent food from being held under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health, or being unfit for food; and to the extent necessary to prevent food from being misbranded under section 403(w). FDA also is finalizing those provisions under sections 311, 361, and 368 of the PHS Act relating to communicable disease to the extent those provisions are necessary to prevent the interstate spread of communicable disease.
D. Comments on Legal Authority
(Comment 1) One comment asserts that FDA does not have authority to regulate intrastate commercial activities. Another comment asserts that FDA does not have authority to regulate farms that are selling wholly intrastate.
(Response 1) With regard to farms, this rule does not apply. With respect to farms that engage in activities outside the farm definition (
i.e.,
farm mixed-type facilities), this rule applies to the non-farm portion of the operation.
FDA disagrees with the comments regarding application of this rule to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (§ 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility because food from such a facility is not in interstate commerce. Section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) provides that “the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418” is a prohibited act. Notably, other subsections in section 301 of the FD&C Act, and section 304 of the FD&C Act (21 U.S.C. 334) demonstrate that Congress has included a specific interstate commerce nexus in the provisions of the FD&C Act when that is its intent. Accordingly, it is reasonable to interpret sections 418 and 301(uu) of the FD&C Act as not limiting the application of the rule only to those facilities with a direct connection to interstate commerce.
FDA is mindful that its interpretation of FSMA and the FD&C Act should not cast doubt on their constitutionality. (See Solid Waste Agency of Northern Cook County v. U.S., 531 U.S. 159 (2001)). FDA has considered the relevant provisions of FSMA and the FD&C Act, FDA's responsibilities in implementing those laws, and the law interpreting the commerce clause of the Constitution (Article I, section 8). Congress' power to legislate under the commerce clause is very broad. However, such power is not without limits, see United States v. Lopez, 514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S. 598, 618 (2000), and these limits have been construed in light of relevant and enduring precedents. In particular, in Lopez, supra, the Supreme Court acknowledged the continuing vitality of Wickard v. Filburn, 317 U.S. 111 (1942), noting that “although Filburn's own contribution to the demand for wheat may have been trivial by itself, that was not `enough to remove him from the scope of Federal regulation where, as here, his contribution, taken together with that of many others similarly situated, is far from trivial.' ” (514 U.S. at 556.) See also Gonzales v. Raich, 545 U.S. 1, 17-25 (2005). This principle applies to the application of sections 418 and 301(uu) of the FD&C Act, as added by section 104 of FSMA. Accordingly, given the collective impact on commerce of facilities that manufacture, process, pack, or hold food that is sold in intrastate commerce, FDA concludes that such facilities should be subject to the rule. FDA notes that to the extent these facilities are very small, they are subject to modified requirements under § 117.201. This outcome regarding intrastate commerce is consistent with section 709 of the FD&C Act (21 U.S.C. 379a), which states that in any action to enforce the act's requirements respecting foods, drugs, devices, and cosmetics, any necessary connection
with interstate commerce is presumed. Likewise, this outcome is consistent with FSMA's risk-based, preventive approach to food safety because the risk presented by unsafe food can be significant, whether or not the food moves from one state to another.
III. General Comments on the Proposed Rule
(Comment 2) Several comments ask us to develop guidance to accompany the rule, particularly with respect to the new requirements for hazard analysis and risk-based preventive controls. For example, comments ask us to provide guidance on topics such as hazard analysis, environmental monitoring, and validation. Some of these comments ask that drafts of the guidance first be made available for public comment.
Other comments emphasize the importance of education and outreach and ask us to provide support for ongoing education and outreach, including an active role in providing needed instructional examples and lessons learned from current investigations and foodborne outbreaks. Some comments ask us to convene a scientific workgroup that includes experts in food and laboratory science, public health, proficiency testing, quality control, and other areas on at least an annual basis to assess what pathogens should be addressed in a food safety plan.
Some comments ask that funding and information on funding for training be provided. Other comments assert that we must make available adequate resources to support outreach and technical assistance delivered by State regulatory agencies, as well as Cooperative Extension programs and non-governmental organizations that work directly with farmers and facilities.
(Response 2) We are developing several guidance documents, including general guidance on hazard analysis and preventive controls, as well as guidance on specific aspects such as environmental monitoring and food allergen control (Ref. 5). We also intend to develop guidance specific to a variety of food types based in part on technical information we obtained through a grant for this purpose, as well as on other topics, such as validation. We will develop and issue this guidance in accordance with our good guidance practices regulation, which establishes criteria for when we issue a guidance document as an initial draft, invite public comment, and prepare a final version of the guidance document that incorporates suggested changes, when appropriate (§ 10.115(g)) (21 CFR 10.115(g)). The public may submit comments on any guidance document at any time (§ 10.115(g)(5)).
We agree with comments that stress the importance of education and outreach. A central element of our strategy to gain industry compliance is to help make available to facilities subject to this rule the education and technical assistance they need to understand and implement the requirements (Ref. 6). Within the Agency we are establishing a Food Safety Technical Assistance Network and seeking funding to increase FDA staffing to provide a central source of information to support industry understanding and implementation of FSMA standards (Ref. 6). This will allow us to respond in a timely and consistent way to industry questions on preventive controls technical and compliance issues (Ref. 6).
We also are working in collaboration with the Food Safety Preventive Controls Alliance (FSPCA) to develop training materials and establish training and technical assistance programs (Ref. 5) and (Ref. 7). The Alliance includes members from FDA, State food protection agencies, the food industry, and academia. It is funded by a grant to the Illinois Institute of Technology's Institute for Food Safety and Health, a nationally-recognized leader in food safety. In addition to developing a standardized preventive controls training curriculum, the FSPCA is developing selected sections of model food safety plans for several food types that will provide needed instructional examples. Although we have provided funding to the FSPCA to develop a standardized preventive controls training curriculum, we are unable to fund training for individual groups who might need particular training materials.
We also are partnering with the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) to administer the FSMA-mandated National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program, a grant program to provide technical assistance for FSMA compliance to owners and operators of small and medium-size farms and small food processors (Ref. 8). Such efforts will help ensure widespread voluntary compliance by encouraging greater understanding and adoption of established food safety standards, guidance, and protocols.
At this time, we intend to rely on scientific publications and epidemiological findings to assess the potential that new pathogens, or more virulent pathogenic strains, have emerged, and do not intend to convene annual workgroups to assess that data and information.
(Comment 3) Several comments ask us to classify specific on-farm activities as harvesting, packing, holding, or manufacturing/processing so that an operation that conducts these activities on a farm can determine whether conducting that specific activity is within, or outside, the “farm” definition. These comments emphasize that a farm operation needs to know when a specific activity that it conducts would be outside the “farm” definition for the purposes of the requirements to register as a food facility and, thus, require that the farm operation both register as a food facility and comply with the new requirements for hazard analysis and risk-based preventive controls. Some of these comments focus on activities that we have previously classified in more than one way (
e.g.,
“washing,” which we have previously classified as both “harvesting” and “manufacturing/processing,” depending on when the activity occurs) (See table 1 in the Appendix to the 2014 supplemental human preventive controls rule, 79 FR 58524 at 58571-58572.) Other comments ask us to periodically review our lists of harvesting, packing, holding, and manufacturing/processing activities to ensure that they reflect current practices. Some comments ask us to make a table of activities prominently available on our Internet site for easy access whenever the public seeks out information regarding the forthcoming produce safety rule and the human preventive controls rule.
