likely to occur'' to ``Recall plan''.  proposed deletion of the term
                                                                             ``hazards that are reasonably
                                                                             likely to occur''.
117.145, 117.150, 117.155..........  Redesignate the section numbers from   Accommodate insertions of new Sec.
                                      the original section numbers in the    117.136 (supplier program) and new
                                      2013 proposed preventive controls      Sec.   117.140 (preventive control
                                      rule (proposed Sec.  Sec.   117.140,   management components).
                                      117.145, and 117.150, respectively).
117.155, 117.160, 117.165, and       Move the more extensive verification   Improve clarity and readability.
 117.170.                             requirements for validation,
                                      implementation and effectiveness,
                                      and reanalysis from the single
                                      proposed section (proposed Sec.
                                      117.150) to separate sections
                                      (proposed Sec.  Sec.   117.160,
                                      117,165, and 117.170, respectively).
117.170(a)(4)......................  Revise the requirements for            Simplify the presentation of
                                      reanalysis of the food safety plan     requirements and reduce redundancy
                                      after an unanticipated event in        in regulatory text for inter-
                                      which a preventive control is not      related requirements.
                                      properly implemented to refer to the
                                      requirements for corrective actions
                                      in light of such an event rather
                                      than repeat the full text of those
                                      requirements for corrective actions.
117.170(c).........................  Specify the ``written food safety      Use the term ``food safety plan''
                                      plan'' rather than the ``written       for consistency throughout subpart
                                      plan.''.                               C.
117.170(c).........................  Specify ``document the basis for the   Improve clarity and readability.
                                      conclusion that no revisions are
                                      needed'' rather than ``document the
                                      basis for the conclusion that no
                                      additional or revised preventive
                                      controls are needed''.
117.170(e).........................  Specify ``You must conduct a           Improve clarity by specifying what
                                      reanalysis of the food safety plan     the owner, operator, or agent in
                                      when FDA determines it is necessary    charge of the facility must do in
                                      to respond to new hazards and          certain circumstances rather than
                                      developments in scientific             what FDA may require.
                                      understanding'' rather than ``FDA
                                      may require a reanalysis of the food
                                      safety plan to respond to new
                                      hazards and developments in
                                      scientific understanding.''
117.190............................  Change the title from ``Records        Accurately reflect the nature of the
                                      required for subpart C'' to            listed records after moving
                                      ``Implementation records''.            recordkeeping requirements for the
                                                                             food safety plan to Sec.   117.126.
117.190(a)(3)(ii) and (iii)........  Add ``verification of'' in front of    Distinguish these requirements for
                                      ``monitoring'' and ``corrective        records applying to ``verification
                                      actions''.                             of monitoring'' and ``verification
                                                                             of corrective actions'' from other
                                                                             requirements for ``records of
                                                                             monitoring'' and ``records of
                                                                             corrective actions''.
----------------------------------------------------------------------------------------------------------------

XVI. Holding Human Food By-Products Intended for Use in Animal Food

    Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities)
provides a rule of construction for certain facilities engaged in the
manufacturing, processing, packing, or holding of alcoholic beverages
and other food. Based on our interpretation of section 116, we proposed
that subpart C would not apply with respect to alcoholic beverages at
facilities meeting two specified conditions (proposed Sec.  117.5(i);
78 FR 3646 at 3707 to 3709). We also proposed that subpart C would not
apply with respect to food other than alcoholic beverages at facilities
described in the exemption, provided such food is in prepackaged form
that prevents direct human contact with the food and constitutes not
more than 5 percent of the overall sales of the facility. However, we
did note that in the case of a brewery manufacturing animal feed,
section 418 of the FD&C Act would apply to the spent grain sold as
animal feed once the spent grain is physically separated from the beer.
    Some comments ask us to include the production of by-products of
the alcoholic beverage manufacturing process (such as spent grains,
distillers' grains, and grape pomace) within the exemption applicable
to alcoholic beverages. These comments argue that the mere act of
separating and disposing of those by-products by sale or otherwise
should not trigger an

obligation to meet onerous and expensive food safety regulations.
    The byproducts described in these comments appear to be products
that would be used in food for animals rather than in human food. In
response to the 2013 proposed animal food rule, we received many
comments expressing concerns from brewers and distillers about whether
that rule would allow them to continue providing spent grains for
animal food. These spent grains are very commonly used as animal food,
and are a subset of the much broader practice of human food
manufacturers sending their peels, trimmings, and other by-products to
local farmers or animal food manufacturers rather than to landfills.
    Elsewhere in this issue of the Federal Register, we are issuing a
supplemental notice of proposed rulemaking to amend the 2013 proposed
animal food rule. Human food processors already complying with human
food safety requirements would not need to implement additional
preventive controls or Current Good Manufacturing Practice regulations
when supplying a by-product (e.g., wet spent grains, fruit or vegetable
peels, liquid whey) for animal food, except for proposed CGMPs to
prevent physical and chemical contamination when holding and
distributing the by-product (e.g., ensuring the by-product it is not
comingled with garbage when being held or distributed). However,
further processing a by-product for use as animal food (e.g., drying,
pelleting, heat-treatment) would require compliance with the Preventive
Controls for Animal Food rule. If any requirement regarding preventing
physical and chemical contamination in human food by-products for use
as animal food is finalized, it will be finalized as part of a final
preventive controls rule for human food.

XVII. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). FDA has developed a PRIA that presents the benefits and costs
of this proposed rule (Ref. 26). FDA believes that the proposed rule
will be a significant regulatory action as defined by Executive Order
12866. FDA requests comments on the PRIA.
    The summary analysis of benefits and costs included in this
document is drawn from the detailed PRIA (Ref. 26) which is available
at http://www.regulations.gov (enter Docket No. FDA-2011-N-0920), and
is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because many small businesses will need to implement
a number of new preventive controls, FDA acknowledges that the final
rules resulting from this proposed rule will have a significant
economic impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    The Small Business Regulatory Enforcement Fairness Act of 1996
(Public Law 104-121) defines a major rule for the purpose of
congressional review as having caused or being likely to cause one or
more of the following: An annual effect on the economy of $100 million
or more; a major increase in costs or prices; significant adverse
effects on competition, employment, productivity, or innovation; or
significant adverse effects on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic or
export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, the Office of Management and Budget (OMB) has
determined that this proposed rule is a major rule for the purpose of
congressional review.

D. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA expects that the
proposed rule will result in a 1-year expenditure that would exceed
this amount.

XVIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in the proposed
rule have been submitted to OMB for review under Section 3507(d) of the
Paperwork Reduction Act of 1995. FDA invites comments on: (1) Whether
the proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Title: Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Human Food Proposed Rule and
Amendments to Proposed Rule
    Description: FDA is proposing to amend its proposed regulation for
Current Good Manufacturing Practice In Manufacturing, Packing, Or
Holding Human Food (CGMPs) to add requirements for domestic and foreign
facilities that are required to register under section 415 of the FD&C
Act. The amendments include potential provisions that would require
facilities to establish and implement, as necessary, the following
verification activities: product testing, environmental monitoring, and
a supplier program. In addition, FDA is amending its proposed rule to
require that the hazard analysis and risk-based preventive controls for
human food take into account the possibility of economically motivated
adulteration of food.
    Description of Respondents: Section 418 of the FD&C Act is
applicable to the owner, operator or agent in charge of a food facility
required to register under section 415 of the FD&C Act. Generally, a
facility is required to register if it

