81 FR 3714 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 14 (January 22, 2016)

Page Range		3714-3716
FR Document		2016-01091

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.

Federal Register, Volume 81 Issue 14 (Friday, January 22, 2016)

[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Rules and Regulations]
[Pages 3714-3716]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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

3714 Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations

(2) In the case of historic preservation reasonable accommodations in policies, restrict, or authorize the conducting of
programs, require the Agency to take practices, or procedures or the provision testing for the illegal use of drugs.
any action that would threaten or of auxiliary aids or services will Cheryl E. Parker,
destroy the historic significance of mitigate the risk.
NASA Federal Register Liaison Officer.
historic properties.
■ 25. Add § 1251.581 to subpart 1251.5 [FR Doc. 2016–00610 Filed 1–21–16; 8:45 am]
* * * * * to read as follows: BILLING CODE 7510–13–P
■ 22. Revise § 1251.551 to read as
follows: § 1251.581 Reasonable accommodation.

§ 1251.551 Program accessibility: New The Agency shall make reasonable DEPARTMENT OF HEALTH AND
construction and alterations. accommodations in policies, practices, HUMAN SERVICES
Each building or part of a building or procedures when such
that is constructed or altered by, on accommodations are necessary to avoid Food and Drug Administration
behalf of, or for the use of the agency discrimination on the basis of disability,
shall be designed, constructed, or unless the Agency can demonstrate that 21 CFR Parts 1 and 117
altered so as to be readily accessible to making the accommodations would [Docket No. FDA–2011–N–0920]
and usable by individuals with fundamentally alter the nature of the
RIN 0910–AG36
disabilities. The definitions, service, program, or activity or result in
requirements, and standards of the an undue financial and administrative Current Good Manufacturing Practice,
Architectural Barriers Act (42 U.S.C. burden. Hazard Analysis, and Risk-Based
4151–4157), as established in 41 CFR Preventive Controls for Human Food;
part 102–76, subpart C, apply to ■ 26. Add § 1251.582 to subpart 1251.5
to read as follows: Technical Amendment
buildings covered by this section.
■ 23. In § 1251.570, revise paragraphs
AGENCY: Food and Drug Administration,
§ 1251.582 Illegal use of drugs
(b) and (c) to read as follows: HHS.
(a) General. (1) Except as provided in Final rule; technical
ACTION:
§ 1251.570 Compliance procedures. paragraph (b) of this section, this part amendment.
* * * * * does not prohibit discrimination against
(b) The Agency shall process an individual based on that individual’s SUMMARY: The Food and Drug
complaints alleging violations of section current illegal use of drugs. Administration (FDA or we) is
504 of the Rehabilitation Act with amending a final rule that published in
(2) The Agency shall not discriminate the Federal Register of September 17,
respect to employment according to the on the basis of illegal use of drugs
procedures established by the Equal 2015. That final rule amended our
against an individual who is not regulation for current good
Employment Opportunity Commission engaging in current illegal use of drugs
in 29 CFR part 1640 pursuant to section manufacturing practice in
and who— manufacturing, packing, or holding
501 of the Rehabilitation Act of 1973 (29
U.S.C. 791). (i) Has successfully completed a human food to modernize it, and to add
(c) The Associate Administrator for supervised drug rehabilitation program requirements for domestic and foreign
Diversity and Equal Opportunity shall or has otherwise been rehabilitated facilities that are required to register
be responsible for coordinating successfully; under the Federal Food, Drug, and
implementation of this section. Cosmetic Act (the FD&C Act) to
(ii) Is participating in a supervised
Complaints may be sent to the Office of establish and implement hazard
rehabilitation program; or analysis and risk-based preventive
Diversity and Equal Opportunity, NASA
(iii) Is erroneously regarded as controls for human food. That final rule
Headquarters, 300 E Street SW.,
engaging in such use. also revised certain definitions in our
Washington, DC 20546.
(b) Health and drug rehabilitation current regulation for registration of
* * * * * food facilities to clarify the scope of the
services. (1) The Agency shall not deny
■ 24. Add § 1251.580 to subpart 1251.5 exemption from registration
health services, or services provided in
to read as follows: requirements provided by the FD&C Act
connection with drug rehabilitation, to
§ 1251.580 Direct threat. an individual on the basis of that for ‘‘farms.’’ The final rule published
individual’s current illegal use of drugs, with some editorial and inadvertent
(a) This part does not require the errors. This document corrects those
Agency to permit an individual to if the individual is otherwise entitled to
such services. errors.
participate in or benefit from the
services, programs, or activities of that DATES: Effective January 22, 2016.
(2) A drug rehabilitation or treatment
recipient when that individual poses a program may deny participation to FOR FURTHER INFORMATION CONTACT:
direct threat to the health or safety of individuals who engage in illegal use of Jenny Scott, Center for Food Safety and
others. drugs while they are in the program. Applied Nutrition (HFS–300), Food and
(b) In determining whether an Drug Administration, 5100 Paint Branch
(c) Drug testing. (1) This part does not Pkwy., College Park, MD 20740, 240–
individual poses a direct threat to the
prohibit the Agency from adopting or 402–2166.
health or safety of others, the Agency
must make an individualized administering reasonable policies or SUPPLEMENTARY INFORMATION: In the
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assessment, based on reasonable procedures, including but not limited to Federal Register of Thursday,
judgment that relies on current medical drug testing, designed to ensure that an September 17, 2015 (80 FR 55908), FDA
knowledge or on the best available individual who formerly engaged in the published the final rule ‘‘Current Good
objective evidence, to ascertain: The illegal use of drugs is not now engaging Manufacturing Practice, Hazard
nature, duration, and severity of the in current illegal use of drugs. Analysis, and Risk-Based Preventive
risk; the probability that the potential (2) Nothing in this paragraph (c) shall Controls for Human Food’’ with some
injury will actually occur; and whether be construed to encourage, prohibit, editorial and inadvertent errors. This

