applicable to a farm under sections 415 and 418 of the FD&C Act. We
then articulated a comprehensive set of organizing principles that
formed the basis for proposed revisions to the section 415 registration
regulations. Because these definitions also are established in the
section 414 recordkeeping regulations, these organizing principles also
formed the basis for proposed revisions to definitions in the section
414 recordkeeping regulations.
    Our previous description (78 FR 3646 at 3675-3676) of the current
legal and regulatory framework that governs the determination of when
an establishment is required to register as a food facility in
accordance with the section 415 registration regulations focused on the
framework that governs whether an establishment that grows and harvests
crops or raises animals satisfies the definition of ``farm,'' because
the facility registration requirements of section 415 of the FD&C Act
do not apply to ``farms.'' Under that framework, a key factor in
whether an establishment falls within the definition of ``farm,'' even
with respect to crops it grows and harvests itself, is whether the
activities conducted by the establishment fall within definitions of
``harvesting,'' ``packing'' or ``holding'' (which are within the
``farm'' definition). Another key factor is whether activities
conducted by the establishment fall within the definition of
manufacturing/processing (which have been outside the ``farm''
definition).
    We previously described comments regarding proposed revisions to
the definitions of ``farm,'' ``harvesting,'' ``packing'' and
``holding,'' as well as comments regarding the triggers for an activity
to be considered manufacturing/processing (79 FR 58524 at 58530-58538).
In the 2014 supplemental human preventive controls notice, we proposed
additional revisions to the definitions of ``farm,'' ``harvesting,''
``packing,'' and ``holding'' to address these comments.
    Even after the revisions we proposed in the 2014 supplemental human
preventive controls notice, some comments assert that the overall
``farm'' definition still presents an unrealistic and incomplete
understanding of how most farms in the United States are structured
with regard to their physical location(s) and business models. Most of
the comments suggest alternative or additional regulatory text (see,
e.g., Comment 22, Comment 23, Comment 24, Comment 25, Comment 27,
Comment 37, Comment 39, and Comment 50) or ask us to clarify how we
will interpret the provisions (see, e.g., Comment 26, Comment 28,
Comment 29, Comment 40, Comment 41, Comment 42, Comment 43, Comment 44,
Comment 47, and Comment 48).
    As discussed in section I.A, there are several FSMA-required
regulations that provide the framework for industry's implementation of
preventive controls and enhance our ability to oversee their
implementation for both domestic and imported food (see the seven
foundational rules listed in table 1). Two of the proposed rules listed
in table 1 (i.e., the 2013 proposed animal preventive controls rule and
the 2013 proposed intentional adulteration rule) proposed to include a
cross-reference to the ``farm'' definition in Sec.  1.227, and a third
proposed rule (i.e., the 2013 proposed produce safety rule) proposed to
establish the same ``farm'' definition as would be in Sec.  1.227. A
fourth proposed rule (i.e., the 2013 proposed FSVP rule) did not
propose to establish the ``farm'' definition (or a cross-reference to
the ``farm'' definition in Sec.  1.227), but under its proposed
definition of ``foreign supplier'' some foreign suppliers would be
farms--i.e., establishments that harvest food that is exported to the
United States. As a result, we received comments relevant to the
``farm'' definition for all of these rules. The majority of the
comments submitted to these other rulemakings addressed issues that
were the same as, or similar to, the issues raised in the comments
submitted to this rulemaking. One comment submitted to the proposed
rulemaking for the forthcoming FSVP rule requested clarification
regarding harvesting companies, and we are also providing

that clarification in this rulemaking. See Response 32.
    We proposed to redesignate all definitions in Sec.  1.227 in the
section 415 registration regulations (i.e., current Sec.  1.227) to
eliminate paragraph designations (such as (a) and (b)). We received no
comments that disagreed with our proposed redesignations and are
finalizing them as proposed.
    We proposed several technical amendments and conforming changes to
the section 415 registration regulations and to the section 414
recordkeeping regulations. No comments opposed the proposed technical
amendments and conforming changes, except for comments noting that our
proposed technical amendment to Sec.  1.361 was unnecessary because we
had already made this change in a different rulemaking (see 77 FR
10662, February 23, 2012). We are finalizing these technical amendments
and conforming changes without change.
    In the following sections, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one
or more changes to, the proposed requirements. After considering these
comments, we have revised the proposed definitions as shown in table 4,
with editorial and conforming changes as shown in table 52. We also are
establishing a new provision to allow off-farm establishments that
package, pack, and hold RACs that are produce as will be defined in the
produce safety rule to comply with the CGMPs in part 117, subpart B by
complying with the applicable requirements for packing and holding that
will be established in the final produce safety rule (see Sec.  117.8
and Response 25). Because the new provision refers to provisions in a
future produce safety rule, we will publish a document in the Federal
Register announcing the effective date of Sec.  117.8 once we finalize
the produce safety rule.

    Table 4--Revisions to the Proposed Definitions in the Section 415
 Registration Regulations and the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
                  Definition                            Revision
------------------------------------------------------------------------
Farm.........................................   A farm is an
                                                ``operation'' rather
                                                than an
                                                ``establishment.''
                                                There are two
                                                types of farms: (1)
                                                Primary production farm;
                                                and (2) secondary
                                                activities Farm.
Primary production farm......................   A primary
                                                production farm is
                                                ``under one management''
                                                rather than ``under one
                                                ownership.''
                                                Although a
                                                primary production farm
                                                continues to be ``in one
                                                general physical
                                                location,'' we have
                                                clarified that ``one
                                                general physical
                                                location'' is ``not
                                                necessarily
                                                contiguous.''
                                                A primary
                                                production farm is an
                                                operation devoted to the
                                                growing of crops, the
                                                harvesting of crops, the
                                                raising of animals
                                                (including seafood), or
                                                any combination of these
                                                activities. Although
                                                some primary production
                                                farms both grow and
                                                harvest crops, other
                                                primary production farms
                                                grow crops but do not
                                                harvest them, and other
                                                primary production farms
                                                harvest crops but do not
                                                grow them.
                                                Treatment to
                                                manipulate the ripening
                                                of RACs, and packaging
                                                and labeling the treated
                                                RACs, without additional
                                                manufacturing/
                                                processing, is within
                                                the ``farm'' definition.
                                                We added an
                                                example of drying/
                                                dehydrating RACs to
                                                create a distinct
                                                commodity that would
                                                fall within the ``farm''
                                                definition (i.e., drying/
                                                dehydrating grapes to
                                                produce raisins), as
                                                well as an example of
                                                additional manufacturing/
                                                processing that would
                                                cause an operation that
                                                dries/dehydrates RACs to
                                                create a distinct
                                                commodity to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                slicing).
                                                We added an
                                                example of additional
                                                manufacturing/processing
                                                that can cause an
                                                operation that packages
                                                and labels RACs to fall
                                                outside the ``farm''
                                                definition (i.e.,
                                                irradiation).
Secondary activities farm....................   A ``secondary
                                                activities farm'' is an
                                                operation, not located
                                                on a primary production
                                                farm, devoted to
                                                harvesting (such as
                                                hulling or shelling),
                                                packing, and/or holding
                                                of RACs, provided that
                                                the primary production
                                                farm(s) that grows,
                                                harvests, and/or raises
                                                the majority of the RACs
                                                harvested, packed, and/
                                                or held by the secondary
                                                activities farm owns, or
                                                jointly owns, a majority
                                                interest in the
                                                secondary activities
                                                farm.
                                                A secondary
                                                activities farm may also
                                                conduct those additional
                                                activities allowed on a
                                                primary production farm.
Harvesting...................................   We added
                                                additional examples of
                                                harvesting activities.
Holding......................................   We added
                                                additional examples of
                                                holding activities.
Manufacturing/Processing.....................   We added
                                                additional examples of
                                                manufacturing/processing
                                                activities.
------------------------------------------------------------------------

B. Proposed Revisions to the Definition of Farm

    We proposed to revise the ``farm'' definition to: (1) Provide for
on-farm packing and holding of RACs to remain within the farm
definition regardless of ownership of the RACs; (2) include, within the
``farm'' definition, a description of packing activities that include
packaging RACs grown or raised on a farm without additional
manufacturing/processing; and (3) provide for drying/dehydrating RACs
to create a distinct commodity (such as the on-farm drying of grapes to
produce raisins), and packaging and labeling such commodities, without
additional manufacturing/processing, to remain within the farm
definition. We also requested comment on whether we should retain,
remove, or modify the phrase ``in one general physical location'' in
the ``farm'' definition.
    (Comment 21) Most of the comments support our proposed revision to
provide for on-farm packing and holding of RACs to remain within the
farm definition regardless of ownership of the RACs. However, some
comments oppose this proposed revision. Some comments ask us to require
that a farm that packs, packs and sells, commingles lots, and holds
produce grown on a farm under different ownership comply with the
requirements of this rule for hazard analysis and risk-based preventive
controls for six reasons: (1) Commingling. Contamination from one farm
could find its way to another farm, leading to potential contamination
of products from both farms, making it difficult to pinpoint the source
of contamination in the event of a recall. (2) Recall Plan. It is
critical for everyone in the produce supply chain to be ``recall
ready,'' especially those packing, commingling lots, and selling
produce grown on another farm under different ownership. (3)
Traceability. It is important that produce be traceable from the
specific farm where it was grown to the end-user, and from the end-user
back to the farm where it was grown. (4) Exemptions. A covered farmer
packing, packing and selling, commingling lots, or holding others'
produce might be doing so from a farm that is exempt from the produce
safety rule. (5) Supplier program. Under the