manufactures, processes, packs, or holds food for consumption in the
United States. There are 97,646 such facilities; 74,900 of which are
considered ``qualified'' facilities under a very small business
definition with a $1 million threshold and thus have reduced
requirements in regards to this rule-making.
    The information collection estimate for the preventive controls for
human food proposed rule may increase if the potential requirements
(the addition of provisions for product testing, environmental
monitoring, a supplier program, and identifying any potential hazards
caused because of economically motivated adulteration) are finalized.
The information collection burden was previously estimated to be
3,686,897 hours; the revised estimate includes an additional 74,692
hours should the newly proposed provisions be finalized. To see the
calculations for these additional burden hours, see Table 9. For more
information on the original calculation of the information burden
estimate please refer to the proposed rule PRA (See Ref. 194 in Docket
FDA-2011-N-0920).
Information Collection Burden Estimate
Supplemental Notice of Proposed Rulemaking Burden
    FDA estimates the burden for this information collection as
follows:
Recordkeeping Burden
    Should the potential provisions in this proposed rule be included
in any final rule, we estimate 1,867 facilities subject to subpart C--
Hazard Analysis and Risk-Based Preventive Controls will choose to
include environmental monitoring procedures as a verification activity
under Sec.  117.165(a)(3). These facilities would need to write-up such
procedures; a one-time burden of 16 hours (5.33 hours annualized). We
also estimate that 319 food manufacturers would choose to make use of
product testing as a verification activity under Sec.  117.165(a)(2).
These facilities would create written procedures for such testing. This
is a one-time potential burden of 16 hours (5.33 hours annualized).
These potential burdens are shown in Table 9 rows 1 and 2.
    Should the potential supplier program discussed above be finalized
a receiving facility would establish and implement a risk-based
supplier program for those raw materials and ingredients for which the
receiving facility has identified a hazard that needs to be addressed
in the food safety plan; this includes whenever the receiving facility
determines that a hazard that needs to be addressed in the food safety
plan is controlled before receipt of the raw material or ingredient. We
estimate that should this potential provision be included, about 2,417
receiving facilities would incur a one-time burden of 16 hours (5.33
hours annualized) to write up such a program. This potential burden is
shown in Table 9 row 3.
    Should product testing, environmental monitoring, and supplier
programs be finalized, records would need to be reviewed and
maintained. We estimate that there are 689 facilities that would review
and keep such records as a result. These records would require on
average about 30 minutes a month to review and file. There are
operating and maintenance costs associated with the creation of these
records in the form of product testing costs ($6,400,000 annually) and
environmental monitoring sampling costs ($7,200,000 annually) and
audits and ingredient testing costs of/for suppliers ($7,000,000 audits
annually + $1,000,000 testing annually). This potential burden is shown
in Table 9 row 4.
    Under Sec.  117.130(b)(2)(iii) the supplemental notice of proposed
rulemaking adds a new element to the required hazard analysis to be
performed by each facility. Facilities must now also consider hazards
that may be intentionally introduced for purposes of economic gain. We
estimate that this added requirement will increase the one-time needed
to write up the hazard analysis by 1 to 5 hours (average 3 hours; 1
hour annualized burden over 3 years) depending on facility size and
number of processes for 16,000 facilities. The operating and
maintenance costs associated with conducting the initial hazard
analysis to assess the possibility of EMA are $5,100,000. These
estimates are shown in Table 9 row 5.
    We estimate on an annual basis that all 16,000 facilities will
spend 0.1 hours per year updating the EMA section of their hazard
analyses and that this recurring burden has an associated operating and
maintenance cost of $1,300,000. This burden is shown in Table 9 row 6.
    Some receiving facilities will have supplying facilities that meet
the definition of ``qualified'' facilities; these facilities are not
required to comply with subpart C of the proposed rule. In addition, in
some cases the supplier may be a farm not subject to the requirements
in part 112 regarding the raw material or ingredient that the receiving
facility receives from the farm. Under proposed Sec.  117.136(c)(3) and
Sec.  117.136(c)(4) these qualified facilities and exempt farms will
need to create written assurances (to be given to their receiving
facility customers) to describe the processes and procedures that the
supplier is following to ensure the safety of the food. We estimate
that there are 14,212 facility suppliers and farms that would need to
create these documents. We estimate that it will take 2 hours annually
to prepare such documentation. This burden is shown in Table 9, row 7.

                                                Table 9--Estimated Potential Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                                  Number of         Number of       Total annual           per                           Total operating
         21 CFR Part 117, subpart C             recordkeepers      records per         records        recordkeeping      Total hours     and maintenance
                                                                  recordkeeper                         (in hours)                             costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potential product testing written procedures               319                 1               319              5.33             1,700  ................
 (potential Sec.   117.165(a)(2))...........
Potential environmental monitoring written               1,867                 1             1,867              5.33             9,951  ................
 procedures (potential Sec.   117.165(a)(3))
Potential supplier program written                       2,417                 1             2,417              5.33            12,883  ................
 (potential Sec.   117.136(a)(2))...........

Sec.   117.136(a)(3); Sec.   117.165(a)(4)                 689                12             8,268               0.5             4,134       $21,600,000
 verification records.......................
Sec.   117.130(b)(2)(iii) written HA for EMA            16,000                 1            16,000                 1            16,000        $5,100,000
Sec.   117.130(b)(2)(iii) updating written              16,000                 1            16,000               0.1             1,600        $1,300,000
 HA for EMA.................................
Sec.   117.136(c)(3); Sec.   117.136(c)(4)              14,212                 1            14,212                 2            28,424  ................
 qualified or exempt suppliers assurances...
                                             -----------------------------------------------------------------------------------------------------------
    Total annual burden hours and costs.....  ................  ................  ................  ................            74,692       $28,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

Reporting Burden
    There is no additional reporting burden under this supplemental
notice of proposed rulemaking.
Third Party Disclosure Burden
    There is no additional third party disclosure burden under this
supplemental notice of proposed rulemaking.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should
be identified with the title ``Current Good Manufacturing Practice And
Hazard Analysis And Risk-Based Preventive Controls For Human Food.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. These requirements
will not be effective until FDA obtains OMB approval. FDA will publish
a notice concerning OMB approval of these requirements in the Federal
Register.

XIX. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment (Ref. 35) (Ref. 36). Therefore, neither
an environmental assessment nor an environmental impact statement is
required.

XX. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XXI. 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.

1. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
One. February 28, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket No. FDA-2011-N-
0920.
2. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
Two. March 1, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket No. FDA-2011-N-
0920.
3. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
One. March 11, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket No. FDA-2011-N-
0920.
4. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
Two. March 12, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket No. FDA-2011-N-
0920.
5. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
One. March 27, 2013. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket No. FDA-2011-N-
0920.
6. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
Two. March 28, 2013. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket No. FDA-2011-N-
0920.
7. FDA, ``Record of Outreach Sessions on FDA Proposed Rules,'' 2013.
Available in Docket No. FDA-2011-N-0920.
8. Taylor, M., ``Statement From FDA Deputy Commissioner for Foods
and Veterinary Medicine, Michael Taylor, on Key Provisions of the
Proposed FSMA Rules Affecting Farmers,'' December 19, 2013.
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm. Accessed and printed on January 29, 2014.
9. Taylor, M., ``Your Input Is Bringing Change to Food Safety
Rules,'' December 19, 2013. Available at http://blogs.fda.gov/fdavoice/index.php/2013/12/your-input-is-bringing-change-to-food-safety-rules. Accessed and printed on January 29, 2014.
10. FDA, ``Guidance for Industry: Questions and Answers Regarding
Food Facility Registration (Fifth Edition),'' 2012.
11. FDA, ``Guidance for Industry: What You Need to Know About
Registration of Food Facilities; Small Entity Compliance Guide,''
2012.
12. FDA, ``Guidance for Industry: Questions and Answers Regarding
Establishment and Maintenance of Records By Persons Who Manufacture,
Process, Pack, Transport,