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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations 3715

action is being taken to correct activities performed for the safe or (b) The operation of a facility that
inadvertent errors by making the effective packing or re-packing of that manufactures, processes, packs, or holds
following correcting amendments. food (such as sorting, culling, grading, food for sale in the United States if the
and weighing or conveying incidental to owner, operator, or agent in charge of
List of Subjects
packing or re-packing)), but does not such facility is required to comply with,
21 CFR Part 1 include activities that transform a raw and is not in compliance with, section
Cosmetics, Drugs, Exports, Food agricultural commodity, as defined in 418 of the Federal Food, Drug, and
labeling, Imports, Labeling, Reporting section 201(r) of the Federal Food, Drug, Cosmetic Act or subpart C, D, E, F, or
and recordkeeping requirements. and Cosmetic Act, into a processed food G of this part is a prohibited act under
as defined in section 201(gg) of the section 301(uu) of the Federal Food,
21 CFR Part 117 Federal Food, Drug, and Cosmetic Act. Drug, and Cosmetic Act.
Food packaging, Foods. * * * * * * * * * *
■ 3. Amend § 1.328 to revise the ■ 6. Amend § 117.3 to:
PART 1—GENERAL ENFORCEMENT definition of ‘‘harvesting’’ to read as ■ a. Revise the definitions of ‘‘audit’’,
REGULATIONS follows: ‘‘harvesting’’, and ‘‘packing’’;
■ b. Revise the introductory text of
■ 1. The authority citation for 21 CFR § 1.328 What definitions apply to this paragraph (1) of the definition of
part 1 continues to read as follows: subpart? ‘‘qualified end-user’’; and
Authority: 15 U.S.C. 1333, 1453, 1454, * * * * * ■ c. Revise the definition of ‘‘small
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. Harvesting applies to farms and farm business’’.
321, 331, 332, 333, 334, 335a, 343, 350c, mixed-type facilities and means The revisions read as follows:
350d, 352, 355, 360b, 360ccc, 360ccc–1, activities that are traditionally
360ccc–2, 362, 371, 374, 381, 382, 387, 387a, § 117.3 Definitions.
performed on farms for the purpose of
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264. removing raw agricultural commodities * * * * *
from the place they were grown or Audit means the systematic,
■ 2. Amend § 1.227 to revise the
raised and preparing them for use as independent, and documented
definitions of ‘‘harvesting’’ and
food. Harvesting is limited to activities examination (through observation,
‘‘packing’’ to read as follows:
performed on raw agricultural investigation, records review,
§ 1.227 What definitions apply to this commodities, or on processed foods discussions with employees of the
subpart? created by drying/dehydrating a raw audited entity, and, as appropriate,
* * * * * agricultural commodity without sampling and laboratory analysis) to
Harvesting applies to farms and farm additional manufacturing/processing, assess an audited entity’s food safety
mixed-type facilities and means on a farm. Harvesting does not include processes and procedures.
activities that are traditionally activities that transform a raw * * * * *
performed on farms for the purpose of agricultural commodity into a processed Harvesting applies to farms and farm
removing raw agricultural commodities food as defined in section 201(gg) of the mixed-type facilities and means
from the place they were grown or Federal Food, Drug, and Cosmetic Act. activities that are traditionally
raised and preparing them for use as Examples of harvesting include cutting performed on farms for the purpose of
