systems, or earthen diversion berms, ditches, or other barriers to help
minimize the influence of runoff on sources and distribution systems.
Information on adjacent or nearby land uses could be acquired through
visual observations, discussions with local extension agents or
associations, online resources such as mapping tools, or other means
that are appropriate to the circumstances.
    The factors a covered farm might consider in evaluating the
likelihood of hazards being introduced from adjacent or nearby lands
may depend on the specific animal activity in question. For example, if
a covered farm draws water from a stream with upstream grazing and
pasturing of animals, the covered farm might consider the proximity of
the grazing and pasture areas to the stream, whether the animals have
direct access to the stream for loafing and drinking, and whether
runoff from the grazed and pastured lands is likely to be introduced
into the stream.
    While a covered farm might consider similar factors to these if it
draws water from a canal with an upstream dairy operation, there may be
additional factors to consider when evaluating the likelihood of
introduction of hazards, such as whether the operation has any best
management practices in place (such as to prevent overflow of manure
lagoons), the locations of waste storage

or composting operations relative to the canal, and animal and traffic
patterns throughout the dairy that have the potential to spread
contaminants.
    We recognize that farms may face uncertainty around evaluating
factors like these where they are unable to obtain the relevant
information, such as if adjacent or nearby land users are not willing
to share information. Due to the nature of the risks associated with
animal activity, in these instances, farms should consider accounting
for the increased likelihood of hazard introduction to the water
systems from adjacent or nearby lands when making decisions around the
safe use of their water.
    d. Endangered Species Act. Section 112.84 of the produce safety
regulation clarifies that the regulation does not authorize or require
covered farms to take actions that would constitute the ``taking'' of
threatened or endangered species in violation of the Endangered Species
Act (16 U.S.C. 1531-1544), or require covered farms to take measures to
exclude animals from outdoor growing areas, or destroy animal habitat
or otherwise clear farm borders around outdoor growing areas or
drainages.
    We note that nothing in proposed subpart E would require covered
farms to take measures to exclude animals from covered farms or from
adjacent or nearby lands, or to destroy animal habitat or otherwise
clear farm borders.
    e. BSAAOs. Proposed Sec.  112.43(a)(1) also would require covered
farms to evaluate the presence of BSAAOs on adjacent and nearby lands
that may introduce known or reasonably foreseeable hazards into sources
and distribution systems for pre-harvest agricultural water for non-
sprout covered produce, such as through runoff.
    Section 112.3 of the produce safety regulation defines BSAAO to
mean ``any biological soil amendment which consists, in whole or in
part, of materials of animal origin, such as manure or non-fecal animal
byproducts including animal mortalities, or table waste, alone or in
combination. The term biological soil amendment of animal origin does
not include any form of human waste.''
    The QAR (Ref. 11) concluded that biological soil amendments can
transmit human pathogens to surface water or ground water when
stockpiled or applied to fields. Composting is less likely than
controlled chemical or physical treatments to fully eliminate human
pathogens from animal waste. Incompletely treated, or re-contaminated,
BSAAOs may contain human pathogens. (See also 80 FR 74534 at 74461-
74478.)
    Soil amendments have been identified as possible sources of
pathogens in produce outbreak investigations (Ref. 11). For example,
investigators identified soil amendments on adjacent lands as a
possible source of contamination in the 2018 romaine lettuce outbreak
in which the outbreak strain of E. coli O157:H7 was introduced into the
on-farm water reservoir (Ref. 15).
    In evaluating whether the application of BSAAOs on adjacent and
nearby lands may introduce contamination into sources or distribution
systems for pre-harvest agricultural water for non-sprout covered
produce, a covered farm would consider whether the BSAAO is treated or
applied to the land in accordance with the produce safety regulation
(such as where adjacent or nearby lands are covered farms subject to
the produce safety regulation) or any other Federal, State, or
international regulations, recommendations, or guidelines for soil
amendments. Covered farms would consider whether any BSAAOs on adjacent
and nearby lands are handled, conveyed, and stored in a manner and
location so that they do not become a potential source of contamination
to water sources and water distribution systems for pre-harvest
agricultural water for non-sprout covered produce (proposed Sec.
112.43(a)(1)).
    Factors to consider when evaluating the likelihood of potential
hazards being introduced into a water system include, for example: (1)
The distance between the fields and the water source; (2) the measures,
if any, an upstream farm uses to control runoff; (3) whether the BSAAOs
are treated and to what extent; (4) how BSAAOs are handled, conveyed,
and stored on the land; and (5) whether runoff is likely to occur. In
the event of uncertainty about use of BSAAO on adjacent and nearby
lands, such as where the upstream farm does not provide information,
farms should consider accounting for the increased likelihood of hazard
introduction to the water systems from such BSAAO uses when making
decisions around the safe use of their pre-harvest agricultural water.
    f. Untreated or improperly treated human waste. Proposed Sec.
112.43(a)(1) also would require covered farms to consider adjacent and
nearby land uses related to untreated or improperly treated human
waste.
    As described in the QAR (Ref. 11), human waste may contain
pathogens in relatively high concentrations. Runoff associated with
human waste from adjacent and nearby lands may contaminate sources or
distribution systems for pre-harvest agricultural water for non-sprout
covered produce--such as where untreated or improperly treated human
waste is applied as a soil amendment or where human waste systems are
not properly constructed and maintained. Covered farms also should
consider whether any portable toilet facilities on adjacent and nearby
lands are appropriately located away from water sources and
distribution systems in the event of malfunctioning, flooding, or high
winds. Fixed human waste systems also may introduce contamination to
water sources or water distribution systems. For example, investigators
identified a recreational vehicle (RV) park as a potential source of
contamination in a 2010 STEC O145 outbreak associated with romaine
lettuce (Ref. 53). Investigators found that the RV park property had
multiple septic leach systems with subterranean moisture in the area
that drains into an irrigation canal.
    When evaluating proposed Sec.  112.43(a)(2)-(4), the covered farm
would consider the likelihood that any hazards, if present in its
agricultural water system, would be reasonably likely to introduce
hazards into or onto non-sprout covered produce, due to the
agricultural water practices employed by the farm, the characteristics
of the crop(s) to which the pre-harvest agricultural water is applied,
and the environmental conditions that may impact the introduction and/
or persistence of hazards. An evaluation of the hazards associated with
untreated or improperly treated human waste from adjacent or nearby
lands could include consideration of potential sources of
contamination, such as wastewater treatment plants, toilet facilities
(portable and fixed), sewage systems, septic tanks, and drain fields.
In considering whether hazards associated with human waste from
adjacent or nearby lands might be introduced to water systems, covered
farms might consider: (1) Whether and how the human waste is treated;
(2) whether the source of human waste is discharged directly into the
water system; (3) the proximity of the potential source to the water
system; (3) the topography between the potential source of human waste
and the water system; and (4) whether there are any physical measures
in place between the potential source of human waste and water system
that would reduce the likelihood of hazards being introduced. In the
event of uncertainty about adjacent and nearby land uses related to
untreated or improperly treated human waste, such

as if adjacent and nearby land users are not willing to share
information, farms should consider accounting for the increased
likelihood of hazard introduction to the water systems from such land
uses when making decisions around the safe use of their pre-harvest
agricultural water.
    We note that in the United States, the use and disposal of treated
sewage sludge (biosolids), including domestic septage, are regulated
under 40 CFR part 503. Subpart D of the Part 503 regulation protects
public health and the environment through requirements designed to
reduce the potential for contact with the disease-bearing
microorganisms (pathogens) in sewage sludge and domestic septage
applied to the land or placed on a surface disposal site (Ref. 54).
8. Agricultural Water Practices
    a. Time to harvest. In evaluating any conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce (other than sprouts) or food contact
surfaces under proposed Sec.  112.43(a)(2), a covered farm would
consider the interval between the last time pre-harvest agricultural
water was applied to the covered produce and the date of harvest. For
example, a covered farm that uses furrow irrigation and crop protection
sprays for its non-sprout covered produce would consider the timing of
both types of applications.
    As explained in the QAR (Ref. 11), the timing of water application
is an important factor in determining the likelihood of contamination,
because pathogens die off over time on the surface of produce.
Generally, bacteria or pathogens in water that is applied early in the
growing cycle are subject to die-off from several environmental forces,
such as UV exposure, temperature, humidity, and the presence of
competitive organisms (Ref. 55). In contrast, pathogens present in
agricultural water that is applied shortly before harvest may not be
exposed to the same environmental conditions for sufficient time to
provide a similar magnitude of die-off (Ref. 11). For more discussion
of microbial die off rates, see section VI.F.
    b. Method of application. Proposed Sec.  112.43(a)(2) also would
require a covered farm to evaluate the method(s) by which pre-harvest
agricultural water is applied to non-sprout covered produce during
growing activities.
    The most frequently used irrigation methods include overhead
sprinkler (or spray), surface and subsurface drip, furrow, flood, and
seep irrigation (Ref. 56). The QAR (Ref. 11) explains that different
irrigation methods present different risks based on the extent to which
the irrigation water is directly applied to the harvestable portion of
the crop.\7\ Overhead sprinkler irrigation increases the risk of
contamination as compared with furrow and subsurface drip irrigation
(Ref. 57). The location of the harvestable portion of a plant in
relation to irrigation water plays a significant role in contamination
in studies of lettuce, cantaloupe, and bell pepper (Ref. 58). The
likelihood of produce contamination may be reduced if irrigation water
is delivered by subsurface drip irrigation as compared to using the
same water to irrigate by overhead spray (Refs. 33 and 59).
---------------------------------------------------------------------------

    \7\ Irrigation water as described in the QAR is broader than the
definition of agricultural water in Sec.  112.3 of the produce
safety regulations that would apply under this proposed rule.
---------------------------------------------------------------------------

    Pathogenic E. coli has been recovered from lettuce tissue after
surface irrigation and spray irrigation with suspensions of E. coli
O157:H7; the level of contamination was lower from drip than from
sprinkler irrigation (Ref. 60). The lettuce leaves remained
contaminated with E. coli O157:H7 even after washing, indicating that
surface and spray irrigation of food crops with water of unknown
microbiological quality may introduce risk.
9. Crop Characteristics
    Under proposed Sec.  112.43(a)(3), a covered farm would be required
to evaluate whether the covered produce has any characteristics that
make it vulnerable to contamination, such as whether it is susceptible
to surface adhesion of bacteria or internalization of microbial
hazards. This includes increased susceptibility to internalization of
hazards due to physical damage from weather events (such as freezing of
an epidermal peel and hail damage) or biological damage (such as
phytopathogens).
    The QAR (Ref. 11) concluded that:
     The physical characteristics of the crop is one of the
likely factors contributing to the likelihood of contamination,
exposure, and illness.
     In particular, the growth characteristics (e.g., near to
the ground) and surface properties (e.g., porosity) affect the
probability and degree of contamination.
     No physical characteristics were identified that would be
protective against contamination.
    As discussed in the QAR (Ref. 11), although some physical
characteristics of produce commodities (e.g., netted rind of cantaloupe
or large, rough surface area of some leafy greens) may increase the
likelihood of contaminants being trapped and surviving long enough to
cause illness, physical characteristics that could alter the potential
for contamination (e.g., smooth surfaces) do not always appear to do
so. For example, while honeydew melon has a smooth rind, seemingly
making it less likely to harbor pathogens, it has been associated with
outbreaks. Some crops are more susceptible to the persistence and
growth of human pathogens, including co-infections with plant pathogens
(Ref. 61). (See also, the Codex Alimentarius Commission, Code of
Hygienic Practice for Fresh Fruits and Vegetables (CXC 53-2003) (the
Codex Code) section <IP_ADDRESS>.1 (Ref. 62). We anticipate that as more
information is learned about how commodity characteristics can impact
produce safety, covered farms would use this information to further
inform their pre-harvest agricultural water assessments.
10. Environmental Conditions
    Proposed Sec.  112.43(a)(4) would require a covered farm to
evaluate the potential impacts of weather conditions, including
seasonal rainfall patterns, the frequency of extreme weather events
(such as heavy winds or rain), and other relevant agro-ecological
conditions (such as temperature, sunlight (UV exposure)). As described
in the QAR (Ref. 11), survival of pathogens in the environment is
influenced by complex physical, chemical, and biological interactions.
Some pathogens are widely distributed and naturally capable of long-
term survival under a wide range of natural conditions (e.g., Listeria
monocytogenes) while the distribution of others (e.g., Salmonella, E.
coli H7:O157) may be more narrowly defined by temperature, sunlight (UV
exposure), moisture level, pH, available nutrients and related factors,
each of which may limit survival to some degree.
    Changes in temperature and seasonality are expected to impact
persistence of foodborne pathogens in the environment (Ref. 56). In
general, the survival of pathogens in water sources decreases with
increasing temperatures (Ref. 56). For example, in mid-latitude areas,
it is thought that the overall survival of foodborne pathogens in
soils, manure-amended soils and surface waters is likely to decrease
with increasing temperatures (Ref. 63). However, exceptions may be
observed in certain geographic areas and/or on certain farm
environments due to factors that confound the effects of temperature,
such as nutrient levels and humidity (Refs. 63 and 64).

    Airborne transmission may also result in contamination of the
environment--such as agricultural water and growing areas--particularly
when dry, windy conditions are present (Ref. 65). One study (Ref. 66)
found that E. coli was present in air samples from the edge of a beef
cattle feedlot, indicating that airborne transfer of microorganisms can
occur. Another study (Ref. 67) found that E. coli was recovered from 20
percent of air samples from an almond orchard downwind from a poultry
operation and from 0.48 percent of air samples from an almond orchard
not located near an animal operation. Increased levels of global dust
activity due to desertification as well as increased wind speeds
associated with storm systems may promote the dispersal and persistence
of some microbial hazards in the environment, especially those that
demonstrate higher levels of resistance to environmental conditions,
such as spore-formers (Ref. 63).
    Precipitation and its effects (e.g., discharge and flow rate),
along with temperature, are common factors reported to affect the
microbial quality of watersheds with agricultural land inputs. Seasonal
changes in rainfall--particularly heavy rainfall and flooding events--
can greatly affect surface water quality (Refs. 33 and 62) and may
result in sediments, which can serve as reservoirs for pathogens, being
dispersed within the water column (Ref. 68). One study (Ref. 48) found
that that as rainfall increases, populations of various indicators
(fecal coliforms, generic E. coli, Enterococcus) increased; moreover,
swine-specific markers were detected more frequently in water samples
in the 48 hours following a rainfall event greater than the mean.
    Rainfall events are reported to result in enhanced loading of fecal
pollutants from adjacent lands into water systems (Ref. 63) and
increased transport of pathogens onto growing fields (Ref. 63).
Alternately, rainfall may also have a dilution effect on pathogens or
indicator organisms that are already present in growing areas (Ref.
63). Although more research is needed, the possibility of splash
dispersal and internalization of pathogens may also become problematic
during periods of rainfall (Refs. 62 and 69), especially when increased
levels of pathogens are transported to growing areas.
11. Other Relevant Factors
    Under proposed Sec.  112.43(a)(5), covered farms would consider any
other factors relevant to identifying any conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce (other than sprouts) or food contact
surfaces. Those relevant factors may include, for example, whether the
covered farm elected to conduct testing under Sec.  112.43(d) to help
inform its agricultural water assessment, as discussed below.
12. Written Annual Assessments
    Under proposed Sec.  112.43(a), covered farms using pre-harvest
agricultural water for non-sprout covered produce would prepare a
written assessment of their pre-harvest agricultural water, at least
once each year, to identify any conditions that would be reasonably
likely to introduce known or reasonably foreseeable hazards into or
onto non-sprout covered produce or food contact surfaces, unless the
farm is exempt under proposed Sec.  112.43(b).
    A written agricultural water assessment would help FDA to verify
that covered farms conducted comprehensive assessments that included
all of the elements required by proposed Sec.  112.43(a) and made a
written determination as required by proposed Sec.  112.43(c). A
written agricultural water assessment also would allow covered farms
using pre-harvest water for non-sprout produce to more effectively
manage their agricultural water (such as in evaluating the
effectiveness of any mitigation measures), identify trends and changes
impacting their agricultural water systems (such as a change in nearby
land use that might introduce known or reasonably foreseeable hazards),
and help identify potential sources of contamination of the water
system and covered produce. Records of annual agricultural water
assessments also would help covered farms in determining whether
changed conditions would require covered farms to conduct a
reassessment under proposed Sec.  112.43(f)(2), prior to an annual
reassessment.
    The proposed requirement for an annual, written agricultural water
assessment for pre-harvest agricultural water, with the elements
described in paragraphs (a)(1)-(5), aligns with the Codex Code Section
<IP_ADDRESS> (Ref. 63), which recommends the assessment of agricultural
water for suitability for use, and the USDA Harmonized GAP Plus+
Standard, section F-4.1 (Ref. 70).
13. Proposed Sec.  112.43(b)--Exemptions
    Proposed Sec.  112.43(b) would create various exemptions from the
requirement to conduct an assessment of pre-harvest agricultural water
for application to non-sprout covered produce.
    Under proposed Sec.  112.43(b)(1), a covered farm would be exempt
from the requirement to conduct an assessment for pre-harvest
agricultural water if the farm can demonstrate that the agricultural
water meets the requirements of proposed Sec.  112.44(a), which is
applicable to agricultural water used for sprout irrigation or for
harvest or post-harvest uses--i.e., untreated ground water that meets
the microbial water quality criterion of no detectable generic E. coli,
based on testing requirements in proposed Sec. Sec.  112.44(b), 112.47,
and 112.151. The exclusion in proposed Sec.  112.43(b)(1) does not
apply to untreated surface water, because proposed Sec.  112.44(a)
prohibits the use of untreated surface water for sprout irrigation or
harvest or post-harvest application on covered produce.
    For example, if a covered farm uses the same untreated ground water
source for pre-harvest and harvest application to non-sprout covered
produce, the farm would be exempt from conducting an agricultural water
assessment for the untreated ground water provided that the farm could
demonstrate, through results of testing as required by proposed
Sec. Sec.  112.44(b), 112.47, and 112.151, that its agricultural water
meets microbial water quality criterion in proposed Sec.  112.44(a).
    Ground water obtained from deep underground aquifers with properly
designed, located, and constructed wells, is not subject to the impacts
of runoff from adjacent and nearby lands and similar conditions
evaluated as part of an agricultural water assessment. As explained in
the 2015 produce safety final rule (80 FR 74354 at 74430), the
microbial quality requirement of no detectable generic E. coli in Sec.
112.44(a) in untreated ground water is intended to address the known or
reasonably foreseeable hazards associated with fecal contamination of
agricultural water. The stringency of the requirements in proposed
Sec.  112.44(a) is commensurate with the risks associated with using
contaminated water for sprout irrigation and for harvest and post-
harvest uses.
    Proposed Sec.  112.43(b)(2) would exempt a covered farm from the
requirement to conduct an agricultural water assessment for pre-harvest
agricultural water for non-sprout covered produce that a covered farm
receives from a public water system that the covered farm can
demonstrate:
     Meets the microbial requirements of EPA Safe Drinking
Water Act (SDWA) regulations in 40 CFR part 141 (or the regulations of
a State approved to administer the SDWA program) through

