through time/temperature combinations other than those described in
Sec.  112.54(c)(1) and (2) may be considered ``treated'' provided that
they meet the requirements of Sec.  112.54, including satisfying one of
the microbial standards in Sec.  112.55. On the other hand, raw manure
must be regarded as ``untreated'' under Sec.  112.51. An agricultural
tea made with biological materials of animal origin that contains an
agricultural tea additive (such as molasses or sea kelp) is considered
``untreated'' under Sec.  112.51(b)(5) due to the heightened risk
presented by the use of such additives (see also Comment 44), and is
therefore in the same category as raw manure with regard to application
restrictions in Sec.  112.56.

C. Handling, Conveying, and Storing Biological Soil Amendments of
Animal Origin (Sec.  112.52)

    As proposed, Sec.  112.52 would establish requirements for
handling, conveying and storing soil amendments of animal origin. In
Table 15, we describe the codified provisions of Sec.  112.52 and any
changes we made to those provisions in the final rule. Comments
specific to Sec.  112.52 follow the table.

           Table 15--Description of Revisions to Sec.   112.52
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.52(a)............  You must handle,      Revised to add other
                               convey, and store     soil amendments and
                               any biological soil   to clarify that
                               amendment of animal   drip fertigation
                               origin in a manner    with agricultural
                               and location such     teas that are
                               that it does not      biological soil
                               become a potential    amendments of
                               source of             animal origin is
                               contamination to      permitted in
                               covered produce,      compliance with
                               food-contact          other requirements
                               surfaces, areas       of this rule.
                               used for a covered
                               activity, water
                               sources, and water
                               distribution
                               systems.
Sec.   112.52(b)............  You must handle,      No change.
                               convey and store
                               any treated
                               biological soil
                               amendment of animal
                               origin in a manner
                               and location that
                               minimizes the risk
                               of it becoming
                               contaminated by an
                               untreated or in-
                               process biological
                               soil amendment of
                               animal origin.
Sec.   112.52(c)............  You must handle,      Revised.
                               convey, and store
                               any biological soil
                               amendment of animal
                               origin that has
                               become contaminated
                               as if it was
                               untreated.
------------------------------------------------------------------------

    (Comment 278) One comment states that many farms store animal
manure purchased from animal production facilities for several months
before application. The comment maintains that this practice can
threaten produce safety through potential contamination of water and
air, just like animal manure stored on adjacent animal production
facilities.
    (Response) FDA agrees that stored animal manure can be a source of
contamination. Section 112.52(a) requires biological soil amendments of
animal origin to be handled, conveyed, and stored in a manner and
location such that they do not become a potential source of
contamination to covered produce, food-contact surfaces, areas used for
a covered activity, water sources, water distribution systems, and
other soil amendments.
    (Comment 279) One comment interprets Sec.  112.52(a) as forbidding
drip ``fertigation'' with biological soil amendments of animal origin,
even if the material is not reasonably likely to contact covered
produce. The commenter requests that FDA clarify the provision by
adopting the following edit: ``. . .such that it does not become a
potential source of contamination to . . . water distribution systems,
if such contamination may reasonably be likely to result in
contamination of covered produce.''
    (Response) We did not intend for Sec.  112.52(a) to forbid drip
fertigation with biological soil amendments of animal origin.
Biological soil amendments of animal origin may be used in water
distribution systems in accordance with Sec.  112.56 and their status
as ``treated'' or ``untreated'' and, if ``treated'', to what standard.
If ``untreated'' or ``treated'' to the standard in Sec.  112.55(b),
then the biological soil amendment of animal origin must not contact
covered produce at application and contact later must be minimized. If
the biological soil amendment of animal origin is ``treated'' to the
standard in Sec.  112.55(a), then there are no restrictions on use. We
are revising Sec.  112.52(a) to add a statement that agricultural teas
that are biological soil amendments of animal origin may be used in
water distribution systems provided that all other requirements of this
rule are met.
    (Comment 280) One comment is concerned that the proposed language
of Sec.  112.52(c) does not specify the basis for the knowledge or
suspicion that a soil amendment has become contaminated. The commenter
recommends FDA make the following change to Sec.  112.52(c) (additions
underlined): ``(c) You must handle, convey, and store any biological
soil amendment of animal origin that you know or have reason to believe
may have become contaminated as if it was untreated.''
    (Response) FDA is making this change. FDA agrees that you should be
required to regard as ``untreated'' under Sec.  112.51 any biological
soil amendment of animal origin that you know or have reason to believe
may have become contaminated, and not only biological soil amendments
of animal origin that have actually become contaminated. This revision
makes clear that covered farms must regard biological soil amendments
of animal origin as untreated as soon as they have information giving
them reason to believe contamination of the biological soil amendment
may have occurred.

D. Prohibitions Regarding Use of Human Waste (Sec.  112.53)

    In Sec.  112.53 we proposed to prohibit the use of human waste for
growing covered produce, except sewage sludge biosolids used in
accordance with the requirements of 40 CFR part 503, subpart D, or
equivalent regulatory requirements. In Table 16, we describe the
codified provisions of Sec.  112.53 and any changes we made to those
provisions in the final rule. Comments specific to Sec.  112.53 follow
the table.

           Table 16--Description of Revisions to Sec.   112.53
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.53...............  You may not use       No change.
                               human waste for
                               growing covered
                               produce, except
                               sewage sludge
                               biosolids used in
                               accordance with the
                               requirements of 40
                               CFR part 503,
                               subpart D, or
                               equivalent
                               regulatory
                               requirements.
------------------------------------------------------------------------

    (Comment 281) Some comments express concern that FDA's proposed
rule allowed the use of untreated human waste and biosolids for the
production of covered produce, even if users were following the EPA
requirements in 40 CFR part 503, subpart D, or equivalent regulatory
requirements. Comments express particular concern that the rule would
allow foreign producers to use human waste as a soil amendment, even
though their use may not meet EPA standards, and some comments noted
that farms in some countries have historically used human waste in
growing produce. Many commenters request that FDA prohibit the use of
human waste in the production of covered produce. Conversely, at least
one comment requests that FDA allow for the use and application of
human waste in the growing of covered produce.
    (Response) Section 112.53 clearly states that the use of human
waste is prohibited for growing covered produce, except sewage sludge
biosolids used in accordance with the requirements of 40 CFR part 503,
subpart D, or equivalent regulatory requirements. In consultation with
EPA, FDA has concluded that adherence to 40 CFR part 503 remains an
appropriate approach to the use of biosolids for the growing of covered
produce. We continue to believe that these requirements are
appropriately protective of public health.
    With regard to concerns about ensuring that the provisions are
followed for imported produce, we note that Sec.  112.53 refers to
``equivalent regulatory requirements'' to provide for the possibility
that other competent authorities have established such requirements in
other jurisdictions. In addition, please see the response to Comment 50
regarding the provisions of the FSVP regulation. We also note that the
use of human waste for food production has been addressed by the Codex
(Ref. 22). FDA plans to conduct outreach activities regarding the
produce safety rule to help farms understand how to comply (see section
XXII for additional information).
    (Comment 282) Several comments object to referencing the
requirements in 40 CFR part 503. A few comments argue that part 503 is
out of date. One comment points to a National Academy of Sciences
review of part 503, and argues that the requirements for using human
waste for growing covered produce should be strengthened in accordance
with this NAS report, and should use current risk assessment methods.
One comment questions the validity of the application intervals in part
503 and expresses concerns about

the environmental implications of applying biosolids to agricultural
land.
    (Response) FDA, in consultation with EPA, has determined that 40
CFR part 503 remains the most appropriate approach to safe use of
sewage sludge biosolids on land involved in the production of covered
produce. We point out that the NAS 2002 report (Ref. 177) noted that
there is ``. . . no documented evidence to indicate that part 503 has
failed to protect public health''; that EPA responded to the NAS review
with a 14-point action plan, which it is carrying out; and that under
section 405(d)(2)(C) of the CWA, EPA is required to publish a biennial
review of part 503 (Ref. 178). FDA concludes that the provisions of 40
CFR part 503 are appropriate standards for protecting public health
with respect to the use of sewage sludge biosolids in growing covered
produce.
    (Comment 283) A comment requests that source separated human urine
be classified separately from sewage sludge biosolids, thus allowing it
to be used in growing covered produce. The comment maintains that human
urine is sterile, contains bioavailable nutrients, and is an otherwise
wasted resource that could be important to agriculture and is used in
other countries as a fertilizer.
    (Response) Urine is not covered by 40 CFR part 503 and, therefore,
as human waste, Sec.  112.53 prohibits its use in growing covered
produce. The commenter did not provide data or information from which
we could conclude that source separated human urine should be allowed
to be used in growing covered produce, and therefore we are not making
this change.
    (Comment 284) One comment argues that even if human sewage has been
adequately treated to be free of pathogens, it would still be
susceptible to recontamination. This comment suggests that
recontamination should be explicitly addressed in this rule.
    (Response) FDA's requirement is that sewage sludge biosolids be
used in accordance with 40 CFR part 503. Under those requirements if
sewage sludge biosolids that met the standards to be Class A biosolids
have human waste added to them, they become Class B biosolids and need
to be used in accordance with the requirements for Class B biosolids.
However, whether they are Class A or Class B sewage sludge biosolids,
they may be used in accordance with 40 CFR part 503. Therefore, we do
not believe that recontamination needs to be explicitly addressed in
our rule because it is already addressed in 40 CFR part 503 in the
various standards that apply to sewage sludge biosolids.

E. Treatment Processes (Sec.  112.54)

    Section Sec.  112.54 describes acceptable processes for the
treatment of biological soil amendments of animal origin to be used for
growing covered produce. In Table 17, we describe the codified
provisions of Sec.  112.54 and any changes we made to those provisions
in the final rule. Comments specific to Sec.  112.54 follow the table.