(Response 3) We have added several examples of “harvesting,” “packing,” “holding,” and “manufacturing/processing” to the regulatory text (see §§ 1.227, 1.328, and 117.3 and Response 27, Response 28, Response 29, Response 31, Response 37, Response 38 and Response 39). However, it is not practical to include every possible activity conducted by farm operations in the regulatory text. Attempting to include a more extensive set of examples in the regulatory text has the potential to signal—incorrectly—that any activity not specified in the regulatory text cannot be considered to be within the definition of that activity. In addition, we have not previously discussed our approach to classifying some of the activities mentioned in the comments, and we believe that we should provide an opportunity for public comment on a more extensive list of activities classified as “harvesting,” packing,” “holding,” or “manufacturing/processing.”
To address these comments, in the near future we intend to issue a draft guidance with our current thinking on the classification of activities as “harvesting,” packing,” “holding,” or “manufacturing/processing.” In accordance with our regulation on good guidance practices (§ 10.115(g)(1)), we will review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate; publish a notice in the
Federal Register
announcing that the guidance document is available; and post the guidance document on the Internet and make it available in hard copy. Under our good guidance practices regulation (§ 10.115(g) and (h)), the public can comment on any guidance document at any time, and we will revise guidance documents in response to public comments when appropriate.
In addition, our previously issued “Guidance for Industry: Questions and Answers Regarding Food Facility Registration” (Ref. 9) is in its sixth edition, and we intend to update it in the near future to reflect the changes to the definitions of “farm,” “harvesting,” packing,” “holding,” and “manufacturing/processing” that we are establishing in this rulemaking.
(Comment 4) Some comments ask us to prepare a table or flow chart of activities that make an operation a farm, a retail food establishment, or a facility because food businesses will need to be able to easily determine their regulatory classification to comply with the applicable regulations. Other comments ask us to amend the definition of “manufacturing/processing” to ensure that community supported agriculture (CSA) programs will not become subject to the requirements for hazard analysis and risk-based preventive controls. Other comments ask us to clarify how the revised definitions we are establishing in the section 415 registration regulations will affect entities classified as research and development entities, pilot plants, test kitchens, shared use storage facilities, co-packers, sales offices, corporate offices, private residences, and registered foreign facilities that only send samples to the United States. Some comments ask us to clarify how the revised definitions we are establishing in the section 415 registration regulations will affect a determination of whether an entity or program (such as a farmers' market, roadside stand, CSA program, commissary kitchen, community and incubator kitchens) is a retail food establishment that is not required to register as a food facility in the human preventive controls rule rather than through a separate rulemaking. One comment notes that its farm has a store and a café that use products from the farm, and it is not clear if the store and café will be under regulations while nearby restaurants and grocery stores are not. Some comments ask us to define farmers' markets, CSA programs, roadside stands, and other direct-to-consumer programs as retail food establishments not subject to registration as part of the human preventive controls rulemaking rather than through a separate rulemaking.
(Response 4) Section 102(c) of FSMA requires that we revise the definition of “retail food establishment” in § 1.227 to clarify that, in determining the primary function of an establishment or a retail food establishment under the section 415 registration regulations, the sale of food products directly to consumers by such establishments includes the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; the sale and distribution of such food through a CSA program; and the sale and distribution of such food at any other such direct sales platform as determined by the Secretary of HHS. As discussed in section I.E, we have begun the process of amending the definition of “retail food establishment” in a separate rulemaking conducted under section 102(c) of FSMA, and are continuing that separate rulemaking by issuing a separate final rule. We intend to issue a final rule to amend the definition of “retail food establishment” in the section 415 registration regulations in the near future. We also intend to update our previously issued “Guidance for Industry: Questions and Answers Regarding Food Facility Registration” (Ref. 9) to reflect any changes to a determination of whether an entity is a retail food establishment as a result of that rulemaking. In the meantime, commenters may find our existing guidance helpful in addressing their questions.
(Comment 5) Some comments ask us to explain how we will enforce the rule, particularly with respect to coordination with State and local authorities and with other Federal agencies. For example, some comments ask whether FDA or the States will pay for inspections, whereas other comments ask us to coordinate inspection of imports with USDA's Food Safety and Inspection Service (FSIS) or ask us to combine our inspections with those of USDA where possible (such as when USDA conducts inspections for adherence to organic standards). Some comments express concern about the time gap between the effective date of this rule and the time it will take to incorporate applicable provisions into State law.
(Response 5) We are working through the Partnership for Food Protection (PFP) (a group of dedicated professionals from Federal, State, local, tribal, and territorial governments with roles in protecting the food supply and public health) to develop and implement a national Integrated Food Safety System consistent with FSMA's emphasis on establishing partnerships for achieving compliance (see section 209(b) of FSMA). For an example of our current thinking on establishing partnerships for achieving compliance, see the “best practices” document made available by PFP (Ref. 10). This “best practices” document provides information to FDA field and State programs on a variety of issues, including how to coordinate compliance activities. Our document entitled “Operational Strategy for Implementing FSMA” also recognizes the importance of developing operational partnerships with States and other government counterparts to optimize the effectiveness, efficiency, and consistency of FSMA implementation domestically (Ref. 11).
We are implementing a new inspection paradigm focused on whether firms are implementing systems that effectively prevent food contamination, requiring fundamentally different approaches to food safety inspection and compliance (Ref. 12). This new paradigm involves a major reorientation and retraining, for which we are seeking funding, of more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety activities, as well as thousands of State, local, and tribal inspectors (Ref. 12).
(Comment 6) Some comments ask us to specify that the human preventive controls rule does not apply to activities subject to the animal preventive controls rule.
(Response 6) The human preventive controls rule does not apply to activities subject to the animal preventive controls rule. The title of the rule (
i.e.,
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) narrows its applicability to human food. Moreover, regulations directed to food for animals are established in subchapter E of 21 CFR (
i.e.,
Animal Drugs, Feeds, And Related Products, parts 500-599), whereas regulations directed to human food are established
in subchapter B of 21 CFR (
i.e.,
Food For Human Consumption, parts 100-199).
(Comment 7) Some comments ask us to look to existing industry information technology solutions where possible to lower the burden on industry for implementation. These comments also ask us to adopt a centralized information technology solution with robust functionality to facilitate tracking stakeholders' compliance with the rule.
(Response 7) The rule allows for use of any available information technology (
e.g.,
in the creation and retention of records) that will allow industry to comply with the rule, and we encourage the use of information technology to streamline compliance. The long-standing CGMP requirements allow for the use of automated systems (see § 117.40(d)). We are developing new electronic systems to track compliance. However, our internal procedures for tracking compliance are outside the scope of this rule.
(Comment 8) Some comments ask us to re-evaluate the proposed human preventive controls rule, compare it with existing programs, and identify a mechanism for integrating compliance verification with existing industry and governmental programs. These comments note that many handlers/processors use and understand voluntary food safety management systems such as HACCP and HACCP-based certification programs (
e.g.,
certification to Global Food Safety Initiative (GFSI) benchmark schemes) and ask us why we proposed to create a separate inspection framework for FSMA, without integrating that inspection framework with existing programs.
(Response 8) We decline this request. As previously discussed, we are establishing this rule as required by section 103 of FSMA (78 FR 3646 at 3657-3659 and 3668-3669). However, where compliance with this rule mirrors compliance with existing regulatory requirements, there is no need to duplicate existing records, which may be supplemented as necessary to include all of the required information. (See also Response 5 regarding implementation of a national Integrated Food Safety System.)