human preventive controls rule a farmer would be required to have a
valid supplier program. (We note that a farmer might be a supplier to a
facility that is subject to the human preventive controls rule, and
could be subject to the facility's supplier program, but would not
itself be required to ``have a valid supplier program.'') With this
requirement, receiving facilities could purchase in confidence knowing
that if the farm did pack others' produce it was produced in accordance
with the rules required by FSMA. (6) Conflict with the National Organic
Program (NOP). Under the NOP, a grower that purchases produce from
another farm under different ownership, packs produce from another
farm, or mixes produce is no longer considered a crop producer and must
seek certification as a handler--an operation that has additional
requirements to approve suppliers, segregate product, and maintain
records necessary to demonstrate compliance. Comments assert that this
NOP requirement is logical and is a practice that FDA should take into
consideration.
    Other comments assert that allowing a farm to pack produce from
another farm must account for the problem created by our proposal to
exempt farm vehicles transporting RACs from the sanitary transportation
rule. These comments argue that unless we revise that rule to prevent
possible contamination during transport, we should develop guidance for
farms packing produce that is transported from another farm,
particularly where the commodity is high risk.
    (Response 21) The final ``farm'' definition continues to provide
for on-farm packing and holding of RACs to remain within the farm
definition regardless of ownership of the RACs. We have acknowledged
that doing so would have consequences such as those described in these
comments, as well as other consequences (see 79 FR 58524 at 58532).
Although comments pointed out consequences that we had already
considered, they did not point to any other consequences. Therefore, we
affirm our tentative conclusion that impacts such as these, while not
always optimal, are necessary to establish a sensible framework of
risk-based regulations that both implement FSMA and reflect common farm
activities. We intend to issue the final produce safety rule in the
near future and respond to comments related to traceability of produce,
including whether to include a requirement that a farm supplying
produce to another farm that will pack or hold that produce should
provide to the farm that receives the produce its name, complete
business address, and description of the produce in any individual
shipment, as well as respond to comments on whether it would be
appropriate to also require the farm that receives the shipment
maintain such record of information and, if so, for what specified
period of time.
    In the 2014 proposed sanitary transportation rule, we explained our
reasons for tentatively concluding that the sanitary transportation
practices that would be required by that proposed rule are not
necessary to prevent RACs from becoming adulterated during
transportation by farms (79 FR 7006 at 7016, February 5, 2014). For
example, we explained that we are not aware of instances in which
insanitary conditions (e.g., improper temperature control, improper
equipment construction, inadequate equipment cleaning) with regard to
transportation operations conducted by farms involving the
transportation of RACs have contributed to foodborne illness,
regardless of whether the farms are conducting transportation
operations for their own RACs or for others' RACs. We will consider
comments we receive on our proposal to exempt farm vehicles
transporting RACs from the sanitary transportation rule when we issue a
final sanitary transportation rule. We will consider necessary guidance
in light of the final sanitary transportation rule, but we note that
good transportation practices are already included in our 1998 guidance
for industry entitled ``Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruits and Vegetables'' (Ref. 13).
    (Comment 22) Some comments assert that farms are neither facilities
nor establishments. These comments ask us to revise the ``farm''
definition to use a term more suited to the nature of farming.
    (Response 22) We consider a farm to be a type of ``establishment''
but have nonetheless revised the ``farm'' definition to refer to an
``operation'' rather than an ``establishment'' as requested by these
comments.
    (Comment 23) Many comments address the role of ``ownership'' in the
``farm'' definition. Some of these comments emphasize that farming
operations are complex, with complex business structures, and are often
not held under sole ownership. Some comments describe the role of
multiple business models (such as cooperatives, on-farm packinghouses
under ownership by multiple growers, food aggregators, and food hubs)
in modern farming and ask us to revise the ``farm'' definition to
provide for such business models. Other comments emphasize ownership of
the land on which crops are grown or animals are raised, noting that
some farms are operated by ``tenant'' farmers who do not own the land
used in the farm's operations. Some comments ask us to replace the
concept of ownership with the concept of a responsible party, such as a
``farm operator'' and to define a farm operator as ``the person or
entity that has operational control over the farm and benefits in whole
or in part from the farm's normal operation. A farm operator may be an
owner, a tenant, a partner, or an employee.''
    Some comments ask us to remove the phrase ``under one ownership''
to allow sugar makers who share equipment and sugarhouses to qualify as
a farm. Other comments ask us to clarify how renting or leasing storage
rooms or facilities would affect the definition of a farm.
    (Response 23) We have revised the ``farm'' definition by replacing
the phrase ``under one ownership'' with the phrase ``under one
management.'' Although the original phrase ``under one ownership'' was
not referring to a single owner, we agree that the ``farm'' definition
should reflect modern business models (such as cooperatives, on-farm
packinghouses under ownership by multiple growers, food aggregators,
and food hubs) and use language that the modern farming community
understands. We decline the request to define and introduce a new term,
such as ``farm operator.'' The term ``management'' has a common meaning
that captures the request of these comments and is suitable for the
purposes of the farm definition. (Management. The person or persons
controlling and directing the affairs of a business, institution, etc.)
(Ref. 14).
    Under either the previous or the revised ``farm'' definition,
leasing land to grow or store crops or raise animals does not impact
whether an operation is within the ``farm'' definition. Under the
previous definition, ``ownership'' focused on ownership of the business
entity conducting farm operations, not ownership of the land. Leasing
land is a business practice common to a variety of business types, not
just farms. Likewise, leasing buildings to store RACs does not impact
whether an operation is within the ``farm'' definition. See also
Response 24 regarding comments on ``one general physical location.''
    To the extent that sugar makers who share equipment and sugarhouses
only conduct activities that are within the ``farm'' definition, the
revision from ``under one ownership'' to ``under one management''
should clarify that those operations would be within the ``farm''

definition. However, when sugar makers conduct operations outside the
``farm'' definition, they are facilities that are required to register
under the section 415 registration regulations, not ``farms'' that are
exempt from that registration requirement. A sugar maker that is a
small or very small farm mixed-type facility that only conducts the
low-risk activity/food combinations listed in the exemptions in Sec.
117.5(g) and (h) (such as making syrup and sugar (e.g., making maple
syrup from maple sap)) is exempt from the requirements of this rule.
However, a farm mixed-type facility that is not a small or very small
business as those terms are defined in this rule, or that conducts
activities in addition to the low-risk activity/food combinations
listed in the exemptions in Sec.  117.5(g) and (h), is subject to the
requirements for hazard analysis and risk-based preventive controls.
Consistent with the discussion in Response 228, a farm mixed-type
facility that must comply with the requirements for hazard analysis and
risk-based preventive controls and makes sugar from sugarcane or sugar
beets can consider the findings of the section 103(c)(1)(C) RA (i.e.,
that this is a low-risk activity/food combination) in determining
whether there are any hazards requiring a preventive control. A
facility that appropriately determines through its hazard analysis that
there are no hazards requiring preventive controls would document that
determination in its written hazard analysis but would not need to
establish preventive controls and associated management components. For
additional information about the section 103(c)(1)(C) RA and the
exemptions for on-farm low-risk activity/food combinations for farm
mixed-type facilities that are small or very small businesses, see
sections VI and XI.G.
    (Comment 24) Many comments address the role of ``one general
physical location'' in the ``farm'' definition and ask us to revise the
``farm'' definition to acknowledge that farms may be composed of
multiple parcels, buildings, or structures that may or may not be
contiguous. Some comments point out that there are many farming
operations that may fall under the same management and ownership, but
are separated by either a strip of land, body of water, or another
structure, particularly with respect to sites designated for packing
and holding operations. Some comments assert that as long as an
economic unit is operating a farm it should be irrelevant where the
land is located, and state that this interpretation is consistent with
a USDA definition of a ``farm operator.'' Some comments note that sugar
makers rely on sap from existing stands of trees that are often not
concentrated in a single area or even nearby the sugarhouse where the
maple products are made. Some comments suggest that the term
``reasonable distance'' could be used to better define ``general
physical location.'' Some comments ask us to issue guidance that will
clarify and further designate the boundaries of ``one general physical
location.''
    Some comments note that the ``farm'' definition we proposed in the
2014 supplemental human preventive controls notice correctly considers
a farm operation to remain within the ``farm'' definition even if it
packs and holds produce from another farm. However, these comments
state that it is confusing that if the same two farms pack and hold
produce together at an off-farm location, using the exact same
practices, that packing location is considered a ``facility'' even
though there is no difference in risk. Other comments state that both
in-line and off-line egg production facilities should be considered
farms. According to these comments, off-line egg production facilities
receive eggs laid by hens at nearby farms, whereas in-line egg
production facilities receive eggs laid by hens in henhouses adjacent
to the plant and located on the same property.
    Some comments ask us to retain ``one general physical location'' in
the ``farm'' definition because the word ``farm,'' and USDA's
definition of ``farm,' are ``place-based.'' Other comments assert that
if we delete the phrase ``in one general physical location'' then a
fully integrated operation could be a single farm even though it was
made up of numerous distinct farms possibly in several different
states. Other comments ask us to retain ``one general physical
location'' in the ``farm'' definition because different locations may
have different food safety risks, different water sources, different
personnel, and even different types of crops. Some comments assert that
considering each unique and individually State-permitted dairy farm to
be an individual ``farm'' regardless of common ownership or geographic
proximity will prevent conflict and interference with the permitting
and inspection activities of the Grade ``A'' program while maintaining
food safety. Other comments state that regardless of whether we retain
``one general physical location'' in the ``farm'' definition, we must
interpret the term ``farm'' to cover a very limited geographic area and
that separate locations that are not in close proximity to each other
should not be considered the same ``farm.''
    (Response 24) We have revised the ``farm'' definition to specify
that a farm is ``in one general (but not necessarily contiguous)
physical location.'' We have concluded that adding ``not necessarily
contiguous'' makes it clear that farming operations that are under one
management but have some physical separation (e.g., with respect to the
location of packing operations) can remain within the ``farm''
definition and that both in-line and off-line egg production facilities
would be considered ``farms.''
    We agree that separate locations that are not in close proximity to
each other should not be considered the same ``farm.'' As the comments
point out, there already is a framework of State inspections for farms
such as dairy farms, and we will need to work with our State regulatory
partners to identify farms covered by the produce safety rule. However,
even without the new phrase ``not necessarily contiguous,'' some
situations would be complex. We intend to address these types of
situations with our State food safety partners. (See Response 5.)
    We do not see that adding ``not necessarily contiguous'' creates a
``farm'' definition that is not ``place-based,'' as was asserted by
some comments, because the definition continues to specify ``in one
general physical location.'' We also do not see that adding ``not
necessarily contiguous'' presents any food safety concerns, as asserted
by comments noting that different locations may have different food
safety risks, different water sources, different personnel, and
different types of crops. For example, a farm that will be covered by
the forthcoming produce safety rule will be subject to standards for
all of its water sources, all of its personnel, and all food subject to
that rule. Likewise, we also do not believe that adding ``not
necessarily contiguous'' affects a determination of whether a fully
integrated operation could be a single farm.
    (Comment 25) Some comments ask us to consider revising the
regulatory text to ensure that similar activities would be treated the
same way under either the produce safety rule or the human preventive
controls rule and be held to the same risk-based requirements. These
comments point out some of the differences between the requirements
that would be established under the proposed human preventive controls
rule and the requirements that would be established under the proposed
produce safety rule. For example, comments state that the proposed
human