           Table 17--Description of Revisions to Sec.   112.54
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.54...............  Each of the           No change.
                               following treatment
                               processes are
                               acceptable for a
                               biological soil
                               amendment of animal
                               origin that you
                               apply in the
                               growing of covered
                               produce, providing
                               that the resulting
                               biological soil
                               amendments are
                               applied in
                               accordance with the
                               applicable
                               requirements of
                               Sec.   122.56:
Sec.   112.54(a)............  A scientifically      Revised to add
                               valid controlled      biological
                               physical process      processes and
                               (e.g., thermal),      replace
                               chemical process      ``demonstrated''
                               (e.g., high           with ``validated.''
                               alkaline pH), or
                               combination of
                               scientifically
                               valid controlled
                               physical and
                               chemical processes
                               that have been
                               demonstrated to
                               satisfy the
                               microbial standard
                               in Sec.   112.55(a)
                               for L.
                               monocytogenes,
                               Salmonella spp.,
                               and E. coli
                               O157:H7;
Sec.   112.54(b)............  A scientifically      Revised to add
                               valid controlled      biological
                               physical process,     processes and
                               chemical process,     replace
                               or combination of     ``demonstrated''
                               scientifically        with ``validated.''
                               valid controlled
                               physical and
                               chemical processes,
                               that has been
                               demonstrated to
                               satisfy the
                               microbial standard
                               in Sec.   112.55(b)
                               for Salmonella and
                               fecal coliforms; or
Sec.   112.54(c)............  A scientifically      First sentence
                               valid controlled      eliminated because
                               composting process    biological
                               that has been         processes meeting
                               demonstrated to       the Sec.
                               satisfy the           112.55(b) standard
                               microbial standard    are now included in
                               in Sec.   112.55(b)   revised Sec.
                               for Salmonella and    112.54(b). Second
                               fecal coliforms.      sentence is now
                               Scientifically        part of Sec.
                               valid controlled      112.54(b) and has
                               composting            been revised to
                               processes include:    refer again to the
                                                     microbial standard
                                                     in Sec.
                                                     112.55(b).
Sec.   112.54(c)(1).........  Static composting     Renumbered to Sec.
                               that maintains        112.54(b)(1) as a
                               aerobic (i.e.,        conforming change
                               oxygenated)           to the combination
                               conditions at a       of Sec.   112.54(b)
                               minimum of 131        and (c); clarified
                               [deg]F (55 [deg]C)    that ``3 days'' is
                               for 3 days and is     consecutive; and
                               followed by           deleted ``which
                               adequate curing,      includes proper
                               which includes        insulation'' as it
                               proper insulation;    is covered by
                                                     adequate curing.
Sec.   112.54(c)(2).........  Turned composting     Renumbered to Sec.
                               that maintains        112.54(b)(2) as a
                               aerobic conditions    conforming change
                               at a minimum of 131   to the combination
                               [deg]F (55 [deg]C)    of Sec.   112.54(b)
                               for 15 days, with a   and (c); revised to
                               minimum of five       state that ``15
                               turnings, and is      days'' does not
                               followed by           have to be
                               adequate curing,      consecutive;
                               which includes        deleted ``which
                               proper insulation;    includes proper
                               or                    insulation'' as it
                                                     is covered by
                                                     adequate curing;
                                                     and deleted ``or''
                                                     at end because Sec.
                                                       112.54(c)(3) is
                                                     deleted.
Sec.   112.54(c)(3).........  Other scientifically  Eliminated as not
                               valid, controlled     necessary. All
                               composting            scientifically
                               processes, provided   valid, controlled
                               you satisfy the       biological
                               requirements of       treatment
                               Sec.   112.12,        processes,
                               including that the    including
                               alternative has       composting, that
                               been demonstrated     meet the microbial
                               to satisfy the        standards of Sec.
                               microbial standard    112.55 are
                               in Sec.               allowable under
                               112.55(b).            revised Sec.
                                                     112.54(a) and (b),
                                                     making the
                                                     allowance for
                                                     alternative
                                                     processes
                                                     unnecessary.
------------------------------------------------------------------------

    (Comment 285) Some comments states that the rule inappropriately
treats use of physically and chemically treated soil amendments as less
risky than soil amendments treated by composting. One comment proposes
an alternative approach to regulating stabilized compost, including an
additional process to be added for stabilized compost that 1) meets the
time and temperature requirements specified in Sec.  112.54(b)(1) and
(b)(2); and 2) has been demonstrated to satisfy the microbial standard
in Sec.  112.55(a).
    (Response) FDA agrees that flexibility needs to be added to the
provisions of Sec.  112.54 to broaden the allowable methods for
producing stabilized compost that may be regarded as ``treated'' under
Sec.  112.51 and also to allow farms to regard as ``treated''
biological soil amendments of animal origin processed using biological
processes other than composting, such as vermicomposting, provided that
such processes meet the microbial standards in either Sec.  112.55(a)
or (b). We also recognize that the structure of proposed Sec.  112.54
should be revised to better reflect the application requirements in
Sec.  112.56, which we proposed to change in our supplemental notice
without making conforming changes to Sec.  112.54. Thus, we are adding
options for biological treatment processes (including, but not limited
to, composting) in Sec.  112.54(a); and collapsing Sec.  112.54(b) and
(c) to allow for a ``scientifically valid, controlled biological (e.g.,
composting), chemical, or physical process, or combinations thereof,
that has been demonstrated to satisfy the microbial standard in Sec.
112.55(b) for Salmonella and fecal coliforms.'' Importantly, because
these changes retain the requirements that all such treatment processes
be demonstrated to satisfy either the microbial standards in Sec.
112.55(a) or (b), we believe these changes address the comments, make
these provisions as flexible as possible for farms, and provide
sufficient public health protection.
    (Comment 286) A comment recommends that subpart F, in reference to
biological soil amendment treatment processes, change the term
``scientifically valid'' to ``scientifically validated.'' The comment
recommends this revision to clarify the need for validation of the
treatment method(s) used to treat biological soil amendments of animal
origin to meet the microbial standards of Sec.  112.55. The comment
notes that the need for validation is discussed in the preamble, but
contends that it should also be explicitly stated in the codified so
that there is no confusion.
    (Response) We do not agree that we should replace the term
``scientifically valid'' in this subpart with the term ``scientifically
validated,'' as these terms have different meanings. However, a
biological soil amendment of animal origin does not meet the definition
of ``treated'' per this subpart unless the treatment process is
scientifically valid and controlled and has been demonstrated (i.e.,
validated) to meet the applicable microbial standards of Sec.  112.55.
A treatment process that has been demonstrated to satisfy the microbial
standards of Sec.  112.55 has been validated to meet those microbial
standards. Therefore, because this comment suggested that there may be
some confusion on this, we are revising Sec. Sec.  112.54(a) and (b) to
replace the word ``demonstrated'' with the word ``validated.'' We note
that consistent with language in other regulations (see the PCHF
regulation and 21 CFR part 111), we use the term ``scientifically
valid'' in this rule to mean using an approach that is based on
scientific information, data, or results published in, for example,
scientific journals, references, text books, or proprietary research.
    (Comment 287) A comment requests that FDA add the following
language to Sec.  112.54 ``. . .provided that the resulting biological
soil amendments meet the microbial standards for the treatment
processes as stated in Sec.  112.55 and are applied in accordance with
the applicable requirements of Sec.  112.56...''
    (Response) It is not necessary to add this language to the
introductory text of Sec.  112.54 as the requirements to meet the
microbial standards in Sec.  112.55(a) or (b) are contained within the
provisions of Sec.  112.54(a)-(b). To add the language as suggested by
the comment would be duplicative.
    (Comment 288) Comments request that, in order to ensure that
whatever scientifically valid controlled process is chosen by a farm
(or their supplier) to comply with proposed Sec.  112.54 has been
effectively followed, FDA add a required ``condition-specific''
verification as a requirement in the language of the regulation, which
would include appropriate microbial testing using scientifically valid
sampling techniques that include timing and location parameters, to
establish that the appropriate microbial results stated in the proposed
Sec.  112.55 have been achieved.
    (Response) FDA is not making this change. As discussed in the 2013
proposed rule (78 FR 3504 at 3578), FDA is not requiring microbial
testing of treated biological soil amendments of animal origin to
ensure that the meet the relevant microbial standards. Rather, we have
provided the microbial standards against which treatment processes must
be validated. Proper validation to show that a process satisfies the
microbial standards of Sec.  112.55 needs to include specific process
variables, and the person applying the treatment process will need to
monitor the physical parameters of the process (e.g., the temperature
of a compost pile) to ensure they meet the conditions under which the
process was validated. See also our response to Comment 286.
    (Comment 289) One comment suggests there may be a higher risk of
microbial contamination and a greater threat to public health
associated with the use of commercial compost than with compost made
on-farm.
    (Response) FDA is not aware of a greater threat to public health
from the use of commercial compost than compost made on individual
farms. The comment did not provide additional information in support of
this assertion.
    (Comment 290) One comment urges FDA to issue a regulation
specifically for the use of manure from animal production facilities.
The comment states that FDA should require animal production facilities
that sell or give manure to produce farms to take specific steps to
minimize contamination, including by harmful pathogens, in their animal
waste.
    (Response) FDA declines this request. While we recognize the risk
presented by the use of manure in growing of covered produce, manure
comes from many sources, including from produce farms on which it is
used. We believe that it is appropriate to focus this rule's
requirements regarding biological soil amendments of animal origin on
the operations that are using those materials in the growing of covered
produce to minimize the risk presented by such uses.
    (Comment 291) Several comments request clarification on whether FDA
requires testing of individual feedstocks used to prepare an
agricultural tea, at intervals during the brewing process, or the final
agricultural tea product, with attention to the fact that by the time
the tea is applied, the test will no longer be representative of the
original sample. One comment notes that if an agricultural tea is
prepared from a stabilized compost feedstock that meets the
microbiological standard of Sec.  112.55(b), then the remaining
populations of these microorganisms have the potential to experience
rapid population growth. The commenter also notes that the
microbiological criterion