(Comment 9) Some comments ask us to make the various rules we are establishing to implement FSMA consistent with each other.
(Response 9) We have aligned the provisions of the various rules to the extent practicable. For example, we use the same definitions of “farm” and the same terms used in the definition of “farm” (
i.e.,
harvesting, packing, holding, and manufacturing/processing) in this rule, the animal preventive controls rule, and the proposed produce safety rule. However, the statutory direction is not the same for all the rules, and this difference in statutory direction does lead to some differences between the rules. For example, section 418(l) of the FD&C Act (which relates to this rule) provides for modified requirements for facilities that are very small businesses in addition to facilities that satisfy criteria for sales to qualified end-users, but section 419(f) of the FD&C Act (which relates to the proposed produce safety rule) only provides for modified requirements for direct farm marketing.
Likewise, we have worked to align the provisions of this rule with the provisions of the FSVP rule. Again, however, there are statutory differences that lead to some differences between the rules. For example, section 805 of the FD&C Act (21 U.S.C. 348a) applies to an importer whereas section 418 of the FD&C Act applies to a facility that is required to register under section 415 of the FD&C Act.
(Comment 10) Some comments ask us to clarify how the requirements for hazard analysis and risk-based preventive controls will apply to an establishment that supplies raw materials and other ingredients to a registered facility.
(Response 10) The requirements for hazard analysis and risk-based preventive controls apply to facilities that are required to register under section 415 of the FD&C Act. If an establishment that supplies raw materials and other ingredients to a registered facility is itself a facility that is required to register under section 415 of the FD&C Act, that establishment is subject to the requirements for hazard analysis and risk-based preventive controls. If that establishment is not itself a facility that is required to register under section 415 of the FD&C Act, that establishment is not subject to the requirements for hazard analysis and risk-based preventive controls. However, such facilities may be subject to verification activities of manufacturers/processors that are required to verify controls implemented by their suppliers.
(Comment 11) Some comments express concern about the potential for unfair enforcement of the rule relating to business size. Some comments assert that we should strictly enforce the rule for big industry, but be lenient towards small farms.
(Response 11) We intend to enforce the rule in a fair and reasonable manner. We note that farms are not covered by this rule, and the rule contains special provisions applicable to a farm mixed-type facility that is a small or very small business. Specifically, a small or very small business that is a farm mixed-type facility is exempt from the requirements for hazard analysis and risk-based preventive controls if the only activities that it conducts are the low-risk activity/food combinations listed in § 117.5(g) and (h). A very small business that is a farm mixed-type facility, but does not satisfy the criteria for the exemptions for only conducting low-risk activity/food combinations, is eligible for modified requirements as a qualified facility, and we will enforce the modified requirements, rather than the full requirements for hazard analysis and risk-based preventive controls, for such very small businesses.
(Comment 12) Some comments express concern that we will enforce the rule more strictly for domestic facilities than for foreign facilities—
e.g.,
because we lack the funds and manpower to enforce the rule for foreign facilities. Other comments assert that it is unprecedented for importing countries to regulate the production processes in exporting countries and that no scientific evidence supports such regulation. These comments express concern that this regulatory requirement will greatly increase trading costs and might constitute a barrier to trade for exporting countries.
(Response 12) We intend to enforce this rule in a consistent manner to ensure that imported and domestically produced foods are in full compliance with the requirements of this rule. We note that the forthcoming FSVP rule will require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under this rule. The implementation of these supplier verification programs by U.S. importers will thus provide assurances that imported food is in compliance with this regulation.
We disagree that we are seeking to “regulate the production processes in exporting countries” inappropriately. This rule provides for a flexible set of principles and a framework for hazard analysis and risk-based preventive controls to be applied to a given production process in order to ensure the production of safe food destined for the United States. Mandating that a finished food is manufactured under general methods applicable to all foods (
e.g.,
good manufacturing practices) is a widely accepted regulatory practice and
fundamentally different than mandating that food be produced in a certain way. We note that many countries have adopted food safety regulations that mandate certain principles and conditions be applied to food manufacturing. These include mandatory HACCP programs for seafood and other foods. For example, in a guidance document on food safety import requirements, the European Commission stated: “The EU rules on food hygiene confirm that all food businesses in third countries after primary production must put in place, implement and maintain a procedure based on the HACCP principles.” The mandate that preventive controls be applied to control hazards in the production of foods in this rule is similar to the European Union (EU) rules. Because the requirements being implemented by FDA under this regulation are flexible and not prescriptive, we do not agree that this regulation will significantly increase costs or impede trade.
We also disagree that there is no scientific evidence supporting this rule. In the 2013 proposed preventive controls rule, we provided an extensive background discussing the scientific evidence and international food safety standards upon which this rule is based (78 FR 3646 at 3659 through 3667, January 16, 2013). That discussion reviews a number of well documented food safety risks and how they can be controlled by modern food safety systems including the Codex HACCP principles contained in the HACCP Annex of the Codex General Principles of Food Hygiene (78 FR 3646 at 3667, January 16, 2013). In that discussion we stated: “The proposed rule would require that a food safety system similar to HACCP be implemented in food facilities and would harmonize our requirements with the recommendations and requirements of internationally recognized food safety experts/authorities, such as experts/authorities in [Codex Alimentarius], [Food Safety Authority Australia New Zealand], [Canadian Food Inspection Agency], and the European Union.” (78 FR 3646 at 3663, January 16, 2013) In addition, the Appendix to the 2013 proposed preventive controls rule provided additional scientific information on activities such as product testing and environmental monitoring to support their role in ensuring safe food and how these align with international standards such as those of Codex Alimentarius (78 FR 3646 at 3818-3820); republished in its entirety with corrected reference numbers on March 20, 2013, 78 FR 17142 at 17149-17151).
(Comment 13) Some comments assert that the rule should be more concise, and that the average person without a team of experts should be able to understand the rule and manage the application of the rule.
(Response 13) We agree the rule needs to be understandable. We have incorporated plain language techniques—
e.g.,
by using active voice in the new requirements for hazard analysis and risk-based preventive controls. We also have established additional definitions that enable us to improve readability (
e.g.,
“qualified facility exemption,” “raw agricultural commodity,” “unexposed packaged food,” and “you.”) The comprehensive nature of the new requirements for hazard analysis and risk-based preventive controls reflects the extensive statutory provisions they implement and the broad range of activities and foods covered. We have used examples in the regulatory text, where relevant, and provided examples throughout the preamble to assist with understanding the requirements. Likewise, the long-standing CGMP requirements need to be comprehensive, because they are broadly directed to all stages of the production of food. We will be producing guidance documents that will be helpful in understanding the rule (see Response 2).
We will issue a Small Entity Compliance Guide (SECG) in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). A Small Entity Compliance Guide is a guidance that explains the actions a small or very small business must take to comply with a rule.
(Comment 14) Some comments ask whether we will translate the rule into foreign languages, such as Japanese.
(Response 14) We do not intend to translate the rule. As discussed in Response 13, to help small and very small businesses comply with a rule we issue a SECG. We are considering whether to translate the SECG and outreach and technical assistance materials into additional languages.
(Comment 15) Some comments assert that the rule incorrectly assumes that all bacteria are harmful.
