Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction, 3956 [2016-01092]

Download as PDF 3956 Federal Register / Vol. 81, No. 15 / Monday, January 25, 2016 / Rules and Regulations identified the application of SBA’s size standards as well as other size standards used by Federal agencies (60 FR 57988 (November 24, 1995)). SBA is not aware of any Federal rule that would duplicate or conflict with establishing size standards. However, the Small Business Act and SBA’s regulations allow Federal agencies to develop different size standards if they believe that SBA’s size standards are not appropriate for their programs, with the approval of SBA’s Administrator (13 CFR 121.903). The SBA’s regulations (13 CFR 121.903(c)) authorize an agency to establish an alternative small business definition for the sole purpose of performing a regulatory flexibility analysis pursuant to the Regulatory Flexibility Act (5 U.S.C. 601(3)), after consultation with the Office of Advocacy of the U.S. Small Business Administration. 5. What alternatives will allow the Agency to accomplish its regulatory objectives while minimizing the impact on small entities? By law, SBA is required to develop numerical size standards for establishing eligibility for Federal small business assistance programs. Other than varying size standards by industry and changing the size measures, no practical alternative exists to the systems of numerical size standards. SBA’s only other consideration was whether to adopt the size standards presented in the interim final rule with no further increase for the inflation. However, SBA believes that the inflation that has occurred since the publication of the June 12, 2014 interim final rule is not sufficient to warrant an additional increase at this time. List of Subjects in 13 CFR Part 121 Administrative practice and procedure, Government procurement, Government property, Grant programs— business, Individuals with disabilities, Loan programs—business, Reporting and recordkeeping requirements, Small businesses. PART 121—SMALL BUSINESS SIZE REGULATIONS For the reasons set forth in the preamble, the interim rule amending 13 CFR part 121, which was published at 79 FR 33647 on June 12, 2014, is adopted as a final rule without change. mstockstill on DSK4VPTVN1PROD with RULES ■ Dated: January 12, 2016. Maria Contreras-Sweet, Administrator. [FR Doc. 2016–01410 Filed 1–22–16; 8:45 am] BILLING CODE 8025–01–P VerDate Sep<11>2014 13:57 Jan 22, 2016 Jkt 238001 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. 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, SUMMARY: PO 00000 Frm 00018 Fmt 4700 Sfmt 9990 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.’’ 3. On page 56151, beginning in the second column, revise § 117.8 to read as follows: ■ ‘‘§ 117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities. Except as provided by § 117.5(k)(1), subpart B of this part applies to the offfarm 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.’’ § 117.405 [Corrected] 4. On page 56164, in the first column, in § 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 E:\FR\FM\25JAR1.SGM 25JAR1

Agencies

[Federal Register Volume 81, Number 15 (Monday, January 25, 2016)]
[Rules and Regulations]
[Page 3956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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