set in Sec.  112.55 are based on a dry weight (MPN/gram) basis, which
would not be representative of an agricultural tea, in which the solid
fraction is mostly removed prior to application.
    (Response) Like other biological soil amendments of animal origin,
FDA is not requiring that agricultural teas (of animal origin) be
tested. Rather, for an agricultural tea (of animal origin) to be
considered ``treated'' for the purposes of Sec.  112.51, the components
used to make the tea be treated via a process described in Sec.  112.54
(a) or (b) to meet the microbial standards of Sec.  112.55(a) or (b).
If a scientifically valid controlled process has been followed, there
is no need to test the tea to consider it ``treated.'' Agricultural
teas (of animal origin) that are not treated to such standards, or that
contain agricultural tea additives or are made with water not meeting
the requirements in Sec.  112.51(a), must be considered ``untreated''
for purposes of Sec.  112.51. With regard to the potential rapid growth
of pathogens in agricultural teas that meet the microbial standards of
Sec.  112.55, we note that agricultural teas cannot contain
agricultural tea additives if they are to be considered ``treated'' for
purposes of Sec.  112.51, which are the primary contributing factor to
rapid growth of microflora in teas (Ref. 174). Finally, we agree that
the proposed microbial standards in Sec.  112.55 were established on a
dry weight basis, which would not be appropriate for agricultural teas.
Therefore, we have modified Sec.  112.55 to add a liquid weight basis
for sampling (for use in validation).
    (Comment 292) At least one comment suggests that stabilized compost
be regulated according to a two-tier approach, whereby a farm could use
a zero day application interval if the stabilized compost meets
stringent criteria, but would have a 45-day interval for stabilized
compost meeting general safety standards and being used on certain
covered crops.
    (Response) FDA originally proposed a two-tiered strategy for the
application interval for use of compost (78 FR 3504). However, in the
supplemental notice, FDA proposed that all stabilized compost would
have a zero day application interval (see discussion in 79 FR 58434).
We are finalizing the provision in Sec.  112.56 for a zero-day interval
for stabilized compost. Depending on the microbial standards that the
stabilized compost meets (Sec.  112.55(a) or (b)), the allowable
application methods differ (compare Sec.  112.56(a)(3) and (a)(2)).
    (Comment 293) A comment requests that FDA focus on compost maturity
at the time of field application and requested that FDA provide a
specific definition of ``curing'' along with guidance that would help
farms ensure adequate pathogen reduction in stabilized compost, prior
to field application. Several other comments also support requiring a
curing stage in composting for purposes of considering a biological
soil amendment of animal origin to be ``treated,'' stating that heating
manure during the composting process uniformly and to a sufficient
temperature through one phase of microbial activity is only part of the
pathogen-control process. Other comments indicate that curing must be
done in a manner that prevents cross-contamination and which may
include proper insulation. Some comments express confusion about
insulation, including the type (some comments suggested the use of a
plastic tarp) and the timing of insulation (many comments suggested
compost needs to be turned many times during the compost curing
process). These comments suggest such use of insulation would be
neither economically feasible nor operationally practical. Another
commenter suggests that the specific requirements for use of insulating
material on compost piles during the curing process are impractical for
small-farm methods of composting. Some comments indicate that the
proposed requirement for insulated curing of compost in Sec.  112.54
(b)(1) and (b)(2) (originally proposed as Sec.  112.54(c)(1) and
(c)(2)) is overly burdensome and not necessary for all approaches to
the composting process.
    (Response) Curing is an important part of any type of composting
process (i.e., static or turned), and reduces pathogens if performed in
an adequate manner. The definition of ``composting'' in Sec.  112.3(c)
reflects that curing is an integral part of the process: ``Composting
means a process to produce stabilized compost in which organic material
is decomposed by the actions of microorganisms under thermophilic
conditions for a designated period of time (for example, 3 days) at a
designated temperature (for example, 131[emsp14][deg]F (55 [deg]C)),
followed by a curing stage under cooler conditions.'' Curing involves
the complete decomposition of cellulose and lignin in feedstock such
that it cannot be further broken down by microbial metabolism. Curing
may or may not need to include insulation to be adequate to reduce
pathogens to a specified level, depending on environmental conditions.
For example, insulation may be needed to ensure that compost
temperatures do not drop too fast; proper curing involves a gradual
temperature decline. Thus, we are clarifying the definition of
``curing'' by adding a statement that ``[c]uring may or may not involve
insulation, depending on environmental conditions.'' When there is a
need to protect compost from external temperature changes, a plastic
tarp would typically not be expected to provide effective insulation.
Materials such as a layer of straw, hay, or stabilized compost are
effective for use in insulation.
    We also acknowledge that, for static composting, insulation may
also be used during the first stage of composting as well as during the
curing stage. We have made a change to the definition of ``static
composting'' to reflect this (see Comment 107) such that the definition
reads, in relevant part, ``[s]tatic composting means a process to
produce stabilized compost in which air is introduced into biological
material (in a pile (or row) that may or may not be covered with
insulating material, or in an enclosed vessel) by a mechanism that does
not include turning.
    As noted previously, curing may or may not involve insulation. We
are removing the requirements for proper insulation in Sec.
112.54(b)(1) and (b)(2) because these provisions are examples of
scientifically valid controlled biological (e.g., composting) processes
that meet the microbial standard in Sec.  112.55(b). We agree that
insulation may not be necessary to meet the microbial standard of Sec.
112.55(b) under all circumstances and so we have removed the reference
to insulation in Sec.  112.54(b)(1) and (b)(2). However, those
employing the static and turned composting processes described in Sec.
112.54(b)(1) and (b)(2) will need to make a determination whether
insulation is needed as part of the curing phase to achieve stabilized
compost.
    (Comment 294) A comment requests clarification regarding whether
animal manure, or another biological soil amendment of animal origin,
that is passively composted (that is, simply left in place without
turning or monitoring) for nine months or more, would be considered
``untreated'' or ``treated'' for purposes of Sec.  112.51 and
associated application restrictions in Sec.  112.56. The commenter
suggests that it would be reasonable to consider manure to be
``treated'' if it has been aged for a period equal to the proposed
application interval for untreated biological soil amendments of animal
origin.
    (Response) Processes that meet the requirements of Sec.  112.54
must be scientifically valid, controlled processes that have been
validated to meet the

microbial standards in either Sec.  112.55(a) or (b). We are not aware
of any data or information supporting a conclusion that ``passive
composting'' as described by the commenter (stockpiling or aging
manure) meets the microbial standards in either Sec.  112.55(a) or (b).
    (Comment 295) One comment asks for a revision to the example
process provided for ``turned composting'' in Sec.  112.54(b)(2)
(originally proposed as Sec.  112.54(c)(2)) to read, ``Composting that
maintains a minimum average temperature of 131[emsp14][deg]F (55
[deg]C) or higher for 15 days or longer and is followed by adequate
curing, storage and handling practices. During the period when the
compost is maintained at 131[emsp14][deg]F (55 [deg]C) or higher, there
shall be a minimum of five turnings of the windrow with a minimum of 3
days between turnings. The 15 or more days at or above
131[emsp14][deg]F (55 [deg]C) do not have to be continuous.''
    (Response) We believe it would be appropriate to make some, but not
all, of the changes to the example process for ``turned composting'' in
Sec.  112.54(b)(2) suggested by the commenter. The distinctions between
our language and that suggested by the comment are: (1) The commenter's
additional mention of storage and handling; (2) the commenter's
suggestion of requiring a minimum of 3 days between turnings; and (3)
the commenter's suggestion that the 15 days need not be continuous.
    With respect to storage and handling, the rule already covers these
topics sufficiently in Sec.  112.52, and those requirements apply
equally to all processes used under the rule, including those described
in Sec.  112.54(b)(2).
    With respect to the commenter's suggestion of requiring a minimum
of 3 days between turnings, we are not aware of science sufficient to
support a conclusion that this is required to meet the microbial
standard in Sec.  112.55(b). Every compost pile has a unique size,
shape and feedstock composition, all of which affects how the pile will
generate and maintain heat. For example, many compost windrows will
reach 55 [deg]C relatively quickly, at which time the operator will
begin monitoring the `degree days' above this temperature toward
meeting the fifteen days of exposure to 55 [deg]C per Sec.
112.54(b)(2). To continue this `thermophilic phase' of the process, the
operator will typically manage both oxygen and influx of new nutrient
materials (via turning), and in some situations even moisture, to
maintain the 55 [deg]C temperature for a total of 15 days to rely on
the option in Sec.  112.54(b)(2). Turning the piles also serves the
purpose of maximizing the exposure of as much of the compost material
as possible to the elevated temperatures. To ensure that as much of the
compost as possible is exposed to the 55 [deg]C temperature, to rely on
the option in Sec.  112.54(b)(2), we are requiring a minimum of 5
turnings but we are not specifying a timeframe for the turns. The
timing will be driven by the size, shape and feedstock composition. It
is our understanding that, in order to maintain a compost temperature
of at least 55 [deg]C for the required 15 days, the operator will
likely need to turn the windrow approximately three times per week
(within the first two weeks) and then decrease the frequency to once or
twice per week for the following month(s) as the compost matures.
    As discussed in response to Comment 293, Sec.  112.54(b)(1) and
(b)(2) provide two example processes that farms may use to satisfy the
microbial standard in Sec.  112.55(b), but these are not the only means
of achieving adequate composting to meet the microbial standard in
Sec.  112.55(b). Thus, we do not discourage farms from using processes
that allow a minimum of 3 days between turnings if those processes are
validated to meet the microbial standards in Sec.  112.55(a) or (b),
but we are not revising our example process in Sec.  112.54(b)(2)
because we do not believe it is necessary.
    With respect to the commenter's suggestion that the 15 days need
not be continuous, we agree that the 15 days at 55 [deg]C need not be
continuous and, given the nature of turned composting, it is unlikely
that they would be continuous (Ref. 179). We are revising Sec.
112.54(b)(2) to indicate that the 15 days at 55 [deg]C need not be
consecutive. For clarity, we are also revising Sec.  112.54(b)(1) to
indicate that the 3 days at 55 [deg]C is consecutive. For static
aerated composting, 3 consecutive days at or above 55 [deg]C ensures
that the microbial standard in Sec.  112.55(b) is achieved, considering
the expected die-off rates of various classes of thermophilic and
thermotolerant pathogens (Ref. 180).
    (Comment 296) One comment asks for confirmation that covered
produce grown using biological soil amendments of animal origin
containing pathogens at or below the microbial standards set forth in
Sec.  112.55(a) and (b) are considered ``safe.''
    (Response) In this regulation, FDA is establishing those standards
that we conclude minimize the risk of serious adverse health
consequences or death, including procedures, processes, and practices
that are reasonably necessary to prevent the introduction of hazards
into produce, and to provide reasonable assurances that process is not
adulterated under section 402 of the FD&C Act. We do not expect that
compliance with these standards will eliminate all occurrences of
hazards in covered produce.
    (Comment 297) One comment recommends that rather than focusing on
process standards, which the commenter criticizes as ambiguous, the
rule should instead require that stabilized compost be tested for
indicator microbial species to determine appropriate application
restrictions.
    (Response) FDA disagrees. We have established an approach where we
define ``treated'' and ``untreated'' biological soil amendments of
animal origin through the application of a scientifically valid,
controlled process (described in Sec.  112.54) that has been validated
to satisfy the microbial standards of either Sec.  112.55(a) or (b). We
do not agree that such process standards are ambiguous. See discussions
in Comment 286 and Comment 288. Moreover, we conclude that our approach
is more protective of public health than relying on lot testing for
indicator species. Appropriate indicator species in biological soil
amendments of animal origin may be difficult to identify, and routine
pathogen testing is not an effective indicator of the presence or
absence of pathogens. In addition, such testing could require multiple
target organisms, which could be very costly.
    (Comment 298) Some comments request that accepted treatment
processes be backed by scientific evidence that they will protect
public health.
    (Response) As discussed in the 2013 proposed rule (78 FR 3580-1),
the microbial standards set out in Sec.  112.55 are protective of
public health. Treatments for biological soil amendments of animal
origin must be scientifically valid, controlled processes that have
been validated to satisfy the relevant microbial standard in Sec.
112.55(a) or (b). In Sec.  112.54(b)(1) and (b)(2) we have described
processes for static and turned composting that have been previously
validated to meet the standard in Sec.  112.55(b) for Salmonella and
fecal coliforms when done properly.
    (Comment 299) Some comments request that FDA require suppliers to
provide a guarantee to purchasers that a biological soil amendment the
supplier claims is not of animal origin indeed not include any
components of animal origin.
    (Response) FDA declines to require provision of such guarantees.
Soil amendments that do not contain components of animal origin are not
subject to the requirements in subpart F.

This rule does not require covered farms to receive such guarantees to
use soil amendments that are not of animal origin other than as
provided by subpart F. However, covered farms are responsible for their
compliance with the rule, and we do not discourage farms from
requesting such guarantees from their suppliers, which seems likely to
be a prudent practice.

F. Microbial Standards Applicable to the Treatment Processes in Sec.
112.54 (Sec.  112.55)

    Section 112.55 establishes microbial standards applicable to the
treatment processes in Sec.  112.54. In Table 18, we describe the
codified provisions of Sec.  112.55 and any changes we made to those
provisions in the final rule. Comments specific to Sec.  112.55 follow
the table.