(Response 15) We have long recognized that some bacteria have a role in food production, such as the lactic-acid producing bacteria that our regulations explicitly acknowledge as being added to yogurt (see,
e.g.,
the standards of identity for yogurt, low fat yogurt, and nonfat yogurt, in 21 CFR 131.200, 131.203, and 131.206, respectively). The rule defines the terms “microorganism” and “pathogen,” and the definition of “microorganism” explains that the term “undesirable microorganism” includes those microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. The CGMP provisions directed to either preventing the growth of undesirable microorganisms or preventing contamination with undesirable microorganisms are long-standing, and these comments do not provide any examples of how we have interpreted the CGMP requirements in the past in a way that does not recognize that some bacteria have a role in food production or that creates practical problems for the future. With regard to biological hazards, the new requirements for hazard analysis and risk-based preventive controls focus on pathogens.
(Comment 16) Some comments assert that the rule will disproportionately affect New England farmers because they are small and production costs are higher compared to elsewhere in the country and that the cost of the rule will have negative consequences on New England's food supply. Other comments assert that the rule will force small farmers out of business, forcing us to rely on foreign suppliers who are under very little FDA oversight, and that FDA oversight should be reduced so that the public can continue supporting small, local farmers. Other comments express concern that excessive rules will discourage farmers from supplying the Farm to School market.
(Response 16) We believe that the “farm” definition that we are establishing in this rule greatly reduces the impact on farms of all size, because several operations that would have been required to register as a food facility under the section 415 registration regulations as established in 2003 (68 FR 58894, October 10, 2003) will no longer be required to do so. (See the discussion of the changes to the “farm” definition in section IV.B) In addition, a farm mixed-type facility that is a small or very small business, and that only conducts low-risk activity/food combinations for manufacturing, processing, packing, and holding foods that are not RACs, is exempt from the new requirements for hazard analysis and risk-based preventive controls. A farm mixed-type facility that does not satisfy these criteria for exemption, but is a very small business, is a qualified facility that is subject to modified requirements. All of these factors will reduce the burden on small farms.
(Comment 17) Some comments express concern about contamination of produce and other food in open containers by sulfuric hydrogen being discharged from lead acid batteries that are used to operate forklifts.
(Response 17) The long-standing CGMP provisions require that the food establishment must appropriately use equipment to avoid the adulteration of food with such contaminants (see § 117.40(a)(2)).
(Comment 18) Some comments assert that we do not address comments submitted by individuals.
(Response 18) We address comments on the provisions of the rule regardless of who submits the comments. However, we group similar comments together, and do not discuss the specific text of each submitted comment letter when the point being made by one comment letter can be included in a general discussion of several comment letters that express similar points of view.
(Comment 19) Some comments assert that we need specific standards and quantifiable guidelines for compressed air.
(Response 19) We agree that specific standards and quantifiable guidelines for material such as compressed air could be useful to food establishments that use such material in the production of food. However, we disagree that such standards and guidelines need to be included in the rule. The rule is intended to establish procedures for the safe manufacturing, processing, packing, and holding of food, and for hazard analysis and risk-based preventive controls in the production of food, rather than to set standards for specific levels of contaminants in specific raw materials and other ingredients. If a facility believes that its use of compressed air should be addressed in its food safety plan, then it should do so.
(Comment 20) Some comments ask us to address model laboratory standards and accreditation to ensure that laboratories are using sound and reliable test methods for detecting and identifying pathogens.
(Response 20) We decline this request. A separate section of FSMA addresses “Laboratory Accreditation For Analyses Of Foods” (see section 202 of FSMA). This rule focuses on section 103 of FSMA (section 418 of the FD&C Act).
IV. Comments on Proposed Revisions to the Definitions in the Section 415 Registration Regulations (21 CFR Part 1, Subpart H) and the Section 414 Recordkeeping Regulations (21 CFR Part 1, Subpart J)
A. Definitions That Impact a Determination of Whether an Establishment Is a “Farm”
We previously described section 103(c) of FSMA (78 FR 3646 at 3674). In brief, section 103(c) of FSMA directs us to conduct rulemaking to clarify the on-farm manufacturing, processing, packing, and holding activities that would trigger a requirement for a farm to register as a food facility and, thus, be subject to section 418 of the FD&C Act. We discussed the current legal and regulatory framework for farms under sections 415 and 418 of the FD&C Act, and explained how the status of a food as a RAC or a processed food affects the requirements applicable to a farm under sections 415 and 418 of the FD&C Act. We then articulated a comprehensive set of organizing principles that formed the basis for proposed revisions to the section 415 registration regulations. Because these definitions also are established in the section 414 recordkeeping regulations, these organizing principles also formed the basis for proposed revisions to definitions in the section 414 recordkeeping regulations.
Our previous description (78 FR 3646 at 3675-3676) of the current legal and regulatory framework that governs the determination of when an establishment is required to register as a food facility in accordance with the section 415 registration regulations focused on the framework that governs whether an establishment that grows and harvests crops or raises animals satisfies the definition of “farm,” because the facility registration requirements of section 415 of the FD&C Act do not apply to “farms.” Under that framework, a key factor in whether an establishment falls within the definition of “farm,” even with respect to crops it grows and harvests itself, is whether the activities conducted by the establishment fall within definitions of “harvesting,” “packing” or “holding” (which are within the “farm” definition). Another key factor is whether activities conducted by the establishment fall within the definition of manufacturing/processing (which have been outside the “farm” definition).
We previously described comments regarding proposed revisions to the definitions of “farm,” “harvesting,” “packing” and “holding,” as well as comments regarding the triggers for an activity to be considered manufacturing/processing (79 FR 58524 at 58530-58538). In the 2014 supplemental human preventive controls notice, we proposed additional revisions to the definitions of “farm,” “harvesting,” “packing,” and “holding” to address these comments.
Even after the revisions we proposed in the 2014 supplemental human preventive controls notice, some comments assert that the overall “farm” definition still presents an unrealistic and incomplete understanding of how most farms in the United States are structured with regard to their physical location(s) and business models. Most of the comments suggest alternative or additional regulatory text (see,
e.g.,
Comment 22, Comment 23, Comment 24, Comment 25, Comment 27, Comment 37, Comment 39, and Comment 50) or ask us to clarify how we will interpret the provisions (see,
e.g.,
Comment 26, Comment 28, Comment 29, Comment 40, Comment 41, Comment 42, Comment 43, Comment 44, Comment 47, and Comment 48).
As discussed in section I.A, there are several FSMA-required regulations that provide the framework for industry's implementation of preventive controls and enhance our ability to oversee their implementation for both domestic and imported food (see the seven foundational rules listed in table 1). Two of the proposed rules listed in table 1 (
i.e.,
the 2013 proposed animal preventive controls rule and the 2013 proposed intentional adulteration rule) proposed to include a cross-reference to the “farm” definition in § 1.227, and a third proposed rule (
i.e.,
the 2013 proposed produce safety rule) proposed to establish the same “farm” definition as would be in § 1.227. A fourth proposed rule (
i.e.,
the 2013 proposed FSVP rule) did not propose to establish the “farm” definition (or a cross-reference to the “farm” definition in § 1.227), but under its proposed definition of “foreign supplier” some foreign suppliers would be farms—
i.e.,
establishments that harvest food that is exported to the United States. As a result, we received comments relevant to the “farm” definition for all of these rules. The majority of the comments submitted to these other rulemakings addressed issues that were the same as, or similar to, the issues raised in the comments submitted to this rulemaking. One comment submitted to the proposed rulemaking for the forthcoming FSVP rule requested clarification regarding harvesting companies, and we are also providing
that clarification in this rulemaking. See Response 32.
