food safety plan. After considering comments, we decided that we will
not establish a requirement for submission of a facility profile. To
the extent that this comment is addressing the form used for
registering a food facility with FDA, such a comment is outside the
scope of this rule-making. Moreover, an establishment that meets the
definition of a retail food establishment is not a facility required to
register.
    (Comment 747) Comments believe that our ICR contains redundant
collections. Comments believe that our existing Food Facility
Registration Module requests information on facility type and products
handled, while our ICR seeks the same information. Commenters believe
that we should minimize redundancies to the greatest extent possible
and use the information that we already have. As such, we should not be
requesting information on facility type, products handled and, if it
decides to as we recommend, types of storage, through this ICR. All of
these data points are already collected by the existing Food Facility
Registration Module.
    (Response 747) The ICR associated with this rule-making is not
redundant. The ICR associated with food facility registration with FDA
is a separate rule-making and a separate burden. This PRA contains the
ICR for completing all the requirements for a food facility to develop
a hazard analysis and preventive controls; not register their facility.
See Response 746.
    (Comment 748) Comments suggest that our estimated time and costs to
comply with the requirement to label products from certain qualified
facilities do not come under the PRA because the address requirement is
a disclosure, and not an information collection.
    (Response 748) We concur that the requirement to add a qualified
facility address to the product label is a third-party disclosure
burden, and because it is a disclosure burden, is subject to the PRA.
We revised our estimate for the hour burden for each of these
disclosures to be 15 minutes as shown in table 69 of the PRA, to
reflect that this will not be a coordinated label change for most
qualified facilities so most will not be updating their labels anyway.

Information Collection Burden Estimate

    FDA estimates the burden for this information collection as
follows:

Recordkeeping Burden

    We estimate that about 46,685 facilities subject to subparts C and
G Hazard Analysis and Risk-Based Preventive Controls will need to
create a food safety plan (Sec.  117.175(a)(1)) which is a compilation
of many written food safety procedures. We total the hour burdens as
presented throughout the FRIA (Ref. 38) to then create an average hour
burden for each facility to create or complete a food safety plan. We
estimate that creation of the food safety plan will require 110 hours.
The total hour burden on an annual basis is 46,685 facilities x 110
hours = 5,135,350 hours. There are no capital costs or operating and
maintenance costs associated with this collection of information.
    We estimate the burden for disclosing to a customer, in documents
to accompany foods that require further processing, that the food has
not been processed to control a specified hazard (Sec.  117.136), is 15
minutes per record. We estimate that 16,285 establishments will each
make one of these disclosures for a total recordkeeping burden of 4,071
hours.
    The burden for keeping monitoring records (Sec.  117.175(a)(2))
follows the same pattern as that for the food safety plan. We estimate
that there are 8,143 facilities subject to subparts C and G Hazard
Analysis and Risk-Based Preventive Controls that will need to keep
additional records of the monitoring that they do of different
activities within their food facilities. Based on estimates of
monitoring created, when appropriate, throughout the FRIA, we estimate
that each of the 8,143 facilities will keep records of 730 monitoring
activities and that each record can be made in about 3 minutes (0.05
hours) for a total hour burden of 297,220.
    For the burden for corrective action records (Sec.  117.175(a)(3)
we estimate that twice per year 16,285 facilities subject to subparts C
and G Hazard Analysis and Risk-Based Preventive Controls will have
corrective actions to document. The documentation of those corrective
actions is expected to take one hour for each record for a total hour
burden of 32,570.
    We estimate that there are 8,143 facilities subject to subparts C
and G Hazard Analysis and Risk-Based Preventive Controls that will need
to keep additional records of verification activities. Based on
estimates of verification records created, when appropriate, throughout
the FRIA, we estimate that 8,143 facilities will keep records of 244
verification activities and that each record can be made in about 3
minutes (0.05 hours) for a total hour burden of 101,675.
    The burden for keeping validation records (Sec.  117.160) follows
the same pattern as that for verification records. We estimate that
there are 3,677 facilities subject to subparts C and G Hazard Analysis
and Risk-Based Preventive Controls that will need to keep additional
records of the validation of their process control activities within
their food facilities. Based on estimates of the establishments that
will require validation, when appropriate, throughout the FRIA, we
estimate that each of the 3,677 facilities will keep records of six
validation activities for a total of 22,062 records. We estimate that
each record can be made in about 15 minutes (0.25 hours) for a total
hour burden of 5,515.
    The burden for keeping supplier records is for the use of approved
suppliers and for establishments to document their audits Sec.
117.475(c)(7), the sampling and testing of their ingredients Sec.
117.475(c)(8), and the review of their supplier's relevant food safety
records Sec.  117.475(c)(9), among up to 18 possible supplier related
records. Our estimate follows the same pattern as that for other
records. We estimate that there are 16,285 facilities subject to
subparts C and G Hazard Analysis and Risk-Based Preventive Controls
that will need to keep as many as 18 additional records for an average
of 10 records of their approved suppliers and review records. Based on
estimates throughout the FRIA, we estimate that each of the 16,285
establishments will maintain these records and that the total time for
this recordkeeping will be about 4 hours for a total hour burden of
651,400.
    We estimate that 46,685 establishments subject to subparts C and G
Hazard Analysis and Risk-Based Preventive Controls will need to
document the training of their preventive controls qualified
individuals (Sec.  117.180(d)). We estimate that this will require 15
minutes (0.25 hours) per facility total for a total hour burden of
11,671.
    Under Sec.  117.206(a)(5) facilities are required to keep records
documenting (1) the monitoring of temperature controls for refrigerated
packaged food, (2) the corrective actions taken when there is a problem
with the control of temperature for refrigerated packaged food, and (3)
the verification activities relating to the temperature control of
refrigerated packaged food. We believe that the keeping of such records
is already common industry practice and will not constitute an
additional paperwork burden.
    Table 56 shows the estimated annual recordkeeping burden associated
with this rule. There are no capital costs or operating and maintenance
costs associated with this collection of information.

                                 Table 56--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
   21 CFR Part 1, Subpart 117      recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
117.126 (c) and 117.170(d) food           46,685               1          46,685          110          5,135,350
 safety plan and reanalysis.....
117.136 assurance records.......          16,285               1          16,285            0.25           4,070
117.145 (c) monitoring records..           8,143             730       5,944,390            0.05         297,220
117.150 (d) corrective actions            16,285               2          32,570            1             32,570
 and corrections records........
117.155(b) verification records.           8,143             244       1,986,892            0.05         101,675
117.160 validation records......           3,677               6          22,062             .25           5,515
117.475(c)(7), 117.475(c)(8),             16,285               1          16,285            4            651,400
 and 117.475(c)(9) among up to
 18 supplier records............
117.180(d) Records that document          46,685               1          46,685             .25          11,671
 applicable training for the
 preventive controls qualified
 individual.....................
                                 -------------------------------------------------------------------------------
    Total annual burden hours...  ..............  ..............  ..............  ..............       6,239,471
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information

Reporting Burden

    Table 57 shows the estimated annual reporting burden associated
with this rule.
    Qualified facilities must report their status as such a facility
every 2 years; status will likely be reported electronically through a
web portal maintained by FDA. This requirement will cause the 37,134
qualified facilities to spend 0.5 hour every 2 years reporting to FDA
their status as a qualified facility for a total annual hour burden of
about 9,283 hours (37,134 facilities x 0.5 responses annually x 0.5
hours per response).

                                   Table 57--Estimated Annual Reporting Burden
                                         [Very small business <$1 m] \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
21 CFR Section (or FDA Form No.)     Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
117.201(e) Qualified facility...          37,134             0.5          18,567             0.5           9,283
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total burden hours..........  ..............  ..............  ..............  ..............           9,283
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Third Party Disclosure Burden

    Under Sec.  117.201(e) qualified facilities must add the address of
the facility where the food is manufactured to their label. We estimate
the hour burden of this disclosure is 15 minutes per disclosure. This
requirement will cause the 37,134 qualified facilities to spend 0.25
hours adding their address to their new labels for a total hour burden
of about 9,283 hours (37,134 facilities x 0.25 hours per response).

                                Table 58--Estimated Third-Party Disclosure Burden
                                         [Very small business <$1 m] \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
  20 CFR section  (or FDA Form       Number of       Number of         Total        burden per
              No.)                  respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
117.201(e) Qualified facility...          37,134               1          37,134            0.25           9,283
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total burden hours..........  ..............  ..............  ..............  ..............           9,283
----------------------------------------------------------------------------------------------------------------

LXII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

LXIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
These references are also available electronically at http://www.regulatons.gov. We have verified the Web site addresses, but we are
not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.

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Outreach,'' 2013. See Reference 7 to the 2014 supplemental human
preventive controls notice.
2. FDA Memorandum, ``Memoranda of Outreach,'' 2015.
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2, 2005. Accessed and printed on March 20, 2015. See Reference 1 to
the 2013 proposed human preventive controls rule.
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Combinations for Activities (Outside the Farm Definition) Conducted
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March 5, 2015. Accessed and printed on March 26, 2015.
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January 15, 2015. Accessed and printed on March 27, 2015.
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printed on May 19, 2014.

12. FDA, ``Inspection Modernization and Training: Key Investments
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2014. Accessed and printed on September 26, 2014.
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Contamination by Salmonella Species in Food Containing a Peanut-
Derived Product as an Ingredient,'' 2009. See Reference 6 to the
2013 proposed human preventive controls rule.
30. FDA, ``Guidance for Industry: Measures to Address the Risk for
Contamination by Salmonella Species in Food Containing a Pistachio-
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2013 proposed human preventive controls rule.
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35. National Advisory Committee on Microbiological Criteria for
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68. FDA, ``CPG Sec. 560.750 Radionucleotides in Imported Foods--
Levels of Concern,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074576.htm), November 29, 2005.
Accessed and printed on October 14, 2011. See Reference 151 to the
2013 proposed human preventive controls rule.
69. FDA, ``FDA Recalls Web site,'' (http://www.fda.gov/Safety/Recalls/default.htm), June 4, 2014. Accessed and printed on March
13, 2015.
70. Food Allergy Research & Resource Group and the University of
Nebraska, Lincoln, ``Components of an Effective Allergen Control
Plan,'' (http://farrp.unl.edu/c/document_library/get_file?uuid=3fcc9e7c-9430-4988-99a0-96248e5a28f7&groupId=2103626),
2011. Accessed and printed on October 17, 2011. See Reference 123 to
the 2013 proposed human preventive controls rule.
71. Jackson, L. S., F. M. Al-taher, M. Moorman, J. W. DeVries, R.
Tippett, K. M. J. Swanson, T.-J. Fu, R. Salter, G. Dunaif, S. Estes,
S. Albillos, and S. M. Gendel, ``Cleaning and Other Control and
Validation Strategies to Prevent

Allergen Cross-Contact in Food-Processing Operations,'' Journal of
Food Protection, 71:445-458, 2008. See Reference 124 to the 2013
proposed human preventive controls rule.
72. FDA, ``FDA Allergy Warning Letter,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106546.htm), June 10, 1996. Accessed and printed on October 17,
2011. See Reference 120 to the 2013 proposed human preventive
controls rule.
73. FDA, ``Food Allergen Partnership,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106779.htm), January, 2001. Accessed and printed on September 17,
2014.
74. FDA, ``CPG, Sec. 555.250 Statement of Policy for Labeling and
Preventing Cross-Contact of Common Food Allergens,'' (http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074552.htm), November 29, 2005. Accessed and printed on September
12, 2014.
75. FDA, ``Draft Guidance for Industry: Questions and Answers
Regarding Mandatory Food Recalls,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm445428.htm), May, 2015. Accessed and printed on May 21, 2015.
76. FDA, ``FDA Homepage,'' (http://www.fda.gov/), March 25, 2015.
Accessed and printed on March 25, 2015.
77. FDA, ``Recalls, Market Withdrawals, & Safety Alerts (FDA Email
Sign-up Web page),'' (https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_48), 2015. Accessed and printed
on June 3, 2015.
78. FDA, ``Guidance for Industry: Product Recalls, Including
Removals and Corrections,'' (http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm), November 3, 2003. Accessed and
printed on February 19, 2015.
79. FoodSafety.gov, ``Get Food Safety Widget,'' (http://www.foodsafety.gov/recalls/widget/index.html), March 27, 2015.
Accessed and printed on March 13, 2015.
80. U.S. Department of Health and Human Services, ``Employers and
Health Information in the Workplace HIPAA Privacy Rule,'' (http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/employers.html), 2015. Accessed and printed on April 2, 2015.
81. Codex Alimentarius Commission, ``Recommended International Code
of Practice: General Principles of Food Hygiene CAC/RCP1-1969, Rev.
4-2003,'' (https://www.idfa.org/docs/default-source/resource-library/391_cxp_001e.pdf?sfvrsn=0; http://www.codexalimentarius.org/download/standards/23/CXP_001e.pdf), 2003. Accessed and printed on
October 27, 2009. See Reference 44 to the 2013 proposed human
preventive controls rule.
82. FDA, ``Guidance for Industry: Testing for Salmonella in Human
Foods and Direct-Human-Contact Animal Foods,'' (http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/salmonella/ucm295271.htm), March, 2012. Accessed and printed on
February 20, 2015.
83. FDA Memorandum, ``Supplier Programs,'' 2014. See Reference 24 to
the 2014 supplemental human preventive controls notice.
84. USDA Food Safety and Inspection Service, ``FSIS Compliance
Guideline HACCP Systems Validation,'' (http://www.fsis.usda.gov/wps/wcm/connect/a70bb780-e1ff-4a35-9a9a-3fb40c8fe584/HACCP_Systems_Validation.pdf?MOD=AJPERES), 2015. Accessed and
printed on July10, 2015.
85. FDA Memorandum, ``Product Testing,'' 2014. See Reference 18 to
the 2014 supplemental human preventive controls notice.
86. FDA, ``Draft Qualitative Assessment of Risk to Public Health
From on-Farm Contamination of Produce,'' 2014.
87. FDA, ``Guidance for Industry: Control of Listeria Monocytogenes
in Refrigerated or Frozen Ready-to-Eat Foods (Draft Guidance),''
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodProcessingHACCP/ucm073110.htm), February, 2008. Accessed and printed on September
13, 2011. See Reference 126 to the 2013 proposed human preventive
controls rule.
88. FDA Memorandum, ``Unique Configuration of HACCP Plans,'' 1995.
89. FDA, ``Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards of Fresh-cut Fruits and Vegetables,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm064458.htm), February,
2008. Accessed and printed on June 1, 2015.
90. Codex Alimentarius Commission, ``Codex Alimentarius Commission
Procedural Manual, 23rd Edition,'' (ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_23e.pdf), 2015. Accessed and printed
on March 26, 2015.
91. FDA, ``Inspections, Compliance, Enforcement, and Criminal
Investigations: Warning Letters,'' (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm), March 26, 2015.
Accessed and printed on March 26, 2015.
92. FDA, ``Import Alerts,'' (http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm), 2015. Accessed and printed
on March 26, 2015.
93. FDA, ``Letter to Sunland Inc. Concerning Suspension of Food
Facility Registration; Notice of Opportunity for Hearing,'' (http://www.fda.gov/aboutfda/centersoffices/officeoffoods/cfsan/cfsanfoiaelectronicreadingroom/ucm329370.htm), November 26, 2012.
Accessed and printed on March 26, 2015.
94. Crandall, P., EJ Van Loo, CA O'Bryan, A Mauromoustakos, F
Yiannas, N Dyenson, and I Berdik. 2012. Companies' opinions and
acceptance of Global Food Safety Initiative benchmarks after
implementation. J. Food Protection. 75: 1660-1672.
95. Global Food Safety Initiative, ``GFSI Guidance Document, Version
6.3,'' (http://www.mygfsi.com/images/mygfsi/gfsifiles/gfsi_guidance/GFSI_Guidance_Document_Over.pdf), 2013. Accessed and printed on June
2, 2015.
96. Global Food Safety Initiative & The Consumer Goods Forum, ``GFSI
Food Safety Auditor Competencies, Edition 1,'' (http://www.mygfsi.com/images/mygfsi/gfsifiles/information-kit/GFSI_Food_Safety_Auditor_Competencies_-_Edition_1_October_2013.pdf),
2013. Accessed and printed on April 2, 2015.
97. FDA, ``Information for Foreign Governments: Frequently Asked
Questions on Systems Recognition,'' (http://www.fda.gov/Food/InternationalInteragencyCoordination/ucm367400.htm), September 5,
2013. Accessed and printed on March 26, 2015.
98. World Trade Organization, ``WTO Ministerial Conference:
Implementation-Related Issues and Concerns,'' (https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.pdf),
November 20, 2001. Accessed and printed on March 17, 2015.
99. World Trade Organization, ``The WTO Agreement on the Application
of Sanitary and Phytosanitary Measures (SPS Agreement),'' (https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm), April 15, 1994.
Accessed and printed on March 17, 2015.
100. FDA, ``Comparison of Proposed Subpart C (Hazard Analysis and
Risk-Based Preventive Controls) to Various Existing Domestic and
International HACCP-Based Standards,'' 2012. See Reference 193 to
the 2013 proposed human preventive controls rule.
101. FDA, ``Tribal Summary Impact Statement,'' 2015.
102. FDA, ``Memorandum on the Modernization of Food Current Good
Manufacturing Practices (CGMP) As Required by the Food Safety
Modernization Act of 2011,'' 2011. See Reference 36 to the 2014
supplemental human preventive controls notice.
103. FDA, ``Memorandum on the Re-Proposal of Select Provisions of
the Proposed Rule: Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Human Food,'' 2014.
See Reference 35 to the 2014 supplemental human preventive controls
notice.

List of Subjects

21 CFR Part 1

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

21 CFR Part 11

    Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 106

    Food grades and standards, Infants and children, Nutrition,
Reporting and recordkeeping requirements.

21 CFR Part 110

    Food packaging, Foods.

21 CFR Part 114

    Food packaging, Foods, Reporting and recordkeeping requirements.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 120

    Foods, Fruit juices, Imports, Reporting and recordkeeping
requirements, Vegetable juices.

21 CFR Part 123

    Fish, Fishery products, Imports, Reporting and recordkeeping
requirements, Seafood.

21 CFR Part 129

    Beverages, Bottled water, Food packaging, Reporting and
recordkeeping requirements.

21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation
protection, Reporting and recordkeeping requirements, Signs and
symbols.

21 CFR Part 211

    Drugs, Labeling, Laboratories, Packaging and containers,
Prescription drugs, Reporting and recordkeeping requirements,
Warehouses.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is amended as follows:

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. Revise Sec.  1.227 to read as follows:

Sec.  1.227  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart. In
addition, for the purposes of this subpart:
    Calendar day means every day shown on the calendar.
    Facility means any establishment, structure, or structures under
one ownership at one general physical location, or, in the case of a
mobile facility, traveling to multiple locations, that manufactures/
processes, packs, or holds food for consumption in the United States.
Transport vehicles are not facilities if they hold food only in the
usual course of business as carriers. A facility may consist of one or
more contiguous structures, and a single building may house more than
one distinct facility if the facilities are under separate ownership.
The private residence of an individual is not a facility. Nonbottled
water drinking water collection and distribution establishments and
their structures are not facilities.
    (1) Domestic facility means any facility located in any State or
Territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico that manufactures/processes, packs, or
holds food for consumption in the United States.
    (2) Foreign facility means a facility other than a domestic
facility that manufactures/processes, packs, or holds food for
consumption in the United States.
    Farm means:
    (1) Primary production farm. A primary production farm is an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. The term ``farm'' includes operations
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same management, or is processed food identified in paragraph
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a
distinct commodity (such as drying/dehydrating grapes to produce
raisins), and packaging and labeling such commodities, without
additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and
packaging and labeling treated raw agricultural commodities, without
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing (an
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an
operation, not located on a primary production farm, devoted to
harvesting (such as hulling or shelling), packing, and/or holding of
raw agricultural commodities, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the raw
agricultural commodities harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in
the secondary activities farm. A secondary activities farm may also
conduct those additional activities allowed on a primary production
farm as described in paragraphs (1)(ii) and (iii) of this definition.
    Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act:
    (1) Except for purposes of this subpart, it does not include:
    (i) Food contact substances as defined in section 409(h)(6) of the
Federal Food, Drug, and Cosmetic Act; or
    (ii) Pesticides as defined in 7 U.S.C. 136(u).
    (2) Examples of food include: Fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or as
components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods,
candy, and canned foods.
    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, removing stems and husks from, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural commodities
when the drying/dehydrating does not create a distinct commodity (such
as drying/dehydrating hay or alfalfa)). Holding also includes
activities performed as a practical necessity for the distribution of
that food (such as blending of the same raw agricultural commodity and
breaking down pallets), 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. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, formulating, freezing, grinding,
homogenizing, irradiating, labeling, milling, mixing, packaging
(including modified atmosphere packaging), pasteurizing, peeling,
rendering, treating to manipulate ripening, trimming, washing, or
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting,
packing, or holding.
    Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
    Nonprofit food establishment means a charitable entity that
prepares or serves food directly to the consumer or otherwise provides
food or meals for consumption by humans or animals in the United
States. The term includes central food banks, soup kitchens, and
nonprofit food delivery services. To be considered a nonprofit food
establishment, the establishment must meet the terms of section
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
    Packaging (when used as a verb) means placing food into a container
that directly contacts the food and that the consumer receives.
    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.
    Restaurant means a facility that prepares and sells food directly
to consumers for immediate consumption. ``Restaurant'' does not include
facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
    (1) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
    (2) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
    Retail food establishment means an establishment that sells food
products directly to consumers as its primary function. A retail food
establishment may manufacture/process, pack, or hold food if the
establishment's primary function is to sell from that establishment
food, including food that it manufactures/processes, packs, or holds,
directly to consumers. A retail food establishment's primary function
is to sell food directly to consumers if the annual monetary value of
sales of food products directly to consumers exceeds the annual
monetary value of sales of food products to all other buyers. The term
``consumers'' does not include businesses. A ``retail food
establishment'' includes grocery stores, convenience stores, and
vending machine locations.
    Trade name means the name or names under which the facility
conducts business, or additional names by which the facility is known.
A trade name is associated with a facility, and a brand name is
associated with a product.
    U.S. agent means a person (as defined in section 201(e) of the
Federal Food, Drug, and Cosmetic Act residing or maintaining a place of
business in the United States whom a foreign facility designates as its
agent for purposes of this subpart. A U.S. agent cannot be in the form
of a mailbox, answering machine or service, or other place where an
individual acting as the foreign facility's agent is not physically
present.
    (1) The U.S. agent acts as a communications link between the Food
and Drug Administration (FDA) and the foreign facility for both
emergency and routine communications. The U.S. agent will be the person
FDA contacts when an emergency occurs, unless the registration
specifies under Sec.  1.233(e) another emergency contact.
    (2) FDA will treat representations by the U.S. agent as those of
the foreign facility, and will consider information or documents
provided to the U.S. agent the equivalent of providing the information
or documents to the foreign facility.
    (3) Having a single U.S. agent for the purposes of this subpart
does not preclude facilities from having multiple agents (such as
foreign suppliers) for other business purposes. A firm's commercial
business in the United States need not be conducted through the U.S.
agent designated for purposes of this subpart.

    You or registrant means the owner, operator, or agent in charge of
a facility that manufactures/processes, packs, or holds food for
consumption in the United States.

0
3. In Sec.  1.241, revise paragraph (a) to read as follows:

Sec.  1.241  What are the consequences of failing to register, update,
or cancel your registration?

    (a) Section 301 of the Federal Food, Drug, and Cosmetic Act
prohibits the doing of certain acts or causing such acts to be done.
Under section 302 of the Federal Food, Drug, and Cosmetic Act, the
United States can bring a civil action in Federal court to enjoin a
person who commits a prohibited act. Under section 303 of the Federal
Food, Drug, and Cosmetic Act, the United States can bring a criminal
action in Federal court to prosecute a person who is responsible for
the commission of a prohibited act. Under section 306 of the Federal
Food, Drug, and Cosmetic Act, FDA can seek debarment of any person who
has been convicted of a felony relating to importation of food into the
United States. Failure of an owner, operator, or agent in charge of a
domestic or foreign facility to register its facility, to update
required elements of its facility's registration, or to cancel its
registration in accordance with the requirements of this subpart is a
prohibited act under section 301(dd) of the Federal Food, Drug, and
Cosmetic Act.
* * * * *

0
4. In Sec.  1.276, revise paragraph (b)(9) to read as follows:

Sec.  1.276  What definitions apply to this subpart?

* * * * *
    (b) * * *
    (9) Manufacturer means the last facility, as that word is defined
in Sec.  1.227, that manufactured/processed the food. A facility is
considered the last facility even if the food undergoes further
manufacturing/processing that consists of adding labeling or any
similar activity of a de minimis nature. If the food undergoes further
manufacturing/processing that exceeds an activity of a de minimis
nature, then the subsequent facility that performed the additional
manufacturing/processing is considered the manufacturer.
* * * * *

0
5. In Sec.  1.328, remove the definitions for ``Act'' and
``Packaging''; add definitions in alphabetically order for
``Harvesting'', ``Mixed-type facility'', ``Packaging (when used as a
noun)'', ``Packaging (when used as a verb)'', and ``Packing''; and
revise the definitions for ``Farm'', ``Food'', ``Holding'', and
``Manufacturing/processing'' to read as follows:

Sec.  1.328  What definitions apply to this subpart?

* * * * *
    Farm means:
    (1) Primary production farm. A primary production farm is an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. The term ``farm'' includes operations
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same management, or is processed food identified in paragraph
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a
distinct commodity (such as drying/dehydrating grapes to produce
raisins), and packaging and labeling such commodities, without
additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and
packaging and labeling treated raw agricultural commodities, without
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing (an
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an
operation, not located on a primary production farm, devoted to
harvesting (such as hulling or shelling), packing, and/or holding of
raw agricultural commodities, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the raw
agricultural commodities harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in
the secondary activities farm. A secondary activities farm may also
conduct those additional activities allowed on a primary production
farm as described in paragraphs (1)(ii) and (iii) of this definition.
    Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act. Examples of food include, but are not limited
to fruits; vegetables; fish; dairy products; eggs; raw agricultural
commodities for use as food or as components of food; animal feed,
including pet food; food and feed ingredients and additives, including
substances that migrate into food from the finished container and other
articles that contact food; dietary supplements and dietary
ingredients; infant formula; beverages, including alcoholic beverages
and bottled water; live food animals; bakery goods; snack foods; candy;
and canned foods.
* * * * *
    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, removing stems and husks from,
shelling, sifting, threshing, trimming of outer leaves of, and washing
raw agricultural commodities grown on a farm.
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural

commodities when the drying/dehydrating does not create a distinct
commodity (such as drying/dehydrating hay or alfalfa)). Holding also
includes activities performed as a practical necessity for the
distribution of that food (such as blending of the same raw
agricultural commodity and breaking down pallets), 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. Holding facilities could include warehouses, cold storage
facilities, storage silos, grain elevators, and liquid storage tanks.
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, formulating, freezing, grinding,
homogenizing, irradiating, labeling, milling, mixing, packaging
(including modified atmosphere packaging), pasteurizing, peeling,
rendering, treating to manipulate ripening, trimming, washing, or
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting,
packing, or holding.
    Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
* * * * *
    Packaging (when used as a noun) means the outer packaging of food
that bears the label and does not contact the food. Packaging does not
include food contact substances as they are defined in section
409(h)(6) of the Federal Food, Drug, and Cosmetic Act.
    Packaging (when used as a verb) means placing food into a container
that directly contacts the food and that the consumer receives.
    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
6. Revise Sec.  1.363 to read as follows:

Sec.  1.363  What are the consequences of failing to establish or
maintain records or make them available to FDA as required by this
subpart?

    (a) The failure to establish or maintain records as required by
section 414(b) of the Federal Food, Drug, and Cosmetic Act and this
regulation or the refusal to permit access to or verification or
copying of any such required record is a prohibited act under section
301 of the Federal Food, Drug, and Cosmetic Act.
    (b) The failure of a nontransporter immediate previous source or a
nontransporter immediate subsequent recipient who enters an agreement
under Sec.  1.352(e) to establish, maintain, or establish and maintain,
records required under Sec.  1.352(a), (b), (c), or (d), or the refusal
to permit access to or verification or copying of any such required
record, is a prohibited act under section 301 of the Federal Food,
Drug, and Cosmetic Act.
    (c) The failure of any person to make records or other information
available to FDA as required by section 414 or 704(a) of the Federal
Food, Drug, and Cosmetic Act and this regulation is a prohibited act
under section 301 of the Federal Food, Drug, and Cosmetic Act.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
7. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
0
8. In Sec.  11.1, add and reserve paragraphs (g) and (h) and add
paragraph (i) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (i) This part does not apply to records required to be established
or maintained by part 117 of this chapter. Records that satisfy the
requirements of part 117 of this chapter, but that also are required
under other applicable statutory provisions or regulations, remain
subject to this part.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
9. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
10. In Sec.  16.1(b)(2), add the following entry in numerical order to
read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  117.251 through 117.287 (part 117, subpart E of this
chapter), relating to withdrawal of a qualified facility exemption.
* * * * *

PART 106--INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD
MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY
FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS

0
11. The authority citation for 21 CFR part 106 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 350a, 371.

0
12. In Sec.  106.100, revise paragraph (n) to read as follows:

Sec.  106.100  Records.

* * * * *
    (n) Production control, product testing, testing results,
complaints, and distribution records necessary to verify compliance
with parts 106, 107, 109, 110, 113, and 117 of this chapter, or with
other appropriate regulations, shall be retained for 1 year after the
expiration of the shelf life of the infant formula or 3 years from the
date of manufacture, whichever is greater.
* * * * *

PART 110--[Removed and Reserved]

0
13. Remove and reserve part 110, effective September 17, 2018.

PART 114--ACIDIFIED FOODS

0
14. The authority citation for 21 CFR part 114 continues to read as
follows:

    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

0
15. Revise Sec.  114.5 to read as follows:

Sec.  114.5  Current good manufacturing practice.

    The criteria in Sec. Sec.  114.10, 114.80, 114.83, 114.89, and
114.100, as well as the criteria in parts 110 and 117 of this chapter,
apply in determining whether an article of acidified food is
adulterated:
    (a) Within the meaning of section 402(a)(3) of the Federal Food,
Drug, and Cosmetic Act in that it has been manufactured under such
conditions that it is unfit for food; or
    (b) Within the meaning of section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act in that it has been prepared, packed, or held
under insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to health.

0
16. Add part 117 to read as follows:

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

Subpart A--General Provisions
Sec.
117.1 Applicability and status.
117.3 Definitions.
117.4 Qualifications of individuals who manufacture, process, pack,
or hold food.
117.5 Exemptions.
117.7 Applicability of subparts C, D, and G of this part to a
facility solely engaged in the storage of unexposed packaged food.
117.8 Applicability of subpart B of this part to the off-farm
packing and holding of raw agricultural commodities
117.9 Records required for this subpart.
Subpart B--Current Good Manufacturing Practice
117.10 Personnel.
117.20 Plant and grounds.
117.35 Sanitary operations.
117.37 Sanitary facilities and controls.
117.40 Equipment and utensils.
117.80 Processes and controls.
117.93 Warehousing and distribution.
117.110 Defect action levels.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
117.126 Food safety plan.
117.130 Hazard analysis.
117.135 Preventive controls.
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.
117.137 Provision of assurances required under Sec.  117.136(a)(2),
(3), and (4).
117.139 Recall plan.
117.140 Preventive control management components.
117.145 Monitoring.
117.150 Corrective actions and corrections.
117.155 Verification.
117.160 Validation.
117.165 Verification of implementation and effectiveness.
117.170 Reanalysis.
117.180 Requirements applicable to a preventive controls qualified
individual and a qualified auditor.
117.190 Implementation records required for this subpart.
Subpart D--Modified Requirements
117.201 Modified requirements that apply to a qualified facility.
117.206 Modified requirements that apply to a facility solely
engaged in the storage of unexposed packaged food.
Subpart E--Withdrawal of a Qualified Facility Exemption
117.251 Circumstances that may lead FDA to withdraw a qualified
facility exemption.
117.254 Issuance of an order to withdraw a qualified facility
exemption.
117.257 Contents of an order to withdraw a qualified facility
exemption.
117.260 Compliance with, or appeal of, an order to withdraw a
qualified facility exemption.
117.264 Procedure for submitting an appeal.
117.267 Procedure for requesting an informal hearing.
117.270 Requirements applicable to an informal hearing.
117.274 Presiding officer for an appeal and for an informal hearing.
117.277 Timeframe for issuing a decision on an appeal.
117.280 Revocation of an order to withdraw a qualified facility
exemption.
117.284 Final agency action.
117.287 Reinstatement of a qualified facility exemption that was
withdrawn.
Subpart F--Requirements Applying to Records That Must Be Established
and Maintained
117.301 Records subject to the requirements of this subpart.
117.305 General requirements applying to records.
117.310 Additional requirements applying to the food safety plan.
117.315 Requirements for record retention.
117.320 Requirements for official review.
117.325 Public disclosure.
117.330 Use of existing records.
117.335 Special requirements applicable to a written assurance.
Subpart G--Supply-Chain Program
117.405 Requirement to establish and implement a supply-chain
program.
117.410 General requirements applicable to a supply-chain program.
117.415 Responsibilities of the receiving facility.
117.420 Using approved suppliers.
117.425 Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).
117.430 Conducting supplier verification activities for raw
materials and other ingredients.
117.435 Onsite audit.
117.475 Records documenting the supply-chain program.

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

Subpart A--General Provisions

Sec.  117.1  Applicability and status.

    (a) The criteria and definitions in this part apply in determining
whether a food is:
    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act
in that the food has been manufactured under such conditions that it is
unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act
in that the food has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health; and
    (2) In violation of section 361 of the Public Health Service Act
(42 U.S.C. 264).
    (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, or F of this part is a
prohibited act under section 301(uu) of the Federal Food, Drug, and
Cosmetic Act.
    (c) Food covered by specific current good manufacturing practice
regulations also is subject to the requirements of those regulations.

Sec.  117.3  Definitions.

    The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act apply to such terms when used in
this part. The following definitions also apply:
    Acid foods or acidified foods means foods that have an equilibrium
pH of 4.6 or below.
    Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
    Affiliate means any facility that controls, is controlled by, or is
under common control with another facility.
    Allergen cross-contact means the unintentional incorporation of a
food allergen into a food.
    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 a supplier's food safety processes and procedures.
    Batter means a semifluid substance, usually composed of flour and
other ingredients, into which principal components of food are dipped
or with which they are coated, or which may be used directly to form
bakery foods.
    Blanching, except for tree nuts and peanuts, means a prepackaging
heat treatment of foodstuffs for an adequate time and at an adequate
temperature to partially or completely inactivate the naturally
occurring enzymes and to effect other physical or biochemical changes
in the food.
    Calendar day means every day shown on the calendar.
    Correction means an action to identify and correct a problem that
occurred during the production of food, without other actions
associated with a corrective action procedure (such as actions to
reduce the likelihood that the problem will recur, evaluate all
affected food for safety, and prevent affected food from entering
commerce).
    Critical control point means a point, step, or procedure in a food
process at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce such hazard to an acceptable
level.
    Defect action level means a level of a non-hazardous, naturally
occurring, unavoidable defect at which FDA may regard a food product
``adulterated'' and subject to enforcement action under section
402(a)(3) of the Federal Food, Drug, and Cosmetic Act.
    Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food may be contaminated and may result in
foodborne illness if that food is consumed without treatment to
significantly minimize the environmental pathogen. Examples of
environmental pathogens for the purposes of this part include Listeria
monocytogenes and Salmonella spp. but do not include the spores of
pathogenic sporeforming bacteria.
    Facility means a domestic facility or a foreign facility that is
required to register under section 415 of the Federal Food, Drug, and
Cosmetic Act, in accordance with the requirements of part 1, subpart H
of this chapter.
    Farm means farm as defined in Sec.  1.227 of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food,
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food allergen means a major food allergen as defined in section
201(qq) of the Federal Food, Drug, and Cosmetic Act.
    Food-contact surfaces are those surfaces that contact human food
and those surfaces from which drainage, or other transfer, onto the
food or onto surfaces that contact the food ordinarily occurs during
the normal course of operations. ``Food-contact surfaces'' includes
utensils and food-contact surfaces of equipment.
    Full-time equivalent employee is a term used to represent the
number of employees of a business entity for the purpose of determining
whether the business qualifies for the small business exemption. The
number of full-time equivalent employees is determined by dividing the
total number of hours of salary or wages paid directly to employees of
the business entity and of all of its affiliates and subsidiaries by
the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52
weeks). If the result is not a whole number, round down to the next
lowest whole number.
    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, removing stems and husks from,
shelling, sifting, threshing, trimming of outer leaves of, and washing
raw agricultural commodities grown on a farm.
    Hazard means any biological, chemical (including radiological), or
physical agent that has the potential to cause illness or injury.
    Hazard requiring a preventive control means a known or reasonably
foreseeable hazard for which a person knowledgeable about the safe
manufacturing, processing, packing, or holding of food would, based on
the outcome of a hazard analysis (which includes an assessment of the
severity of the illness or injury if the hazard were to occur and the
probability that the hazard will occur in the absence of preventive
controls), establish one or more preventive controls to significantly
minimize or prevent the hazard in a food and components to manage those
controls (such as monitoring, corrections or corrective actions,
verification, and records) as appropriate to the food, the facility,
and the nature of the preventive control and its role in the facility's
food safety system.
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural commodities
when the drying/dehydrating does not create a distinct commodity (such
as drying/dehydrating hay or alfalfa)). Holding also includes
activities performed as a practical necessity for the distribution of
that food (such as blending of the same raw agricultural commodity and
breaking down pallets), 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. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
    Known or reasonably foreseeable hazard means a biological, chemical
(including radiological), or physical hazard that is known to be, or
has the potential to be, associated with the facility or the food.
    Lot means the food produced during a period of time and identified
by an establishment's specific code.
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, formulating, freezing, grinding,

homogenizing, irradiating, labeling, milling, mixing, packaging
(including modified atmosphere packaging), pasteurizing, peeling,
rendering, treating to manipulate ripening, trimming, washing, or
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting,
packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa,
and microscopic parasites and includes species that are pathogens. The
term ``undesirable microorganisms'' includes those microorganisms that
are pathogens, that subject food to decomposition, that indicate that
food is contaminated with filth, or that otherwise may cause food to be
adulterated.
    Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the
Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or
measurements to assess whether control measures are operating as
intended.
    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 into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Pathogen means a microorganism of public health significance.
    Pest refers to any objectionable animals or insects including
birds, rodents, flies, and larvae.
    Plant means the building or structure or parts thereof, used for or
in connection with the manufacturing, processing, packing, or holding
of human food.
    Preventive controls means those risk-based, reasonably appropriate
procedures, practices, and processes that a person knowledgeable about
the safe manufacturing, processing, packing, or holding of food would
employ to significantly minimize or prevent the hazards identified
under the hazard analysis that are consistent with the current
scientific understanding of safe food manufacturing, processing,
packing, or holding at the time of the analysis.
    Preventive controls qualified individual means a qualified
individual who has successfully completed training in the development
and application of risk-based preventive controls at least equivalent
to that received under a standardized curriculum recognized as adequate
by FDA or is otherwise qualified through job experience to develop and
apply a food safety system.
    Qualified auditor means a person who is a qualified individual as
defined in this part and has technical expertise obtained through
education, training, or experience (or a combination thereof) necessary
to perform the auditing function as required by Sec.  117.180(c)(2).
Examples of potential qualified auditors include:
    (1) A government employee, including a foreign government employee;
and
    (2) An audit agent of a certification body that is accredited in
accordance with regulations in part 1, subpart M of this chapter.
    Qualified end-user, with respect to a food, means the consumer of
the food (where the term consumer does not include a business); or a
restaurant or retail food establishment (as those terms are defined in
Sec.  1.227 of this chapter) that:
    (1) Is located;
    (i) In the same State or the same Indian reservation as the
qualified facility that sold the food to such restaurant or
establishment; or
    (ii) Not more than 275 miles from such facility; and
    (2) Is purchasing the food for sale directly to consumers at such
restaurant or retail food establishment.
    Qualified facility means (when including the sales by any
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of
any entity of which the facility is a subsidiary or affiliate) a
facility that is a very small business as defined in this part, or a
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar
year, the average annual monetary value of the food manufactured,
processed, packed or held at such facility that is sold directly to
qualified end-users (as defined in this part) during such period
exceeded the average annual monetary value of the food sold by such
facility to all other purchasers; and
    (2) The average annual monetary value of all food sold during the
3-year period preceding the applicable calendar year was less than
$500,000, adjusted for inflation.
    Qualified facility exemption means an exemption applicable to a
qualified facility under Sec.  117.5(a).
    Qualified individual means a person who has the education,
training, or experience (or a combination thereof) necessary to
manufacture, process, pack, or hold clean and safe food as appropriate
to the individual's assigned duties. A qualified individual may be, but
is not required to be, an employee of the establishment.
    Quality control operation means a planned and systematic procedure
for taking all actions necessary to prevent food from being
adulterated.
    Raw agricultural commodity has the meaning given in section 201(r)
of the Federal Food, Drug, and Cosmetic Act.
    Ready-to-eat food (RTE food) means any food that is normally eaten
in its raw state or any other food, including a processed food, for
which it is reasonably foreseeable that the food will be eaten without
further processing that would significantly minimize biological
hazards.
    Receiving facility means a facility that is subject to subparts C
and G of this part and that manufactures/processes a raw material or
other ingredient that it receives from a supplier.
    Rework means clean, unadulterated food that has been removed from
processing for reasons other than insanitary conditions or that has
been successfully reconditioned by reprocessing and that is suitable
for use as food.
    Safe-moisture level is a level of moisture low enough to prevent
the growth of undesirable microorganisms in the finished product under
the intended conditions of manufacturing, processing, packing, and
holding. The safe moisture level for a food is related to its water
activity (aw). An aw will be considered safe for
a food if adequate data are available that demonstrate that the food at
or below the given aw will not support the growth of
undesirable microorganisms.
    Sanitize means to adequately treat cleaned surfaces by a process
that is effective in destroying vegetative cells of pathogens, and in
substantially reducing numbers of other undesirable microorganisms, but
without adversely affecting the product or its safety for the consumer.
    Significantly minimize means to reduce to an acceptable level,
including to eliminate.

    Small business means, for purposes of this part, a business
employing fewer than 500 full-time equivalent employees.
    Subsidiary means any company which is owned or controlled directly
or indirectly by another company.
    Supplier means the establishment that manufactures/processes the
food, raises the animal, or grows the food that is provided to a
receiving facility without further manufacturing/processing by another
establishment, except for further manufacturing/processing that
consists solely of the addition of labeling or similar activity of a de
minimis nature.
    Supply-chain-applied control means a preventive control for a
hazard in a raw material or other ingredient when the hazard in the raw
material or other ingredient is controlled before its receipt.
    Unexposed packaged food means packaged food that is not exposed to
the environment.
    Validation means obtaining and evaluating scientific and technical
evidence that a control measure, combination of control measures, or
the food safety plan as a whole, when properly implemented, is capable
of effectively controlling the identified hazards.
    Verification means the application of methods, procedures, tests
and other evaluations, in addition to monitoring, to determine whether
a control measure or combination of control measures is or has been
operating as intended and to establish the validity of the food safety
plan.
    Very small business means, for purposes of this part, a business
(including any subsidiaries and affiliates) averaging less than
$1,000,000, adjusted for inflation, per year, during the 3-year period
preceding the applicable calendar year in sales of human food plus the
market value of human food manufactured, processed, packed, or held
without sale (e.g., held for a fee).
    Water activity (aw) is a measure of the free moisture in
a food and is the quotient of the water vapor pressure of the substance
divided by the vapor pressure of pure water at the same temperature.
    Written procedures for receiving raw materials and other
ingredients means written procedures to ensure that raw materials and
other ingredients are received only from suppliers approved by the
receiving facility (or, when necessary and appropriate, on a temporary
basis from unapproved suppliers whose raw materials or other
ingredients are subjected to adequate verification activities before
acceptance for use).
    You means, for purposes of this part, the owner, operator, or agent
in charge of a facility.

Sec.  117.4  Qualifications of individuals who manufacture, process,
pack, or hold food.

    (a) Applicability. (1) The management of an establishment must
ensure that all individuals who manufacture, process, pack, or hold
food subject to subparts B and F of this part are qualified to perform
their assigned duties.
    (2) The owner, operator, or agent in charge of a facility must
ensure that all individuals who manufacture, process, pack, or hold
food subject to subpart C, D, E, F, or G of this part are qualified to
perform their assigned duties.
    (b) Qualifications of all individuals engaged in manufacturing,
processing, packing, or holding food. Each individual engaged in
manufacturing, processing, packing, or holding food (including
temporary and seasonal personnel) or in the supervision thereof must:
    (1) Be a qualified individual as that term is defined in Sec.
117.3--i.e., have the education, training, or experience (or a
combination thereof) necessary to manufacture, process, pack, or hold
clean and safe food as appropriate to the individual's assigned duties;
and
    (2) Receive training in the principles of food hygiene and food
safety, including the importance of employee health and personal
hygiene, as appropriate to the food, the facility and the individual's
assigned duties.
    (c) Additional qualifications of supervisory personnel.
Responsibility for ensuring compliance by individuals with the
requirements of this part must be clearly assigned to supervisory
personnel who have the education, training, or experience (or a
combination thereof) necessary to supervise the production of clean and
safe food.
    (d) Records. Records that document training required by paragraph
(b)(2) of this section must be established and maintained.

Sec.  117.5  Exemptions.