public water system results or certificates of compliance or
     Meets the microbial quality criterion in Sec.  112.44(a)
through public water system results or certificates of compliance.
    Proposed Sec.  112.43(b)(3) would exempt a covered farm from the
requirement to conduct an agricultural water assessment for pre-harvest
agricultural water for non-sprout covered produce that is treated in
accordance with proposed Sec.  112.46 (such as through application of
an EPA-registered antimicrobial pesticide product).
    Although we are not proposing to require covered farms to treat
their agricultural water to meet applicable requirements, we note that
scientists from FDA's Center for Food Safety and Applied Nutrition have
developed a test protocol for evaluating the efficacy of antimicrobial
chemical treatments against public health organisms in agricultural
water sources and submitted it to EPA. On April 29, 2020, EPA approved
FDA's testing protocol, which potential chemical registrants can now
use to develop data to support registration of their pesticide products
for treatment of agricultural water used during growing activities
(Ref. 71).
    We tentatively conclude that an agricultural water assessment would
not be necessary when a covered farm can demonstrate that it its pre-
harvest agricultural water for non-sprout covered produce meets the
microbial quality criterion of no detectable generic E. coli and
testing requirements that would be applicable to agricultural water for
sprout irrigation and harvest and post-harvest uses; EPA drinking water
standards or other public water supply standards; or the treatment
requirements in proposed Sec.  112.46. We seek comment on this
tentative conclusion.
14. Proposed Sec.  112.43(c)--Outcomes
    Under proposed Sec.  112.43(c), a covered farm would use the
information gathered through inspection and maintenance of its
agricultural water system and evaluation of its agricultural water
practices, the crop characteristics, environmental conditions, and
other relevant factors for hazard identification purposes, as described
in Sec.  112.43(a). The covered farm also would make a written
determination of any corrective or mitigation measures to implement
based on:
     The farm's evaluation of factors described in proposed
Sec.  112.43(a)(1) through (5);
     Any conditions the farm identified that would be
reasonably likely to introduce known or reasonably foreseeable hazards
(specifically, biological hazards, as explained in section III.B.) into
or onto covered produce or food contact surfaces; and
     The results of any inspections and maintenance conducted
by the farm, pursuant to proposed Sec.  112.42, of any agricultural
water systems used during growing activities for non-sprout covered
produce.
    Proposed Sec.  112.43(c) would require a covered farm to record the
determination in the written agricultural water assessment and take
appropriate action, as described in table 4:

    Table 4--Summary of Outcomes of a Pre-Harvest Agricultural Water
           Assessment for Covered Produce (Other Than Sprouts)
                       [Proposed Sec.   112.43(c)]
------------------------------------------------------------------------
         If you determine . . .                Then you must . . .
------------------------------------------------------------------------
that your agricultural water is not       Immediately
 safe or is not of adequate sanitary      discontinue use(s)
 quality for intended use(s).            And
                                          Take corrective
                                          measures before resuming use
                                          of the water for pre-harvest
                                          activities
there is one or more known or             Implement mitigation
 reasonably foreseeable hazards related   measures promptly, and no
 to animal activity, BSAAOs, or           later than the same growing
 untreated or improperly treated human    season,
 waste for which mitigation is
 reasonably necessary.
there is one or more known or             Implement mitigation
 reasonably foreseeable hazards not       measures as soon as
 related to animal activity, BSAAOs, or   practicable and no later than
 untreated or improperly treated human    the following year
 waste, for which mitigation is          Or
 reasonably necessary.                    Test water as part of
                                          the assessment and implement
                                          measures, as needed, based on
                                          the outcome of the assessment
that there are no known or reasonably     Regularly (at least
 foreseeable hazards for which            once each year) inspect and
 mitigation is reasonably necessary.      adequately maintain the water
                                          system(s)
------------------------------------------------------------------------

    With respect to pre-harvest agricultural water for non-sprout
covered produce, under proposed Sec.  112.43(c):
     If the covered farm determines the agricultural water is
not safe or is not of adequate sanitary quality for its intended
use(s), the farm would be required to immediately discontinue use of
the water and take corrective measures under proposed Sec.  112.45(a)
before resuming such use(s);
     If the covered farm determines that mitigation measures
are reasonably necessary to reduce the potential for contamination of
such produce or food contact surfaces with a known or reasonably
foreseeable hazard that is related to animal activity, a biological
soil amendment of animal origin, or untreated or improperly treated
human waste on an adjacent or nearby land, the farm would be required
to implement the mitigation measures within the same growing season as
the assessment.
     If the covered farm determines that mitigation measures
are reasonably necessary to reduce the potential for contamination of
such produce or food contact surfaces with a known or reasonably
foreseeable hazard that is not related to animal activity, a biological
soil amendment of animal origin, or untreated or improperly treated
human waste on adjacent or nearby lands, the farm would be required to
either:
    [cir] Implement mitigation measures under proposed Sec.  112.45(b)
as soon as practicable and no later than the following year; or
    [cir] test the water, pursuant to proposed Sec.  112.43(d),
consider the results as part of the assessment in making a
determination under Sec.  112.43(c), and implement measures as needed
under proposed Sec.  112.45;
     If the covered farm determined that no corrective or
mitigation measures under proposed Sec.  112.45 were reasonably
necessary to reduce the potential for contamination of such produce or
food contact surfaces, the farm would be required to regularly inspect
and adequately maintain the

agricultural water system(s) under proposed Sec.  112.42, and conduct a
written agricultural water assessment annually and whenever a
significant change occurs (such as a change in the manner or timing of
water application) that would increase the likelihood that a known or
reasonably foreseeable hazard would be introduced into or onto covered
produce or food contact surface.
    We are maintaining the requirements for corrective measures in
Sec.  112.45(a), as explained and supported by the 2015 produce safety
final rule (80 FR 74354 at 74429-74431, 74440-74441), including the
requirement that if a covered farm determines or has reason to believe
that the agricultural water is not safe or of adequate sanitary quality
for its intended use, then the farm must immediately discontinue such
use. For example, if in performing the agricultural water assessment a
covered farm finds that there is a dead and decaying sheep in the canal
upstream and at a close distance from where it draws water, the farm
would have reason to believe that the agricultural water is not safe or
of adequate sanitary quality for its intended use because the water is
reasonably likely to contain human pathogens transferred by the dead
and decaying sheep. Therefore, the farm would have to immediately
discontinue that use of the water and take corrective measures under
proposed Sec.  112.45(a) before resuming such use(s).
    We also are maintaining the requirements to mitigate other risks as
soon as practicable and no later than the following year, also
supported by the produce safety final rule (80 FR 74354 at 74441-
74446), except that a covered farm would be required to implement
mitigation measures under proposed Sec.  112.45(b) for known or
reasonably foreseeable hazards related to animal activity, the
application of BSAAOs, or the presence of untreated or improperly
treated human waste on adjacent or nearby lands promptly, and no later
than the same growing season as the agricultural water assessment. For
example, if in performing their agricultural water assessment, a
covered farm identifies upstream lands used for animal grazing from
which runoff is likely to introduce known or reasonably foreseeable
hazards into the water source based on the topography of the land, the
farm would be required to implement mitigation measures promptly, and
no later than the same growing season as the agricultural water
assessment. (We note that proposed Sec.  112.43(c)(2) is not intended
to include those situations in which animal or human waste impacts
result in water no longer being safe or of adequate sanitary quality
for its intended use under Sec.  112.41. In those instances, a covered
farm would be required under Sec.  112.43(c)(1) to immediately
discontinue that use of the water and take corrective measures under
Sec.  112.45(a) before resuming such use.)
    Animal activity, BSAAOs, and untreated or improperly treated human
waste have been identified as possible causal or contributing factors
in several large produce outbreaks in recent years. The pathogens
associated with animal and human waste are well established, as are the
risks associated with introduction of animal or human waste into
agricultural water used in growing covered produce (Ref. 11).
    Subparts B, F, I, and L of the produce safety regulation require
covered farms to take appropriate measures to minimize the risk of
serious adverse health consequences or death from the use of, or
exposure to, covered produce, including those measures reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards associated with animal activity, BSAAOs, and
untreated and improperly treated human waste on the covered farm.
    In considering how best to achieve public health protections under
this proposed approach, we determined that animal activity, BSAAOs, or
human waste impacts on water sources and systems related to adjacent or
nearby lands should elicit an expedited timeline for implementation of
mitigation measures. We recognize that activities associated with
adjacent or nearby lands that introduce contaminants into a water
source or distribution system are often not under a covered farm's
control. While the covered farm may not have control over potential
hazards at their point of introduction into a water source or system,
the potential hazards are no less important for the farm to consider
when determining the safe use of agricultural water on covered produce.
Therefore, it is important that the covered farm not only implement
mitigation measures that are under its control to reduce the risk
associated with that water source or system, but that it do so on an
expedited basis to protect public health.
15. Proposed Sec.  112.43(d)--Testing for Assessment Purposes
    Proposed Sec.  112.43(d) would establish the requirements
applicable to testing that a covered farm chooses to conduct to provide
additional information for its agricultural water assessment. The
testing option for pre-harvest agricultural water for non-sprout
covered produce under proposed Sec.  112.43(d) is science-based and
also provides for flexibility as science evolves. For example, a
covered farm that opts to test pre-harvest agricultural water under
this provision would be required to test its agricultural water for
generic E. coli as an indicator of fecal contamination, but also may
test for another scientifically valid indicator organism, index
organism, or other analyte.
    Proposed Sec.  112.43(d) also would require that samples of pre-
harvest agricultural water tested as part of an agricultural water
assessment be collected aseptically immediately prior to or during the
growing season, representative of the water used in growing non-sprout
covered produce, and tested using a scientifically valid method.
    Additionally, proposed Sec.  112.43(d) would require that the
frequency of testing and any microbial criteria applied be
scientifically valid and appropriate to assist in determining, in
conjunction with other data and information evaluated under paragraph
Sec.  112.43(a), whether measures under Sec.  112.45 are reasonably
necessary to reduce the potential for contamination of non-sprout
covered produce or food contact surfaces with known or reasonably
foreseeable hazards associated with pre-harvest agricultural water.
    a. Generic E. coli. Generic E. coli remains a commonly used analyte
used as an indicator of fecal contamination and currently is the
preferred indicator for monitoring water quality (80 FR 74354 at
74428). However, the potential use of other indicator organisms, index
organisms, or other analytes for monitoring water quality continues to
be of interest for agricultural water, as well as related disciplines.
For example, in its 2012 Recreational Water Quality Criteria (RWQC) EPA
provided various examples of possible alternate indicators, including
Bacteroidales, Clostridium perfringens, human enteric viruses, and
coliphages (Ref. 72). Additionally, as part of the 2017 5-year review
of the 2012 RWQC, EPA evaluated the science related to the recreational
waters and public health to determine if revisions to the criteria
(which specify densities for enterococci and generic E. coli) were
appropriate (Ref. 73). While it did not ultimately revise the 2012 RWQC
during the 2017 review cycle, EPA emphasized that further scientific
research and analysis is likely to contribute to future reviews of the
2012 RWQC. EPA noted, in part, that with further scientific
development, the use of viral indicators such as

coliphages may help to further advance public health protections. FDA
anticipates that as science evolves and more information about other
indicator or index organisms is learned, testing for other organisms
may be used to inform pre-harvest agricultural water assessments by
covered farms, if finalized as proposed.
    b. Frequency of sampling. The 2015 produce safety final rule
established sampling frequencies for covered farms to use in developing
microbial water quality profiles for pre-harvest agricultural water for
non-sprout covered produce. For untreated surface waters, this consists
of an initial profile of at least 20 samples collected over a 2-4-year
period, followed by at least 5 annual samples thereafter; for untreated
ground water sources, this consists of an initial profile of at least 4
samples collected during the growing season or over a period of one
year, followed by at least 1 annual sample thereafter (80 FR 74354 at
74452) (Ref. 74).
    During outreach activities, some stakeholders, including covered
farms and some State regulators, indicated that they found the pre-
harvest microbial water quality criteria and testing requirements in
the 2015 produce safety final rule to be overly complex. (See section
III.B. through III.C.) Some farms anticipated that it would be
infeasible to implement the pre-harvest agricultural water testing
requirements in their operations and asked for additional flexibility--
in addition to the alternatives and variances already allowed by the
produce safety regulation. Moreover, various stakeholders shared the
opinion that, as new science continues to become available in the realm
of water quality monitoring, farms should have the flexibility to take
those findings into account when establishing or updating their
sampling programs (Refs. 3 and 75).
    We continue to believe that the information used to support the
sampling frequencies in the 2015 produce safety final rule for pre-
harvest agricultural water for non-sprout covered produce is well-
grounded, broadly-applicable science. Therefore, for purposes of
proposed Sec.  112.43(d), covered farms that opt to test their
untreated surface water for purposes of proposed Sec.  112.43(d) may
initially collect at least 20 samples over a 2-4-year period, with at
least 5 samples collected annually thereafter; covered farms that opt
to test their untreated ground water may initially collect at least 4
samples over a growing season or year, with at least 1 sample collected
annually thereafter. Depending on the conditions that may affect their
pre-harvest agricultural water, covered farms may consider collecting
additional samples as needed to better understand whether measures are
reasonably necessary to reduce the potential for contamination of
covered produce (other than sprouts) or food contact surfaces with
known or reasonably foreseeable hazards associated with their pre-
harvest agricultural water for non-sprout covered produce.
    We recognize that there are circumstances--for example, when access
to a body of water varies from year to year--in which some covered
farms may not be able to collect samples spanning multiple years. In
situations such as these, covered farms may consider collecting at
least 5 samples per year for untreated surface water sources, or at
least 4 samples per year for untreated ground water sources used for
pre-harvest application to non-sprout covered produce.
    However, we are also providing flexibility in proposed Sec.
112.43(d)(3) for covered farms to use any sampling frequency when
testing under proposed Sec.  112.43(d)(3), provided that it is adequate
to assist in determining, in conjunction with other data and
information evaluated under Sec.  112.43(a), whether measures under
Sec.  112.45 are reasonably necessary to reduce the potential for
contamination of non-sprout covered produce or food contact surfaces
with known or reasonably foreseeable hazards associated with pre-
harvest agricultural water for non-sprout covered produce. For example,
other options could include sampling frequencies a covered farm
establishes based on its historical data and/or knowledge of water
quality variability within its source. A covered farm also could, for
example, include consideration for other site- or region-specific data
or information indicating that a certain sampling frequency is
appropriate. We expect that as covered farms learn more about water
quality relevant to their sources, systems, and operations--for
example, through an evaluation of data shared between farms, within
water systems, and/or within regions--that such information may be used
to establish sampling frequencies that are appropriate to their
specific circumstances and conditions.
    c. Microbial water quality criteria. The microbial water quality
criteria established by the 2015 produce safety final rule for pre-
harvest agricultural water consist of a GM of 126 colony forming units
(CFU) generic E. coli per 100 milliliters (mL), and an STV of 410 CFU
generic E. coli per 100 mL--using the science underlying EPA's RWQC (80
FR 74354 at 74441-74442).
    The information used to support the pre-harvest agricultural water
quality criteria in the 2015 produce safety final rule is the best
science currently available that is broadly applicable to the range of
conditions that exist across the diversity of operations, agricultural
water sources, and agricultural water uses of domestic and foreign
covered farms. Therefore, if a covered farm decides to test its pre-
harvest agricultural water for generic E. coli under proposed Sec.
112.43(d) to inform its agricultural water assessment, the farm may use
a GM of 126 or less CFU generic E. coli per 100 mL and an STV of 410 or
less CFU generic E. coli per 100 mL as microbial criteria.
    However, we acknowledge stakeholder concerns and recognize that the
science around agricultural water quality criteria continues to evolve
(Ref. 3). We recognize that there may be other options for microbial
water quality criteria (for example, alternative criteria relevant to
an indicator organism other than generic E. coli).
    Proposed Sec.  112.43(d) would offer additional flexibility to
apply any microbial criterion or criteria that would be scientifically
valid and appropriate to assist in determining, in conjunction with
other data and information evaluated under proposed Sec.  112.43(a),
whether measures under Sec.  112.45 are reasonably necessary to reduce
the potential for contamination of non-sprout covered produce or food
contact surfaces with known or reasonably foreseeable hazards
associated with pre-harvest agricultural water. We are not proposing to
require that covered farms notify or seek approval from FDA prior to
applying a microbial criterion or criteria when electing to test their
pre-harvest agricultural water. Rather, we would provide flexibility
for a covered farm to determine which microbial criterion or criteria
to apply, when supported by scientific data or information
demonstrating scientific validity and appropriateness under proposed
Sec.  112.43(d). For example, a covered farm could rely on microbial
criterion or criteria available in the scientific literature or made
available by a third party, such as a trade association, provided that
the microbial criterion or criteria would be scientifically valid and
appropriate based on the circumstances.
    When possible, covered farms may continue to collect water quality
data over time--whether historical data, new data, or both--that can
assist in analyzing trends. For example, this approach may be useful in
situations in

which potential hazards are introduced into a water system
intermittently, such that a covered farm is able to compare data to
further refine its assessments of whether measures under Sec.  112.45
are reasonably necessary to reduce the potential for contamination of
non-sprout covered produce or food contact surfaces with known or
reasonably foreseeable hazards associated with pre-harvest agricultural
water.
    d. Records relating to analytes, sampling frequencies, and pre-
harvest water quality criteria. If a covered farm tests its water under
Sec.  112.43(d) for generic E. coli using the sampling frequencies and
pre-harvest microbial water quality criteria outlined in the 2015
produce safety final rule, the covered farm could document its use of
such sampling frequencies and microbial criteria in meeting the
requirements of proposed Sec.  112.50(b)(4), as we have already
determined these sampling frequencies and microbial criteria to be
scientifically valid and appropriate for purposes of proposed Sec.
112.45(b).
    Under proposed Sec.  112.50(b)(3)-(4), a covered farm that tests
its pre-harvest agricultural water using a scientifically valid
indicator organism other than generic E. coli, or an index organism or
other analyte would be required to maintain records under proposed
Sec.  112.50 of the scientific data or information used to support its
selection of other indicator organism, index organism, or other
analyte, as well scientifically valid and appropriate sampling
frequency and microbial criterion (or criteria) being applied. (See
also section VI.G. regarding proposed records requirements.)
    Such data and information could be developed by the covered farm,
available in the scientific literature, or available to the farm
through a third party. Such scientific support could be derived from
the science underlying commodity-specific or other guidance or
recommendations, including those developed by industry, academia, trade
associations, or other stakeholders.
16. Proposed Sec.  112.43(e)--Reassessment
    Under proposed Sec.  112.43(e), a covered farm would conduct an
agricultural water assessment, at a minimum, each year that the farm
applies pre-harvest agricultural water to non-sprout covered produce. A
covered farm also would conduct a reassessment whenever a significant
change occurs in its agricultural water system(s), agricultural water
practices, crop characteristics, environmental conditions, or other
relevant factors that would impact hazard identification or a risk
management determination as described in Sec.  112.43(c). For example,
a change from an untreated ground water source to an untreated surface
water source would be a significant change that would require a
reassessment under proposed Sec.  112.43(e). The reassessment would
evaluate the impacts of those changes on the factors in proposed Sec.
112.43(a)(1) through (5), any new hazards identified, and the outcome
and determination under proposed Sec.  112.43(c).
    Agricultural water assessments are the primary tool that covered
farms would use under this proposed rule for hazard identification and
risk management for their pre-harvest agricultural water used for non-
sprout covered produce. Specifically, covered farms would use the
outcomes of their pre-harvest agricultural water assessments (proposed
Sec.  112.43), together with the results of any inspections and
maintenance performed (proposed Sec.  112.42), in determining whether
measures (proposed Sec.  112.45) are reasonably necessary to reduce the
potential for contamination of covered produce (other than sprouts) or
food contact surfaces with known or reasonably foreseeable hazards
associated with pre-harvest agricultural water.
    The proposed requirements for an agricultural water assessment
align with domestic produce safety standards, such as the USDA
Harmonized GAP Plus+ Standard, section F-4.1 (Ref. 70), and
international standards, such as the Codex Code Section <IP_ADDRESS> (Ref.
62), which recommends the periodic assessment of agricultural water for
suitability for use.
    For the foregoing reasons, we have tentatively concluded that it
would be reasonable and appropriate to require covered farms to conduct
a written pre-harvest agricultural water assessments annually, and
whenever significant changes would impact the hazard identification or
risk management determination relating to pre-harvest agricultural
water for non-sprout covered produce.

F. Mitigation Measures (Proposed Sec.  112.45)

    Proposed Sec.  112.45 would establish requirements for implementing
corrective and mitigation measures for pre-harvest, harvest, and post-
harvest agricultural water that are reasonably necessary to reduce the
potential for contamination of non-sprout covered produce or food
contact surfaces with known or reasonably foreseeable hazards
associated with agricultural water for covered produce. This provision
is supplemented by proposed Sec.  112.42, which would require covered
farms to conduct routine maintenance of agricultural water systems to
the extent of their control including, for example, taking steps to
prevent pooled water from contaminating covered produce.
    We are proposing to retain the requirement from Sec.  112.45(a) of
the produce safety regulation to immediately discontinue use of any
agricultural water that is not safe or not of adequate sanitary quality
for its intended use(s), until the covered farm implements effective
corrective measures and the agricultural water meets the requirements
of Sec.  112.41. We also propose to retain the requirement, from Sec.
112.45(a) of the produce safety regulation, to discontinue use of
harvest or post-harvest water that does not meet the microbial water
quality criterion in Sec.  112.44(a) until effective corrective
measures are implemented.
    Under this proposed rule, a covered farm would make a determination
under Sec.  112.43(c), based on the outcome of its agricultural water
assessment, as to whether mitigation measures would be reasonably
necessary to reduce the potential for contamination of covered produce
(other than sprouts) or food contact surfaces with known or reasonably
foreseeable hazards associated with its pre-harvest agricultural water.
A covered farm would be required to implement mitigation measures under
proposed Sec.  112.45(b) as soon as practicable and no later than one
year after the date of the agricultural water assessment or
reassessment (as required by proposed Sec.  112.43), except that
mitigation measures for known or reasonably foreseeable hazards related
to animal activity, the application of biological soil amendments of
animal origin, or the presence of untreated or improperly treated human
waste on adjacent or nearby lands must be implemented promptly, and no
later than the same growing season as its assessment. (See the
discussions of adjacent and nearby land uses and outcomes in section
VI.E.)
    Under proposed Sec.  112.45(b), mitigation measures include:
     Making necessary changes (such as repairs) to address any
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food contact
surfaces;
     Increasing the time interval between the last direct
application of agricultural water and harvest of the covered produce to
allow for microbial die-off (with a minimum interval of 4 days between
application and harvest, except as supported by test results

conducted under proposed Sec.  112.43(d), or other scientifically valid
data or information in accordance with proposed Sec.  112.12);
     Increasing the time interval between harvest and the end
of storage using an appropriate microbial die-off rate, and/or
conducting other activities, such as commercial washing, to reduce
pathogens using appropriate microbial removal rates, except as
supported by scientifically valid data and information;
     Changing the method of water application to reduce the
likelihood of produce contamination (such as by changing from overhead
spray to subsurface drip irrigation of certain crops);
     Treating the water in accordance with proposed Sec.
112.46; and
     An alternative mitigation measure, in accordance with
proposed Sec.  112.12.
    We are revising our approach to mitigation measures involving
microbial die-off and/or removal in proposed Sec.  112.45(b)(1) to
reflect our proposal to remove the pre-harvest microbial quality
criteria and testing requirements from the produce safety rule. These
changes also reflect feedback we have received throughout stakeholder
engagement activities.
    Proposed Sec.  112.45(b)(1)(i) would provide for an established
time interval between last direct application of agricultural water and
harvest of the covered produce to allow for microbial die-off, with a
minimum interval of 4 days between application and harvest, except as
supported by test results conducted under Sec.  112.43(d), or other
scientifically valid data or information in accordance with Sec.
112.12.
    Survival of pathogens and other microorganisms on produce
commodities prior to harvest is dependent upon several environmental
factors, including sunlight (UV) intensity, moisture level,
temperature, pH, the presence of competitive microbes, and suitable
plant substrate (Ref. 55). Generally, pathogens and other microbes die-
off or are inactivated relatively rapidly under hot, dry, and sunny
conditions compared to inactivation rates observed under cloudy, cool
and wet conditions. The impact of these variables results in a range of
microbial die-off rates of 0.5 to 2.0 log per day, as explained in the
2015 produce safety final rule (80 FR 74534, 74443-74446).
    In general, high initial rates of die-off during the period
immediately following contamination suggests field conditions through
the first few days are critical in reducing microbial populations on
produce compared to weeks after the event. (80 FR 74354 at 74445.) In
studies reporting decay constant(s) measured over time (e.g., 0 hours
to 14 days or more), pathogen die-off rates were found to be highest
immediately following contamination (inoculation) and to slow over
time; this phenomenon is known as ``tailing'' and suggests that
pathogen die-off curves are biphasic (80 FR 74354 at 74445).
    A die-off rate of 0.5 log per day provides a reasonable estimate of
die-off under a broad range of variables including pathogen
characteristics, environmental conditions, crop type, and watering
frequency (80 FR 74354 at 74416). We derived this die-off rate based on
a review of currently available scientific literature and recognize
that microbial die-off rates are dependent on various environmental
factors, including sunlight intensity, moisture level, temperature, pH,
the presence of competitive microbes, and suitable plant substrate.
    We reviewed available literature for a time interval that is
appropriate when applying a microbial die-off rate of 0.5 log per day.
(See 80 FR 74354 at 74444-74445.) The studies we reviewed indicate that
greater microbial die-off or decay rates occur during the early
timeframe post-contamination, and although the die-off rate in these
studies was established from survival data or decay rates for bacterial
studies ranging from 2-7 days, the specific timeframe for the biphasic
shift in die-off was not identified. Within this range identified in
the literature, we determined that a time interval of 4 days is
reasonable because it serves as a general mid-point in time
representing neither end of the range where microbial die-off was
observed in these studies.
    Based on this information, in Sec.  112.45(b)(1)(i)(A) of the
produce safety final rule, we allowed covered farms to apply a time
interval between last irrigation and harvest using a microbial die-off
rate of 0.5 log per day, for no greater than 4 days, if their water
quality exceeded the pre-harvest microbial water quality criteria (80
FR 74354 at 74443). We consider the scientific data used to support
this approach as one example of adequate supporting scientific data and
information on which a time interval between last direct application
and harvest could be established under proposed Sec.  112.45(b).
Therefore, we have tentatively concluded that it would be appropriate
to allow covered farms to use the following approaches for implementing
a pre-harvest time interval as a mitigation measure under proposed
Sec.  112.45(b), without having to develop and maintain additional
supporting scientific data and information. We seek comment on this
tentative conclusion.
1. Time Interval Without Testing Data
    If a covered farm does not test its pre-harvest agricultural water
as part of an agricultural water assessment under proposed Sec.
112.43(d) but determines that the application of a time interval prior
to harvest would be an appropriate mitigation measure, the farm could
use a time interval between last direct application of agricultural
water and harvest of at least 4 days. This would correspond to the
broadly-applicable time frame identified in the 2015 produce safety
final rule that corresponds to the amount of time associated with the
first phase of die-off, when bacterial reduction rates are greatest on
produce surfaces and before ``tailing'' of bacterial populations
occurs. Lacking quantitative test data, the covered farm could not use
less than 4 days as a time interval between last direct application and
harvest under proposed Sec.  112.45(b)(1)(ii), unless the farm had
scientifically valid data or information to support use of a die-off
rate of 0.5 log per day for less than 4 days in accordance with
proposed Sec.  112.12.
2. Time Interval With Testing Data
    If a covered farm tests its pre-harvest agricultural water as part
of an agricultural water assessment under proposed Sec.  112.43(d) and
determines that the application of a time interval prior to harvest is
an appropriate mitigation measure, the farm could choose to use a
microbial die-off rate of 0.5 log per day, for potentially less than 4
days between last direct water application and harvest, to achieve a
(calculated) log reduction to meet the criteria the farm would
establish per proposed Sec.  112.43(d)(3). (Alternately, the covered
farm could choose to use a different time interval (and accompanying
die-off rate) if the farm has scientifically valid data or information
in accordance with proposed Sec.  112.12.)
    While we consider the information used to support the use of a die-
off rate of 0.5 log per day with a maximum time interval of 4 days as
being one example of adequate supporting scientific data and
information on which a time interval between last direct application
and harvest could be established under proposed Sec.  112.45(b), we
recognize that covered farms may have additional information on in-
field die-off that is applicable to their unique circumstances. For
example, we acknowledged in both the 2014 supplemental produce safety
notice and

the 2015 produce safety final rule that practices and conditions on a
covered farm and circumstances unique to a specific commodity could
result in higher die-off rates between last irrigation and harvest,
especially with little or no precipitation, coupled with high
ultraviolet radiation, high temperature exposures, or low humidity.
    Moreover, during outreach activities related to agricultural water
(as described in section III.C), stakeholders described the diversity
of pathogens, commodities, and climates that may be associated with
different microbial die-off rates and/or time intervals. We also are
aware that further research on the various conditions that exist is
likely to impact the appropriate use of a pre-harvest application
interval (Ref. 3). As more studies are conducted that examine in-field
die-off in various circumstances (Refs. 76-78), we expect that this is
an area where science will continue to evolve.
    Therefore, to provide additional flexibility to allow for future
science while continuing to protect public health, we are proposing to
allow covered farms to use a time interval other than the minimum 4
days between last direct water application and harvest as a mitigation
measure, if they have adequate supporting scientific data and
information. We expect that any microbial die-off rate and accompanying
maximum time interval that a covered farm establishes and uses would be
supported by an equally robust and rigorous scientific analysis to that
described above for the 0.5 log per day die-off rate with accompanying
4-day time interval. We expect that scientific data and information
used to support a pre-harvest time interval would be relevant to
conditions on the covered farm (such as the region, crop, and
environment), and be similarly characterized in a manner that addresses
the likely biphasic nature of microbial die-off (i.e., the two
different decay constants of a rapid short-term die-off and a gradual
long-term die-off). We also expect that the scientific approach would
not increase the likelihood that the covered produce will be
adulterated compared to the microbial die-off rate standard in Sec.
112.45(b)(1)(i)(A) of the produce safety regulation.
    Consistent with Sec.  112.45(b)(1)(ii) of the produce safety
regulation, we are proposing to allow covered farms to increase the
time interval between harvest and the end of storage to allow for
microbial die-off, and/or adopt activities such as commercial washing
that result in microbial removal as a mitigation measure. This proposed
revision reflects our proposal to remove the pre-harvest microbial
quality criteria and testing requirements from the produce safety
regulation and would allow a covered farm to use microbial die-off or
removal post-harvest (i.e., between harvest and end of storage, and
during activities such as commercial washing) as a mitigation measure,
provided the covered farm has adequate supporting scientific data and
information.
    We are not proposing to establish a specific microbial die-off
rate(s) between harvest and end of storage or specific microbial
removal rate(s) during postharvest activities such as commercial
washing. The World Health Organization has attributed a 1-log reduction
in microbial load to washing (Ref. 55). (See also 79 FR 58434 at
58446.) As discussed in the produce safety supplemental notice and
final rule, we do not have sufficient information to support the
derivation of appropriate, broadly-applicable microbial die-off or
removal rate(s) for this purpose. While it is reasonable to expect some
die-off during post-harvest storage, the rate and accompanying time
interval would be highly dependent upon the conditions of storage.
Covered farms would be able to more narrowly define die-off and/or
removal rates associated with their specific production practices, and
apply an appropriate time interval between harvest and end of storage
and/or adopt activities such as commercial washing that result in
microbial removal, as applicable to their circumstances. We are
proposing to provide this option so that a covered farm may account for
microbial die-off or removal during post-harvest activities (i.e.,
between harvest and end of storage, and during activities such as
commercial washing), provided the farm has adequate scientific data or
information to support the conclusions in accordance with proposed
Sec.  112.12.
    In light of recent produce outbreaks (including the outbreaks
described in section III.D.), we are proposing in Sec.  112.45(b)(1) to
require expedited mitigation for known or reasonably foreseeable
hazards from animal activity, BSAAOs, or untreated or improperly
treated human waste associated with adjacent or nearby lands.
    For any other identified hazards, proposed Sec.  112.45(b)(1) would
require covered farms to implement mitigation measures as soon as
practicable and no later than one year after the date of the
agricultural water assessment (as required by proposed Sec.  112.43).
This requirement aligns with Sec.  112.45(b) of the produce safety
regulation, which requires mitigation measures to be implemented as
soon as practicable and no later than the following year.
    Proposed Sec.  112.45(b)(2) would provide that if a covered farm
failed to implement appropriate mitigation measures, or if the farm
determined that the measures were not effective to reduce the potential
for contamination of non-sprout covered produce or food contact
surfaces with any known or reasonably foreseeable hazards, the farm
must discontinue use of the pre-harvest agricultural water until it has
implemented mitigation measures adequate to reduce the potential for
such contamination, consistent with Sec.  112.41.
    We note that while not considered agricultural water for purposes
of subpart E, indirect water application methods, such as the use of
drip tape in a manner that water is not likely to contact the
harvestable portion of the crop, remain subject to section 402 of the
FD&C Act. That is, indirect water application may adulterate produce
if, considering the water quality and the manner of its application,
the use of the water causes produce to be prepared, packed, or held
under insanitary conditions whereby it may have been contaminated with
filth or rendered injurious to health under section 402(a)(4) of the
FD&C Act. For example, if a farm uses drip tape in a way that water
does not normally contact the harvestable portion of the crop,
unintentional contact may still occur if the drip tape begins to leak
sprays water on the crop. Although not considered agricultural water
for purposes of subpart E, the farm should consider whether the source
of water may have caused the produce to become adulterated under
section 402 of the FD&C Act (for example, the farm may consider the
conditions described in proposed Sec.  112.43(a)(1)) and, if so,
dispose of the product appropriately.

G. Records Requirements for Pre-Harvest Agricultural Water Assessments
(Proposed Sec.  112.50)

    We propose to amend the records requirements in Sec.  112.50 of the
produce safety regulation to conform with proposed subpart E and to add
new requirements for records relating to pre-harvest agricultural water
assessments and the optional testing that certain covered farms may
elect to conduct under proposed Sec.  112.43.

1. Records of Pre-Harvest Agricultural Water Assessments
    Proposed Sec.  112.50(b)(2) would require covered farms to maintain
records of their agricultural water assessments, including written
determinations on whether mitigation measures under proposed Sec.
112.45(b) would be reasonably necessary to reduce the potential for
contamination of non-sprout covered produce or food contact surfaces
with known or reasonably foreseeable hazards associated with pre-
harvest agricultural water.
    Effective water management includes records necessary to confirm
that agricultural water is safe and of adequate sanitary quality for
its intended use(s). Records of pre-harvest agricultural water
assessments would be critical for a covered farm to maintain to ensure
its own compliance with the requirements of proposed Sec.  112.43. For
example, records of agricultural water assessments would be helpful to
a covered farm in determining whether changed conditions were
sufficient to trigger the requirement to conduct a reassessment under
proposed Sec.  112.43(f)(2), prior to an annual reassessment.
    Such records also are important for FDA to verify, for example,
that the covered farm evaluated all the required elements of an
assessment listed in proposed Sec.  112.43(a), in support of a written
determination, under proposed Sec.  112.43(c), regarding whether
mitigation measures are reasonably necessary to reduce the potential
for contamination of covered produce (other than sprouts) or food
contact surfaces with known or reasonably foreseeable hazards
associated with agricultural water used in growing non-sprout covered
produce.
2. Records Relating to Testing Pre-Harvest Agricultural Water for
Analytes Other Than Generic E. coli
    Under proposed Sec.  112.50(b)(3), a covered farm that tests its
pre-harvest agricultural water to inform its agricultural water
assessment and uses an indicator of fecal contamination, index
organism, or other analyte other than generic E. coli, would be
required to retain records of the scientific data or information the
farm relies on to support the use of such analyte. These records would
be necessary for a covered farm to ensure, and for FDA to verify, that
appropriate scientific methods are being used when the farm elects to
test its pre-harvest agricultural water under proposed Sec.  112.43(d)
to inform its agricultural water assessment.
3. Records Relating to the Sampling and Microbial Criterion (or
Criteria) Applied for Pre-Harvest Agricultural Water
    Under proposed Sec.  112.50(b)(4), a covered farm that tests its
pre-harvest agricultural water would be required to maintain records of
the scientific data or information it relied on to support the sampling
and testing methods and the microbial criterion (or criteria) it
applied. Records of sampling protocols, testing methods, and microbial
criterion (or criteria) would be necessary for a covered farm that uses
testing to ensure that the frequency of testing samples and microbial
criteria applied are adequate to assist in determining, in conjunction
with other data and information from their assessment, whether
mitigation measures are reasonably necessary. Such records would allow
FDA to help verify a covered farm's compliance with proposed Sec.
112.43(d).
    Additionally, we would amend Sec.  112.50(b) of the produce safety
regulation to:
     Move paragraph (b)(2) to proposed Sec.  112.50(b)(5), and
as a clarifying edit add the phrase, ``including any testing conducted
for purposes of Sec. Sec.  112.43 and 112.44'';
     Move paragraphs (b)(3) through (b)(4) to proposed Sec.
112.50(b)(9) through (b)(10);
     Move paragraph (b)(5) to proposed Sec.  112.50(b)(8) and
remove the phrase ``, in accordance with Sec.  112.45(b)(1)(ii)'';
     Move paragraph (b)(6) to proposed Sec.  112.50(b)(7) and
remove the phrase ``in accordance with Sec.  112.45(b)(1)(ii) and/or
(b)(1)(iii)'';
     Move paragraph (b)(7) to proposed Sec.  112.50(b)(6) and
replace ``Sec.  112.46(a)(1) or (2)'' with ``Sec.  112.44(c)(1) or
(c)(2)'';
     Remove paragraph (b)(8); and
     Move paragraph (b)(9) to proposed Sec.  112.50(b)(11).

H. Conforming Changes (Proposed Sec. Sec.  112.12, 112.151, and
112.161)

    As conforming changes in light of our proposal to remove the
microbial water quality criteria in Sec.  112.44(b), the microbial die-
off (calculated log reduction) rate in Sec.  112.45(b), and the testing
requirements in Sec.  112.46(b) of the produce safety regulation, we
would:
     Amend Sec.  112.12 to replace ``Sec.  112.49'' with
``Sec.  112.45(b)'';
     Amend the section heading of Sec.  112.151 to replace
``Sec.  112.46'' with ``subpart E''; and
     Amend Sec.  112.151(b)(2) to replace ``Sec.  112.49(a)''
with ``Sec.  112.43(d)''.
    As an additional conforming change, we propose to revise the
requirements of Sec.  112.161(b) of the produce safety regulation to
require supervisory review of records of pre-harvest agricultural water
assessments and determinations, given the essential role of such
records in establishing compliance with the requirements of proposed
Sec.  112.43 and in confirming that pre-harvest agricultural water is
safe and of adequate sanitary quality for its intended use(s).
Therefore, in Sec.  112.161 of the produce safety regulation, we would
replace ``(b)(4), and (b)(6)'' with ``(b)(7), and (b)(10)''.

I. Other Amendments (Proposed Sec. Sec.  112.42, 112.44, and 112.46-
112.49)

1. Proposed Sec.  112.42
    To provide additional clarity around certain language, based on
stakeholder feedback and questions, we would:
     Add descriptive headings to paragraphs (a) and (b);
     Consolidate the requirements for maintenance of
agricultural water systems in Sec.  112.43(b), (c), and (d) into Sec.
112.42(b)(1)-(4); and
     Clarify the descriptions of possible maintenance measures
for pooled water in Sec.  112.42(b)(4).
2. Proposed Sec.  112.44
    As part of the proposed reorganization of subpart E to group
provisions of a similar nature (i.e., requirements specific to pre-
harvest agricultural water, sprout irrigation water, and harvest/post-
harvest agricultural water), we would:
     Revise the section heading of Sec.  112.44 of the produce
safety regulation by adding ``and testing requirements'' after
``criteria'' and by replacing ``certain intended uses'' with ``sprout
irrigation and for harvesting, packing, and holding covered produce'';
     Move Sec.  112.46(c) of the produce safety regulation to
proposed Sec.  112.44(b), add a paragraph heading, ``Untreated ground
water.'', and replace ``Sec.  112.44(a)'' with ``paragraph (a)''
wherever it appears;
     Move Sec.  112.46(a) of the produce safety regulation to
proposed Sec.  112.44(c) and add a paragraph heading, ``Exemptions.''
and replace ``Sec.  112.43'' with ``Sec.  112.46''; and
     Move the text of Sec.  112.48 of the produce safety
regulation to proposed Sec.  112.44(d) and add a paragraph heading,
``Additional management and monitoring practices.''
3. Proposed Sec.  112.46
    As part of our reorganization of subpart E for clarifying purposes,
we are proposing to move the treatment provision from Sec.  112.43 of
the produce safety regulation to Sec.  112.46.