           Table 18--Description of Revisions to Sec.   112.55
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.55...............  The following         No change.
                               microbial standards
                               apply to the
                               treatment processes
                               in Sec.   112.54 as
                               set forth in that
                               section.
Sec.   112.55(a)............  For L.                No change.
                               monocytogenes,
                               Salmonella species,
                               and E. coli
                               O157:H7, the
                               relevant standards
                               [are those in
                               (a)(1)-(a)(3)] or;
Sec.   112.55(a)(1).........  L. monocytogenes . .  Revised to add
                               . Not detected        liquid sampling.
                               using a method that
                               can detect one
                               colony forming unit
                               (CFU) per 5 gram
                               analytical portion.
Sec.   112.55(a)(2).........  Salmonella species .  Revised to add
                               . . Less than three   liquid sampling and
                               most probable         indicate that it is
                               numbers (MPN) per 4   a `non-detect'
                               grams of total        standard.
                               solids (dry weight
                               basis).
Sec.   112.55(a)(3).........  E. coli O157:H7 . .   Revised to add
                               . Less than 0.3 MPN   liquid sampling and
                               per 1 gram            indicate that it is
                               analytical portion.   a `non-detect'
                                                     standard.
Sec.   112.55(b)............  Less than three MPN   Revised to add
                               Salmonella species    liquid sampling and
                               per four grams of     indicate that the
                               total solids (dry     Salmonella method
                               weight basis); and    is a `non-detect'
                               less than 1,000 MPN   standard.
                               fecal coliforms per
                               gram of total
                               solids (dry weight
                               basis).
------------------------------------------------------------------------

    (Comment 300) One comment suggests that should FDA consider end-use
risk in establishing final microbial standards for treated biological
soil amendments of animal origin. The comment pointed to Austrian
[Ouml]NORM standards for compost, which differ by end-use categories.
    (Response) We believe we have appropriately considered end-use risk
in establishing the microbial standards for treated biological soil
amendments of animal origin. First, we note that this rule does not
apply to end uses such as home gardening or growing crops other than
covered produce. The end uses to which the requirements of subpart F
apply are more limited than those in the Austrian standards noted in
the comment. Second, we conclude that all treated biological soil
amendments of animal origin must meet the standards in Sec.  112.55(a)
or (b), and those that meet the standards of Sec.  112.55(b) must also
be applied in accordance with the restrictions in Sec.  112.56(a)(2).
We also conclude that untreated biological soil amendments of animal
origin must be applied in accordance with the restrictions in Sec.
112.56(a)(1). See Comment 257 regarding our plans for application
intervals for such biological soil amendments of animal origin.
    (Comment 301) Some comments indicate a belief that the standards in
proposed Sec.  112.55 are metrics for required microbial testing. The
comments suggest the use of guidance documents, which can be more
easily updated, in lieu of incorporating metrics in the provisions of
the rule.
    (Response) FDA is not requiring microbial testing of treated
biological soil amendments of animal origin to ensure that they meet
the relevant microbial standards. Rather, we have provided the
microbial standards against which treatment processes must be
validated. Proper validation to show that a process satisfies the
microbial standards of Sec.  112.55 needs to include specific process
variables, and the person applying the treatment process will need to
monitor the physical parameters of the process (e.g., the temperature
of a compost pile) to ensure they meet the conditions under which the
process was validated. See also our response to Comment 286. In
Sec. Sec.  112.54(b)(1) and (b)(2) we have also described processes for
static and turned composting that have been previously validated to
meet the standard in Sec.  112.55(b) for Salmonella and fecal coliforms
when done properly.
    (Comment 302) One comment recommends FDA change the microbial
standards for Salmonella spp. and E. coli O157:H7 in Sec.  112.55(a) to
``negative'' or less than detectable limit (<1/30 grams).
    (Response) The microbial standards as proposed in Sec.  112.55(a)
represented ``less than the detectable limit'' for each pathogen,
though only Sec.  112.55(a)(1) was phrased as ``not detected using a
method that can detect . . .'' We are revising the standards in
Sec. Sec.  112.55(a)(2) and (a)(3) and the Salmonella standard in
112.55(b) to provide a parallel structure. As revised, Sec.
112.55(a)(2), (a)(3), and (b) read as set forth in the regulatory text
of this rule.

G. Application Requirements and Minimum Application Intervals (Sec.
112.56)

    Section 112.56 establishes application restrictions based on
whether biological soil amendments of animal origin are treated or
untreated; and for those biological soil amendments of animal origin
that are treated, based on the level of treatment they received (with
reference to the microbial standards in Sec.  112.55). In Table 19, we
describe the proposed codified provisions of Sec.  112.56 (considering
the 2013 proposed rule and the supplemental notice, taken together) and
any changes we made to those provisions in the final rule. Comments
specific to Sec.  112.56 follow the tables.

         Table 19--Description of Revisions to Sec.   112.56(a)
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.56(a)............  Except as provided    Deleted ``Except as
                               in paragraph (b) of   provided in
                               this section, you     paragraph (b) of
                               must apply the        this section'' as a
                               biological soil       conforming change
                               amendments of         to the deletion of
                               animal origin         (b) (made in the
                               specified in the      supplemental
                               first column of the   notice).
                               table in this        Revised (a)(1)-(4)
                               paragraph in          to (a)(1)-(3).
                               accordance with the
                               application
                               requirements
                               specified in the
                               second column of
                               the table in this
                               paragraph and the
                               minimum application
                               intervals specified
                               in the third column
                               of the table in
                               this paragraph
                               [table follows
                               containing (1)-(4)].
------------------------------------------------------------------------

    Proposed Sec.  112.56(a)(1)-(4) was published at 78 FR 3504,
January 16, 2013.
    Final Sec.  112.56(a)(1)-(3) is set forth in the regulatory text of
this rule.
    The revisions in final Sec.  112.56(a)(1)-(3) consist of conforming
amendments to match changes made in Sec.  112.54 (including biological
processes in both Sec.  112.54(a) and (b), and collapsing Sec.
112.54(b) and (c)); and to renumber proposed (a)(2) as (a)(3).
    (Comment 303) Several comments request that FDA clarify the
meanings of ``does not contact,'' and ``minimizes contact.'' Some
comments suggest that the phrase ``In a manner that does not contact
covered produce during or after application'' might be read to require
that there is absolutely no possibility of contact of the soil
amendment with the covered produce, and one comment suggested that such
a requirement could never be met in light of the variety of activities
performed on farms and the potential that dust from fields may contact
covered produce. Another comment seeks clarification on whether the
harvestable portion of underground crops would be considered to come
into contact with the biological soil amendments of animal origin used
on the soil.
    (Response) FDA intends ``does not contact'' in Sec.  112.56 to mean
there is no intended or likely contact between the biological soil
amendment of animal origin and covered produce during the relevant time
period. For example, when an amendment is applied beneath a high tree
crop that is not intentionally dropped to the ground for harvest, there
would be no intended or likely contact either during or after
application. We do not agree with the comment suggesting that a ``does
not contact'' requirement could never realistically be met. We realize
that there is always a chance that some soil amendment could be present
in dust such that it settles on covered produce; however, we do not
believe at this time that this type of potential contact is significant
enough to be considered intended or likely for purposes of Sec.
112.56. However, we intend to include consideration of wind-blown
contamination in our upcoming risk assessment on untreated biological
soil amendments of animal origin (See discussion under Comment 257).
    FDA intends ``minimizes contact'' to mean there is no intended
contact between the biological soil amendment of animal origin and
covered produce during the relevant time period, but some unintentional
contact is likely due to incidental or environmental action. For
example, a farm choosing to side-dress a leafy green crop with a soil
amendment in the alley between crop rows could apply the amendment in a
manner that does not contact the covered produce at application.
However, it would be likely that some portion of the amendment would
migrate to the area where the crop is located. This post-application
contact would not be intended, but it is likely. Conversely, if the
farm were to apply the soil amendment in the previous example not in
the alley between crop rows but instead in a broadcast manner, it could
be reasonably expected that there would be widespread contact between
the amendment and the harvestable portion of the leafy greens both
during and after application, and that such contact is both intentional
and likely.
    A root crop grown in soil that has been amended with biological
soil amendments of animal origin is both intended and likely to be in
contact with those soil amendments both during and after application.
    We will consider addressing this topic further in our forthcoming
implementation guidance.
    (Comment 304) Some comments state that use of raw manure should be
subject to additional application restrictions beyond those in Sec.
112.56(a)(1)(i) and (a)(1)(ii) because there is risk even if the manure
is applied in such a way that there is no intended or likely contact
with covered produce, noting that there will always be opportunities
for indirect contact from forces such as wind and dust. These comments
provide several references to support their conclusion that raw manure
poses a significant risk to covered produce.
    (Response) As discussed in response to Comment 257, FDA is pursuing
a risk assessment and research agenda to supplement the science on an
appropriate application-to-harvest interval for raw manure. FDA will
consider the information provided by these comments during future risk
assessment and research efforts. We agree that raw manure can be an
important route of contamination for covered produce and encourage
farms to consider use of stabilized compost as an alternative to raw
manure.

H. Records Related to Biological Soil Amendments of Animal Origin
(Sec.  112.60)

    Section 112.60 requires that you establish and keep records for
subpart F in accordance with the requirements of subpart O of this part
and that you establish and keep certain records. In Table 20, we
describe the codified provisions of Sec.  112.60 and any changes we
made to those provisions in the final rule. Comments specific to Sec.
112.60 follow the table.

           Table 20--Description of Revisions to Sec.   112.60
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.60(a)............  You must establish    No change.
                               and keep records
                               required under this
                               subpart F in
                               accordance with the
                               requirements of
                               subpart O of this
                               part.

Sec.   112.60(b)............  For any biological    No change.
                               soil amendment of
                               animal origin you
                               use, you must
                               establish and keep
                               the following
                               records:
Sec.   112.60(b)(1).........  For a treated         Revision to
                               biological soil       eliminate proposed
                               amendment of animal   (1)(ii) and as a
                               origin you receive    conforming change
                               from a third party,   to renumber
                               documentation (such   (1)(iii) to (1)(ii)
                               as a Certificate of   and to require such
                               Conformance) that:    documentation at
                              (i) The process used   least annually.
                               to treat the
                               biological soil
                               amendment of animal
                               origin is a
                               scientifically
                               valid process that
                               has been carried
                               out with
                               appropriate process
                               monitoring;.
                              (ii) The applicable
                               treatment process
                               is periodically
                               verified through
                               testing using a
                               scientifically
                               valid analytical
                               method on an
                               adequately
                               representative
                               sample to
                               demonstrate that
                               the process
                               satisfies the
                               applicable
                               microbial standard
                               in Sec.   112.55,
                               including the
                               results of such
                               periodic testing;
                               and.
                              (iii) The biological
                               soil amendment of
                               animal origin has
                               been handled,
                               conveyed and stored
                               in a manner and
                               location to
                               minimize the risk
                               of contamination by
                               an untreated or in
                               process biological
                               soil amendment of
                               animal origin.
Sec.   112.60(b)(2).........  For a treated         No change.
                               biological soil
                               amendment of animal
                               origin you produce
                               for your own
                               covered farm(s),
                               documentation that
                               process controls
                               (for example, time,
                               temperature and
                               turnings) were
                               achieved.
Sec.   112.60(b)(3).........  Scientific data or    Elimination of Sec.
                               information you        112.60(b)(3) as a
                               rely on to support    conforming change
                               a process used to     since Sec.
                               treat a biological    112.54(c)(3) has
                               soil amendment of     been deleted.
                               animal origin in
                               accordance with the
                               requirements of
                               Sec.   112.54(c)(3).
------------------------------------------------------------------------

