baskets.
Sec.   112.112.................................  --Revision to clarify that Sec.   112.112 applies during and
                                                  immediately prior to harvest, in contrast to the related Sec.
                                                   112.83, which applies during the growing season.
                                                 --Revision to specify that ``[a]t a minimum, identifying and
                                                  not harvesting covered produce that is reasonably likely to be
                                                  contaminated with animal excreta or that is visibly
                                                  contaminated with animal excreta requires a visual assessment
                                                  of the growing area and all covered produce to be harvested,
                                                  regardless of the harvest method used.''
Sec.   112.113.................................  --Revision to add the phrase ``to the degree practicable''
                                                  considering covered commodities that are harvested near the
                                                  soil line, where avoiding contact of cut surfaces of harvested
                                                  produce with soil may not be practicable.
Sec.   112.114.................................  --Revisions to clarify meaning of ``dropped covered produce,''
                                                  including explicitly state that dropped covered produce does
                                                  not include root crops (such as carrots) that grow
                                                  underground, crops (such as cantaloupe) that grow on the
                                                  ground, or produce that is intentionally dropped to the ground
                                                  as part of the harvesting method (such as almonds).
                                                 --Deletion of ``unless it is exempt under Sec.   112.2(b)'' as
                                                  confusing and unnecessary.
Sec.   112.115.................................  --No change.
Sec.   112.116.................................  --Revision to Sec.   112.116(a) to clarify that food-packing
                                                  materials used must be adequate for their intended use, which
                                                  includes being: (1) Cleanable or designed for single use and
                                                  (2) unlikely to support growth or transfer of bacteria.
                                                 --Revision to Sec.   112.116(b) to remove the reference to
                                                  ``sanitizing'' and to make clear the steps taken, including
                                                  the frequency of cleaning or replacing liners, must be
                                                  adequate.
----------------------------------------------------------------------------------------------------------------

A. Growing, Harvesting, Packing, or Holding Both Covered and Excluded
Produce (Sec.  112.111)

    (Comment 330) Some comments generally express support for this
provision. Some comments request further clarification regarding the
requirement to keep covered produce separate from produce not covered
under this rule. One commenter suggests defining ``separate'' as
``preventing the ability of cross-contamination by separating in space
so that covered and non-covered produce is not in direct contact with
one another.'' Another commenter asks FDA to explain how this
requirement would apply to covered and excluded produce items that are
sold together, as in the case of gift baskets. This commenter asks
whether gift baskets with other ingredients such as chocolate, would be
covered under this rule, and whether the place where the non-produce
item is originally packed is a factor is this determination.
    (Response) Section 112.111 requires covered farms to keep covered
produce separate from excluded produce (that is

not grown, harvested, packed or held in accordance with part 112)
during growing, harvesting, packing, and holding as applicable, to
avoid physical contact between the two categories so as to minimize
risk of transfer of pathogens from one to the other. We do not believe
it is necessary to define the term ``separate;'' as used in this
provision, we believe the common meaning of this term to be
sufficiently descriptive for the purposes of conveying the intent of
this requirement.
    For the purposes of part 112, covered produce includes not only
fruits and vegetables, but also mixes of intact fruits and vegetables
(see Sec.  112.1(b)(2)). However, it was not our intent to preclude the
placing together of covered and excluded produce in containers for
distribution, such as in gift baskets. We are revising Sec.  112.111(a)
to make this intent clear. This provision also does not prevent you
from placing covered produce into the same container (such as a gift
basket) with other food items not covered under part 112. Excluded
produce and/or other food items not covered under part 112 must adhere
to all other applicable requirements under the FD&C Act. In addition,
to the extent the establishment that assembles the basket or package is
a mixed-type facility (including a farm mixed-type facility) or other
facility that is required to register with FDA, such an establishment
may be subject to the requirements of part 117, the PCHF regulation.

B. Harvesting Covered Produce (Sec.  112.112)

    (Comment 331) Some comments cite specific circumstances where
contamination is likely and request clarification regarding applicable
requirements under Sec.  112.112. One comment argues that produce is
likely to be contaminated with animal excreta when a flock of birds
land on an iceberg lettuce field, and should not be harvested under
Sec.  112.112 although the excreta may not be visible. According to
this commenter, some farms may routinely harvest produce that has been
in contact with fecal material if the outer layers of the fruit or
vegetable can be removed before depositing it into the harvest
container, as in the case of lettuce. The commenter is concerned that,
in such instances, all surfaces that come in contact with excreta may
not have been identified or removed. Another comment points to an
instance where covered produce comes into contact with water that is
thought to be contaminated, and suggests that such produce should not
be harvested under Sec.  112.112.
    (Response) Section 112.112 requires covered farms to take all
reasonably necessary measures to identify, and not harvest, produce
that is reasonably likely to be contaminated with a known or reasonably
foreseeable hazard. See section IX of this document for a discussion of
the definition of ``known or reasonably foreseeable hazard.'' We have
revised Sec.  112.112 to clarify when and how this provision applies,
and to distinguish it from the related Sec.  112.83. See our discussion
of Sec.  112.83 in section XV of this document. Section 112.112 applies
immediately prior to and during harvest, while Sec.  112.83 applies
during the growing season. Section 112.112 applies generally to covered
farms with respect to all covered produce, while Sec.  112.83 only
applies when under the circumstances there is a reasonable probability
that animals will contaminate covered produce. Section 112.112 applies
generally to all covered produce that is reasonably likely to be
contaminated with any known or reasonably foreseeable hazards covered
under this rule, while Sec.  112.83 applies only when the reasonably
likely source of contamination is animal activity.
    Within Sec.  112.112, we explicitly identify as an example one
known or reasonably foreseeable hazard in relation to harvest
activities, i.e., pathogens are likely to be introduced into or onto
covered produce by animal excreta when it is present. Thus, one
important aspect of Sec.  112.112 is that it requires farms to identify
and not harvest covered produce that is reasonably likely to be
contaminated with animal excreta, or that is visibly contaminated with
animal excreta. We are clarifying in the text of Sec.  112.112 that
identifying and not harvesting covered produce that is reasonably
likely to be contaminated with animal excreta or that is visibly
contaminated with animal excreta requires a visual assessment of all
covered produce to be harvested, regardless of the harvest method used.
This may be achieved by, for example, visually examining each article
of produce and surrounding areas immediately prior to harvesting the
article of produce by hand; or by conducting a visual assessment of all
of the growing area and the produce in the growing area to be harvested
immediately prior to the start of mechanical or hand harvesting.
Underground produce that is not visible prior to harvest must be
visually assessed during harvest to comply with this requirement.
    Section 112.112 includes, but is not limited to, visibly
contaminated articles of covered produce. For example, you would comply
with this provision by not harvesting a head of lettuce if you see
excreta on the head of lettuce. As another example, if you see
significant evidence of crop destruction from animal activity in an
area of your field of carrots, you would comply with this provision by
not harvesting the carrots from that area of the field, even if some of
the carrots (not grazed on) may be intact, to the extent that these
carrots, too, are reasonably likely to be contaminated as a result of
the animal activity.
    Section 112.112 requires that these actions be taken ``immediately
prior to and during harvest.'' We use the term ``immediately prior to .
. . harvest'' in Sec.  112.112 to refer to the time period prior and as
close to commencing harvesting as is practicable. We expect that in
most cases covered farms will choose to take steps to identify covered
produce that may not be harvested ``immediately prior to harvest,''
although this step may also be done during harvest. The required visual
examination is most effective when done as close in time before
beginning harvesting as is practicable, under the circumstances of the
farm's operation, or during harvesting itself. We are not specifying
the exact time period when such visual assessment must be done, given
the practicability of such assessment is dependent, in part, on the
farm's operation and commodity.
    In addition to potential pathogen contamination from animal
activity, there may be other known or reasonably foreseeable hazards
that a covered farm would need to identify and address under Sec.
112.112. We consider, for example, the circumstance a commenter raised
where covered produce may come into contact with water that is likely
to be contaminated with pathogens. In subpart E, we are establishing
requirements related to agricultural water, including that all
agricultural water must be safe and of adequate sanitary quality for
its intended use (Sec.  112.41). Subpart E provides the relevant
requirements for what farms must do when agricultural water does not
meet this standard (Sec.  112.45(a)), or other specific microbial
quality criteria we are establishing for certain uses (Sec. Sec.
112.45(a) and (b)), and therefore, we do not believe additional
standards are needed under Sec.  112.112 with respect to harvesting
based on agricultural water quality. Circumstances may arise, however,
in which water that is likely to be contaminated with known or
reasonably foreseeable hazards, such as flood water, contacts covered
produce. Flood water is outside the definition of agricultural water
established in this rule and is

therefore not subject to the requirements in subpart E. However, both
Sec. Sec.  112.11 and 112.112 apply to flooding situations. In
accordance with Sec.  112.11, covered farms must take appropriate
measures to minimize the risk of serious adverse health consequences or
death from the use of, or exposure to, covered produce, including those
measures reasonably necessary to prevent the introduction of known or
reasonably foreseeable hazards into covered produce as well as to
provide reasonable assurances that the produce is not adulterated under
section 402 of the FD&C Act on account of such hazards. Moreover, in
accordance with Sec.  112.112, a covered farm that has experienced
flooding will be required to assess the extent of flooding and not
harvest covered produce that is reasonably likely to be contaminated
with known or reasonably foreseeable hazards through contact with flood
water.
    (Comment 332) One commenter suggests revising Sec.  112.112 to
provide that ``harvesting covered produce that is visibly contaminated
with excreta should be avoided to the extent practicable.''
    (Response) We disagree with the suggestion to revise Sec.  112.112
to provide that ``harvesting covered produce that is visibly
contaminated with excreta should be avoided to the extent
practicable.'' As discussed in the QAR, it is well established that
animal excreta is a source of pathogens. Transmission of pathogens from
animal excreta to covered produce and, subsequently, to humans through
consumption is reasonably likely in cases where the presence of animal
excreta can be visually confirmed. Therefore, we conclude that covered
produce that is visibly contaminated with animal excreta must not be
harvested. Accordingly, Sec.  112.112 requires that you take all
measures reasonably necessary to identify and not harvest produce that
is reasonably likely to be contaminated with a known or reasonably
foreseeable hazard. Section 112.112 further specifies, to remove any
possible confusion, that this includes taking steps to identify and not
harvest covered produce that is visibly contaminated with animal
excreta. For these reasons, we are not making the requested change.