We proposed to redesignate all definitions in § 1.227 in the section 415 registration regulations (
i.e.,
current § 1.227) to eliminate paragraph designations (such as (a) and (b)). We received no comments that disagreed with our proposed redesignations and are finalizing them as proposed.
We proposed several technical amendments and conforming changes to the section 415 registration regulations and to the section 414 recordkeeping regulations. No comments opposed the proposed technical amendments and conforming changes, except for comments noting that our proposed technical amendment to § 1.361 was unnecessary because we had already made this change in a different rulemaking (see 77 FR 10662, February 23, 2012). We are finalizing these technical amendments and conforming changes without change.
In the following sections, we discuss comments that ask us to clarify the proposed requirements or that disagree with, or suggest one or more changes to, the proposed requirements. After considering these comments, we have revised the proposed definitions as shown in table 4, with editorial and conforming changes as shown in table 52. We also are establishing a new provision to allow off-farm establishments that package, pack, and hold RACs that are produce as will be defined in the produce safety rule to comply with the CGMPs in part 117, subpart B by complying with the applicable requirements for packing and holding that will be established in the final produce safety rule (see § 117.8 and Response 25). Because the new provision refers to provisions in a future produce safety rule, we will publish a document in the
Federal Register
announcing the effective date of § 117.8 once we finalize the produce safety rule.
Table 4—Revisions to the Proposed Definitions in the Section 415 Registration Regulations and the Section 414 Recordkeeping Regulations
Definition
Revision
Farm
• A farm is an “operation” rather than an “establishment.”
• There are two types of farms: (1) Primary production farm; and (2) secondary activities Farm.
Primary production farm
• A primary production farm is “under one management” rather than “under one ownership.”
• Although a primary production farm continues to be “in one general physical location,” we have clarified that “one general physical location” is “not necessarily contiguous.”
• A primary production farm is an operation devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. Although some primary production farms both grow and harvest crops, other primary production farms grow crops but do not harvest them, and other primary production farms harvest crops but do not grow them.
• Treatment to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without additional manufacturing/processing, is within the “farm” definition.
• We added an example of drying/dehydrating RACs to create a distinct commodity that would fall within the “farm” definition (i.e., drying/dehydrating grapes to produce raisins), as well as an example of additional manufacturing/processing that would cause an operation that dries/dehydrates RACs to create a distinct commodity to fall outside the “farm” definition (i.e., slicing).
• We added an example of additional manufacturing/processing that can cause an operation that packages and labels RACs to fall outside the “farm” definition (i.e., irradiation).
Secondary activities farm
• A “secondary activities farm” is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.
• A secondary activities farm may also conduct those additional activities allowed on a primary production farm.
Harvesting
• We added additional examples of harvesting activities.
Holding
• We added additional examples of holding activities.
Manufacturing/Processing
• We added additional examples of manufacturing/processing activities.
B. Proposed Revisions to the Definition of Farm
We proposed to revise the “farm” definition to: (1) Provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs; (2) include, within the “farm” definition, a description of packing activities that include packaging RACs grown or raised on a farm without additional manufacturing/processing; and (3) provide for drying/dehydrating RACs to create a distinct commodity (such as the on-farm drying of grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing, to remain within the farm definition. We also requested comment on whether we should retain, remove, or modify the phrase “in one general physical location” in the “farm” definition.
(Comment 21) Most of the comments support our proposed revision to provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs. However, some comments oppose this proposed revision. Some comments ask us to require that a farm that packs, packs and sells, commingles lots, and holds produce grown on a farm under different ownership comply with the requirements of this rule for hazard analysis and risk-based preventive controls for six reasons: (1) Commingling. Contamination from one farm could find its way to another farm, leading to potential contamination of products from both farms, making it difficult to pinpoint the source of contamination in the event of a recall. (2) Recall Plan. It is critical for everyone in the produce supply chain to be “recall ready,” especially those packing, commingling lots, and selling produce grown on another farm under different ownership. (3) Traceability. It is important that produce be traceable from the specific farm where it was grown to the end-user, and from the end-user back to the farm where it was grown. (4) Exemptions. A covered farmer packing, packing and selling, commingling lots, or holding others' produce might be doing so from a farm that is exempt from the produce safety rule. (5) Supplier program. Under the
human preventive controls rule a farmer would be required to have a valid supplier program. (We note that a farmer might be a supplier to a facility that is subject to the human preventive controls rule, and could be subject to the facility's supplier program, but would not itself be required to “have a valid supplier program.”) With this requirement, receiving facilities could purchase in confidence knowing that if the farm did pack others' produce it was produced in accordance with the rules required by FSMA. (6) Conflict with the National Organic Program (NOP). Under the NOP, a grower that purchases produce from another farm under different ownership, packs produce from another farm, or mixes produce is no longer considered a crop producer and must seek certification as a handler—an operation that has additional requirements to approve suppliers, segregate product, and maintain records necessary to demonstrate compliance. Comments assert that this NOP requirement is logical and is a practice that FDA should take into consideration.
Other comments assert that allowing a farm to pack produce from another farm must account for the problem created by our proposal to exempt farm vehicles transporting RACs from the sanitary transportation rule. These comments argue that unless we revise that rule to prevent possible contamination during transport, we should develop guidance for farms packing produce that is transported from another farm, particularly where the commodity is high risk.
(Response 21) The final “farm” definition continues to provide for on-farm packing and holding of RACs to remain within the farm definition regardless of ownership of the RACs. We have acknowledged that doing so would have consequences such as those described in these comments, as well as other consequences (see 79 FR 58524 at 58532). Although comments pointed out consequences that we had already considered, they did not point to any other consequences. Therefore, we affirm our tentative conclusion that impacts such as these, while not always optimal, are necessary to establish a sensible framework of risk-based regulations that both implement FSMA and reflect common farm activities. We intend to issue the final produce safety rule in the near future and respond to comments related to traceability of produce, including whether to include a requirement that a farm supplying produce to another farm that will pack or hold that produce should provide to the farm that receives the produce its name, complete business address, and description of the produce in any individual shipment, as well as respond to comments on whether it would be appropriate to also require the farm that receives the shipment maintain such record of information and, if so, for what specified period of time.
In the 2014 proposed sanitary transportation rule, we explained our reasons for tentatively concluding that the sanitary transportation practices that would be required by that proposed rule are not necessary to prevent RACs from becoming adulterated during transportation by farms (79 FR 7006 at 7016, February 5, 2014). For example, we explained that we are not aware of instances in which insanitary conditions (
e.g.,
improper temperature control, improper equipment construction, inadequate equipment cleaning) with regard to transportation operations conducted by farms involving the transportation of RACs have contributed to foodborne illness, regardless of whether the farms are conducting transportation operations for their own RACs or for others' RACs. We will consider comments we receive on our proposal to exempt farm vehicles transporting RACs from the sanitary transportation rule when we issue a final sanitary transportation rule. We will consider necessary guidance in light of the final sanitary transportation rule, but we note that good transportation practices are already included in our 1998 guidance for industry entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (Ref. 13).
(Comment 22) Some comments assert that farms are neither facilities nor establishments. These comments ask us to revise the “farm” definition to use a term more suited to the nature of farming.
(Response 22) We consider a farm to be a type of “establishment” but have nonetheless revised the “farm” definition to refer to an “operation” rather than an “establishment” as requested by these comments.
