81_FR_3971 81 FR 3956 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction

81 FR 3956 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 15 (January 25, 2016)

Page Range3956-3956
FR Document2016-01092

The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' The final rule published with some editorial and inadvertent errors. This document corrects those errors.

Federal Register, Volume 81 Issue 15 (Monday, January 25, 2016) 
[Federal Register Volume 81, Number 15 (Monday, January 25, 2016)]
[Rules and Regulations]
[Page 3956]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01092]


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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]
RIN 0910-AG36


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a 
final rule that published in the Federal Register of September 17, 
2015. That final rule amended our regulation for current good 
manufacturing practice in manufacturing, packing, or holding human food 
to modernize it, and to add requirements for domestic and foreign 
facilities that are required to register under the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) to establish and implement hazard 
analysis and risk-based preventive controls for human food. That final 
rule also revised certain definitions in our current regulation for 
registration of food facilities to clarify the scope of the exemption 
from registration requirements provided by the FD&C Act for ``farms.'' 
The final rule published with some editorial and inadvertent errors. 
This document corrects those errors.

DATES: Effective: January 26, 2016.

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: In the Federal Register of Thursday, 
September 17, 2015 (80 FR 55908), FDA published the final rule 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food'' with some editorial and 
inadvertent errors. This action is being taken to correct inadvertent 
errors in the preamble and codified.
    In FR Doc. 2015-21920, appearing on page 55908 in the Federal 
Register of Thursday, September 17, 2015, the following corrections are 
made:
    1. On page 55908, in the first column, the headings section of the 
document, under the line containing ``[Docket No. FDA-2011-N-0920],'' 
is corrected by adding ``RIN 0910-AG36''.
    2. On page 55938, in the second column, in the first paragraph 
under ``VII. Comments on Proposed General Revisions to Current Part 110 
(Final Part 117),'' ``revising provisions directed to preventing 
contamination of food and food-contact substances'' is corrected to 
read ``revising provisions directed to preventing contamination of food 
and food-contact surfaces.''

0
3. On page 56151, beginning in the second column, revise Sec.  117.8 to 
read as follows:


``Sec.  117.8  Applicability of subpart B of this part to the off-farm 
packing and holding of raw agricultural commodities.

    Except as provided by Sec.  117.5(k)(1), subpart B of this part 
applies to the off-farm packaging, packing, and holding of raw 
agricultural commodities. Compliance with this requirement for raw 
agricultural commodities that are produce as defined in part 112 of 
this chapter may be achieved by complying with subpart B of this part 
or with the applicable requirements for packing and holding in part 112 
of this chapter.''


Sec.  117.405  [Corrected]

0
4. On page 56164, in the first column, in Sec.  117.405 Requirements to 
establish and implement a supply chain program, paragraph (c) 
introductory text is corrected to read as follows:
    ``(c) When a supply-chain-applied control is applied by an entity 
other than the receiving facility's supplier (e.g., when a non-supplier 
applies controls to certain produce (i.e., produce covered by part 112 
of this chapter), because growing, harvesting, and packing activities 
are under different management), the receiving facility must:''

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01092 Filed 1-22-16; 8:45 am]
BILLING CODE 4164-01-P

