Vol. 80 Thursday, No. 180 September 17, 2015 Part III Department of Health and Human Services Food and Drug Administration 21 CFR Parts 11, 16, 117, et al. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Final Rule VerDate Sep<11>2014 19:06 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17SER3.SGM 17SER3 mstockstill on DSK4VPTVN1PROD with RULES3 56170 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations DEPARTMENT OF HEALTH AND Administration, 7519 Standish Pl., IX. Subpart A: Comments on Qualifications HUMAN SERVICES Rockville, MD 20855, 240–402–6246, of Individuals Who Manufacture, email: [email protected]. Process, Pack, or Hold Animal Food Food and Drug Administration A. Applicability and Qualifications of All SUPPLEMENTARY INFORMATION: Individuals Engaged in Manufacturing, Table of Contents Processing, Packing, or Holding Animal 21 CFR Parts 11, 16, 117, 500, 507, and Food (Final § 507.4(a), (b), and (d)) 579 Executive Summary B. Additional Requirements Applicable to Purpose and Coverage of the Rule Supervisory Personnel (Final § 507.4(c)) [Docket No. FDA–2011–N–0922] Summary of the Major Provisions of the Rule X. Subpart A: Comments on Proposed RIN 0910–AG10 Costs and Benefits § 507.5—Exemptions I. Background A. General Comments on the Proposed Current Good Manufacturing Practice, A. FDA Food Safety Modernization Act Exemptions Hazard Analysis, and Risk-Based B. Stages in the Rulemaking for the Animal B. Proposed § 507.5(a)—Exemption for Food Preventive Controls Rule Facilities Not Required To Register Preventive Controls for Food for C. Summary of the Major Provisions of Under Section 415 Regulations Animals Proposed Rule for Preventive Controls C. Proposed § 507.5(b)—Exemption for Food for Animals Applicable to Food Subject to 21 CFR AGENCY: Food and Drug Administration, D. Draft Risk Assessment part 113—Thermally Processed Low- HHS. E. Public Comments Acid Foods Packaged in Hermetically ACTION: Final rule. II. Legal Authority Sealed Containers A. Current Good Manufacturing Practice D. Proposed § 507.5(c)—Exemption SUMMARY: The Food and Drug Regulations Applicable to Activities Subject to Administration (FDA or we) is adding B. Hazard Analysis and Risk-Based Standards for Produce Safety in Section regulations for the Current Good Preventive Controls 419 of the FD&C Act Manufacturing Practice, Hazard III. General Comments on the Proposed Rule E. Proposed § 507.5(d)—Exemption Analysis, and Risk-Based Preventive IV. Definitions in the Section 415 Applicable to a Qualified Facility Controls for Food for Animals. These Registration Regulations (21 CFR Part 1, F. Proposed § 507.5(e) and (f)—Exemptions Subpart H) Applicable to On-Farm Low-Risk regulations will, for the first time, A. Definitions That Impact a Determination Activity/Animal Food Combinations establish requirements for the current of Whether an Establishment Is a ‘‘Farm’’ Conducted by a Small or Very Small good manufacturing practice (CGMP) for B. Proposed Revisions to the Definition of Business food for animals. In addition, we are Farm G. Proposed § 507.5(g)—Exemption adding requirements for certain C. Proposed Revisions to Definitions of Applicable to Facilities Solely Engaged domestic and foreign animal food Harvesting, Holding, Manufacturing/ in Storage of Raw Agricultural facilities to establish and implement Processing, Mixed-Type Facility, and Commodities Other Than Fruits and hazard analysis and risk-based Packing Vegetables Intended for Further preventive controls for food for animals. D. Comments on Feed Mills Associated Distribution or Processing With Fully Vertically Integrated Farming H. Proposed § 507.5(h)—Exemption We are taking this action to provide Operations Applicable to the Holding or greater assurance that animal food is V. Comments on the Organizing Principles Transportation of One or More Raw safe and will not cause illness or injury for How the Status of a Food as a Raw Agricultural Commodities to humans and animals and to Agricultural Commodity or as a I. Comments Requesting Additional implement new statutory provisions in Processed Food Affects the Requirements Exemptions the FDA Food Safety Modernization Act Applicable to a Farm Under Sections 415 XI. Subpart A: Comments on Proposed (FSMA). The rule is intended to build and 418 of the FD&C Act § 507.7—Requirements That Apply to a an animal food safety system for the VI. Rulemaking Required by Section 103(c) of Qualified Facility future that makes modern science- and FSMA: On-Farm Activities A. Comments on Submission of a A. Section 103(c)(1)(C) of FSMA Certification Statement risk-based preventive controls the norm B. Comments on Qualitative Risk B. General Comments on Requirements across all sectors of the animal food Assessment of On-Farm Activities