(Comment 23) Many comments address the role of “ownership” in the “farm” definition. Some of these comments emphasize that farming operations are complex, with complex business structures, and are often not held under sole ownership. Some comments describe the role of multiple business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and food hubs) in modern farming and ask us to revise the “farm” definition to provide for such business models. Other comments emphasize ownership of the land on which crops are grown or animals are raised, noting that some farms are operated by “tenant” farmers who do not own the land used in the farm's operations. Some comments ask us to replace the concept of ownership with the concept of a responsible party, such as a “farm operator” and to define a farm operator as “the person or entity that has operational control over the farm and benefits in whole or in part from the farm's normal operation. A farm operator may be an owner, a tenant, a partner, or an employee.”
Some comments ask us to remove the phrase “under one ownership” to allow sugar makers who share equipment and sugarhouses to qualify as a farm. Other comments ask us to clarify how renting or leasing storage rooms or facilities would affect the definition of a farm.
(Response 23) We have revised the “farm” definition by replacing the phrase “under one ownership” with the phrase “under one management.” Although the original phrase “under one ownership” was not referring to a single owner, we agree that the “farm” definition should reflect modern business models (such as cooperatives, on-farm packinghouses under ownership by multiple growers, food aggregators, and food hubs) and use language that the modern farming community understands. We decline the request to define and introduce a new term, such as “farm operator.” The term “management” has a common meaning that captures the request of these comments and is suitable for the purposes of the farm definition. (Management. The person or persons controlling and directing the affairs of a business, institution, etc.) (Ref. 14).
Under either the previous or the revised “farm” definition, leasing land to grow or store crops or raise animals does not impact whether an operation is within the “farm” definition. Under the previous definition, “ownership” focused on ownership of the business entity conducting farm operations, not ownership of the land. Leasing land is a business practice common to a variety of business types, not just farms. Likewise, leasing buildings to store RACs does not impact whether an operation is within the “farm” definition. See also Response 24 regarding comments on “one general physical location.”
To the extent that sugar makers who share equipment and sugarhouses only conduct activities that are within the “farm” definition, the revision from “under one ownership” to “under one management” should clarify that those operations would be within the “farm”
definition. However, when sugar makers conduct operations outside the “farm” definition, they are facilities that are required to register under the section 415 registration regulations, not “farms” that are exempt from that registration requirement. A sugar maker that is a small or very small farm mixed-type facility that only conducts the low-risk activity/food combinations listed in the exemptions in § 117.5(g) and (h) (such as making syrup and sugar (
e.g.,
making maple syrup from maple sap)) is exempt from the requirements of this rule. However, a farm mixed-type facility that is not a small or very small business as those terms are defined in this rule, or that conducts activities in addition to the low-risk activity/food combinations listed in the exemptions in § 117.5(g) and (h), is subject to the requirements for hazard analysis and risk-based preventive controls. Consistent with the discussion in Response 228, a farm mixed-type facility that must comply with the requirements for hazard analysis and risk-based preventive controls and makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (
i.e.,
that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring preventive controls would document that determination in its written hazard analysis but would not need to establish preventive controls and associated management components. For additional information about the section 103(c)(1)(C) RA and the exemptions for on-farm low-risk activity/food combinations for farm mixed-type facilities that are small or very small businesses, see sections VI and XI.G.
(Comment 24) Many comments address the role of “one general physical location” in the “farm” definition and ask us to revise the “farm” definition to acknowledge that farms may be composed of multiple parcels, buildings, or structures that may or may not be contiguous. Some comments point out that there are many farming operations that may fall under the same management and ownership, but are separated by either a strip of land, body of water, or another structure, particularly with respect to sites designated for packing and holding operations. Some comments assert that as long as an economic unit is operating a farm it should be irrelevant where the land is located, and state that this interpretation is consistent with a USDA definition of a “farm operator.” Some comments note that sugar makers rely on sap from existing stands of trees that are often not concentrated in a single area or even nearby the sugarhouse where the maple products are made. Some comments suggest that the term “reasonable distance” could be used to better define “general physical location.” Some comments ask us to issue guidance that will clarify and further designate the boundaries of “one general physical location.”
Some comments note that the “farm” definition we proposed in the 2014 supplemental human preventive controls notice correctly considers a farm operation to remain within the “farm” definition even if it packs and holds produce from another farm. However, these comments state that it is confusing that if the same two farms pack and hold produce together at an off-farm location, using the exact same practices, that packing location is considered a “facility” even though there is no difference in risk. Other comments state that both in-line and off-line egg production facilities should be considered farms. According to these comments, off-line egg production facilities receive eggs laid by hens at nearby farms, whereas in-line egg production facilities receive eggs laid by hens in henhouses adjacent to the plant and located on the same property.
Some comments ask us to retain “one general physical location” in the “farm” definition because the word “farm,” and USDA's definition of “farm,' are “place-based.” Other comments assert that if we delete the phrase “in one general physical location” then a fully integrated operation could be a single farm even though it was made up of numerous distinct farms possibly in several different states. Other comments ask us to retain “one general physical location” in the “farm” definition because different locations may have different food safety risks, different water sources, different personnel, and even different types of crops. Some comments assert that considering each unique and individually State-permitted dairy farm to be an individual “farm” regardless of common ownership or geographic proximity will prevent conflict and interference with the permitting and inspection activities of the Grade “A” program while maintaining food safety. Other comments state that regardless of whether we retain “one general physical location” in the “farm” definition, we must interpret the term “farm” to cover a very limited geographic area and that separate locations that are not in close proximity to each other should not be considered the same “farm.”
(Response 24) We have revised the “farm” definition to specify that a farm is “in one general (but not necessarily contiguous) physical location.” We have concluded that adding “not necessarily contiguous” makes it clear that farming operations that are under one management but have some physical separation (
e.g.,
with respect to the location of packing operations) can remain within the “farm” definition and that both in-line and off-line egg production facilities would be considered “farms.”
We agree that separate locations that are not in close proximity to each other should not be considered the same “farm.” As the comments point out, there already is a framework of State inspections for farms such as dairy farms, and we will need to work with our State regulatory partners to identify farms covered by the produce safety rule. However, even without the new phrase “not necessarily contiguous,” some situations would be complex. We intend to address these types of situations with our State food safety partners. (See Response 5.)
We do not see that adding “not necessarily contiguous” creates a “farm” definition that is not “place-based,” as was asserted by some comments, because the definition continues to specify “in one general physical location.” We also do not see that adding “not necessarily contiguous” presents any food safety concerns, as asserted by comments noting that different locations may have different food safety risks, different water sources, different personnel, and different types of crops. For example, a farm that will be covered by the forthcoming produce safety rule will be subject to standards for all of its water sources, all of its personnel, and all food subject to that rule. Likewise, we also do not believe that adding “not necessarily contiguous” affects a determination of whether a fully integrated operation could be a single farm.
(Comment 25) Some comments ask us to consider revising the regulatory text to ensure that similar activities would be treated the same way under either the produce safety rule or the human preventive controls rule and be held to the same risk-based requirements. These comments point out some of the differences between the requirements that would be established under the proposed human preventive controls rule and the requirements that would be established under the proposed produce safety rule. For example, comments state that the proposed human
preventive controls rule, but not the proposed produce safety rule, would require off-farm packinghouses and off-farm cooling and storage facilities to have a written hazard analysis; written preventive controls; written procedures for monitoring and corrective actions; validation of process controls; a written recall plan; environmental monitoring and product testing requirements; and a written supplier program. As another example, comments state that off-farm packing and holding operations would be required to comply with the human preventive controls rule one year earlier than we proposed that similar sized on-farm packing and holding operations would be required to comply with the forthcoming produce safety rule.