C. Handling Harvested Covered Produce (Sec.  112.113)

    (Comment 333) One commenter recommends that we include the
following types of explicit and specific requirements in Sec.  112.113,
and that such requirements should also be commodity-specific: ideal
harvest time of day, postharvest chill requirement, chill temperature,
wash requirement(s), wash specifications, and ideal storage
temperature(s). In addition, noting that many produce commodities cut
during harvest grow near or in contact with the soil, the commenter
questions the feasibility of the example provided in Sec.  112.113,
i.e., ``by avoiding contact of cut surfaces of harvested produce with
soil,'' and suggests revising it by adding the phrase ``to the degree
practicable.''
    (Response) Due to the diversity of covered produce commodities and
our desire to allow appropriate flexibility, FDA is not establishing
commodity-specific handling requirements for harvested produce in this
rule. We note, however, that FDA is working on certain commodity-
specific guidance documents. We have issued draft guidances for
tomatoes, melons, and leafy greens and will consider developing
guidances covering other commodities.
    With respect to the comment about the example listed within Sec.
112.113, we agree that adding the phrase ``to the degree practicable''
is appropriate, considering covered produce commodities that are
harvested near the soil line, such as herbs and celery, where avoiding
contact of cut surfaces of harvested produce with soil may not be
practicable. However, Sec.  112.113 requires covered farms to handle
harvested covered produce in a manner that protects against
contamination with known or reasonably foreseeable hazards, including
pathogens that may be present in soil. This includes taking all
measures that are reasonably necessary and practicable.
    Accordingly, we are revising Sec.  112.113 to read as set forth in
the regulatory text of this rule.
    (Comment 334) Several comments support our tentative conclusion not
to require washing of produce after harvesting. Some of these comments
acknowledge that disinfectants added to wash water cannot be expected
to kill all pathogens that may be present on produce, and may also
accelerate decomposition of certain commodities.
    (Response) In light of these comments, and in the absence of new
data or factual information, we are not establishing any requirement to
wash harvested produce in this rule. Wash water, with or without an
active antimicrobial agent, does not completely disinfect produce that
may contain microorganisms of public health significance (Ref. 181)
(Ref. 182) (Ref. 183). Bacteria may find harborage and protection on
plants through hydrophobic areas, stomata, lenticels, punctures, and
bruises and where it is not readily washed off (Ref. 184) (Ref. 185).
As appropriate, farms may choose to wash covered produce, and to add
safe and suitable disinfectants to wash water, according to label
instructions, to reduce the likelihood of produce contamination,
including for example to help prevent the cross-contamination of
surrounding produce with any pathogens that may be introduced into the
wash water from a single fruit or vegetable.
    (Comment 335) Specifically in the context of harvested produce, one
comment requests FDA to require facilities handling ``high-risk''
produce to periodically test the finished product for pathogens, and
cites cantaloupe as an example of a produce commodity that should be
subject to such a requirement.
    (Response) In the 2013 proposed rule (78 FR 3504 at 3533), we
discussed the challenges associated with requiring microbiological
product testing, either routinely or under specific conditions, as a
strategy to minimize known or reasonably foreseeable hazards in covered
produce. We have no new information suggesting that we should change
our conclusion, nor did this commenter provide any new data or factual
information. Therefore, we are not establishing a requirement for
microbiological product testing of covered produce, except as
established in subpart M under certain circumstances for sprouts (Sec.
112.144(b) and (c)). See section III.F of this document.

D. Dropped Covered Produce (Sec.  112.114)

    In Sec.  112.114, we proposed to prohibit you from distributing
covered produce that drops to the ground before harvest (dropped
covered produce) unless it is exempt under Sec.  112.2(b) (i.e. if it
receives commercial processing to adequately reduce the presence of
microorganisms of public health significance). We also proposed to
clarify in this provision that dropped covered produce does not include
root crops (such as carrots) that grow underground or crops (such as
cantaloupe) that grow on the ground. We also noted that produce that is
intentionally dropped to the ground as part of the harvesting method
would not be considered ``dropped covered produce'' as defined in
proposed Sec.  112.114 (i.e., produce that drops to the ground before
harvest). We are finalizing this section with certain changes as
described in the paragraphs that follow.
    (Comment 336) Several comments favor the requirements of this
provision, as proposed. However, one comment expresses a view that this
requirement

should be applied by a farm according to an operational assessment of
risk specific to that farm.
    (Response) We refer you to the discussion in section VII of this
document, where we explain our conclusion not to require covered farms
to conduct operational assessments or develop farm-specific food safety
plans, although we encourage farms to do so voluntarily to identify any
specific risks and operational efficiencies appropriate for their
circumstances. We recognize the importance of tailoring your food
safety practices to the commodities, practices, and conditions
applicable to your individual operation. Covered farms may take steps
to ensure the safety of their dropped covered produce as determined by
a farm-specific operational assessment, as long as those steps are
consistent with and do not violate the requirements of this rule,
including Sec.  112.114.
    (Comment 337) Several comments express that certain produce
commodities are intentionally dropped on the ground as part of their
regular harvesting practice. For example, some comments refer to the
harvesting practices of the tree nut industry in which some types of
tree nuts (e.g. hazelnuts, chestnuts, and almonds) are typically shaken
from the trees onto the ground as part of harvesting, and agree with
our proposal that tree nuts and other commodities that are
intentionally dropped as a part of harvesting should not be covered
under this provision. Other comments request that FDA exclude from this
provision any commodity that has an outer covering (such as a rind or
husk) that is not typically consumed. Some comments generally question
the scientific basis supporting this requirement. These commenters
argue that there is no certainty that pathogens transfer into produce
after contact with the ground, and assert that the likelihood of
pathogens being at the exact spot where the produce drops is remote.
    (Response) In the 2013 proposed rule, we acknowledged that some
produce is intentionally dropped to the ground as a part of the
harvesting practice (e.g., some tree nuts), and that we expect that
such harvesting practices were developed because the fall does not
damage the edible crop, which is protected by a durable shell.
Accordingly, we proposed to define ``dropped covered produce'' within
Sec.  112.114 in a manner that excludes produce that is intentionally
dropped as part of harvesting (i.e., produce that drops to the ground
before harvest). Taking this into account and in light of other
comments (see our response to Comment 338) we are revising Sec.
112.114 to explicitly state that dropped covered produce does not
include produce that is intentionally dropped as part of the harvesting
method (for example, when trees bearing tree nuts, such as almonds, are
intentionally shaken to drop tree nuts to the ground to be harvested).
We note that this rule, including Sec.  112.114, is not applicable to
produce commodities that are identified in 112.2(a)(1) as rarely
consumed raw, such as hazelnuts.
    However, we have concluded that we should not similarly exclude all
produce that has an outer peel that is inedible or not typically
consumed. Evidence from studies of tree fruit (e.g., apples and pears)
indicates that dropped and damaged fruit contain coliform bacteria in
significantly higher numbers than intact tree fruit (Ref. 192). In
addition, risk assessment models for apple contamination (Ref. 193)
show that dropped apples are more likely to be contaminated with
bacteria than tree-picked apples, and dropped fruit used in the
production of apple products (e.g., apple cider) are likely to increase
rates of product contamination (Ref. 193). Moreover, fruits with outer
layers that are inedible or typically not consumed have been implicated
in illness outbreaks. In 2011-2012, outbreak events have been linked to
whole, intact mangoes, papayas, and cantaloupes (Ref. 194) (Ref. 195)
(Ref. 196). Although these outbreak investigations did not conclude
that contamination was a result of dropped produce that was harvested
and sold, each of these fruits has an outer covering that is either
inedible or typically not consumed. Moreover, as discussed in our QAR,
there are limited data on the effect of peeling (and cutting) on the
levels of pathogens across the range of commodities. Some produce
commodities have an inedible rind that is generally removed in such a
way that minimizes the potential for any surface contamination to come
in contact with the edible portion of the fruit. In such commodities,
for example bananas and coconuts, peeling before consumption may
significantly reduce the potential for contamination. However, other
produce commodities (e.g., mangos, oranges, carrots) are usually peeled
in such a way (e.g., using a knife) that contamination on the surface
can be carried to the edible portion of the produce. Thus, FDA
maintains that provision Sec.  112.114 should apply generally to
covered produce with only the exclusions specified in the provision,
irrespective of whether such produce also has an inedible or rarely
consumed outer layer. This conclusion is based on the likelihood of
damage to the outer layer allowing access to the interior of the
commodity, increased rates of contamination observed on some types of
dropped produce, and the uncertainty that having some kind of inedible
or rarely consumed outer layer provides sufficient protection to
counteract these concerns as a general matter.
    (Comment 338) Several comments note that proposed Sec.  112.114, as
worded, suggests that covered produce that is unintentionally dropped
to the ground during harvest would be acceptable for distribution. One
comment recommends revising this provision to clarify that covered
farms must not distribute covered produce that falls to the ground
``before and during harvest.'' Another comment states that dropped
produce should not include produce that is still attached to the plant
at the time of harvest.
    (Response) Covered produce is subject to the requirements in Sec.
112.114 unless it is specifically identified as not being included
within the meaning of ``dropped covered produce.'' Under revised Sec.
112.114, dropped covered produce does not include root crops (such as
carrots) that grow underground, crops (such as cantaloupe) that grow on
the ground, or produce that is intentionally dropped to the ground as
part of the harvesting method (such as almonds). However, produce that
grows off the ground, such as tomatoes and apples, and that drop to the
ground before harvest is considered dropped covered produce, even if
articles of produce are still attached to the plant when they contact
the ground. Moreover, an article of covered produce that drops to the
ground before that specific article can be harvested, regardless of
whether the farm has started harvesting generally, is still dropped
covered produce subject to Sec.  112.114 unless it is otherwise
excluded (e.g., if dropping is an intentional part of the harvesting
process). For example, when an apple drops to the ground before it is
harvested, it is dropped covered produce, whether or not the covered
farm has already begun harvesting apples from that orchard such that
the farm might consider the apple to have unintentionally fallen
``during'' its harvesting of the orchard. The apple in this example
dropped before the apple was harvested.
    (Comment 339) One commenter requests that FDA clarify that dropped
covered produce may be used for personal consumption, for commercial
processing, or for food for animals.

    (Response) We are removing the reference to produce that is exempt
under Sec.  112.2(b) from the codified text of this section. We are
making this change because produce that is exempt from the requirements
of part 112 under Sec.  112.2(b) is exempt from all the requirements in
part 112 except those specified in Sec.  112.2(b). We are concerned
that including a specific reference to exempt produce in Sec.  112.114
might have misleadingly and incorrectly suggested that produce that is
not covered by part 112 (under Sec.  112.2(a), because it is rarely
consumed raw, produced by an individual for personal consumption or
produced for consumption on the farm or another farm under the same
management, or not a RAC), or produce that is exempt from part 112
(under Sec.  112.2(b), because it receives commercial processing that
adequately reduces the presence of microorganisms of public health
significance), is subject to certain requirements other than as
specified in Sec.  112.2. In fact, neither produce that is not covered
by part 112 (under Sec.  112.2(a)), or produce that is exempt from part
112 (under Sec.  112.2(b)) is subject to Sec.  112.114.

