experienced during sprouting. We view spent irrigation water sampling
and testing as an additional reasonably necessary food safety measure
to help ensure that contaminated product is not marketed. This measure
is consistent with FDA's Sprout Testing Guide and also consistent with
the Codex Guide. See also revised and renumbered Sec.  112.142 and new
Sec.  112.148.
    (Comment 370) Some comments request that FDA either specify
``pathogens of concern'' that are the most often associated with
foodborne illness linked to sprouts (e.g., Salmonella, E. coli O157:H7,
and L. monocytogenes) in proposed Sec.  112.141(a), or add language
such as ``contaminated with a hazard likely to cause foodborne
illness'' to that provision.
    (Response) For the purposes of the produce safety regulation, in
Sec.  112.3, we define ``hazard'' to mean ``any biological agent that
has the potential to cause illness or injury in the absence of its
control'' and ``known or reasonably foreseeable hazard'' to mean a
hazard that is known to be, or has the potential to be, associated with
the farm or the food. Given these definitions, we believe it is not
necessary or appropriate to specify ``hazard likely to cause foodborne
illness'' within Sec.  112.142(a). We also do not believe it necessary
or appropriate to list specific pathogens of concern or those most
often associated with sprout-related illness outbreaks in lieu of the
phrase ``known or reasonably foreseeable hazards'' in Sec.  112.142(a).
Although we agree that Salmonella, E. coli O157:H7, and L.
monocytogenes have been most often implicated in sprout-related illness
outbreaks, there may be other biological agents with the potential to
cause illness or injury that may be associated with the sprouting farm
or sprouts. We conclude that we should not restrict the scope of
hazards that are expected to be controlled under this provision. See
discussion under Comment 375 of other pathogens that have been
associated with sprouts.
    (Comment 371) One commenter believes that seed suppliers should be
required to test seed for the presence of pathogens using statistically
valid sampling and testing protocols and to provide sprout operations
with a Certificate of Analysis for the seeds and beans, despite the
recognized limitations of testing.
    (Response) We considered and tentatively rejected this approach in
the 2013 proposed rule, and the commenter did not provide any new
information suggesting we should change our conclusion. We recognize
that at least one other competent authority has established
microbiological criteria and requirements for testing all batches of
seeds intended for sprouting (i.e., European Commission Regulation No.
2073/2005). However, as explained in the 2013 proposed rule, although
epidemiological investigations often identify seeds and beans as the
most likely source of contamination, contamination may be at very low
levels (4 CFU/kg seed) (Ref. 21) and laboratory analyses have
frequently been unable to isolate pathogens from implicated seeds or
beans (Ref. 223). Nevertheless, we recognize that a positive test
result can detect contaminated seeds and beans even though a negative
test result is not a guarantee of the absence of pathogens. Therefore,
we encourage seed suppliers and sprouters to test seed using
statistically valid sampling and testing protocols. However, we
continue to believe that testing seeds and beans is not sufficiently
reliable to require it as a measure necessary to prevent the
introduction of known or reasonably foreseeable hazards into sprouts.

C. Growing, Harvesting, Packing, and Holding Sprouts (Sec.  112.143)

    These requirements were proposed as Sec.  112.142. We have now
renumbered this section as Sec.  112.143 as a consequential change from
the addition of new Sec.  112.141. For purposes of clarification, we
are revising final Sec.  112.143 to summarize under this section the
various measures related to the growing, harvesting, packing, and
holding of sprouts required in this subpart M, with relevant cross-
references to other sections of subpart M. Thus, we have added Sec.
112.143(c) referring to testing requirements in Sec.  112.144; Sec.
112.143(d) referring to the written environmental monitoring plan
required in Sec.  112.145; Sec.  112.143(e) referring to the actions
you must take when Listeria spp. or L. monocytogenes is detected in the
growing, harvesting, packing, or holding environment as required in
Sec.  112.146; Sec.  112.143(f) referring to the written sampling plan
required in Sec.  112.147, and Sec.  112.143(g) referring to the
actions you must take when samples of spent irrigation water or sprouts
test positive for a pathogen as required in Sec.  112.148.
    In addition, because the requirement for seed treatment proposed as
Sec.  112.142(c) establishes standards applicable to seeds and beans
used for sprouting, it fits more directly under final Sec.  112.142
rather than under final Sec.  112.143 (which was proposed as Sec.
112.142). Therefore, we are moving this provision, as revised, into
renumbered final Sec.  112.142 and finalizing it as Sec.  112.142(e).
We discuss other changes to this provision in response to Comment 368.
    (Comment 372) Several comments agree with our proposed requirement
for sprout operations to treat seeds or beans used for growing sprouts,
and that prior treatment would not eliminate the sprout farm's
responsibility for treatment immediately before sprouting. A number of
these comments encourage FDA to support research to determine effective
means of seed treatment prior to sprout production. Some comments
express concern that this rule may require treatment of seeds using
extremely high levels of chlorine (e.g., 20,000 ppm), and recommend
allowing alternative effective treatments. One commenter believes seed
treatment

resulting in at least a 3-log pathogen reduction should be required.
Another comment suggests using the term ``disinfect'' rather than
``treat'' when referring to seed treatments. Some comments also ask
that FDA not require seeds to be treated immediately before sprouting,
and urge FDA to create an information-sharing portal where sprout farms
can share valid treatment and testing methods and data to better inform
the sprout community. Another comment requests that FDA reconsider
allowing for the use of ``proprietary research'' to determine the
scientific validity of seed treatment. Finally, one comment suggests
that FDA require seeds used for sprouting to be irradiated by the seed
supplier, noting that this sprout operation's foreign seed supplier
currently treats seeds in this manner.
    (Response) We are retaining the term ``treat'' when referring to
seed treatments because of its longstanding use in our guidances to
industry and common use within the sprouts industry. Moreover, because
most current seed treatments cannot guarantee the elimination of
pathogens, we conclude that the term ``disinfect'' would not be an
appropriate description. (See also Comment 368 comparing most current
treatment processes to more robust treatments processes that are
reasonably certain to achieve destruction or elimination in the seeds
or beans of the most resistant microorganisms of public health
significance that are likely to occur in the seeds or beans).
    FDA has been working independently and in collaboration with others
to develop a framework to conduct research on effective seed
treatments, and we will support a variety of mechanisms to make this
information available to sprout farms. For example, we are working
through the SSA to facilitate development of an educational curriculum
and sharing of best practices among sprout farms. We acknowledge that a
number of treatments have been shown to reduce levels of, but not
eliminate, pathogenic bacteria present on seeds. Such treatments are
likely to reduce the level of contamination if present and, in turn,
decrease the risk for foodborne disease with sprouted seeds (Ref. 21).
We cited 20,000 ppm calcium hypochlorite treatment in the Sprout Guide
and in the 2013 proposed rule as an example of a treatment that has
been shown to be effective for the reduction of pathogens. However,
Sec.  112.142(e) (proposed Sec.  112.142(c)) allows you to use any
scientifically valid method to treat seeds or beans that will be used
to grow sprouts. We are also not precluding the use of proprietary seed
treatments. We would expect a farm using a proprietary seed treatment
to take steps to ensure that it is in compliance with all relevant
laws, including FIFRA, if applicable, and to ensure that its treatment
is effective in reducing pathogens on seed. In the event of an
inspection or investigation of a sprout operation, we may ask to review
the science supporting the use of the proprietary treatment to ensure
the scientific validity of the treatment.
    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. Our use of proprietary research in this
context is consistent with our considerations in other rulemakings (see
Current Good Manufacturing Practice Requirements for Dietary
Ingredients and Dietary Supplements; 68 FR 12157 at 12198).
    Under proposed Sec.  112.142(c), we proposed to require sprout
operations to treat seeds or beans using a scientifically valid method
immediately before sprouting to reduce microorganisms of public health
significance. We have since conducted a thorough review of currently
available treatment methods as well as treatment methods under
development and evaluation. Based on this review, we conclude that
there are treatment methods that can be effectively applied by a
grower, handler, or distributor of seeds or beans such that, when
followed by good handling and packaging procedures, they can eliminate
the need for follow-up treatment of the seeds or beans at the farm
immediately before sprouting (Ref. 232). For example, as suggested by a
commenter, irradiation is an option for seed treatment that could be
applied by a seed supplier, handler, or distributor to reduce
microorganisms of public health significance that may not be feasible
for a sprout farm to apply on-site. In addition, hot water treatments
have been demonstrated to reduce pathogens on seeds by more than 5 log
CFU/g in one study (Ref. 233) and to undetectable levels in another
(Ref. 234). However, these treatments can require use of equipment such
as industrial-sized hot water pasteurization machines (Ref. 235) that
might be cost-prohibitive for a small sprout farm. Therefore, in final
Sec.  112.142(e)(1), we are removing the requirement to treat seeds or
beans used for sprouting ``immediately before sprouting'' as well as
the provision that stated ``prior treatment conducted by a grower,
handler, or distributor of seeds or beans does not eliminate your
responsibility to treat seeds or beans immediately before sprouting at
your covered farm.'' We are also adding Sec.  112.142(e)(2) to
explicitly allow covered sprout farms to rely on prior treatment of
seeds or beans conducted by a grower, distributor, or supplier of the
seeds or beans (whether to fulfill this requirement completely or for
the purpose of considering such prior treatment when applying
appropriate additional treatment of the seeds or beans at the covered
sprout farm immediately before sprouting), provided that you obtain
documentation (such as a Certificate of Conformance) from the grower,
distributor, or supplier of the seeds or beans that (i) the prior
treatment was conducted using a scientifically valid method to reduce
microorganisms of public health significance; and (ii) the treated
seeds or beans were handled and packaged following the treatment in a
manner that minimizes the potential for contamination.
    Finally, as discussed previously, because this provision
establishes standards applicable to seeds and beans used for sprouting,
it fits more directly under final Sec.  112.142 rather than under final
Sec.  112.143 (which was proposed as Sec.  112.142). Therefore, we are
moving this provision, as revised, into renumbered final Sec.  112.142
and finalizing it as Sec.  112.142(e). In addition, we are revising the
corresponding recordkeeping provision in Sec.  112.150(b)(1) to require
you to establish and keep documentation of your treatment of seeds or
beans to reduce microorganisms of public health significance in the
seeds or beans, at your farm; or alternatively, documentation (such as
a Certificate of Conformance) from your seed supplier that seeds or
beans are treated to reduce microorganisms of public health
significance and are appropriately handled and packaged following the
treatment, in accordance with the requirements of Sec.  112.142(e).

