
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Rules and Regulations]
[Pages 3714-3716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 117

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending 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 22, 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

[[Page 3715]]

action is being taken to correct inadvertent errors by making the 
following correcting amendments.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 117

    Food packaging, Foods.

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as 
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.


0
2. Amend Sec.  1.227 to revise the definitions of ``harvesting'' and 
``packing'' to read as follows:


Sec.  1.227  What definitions apply to this subpart?

* * * * *
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, shelling, sifting, threshing, 
trimming of outer leaves of, and washing raw agricultural commodities 
grown on a farm.
* * * * *
    Packing means placing food into a container other than packaging 
the food and also includes re-packing and activities performed 
incidental to packing or re-packing a food (e.g., activities performed 
for the safe or effective packing or re-packing of that food (such as 
sorting, culling, grading, and weighing or conveying incidental to 
packing or re-packing)), but does not include activities that transform 
a raw agricultural commodity, as defined in section 201(r) of the 
Federal Food, Drug, and Cosmetic Act, into a processed food as defined 
in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *

0
3. Amend Sec.  1.328 to revise the definition of ``harvesting'' to read 
as follows:


Sec.  1.328  What definitions apply to this subpart?

* * * * *
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots, or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, shelling, sifting, threshing, 
trimming of outer leaves of, and washing raw agricultural commodities 
grown on a farm.
* * * * *

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
4. The authority citation for 21 CFR part 117 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.


0
5. In Sec.  117.1, revise paragraph (b) to read as follows:


Sec.  117.1  Applicability and status.

* * * * *
    (b) The operation of a facility that manufactures, processes, 
packs, or holds food for sale in the United States if the owner, 
operator, or agent in charge of such facility is required to comply 
with, and is not in compliance with, section 418 of the Federal Food, 
Drug, and Cosmetic Act or subpart C, D, E, F, or G of this part is a 
prohibited act under section 301(uu) of the Federal Food, Drug, and 
Cosmetic Act.
* * * * *
0
6. Amend Sec.  117.3 to:
0
a. Revise the definitions of ``audit'', ``harvesting'', and 
``packing'';
0
b. Revise the introductory text of paragraph (1) of the definition of 
``qualified end-user''; and
0
c. Revise the definition of ``small business''.
    The revisions read as follows:


Sec.  117.3  Definitions.

* * * * *
    Audit means the systematic, independent, and documented examination 
(through observation, investigation, records review, discussions with 
employees of the audited entity, and, as appropriate, sampling and 
laboratory analysis) to assess an audited entity's food safety 
processes and procedures.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed on farms for the 
purpose of removing raw agricultural commodities from the place they 
were grown or raised and preparing them for use as food. Harvesting is 
limited to activities performed on raw agricultural commodities, or on 
processed foods created by drying/dehydrating a raw agricultural 
commodity without additional manufacturing/processing, on a farm. 
Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, shelling, sifting, threshing, 
trimming of outer leaves of, and washing raw agricultural commodities 
grown on a farm.
* * * * *
    Packing means placing food into a container other than packaging 
the food

[[Page 3716]]

and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe 
or effective packing or re-packing of that food (such as sorting, 
culling, grading, and weighing or conveying incidental to packing or 
re-packing)), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    Qualified end-user * * *
    (1) Is located:
* * * * *
    Small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) employing fewer than 500 
full-time equivalent employees.
* * * * *

0
7. In Sec.  117.5, revise the first sentence of paragraph (a), and 
revise paragraph (h)(3)(v) to read as follows:


Sec.  117.5  Exemptions.

    (a) Except as provided by subpart E of this part, subparts C and G 
of this part do not apply to a qualified facility. * * *
* * * * *
    (h) * * *
    (3) * * *
    (v) Extracting (including by pressing, by distilling, and by 
solvent extraction) dried/dehydrated herb and spice products (e.g., 
dried mint), fresh herbs (e.g., fresh mint), fruits and vegetables 
(e.g., olives, avocados), grains (e.g., oilseeds), and other herb and 
spice products (e.g., chopped fresh mint, chopped dried mint);
* * * * *

0
8. In Sec.  117.136, revise paragraphs (a)(2) introductory text, 
(a)(5), and (b)(5) to read as follows:


Sec.  117.136  Circumstances in which the owner, operator, or agent in 
charge of a manufacturing/processing facility is not required to 
implement a preventive control.

    (a) * * *
    (2) You rely on your customer who is subject to the requirements 
for hazard analysis and risk-based preventive controls in this subpart 
to ensure that the identified hazard will be significantly minimized or 
prevented and you:
* * * * *
    (5) You have established, documented, and implemented a system that 
ensures control, at a subsequent distribution step, of the hazards in 
the food you distribute and you document the implementation of that 
system.
    (b) * * *
    (5) Your system, in accordance with paragraph (a)(5) of this 
section, that ensures control, at a subsequent distribution step, of 
the hazards in the food you distribute.

0
9. In Sec.  117.145, revise paragraph (a) to read as follows:


Sec.  117.145  Monitoring.

* * * * *
    (a) Written procedures. You must establish and implement written 
procedures, including the frequency with which they are to be 
performed, for monitoring the preventive control; and
* * * * *

0
10. In Sec.  117.201, revise paragraphs (b)(2)(i)(B) and (b)(2)(ii) to 
read as follows:


Sec.  117.201  Modified requirements that apply to a qualified 
facility.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5100 
Paint Branch Pkwy., College Park, MD 20740; or
* * * * *
    (ii) Send a paper Form FDA 3942a to the U.S. Food and Drug 
Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD 
20740. We recommend that you submit a paper copy only if your facility 
does not have reasonable access to the Internet.
* * * * *

0
11. In Sec.  117.257, revise paragraph (e) to read as follows:


Sec.  117.257  Contents of an order to withdraw a qualified facility 
exemption.

* * * * *
    (e) A statement that a facility may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec.  
117.287;
* * * * *

0
12. In Sec.  117.264, revise paragraph (a)(1) to read as follows:


Sec.  117.264  Procedure for submitting an appeal.

    (a) * * *
    (1) Submit the appeal in writing to the FDA District Director in 
whose district the facility is located (or, in the case of a foreign 
facility, the Director of the Office of Compliance in the Center for 
Food Safety and Applied Nutrition), at the mailing address, email 
address, or facsimile number identified in the order within 15 calendar 
days of the date of receipt of confirmation of the order; and
* * * * *

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01091 Filed 1-21-16; 8:45 am]
BILLING CODE 4164-01-P