E. Packaging Covered Produce (Sec.  112.115)

    (Comment 340) Several comments generally support this provision.
One such comment finds no reason to highlight mushrooms as an example,
and requests removing it from the text of the codified provision. This
commenter states that there have been significant updates to packaging
practices since the research FDA cited, which was conducted in 1978. In
addition, this commenter believes that packaging mushrooms is likely
done in a packinghouse that would be subject to the PCHF regulation,
rather than to the produce safety regulation. Furthermore, some
commenters express a view that it is important to consider whether
Clostridium botulinum (C. botulinum) is a potential hazard for any
commodity, just as it is important to consider all pathogens, and not
just anaerobic bacteria, to ensure appropriate packaging.
    (Response) The provision in Sec.  112.115 requires you to package
covered produce in a manner that prevents the formation of C. botulinum
toxin, if such toxin is a known or reasonably foreseeable hazard. This
requirement applies to the packaging of any covered produce where the
formation of C. botulinum toxin is a known or reasonably foreseeable
hazard. Within this provision, we explicitly list mushrooms as an
example because the formation of C. botulinum toxin in mushrooms, when
packaged under certain conditions, is a known or reasonably foreseeable
hazard. As discussed in the 2013 proposed rule, the potential for toxin
production by C. botulinum in mushrooms packaged under reduced oxygen
conditions is well-established (Ref. 197). Mushrooms grow close to the
ground, which is a source of C. botulinum spores, and mushrooms remain
metabolically active after harvest, which may quickly reduce the amount
of oxygen, particularly when mushrooms are packaged under conditions
that limit the transfer of oxygen across the layer of packaging (Ref.
198). In such reduced oxygen or anoxic conditions, C. botulinum spores
can germinate and multiply resulting in the formation of botulinum
toxin, which can occur before any overt signs of mushroom spoilage
(Ref. 197). Therefore, we continue to believe that mushrooms are an
appropriate example.
    Modified atmosphere or other reduced-oxygen packaging of produce
other than mushrooms may present a similar risk for botulinum toxin
formation (Ref. 199). Therefore, it would be incorrect to infer that
packaging of mushrooms is the only circumstance where C. botulinum
toxin formation is a known or reasonably foreseeable hazard. We
continue to include mushrooms as an example, but they are only an
example.
    Moreover, covered farms must ensure their food packing (including
food packaging) material is adequate for its intended use, as required
in Sec.  112.116 (discussed in the paragraphs that follow). Section
112.116 relates to all pathogens, and is not limited to C. botulinum
toxin. Section 112.115 goes beyond the packing material requirements in
Sec.  112.116 and applies specifically to the hazard of formation of C.
botulinum toxin. Whereas Sec.  112.116 is aimed at ensuring that
packing materials themselves do not introduce hazards into produce,
Sec.  112.115 is aimed at the specific hazard of C. botulinum toxin
when produce is packaged in a manner that allows C. botulinum spores to
germinate and multiply, resulting in the formation of botulinum toxin,
which can occur before any overt signs of spoilage of the produce. A
farm using reduced oxygen packaging might comply with this requirement
by applying means to reduce the potential for toxin formation. For
example, perforated packaging film allows free air access and is a
means to reduce the potential for toxin formation in mushrooms (Ref.
200) (Ref. 201). Other means of preventing toxin formation in reduced
oxygen packaging may include use of time-temperature integrators on
individual packages of produce to signal when a cumulative time-
temperature combination has been reached that presents a risk for C.
botulinum toxin formation, or use of antimicrobial compounds (Ref.
199). Scientific information should support the use of methods used to
prevent toxin formation, such as use of perforated packaging film,
time-temperature integrators and antimicrobial compounds.
    We also note that, even if some packing or packaging of mushrooms
may be done in facilities subject to the PCHF regulation, it is also
likely that covered farms will conduct relevant activities within the
coverage of the produce safety regulation. The definition of ``farm''
as provided in both this regulation (in Sec.  112.3(c)) and the PCHF
regulation includes packing of RACs, and packaging of RACs when such
packaging does not include additional manufacturing/processing. An
example of additional manufacturing/processing is irradiation. However,
Sec.  112.115 applies to packaging that does not include additional
manufacturing/processing; such packaging includes modified atmosphere
packaging and other methods of packaging of covered produce in a manner
that creates anaerobic conditions where the formation of C. botulinum
toxin is a known or reasonably foreseeable hazard. For example,
packaging of mushrooms or other covered produce in semipermeable
plastic films is a covered activity that fits within the farm
definition and is, therefore, subject to this rule and to Sec.
112.115.
    Accordingly, we are finalizing Sec.  112.115, as proposed, with no
changes.

F. Food-Packing (Including Food Packaging) Material (Sec.  112.116)

    (Comment 341) Several comments agree that food-packing and
packaging material must be adequate for its intended use. One comment
requests clarification of what is meant by ``adequate for its intended
use,'' and suggests incorporating the following text from the preamble
of the 2013 proposed rule into the codified provision: ``To implement
this provision, you would have to use food-packing materials that are:
(1) Cleanable or designed for single use and (2) unlikely to support
growth or transfer of bacteria.''
    (Response) In the 2013 proposed rule, we provided some examples of
what food-packing material would be adequate for its intended use in
compliance with Sec.  112.116(a). For

example, food packing material that is adequate for its intended use
includes plastic bins for holding fresh-picked fruit, wax impregnated
corrugated cardboard for broccoli to be hydro-cooled or top-iced after
packing, plastic clamshells used for packaging strawberries for retail
sale, and single-use cardboard containers for packing tomatoes. Wooden
bins or boxes, and canvas bags that are used during harvest also must
meet the requirement in Sec.  112.116(a), and can be used if they are
adequately clean and sanitary for their intended use. This section
requires that you use food-packing materials that are adequate for
their intended use, which includes being: (1) Cleanable or designed for
single use and (2) unlikely to support growth or transfer of bacteria.
We are revising Sec.  112.116(a) to include this additional
information.
    (Comment 342) Several comments discuss the use of containers (or
bags or sacks) made from wooden, plastic, or cloth-like materials and
pulp materials, as well as decorative containers used to enhance retail
presentation. Many of these comments discuss the variety of on-farm and
off-farm uses of such containers, and request that we allow the
continued use of wooden containers and other porous materials during
harvesting. Several other commenters point out requiring farms to
switch to plastic containers would cause significant economic burden
and may also result in loss of crop due to reduced air flow observed
with plastic packing materials.
    (Response) The only restriction we are establishing on the types of
food packing materials you may use for covered produce is that such
materials must be adequate for their intended use (Sec.  112.116(a)).
As discussed in response to Comment 341, this includes being (1)
cleanable or designed for single use and (2) unlikely to support growth
or transfer of bacteria. Thus, you may re-use food-packing material
provided that it is cleanable and it is unlikely to support growth or
transfer of bacteria. Moreover, if you re-use food packing material,
you must take steps to ensure that food-contact surfaces are clean; for
example, you must clean the food packing containers or use a clean
liner on the food packing container to protect produce from
contamination (Sec.  112.116(b)). The necessary frequency of such
cleaning, and the necessary frequency with which liners must be
replaced, will likely vary depending on the circumstances. Therefore we
are not specifying a single required cleaning frequency in this
regulation. However, we are revising this section to make clear that
the steps you take, including the frequency of cleaning or replacing
liners, must be adequate.
    We are not requiring farms that use wooden or other porous food
packing materials to stop using them, but we are requiring that such
materials be used only to the extent they are cleanable and unlikely to
support the growth or transfer of bacteria. As noted in the 2013
proposed rule, although some food-packing materials are sufficiently
sturdy to be used multiple times, such materials may serve as a source
of contamination if they are not adequately clean and/or if the
material is used beyond its shelf life and adequate cleaning cannot be
achieved.
    (Comment 343) One comment generally supports requiring that food-
contact surfaces of reusable food packing material be cleaned and
sanitized between uses. In contrast, a few comments object to provision
Sec.  112.116(b) to the extent it may require sanitizing food
containers. One such comment states that it is not feasible for farmers
to sanitize all harvest containers, and another comment notes some
current practices involve using wooden bins, carpet-cushioned or
cardboard-cushioned trailers and transporters, and other materials that
cannot be sanitized. Yet another comment states that wooden bins used
on farms during harvesting should be required to be kept clean, but not
required to be sanitized.
    (Response) We are not requiring you to sanitize all food packing
containers or food-contact surfaces that you re-use during harvesting,
packing, or holding of covered produce. Rather, per Sec.  112.116(a),
you must use food-packing material that is adequate for its intended
use and, per Sec.  112.116(b), if you re-use a food packing container,
you must take measures to ensure that the food-contact surfaces of that
container are clean. We recognize the use of ``sanitizing'' in the
example we provided within proposed Sec.  112.116(b) (i.e., ``such as
by cleaning and sanitizing, when necessary, food-packing containers'')
is confusing and implies a requirement that goes beyond that described
in the established measure (i.e., ``if you reuse food-packing material,
you must take steps to ensure that food-contact surfaces are clean'').
Therefore, we are revising Sec.  112.116(b) by removing the reference
to ``sanitizing'' such that the provision reads as follows: ``if you
reuse food-packing material, you must take adequate steps to ensure
that food-contact surfaces are clean, such as by cleaning food-packing
containers or using a clean liner.''
    However, under Sec.  112.111(b), you are required to adequately
clean and sanitize, as necessary, any food-contact surfaces that
contact excluded produce before using such food-contact surfaces for
covered activities on covered produce. For example, if you use food
packing containers that were previously used to pack or hold excluded
produce, and the excluded produce is not grown, harvested, packed, or
held in accordance with part 112, you must clean and sanitize, as
necessary, the food-contact surfaces of the containers that came into
contact with the excluded produce before subsequently using the same
containers for packing covered produce. In summary, taking adequate
steps to ensure that food-contact surfaces of food-packing materials
are clean is required whenever you are re-using food packing material
for covered produce, and sanitizing such surfaces is also required, as
necessary, when re-using such materials after using them on excluded
produce not handled in accordance with part 112.

XVII. Subpart L--Comments on Equipment, Tools, Buildings, and
Sanitation

    In subpart L of proposed part 112, we proposed to establish
science-based minimum standards that are reasonably necessary to
prevent equipment, tools, buildings, and inadequate sanitation from
introducing known or reasonably foreseeable hazards into or onto
covered produce or food-contact surfaces, and to provide reasonable
assurances that the covered produce is not adulterated under section
402 of the FD&C Act. We asked for comment on the proposed provisions of
this subpart.
    We are finalizing these provisions with revisions (see Table 23).
We discuss these changes in this section.

             Table 23--Description of Revisions to Subpart L
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.121...............  --Revisions to delete the term ``other
                                contamination'', and replace
                                ``undesirable microorganisms'' with
                                ``microorganisms of public health
                                significance''.

Sec.   112.123(d)............  --Revision to move ``when necessary and
                                appropriate'' before ``sanitize'' to
                                clarify applicability.
Sec.   112.124...............  --Revisions to delete the term ``other
                                contamination'', and replace
                                ``undesirable microorganisms'' with
                                ``microorganisms of public health
                                significance''.
Sec.   112.126...............  --Revision to eliminate proposed Sec.
                                112.126(a)(3) and, instead, establish
                                new provision Sec.   112.126(b)
                                requiring measures to prevent
                                contamination of covered produce and
                                food contact surfaces in buildings, as
                                appropriate, considering the potential
                                for contamination through floors, walls,
                                ceilings, fixtures, ducts, or pipes, and
                                drip or condensate.
Sec.   112.129...............  --Revision to clarify the required
                                frequency of servicing and cleaning
                                toilet facilities.
Sec.   112.130...............  --Revision to amend the list of examples
                                of adequate drying devices (removing
                                clean cloth towels and adding electric
                                hand dryers).
                               --Revision to use the term ``antiseptic
                                hand rubs'' in lieu of ``hand antiseptic/
                                sanitizer or wipes''.
                               --Revision to permit the use of ``other
                                effective surfactants'' in lieu of soap.
Sec.   112.140...............  --No change.
------------------------------------------------------------------------

    We are finalizing the other provisions of subpart L as proposed.
For Sec. Sec.  112.127, 112.128, 112.131, 112.132, 112.133, and
112.140, we did not receive any comments or received only general
comments in support of the proposed provision and, therefore, we do not
specifically discuss these provisions.

A. Types of Buildings That Are Subject to the Requirements of Subpart L
(Sec.  112.122)

    (Comment 344) Some comments express concern with the applicability
of the proposed provisions in subpart L to greenhouses (including high
tunnels), germination chambers, or other protected environment
production areas. A comment states that applying the proposed building
requirements to greenhouses would negatively impact small farmers in
areas without a warm climate for most of the year, such as in the North
east, where farmers rely on greenhouses to grow produce throughout the
year. Other comments contend that protected environment production
areas enable farms to control various aspects of growing, such as
humidity, temperature, or light, and believe it is highly improbable
that a pathogen of public health significance would find its way into
the controlled system.
    (Response) The provisions in subpart L apply to any fully or
partially-enclosed buildings used for covered activities, including
greenhouses, germination chambers, or other such structures. These
structures used for growing activities can create an enclosed system
where potential hazards can be amplified (Ref. 202). Therefore, we do
not agree that greenhouses, high tunnels, germination chambers, or
``protected environment production areas'' should be generally exempt
from the standards in subpart L.
    We do not discourage the practice of growing produce inside
greenhouses, germination chambers, or other such structures nor do we
intend our requirements in subpart L to specifically impact small farms
that use such structures for growing produce. Rather, our concern is to
establish those procedures, processes, and practices that are
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto covered produce or food-contact
surfaces, and to provide reasonable assurances that the covered produce
is not adulterated under section 402 of the FD&C Act. In response to
these and other comments, we reviewed the provisions in subpart L to
determine their appropriateness and practicability when applied to
greenhouses (including high tunnels), germination chambers, and other
such structures used for growing covered produce. We are deleting one
provision in subpart L (i.e., Sec.  112.126(a)(3)) and replacing it
with a new provision we believe is more appropriate to apply to all
covered farm buildings, including greenhouses, germination chambers,
and other such structures (see Comment 352).
    (Comment 345) Some comments state many existing on-farm structures
will likely not meet the proposed building requirements, and one
comment additionally states there are no data available on the number
or quality of on-farm buildings such as packing sheds and storage
facilities.
    (Response) We used available data sources to inform proposed
provisions and our estimates of economic burden associated with the
provisions in subpart L (Ref. 142). Under Sec.  112.122(b), storage
sheds, buildings, or other structures used to store food-contact
surfaces (such as harvest containers and food-packing materials) are
subject to the requirements of subpart L. We believe it is important to
apply the science-based minimum standards in subpart L to such
buildings because contaminated food-contact surfaces can contaminate
covered produce (Ref. 203) and, thus, present a potential hazard.

