
[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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