D. Testing During Growing, Harvesting, Packing, and Holding Sprouts
(Sec.  112.144)

    These requirements were proposed as Sec.  112.143. We have now
renumbered this section as Sec.  112.144 as a consequential change from
the addition of new Sec.  112.141.
    (Comment 373) Some comments suggest that FDA issue through
guidance, rather than in regulation, recommendations to test for
pathogens that have been linked to a sprout outbreak causing human
illness. Other comments support our proposed requirements for
environmental testing

and testing of spent sprout irrigation water or sprouts.
    (Response) In developing the proposed provisions of subpart M, we
tentatively concluded that testing the growing, harvesting, packing and
holding environment for Listeria spp. or L. monocytogenes is a
necessary measure to ensure the safety of sprouts. We also tentatively
concluded that testing spent sprout irrigation water or sprouts for E.
coli O157:H7 and Salmonella spp. is a necessary measure to ensure the
safety of sprouts. Given the outbreaks associated with sprouts and
these pathogens, we are finalizing our conclusion that requiring this
testing is warranted. These comments did not provide information that
would change our conclusion.
    (Comment 374) Some comments state that requiring testing for
Listeria at the genus level does not confirm the presence of a pathogen
of interest and, therefore, recommend that FDA require testing for
Listeria at the species level. In contrast, one comment states that
frequent testing for Listeria would be expensive, arbitrary, and
difficult to implement. The comment recommends that we instead require
initial swab testing for Listeria, followed by a program of testing and
cleaning until repeated tests are negative and, as an alternative,
suggests that routine cleaning of equipment and facility inspections
should be sufficient for controlling Listeria.
    (Response) The purpose of environmental monitoring is to verify the
adequacy, or lack thereof, of cleaning and sanitizing practices through
monitoring for the presence of pathogens in the environment and, if
pathogens are present, to eliminate or minimize their presence and
prevent transfer of pathogens to food-contact surfaces or to sprouts
where they might cause illness. Testing for either the pathogen
directly or an indicator organism facilitates accomplishing these
objectives and, therefore, we are providing for the option to either
directly test for L. monocytogenes (pathogen) or for an indicator
organism (Listeria spp.). As discussed in the scientific literature,
the term ``indicator organism'' means a microorganism or group of
microorganisms that is indicative that (1) a food has been exposed to
conditions that pose an increased risk for contamination of the food
with a pathogen or (2) a food has been exposed to conditions under
which a pathogen can increase in numbers (Ref. 236). Listeria spp. is
an appropriate indicator organism for L. monocytogenes because tests
for Listeria spp. will detect multiple species of Listeria, including
L. monocytogenes (Ref. 237) (Ref. 238), and because the available
information supports a conclusion that modern sanitation programs,
which incorporate environmental monitoring for Listeria spp., have
public health benefits (Ref. 239) (Ref. 240). With regard to the
suggestion for initial swab testing with repeated cleaning until
negative findings, we agree that negative findings from repeated tests
indicate that current cleaning and sanitizing is likely effective.
However, because Listeria can be reintroduced into the environment
through different routes which can vary over time, it is important to
continuously monitor the environment with routine sampling and testing,
at a regular frequency, to verify effectiveness of cleaning and
sanitizing practices.
    (Comment 375) With respect to testing of spent sprout irrigation
water or sprouts in proposed Sec.  112.143(b), several comments express
concern that additional pathogen strains may be associated with sprouts
in the future, similar to the 2012 outbreak of E. coli O104:H4 linked
to sprouts in Europe, and that requiring testing just for Salmonella
and E. coli O157:H7 is too limited. Other comments were supportive of
testing for Salmonella spp. and E. coli O157:H7. Another comment
supports FDA's tentative decision not to require testing of spent
irrigation water for Listeria, and believes that it would not be an
appropriate use of resources to require such testing given the ubiquity
of Listeria spp. in water and the limitations of current testing
methods to detect L. monocytogenes.
    (Response) With respect to requiring testing of spent sprout
irrigation water or sprouts, we focus on the two pathogens most
commonly associated with sprout outbreaks, while also taking into
consideration currently available analytical methodology. There is a
long history of sprout-related outbreaks associated with E. coli
O157:H7 and Salmonella spp. (Ref. 26) (Ref. 27) (Ref. 28) (Ref. 241)
and we are retaining the requirement from proposed Sec.  112.143(b) in
renumbered Sec.  112.144(b) for testing spent sprout irrigation water
or sprouts for these two pathogens.
    We also recognize that two recent sprout-associated outbreaks in
the United States, as well as the large 2012 sprout outbreak in Europe,
were due to non-O157 STEC (Ref. 28). In the 2013 proposed rule, we
requested comments on whether pathogens other than Salmonella spp. and
E. coli O157:H7 should be included in testing of spent sprout
irrigation water or in-process sprouts, either by specifically listing
the additional pathogens or by set criteria. We discussed the
challenges of requiring testing for non-O157 STECs in the 2013 proposed
rule (78 FR 3504 at 3598). For example, there are hundreds of serotypes
of STECs, and many are non-pathogenic or of low pathogenicity such that
detection of an STEC alone in spent sprout irrigation water or sprouts
would not be necessarily indicative of a public health concern, as not
all STECs cause illness. Moreover, although laboratory tests to detect
non-O157 STECs are currently available, methods necessary for follow-up
testing to determine pathogenicity are not readily available (Ref.
242). We also considered requiring STEC testing for the major six
pathogenic STEC serogroups (O26, O103, O111, O121, O45 and O145)
identified by FSIS for non-intact raw beef. In addition, we reviewed
the European Commission Regulation No. 209/2013, which amended
Regulation No. 2073/2005 and established microbiological criteria for
the testing of sprouts in an approach similar to that of FSIS'
serogroup testing. Four serogroups, i.e., O26, O103, O111, and O145,
are identified for testing in both the EC and FSIS approaches. However,
available sampling data from the AMS' Microbiological Data Program
(MDP) and from FDA's sampling assignments infrequently recovered these
STECs from fresh produce, including sprouts (Ref. 242), and so it is
not clear that these serogroups should be prioritized in terms of
testing for sprouts. Because we recognize that in the future there may
be additional pathogens associated with sprouts for which
scientifically valid test methods become available such that testing
for those additional pathogens would be warranted, we have revised
Sec.  112.144(b) and added new Sec.  112.144(c) to address this
situation.
    Revised Sec.  112.144(b) adds to the pathogens that covered sprout
operations are required to test for in either spent sprout irrigation
water or in-process sprouts ``any pathogens meeting the conditions
identified in Sec.  112.144(c).'' New Sec.  112.144(c) requires sprout
operations to conduct the tests required in Sec.  112.144(b) for
additional pathogens when the following conditions are met: (1) Testing
for the pathogen is reasonably necessary to minimize the risk of
serious adverse health consequences or death from use of, or exposure
to, sprouts; and (2) A scientifically valid test method is available to
detect the pathogen in spent sprout irrigation water (or sprouts).
These provisions require additional pathogen testing, in the future, if
the criteria in Sec.  112.144(c) are met. First, the

association of the pathogen and sprout-related outbreaks or illness
must be established to the point that routine testing for such a
pathogen is reasonably necessary to protect public health and minimize
the risk of serious adverse health consequences or death from use of,
or exposure to, sprouts. As mentioned previously, both E. coli O157:H7
and Salmonella spp. have a long history of association with sprout-
related illness. However, a new pathogen need not equal or surpass the
history of association of E. coli O157:H7 and Salmonella spp. with
sprout-related illness in order to warrant testing under Sec.
112.144(b) and (c). To satisfy Sec.  112.144(c)(1), a new pathogen
would need to have an established association with sprout-related
illness. Second, there must be a scientifically valid test method
available to detect the pathogen in spent sprout irrigation water (or
sprouts). As mentioned previously with regard to STECs, we are not
currently aware of an appropriate test to identify pathogenic non-O157
STECs in spent sprout irrigation water (or sprouts) that is available
to industry. However, test methods are continually under development
and there will likely be improved methods in the future.
    In the event that, in the future, both criteria are met for a
particular pathogen such that testing would be required, FDA intends to
issue guidance in accordance with good guidance practices to advise
sprout farms of FDA's assessment that: (1) There is a pathogen, in
addition to E. coli O157:H7 and Salmonella spp., for which testing is
reasonably necessary to minimize the risk of serious adverse health
consequences or death from use of, or exposure to, sprouts, and (2) a
scientifically valid test method is available to detect the pathogen in
spent sprout irrigation water (or sprouts). In this guidance, we would
address the history of the association of the pathogen and sprout-
related illness and also any relevant information about the testing
protocol. We anticipate issuing such guidance initially as a draft for
comment, unless, due to urgent circumstances, it is not feasible or
appropriate to issue the document first in draft. Under those
circumstances, we would invite comment on the final guidance, and
revise it as appropriate. FDA intends to enforce the requirements for
additional pathogen testing required in accordance with Sec.
112.144(b) and (c) of this rule only after FDA issues a final guidance
advising industry and the public of FDA's assessment that the criteria
for additional pathogen testing have been met.
    With regard to testing spent sprout irrigation water for L.
monocytogenes, for the reasons described in the 2013 proposed rule (78
FR 3505 at 3597-3599) and in light of comments received, we conclude
that, at this time, monitoring the environment, rather than spent
sprout irrigation water, for Listeria spp. or L. monocytogenes is the
most effective approach for controlling L. monocytogenes in a sprout
operation (see next section).

E. Environmental Testing for Listeria Species or L. monocytogenes
(Sec.  112.145)

    These requirements were proposed as Sec.  112.144. We have now
renumbered this section as Sec.  112.145 as a consequential change from
the addition of new Sec.  112.141.
    (Comment 376) Several comments agree with our proposed requirement
for establishing and implementing a written environmental monitoring
plan for Listeria. These comments maintain that it is critical that
sprout farms recognize the importance of designing and maintaining a
monitoring plan that is not simply compliant with regulations, but is
also sufficiently tailored to their operations to be appropriately
protective of public health. According to another comment, sprout farms
currently routinely test spent irrigation water, but are not familiar
with and do not currently utilize environmental monitoring.
    (Response) Testing the environment of a sprouting operation for L.
monocytogenes (or for Listeria spp. as an indicator of potential
contamination with L. monocytogenes), and taking actions to eliminate
L. monocytogenes or Listeria spp. when found in the environment of a
sprouting operation, is an important component of controlling
microorganisms of public health significance (Ref. 214) (Ref. 243). We
conclude that testing the growing, harvesting, packing and holding
environment for Listeria spp. or L. monocytogenes is a reasonably
necessary measure to prevent the introduction of hazards into sprouts
and to provide reasonable assurances that sprouts are not adulterated.
Therefore, we are retaining the provisions of proposed Sec.  112.144 in
renumbered Sec.  112.145, with three revisions. First, we are requiring
that the sampling plan, a necessary aspect of the required
environmental monitoring plan, must also specify the timing of
collection of the environmental samples during production (see Sec.
112.145(c)(2)). We believe this is an important addition to the
sampling plan to ensure that sampling is conducted in a manner to
optimize detection of Listeria, if present, and ensure consistency in
the sampling strategy and facilitate the tailoring of the corrective
action plan to the finding of a positive at a certain point during
production. Second, we are requiring that environmental samples must be
aseptically collected. This revision is consistent with proposed Sec.
112.146(b) regarding aseptic collection of samples of spent sprout
irrigation water or sprouts, which we are retaining in final Sec.
112.147(b) (see also Comment 233 where we explain the importance of
aseptic sampling). Third, we are requiring that the written
environmental monitoring plan must include a corrective action plan
that, at a minimum, requires you to take the actions in Sec.  112.146,
and details when and how you will accomplish those actions, if the
growing, harvesting, packing, or holding environment tests positive for
Listeria spp. or L. monocytogenes (see Sec.  112.145(e)). Requiring
that your written environmental monitoring plan include a corrective
action plan aligns with the requirement for you to take appropriate
actions under Sec.  112.146. Establishing and implementing a written
corrective action plan will help ensure that corrective actions are
taken quickly in response to positive findings of testing the
production environment. This requires you to review appropriate sprout
safety resources and consider the likely scenarios in advance of
needing to take corrective actions, rather than reacting to these
scenarios on an ad hoc basis after the fact. The requirement to have a
written plan is consistent with other FDA food safety regulations, such
as our juice and seafood HACCP regulations.
    (Comment 377) One comment suggests that daily verification of
sanitation using rapid detection methods (such as bioluminescence, ATP,
or protein tests) serves as a better indicator of sanitation than
environmental sampling on food-contact surfaces.
    (Response) While rapid detection methods such as those mentioned
are very useful for monitoring overall sanitation, they cannot
substitute for environmental monitoring for Listeria spp. or L.
monocytogenes to help ensure that L. monocytogenes has not become
established in a harborage site, or niche, in a sprout operation.
Cleaning and sanitizing may not remove all microorganisms and rapid
methods such as those mentioned may not detect the presence of L.
monocytogenes in harborage sites. However, daily monitoring of
sanitation with a rapid

method such as those mentioned that allows for corrections to be made
in ``real time'' if the cleaning and sanitizing have not been effective
can be useful and we encourage sprout farms to use them in combination
with required periodic sampling for Listeria spp. or L. monocytogenes
to provide a robust approach to verifying cleaning and sanitization
practices are adequately addressing L. monocytogenes in the
environment.