B. Equipment and Tools (Sec.  112.123)

    (Comment 346) Some comments recommend covered farms be allowed to
clean equipment and tools as an alternative to the requirement related
to storage and maintenance of equipment and tools in proposed Sec.
112.123(b)(2).
    (Response) We are establishing the requirement in Sec.
112.123(b)(2) because appropriate practices for storing and maintaining
equipment and tools can protect against contamination and reduce the
potential for attracting or harboring pests, which can carry human
pathogens. Pest harborage by equipment not only can contaminate the
equipment; it can also increase the prevalence of pests near a
building, and provide a place for them to live and breed. We have
included sufficient flexibility in this requirement such that you may
store equipment and tools in a manner that is practical but also
protects against contamination and prevents attraction and harborage of
pests. For example, you may satisfy this requirement by storing
equipment indoors or outdoors, provided that the location appropriately
protects against contamination and you appropriately minimize
surrounding debris, check periodically for pests, and take any other
measures reasonably necessary under the circumstances. Separate and
distinct from this requirement regarding storage and maintenance is the
provision in Sec.  112.123(d)(1), which requires you to inspect,
maintain, and clean and sanitize (when necessary and appropriate) all
food-contact surfaces of equipment and tools used in covered
activities. This provision is intended to prevent transfer of
contaminants on food-contact surfaces of equipment or tools to covered
produce. Appropriate storage, maintenance, and cleaning of equipment
are all reasonably necessary to minimize the risk of produce

contamination, and we disagree that cleaning of equipment and tools
alone should relieve a covered farm of the need for proper storage and
maintenance of equipment and tools.
    (Comment 347) Two comments question the applicability and
practicality of the requirement to ``sanitize'' food-contact surfaces
of equipment and tools under Sec.  112.123(d)(1) with respect to the
knife that cuts the asparagus below the ground if the part of the spear
that the knife contacts is cut off before the spear is shipped to
consumers. One comment acknowledges that asparagus was not covered
under the 2013 proposed rule, and asks us to clarify what would be
required with respect to sanitation of ``asparagus boxes'' containers,
if asparagus were to be covered by the final rule.
    (Response) We are establishing the requirement in Sec.
112.123(d)(1) taking into account evidence that pathogens can be
transferred to produce from contaminated coring devices and
contaminated food-contact surfaces of tools (Ref. 204) (Ref. 205). We
acknowledge that sanitizing all food-contact surfaces of equipment and
tools used in covered activities is impractical, considering the wide
range of equipment and tools used in covered activities and the
diversity of produce growing, harvesting, packing, and holding
practices. Therefore, in Sec.  112.123(d)(1), we are requiring you to
sanitize only when necessary and appropriate, but to always inspect,
maintain, and clean all food-contact surfaces of equipment and tools
used in covered activities, and to do so as frequently as reasonably
necessary to protect against contamination of covered produce. As the
commenter noted, asparagus is not covered under this rule because it is
rarely consumed raw (see Sec.  112.2(a)(1)).
    (Comment 348) With respect to proposed Sec.  112.123(d)(2) related
to non-food-contact surfaces, some comments point out that non-food-
contact surfaces (such as on trailers, tractors, and vehicles) are, by
definition, not expected to come into contact with produce and, as
such, are rarely designed to be cleaned to the same degree of
cleanliness as food-contact surfaces. These comments request us either
to provide clarification on how operations would be expected to
implement this requirement or to delete this requirement.
    (Response) As discussed in the 2013 proposed rule, the potential
for equipment or a tool to come into contact with covered produce
varies with the type and intended use of the equipment or tool. Non-
food-contact surfaces of tools and equipment used with covered produce
can be sources of contamination. Therefore, it is important to maintain
such surfaces of covered equipment and tools in a clean and sanitary
condition. However, we acknowledge that such surfaces may not require
cleaning as frequently as those that come into direct contact with
produce, and also may not require sanitizing. Under this provision, you
are required to maintain and clean all non-food-contact surfaces of
equipment and tools used in covered activities during harvesting,
packing, and holding as frequently as reasonably necessary to protect
against contamination of covered produce. We provide examples of
equipment and tools subject to the requirements of subpart L in Sec.
112.121.
    In contrast to the requirements regarding food-contact surfaces in
Sec.  112.123(d)(1), the requirements related to non-food-contact
surfaces in Sec.  112.123(d)(2) do not require sanitizing such
surfaces. As an example, the blades and conveyors in a harvesting
machine that directly contact produce are considered a food-contact
surface, but the portion of the truck that is used to hold boxes or
crates containing harvested produce is not a food-contact surface.
Likewise, the brush rollers on a sorting or grading machine where the
rollers come in direct contact with the produce are food-contact
surfaces, and must be inspected, maintained, and cleaned and, as
necessary and appropriate, sanitized per Sec.  112.123(d)(1). In
contrast, a gear box attached to the rollers that does not come into
contact with produce is a non-food-contact surface, and must be
maintained and cleaned per Sec.  112.123(d)(2).

C. Instruments and Controls Used To Measure, Regulate, or Record (Sec.
112.124)

    (Comment 349) One comment generally supports proposed Sec.
112.124. Another comment requests clarification regarding what is meant
or intended by ``other contamination''.
    (Response) We are revising Sec. Sec.  112.121 and 112.124 to delete
the term ``other contamination'' and to replace ``undesirable
microorganisms'' with ``microorganisms of public health significance.''
The requirements in this rule are intended to address microorganisms of
public health concern and not all forms of contamination or undesirable
microorganisms generally.

D. Equipment Used in the Transport of Covered Produce (Sec.  112.125)

    (Comment 350) Some comments express concern that requiring cleaning
of surfaces that come into contact with covered produce during their
transport would be problematic for the watermelon industry. Comments
state that harvest transportation from field to packing shed for
watermelons is often done by using buses that are adapted for this
purpose by, for example, covering the interior of the bus at the
beginning of the season with either carpet or cardboard to cushion and
protect the watermelons from damage and pathogen contamination from
bruises or cuts that could occur during transport.
    (Response) Section 112.125 is not prescriptive about the manner in
which farms ensure that their equipment used to transport covered
produce is adequately cleaned before use in transporting covered
produce and is adequate for use in transporting covered produce. This
provision requires covered farms to take measures to minimize the risk
that equipment used during transportation becomes a potential source of
contamination of covered produce. In the specific instance described in
these comments, we expect the cushioning material(s) that comes into
contact with the watermelons to be adequately cleaned prior to
transportation and to be adequate for its intended use (meaning it must
be cleanable or designed for single use, and unlikely to support growth
or transfer of bacteria).

E. Buildings (Sec.  112.126)

    (Comment 351) One comment states that, under proposed Sec.
112.126, a cooler in a packing house would be required to have 18'' of
separation from the wall around the entire perimeter on the inside of
the cooler, such that a 10,000 sq. ft. cooler might lose 5 percent of
its floor space. This comment also notes that such a requirement would
discriminate against smaller operations, and also create an unsafe
working environment due to ``free standing'' stacks of bins.
    (Response) Under Sec.  112.126(a)(1)(i), buildings must provide
sufficient space for placement of equipment and storage of materials.
We are not establishing a precise amount of space needed for the
placement or storage of materials, or a minimum distance required
between an interior wall and any stacked bins or pallets. The intent of
this provision is to ensure that buildings are spacious enough for the
maintenance of sanitary operations and the conduct of covered
activities. In the specific circumstance

described by the commenter, space between the bins or pallets and the
interior wall is not necessary if the bins or pallets can be moved to
allow for cleaning activities.
    (Comment 352) Some comments express concern regarding proposed
Sec.  112.126(a)(3) requiring that buildings must be constructed in a
manner such that drip or condensate does not contaminate covered
produce, food-contact surfaces, or packing materials. Comments note, by
nature of the indoor growing process or cold-storage process, it would
be impossible to prevent formation of condensate. Comments also note
condensate sometimes is present in a produce growing room but that
because growing rooms are cleaned and sanitized between each crop, the
condensation does not come from an unsanitary surface and, therefore,
poses no threat of contamination. Comments object to this proposed
requirement particularly with respect to its applicability to certain
types of buildings, such as greenhouses (including high tunnels) and
cold storage buildings. Comments recommend excluding greenhouses
(including high tunnels and low tunnels) and other season-extending,
non-permanent structures used for growing, as well as cold storage
buildings from coverage under proposed Sec.  112.126(a)(3) and/or
creating alternative standards, recognizing that condensation cannot be
prevented in such buildings.
    (Response) Proposed Sec.  112.126(a)(3) would have applied equally
to fully-enclosed structures used in growing activities as it would to
storage sheds, packing sheds, barns, or other farm buildings used for
packing or holding activities, and would have required that buildings
be kept in good repair so as to prevent drip or condensate from pipes
or ceilings to drop onto covered produce or food-contact surfaces. Upon
review of these comments, we agree there is a need to incorporate
flexibility in the implementation of this provision to account for
differences inherent to certain covered activities conducted in fully-
or partially-enclosed buildings. For example, condensation is a common
occurrence in fully-enclosed buildings used for growing activities
(such as greenhouses, including high tunnels, which are substituting
for growing conditions in an open field), and may not represent a
likely source of contamination of covered produce if produce is
physically protected from condensate drip or the interior of the fully-
enclosed building (such as walls and ceiling) where condensate is
formed (and may drip onto covered produce) is kept adequately clean.
Similarly, condensation is a natural phenomenon during storage under
high relative humidity conditions and if produce is physically
protected from condensate drip or the interior of such cold-storage
building is adequately clean, any condensate that forms on walls or
ceiling is not likely to be a potential source of contamination. We are
making revisions to the codified text so that a covered farm is
required to take measures necessary to protect covered produce and
food-contact surfaces from potential contamination from building
surfaces such as floors, walls, ceilings, fixtures, ducts, or pipes,
and generally through condensation or drip from these or other
surfaces, rather than requiring farms to prevent condensation or drip
contact with covered produce or food-contact surfaces.
    We are deleting proposed Sec.  112.126(a)(3) and replacing it with
a new provision under Sec.  112.126(b), which requires that covered
farms implement measures to prevent contamination of covered produce
and food-contact surfaces in the farm's buildings, as appropriate,
considering the potential for such contamination through: (1) Floors,
walls, ceilings, fixtures, ducts, or pipes; and (2) drip or condensate.
For example, to comply with this provision, you must consider whether
for your growing or storage practices in your buildings, the occurrence
of drip or condensate presents a potential for contamination of your
covered produce, and take measures to minimize or prevent that
potential for contamination. Such measures include, for example,
keeping buildings in good repair so as to prevent leakage of rainwater
into the walls or ceilings of buildings, so that any drip or condensate
from overhead pipes or ceilings that may drop onto covered produce or
food-contact surfaces does not contaminate covered produce. Such
measures also include adequately and regularly cleaning fixtures,
ducts, or pipes inside the building where covered activities occur in
order to minimize the presence or persistence of hazards, such as in
biofilms, and the potential for contamination of covered produce.
    (Comment 353) With respect to the requirement in proposed Sec.
112.126(a)(3) that buildings must be constructed in a manner such that
floors, walls, ceilings, fixtures, ducts, and pipes can be adequately
cleaned and kept in good repair, one comment suggests that this
requirement may preclude use of certain older barns, and further
asserts that ``modern'' warehouses have been associated with foodborne
illnesses.
    (Response) It is not our intent to preclude the use of any specific
types of buildings or barns; rather, we are establishing the provisions
in subpart L to ensure that buildings used in covered activities are
suitable and facilitate sanitary operations, and can be adequately
cleaned and maintained to prevent contamination of the covered produce,
food-contact surfaces, or packing materials. We are deleting Sec.
112.126(a)(3) and replacing it with a new provision under Sec.
112.126(b) that we believe is more appropriate to apply to all covered
farm buildings (see our response to Comment 352). We have no data or
information to suggest that large warehouse-like structures pose a
greater risk of produce contamination compared to smaller barn-like
structures, and the commenter provided no data to support this claim.
    (Comment 354) One comment expresses concern that proposed Sec.
112.126(a)(3) would require farms to prevent the pooling of water on
the floor and lay out the crops in a manner that workers may move
freely without their clothes touching the produce.
    (Response) We are deleting proposed Sec.  112.126(a)(3) and
replacing it with a new provision under Sec.  112.126(b); see Comment
352. Under Sec.  112.126(a)(2), you must provide adequate drainage in
all areas where normal operations release or discharge water or other
liquid waste on the ground or floor of the building. We acknowledge the
potential for small pools of water to temporarily form on the floor of
buildings used for growing activities, and that pooling of water of
this nature, which is temporary and may occur in the normal course of
watering practices, is not reasonably likely to contribute to the
contamination of covered produce. We are not suggesting that it will
always be possible to eliminate pooling. Avoiding pooling by careful
control of greenhouse watering practices with consideration to your
drainage system is ideal; however, to the extent pooling may be
inevitable or may sometimes occur, despite adequate drainage, we expect
covered farms to take steps to protect covered produce from any
contamination that may build in the pooled water. Moreover, Sec.
112.126(a), which addresses building design and construction
requirements, does not impose any specifications regarding crop layout
in buildings used for growing activities or establish measures for
movement of workers within covered areas in a building. Rather, a
covered farm is required to implement measures related to worker health
and hygiene in accordance with subpart D of part 112.