food. Harvesting is limited to activities (or otherwise separating) the edible removing raw agricultural commodities
performed on raw agricultural portion of the raw agricultural from the place they were grown or
commodities, or on processed foods commodity from the crop plant and raised and preparing them for use as
created by drying/dehydrating a raw removing or trimming part of the raw food. Harvesting is limited to activities
agricultural commodity without agricultural commodity (e.g., foliage, performed on raw agricultural
additional manufacturing/processing, husks, roots, or stems). Examples of commodities, or on processed foods
on a farm. Harvesting does not include harvesting also include cooling, field created by drying/dehydrating a raw
activities that transform a raw coring, filtering, gathering, hulling, agricultural commodity without
agricultural commodity into a processed shelling, sifting, threshing, trimming of additional manufacturing/processing,
food as defined in section 201(gg) of the outer leaves of, and washing raw on a farm. Harvesting does not include
Federal Food, Drug, and Cosmetic Act. agricultural commodities grown on a activities that transform a raw
Examples of harvesting include cutting farm. agricultural commodity into a processed
(or otherwise separating) the edible * * * * * food as defined in section 201(gg) of the
portion of the raw agricultural Federal Food, Drug, and Cosmetic Act.
commodity from the crop plant and PART 117—CURRENT GOOD Examples of harvesting include cutting
removing or trimming part of the raw MANUFACTURING PRACTICE, (or otherwise separating) the edible
agricultural commodity (e.g., foliage, HAZARD ANALYSIS, AND RISK- portion of the raw agricultural
husks, roots or stems). Examples of BASED PREVENTIVE CONTROLS FOR commodity from the crop plant and
harvesting also include cooling, field HUMAN FOOD removing or trimming part of the raw
coring, filtering, gathering, hulling, agricultural commodity (e.g., foliage,
shelling, sifting, threshing, trimming of ■ 4. The authority citation for 21 CFR husks, roots or stems). Examples of
outer leaves of, and washing raw part 117 continues to read as follows: harvesting also include cooling, field
agricultural commodities grown on a Authority: 21 U.S.C. 331, 342, 343, 350d coring, filtering, gathering, hulling,
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farm. note, 350g, 350g note, 371, 374; 42 U.S.C. shelling, sifting, threshing, trimming of
* * * * * 243, 264, 271. outer leaves of, and washing raw
Packing means placing food into a ■ 5. In § 117.1, revise paragraph (b) to agricultural commodities grown on a
container other than packaging the food read as follows: farm.
and also includes re-packing and * * * * *
activities performed incidental to § 117.1 Applicability and status. Packing means placing food into a
packing or re-packing a food (e.g., * * * * * container other than packaging the food

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Document Created: 2016-01-22 01:17:15
Document Modified: 2016-01-22 01:17:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		Effective January 22, 2016.
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.
FR Citation		81 FR 3714
RIN Number		0910-AG36
CFR Citation		21 CFR 117 21 CFR 1
CFR Associated		Cosmetics; Drugs; Exports; Food Labeling; Imports; Labeling; Reporting and Recordkeeping Requirements; Food Packaging and Foods

81 FR 3714 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 14 (January 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration