than that required in Sec.  112.46(b)(1)(i)(A) or Sec.
112.46(b)(2)(i)(A). To account for such circumstances, we are providing
for the use of an alternative testing frequency in lieu of the required
minimum number of samples (see Sec. Sec.  112.49(c) and (d) and
112.12).
    (Comment 241) Some comments state the proposed minimum 20 samples
for baseline survey for each untreated surface water source would be
economically burdensome, especially for small farms, with no
appreciable increase to produce safety. These comments also contend
that reducing the testing frequency (and thereby reducing the
significant burden on small farmers) would be consistent with the
public health goals of the rule.
    (Response) See our response to Comment 235 where we explain our
rationale for the minimum testing frequencies we are establishing in
Sec.  112.46(b)(1)(i)(A) for the initial survey. We intend to work with
stakeholders to develop a network of institutions that can provide
technical assistance to the farming community, especially small and
very small farms, as they endeavor to comply with the provisions of the
final rule. Moreover, we are providing for extended compliance periods
of an additional 2 years each for covered activities involving covered
produce (except sprouts), which results in compliance periods of 6
years for very small farms, 5 years for small farms, and 4 years for
all other farms for compliance with certain water provisions, Sec.
112.46(b) among them (except Sec.  112.46(a) and (b)(1) with respect to
untreated surface water sources) as explained in response to Comment
240 and in section XIII.K of this document. (See also section XXIV for
compliance dates for covered activities involving sprouts, which are
subject to all of part 112 including subpart M). We also have included
certain size-based provisions, including a coverage threshold and a
qualified exemption described in Sec. Sec.  112.4 and 112.5.
    (Comment 242) Several comments oppose the minimum sample size of
five samples for the annual survey, under proposed Sec.
112.45(b)(2)(i), stating that such a frequency of testing is
unnecessary, burdensome, and not scientifically determined. These
comments suggest different acceptable minimum samples sizes ranging
from three samples annually (along with a request to align with USDA
GAPs guidelines) to one sample annually.
    (Response) See our response to Comment 238 where we explain our
rationale for the minimum testing frequency we are establishing for the
annual survey in Sec.  112.46(b)(2)(i)(A) and our intent to work with
USDA as they update their GAPs audit program to align with the
requirements of the produce safety regulation.
6. Use of Historical Data for Testing Untreated Surface Water Used in a
Direct Water Application Method During Growing Activities (Sec.
112.46(b))
    (Comment 243) Some comments note farms currently conduct water
testing (including, for example, consistent with relevant industry
guidelines) and maintain these historical data, and ask that these
farms be allowed to use such data in their baseline survey to establish
the water quality profile. Comments also request FDA to clarify that
farms would be able to start collecting samples immediately on
publication of the final produce safety rule to allow sufficient time
to conduct the proposed baseline survey.
    (Response) To develop the microbial water quality profile required
under Sec.  112.46(b)(1) for untreated surface water used in growing
covered produce other than sprouts using a direct water application
method, covered farms are required to conduct an initial survey over a
minimum period of 2 years and not greater than 4 years, using a minimum
total of 20 samples. We do not expect farms to incur additional
sampling costs to satisfy the initial survey requirement in Sec.
112.46(b)(1), if they already possess sufficient microbial water
quality data (consisting of the minimum required number of samples)
collected in the manner required under Sec.  112.46(b). Under these
circumstances, a farm is permitted to use available historical
microbial water quality data, from the previous four years, to make up
the minimum 20 samples to calculate the current microbial water quality
profile. Moreover, covered farms will have an additional 2 years, i.e.,
a total of 4 to 6 years, depending on farm size, from the effective
date of this rule for compliance with the water testing provisions in
Sec.  112.46, except Sec.  112.46(a) and (b)(1) with respect to
untreated surface water, for covered activities involving covered
produce (except sprouts).
    We exclude Sec.  112.46(b)(1), with respect to untreated surface
water only, from the 2-year extended compliance period provided for the
remainder of Sec.  112.46 because, in order to comply with the
microbial quality criteria in 112.44(b), farms must have developed a
microbial water quality profile based on the initial survey conducted
over a minimum of 2 years and not greater than 4 years. Accordingly, to
develop the microbial water quality profile prior to the point at which
they must comply with all of the requirements of subpart E, covered
farms must begin water sampling and subsequent testing not later than 4
years after issuance of this

rule for very small farms; not later than 3 years after issuance of
this rule for small farms; and not later than 2 years after issuance of
this rule for all other farms. If they choose to, a farm that is not
small or very small can begin water sampling and subsequent testing as
early as when this rule is published, and expect to use those test
results to comply with the rule by the compliance date. Initiating
water sampling upon publication of this rule will allow those covered
farms to collect 5 samples per year over the next four years,
sufficient to make up the minimum 20 samples necessary to develop the
microbial water quality profile required under Sec.  112.46(b) at the
point at which they must comply with all of the requirements of subpart
E. On the other hand, if these covered farms initiate water sampling
two years after issuance of this rule, the farms will need to collect
10 samples per year over the next two years to make up the minimum 20
samples necessary to develop the microbial water quality profile. In
either instance, the covered farms will have sufficient time to develop
a microbial water quality profile and determine the appropriate way(s)
in which to use water from that source based on that profile, in
accordance with Sec.  112.45(b)(1) through (b)(3). Covered farms that
are small and very small may decide not to begin testing upon issuance
of this rule with the expectation of using those test results at their
compliance date because they are not required to have established the
microbial water quality profile under Sec.  112.46(b) until 5 and 6
years, respectively, after the effective date of this rule and because
farms must use data that are no more than 4 years old to establish
their microbial water quality profile. We are not similarly excluding
Sec.  112.46(b)(1) with respect to untreated ground water from the
extended compliance period because the amount of time needed for the
initial survey for such sources is significantly shorter (compare Sec.
112.46(b)(1)(i)(A) and (B)).
    Note that the exclusion of Sec.  112.46(b)(1) with respect to
untreated surface water from the extended compliance period does not
mean that covered farms must bring untreated surface water used for
Sec.  112.44(b) purposes into compliance with that microbial quality
requirement within the 2-4 year compliance period (depending on farm
size) applicable to the remaining provisions of this rule. Rather the
exclusion is intended to ensure that covered farms will begin
collecting and testing samples and obtain data to develop the microbial
water quality profile necessary to then comply with the remainder of
the water requirements, for which the extended compliance period of 4
to 6 years (depending on farm size) applies.
    We are also excluding Sec.  112.46(a) from the extended compliance
period because this provision provides an important exception to the
testing requirements in Sec.  112.46(b)(1) and is referenced therein.
Section 112.47 is also subject to the shorter compliance period because
it establishes requirements that are relevant to testing requirements
when they become applicable.
    We are not similarly providing extended compliance periods for
these specified water requirements, in the case of covered activities
involving sprouts, as discussed in section XVIII.J of this document.
Therefore, covered farms must comply with all of the applicable
requirements of part 112, including subpart E, for all covered
activities involving sprouts, within one to three years of the
effective date of the rule, depending on the size of the farm. See also
section XXIV for additional information.
7. Updating the Microbial Water Quality Profile Annually for Water Used
in a Direct Water Application Method During Growing Activities (Sec.
112.46(b)(2))
    In the supplemental notice, we acknowledged that there are certain
limitations to our proposed tiered approach, particularly regarding
whether and how annual verification data may be used to identify the
need for changes to water use practices in the current season and/or
the need for a new water quality profile. For example, we asked if
there is a threshold based on magnitude of deviation indicated in an
annual survey that would suggest that the existing water quality
profile is no longer representative of the current water quality.
    (Comment 244) Some comments disagree that water quality profiles
should be re-characterized every ten years, as would have been required
under proposed Sec.  112.45(b)(1)(iii)(A), and, instead, recommend
applying a rolling set of samples such that the water quality profile
is updated on an ongoing basis. Similarly, one other comment recommends
eliminating the concept of a baseline water quality profile followed by
an annual verification survey, in favor of a rolling geometric mean
coupled with appropriate guidance on steps to take when a test exceeds
a threshold limit; however, this commenter did not further specify what
such threshold limit should be. One comment states that a single high
test result should be followed-up by retesting to confirm the previous
finding and rule out a potential false positive. Another comment finds
it unclear whether and when the water quality profile would need to be
re-characterized based on annual survey test results.
    (Response) We are making several revisions to our proposed baseline
and annual survey provisions to simplify the requirements related to
developing a new or updated microbial water quality profile, while
retaining the advantages of the tiered approach proposed in the
supplemental notice. We are also combining the testing provisions for
untreated surface water and untreated ground water sources used for
direct water application during growing covered produce other than
sprouts into the same provision (Sec.  112.46(b)).
    We are revising our tiered approach to testing by, first,
eliminating (1) the proposed requirement to develop a new water quality
profile at least once every 10 years (proposed Sec.
112.45(b)(1)(iii)(A)); and (2) the proposed requirement that, if the GM
and/or STV values of the annual survey samples do not support your
water quality profile and therefore your existing water use as
specified in Sec.  112.44(c), you must develop a new water quality
profile (proposed Sec.  112.45(b)(2)(ii)).
    Second, in lieu of the eliminated provisions, we are adding these
revised requirements in final Sec.  112.46(b)(2): (1) Following the
development of the microbial water quality profile based on an initial
survey, you must test water annually to update your existing microbial
water quality profile to confirm that the way(s) in which the water is
used continues to be appropriate. You must analyze a minimum number of
five samples per year (for untreated surface water) or one sample per
year (for untreated ground water). These samples must be representative
of your use of the water and must be collected as close in time as
practicable to, but prior to, harvest (Sec.  112.46(b)(2)(i) and (ii));
and (2) To update the microbial water quality profile, you must
calculate revised GM and STV values using your current annual survey
data, combined with your most recent initial or annual survey data from
prior years, but within the previous 4 years, to make up a rolling data
set of at least 20 samples (for untreated surface water) or 4 samples
(for untreated ground water) (Sec.  112.46(b)(2)(iii)); and (3) You
must modify your water use, as appropriate, based on the revised GM and
STV

values in your updated water quality profile, in accordance with Sec.
112.45(b)(1) through (3) (Sec.  112.46(b)(2)(iv)), as soon as
practicable, and no later than the following year.
    This revised approach, which relies on an annually updated
microbial water quality profile comprised of rolling GM and STV values,
has several advantages compared to the approach proposed in the
supplemental notice. It maintains the advantages of the tiered approach
proposed in the supplemental notice compared to the originally proposed
approach in the 2013 proposed rule in that it reduces the required
frequency of testing compared to the originally proposed requirements.
It also maintains the flexibility of the tiered approach by allowing
farms to make decisions about safe use of available water sources as
soon as practical, but no later than the following year, as well as
adjusting testing frequencies based on long-term test results. In
addition, unlike the approach in the 2013 proposed rule, use of GM with
accompanying STV values eliminates the need for a single sample maximum
threshold, while accounting for variability of water quality and
occasional high sample results that could highlight potential risk
associated with use of the water. Moreover, the revised approach
established in Sec.  112.46(b) eliminates the need for specific
thresholds based on annual verification survey data to determine
whether and when a new microbial water quality profile is needed
(using, for example for untreated surface water sources, previous
years' 15 samples versus a complete new set of 20 samples).
    Under this revised approach, codified in Sec.  112.46(b), covered
farms must develop an updated microbial water quality profile,
consisting of revised GM and STV values based on each year's annual
survey of a minimum of 5 samples or 1 sample (for untreated surface
water, or untreated ground water, respectively) plus the data of the
most recent 15 samples or 3 samples (for untreated surface water, or
untreated ground water, respectively) collected within the previous 4
years to make up the minimum 20 samples or 4 samples (for untreated
surface water, or untreated ground water, respectively) necessary to
establish the GM and STV values. Under this approach, the microbial
water quality profile is continually updated on an annual basis so that
changes in the water quality can be identified to inform any necessary
modifications to practices. You must make those modifications to
practices as soon as practical, and no later than the following year.
If you are aware, based on your GM and STV, that you need to make
modifications in your water use practices and it is practicable for you
to make those modifications for the crop in the field at the time you
receive your test results, at your next harvest if you have multiple
harvests of a crop, or during the next growing season if you have
multiple growing seasons within a calendar year, you must do so. If
none of these timeframes are practicable or applicable to your
operation, you must make the modifications to your water use practices
no later than the following year.
    This approach also alleviates the complexity around determining
when to re-characterize the microbial water quality profile. For
example, if a single crop farm with a single surface water source
calculates the GM of 20 untreated surface water samples at the end of
the growing season in year 3 to be 126 CFU generic E. coli/100 mL and
the STV of 20 samples to be 300 CFU generic E. coli/100 mL, and then
determines the updated GM at the end of the growing season in year 4 to
be 200 CFU generic E. coli/100 mL and his STV to be 450 CFU generic E.
coli/100 mL, the farm can adjust its practices for year 5, such as to
include a 1 day die-off interval, reflecting the change in the water
quality profile. In year 5, the farm finds the GM to be 230 CFU generic
E. coli/100 mL, and STV to be 460 CFU generic E. coli/100 mL. No
further mitigation strategy (beyond the 1 day die-off interval) is
required in this scenario from the previous year, because the farm's
existing practices reflect the required mitigation strategies to
achieve the microbial water quality criteria in Sec.  112.44(b). While
the GM and STV do not match exactly those from the previous year, the
farm recognizes that its mitigation strategies are still sufficient to
meet the Sec.  112.44(b) criteria, and so does not have to make changes
to its current water use. We believe that annually-updated, rolling GM
and STV calculations address commenters' concerns about false positives
or single high test results, by allowing any high data to be
incorporated into the long-term profile.
    As another example, a diversified farm growing multiple crops per
year using a surface water source for direct water application measures
the GM at the end of the growing season for the first crop of the
season in year 3 to be 150 CFU generic E. coli/100 mL and the STV to be
400 CFU generic E. coli/100 mL of agricultural water. The STV achieves
the microbial water quality criteria, but the GM exceeds the criteria
of 126 CFU generic E. coli/100 mL. The farm calculates the values for
the microbial water quality profile prior to the harvest of the second
crop of the year, and is therefore able to adjust the growing practices
for the harvest of this crop to provide 1 day of microbial die-off
between last irrigation and harvest to achieve the specified GM of the
microbial water quality criteria.
    The GM and STV are sensitive to extremes among individual sample
measurements and a sufficiently high level (spike) in even one sample
can elevate the GM (and/or STV) over the microbial quality criteria in
Sec.  112.44(b). For example, a grower calculates his/her microbial
water quality profile and find that the GM is 118 CFU generic E. coli
per 100 mL, and the STV is 140 CFU generic E. coli per 100 mL. In the
next year the grower collects five new samples as part of the annual
survey and the sample results include 95, 147, 96, 6,000 and 137 CFU
generic E. coli per 100 mL. These values are rolled into the previous
year's microbial water quality profile, and it now includes the latest
five samples. The updated microbial water quality profile has a GM of
143 CFU generic E. coli per 100 mL, and STV of 448 generic E. coli per
100 mL. The grower uses this information to apply a one-day die-off
period between last irrigation and harvest, as soon as practicable, but
no later than the following year. This sensitivity is one of the
reasons we believe that the rolling GM and STV calculations are the
appropriate tool for determining microbial water quality while
protecting public health. We realize that farms have concerns about
single high samples and we encourage farms to treat each sample as a
marker in the variability of the water source to identify trends over
long periods of time. This approach will help covered farms understand
how their water sources may vary in the long term.
    Even though we are finalizing a rolling GM and STV measurement so
covered farms can develop a microbial water quality profile over time,
we are also retaining the requirement, in Sec.  112.46(b)(3), that if
you have determined or have reason to believe that your microbial water
quality profile no longer represents the quality of your water (for
example, if there are significant changes in adjacent land use that are
reasonably likely to adversely affect the quality of your water
source), you must develop a new microbial water quality profile
reflective of the time period at which you believe your microbial water
quality profile changed. To develop a new microbial water quality
profile, you must calculate new

GM and STV values, using your current annual survey data (if taken
after the time of the change), combined with new data, to make up a
data set of at least 20 samples or 4 samples (for untreated surface
water, or untreated ground water, respectively). You must then modify
your water use based on the new GM and STV values in your new microbial
water quality profile in accordance with Sec.  112.45(b) (see Sec.
112.46(b)(3)).
8. Testing Highly Variable Untreated Surface Water Sources
    (Comment 245) In the supplemental notice, we requested comment on
whether, for a highly variable water source (e.g., a moving water
body), we should require more than a five-sample annual verification
survey. Some comments oppose increasing the sampling frequency, stating
that most, if not all, surface water sources would qualify as a
``moving water body.'' In addition, comments argue if a water source
does not consistently achieve the proposed GM and STV standard because
of uncontrolled variability, an increased frequency of testing would
not achieve compliance. These comments suggest, in such instances, the
farm should acknowledge the uncontrolled variability and implement
proposed mitigation measures, rather than test more frequently.
    (Response) We are not establishing water testing requirements
specific to highly variable untreated surface water sources. Rather,
under our revised approach established in Sec.  112.46(b), such water
sources would be subject to the same testing requirements as all other
untreated surface water used during growing of covered produce (other
than sprouts) using a direct water application method. We have
incorporated flexibility in the requirements in Sec.  112.46(b) to
allow farms to independently determine, in compliance with Sec. Sec.
112.49(c) and (d) and 112.12, the appropriate number of samples
required to characterize an untreated surface water source based on
their knowledge of the water system, its inherent variability, and the
vulnerability of their water source to contamination. The untreated
surface water testing requirements are used to inform the appropriate
use of the water source, by accounting for the variability of the
source. Therefore, you must first characterize the microbial water
quality of the water source by testing in accordance with Sec.
112.46(b) and developing a microbial water quality profile. If the GM
or STV do not meet the microbial quality criteria in Sec.  112.44(b),
then you must consider and implement the options provided in Sec.
112.45(b)(1) through (b)(3), as appropriate for your commodity and
practices and conditions on your farm.
9. Follow-Up Actions Based on Water Testing Results or Other
Information (Sec. Sec.  112.45 and 112.46)
    (Comment 246) Some comments state that FDA did not clearly outline
the actions a covered farm must take under the tiered testing approach
for untreated surface water. For example, comments ask for
clarification about the steps a farm must take if the annual test
results indicate a change in microbial water quality and do not confirm
the baseline water quality profile. Some comments also request
clarification of necessary actions if the test results are not
available prior to harvest and additional storage die-off rates and/or
appropriate microbial removal rates have not been developed. Some
comments also point out the proposed provisions do not provide an
exception for circumstances where a high positive finding is later
corrected and confirmed to be within the established water quality
profile.
    (Response) With the revisions we have made to Sec.  112.46(b), you
will have a rolling microbial water quality profile consisting of 20
samples for untreated surface water sources (e.g., 5 samples from your
annual survey and the most recent 15 samples, taken within the last 4
years) or 4 samples for untreated ground water sources (e.g., 1 annual
sample and the most recent 3 from within the last 4 years). From this
data set, you will update the GM and STV values each year. If the GM
and STV do not meet the microbial quality criteria in Sec.  112.44(b),
you must take actions in accordance with Sec.  112.45(b). See also
discussion in Comment 214 regarding taking action at your next harvest
or in the next growing season, if more immediate changes are not
practicable.
    We appreciate the concerns of commenters seeking additional
information and clarification on follow-up corrective measures that are
required under the different provisions, including in response to
results of testing required in Sec.  112.46 and/or in response to your
knowledge or determination that water is not safe or of adequate
sanitary quality and/or does not meet the microbial quality criteria in
Sec.  112.44. We discuss some examples in the paragraphs that follow.

    Example 1: Knowledge of Upstream Change in Conditions--A
concentrated animal feeding operation (CAFO) is established upstream
and is discharging untreated wastewater into your water source. In
this example, a farmer uses water from a stream for direct water
application method irrigation during growing covered produce that is
not sprouts. The farm has established a water quality profile for
the stream over the years and is using the water from the stream in
compliance with the relevant provisions of the rule. The farm now
learns that a CAFO has started operation upstream from the farm and
within a close distance and is regularly discharging untreated
wastewater into its water source. The farm has reason to believe
that its microbial water quality profile no longer represents the
quality of the water from the stream. This is because, under the
circumstances, the addition of the CAFO upstream and its regular
discharge of untreated wastewater is a significant change in nearby
land use that is reasonably likely to adversely affect the quality
of the water source. Thus, under Sec.  112.46(b)(3), the farm must
develop a new microbial water quality profile reflective of the time
period at which the farm believes the microbial water quality
profile changed. In this case, the farm's new microbial water
quality profile must reflect only data from after the time the CAFO
began operation upstream. The farm must take new samples of the
water, combined with as many test results as it already has from its
previous data set from samples taken after the CAFO began
operations, to make up a data set of at least 20 samples, and
calculate new GM and STV (the new water quality profile) from that
data set. Then the farm must modify its water use based on the new
GM and STV values in its new microbial water quality profile in
accordance with Sec.  112.45(b).
    Example 2: Knowledge of Likely Contamination Event--Dead deer in
stream. In this example, as in Example 1, a farmer uses water from a
stream for direct water application method irrigation during growing
covered produce that is not sprouts. The farm has established a
microbial water quality profile for the stream over the years and is
using the water from the stream in compliance with the relevant
provisions of the rule. During the growing season, the farm finds
deceased and decaying deer in the area of the stream under the
farm's control, upstream from where the farm draws its water and at
a close distance. The farm now has reason to believe that its
agricultural water is not safe or of adequate sanitary quality for
its intended use as required under Sec.  112.41 because the water is
reasonably likely to contain human pathogens transferred by the dead
and decaying deer. Therefore, under Sec.  112.45(a), the farm must
immediately discontinue using the water for irrigation until it
completes one of the actions described in Sec.  112.45(a). The
approach that the farm is most likely to take (as most likely the
most feasible option) is to re-inspect the entire affected
agricultural water system to the extent it is under the farm's
control, identify any conditions that are reasonably likely to
introduce known or reasonably foreseeable hazards into or onto
covered produce or food-contact surfaces, make necessary changes,
and take adequate measures to determine if the changes were
effective (Sec.  112.45(a)(1)). In this case, that would entail, at
a minimum: re-inspecting the entire water system potentially
affected by the dead deer to the extent it is under the farm's
control to identify any relevant

conditions (such as additional dead deer, including carcass
materials that may have contaminated the farm's water distribution
system if applicable); removing the dead deer and any related
hazards identified during the re-inspection; cleaning any necessary
equipment that may have been contaminated (such as the water
distribution system impacted by the deer); and visually verifying
that all carcass materials have been removed. Once the farm has
taken all of the appropriate steps in light of its specific
circumstances, it may resume using the water for direct water
application irrigation of its covered produce.
    Example 3:  Exceedance of no detectable generic E. coli
criterion in Sec.  112.44(a) in water used for hand-washing and
rinsing produce during and after harvest. In this example, a farmer
uses water drawn directly from a properly protected well that
qualifies as an untreated ground water source for hand-washing and
rinsing produce during and after harvest. The farm has tested the
well over the years and is using the water from the well in
compliance with the relevant provisions of the rule (in this
example, the farm has never detected generic E. coli in the well
water before). This year, the farm conducts its annual test of the
well water, taking a sample that is representative of the intended
use (in this case, taken during the time the farm is using the water
for hand-washing and produce rinsing), and detectable generic E.
coli is found, thus exceeding the required criterion in Sec.
112.44(a). Under Sec.  112.45(a), the farm must immediately
discontinue using the water for hand-washing and produce rinsing and
may not re-use it for those purposes until it completes one of the
actions described in Sec.  112.45(a). The farm's choices are to re-
inspect the entire affected agricultural water system to the extent
it is under the farm's control, identify any conditions that are
reasonably likely to introduce known or reasonably foreseeable
hazards into or onto covered produce or food-contact surfaces, make
necessary changes, and take adequate measures to determine if the
changes were effective (Sec.  112.45(a)(1)), or to treat the water
in accordance with Sec.  112.43 (Sec.  112.45(a)(2)). The farm may,
of course, also choose to use a different water source that does
meet the microbial quality criterion in Sec.  112.44(a) for hand-
washing and rinsing of produce either permanently or while it
pursues these corrective actions. The farm may not use untreated
surface water for these purposes (see Sec.  112.44(a)). If the
circumstances allow the farm to use Sec.  112.45(a)(1) to correct
the problem (for example, if a fixable problem is identified with
respect to the farm's affected water distribution system that the
farm is able to adequately correct in compliance with that
provision), a required aspect of compliance with this provision
under the circumstances is to re-test the water to adequately ensure
that it now meets the microbial quality criterion in Sec.  112.44(a)
(see Sec.  112.45(a)(1)). Making necessary changes to address the
identified conditions (as required by Sec.  112.45(a)(1)) also
includes steps such as cleaning affected food contact surfaces, for
example. Moreover, under Sec.  112.46(c), the farm must also test
the well at least four times per growing season or year in the next
year because of the test result that failed to meet the microbial
quality criterion in Sec.  112.44(a). If all four tests in the next
year meet the criterion, the farm may switch back to testing once
per year.
    Example 4: Exceedance of GM/STV generic E. coli criteria in
Sec.  112.44(b). In this example, a farmer uses water from a stream
for direct water application method irrigation during growing
covered produce that is not sprouts. The farm has established a
water quality profile for the stream over the years and is using the
water from the stream in compliance with the relevant provisions of
the rule. In past years, the GM and STV calculated using the farm's
test results have been within the bounds of the microbial water
quality criteria of Sec.  112.44(b) (so no time intervals based on
microbial die-off, or log reductions based on microbial removal
rates have been applied). This year, however, the calculation of the
GM and STV values for the updated microbial water quality profile
(calculated, in this case, after the harvest has been completed and
the water is no longer being used for direct water application
method irrigation) exceed the microbial quality criteria. In this
case, the covered farm must take actions, as appropriate, based on
the revised GM and STV values in the updated microbial water quality
profile, in accordance with Sec.  112.45(b)(1) through (3) as soon
as practicable, and no later than the following year. The farm's
practices related to that water use can be modified through applying
an adequate time interval (in days) between last irrigation and
harvest in accordance with Sec.  112.45(b)(1)(i); or applying a time
interval (in days) between harvest and end of storage, or applying a
calculated log reduction during activities such as commercial
washing, provided the farm has adequate supporting scientific data
and information in accordance with Sec.  112.45(b)(1)(ii). If these
mitigation options are not selected or cannot be appropriately
applied to achieve the microbial water quality criteria, the farm
may consider the options in Sec.  112.45(b)(2) or (b)(3), i.e., the
farm must either re-inspect the entire affected agricultural water
system to the extent it is under the farm's control and take other
steps, including make necessary changes and retesting the water to
determine if the changes were effective and the water now meets the
criteria; or treat the water in accordance with Sec.  112.43. If
none of the above mitigation options are selected and appropriately
applied to achieve the microbial water quality criteria, the farm
must discontinue using water from that source for direct water
application method irrigation of covered produce no later than one
year from the time that the farm determined that the water did not
meet the required criteria.

    There may be circumstances that allow the farm to use Sec.
112.45(b)(2) to correct the problem. For example, the farm might
reasonably determine, under the circumstances, that the change in
microbial water quality was due to non-recurring point-source
contamination that can be adequately corrected in compliance with this
provision. An example of such a finding would be visible damage to a
water dam on the farm's property (and under the farm's control)
upstream from where the farm draws its water, where the dam serves to
reduce water flow by holding back water from a stream that would
otherwise converge with the stream water the farm uses. The farm might
reasonably conclude, under these circumstances, that the damage to the
dam is a correctable, non-recurring point-source of contamination. If
the farm is able to stop the leak and repair the damaged dam, the farm
may use Sec.  112.45(b)(2) as a mitigation option. In such cases, a
required aspect of compliance with this provision under the
circumstances is to re-test the water after the correction has been
made to adequately ensure that the water meets the microbial quality
criteria in Sec.  112.44(b) (see Sec.  112.45(b)(2)). Under Sec.
112.45(b), the farm in this example has up to a year before it must
discontinue use of the water for direct application method irrigation
of covered produce, and post-correction sampling should be conducted
and analyzed within such time if the farm wishes to continue using the
water for this purpose without interruption. We note that to meet the
requirements of Sec.  112.46(b)(2) for the annual survey, samples must
be representative of your use of the water and must be collected as
close in time as practicable to, but prior to, harvest. However, we
also encourage farms in such situations to voluntarily conduct
additional sampling earlier (such as immediately post-correction, even
if not close in time to harvest) as may be appropriate.
    In rare situations such as that described in this example, the farm
need not include in its rolling dataset of 20 samples for calculation
of the GM and STV the set of 5 samples that caused the exceedance,
leading it to re-inspect, find, and correct the non-recurring point
source contamination. In this rare situation the data set should be
made up only of samples that are not reasonably likely to have been
affected by the non-recurring point-source contamination. With respect
to calculations for the microbial water quality profile, we encourage
farms in such situations to take more than the minimum 5 samples in the
following year(s), because doing so would make it unnecessary to
include data older than 4 years in the microbial water quality profile.
However, because the circumstances in which you need not include the
samples that caused the exceedance in your microbial water

quality profile are likely to be rare (i.e., we consider that such
situations most likely only involve non-recurring point-source
contamination that can be immediately eliminated), we intend to
exercise enforcement discretion with respect to the 4 year limitation
in Sec.  112.46(b)(2)(iii) in such situations. This would allow the
farm in this example to make up its microbial water quality profile in
the following year using its new annual survey data, combined with its
most recent initial or annual survey data (not including the samples
that caused the exceedance), to make up a rolling data set of 20
samples.
    (Comment 247) One comment argues the proposed water testing
approach fails to respond to significant changes in water quality in a
timely manner. Similarly, another comment points out the proposed
approach for testing untreated surface water reflects a retrospective
testing scheme, where results of water testing may not be available in
time to take actions on the harvested produce because the harvested
produce may already be in commerce by the time the analysis is
completed and the farm receives the results.
    (Response) The goal of our framework for testing of agricultural
water that is used for direct water application during growing
activities for covered produce other than sprouts is to establish a
microbial water quality profile to help covered farms characterize
their water sources, understand the variability of those sources, and
make appropriate long-term decisions about the use of that water for
the specific purpose of direct water application during growing. As
explained in response to Comment 180, our framework for the microbial
quality criteria for water used in direct water application coupled
with our decision to test for generic E. coli as an indicator organism
means that exceeding the microbial water quality criteria in Sec.
112.44(b) does not result in a determination that, based on this
testing in and of itself, the produce is adulterated. Therefore, the
follow-up actions listed in Sec.  112.45(b) that must be taken when the
microbial water quality criteria in Sec.  112.44(b) are not met involve
longer-term decisions (rather than the immediate decisions required
under Sec.  112.45(a)) about the use of that water as soon as
practicable (considering crop in the field, next harvest, or next
growing season), and no later than the following year. Given the
logistical realities of sampling and testing close to harvest, there
may not be time for a farm to adjust water use practices for the
current year's crop because they may not receive test results in
sufficient time to take actions related to that crop (for example, test
results may not be received until after the crop is out of the field
and into distribution). However, the point of this testing is to
develop a long-term strategy to ensure that covered farms understand
the quality of their water, pay attention to changes (such as the
establishment of a CAFO upstream) that may affect water quality, and
make appropriate decisions going forward about use of that water.
Regardless, if the farm has reason to believe that its agricultural
water is contaminated such that it would render the produce adulterated
under section 402 of the FD&C Act (e.g., a finding of a pathogen in
dump tank water), the farm must take appropriate actions to ensure that
affected food does not enter commerce.
    Under our framework where the microbial quality criteria in Sec.
112.44(b) and the corresponding testing scheme in Sec.  112.46(b) serve
as a long-term strategy to help covered farms to understand the quality
of their water sources and plan the appropriate use of water from those
sources accordingly, and in light of the options for corrective
measures in Sec.  112.45(b)(1) through (b)(3), a requirement to
immediately implement corrective actions on the current crop during
growing or harvested crop solely based on the results of Sec.
112.46(b) is not warranted. Rather, we conclude the general requirement
in Sec. Sec.  112.41 and corresponding 112.45(a) sufficiently address
those circumstances and necessary immediate actions when water is not
safe or of adequate sanitary quality for its intended use.

H. Sharing of Water Testing Data (Sec.  112.47(a))

    (Comment 248) One comment requests that FDA provide for the
establishment of water quality profiles for common water sources
affecting various farms in a specific geographic area or region.
    (Response) Section 112.47(a)(2) explicitly allows data sharing
under certain circumstances. However, we do not expect that it will
typically be possible to develop water quality profiles as described
under Sec.  112.46(b) on a regional basis for large water sources such
as rivers. As provided in Sec.  112.47(a)(2), you may use data
collected by a third party or parties only if the water source(s)
sampled by the third party or parties adequately represent your
agricultural water source(s) and all other applicable requirements of
the rule are met. As explained in the supplemental notice (79 FR 58434
at 58455), a water source sampled by a third party adequately
represents your water source if the third party takes its samples from
the same water source you use (e.g., the same river), and there is no
reasonably identifiable source of likely microbiological contamination
(e.g., an untreated sewage discharge point, a source of significant
amounts of untreated animal feces such as a livestock farm) between the
point(s) at which the third party collects its samples and the point(s)
at which you draw the water. Thus, under this provision, testing data
may only be shared if there is no reasonably identifiable source of
likely microbiological contamination between the sampling site(s) and
the farm(s) involved. For a regional water source such as a river, we
expect that in most cases there will be reasonably identifiable
source(s) of likely microbiological contamination at various points
along the river that will prevent all users of the river from sharing
the same data under this provision. Some users of a river may be able
to share data under this provision, but only if there are no reasonably
identifiable source(s) of likely microbiological contamination between
their sampling point(s) and draw point(s) and all other requirements of
the rule are met.
    (Comment 249) One comment recommends that FDA work with EPA and
other agencies to develop and share water testing data with relevant
parties.
    (Response) To the extent this commenter is referring to water from
a Public Water System, as defined under EPA's Safe Drinking Water Act
(SDWA) regulations, 40 CFR part 141, that furnishes water that meets
the microbial requirements under those regulations or under the
regulations of a State (as defined in 40 CFR 141.2) approved to
administer the SDWA public water supply program, we note that under
Sec.  112.46(a)(1), there is no requirement to test any agricultural
water that is subject to the requirements of Sec.  112.44 when you
receive water from such a system and you have Public Water System
results or certificates of compliance that demonstrate that the water
meets that requirement.
    (Comment 250) Referring to leased lands where an owner may lease a
field or a portion of the land each year to different farms, one
comment recommends that, in such cases, the current tenant farmer
should be able to use the previous tenant farm's water sampling results
to establish the water quality profile when one is required under
proposed Sec.  112.45(b), rather than having to conduct a new baseline
survey.

    (Response) Under Sec.  112.47(a)(2), you may use test data
collected by a third party or parties, provided the water source(s)
sampled by the third party or parties adequately represent your
agricultural water and all other applicable requirements of the rule
are met. A water source sampled by a third party adequately represents
your water source if the third party takes its samples from the same
water source you use (e.g., the same canal, stream, or reservoir) and
there is no reasonably identifiable source of likely microbiological
contamination between the point(s) at which the third party collects
its samples and the point(s) at which you draw the water. Thus, if a
farmer of leased land has access to previous years' water testing data
that meets the requirements of Sec.  112.47(a)(2), the farmer may use
such data to satisfy relevant testing requirements under Sec.  112.46,
including those required under Sec.  112.46(b). On the other hand, if a
farmer of a leased land does not have access to previous years' water
testing data, or the farmer has access to such data but those data do
not meet the requirements of Sec.  112.47(a)(2), the farm will need to
perform its own testing to develop the initial microbial water quality
profile.

I. Agricultural Water Used During Harvest, Packing, and Holding
Activities (Sec.  112.48)

    (Comment 251) Some comments state that it would be impossible to
maintain a potable water standard for postharvest water at all times.
Comments also state that FDA should include a cost-effective
recommendation for visual monitoring, and clearer criteria for how
farms should deal with organic build-up in water and when to change the
water. Some of these comments also maintain that reliance on visual
inspection in place of other testing mechanisms may not be safe.
    (Response) Section 112.48(b) requires you to visually monitor the
quality of water that you use during harvest, packing, and holding
activities for covered produce (for example, water used for washing
covered produce in dump tanks, flumes, or wash tanks, and water used
for cooling covered produce in hydrocoolers) for build-up of organic
material (such as soil and plant debris). We are including this
monitoring requirement to highlight conditions that require action,
such as a water change in a dump tank, and take appropriate measures,
as necessary. The specific method and criteria for monitoring to
maintain water quality will need to be operation-specific and,
therefore, we recommend that you consider establishing protocols
specific to your harvesting, packing, or holding activity. We note that
this requirement is not the only requirement applicable to agricultural
water used for these purposes. Section 112.44(a) establishes a
microbial quality criterion for such water and prohibits using
untreated surface water for such purposes. We consider the Sec.
112.44(a) criterion to apply to the water as it is being added to a
dump tank, flume, or wash tank. Section 112.45(a) establishes steps
that a farm must take when the water does not meet the Sec.  112.44(a)
microbial criterion. In addition, Sec.  112.46(a) establishes the
circumstances in which water used for the purposes listed in Sec.
112.44(a) is not required to be tested, and Sec.  112.46(c) requires
testing untreated ground water used for these purposes. Thus, this rule
does not rely on visual inspection in place of testing water quality as
suggested by some comments. Where we have determined that a testing
requirement is appropriate (i.e., for untreated ground water used for
these purposes), we have established such a requirement.
    (Comment 252) One comment suggests requiring disinfection treatment
of re-circulated water used during and after harvest. By contrast,
another comment states that disinfection of re-circulated water in case
of dump tanks is unnecessary and impractical.
    (Response) Section 112.48(a) requires you to manage the water used
during harvest, packing, and holding activities for covered produce as
necessary, including by establishing and following water-change
schedules for re-circulated water to maintain the safety and adequate
sanitary quality and minimize the potential for contamination of
covered produce and food-contact surfaces with known or reasonably
foreseeable hazards (for example, hazards that may be introduced into
the water from soil adhering to the covered produce). In addition,
under Sec.  112.44(a), agricultural water applied in any manner that
directly contacts covered produce during or after harvest activities is
required to meet the zero detectable generic E. coli in 100 mL
microbial quality criterion. This requirement applies to the water as
it is being added to a dump tank, flume, or wash tank (see Comment
251). Recognizing the wide-range of handling procedures, washing line
set-ups, and commodity-specific practices where agricultural water
directly contacts covered produce during or after harvest activities,
we are not requiring treatment of re-circulated water. Instead, we have
provided flexibility for farms to implement measures appropriate to
their practices to comply with Sec.  112.48(a), which may include
disinfection treatment during re-circulation. See also Comment 196.
    (Comment 253) Some comments express a need for commodity-specific
research to tailor requirements for the use of water during harvest,
packing, and holding activities to specific covered produce
commodities. Some commenters also believe that, although maintaining a
positive temperature differential between the produce and wash water
could be a good practice, it may not be practicable based on current
industry practices. In addition, some commenters do not believe
applying a water temperature differential has been demonstrated to
minimize the risk of infiltration of microorganisms.
    (Response) As described in the 2013 proposed rule, water
temperature can influence processes leading to infiltration of
microorganisms into many types of produce. In the QAR, too, we noted
that infiltration of water containing pathogens into produce has been
demonstrated in apples (Ref. 158), oranges (Ref. 159), tomatoes (Ref.
160) (Ref. 161), and mangoes (Ref. 162), and was suggested to play a
role in a 1999 Salmonella outbreak associated with mangoes (Ref. 163).
In the development of the 2013 proposed rule, we considered proposing a
specific temperature differential between water and product core
temperature (e.g., water must be at least 10 [deg]F warmer than core),
and tentatively concluded that there is insufficient scientific
evidence supporting the application of such a specific temperature
differential requirement across all covered produce. Instead, we
proposed and now finalize Sec.  112.48(c), which requires that you must
maintain and monitor the temperature of water at a temperature that is
appropriate for the commodity and operation (considering the time and
depth of submersion) and is adequate to minimize the potential for
infiltration of microorganisms of public health significance. Thus, the
requirement is tailored to apply only to appropriate commodities and
practices, and only as needed to minimize the potential for
infiltration of pathogens.
    Although research suggests that water temperature can influence the
infiltration of microorganisms into various types of produce, including
apples, oranges, mangoes and tomatoes, other studies demonstrate that
infiltration can occur without a temperature differential (Ref. 159)
(Ref. 164). For example, it was demonstrated that internalization of
Salmonella into tomatoes via their stem scar can occur

even under a zero temperature differential, and temperature
differentials up to 10[emsp14][deg]F have no effect on the
internalization frequency and have limited impact on Salmonella spp.
cell populations internalized in tomatoes. In addition, factors such as
tomato variety and the time delay between tomato stem removal and water
immersion have a significant impact on the frequency and population of
internalized Salmonella spp. in tomatoes (Ref. 164). We did not receive
data or information in response to the 2013 proposed rule that would
support a requirement for a specific temperature differential to be
maintained in agricultural water used during harvest, packing, and
holding activities across all covered produce.

J. Records Related to Agricultural Water (Sec.  112.50)

    (Comment 254) In response to the 2013 proposed rule, several
comments support the recordkeeping requirements of proposed Sec.
112.50, and state that effective water management includes
recordkeeping that is sufficient to confirm that agricultural water is
safe throughout the growing season. Comments also agree that farms must
establish and keep records relating to the findings of the inspection
of the agricultural water system; the results of any analytical tests
conducted to determine whether water is safe and of adequate sanitary
quality for its intended use; and scientific data relied on to support
the adequacy of methods used to treat agricultural water. One comment
also agrees with the proposed requirement to maintain annual
documentation from a public water system, if applicable. Another
comment suggests that FDA should require documentation of any
corrective actions that farms employ to address problems identified
with their water system and to verify that those corrective actions
were effective.
    (Response) We conclude that certain records are necessary for you
to ensure your own compliance with the requirements in this rule for
use of agricultural water, and so that FDA can verify your compliance
with the relevant requirements of subpart E. We agree that
documentation of corrective actions is necessary to verify
effectiveness of the corrective actions and compliance with the
relevant requirements. In proposed Sec.  112.161(b), we proposed a
general provision applicable to records 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, subparts E and M. In subpart E as edited, under
new Sec.  112.50(b)(6), you must establish and keep documentation of
actions you take in accordance with Sec.  112.45. For example, if you
determine that water you use for a purpose listed in Sec.  112.44(a)
does not meet the microbial quality criterion established in that
section, Sec.  112.45(a) provides that you must take certain steps as a
result. This Sec.  112.50(b)(6) requires that you establish and keep
documentation of the steps taken to satisfy Sec.  112.45(a). In
addition, in this section we are also establishing specific
requirements for documentation of time intervals or calculated log
reductions applied in accordance with Sec.  112.45(b)(1).
    We are also adding new Sec.  112.50(b)(9) to require that you
retain documentation of any analytical methods you use in lieu of the
method that is incorporated by reference in Sec.  112.151(a). Under
Sec.  112.151(b)(1), you may use any scientifically valid method that
is at least equivalent to the method of analysis in Sec.  112.151(a) in
accuracy, precision, and sensitivity to satisfy the water testing
requirements under Sec.  112.46. In addition, under Sec.
112.151(b)(2), 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. We conclude such
records are necessary for us to verify and for you to ensure that
appropriate methods are used for testing agricultural water. This
provision is consistent with proposed Sec.  112.150(b)(5), which we
have retained in this rule and which requires similar records regarding
alternative analytical methods used when conducting testing required
under subpart M for sprouts. We are also combining two proposed records
requirements related to water testing results (proposed Sec.
112.50(b)(2) and (5)) into one requirement in final Sec.  112.50(b)(2).
    (Comment 255) A comment requests clarification on the type of
record that will sufficiently verify that the inspection of each water
source and identification of potential hazards has been conducted as
required in proposed Sec.  112.42.
    (Response) Under Sec.  112.50(b)(1), you are required to establish
and keep records of your agricultural water system inspection findings
under Sec.  112.42(a). Other than as provided generally for records
required under this rule in subpart O, we are not further specifying
the manner or format in which you prepare the record(s) to satisfy this
recordkeeping requirement. We note that under Sec.  112.161(a)(1), all
records required under this part must include, as applicable, the name
and location of your farm, actual values and observations obtained
during monitoring, an adequate description of covered produce
applicable to the record, the location of a growing area or other area
applicable to the record, and the date and time of the activity
documented. Under Sec.  112.161(a)(2), records must be created at the
time an activity is performed or observed, under Sec.  112.161(a)(3)
they must be accurate, legible, and indelible, and under Sec.
112.161(a)(4) they must be dated, and signed or initialed by the person
who performed the activity documented. Covered farms may prepare and
maintain documentation of their inspections and associated findings in
a manner that is appropriate for the farm's operation provided that the
records contain all necessary information and satisfy subpart O. Under
Sec.  112.163(a), you are not required to duplicate any existing
records if those records contain all of the required information and
satisfy the requirements of this rule. Similarly, if you have records
containing some but not all of the required information, Sec.  112.163
provides you the flexibility to keep any additional information
required either separately or combined with your existing records, even
where the formats for each record may not be the same.

K. Compliance Periods Related to Agricultural Water

    For covered activities involving covered produce (except sprouts
subject to subpart M), the compliance dates for water quality
requirements in Sec.  112.44 and certain related provisions are two
years beyond the compliance date for the rest of the final rule
applicable to the covered farm based on its size. See Table 12.