F. Toilet Facilities (Sec.  112.129) and Hand-Washing Facilities (Sec.
112.130)

    (Comment 355) A few comments note that it is not necessary for
toilet facilities to be cleaned ``on a schedule'', and request that
Sec.  112.129(b)(2) be revised to remove the reference to a schedule
and require instead that they must be ``serviced and cleaned at a
frequency sufficient to ensure suitability of use.''
    (Response) We intend for this requirement to provide flexibility
for covered farms to determine the frequency of servicing necessary to
keep the toilet facilities clean and suitable for use. We are revising
this provision, as suggested by commenters, to make our intent more
clear.
    (Comment 356) One comment recommends that the requirements
applicable to toilet facilities (in Sec.  112.129) and hand-washing
facilities (in Sec.  112.130) should either simply reference OSHA field
sanitation standards in 29 CFR 1928.110 or mirror those standards as
closely as possible to avoid confusion and conflicting requirements.
    (Response) The requirements for toilet and hand-washing facilities
in Sec. Sec.  112.129 and 112.130 are generally similar and consistent
with the requirements in the United States Occupational Safety and
Health Administration's (OSHA) field sanitation standards in 29 CFR
1928.110, although the OSHA standards are more prescriptive in some
provisions. For example, whereas we are establishing a general
requirement that you must provide personnel with adequate, readily
accessible toilet facilities, including facilities readily accessible
to growing areas during harvesting activities (Sec.  112.129(a)), the
OSHA standards include specific requirements on the number and
proximity of such facilities. The field sanitation standards in 29 CFR
1928.110 specify that one toilet facility and one hand-washing facility
must be provided for each twenty employees or fraction thereof (with
additional exception) (paragraph (c)(2)(i)), and that the toilet and
hand-washing facilities shall be located within a one-quarter-mile walk
of each hand laborer's place of work in the field (paragraph
(c)(2)(iii)).
    Nevertheless, we disagree that the toilet and hand-washing
provisions in part 112 should simply refer to the field sanitation
standards in 29 CFR 1928.110. Unlike the OSHA field sanitation
standards, the requirements in Sec. Sec.  112.129 and 112.130 relate
specifically to the growing, harvesting, packing, and holding of
covered produce, with a focus on minimizing the risk of contamination
of covered produce, food-contact surfaces, or areas used for a covered
activity with human waste or by ill or infected workers. Moreover, the
OSHA field sanitation standards apply only to an agricultural
establishment where 11 or more employees are engaged on any given day
in hand-labor operations in the field. (As defined in paragraph (b) of
that regulation, hand-labor operations exclude those conducted in
permanent structures such as in packing houses). It is not clear that
this scope, established for the purposes of the OSHA field sanitation
standards, sufficiently addresses the covered farms and covered
activities defined in this rule for the purposes of produce safety
standards. Therefore, we decline the request to simply refer to 29 CFR
1928.110 in lieu of establishing requirements for toilet and hand-
washing facilities in part 112. Compliance with our provisions for
toilet and hand-washing provisions in part 112 do not preclude
compliance with OSHA field sanitation requirements, and we believe our
requirements in part 112 can be met concurrently with those of OSHA
field sanitation.
    (Comment 357) According to one comment, hand-washing stations are
typically located together with field toilets and, in the case of open
fields, it would not be possible or realistic to have a hand-washing
station located in a fully-enclosed building.
    (Response) We are not requiring hand-washing stations to be located
inside a fully-enclosed building. Rather, under Sec.  112.129(c),
during growing activities that take place in a fully-enclosed building,
and during covered harvesting, packing, or holding activities, you are
required to provide a hand-washing station that is in sufficiently
close proximity to toilet facilities, such that it is practical for
persons who use the toilet facility to wash their hands.
    (Comment 358) One comment generally notes that employers must
provide agricultural workers with necessary training, protective
equipment, and hygienic supplies (such as enough clean bathrooms and
hand-washing facilities) while working on the farm.
    (Response) We agree that employers must provide agricultural
workers with necessary training, and hygienic supplies while working on
the farm. In this subpart L, we are finalizing provisions Sec. Sec.
112.129 and 112.130 to establish requirements for toilet and hand-
washing facilities, and in subpart C of this rule, we are establishing
requirements related to worker training.
    (Comment 359) With respect to the provision related to hand-drying
devices in proposed Sec.  112.130(b)(3), one comment recommends that
the use of ``clean cloth towels'' be limited to operations where only
one person would be using the ``clean cloth towel'' to dry their hands.
This comment notes that use of a ``clean cloth towel'' to dry multiple
persons' hands should not be allowed as this is likely to facilitate
the transference of pathogens (if present) from one towel user to the
next. An additional comment notes that the example of ``clean cloth
towels'' listed as an adequate drying device conflicts with OSHA's
requirement of single-use towels. Finally, another comment requests
that we provide for use of electric hand dryers because the quality of
drying from these devices can be similar to paper towels.
    (Response) Under OSHA's field sanitation standards, a ``hand-
washing facility'' means a facility providing a basin, container, or
outlet with an adequate supply of potable water, soap and single-use
towels (29 CFR 1928.110). In light of the OSHA definition and comments,
we are revising Sec.  112.130(b)(3), which requires that hand-washing
facilities be furnished with adequate drying devices, to revise the
examples of ``adequate drying devices'' to no longer include ``clean
cloth towels'' because the repeated use of towels or use by multiple
users can increase the potential for contamination (Ref. 103). We are
also revising the list of examples to include electric hand dryers,
which we agree can be adequate drying devices. We acknowledge that this
provides additional flexibility compared to OSHA's field sanitation
standards; however, this provision does not prevent covered farms that
are subject to this OSHA requirement from complying with the OSHA
requirement. We also note that our list of examples is not intended to
be exhaustive.
    (Comment 360) With respect to the provision related to hand
antiseptic/sanitizer in proposed Sec.  112.130(d), some comments state
that although hand antiseptic/sanitizer or wipes may not be a
substitute for soap and water, this requirement prohibits the use of
future innovation in hand sanitizers. Comments recommend revising this
requirement to read ``. . . as a substitute for soap and water unless
validated by the manufacturer as effective for that purpose.''
    (Response) As discussed in the 2013 proposed rule, ``hand
sanitizers'' have not been found to be effective

substitutes for washing hands with soap and water, because the presence
of dirt, grease, or soil reduces their effectiveness in eliminating
bacteria. However, we are not prohibiting the use of antiseptic hand
rubs because such products may be effective as an additional measure in
reducing the number of bacteria on hands after proper washing with soap
and water followed by drying. Should there be advancements in product
development in this area, we will consider revisiting this issue in the
future, as needed. We recognize, however, that effective surfactants
other than soap may be used in lieu of soap during hand-washing, and we
are revising Sec.  112.130(d) to be consistent with Sec.
112.130(b)(1), which we are retaining as proposed. We are also revising
Sec.  112.130(d) to use the term ``antiseptic hand rubs'' to
collectively refer to leave-on antiseptic products, such as hand
sanitizers or wipes.

G. Controlling Animal Excreta and Litter From Domesticated Animals
(Sec.  112.134)

    (Comment 361) One comment requests clarification on whether Sec.
112.134 would allow cats and dogs to be present on produce farms if the
farmer can demonstrate reasonable precautions that can reasonably
minimize the risk of their excreta contaminating covered produce.
    (Response) You are permitted to have cats or dogs on your covered
farm, provided that under Sec.  112.134 you (1) adequately control
their excreta and litter and (2) maintain a system for control of their
excreta and litter. These measures are necessary to prevent
contamination of covered produce, food-contact surfaces, areas used for
a covered activity, agricultural water sources, and agricultural water
distribution systems with waste from your cats or dogs. In addition,
you must comply with the requirements of Sec.  112.127 regarding
domesticated animals in and around a fully-enclosed building, and, when
applicable, the requirements related to animals in subpart I.

XVIII. Subpart M--Comments on Sprouts

    In subpart M of proposed part 112, we proposed to establish
science-based minimum standards specific to the growing, harvesting,
packing and holding of sprouts that are reasonably necessary to
minimize the risk of known or reasonably foreseeable hazards that are
associated with serious adverse health consequences or death (in
combination with the standards in other subparts of part 112 that also
would apply to sprout operations). We tentatively concluded that it is
necessary to incorporate this subpart establishing additional standards
specific to sprouts because sprouts present a special concern with
respect to human pathogens compared to other covered produce. We asked
for comment on our proposed provisions in subpart M for sprouts,
including on whether, or to what extent, the measures in this subpart
should be applied to soil-grown sprouts; and on whether, in a final
rule, a food safety plan and/or an operational assessment should be
required for farms conducting covered activities related to sprouts,
either in addition to, or in place of, the standards proposed in this
subpart. We also requested comments on whether a supplier approval and
verification program for seeds and beans intended for sprout production
is practical and effective.
    We are finalizing these provisions with several revisions (See
Table 24). We discuss these changes in this section.