    (a) Except as provided by subpart E of this part, subparts C and G
of this part does not apply to a qualified facility. Qualified
facilities are subject to the modified requirements in Sec.  117.201.
    (b) Subparts C and G of this part do not apply with respect to
activities that are subject to part 123 of this chapter (Fish and
Fishery Products) at a facility if you are required to comply with, and
are in compliance with, part 123 of this chapter with respect to such
activities.
    (c) Subparts C and G of this part do not apply with respect to
activities that are subject to part 120 of this chapter (Hazard
Analysis and Critical Control Point (HACCP) Systems) at a facility if
you are required to comply with, and are in compliance with, part 120
of this chapter with respect to such activities.
    (d)(1) Subparts C and G of this part do not apply with respect to
activities that are subject to part 113 of this chapter (Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at
a facility if you are required to comply with, and are in compliance
with, part 113 of this chapter with respect to such activities.
    (2) The exemption in paragraph (d)(1) of this section is applicable
only with respect to the microbiological hazards that are regulated
under part 113 of this chapter.
    (e) Subparts C and G do not apply to any facility with regard to
the manufacturing, processing, packaging, or holding of a dietary
supplement that is in compliance with the requirements of part 111 of
this chapter (Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements) and
section 761 of the Federal Food, Drug, and Cosmetic Act (Serious
Adverse Event Reporting for Dietary Supplements).
    (f) Subparts C and G of this part do not apply to activities of a
facility that are subject to section 419 of the Federal Food, Drug, and
Cosmetic Act (Standards for Produce Safety).
    (g)(1) The exemption in paragraph (g)(3) of this section applies to
packing or holding of processed foods on a farm mixed-type facility,
except for processed foods produced by drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins, and drying/dehydrating
fresh herbs to produce dried herbs), and packaging and labeling such
commodities, without additional manufacturing/processing (such as
chopping and slicing), the packing and holding of which are within the
``farm'' definition in Sec.  1.227 of this chapter. Activities that are
within the ``farm'' definition, when conducted on a farm mixed-type
facility, are not subject to the requirements of subparts C and G of
this part and therefore do not need to be specified in the exemption.
    (2) For the purposes of paragraphs (g)(3) and (h)(3) of this
section, the following terms describe the foods associated with the
activity/food combinations. Several foods that are fruits or vegetables
are separately considered for the purposes of these activity/food
combinations (i.e., coffee

beans, cocoa beans, fresh herbs, peanuts, sugarcane, sugar beets, tree
nuts, seeds for direct consumption) to appropriately address specific
hazards associated with these foods and/or processing activities
conducted on these foods.
    (i) Dried/dehydrated fruit and vegetable products includes only
those processed food products such as raisins and dried legumes made
without additional manufacturing/processing beyond drying/dehydrating,
packaging, and/or labeling.
    (ii) Other fruit and vegetable products includes those processed
food products that have undergone one or more of the following
processes: acidification, boiling, canning, coating with things other
than wax/oil/resin, cooking, cutting, chopping, grinding, peeling,
shredding, slicing, or trimming. Examples include flours made from
legumes (such as chickpea flour), pickles, and snack chips made from
potatoes or plantains. Examples also include dried fruit and vegetable
products made with additional manufacturing/processing (such as dried
apple slices; pitted, dried plums, cherries, and apricots; and sulfited
raisins). This category does not include dried/dehydrated fruit and
vegetable products made without additional manufacturing/processing as
described in paragraph (g)(2)(i) of this section. This category also
does not include products that require time/temperature control for
safety (such as fresh-cut fruits and vegetables).
    (iii) Peanut and tree nut products includes processed food products
such as roasted peanuts and tree nuts, seasoned peanuts and tree nuts,
and peanut and tree nut flours.
    (iv) Processed seeds for direct consumption include processed food
products such as roasted pumpkin seeds, roasted sunflower seeds, and
roasted flax seeds.
    (v) Dried/dehydrated herb and spice products includes only
processed food products such as dried intact herbs made without
additional manufacturing/processing beyond drying/dehydrating,
packaging, and/or labeling.
    (vi) Other herb and spice products includes those processed food
products such as chopped fresh herbs, chopped or ground dried herbs
(including tea), herbal extracts (e.g., essential oils, extracts
containing more than 20 percent ethanol, extracts containing more than
35 percent glycerin), dried herb- or spice-infused honey, and dried
herb- or spice-infused oils and/or vinegars. This category does not
include dried/dehydrated herb and spice products made without
additional manufacturing/processing beyond drying/dehydrating,
packaging, and/or labeling as described in paragraph (g)(2)(v) of this
section. This category also does not include products that require
time/temperature control for safety, such as fresh herb-infused oils.
    (vii) Grains include barley, dent- or flint-corn, sorghum, oats,
rice, rye, wheat, amaranth, quinoa, buckwheat and oilseeds for oil
extraction (such as cotton seed, flax seed, rapeseed, soybeans, and
sunflower seed).
    (viii) Milled grain products include processed food products such
as flour, bran, and corn meal.
    (ix) Baked goods include processed food products such as breads,
brownies, cakes, cookies, and crackers. This category does not include
products that require time/temperature control for safety, such as
cream-filled pastries.
    (x) Other grain products include processed food products such as
dried cereal, dried pasta, oat flakes, and popcorn. This category does
not include milled grain products as described in paragraph
(g)(2)(viii) of this section or baked goods as described in paragraph
(g)(2)(ix) of this section.
    (3) Subparts C and G of this part do not apply to on-farm packing
or holding of food by a small or very small business, and Sec.  117.201
does not apply to on-farm packing or holding of food by a very small
business, if the only packing and holding activities subject to section
418 of the Federal Food, Drug, and Cosmetic Act that the business
conducts are the following low-risk packing or holding activity/food
combinations--i.e., packing (or re-packing) (including weighing or
conveying incidental to packing or re-packing); sorting, culling, or
grading incidental to packing or storing; and storing (ambient, cold
and controlled atmosphere) of:
    (i) Baked goods (e.g., bread and cookies);
    (ii) Candy (e.g., hard candy, fudge, maple candy, maple cream, nut
brittles, taffy, and toffee);
    (iii) Cocoa beans (roasted);
    (iv) Cocoa products;
    (v) Coffee beans (roasted);
    (vi) Game meat jerky;
    (vii) Gums, latexes, and resins that are processed foods;
    (viii) Honey (pasteurized);
    (ix) Jams, jellies, and preserves;
    (x) Milled grain products (e.g., flour, bran, and corn meal);
    (xi) Molasses and treacle;
    (xii) Oils (e.g., olive oil and sunflower seed oil);
    (xiii) Other fruit and vegetable products (e.g., flours made from
legumes; pitted, dried fruits; sliced, dried apples; snack chips);
    (xiv) Other grain products (e.g., dried pasta, oat flakes, and
popcorn);
    (xv) Other herb and spice products (e.g., chopped or ground dried
herbs, herbal extracts);
    (xvi) Peanut and tree nut products (e.g., roasted peanuts and tree
nut flours);
    (xvii) Processed seeds for direct consumption (e.g., roasted
pumpkin seeds);
    (xviii) Soft drinks and carbonated water;
    (xix) Sugar;
    (xx) Syrups (e.g., maple syrup and agave syrup);
    (xxi) Trail mix and granola;
    (xxii) Vinegar; and
    (xxiii) Any other processed food that does not require time/
temperature control for safety (e..g., vitamins, minerals, and dietary
ingredients (e.g., bone meal) in powdered, granular, or other solid
form).
    (h)(1) The exemption in paragraph (h)(3) of this section applies to
manufacturing/processing of foods on a farm mixed-type facility, except
for manufacturing/processing that is within the ``farm'' definition in
Sec.  1.227 of this chapter. Drying/dehydrating raw agricultural
commodities to create a distinct commodity (such as drying/dehydrating
grapes to produce raisins, and drying/dehydrating fresh herbs to
produce dried herbs), and packaging and labeling such commodities,
without additional manufacturing/processing (such as chopping and
slicing), are within the ``farm'' definition in Sec.  1.227 of this
chapter. In addition, treatment to manipulate ripening of raw
agricultural commodities (such as by treating produce with ethylene
gas), and packaging and labeling the treated raw agricultural
commodities, without additional manufacturing/processing, is within the
``farm'' definition. In addition, coating intact fruits and vegetables
with wax, oil, or resin used for the purpose of storage or
transportation is within the ``farm'' definition. Activities that are
within the ``farm'' definition, when conducted on a farm mixed-type
facility, are not subject to the requirements of subparts C and G of
this part and therefore do not need to be specified in the exemption.
    (2) The terms in paragraph (g)(2) of this section describe certain
foods associated with the activity/food combinations in paragraph
(h)(3) of this section.
    (3) Subparts C and G of this part do not apply to on-farm
manufacturing/processing activities conducted by a small or very small
business for