Some comments recommend options to achieve the goal of regulating on-farm and off-farm packinghouses the same way. These options include adding an exclusion to the “farm” definition in the produce safety rule; adding provisions to the human preventive controls rule to enable off-farm packinghouses to meet their obligation by complying with specified, applicable subparts of the produce safety rule; shortening the “farm” definition to simply state “Farm means an establishment under one ownership devoted to the growing and/or harvesting of crops, the raising of animals (including seafood), or any or all of these activities;” addressing off-farm establishments engaged solely in “low-risk” farming and harvesting activities by adding low-risk activities such as hulling, shelling, and drying of tree nuts; expanding the scope of the produce safety rule to include registered facilities; and allowing modified requirements in the human preventive controls rule to allow off-farm packinghouses to be subject to requirements (and exemptions) of the produce safety rule within the framework of the human preventive controls rule.
Some comments emphasize that farm activities are farm activities, regardless of where they happen. Some comments assert that establishments that are engaged solely in traditional harvesting, holding, or packing activities associated with a RAC that will be covered by the produce safety rule should be subject to the produce safety rule, rather than the human preventive controls rule, regardless of physical location, ownership, or legal ties to an operation devoted to the growing and harvesting of produce. Some comments assert that an off-farm operation that packs and holds RACs could be regulated in an identical fashion to an on-farm operation that packs and holds RACs without changing the section 415 requirement for registration by making them subject to the requirements of the produce safety rule for compliance purposes. Some comments ask us to provide an exemption from, or waiver for, the requirements of the human preventive controls rule if a business entity provides documentation that the entity is following the standards of the produce safety rule even though it is not on a farm. Other comments ask us to clarify that a farm can pack or hold RACs that have already undergone packing or holding activities by another farm.
Some comments ask to revise the “farm” definition to include establishments solely engaged in “packing” and “holding” activities performed on RACs, regardless of whether the establishment grows crops. Other comments emphasize that any revisions to the “farm” definition must allow genuine farm operators to carry out harvesting, packing, and holding without opening loopholes for packing and processing businesses. Some comments ask us to revise the “farm” definition to provide for a multi-ownership operation provided that all of the partial owners are themselves farmers.
Some comments ask us to provide that off-farm packing and holding operations that do not change the status of a RAC into a processed food should be able to comply with either the produce safety rule or with the CGMPs in subpart B of the human preventive controls rule. According to these comments, we could simply apply the same logic that we applied when providing that the packing and holding of RACs that have been dried/dehydrated to create a distinct commodity that is a processed food (
i.e.,
no longer a RAC) may achieve compliance with the CGMP requirements by complying either with subpart B of the human preventive controls rule or by complying with the applicable requirements for packing and holding produce RACs in the produce safety rule (see § 117.5(k)(2)).
(Response 25) We have revised the “farm” definition to provide for two types of farms: (1) A primary production farm and (2) a secondary activities farm (see § 117.3). We use the term “primary production farm” to refer to the “farm” definition as proposed, with the revisions described in this final rule. We use the term “secondary activities farm” to mean an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm. With the added definition of “secondary activities farm,” off-farm packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the “farm” definition. We are making these changes to reflect the current reality of what it means to be a farm. The changes will allow farms that use certain business models to harvest, pack, and/or hold produce to be able to comply with the produce safety rule for all of their operations. We believe that this flexibility allows for the requirements of the produce safety rule to apply to a wider array of activities than our original proposal without opening the “farm” definition to operations that have no connection to the growing of crops or the raising of animals—the core activities of a farm. By specifying that the farms that grow or raise the majority of the RACs harvested, packed, and/or held by the operation must own, or jointly own, a majority interest in the secondary activities farm, the revised “farm” definition does, as requested by comments, allow “farms” to carry out harvesting, packing, and holding activities in the same way as the produce safety rule.
We are, as requested by some comments, establishing a new provision to allow off-farm establishments that package, pack, and hold RACs that are produce as will be defined in the produce safety rule to comply with the CGMPs in part 117, subpart B by complying with the applicable requirements for packing and holding that will be established in the final produce safety rule (see § 117.8). Because the new provision refers to provisions in a future produce safety rule, we will publish a document in the
Federal Register
announcing the effective date of that provision once we finalize the produce safety rule.
However, the revised “farm” definition does not, as requested by some comments, establish the exact same regulatory framework for operations, such as certain packinghouses and hulling/shelling operations, that are within the “farm” definition as for operations that conduct similar activities but are outside the “farm” definition by allowing off-farm operations to be subject to the produce
safety rule rather than the requirements for hazard analysis and risk-based preventive controls. We disagree that the statutory framework provides flexibility for entities such as packinghouses and hulling/shelling operations that do not have a connection to a farm to be subject to the requirements of the produce safety rule for compliance purposes. (See the discussion at 79 FR 58524 at 58536.) We continue to believe that an off-farm packinghouse that is subject to this rule will be able to draw from the provisions of the produce safety rule in developing its food safety plan and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. For example, as previously discussed (79 FR 58524 at 58536) we expect that the food safety plan for an off-farm packinghouse would focus on a few key preventive controls, including some that would have counterparts in the proposed produce safety rule, such as maintaining and monitoring the temperature of water used during packing (which would have counterparts under proposed § 112.46(c) in the proposed produce safety rule). We also expect that an off-farm packinghouse would establish sanitation controls to address the cleanliness of food-contact surfaces (including food-contact surfaces of utensils and equipment) and the prevention of cross-contamination from insanitary objects and from personnel to food, food-packaging material, and other food-contact surfaces. On-farm packinghouses would be subject to similar, but not identical, requirements (see
e.g.,
proposed § 112.111(b) for cleanliness of food-contact surfaces and proposed § 112.113 for protection against contamination).
We acknowledge that some of the provisions of the human preventive controls rule have no explicit counterparts in the proposed produce safety rule (
e.g.,
the requirements for product testing and environmental monitoring as verification activities). As discussed in Response 525, we do not expect either product testing or environmental monitoring to be common in facilities that process, pack, or hold produce RACs.
Finally, in response to comments that ask for a clarification that a farm can pack or hold RACs that have already undergone packing or holding activities by another farm, we presume that the commenter was asking about a case where the farm that did the previous packing and holding activities was not the farm on which the RACs were grown and harvested. The definition of “farm” allows packing and holding of one's own RACs and other's RACs, even if they have been previously packed or held by another farm that was not the farm on which the RACs were grown and harvested.
(Comment 26) Some comments ask us to clarify whether the “and” between provisions that allow a farm to dry/dehydrate RACs to create a distinct commodity, and provisions that allow a farm to package and label RACs, means that an operation must do both of these activities to remain within the farm definition. These comments state that they do not think this is the intended (or logical) outcome, which is to provide that farms can do either or both activities and still be within the farm definition and ask us to consider editorial changes (such as replacing “and” with “or,” or adding a new paragraph that would encompass both activities).
(Response 26) The rule does not require a farm to do both activities (
i.e.,
drying/dehydrating RACs to create a distinct commodity, and packaging and labeling RACs) to remain within the farm definition.