That Apply to a Qualified Facility system. Outside of the Farm Definition C. Proposed § 507.7(a)—Documentation To DATES: This rule is effective November C. Comments Regarding an Exemption for Be Submitted 16, 2015, except for paragraph (2) of the Small and Very Small Farm Mixed-Type D. Proposed § 507.7(b)—Procedure for Facilities Under Section 421 of the FD&C Submission definition of ‘‘qualified auditor’’ in Act E. Proposed § 507.7(c)—Frequency of § 507.3, and §§ 507.12(a)(1)(ii), VII. Subpart A: Comments on Proposed Determination and Submission 507.105(a)(2), 507.105(c), § 507.1—Applicability and Status F. Proposed § 507.7(d)—Notification to 507.110(d)(2)(ii), 507.130(d), 507.135(d), A. Comments on Proposed § 507.1(a)— Consumers (Final § 507.7(e)) 507.175(c)(2), and 507.175(c)(13). FDA Applicability G. Proposed § 507.7(e)—Records (Final will publish a document in the Federal B. Comments on Proposed § 507.1(b)— § 507.7(f)) Register announcing the effective dates Prohibited Act XII. Subpart A: Comments on Proposed of paragraph (2) of the definition of C. Comments on Proposed § 507.1(c)— § 507.10—Applicability of Part 507 to a ‘‘qualified auditor’’ in § 507.3, Specific CGMP Requirements Facility Solely Engaged in the Storage of D. Comments on Proposed § 507.1(d)— Unexposed Packaged Animal Food §§ 507.12(a)(1)(ii), 507.105(a)(2), Human Food Facilities That Manufacture XIII. Subpart A: Comments on Proposed 507.105(c), 507.110(d)(2)(ii), 507.130(d), Animal Food § 507.12—Applicability of Part 507 to the 507.135(d), 507.175(c)(2), and VIII. Subpart A: Comments on Proposed Holding and Distribution of Human Food 507.175(c)(13). Certain provisions have § 507.3—Definitions By-Products for Use as Animal Food later compliance dates as discussed in A. Definitions We Proposed To Establish in XIV. Subpart B: General Comments on section LIII ‘‘Effective and Compliance Part 507 Proposed Subpart B—Current Good Dates.’’ B. Comments Asking FDA To Establish Manufacturing Practice Additional Definitions or Otherwise XV. Subpart B: Comments on Proposed FOR FURTHER INFORMATION CONTACT: Clarify Terms Not Defined in the Rule § 507.14—Personnel Jeanette Murphy, Center for Veterinary C. Additional Definitions To Clarify Terms A. Proposed § 507.14(a)(1)—Personal Medicine (HFV–200), Food and Drug Not Defined in the Proposed Rule Cleanliness (Final § 507.14(b)(1)) VerDate Sep<11>2014 19:06 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\17SER3.SGM 17SER3 mstockstill on DSK4VPTVN1PROD with RULES3 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations 56171 B. Proposed § 507.14(a)(2)—Hand Washing E. Proposed § 507.25(a)(5)—Responsibility B. Proposed § 507.31(b)—Preparation of the (Final § 507.14(b)(2)) for Overall Plant Cleanliness (Final Food Safety Plan by a Preventive C. Proposed § 507.14(a)(3)—Unsecured § 507.25(a)(4)) Controls Qualified Individual Jewelry and Other Objects (Final F. Proposed § 507.25(a)(6)—Contamination C. Proposed § 507.31(c)—Contents of a § 507.14(b)(3)) Precautions (Final § 507.25(a)(5)) Food Safety Plan D. Proposed § 507.14(a)(4)—Storing G. Proposed § 507.25(a)(7)—Testing D. Proposed § 507.31(d)—Records Clothing and Personal Belongings (Final Procedures (Final § 507.25(a)(6)) E. Comments on Potential Requirements § 507.14(b)(4)) H. Proposed § 507.25(a)(8)—Contaminated for Submission of a Facility Profile to E. Proposed § 507.14(a)(5)—Taking Other Product (Final § 507.25(a)(7)) FDA Necessary Precautions (Final I. Proposed § 507.25(a)(9)—Protecting XXV. Subpart C: Comments on Proposed § 507.14(b)(5)) Against Contamination (Final § 507.33—Hazard Analysis XVI. Subpart B: Comments on Proposed § 507.25(a)(8)) A. Proposed § 507.33(a)—Requirement for § 507.17—Plant and Grounds J. Proposed § 507.25(b)(1)—Raw Materials a Written Hazard Analysis A. Proposed § 507.17(a)—Grounds and Ingredients B. Proposed § 507.33(b)—Hazard Identification Surrounding an Animal Food Plant K. Proposed § 507.25(b)(1)(i)—Shipping C. Proposed § 507.33(c) and (d)— B. Proposed § 507.17(b)(1)—Adequate Containers Evaluation of Whether a Hazard Requires Space Between Equipment, Walls, and L. Proposed § 507.25(b)(1)(ii)—Raw Stored Materials a Preventive Control Materials XXVI. Subpart C: Comments on Proposed C. Proposed § 507.17(b)(2)—Dripping and M. Proposed § 507.25(b)(1)(iii)—Raw Condensation § 507.36—Preventive Controls (Final Materials § 507.34) D. Proposed § 507.17(b)(3)—Ventilation N. Proposed § 507.25(b)(2)—Raw Materials E. Proposed § 507.17(b)(4)—Lighting A. Proposed § 507.36(a)—Requirement To Susceptible to Mycotoxins F. Proposed § 507.17(b)(5)—Glass Identify and Implement Preventive O. Proposed § 507.25(b)(3)—Raw Materials G. Proposed § 507.17(b)(6)—Outdoor Controls (Final § 507.34(a)) and Rework (Final § 507.25(b)(1)(iii)) Storage B.