Distribute, Receive, Hold, or Import Food (Edition 5),'' 2012.
13. FDA, ``What You Need to Know About Establishment and Maintenance
of Records,'' 2014.
14. FDA, ``Guidance for Industry: Antimicrobial Food Additives,''
1999.
15. Cooperative Extension Service, Division of Agricultural Sciences
and Natural Resources, Oklahoma State University; USDA, Federal
Grain Inspection Service; USDA, Extension Service; USDA, Animal and
Plant Health Inspection Service, ``Stored Product Management,''
Circular No. E-912, January 1995. Available at http://entomology.k-
state.edu/doc/extension--crop-pests/
E912AllStoredProductMay3.pdf.
Accessed and printed on August 14, 2014.
16. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/Food
Combinations for Activities (Outside the Farm Definition) Conducted
in a Facility Co-Located on a Farm,'' 2012.
17. National Advisory Committee on Microbiological Criteria for
Foods, ``Hazard Analysis and Critical Control Point Principles and
Application Guidelines,'' Journal of Food Protection, 61:1246-1259,
1998.
18. FDA Memorandum, ``Product Testing,'' 2014.
19. Codex Alimentarius Commission, ``Hazard Analysis And Critical
Control Point (HACCP) System And Guidelines For Its Application.
Annex to CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
20. Codex Alimentarius Commission, ``General Principles of Food
Hygiene, CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
21. Codex Alimentarius Commission, ``Guidelines on the Application
of General Principles of Food Hygiene to the Control of Listeria
monocytogenes in Ready-to-Eat Foods, CAC/GL 61--2007,'' 2007.
22. Codex Alimentarius Commission, ``Code of Hygienic Practice for
Powdered Formulae for Infants and Young Children, CAC/RCP 66-2008,''
2008.
23. FDA Memorandum, ``Environmental Monitoring,'' 2014.
24. FDA Memorandum, ``Supplier Program,'' 2014.
25. U.S. Pharmacopeial Convention, ``U.S. Pharmacopeial Convention
(USP) Food Fraud Database,'' March 6, 2014. Available at http://www.usp.org/food-ingredients/food-fraud-database. Accessed and
printed on February 20, 2014.
26. FDA, ``FSMA Supplemental Notice of Proposed Rulemaking for
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food. Preliminary Regulatory
Impact Analysis,'' 2014.
27. FDA, ``Supporting Document for Recommended Maximum Level for
Lead in Candy Likely to Be Consumed Frequently by Small Children,''
November, 2006.
28. FDA, ``Best Value, Inc., Recalls PRAN Bran[d] Turmeric Powder
Due to Elevated Levels of Lead,'' October 16, 2013. Available at
http://www.fda.gov/safety/recalls/ucm371042.htm. Accessed and
printed on February 25, 2014.
29. LEAD Action News, ``Adulteration of Paprika in Hungary,'' 1995.
Available at http://www.lead.org.au/lanv3n3/lanv3n3-6.html. Accessed
and printed on February 20, 2014.
30. International Agency for Research on Cancer, ``Agents Classified
by the IARC Monographs, Volumes 1-109,'' January 14, 2014. Available
at http://monographs.iarc.fr/ENG/Classification/ClassificationsAlphaOrder.pdf. Accessed and printed on August 13,
2014.
31. U.K. Food Standards Agency, ``Sudan I Timeline,'' February 24,
2005. http://webarchive.nationalarchives.gov.uk/20111206002505/http://www.food.gov.uk/safereating/chemsafe/sudani/sudanitimeline.
Accessed and printed on February 25, 2014.
32. Congressional Research Service, ``Food Fraud and ``Economically
Motivated Adulteration'' of Food and Food Ingredients,'' January 10,
2014. Available at http://www.fas.org/sgp/crs/misc/R43358.pdf.
Accessed and printed on March 6, 2014.
33. Everstine, K., J. Spink, and S. Kennedy, ``Economically
Motivated Adulteration (EMA) of Food: Common Characteristics of EMA
Incidents,'' Journal of Food Protection, 76:723-735, 2013.
34. Muth, M.K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator,
``Food Processing Sector Study, Contract HHSF<PHONE_NUMBER>5G, Task
Order 13, Final Report,'' 2011.
35. FDA Memorandum, ``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.
36. FDA Memorandum, ``Modernization of food current Good
Manufacturing Practices (cGMP) as required by the Food Safety
Modernization Act of 2011,'' 2011.

List of Subjects

21 CFR Part 1

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

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 117

    Food packaging, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I, as proposed to be amended on January
16, 2013 (78 FR 3646), be further 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. Section 1.227 is amended by revising the definitions for ``Farm'',
``Harvesting'', ``Holding'', and ``Packing'' to read as follows:

Sec.  1.227  What definitions apply to this subpart?

* * * * *
    Farm means an establishment under one ownership in one general
physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. The term ``farm''
includes establishments that, in addition to these activities:
    (1) Pack or hold raw agricultural commodities;
(2) 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 ownership, or is processed food identified in paragraph
(3)(ii)(A) of this definition; and
    (3) Manufacture/process food, provided that:
    (i) All food used in such activities is consumed on that farm or
another farm under the same ownership; or
    (ii) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same ownership consists only of:
    (A) Drying/dehydrating raw agricultural commodities to create a
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and
    (B) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing.
* * * * *
    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 on a
farm. Harvesting 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. Gathering,
field coring, washing, trimming of outer leaves of, removing stems and
husks from, sifting, filtering, threshing, shelling, and

cooling raw agricultural commodities grown on a farm are examples of
harvesting.
    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 and 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, 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. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)), but does not include
activities that transform a raw agricultural commodity, as defined in
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act.
* * * * *
0
3. Section 1.328 is amended by revising the definitions for ``Farm'',
``Harvesting'', ``Holding'', and ``Packing'' to read as follows:

Sec.  1.328  What definitions apply to this subpart?

* * * * *
    Farm means an establishment under one ownership in one general
physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. The term ``farm''
includes establishments that, in addition to these activities:
    (1) Pack or hold raw agricultural commodities;
    (2) 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 ownership, or is processed food identified in paragraph
(3)(ii)(A) of this definition; and
    (3) Manufacture/process food, provided that:
    (i) All food used in such activities is consumed on that farm or
another farm under the same ownership; or
    (ii) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same ownership consists only of:
    (A) Drying/dehydrating raw agricultural commodities to create a
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and
    (B) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing.
* * * * *
    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 on a
farm. Harvesting 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. Gathering,
field coring, washing, trimming of outer leaves of, removing stems and
husks from, sifting, filtering, threshing, shelling, and cooling raw
agricultural commodities grown on a farm are examples of harvesting.
    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 and 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, 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. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)), 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.
* * * * *

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

0
4. 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
5. Section 16.1 is amended by revising the entry for ``Sec. Sec.
117.251 through 117.284'' in paragraph (b)(2) to read as follows:

Sec.  16.1  Scope.

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

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

0
6. The authority citation for part 117, as proposed to be added on
January 16, 2013 (78 FR 3646), continues to read as follows:

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

Subpart A--General Provisions

Sec.  117.3  [Amended]

0
7. Section 117.3 is amended as follows:
0
a. By removing the definitions for ``cross-contact'', ``hazard
reasonably likely to occur'', and ``reasonably foreseeable hazard'';
0
b. By adding definitions for ``allergen-cross contact'', ``known or
reasonably foreseeable hazard'', ``pathogen'', ``qualified auditor'',
``receiving facility'', ``significant hazard'', ``supplier'', and ``you
``; and
0
c. By revising the definitions for ``environmental pathogen'',
``harvesting'', ``hazard,'' ``holding'', ``packing'', and ``very small
business''.
    The additions and revisions read as follows:

Sec.  117.3  Definitions.