preventive controls rule, but not the proposed produce safety rule,
would require off-farm packinghouses and off-farm cooling and storage
facilities to have a written hazard analysis; written preventive
controls; written procedures for monitoring and corrective actions;
validation of process controls; a written recall plan; environmental
monitoring and product testing requirements; and a written supplier
program. As another example, comments state that off-farm packing and
holding operations would be required to comply with the human
preventive controls rule one year earlier than we proposed that similar
sized on-farm packing and holding operations would be required to
comply with the forthcoming produce safety rule.
    Some comments recommend options to achieve the goal of regulating
on-farm and off-farm packinghouses the same way. These options include
adding an exclusion to the ``farm'' definition in the produce safety
rule; adding provisions to the human preventive controls rule to enable
off-farm packinghouses to meet their obligation by complying with
specified, applicable subparts of the produce safety rule; shortening
the ``farm'' definition to simply state ``Farm means an establishment
under one ownership devoted to the growing and/or harvesting of crops,
the raising of animals (including seafood), or any or all of these
activities;'' addressing off-farm establishments engaged solely in
``low-risk'' farming and harvesting activities by adding low-risk
activities such as hulling, shelling, and drying of tree nuts;
expanding the scope of the produce safety rule to include registered
facilities; and allowing modified requirements in the human preventive
controls rule to allow off-farm packinghouses to be subject to
requirements (and exemptions) of the produce safety rule within the
framework of the human preventive controls rule.
    Some comments emphasize that farm activities are farm activities,
regardless of where they happen. Some comments assert that
establishments that are engaged solely in traditional harvesting,
holding, or packing activities associated with a RAC that will be
covered by the produce safety rule should be subject to the produce
safety rule, rather than the human preventive controls rule, regardless
of physical location, ownership, or legal ties to an operation devoted
to the growing and harvesting of produce. Some comments assert that an
off-farm operation that packs and holds RACs could be regulated in an
identical fashion to an on-farm operation that packs and holds RACs
without changing the section 415 requirement for registration by making
them subject to the requirements of the produce safety rule for
compliance purposes. Some comments ask us to provide an exemption from,
or waiver for, the requirements of the human preventive controls rule
if a business entity provides documentation that the entity is
following the standards of the produce safety rule even though it is
not on a farm. Other comments ask us to clarify that a farm can pack or
hold RACs that have already undergone packing or holding activities by
another farm.
    Some comments ask to revise the ``farm'' definition to include
establishments solely engaged in ``packing'' and ``holding'' activities
performed on RACs, regardless of whether the establishment grows crops.
Other comments emphasize that any revisions to the ``farm'' definition
must allow genuine farm operators to carry out harvesting, packing, and
holding without opening loopholes for packing and processing
businesses. Some comments ask us to revise the ``farm'' definition to
provide for a multi-ownership operation provided that all of the
partial owners are themselves farmers.
    Some comments ask us to provide that off-farm packing and holding
operations that do not change the status of a RAC into a processed food
should be able to comply with either the produce safety rule or with
the CGMPs in subpart B of the human preventive controls rule. According
to these comments, we could simply apply the same logic that we applied
when providing that the packing and holding of RACs that have been
dried/dehydrated to create a distinct commodity that is a processed
food (i.e., no longer a RAC) may achieve compliance with the CGMP
requirements by complying either with subpart B of the human preventive
controls rule or by complying with the applicable requirements for
packing and holding produce RACs in the produce safety rule (see Sec.
117.5(k)(2)).
    (Response 25) We have revised the ``farm'' definition to provide
for two types of farms: (1) A primary production farm and (2) a
secondary activities farm (see Sec.  117.3). We use the term ``primary
production farm'' to refer to the ``farm'' definition as proposed, with
the revisions described in this final rule. We use the term ``secondary
activities farm'' to mean an operation, not located on a primary
production farm, devoted to harvesting (such as hulling or shelling),
packing, and/or holding of RACs, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the RACs
harvested, packed, and/or held by the secondary activities farm owns,
or jointly owns, a majority interest in the secondary activities farm.
A secondary activities farm may also conduct those additional
activities allowed on a primary production farm. With the added
definition of ``secondary activities farm,'' off-farm packinghouses
that are managed by a business entity (such as a cooperative) that is
different from the business entity growing crops (such as individual
farms) can be within the ``farm'' definition. We are making these
changes to reflect the current reality of what it means to be a farm.
The changes will allow farms that use certain business models to
harvest, pack, and/or hold produce to be able to comply with the
produce safety rule for all of their operations. We believe that this
flexibility allows for the requirements of the produce safety rule to
apply to a wider array of activities than our original proposal without
opening the ``farm'' definition to operations that have no connection
to the growing of crops or the raising of animals--the core activities
of a farm. By specifying that the farms that grow or raise the majority
of the RACs harvested, packed, and/or held by the operation must own,
or jointly own, a majority interest in the secondary activities farm,
the revised ``farm'' definition does, as requested by comments, allow
``farms'' to carry out harvesting, packing, and holding activities in
the same way as the produce safety rule.
    We are, as requested by some comments, establishing a new provision
to allow off-farm establishments that package, pack, and hold RACs that
are produce as will be defined in the produce safety rule to comply
with the CGMPs in part 117, subpart B by complying with the applicable
requirements for packing and holding that will be established in the
final produce safety rule (see Sec.  117.8). Because the new provision
refers to provisions in a future produce safety rule, we will publish a
document in the Federal Register announcing the effective date of that
provision once we finalize the produce safety rule.
    However, the revised ``farm'' definition does not, as requested by
some comments, establish the exact same regulatory framework for
operations, such as certain packinghouses and hulling/shelling
operations, that are within the ``farm'' definition as for operations
that conduct similar activities but are outside the ``farm'' definition
by allowing off-farm operations to be subject to the produce

safety rule rather than the requirements for hazard analysis and risk-
based preventive controls. We disagree that the statutory framework
provides flexibility for entities such as packinghouses and hulling/
shelling operations that do not have a connection to a farm to be
subject to the requirements of the produce safety rule for compliance
purposes. (See the discussion at 79 FR 58524 at 58536.) We continue to
believe that an off-farm packinghouse that is subject to this rule will
be able to draw from the provisions of the produce safety rule in
developing its food safety plan and establishing preventive control
management components that are appropriate in light of the nature of
the preventive controls and their role in the facility's food safety
system. For example, as previously discussed (79 FR 58524 at 58536) we
expect that the food safety plan for an off-farm packinghouse would
focus on a few key preventive controls, including some that would have
counterparts in the proposed produce safety rule, such as maintaining
and monitoring the temperature of water used during packing (which
would have counterparts under proposed Sec.  112.46(c) in the proposed
produce safety rule). We also expect that an off-farm packinghouse
would establish sanitation controls to address the cleanliness of food-
contact surfaces (including food-contact surfaces of utensils and
equipment) and the prevention of cross-contamination from insanitary
objects and from personnel to food, food-packaging material, and other
food-contact surfaces. On-farm packinghouses would be subject to
similar, but not identical, requirements (see e.g., proposed Sec.
112.111(b) for cleanliness of food-contact surfaces and proposed Sec.
112.113 for protection against contamination).
    We acknowledge that some of the provisions of the human preventive
controls rule have no explicit counterparts in the proposed produce
safety rule (e.g., the requirements for product testing and
environmental monitoring as verification activities). As discussed in
Response 525, we do not expect either product testing or environmental
monitoring to be common in facilities that process, pack, or hold
produce RACs.
    Finally, in response to comments that ask for a clarification that
a farm can pack or hold RACs that have already undergone packing or
holding activities by another farm, we presume that the commenter was
asking about a case where the farm that did the previous packing and
holding activities was not the farm on which the RACs were grown and
harvested. The definition of ``farm'' allows packing and holding of
one's own RACs and other's RACs, even if they have been previously
packed or held by another farm that was not the farm on which the RACs
were grown and harvested.
    (Comment 26) Some comments ask us to clarify whether the ``and''
between provisions that allow a farm to dry/dehydrate RACs to create a
distinct commodity, and provisions that allow a farm to package and
label RACs, means that an operation must do both of these activities to
remain within the farm definition. These comments state that they do
not think this is the intended (or logical) outcome, which is to
provide that farms can do either or both activities and still be within
the farm definition and ask us to consider editorial changes (such as
replacing ``and'' with ``or,'' or adding a new paragraph that would
encompass both activities).
    (Response 26) The rule does not require a farm to do both
activities (i.e., drying/dehydrating RACs to create a distinct
commodity, and packaging and labeling RACs) to remain within the farm
definition.
    (Comment 27) Some comments ask us to add artificial ripening of
RACs as an activity that is within the farm definition. Some comments
assert that artificial ripening of RACs is not manufacturing/processing
because artificial ripening does not transform a RAC into a processed
food.
    (Response 27) We have revised the ``farm'' definition to specify
that treatment to manipulate the ripening of RACs (such as by treating
produce with ethylene gas), and packaging and labeling the treated
RACs, without additional manufacturing/processing, are within the
``farm'' definition. We agree that a treatment such as artificial
ripening does not transform a RAC into a processed food but disagree
that such a treatment is not manufacturing/processing. To make that
clearer, we have added ``treating to manipulate ripening'' to the list
of examples of manufacturing/processing in the definition of that term.
As discussed during the rulemaking to establish the section 415
registration regulations, artificial ripening constitutes
manufacturing/processing because it involves treating, modifying, or
manipulating food (68 FR 58894 at 58912, October 10, 2003). See also
our previous statements about artificial ripening in this rulemaking
(78 FR 3646 at 3683 and 79 FR 58524 at 58572).
    As previously discussed, the activities that transform a RAC into a
processed food (and are sometimes therefore referred to as
``processing'' in the context of a food's status as a RAC or processed
food) are not coextensive with the activities described in our
definition of ``manufacturing/processing'' (78 FR 3646 at 3679). When
we first established the section 415 registration regulations, a key
criterion in determining whether a business entity was a ``farm'' or a
``facility'' was whether the operation conducted activities classified
as ``manufacturing/processing.'' Indeed, in the 2013 proposed
preventive controls rule we continued to rely on that key criterion in
proposing revisions to the ``farm'' definition. However, as already
discussed, some changes to the ``farm'' definition are necessary to
establish a sensible framework of risk-based regulations that both
implement FSMA and reflect common farm activities (see Response 21).
One of these changes is to specify those manufacturing/processing
activities that are within the ``farm'' definition, rather than attempt
to re-classify an activity that arguably is manufacturing/processing as
harvesting, packing, or holding in order to provide for the activity to
remain within the ``farm'' definition.
    (Comment 28) Some comments disagree that we should provide for
drying/dehydrating RACs to create a distinct commodity to be within the
``farm'' definition because this activity is a manufacturing/processing
activity and should be subject to the requirements for hazard analysis
and risk-based preventive controls. Other comments agree that we should
provide for this activity but assert that ``drying/dehydrating RACs to
create a distinct commodity'' is confusing to the average reader and
ask us to add examples of what this means. Some comments ask us to
clarify whether this activity applies to specific situations, such as
drying/baling of hops (because hops are a low-risk product and beer
brewing should eliminate any pathogens on the hops), drying plums to
create prunes, and concentrating maple sap into maple syrup, cream, and
candy. Some comments assert that maple syrup should be considered a RAC
because the process of producing maple syrup mirrors the regulatory
text ``drying/dehydrating RACs to create a distinct commodity,''
because maple syrup can only be produced through the concentration of
maple sap and the process of that concentration is akin to the
harvesting of other raw products. Other comments assert that the
processing of sap is more appropriately viewed as a harvesting activity
(rather than food manufacturing).