distribution into commerce, and Sec.  117.201 does not apply to on-farm
manufacturing/processing activities conducted by a very small business
for distribution into commerce, if the only manufacturing/processing
activities subject to section 418 of the Federal Food, Drug, and
Cosmetic Act that the business conducts are the following low-risk
manufacturing/processing activity/food combinations:
    (i) Boiling gums, latexes, and resins;
    (ii) Chopping, coring, cutting, peeling, pitting, shredding, and
slicing acid fruits and vegetables that have a pH less than 4.2 (e.g.,
cutting lemons and limes), baked goods (e.g., slicing bread), dried/
dehydrated fruit and vegetable products (e.g., pitting dried plums),
dried herbs and other spices (e.g., chopping intact, dried basil), game
meat jerky, gums/latexes/resins, other grain products (e.g., shredding
dried cereal), peanuts and tree nuts, and peanut and tree nut products
(e.g., chopping roasted peanuts);
    (iii) Coating dried/dehydrated fruit and vegetable products (e.g.,
coating raisins with chocolate), other fruit and vegetable products
except for non-dried, non-intact fruits and vegetables (e.g., coating
dried plum pieces, dried pitted cherries, and dried pitted apricots
with chocolate are low-risk activity/food combinations but coating
apples on a stick with caramel is not a low-risk activity/food
combination), other grain products (e.g., adding caramel to popcorn or
adding seasonings to popcorn provided that the seasonings have been
treated to significantly minimize pathogens, peanuts and tree nuts
(e.g., adding seasonings provided that the seasonings have been treated
to significantly minimize pathogens), and peanut and tree nut products
(e.g., adding seasonings provided that the seasonings have been treated
to significantly minimize pathogens));
    (iv) Drying/dehydrating (that includes additional manufacturing or
is performed on processed foods) other fruit and vegetable products
with pH less than 4.2 (e.g., drying cut fruit and vegetables with pH
less than 4.2), and other herb and spice products (e.g., drying chopped
fresh herbs, including tea);
    (v) Extracting (including by pressing, by distilling, and by
solvent extraction) from 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);
    (vi) Freezing acid fruits and vegetables with pH less than 4.2 and
other fruit and vegetable products with pH less than 4.2 (e.g., cut
fruits and vegetables);
    (vii) Grinding/cracking/crushing/milling baked goods (e.g.,
crackers), cocoa beans (roasted), coffee beans (roasted), dried/
dehydrated fruit and vegetable products (e.g., raisins and dried
legumes), dried/dehydrated herb and spice products (e.g., intact dried
basil), grains (e.g., oats, rice, rye, wheat), other fruit and
vegetable products (e.g., dried, pitted dates), other grain products
(e.g., dried cereal), other herb and spice products (e.g., chopped
dried herbs), peanuts and tree nuts, and peanut and tree nut products
(e.g., roasted peanuts);
    (viii) Labeling baked goods that do not contain food allergens,
candy that does not contain food allergens, cocoa beans (roasted),
cocoa products that do not contain food allergens), coffee beans
(roasted), game meat jerky, gums/latexes/resins that are processed
foods, honey (pasteurized), jams/jellies/preserves, milled grain
products that do not contain food allergens (e.g., corn meal) or that
are single-ingredient foods (e.g., wheat flour, wheat bran), molasses
and treacle, oils, other fruit and vegetable products that do not
contain food allergens (e.g., snack chips made from potatoes or
plantains), other grain products that do not contain food allergens
(e.g., popcorn), other herb and spice products (e.g., chopped or ground
dried herbs), peanut or tree nut products, (provided that they are
single-ingredient, or are in forms in which the consumer can reasonably
be expected to recognize the food allergen(s) without label
declaration, or both (e.g., roasted or seasoned whole nuts, single-
ingredient peanut or tree nut flours)), processed seeds for direct
consumption, soft drinks and carbonated water, sugar, syrups, trail mix
and granola (other than those containing milk chocolate and provided
that peanuts and/or tree nuts are in forms in which the consumer can
reasonably be expected to recognize the food allergen(s) without label
declaration), vinegar, and any other processed food that does not
require time/temperature control for safety and that does not contain
food allergens (e.g., vitamins, minerals, and dietary ingredients
(e.g., bone meal) in powdered, granular, or other solid form);
    (ix) Making baked goods from milled grain products (e.g., breads
and cookies);
    (x) Making candy from peanuts and tree nuts (e.g., nut brittles),
sugar/syrups (e.g., taffy, toffee), and saps (e.g., maple candy, maple
cream);
    (xi) Making cocoa products from roasted cocoa beans;
    (xii) Making dried pasta from grains;
    (xiii) Making jams, jellies, and preserves from acid fruits and
vegetables with a pH of 4.6 or below;
    (xiv) Making molasses and treacle from sugar beets and sugarcane;
    (xv) Making oat flakes from grains;
    (xvi) Making popcorn from grains;
    (xvii) Making snack chips from fruits and vegetables (e.g., making
plantain and potato chips);
    (xviii) Making soft drinks and carbonated water from sugar, syrups,
and water;
    (xix) Making sugars and syrups from fruits and vegetables (e.g.,
dates), grains (e.g., rice, sorghum), other grain products (e.g.,
malted grains such as barley), saps (e.g., agave, birch, maple, palm),
sugar beets, and sugarcane;
    (xx) Making trail mix and granola from cocoa products (e.g.,
chocolate), dried/dehydrated fruit and vegetable products (e.g.,
raisins), other fruit and vegetable products (e.g., chopped dried
fruits), other grain products (e.g., oat flakes), peanut and tree nut
products, and processed seeds for direct consumption, provided that
peanuts, tree nuts, and processed seeds are treated to significantly
minimize pathogens;
    (xxi) Making vinegar from fruits and vegetables, other fruit and
vegetable products (e.g., fruit wines, apple cider), and other grain
products (e.g., malt);
    (xxii) Mixing baked goods (e.g., types of cookies), candy (e.g.,
varieties of taffy), cocoa beans (roasted), coffee beans (roasted),
dried/dehydrated fruit and vegetable products (e.g., dried blueberries,
dried currants, and raisins), dried/dehydrated herb and spice products
(e.g., dried, intact basil and dried, intact oregano), honey
(pasteurized), milled grain products (e.g., flour, bran, and corn
meal), other fruit and vegetable products (e.g., dried, sliced apples
and dried, sliced peaches), other grain products (e.g., different types
of dried pasta), other herb and spice products (e.g., chopped or ground
dried herbs, dried herb- or spice-infused honey, and dried herb- or
spice-infused oils and/or vinegars), peanut and tree nut products,
sugar, syrups, vinegar, and any other processed food that does not
require time/temperature control for safety (e.g., vitamins, minerals,
and dietary ingredients (e.g., bone meal) in powdered, granular, or
other solid form);
    (xxiii) Packaging baked goods (e.g., bread and cookies), candy,
cocoa beans (roasted), cocoa products, coffee beans (roasted), game
meat jerky, gums/latexes/resins that are processed foods, honey
(pasteurized), jams/jellies/preserves, milled grain products (e.g.,

flour, bran, corn meal), molasses and treacle, oils, other fruit and
vegetable products (e.g., pitted, dried fruits; sliced, dried apples;
snack chips), other grain products (e.g., popcorn), other herb and
spice products (e.g., chopped or ground dried herbs), peanut and tree
nut products, processed seeds for direct consumption, soft drinks and
carbonated water, sugar, syrups, trail mix and granola, vinegar, and
any other processed food that does not require time/temperature control
for safety (e.g., vitamins, minerals, and dietary ingredients (e.g.,
bone meal) in powdered, granular, or other solid form);
    (xxiv) Pasteurizing honey;
    (xxv) Roasting and toasting baked goods (e.g., toasting bread for
croutons);
    (xxvi) Salting other grain products (e.g., soy nuts), peanut and
tree nut products, and processed seeds for direct consumption; and
    (xxvii) Sifting milled grain products (e.g., flour, bran, corn
meal), other fruit and vegetable products (e.g., chickpea flour), and
peanut and tree nut products (e.g., peanut flour, almond flour).
    (i)(1) Subparts C and G of this part do not apply with respect to
alcoholic beverages at a facility that meets the following two
conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986
(26 U.S.C. 5001 et seq.) the facility is required to obtain a permit
from, register with, or obtain approval of a notice or application from
the Secretary of the Treasury as a condition of doing business in the
United States, or is a foreign facility of a type that would require
such a permit, registration, or approval if it were a domestic
facility; and
    (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act
the facility is required to register as a facility because it is
engaged in manufacturing, processing, packing, or holding one or more
alcoholic beverages.
    (2) Subparts C and G of this part do not apply with respect to food
that is not an alcoholic beverage at a facility described in paragraph
(i)(1) of this section, provided such food:
    (i) Is in prepackaged form that prevents any direct human contact
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of
the facility, as determined by the Secretary of the Treasury.
    (j) Subparts C and G of this part do not apply to facilities that
are solely engaged in the storage of raw agricultural commodities
(other than fruits and vegetables) intended for further distribution or
processing.
    (k)(1) Except as provided by paragraph (k)(2) of this section,
subpart B of this part does not apply to any of the following:
    (i) ``Farms'' (as defined in Sec.  1.227 of this chapter);
    (ii) Fishing vessels that are not subject to the registration
requirements of part 1, subpart H of this chapter in accordance with
Sec.  1.226(f) of this chapter;
    (iii) Establishments solely engaged in the holding and/or
transportation of one or more raw agricultural commodities;
    (iv) Activities of ``farm mixed-type facilities'' (as defined in
Sec.  1.227 of this chapter) that fall within the definition of
``farm''; or
    (v) Establishments solely engaged in hulling, shelling, drying,
packing, and/or holding nuts (without additional manufacturing/
processing, such as roasting nuts).
    (2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates
raw agricultural commodities that are produce as defined in part 112 of
this chapter to create a distinct commodity, subpart B of this part
applies to the packaging, packing, and holding of the dried
commodities. Compliance with this requirement 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.  117.7  Applicability of subparts C, D, and G of this part to a
facility solely engaged in the storage of unexposed packaged food.

