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

DEPARTMENT OF HEALTH AND HUMANSERVICES

117.435(d),117.475(c)(2),and 117.475[c](13).See section LVI for the compliance dates.

Food and Drug Administration 21 CFR Parts 1,11,16,106,110,114, 117,120,123,129,179,and211 [Docket No.FDA-2011-N-0920]

FOR FURTHER INFORMATION CONTACT:Jenny Scott,Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration,5100 Paint Branch Pkwy.,CollegePark,MD20740,240-402-2166.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AGENCY:Food and Drug Administration, HHS.

SUPPLEMENTARYINFORMATION:Table of Contents Executive Summary

Purpose and Coverage of the Rule Summary of the Major Provisions of the Rule

ACTION:Final rule.

Costs and Benefits I.Background

SUMMARY:TheFoodandDrug 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

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)

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.

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

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),

Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and418oftheFD&CAct

VI.Rulemaking Required by Section 103〔c〕of

FSMA:On-FarmActivities 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(21CFR 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

ApplicabletoaFacilityThat 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 §5117.5(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