    (Comment 305) One comment requests clarification on what compost
suppliers should document to ensure covered farms could rely on such
documentation to satisfy the rule and on documentation needed when
using alternative composting procedures. Another comment asks us to
clarify the requirements for records related to process verification in
composting.
    (Response) With regard to documentation that a farm receives from a
third party, such as a stabilized compost supplier, we have revised the
proposed requirements. We are sensitive to requests that we minimize
the burden of testing. Therefore, we are eliminating proposed Sec.
112.60(b)(1)(ii) that would have required documentation of testing of
treated biological soil amendments of animal origin received from third
parties to verify that the treatment process satisfies the applicable
microbial standard in Sec.  112.55 and the results of the periodic
testing. We consider such periodic verification testing to be a best
practice, but we conclude it is not necessary to mandate that farms
maintain documentation of such testing performed by their suppliers. We
are requiring in Sec.  112.60(b)(1)(i) that, with respect to treated
biological soil amendments of animal origin received from a third
party, covered farms must maintain documentation demonstrating that the
process used to treat the biological soil amendment of animal origin is
a scientifically valid process that has been carried out with
appropriate process monitoring. Parameters will be process specific and
may include, for example, time/temperature, moisture content, and pH.
We are also renumbering proposed Sec.  112.60(b)(1)(iii) to Sec.
112.60(b)(1)(ii) and maintaining the requirement, as proposed, that
with respect to treated biological soil amendments of animal origin
received from a third party, covered farms must maintain documentation
that the biological soil amendment of animal origin has been handled,
conveyed, and stored in a manner and location to minimize the risk of
contamination by an untreated or in process biological soil amendment
of animal origin.
    Regarding documentation that a farm producing its own treated
biological soil amendment of animal origin must have, in accordance
with Sec.  112.60(b)(2) a farm must have documentation that process
controls (for example, time, temperature and turnings) were achieved.
As a conforming change to the elimination of Sec.  112.54(c)(3), we are
eliminating proposed Sec.  112.60(b)(3) which would have required
records documenting the scientific data or information relied on to
support any alternative composting process used to treat biological
soil amendments of animal origin in accordance with Sec.  112.54(c)(3).
    (Comment 306) Several comments agree with FDA's decision to require
certain documentation for any treated biological soil amendment of
animal origin received from a third party. These comments stated this
was consistent with established industry programs. Other commenters
suggest that requiring certificates of conformance will be economically
burdensome to compost suppliers, and requested clarification on how
often such documentation would need to be obtained from a supplier.
    (Response) FDA agrees that documentation, meeting the requirements
in Sec.  112.60(b)(1) should be required for a treated biological soil
amendment of animal origin that you receive from a third party. Note
that FDA proposes ``such as a Certificate of Conformance'' in the
codified language only to serve as one possible example of adequate
documentation. Any form of documentation is acceptable provided that it
includes the information required in Sec.  112.60(b)(1); it need not be
named a ``Certificate of Conformance.'' We disagree with the comment
suggesting that such documentation is economically burdensome as we
understand that such documentation is already frequently provided and
is consistent with industry standards. Documentation must be obtained
from third-party suppliers at least annually. We are adding the annual
requirement to the codified in Sec.  112.60(b)(1).

    (Comment 307) Some comments suggest that, in order to best protect
consumers from the risk of pathogens, FDA should require adequate
recordkeeping for application intervals for all biological soil
amendments of animal origin, whether treated or untreated, and without
regard to whether produce contacts the soil.
    (Response) FDA agrees that robust recordkeeping is a best practice.
However, FDA disagrees that it is reasonably necessary to require
covered farms to maintain records of dates of application and harvest
when they use biological soil amendments of animal origin that have a
required application interval of zero days as described in Sec.
112.56, which at this time includes all biological soil amendments of
animal origin. Should FDA establish application intervals greater than
zero days for any uses of biological soil amendments of animal origin
at a later date, we will also establish appropriate recordkeeping
requirements related to those intervals. See Comment 257 regarding our
plans on this topic.
    (Comment 308) One comment states that FDA should require farms to
document the particular fields on which biological soil amendments of
animal origin received from a supplier are applied. This comment states
that such a requirement could help facilitate traceback investigations
if problems are identified, and may help limit the scope of a recall or
product withdrawal.
    (Response) While we agree that this information could be useful in
some very limited circumstances, we do not agree that it is reasonably
necessary to establish such a requirement to minimize the risk of
serious adverse health consequences or death, to prevent the
introduction of hazards into or onto produce, or to provide reasonable
assurances that produce is not adulterated under section 402 of the
FD&C Act. We will consider addressing this topic in guidance.

I. Other Comments

    (Comment 309) Several comments address our request regarding how to
classify spent mushroom mulch (growth media already used in the
production of mushrooms for subsequent use as a biological soil
amendment of animal origin in the growing of other covered produce).
Some comments argue that spent mushroom mulch should not be defined as
a biological soil amendment of animal origin regardless of the contents
of its feedstock because it is processed with a steam treatment after
the mushrooms are harvested and it originally met the microbial
standards of Sec.  112.55(a) prior to use in growing mushrooms. These
comments argue that spent mushroom mulch should have no restrictions on
its use. On the other hand, many comments agree with FDA's tentative
conclusion that if the spent mushroom mulch has been subject to a
treatment process which met the microbial standard in Sec.  112.55(a),
it would still be considered a ``treated'' biological soil amendment
after use for growing mushrooms and therefore available for use as
``treated'' in growing any covered produce commodity without any
intervening treatment unless you know or have reason to believe it has
been otherwise contaminated with a hazard or has been associated with
foodborne illness.
    (Response) FDA disagrees with the commenters that argued that spent
mushroom mulches or other spent growth media should not be defined as
biological soil amendments of animal origin, when it was defined as
such before it was used. We conclude that if a substrate such as spent
mushroom mulch previously met the requirements to be considered a
``treated'' biological soil amendment of animal origin under Sec.
112.51, then it retains that status after use as a growth media, unless
you know or have reason to believe it has been otherwise contaminated
with a hazard or has been associated with foodborne illness.

XV. Subpart I--Comments on Domesticated and Wild Animals

    In subpart I of proposed part 112, we proposed science-based
minimum standards that are directed to domesticated and wild animals.
As proposed, subpart I included standards that would be directed to the
potential for biological hazards from animal excreta to be deposited by
your own domesticated animals (such as livestock, working animals, and
pets), by domesticated animals from a nearby area (such as livestock
from a nearby farm), or by wild animals (such as deer and wild swine)
on covered produce or in an area where you conduct a covered activity
on covered produce. We requested comment on all provisions in subpart
I, including specifically on the scope of the subpart's proposed
applicability, including the meaning of the phrase ``under the
circumstances'' and our tentative conclusion that crops that grow
completely underground would not be subject to the proposed
requirements of subpart I. We also requested comment on the
interactions of the proposed provisions of subpart I with the NOP.
    In addition, in the supplemental notice, taking into account
comments on the 2013 proposed rule, we proposed Sec.  112.84 to state
that part 112 does not authorize or require covered farms to take
certain actions. We asked for comment on our current thinking,
including on proposed Sec.  112.84 (79 FR 58434 at 58463-58464).
    We solicited additional comments on the potential impact of the
proposed produce safety rule on wildlife and animal habitat. We
considered these comments in our EIS (see section XXVII of this
document. In this section of this document we discuss comments we
received on the standards directed to wild or feral animals and
domesticated animals, in the 2013 proposed rule, but that we did not
address in the supplemental notice. We discuss comments received on
proposed Sec.  112.84 in the supplemental notice in section III.E of
this document.
    We are finalizing these provisions with revisions (see Table 21).
We discuss these changes in this section. We are finalizing the other
provisions of subpart I without change.

   Table 21--Description of Re-Arrangement and Revisions to Subpart I
------------------------------------------------------------------------
    Proposed provision  (as
 proposed in the 2013 proposed                         Description of
    rule and amended in the      Final provision         revisions
     supplemental notice)
------------------------------------------------------------------------
Sec.   112.81.................  Sec.   112.81....  --Revision to Sec.
                                                    112.81(b) to state
                                                    that subpart I does
                                                    not apply to fish
                                                    used in aquaculture
                                                    operations.

Sec.   112.82.................  Sec.   112.83....  --Revision to combine
                                                    and unify
                                                    requirements related
                                                    to grazing and
                                                    working animals and
                                                    animal intrusion.
                                                   --Revision to require
                                                    farms to assess
                                                    relevant areas and
                                                    take certain steps
                                                    to prevent covered
                                                    produce that is
                                                    reasonably likely to
                                                    be contaminated
                                                    when, under the
                                                    circumstances, there
                                                    is a reasonable
                                                    probability that
                                                    grazing animals,
                                                    working animals, or
                                                    animal intrusion
                                                    will contaminate
                                                    covered produce.
                                                   --Revision to clarify
                                                    that Sec.   112.83
                                                    applies during the
                                                    growing season, in
                                                    contrast to the
                                                    related Sec.
                                                    112.112, which
                                                    applies during and
                                                    immediately prior to
                                                    harvest.
                                                   --Revisions to
                                                    further clarify what
                                                    type of evidence of
                                                    potential
                                                    contamination
                                                    requires a covered
                                                    farm to take action
                                                    under Sec.   112.83
                                                    (observation of
                                                    significant
                                                    quantities of
                                                    animals, significant
                                                    amounts of animal
                                                    excreta, or
                                                    significant crop
                                                    destruction), and
                                                    what kind of action
                                                    is required
                                                    (evaluate whether
                                                    the covered produce
                                                    can be harvested and
                                                    take measures
                                                    reasonably necessary
                                                    during growing to
                                                    assist you later
                                                    during harvest when
                                                    you must identify,
                                                    and not harvest,
                                                    covered produce that
                                                    is reasonably likely
                                                    to be contaminated
                                                    with a known or
                                                    reasonably
                                                    foreseeable hazard.
Sec.   112.83
Sec.   112.84.................  Sec.   112.84....  --No change.
------------------------------------------------------------------------

A. Subpart I and Prevention of Contamination

    (Comment 310) Some comments suggest that FDA should address
contamination of produce from domesticated and wild animals through
postharvest processing or treatment (including steps such as washing)
rather than requiring measures to prevent contamination of covered
produce with fecal material.
    (Response) We disagree that postharvest processing or treatments
provide viable options for addressing the potential for contamination
of covered produce by domesticated or wild animals. Produce that
receives commercial processing that adequately reduces the presence of
microorganisms of public health significance is eligible for exemption
from this rule with certain documentation under Sec.  112.2(b). In
addition, produce that is rarely consumed raw (i.e., it is typically
cooked before consumption) is not subject to this rule under Sec.
112.2(a). Thus, by definition, covered produce is produce that is not
likely to receive a postharvest processing or a treatment step that
will adequately reduce the presence of microorganisms of public health
concern. As discussed in the 2013 proposed rule, studies have concluded
that 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). In
addition, 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). Thus, our rule
takes an approach consistent with the requirement in section
419(c)(1)(A) that this regulation set forth the procedures, processes,
and practices the Secretary determines to be reasonably necessary to
prevent the introduction of known or reasonably foreseeable hazards
into fruits and vegetables.