    Other comments ask us to clarify the specific methods of drying/
dehydrating that we would consider to be within the ``farm''
definition--e.g., whether drying/dehydrating is constrained to in situ,
with no heat or mechanical air circulation, because the example we
discussed in the 2014 supplemental preventive controls notice was
``natural condition raisins.'' These comments ask us to specify the
allowable methods of drying to avoid confusion, and assert that there
is no food safety reason to exclude use of heat or air, especially if
sun and light are to be permitted. Other comments ask us to clarify
what we mean by ``without additional manufacturing/processing.''
    (Response 28) We are retaining drying/dehydrating RACs to create a
distinct commodity as an activity that is within the ``farm''
definition even though it is manufacturing/processing. As previously
discussed, the processes (described in comments to the 2013 proposed
human preventive controls rule) for drying grapes to ``natural
condition raisins'' are akin to other harvesting activities
traditionally conducted by farms on RACs grown and harvested on farms,
because they are traditionally performed by farms for the purpose of
removing RACs from the place they were grown or raised and preparing
them for use as food (79 FR 58524 at 58533). As also previously
discussed, the information provided by the comments to the 2013
proposed human preventive controls rule included information that
``natural condition raisins'' are produced with either sun-drying or
artificial dehydration (79 FR 58524 at 58533). We did not intend to
limit the processes for drying/dehydrating RACs to sun-drying, and the
regulatory text includes no such limitation. We decline the request to
specify specific methods of drying/dehydrating that would remain within
the ``farm'' definition because doing so could imply that the list of
methods was exhaustive and preclude use of new technology in the
future.
    However, we are adding ``boiling'' and ``evaporating'' to the list
of activities that we classify as manufacturing/processing to preclude
interpretations, such as those expressed in some of these comments,
that the processes to produce products such as maple syrup, maple
cream, and maple candy are ``drying/dehydrating.'' In the 2013 proposed
human preventive controls rule we included ``Boiling/evaporation of
maple sap to make maple syrup'' as a low-risk manufacturing/processing
activity/food combination in the exemption for small and very small
businesses that only conduct specified on-farm low-risk activity/food
combinations (proposed Sec.  117.5(h)), and we have retained--and
broadened--that activity/food combination as an on-farm, low-risk
manufacturing/processing activity/food combination in the final human
preventive controls rule (see Sec.  117.5(h), which includes making
sugar and syrup from fruits and vegetables (e.g., dates), grains (e.g.,
rice, sorghum), other grain products (e.g., malted grains such as
barley), saps (e.g., agave, birch, maple, palm), sugar beets, and
sugarcane). Processes such as ``boiling,'' ``concentrating,'' and
``evaporating'' are not ``drying/dehydrating'' as the term ``drying/
dehydrating'' is used in this rule, and maple syrup is a processed
food, not a RAC. See also the discussion in Response 23 regarding how a
farm mixed-type facility that makes sugar from sugarcane or sugar beets
can consider the findings of the section 103(c)(1)(C) RA (i.e., that
this is a low-risk activity/food combination) in determining whether
there are any hazards requiring a preventive control. A farm mixed-type
facility that makes maple products from maple sap could follow the same
approach.
    We have added ``slicing'' to the regulatory text as an example of
additional manufacturing/processing that would be outside the ``farm''
definition. We also have added ``drying/dehydrating grapes to produce
raisins'' to the regulatory text as an example of what we mean by
``drying/dehydrating RACs to create a distinct commodity.'' Drying
plums to produce prunes is another example of drying/dehydrating RACs
to create a distinct commodity. Drying/baling hops is within the
``farm'' definition, but as a ``holding'' activity because drying/
baling hops does not create a distinct commodity. As discussed in
Response 39, we have revised the definition of ``holding'' to add
drying/dehydrating RACs when the drying/dehydrating does not create a
distinct commodity (such as drying/dehydrating hay or alfalfa) as an
example of a holding activity.
    (Comment 29) Some comments agree that the activities of packaging
and labeling RACs should remain within the ``farm'' definition but ask
us to reclassify these activities so that they are not considered
manufacturing/processing because they do not transform a RAC into a
processed food or change the nature of the RAC. These comments ask us
to add examples to regulatory text to explain what we mean by
``packaging and labeling without additional manufacturing/processing.''
As an example, these comments ask whether a farm that packs produce
grown by another farm, and washes the produce before packing it, would
be conducting ``additional manufacturing/processing.''
    Other comments ask us to clarify whether packaged RACs are
processed food because ``packaging'' is defined as a manufacturing/
processing operation. These comments also ask us to clarify whether a
farm would be precluded from holding RACs packaged in retail form
because the packaged RACs are processed food.
    (Response 29) See Response 27. We decline the request to reclassify
packaging and labeling so that they would not be considered
manufacturing/processing. Although we classify packaging and labeling
as manufacturing/processing, packaging and labeling RACs do not
transform the RACs into processed food, and we classify ``packaged
RACs'' as RACs.
    We classify washing RACs as a harvesting or packing activity when
done on RACs before or during packing or packaging, regardless of
whether a farm is packing or packaging its own RACs or others' RACs. As
requested by the comments, we have added an example of additional
manufacturing/processing that would not be within the ``farm''
definition--i.e., irradiating--to both the ``farm definition'' and to
the definition of ``manufacturing/processing.'' This example is
different from the example we used in the preamble of the 2014
supplemental human preventive controls notice to describe a limitation
on activities within the ``farm definition''--i.e., ``modified
atmosphere packaging'' (see 79 FR 58524 at 58532). We have decided to
not restrict the specific types of packaging procedures that are within
the ``farm'' definition because doing so could be confusing. Moreover,
the specific safety concern that can be associated with modified
atmosphere packaging (i.e., the production of Clostridium botulinum
toxin), would be addressed by a proposed provision in the forthcoming
produce safety rule, if that provision is finalized (see proposed Sec.
112.115; 78 FR 3504 at 3589 and 3638). To clarify that ``modified
atmosphere packaging'' is a type of ``packaging,'' we have revised the
definition of ``manufacturing/processing'' to specify ``packaging
(including modified atmosphere packaging)'' as an example of a
manufacturing/processing activity.
    (Comment 30) Some comments assert that non-produce botanicals
require treatments that do not create a new commodity and ask us to
recognize these treatments as farm activities rather than
manufacturing/processing activities. As examples, these comments

assert that activities such as cutting, slicing, drying, freezing, wet
or dry heat treating to kill plant tissues, and aging or fermenting are
all activities that are traditionally performed by farms on non-produce
botanicals for the purpose of removing non-produce botanical RACs from
the place where they were grown and preparing them for use as food.
These comments also assert that we have been inconsistent in our
activity classifications because we both state that ``heat treatment''
is a food processing activity and state that activities traditionally
performed by farmers to prepare crops for use are farm activities.
These comments express concern that farmers won't use heat treatments
to control pests, based on a misunderstanding of what constitutes
``food processing.''
    (Response 30) We note that these comments used the term ``non-
produce botanicals,'' which is not a term we have used or defined, and
it is not clear to us what the commenters intended this term to
represent. In this document, we are not addressing the question of
whether certain ``botanicals'' are or are not ``produce.'' The term
``produce'' was proposed to be defined in the forthcoming produce
safety rule, and we intend to define it in that rule.
    However, we can address in this rule these commenters' questions
about activity classification. Some of these activities are within the
``farm'' definition. For example, drying/dehydrating a RAC without
creating a distinct commodity is part of ``holding'' and drying/
dehydrating a RAC that creates a distinct commodity, without additional
manufacturing/processing, is manufacturing/processing that is included
within the ``farm'' definition. (See Response 28.) Cutting (or
otherwise separating) the edible portion of the RAC from the crop plant
and removing or trimming part of the RAC (e.g., foliage, husks, roots
or stems) are harvesting activities. (See Response 37.) We have revised
the definition of ``holding'' to include the example of ``fumigating
food during storage.'' (See Response 39.) We decided to include this
example of a holding activity based on previous discussions of how we
classify fumigating as a type of pest control (see, e.g., 78 FR 3646 at
3682 and 79 FR 28524 at 28571). Although we have not previously
classified heat treatment for purposes of pest control, we agree that
we should classify heat treatment for purposes of pest control the same
way that we have classified fumigating for purposes of pest control--
i.e., as a holding activity. Regarding classification of the other
activities listed in these comments, see Response 3.
    (Comment 31) Some comments assert that the ``farm'' definition is
too limited and ask us to include standard farm activities such as
culling, conveying, sorting, waxing, labeling, storing, packaging and
shipping of raw, whole produce. These comments assert that these normal
activities do not change the shape or structure of RACs, or alter the
hazards, and should be covered under the produce safety rule rather
than the human preventive controls rule.
    (Response 31) All of the activities described by these comments
could be within the ``farm'' definition (see 79 FR 58524 at 58571-
58572), either because they are specified in the ``farm'' definition
itself or because they are examples of activities within the definition
of ``packing'' or holding.'' Packaging and labeling RACs, without
additional manufacturing/processing, are specified in the regulatory
text of the ``farm'' definition. Sorting and culling are included in
the regulatory text of the definition of ``packing.'' Storing is simply
another term for ``holding.'' We had already included ``weighing and
conveying'' as an example of a low-risk packing or holding activity in
the exemption applicable to on-farm low-risk activity/food combinations
(Sec.  117.5(g)). To give more prominence to this packing activity, we
have added it to the definition of ``packing'' as well.
    (Comment 32) One comment, submitted to Docket No. FDA-2011-N-0143
for the FSVP rulemaking, notes that RACs often are harvested by a
contract harvest company (Ref. 16). This comment asks us to clarify
what is meant by ``establishment that harvests a food'' in the
definition of ``foreign supplier'' and whether, in such circumstances,
the supplier of the RAC would be the contract harvest company or the
establishment that owns the crop and sells it to an importer.
    (Response 32) The 2014 supplemental human preventive controls
notice had similar phrasing (``establishment that harvests the food'')
in the definition of ``supplier.'' In the final rule the definition of
``supplier'' has changed in relevant part to include the
``establishment that grows the food,'' consistent with changes to the
farm definition and as described in the following paragraphs.
    There are several different business models in which RACs are
harvested by a contract harvester (Ref. 17). In one business model, a
grower contracts with a harvester to perform harvesting on behalf of
the grower. In another business model, a third-party handler enters
into separate contracts with the grower and the harvester. In another
business model, a grower sells its crop to an entity that contracts
with a separate harvester to harvest the RACs and then packs the RACs.
There are variations on these business models, such as when a grower
sells its crop to an entity that both harvests and packs the RACs,
without a contract with a separate harvester.
    Growing and harvesting operations are not under the same management
in some of these business models. As discussed in Comment 23, comments
emphasize that farming operations can have complex business structures,
and ask us to revise the ``farm'' definition to provide for these
business models. To explicitly include these business models in the
``farm'' definition, we have revised the ``farm'' definition to mean an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. With this revision, an operation can
be within the ``farm'' definition if it grows crops but does not
harvest them or if it harvests crops but does not grow them.
    The ``farm'' definition established in the section 415 registration
regulations in 2003 (68 FR 58894), and the proposed revisions to the
``farm'' definition in the 2013 proposed human preventive controls rule
and the 2014 supplemental human preventive controls notice, all
describe a ``farm'' as an entity ``devoted to the growing and
harvesting of crops'' (emphasis added). In light of the revision to the
``farm'' definition and as discussed more fully in section IX.C.35, we
have revised the ``supplier'' definition to include the establishment
that ``grows the food'' rather than the establishment that ``harvests
the food.'' With this change in the ``supplier'' definition, the
supplier is the farm that grows the food regardless of the business
model for harvesting the food.
    (Comment 33) Some comments ask us to modify the ``farm'' definition
to exclude feed mills that provide feed to more than 5 other farms.
These comments assert that egg farms are most likely to be company
owned and the median number of farms owned by a company is under 8 and
cite USDA as the source of this information. These comments assert that
setting the limit at 5 would not automatically exempt feed mills
operated by these large egg laying businesses from the animal
preventive controls rule.
    (Response 33) We decline this request. The statutory exemption from