* * * * *

    Allergen cross-contact means the unintentional incorporation of a
food allergen into a food.
* * * * *
    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. Environmental
pathogen does not include the spores of pathogenic sporeformers.
* * * * *
    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 on a
farm. Harvesting 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. Gathering,
field coring, washing, trimming of outer leaves of, removing stems and
husks from, sifting, filtering, threshing, shelling, and cooling raw
agricultural commodities grown on a farm are examples of harvesting.
    Hazard means any biological, chemical (including radiological), or
physical agent that is reasonably likely to cause illness or injury in
the absence of its control.
    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 and 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, 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. 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 has the potential to
be associated with the facility or the food.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)), 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.
    Pathogen means a microorganism of public health significance.
* * * * *
    Qualified auditor means a person who is a qualified individual as
defined in this part and has technical expertise obtained by a
combination of training and experience appropriate to perform the
auditing function as required by Sec.  117.180(c)(2).
* * * * *
    Receiving facility means a facility that is subject to subpart C of
this part and that manufactures/processes a raw material or ingredient
that it receives from a supplier.
* * * * *
    Significant hazard 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, establish 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 control.
* * * * *
    Supplier means the establishment that manufactures/processes the
food, raises the animal, or harvests 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.
* * * * *
    Very small business means, for purposes of this part, a business
that has less than $1,000,000 in total annual sales of human food,
adjusted for inflation.
* * * * *
    You means, for purposes of this part, the owner, operator, or agent
in charge of a facility.
0
8. Amend Sec.  117.5 by revising paragraph (k) to read as follows:

Sec.  117.5  Exemptions.

* * * * *
    (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 part in accordance with Sec.
1.226(f);
    (iii) The holding or transportation of one or more ``raw
agricultural commodities,'' as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act;
    (iv) Activities of ``farm mixed-type facilities'' (as defined in
Sec.  1.227) that fall within the definition of ``farm''; or
    (v) Hulling, shelling, and drying nuts (without manufacturing/
processing, such as roasting nuts).
    (2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates
raw agricultural commodities 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 or with the applicable requirements for
packing and holding in part 112 of this chapter.
0
9. Revise subpart C to read as follows:

Subpart C--Hazard Analysis and Risk-Based Preventive Controls

Sec.
117.126 Food safety plan.
117.130 Hazard analysis.
117.135 Preventive controls.
117.136 Supplier program.
117.137 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 qualified individual and a
qualified auditor.
117.190 Implementation records.

Sec.  117.126  Food safety plan.

    (a) Requirement for a food safety plan. (1) You must prepare, or
have prepared, and implement a written food safety plan.
    (2) The food safety plan must be prepared, or its preparation
overseen, by one or more qualified individuals.
    (b) Contents of a food safety plan. The written food safety plan
must include:

    (1) The written hazard analysis as required by Sec.  117.130(a)(2);
    (2) The written preventive controls as required by Sec.
117.135(b);
    (3) The written supplier program as required by Sec.
117.136(a)(2);
    (4) The written recall plan as required by Sec.  117.137(a); and
    (5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec.  117.145(a)(1);
    (6) The written corrective action procedures as required by Sec.
117.150(a)(1); and
    (7) The written verification procedures as required by Sec.
117.165(b).
    (c) Records. The food safety plan required by this section is a
record that is subject to the requirements of subpart F of this part.

Sec.  117.130  Hazard analysis.

    (a) Requirement for a hazard analysis. (1) You must identify and
evaluate, based on experience, illness data, scientific reports, and
other information, known or reasonably foreseeable hazards for each
type of food manufactured, processed, packed, or held at your facility
to determine whether there are significant hazards.
    (2) The hazard analysis must be written.
    (b) Hazard identification. The hazard identification must consider:
    (1) Hazards that include:
    (i) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances
such as pesticide and drug residues, natural toxins, decomposition,
unapproved food or color additives, and food allergens; and
    (iii) Physical hazards; and
    (2) Hazards that may be present in the food for any of the
following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of
economic gain.
    (c) Hazard evaluation. (1)(i) The hazard analysis must include an
evaluation of the hazards identified in paragraph (b) of this section
to assess 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.
    (ii) The hazard evaluation required by paragraph (c)(1)(i) of this
section must include an evaluation of environmental pathogens whenever
a ready-to-eat food is exposed to the environment prior to packaging
and the packaged food does not receive a treatment that would
significantly minimize the pathogen.
    (2) The hazard evaluation must consider the effect of the following
on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the facility and
equipment;
    (iii) Raw materials and ingredients;
    (iv) Transportation practices;
    (v) Manufacturing/processing procedures;
    (vi) Packaging activities and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors.

Sec.  117.135  Preventive controls.

    (a)(1) You must identify and implement preventive controls to
provide assurances that significant hazards will be significantly
minimized or prevented and the food manufactured, processed, packed, or
held by your facility will not be adulterated under section 402 of the
Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w)
of the Federal Food, Drug, and Cosmetic Act.
    (2) Preventive controls required by paragraph (a)(1) of this
section include, as appropriate to the facility and the food:
    (i) Controls at critical control points (CCPs), if there are any
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate
for food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and
the food:
    (1) Process controls. Process controls include procedures,
practices, and processes to ensure the control of parameters during
operations such as heat processing, acidifying, irradiating, and
refrigerating foods. Process controls must include, as appropriate to
the applicable control:
    (i) Parameters associated with the control of the hazard; and
    (ii) The maximum or minimum value, or combination of values, to
which any biological, chemical, or physical parameter must be
controlled to significantly minimize or prevent a significant hazard.
    (2) Food allergen controls. Food allergen controls include
procedures, practices, and processes to control food allergens. Food
allergen controls must include those procedures, practices, and
processes employed for:
    (i) Ensuring protection of food from allergen cross-contact,
including during storage and use; and
    (ii) Labeling the finished food, including ensuring that the
finished food is not misbranded under section 403(w) of the Federal
Food, Drug, and Cosmetic Act.
    (3) Sanitation controls. Sanitation controls include procedures,
practices, and processes to ensure that the facility is maintained in a
sanitary condition adequate to significantly minimize or prevent
hazards such as environmental pathogens, biological hazards due to
employee handling, and food allergen hazards. Sanitation controls must
include, as appropriate to the facility and the food, procedures,
practices, and processes for the:
    (i) Cleanliness of food-contact surfaces, including food-contact
surfaces of utensils and equipment;
    (ii) Prevention of allergen cross-contact and cross-contamination
from insanitary objects and from personnel to food, food packaging
material, and other food-contact surfaces and from raw product to
processed product.
    (4) Supplier controls. Supplier controls include the supplier
program as required by Sec.  117.136.
    (5) Recall plan. Recall plan as required by Sec.  117.137.
    (6) Other controls. Preventive controls include any other
procedures, practices, and processes necessary to satisfy the
requirements of paragraph (a) of this section. Examples of other
controls include hygiene training and other current good manufacturing
practices.

Sec.  117.136  Supplier program.

    (a) Supplier program. (1)(i) Except as provided in paragraph
(a)(1)(ii) of this section, the receiving facility must establish and
implement a risk-based supplier program for those raw materials and
ingredients for which the receiving facility has identified a
significant hazard when the hazard is controlled before receipt of the
raw material or ingredient.
    (ii) The receiving facility is not required to establish and
implement a supplier program for raw materials and ingredients for
which:
    (A) There are no significant hazards;
    (B) The preventive controls at the receiving facility are adequate
to significantly minimize or prevent each of the significant hazards;
or
    (C) The receiving facility relies on its customer to control the
hazard and annually obtains from its customer written assurance that
the customer has established and is following procedures (identified in
the written assurance) that