3956 Federal Register / Vol. 81, No. 15 / Monday, January 25, 2016 / Rules and Regulations identified the application of SBA’s size DEPARTMENT OF HEALTH AND under the line containing ‘‘[Docket No. standards as well as other size standards HUMAN SERVICES FDA–2011–N–0920],’’ is corrected by used by Federal agencies (60 FR 57988 adding ‘‘RIN 0910–AG36’’. (November 24, 1995)). SBA is not aware Food and Drug Administration 2. On page 55938, in the second of any Federal rule that would duplicate column, in the first paragraph under or conflict with establishing size 21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 ‘‘VII. Comments on Proposed General standards. Revisions to Current Part 110 (Final Part However, the Small Business Act and [Docket No. FDA–2011–N–0920] 117),’’ ‘‘revising provisions directed to SBA’s regulations allow Federal agencies to develop different size RIN 0910–AG36 preventing contamination of food and standards if they believe that SBA’s size food-contact substances’’ is corrected to Current Good Manufacturing Practice, read ‘‘revising provisions directed to standards are not appropriate for their Hazard Analysis, and Risk-Based preventing contamination of food and programs, with the approval of SBA’s Preventive Controls for Human Food; food-contact surfaces.’’ Administrator (13 CFR 121.903). The Correction SBA’s regulations (13 CFR 121.903(c)) ■ 3. On page 56151, beginning in the authorize an agency to establish an AGENCY: Food and Drug Administration, second column, revise § 117.8 to read as alternative small business definition for HHS. follows: the sole purpose of performing a ACTION: Final rule; correction. regulatory flexibility analysis pursuant ‘‘§ 117.8 Applicability of subpart B of this to the Regulatory Flexibility Act (5 SUMMARY: The Food and Drug part to the off-farm packing and holding of U.S.C. 601(3)), after consultation with Administration (FDA or we) is raw agricultural commodities. the Office of Advocacy of the U.S. Small correcting a final rule that published in the Federal Register of September 17, Except as provided by § 117.5(k)(1), Business Administration. 2015. That final rule amended our subpart B of this part applies to the off- 5. What alternatives will allow the regulation for current good farm packaging, packing, and holding of Agency to accomplish its regulatory manufacturing practice in raw agricultural commodities. objectives while minimizing the impact manufacturing, packing, or holding Compliance with this requirement for on small entities? human food to modernize it, and to add raw agricultural commodities that are By law, SBA is required to develop requirements for domestic and foreign produce as defined in part 112 of this numerical size standards for facilities that are required to register chapter may be achieved by complying establishing eligibility for Federal small under the Federal Food, Drug, and with subpart B of this part or with the business assistance programs. Other Cosmetic Act (the FD&C Act) to applicable requirements for packing and than varying size standards by industry establish and implement hazard holding in part 112 of this chapter.’’ and changing the size measures, no analysis and risk-based preventive controls for human food. That final rule § 117.405 [Corrected] practical alternative exists to the systems of numerical size standards. also revised certain definitions in our ■ 4. On page 56164, in the first column, SBA’s only other consideration was current regulation for registration of in § 117.405 Requirements to establish whether to adopt the size standards food facilities to clarify the scope of the and implement a supply chain program, presented in the interim final rule with exemption from registration paragraph (c) introductory text is no further increase for the inflation. requirements provided by the FD&C Act corrected to read as follows: However, SBA believes that the for ‘‘farms.’’ The final rule published inflation that has occurred since the with some editorial and inadvertent ‘‘(c) When a supply-chain-applied publication of the June 12, 2014 interim errors. This document corrects those control is applied by an entity other final rule is not sufficient to warrant an errors. than the receiving facility’s supplier additional increase at this time. (e.g., when a non-supplier applies DATES: Effective: January 26, 2016. controls to certain produce (i.e., List of Subjects in 13 CFR Part 121 FOR FURTHER INFORMATION CONTACT: produce covered by part 112 of this Jenny Scott, Center for Food Safety and Administrative practice and chapter), because growing, harvesting, Applied Nutrition (HFS–300), Food and procedure, Government procurement, Drug Administration, 5100 Paint Branch and packing activities are under Government property, Grant programs— Pkwy., College Park, MD 20740, 240– different management), the receiving business, Individuals with disabilities, 402–2166. facility must:’’ Loan programs—business, Reporting Dated: January 14, 2016. SUPPLEMENTARY INFORMATION: In the and recordkeeping requirements, Small Federal Register of Thursday, Leslie Kux, businesses. September 17, 2015 (80 FR 55908), FDA Associate Commissioner for Policy. PART 121—SMALL BUSINESS SIZE published the final rule ‘‘Current Good [FR Doc. 2016–01092 Filed 1–22–16; 8:45 am] REGULATIONS Manufacturing Practice, Hazard BILLING CODE 4164–01–P Analysis, and Risk-Based Preventive ■ For the reasons set forth in the Controls for Human Food’’ with some preamble, the interim rule amending 13 editorial and inadvertent errors. This CFR part 121, which was published at action is being taken to correct 79 FR 33647 on June 12, 2014, is inadvertent errors in the preamble and mstockstill on DSK4VPTVN1PROD with RULES adopted as a final rule without change. codified. In FR Doc. 2015–21920, appearing on Dated: January 12, 2016. page 55908 in the Federal Register of Maria Contreras-Sweet, Thursday, September 17, 2015, the Administrator. following corrections are made: [FR Doc. 2016–01410 Filed 1–22–16; 8:45 am] 1. On page 55908, in the first column, BILLING CODE 8025–01–P the headings section of the document, VerDate Sep<11>2014 13:57 Jan 22, 2016 Jkt 238001 PO 00000 Frm 00018 Fmt 4700 Sfmt 9990 E:\FR\FM\25JAR1.SGM 25JAR1


Document Created: 2018-02-02 12:35:27
Document Modified: 2018-02-02 12:35:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; correction.
DatesEffective: January 26, 2016.
ContactJenny 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.
FR Citation81 FR 3956 
RIN Number0910-AG36
CFR Citation21 CFR 1
21 CFR 106
21 CFR 11
21 CFR 110
21 CFR 114
21 CFR 117
21 CFR 120
21 CFR 123
21 CFR 129
21 CFR 16
21 CFR 179
21 CFR 211
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