F. Follow-Up Actions for Positive Environmental Testing Results (Sec.
112.146)

    These requirements were proposed as Sec.  112.145. We have now
renumbered this section as Sec.  112.146 as a consequential change from
the addition of new Sec.  112.141.
    (Comment 378) Some comments state that the language in proposed
Sec.  112.145(d) is insufficient for public health protection. One
comment notes that the requirement as written will cause sprout farms
to target sampling in order to achieve negative results with a minimum
number of tests, rather than to target sampling to identify any
potential sources of Listeria. According to another comment, finished
product testing as a follow-up to a positive environmental finding is
both useful and advisable, but is itself insufficient without a
commensurate action step upon a positive result. This comment states
that mandating testing throughout production and of finished product is
a critically important part of ensuring that food is not contaminated--
but it is logically necessary that a discovery of contamination must
carry an appropriate response. Some commenters also maintain that FDA
should require the disposal of any food that has come into contact with
contaminated water or production equipment.
    (Response) We agree that environmental monitoring is only effective
when designed to identify L. monocytogenes if present and if followed
by appropriate and effective corrective actions, where necessary. For
this reason, we specify in Sec.  112.145(a) that sprout farms must
establish and implement a written environmental monitoring plan that is
designed to identify L. monocytogenes if it is present in the growing,
harvesting, packing, or holding environment. As previously discussed,
we are revising the rule to require that you establish and implement a
written corrective action plan (as required under Sec.  112.145(e)) to
help ensure that corrective actions are taken quickly in response to
positive findings of testing the production environment. This requires
you to consider the likely scenarios in advance, developed through
review of appropriate sprout safety resources, rather than react to
these scenarios on an ad hoc basis.
    Specifically with respect to renumbered Sec.  112.146(d), finished
product testing can provide useful information in certain situations
when pathogens have been detected in the environment. For example,
finished product testing is likely appropriate if a food-contact
surface tests positive for Listeria spp. in tests conducted following
cleaning and sanitizing the surface to address an initial positive for
Listeria spp., especially if production has occurred between the
positive findings. The finding of Listeria spp. after a production run
on a food-contact surface following corrective actions indicates that
product contamination is reasonably likely, because it may indicate
that the Listeria has become established in a niche on the equipment
and is being dislodged during production. Our draft guidance to
industry, the Listeria Guide (Ref. 244), includes draft recommendations
for responses to positive environmental testing. A positive finding
from environmental testing, as appropriate, can be confirmed through
finished product testing and, if confirmed, necessary steps must be
taken to remove the contaminated sprouts from the market and/or prevent
contaminated sprouts from entering the market. We expect to address
this issue further as we finalize the Listeria Guide. Accordingly, we
are retaining in renumbered Sec.  112.146 the provisions proposed as
Sec.  112.145 to require sprout operations to take certain minimum
actions when there is a positive finding of L. monocytogenes or
Listeria spp. in the production environment. Among these actions,
listed in renumbered Sec.  112.146, we are also specifying that the
sprout farm must take appropriate action to prevent any food that is
adulterated under section 402 of the FD&C Act from entering into
commerce (see Sec.  112.146(f)).

G. Collection and Testing of Samples of Spent Sprout Irrigation Water
or Sprouts (Sec.  112.147)

    These requirements were proposed as Sec.  112.146. We have now
renumbered this section as Sec.  112.147 as a consequential change from
the addition of new Sec.  112.141.
    (Comment 379) Several comments support our proposed requirement to
develop a written sampling plan and to test spent irrigation water or
sprouts for E. coli O157:H7 and Salmonella. One comment states that
testing of spent irrigation water should apply to ``green sprouts''
(e.g., alfalfa, clover) only, and that mung bean sprouts should be
exempt from this requirement. According to this commenter, mung bean
sprouts are periodically irrigated with large volumes of water (i.e.,
200 gallons per growing container) and it would be difficult to collect
and analyze a meaningfully representative sample of spent irrigation
water during mung bean sprout production.
    (Response) Sampling spent sprout irrigation water or sprouts is an
important testing procedure to ensure contaminated product does not
enter commerce, and, therefore, we are retaining the provisions in
proposed Sec.  112.146 as renumbered Sec.  112.147 with certain
revisions, as explained in the paragraphs that follow. We expect the
written sampling plan to be developed taking into account the farm's
specific growing and irrigation practices so the samples collected and
tested are representative of the farm's spent sprout irrigation water
or sprouts. For example, in some situations, a sprout farm may want to
temporarily adjust the volume of water that flows through a growing
unit for the purposes of collecting spent irrigation water samples.
With regard to mung bean sprout production, research has shown that
testing spent irrigation water of sprouting mung bean beds can provide
a useful assessment of its microbiological status, and we disagree that
mung bean sprouts should be exempt from the requirements of Sec.
112.147 in light of certain irrigation practices (Ref. 227). One means
to comply with Sec.  112.147(b) is to follow the recommendations in the
Sprouts Testing Guide (Ref. 97).
    We are revising Sec.  112.147(b) to reflect the new provisions in
Sec.  112.144(b) and (c) for testing for additional pathogens when the
criteria in the rule are met. Thus, we are revising the introductory
text in Sec.  112.147 to refer to testing ``for pathogens as required
in Sec.  112.114(b)'' and revising Sec.  112.147(b) to refer not to
testing for E. coli O157:H7 and Salmonella spp., but instead generally
to ``pathogens,'' by which we mean those pathogen tests required by
Sec.  112.144(b) and (c). We are also revising Sec.  112.147(b) to
require testing using a method as set forth in new Sec.  112.153 (see
discussion in section XIX.B of this document).
    As we previously noted in Comment 369, testing of spent sprout
irrigation water or sprouts is a process control as well as a
verification step. Accordingly, we have added text in Sec.  112.147(b)
to require that you must not allow the production batch of sprouts to
enter commerce unless the results of the

testing of spent sprout irrigation water or sprouts are negative for E.
coli O157:H7, Salmonella spp., and, if applicable, a pathogen meeting
the criteria in Sec.  112.144(c). This is consistent with the
requirement in Sec.  112.148(a) that, if samples of spent sprout
irrigation water or sprouts are positive for E. coli O157:H7,
Salmonella spp., or a pathogen meeting the criteria in Sec.
112.144(c), you must take appropriate action to prevent any food that
is adulterated under section 402 of the FD&C Act from entering
commerce. The requirement to not allow sprouts to enter into commerce
until pathogen testing results are negative is consistent with current
industry best practices (Ref. 219).
    In addition, as in Sec.  112.145 for environmental testing
(discussed in Comment 378), we are adding a requirement that your
written sampling plan for spent sprout irrigation water testing (or
sprout testing) include a corrective action plan that at a minimum,
requires you to take the actions in Sec.  112.148, and details when and
how you will accomplish those actions, if the samples of spent sprout
irrigation water or sprouts test positive for E. coli O157:H7,
Salmonella spp., or a pathogen meeting the criteria in Sec.  112.144(c)
(see Sec.  112.147(c)). Establishing and implementing a written
corrective action plan will help ensure that corrective actions are
taken quickly in response to positive findings of pathogens in spent
irrigation water or sprouts. This requires you to consider the likely
scenarios in advance, developed through review of appropriate sprout
safety resources, rather than react to these scenarios on an ad hoc
basis. The requirement to have a written plan is consistent with other
FDA food safety regulations, such as our juice and seafood HACCP
regulations.

H. Actions if Spent Sprout Irrigation Water or Sprouts Test Positive
for a Pathogen (Sec.  112.148)

    (Comment 380) Several comments state that FDA should establish the
steps that sprouters must take on a finished batch or lot of sprouts
found to be contaminated through the testing requirements of this
subpart. One comment states that FDA should require the immediate
destruction or disposal of any finished product that may be
adulterated, as indicated by a positive finding in the tests required
under proposed Sec.  112.146.
    (Response) In light of these comments, we are establishing new
Sec.  112.148 to require sprout operations to take certain actions if
the samples of spent sprout irrigation water or sprouts test positive
for E. coli O157:H7, Salmonella spp., or a pathogen meeting the
criteria in Sec.  112.144(c). In part, Sec.  112.148 requires you to
take appropriate action to ensure that adulterated food does not enter
commerce (see Sec.  112.148(a)).
    Testing of spent sprout irrigation water or sprouts for Salmonella
spp., E. coli O157:H7, or a pathogen meeting the criteria in Sec.
112.144(c) is required under Sec.  112.144(b). A production batch of
sprouts for which any of these pathogens is detected in the spent
sprout irrigation water is considered adulterated under section
402(a)(4) of the FD&C Act, in that it has been prepared, packed, or
held under insanitary conditions whereby it may have been rendered
injurious to health. Similarly, a production batch of sprouts for which
any of these pathogens is detected in the sprouts is considered
adulterated under sections 402(a)(1) of the FD&C Act, in that the
sprouts contain a poisonous or deleterious substance which may render
them injurious to health. In such a circumstance, the covered farm must
take appropriate steps to ensure that the adulterated food does not
enter commerce, including, as appropriate, destroying or diverting the
product to non-food use.
    In addition, new Sec.  112.148(b) requires you to take the steps
required in Sec.  112.142(b) with respect to the lot of seeds or beans
used to grow the affected production batch of sprouts (except as
allowed under Sec.  112.142(c)). This provision is intended to make
clear that the requirements in Sec.  112.142(b) relating to seeds or
beans apply to all situations in which your required testing of spent
irrigation water or sprouts results in a positive pathogen finding,
except as otherwise provided in section Sec.  112.142(c). For a
detailed discussion of these requirements, see section XVIII.B of this
document.
    In addition, Sec.  112.148(c) requires you to clean and sanitize
the affected surfaces and surrounding areas. This provision is
consistent with our recommendations in the Sprouts Testing Guide.
Anything in the sprouting operation that has come into contact with the
contaminated production batch or its water (e.g., drums, trays, bins,
buckets, tools and other sprouting equipment, testing equipment, and
other possible surfaces, such as floors, drains, walls, and tables),
must be thoroughly cleaned and sanitized to avoid contamination of
subsequent batches of sprouts (Ref. 97).
    Finally, Sec.  112.148(d) requires you to perform any other actions
necessary to prevent reoccurrence of the contamination. For example, a
sprout grower may consider re-evaluating their seed treatment protocol,
consider switching their seed supplier, or consider switching to using
seeds that have been grown under Good Agricultural Practices and
conditioned, handled and stored under sanitary conditions.

I. Records Related to Sprouts (Sec.  112.150)

    We are making conforming changes to this section to reflect
renumbering and revisions to other provisions in this subpart. In
addition, we note that while we have added requirements for covered
sprout farms to establish corrective action plans, such plans are
required as part of the written environmental monitoring plan already
required under Sec.  112.145 and the written sampling plan for each
production batch of sprouts already required under Sec.  112.147. Thus,
we are not revising Sec.  112.150 to add separate records requirements
for these corrective action plans because they are already covered in
Sec.  112.150(b)(2) (written environmental monitoring plans) and Sec.
112.150(b)(3) (written sampling plans for each production batch of
sprouts). We are also adding new requirement in final Sec.
112.150(b)(6), discussed further in Comment 381.
    (Comment 381) Several comments state that the recordkeeping
requirements should be expanded to include documentation of any
corrective actions that farms employ to address problems identified and
verification that those corrective actions were effective.
    (Response) In proposed Sec.  112.161(b), we proposed a general
provision applicable to records are required under subparts C, E, F, L,
and M of part 112 that you must establish and keep documentation of
actions you take when a standard in any of these subparts is not met.
For clarification, we are eliminating proposed Sec.  112.161(b) and,
instead, adding that requirement within the records provisions of two
relevant subparts, including subpart M. As revised, under Sec.
112.150(b)(6), you must establish and keep documentation of actions you
take in accordance with Sec. Sec.  112.142(b) and (c), 112.146, and
112.148. This requires covered sprout farms to keep documentation of
actions taken related to seeds and beans that may be contaminated, in
accordance with Sec.  112.142(b) and (c), and corrective actions in
accordance with Sec. Sec.  112.146 or 112.148. For example, if your
testing required under Sec.  112.144(a) indicates a detection of
Listeria spp. or L. monocytogenes in the growing, harvesting, packing,
or holding

environment, this provision requires you to establish and keep a record
of the corrective steps that you took in response to that positive
finding in compliance with Sec.  112.146.
    In addition, in final Sec.  112.150(b)(5), we are requiring records
of any analytical methods you use in lieu of the methods that are
incorporated by reference in new Sec.  112.153 (see section XIX.B of
this document). This requirement is consistent with proposed Sec.
112.150(b)(5), in which we proposed to require records of any
analytical methods you use in lieu of the methods that are incorporated
by reference in Sec.  112.152, which we have retained in final Sec.
112.150(b)(5). That is, in final Sec.  112.150(b)(5), we require
records of any analytical methods you use in lieu of the methods that
are incorporated by reference in Sec. Sec.  112.152 and 112.153. In
addition, we are eliminating proposed Sec.  112.150(b)(6) as a
corresponding change.
    We are also revising proposed Sec.  112.150(b)(4) to clarify that
documentation of the results of all analytical tests conducted for
purposes of compliance with subpart M is required. This revision is
consistent with the records requirement for agricultural water in Sec.
112.50(b)(2).