will significantly minimize or prevent the hazard.
    (2) The supplier program must be written.
    (3) The supplier program must include:
    (i) Verification activities, as appropriate to the hazard, and
documentation of these activities, to ensure raw materials and
ingredients are received only from suppliers approved for control of
the hazard(s) in that raw material or ingredient (or, when necessary
and appropriate, on a temporary basis from unapproved suppliers whose
raw materials or ingredients the receiving facility subjects to
adequate verification activities before acceptance for use); and
    (ii) Verification activities and documentation of these activities,
as required by paragraph (b) of this section, to verify that:
    (A) The hazard is significantly minimized or prevented;
    (B) The incoming raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act or
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic
Act: and
    (C) The incoming raw material or ingredient is produced in
compliance with the requirements of applicable FDA food safety
regulations.
    (4) When supplier verification activities are required under
paragraph (c) of this section for more than one type of hazard in a
food, the receiving facility must conduct the verification activity or
activities appropriate for each of those hazards.
    (5) For some hazards, in some situations under paragraph (b) it
will be necessary to conduct more than one verification activity and/or
to increase the frequency of one or more verification activities to
provide adequate assurances that the hazard is significantly minimized
or prevented.
    (b) Determination and documentation of the appropriate verification
activities. In determining and documenting the appropriate verification
activities, the receiving facility must consider the following:
    (1) The hazard analysis, including the nature of the hazard,
applicable to the raw material and ingredients;
    (2) Where the preventive controls for those hazards are applied for
the raw material and ingredients--such as at the supplier or the
supplier's supplier;
    (3) The supplier's procedures, processes, and practices related to
the safety of the raw material and ingredients;
    (4) Applicable FDA food safety regulations and information relevant
to the supplier's compliance with those regulations, including an FDA
warning letter or import alert relating to the safety of the food;
    (5) The supplier's food safety performance history relevant to the
raw materials or ingredients that the receiving facility receives from
the supplier, including available information about results from
testing raw materials or ingredients for hazards, audit results
relating to the safety of the food, and responsiveness of the supplier
in correcting problems; and
    (6) Any other factors as appropriate and necessary. Examples of
factors that a receiving facility may determine are appropriate and
necessary are storage and transportation practices.
    (c) Supplier verification activities for raw materials and
ingredients. (1) Except as provided in paragraph (c)(2) or (3) of this
section, the receiving facility must conduct and document one or more
of the following supplier verification activities as determined by the
receiving facility under paragraph (b) of this section, for each
supplier before using the raw material or ingredient and periodically
thereafter:
    (i) Onsite audits;
    (ii) Sampling and testing of the raw material or ingredient, which
may be conducted by either the supplier or receiving facility.
    (iii) Review by the receiving facility of the supplier's relevant
food safety records; or
    (iv) Other appropriate supplier verification activities based on
the risk associated with the ingredient and the supplier.
    (2)(i) Except as provided by paragraph (c)(2)(ii) of this section,
when a hazard in a raw material or ingredient will be controlled by the
supplier and is one for which there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans, the receiving facility must have
documentation of an onsite audit of the supplier before using the raw
material or ingredient from the supplier and at least annually
thereafter.
    (ii) The requirements of paragraph (c)(2)(i) of this section do not
apply if the receiving facility documents its determination that other
verification activities and/or less frequent onsite auditing of the
supplier provide adequate assurance that the hazards are controlled.
    (3) If a supplier is a qualified facility as defined by Sec.
117.3, the receiving facility need not comply with paragraphs (c)(1)
and (2) of this section if the receiving facility:
    (i) Documents, at the end of each calendar year, that the supplier
is a qualified facility as defined by Sec.  117.3; and
    (ii) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act or misbranded under section 403(w) of the
Federal Food, Drug, and Cosmetic Act. The written assurance must
include a brief description of the processes and procedures that the
supplier is following to ensure the safety of the food.
    (4) If a supplier is a farm that is not subject to the requirements
established in part 112 of this chapter in accordance with Sec.  112.4
regarding the raw material or ingredient that the receiving facility
receives from the farm, the receiving facility does not need to comply
with paragraphs (c)(1) and (2) of this section if the receiving
facility:
    (i) Documents, at the end of each calendar year, that the raw
material or ingredient provided by the supplier is not subject to part
112 of this chapter; and
    (ii) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act.
    (d) Onsite audit. (1) An onsite audit of a supplier must be
performed by a qualified auditor.
    (2) If the raw material or ingredient at the supplier is subject to
one or more FDA food safety regulations, an onsite audit must consider
such regulations and include a review of the supplier's written plan
(e.g., HACCP plan or other food safety plan), if any, including its
implementation, for the hazard being audited.
    (e) Substitution of inspection by FDA or an officially recognized
or equivalent food safety authority. (1) Instead of an onsite audit, a
receiving facility may rely on the results of an inspection of the
supplier by FDA or, for a foreign supplier, by FDA or the food safety
authority of a country whose food safety system FDA has officially
recognized as comparable or has determined to be equivalent to that of
the United States, provided that the inspection was conducted within 1
year of the date that the onsite audit would have been required to be
conducted.
    (2) For inspections conducted by the food safety authority of a
country whose

food safety system FDA has officially recognized as comparable or
determined to be equivalent, the food that is the subject of the onsite
audit must be within the scope of the official recognition or
equivalence determination, and the foreign supplier must be in, and
under the regulatory oversight of, such country.
    (f) Supplier non-conformance. If the owner, operator, or agent in
charge of a receiving facility determines through auditing,
verification testing, relevant consumer, customer or other complaints,
or otherwise that the supplier is not controlling hazards that the
receiving facility has identified as significant, the receiving
facility must take and document prompt action in accordance with Sec.
117.150 to ensure that raw materials or ingredients from the supplier
do not cause food that is manufactured or processed by the receiving
facility to be adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act or misbranded under section 403(w) of the Federal
Food, Drug, and Cosmetic Act.
    (g) Records. The receiving facility must document the following in
records and review such records in accordance with Sec.  117.165(a)(4).
    (1) The written supplier program;
    (2) Documentation of the appropriate verification activities;
    (3) The annual written assurance that a receiving facility's
customer who is controlling a significant hazard has established and is
following procedures (identified in the written assurance) that will
significantly minimize or prevent the hazard;
    (4) Documentation demonstrating that products are received only
from approved suppliers;
    (5) Documentation of an onsite audit. This documentation must
include:
    (i) Documentation of audit procedures;
    (ii) The dates the audit was conducted;
    (iii) The conclusions of the audit;
    (iv) Corrective actions taken in response to significant
deficiencies identified during the audit; and
    (v) Documentation that the audit was conducted by a qualified
auditor.
    (6) Records of sampling and testing. These records must include:
    (i) Identification of the raw material or ingredient tested
(including lot number, as appropriate) and the number of samples
tested;
    (ii) Identification of the test(s) conducted, including the
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards;
and
    (vi) Information identifying the laboratory conducting the testing.
    (7) Records of the review by the receiving facility of the
supplier's relevant food safety records. These records must include:
    (i) The date(s) of review;
    (ii) Corrective actions taken in response to significant
deficiencies identified during the review; and
    (iii) Documentation that the review was conducted by a qualified
individual.
    (8) Records of other appropriate supplier verification activities
based on the risk associated with the ingredient.
    (9) Documentation of any determination that verification activities
other than an onsite audit, and/or less frequent onsite auditing of a
supplier, provide adequate assurance that the hazards are controlled;
    (10) Documentation of an alternative verification activity for a
supplier that is a qualified facility, including:
    (i) The documentation that the supplier is a qualified facility as
defined by Sec.  117.3; and
    (ii) The written assurance that the supplier is producing the raw
material or ingredient in compliance with applicable FDA food safety
regulations and that the raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act or
misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic
Act.
    (11) Documentation of an alternative verification activity for a
supplier that is a farm that supplies a raw material or ingredient that
is not subject to part 112 of this chapter, including:
    (i) The documentation that the raw material or ingredient provided
by the supplier is not subject to part 112 of this chapter; and
    (ii) The written assurance that the supplier is producing the raw
material or ingredient in compliance with applicable FDA food safety
regulations and that the raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
    (12) Evidence of an inspection of the supplier by FDA or the food
safety authority of another country.
    (13) Documentation of actions taken with respect to supplier non-
conformance.