B. Limited Scope of Applicability of Subpart I (Sec.  112.81)

    (Comment 311) Several comments support limiting the applicability
of subpart I to outdoor areas and partially-enclosed buildings, and not
to fully-enclosed buildings. In contrast, some comments express
concerns about intrusion by pests in both fully- and partially-enclosed
buildings, and suggest that the scope of subpart I be expanded to
include fully-enclosed buildings for this reason. One commenter
believes we exempted activities that take place in fully enclosed
buildings from subpart I on the basis that mammals and other carriers
of human pathogens are less likely to come into contact with produce
that is grown in controlled areas.
    (Response) We are maintaining the limitation on applicability of
subpart I to outdoor areas and partially-enclosed buildings, as
proposed. We are not expanding the applicability of subpart I to fully-
enclosed buildings. We identified mammals (such as cows, dogs, swine,
and deer) as examples, and not to suggest that these are the only
animals that can be a potential source of contamination of covered
produce. We acknowledge that domesticated animals and intrusion by
pests can be potential hazards for covered activities that take place
in fully-enclosed buildings, and we are establishing requirements
addressing these hazards in subpart L of part 112. Specifically,
measures directed at domesticated animals in a fully-enclosed building
are described under Sec.  112.127, and requirements regarding pest
control in both fully-enclosed and partially-enclosed buildings are
described under Sec.  112.128. We have also revised Sec.  112.181(b) to
reflect that subpart I does not apply to fish used in aquaculture
operations (See Comment 17).
    (Comment 312) One comment disagrees with our tentative conclusion
that there would not be a reasonable probability of contamination by
animals when covered produce grows completely underground, and that
therefore such produce would not be subject to the requirements in
subpart I. This comment stated that different scenarios of animal
interaction with produce operations entail different levels of risk,
and that it may not be appropriate to harvest covered produce grown
underground in areas where there is a prolonged, high concentration of
animals known to be vectors of key human pathogens, and suggested that
the provisions of subpart I should apply under such circumstances.
    (Response) We agree that there may be situations in which even
produce that grows completely underground should not be harvested as a
result of wild animal activity, e.g., if the produce is visibly
contaminated with animal excreta. We are revising both Sec.  112.112
and Sec.  112.83 to make explicit when and how these provisions apply
and how they differ from each other, clarifying

that Sec.  112.112 applies immediately prior to and during harvest,
while Sec.  112.83 applies during the growing season. The requirement
in Sec.  112.112 of subpart K requires covered farms to take all
measures reasonably necessary to identify and not harvest covered
produce that is reasonably likely to be contaminated with a known or
reasonably foreseeable hazard, including produce that is visibly
contaminated with animal excreta. At 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 all covered produce to be harvested,
regardless of the harvest method used. This requirement (Sec.  112.112)
applies even to covered produce grown completely underground and FDA
concludes that it is sufficient to address the majority of potential
scenarios in which animals may contaminate covered produce grown
completely underground.
    For example, section 112.112 requires farms to take steps to
identify and not harvest covered carrots that are reasonably likely to
be contaminated, including carrots that are visibly contaminated with
animal excreta. At a minimum, with respect to animal excreta, this
requires a covered farm to conduct a visual assessment of the growing
area and all covered produce to be harvested, regardless of the harvest
method used. Underground produce that is not visible prior to harvest
must be visually assessed during harvest to comply with this
requirement. If, during your assessment of the growing area or of the
covered carrots, you see evidence of animal excreta on or surrounding a
carrot, you must not harvest that carrot; and you must not harvest an
area of carrots if animal excreta that is present in the growing area
would be likely to contaminate carrots or food-contact surfaces of
harvest equipment. By contrast, the requirements in subpart I include
assessing relevant areas for evidence of potential contamination of
covered produce as needed during the growing season, with required
follow-up actions to be taken during the growing season if evidence of
potential contamination is found (Sec.  112.83). FDA concludes it is
not necessary to apply the additional requirements in subpart I to
covered produce that grows completely underground because the growth
habit of such commodities means that there will not be a reasonable
probability of contamination of such commodities by animals as a
general matter. We acknowledge that there is a rare and limited range
of potential scenarios in which animals may contaminate covered produce
grown completely underground during the growing season but where no
evidence of such contamination would be visible immediately prior to or
during harvest of that produce. For example, it is theoretically
possible that pigs may root in a field of carrots, exposing those
carrots to potential contamination from the pigs' excreta, and weather
events may remove the evidence of the pigs' activity prior to harvest.
However, we do not think this rare and limited scenario presents a
reasonable probability of contamination during the growing season as a
general matter that warrants application of the additional requirements
in Sec.  112.83 during the growing season. Our QAR, too, suggests
limited concerns of contamination of such underground produce from
animals during the growing of these produce. Given the limited chance
that animals will contaminate covered produce that grows completely
underground in a manner not visible at harvest such that appropriate
measures may be taken at that time, we do not think it is necessary to
require covered farms to take the measures required in subpart I with
respect to such produce. We emphasize, however, that covered produce
commodities that grow completely underground will be subject to the
rest of this rule, as applicable, including Sec.  112.112. We note that
even covered produce grown completely underground is reasonably
vulnerable to contamination with known or reasonably foreseeable
hazards during and after harvest, as harvesting exposes such produce to
contamination through various pathways. Thus, we conclude that it is
warranted to apply Sec.  112.112 even to covered produce grown
completely underground. We also emphasize that covered produce
commodities that do not grow completely underground (for example,
spinach or tomatoes) are subject to the requirements of subpart I.
    (Comment 313) One comment asserts that occasional animal intrusions
should not represent a threat for the harvest of apples, in particular,
given that the fruit is located above the ground while it grows and is
typically hand-harvested, suggesting that such produce should not be
subject to subpart I.
    (Response) We cannot draw a categorical conclusion with regard to
the applicability of subpart I to all tree crops that grow high above
the ground and are hand-harvested. Animal intrusion is outside the
farm's control, and may include intrusion by significant quantities of
birds that may, in some circumstances, be reasonably likely to
contaminate such crops. There may be circumstances in which subpart I
does not apply to such crops, and there will likely be circumstances in
which subpart I does apply to such crops. That determination must be
based on the farm's specific circumstances.

C. Grazing and Working Animals (Sec.  112.83)

    (Comment 314) Some comments request that FDA clarify what would be
considered an adequate waiting period under proposed Sec.  112.82(a)
and request that FDA specify a minimum waiting period between grazing
of animals in a field and harvest of covered produce from that field.
Some comments suggest that FDA should not require a waiting period
between grazing and harvesting, or that certain commodities should not
be subject to such a requirement. Several comments express concern
about the ability of farmers who employ diversified crop-livestock
farming systems that integrate or rotate livestock farming and produce
growing to comply with proposed Sec.  112.82(a). Several comments
express concerns with FDA's statement in the 2013 proposed rule that we
would not expect it to be necessary for an adequate waiting period
between grazing and harvest to exceed 9 months, which was the
application interval we proposed for use of raw manure as a soil
amendment in originally proposed Sec.  112.56(a)(1)(i). In contrast,
other commenters recommend that FDA require a waiting period of nine
months. One comment asks whether a visual evaluation of the presence of
fecal material, as required in certain situations under Sec.  112.83
relating to wildlife, could be used to satisfy the requirements of
proposed Sec.  112.82(b) for working animals. Several comments noted
the importance of working animals to farm operations and expressed
concerns about how farmers who rely on working animals would comply
with proposed Sec.  112.82(b). For example, some comments suggest that
Sec.  112.82(b) may limit the use of working animals such as horses
used for tilling and harvest activities and transporting produce,
stating that it would be difficult to maintain a designated path
completely segregated from growing produce to be used by draft animals
such as working horses. Some comments express concerns about whether
proposed Sec.  112.82(b) would prevent covered farms from using dogs,
cats, or chickens to deter pests in growing areas; or prevent farms
from

using guard dogs to keep other animals out of fields.
    (Response) We are removing Sec.  112.82 from the rule and replacing
it with revised requirements related to grazing and working animals in
Sec.  112.83, discussed further in the paragraphs that follow. FDA
continues to believe that an adequate waiting period between grazing
and harvest is an important consideration when, under the
circumstances, there is a reasonable probability that grazing animals
will contaminate covered produce. As discussed in the 2013 proposed
rule and our QAR, domesticated animals can be a source of human
pathogens. Some human pathogens of public health concern (e.g., E. coli
O157:H7) that have been associated with produce-related foodborne
outbreaks are zoonotic. Moreover, domesticated animals, due to their
close proximity and interaction with humans, are generally more likely
to harbor zoonotic pathogens than are wild animals (Ref. 186). The
likelihood of contaminating produce with human pathogens from excreta
from grazing animals is determined by numerous factors, including, but
not limited to, the species of the animal and its association with
human or domesticated animal activity or waste, the number of animals
per unit area of land, agro-ecological conditions, the type of
commodity and the time period between animal grazing in fields and the
harvest of produce (Ref. 187) (Ref. 188) (Ref. 189) (Ref. 190) (Ref.
191).
    However, currently available science does not allow us to identify
a specific minimum time period between grazing and harvesting that is
generally applicable across various commodities and farming practices.
Rather, the appropriate minimum time period between grazing and
harvesting would need to be determined based on the specific factors
applicable to the conditions and practices associated with growing and
harvesting the commodity. We are eliminating the proposed requirement
for an adequate waiting period between grazing and harvesting in
proposed Sec.  112.82(a). However, we encourage covered farms to
voluntarily consider applying such waiting periods, as appropriate for
the farm's commodities and operations. We will consider providing
guidance on this practice in the future, as needed.
    In response to comments suggesting that the assessment strategy in
proposed Sec.  112.83 was a reasonable approach not only to the risk of
animal intrusion, but also to the risk posed by working animals, we
evaluated applying that strategy more broadly to grazing animals,
working animals, and animal intrusion. We have concluded that such an
approach was reasonable, scientifically sound, and simpler than
establishing different requirements based on different types of animal
activity. Therefore, we are removing the proposed requirements for a
waiting period between grazing and harvesting in relation to grazing
animals (proposed Sec.  112.82(a)) and measures to prevent introduction
of hazards from working animals into or onto covered produce (proposed
Sec.  112.82(b)), and we are adopting an approach that unifies the
requirements addressing the potential for contamination from grazing
animals, working animals, and animal intrusion. Under revised Sec.
112.83, we are requiring that you take the same steps if, under the
circumstances there is a reasonable probability that grazing animals,
working animals, or animal intrusion will contaminate covered produce
(Sec.  112.83(a)). In such cases, you must assess the relevant areas
used for a covered activity for evidence of potential contamination of
covered produce as needed during the growing season (based on your
covered produce; your practices and conditions; and your observations
and experience) (Sec.  112.83(b)(1)). If you find evidence of potential
contamination during that assessment (such as observation of
significant quantities of animals, significant amounts of animal
excreta, or significant crop destruction), you must evaluate whether
the covered produce can be harvested in accordance with the
requirements of Sec.  112.112, and you must take measures reasonably
necessary during growing to assist you later during harvest when under
Sec.  112.112 you must identify, and not harvest, covered produce that
is reasonably likely to be contaminated with a known or reasonably
foreseeable hazard (Sec.  112.83(b)(2)).
    Assessing the growing areas as needed during the growing season
will enable you to identify instances when covered produce cannot be
harvested for safe consumption, such as produce that was directly
exposed to animal excreta or that may be cross-contaminated during
harvest (e.g., contamination of covered produce by contact with a food-
contact surface that contacted animal excreta). Depending on the
quantity of animals, extent of animal excreta, or extent of crop
destruction, the affected growing areas may be localized (for example,
a specific area of the field where you allowed grazing) or more
widespread. We expect that, in cases of grazing and working animals, in
particular, it is more likely that affected areas will be localized
because grazing or working animals are expected to be present
intermittently and in known areas of the field. Once you identify
produce, or an area of produce, that cannot be harvested in accordance
with Sec.  112.112, Sec.  112.83(b)(2) requires you to take measures
reasonably necessary during growing to assist you later during harvest
in complying with the requirements of Sec.  112.112. For example, if
you have identified an area with significant animal excreta that is
likely to cross-contaminate any covered produce harvested from that
area such that the area may not be harvested, you could mark that area
in a manner that will ensure it is not harvested, even if weather
events or other occurrences remove the animal excreta so it is not
visible later during harvest. For example, you might mark such an area
by placing flags outlining the affected area. This provides additional
protection in the event that the evidence of animal intrusion or other
animal activity is no longer visible by the time of harvest, such as if
a significant rain event washes away fecal deposits.
    FDA recognizes the longstanding co-location of animals and plant
food production in agriculture. This rule does not prohibit the use of
grazing or working animals on covered farms. We believe this approach
addresses concerns regarding the feasibility of compliance with the
rule for farms that rely on grazing animals (such as integrated or
diversified farms with crop-livestock rotation systems) and farms that
rely on working animals for various purposes, including horses, dogs,
cats, and chickens. Under revised Sec.  112.83, farms would be required
to apply the same approach to any of these uses of animals, and only if
under the circumstances there is a reasonable probability that animals
will contaminate covered produce (Sec.  112.83(a)). Farms in such
circumstances must assess the relevant areas as needed during the
growing season (Sec.  112.83(b)(1)), and if evidence of potential
contamination is found, evaluate whether the covered produce can be
harvested and take measures reasonably necessary to assist the farm
later during harvest in identifying and not harvesting affected covered
produce (Sec.  112.83(b)(2)). We also note that Sec.  112.83, like the
rest of this rule, applies only to covered produce. Farms may graze
animals on growing areas used for crops other than covered produce, or
use working animals in such areas, without triggering Sec.  112.83. We
will consider providing guidance on issues related to integrated or