J. Compliance Periods for Covered Activities Involving Sprouts

    (Comment 382) Some comments request clarification regarding
coverage of sprout operations under part 112 and the applicability of
the provisions of part 112 (other than subpart M) to sprout operations.
Some comments request clarification on whether all sprout farms will be
subject to part 112 in addition to proposed subpart M, and whether
sprout farms may also be eligible for a qualified exemption or extended
compliance periods based on the farm's size. Citing the high risk
nature of sprout production, one commenter argues that sprout farms
should not be eligible for the qualified exemption or extended
compliance periods. Some comments specifically asked us to shorten the
compliance periods for sprouts to protect public health.
    (Response) As described throughout the 2013 proposed rule and in
this rule, part 112 establishes the minimum science-based standards
that we determine to minimize the risk of serious adverse health
consequences or death, including procedures, processes, and practices
that we determine to be reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into fruits and
vegetables, and to provide reasonable assurances that the produce is
not adulterated. Sprouts are produce (see definition of ``produce'' in
Sec.  112.3) and, therefore, sprout farms are subject to all of part
112, as applicable. In addition, as discussed in the 2013 proposed rule
(78 FR 3504 at 3594), because sprouts present a special concern with
respect to human pathogens compared to other covered produce due to the
warm, moist, and nutrient-rich conditions required to produce sprouts,
we have incorporated the additional standards in subpart M specifically
targeted to sprout operations. Accordingly, covered sprout farms are
subject to all applicable requirements of part 112, including the
specific requirements of subpart M.
    The threshold for coverage (under Sec.  112.4(a)) and the qualified
exemption and associated modified requirements (under Sec. Sec.
112.4(b) and 112.5-112.7) all apply to sprout farms.
    With regard to compliance dates for covered activities involving
sprouts, we agree that our proposed compliance dates were not
sufficiently protective of public health. There is a long history of
food safety problems associated with sprouts (78 FR 3504 at 3594-3601)
and, therefore, we agree that we should establish shorter compliance
periods for sprouts as compared to other covered produce. Section
419(a)(4) of the FD&C Act provides that we shall prioritize the
implementation of this rule for specific fruits and vegetables based on
known risks which may include a history and severity of foodborne
illness outbreaks. We believe it is appropriate to expedite the
implementation of the provisions of part 112, including subpart M, for
covered activities involving sprouts, based in part on the history and
severity of sprout-related foodborne illness outbreaks, to reduce the
likelihood of future sprout-related outbreaks.
    We also believe it is not necessary to give sprout farms extra time
to comply with the certain water provisions of subpart E as we are
doing with respect to other commodities (see section XIII.K of this
document). Based on information available to us, we believe that most,
if not all, sprout farms already use public water supplies and/or
ground water sources for all relevant purposes subject to the microbial
quality criterion in Sec.  112.44(a) (Ref. 245). The other provisions
in subpart E for which we are allowing extended compliance dates for
other commodities are either (1) directly linked to compliance with the
microbial quality criterion in Sec.  112.44(a); or (2) are not relevant
to sprouts (i.e., the criteria in Sec.  112.44(b) are only for produce
other than sprouts).
    Therefore, for covered activities involving sprouts, we are
establishing that businesses other than small and very small businesses
would have one year after the effective date of the final rule to
comply with all of the provisions of this rule, whereas small
businesses would have two years and very small businesses would have
three years to comply with all of the provisions of this rule. This is
consistent with the requirements in section 419(b)(3) of the FD&C Act
that this rule shall apply to a small business after the date that is 1
year after the effective date of the final regulation, and to a very
small business after the date that is 2 years after the effective date
of the final regulation. See also XXIV of this document for additional
information.

K. Other Comments

    (Comment 383) One comment recommends that FDA require a food safety
plan, and that this plan should also include a sprout-specific section.
    (Response) As explained in section VII of this document, although
we are not establishing a general requirement for covered farms to
conduct an operational assessment or develop and implement a food
safety plan, we encourage all farms to do so because food safety plans
can help a farm to be more effective in ensuring the safety of produce
grown, harvested, packed, or held at that farm.
    (Comment 384) One comment asks us to consider establishing audit
and inspection requirements specific to the sprout industry, and to
provide appropriate training to auditors and inspectors. This commenter
also suggests that FDA should require GFSI audits and unannounced
inspections of sprout operations to verify best practices and food
safety and quality standards.
    (Response) We are not establishing requirements in this rule for
audits of covered farms, generally, or of sprout farms, specifically.
We do not see a reason to impose audit requirements specific to sprout
farms in this rule. However, we recognize the role that third-party
audits can play in promoting food safety. In the final human preventive
controls rule (80 FR 55908) and the final FSVP rule (published
elsewhere in this issue of the Federal Register), we are establishing
certain supplier verification requirements that we expect to play a
role in achieving compliance with this rule. In addition, we note that
in the final third-party certification rule (published elsewhere in
this issue of the Federal Register), FDA is establishing a voluntary
program for the accreditation of third-party certification bodies that
may conduct audits and issue certifications for purposes of
establishing an entity's

eligibility to participate in the Voluntary Qualified Importer Program
(VQIP) or to satisfy conditions set forth under section 801(q) of the
FD&C Act.
    We are also working with our partners to develop sprout-specific
training, including training for use by inspectors. See section XXII of
this document where we discuss our strategy for the implementation of
the produce safety regulation, including the role of our federal,
State, local, territorial, and tribal partners as well as private
entities.

XIX. Subpart N--Comments on Analytical Methods

    In subpart N of proposed part 112, we proposed methods of analysis
for testing the quality of agricultural water and the growing
environment for sprouts, as required under proposed subparts E and M,
respectively. We asked for comment on our proposed provisions in
subpart N, including specific methods and an allowance for alternative
methods to be used provided they are at least equivalent to the
proposed methods in accuracy, precision, and sensitivity.
    We are finalizing these provisions with revisions (see Table 25).
We discuss these changes in this section.

             Table 25--Description of Revisions to Subpart N
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.151...............  --Revision to eliminate the Official
                                Methods of Analysis of the AOAC
                                International, the Standard Methods for
                                the Examination of Water and Wastewater
                                of the American Public Health
                                Association, and the FDA's
                                Bacteriological Analytical Manual from
                                the list of specified methods.
                               --Revision to specify as the prescribed
                                method of analysis, and to incorporate
                                by reference, Method 1603 published by
                                EPA.
                               --Revision to clarify that methods used
                                other than that specifically
                                incorporated must be scientifically
                                valid.
                               --Revision to indicate that methods used
                                for other indicators of fecal
                                contamination must be scientifically
                                valid.
                               --Editorial revision, moving ``a method
                                of analysis'' into subparagraphs.
                               --Conforming revision to change cross-
                                reference in title to Sec.   112.46.
Sec.   112.152...............  --Revision to incorporate by reference a
                                specific method that is based on methods
                                and procedures described in FDA's
                                Bacteriological Analytical Manual (BAM),
                                USDA's Microbiology Laboratory
                                Guidebook, and those used in FDA's
                                compliance activities (in lieu of
                                specifying a chapter of FDA's BAM)
                                Revision to the locations where a copy
                                of the specified method may be obtained
                                or inspected.
                               --Revision to clarify that methods used
                                other than that specifically
                                incorporated must be scientifically
                                valid.
                               --Editorial revision to shorten
                                introductory text by removing
                                duplicative phrase ``by testing'' and
                                unnecessary reference to ``in
                                environmental samples''.
                               --Conforming revision to change cross-
                                reference in title to Sec.   112.144(a),
                                and to add ``harvesting, packing, and
                                holding'' to title and introductory
                                text.
Sec.   112.153...............  --New section to: (1) Prescribe a method
                                of analysis for testing spent sprout
                                irrigation water (or sprouts) from each
                                production batch of sprouts for E. coli
                                O157:H7 and Salmonella to satisfy the
                                requirements of Sec.   112.144(b), and
                                to provide flexibility for use of other
                                scientifically valid methods (see Sec.
                                112.153(a)) and (2) specify that a
                                scientifically valid method must be used
                                for any other pathogens meeting the
                                criteria in Sec.   112.144(c) (see Sec.
                                 112.153(b)).
------------------------------------------------------------------------

A. Responses to Comments

    (Comment 385) One comment suggests revising proposed Sec.
112.151(a)(1) to cite the 19th edition of the Official Methods of
Analysis published by AOAC INTERNATIONAL in 2012, rather than the 18th
edition that was issued in 2011.
    (Response) We are revising final Sec.  112.151 to eliminate the
method of analysis, as published in the Official Methods of Analysis of
AOAC International, as a prescribed method for testing the quality of
water to satisfy the requirements of Sec.  112.46. See section XIX.B of
this document.
    (Comment 386) Some comments seek clarification on the allowance for
use of equivalent methods. One comment asks whether FDA would review a
method to determine its equivalency to the relevant specified
method(s), and requests clarification on how such equivalency should be
determined. In addition, another comment suggests FDA should consider
EPA-approved test methods for water acceptable for purposes of testing
the quality of water required under this rule.
    (Response) We have specified in subpart N certain analytical
methods for use to satisfy the testing requirements related to
agricultural water and sprouts. We reviewed EPA-approved test methods
for water, and determined that Method 1603, an EPA-approved test method
identified in 40 CFR 136.3, Table IH, is appropriate for testing water
quality to satisfy the requirements of Sec.  112.46 (see section XIX.B
of this document).
    However, we recognize that other scientifically valid methods,
particularly test kits, may be available or may become available in the
future. Therefore, we provide flexibility for covered farms to use any
other scientifically valid method that is at least equivalent to a
prescribed analytical method in accuracy, precision, and sensitivity.
See also Comment 9. We are clarifying in Sec. Sec.  112.151(b),
112.152(b), and 112.153(a)(2) and (b) that such methods must be
scientifically valid. As noted in response to Comment 26, the term
``scientifically valid'' means an approach that is based on scientific
information, data, or results published in, for example, scientific
journals, references, text books, or proprietary research. Any
scientifically valid method can be used provided you ensure that the
method is at least equivalent to the applicable prescribed analytical
method in accuracy, sensitivity, and precision in detecting the
relevant organism or indicator (e.g., generic E. coli, Salmonella, L.
monocytogenes, or Listeria spp.) in the relevant sample matrix (e.g.,
ground water, surface water, environmental swabs, spent sprout
irrigation water, or sprouts). We are not further requiring covered
farms to notify or submit information about such methods of analysis
for FDA's review or approval prior to use, nor do we believe that such
a requirement is warranted. We intend to disseminate useful scientific
information, when available, including on any new scientifically valid
methods of analysis at least equivalent in accuracy, precision, and
sensitivity to our prescribed methods.
    (Comment 387) Another comment states that if samples are not
collected in a sanitary manner there is no

guarantee that the results will be scientifically valid.
    (Response) We agree aseptic collection of samples is important, and
have added this requirement under Sec. Sec.  112.47(b) and 112.145(d).
In addition, we have retained the requirement to collect samples
aseptically, as previously proposed, in renumbered Sec.  112.147(b).
See also Comment 233 and Comment 376.