             Table 24--Description of Revisions to Subpart M
------------------------------------------------------------------------
                                                       Description of
      Proposed provision         Final provision         revisions
------------------------------------------------------------------------
                                Sec.   112.141...  --New section to
                                                    describe the scope
                                                    of subpart M.
Sec.   112.141................  Sec.   112.142...  --Revision to combine
                                                    all requirements for
                                                    seeds and beans into
                                                    Sec.   112.142.
                                                   --Revision to Sec.
                                                    112.142(b) to
                                                    include a
                                                    requirement to
                                                    discontinue use of a
                                                    lot of seeds or
                                                    beans that you know
                                                    or have reason to
                                                    believe may be
                                                    contaminated with a
                                                    pathogen due to
                                                    association with
                                                    foodborne illness or
                                                    positive microbial
                                                    test results and
                                                    adding actions that
                                                    must be taken with
                                                    regard to a lot that
                                                    may be contaminated.
                                                   --Revision to
                                                    establish in Sec.
                                                    112.142(c) certain
                                                    limited
                                                    circumstances under
                                                    which you are not
                                                    required to take the
                                                    steps set forth in
                                                    Sec.   112.142(b).
Sec.   112.142................  Sec.   112.143...  --Revision to
                                                    summarize in this
                                                    section all measures
                                                    that need to be
                                                    taken for growing,
                                                    harvesting, packing,
                                                    and holding, with
                                                    relevant cross-
                                                    references to other
                                                    parts of subpart M.
                                                    (We have added Sec.
                                                     112.143(c)
                                                    referring to testing
                                                    requirements in Sec.
                                                      112.144; Sec.
                                                    112.143(d) referring
                                                    to the written
                                                    environmental
                                                    monitoring plan
                                                    required in Sec.
                                                    112.145; Sec.
                                                    112.143(e) referring
                                                    to the actions you
                                                    must take when
                                                    Listeria spp. or L.
                                                    monocytogenes is
                                                    detected in the
                                                    growing, harvesting,
                                                    packing, or holding
                                                    environment as
                                                    required in Sec.
                                                    112.146; Sec.
                                                    112.143(f) referring
                                                    to the written
                                                    sampling plan
                                                    required in Sec.
                                                    112.147, and Sec.
                                                    112.143(g) referring
                                                    to the actions you
                                                    must take when
                                                    samples of spent
                                                    irrigation water or
                                                    sprouts test
                                                    positive for a
                                                    pathogen as required
                                                    in Sec.   112.148.)
                                                   --Revision to move
                                                    requirement for
                                                    treating seeds and
                                                    beans into Sec.
                                                    112.42.
Sec.   112.143................  Sec.   112.144...  --Revision to clarify
                                                    the soil-grown
                                                    sprouts example in
                                                    Sec.
                                                    112.144(b)(2).
                                                   --Addition of new
                                                    Sec.   112.144(c),
                                                    and revision to Sec.
                                                      112.144(b), to
                                                    require additional
                                                    pathogen testing
                                                    when certain
                                                    specified criteria
                                                    are met.

Sec.   112.144................  Sec.   112.145...  --Revision to clarify
                                                    that you must
                                                    aseptically collect
                                                    environmental
                                                    samples in Sec.
                                                    112.145(d).
                                                   --Addition of
                                                    requirement in Sec.
                                                     112.145(e) that
                                                    your written
                                                    environmental
                                                    monitoring plan must
                                                    include a corrective
                                                    action plan that
                                                    details the actions
                                                    you will take if the
                                                    environment tests
                                                    positive for
                                                    Listeria spp. or L.
                                                    monocytogenes.
Sec.   112.145................  Sec.   112.146...  --New provision Sec.
                                                     112.146(f) to
                                                    indicate that you
                                                    must take
                                                    appropriate action
                                                    to prevent any food
                                                    that is adulterated
                                                    from entering
                                                    commerce.
Sec.   112.146................  Sec.   112.147...  --Addition of
                                                    requirement in Sec.
                                                     112.147(b) that you
                                                    must not allow a
                                                    production batch of
                                                    sprouts to enter
                                                    commerce until you
                                                    receive negative
                                                    pathogen testing
                                                    results on spent
                                                    sprout irrigation
                                                    water or sprouts.
                                                   --Addition of
                                                    requirement in Sec.
                                                     112.147(c) that
                                                    your written
                                                    sampling plan must
                                                    include a corrective
                                                    action plan if your
                                                    spent irrigation
                                                    water or sprouts
                                                    test positive for a
                                                    pathogen.
                                Sec.   112.148...  --New section to
                                                    describe actions
                                                    that must be taken
                                                    if spent irrigation
                                                    water or sprouts
                                                    test positive for E.
                                                    coli O157:H7,
                                                    Salmonella spp., or
                                                    a pathogen
                                                    identified in
                                                    accordance with Sec.
                                                      112.144(c).
Sec.   112.150................  Sec.   112.150...  --Revision to Sec.
                                                    112.150(b)(3) to
                                                    clarify
                                                    recordkeeping
                                                    requirement related
                                                    to written sampling
                                                    plan for each
                                                    production batch of
                                                    sprouts in
                                                    accordance with Sec.
                                                      112.147(a) and
                                                    (c).
                                                   --Revision to Sec.
                                                    112.150(b)(4) to
                                                    require
                                                    documentation of
                                                    results of all
                                                    analytical testing
                                                    conducted to comply
                                                    with subpart M.
                                                   --Revision to Sec.
                                                    112.150(b)(5) to
                                                    clarify
                                                    recordkeeping
                                                    requirement related
                                                    to any analytical
                                                    methods used in lieu
                                                    of methods
                                                    incorporated by
                                                    reference in Sec.
                                                    Sec.   112.152 and
                                                    112.153.
                                                   --Elimination of
                                                    proposed Sec.
                                                    112.150(b)(6) as a
                                                    corresponding change
                                                    to final Sec.
                                                    112.150(b)(5).
                                                   --Addition of new
                                                    provision (i.e.,
                                                    final Sec.
                                                    112.150(b)(6)) to
                                                    clarify the
                                                    recordkeeping
                                                    requirement for
                                                    actions taken in
                                                    accordance with Sec.
                                                     Sec.   112.142(b)
                                                    and (c), 112.146,
                                                    and 112.148.
------------------------------------------------------------------------

A. General Comments

    (Comment 362) Several comments agree with FDA's proposal to
establish additional standards specific to sprouts in subpart M. In
contrast, one comment maintains that the proposed requirements for
sprouts are unlikely to improve the safety of sprouts, and argues there
is little known about the causes of sprout contamination and that many
interventions, such as seed treatments, occur before sprouting whereas
most pathogens of concern are introduced or proliferate during
sprouting. Several comments also mention that additional research is
needed to improve the safety of sprouts.
    (Response) We are finalizing the rule with certain sprout-specific
requirements in subpart M. We disagree with the comment arguing that
little is known about the causes of sprout contamination. We have
learned much in this area through extensive direct experience
conducting inspections at sprout operations, as well as investigations
to follow-up on foodborne illness outbreaks and/or positive sample
findings. We also published guidances to industry (Ref. 97) (Ref. 206),
and issued a letter to suppliers and distributors of seeds and beans to
urge firms to review their operations in light of our guidances and
other available information (Ref. 207), and to modify their operations
accordingly. FDA's 2014 sprouts assignment suggested that although many
operations were taking some steps to implement at least some of the
recommendations in our sprout guidances, this effort was not universal
across sprout farms visited nor was it across all recommendations
within a single operation (Ref. 208).
    Sprouts have been frequently associated with foodborne illness
outbreaks. Between 1996 and 2010, there were a total of 34 outbreaks,
2,150 illnesses, and 123 hospitalizations associated with sprouts (Ref.
26) (Ref. 27). Moreover, there have been an additional nine outbreaks
associated with sprouts, accounting for 255 illnesses and 48
hospitalizations, between 2011 and 2014, including the first documented
L. monocytogenes sprout outbreak in the United States that resulted in
deaths (Ref. 28).
    We have relied on available science and evidence to inform the
development of the sprout-specific requirements in subpart M. For
example, it is well-established that sprouts can become contaminated
through the use of contaminated seeds for sprouting, and we are aware
of outbreaks associated with multiple sprout farms using the same lot
of seed (Ref. 29). In addition, although treatment of seeds prior to
sprouting does not guarantee pathogen-free sprouts, treatment can be
expected to reduce the percentage of contaminated batches (Ref. 209)
(Ref. 210). Therefore, we are including certain requirements applicable
to seeds or beans used to grow sprouts to help prevent seeds and beans
from serving as a vehicle for introducing contamination in sprouts. We
are also requiring testing of spent sprout irrigation water (or
production batches of sprouts) for certain pathogens, which is
consistent with current recommendations in our guidances, and existing
international guidelines and regulations (Ref. 23) (Ref. 211) (Ref.
212) (Ref. 213). Such testing is appropriate in addition to the seed
treatment requirements because pathogens that are not eliminated by
seed treatment could potentially grow out again when subjected to
enrichment conditions, as experienced during sprouting (Ref. 21) (Ref.
23). We are also requiring testing the growing, harvesting, packing,
and holding environment for Listeria spp. or L. monocytogenes.
Contamination from L. monocytogenes from the environment is