the section 415 registration regulations (and, thus, from the
requirements for hazard analysis and risk-based preventive controls)
for ``farms'' is based on the activities that an operation conducts
rather than on the size of the operation.
    (Comment 34) Some comments assert that the hulling or dehydration
of walnuts should not be considered processing and, thus, that an
establishment that conducts hulling or dehydration activities on tree
nuts such as walnuts should not be considered a facility subject to the
requirements for hazard analysis and risk-based preventive controls.
These comments also assert that all growers who hull and dry should
operate under the same rules, regardless of whether or not they own
their own crop. Some comments assert that the hulling and shelling
operations in the nut industry are part of the harvesting operation in
which the outer shells are removed. These comments state that
regardless of whether activities are conducted on the farm in which
they are grown or at an off-farm facility that provides hulling and
shelling services, the food is a RAC, the activity is low-risk and does
not transform the RAC into a processed food, and the product is
delivered to a processing facility and is not distributed in commerce.
The comments argue that for all these reasons and because hulling and
shelling activities are not subject to subpart B, it is not appropriate
to subject facilities that conduct such activities to subpart C.
Comments request that hulling, shelling, and drying of tree nuts be
considered ``on farm'' for the purposes of this rule. Other comments
ask us to specify that the production of ``natural dried raisins,''
dried plums, and dried hops are within the ``farm'' definition.
    (Response 34) Hulling of tree nuts (such as walnuts, almonds, and
pistachios) is a harvesting activity that is within the ``farm''
definition when conducted on a farm or the farm part of a farm mixed-
type facility. Drying/dehydrating RACs without creating a distinct
commodity (such as drying walnuts and hops) is a holding activity that
also is within the ``farm'' definition when conducted on a farm or farm
mixed-type facility. As discussed in Response 25, we have revised the
``farm'' definition to provide that an operation, not located on a
primary production farm, devoted to harvesting (such as hulling or
shelling), packing, and/or holding of RACs is within the ``farm''
definition (as a ``secondary activities farm''), provided that the
primary production farm(s) that grows, harvests, and/or raises the
majority of the RACs harvested, packed, and/or held by the secondary
activities farm owns, or jointly owns, a majority interest in the
secondary activities farm.
    Drying/dehydrating RACs (such as grapes and plums) to create a
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing is within the ``farm''
definition when conducted on a farm or farm mixed-type facility. (See
Response 28.) However, additional manufacturing/processing activities
(such as removing pits from dried plums) are outside the ``farm''
definition, and a farm or farm mixed-type facility that conducts such
activities becomes a facility that is required to register and is
subject to the requirements for hazard analysis and risk-based
preventive controls for those activities outside the farm definition.
The exception is when a farm is a small or very small business eligible
for the exemptions in Sec.  117.5(g) and (h) for a farm mixed-type
facility that only conducts low-risk activity/food combinations. Such a
small or very small business must still register as a food facility,
but will be exempt from the requirements for hazard analysis and risk-
based preventive controls. (See also the discussion in in the 2014
supplemental human preventive controls notice (79 FR 58524 at 58533-
58534 and table 1 in the Appendix to the 2014 supplemental human
preventive controls notice (79 FR 58524 at 58571-58572)).
    (Comment 35) Some comments assert that we have referred to raw milk
as being ``inherently dangerous'' and should not consider any
activities that result in the preparation of an inherently unsafe
product for sale to consumers to be within the ``farm'' definition
(i.e., production of raw milk for direct human consumption should not
be considered ``harvesting'' or ``packing''). These comments ask us to
re[hyphen]consider the definition of ``farm'' as it applies to the
production of raw milk for human consumption. Specifically, these
comments ask us to consider such activities to be outside the
traditional business of a dairy farm and to subject businesses that
conduct such activities to FSMA's requirements for hazard analysis and
risk-based preventive controls requirements as a means of advancing
public health.
    (Response 35) We decline this request. Producing milk is a
traditional activity of a dairy farm, regardless of whether the milk
produced by that dairy farm is pasteurized and introduced into
interstate commerce in accordance with Sec.  1240.61 (Mandatory
pasteurization for all milk and milk products in final package form
intended for direct human consumption) or sold unpasteurized to
consumers within a State consistent with applicable State laws and
regulations. Distributing raw milk in interstate commerce would be
unlawful, but would not form the basis for a decision that the business
is ``not a farm.''
    (Comment 36) Some comments express concern that farmers who grow
seed that is sold as animal feed must register as a food facility.
These comments ask why sales of grain for animal feed are included in a
rule that is focused on the safety of human food and ask us to exempt
this category of farms and their sales of grain for animal feed from
the registration rule.
    (Response 36) Establishments that satisfy the ``farm'' definition,
including farms that grow seed that is sold as animal food, are not
required to register as a food facility. These comments may mistakenly
believe that we intended any food establishment that is required to
register as a food facility to comply with the regulations we are
establishing in part 117 regarding human food, regardless of whether
the facility produces food for consumption by humans or food for
consumption by animals. This is not the case. We simply proposed to
revise definitions in the section 415 registration regulations relevant
to the definition of ``facility'' in the same notice in which we
proposed to modernize the current CGMPs for food and establish
requirements for hazard analysis and risk-based preventive controls for
human food, because section 103 of FSMA addresses the definitions in
the section 415 registration regulations, as well as the requirements
for hazard analysis and risk-based preventive controls. If a facility
sells grain for use as animal food, and is not exempt from the section
415 registration regulations, that facility would be subject to the
animal preventive controls rule, not the human preventive controls rule
that is the subject of this document.

C. Proposed New Definition of Harvesting

    We proposed to define ``Harvesting,'' as a new definition in
Sec. Sec.  1.227 and 1.328, to apply to farms and farm mixed-type
facilities and to mean activities that are traditionally performed by
farms for the purpose of removing RACs from the place they were grown
or raised and preparing them for use as food. We proposed that
harvesting be limited to activities performed on RACs on a farm, and
that harvesting does not include activities that transform a RAC into a
processed

food. The proposed definition included examples of activities that
would be harvesting. As noted in table 52 of this document, we have
reorganized the listed examples of harvesting to present them in
alphabetical order. We also have modified the proposal that harvesting
be limited to activities performed on RACs on a farm to provide that
harvesting can also be performed on processed foods created by drying/
dehydrating a RAC without additional manufacturing/processing, because
processed foods created by drying/dehydrating RACs are within the
``farm'' definition. See Response 28 and 79 FR 58524 at 58533 regarding
drying/dehydrating RACs to create a distinct commodity.
    (Comment 37) Some comments ask us to provide more examples of
harvesting activities, in the regulatory text and in guidance. Examples
of the requested activities include braiding; bunching; cutting the
edible portion of the crop from the plant; hydro-cooling; maintaining
hydration of product; refrigerating; removing foliage; removing free
water from (e.g., spinning); removing or trimming roots; trimming the
tops of bunches of allium crops such as leeks, chives, or garlic and
root crops such as carrots, beets, turnips, parsnips, etc. to prepare
them for sale; and trimming the lower stems of harvested herb crops
such as parsley, basil, or cilantro, or the lower stems of leafy
greens. Other comments ask us to specify that harvesting also
encompasses seed conditioning (i.e., cleaning the seed, including
removal of leaves, stems, and husks to prepare for marketing), ripening
(artificial or natural) of fruit, and waxing or coating of RACs.
    (Response 37) We have added or modified several examples of
harvesting in the regulatory text (i.e., cutting (or otherwise
separating) the edible portion of the RAC from the crop plant, removing
or trimming part of the RAC (e.g., foliage, husks, roots or stems),
field coring, and hulling). In table 1 in the Appendix to the 2014
supplemental human preventive controls notice (79 FR 58524 at 58571-
58572), we provided a more extensive list of examples of harvesting
activities, including examples that are not in the regulatory text.
Although we have classified some of these activities in more than one
way (see 79 FR 58524 at 58571-58572), in general these activities would
fall within the ``farm'' definition when conducted on RACs that are not
otherwise processed. For example, coating RACs with wax/oil/resin for
the purpose of storage or transport can be a packing (not harvesting)
activity, but waxing also has long been considered a manufacturing/
processing activity during the production of processed food (because it
involves making food from one or more ingredients, or synthesizing,
preparing, treating, modifying or manipulating food) (see 78 FR 3646 at
3679). Artificial ripening of fruit is manufacturing/processing (not
harvesting), but is now within the ``farm'' definition (see Sec.  117.3
and Response 27). Regarding classification of the other activities
listed in these comments, see Response 3.
    (Comment 38) Some comments assert that fermenting cocoa beans and
coffee beans should be classified as ``harvesting'' rather than
``holding.''
    (Response 38) We agree that the process of fermenting cocoa beans
and coffee beans begins as a ``harvesting'' activity, when the pods are
harvested and the beans are removed; it continues as ``holding,'' while
the harvested beans ferment. Thus, fermenting cocoa beans and coffee
beans has elements of both ``harvesting'' and ``holding,'' which are
both within the ``farm'' definition. It is not necessary to place the
process of fermenting cocoa beans and coffee beans squarely in one
activity or the other for the regulatory purpose of determining whether
an operation is within the ``farm'' definition. See also Response 41.

D. Proposed Revision to the Definition of Holding

    We proposed to revise the definition of ``Holding'' in Sec. Sec.
1.227 and 1.328 to add that holding also includes activities performed
incidental to storage of a food, but does not include activities that
transform a RAC into a processed food. Holding facilities could include
warehouses, cold storage facilities, storage silos, grain elevators,
and liquid storage tanks.
    (Comment 39) Some comments ask us to provide more examples of
holding activities, in the regulatory text and in guidance. Examples of
the requested activities include fumigating RACs; application of
chemicals (including fungicides, sanitizers, and anti-oxidants);
application of ripening agents; using wax as a carrier of fungicides or
anti-oxidants applied before storage; and waxing or coating of RACs,
including ``coating'' grain RACs with diatomaceous earth to control
insects. According to these comments, these activities are incidental
to storage and do not transform RACs into processed food.
    (Response 39) We have added or modified several examples of holding
in the regulatory text (i.e., fumigating food during storage, and
drying/dehydrating RACs when the drying/dehydrating does not create a
distinct commodity (such as drying/dehydrating hay or alfalfa)). In
table 1 in the Appendix to the 2014 supplemental human preventive
controls notice (79 FR 58524 at 58571-58572), we provided a more
extensive list of examples of holding activities, including examples
that are not in the regulatory text. We have previously classified some
of these activities in more than one way (see 79 FR 58524 at 58571-
58572) depending on when the activity occurs. For example, sorting,
culling, and grading RACs can be either a holding activity or a packing
activity. Drying/dehydrating RACs is holding when the drying/
dehydrating does not create a distinct commodity, but is manufacturing/
processing when the drying/dehydrating creates a distinct commodity
(see Response 28). Regarding classification of the other activities
listed in these comments, see Response 3.
    (Comment 40) Some comments ask us to clarify that mixing or
blending intact RACs is considered ``holding'' regardless of whether
the RACs are the same or different.
    (Response 40) We use the term ``blending'' when referring to RACs
such as grain and when the RACs are the same. For example, we consider
the activity of ``blending'' different lots of the same grain to meet a
customer's quality specifications to be a practical necessity for
product distribution and, thus, to be within the definition of
``holding'' (see 79 FR 58524 at 58537). However, we use the term
``mixing'' when the RACs are different. For example, we consider the
activity of ``mixing'' corn and oats in the production of animal food
to be manufacturing/processing, because mixing two different foods is
``making food from one or more ingredients'' (which is our definition
of ``manufacturing/processing''), and the animal food produced by
mixing corn and oats is a processed food.
    We classify ``mixing'' intact RACs that does not create a processed
food as incidental to, and therefore part of, ``packing'' or
``holding'' as applicable.
    (Comment 41) Some comments ask us to clarify whether the expanded
definition of holding that we proposed in the 2014 supplemental human
preventive controls notice would mean that a warehouse that both stores
cocoa beans and fumigates the cocoa beans to prevent pest infestation
would be exempt from the requirements for hazard analysis and risk-
based preventive controls for a facility solely engaged in the storage
of RACs (other than fruits and vegetables) for further distribution or
processing (Sec.  117.5(j)).

    (Response 41) Fumigating RACs such as cocoa beans to prevent pest
infestation would be within the definition of ``holding.'' Therefore,
such fumigation would not prevent a facility that stores RACs (other
than fruits and vegetables) from being eligible for the exemption in
Sec.  117.5(j), provided that the facility does not conduct other
activities not classified as ``holding.'' However, a threshold question
for any facility solely engaged in the storage of RACs is whether the
stored RACs are fruits or vegetables. We classify cocoa beans within
the category of ``fruits and vegetables'' (78 FR 3646 at 3690) and,
thus, a facility that stores cocoa beans is not eligible for the
exemption in Sec.  117.5(j).
    (Comment 42) Some comments ask us to clarify whether there is a
timeframe associated with holding and to better distinguish between
``holding'' and ``storage.''
    (Response 42) There is no timeframe (maximum or minimum) associated
with holding. The definition of holding states ``Holding means storage
of food'' and, thus, there is no distinction between ``holding'' and
``storing.''
    (Comment 43) Some comments ask us to clarify how the definition of
holding relates to practices, such as fumigation, on almond hull
stockpiles held on a farm, a farm mixed-type facility, or off-farm.
    (Response 43) Practices that are incidental to storage of food,
such as fumigation of almond hull stockpiles, are holding, regardless
of whether they are conducted on-farm, on a farm mixed-type facility,
or off-farm.
    (Comment 44) Some comments ask us to clarify that value added
activities (such as repacking and blast freezing) conducted in
facilities such as warehouses would be considered holding when product
is not exposed to the environment.
    (Response 44) We consider the activities described in these
comments to be activities performed as a practical necessity for the
distribution of the food and, thus, to be within the definition of
holding.
    (Comment 45) Some express concern that the definition of holding
would prevent a facility that samples food (such as sugar) for grading
or quality control purposes from qualifying for the exemption for
facilities engaged solely in holding unexposed packaged food because
they would temporarily expose otherwise unexposed packaged food to the
environment. These comments ask us to make clear that the requirements
for hazard analysis and risk-based preventive controls only apply to
the sampling activities and that engaging in sampling activities does
not remove a warehouse's exemption altogether.
    (Response 45) We consider that sampling food in the manner
described by this comment is a practical necessity for the distribution
of the food within the definition of ``holding,'' and that the
exemption still applies to a facility that conducts such sampling.
Importantly, the sampling must be in done in accordance with CGMPs such
that the exposure does not result in contamination of the food.