B. Other Revisions

    With respect to the prescribed methods for testing agricultural
water, we are eliminating proposed Sec. Sec.  112.151(a)(1),
112.151(a)(2), and 112.151(a)(3). On further review, we find the
testing methods specified in proposed Sec.  112.151(a)(1) to (3)
inadequate for the purpose of testing the quality of water to satisfy
the requirements of Sec.  112.46. The methods of analysis in the
Official Methods of Analysis of AOAC INTERNATIONAL and the Standard
Methods for the Examination of Water and Wastewater specified in
proposed Sec. Sec.  112.151(a)(1) and 112.151(a)(2), respectively, are
not intended to capture discrete concentrations of microbial
populations in sources of water that may be turbid or whose microbial
quality may potentially vary irregularly. Likewise, the FDA's
Bacteriological Analytical Manual (BAM) method specified in proposed
Sec.  112.151(a)(3) covers examination of bottled water only and does
not explicitly address testing of agricultural water. Instead, for
analysis of environmental water, the FDA's BAM method refers to EPA-
approved test methods, which we have reviewed and we are specifying
EPA's Method 1603 as a prescribed method in final Sec.  112.151(a). We
are also adding Sec.  112.151(b)(2) to clarify that if you use an
alternative indicator of fecal contamination in accordance with Sec.
112.49(a) you must use a scientifically valid method to test for the
indicator.
    With respect to the prescribed methods for testing the sprout
growing, harvesting, packing, and holding environment for Listeria spp.
or L. monocytogenes, we are retaining proposed Sec.  112.152 with
revisions. Under final Sec.  112.152(a), we are prescribing the
relevant method, i.e., FDA's method of analysis described in ``Testing
Methodology for Listeria species or L. monocytogenes in Environmental
Samples,'' October, 2015, rather than prescribing a particular chapter
of FDA's BAM (as in proposed Sec.  112.152). On further review, we find
the method that is described in the particular chapter of FDA's BAM
(cited in proposed Sec.  112.152) has been validated for detection of
Listeria spp. or L. monocytogenes primarily in food samples. For the
purposes of testing environmental samples for detection of Listeria
spp. or L. monocytogenes to satisfy the requirements of 112.144(a), we
are incorporating by reference a method that is based on the methods
and procedures in USDA's Microbiology Laboratory Guidebook, FDA's BAM,
and those used in FDA's compliance activities. In addition, consistent
with Sec.  112.151(b)(1), under Sec.  112.152(b), we are retaining the
proposed flexibility for the use of other method(s) in lieu of the
prescribed methods of analysis, provided the other method is
scientifically valid and is at least equivalent in accuracy,
sensitivity, and precision to the method in Sec.  112.152(a). We
believe these changes in final Sec.  112.152 are necessary to prescribe
the appropriate testing methods, while retaining flexibility for use of
other scientifically valid methods, to meet our testing requirements in
Sec.  112.144(a).
    We are revising both proposed Sec. Sec.  112.151 and 112.152 to
provide current information about the location where you may obtain or
inspect a copy of the prescribed methods. We are also making certain
conforming changes in these sections to update the cross-references to
other provisions. We are also making certain non-substantive editorial
changes in these sections (moving the phrase ``a method of analysis''
in Sec.  112.151, and shortening the introductory text in Sec.  112.152
by removing the duplicative phrase ``by testing'' and an unnecessary
reference to ``in environmental samples'').
    We are adding new Sec.  112.153 to specify certain methods of
analysis for testing spent sprout irrigation water (or sprouts) from
each production batch of sprouts, which is required under Sec.
112.144(b). We are specifying that you must test for E. coli O157:H7
and Salmonella spp. using FDA's method of analysis described in
``Testing Methodologies for E. coli O157:H7 and Salmonella species in
Spent Sprout Irrigation Water (or Sprouts),'' October, 2015 (Sec.
112.153(a)(1)); or using a scientifically valid alternative method
(Sec.  112.153(a)(2)). The method described in Sec.  112.153(a)(1) is
based on the method described in the current edition of FDA's BAM with
additional details for testing spent irrigation water or sprouts, and
we are incorporating by reference this particular method into part 112
for the purposes of testing required under Sec.  112.144(b). In Sec.
112.153(a)(2), consistent with Sec. Sec.  112.151(b)(1) and 112.152(b),
we are providing flexibility for the use of an alternative method(s)
for E. coli O157:H7 or Salmonella spp., in lieu of the prescribed
method of analysis, provided the alternative method is scientifically
valid and is at least equivalent in accuracy, sensitivity, and
precision to the method in Sec.  112.153(a)(1). In addition, Sec.
112.153(b) specifies that a scientifically valid method must be used to
test spent sprout irrigation water (or sprouts) from each production
batch of sprouts for any other pathogen(s) that meet the criteria in
Sec.  112.144(c). By prescribing the method of analysis and
incorporating sufficient flexibility for the use of scientifically
valid alternative methods, we expect new Sec.  112.153 to help covered
farms meet our testing requirements in Sec.  112.144(b).

C. Incorporation by Reference

    In Sec.  112.152(a), FDA is incorporating by reference ``Testing
Methodology for Listeria species or L. monocytogenes in Environmental
Samples,'' Version 1, dated October 2015, U.S. Food and Drug
Administration and, in Sec.  112.153(a)(1), FDA is incorporating by
reference ``Testing Methodologies for E. coli O157:H7 and Salmonella
species in Spent Sprout Irrigation Water (or Sprouts),'' Version 1,
dated October 2015, U.S. Food and Drug Administration, which was
approved by the Office of the Federal Register. You may obtain a free
copy of the material from the Division of Produce Safety, Center for
Food Safety and Applied Nutrition, U.S. Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>; the
Docket at www.regulations.gov; or from the Food and Drug
Administration, at FDA's Main Library, 10903 New Hampshire Ave., Bldg.
2, Third Floor, Silver Spring, MD 20993,<PHONE_NUMBER>. These methods
are related to the detection of pathogens in the production of sprouts.
We are specifying the prescribed method for testing of the sprout
production environment for Listeria in accordance with Sec.
112.144(a). This is an enrichment method for the detection of Listeria
spp. in the environment of sprout farms and the confirmation of the
presence of L. monocytogenes in samples that are positive for Listeria
spp. We are also specifying the prescribed method for testing of spent
sprout irrigation water or sprouts for two pathogens in accordance with
Sec.  112.144(b). This method includes: (1) Screening procedures by
real-time PCR to establish the presumptive presence of E. coli O157:H7,
followed by culture confirmation of E. coli O157:H7, and (2) screening
procedures to detect a presumptive positive for the presence of

Salmonella spp., followed by confirmation of the presence of Salmonella
spp. by a variety of confirmatory tests. We are specifying these
prescribed methods, while also providing the flexibility for use of
other scientifically valid methods, to help covered farms to meet our
testing requirements in Sec.  112.144.
    In Sec.  112.151(a), FDA is incorporating by reference ``Method
1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using
Modified membrane-Thermotolerant Escherichia coli Agar (Modified
mTEC),'' dated December 2009, U.S. Environmental Protection Agency
(EPA), EPA-821-R-09-007, which was approved by the Office of the
Federal Register. You may obtain a free copy of the material from EPA,
Office of Water (4303T), 1200 Pennsylvania Avenue NW., Washington, DC
20460.<PHONE_NUMBER>; http://water.epa.gov/scitech/methods/cwa/bioindicators/upload/method_1603.pdf; the Docket at
www.regulations.gov; or from the Food and Drug Administration, at FDA's
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver
Spring, MD 20993,<PHONE_NUMBER>. This method is an EPA-approved
analytical test method. It provides the procedures for testing
agricultural water samples to determine the microbial quality of water
to satisfy the requirements of Sec.  112.46. We are specifying this
prescribed method, while also providing the flexibility for use of
other scientifically valid methods, to help covered farms to meet our
testing requirements in Sec.  112.46.

XX. Subpart O--Comments on Records

    In subpart O of proposed part 112, we proposed requirements that
would be applicable to all records required by part 112. We tentatively
concluded that the requirements in subpart O describing how records
must be established and maintained, including the general requirements,
record retention requirements, and requirements for official review and
public disclosure, are applicable to all records that would be required
under all subparts, because records that would be required under each
of the subparts would aid farms in complying with the requirements of
part 112; and allow farms to show, and FDA to determine, compliance
with the requirements of part 112. We asked for comment on our proposed
provisions.
    We are finalizing these provisions with revisions (see Table 26).
We discuss these changes in this section. Some comments support one or
more of the proposed provisions without change. We discuss the comments
that ask us to clarify the proposed requirements or that disagree with,
or suggest one or more changes to, the proposed requirements. For Sec.
112.166, we did not receive any comments or received only general
comments in support of the proposed provision and, therefore, we do not
specifically discuss these provisions.

             Table 26--Description of Revisions to Subpart O
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.161...............  --Revision to eliminate proposed Sec.
                                112.161(b) and, instead, add that
                                requirement within the records
                                provisions of the relevant subpart,
                                i.e., Sec.  Sec.   112.50(b)(6) and
                                112.150(b)(6).
                               --Renumber proposed Sec.   112.161(c) as
                                Sec.   112.161(b) and make conforming
                                edits to update cross references.
                               --Revision to add the phrase ``except as
                                otherwise specified'' in Sec.
                                112.161(a) to reflect that certain
                                records requirements specified in the
                                relevant subparts of part 112 include
                                requirements that are different from the
                                ones in subpart O.
                               --Revision to cover new provision Sec.
                                112.7 within renumbered Sec.
                                112.161(b).
Sec.   112.162...............  --Revision to remove ``after 6 months
                                following the date the record was made''
                                to allow immediate offsite storage of
                                records provided they can be retrieved
                                and provided onsite within 24 hours of
                                request for official review.
Sec.   112.163...............  --Revision to clarify types of existing
                                records that do not need to be
                                duplicated to comply with this part.
                               --Revision to clarify that such records
                                must satisfy the requirements of this
                                part.
                               --Revision to add ``Existing records may
                                be supplemented as necessary to include
                                all of the required information and
                                satisfy the requirements of this part
                                112''.
                               --Revision to clarify that the
                                information required by this part need
                                not be kept in one set of records, and
                                any new information required by this
                                part may be kept separately or combined
                                with existing records.
Sec.   112.164...............  --Revision to add new Sec.
                                112.164(a)(2) to specify that records
                                that a farm relies on during the 3-year
                                period preceding the applicable calendar
                                year to satisfy the criteria for a
                                qualified exemption must be retained as
                                long as necessary to support the farm's
                                status during the applicable calendar
                                year.
                               --Revision to Sec.   112.164(a)(1) to
                                replace ``2 years'' with ``at least 2
                                years'' so the length of record
                                retention in this provision is
                                harmonized with new Sec.
                                112.164(a)(2).
                               --Revision to Sec.   112.164(b) to
                                specify that ``records that relate to
                                analyses, sampling, or action plans
                                being used by a farm, including the
                                results of scientific studies, tests,
                                and evaluations'' must be retained for
                                at least two years after the use of such
                                records is discontinued.
Sec.   112.165...............  --Revision to establish that electronic
                                records maintained to satisfy this part
                                112 are exempt from the requirements of
                                part 11 of this chapter, except to the
                                extent that they are also required under
                                other applicable statutory provisions or
                                regulations and are therefore subject to
                                part 11.
Sec.   112.167...............  --Revision to clarify that records
                                ``obtained by FDA in accordance with
                                this part'' are subject to the
                                disclosure requirements under part 20.
------------------------------------------------------------------------

