Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Technical Amendment, 3714-3716 [2016-01091]

Download as PDF 3714 Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations (2) In the case of historic preservation programs, require the Agency to take any action that would threaten or destroy the historic significance of historic properties. * * * * * ■ 22. Revise § 1251.551 to read as follows: § 1251.551 Program accessibility: New construction and alterations. Each building or part of a building that is constructed or altered by, on behalf of, or for the use of the agency shall be designed, constructed, or altered so as to be readily accessible to and usable by individuals with disabilities. The definitions, requirements, and standards of the Architectural Barriers Act (42 U.S.C. 4151–4157), as established in 41 CFR part 102–76, subpart C, apply to buildings covered by this section. ■ 23. In § 1251.570, revise paragraphs (b) and (c) to read as follows: § 1251.570 Compliance procedures. * * * * * (b) The Agency shall process complaints alleging violations of section 504 of the Rehabilitation Act with respect to employment according to the procedures established by the Equal Employment Opportunity Commission in 29 CFR part 1640 pursuant to section 501 of the Rehabilitation Act of 1973 (29 U.S.C. 791). (c) The Associate Administrator for Diversity and Equal Opportunity shall be responsible for coordinating implementation of this section. Complaints may be sent to the Office of Diversity and Equal Opportunity, NASA Headquarters, 300 E Street SW., Washington, DC 20546. * * * * * ■ 24. Add § 1251.580 to subpart 1251.5 to read as follows: mstockstill on DSK4VPTVN1PROD with RULES § 1251.580 Direct threat. (a) This part does not require the Agency to permit an individual to participate in or benefit from the services, programs, or activities of that recipient when that individual poses a direct threat to the health or safety of others. (b) In determining whether an individual poses a direct threat to the health or safety of others, the Agency must make an individualized assessment, based on reasonable judgment that relies on current medical knowledge or on the best available objective evidence, to ascertain: The nature, duration, and severity of the risk; the probability that the potential injury will actually occur; and whether VerDate Sep<11>2014 16:27 Jan 21, 2016 Jkt 238001 reasonable accommodations in policies, practices, or procedures or the provision of auxiliary aids or services will mitigate the risk. 25. Add § 1251.581 to subpart 1251.5 to read as follows: ■ § 1251.581 26. Add § 1251.582 to subpart 1251.5 to read as follows: ■ [FR Doc. 2016–00610 Filed 1–21–16; 8:45 am] BILLING CODE 7510–13–P Frm 00016 Fmt 4700 Sfmt 4700 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: Illegal use of drugs Food and Drug Administration, HHS. (a) General. (1) Except as provided in paragraph (b) of this section, this part does not prohibit discrimination against an individual based on that individual’s current illegal use of drugs. (2) The Agency shall not discriminate on the basis of illegal use of drugs against an individual who is not engaging in current illegal use of drugs and who— (i) Has successfully completed a supervised drug rehabilitation program or has otherwise been rehabilitated successfully; (ii) Is participating in a supervised rehabilitation program; or (iii) Is erroneously regarded as engaging in such use. (b) Health and drug rehabilitation services. (1) The Agency shall not deny health services, or services provided in connection with drug rehabilitation, to an individual on the basis of that individual’s current illegal use of drugs, if the individual is otherwise entitled to such services. (2) A drug rehabilitation or treatment program may deny participation to individuals who engage in illegal use of drugs while they are in the program. (c) Drug testing. (1) This part does not prohibit the Agency from adopting or administering reasonable policies or procedures, including but not limited to drug testing, designed to ensure that an individual who formerly engaged in the illegal use of drugs is not now engaging in current illegal use of drugs. (2) Nothing in this paragraph (c) shall be construed to encourage, prohibit, PO 00000 Cheryl E. Parker, NASA Federal Register Liaison Officer. Reasonable accommodation. The Agency shall make reasonable accommodations in policies, practices, or procedures when such accommodations are necessary to avoid discrimination on the basis of disability, unless the Agency can demonstrate that making the accommodations would fundamentally alter the nature of the service, program, or activity or result in an undue financial and administrative burden. § 1251.582 restrict, or authorize the conducting of testing for the illegal use of drugs. Final rule; technical amendment. ACTION: 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 SUMMARY: E:\FR\FM\22JAR1.SGM 22JAR1 Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations PART 1—GENERAL ENFORCEMENT REGULATIONS 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. * * * * * ■ 3. Amend § 1.328 to revise the definition of ‘‘harvesting’’ to read as follows: ■ 1. The authority citation for 21 CFR part 1 continues to read as follows: § 1.328 What definitions apply to this subpart? 