Vol. 80 Thursday,

No. 180 September 17, 2015

Part II

Department of Health and Human Services Food and Drug Administration 21 CFR Parts 1, 11, 16, 106, 110, et al. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule

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55908 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations

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. FDA2011N0920]

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 (HFS300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240 4022166. 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

117.1Applicability 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

117.3Definitions 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 117.5Exemptions

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

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55909 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations

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 117.7Applicability of Part 117 to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

XIII. Subpart B: Comments on Proposed 117.10Personnel

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 117.20Plant and Grounds

A. Proposed 117.20(a)Grounds B. Proposed 117.20(b)Plant

Construction and Design XV. Subpart B: Comments on Proposed

117.35Sanitary 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 117.37Sanitary Facilities and Controls

A. Proposed 117.37(a)Water Supply B. Proposed 117.37(b)Plumbing C. Proposed 117.37(c)Sewage Dispo