A. General Comments

    (Comment 388) Several comments express support for our proposed
approach to limit recordkeeping requirements. These commenters state
that records of required monitoring activities and corrective actions
are sufficient for FDA to evaluate an operation's level of compliance
with the requirements of the rule. Conversely, one commenter recommends
that fruits and vegetables with little or no associated risk of
foodborne illness should have a lower recordkeeping burden, whereas
another commenter, while not providing specific suggestions, urges us
to reduce the recordkeeping requirements to a minimum.
    (Response) The recordkeeping requirements in this rule are limited
to those specific instances where: (1) Maintenance of detailed
information is needed to keep track of measures directed at minimizing
the risk of known or reasonably foreseeable hazards; (2) identification
of a pattern of problems is important to minimizing the risk of such
hazards; and (3) records are

important to facilitate verification and compliance with standards and
such verification and compliance cannot be effectively done by means
other than a review of relevant records. Therefore, we believe that the
requirements for developing and maintaining records established in part
112 are the minimum necessary.
    With respect to the comment about establishing different
recordkeeping requirements for different commodities based on their
associated risk of foodborne illness, we refer you to the discussion in
section IV of this document, in which we explain our rationale for
relying on an integrated regulatory approach that focuses on practices,
processes, and procedures and the potential for contamination through
common on-farm routes, rather than on a commodity-specific regulatory
framework. The recordkeeping requirements in this rule stem from our
integrated regulatory approach.
    (Comment 389) Several comments state that recordkeeping may cause
financial hardship, such as lost time and revenue, for small- to mid-
size farms.
    (Response) As we discussed in sections IV.E and V.O of the 2013
proposed rule, in determining the circumstances in which records are
necessary as part of science-based minimum standards that minimize the
risk of serious adverse health consequences or death and provide
reasonable assurances that produce is not adulterated under section 402
of the FD&C Act, we considered the statutory direction in section
419(c)(1)(C) of the FD&C Act to comply with the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.) ``with special attention to minimizing'' the
recordkeeping burden on the business and collection of information as
defined in that act.
    We appreciate the concerns with respect to cost and burden to farms
and, to the extent possible, we have established documentation
requirements that are risk-based and capable of being tailored to an
individual farm, taking into account the unique characteristics of the
operation, the commodities handled, and the operation's growing,
harvesting, packing, and holding procedures. The recordkeeping
requirements in subpart O of part 112 allow the use of existing
records, provided such records satisfy all of the applicable
requirements of part 112 (see Sec.  112.163). We are further clarifying
in this final rule that you are not required to keep all of the
information required by part 112 in one set of records. In addition,
per Sec.  112.165, electronic records are acceptable, although not
required. Records in forms as diverse as hard copies of handwritten
logs, invoices, and documents reporting laboratory results are also
acceptable, provided they are indelible and legible. We estimated the
costs associated with our recordkeeping requirements (Ref. 142).
    (Comment 390) A few comments request that we more clearly define
the records that must be kept and the content of such records. One of
these comments asks whether FDA will provide training, including
specific forms, templates or checklists, for farmers to comply with the
records requirements.
    (Response) The records required under this regulation are
dependent, in part, on the nature of practices and procedures related
to the covered activities in your operation, and are listed under the
applicable sections of part 112, including in subparts A, C, E, F, L,
and M (i.e., Sec. Sec.  112.2(b)(4), 112.7, 112.30, 112.50, 112.60,
112.140, and 112.150). We will consider providing guidance on the
required records and their content, as needed. We also expect that the
training curriculum and materials being developed by the PSA will
address recordkeeping, and the SSA intends to provide ``model'' forms
and training for sprout farmers on how to develop and maintain
appropriate records.
    (Comment 391) One comment suggests that records related to safety,
including testing reports, should appear as part of labeling that
accompanies produce as the commodity moves through the food chain. This
commenter also asks us to make labels an active component of the food
safety system instead of establishing the recordkeeping requirements we
proposed.
    (Response) Documentation of some practices is critical to ensure
that this rule is adequately implemented on the farm. Records are
useful for keeping track of detailed information over a period of time,
and can identify patterns of problems and, thus, enable a farm to find
and correct the source of problems. Records are also useful during FDA
inspections for investigators to determine compliance with relevant
requirements of the rule. We are not establishing new labeling
requirements in this rule other than as set forth in Sec.  112.6(b) for
farms eligible for the qualified exemption and Sec.  112.2(b) for
produce eligible for the commercial processing exemption. We do not
agree that product labels or labeling should be used as a substitute
for the recordkeeping requirements in subpart O of part 112. Produce
commodities, in packaged form, are subject to certain labeling
requirements specified in 21 CFR part 100; however, such requirements
are outside the scope of this rule.

B. General Requirements Applicable to Records Required Under Part 112
(Sec.  112.161)

    (Comment 392) Stating that on-farm records are often recorded in
pencil, one comment expresses concern that, under the proposed
requirements of Sec.  112.161, records would have to be recorded in
ink. This commenter states that outdoor on-farm environmental
conditions often dictate the use of pencils instead of pens because
rain can cause smearing of ink-recorded paperwork.
    (Response) This comment appears to be in response to the
requirement in Sec.  112.161(a)(3) that records must be, among other
things, indelible. We believe it is important for records to be
indelible, and are retaining this requirement, as proposed. If a
covered farm were to prepare the required record in pencil, we could
not be confident that the record had not been altered from its original
content. In addition, we do not believe the requirement is impractical
for farms because we understand that a number of products such as all-
weather and ballpoint pens are available that can write on wet paper
and also do not cause smearing. This requirement is consistent with the
provisions of the PCHF regulation and we are finalizing it as proposed.
    (Comment 393) Some comments express support for proposed Sec.
112.161(c) requiring a supervisor or responsible party to review
certain records. Another comment recommends that allowances be made for
a situation where the person who is responsible for the initial record
is the owner or supervisor, in which case he or she should also be
allowed to document the review of the records.
    (Response) We are making some changes by eliminating proposed Sec.
112.161(b) and, instead, adding that requirement (as necessary) within
the records provisions of the relevant subparts. Rather than a general
requirement for documentation of actions you take when a requirement
subparts C, E, F, L, or M is not met, we are limiting this requirement
as compared to that in the 2013 proposed rule, and making our intent
clear by specifying the corrective measures in relation to which your
actions must be recorded and such records retained. As revised, under
final Sec. Sec.  112.50(b)(6) and 112.150(b)(6), you must establish and
keep documentation of actions you take in accordance with certain
specified corrective measures established in

subparts E and M, respectively. We do not see the need for a similar
documentation requirement in subparts C or L because we are not
establishing specific corrective measures in relation to requirements
in those subparts. Subpart F, too, does not include specific corrective
measures for which additional documentation requirements (beyond the
provisions we are finalizing, as discussed in section XIV.H of this
document) are necessary. Therefore, we are not adding additional
documentation requirements in Sec. Sec.  112.30, 112.60, or 112.140
solely as a result of eliminating proposed Sec.  112.161(b). With the
elimination of proposed Sec.  112.161(b), we have renumbered proposed
Sec.  112.161(c) as Sec.  112.161(b), and we have also made conforming
edits to update the cross-references in the provision that is now Sec.
112.161(b).
    Regardless of who creates or prepares the initial documentation, if
the record is one that is required under Sec. Sec.  112.7(b),
112.30(b)(2), 112.50(b)(2), 112.50(b)(4), 112.50(b)(6), 112.60(b)(2),
112.140(b)(1), 112.140(b)(2), 112.150(b)(1), 112.150(b)(4), or
112.150(b)(6), it must be reviewed, dated, and signed by a supervisor
or responsible party. This includes the records being required under
new Sec.  112.7(b) (see Comment 139). In addition, in accordance with
Sec.  112.161(a)(4), applicable records must be dated, and signed or
initialed by the person who performed the activity that is documented.
Where the owner or supervisor is both the person who performed the
activity as well as the responsible party, by signing and dating the
record, the owner or supervisor will have satisfied the requirements in
both Sec. Sec.  112.161(a)(4) and 112.161(b).
    We have also revised Sec.  112.161(a) to add ``except as otherwise
specified'' to reflect the fact that certain records requirements
specified in relevant subparts of part 112 include requirements that
are different from the ones in subpart O (e.g., Sec.  112.7(a),
providing that we are not requiring sales receipts kept in the normal
course of business to be signed or initialed by the person who
performed the sale) (see Comment 139).

C. Storage of Records (Sec.  112.162)

    (Comment 394) Several comments express concern with our proposed
provision Sec.  112.162(a) that would prohibit off-site storage of
records for the first six months after a record is created. These
comments find this provision to be unnecessarily burdensome, and argue
that operations that move seasonally or that operate multiple growing
sites should be able to retain records at an offsite location. These
comments recommend revising this provision to read: ``Offsite storage
of records is permitted if such records can be retrieved and provided
onsite within 24 hours of request for official review.'' Another
comment recommends also adding ``or a reasonable period of time'' as an
alternative to help alleviate the burden.
    (Response) We understand the seasonal nature of certain farming
operations and the fact that many farms have multiple growing sites
that may not be contiguous. Proposed Sec.  112.162(a) would not require
a farm with multiple growing sites to establish multiple records
storage locations. Where multiple growing sites are operated under one
management in one general (but not necessarily contiguous) physical
location, they are part of one farm under our definition of farm (see
Sec.  112.3(c)). We consider records to be on-site at a farm as long as
they are located at a site on that farm (or in the case of electronic
records, accessible from a site on that farm, see Sec.  112.162(b)).
Thus, a farm's records would be considered to be on-site even if
records related to field A are stored at field B, provided both fields
are operated by the same farm under our definition. This allows a
covered farm to store all of its records, including those records
created during covered activities on seasonally-rented field(s) or in
multiple growing locations, in the main offices of the farm's
operation, for example, and does not require a single farm to set up a
mechanism to store records related to each field separately at
different locations. Nevertheless, we are revising Sec.  112.162(a) to
permit offsite storage of required records provided such records can be
retrieved and provided onsite within 24 hours of request for official
review. Because the records will be available within 24 hours of an
official request, and because we expect that a farm will also be able
to retrieve and review all necessary records from its recent operations
within a 24 hour period (allowing them to use the records to review
detailed information needed to keep track of measures minimizing the
risk of hazards, and identifying patterns of problems for the same
purpose), we consider that this provision will satisfy the purposes of
record retention. In order to maintain inspectional efficiency and to
ensure that farms can use their own records as described previously, we
are requiring that the time period between an FDA request for the
records and their arrival not exceed 24 hours. Allowing for offsite
storage of records under the conditions noted in Sec.  112.162(a) is
consistent with our regulation on Production, Storage, and
Transportation of Shell Eggs, 21 CFR part 118, which allows for offsite
storage of records, except for the written Salmonella Enteritidis
prevention plan, which must be stored on-site (see Sec.  118.10).

D. Use of Existing Records (Sec.  112.163)

    (Comment 395) Several commenters express support for proposed Sec.
112.163, and ask that we clarify that records already kept for other
purposes and information presented across multiple records in different
forms are sufficient to meet the recordkeeping requirements of the
produce safety regulation.
    (Response) We are revising proposed Sec.  112.163 to provide
additional clarity about the fact that the regulations in part 112 do
not require duplication of existing records if those records contain
all of the information required by part 112. We have minimized the
burden of keeping records to that which is necessary to accomplish the
intended purposes of part 112. As discussed in the 2013 proposed rule,
for example, you are not required to duplicate existing records, such
as records kept to satisfy the requirements of the NOP, if those
records contain all of the information required by this part.
Additionally, you are not required to keep all of the information
required by this part in one set of records. Similarly, if you have
records containing some but not all of the required information, the
produce safety regulation provides you the flexibility to keep any
additional information required by this part either separately or
combined with your existing records, even where the formats for each
record may not be the same. However, note that keeping records together
in one place likely will expedite review of records in the event of a
public health emergency or during an FDA inspection or investigation.
    To make our intent clear, and consistent with a similar provision
Sec.  117.330 in the PCHF regulation, we are revising proposed Sec.
112.163 to read as follows: (a) Existing records (e.g., records that
are kept to comply with other federal, State, or local regulations, or
for any other reason) do not need to be duplicated if they contain all
of the required information and satisfy the requirements of this part
112. Existing records may be supplemented as necessary to include all
of the required information and satisfy the requirements of this part
112; and (b) The information required by this part does not need to be
kept in one set of records. If existing records contain some

of the required information, any new information required by this part
may be kept either separately or combined with the existing records.
    We acknowledge that the records required by this part may be multi-
component--a web of related documents. This provision provides
flexibility, but it is not without limitations. As an example, a farm
that collects spent sprout irrigation water samples and sends them to a
laboratory for testing may have sampling records that contain the
information required by Sec.  112.161(a)(1), such as the name and
location of the farm, the date when the samples were collected, the
signature or initials of the person collecting the samples and an
adequate description of the sprouts applicable to the record (including
a lot number or other identifier, when available). The laboratory
report may not include some of the information, such as the location of
the farm, but would contain some identifying information relating to
the sample tested, such as the date of the sample or the lot number for
the applicable sprouts. These records together contain all the required
information to associate them with a farm and a specific lot of
product. However, the following example for monitoring records
illustrates there can be limitations on supplementing existing records
with required information kept in other documents. Monitoring records
must be created concurrently with the monitoring activity and contain
the signature or initials of the person conducting the monitoring. If
the existing records document the monitoring activity and the date and
time but do not provide space for the name and location of the farm or
the signature or initials of the person performing the activity, it
would not be acceptable to supplement that record with the name and
location of the farm and signatures on a separate page.