Sec.  117.137  Recall plan.

    For food with a significant hazard:
    (a) You must establish a written recall plan for the food.
    (b) The written recall plan must include procedures that describe
the steps to be taken, and assign responsibility for taking those
steps, to perform the following actions as appropriate to the facility:
    (1) Directly notify the direct consignees of the food being
recalled, including how to return or dispose of the affected food;
    (2) Notify the public about any hazard presented by the food when
appropriate to protect public health;
    (3) Conduct effectiveness checks to verify that the recall is
carried out; and
    (4) Appropriately dispose of recalled food (e.g., through
reprocessing, reworking, diverting to a use that does not present a
safety concern, or destroying the food).

Sec.  117.140  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section,
the preventive controls required under Sec.  117.135 are subject to the
following preventive control management components as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control:
    (1) Monitoring in accordance with Sec.  117.145;
    (2) Corrective actions and corrections in accordance with Sec.
117.150; and
    (3) Verification in accordance with Sec.  117.155.
    (b) The supplier program established in Sec.  117.136 is subject to
the following preventive control management components as appropriate
to ensure the effectiveness of the supplier program taking into account
the nature of the hazard controlled before receipt of the raw material
or ingredient:
    (1) Corrective actions and corrections in accordance with Sec.
117.150, taking into account the nature of any supplier non-
conformance;
    (2) Review of records in accordance with Sec.  117.165(a)(4); and
    (3) Reanalysis in accordance with Sec.  117.170.
    (c) The recall plan established in Sec.  117.137 is not subject to
the requirements of paragraph (a) of this section.

Sec.  117.145  Monitoring.

    (a) As appropriate to the preventive control, you must:
    (1) Establish and implement written procedures, including the
frequency with which they are to be performed, for monitoring the
preventive controls; and
    (2) Monitor the preventive controls with adequate frequency to
provide assurance that they are consistently performed.
    (b) All monitoring of preventive controls in accordance with this
section

must be documented in records that are subject to verification in
accordance with Sec.  117.155(a)(2) and records review in accordance
with Sec.  117.165(a)(4)(i).

Sec.  117.150  Corrective actions and corrections.

    (a) Corrective action procedures. As appropriate to the preventive
control, except as provided by paragraph (c) of this section:
    (1)(i) You must establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented.
    (ii) The corrective action procedures required by paragraph
(a)(1)(i) of this section must include procedures to address, as
appropriate:
    (A) The presence of a pathogen or appropriate indicator organism in
a ready-to-eat product detected as a result of product testing
conducted in accordance with Sec.  117.165(a)(2); and
    (B) The presence of an environmental pathogen or appropriate
indicator organism detected through the environmental monitoring
conducted in accordance with Sec.  117.165(a)(3).
    (2) The corrective action procedures must describe the steps to be
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken, when necessary, to reduce the
likelihood that the problem will recur;
    (iii) All affected food is evaluated for safety; and
    (iv) All affected food is prevented from entering into commerce, if
you cannot ensure that the affected food is not adulterated under
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded
under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
    (b) Corrective action in the event of an unanticipated food safety
problem. (1) Except as provided by paragraph (c) of this section, you
are subject to the requirements of paragraph (b)(2) of this section if
any of the following circumstances apply:
    (i) A preventive control is not properly implemented and a specific
corrective action procedure has not been established;
    (ii) A preventive control is found to be ineffective; or
    (iii) A review of records in accordance with Sec.  117.165(a)(4)
finds that the records are not complete, the activities conducted did
not occur in accordance with the food safety plan, or appropriate
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this
section apply, you must:
    (i) Take corrective action to identify and correct the problem,
reduce the likelihood that the problem will recur, evaluate all
affected food for safety, and, as necessary, prevent affected food from
entering commerce as would be done following a corrective action
procedure under paragraphs (a)(2)(i) through (iv) of this section; and
    (ii) When appropriate, reanalyze the food safety plan in accordance
with Sec.  117.170 to determine whether modification of the food safety
plan is required.
    (c) Corrections applicable to food allergen controls and sanitation
controls. You do not need to comply with the requirements of paragraphs
(a) and (b) of this section for conditions and practices that are not
consistent with the food allergen controls in Sec.  117.135(c)(2)(i) or
the sanitation controls in Sec.  117.135(c)(3)(i) or (ii) if you take
action, in a timely manner, to correct such conditions and practices.
    (d) Documentation. All corrective actions (and, when appropriate,
corrections) taken in accordance with this section must be documented
in records. These records are subject to verification in accordance
with Sec.  117.155(a)(3) and records review in accordance with Sec.
117.165(a)(4)(i).

Sec.  117.155  Verification.

    (a) Verification activities. Verification activities must include,
as appropriate to the preventive control:
    (1) Validation in accordance with Sec.  117.160.
    (2) Verification that monitoring is being conducted as required by
Sec.  117.140 (and in accordance with Sec.  117.145).
    (3) Verification that appropriate decisions about corrective
actions are being made as required by Sec.  117.140 (and in accordance
with Sec.  117.150).
    (4) Verification of implementation and effectiveness in accordance
with Sec.  117.165; and
    (5) Reanalysis in accordance with Sec.  117.170.
    (b) Documentation. All verification activities conducted in
accordance with this section must be documented in records.

Sec.  117.160  Validation.

    (a) Except as provided by paragraph (b)(3) of this section, you
must validate that the preventive controls identified and implemented
in accordance with Sec.  117.135 to control the significant hazards are
adequate to do so as appropriate to the nature of the preventive
control.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a qualified individual:
    (i) Prior to implementation of the food safety plan or, when
necessary, during the first 6 weeks of production; and
    (ii) Whenever a reanalysis of the food safety plan reveals the need
to do so;
    (2) Must include collecting and evaluating scientific and technical
information (or, when such information is not available or is
inadequate, conducting studies) to determine whether the preventive
controls, when properly implemented, will effectively control the
significant hazards; and
    (3) Need not address:
    (i) The food allergen controls in Sec.  117.135(c)(2);
    (ii) The sanitation controls in Sec.  117.135(c)(3);
    (iii) The supplier program in Sec.  117.136; and
    (iv) The recall plan in Sec.  117.137.

Sec.  117.165  Verification of implementation and effectiveness.

    (a) Verification activities. You must verify that the preventive
controls are consistently implemented and are effectively and
significantly minimizing or preventing the significant hazards. To do
so you must conduct activities that include the following, as
appropriate to the facility, the food, and the nature of the preventive
control:
    (1) Calibration of process monitoring instruments and verification
instruments;
    (2) Product testing, for a pathogen (or appropriate indicator
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for
an appropriate indicator organism, if contamination of a ready-to-eat
food with an environmental pathogen is a significant hazard, by
collecting and testing environmental samples; and
    (4) Review of the following records within the specified
timeframes, by (or under the oversight of) a qualified individual, to
ensure that the records are complete, the activities reflected in the
records occurred in accordance with the food safety plan, the
preventive controls are effective, and appropriate decisions were made
about corrective actions:
    (i) Records of monitoring and corrective action records within a
week after the records are created.
    (ii) Records of calibration, product testing, environmental
monitoring, and supplier verification activities within a reasonable
time after the records are created.
    (b) Written procedures. As appropriate to the facility, the food,
and

the nature of the preventive control, you must establish and implement
written procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring
instruments and verification instruments as required by paragraph
(a)(1) of this section.
    (2) Product testing as required by paragraph (a)(2) of this
section. Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
117.150(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of
this section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected
and the number of sites to be tested during routine environmental
monitoring. The number and location of sampling sites must be adequate
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing
samples. The timing and frequency for collecting and testing samples
must be adequate to determine whether preventive controls are
effective;
    (v) Identify the test(s) conducted, including the analytical
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec.
117.150(a)(1).