  Table 12--Compliance Dates for Requirements in Subpart E for Covered
 Activities Involving Covered Produce (Except Sprouts Subject to Subpart
                                   M)
                           [See also Table 30]
------------------------------------------------------------------------
                                           Extended compliance date of
     Compliance dates of 2-4 years        additional 2 years beyond the
  applicable to the farm based on its     compliance date based on size
                  size                               of farm
------------------------------------------------------------------------
Sec.   112.41..........................  Sec.   112.44.
Sec.   112.42..........................  Sec.   112.45(a) with respect
                                          to Sec.   112.44(a) criterion.
Sec.   112.43..........................  Sec.   112.45(b).
Sec.   112.45(a) with respect to safe    Sec.   112.46(b)(2) and
 and adequate standard.                   (b)(3)Sec.   112.46(c).
Sec.   112.46(a).......................  Sec.   112.46(b)(1) with
                                          respect to untreated ground
                                          water.
Sec.   112.46(b)(1) with respect to
 untreated surface water.
Sec.   112.47..........................
Sec.   112.48..........................
Sec.   112.49..........................
Sec.   112.50..........................
------------------------------------------------------------------------

    Note that although most of Sec.  112.46 is subject to the extended
compliance periods, Sec.  112.46(a) is not, and Sec.  112.46(b)(1) with
respect to untreated surface water is not. Therefore, covered farms
must initiate actions in compliance with Sec.  112.46(a) and, with
respect to untreated surface water, Sec.  112.46(b)(1) under the
regular compliance periods applicable to the remaining sections of this
rule. Similarly, Sec.  112.47 is subject to the shorter compliance
period because it establishes requirements that are relevant to testing
requirements when they become applicable. See our response to Comment
243 for an explanation for treating Sec.  112.46(b)(1) with respect to
untreated surface water differently from the remaining water testing
requirements for purposes of compliance. We recognize that farms may
need additional time to prepare for implementation of the water quality
testing, monitoring, and related record-keeping provisions. This
additional 2-year compliance period for water quality requirements is
also expected to permit farms to consider alternatives to the microbial
quality criteria in Sec.  112.44(b), the microbial die-off rate in
Sec.  112.45(b)(1)(i), or the testing frequencies in Sec.
112.46(b)(1)(i)(A) and Sec.  112.46(b)(2)(i)(A), and develop adequate
scientific data or information necessary to support a conclusion that
the alternative would provide the same level of public health
protection as the relevant requirement, and would not increase the
likelihood that the covered produce will be adulterated under section
402 of the FD&C Act, in light of the farm's covered produce, practices,
and conditions. Therefore, for covered activities involving covered
produce (except sprouts subject to subpart M), the extended compliance
dates for certain water quality testing, monitoring, and related
recordkeeping requirements identified in column 2 of Table 12 are six
years from the effective date for very small businesses, five years
from the effective date for small businesses, and four years from the
effective date for all other farms.
    We are not similarly providing extended compliance periods for
these specific water requirements, in the case of covered activities
involving sprouts, as discussed in section XVIII.J of this document.
Therefore, covered farms must comply with all of the applicable
requirements of part 112, including subpart E, for all covered
activities involving sprouts subject to subpart M, within one to three
years of the effective date of the rule, depending on size of the farm.
See also section XXIV.A of this document for additional information.

XIV. Subpart F--Comments on Biological Soil Amendments of Animal Origin
and Human Waste

    In subpart F of proposed part 112, we proposed minimum standards
directed to treated and untreated biological soil amendments of animal
origin and human waste that are reasonably necessary to minimize the
risk of serious adverse health consequences or death from the use of,
or exposure to, covered produce, including those reasonable necessary
to prevent the introduction of known or reasonably foreseeable hazards
into covered produce, and to provide reasonable assurances that the
covered produce is not adulterated under section 402 of the FD&C Act.
In the 2013 proposed rule and the supplemental notice, we asked for
comment on our proposed provisions, including our decision not to
establish requirements for chemical or physical soil amendments, or
biological soil amendments that are not of animal origin; the
appropriateness of treatment options considered for treated soil
amendments; the appropriateness of the microbial standards selected and
potential alternatives; and the proposed waiting periods between
application and harvest (``application intervals''). In the
supplemental notice, we withdrew our proposal for an application
interval for untreated biological soil amendments of animal origin
(including raw manure) and deferred our decision on an appropriate
minimum application interval until such time as necessary for us to
pursue certain steps, including a risk assessment and research to
supplement the science on an appropriate interval.
    In this section of this document, we discuss comments we received
on the standards directed to biological soil amendments of animal
origin and human waste in the 2013 proposed rule, but that we did not
address in the supplemental notice. We also discuss comments that we
received on the new and amended proposed provisions in the supplemental
notice.
    We are finalizing these provisions with revisions (see Table 13).
We discuss these changes in this section. There are also revisions
relevant to subpart F in the Definitions section in Sec.  112.3, which
are described in section IX of this document.

             Table 13--Description of Revisions to Subpart F
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.51................  --Revision to (a) and (b)(1) clarify that
                                agricultural teas covered are those for
                                which the biological materials include
                                materials of animal origin, and to
                                replace reference to Sec.   112.44(a)
                                with clarifying text.
                               --Revision to (b)(5) to clarify that
                                agricultural teas covered are those for
                                which the biological materials include
                                materials of animal origin.
                               --See Table 14 for additional
                                information.
Sec.   112.52................  --Revision to (a) to add other soil
                                amendments and to clarify that drip
                                fertigation with agricultural teas that
                                are biological soil amendments of animal
                                origin is permitted in compliance with
                                other requirements of this rule.
                               --Revision to (c) to replace ``that has
                                become'' with ``that you know or
                                reasonably believe may have become.''
                               --See Table 15 for additional
                                information.
Sec.   112.53................  --No change
Sec.   112.54................  --Revision to (a) and (b) to add
                                biological processes and replace
                                ``demonstrated'' with ``validated.''
                               --Rearrangement to combine relevant
                                provisions of proposed (c) into revised
                                (b).
                               --Renumbering of proposed (c)(1) to
                                (b)(1) and proposed (c)(2) to (b)(2) as
                                a conforming change to combining (b) and
                                (c).
                               --Elimination of proposed (c)(3) as not
                                necessary.
                               --Revision to descriptions of static
                                composting (in (b)(1)) and turned
                                composting (in (b)(2)) to further
                                clarify the processes.
                               --See Table 17 for additional
                                information.
Sec.   112.55................  --Revision to (a)(1) to add liquid
                                sampling.
                               --Revision to (a)(2) and (a)(3) to add
                                liquid sampling and indicate that it is
                                a `non-detect' standard.
                               --Revision to (b) to add liquid sampling
                                and indicate that the Salmonella method
                                is a `non-detect' standard.
                               --See Table 18 for additional
                                information.
Sec.   112.56................  --Revision to (a) to delete ``except as
                                provided in paragraph (b) of this
                                section.''
                               --Revision to combine proposed (a)(3) and
                                proposed (a)(4) as renumbered (a)(2),
                                corresponding to revised Sec.
                                112.54(b).
                               --Renumbering of proposed (a)(2) as
                                (a)(3).
                               --See Table 19 for additional
                                information.
Sec.   112.60................  --Revision to (b)(1) to eliminate
                                proposed (b)(1)(ii) and as a conforming
                                change to renumber (b)(1)(iii) to
                                (b)(1)(ii) and to require such
                                documentation at least annually.
                               --Elimination of (b)(3) as a conforming
                                change since proposed Sec.
                                112.54(c)(3) has been deleted.
                               --See Table 20 for additional
                                information.
------------------------------------------------------------------------

A. General Comments

    (Comment 256) Many comments state that biological soil amendments
of animal origin can contain pathogenic bacteria that can cause
foodborne illness in humans and therefore special precautions must be
taken in their use. Some comments further cite certain provisions
within subpart F that address the need for such special precautions and
state that they were in alignment with current GAPs, some marketing
orders, certain industry standards (in particular the mushroom industry
standards), and that they are currently being followed by segments of
the industry. These commenters generally agree with FDA's approach.
    Conversely, many comments take exception to our coverage of
biological soil amendments and our approach to doing so, particularly
the original proposal to require a 9-month application interval for
untreated biological soil amendments of animal origin, including raw
manure. Some comments state that mandatory requirements for biological
soil amendments of animal origin are not needed, or should be in
guidance rather than a regulation.
    (Response) FDA continues to conclude that biological soil
amendments of animal origin are an important route of contamination on
farm and, therefore, we do not believe it would be sufficient merely to
make recommendations related to biological soil amendments of animal
origin in guidance. We have finalized our QAR and it supports this
conclusion. With regard to comments on the application interval for
untreated biological soil amendments of animal origin, including raw
manure, which was proposed in the 2013 proposed rule and withdrawn in
the supplemental notice, see Comment 257.
    (Comment 257) Many commenters suggest that provisions within
subpart F should be written to align with NOP standards. Some comments
expressed concern that the provisions of subpart F would cause farms to
use specific methods of agriculture, including use of synthetic
fertilizers, which would eliminate a farm's ability to become certified
organic. Some comments state that organic farming provides a benefit in
protecting the public health from consequences associated with the use
of harmful chemical pesticides, herbicides, and synthetic fertilizers,
and already includes a food safety component and has an excellent track
record on food safety. Other comments suggest FDA adopt NOP standards
because farms are already accustomed to implementing them. Further,
other comments recommended that FDA and USDA collaborate to align their
respective regulations to be maximally protective of the public health
from both foodborne illness and environmental health perspectives.
    (Response) We do not agree that the provisions of subpart F are in
conflict with NOP standards or would require farms to use synthetic
amendments such that they could not achieve organic certification. The
provisions of subpart F allow use of both treated and untreated
biological soil amendments of animal origin, as long as they are
applied in accordance with Sec.  112.56. The provisions of Sec.  112.54
allow for biological (including composting), chemical, and physical
treatment processes, or combinations thereof, for producing treated
biological soil amendments of animal origin, as long as they meet the
microbial standards in Sec.  112.55. We do not believe it would be
appropriate to broadly adopt USDA's NOP standards for biological soil
amendments of animal origin because they were established for purposes
of organic certification and not for produce safety. However, we do
agree that inter-agency collaboration to align goals and approaches, in
order to minimize individual requirements placed on the

industry, is beneficial. FDA has worked, and will continue to work,
with USDA to ensure our programs do not have conflicting or duplicative
measures.
    With regard to the application interval for use of untreated
biological soil amendments of animal origin, including raw manure, in
response to our original proposal we received many comments taking
issue with our proposed 9-month interval. In response to these
comments, we indicated in the supplemental notice (79 FR 58434 at
58460-58461) that we were deferring action on an application interval
until we pursued certain steps including a risk assessment and research
to supplement the science on an appropriate interval. We anticipate
that these efforts will take 5 to 10 years to complete. Following the
completion of the risk assessment and research work, we expect to: (1)
Provide stakeholders with data and information gathered from scientific
investigations and risk assessment; (2) consider such new data and
information to develop tentative scientific conclusions; (3) provide an
opportunity for public comment on our tentative decisions; and (4)
consider public input to finalize the provision(s) establishing an
appropriate minimum application interval(s).
    (Comment 258) Several comments agree with our decision in the
supplemental notice to pursue a risk assessment and research prior to
establishing an application interval for untreated biological soil
amendments of animal origin, including raw manure. However, other
comments state that 5-10 years would be too long to wait for the public
health benefits of setting such an application interval, that there is
science demonstrating that a 120-day interval would be an appropriately
protective interim standard while FDA pursues its risk assessment and
research, that many in the agricultural community are already applying
a 120-day interval, and that FDA should establish a 120-day application
interval for raw manure as an ``interim'' standard for the intervening
5-10 years while FDA pursues its risk assessment and research agenda
and additional rulemaking. Conversely, some comments state it is not
appropriate for FDA to establish an application interval based on the
NOP interval (90/120 days depending on the crop), because the NOP
standards require incorporating manure into the soil after application
and were established for the purpose of maintaining organic integrity,
and not for produce safety.
    Some other comments relating to application intervals include a
suggestion that we subject only liquid manures to a 9-month application
interval based on an asserted greater risk presented by liquid manure
as compared to non-liquid manure, a suggestion that we count the time
period when soil is frozen toward any application interval, and a
request that we conduct research to determine the impact of hard
freezes on survivorship of pathogens in northern climates.
    (Response) As explained in the supplemental notice (79 FR 58434 at
58460-58461), FDA withdrew its proposal for an application interval for
untreated biological soil amendments of animal origin, including raw
manure, and indicated that it would establish such an interval after
pursuing a risk assessment and research agenda to supplement the
science regarding an appropriate interval. Because FDA withdrew its
proposal for such an application interval, we do not have a proposal to
finalize at this time. To establish an application interval for
untreated biological soil amendments of animal origin, FDA will need to
undertake notice-and-comment rulemaking consistent with the
Administrative Procedure Act (5 U.S.C. 553). We recognize that we could
provide public health protection by applying an application interval
for untreated biological soil amendments of animal origin while we
pursue our risk assessment and research, and the familiarity of the
farm community with the NOP 90/120-day interval. We also recognize that
FDA stated in the supplemental notice that it would pursue its risk
assessment and research agenda before proposing to establish such an
application interval, and that some comments oppose establishing an
interval by regulation before completion of that agenda. FDA is
considering appropriate next steps. However, we will not establish an
application interval for untreated biological soil amendments of animal
origin without giving the public a chance to provide comment on a
proposed interval.
    As noted in the supplemental notice, we continue to believe that a
quantitative application interval standard, established in part 112, is
necessary to minimize the likelihood of contamination of produce
resulting from the use of untreated biological soil amendments of
animal origin, including raw manure, in a manner that contacts covered
produce. We acknowledged in the supplemental notice that many farms
currently employ the NOP standard of 90 days or 120 days, as specified
in 7 CFR 205.203(c)(1), and we recognize that such farms will likely
continue their current practice to use this standard in organic crop
production, in the absence of an FDA regulation that establishes a food
safety standard for minimum application intervals associated with the
use of untreated biological soil amendments of animal origin such as
raw manure. Given that the scientific literature demonstrates that the
probability of pathogen survival decreases as the length of time
between application of untreated biological soil amendments of animal
origin and harvest increases, and that more rapid die-off occurs during
the months immediately following application (e.g., three to four
months) as compared to subsequent months (followed by prolonged
survival of pathogens at low levels), we believe adherence to the NOP
standard to be a prudent step toward minimizing the likelihood of
contamination while the above described risk assessment and research
program is ongoing. At this time, we do not intend to take exception to
the continuation of this practice in the interim period.
    (Comment 259) One comment recommends only stabilized compost that
has not been subjected to cross-contamination and re-growth of
pathogens be allowed for use on agricultural lands designated for
production of ready-to-eat foods.
    (Response) FDA agrees that stabilized compost (or any treated
biological soil amendment of animal origin) must be handled, conveyed,
and stored in a manner and location that minimizes the risk of it
becoming contaminated by an untreated or in-process biological soil
amendment of animal origin (Sec.  112.52(b)) and that it should be
considered untreated if it has become contaminated (Sec.  112.52(c)).
However, we do not agree that only stabilized compost should be allowed
to be used during the growing of covered produce (or more broadly as
suggested by the comment). As described in Comment 277 there are
several different types of biological soil amendments of animal origin
that are appropriate for use on land used to grow covered produce, and
this rule does not restrict use of other types of soil amendments not
subject to subpart F (such as chemical and physical soil amendments and
biological soil amendments that are not of animal origin). All such
soil amendments may be used in the growing of covered produce, provided
that all biological soil amendments of animal origin and human waste
are used in accordance with the requirements in subpart F.
    (Comment 260) A commenter requests only mammalian and avian species
be included in the definition of ``biological soil amendments of animal
origin'' and

therefore subject to the requirements of subpart F.
    (Response) Animals other than mammalian and avian species, such as
fish, amphibians, and reptiles, are known to carry human pathogens
(e.g., Salmonella) (Ref. 165) (Ref. 166) (Ref. 167) and fecal
contamination by such animals is a concern. The comment did not provide
information to support the request that only certain species be
covered. FDA concludes that the risks posed by biological soil
amendments from all animal sources should be addressed through
inclusion in the term ``biological soil amendments of animal origin''
and resulting requirements under subpart F of this rule.
    (Comment 261) Some comments state that food safety on a farm is
related to the microbial soil ecology, and that biological diversity
adds to soil health and protects the environment, while ``sterile''
soils lack this healthy fertility. Some comments also suggest healthy
soils are essential to food safety, can boost the nutrient content of
food, and contribute to long-term food security by ensuring land is
viable for diverse, long-term production systems. Comments request that
we explore ways to enhance the safety of covered produce while
promoting biological diversity in soil ecology.
    (Response) FDA agrees that soil health, environmental stewardship,
and reducing the risk of food becoming contaminated with pathogens are
all important and are not mutually exclusive. We intend to work with
stakeholders to address co-management of produce safety and the
environment.
    (Comment 262) Comments focusing on environmental concerns
associated with chemical fertilizer use requested that FDA revise the
proposed produce safety rule to remove any incentives it may create for
using chemical fertilizers as a replacement for biological soil
amendments of animal origin.
    (Response) As discussed in the 2013 proposed rule (78 FR 3504 at
3576), animal waste is likely to contain human pathogens. Material that
does not contain any animal waste is far less likely to harbor these
food safety hazards at microbial populations that can reasonably be
expected to lead to severe adverse health consequences or death, and we
are still not aware of any situation in which chemical or physical soil
amendments, such as elemental fertilizers, soil stabilizers, or others
typically made of mined or synthetic materials, have served as sources
of microbial contamination. Therefore, neither chemical nor physical
soil amendments are a focus of this rule. Instead, we focus on
biological soil amendments of animal origin and human waste, which
present a reasonable likelihood of harboring human enteric pathogens.
We do not believe our focus on biological soil amendments of animal
origin incentivizes the use of chemical fertilizers. However, we did
consider the effect of farms switching to chemical fertilizers in the
EIS and concluded that a switch away from biological soil amendments of
animal origin to chemical fertilizers could cause moderate adverse
environmental impacts to soils, but not to a significant level because
such effects are reversible and may be mitigated through other
practices that are growing in popularity such as green manuring, no-
till practices, and use of cover crops. FDA expects that the cumulative
effects nationwide related to soil health and biological soil
amendments of animal origin will not be significant. See discussion in
Chapter 5.5 of the EIS (Ref. 126).
    (Comment 263) One comment suggested that biological soil amendments
that do not contain animal waste, such as yard trimmings from a
municipal source, residential, or public properties, have the potential
to be contaminated with domestic and wild animal feces and pose a risk
to public health. The commenter therefore suggests FDA include
requirements for complete composting before allowing use of any ``green
waste'' (meaning biological soil amendments not of animal origin).
Another comment noted a study (Ref. 168) that concluded the presence or
absence of manure is not a suitable predictor of the pathogen load of a
stabilized compost, suggesting that ``green waste'' should not be
treated as less risky than biological soil amendments of animal origin.
Conversely, other comments agreed with FDA's tentative conclusion that
biological soil amendments that do not contain animal or human waste
products are low-risk products, suggesting that the tentative
conclusion to exclude biological soil amendments not of animal origin
from the requirements of the rule is sensible. These commenters
believed that restrictions on the use of biological soil amendments
that are not of animal origin, as defined in this subpart, would be
unnecessary due to an extremely low likelihood of contamination from
these soil amendments.
    (Response) FDA appreciates the comments indicating that there is
some risk associated with biological soil amendments not of animal
origin (or ``green waste''). First, we note that the definitions of
``yard trimmings'' and ``pre-consumer vegetative waste'' in Sec.
112.3(c) stipulates that these are purely vegetative materials. To the
extent that vegetative waste is known to include animal feces, it would
not meet the definitions of ``yard trimmings'' or ``pre-consumer
vegetative waste,'' and a soil amendment made from such material would
instead be a biological soil amendment of animal origin included in the
scope of the provisions of subpart F. However, we recognize that even
in purely vegetative material such as that described in the definition
of ``yard trimmings'' or ``pre-consumer vegetative waste,'' there is
the potential for unknown and unavoidable contamination with animal
waste. We have concluded that the likelihood of contaminating produce
with pathogens by use of biological soil amendments that are not known
to contain, and not likely to contain significant animal waste or human
waste (e.g., yard trimmings, pre-consumer vegetative waste) is low, and
therefore they are not subject to the requirements of this rule.
    With regard to the comment that highlighted a paper on the presence
of pathogens of public health concern in purely vegetative material, we
agree that no biological soil amendment is without risk. However, we
conclude that the relative risks are greatest with untreated biological
soil amendments of animal origin due to the highly likely presence of
human pathogens in such materials, and that is where we are choosing to
focus our regulatory efforts. We note that there is currently not a
great deal of research on pathogen presence in biological soil
amendments not containing animal material. We will continue to follow
the science pertaining to this issue and will consider appropriate next
steps should there be additional evidence that this is an area of
public health concern.
    Finally, we note that Sec.  112.52(a) requires that a biological
soil amendment of animal origin be handled, conveyed, and stored in a
manner and location such that it does not become a potential source of
contamination to covered produce, food-contact surfaces, areas used for
a covered activity, water sources, and water distribution systems. We
are revising this provision to include a requirement that biological
soil amendments be handled, conveyed and stored such that they do not
contaminate other soil amendments. In addition, if you know that a soil
amendment that had originally not contained animal material has been in
contact with, or otherwise contaminated by, a biological soil amendment
of animal origin, you should consider the

possibility that, depending on the circumstances, the soil amendment
may meet the definition of a biological soil amendment of animal origin
and therefore be subject to the requirements of subpart F.
    (Comment 264) Some comments suggest that the provisions in subpart
F would disallow farmers from utilizing manure produced on their own
farms as part of a ``closed-loop'' or ``zero-input'' sustainability
program, or that farms would be disallowed from having compost curing
and storage on site.
    (Response) The provisions of subpart F do not prohibit farms from
using manure produced on the farm, including manure produced as part of
a sustainability program, nor does it prohibit farms from curing or
storing compost on site. Covered farms must conduct relevant activities
in accordance with the provisions of subpart F.
    (Comment 265) One comment requests clarification on whether ``table
waste'' would be an example of a biological soil amendment of animal
origin. In addition, other comments request clarification on what is
included in the category ``table waste,'' and express concern that this
may also include food preparation waste such as raw meat. Some comments
state stabilized compost derived from ``table waste'' or ``post-
consumer food waste,'' and stabilized compost derived from manure
represent different types and levels of risk and should be examined
separately.
    (Response) FDA proposed to define, and is now finalizing its
definition of ``table waste'' as ``any post-consumer food waste,
irrespective of whether the source material is animal or vegetative in
origin, derived from individuals, institutions, restaurants, retail
operations, or other sources where the food has been served to a
consumer'' (Sec.  112.3(c)). Table waste is explicitly included within
the definition of ``biological soil amendment of animal origin'' in
Sec.  112.3(c), making it subject to the requirements in subpart F of
this rule. As discussed in the 2013 proposed rule (78 FR 3504 at 3548-
9), the definition of ``table waste'' is intended to distinguish post-
consumer food waste from pre-consumer vegetative waste. Also as
discussed in the 2013 proposed rule (78 FR 3504 at 3574), post-consumer
food waste, or table waste (such as plate scrapings), has a greater
likelihood of being contaminated, or being contaminated at higher
populations, with human pathogens of public health significance due to
its unknown content (e.g., animal products, vegetable products, etc.)
and its greater likelihood of containing human fluids or waste (e.g.,
spittle, vomitus, etc.). On the other hand, food preparation waste that
is solely of plant origin may be considered ``pre-consumer vegetative
waste'' (and therefore not subject to the requirements in subpart F) if
it meets the terms of that definition (Sec.  112.3(c)). Notably, we are
defining ``pre-consumer vegetative waste'' in part to require that
these materials may not have come in contact with animal products,
byproducts or manure or with an end-user (consumer). We are also
excluding table waste, packaging that has come in contact with
materials (such as meat) that are not vegetative in origin, and any
waste generated by restaurants. Any material of animal origin (such as
meat) that is added to a soil amendment, regardless of whether it has
been served to or come in contact with a consumer, renders that soil
amendment a biological soil amendment of animal origin subject to the
requirements of subpart F. We acknowledge that a variety of feedstocks
may be used to produce treated biological soil amendments of animal
origin, including stabilized compost, and that feedstocks differ with
respect to their inherent risk. Therefore, in subpart F we chose to
establish requirements for the end product of treatment (i.e., the
stabilized compost) rather than the feedstock. If a feedstock is
treated to meet the standards of Sec. Sec.  112.54 and 112.55, we
conclude that the end product may be used in accordance with
requirements for treated biological soil amendments of animal origin
rather than untreated biological soil amendments of animal origin in
Sec.  112.56. We note that, depending on the level of treatment
received, the end products present differing levels of risk reflected
in the different application requirements established in Sec.  112.56.
    (Comment 266) One comment requests FDA not subject manure from
grass-fed animals to the requirements of subpart F. The comment states
manure from grass-fed animals does not contain harmful levels of E.
coli and other noxious bacteria.
    (Response) FDA is not providing an exemption from subpart F for
manure from grass-fed animals used as a soil amendment. We are not
aware of evidence to support the assertion made by the commenter and
the comment did not provide any such data or other information.
    (Comment 267) Some comments recommend FDA specifically exempt tree
nuts from the biological soil amendment requirements in the rule. These
comments state that certain types of tree nuts never touch the ground
and most tree nut farms use non-biological soil amendments.
    (Response) If a covered farm does not use biological soil
amendments of animal origin, then the provisions of subpart F are not
applicable to that covered farm. In addition, the requirements we are
establishing in Sec.  112.56 allow use of both treated and untreated
biological soil amendments of animal origin in situations where there
is no contact between the covered produce and the soil amendment. Thus,
we do not believe it is necessary or appropriate to exempt tree nuts
from this subpart, as suggested by the comment.
    (Comment 268) Some comments stated that raw manure is preferable to
stabilized compost because raw manure has greater nitrogen content.
These comments indicated that farms that switch from raw manure to
stabilized compost will need to use additional stabilized compost to
make up the loss in nitrogen content. These comments expressed concern
that such changes would interfere with nutrient management programs and
increase nutrient runoff into waterways.
    (Response) As we noted in the supplemental notice, we recognize
that some loss of nitrogen during the composting process is likely
(Ref. 169) and that adjustments to fertility management will be
necessary when shifting to use of stabilized compost. However, we
continue to believe that use of stabilized compost is preferable to use
of raw manure for growing covered produce because of the higher
likelihood of pathogens associated with raw manure. With regard to
concerns about nutrient management programs and runoff, we note that
stabilized compost has stabilized forms of nitrogen, which are less
susceptible to leaching or runoff than unstabilized forms (Ref. 170)
(Ref. 171). At the same time, stabilized compost also retains many
other key values of raw manure, including serving as a supply of carbon
to support diverse and abundant soil microbial communities, which serve
important functions in nutrient cycling, conditioning of soil physical
and chemical properties, and in some cases crop protection from
phytopathogenic diseases (Ref. 171) (Ref. 172) (Ref. 173). Concerns
about runoff from biological soil amendments of animal origin are also
addressed in the final EIS (Ref. 126).
    (Comment 269) One comment points out that the ability to safely and
responsibly handle waste from animal livestock production and
processing, primarily swine and poultry operations, is critical to the
agricultural economy.

The comment further states swine and poultry waste is applied primarily
to crops such as corn or soybeans, or in forestry plantations.
    (Response) Nothing in this rule prevents the use of waste from
animal livestock production and processing as biological soil
amendments of animal origin, provided that the amendments are produced
and used in accordance with the relevant provisions of subpart F. We
also note that dent- or flint-corn and soybeans are excluded from the
definition of ``produce'' in this rule because they are grains (Sec.
112.3(c)) and are therefore not subject to this rule. Sweet corn is
exempt from the rule because it is on the list of produce that FDA has
determined is ``rarely consumed raw'' in Sec.  112.2(a)(1). Further,
lumber is also not ``produce'' for purposes of this rule and forestry
plantations producing lumber are therefore not subject to this rule.
1. Use of Agricultural Teas
    (Comment 270) Many comments recommend agricultural teas should be
regulated using the same standards as stabilized compost. Specifically,
some comments suggest that agricultural tea used as a soil amendment in
direct soil application with covered produce poses a significant risk,
and that such teas are often produced on-farm, with little emphasis on
minimizing the presence of pathogens. Several other comments discuss
agricultural tea as having unique food safety risks and request that
FDA address agricultural teas separately within Sec.  112.56. These
comments ask FDA to establish reasonable, scientifically based minimum
application intervals for use of agricultural teas as soil amendments
and to require that they be applied in a manner that has minimal
potential for contact with covered produce during and after
application. On the other hand, some comments argue that agricultural
teas prepared from stabilized compost in accordance with NOP standards
do not carry any food safety risks and therefore should have no
application interval requirements. One such comment provides two
literature citations to argue that pathogens such as E. coli and
Salmonella, are poor at surviving on plants and are quickly overrun by
normal, plant colonizing bacteria. The comment argues that more
significant risks are posed by anaerobically prepared manure or non-NOP
compliant agricultural teas, which the comment argues should be banned
from use as soil amendments.
    (Response) FDA agrees that agricultural teas that are biological
soil amendments of animal origin (see Comment 271) should be regulated
similarly to other biological soil amendments of animal origin, with
appropriate attention given to their unique qualities, and we believe
we have done so in this rule. Under Sec.  112.51, the components of an
agricultural tea (of animal origin) must be processed to the same
standards as other biological soil amendments of animal origin to be
classified as a treated biological soil amendment of animal origin,
with the addition of specific requirements for the quality of the water
used to produce the tea (see Sec. Sec.  112.51(a) and (b)(1)) and the
heightened risk presented by the use of agricultural tea additives (see
Sec.  112.51(b)(5)). We consider that, in connection with the
provisions of Sec.  112.51 just described, the treatment processes
described in Sec.  112.54 and the microbial standards of Sec.  112.55
are adequate for all biological soil amendments of animal origin,
including agricultural teas (of animal origin), and it is not necessary
to also include a separate section in Sec.  112.56 regarding
agricultural teas (of animal origin). We have addressed the unique
risks of agricultural teas (of animal origin) by limiting in Sec.
112.51 the circumstances under which they may be considered
``treated.'' Thus, agricultural teas (of animal origin) made with
untreated surface water, or water that has detectable generic E. coli
in 100 mL of water; and agricultural teas (of animal origin) that
contain agricultural tea additives are considered ``untreated'' and
must be applied in accordance with Sec.  112.56(1)(i) or (ii). In
addition, like all other biological soil amendments of animal origin,
agricultural teas (of animal origin) must be considered untreated and
applied in accordance with Sec.  112.56(1)(i) or (ii) if they fall
within any of the categories in Sec.  112.51(b) (for example, if the
biological materials of animal origin used to make the tea are not
processed to completion in accordance with the requirements of Sec.
112.54, or if they have been contaminated after treatment).
    The comment asserting the safety of agricultural teas produced from
stabilized compost following NOP standards did not provide data or
information supporting that assertion. However, we note that under
Sec. Sec.  112.56(a)(2) or (a)(3), biological soil amendments of animal
origin that are agricultural teas prepared from properly handled
stabilized compost (i.e., biological materials of animal origin are
processed to completion in accordance with Sec.  112.54 to meet
relevant microbial standards in Sec.  112.55; made with water
satisfying the requirements of Sec.  112.51(a); and not otherwise
considered ``untreated'' under Sec.  112.51(b)) have an application
interval of zero days, and application method restrictions that vary
based only on the level of treatment provided by the processing. Under
Sec.  112.56(a)(1), other biological soil amendments of animal origin
that are agricultural teas and that are considered ``untreated'' under
Sec.  112.51(b) must be applied in a manner that does not contact
covered produce at application and minimizes potential for contact
after application, or in a manner that does not contact covered produce
during or after application. See Comment 257 regarding our plans
relating to a minimum application interval for untreated biological
soil amendments of animal origin applied in a manner that contacts
covered produce.
    With regard to the comment about anaerobic preparation, FDA does
not consider that there is enough evidence in the literature to link
the method of agricultural tea production (actively aerated or
anaerobic brewing) to a difference in E. coli risk. Most enteric
bacterial pathogens (such as E. coli and Salmonella spp.) are
classified as facultative anaerobic organisms; these organisms will
grow faster and out-compete other organisms at a faster rate in an
aerobic environment, as compared to an anaerobic environment, provided
the same amount of nutrients and conditions for growth are present in
both environments. It is a common misperception that these pathogens
thrive better in an anaerobic environment than in an aerobic one (Ref.
174). The scientific literature points to agricultural tea additives,
and not brewing method, as the main factor associated with human
pathogen growth in agricultural teas (Ref. 174).
    (Comment 271) Several comments state that agricultural teas are not
typically considered to be agricultural water; are applied
sporadically, sometimes very close to harvest; and are used in
conjunction with plants, other microbes, nutrients, and the soil to
suppress disease, improve soil structure, maintain nutrients, and
increase water holding capacity. These comments recommend that FDA
clarify that the water used to make agricultural tea, or the resulting
agricultural tea, does not need to meet the requirements for
``agricultural water'' in subpart E.
    (Response) In Sec.  112.3(c) of this rule, we are revising the
definition of ``agricultural tea'' to include an explicit statement
that ``[a]gricultural teas are soil amendments for purposes of this
rule.'' We recognize that agricultural

teas may be applied in some cases for purposes in addition to those
specified in our definition of ``soil amendment,'' that is, ``to
improve the chemical or physical condition of the soil in relation to
plant growth or to improve the capacity of the soil to hold water.''
However, we understand that even when such additional purposes exist,
agricultural teas are generally used for the purposes described in the
definition of ``soil amendment'' in this rule. In addition, we believe
that the appropriate requirements to apply to agricultural teas made
with materials of animal origin are those we have established in
subpart F of this rule for biological soil amendments of animal origin,
and not the requirements in subpart E that apply to agricultural water.
We are removing the reference to agricultural tea in subpart E of this
rule, in proposed Sec.  112.44(a)(3), because it was confusing. Water
used to make an agricultural tea must not be untreated surface water,
and must meet the same microbial criteria as that set forth in Sec.
112.44(a) for the resulting agricultural tea to be considered
``treated'' under Sec.  112.51 in subpart F. Whether a biological soil
amendment of animal origin is ``treated'' or ``untreated'' under Sec.
112.51 affects the application restrictions that apply to its use in
Sec.  112.56. However, we do not intend to require that agricultural
teas, or the water used to make them, meet other requirements in
subpart E for agricultural water. Thus, we are deleting the reference
to agricultural teas in subpart E, making the revision discussed
previously to the definition of ``agricultural tea,'' and revising to
Sec.  112.51(a) and (b)(1) to clarify this. As revised, Sec.  112.51(a)
provides that ``a biological soil amendment of animal origin is treated
if it has been processed to completion to adequately reduce
microorganisms of public health significance in accordance with the
requirements of Sec.  112.54, or, in the case of an agricultural tea,
the biological materials of animal origin used to make the tea have
been so processed, the water used to make the tea is not untreated
surface water, and the water used to make the tea has no detectable
generic Escherichia coli (E. coli) in 100 milliliters (mL) of water.''
As revised, Sec.  112.51(b)(1) provides that ``a biological soil
amendment of animal origin is untreated if it has not been processed to
completion in accordance with the requirements of Sec.  112.54, or in
the case of an agricultural tea, the biological materials of animal
origin used to make the tea have not been so processed, or the water
used to make the tea is untreated surface water, or the water used to
make the tea has detectable generic Escherichia coli (E. coli) in 100
milliliters (mL) of water.''
    We also note that to the extent agricultural teas are being used as
pesticides, FIFRA provides for federal regulation of their
distribution, sale, and use. All pesticides distributed or sold in the
United States must be registered (licensed) by EPA. The term
``pesticide chemical'' is also defined in section 201(q) of the FD&C
Act. Food bearing or containing a pesticide chemical residue is
adulterated under 402(a)(2)(B) unless a tolerance is in effect and the
quantity of the residue is within the limits of the tolerance, or an
exemption from the requirement of a tolerance is in effect (see section
408(a) of the FD&C Act). EPA has established tolerances, and exemptions
from the requirement of a tolerance, in 40 CFR part 180, subparts C and
D, respectively. For more information, see http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide#laws and http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-11-tolerance-petitions (Ref. 127) (Ref. 174a)
    (Comment 272) One comment states that the 2013 proposed rule does
not distinguish between ``compost extracts'' and ``compost teas.''
Compost extracts as described by the commenter are simply water
infusions of compost, without any ``compost tea additive'' (what we
have termed ``agricultural tea additive''). The comment states that
compost extracts without ``compost tea additives'' should have no
greater restrictions than the compost that was used to make the tea.
    (Response) As discussed in response to Comment 270, this rule
regulates agricultural teas that are biological soil amendments of
animal origin similarly to other biological soil amendments of animal
origin, with appropriate attention given to their unique qualities,
including whether they contain agricultural tea additives as we have
defined that term in Sec.  112.3(c). Further, this rule does
distinguish between agricultural teas, as we have defined that term in
Sec.  112.3(c), and other extracts. FDA defines ``agricultural tea'' to
mean ``a water extract of biological materials (such as stabilized
compost, manure, non-fecal animal byproducts, peat moss, pre-consumer
vegetative waste, table waste, or yard trimmings), excluding any form
of human waste, produced to transfer microbial biomass, fine
particulate organic matter, and soluble chemical components into an
aqueous phase. Agricultural teas are held for longer than one hour
before application. Agricultural teas are soil amendments for purposes
of this rule.'' An agricultural tea (of animal origin) must be used in
accordance with the provisions of Sec.  112.56 in accordance with its
status as a `treated' or `untreated' biological soil amendment of
animal origin. In response to Comment 270, we describe how those
requirements differ for agricultural teas that are biological soil
amendments of animal origin as compared to other biological soil
amendments of animal origin. A water extract of biological materials of
animal origin that is not an agricultural tea (such as extracts that
are held (i.e., ``steeped'') for less than one hour before application)
may still be a biological soil amendment of animal origin if it fits
that definition, in which case it is subject to the requirements for
biological soil amendments of animal origin in subpart F.
    (Comment 273) One comment argues that the rule places restrictions
on agricultural teas made from biological materials not of animal
origin that are not reasonable, given the proposed exclusion of other
biological soil amendments of non-animal origin from the coverage of
subpart F.
    (Response) We based our proposed definition of ``agricultural tea''
in part on a similar definition of ``compost tea'' used by the NOSB (78
FR 3545). We did not limit this definition to teas made from biological
materials of animal origin because we intended to describe the wide
range of agricultural teas used in the production of produce in this
definition. However, we agree that, consistent with the scope of this
rulemaking, agricultural teas made entirely from vegetative material
are excluded from the requirements of subpart F that apply to
biological soil amendments of animal origin. This is achieved not
through the scope of the definition of ``agricultural tea,'' but by the
fact that the requirements in subpart F refer in all relevant locations
to biological soil amendments of animal origin, thus requiring that
there be some component of animal origin in the biological soil
amendment feedstock (or, in the case of Sec.  112.53, human waste). To
improve clarity, we are amending the three appearances of the term
``agricultural tea'' in Sec.  112.51 to specify that the biological
materials used to make the tea include materials of animal origin.