(Comment 27) Some comments ask us to add artificial ripening of RACs as an activity that is within the farm definition. Some comments assert that artificial ripening of RACs is not manufacturing/processing because artificial ripening does not transform a RAC into a processed food.
(Response 27) We have revised the “farm” definition to specify that treatment to manipulate the ripening of RACs (such as by treating produce with ethylene gas), and packaging and labeling the treated RACs, without additional manufacturing/processing, are within the “farm” definition. We agree that a treatment such as artificial ripening does not transform a RAC into a processed food but disagree that such a treatment is not manufacturing/processing. To make that clearer, we have added “treating to manipulate ripening” to the list of examples of manufacturing/processing in the definition of that term. As discussed during the rulemaking to establish the section 415 registration regulations, artificial ripening constitutes manufacturing/processing because it involves treating, modifying, or manipulating food (68 FR 58894 at 58912, October 10, 2003). See also our previous statements about artificial ripening in this rulemaking (78 FR 3646 at 3683 and 79 FR 58524 at 58572).
As previously discussed, the activities that transform a RAC into a processed food (and are sometimes therefore referred to as “processing” in the context of a food's status as a RAC or processed food) are not coextensive with the activities described in our definition of “manufacturing/processing” (78 FR 3646 at 3679). When we first established the section 415 registration regulations, a key criterion in determining whether a business entity was a “farm” or a “facility” was whether the operation conducted activities classified as “manufacturing/processing.” Indeed, in the 2013 proposed preventive controls rule we continued to rely on that key criterion in proposing revisions to the “farm” definition. However, as already discussed, some changes to the “farm” definition are necessary to establish a sensible framework of risk-based regulations that both implement FSMA and reflect common farm activities (see Response 21). One of these changes is to specify those manufacturing/processing activities that are within the “farm” definition, rather than attempt to re-classify an activity that arguably is manufacturing/processing as harvesting, packing, or holding in order to provide for the activity to remain within the “farm” definition.
(Comment 28) Some comments disagree that we should provide for drying/dehydrating RACs to create a distinct commodity to be within the “farm” definition because this activity is a manufacturing/processing activity and should be subject to the requirements for hazard analysis and risk-based preventive controls. Other comments agree that we should provide for this activity but assert that “drying/dehydrating RACs to create a distinct commodity” is confusing to the average reader and ask us to add examples of what this means. Some comments ask us to clarify whether this activity applies to specific situations, such as drying/baling of hops (because hops are a low-risk product and beer brewing should eliminate any pathogens on the hops), drying plums to create prunes, and concentrating maple sap into maple syrup, cream, and candy. Some comments assert that maple syrup should be considered a RAC because the process of producing maple syrup mirrors the regulatory text “drying/dehydrating RACs to create a distinct commodity,” because maple syrup can only be produced through the concentration of maple sap and the process of that concentration is akin to the harvesting of other raw products. Other comments assert that the processing of sap is more appropriately viewed as a harvesting activity (rather than food manufacturing).
Other comments ask us to clarify the specific methods of drying/dehydrating that we would consider to be within the “farm” definition—
e.g.,
whether drying/dehydrating is constrained to in situ, with no heat or mechanical air circulation, because the example we discussed in the 2014 supplemental preventive controls notice was “natural condition raisins.” These comments ask us to specify the allowable methods of drying to avoid confusion, and assert that there is no food safety reason to exclude use of heat or air, especially if sun and light are to be permitted. Other comments ask us to clarify what we mean by “without additional manufacturing/processing.”
(Response 28) We are retaining drying/dehydrating RACs to create a distinct commodity as an activity that is within the “farm” definition even though it is manufacturing/processing. As previously discussed, the processes (described in comments to the 2013 proposed human preventive controls rule) for drying grapes to “natural condition raisins” are akin to other harvesting activities traditionally conducted by farms on RACs grown and harvested on farms, because they are traditionally performed by farms for the purpose of removing RACs from the place they were grown or raised and preparing them for use as food (79 FR 58524 at 58533). As also previously discussed, the information provided by the comments to the 2013 proposed human preventive controls rule included information that “natural condition raisins” are produced with either sun-drying or artificial dehydration (79 FR 58524 at 58533). We did not intend to limit the processes for drying/dehydrating RACs to sun-drying, and the regulatory text includes no such limitation. We decline the request to specify specific methods of drying/dehydrating that would remain within the “farm” definition because doing so could imply that the list of methods was exhaustive and preclude use of new technology in the future.
However, we are adding “boiling” and “evaporating” to the list of activities that we classify as manufacturing/processing to preclude interpretations, such as those expressed in some of these comments, that the processes to produce products such as maple syrup, maple cream, and maple candy are “drying/dehydrating.” In the 2013 proposed human preventive controls rule we included “Boiling/evaporation of maple sap to make maple syrup” as a low-risk manufacturing/processing activity/food combination in the exemption for small and very small businesses that only conduct specified on-farm low-risk activity/food combinations (proposed § 117.5(h)), and we have retained—and broadened—that activity/food combination as an on-farm, low-risk manufacturing/processing activity/food combination in the final human preventive controls rule (see § 117.5(h), which includes making sugar and syrup from fruits and vegetables (
e.g.,
dates), grains (
e.g.,
rice, sorghum), other grain products (
e.g.,
malted grains such as barley), saps (
e.g.,
agave, birch, maple, palm), sugar beets, and sugarcane). Processes such as “boiling,” “concentrating,” and “evaporating” are not “drying/dehydrating” as the term “drying/dehydrating” is used in this rule, and maple syrup is a processed food, not a RAC. See also the discussion in Response 23 regarding how a farm mixed-type facility that makes sugar from sugarcane or sugar beets can consider the findings of the section 103(c)(1)(C) RA (
i.e.,
that this is a low-risk activity/food combination) in determining whether there are any hazards requiring a preventive control. A farm mixed-type facility that makes maple products from maple sap could follow the same approach.
We have added “slicing” to the regulatory text as an example of additional manufacturing/processing that would be outside the “farm” definition. We also have added “drying/dehydrating grapes to produce raisins” to the regulatory text as an example of what we mean by “drying/dehydrating RACs to create a distinct commodity.” Drying plums to produce prunes is another example of drying/dehydrating RACs to create a distinct commodity. Drying/baling hops is within the “farm” definition, but as a “holding” activity because drying/baling hops does not create a distinct commodity. As discussed in Response 39, we have revised the definition of “holding” to add drying/dehydrating RACs when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa) as an example of a holding activity.
(Comment 29) Some comments agree that the activities of packaging and labeling RACs should remain within the “farm” definition but ask us to reclassify these activities so that they are not considered manufacturing/processing because they do not transform a RAC into a processed food or change the nature of the RAC. These comments ask us to add examples to regulatory text to explain what we mean by “packaging and labeling without additional manufacturing/processing.” As an example, these comments ask whether a farm that packs produce grown by another farm, and washes the produce before packing it, would be conducting “additional manufacturing/processing.”
Other comments ask us to clarify whether packaged RACs are processed food because “packaging” is defined as a manufacturing/processing operation. These comments also ask us to clarify whether a farm would be precluded from holding RACs packaged in retail form because the packaged RACs are processed food.
(Response 29) See Response 27. We decline the request to reclassify packaging and labeling so that they would not be considered manufacturing/processing. Although we classify packaging and labeling as manufacturing/processing, packaging and labeling RACs do not transform the RACs into processed food, and we classify “packaged RACs” as RACs.
We classify washing RACs as a harvesting or packing activity when done on RACs before or during pac
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