Sec.  117.170  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan:
    (1) At least once every 3 years;
    (2) Whenever a significant change is made in the activities
conducted at your facility if the change creates a reasonable potential
for a new hazard or creates a significant increase in a previously
identified hazard;
    (3) Whenever you become aware of new information about potential
hazards associated with the food;
    (4) Whenever appropriate after an unanticipated food safety problem
in accordance with Sec.  117.150(b); and
    (5) Whenever you find that a preventive control is ineffective.
    (b) You must complete the reanalysis required by paragraph (a) of
this section and implement any additional preventive controls needed to
address the hazard identified, if any, before the change in activities
at the facility is operative or, when necessary, during the first 6
weeks of production.
    (c) You must revise the written food safety plan if a significant
change is made or document the basis for the conclusion that no
revisions are needed.
    (d) A qualified individual must perform (or oversee) the
reanalysis.
    (e) You must conduct a reanalysis of the food safety plan when FDA
determines it is necessary to respond to new hazards and developments
in scientific understanding.

Sec.  117.180  Requirements applicable to a qualified individual and a
qualified auditor.

    (a) One or more qualified individuals must do or oversee the
following:
    (1) Preparation of the food safety plan (Sec.  117.126(a)(2));
    (2) Validation of the preventive controls (Sec.  117.160(b)(1));
    (3) Review of records (Sec.  117.165(a)(4)); and
    (4) Reanalysis of the food safety plan (Sec.  117.170(d)).
    (b) A qualified auditor must conduct an onsite audit (Sec.
117.136(d)).
    (c)(1) To be a qualified individual, the individual must have
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 be
otherwise qualified through job experience to develop and apply a food
safety system. Job experience may qualify an individual to perform
these functions if such experience has provided an individual with
knowledge at least equivalent to that provided through the standardized
curriculum. This individual may be, but is not required to be, an
employee of the facility.
    (2) To be a qualified auditor, a qualified individual must have
technical expertise obtained by a combination of training and
experience appropriate to perform the auditing function.
    (d) All applicable training must be documented in records,
including the date of the training, the type of training, and the
person(s) trained.

Sec.  117.190  Implementation records.

    (a) You must establish and maintain the following records
documenting implementation of the food safety plan:
    (1) Records that document the monitoring of preventive controls;
    (2) Records that document corrective actions;
    (3) Records that document verification, including, as applicable,
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification
instruments;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (4) Records that document the supplier program; and
    (5) Records that document applicable training for the qualified
individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to
the requirements of subpart F of this part.
0
10. Revise Sec.  117.251 to read as follows:

Sec.  117.251  Circumstances that may lead FDA to withdraw an exemption
applicable to a qualified facility.

    (a) FDA may withdraw the exemption applicable to a qualified
facility under Sec.  117.5(a):
    (1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conditions or conduct associated with the qualified facility that are
material to the safety of the food manufactured, processed, packed, or
held at such facility.
    (b) Before FDA issues an order to withdraw an exemption applicable
to a qualified facility, FDA:
    (1) May consider one or more other actions to protect the public
health or mitigate a foodborne illness outbreak, including, a warning
letter, recall, administrative detention, suspension of registration,
import alert, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the
facility, in writing, of circumstances that may lead FDA to withdraw
the exemption, and provide an opportunity for the owner, operator, or
agent in charge of the facility to respond in writing, within 10
calendar days of the date of receipt of the notification, to FDA's
notification; and
    (3) Must consider the actions taken by the facility to address the
circumstances that may lead FDA to withdraw the exemption.
0
11. Revise Sec.  117.254 to read as follows:

Sec.  117.254  Issuance of an order to withdraw an exemption applicable
to a qualified facility.

    (a) An FDA District Director in whose district the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Office of Compliance in the Center for Food Safety and
Applied Nutrition), or an FDA official senior to such Director, must
approve an order to withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.
0
12. Amend Sec.  117.257 by revising paragraph (d) to read as follows:

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

* * * * *
    (d) A statement that the facility must either:
    (1) Comply with subpart C of this part on the date that is 120
calendar days after the date of receipt of the order; or
    (2) Appeal the order within 10 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  117.264.
* * * * *
0
13. Amend Sec.  117.260 by revising paragraphs (a) and (c) to read as
follows:

Sec.  117.260  Compliance with, or appeal of, an order to withdraw an
exemption applicable to a qualified facility.

    (a) If you receive an order under Sec.  117.254 to withdraw an
exemption applicable to that facility under Sec.  117.5(a), you must
either:
    (1) Comply with applicable requirements of this part within 120
calendar days of the date of receipt of the order; or
    (2) Appeal the order within 10 calendar days of the date of receipt
of the order in accordance with the requirements of Sec.  117.264.
* * * * *
    (c) If you appeal the order, and FDA confirms the order, you must
comply with applicable requirements of this part within 120 calendar
days of the date of receipt of confirmation of the order.
0
14. Amend Sec.  117.264 by revising paragraphs (a) introductory text
and (a)(1) to read as follows:

Sec.  117.264  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw an exemption applicable to a
qualified facility under Sec.  117.5(a), you must:
    (1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, the Director of the Office of Compliance in the Center for
Food Safety and Applied Nutrition), at the mailing address, email
address, or facsimile number identified in the order within 10 calendar
days of the date of receipt of the order;
* * * * *
0
15. Amend Sec.  117.267 by revising paragraph (a) to read as follows:

Sec.  117.267  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with
your written appeal submitted in accordance with Sec.  117.264 within
10 calendar days of the date of receipt of the order.
* * * * *
0
16. Add Sec.  117.287 to subpart E to read as follows:

Sec.  117.287  Reinstatement of an exemption that was withdrawn.

    (a) If the FDA District Director in whose district your facility is
located (or, in the case of a foreign facility, the Director of the
Office of Compliance in the Center for Food Safety and Applied
Nutrition) determines that a facility has adequately resolved problems
with the conditions and conduct that are material to the safety of the
food manufactured, processed, packed, or held at the facility and that
continued withdrawal of the exemption is not necessary to protect
public health and prevent or mitigate a foodborne illness outbreak, the
FDA District Director in whose district your facility is located (or,
in the case of a foreign facility, the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition) will,
on his own initiative or on the request of a facility, reinstate the
exemption.
    (b) You may ask FDA to reinstate an exemption that has been
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in
whose district your facility is located (or, in the case of a foreign
facility, the Director of the Office of Compliance in the Center for
Food Safety and Applied Nutrition); and
    (2) Present data and information to demonstrate that you have
adequately resolved the problems with the conditions or conduct that
are material to the safety of the food manufactured, processed, packed,
or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public health and prevent or
mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec.  117.251(a)(1) and
FDA later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will reinstate your exemption under Sec.  117.5(a),
and FDA will notify you in writing that your exempt status has been
reinstated.
    (d) If your exemption was withdrawn under both Sec.  117.251(a)(1)
and (2) and FDA later determines, after finishing the active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to your facility, FDA will inform you of this finding,
and you may ask FDA to reinstate your exemption under Sec.  117.5(a) in
accordance with the requirements of paragraph (b) of this section.
0
17. Amend Sec.  117.305 by revising paragraph (b) to read as follows:

Sec.  117.305  General requirements applying to records.

* * * * *
    (b) Contain the actual values and observations obtained during
monitoring and, as appropriate, during verification activities;
* * * * *
0
18. Add Sec.  117.330 to subpart F to read as follows:

Sec.  117.330  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with
other Federal, State, or local regulations, or for any other reason) do
not need to be duplicated if they contain all of the required
information and satisfy the requirements of this subpart F. Existing
records may be supplemented as necessary to include all of the required
information and satisfy the requirements of this subpart F.
    (b) The information required by this part does not need to be kept
in one set of records. If existing records contain some of the required
information, any new information required by this part may be kept
either separately or combined with the existing records.

    Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.

    Note: The following appendix will not appear in the Code of
Federal Regulations.