E. Length of Records Retention (Sec.  112.164)

    We received some comments generally supporting proposed Sec.
112.164. We are retaining Sec.  112.164 with certain changes. First, we
are adding new Sec.  112.164(a)(2) to require that records that a farm
relies on during the 3-year period preceding the applicable calendar
year to satisfy the criteria for a qualified exemption, in accordance
with Sec. Sec.  112.5 and 112.7, must be retained at the farm as long
as necessary to support the farm's status during the applicable
calendar year. As discussed in section IX of this document, the
criteria for a qualified exemption established in this rule (in Sec.
112.5) are based, in part, on average sales during the 3-year period
preceding the applicable calendar year. Thus, a farm that does not
retain records documenting its sales during the 3 to 4 years prior to
the applicable calendar year will not have documentation adequate to
demonstrate its eligibility for the qualified exemption. The actual
retention time necessary to support its eligibility during the
applicable calendar year could be as long as 4 years. For example, if a
farm were to be inspected on May 1, 2024, the farm would have retained
the records from 2021-2023 for 3 years and four months. On the other
hand, if a farm were to be inspected on December 28, 2024, the farm
would have retained the records from 2021-2023 for nearly 4 years.
    Second, we are making a corresponding revision to Sec.
112.164(a)(1) to replace ``2 years'' with ``at least 2 years'' so the
length of record retention in this provision is harmonized with new
Sec.  112.164(a)(2).
    Finally, we are revising Sec.  112.164(b) to make clear that it
covers such records as those related to analyses, sampling, or action
plans being used by a farm, including the results of scientific
studies, tests, and evaluations. For example, the initial or annual
surveys that a farm conducts to develop or update the microbial water
quality profile under Sec.  112.46(b) can be comprised of data derived
from water tests conducted within the previous 4 years, and these
results inform the farm's use of that agricultural water in accordance
with Sec.  112.45. Because these results are necessary to verify the
use of the agricultural water in compliance with the microbial quality
criteria in Sec.  112.44 as well as any time interval in compliance
with the microbial die-off provisions in Sec.  112.45(b)(1)(i) and/or
(b)(1)(ii), we conclude a retention period of 2 years after their use
is discontinued (i.e., 2 years after the test results are used to
inform the microbial water quality profile) is warranted for these
water test results. Likewise, the written environmental monitoring plan
(required under Sec.  112.145) and written sampling plan (required
under Sec.  112.147) that a sprouting operation establishes and
implements must be retained at the farm for at least 2 years after
their use is discontinued.

F. Acceptable Formats for Records (Sec.  112.165)

    (Comment 396) Several comments express concern about the proposed
requirement in proposed Sec.  112.165(c) that any electronic records
maintained to satisfy the requirements of part 112 be kept in
compliance with part 11 of this chapter. These commenters state that
while large operations may have invested in part 11-compliant software,
other farm operations currently maintain electronic records using
commonly available software, such as Excel. Comments also state that
only a few farms currently have the computer training necessary to
implement the requirements of part 11, and that adapting their existing
systems to be in compliance with part 11 would require significant
investments by many farms. These commenters request that the
requirement for electronic records to comply with part 11 be deleted
from the final produce safety regulation. In addition, one commenter
recommends that FDA provide information in guidance as to how
operations should protect electronic records from intentional or
unintentional falsification. In contrast, another commenter agrees that
electronic records should be required to be in compliance with part 11.
This commenter notes that most electronic records include a date stamp
indicating when they were last modified, suggesting that this should be
considered sufficient evidence of compliance with part 11 and allow
such records to be considered original records.
    (Response) We agree that the need to redesign large numbers of
already existing electronic records and recordkeeping systems would
create a substantial burden, particularly in light of frequent software
patches and security updates and the use of open source software by
some farms. Therefore, we are revising Sec.  112.165(c) to provide that
records that are established or maintained to satisfy the requirements
of part 112 and that meet the definition of electronic records in Sec.
11.3(b)(6) are exempt from the requirements of part 11. We also are
specifying that records that satisfy the requirements of part 112, but
that also are required under other applicable statutory provisions or
regulations, remain subject to part 11. This rule provides that a farm
may rely on existing records to satisfy the requirements of this rule,
and this rule does not change the status under part 11 of any such
records if those records are currently subject to part 11. As we did in
the PCHF regulation, we are establishing a conforming change in part 11
to specify in new provision Sec.  11.1(k) that part 11 does not apply
to records required to be established or maintained under part 112, and
that records that satisfy the requirements of part 112, but

that also are required under other applicable statutory provisions or
regulations, remain subject to part 11. Although we are not specifying
that part 11 applies, covered farms should take appropriate measures to
ensure that electronic records are trustworthy, reliable, and generally
equivalent to paper records and handwritten signatures executed on
paper.
    Note, however, that we are not requiring electronic records.
Indeed, to minimize the burden this regulation may have on covered
farms, FDA is not specifying the form or format of the records that
must be established and maintained except as set forth in part O. To
satisfy the requirements of the produce safety regulation, paper or
electronic records or a combination of the two may be used. We also
expect that the training curriculum and materials being developed by
the PSA and SSA will include training on how to develop and maintain
appropriate records.

G. Disclosure of Records Submitted to FDA (Sec.  112.167)

    (Comment 397) One comment asks FDA to affirm that the regulations
under 21 CFR part 20 will be followed. This comment also generally
expresses concern about disclosure of confidential information
submitted by a covered farm to FDA, and that small businesses may not
be fully aware of FDA's ability to disclose certain types of materials.
The commenter asks FDA to provide guidance to assure that covered farms
understand FDA's procedures for publicly disclosing certain submitted
materials.
    (Response) We understand the concerns regarding confidentiality.
Section 112.167 explicitly states that records obtained by FDA in
accordance with part 112 are subject to the disclosure requirements
under 21 CFR part 20. Our disclosure of information is subject to the
Freedom of Information Act (FOIA) (5 U.S.C. 552), the Trade Secrets Act
(18 U.S.C. 1905), the FD&C Act, and our implementing regulations under
21 CFR part 20, which include protection for confidential commercial
information and trade secrets. Our general policies, procedures, and
practices relating to the protection of confidential information
received from third parties would apply to information received under
this rule. We will consider addressing this topic in our SECG to be
issued in the near term following this rule. We are revising this
provision to specify that records obtained by FDA in accordance with
this part are subject to the disclosure requirements under part 20. FDA
is making this change to clarify that the requirements in part 20
attach to those documents obtained by FDA under this rule.

XXI. Subpart P--Comments on Variances

    In subpart P of proposed part 112, we proposed a process by which a
State or a foreign country may request a variance(s) from one or more
requirements of part 112, consistent with the statutory provisions in
section 419(c) of the FD&C Act. We proposed that the competent
authority for a State or foreign country submit the petition requesting
the variance, what information must accompany such requests, and the
procedures and circumstances under which FDA may grant or deny such
requests, and modify or revoke such variances.
    We asked for comment on our proposed provisions in subpart P for
variances, including related process and scientific data and
information to support a request for variance, and circumstances for
approval or denial of a request for variance and for modification or
revocation of an approved variance. We also asked whether there are any
specific concerns that we should consider in finalizing the procedures
and processes for requests for variances, as applicable to foreign
governments.
    We are finalizing these provisions with revisions (see Table 27).
We discuss these changes in this section. We are finalizing the other
provisions of subpart P without change. For Sec. Sec.  112.174,
112.175, 112.177, 112.178, 112.179, 112.180, and 112.181, we did not
receive any comments or received only general comments in support of
the proposed provision and, therefore, we do not specifically discuss
these provisions further.

             Table 27--Description of Revisions to Subpart P
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.171...............  --Revision to establish that Federally-
                                recognized tribes may submit a variance
                                petition; and corresponding changes
                                throughout subpart P.
Sec.   112.172...............  --Revision to make clear that a competent
                                authority, for purposes of submitting a
                                request for a variance in accordance
                                with this rule, is the regulatory
                                authority for food safety (replacing
                                ``e.g.,'' with ``i.e.'').
Sec.   112.176...............  --Revision of Sec.   112.176(b) to
                                replace ``either'' with ``e.g.'' to make
                                clear that the situations described are
                                merely examples and not limitations on
                                who may comment.
                               --Editorial revision to treat ``website''
                                as one word.
Sec.   112.177...............  --Editorial revision to treat ``website''
                                as one word.
Sec.   112.179...............  --Editorial revision to add the word
                                ``on'' before ``the date of our written
                                decision''.
Sec.   112.181...............  --Editorial revision to treat ``website''
                                as one word.
Sec.   112.182...............
                               --Revision to clarify that the
                                permissible types of variances are not
                                limited to the examples provided (adding
                                ``A variance(s) may be requested for one
                                or more requirements in subparts A
                                through O in part 112'').
                               --Revision to include additional examples
                                and delete examples that are no longer
                                applicable due to revisions in other
                                sections of part 112.
                               --Revisions to update cross references in
                                examples and descriptions of cross
                                referenced requirements.
------------------------------------------------------------------------

A. Requesting a Variance (Sec. Sec.  112.171 and 112.172)

    (Comment 398) Several comments express concerns about the lack of
allowance for tribes to request variances from the requirements of part
112.
    (Response) Tribal governments may request a variance(s) from part
112 under the same provision that permits States to request a
variance(s) from part 112. FDA interprets 21 U.S.C. 350h(c)(2) to allow
Federally-recognized tribes (which we refer to in the rule as
``tribes'') to be treated in the same manner as States for the purpose
of the variance provision. Therefore, any one or more of Federally-
recognized tribes may submit a variance petition, in accordance with
Sec.  112.171, and all other provisions in subpart P that apply to a
petition submitted by a State apply equally to a petition submitted by
a