common (Ref. 214) and, thus, targeted preventive controls to minimize
L. monocytogenes in sprouts are warranted. While appropriate sanitation
measures can minimize the presence of environmental pathogens in a
sprouting operation, we conclude that environmental monitoring is still
necessary for sprouting operations as an added safety measure. There
have been positive sample findings and multiple recalls associated with
L. monocytogenes in sprouts (Ref. 215) (Ref. 216) (Ref. 217). Between
2002 and 2015, there have been 28 recalls involving multiple sprout
types due to potential or confirmed contamination with L. monocytogenes
(Ref. 218). In one of these recalls, the strain found in sprouts
matched the strain isolated from 20 confirmed cases of Listeriosis in 6
States and positive sample findings from an environmental investigation
at the sprouting operation (Ref. 215). Moreover, we are adding a
requirement that sprout operations must not allow the production batch
of sprouts to enter commerce unless the results of the testing of spent
sprout irrigation water or sprouts are negative for certain specified
pathogens (see Sec.  112.147(b)). This requirement is consistent with
current industry best practices (Ref. 219). Together with new Sec.
112.148(a), this requirement will help ensure that sprout operations
take appropriate steps to prevent contaminated sprouts from entering
commerce.
    We discuss these and other sprout-specific requirements in greater
detail in this section. For additional information, see also sections
II and V.M of the 2013 proposed rule.
    The requirements in subpart M are consistent with recommendations
in FDA's guidances (Ref. 97) (Ref. 206), industry guidance (Ref. 219),
and international regulations and guidelines (Ref. 23) (Ref. 211) (Ref.
212) (Ref. 220).
    We intend to promote and support additional research in this area,
as needed. In addition, seeds have been the source of contamination in
many, but not all, sprout outbreaks (Ref. 21) (Ref. 26) (Ref. 27) (Ref.
28)). Interventions applied before sprouting, such as those directed to
seed, are meant to avoid, eliminate, or reduce pathogen load on seeds
and, therefore, reduce the risk of pathogen proliferation during
sprouting.
    (Comment 363) Some comments ask whether microgreens would be
subject to subpart M and/or to the general provisions of part 112. Some
comments maintain that, because differences in the length of the
growing period and practices followed for microgreen production result
in a lower risk for cross-contamination than in sprout production,
microgreens should not be subject to requirements directed to sprouts.
Other comments suggest microgreens are a ready-to-eat produce item that
is growing in popularity and could carry risks similar to sprouts.
    (Response) Subpart M applies to the production of all types of
sprouts, including alfalfa, clover, and mung bean sprouts, except for
soil-grown sprouts harvested without roots (see Comment 364). FDA
agrees that microgreens and sprouts are different products. Our
longstanding guidances to industry on sprouts do not list microgreens
as sprouts. This interpretation is also consistent with other public
and private standards, e.g., the IFSH Sprout Taskforce sprout-specific
audit check list and the Food Safety Australia New Zealand (FSANZ)
standards for sprouts. In addition, in the 2013 proposed rule
discussion of potential differences in practices and risk factors
related to soil-grown versus hydroponically-grown sprouts, we did not
specifically mention microgreens because we do not consider microgreens
to be sprouts. Historically, the primary criterion FDA has used to
distinguish between the two product categories has been the growth
stage of the leaves (Ref. 221). Sprouts are usually harvested when the
cotyledons (or seed leaves) are still un- or under-developed and true
leaves have not begun to emerge. In contrast, microgreens reach a later
stage of growth, typically associated with the emergence of ``true''
leaves. Microgreens are also typically grown in soil or substrate and
harvested above the soil or substrate line. Because microgreens are not
sprouts, they are not subject to the requirements in subpart M.
However, microgreens are considered ``covered produce'' for the
purposes of this rule and, unless exempt or excluded under the
provisions in subpart A, microgreens and microgreen farms are subject
to all other subparts of part 112.
    Additional research would be helpful to better define the risk
profile of microgreens that are grown using conditions similar to those
of sprouts (i.e., warm, moist, and nutrient-rich media) (Ref. 222). To
the extent the specific microgreen production practices may present
risks similar to those associated with sprouts, we encourage microgreen
operations to consider voluntarily implementing the standards in
subpart M, in addition to complying with the required provisions of
part 112.
    (Comment 364) Some comments seek clarification on whether soil-
grown sprouts are covered under subpart M. One comment maintains that
measures described under subpart M should be applied to both soil-grown
and hydroponically-grown sprouts. This comment states that, although
they are not aware of any outbreaks associated with sprouts grown in
soil or media, contaminated soil has been a concern in the context of
other produce commodities. In contrast, one comment requests different
standards for soil-grown sprouts, and states that FDA should require
that sprouters take steps to minimize cross-contamination between
hydroponic and soil-grown sprouts.
    (Response) Soil- or substrate-grown sprout shoots that are
harvested above the soil or substrate line, such that their roots are
not harvested for human consumption, do not present the same risks as
other types of sprouts and we are therefore excluding them from
coverage under subpart M. We have added new Sec.  112.141 to address
this. New Sec.  112.141 states that the requirements of subpart M apply
to growing, harvesting, packing, and holding of all sprouts, except
soil- or substrate-grown sprouts harvested without their roots.
However, soil- or substrate-grown sprouts harvested above the soil line
are ``covered produce'' and, unless exempt or excluded under the
provisions of subpart A, are subject to all other applicable
requirements of part 112.
    We believe the potential risks are sufficiently different between
sprouts where the entire plant is consumed and sprout products that are
harvested without the roots (Ref. 223) (Ref. 224). Microscopic
examination of sprouts has been reported to show that pathogens target
root hairs of sprouts for colonization, with presence of few viable
cells elsewhere on the sprout, which indicates that root hairs provide
a niche for pathogen proliferation (Ref. 224) (Ref. 225). Therefore, we
do not see the need to apply the additional sprout-specific safety
standards in subpart M to soil- or substrate-grown sprouts that are
harvested above the soil or substrate line. However, we are applying
the requirements of subpart M to soil- or substrate-grown sprouts that
are harvested with the roots. We also agree that all hydroponically
grown sprouts should be covered under subpart M. Under typical
conditions for growing hydroponic sprouts, water runs through sprouts
in the same growing unit, and any pathogens present in the seed or
sprouting seed can spread throughout the production lot of sprouts
(Ref. 21) (Ref. 226) (Ref. 227).
    To avoid any confusion about the applicability of subpart M to
soil- or substrate-grown sprouts, we are also revising the term ``soil-
grown sprouts''

used as an example in proposed Sec.  112.143(b)(2) so that the example
now refers specifically to ``soil-grown sprouts harvested with roots''
in final Sec.  112.144(b)(2). To the extent production practices for
soil- or substrate-grown sprouts that are harvested above the soil or
substrate line may present risks similar to those associated with other
sprouts, we encourage such operations to consider voluntarily
implementing the standards in subpart M, in addition to complying with
the required provisions of part 112. We are also including, in the
examples in renumbered Sec.  112.144(b)(2), ``hydroponically grown
sprouts that use very little water,'' as another example for which
testing spent sprout irrigation water may not be practicable such that
you may, therefore, test each production batch of sprouts at the in-
process stage (i.e., while sprouts are still growing) for E. coli
O157:H7 and Salmonella spp. in accordance with the requirements of
Sec.  112.147.
    The potential for soil or substrate to be a source of contamination
in a soil- or substrate-grown sprout operation is a valid concern, and
we agree with comments stating that measures must be taken to minimize
the risk of the soil or substrate serving as a source of contamination,
for either sprouts grown in the soil or substrate, or for other produce
that may be grown or handled at the sprout operation. We are
establishing minimum science-based standards directed to biological
soil amendments of animal origin and human waste under subpart F of
part 112, which are applicable to all covered produce, including soil-
or substrate-grown sprouts (however they are harvested).
    (Comment 365) Some comments question whether wheatgrass would be
covered under subpart M as a sprout, particularly since the seed is not
consumed whether grown hydroponically or in a medium.
    (Response) Sprouts, as a category, include many varieties,
including wheatgrass. Wheatgrass has long been considered a sprout
within the industry. For example, it was considered a sprout in the
NACMCF recommendations (Ref. 21), the Sprout Testing Guide, and the
FDA/CDPH sprout video (Ref. 228). We consider it a sprout for purposes
of this rule and in particular for the application of subpart M of this
rule. However, wheatgrass is typically grown in soil or substrate and
harvested above the soil or substrate-line, and in those circumstances,
it is not subject to subpart M.
    (Comment 366) One comment requests that we subject small onions
that are thinned from a starter tray to the requirements of subpart M.
    (Response) We understand that some operations use a starter tray,
where seeds are sown thickly, and then weaker seedlings are thinned
out, providing the stronger seedlings with more space to grow. When
small onions are grown in starter trays, some operations discard the
produce resulting from the first thinning and others sell that produce
for use as food. In terms of potential hazards associated with
production, such produce is akin to soil- or substrate-grown sprouts
that are harvested above the soil line or to microgreens, both of which
we are not subjecting to the requirements of subpart M. Therefore, we
conclude that small onions grown in flats should not be subject to the
requirements of subpart M, and we are not subjecting them to the
requirements of that subpart. Such produce is subject to the other
requirements of part 112, as applicable, however.

B. Seeds or Beans Used To Grow Sprouts (Sec.  112.142)

    These requirements were proposed as Sec.  112.141. We have now
renumbered this section as Sec.  112.142 as a consequential change from
the addition of new Sec.  112.141.
    (Comment 367) Pointing out that seeds are often the source of
contamination for sprouts, several comments argue that proposed subpart
M lacks sufficient emphasis on the origin of seeds, their traceability,
and the growing and production of seeds intended for sprouting. One
comment suggests that seeds destined for sprouting should be labeled as
such with the seed producer's name and full address. Some comments
maintain that seeds and beans should be covered under the produce
safety regulation, and that FDA should require seeds to be grown and
produced under good agricultural practices and specifically for
sprouting for human consumption, rather than being potentially sourced
from fields where the seeds were intended to be directed toward animal
feed production. Several comments also support a requirement for a
supplier approval and verification program for seeds and beans received
by sprouters for sprouting purposes (including seed lot testing and use
of a HACCP approach). In this regard, one comment suggests FDA should
require documentation of the processes that the seeds are subjected to
during their cleaning and preparation for sale while another argues
that unless seeds from a particular crop or variety can be produced in
a safe manner, industry should be required to cease production of
sprouts from that crop or variety.
    (Response) Since 1999, FDA has taken a number of steps to provide
guidance to the sprouts industry, including those involved in the
growing and production of seeds (78 FR 3504 at 3509). In developing
this rule, FDA has carefully considered the growing and distribution of
seeds for sprouting. As noted in the 2013 proposed rule, various crops
may be grown to produce seeds and beans for sprouting with different
production practices, growing seasons, conditions, and crop needs.
Harvesting, packing, and holding may also vary by seed type and by the
conditions needed to maintain seed quality, such as germination.
Because of the diversity of practices, processes, and procedures, the
controls reasonably necessary to prevent the introduction of known or
reasonably foreseeable hazards into or onto seeds or beans that are
used for sprouting may vary. Therefore, we did not propose to prescribe
specific provisions to prevent the introduction of known or reasonably
foreseeable hazards into or onto seeds or beans during growing,
harvesting, conditioning, or holding. Instead, we referred to our
recommendations in relevant guidances, including the GAPs Guide (78 FR
3504 at 3595).
    In the 2013 proposed rule, we considered proposing a supplier
approval and verification program for seeds and beans received by
sprout operations for sprouting purposes. Such a program would provide
assurance that seeds or beans received from a third party for use to
grow sprouts are grown, harvested, stored, and handled using measures
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto seeds or beans used for sprouting.
However, we also noted that a supplier approval and verification
program may not be practical or effective for seeds and beans received
by sprout operations for sprouting purposes because, for most crops,
only a small percentage of the harvested seeds or beans is used for
sprout production. In addition, seeds and beans often pass through a
number of business entities before their final sale. Therefore, the
ultimate end use of seeds and beans will likely not be known by many
growers, handlers, or distributors (at 78 FR 3504 at 3595-3596).
    Information we have received subsequent to the 2013 proposed rule
suggests that seed distributors may request that their seed growers and
handlers provide assurance, through the use of agreements, that safe
growing and handling practices are employed during