Appendix

    The proposed rule that is the subject of this document includes
a discussion of our reconsideration of the classification of
specific activities as harvesting, packing, holding, or
manufacturing/processing, when conducted on farms or on farm mixed-
type facilities (see the discussion of the proposed additional
example of a harvesting activity in the definition of ``harvesting''
in section V.C and the discussion and Table 5 in section VII.C).
Table 1 in this Appendix compares the classification of on-farm
activities as harvesting, packing, holding, or manufacturing/
processing in the 2013 proposed preventive controls rule to our
current thinking on the classification of these on-farm activities
as a result of the proposed revisions to the ``farm'' definition. As
can be seen in Table 1, several on-farm activities can be classified
in more than one way, and most of the changes in activity
classification merely reflect additional activities (relative to the
2013 proposed preventive controls rule) that could be classified in
more than one way.

             Table 1--Classification of Activities Conducted On-Farms and Farm Mixed-Type Facilities
----------------------------------------------------------------------------------------------------------------
                                                                                Examples using the proposed
            Classification                Examples using the 2013 proposed        revisions to the ``farm''
                                               ``farm'' definition *                      definition
----------------------------------------------------------------------------------------------------------------
Harvesting: Activities traditionally     Cooling RACs.                Cooling RACs.
 performed by farms for the purpose of   Fermenting cocoa beans and   Field coring RACs ** (new
 removing RACs from growing areas and    coffee beans ** (would change to     example, not previously
 preparing them for use as food.         ``holding'').                        classified).
 Harvesting does not include             Filtering RACs.              Filtering RACs.
 activities that change a RAC into       Gathering RACs.              Gathering RACs.
 processed food.                         Removing stems and husks     Removing stems and husks
                                         from RACs.                           from RACs.
                                         Shelling RACs.               Shelling RACs.
                                         Sifting RACs.                Sifting RACs.
                                         Threshing RACs.              Threshing RACs.
                                         Trimming of outer leaves     Trimming outer leaves from
                                         from RACs.                           RACs.
                                         Using pesticides in wash     Using pesticides in wash
                                         water on RACs.                       water on RACs.
                                         Washing RACs.                Washing RACs.
Packing: Placing food in a container     Coating RACs with wax/oil/   Coating RACs with wax/oil/
 other than packaging the food and       resin for the purpose of storage     resin for the purpose of storage
 activities performed incidental to      or transport.                        or transport.
 packing a food (e.g., activities        Drying RACs for the          Cooling RACs ** (add'l
 performed for the safe or effective     purpose of storage or transport **   classification) ***.
 packing of that food (such as           (would change to only be             Filtering RACs ** (add'l
 sorting, culling and grading)), but     classified as ``holding'').          classification).
 does not include activities that        Labeling RACs.               Labeling RACs.
 transform a RAC into a processed food.  Mixing RACs.                 Mixing RACs.
                                         Packaging a farm's or farm   Packaging RACs regardless
                                         mixed-type facility's own RACs **    of ownership ** (expanded to
                                         (would no longer be limited to       include others' RACs).
                                         ``own RACs'').                       Putting RACs or individual
                                         Putting RACs or individual   unit cartons into non-consumer
                                         unit cartons into non-consumer       containers.
                                         containers.                          Removing stems and husks
                                         Sorting/grading/culling      from RACs ** (add'l
                                         RACs.                                classification).
                                         Stickering RACs.             Sifting RACS ** (add'l
                                                                              classification).
                                                                              Sorting/culling/grading
                                                                              RACs.
                                                                              Stickering RACs.
                                                                              Using pesticides in wash
                                                                              water on RACs ** (add'l
                                                                              classification).
                                                                              Washing RACs ** (add'l
                                                                              classification).
Holding: Storage of food and             Drying/dehydrating RACs      Cooling RACs ** (add'l
 activities performed incidental to      during storage (incidental to        classification).
 storage of a food (e.g., activities     packing or storing when the drying/  Drying/dehydrating RACs
 performed for the safe or effective     dehydrating does not create a        (incidental to storing when the
 storage of that food, and activities    distinct commodity) ** (would no     drying/dehydrating does not create
 performed as a practical necessity      longer be incidental to packing,     a distinct commodity).
 for the distribution of that food       would only be incidental to          Fermenting cocoa beans and
 (such as blending of the same           holding).                            coffee beans (change from previous
 commodity and breaking down             Fumigating RACs during       classification as harvesting).
 pallets)). Holding does not include     storage.                             Fumigating RACs during
 activities that change a RAC into a     Sorting/culling/grading      storage to control pests.
 processed food.                         RACs.                                Sorting/culling/grading
                                         Storing food.                RACs.
                                                                              Storing food.

Manufacturing/Processing: Making food    Artificial ripening.         Artificial ripening.
 from one or more ingredients, or        Baking.                      Baking.
 synthesizing, preparing, treating,      Boiling/Evaporating.         Boiling/Evaporating.
 modifying, or manipulating food,        Bottling.                    Bottling.
 including food crops or ingredients.    Canning.                     Canning.
 Examples of manufacturing/processing    Chopping.                    Chopping.
 activities are cutting, peeling,        Coating RACs for purposes    Coating RACs for purposes
 trimming, washing, waxing,              other than storage/transport.        other than storage/transport.
 eviscerating, rendering, cooking,       Cooking.                     Cooking.
 baking, freezing, cooling,              Cooling.                     Cooling.
 pasteurizing, homogenizing, mixing,     Coring.                      Coring (except field
 formulating, bottling, milling,         Cracking.                    coring) ** (because field coring
 grinding, extracting juice,             Crushing.                    would be newly classified as
 distilling, labeling, or packaging.     Cutting.                     harvesting).
 For farms and farm mixed-type           Distilling.                  Cracking.
 facilities, manufacturing/processing    Drying/dehydrating RACS to   Crushing.
 does not include activities that are    create a distinct commodity.         Cutting.
 part of harvesting, packing, or         Eviscerating.                Distilling.
 holding.                                Extracting.                  Drying/dehydrating RACs to
                                         Formulating.                 create a distinct commodity.
                                         Freezing.                    Eviscerating.
                                         Grinding.                    Extracting.
                                         Homogenizing.                Formulating.
                                         Infusing.                    Freezing.
                                         Irradiating.                 Grinding.
                                         Labeling (other than         Homogenizing.
                                         RACs).                               Infusing.
                                         Milling.                     Irradiating.
                                         Mixing.                      Labeling (other than
                                         Packaging (other than        RACs).
                                         RACs).                               Milling.
                                         Pasteurizing.                Mixing.
                                         Peeling.                     Packaging (other than
                                         Rendering.                   RACs).
                                         Roasting.                    Pasteurizing.
                                         Salting.                     Peeling.
                                         Slaughtering and post-       Rendering.
                                         slaughter operations.                Roasting.
                                         Slicing.                     Salting.
                                         Smoking.                     Slaughtering and post-
                                         Sorting, culling, grading    slaughter operations.
                                         (not incidental to packing or        Slicing.
                                         holding).                            Smoking.
                                         Trimming.                    Sorting, culling, grading
                                         Washing.                     (not incidental to packing or
                                         Waxing.                      holding).
                                                                              Trimming.
                                                                              Washing.
                                                                              Waxing.
----------------------------------------------------------------------------------------------------------------
* Examples were included in Table 4, Table 5, and/or Proposed Sec.  Sec.   117.3 and 117.5(g) and (h) in the
  2013 Proposed Preventive Controls Rule and/or in the Draft Risk Assessment (Ref. 1).
** Activities listed in italics represent a change between the 2013 ``farm'' definition and our current thinking
  in light of the proposed revisions to the ``farm'' definition.
*** Add'l = additional.

    The following reference has 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.
This reference is also available electronically at http://www.regulatons.gov.
    1. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm,'' 2012.

[FR Doc. 2014-22446 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P