diversified farming practices in the future, as needed.
    (Comment 315) One comment suggests that farmers should be
prohibited from cultivating covered produce and grazing animals on the
same soil.
    (Response) FDA believes this suggestion goes beyond what is
reasonably necessary to minimize the risk of serious adverse health
consequences or death, to prevent the introduction of known or
reasonably foreseeable hazards into or onto produce, and to provide
reasonable assurances that produce is not adulterated under section 402
of the FD&C Act. We acknowledge the longstanding co-location of animals
and plant food production in agriculture, and we do not believe it is
necessary to prohibit grazing in areas where covered produce is grown
to achieve the statutory purposes set forth in section 419 of the FD&C
Act. We are requiring farms to assess relevant areas used for a covered
activity as needed during the growing season for evidence of potential
contamination, to evaluate whether produce can be safely harvested, and
to take measures reasonably necessary during growing to assist the farm
later during harvest when the farm must identify, and not harvest,
covered produce that is reasonably likely to be contaminated with a
known or reasonably foreseeable hazard when, under the circumstances,
there is a reasonable probability that grazing animals, working
animals, or animal intrusion will contaminate covered produce (Sec.
112.83). We believe this rule requires an appropriate level of public
health protection while also appropriately providing sufficient
flexibility considering the diversity of production and harvesting of
produce (sections 419(a)(3)(A) and (c)(1)(B) of the FD&C Act).
    (Comment 316) Some comments suggested that proposed Sec.  112.82(a)
would require covered farms to implement a waiting period every time
they suspected that a domesticated or wild animal had intruded upon a
growing area, and expressed concern that such a requirement would lead
to a de facto requirement for farms to exclude wildlife from areas
where covered produce is grown.
    (Response) We are eliminating proposed Sec.  112.82(a) for the
reasons discussed in response to Comment 314. In addition, to remove
any possible confusion, FDA has added Sec.  112.84 to the rule
explicitly stating that the rule does not require covered farms to take
measures to exclude animals from outdoor growing areas, or to destroy
animal habitat or otherwise clear farm borders around outdoor growing
areas or drainages.
    (Comment 317) Some comments ask that FDA clarify that working
animals are permitted in growing areas and that terminating the use of
working animals is not necessary to comply with the regulation.
    (Response) Working animals are permitted in growing areas, and the
regulation does not require termination of the use of working animals
on covered farms. As discussed in response to Comment 314, we are
revising requirements related to working animals, now established in
Sec.  112.83. Revised Sec.  112.83 does not prohibit the use of working
animals on covered farms. Therefore, covered farms can use working
animals provided that the farm complies with Sec.  112.83, as
applicable.
    (Comment 318) One comment suggests requiring domesticated animals
to be vaccinated.
    (Response) We do not agree that we should specifically require
vaccination of domesticated animals on covered farms, including working
animals. We are not aware of currently available vaccines that would
prevent animal excreta from containing human pathogens, and the comment
did not provide information from which we could conclude that such
vaccines are available.

D. Animal Intrusion (Sec.  112.83)

    (Comment 319) In response to the 2013 proposed rule, several
comments express support for the monitoring requirement in proposed
Sec.  112.83, and assert that the proposed provisions provide
sufficient flexibility to accommodate regional, operational, and
commodity diversity in farming operations, and are consistent with
current industry practices. On the other hand, several comments argue
that proposed Sec.  112.83 would be impracticable or burdensome. Some
of these comments state that any requirement to monitor for animal
intrusion is untenable, particularly in the case of monitoring for
birds on open-air farms. Such comments argue that farms would not be
able to prevent all wildlife interaction with covered produce or detect
every animal intrusion that occurs and, therefore, no reasonable effort
to monitor animal intrusion could provide assurance that covered
produce is not contaminated or adulterated. Some comments suggest FDA
should use an ``outcome-based approach'' to animal intrusion, and
suggest that monitoring of crop during harvest as set out in Sec.
112.112 is the most appropriate control point at which to ensure
contaminated produce is excluded. These comments appear to argue that
monitoring as required by proposed Sec.  112.83, during the growing
season and immediately prior to harvest, is unnecessary in light of the
requirements of Sec.  112.112 that apply immediately prior to and
during harvest.
    (Response) We disagree with comments that state that monitoring for
evidence of animal intrusion is burdensome or impracticable. As
discussed in the preamble of the 2013 proposed rule, periodic
monitoring for evidence of animal intrusion and deposition of their
excreta is a reasonably necessary measure to prevent contamination of
covered produce with biological food safety hazards when there is a
reasonable probability that animals will contaminate covered produce.
We consider that such assessment during the growing season is a
practical and reasonably necessary standard to sufficiently ensure that
potential hazards related to animal intrusion are identified for
appropriate follow-up actions, including the requirements that apply
immediately prior to and during harvesting in Sec.  112.112. Section
112.83 provides flexibility for farmers to consider the nature of their
covered produce, their practices and conditions, and their observations
and experience to determine when and how often to assess the relevant
areas during the growing season when there is a reasonable probability
that animals will contaminate covered produce (see Sec.  112.83(b)(1)).
We do not expect the requirements of Sec.  112.83 to, as one comment
suggested, prevent all wildlife interaction with covered produce or
detect every animal intrusion that occurs. We have added a new
provision, Sec.  112.84, to make explicit that this rule does not
require exclusion of wild or feral animals from covered farms. By
``wild'' animals we refer to those animals living in a state of nature
and not ordinarily tamed or domesticated, and by ``feral'' animals we
refer to those that have escaped from domestication and become wild. In
the title of subpart I, ``Domesticated and Wild Animals,'' we use the
term ``wild'' to refer collectively to both wild and feral animals.
These provisions are intended to provide you with information about
animal movements on your farm, allow you to recognize significant
animal intrusion, and facilitate your taking appropriate measures
following significant animal intrusion without being unduly
restrictive.
    As discussed in response to Comment 314, Sec. Sec.  112.83 and
112.112 are