    (a) Applicability of subparts C and G. Subparts C and G of this
part do not apply to a facility solely engaged in the storage of
unexposed packaged food.
    (b) Applicability of subpart D. A facility solely engaged in the
storage of unexposed packaged food, including unexposed packaged food
that requires time/temperature control to significantly minimize or
prevent the growth of, or toxin production by, pathogens is subject to
the modified requirements in Sec.  117.206 for any unexposed packaged
food that requires time/temperature control to significantly minimize
or prevent the growth of, or toxin production by, pathogens.

Sec.  117.8  Applicability of subpart B of this part to the off-farm
packing and holding of raw agricultural commodities.

    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.  117.9  Records required for this subpart.

    (a) Records that document training required by Sec.  117.4(b)(2)
must be established and maintained.
    (b) The records that must be established and maintained are subject
to the requirements of subpart F of this part.

Subpart B--Current Good Manufacturing Practice

Sec.  117.10  Personnel.

    The management of the establishment must take reasonable measures
and precautions to ensure the following:
    (a) Disease control. Any person who, by medical examination or
supervisory observation, is shown to have, or appears to have, an
illness, open lesion, including boils, sores, or infected wounds, or
any other abnormal source of microbial contamination by which there is
a reasonable possibility of food, food-contact surfaces, or food-
packaging materials becoming contaminated, must be excluded from any
operations which may be expected to result in such contamination until
the condition is corrected, unless conditions such as open lesions,
boils, and infected wounds are adequately covered (e.g., by an
impermeable cover). Personnel must be instructed to report such health
conditions to their supervisors.
    (b) Cleanliness. All persons working in direct contact with food,
food-contact surfaces, and food-packaging materials must conform to
hygienic practices while on duty to the extent necessary to protect
against allergen cross-contact and against contamination of food. The
methods for maintaining cleanliness include:
    (1) Wearing outer garments suitable to the operation in a manner
that protects against allergen cross-contact and against the
contamination of food, food-contact surfaces, or food-packaging
materials.
    (2) Maintaining adequate personal cleanliness.
    (3) Washing hands thoroughly (and sanitizing if necessary to
protect against contamination with undesirable microorganisms) in an
adequate hand-washing facility before starting work, after each absence
from the work station, and at any other time when the hands may have
become soiled or contaminated.

    (4) Removing all unsecured jewelry and other objects that might
fall into food, equipment, or containers, and removing hand jewelry
that cannot be adequately sanitized during periods in which food is
manipulated by hand. If such hand jewelry cannot be removed, it may be
covered by material which can be maintained in an intact, clean, and
sanitary condition and which effectively protects against the
contamination by these objects of the food, food-contact surfaces, or
food-packaging materials.
    (5) Maintaining gloves, if they are used in food handling, in an
intact, clean, and sanitary condition.
    (6) Wearing, where appropriate, in an effective manner, hair nets,
headbands, caps, beard covers, or other effective hair restraints.
    (7) Storing clothing or other personal belongings in areas other
than where food is exposed or where equipment or utensils are washed.
    (8) Confining the following to areas other than where food may be
exposed or where equipment or utensils are washed: eating food, chewing
gum, drinking beverages, or using tobacco.
    (9) Taking any other necessary precautions to protect against
allergen cross-contact and against contamination of food, food-contact
surfaces, or food-packaging materials with microorganisms or foreign
substances (including perspiration, hair, cosmetics, tobacco,
chemicals, and medicines applied to the skin).

Sec.  117.20  Plant and grounds.

    (a) Grounds. The grounds about a food plant under the control of
the operator must be kept in a condition that will protect against the
contamination of food. The methods for adequate maintenance of grounds
must include:
    (1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant that
may constitute an attractant, breeding place, or harborage for pests.
    (2) Maintaining roads, yards, and parking lots so that they do not
constitute a source of contamination in areas where food is exposed.
    (3) Adequately draining areas that may contribute contamination to
food by seepage, foot-borne filth, or providing a breeding place for
pests.
    (4) Operating systems for waste treatment and disposal in an
adequate manner so that they do not constitute a source of
contamination in areas where food is exposed.
    (5) If the plant grounds are bordered by grounds not under the
operator's control and not maintained in the manner described in
paragraphs (a)(1) through (4) of this section, care must be exercised
in the plant by inspection, extermination, or other means to exclude
pests, dirt, and filth that may be a source of food contamination.
    (b) Plant construction and design. The plant must be suitable in
size, construction, and design to facilitate maintenance and sanitary
operations for food-production purposes (i.e., manufacturing,
processing, packing, and holding). The plant must:
    (1) Provide adequate space for such placement of equipment and
storage of materials as is necessary for maintenance, sanitary
operations, and the production of safe food.
    (2) Permit the taking of adequate precautions to reduce the
potential for allergen cross-contact and for contamination of food,
food-contact surfaces, or food-packaging materials with microorganisms,
chemicals, filth, and other extraneous material. The potential for
allergen cross-contact and for contamination may be reduced by adequate
food safety controls and operating practices or effective design,
including the separation of operations in which allergen cross-contact
and contamination are likely to occur, by one or more of the following
means: location, time, partition, air flow systems, dust control
systems, enclosed systems, or other effective means.
    (3) Permit the taking of adequate precautions to protect food in
installed outdoor bulk vessels by any effective means, including:
    (i) Using protective coverings.
    (ii) Controlling areas over and around the vessels to eliminate
harborages for pests.
    (iii) Checking on a regular basis for pests and pest infestation.
    (iv) Skimming fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and
ceilings may be adequately cleaned and kept clean and kept in good
repair; that drip or condensate from fixtures, ducts and pipes does not
contaminate food, food-contact surfaces, or food-packaging materials;
and that aisles or working spaces are provided between equipment and
walls and are adequately unobstructed and of adequate width to permit
employees to perform their duties and to protect against contaminating
food, food-contact surfaces, or food-packaging materials with clothing
or personal contact.
    (5) Provide adequate lighting in hand-washing areas, dressing and
locker rooms, and toilet rooms and in all areas where food is examined,
manufactured, processed, packed, or held and where equipment or
utensils are cleaned; and provide shatter-resistant light bulbs,
fixtures, skylights, or other glass suspended over exposed food in any
step of preparation or otherwise protect against food contamination in
case of glass breakage.
    (6) Provide adequate ventilation or control equipment to minimize
dust, odors and vapors (including steam and noxious fumes) in areas
where they may cause allergen cross-contact or contaminate food; and
locate and operate fans and other air-blowing equipment in a manner
that minimizes the potential for allergen cross-contact and for
contaminating food, food-packaging materials, and food-contact
surfaces.
    (7) Provide, where necessary, adequate screening or other
protection against pests.

Sec.  117.35  Sanitary operations.

    (a) General maintenance. Buildings, fixtures, and other physical
facilities of the plant must be maintained in a clean and sanitary
condition and must be kept in repair adequate to prevent food from
becoming adulterated. Cleaning and sanitizing of utensils and equipment
must be conducted in a manner that protects against allergen cross-
contact and against contamination of food, food-contact surfaces, or
food-packaging materials.
    (b) Substances used in cleaning and sanitizing; storage of toxic
materials. (1) Cleaning compounds and sanitizing agents used in
cleaning and sanitizing procedures must be free from undesirable
microorganisms and must be safe and adequate under the conditions of
use. Compliance with this requirement must be verified by any effective
means, including purchase of these substances under a letter of
guarantee or certification or examination of these substances for
contamination. Only the following toxic materials may be used or stored
in a plant where food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide
chemicals must be identified, held, and stored in a manner that
protects against contamination of food, food-contact surfaces, or food-
packaging materials.
    (c) Pest control. Pests must not be allowed in any area of a food
plant.

Guard, guide, or pest-detecting dogs may be allowed in some areas of a
plant if the presence of the dogs is unlikely to result in
contamination of food, food-contact surfaces, or food-packaging
materials. Effective measures must be taken to exclude pests from the
manufacturing, processing, packing, and holding areas and to protect
against the contamination of food on the premises by pests. The use of
pesticides to control pests in the plant is permitted only under
precautions and restrictions that will protect against the
contamination of food, food-contact surfaces, and food-packaging
materials.
    (d) Sanitation of food-contact surfaces. All food-contact surfaces,
including utensils and food-contact surfaces of equipment, must be
cleaned as frequently as necessary to protect against allergen cross-
contact and against contamination of food.
    (1) Food-contact surfaces used for manufacturing/processing,
packing, or holding low-moisture food must be in a clean, dry, sanitary
condition before use. When the surfaces are wet-cleaned, they must,
when necessary, be sanitized and thoroughly dried before subsequent
use.
    (2) In wet processing, when cleaning is necessary to protect
against allergen cross-contact or the introduction of microorganisms
into food, all food-contact surfaces must be cleaned and sanitized
before use and after any interruption during which the food-contact
surfaces may have become contaminated. Where equipment and utensils are
used in a continuous production operation, the utensils and food-
contact surfaces of the equipment must be cleaned and sanitized as
necessary.
    (3) Single-service articles (such as utensils intended for one-time
use, paper cups, and paper towels) must be stored, handled, and
disposed of in a manner that protects against allergen cross-contact
and against contamination of food, food-contact surfaces, or food-
packaging materials.