E. Proposed Revision to the Definition of Manufacturing/Processing

    We proposed to revise the definition of ``Manufacturing/
Processing'' in Sec. Sec.  1.227 and 1.328 by adding to the existing
definition a criterion applicable to farms and farm mixed-type
facilities. As noted in table 52, we have reorganized the listed
examples of manufacturing/processing to present them in alphabetical
order.
    (Comment 46) Some comments express concern that some activities
included in the definition of ``manufacturing/processing'' overlap with
activities (such as trimming, washing, and cooling) included in the
definition of ``harvesting.''
    (Response 46) We acknowledge that there is some overlap in the
activities that the regulatory text lists as examples of both
``manufacturing/processing'' and ``harvesting,'' because some
activities can occur during more than one operation (see also the
discussion at 79 FR 58524 at 58538 and table 1 in the Appendix to the
2014 supplemental human preventive controls notice (79 FR 58524 at
58571-58572)). For example, ``cutting'' the core of the lettuce from
the crop plant can occur on-farm in the field where the lettuce is
harvested, and ``cutting'' the core of the lettuce from the rest of the
harvested lettuce also can occur in a fresh-cut processing facility. An
important consequence of the multiple revisions we have made to the
``farm'' definition in this rulemaking is that there are fewer
situations in which classification of a particular activity is the only
trigger for an operation to be subject to the section 415 registration
regulations. For example, the revised ``farm'' definition no longer
classifies the packing and holding of others' RACs to be a
manufacturing/processing activity that triggers the registration
requirement. As another example, the revised ``farm'' definition
specifies three manufacturing/processing activities that are within the
``farm'' definition. We conclude that the overlap in the examples of
activities listed in the definitions of ``harvesting'' and
``manufacturing/processing'' does not create problems with determining
the status of an operation as a ``farm'' or a ``facility'' and we are
retaining examples in both definitions because doing so reflects
current practices on farms and in manufacturing/processing facilities.
    (Comment 47) Some comments ask us to clarify that the traditional
activities of a packing shed--cleaning and packing intact fruits and
vegetables--do not constitute ``manufacturing/processing'' that would
trigger the requirement to register as a facility.
    (Response 47) Packing activities are within the definition of
``packing,'' and holding activities are within the definition of
``holding,'' regardless of whether the packing or holding activities
take place on-farm or off-farm. In other words, neither packing produce
nor holding produce would be classified as manufacturing/processing
merely because the business entity conducting the activity is a
facility that is subject to the section 415 registration regulations.
As discussed in Response 25, we have revised the ``farm'' definition to
provide that an operation devoted to harvesting (such as hulling or
shelling), packing, and/or holding of RACs is within the ``farm''
definition (as a ``secondary activities farm''), provided that the
primary production farm(s) that grows, harvests, and/or raises the
majority of the RACs harvested, packed, and/or held by the secondary
activities farm owns, or jointly owns, a majority interest in the
secondary activities farm. With this revision, some off-farm
packinghouses that are managed by a business entity (such as a
cooperative) that is different from the business entity growing crops
(such as individual farms) can be within the ``farm'' definition,
provided that the primary production farm(s) that grows, harvests, or
raises the majority of the RACs harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in
the packing operation.
    (Comment 48) Some comments ask us to make clear, in our response to
comments in the final rule, that any adjustments we make to the
definition of manufacturing/processing in no way change the definitions
of ``raw agricultural commodity,'' ``processing,'' and ``processed
food,'' which were mutually agreed to by EPA and FDA (Ref. 15) to
address regulatory responsibilities for antimicrobials applied to food,
process water contacting food, or hard food-contact surfaces.
    (Response 48) The revisions we made to the ``farm'' definition, and
to the classification of activities relevant to the

``farm'' definition, do not change the statutory definitions of ``raw
agricultural commodity,'' and ``processed food,'' or impact our
interpretation of the definition of ``processing,'' with respect to
regulatory jurisdiction for antimicrobials applied to food, process
water contacting food, or hard food-contact surfaces.

F. Proposed New Definition of Mixed-Type Facility

    We proposed to define ``Mixed-type facility,'' as a new definition
in Sec. Sec.  1.227 and 1.328, to mean an establishment that engages in
both activities that are exempt from registration under section 415 of
the FD&C Act and activities that require the establishment to be
registered. We specified in the regulatory text that an example of such
a facility is a ``farm mixed-type facility,'' which is an establishment
that grows and harvests crops or raises animals and may conduct other
activities within the farm definition, but also conducts activities
that require the establishment to be registered. As a conforming change
associated with the revisions to the ``farm'' definition, we have
revised the example of a ``farm mixed-type facility'' to specify that
it is an establishment that is a farm, but also conducts activities
outside the farm definition that require the establishment to be
registered.
    (Comment 49) Some comments assert that there is no scientific basis
for the definition of mixed-type facility.
    (Response 49) The proposed definition is not a science-based
definition. It is a descriptive term that we are using to refer to
certain food establishments. We used this same term during the
rulemaking to establish the section 415 registration regulations (see
response to comment 46, 68 FR 58894 at 58906, October 10, 2003).
    (Comment 50) Some comments ask us to revise the definition to add
more details about activities that are inside the farm definition and
activities that are outside the farm definition.
    (Response 50) We decline the request of these comments. Adding such
details would detract from the focus of the definition--i.e., that it
refers to a facility that conducts both activities that are inside the
farm definition and activities that are outside the farm definition. We
have included additional examples of ``harvesting,'' ``packing,'' and
``holding'' activities in the regulatory text of the definitions for
those terms (see Sec. Sec.  1.227, 1.328 and 117.3 and Response 31,
Response 37 and Response 39). (See also Response 3.)
    (Comment 51) Some comments ask us to revise the definition to
exclude those establishments that only conduct low-risk activities
specified in the exemptions for on-farm, low-risk activity/food
combinations (Sec.  117.5(g) and (h)).
    (Response 51) We decline this request. Whether a particular
establishment that falls within the definition of ``mixed-type
facility'' is subject to the requirements for hazard analysis and risk-
based preventive controls is governed by the exemptions established in
this rule.

G. Proposed Revision to the Definition of Packing

    We proposed to revise the definition of ``Packing'' in Sec. Sec.
1.227 and 1.328 by adding that packing includes activities performed
incidental to packing a food, but does not include activities that
transform a RAC into a processed food. We have revised the definition
to clarify that packing includes ``re-packing.''
    (Comment 52) Some comments ask us to include minimal
``manufacturing/processing'' of RACs in the definition of packing when
the minimal ``manufacturing/processing'' does not transform the RAC
into a processed food. The comments describe waxing of fresh fruit
(such as apples) and vegetables as examples of activities that do not
transform a RAC into a processed food.
    (Response 52) As already discussed, the activities that transform a
RAC into a processed food (and are sometimes therefore referred to as
``processing'' in the context of a food's status as a RAC or processed
food) are not coextensive with the activities described in our
definition of ``manufacturing/processing.'' (See Response 27.) Although
waxing has long been considered a manufacturing/processing activity
during the production of processed food (because it involves making
food from one or more ingredients, or synthesizing, preparing,
treating, modifying or manipulating food), we classify coating RACs
with wax/oil/resin for the purpose of storage or transport as a packing
activity. (See Response 37).
    (Comment 53) Some comments ask us to clarify the distinction
between ``packing'' and ``packaging'' because the terms are different
but seem to be used interchangeably. These comments express concern
that ``placing food into containers'' on farms that have traditionally
done so will be classified as ``manufacturing/processing'' and trigger
the requirement to register as a food facility and ask us to reclassify
``packaging'' within the definition of ``packing.'' Other comments ask
us to remove the words ``other than packaging of food'' from the
definition of ``packing.'' Some comments state that when a RAC is
packed in the field and/or is placed into a clamshell container, as a
practical matter it is considered to have been ``packed,'' not
``packaged.''
    (Response 53) We acknowledge that farms traditionally refer to
field packing, including placing RACs into clamshell containers that
will serve as a consumer package, as ``packing,'' not ``packaging.''
Indeed, in the 2013 human preventive controls rule we proposed to
revise the definition of ``packing'' to specify that, for farms and
farm mixed-type facilities, ``packing'' includes ``packaging.''
However, in the 2014 supplemental human preventive controls notice we
proposed a simpler approach to accommodate requests such as those in
these comments, by simply specifying in the ``farm'' definition that
packaging and labeling RACs, without additional manufacturing/
processing, is within the ``farm'' definition. We conclude that the
distinctions between the terms ``packing'' and ``packaging'' do not
create problems with determining the status of an operation as a
``farm'' or a ``facility.'' Further, we note that we have given these
terms identical meanings across multiple FDA regulations that are
applicable to facilities.
    (Comment 54) Some comments refer to discussions at a ``listening
session'' regarding harvesting several varieties of lettuce, washing
them, and combining heads or bunches of the different varieties in one
bag that is sealed with a knot or twist tie. During these discussions,
this type of activity was classified as being within the ``farm''
definition. These comments ask how this activity can be classified as
being within the ``farm'' definition when mixing and washing are listed
as manufacturing/processing activities that trigger registration as a
food facility and whether there is a discrepancy between what the rule
requires and what they heard at the listening session. Other comments
express the view that mixing RACs that have not been transformed into
processed food (such as bagging mixed greens or different types of
whole produce, such as potatoes, beets, and carrots) should not put a
farm in the category of a mixed-type facility.
    (Response 54) Removing several varieties of lettuce from the place
in which they were grown, washing them on the farm, and combining heads
or bunches of the different varieties in one bag that is sealed with a
knot or twist tie on the farm are all activities within the ``farm''
definition. We classify ``washing'' and ``mixing'' in more than one way
depending on when the activity occurs, and the ``farm'' definition now
specifies that

``packaging'' RACs (without additional manufacturing/processing, such
as slicing) is a farm activity, even though it is a type of
``manufacturing/processing.'' We have recognized ``washing'' as a
harvesting activity since we first issued the section 415 registration
regulations (68 FR 58894 at 58961, October 10, 2003), even though we
also classify ``washing'' RACs as ``manufacturing/processing'' when
done in a food processing facility (such as a fresh-cut processing
facility). We classify ``mixing'' intact RACs that does not create a
processed food as incidental to, and therefore part of, ``packing'' or
``holding'' as applicable. Mixing heads or bunches of lettuce as
described in the example does not create a processed food, because he
mixing has not created a distinct commodity, but only a set of mixed
RACs. On the other hand, mixing that creates a processed food is not
``packing'' or ``holding.'' The definitions of both ``packing'' and
``holding'' are limited so that they do not include activities that
transform a RAC into processed food. Some kinds of mixing of RACs do
create a distinct commodity (for example, mixing corn and oats to make
animal food). In such cases, the mixing is manufacturing/processing and
is not within the farm definition. Likewise, although we classify
placing RACs in a plastic bag with a twist tie as ``packaging'' rather
than ``packing'' when the plastic bag is the container that the
consumer receives, we have provided for ''packaging'' RACs as an
activity within the ``farm'' definition.