Federally-recognized tribe (Ref. 246). In light of comments, we are
adding ``tribe'' in part 112 to clarify for purposes of this rule that
``tribes'' are included. To make this explicit, we are revising Sec.
112.171 to establish that a State, tribe, or foreign country may submit
a petition requesting a variance(s) from the requirements of part 112,
and making corresponding revisions throughout subpart P.
    (Comment 399) One comment seeks clarification on who would be
considered a competent authority for a State or foreign government, as
proposed in Sec.  112.172.
    (Response) A competent authority is commonly understood to be a
person or organization that has the legally delegated or invested
authority, capacity, or power to perform a designated function. For the
purposes of the produce safety regulation, a competent authority is the
regulatory authority for food safety for a State (e.g., State
Department of Agriculture, etc.), tribe, or a foreign country importing
food into the United States. Our reference to this term in the produce
safety regulation is consistent with the use of term in other
regulatory contexts. For example, competent authority is used in
various Codex guidelines, referring to the official government agency
having jurisdiction (Ref. 247) (Ref. 248). This term is also used to
refer to relevant regulatory authorities in the European Union (Ref.
249). We are editing Sec.  112.172 to replace ``e.g.'' with ``i.e.'' to
make this clear.
    (Comment 400) Some comments state that entities allowed to submit
variance requests should not be limited to State and foreign
governments. A number of comments contend that additional groups,
including State and federal commodity organizations, commodity boards,
commodity commissions, trade associations, or other coalitions of farms
should also be permitted to request variances using the same procedures
available to States and foreign governments. These comments maintain
that such groups are more likely to encompass the affected industry and
are in a better position to consider and represent the risks and
practices of the covered commodity. One comment states that a commodity
commission is a State entity and should be able to submit a variance on
behalf of a State. Some comments note that commodity boards have long
partnered with research institutions and farms to investigate ways to
improve produce safety, and are well positioned to present the
information necessary to support a variance request. Some comments also
state that allowing petitions for variances from parties other than
State governments would reduce the burden currently placed solely on
State agencies.
    (Response) The provision in Sec.  112.171 establishes that a State,
tribe, or foreign country from which food is imported into the United
States may request a variance from one or more of the requirements
proposed in part 112. This provision implements the statutory
provisions in sections 419(c)(1)(F) and 419(c)(2)(A) of the FD&C Act,
which specify the criteria for the final regulation and explicitly
provide for ``States and foreign countries from which food is imported
into the United States'' to request variances from the requirements of
the produce safety regulation. These statutory provisions do not
identify private industry groups or trade associations. With respect to
an entity that may be a State entity, such as a State commodity
commission, but that is not the competent authority for that State,
such entities are not eligible to request a variance. We are limiting
this provision to competent authorities for a State, tribe, or foreign
country because these entities with legally delegated or invested
authority for food safety issues are the most appropriate to represent
a State, tribe, or foreign country in food safety regulatory matters.
    FDA recognizes the knowledge of industry groups and appreciates
their contributions to public and private partnerships to improve
produce safety. FDA also appreciates that many groups have already
instituted or are developing their own commodity-specific programs and
guidelines (for example, in the case of strawberries, tomatoes, leafy
greens, potatoes, and mushrooms) as well as with programs and guidance
that cut across different commodity groups (for example, the AFDO Model
Code; the Global GAPs (Ref. 250); and the Produce GAPs Harmonization
Initiative (Ref. 251) (Ref. 252)). As noted previously, the processes
in part 112, subpart P, do not preclude any entity from working with
the competent authority (i.e., the regulatory authority for food
safety) for their State, tribe, or foreign country to develop a
petition to request a variance. FDA anticipates that industry groups
and other relevant stakeholders would be willing to provide assistance
to reduce the burden on States, tribes, and foreign governments,
including, as appropriate, by developing the necessary scientific data
to support a request for a variance and/or drafting the variance
petitions for signature and submission by the State, tribe, or foreign
country. As discussed in the paragraphs that follow, FDA also intends
to take a number of steps, including providing for pre-submission
consultations and making public scientific data and other information
in petitions submitted, which may further ease the burden on States,
tribes, and foreign governments with similarly situated covered farms.
    (Comment 401) A comment states that the process of submitting a
variance would require significant resources.
    (Response) As noted previously, if a State, tribe, or foreign
government chooses to submit a variance, we encourage them to work with
other entities to develop variance petitions. FDA also intends to take
a number of steps to provide assistance to States, tribes, and foreign
governments interested in submitting petitions requesting a variance,
including providing for pre-submission consultations and making public
scientific data and other information in petitions submitted (see Sec.
112.174), which may ease the burden on States, tribes, and foreign
governments. In addition, in accordance with Sec.  112.177, we may
extend a variance granted to a State, tribe, or foreign government
petition to another State, tribe, or foreign country that requests a
similar variance for covered farms who are similarly situated within
its jurisdiction.
    (Comment 402) One comment requests us to follow the World Trade
Organization (WTO) Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement) guidelines for the process for
requests for variances from foreign competent authorities. This comment
notes unfamiliarity with the petition process in Sec.  10.30, but
expects FDA to compare and contrast, and modify the currently proposed
process to fit with WTO guidelines.
    (Response) The process established under part 112 is appropriate
not only for the petitioners for a variance, but also for the specific
nature of the determinations that FDA is required to make when
considering a variance request. In developing this process, FDA took
into account WTO guidelines for considering petitions for variance,
including documents by the relevant international organizations such as
the Codex. Where appropriate, the petition process established by this
rule should satisfy the recommendations of such guidelines.

B. The Statement of Grounds in a Variance Petition (Sec.  112.173)

    (Comment 403) Comments generally support the proposed requirements
related to processes, scientific data, and information to support a
variance

request. Contrastingly, some comments request additional clarification
on the scientific data and information necessary to support variance
requests. Comments express concern with the availability,
accessibility, and adequacy of the scientific data or information
needed to demonstrate that the variance provides the same level of
public health protection as the requirements of the produce safety
regulation. Comments note that the lack of peer-reviewed scientific
information will hamper the practicality and usefulness of the
flexibility of variances, and information does not need to be published
in peer reviewed journals in order to be used in support of a request
for variance. Comments also support the use of industry-generated
scientific data conducted through accredited or university
laboratories, and suggest that data sets, methodology and analysis
should be publicly shared so that other stakeholders can access and
leverage such scientific information.
    (Response) With regard to the scientific data and information
necessary to support variance requests, States, tribes, and foreign
countries may, among other things, consult scientific papers. FDA
agrees that information does not need to be published in peer reviewed
journals in order to be used in support of a request for variance,
although we encourage use of peer-reviewed data and information, to the
extent available. A State, tribe, or foreign country is required to
submit relevant and scientifically-valid information or materials
specific to the covered produce and/or covered activity to support the
petitioner's request for a variance(s) from corresponding requirements
established in part 112. Depending on the variance(s) requested, this
could include information about the crop, climate, soil, and
geographical or environmental conditions of a particular region, as
well as the processes, procedures, or practices followed in that
region. For example, a State, tribe, or foreign country may conclude
that meeting certain requirements of the rule would be problematic in
light of local growing conditions and that a variance from some or all
provisions of this proposed rule is necessary. The State, tribe, or
foreign country might consider the historical performance of an
industry within their jurisdiction (e.g., as indicated by the
epidemiological record) and the combination of measures taken by that
industry merits requesting a variance. In requesting a variance, among
other things, the State, tribe, or foreign country would submit
information that, while the procedures, processes and practices to be
followed under the variance would be different from those prescribed in
this rule, the requested variance is reasonably likely to ensure that
the produce is not adulterated under section 402 of the FD&C Act and
provide the same level of public health protection as the corresponding
requirement(s) of the produce safety regulation for which a variance is
requested. FDA encourages consideration of these types of information
to support a request for a variance.
    For example, the microbial die-off rate of 0.5 log per day to
determine an adequate time interval, no greater than four consecutive
days, between last irrigation and harvest is established in Sec.
112.45(b)(1)(i). We derived this die-off rate based on a review of
currently available scientific literature that shows a range of
microbial die-off rates of 0.5 to 2.0 log per day, dependent on various
environmental factors, including sunlight intensity, moisture level,
temperature, pH, the presence of competitive microbes, and suitable
plant substrate. Generally, pathogens and other microbes die off or are
inactivated relatively rapidly under hot, dry, and sunny conditions
compared to inactivation rates observed under cloudy, cool, and wet
conditions. Our analysis led us to conclude that a rate of 0.5 log per
day provides a reasonable estimate of microbial die-off under a broad
range of variables to include microbe characteristics, environmental
conditions, crop type, and watering frequency (see discussion on 79 FR
58434 at 58445-446; see also (Ref. 45)). Nevertheless, we acknowledge
that practices and conditions on a farm and circumstances unique to a
specific commodity could result in higher die-off rates between last
irrigation and harvest, especially under conditions of high ultraviolet
radiation, high temperature exposures or low humidity, coupled with
little or no precipitation. A State, tribe, or foreign country may
submit a petition for a variance to the microbial die-off rate, as well
as to the accompanying maximum time interval between last irrigation
and harvest, established in Sec.  112.45(b)(1)(i), along with
scientific information and data demonstrating that the requested
microbial die-off rate is appropriate for the specific crop, based on
climate, soil, and/or geographical or environmental conditions of a
particular region, and/or the processes, procedures, or practices
followed in that region for the specific crop, as described in its
petition to FDA. (Note that a covered farm can also establish an
alternative microbial die-off rate and an accompanying maximum time
interval, in accordance with Sec. Sec.  112.12(a) and 112.49(b),
without the need for a variance for this specific requirement, although
a variance approved by FDA could provide assurance to covered farms of
the scientific basis for the deviation from FDA-established microbial
die-off rate and also minimize the resource burden on individual farms
developing the scientific support for an alternative as opposed to a
State requesting a variance for all covered farms for which a variance
would apply in a specified region.) Such scientific information and
data may include scientific literature, such as research data on
microbial populations and survival and/or die-off rates under
conditions representative of that specific region (e.g., temperature,
humidity, precipitation); weather station data comparing their
environment to that in the scientific literature; any historical,
reliable water sampling or survey data relevant to the specific region;
and/or data on current industry practices for the commodity in the
specific region. The weather conditions are likely to vary based on
factors such as topographic and environmental conditions. Therefore, we
envision that the information and data supporting such a request for a
variance would demonstrate the microbial die-off between last
irrigation and harvest for a specific commodity, and under the
environmental conditions of a particular region, that is requested in
the petition to FDA.
    Interested parties may work independently or in collaboration with
their competent authority to compile supporting information for use by
the State, tribe, or foreign country in its submission of a variance
petition. In addition, Sec.  112.177 ensures consideration of the
application of variances to similarly situated persons and provides for
transparency and accountability in FDA's review of requests and
decision-making. FDA also welcomes pre-petition consultations with
interested States, tribes, or foreign countries to facilitate the
development of variance petitions, including a discussion of the types
of data and information that would be needed to support the specific
variance the State, tribe, or foreign country expects to request in its
petition.

C. Process for Requesting a Variance (Sec.  112.176)

    (Comment 404) One comment recommends that we clearly delineate the
processes associated with the approval or denial of the variance, while
another comment asks us to establish

criteria for how information supplied in support of variances will be
evaluated.
    (Response) We are establishing the general procedures applying to
variance petitions in Sec.  112.176. Under these procedures, a State,
tribe, or foreign country from which food is imported into the United
States may in writing submit a request for a variance(s) to the FDA
using the process described in Sec.  10.30. Such a request shall
describe the variance requested and present information demonstrating
that the variance does not increase the likelihood that the food for
which the variance is requested will be adulterated under section 402,
and that the variance provides the same level of public health
protection as the requirements of the produce safety regulation. Under
the procedures described in Sec.  112.176, FDA will review such
requests and may approve the variance requested either in whole or in
part, as appropriate, and may specify the scope of applicability of the
variance to other similarly situated persons. FDA will publish a notice
in the Federal Register, requesting information and views on the filed
petition, including information and views from persons who could be
affected by the variance if the petition were to be granted. FDA will
respond to the petitioner in writing and will publish a notice on our
Web site announcing our decision to either grant or deny the petition.
If the petition is granted, either in whole or in part, FDA will
specify the persons to whom the variance would apply and the
provision(s) of part 112 to which the variance would apply. If the
petition is denied (including partial denials), FDA will explain the
reason(s) for the denial in its written response to the petitioner and
will post this information on our Web site. We intend to make readily
accessible to the public, and periodically update, a list of filed
petitions requesting variances, including the status of each petition.
    In evaluating petitions, FDA will look to see if the petition
addressed the relevant requirements, for example, whether the petition
included information on the need for the variance and that procedures,
processes, and practices to be followed under the variance provide the
same level of public health protection as the relevant requirement(s)
of part 112 (see Sec.  112.171). We will also look for a Statement of
Grounds describing with particularity the variance requested, including
the persons to whom the variance would apply and the provision(s) of
part 112 to which the variance would apply (Sec.  112.173(b)). We will
assess whether the scientific information, data, and materials included
in the petition sufficiently support the variance requested and
accompanying rationale for the request. If FDA finds that we need
additional information to make a decision, we intend to communicate
with the petitioner. As noted previously, we welcome pre-submission
consultations so that data and information necessary to adequately
support a specific variance can be identified. FDA anticipates
providing guidance and other information, as appropriate, to assist
States, tribes, and foreign countries in preparing petitions for
requests for variances and developing the necessary scientific basis to
support such requests.
    (Comment 405) One comment asks whether we would be able to assess
and provide a decision on variance requests before the implementation
date if FDA were faced with large number of variance applications. This
comment also suggests that, if we are not able to decide on a variance
request before the implementation date, variance requestors should be
able to continue operating under their existing practices until the FDA