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. * 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. 2. Amend § 1.227 to revise the definitions of ‘‘harvesting’’ and ‘‘packing’’ to read as follows: ■ § 1.227 What definitions apply to this subpart? mstockstill on DSK4VPTVN1PROD with RULES * * * * * 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., VerDate Sep<11>2014 16:27 Jan 21, 2016 Jkt 238001 * * * * 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 RISKBASED PREVENTIVE CONTROLS FOR HUMAN FOOD 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. 5. In § 117.1, revise paragraph (b) to read as follows: ■ § 117.1 * PO 00000 * Applicability and status. * Frm 00017 * Fmt 4700 * Sfmt 4700 3715 (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. * * * * * ■ 6. Amend § 117.3 to: ■ a. Revise the definitions of ‘‘audit’’, ‘‘harvesting’’, and ‘‘packing’’; ■ b. Revise the introductory text of paragraph (1) of the definition of ‘‘qualified end-user’’; and ■ c. Revise the definition of ‘‘small business’’. The revisions read as follows: § 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 E:\FR\FM\22JAR1.SGM 22JAR1 3716 Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Rules and Regulations 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. * * * * * ■ 7. In § 117.5, revise the first sentence of paragraph (a), and revise paragraph (h)(3)(v) to read as follows: § 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); * * * * * ■ 8. In § 117.136, revise paragraphs (a)(2) introductory text, (a)(5), and (b)(5) to read as follows: mstockstill on DSK4VPTVN1PROD with RULES § 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) * * * VerDate Sep<11>2014 16:27 Jan 21, 2016 Jkt 238001 (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. ■ 9. In § 117.145, revise paragraph (a) to read as follows: § 117.145 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 * * * * * ■ 10. In § 117.201, revise paragraphs (b)(2)(i)(B) and (b)(2)(ii) to read as follows: Food and Drug Administration 21 CFR Part 507 [Docket No. FDA–2011–N–0922] RIN 0910–AG10 § 117.201 Modified requirements that apply to a qualified facility. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment * AGENCY: * * * * (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. * * * * * ■ 11. In § 117.257, revise paragraph (e) to read as follows: § 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 § 117.287; * * * * * ■ 12. In § 117.264, revise paragraph (a)(1) to read as follows: § 117.264 appeal. Procedure for submitting an (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 * * * * * PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 Food and Drug Administration, HHS. Final rule, technical amendment. ACTION: 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 established requirements for domestic and foreign facilities required to register under the Federal Food, Drug, and Cosmetic Act for current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals. The final rule published with some editorial and inadvertent errors. This document corrects those errors. DATES: Effective January 22, 2016. FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary Medicine (HFV–200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6246, email: jenny.murphy@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, September 17, 2015 (80 FR 56170), FDA published the final rule ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’ with some editorial and inadvertent errors. This action is being taken to correct those errors by making the following correcting amendments. SUMMARY: List of Subjects in 21 CFR Part 507 Animal foods, Labeling, Packaging and containers, Reporting and recordkeeping requirements. Accordingly, FDA is amending 21 CFR part 507 with the following technical amendments: E:\FR\FM\22JAR1.SGM 22JAR1

Agencies

[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]


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

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