V. Comments on the Organizing Principles for How the Status of a Food
as a Raw Agricultural Commodity or as a Processed Food Affects the
Requirements Applicable to a Farm Under Sections 415 and 418 of the
FD&C Act

    In the 2014 supplemental human preventive controls notice, we
discussed comments on the organizing principles that formed the basis
for proposed revisions to the section 415 registration regulations and
the section 414 recordkeeping regulations (79 FR 58524 at 58538). We
also explained how our proposed revisions to the ``farm'' definition
would require us to reconsider those organizing principles (79 FR 58524
at 58538).
    (Comment 55) Some comments assert that we should revise the
organizing principles to reflect the realities and range of activities
that farms conduct to prepare their crops for market and to make the
organizing principles consistent with FSMA's risk-based mandate. These
comments ask us to revise the organizing principles as follows: (1) The
basic purpose of farms is to produce RACs and deliver them for sale to
end-users or other buyers; (2) activities that involve RACs and that
farms perform for the purposes of selling their own RACs, including
growing them, harvesting them, preparing them for consumption in their
raw and unprocessed state, and packing, sorting, grading, packaging,
labeling, holding, transporting, marketing, and delivering them, should
all be within the definition of ``farm;'' (3) even though farms
traditionally also do a wide variety of activities that may be
considered processing, for the purpose of these organizing principles,
activities should be classified based on whether the activity
transforms a RAC into a processed food (as defined by these rules); (4)
manufacturing/processing, packing, or holding food--whether RACs or
processed foods, from any source--for consumption on the farm should
remain within the farm definition.
    (Response 55) We have revised the ``farm'' definition to refer to
farms as ``operations'' rather than ``facilities'' or
``establishments''; reflect modern business models (such as
cooperatives, on-farm packinghouses under ownership by multiple
growers, food aggregators, and some types of food hubs (e.g., those
that consolidate and distribute RACs but do not conduct activities that
transform the RACs into a processed food)); specify that a farm is in
one general (but not necessarily contiguous) physical location; and
provide that an operation devoted to harvesting (such as hulling or
shelling), packing, and/or holding of RACs is within the ``farm''
definition as a secondary activities farm, provided that the primary
production farm(s) that grows, harvests, and/or raises the majority of
the RACs harvested, packed, and/or held by the secondary activities
farm owns, or jointly owns, a majority interest in the secondary
activities farm (e.g., an off-farm produce packinghouse owned by
farmers or a farmer-owned tree nut hulling and drying operation). (See
Response 22, Response 23, Response 24, and Response 25.) All of these
changes to the ``farm'' definition do, as requested by these and other
comments, reflect the realities and range of activities that farms
conduct. See table 5 for organizing principles regarding classification
of activities on-farm and off-farm in light of the changes to the
``farm'' definition.

Table 5--Organizing Principles Regarding Classification of Activities On-
                            Farm and Off-Farm
------------------------------------------------------------------------
             No.                         Organizing principle
------------------------------------------------------------------------
1...........................  The basic purpose of farms is to produce
                               RACs, and RACs are the essential products
                               of farms.
2...........................  A farm is in one general (but not
                               necessarily contiguous) location.
3...........................  Farm operations include business models
                               such as cooperatives, on-farm
                               packinghouses under ownership by multiple
                               growers, food aggregators, and some types
                               of food hubs.
4...........................  Activities that involve RACs and that
                               farms traditionally do for the purposes
                               of growing RACs, removing them from the
                               growing areas, and preparing them for use
                               as a food RAC, and for packing, holding,
                               and transporting them, are all within the
                               ``farm'' definition.
5...........................  Activities are classified based in part
                               whether the activity transforms a RAC
                               into a processed food.
6...........................  A limited number of traditional operations
                               that farms do for the purpose of
                               preparing RACs for use as a food RAC, but
                               that are classified as ``manufacturing/
                               processing,'' are within the ``farm''
                               definition. These are: (1) Drying/
                               dehydrating RACs to create a distinct
                               commodity, and packaging and labeling
                               such commodities, without additional
                               manufacturing/processing; (2) treatment
                               to manipulate the ripening of RACs, and
                               packaging and labeling the treated RACs,
                               without additional manufacturing/
                               processing; and (3) packaging and
                               labeling RACs, when these activities do
                               not involve additional manufacturing/
                               processing.
7...........................  Manufacturing/processing, packing, or
                               holding food--whether RACs or processed
                               foods, from any source--for consumption
                               on the farm is within the farm
                               definition.
------------------------------------------------------------------------

VI. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c)(1)(C) of FSMA

    We previously described provisions of FSMA that direct us to
conduct a science-based risk analysis to cover specific types of on-
farm packing, holding, and manufacturing/processing activities that
would be outside the ``farm'' definition and, thus, subject to the
requirements for hazard analysis and risk-based preventive controls
(see section 103(c)(1)(C) of FSMA and 78 FR 3646 at 3674 and 3689-
3691). Consistent with this statutory direction, we developed the
section 103(c)(1)(C) draft RA and made it available for public comment
(Ref. 18 and 78 FR 3824). We are including the final risk assessment
(the section 103(c)(1)(C) RA) in the docket established for this
document (Ref. 4).
    We previously described provisions of FSMA that direct us to
consider the results of the science-based risk analysis and exempt
facilities that are small or very small businesses from the
requirements for hazard analysis and risk-based preventive controls (or
modify these requirements, as we determine appropriate), if such
facilities are engaged only in specific types of on-farm activities
that we determine to be low risk involving specific foods that we
determine to be low risk (see section 103(c)(1)(D) of FSMA and 78 FR
3646 at 3675, 3691, and 3705-3707). Later in this document (see section
XI.G), we discuss the provisions we are establishing in Sec.  117.5(g)
and (h), based on the results of the section 103(c)(1)(C) RA, to exempt
farm mixed-type facilities that are small or very small businesses from
requirements for hazard analysis and risk-based preventive controls if
the only activities that the business conducts that are subject to
those requirements are low-risk activity/food combinations.
    We also previously described provisions of FSMA that direct us to:
(1) Identify high risk-facilities and allocate resources to inspect
facilities according to the known safety risks of the facilities (as
determined by several factors) and immediately increase the frequency
of inspection of all facilities (see the discussion of section 421 of
the FD&C Act at 78 FR 3646 at 3654-3655); and (2) consider a possible
exemption from or modification of requirements of section 421 of the
FD&C Act as we deem appropriate (see the discussion of section
103(c)(1)(D) of FSMA at 78 FR 3646 at 3658). We tentatively concluded
that we should not exempt or modify the frequency requirements under
section 421 based solely upon whether a facility only engages in low-
risk activity/food combinations and is a small or very small business
and requested comment on this tentative conclusion.

B. Comments on Qualitative Risk Assessment of On-Farm Activities
Outside of the Farm Definition

    (Comment 56) Some comments address the qualitative nature of the
section 103(c)(1)(C) draft RA and assert that it is based on
professional judgment rather than data. These comments ask us to update
the section 103(c)(1)(C) draft RA when more data become available. Some
comments assert that we should not rely on data from the Food
Processing Sector Study (Ref. 19), but instead collect data from large-
scale surveys of actual farm mixed-type facilities and their
activities. Other comments ask us to dedicate resources and enter into
agreements with agencies/organizations to collect, analyze, and
interpret data. Some comments ask us to consult with subject matter
experts to ensure that the final risk assessment reflects sufficient
geographic diversity.
    (Response 56) We have acknowledged the limitations of the section
103(c)(1)(C) draft RA (Ref. 18; see section I.F in that document).
Rather than limit public input to subject matter experts, we requested
comment from all interested persons, and received a number of comments
alerting us to activity/food combinations conducted on farms and farm
mixed-type facilities, including comments from diverse geographic
areas. We also received comments about activity/food combinations
focused on botanicals that might be used in the production of dietary
ingredients. We disagree that we need to conduct large scale surveys,
or enter into agreements with agencies/organizations, to collect
additional information in light of the previous opportunity for broad
public input regarding the activity/food combinations conducted on
farms and farm mixed-type facilities. (See also Response 139 regarding
the Food Processing Sector Study.)
    (Comment 57) Some comments state that it is not clear how certain
high- or moderate-risk practices (e.g., washing), which are necessary
to move product from the field, will affect exemptions. These comments
recommend that future risk assessments examine the impact of these
practices by commodity and volume of intact fruits and vegetables
marketed through small and very small farm mixed-type facilities. Other
comments ask us to re-examine our data sources in assessing commodity-
specific risks, and assert that it is likely that many will be found to
be low risk. Other comments suggest that the Centers for Disease
Control and Prevention (CDC) expand its data analysis effort (Ref. 20)
to separate out commodities to assess attribution of foodborne
illnesses for additional commodities.
    (Response 57) Because of changes we made to the farm definition,
practices such as washing that are necessary to move product from the
field are within the farm definition and are not addressed in the
section 103(c)(1)(C) RA. We disagree that we should re-examine our data
sources in assessing commodity-specific risks. As we discussed in the
section 103(c)(1)(C) draft RA, we focused on considering the risk of
activity/food combinations rather than separately considering the risk
of specific food categories because doing so would better enable us to
focus on whether a specific manufacturing, processing, packing, or
holding activity conducted on food by a farm mixed-type facility
warranted an exemption from, or modified requirements for, the
provisions of section 418 of the FD&C Act. The comments did not
identify additional data sources to use in assessing commodity-specific
risks. However, we did revise the section 103(c)(1)(C) draft RA by
taking into consideration: (1) Comments submitted to Docket FDA-2012-N-
1258 on the section 103(c)(1)(C) Draft RA; (2) comments submitted to
Docket FDA-2011-N-0920 on the proposed rule relevant to activities
conducted on foods on farms; and (3) a revised Food Processing Sector
Study on domestic establishments co-located on farms (Ref. 21). This
led us to include additional activity/food combinations in our
evaluation, and many were found to be low risk. With respect to CDC
expanding its data analysis effort, the CDC publication cited by the
comments (Ref. 20) is the most up-to-date publication available, and
more finely grained data for additional commodities are not currently
available.
    (Comment 58) Some comments assert that we should revise the section
103(c)(1)(C) draft RA and then make it available for additional public
comment before finalizing the rule.
    (Response 58) As we previously noted (78 FR 3824 at 3826, January
16, 2013), we subjected the section 103(c)(1)(C) draft RA to peer
review in accordance with the requirements of the Final Information
Quality Bulletin for Peer Review (issued by the Office of Management
and Budget to implement the Information Quality Act (Pub. L. 106-554))
before we made it available for broader public comment during a

time period that exceeded 10 months. The additional iterative process
recommended by these comments is not necessary and would go beyond the
processes we routinely apply for public input on a risk assessment.

C. Comments Regarding an Exemption for Small and Very Small Farm Mixed-
Type Facilities Under Section 421 of the FD&C Act

1. Request for Comment on Data Submission Requirements
    We requested comment on whether we should establish data submission
requirements that would allow us to identify types of facilities in
order to exempt them from the inspection frequencies, or modify the
inspection frequencies that apply to them, under section 421 of the
FD&C Act. We provided examples of such data elements, including
identification of a facility as a farm mixed-type facility, annual
monetary value of sales, number of employees, and food category/
activity type. We also requested comment on any other criteria that may
be appropriate for the purposes of allocating inspection resources to
these facilities.
    Comments did not support these data submission requirements. We are
not establishing any data submission requirements that would allow us
to identify types of facilities in order to exempt them from the
inspection frequencies, or modify the inspection frequencies that apply
to them, under section 421 of the FD&C Act.
2. Request for Comment on an Exemption From the Requirements of Section
421 of the FD&C Act
    We received no comments that disagreed with our tentative
conclusion that we should not exempt or modify the inspection frequency
requirements under section 421 based solely upon whether a facility
only engages in low-risk activity/food combinations and is a small or
very small business. We are not establishing any exemption from, or
modification to, the inspection frequency requirements under section
421 for facilities that only engage in low-risk activity/food
combinations and are a small or very small business.

VII. Comments on Proposed General Revisions to Current Part 110 (Final
Part 117)

    We proposed some general revisions to the CGMP requirements in part
110, including revising the title; redesignating the provisions in part
117; revising some terms for consistency within the rule; referring to
the ``owner, operator, or agent in charge'' rather than to ``plant
management'' or ``operator''; revising provisions directed to
preventing contamination of food and food-contact substances so that
they also are consistently directed to preventing contamination of
food-packaging materials; revising several provisions to explicitly
address allergen cross-contact, as well as contamination; referring to
``raw materials and ingredients'' rather than ``raw materials and other
ingredients''; deleting some non-binding provisions; and making some
editorial revisions (78 FR 3646 at 3692 to 3693).
    Some comments support one or more of these proposed general
revisions without change. For example, some comments agree that there
is no meaningful distinction between ``manufacturing/processing,''
``packing,'' and ``holding'' as defined in the proposed revisions to
Sec. Sec.  1.227 and 1.328 and those terms as they have been used in
the long-standing CGMP requirements. These comments also agree that
consistent use of these terms throughout proposed part 117, in
reference to activities taking place in food facilities,
establishments, or plants, would make the regulations more clear and
have no substantive effect on the current requirements. Other comments
support the proposed replacement of the term ``facility'' or
``facilities'' in the CGMP requirements with the term ``establishment''
or ``plant'' whenever the term ``facility'' or ``facilities'' could be
confused with the firms that are subject to the proposed requirements
for hazard analysis and risk-based preventive controls. Other comments
agree that it is appropriate to replace the word ``shall'' with the
term ``must.'' Some comments that support the proposed provisions
suggest alternative or additional regulatory text (see, e.g., Comment
59, Comment 63, and Comment 65).
    We received no comments that disagreed with our proposed
redesignations and are finalizing them as proposed. In the following
sections, we discuss comments that ask us to clarify the proposed
requirements or that disagree with, or suggest one or more changes to,
the proposed requirements. After considering these comments, we have
revised the proposed provisions as shown in table 6.

     Table 6--Outcome of the Proposed General Revisions to Part 110
------------------------------------------------------------------------
         Proposed revision                         Outcome
------------------------------------------------------------------------
Establish the title of part 117...  We have revised the title to read
                                     ``Current Good Manufacturing
                                     Practice, Hazard Analysis, and Risk-
                                     Based Preventive Controls for Human
                                     Food.''
Consistency of terms: Activities    We are establishing in part 117 the
 subject to part 117.                same definitions for the terms
                                     ``manufacturing/processing,''
                                     ``packing,'' and '' holding'' as we
                                     are establishing in the section 415
                                     registration regulations and the
                                     section 414 recordkeeping
                                     regulations.
Consistency of terms: Facility....  We have made the following changes
                                     to the proposed rule:
                                    1. We have revised the definition of
                                     ``plant'' to focus it on the
                                     building, structure, or parts
                                     thereof, used for or in connection
                                     with the manufacturing, processing,
                                     packing, or holding of human food.
                                    2. We have revised applicable
                                     provisions to use ``establishment''
                                     rather than ``plant'' when focusing
                                     on a business entity rather than on
                                     buildings or other structures.
                                    3. We have made conforming changes
                                     throughout the rule.
Consistency of terms: Owner,        We are: (1) Defining the term
 operator, or agent in charge.       ``you'' to mean, for purposes of
                                     part 117, the owner, operator, or
                                     agent in charge of a facility and
                                     (2) limiting use of the term
                                     ``you'' to provisions directed to
                                     ``facilities'' (i.e., provisions in
                                     subparts C, D, E, and G).
Consistency of terms: Food-         We received no comments that
 packaging materials.                disagreed with our proposal that
                                     provisions of current part 110
                                     directed to preventing
                                     contamination of food and food-
                                     contact substances consistently be
                                     directed to preventing
                                     contamination of food-packaging
                                     materials as well and are
                                     finalizing the applicable
                                     provisions as proposed.
Additions regarding allergen cross- The CGMPs that we are establishing
 contact.                            in subpart B explicitly address
                                     allergen cross-contact.

Revisions for consistency with the  We have retained the current phrase
 definition of ``food''.             ``raw materials and other
                                     ingredients'' (rather than the
                                     proposed phrase ``raw materials and
                                     ingredients'') throughout the rule
                                     to make it clear that raw materials
                                     are ingredients.
Revisions to delete some non-       We are deleting those nonbinding
 binding provisions.                 provisions of current part 110 that
                                     we proposed to delete. (For a list
                                     of these deleted provisions, see
                                     table 8 in the 2013 proposed human
                                     preventive controls rule, 78 FR
                                     3646 at 3714).
Revisions to re-establish some non- With one exception, we are, as
 binding provisions of part 110 as   proposed, re-establishing certain
 binding provisions in part 117.     non-binding provisions of part 110
                                     in part 117 as binding provisions.
                                     See table 11 in the 2013 proposed
                                     human preventive controls rule (78
                                     FR 3646 at 3728). The exception is
                                     one provision of Sec.
                                     110.80(b)(1) regarding inspecting
                                     containers of raw materials on
                                     receipt, which we are deleting
                                     rather than re-establishing it as a
                                     requirement.
Editorial changes.................  We are finalizing the proposed
                                     editorial changes regarding
                                     ``Federal Food, Drug, and Cosmetic
                                     Act,'' ``includes, but is not
                                     limited to,'' ``must,''
                                     ``adulteration,'' and ``when'' as
                                     proposed, except that we are
                                     retaining the term ``such as'' in
                                     place of the proposed term
                                     ``including'' in two provisions.
------------------------------------------------------------------------

A. Title of Part 117

    We proposed to re-establish the provisions of current part 110 in
new part 117 and to establish the title of part 117 as ``Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Human Food'' (78 FR 3646 at 3691). (Note that in the 2013
proposed human preventive controls rule, we described this as revising
the title of ``current subpart B.'' We should have described this as
revising the title of current part 110.)
    (Comment 59) Some comments ask us to revise the title to read
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food.''
    (Response 59) We have revised the title of the rule as requested.

B. Proposed Revisions for Consistency of Terms

1. Activities Subject to Proposed Part 117
    We noted that we had previously described activities that may be
considered ``manufacturing, processing, packing, or holding'' by
establishing definitions for these terms in the section 415
registration regulations and the section 414 recordkeeping regulations
(78 FR 3646 at 3692). We proposed to revise these existing definitions
(see sections IV.D, IV.E, and IV.G) and to incorporate the revised
definitions in part 117. We tentatively concluded that there is no
meaningful distinction between these terms as we would define them in
the revised definitions and these terms as they had been used in the
CGMPs. We also tentatively concluded that consistent use of these terms
throughout part 117, in reference to activities taking place in food
facilities, establishments, or plants, would make the regulations more
clear and have no substantive effect on the current requirements (78 FR
3646 at 3692). In the 2014 preventive controls supplemental notice, we
proposed revisions to the definitions of ``holding'' and ``packing''
after considering comments submitted to the 2013 proposed human
preventive controls rule.
    (Comment 60) Some comments ask us to clarify how we were
``revising'' the definitions of the terms manufacturing, processing,
packing, and holding because these terms had not been defined in the
CGMPs in part 110.
    (Response 60) The comments are correct that these terms had not
been defined in the CGMPs in part 110. We proposed to ``revise'' these
definitions in the section 415 registration regulations and the section
414 recordkeeping regulations and then establish in part 117 those
revised definitions.
    (Comment 61) Some comments from the produce industry state that it
is difficult to assess whether there is a meaningful distinction
between ``packing'' and ``holding'' as would be defined in the proposed
human preventive controls rule and as had been used in the CGMPs in
part 110 because most harvesting and post-harvest handling activities
of RACs had been excluded from the CGMP requirements under Sec.
110.19.
    (Response 61) We assume that these comments are concerned about
distinguishing ``packing'' from ``holding'' because some exemptions
(e.g., the exemption in Sec.  117.5(k) from the CGMP requirements for
holding RACs and the exemption in Sec.  117.5(j) from the requirements
for hazard analysis and risk-based preventive controls) apply to
``holding'' RACs. As previously discussed, we have previously
classified several on-farm activities in more than one way (79 FR 58524
at 58538 and 58571) depending on when the activity occurs. For example,
sorting, culling, and grading RACs can occur during both packing and
holding activities. However, we disagree that the full regulatory text
of the definitions for ``packing'' and ``holding'' are not adequate to
provide a meaningful distinction between the two terms. ``Packing''
means, in part, ``placing food into a container'' whereas holding
means, in part ``storage of food.'' ``Placing food into a container''
is in no way similar to ``storage of food.''
    (Comment 62) Some comments disagree with our tentative conclusion
that there is no meaningful distinction between ``manufacturing/
processing,'' ``packing,'' and ``holding'' as we would define them in
the revised definitions and these terms as they had been used in the
CGMPs. These comments ask us to define these terms differently in the
human preventive controls rule. These comments state that although they
do not object to the consistent use of these terms throughout part 117
in reference to activities taking place in food facilities,
establishments, or plants, they believe there are significant
distinctions in these terms that need to be considered when finalizing
the requirements of part 117.
    (Response 62) These comments provide neither specific suggestions
for how we should define these terms for the purpose of the human
preventive controls rule nor specific reasons for their assertion that
there are significant distinctions in these terms that need to be
considered when finalizing the requirements of part 117. Without more
specific information, we assume that the changes we have made to the
definitions of ``farm,'' ``holding,'' and ``packing'' adequately
address these comments.
2. The Term ``Facility''
    We proposed to replace the term ``facility'' or ``facilities'' in
current part 110 with the term ``establishment'' or ``plant'' in
proposed part 117 whenever the term ``facility'' or ``facilities''
could be confused with the firms that are subject to the proposed
requirements for hazard analysis and risk-based

preventive controls required by section 418 of the FD&C Act (78 FR 3646
at 3692). However, we tentatively concluded that it would not be
necessary to replace the use of the term ``facilities'' in current
requirements directed to specific functional parts of a plant or
establishment, such as ``toilet facilities'' and ``hand-washing
facilities,'' because the use of the term ``facilities'' in these
contexts would not create confusion.
    (Comment 63) Some comments state that it would not be helpful to
use ``plant'' interchangeably with ``establishment'' when referring to
a business that is not required to register. These comments ask us to
consistently use one of these terms and to define a term that would
mean ``a business that is not required to register'' to help
distinguish such businesses from ``facilities.''
    (Response 63) We agree that it is appropriate to consistently use
one term when referring to a business entity. However, we disagree that
it is necessary to establish a definition for a business entity that is
not required to register. A business that meets the definition of
``facility'' is required to register; a business that is not required
to register is simply a business that does not meet the definition of
``facility.''
    To address these comments, we have revised provisions of the rule
in three ways. First, we have revised the definition of ``plant'' to
focus it on the building, structure, or parts thereof, used for or in
connection with the manufacturing, processing, packing, or holding of
human food, rather than on the ``building or establishment.'' Second,
we have revised applicable provisions of part 117 to use
``establishment'' rather than ``plant'' when focusing on a business
entity rather than on buildings or other structures. Third, we have
revised provisions that use the terms ``plant,'' ``establishment,'' or
both to conform to the definition of ``plant'' and the described usage
of ``establishment.'' For example, Sec.  117.10 establishes
requirements for ``the management of the establishment'' rather than
``plant management,'' because ``establishment'' is the term focusing on
the business entity. As another example, Sec.  117.20(a)(1) establishes
requirements for properly storing equipment, removing litter and waste,
and cutting weeds or grass within the immediate vicinity of the