B. Determining the Status of a Biological Soil Amendment of Animal
Origin (Sec.  112.51)

    In proposed Sec.  112.51, we proposed to establish requirements for
determining

the status of a biological soil amendment of animal origin as being
treated or untreated, for use in covered activities. In Table 14, we
describe the codified provisions of Sec.  112.51 and any changes we
made to those provisions in the final rule. Comments specific to Sec.
112.51 follow the table.

           Table 14--Description of Revisions to Sec.   112.51
------------------------------------------------------------------------
                                                     Final revisions, if
     Proposed provision         Proposed language            any
------------------------------------------------------------------------
Sec.   112.51(a)............  A biological soil     Revised to clarify
                               amendment of animal   that agricultural
                               origin is treated     teas covered are
                               if it has been        those for which the
                               processed to          biological
                               completion to         materials include
                               adequately reduce     materials of animal
                               microorganisms of     origin, and to
                               public health         replace reference
                               significance in       to Sec.   112.44(a)
                               accordance with the   with clarifying
                               requirements of       text.
                               Sec.   112.54, or
                               in the case of an
                               agricultural tea,
                               the biological
                               materials used to
                               make the tea have
                               been so processed
                               and the water used
                               to make the tea
                               satisfies the
                               requirements of
                               Sec.   112.44(a).
Sec.   112.51(b)(1).........  A biological soil     Revised to clarify
                               amendment of animal   that agricultural
                               origin is untreated   teas covered are
                               if: (1) It has not    those for which the
                               been processed to     biological
                               completion in         materials include
                               accordance with the   materials of animal
                               requirements of       origin, and to
                               Sec.   112.54, or     replace reference
                               in the case of an     to Sec.   112.44(a)
                               agricultural tea,     with clarifying
                               the biological        text.
                               materials used to
                               make the tea have
                               not been so
                               processed or the
                               water used to make
                               the tea does not
                               satisfy the
                               requirements of
                               Sec.   112.44(a).
Sec.   112.51(b)(2).........  A biological soil     No change.
                               amendment of animal
                               origin is untreated
                               if: (2) It has
                               become contaminated
                               after treatment.
Sec.   112.51(b)(3).........  A biological soil     No change.
                               amendment of animal
                               origin is untreated
                               if: (3) It has been
                               recombined with an
                               untreated
                               biological soil
                               amendment of animal
                               origin.
Sec.   112.51(b)(4).........  A biological soil     No change.
                               amendment of animal
                               origin is untreated
                               if: (4) It is or
                               contains a
                               component that is
                               untreated waste
                               that you know or
                               have reason to
                               believe is
                               contaminated with a
                               hazard or has been
                               associated with
                               foodborne illness.
Sec.   112.51(b)(5).........  A biological soil     Revised to clarify
                               amendment of animal   that agricultural
                               origin is untreated   teas covered are
                               if: (5) It is an      those for which the
                               agricultural tea      biological
                               that contains an      materials include
                               agricultural tea      materials of animal
                               additive.             origin.
------------------------------------------------------------------------

    (Comment 274) A comment recommends that FDA make a distinction
between raw animal manures and other animal-based fertilizers such as
bone, feather, and blood meal, which are commercially processed.
    (Response) FDA's approach does distinguish between ``treated'' and
``untreated'' biological soil amendments of animal origin. The
distinction is established in Sec.  112.51 and is made based upon the
components, processing, handling, and other information about the soil
amendment, and not the particular type of animal component that was the
feedstock (starting material). Application restrictions for treated and
untreated biological soil amendments of animal origin are described in
Sec.  112.56.
    (Comment 275) One comment generally agrees with our regulatory
descriptions in Sec.  112.51(b) of biological soil amendments of animal
origin that are untreated, but asked us to modify Sec.  112.51(b)(4) so
that if any discrete component of a soil amendment is untreated, the
entirety is considered untreated. The comment argues that whether any
untreated component part renders the entirety ``untreated'' should not
depend on whether the farm knows or has reason to believe that the
untreated component is contaminated.
    (Response) FDA agrees that if any discrete component of a soil
amendment is untreated, the entirety is considered untreated. However,
such situations are addressed in Sec.  112.51(b)(1) (not processed to
completion), (b)(2) (contaminated after treatment), and (b)(3)
(recombined with an untreated biological soil amendment of animal
origin). The comment misunderstands Sec.  112.51(b)(4), which refers to
a situation in which, for example, you find out that your feedstock (or
a portion of it) was contaminated with a pathogen, or associated with
foodborne illness. In such cases, FDA concludes that you should be
required to consider the biological soil amendment to be untreated for
purposes of subpart F, including the application restrictions in Sec.
112.56. If there is reason to think that materials used in a biological
soil amendment of animal origin are actually contaminated or associated
with foodborne illness, there is a need to apply the most stringent
controls to such materials, even if they have undergone a treatment
process meeting the requirements of Sec. Sec.  112.54 and 112.55.
    (Comment 276) One comment disagrees with FDA's decision to treat
agricultural teas (of animal origin) that contain additives as
``untreated'' because FDA cited only one study by Ingram and Millner
(Ref. 174). This comment cites a reference (Ref. 175) which, according
to the commenter, showed that while the addition of molasses as an
agricultural tea additive at 1 percent enhanced growth of Salmonella
and E. coli O157:H7 in an agricultural tea, the addition of 0.2 percent
molasses did not. Further, the comment argues that the addition of
carrot juice as an agricultural tea additive was shown to inhibit the
growth of nonpathogenic E. coli in swine manure compost extract (Ref.
176). This comment contends that FDA should focus on factors other than
the addition of additives to determine requirements for agricultural
teas.
    (Response) FDA recognizes that many agricultural tea production
practices include the addition of nutrient additives (such as molasses)
during the steeping process, a practice designed to rapidly increase
the indigenous heterotrophic microbiological populations extracted from
the biological feedstock. The two studies mentioned in the comment do,
however, provide scientific evidence to support FDA's conclusion that
even when stabilized compost or other biological

materials of animal origin used as feedstock for an agricultural tea
meet the microbial standards of Sec.  112.55(a) or the microbial
standard of Sec.  112.55(b), when an agricultural tea additive is used,
it can result in a final product that contains human pathogens capable
of causing serious adverse health consequences or death (Ref. 174)
(Ref. 175) if used as a soil amendment in growing covered produce
without restriction. In these same studies, when agricultural teas were
produced using the same compost feedstocks without the addition of
agricultural tea additives, pathogens were undetectable in the final
product.
    The scientific body of evidence is inconclusive as to what
component or components (e.g., soluble carbon content) in agricultural
tea additives may be contributing to the propagation of human pathogens
during the production of agricultural teas, so it is difficult for FDA
to ascertain the significance between 0.2 percent (vol:vol) molasses
that did not support growth in the Duffy et al. 2004 study and 0.5
percent (vol:vol) of Soil Soup Additive (contains molasses) in the
Ingram study that supported pathogen growth. It should be noted that
Kannangara (2006) noticed a population increase in generic E. coli
during aerated agricultural tea production amended with only 0.01
percent molasses, but did document a reduction (but not elimination) of
generic E. coli in response to the addition of carrot juice extract
used as an agricultural tea additive. We continue to believe the
preponderance of evidence supports the conclusion that the use of an
agricultural tea additive will increase the likelihood of pathogen
growth in an agricultural tea (of animal origin). However, FDA supports
innovation and encourages development and scientific evaluation of
agricultural tea additives that can reliably suppress the growth of, or
eliminate, foodborne pathogens in agricultural tea. Should consistently
safe production and use of agricultural tea additives become
established, we will consider appropriate next steps, including
possibly revisiting these requirements.
    (Comment 277) Several comments disagree with the proposed
distinctions related to treated and untreated biological soil
amendments. These commenters believe that, as proposed, various types
of biological soil amendments of animal origin (such as static compost,
vermicompost, compost teas with additives such as molasses or sea kelp,
and compost that is produced outside of the proposed time and
temperature requirements) would be treated as raw manure even though,
in the view of these commenters, such biological soil amendments may
not pose the same risks as raw manure.
    (Response) We disagree that our requirements would result in all
the listed biological soil amendments of animal origin being subject to
the same requirements as raw manure. Section 112.51 distinguishes
between `treated' and `untreated' biological soil amendments of animal
origin, and Sec.  112.56 describes the application restrictions that
apply to biological soil amendments of animal origin depending on
whether they are treated or untreated (and if treated, depending on
which level of treatment they received). The provisions of Sec.  112.51
refer to the treatment processes of Sec.  112.54, which in turn refers
to the microbial standard provisions of Sec.  112.55. We have revised
the text throughout Sec.  112.54 to refer to ``biological
process[es],'' and we use ``composting'' as an example of a biological
process. Thus, under the revised options for treatment processes in
Sec.  112.54, this rule classifies the end products of any
scientifically valid controlled biological processes that have been
validated to satisfy the microbial standard in Sec.  112.55(a) or (b)
as ``treated'' biological soil amendments of animal origin (provided
there is no other reason to consider them untreated under Sec.
112.51(b), such as contamination after treatment). Therefore,
stabilized compost produced by static composting processes, end
products of vermicomposting processes, or stabilized compost produced