the growing, harvesting, conditioning, storage, handling, and
transportation of the seeds that the distributor will sell to sprouting
operations (Ref. 229). In addition, we believe that proposed Sec.
112.141(a) would not have been effective at addressing hazards
associated with the growing of seeds or beans used for sprouts because
few, if any, sprout operations in the United States grow their own
seeds or beans but instead, receive the seeds or beans from other
entities, such as seed growers or distributors (Ref. 230). It is
important that this rule includes measures to prevent the introduction
of known or reasonably foreseeable hazards into seeds or beans that are
used for sprouting. Therefore, and in light of information that
sprouting operations typically receive (rather than grow their own)
seeds or beans, we are revising proposed Sec.  112.141(a), renumbered
as Sec.  112.142(a), to require the sprout operation to take measures
reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto seeds or beans that they will then use
for sprouting regardless of whether the sprouter also grew the seeds or
beans.
    Measures required under renumbered Sec.  112.142(a) include, for
example, keeping the seed storage area clean and dry, and dedicated to
seed storage. Seed containers must be tightly covered or closed, stored
off the floor and away from the walls, clean, identified with lot
numbers, and, for reusable containers, emptied, cleaned, and sanitized
between uses. Sprout operations must also complete a visual examination
of seeds/beans and their packaging upon receipt and prior to use for
potential contamination (e.g. visual exam and/or black light/UV exam of
seed bags for evidence of insects, rodents, or other contamination).
    As noted previously, we also asked for comment on a seed supplier
program. While we believe that the agreements and assurances made
between seed suppliers and other entities in the supply chain providing
assurances that the seeds and beans have been grown and handled under
good agricultural practices and that seeds that may be used for
sprouting have been conditioned, stored, and transported in a manner
that minimizes the likelihood that the seeds will be contaminated with
pathogens, are valuable, we are not requiring that sprouters request,
receive, or provide such agreements and assurances. We recommend these
practices, consistent with recommendations in our 1999 guidance to
industry, ``Reducing Microbial Food Safety Hazards for Sprouted
Seeds,'' (the Sprout Guide) and recommendations or requirements by
other competent authorities (Ref. 211) (Ref. 212) (Ref. 231), and are
encouraged that some comments indicated that this is already happening.
However, we do not believe that it is currently feasible for all seeds
and beans used for sprouting to be produced under GAPs, particularly
when the vast majority of seed is not produced for such use. If the
situation changes, we may revisit this in the future. The other
requirements in Sec.  112.142 also address potential contamination in
seeds and beans.
    (Comment 368) Several comments state that sprout operations should
not use sprouts if they have reason to believe that a lot of seeds or
beans has been associated with foodborne illness. Comments also request
that FDA further clarify that if a farm has reason to believe that a
lot of seeds has been contaminated with a hazard likely to cause
foodborne illness, the farm should not use that lot to produce sprouts,
regardless of whether that contamination has caused illness. In this
regard, one comment explains that farms will be unable to accurately
and reliably assess whether a particular batch of seeds has been linked
to consumer illness. Finally, one comment expresses concern with
requiring sprout operations to discontinue use of a seed lot found to
be contaminated through microbial testing. This commenter poses several
questions regarding follow-up actions that a sprouter may have to take
in response to a positive test finding.
    (Response) Proposed Sec.  112.141(b), now renumbered as Sec.
112.142(b), focuses on reasonably necessary measures when it is known
or there is reason to believe that a lot of seeds or beans that will be
used for sprouting is contaminated. As proposed, Sec.  112.141(b) would
have required that if you know or have reason to believe that a lot of
seeds or beans has been associated with foodborne illness, you must not
use that lot of seeds or beans to produce sprouts. As discussed in the
2013 proposed rule, we concluded that once you know or have reason to
believe that a lot of seeds or beans is contaminated, through microbial
testing or implication as the vehicle in an outbreak, there is reason
to believe that other parts of that lot may also be contaminated, and
you must not use that lot of seeds or beans to produce sprouts (78 FR
3504 at 3596). We are revising this section to make clear that relevant
knowledge or reason to believe seeds or beans may be contaminated may
be based either on an implication of the seeds or beans in a foodborne
illness outbreak or on a positive microbial test result, including a
finding made after testing spent sprout irrigation water or sprouts.
For example, section 112.144(b) requires testing of spent sprout
irrigation water from each production batch of sprouts or, if such
testing is not practicable, testing of each production batch of sprouts
at the in-process stage. In either circumstance, i.e., through
implication in an outbreak or through microbial testing (including that
required under Sec.  112.144(b)), the information gathered is
sufficient to indicate that the lot of seeds or beans may be
contaminated and there is reason to believe that other parts of that
lot may also be contaminated. Therefore, we continue to believe that it
is reasonably necessary to prevent the introduction of known or
reasonably foreseeable hazards into sprouts that you discontinue use of
all seeds or beans from that lot for sprout production (Sec.
112.142(b)(1)). We are also expanding the duties you have under Sec.
112.142(b) beyond simply not using the seeds or beans to produce
sprouts, to include ensuring that sprouts grown from that lot of seeds
or beans do not enter commerce (Sec.  112.142(b)(1)), and reporting the
information (association with illness and/or findings of microbial
testing) to the seed grower, distributor, supplier, or other entity
from whom you received the seeds or beans (Sec.  112.142(b)(2)). Since
the lot of seeds or beans may be contaminated, it is critical to
discontinue use of the seeds and beans for sprout production for human
consumption and ensure that sprouts grown from that lot do not enter
commerce. Other national or international standards, too, require or
recommend discontinuing use of a lot of seeds or beans that may be
contaminated and is likely to present a health hazard (Ref. 23) (Ref.
211) (Ref. 212).
    It is also important that the sprout operation report the findings
to the entity (seed grower, distributor, or supplier) that supplied the
seeds or beans so that the seed grower, distributor, or supplier, upon
receiving such information, could then take appropriate follow-up
actions, which may include reporting the finding to other buyers of the
suspected lot of seeds or beans, destroying or diverting any remaining
seed or beans to other uses, including non-food uses and/or
investigating the potential source of contamination, as necessary. In
such circumstance, where applicable, the seed grower, distributor, or
supplier may be required to submit a report to the Reportable Food
Registry (RFR), in

accordance with section 417 of the FD&C Act (21 U.S.C. 350d), which
requires responsible parties for food facilities that are required to
register under section 415 of the FD&C Act (21 U.S.C. 350d) to report
certain information to FDA when there is a reasonable probability that
the use of, or exposure to, an article of food will cause serious
adverse health consequences or death to humans or animals.
    In addition, we are adding two provisions under new Sec.
112.142(c) that apply only if your reason for believing the lot of
seeds or beans may be contaminated is based only on microbial test
results. First, we are providing that you do not have to take the steps
in Sec.  112.142(b)(1) if you treat your lot of seeds or beans with a
process that is reasonably certain to achieve destruction or
elimination in the seeds or beans of the most resistant microorganisms
of public health significance that are likely to occur in the seeds or
beans (may also be referred to as a ``pasteurization'' step) ((Sec.
112.142(c)(1)). We are including this option to allow sprout farms
flexibility in responding to a finding that would otherwise mean they
would have to discontinue use of the seeds and to encourage future
innovation in seed treatment processes. However, we note that processes
that meet the description in (c)(1) are not currently commonly used in
the sprouting industry. Such processes are far more robust than the
seed treatment processes described in Sec.  112.142(e) because the seed
treatments described in Sec.  112.142(e) typically only reduce
microorganisms of public health significance (these treatments do not
eliminate or destroy pathogens), and are therefore part of a multi-
hurdle risk reduction framework that also includes spent irrigation
water or sprout testing for pathogens on a lot by lot basis.
Irradiation is an example of a process that may be able to meet the
description in Sec.  112.142(c)(1).
    Second, we are adding new Sec.  112.142(c)(2) to provide that you
do not have to take the steps in Sec.  112.142(b)(1) and (2) if you
later reasonably determine through appropriate follow-up actions that
the lot of seeds or beans is not the source of contamination (for
example, the lot of seeds or beans is not the source of a pathogen
found in spent sprout irrigation water or sprouts).
    We expect that the situations in which you could take follow-up
actions that would be adequate to make a reasonable determination that
the lot of seeds or beans was not the source of the contamination are
not extensive. However, the following are examples of situations in
which we believe such a determination might be appropriate:
    1. Seed lot A is recalled by the seed supplier due to contamination
with Salmonella while an operation has sprouting in process with that
seed lot. The sprout operation immediately stops production of sprouts
using seed lot A, disposes of the sprouts and returns unused seed to
the distributor. The sprouts operation cleans the equipment and starts
using the same equipment to grow another batch of sprouts using seed
lot B. Spent irrigation water from the next lot of sprouts using seed
lot B then tests positive for Salmonella, and follow-up sample analysis
shows the same Salmonella serotype that was identified as contaminating
seed lot A. The sprout operation discovers that cleaning and sanitizing
protocols were not followed properly following sprout production using
seed lot A, and swabs the equipment and finds a matching Salmonella
serotype on the equipment that had been used to sprout both seed lots A
and B. After adequately and thoroughly re-cleaning and sanitizing the
equipment and re-testing food-contact surfaces for Salmonella with
negative results, the sprout operation starts a new production batch of
sprouts using seed lot B as a follow-up action to the positive test
result to determine whether seed lot B may also be contaminated. The
second time, all spent irrigation water tests from seed lot B sprouts
come back negative. In this circumstance, the sprout operator could
reasonably conclude that seed lot A had contaminated the equipment,
which was not initially adequately cleaned and sanitized and therefore
contaminated the first batch of sprouts produced from seed lot B. If
the farm is following appropriate follow-up sanitation procedures,
spent irrigation water from seed lot B is no longer testing positive
for Salmonella, under these circumstances the farm may reasonably
conclude that seed lot B was not the source of contamination that
generated the positive test result when testing spent irrigation water
from seed lot B sprouts. We note that in general a negative test for
seeds or spent irrigation water would not, by itself, be enough
evidence that seed lot B was not contaminated. However, in this
example, the seed supplier's Salmonella serotype result from seed lot A
that matches serotype found in the positive spent irrigation water
sample and the swab from equipment used to sprout seed lot B, combined
with the improper cleaning and sanitizing of equipment, negative
subsequent test results, and the intervening improvements in cleaning
procedures, supports the conclusion that the positive spent irrigation
water sample from sprouts made with seed lot B was most likely due to
contamination of shared production equipment with seed lot A.
    2. A sprout operation mixes two seed lots (lot A and B) together to
result in a mixed sprout product for which the spent irrigation water
tests positive for Salmonella. The sprout operation could sprout each
seed lot individually. If upon follow-up serotype sample analysis,
spent irrigation water from only one seed lot (lot A) tests positive
for Salmonella matching the original positive, the sprout operation
could reasonably determine that seed lot A was the source of the
Salmonella positive in spent irrigation water from the mixed seed
sprouts. The sprout operation would be required to discontinue use of
all seeds from the affected seed lot for sprout production (unless it
treats the seed lot in accordance with Sec.  112.142(b)(1)), ensure
that sprouts grown from that seed lot do not enter into commerce, and
report the information to the grower, distributor, supplier, or other
entity from whom the farm received the seeds, in compliance with Sec.
112.142(b). Under Sec.  112.142(c), the sprout farm could continue to
use seed lot B, provided there were no subsequent positive test results
and no information suggesting association of that seed lot with
foodborne illness.
    We recognize that there may be other microbial testing through
which you may conclude that a lot of seeds or beans is contaminated.
For example, testing of seeds (although not required under this rule)
using statistically valid sampling and testing protocols may lead you
to conclude that seeds or beans are contaminated. Information of this
kind triggers the requirements in Sec.  112.142(b) and requires farms
to discontinue use of all seeds or beans from that lot, ensure that
sprouts grown from that lot of seeds or beans do not enter commerce,
and report the information to the grower, distributor, supplier, or
other entity from whom the farm received the seeds.
    Although we believe there may be follow-up actions that could allow
a sprout operation to determine that a lot of seeds or beans that had
been associated with a positive microbial test result from testing
spent sprout irrigation water or sprouts at their operation (required
under Sec.  112.144(b)) were not the source of contamination, we do not
believe the same is true of a lot of seeds or beans that have been
associated with a foodborne illness. We are not aware of actions that a
sprout farm could take to demonstrate that the lot of seeds or beans
was not the source

of contamination following an outbreak of foodborne illness. A sprout
farm, along with regulators, may make a determination that the farm's
seeds or beans were not associated with a foodborne illness outbreak,
but it is unlikely that the sprout farm would have adequate information
(e.g., epidemiological data and traceback information) to make that
determination independently. Therefore, we are not providing a similar
option to Sec.  112.142(c) applicable in instances where there is
knowledge or reason to believe that a lot of seeds or beans has been
associated with foodborne illness.
    (Comment 369) One comment asked whether, in sprout production,
sampling and testing can be properly defined as a process control, or
whether it should be defined simply as a confirmation that a process
control has worked as intended. The comment maintained that if sampling
and testing is a process control then a positive test may not be
grounds for discontinuation of a seed lot since the control worked as
intended.
    (Response) In the case of sprouts, sampling and testing of spent
sprout irrigation water can be viewed as both a verification of a
process control (e.g. of seed treatment) as well as a process control
itself (``hold and release'' testing that is used to prevent a
contaminated lot from entering commerce (see Sec.  112.147(b)). Even if
a sprout operation's spent irrigation water testing is effective and
identifies pathogen-positive lots of sprouts where seed treatment
failed to eliminate a pathogen, the fact remains that seed is most
often the source of contamination and that current seed treatments
cannot guarantee the elimination of pathogens on seed. Currently
available seed treatments typically reduce, but do not eliminate,
pathogen presence on seeds, and these pathogens could potentially
multiply when subjected to enrichment conditions, such as those