complementary rather than duplicative, and we have revised them to
remove overlap and clarify how they are different from each other, as
well as revising Sec.  112.83 to apply to grazing animals, working
animals, and animal intrusion. We have deleted requirements from
proposed Sec.  112.83 that would have applied ``immediately prior to
harvest'' and limited its application to ``during the growing season.''
By contrast, Sec.  112.112 is a generally applicable requirement that
applies immediately prior to and during harvest activities. We are
revising both Sec. Sec.  112.83 and 112.112 to make this distinction
clear. We believe that Sec.  112.83 adds an important level of public
health protection beyond the general harvest-related requirement in
Sec.  112.112, and that the additional requirements of Sec.  112.83
should apply whenever, under the circumstances, there is a reasonable
probability that grazing animals, working animals, or animal intrusion
will result in contamination of covered produce. Under such
circumstances, covered farms must do more than just identify and not
harvest covered produce that is reasonably likely to be contaminated
based on observations made during and immediately prior to harvest
(Sec.  112.112). In these situations, covered farms must take proactive
steps under Sec.  112.83 to assess relevant areas during the growing
season for evidence of potential contamination. Moreover, if such
evidence is found (such as significant quantities of animals,
significant amounts of animal excreta, or significant crop
destruction), Sec.  112.83 requires covered farms to evaluate whether
covered produce can be harvested and take measures reasonably necessary
during growing to assist the farm later during harvest when the farm
must identify and not harvest, covered produce that is reasonably
likely to be contaminated with a known or reasonably foreseeable
hazard. For example, if you have identified an area with significant
animal excreta that is likely to cross-contaminate any covered produce
harvested from that area such that the area may not be harvested, you
could mark that area in a manner that will ensure it is not harvested,
even if weather events or other occurrences remove the animal excreta
so it is not visible later during harvest. For example, you might mark
such an area by placing flags outlining the affected area. This
provides additional protection in the event that the evidence of animal
intrusion or other animal activity is no longer visible by the time of
harvest, such as if a significant rain event washes away fecal
deposits.
    We understand that when covered produce is grown in an outdoor
environment, wild or feral animals are likely to have access to
production fields. We reiterate that the presence of animals in a
production field of covered produce, in and of itself, is not a
significant food safety risk. However, wild or feral animals are known
zoonotic disease reservoirs for human pathogens, and therefore their
excreta may contaminate growing covered produce crops (Ref. 186) (Ref.
188). Therefore, we conclude that assessing for evidence of potential
contamination and taking appropriate follow-up actions, as described in
Sec.  112.83, is a reasonably necessary when, under the circumstances,
there is a reasonable probability that animals will contaminate covered
produce. We note that, as discussed in our response to Comment 314, not
all circumstances present a reasonable probability that animals will
contaminate covered produce, such that not all covered farms or growing
areas will be subject to the requirements in Sec.  112.83.
    (Comment 320) Some comments request that any requirements for
recordkeeping related to animal intrusion be eliminated from the
regulation. In contrast, one comment suggests requiring records to be
maintained in relation to the requirements in subpart I.
    (Response) Part 112 does not include requirements for establishing
or maintaining records related to subpart I. We do not believe such a
requirement is warranted, although we encourage covered farms to
prepare and keep documentation as appropriate to facilitate their
implementation of the provisions of subpart I. Therefore, a covered
farm is not required to develop or keep a record of its activities
related to assessment for animal intrusion.
    (Comment 321) One comment suggests that FDA add a requirement that
covered farms take reasonable measures to keep animals out of growing
areas and water sources based on the farm's observations from
assessment for animal intrusion.
    (Response) We do not believe it is necessary to establish such a
requirement in subpart I. The presence of animals in a production field
of covered produce, in and of itself, is not a significant food safety
risk. We believe that assessing for animal intrusion and taking
appropriate follow-up actions, as described in Sec.  112.83, is an
appropriate approach to ensure the safety of covered produce when,
under the circumstances, there is a reasonable probability that animal
intrusion will contaminate covered produce. Moreover, Sec.  112.42(c)
requires covered farms to adequately maintain all agricultural water
sources that are under the farm's control (such as wells), including by
regularly inspecting each source and keeping the source free of debris,
trash, domesticated animals, and other possible sources of
contamination of covered produce to the extent practicable and
appropriate under the circumstances.
    (Comment 322) One comment requests that FDA define more
specifically the time period that would be appropriate for fulfilling
the proposed requirement in proposed Sec.  112.83(a)(2) to monitor for
animal intrusion ``immediately prior to harvest.''
    (Response) We are eliminating the phrase ``immediately prior to
harvest'' in Sec.  112.83. As described in response to Comment 314,
revised Sec.  112.83 applies during the growing season. We are,
however, retaining similar language in Sec.  112.112. As discussed in
section XVI.B of this document, we use ``immediately prior to harvest''
in Sec.  112.112 to refer to the time period prior and as close to
commencing harvesting as is practicable.
    (Comment 323) One comment suggests that FDA consider including in
the regulation the CA LGMA Animal Hazard/Fecal Matter Decision Tree.
    (Response) We are aware that some decision-making tools, such as
the CA LGMA Animal Hazard/Fecal Matter Decision Tree (the CA LGMA
animal hazard decision tree) and the Cornell University National GAPs
Program Wildlife and Animal Management Decision Tree (the Cornell
animal management decision tree), are intended to help covered farms
evaluate their fields for signs of animal intrusion and take follow-up
action. Although these may be useful resources, we find the information
and variables addressed in these tools to be more prescriptive than we
consider necessary in this rule, and not necessarily applicable across
all commodities and agro-ecological conditions. For example, the CA
LGMA animal hazard decision tree is commodity-specific and tailored
specifically for leafy greens operations in California. We decline to
incorporate these decision-making tools into this regulation as
requirements.
    (Comment 324) Some comments argue that the requirements of proposed
Sec.  112.83 are vague and request that FDA provide guidance regarding
methods for evaluating potential contamination of produce and
determining if it is safe to harvest.

    (Response) As discussed in section XVI of this document, we have
revised Sec.  112.112 to provide more specificity regarding the
evaluation that is necessary during and immediately prior to harvest 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. At a minimum, this requires a visual assessment of
the growing area and all covered produce to be harvested, regardless of
the harvest method used. We also explain in that section that 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. For
example, if you identify an article of covered produce that is visibly
contaminated with excreta, you may not harvest that article of covered
produce (e.g., watermelon with cow feces on it). As another example, if
you identify an area with significant animal excreta that is likely to
cross-contaminate any covered produce harvested from that area, the
covered produce in that area may not be harvested (e.g., a ``no harvest
zone'' in an area of a spinach field containing wild hog feces).
    Section 112.83 applies during the growing season rather than during
or immediately prior to harvest. It requires an additional step during
the growing season applicable only when under the circumstances there
is a reasonable probability that grazing animals, working animals, or
animal intrusion will contaminate covered produce. In such cases,
covered farms must assess relevant areas used for a covered activity
for evidence of potential contamination. This requires a visual
assessment of all of the relevant areas used for a covered activity
(including growing areas and any other areas in which there is a
reasonable probability of contamination of covered produce from
animals) and the covered produce. If evidence of potential
contamination is found (such as significant quantities of animals,
significant amounts of animal excreta, or significant crop
destruction), Sec.  112.83(b)(2) requires covered farms to evaluate
whether covered produce can be harvested. This evaluation described in
Sec.  112.83(b)(2) is the same type of evaluation described in Sec.
112.112, but under Sec.  112.83(b)(2) an evaluation is also performed
earlier, during the growing season. This evaluation requires a farm
that becomes aware of potential contamination to evaluate affected
areas and produce, and to take appropriate measures to facilitate its
identification of produce that may not be harvested later in the season
(such as marking affected areas or produce, as discussed in response to
Comment 314).
    (Comment 325) Some comments suggest that farms should be required
to evaluate whether their covered produce can be harvested in
accordance with Sec.  112.112 upon finding any evidence of animal
intrusion; suggesting that the phrase ``significant quantities of'' in
proposed Sec.  112.83(b) should be removed.
    (Response) We disagree. As noted previously, we do not expect the
requirements of Sec.  112.83 to detect every animal intrusion that
occurs or to require farms to take measures in response to every such
intrusion. The requirements of Sec.  112.83 are intended to provide you
with information about animal movements on your farm, allow you to
recognize significant animal intrusion, and facilitate your taking
appropriate measures following significant animal intrusion without
being unduly restrictive. We believe that the harvest-related
requirement in Sec.  112.112 provides sufficient protection to address
less than significant animal intrusion (i.e., intrusion that occurs
without the farm observing, during required assessment, significant
quantities of animals, significant animal excreta, or significant crop
destruction).
    (Comment 326) One comment suggests that, for tree crops, covered
farms should be required to cover and remove animal excreta from the
harvest area so that it does not contaminate workers or equipment.
Other comments suggest that covered farms should be required to cordon
off areas of ground crops where potential contamination may have
occurred as a result of animal intrusion and ensure that covered
produce is not harvested from those areas.
    (Response) Specific determinations about whether certain covered
produce can be harvested, and what specific measures to take to assist
the farm later during harvest will likely vary dependent on the
specific circumstances relevant to the commodity and/or the farm's
practices, procedures, and processes. The requirements of Sec.  112.83
and related Sec.  112.112 are purposefully flexible, to allow covered
farms to take steps in compliance with those requirements that are most
appropriate to their operations, in light of their covered produce and
the nature of their covered activities. We note that section
419(c)(1)(D) of the FD&C Act directs us to minimize, as appropriate,
the number of separate standards that apply to separate foods. We
believe it is appropriate to establish one standard addressing the risk
of contamination of covered produce from grazing animals, working
animals, and animal intrusion, which is applicable whenever under the
circumstances there is a reasonable probability that animals will
contaminate covered produce. Therefore, we decline to establish more
specific requirements such as those suggested by the comments. We will
consider providing more specific recommendations with respect to how
farms may implement these requirements for specific situations in the
Produce Safety Regulation implementation guidance, which we expect to
issue in the near term. We agree that the practices suggested by the
commenters may be appropriate strategies for compliance with Sec.
112.83, depending on the circumstances.
    (Comment 327) One comment maintains that the provisions should
differentiate between produce that is hand-harvested and that harvested
by a machine. The comment urges FDA to create a less stringent standard
with respect to animal intrusion for producers who employ hand
harvesting, noting that a machine cannot detect animal intrusions or
animal excreta and, therefore, the presence of animals on large-scale
farms that employ machine harvesting poses a significantly different
level of risk than on farms that use hand harvesting.
    (Response) As discussed in section XVI of this document, we have
revised Sec.  112.112 to provide more specificity regarding the
evaluation that is necessary during and immediately prior to harvest 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. At a minimum, this requires a visual assessment of
the growing area and all covered produce to be harvested, regardless of
the harvest method used. We also explain in that section that 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. Thus,
we have revised Sec.  112.112 to address the differences between hand
harvesting and machine harvesting with respect to the ability to detect
evidence of

potential contamination. We have also revised Sec.  112.83 to specify
that it applies only during the growing season and not during or
immediately prior to harvest. Thus, we do not consider it to be
necessary to take into account harvesting practices in Sec.  112.83
because we consider that they are sufficiently addressed in Sec.
112.112.
    (Comment 328) Several comments express concern that proposed Sec.
112.83 could be perceived as requiring measures to exclude wildlife
from growing areas. Citing concerns that some on-farm food safety
certification programs have resulted in farmers' abandoning
conservation practices and actively excluding wildlife from farms, some
comments ask FDA to explicitly clarify that the regulation does not
require producers to exclude wild animals from the growing area. Some
comments express concern that this proposed provision can be
interpreted to conflict with other federal and State programs to
establish buffer zones or other natural vegetation buffer strips
intended to improve water quality, protect endangered species, and
enhance wildlife habitat.
    (Response) We believe that these concerns have been addressed
through our addition of Sec.  112.84, as discussed in the supplemental
notice.

E. List of ``Animals of Concern''

    (Comment 329) Several commenters express support for FDA's
tentative conclusion to not establish a list of ``animals of concern,''
agreeing that current scientific evidence is inadequate to develop such
a list. On the other hand, some comments request FDA to establish a
list of ``animals of concern'' to assist farms in determining the risk
of animal intrusion in growing area. One such comment states that some
research indicates that certain types of animals are not routine
carriers of specific pathogenic organisms.
    (Response) We continue to find that currently available scientific
data and information are insufficient to develop a list of specific
animals that present the greatest risk for pathogens. The commenters
that requested us to establish such a list did not provide specific
scientific research or data in support of their request. Therefore, we
decline the request to establish a list of ``animals of concern.''

XVI. Subpart K--Comments on Growing, Harvesting, Packing, and Holding
Activities

    In subpart K of proposed part 112, we proposed science-based
minimum standards directed to growing, harvesting, packing, and holding
activities that are reasonably necessary to minimize the risk of
serious adverse health consequences or death from the use of, or
exposure to, covered produce, including those reasonably necessary to
prevent the introduction of known or reasonably foreseeable hazards
into covered produce, and to provide reasonable assurances that the
produce is not adulterated under section 402 of the FD&C Act. We asked
for comment on our proposed provisions, including proposed Sec.
112.114 related to dropped produce; and proposed Sec.  112.115 related
to measures to prevent formation of botulinum toxin.
    We are finalizing these provisions with revisions (see Table 22).
We discuss these changes in this section. We are finalizing the other
provisions of subpart K as proposed.

                                 Table 22--Description of Revisions to Subpart K
----------------------------------------------------------------------------------------------------------------
                Final provision                                      Description of revisions
----------------------------------------------------------------------------------------------------------------
Sec.   112.111(a)..............................  --Revision to add ``(except when covered produce and excluded
                                                  produce are placed together in the same container for
                                                  distribution)'' to make our intent clear that this provision
                                                  does not preclude the placing together of covered and excluded
                                                  produce in containers for distribution, such as in gift