4. Proposed Sec.  112.47
    As clarifying edits, we would:
     In Sec.  112.47(a) of the produce safety regulation,
replace ``Sec.  112.46'' with ``Sec. Sec.  112.43(c)(4)(ii) and
``112.44'' and
     In Sec.  112.47(b) of the produce safety regulation,
replace ``method as set forth in Sec.  112.151'' with ``method set
forth in Sec.  112.151, as applicable''.
5. Proposed Sec.  112.48
    As part of our reorganization of subpart E, we would move the
requirements in Sec.  112.48 of the produce safety regulation to
proposed Sec.  112.44(d), which would contain other requirements
applicable to harvest and post-harvest uses of agricultural water, and
reserve Sec.  112.48.
6. Proposed Sec.  112.49
    As part of our reorganization of subpart E, we would remove and
reserve Sec.  112.49 of the produce safety regulation that allows for
various alternatives based on the pre-harvest agricultural water
quality profile and testing requirements that we propose to remove from
subpart E.

VII. Online Tool

    We recognize that covered farms would likely benefit from resources
to assist them in complying with the proposed requirements, if
finalized. As such, we are developing an online tool that would assist
farms in developing the pre-harvest agricultural water assessments
described in this proposed rule. We plan to provide additional
information about this online tool in the near future.

VIII. Proposed Effective and Compliance Dates

    We are proposing that a final rule based on this proposed rule be
effective 60 days after the date of publication of the final rule.
    Covered farms currently are required to comply with the subpart E
pre-harvest, harvest, and post-harvest agricultural water requirements
for covered produce (other than sprouts) beginning on January 26, 2024,
for very small farms; January 26, 2023, for small farms; and January
26, 2022, for all other covered farms (84 FR 9706). We intend to
exercise enforcement discretion for these subpart E requirements while
pursuing a targeted compliance date rulemaking, with the goal of
completing the rulemaking as quickly as possible.
    In the meantime, covered farms (other than sprout operations, for
which compliance dates have already passed) should focus their
attention good agricultural practices to maintain and protect the
quality of their water sources (Ref. 32). We note that produce remains
subject to the other applicable provisions of the produce safety
regulation and the applicable provisions of the FD&C Act.

IX. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). This proposed rule has
been designated a significant regulatory action as defined by E.O.
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we estimate that annualized costs will not be larger
than 3 percent of revenue for any covered farms, we anticipate that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. If the proposed rule is
finalized, we may, if appropriate, certify that the final rule does not
have a significant impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts (PRIA) that assesses the impacts of the proposed rule (Ref.
79). We estimate costs of the proposed rule resulting from reading the
rule, conducting pre-harvest agricultural water assessments, conducting
mitigation measures when reasonably necessary based on the outcomes of
the pre-harvest agricultural water assessments, and recordkeeping as a
result of the pre-harvest agricultural water assessments. We estimate
cost savings of the proposed rule resulting from pre-harvest
agricultural water testing and corrective measure provisions in the
2015 final rule that would be replaced by the proposed provisions for
pre-harvest agricultural water assessments and mitigation measures. Our
primary estimates of annualized net costs are approximately $11.3
million at a 3 percent discount rate over 10 years and approximately
$11.2 million at a 7 percent discount rate over 10 years.
    We estimate benefits of the proposed rule resulting from the dollar
burden of foodborne illnesses averted, and we estimate forgone benefits
of the proposed rule resulting from foodborne illnesses not averted due
to the current pre-harvest agricultural water testing provisions. Our
primary estimates of annualized net benefits are approximately $9.9
million at a 3 percent discount rate and approximately $9.6 million at
a 7 percent discount rate. We discuss qualitative benefits of the
proposed rule stemming from increased flexibility for covered farms to
comprehensively evaluate their agricultural water systems. These
changes to pre-harvest agricultural water provisions are being
proposed, in part, to address practical implementation challenges of
the current pre-harvest agricultural water testing requirements.
    The full preliminary analysis of economic impacts is available in
the docket for this proposed rule and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

X. Analysis of Environmental Impact

    The Agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The Agency's finding of
no significant impact and the evidence supporting that finding may be
seen in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and
4 p.m., Monday through Friday (Refs. 80-81). Under FDA's regulations
implementing the National Environmental Policy Act (21 CFR part 25), an
action of this type would require an EA under 21 CFR 25.31a(a) (an
abbreviated EA under 21 CFR 25.31a(b)).

XI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section
with an estimate of the annual recordkeeping burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Standards for the Growing, Harvesting, Packing, and Holding
of Produce; Recordkeeping--OMB Control Number 0910-0816--Revision.
    Description: The proposed rule would replace current recordkeeping
requirements (found in 21 CFR part 112, subpart E) associated with
sampling and testing of pre-harvest agricultural water for non-sprout
covered produce with revised requirements to prepare and maintain
documentation of written agricultural water assessments for certain
pre-harvest agricultural water.
    Description of Respondents: Farms subject to the regulation in part
112.
    We estimate the burden of the information collection as follows:

                      Table 5--Cumulative Average Annual Burden, Covered Farms of All Sizes
----------------------------------------------------------------------------------------------------------------
                                                                                Average
   21 CFR part 112, subpart E:     Total number      Number of     Total annual     burden per
     Requirements that apply      of respondents    records per       records        farm  (in      Total hours
        regarding records                           respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Agricultural Water Assessment              8,218             1.1           9,040               4          36,160
 and Records Maintenance--Very
 small covered farms (proposed
 Sec.   112.50(b)(2))...........
Agricultural Water Assessment              1,613             1.1           1,774               8          14,192
 and Records Maintenance--Small
 covered farms (proposed Sec.
 112.50(b)(2))..................
Agricultural Water Assessment              4,283             1.1           4,711               9          42,399
 and Records Maintenance--All
 other (Large) Covered Farms
 (proposed Sec.   112.50(b)(2)).
----------------------------------------------------------------------------------------------------------------
    Cumulative totals for                 14,114             3.3          15,525             7.0          92,751
     covered farms of all sizes.
----------------------------------------------------------------------------------------------------------------
    Cumulative average 7.0 burden hours per covered farm annually...............................................
----------------------------------------------------------------------------------------------------------------

    Covered farms using pre-harvest agricultural water for non-sprout
covered produce would prepare and maintain records of their
agricultural water assessments unless excluded under proposed Sec.
112.43(b). We estimate that a total of 14,114 covered farms (8,218 very
small farms, 1,613 small farms, and 4,283 other (large) covered farms)
would be subject to information collection requirements under the
proposed rule, consistent with figures in our current approval and our
PRIA (Ref. 79) for this proposed rule and informed by a 2018 USDA
survey of covered farms' irrigation practices (Ref. 82). We are
estimating a range of burden: 4 hours of burden for very small farms, 8
hours of burden for small farms, and 9 hours for other (large) farms,
based on estimates of the amount of time in hours to conduct
recordkeeping for pre-harvest agricultural water assessments.
    To ensure that comments on information collection are received, OMB
recommends that written comments be submitted through reginfo.gov (see
ADDRESSES). All comments should be identified with the title of the
information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. These information collection
requirements will not be effective until FDA publishes a final rule,
OMB approves the information collection requirements, and the rule goes
into effect. FDA will announce OMB approval of these requirements in
the Federal Register.

XII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. We have determined that the
proposed rule does not contain policies that have substantial direct
effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

XIII. Consultation and Coordination With Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13175. We have tentatively determined that
the rule does not contain policies that would have a substantial direct
effect on one or more Indian Tribes, on the relationship between the
Federal Government and Indian Tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian Tribes.
We invite comments from tribal officials on any potential impact on
Indian Tribes from this proposed action.

XIV. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://

www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

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2. * Collaborative Food Safety Forum, ``Agricultural Water Standards
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Outcomes from a Collaborative Summit on Agricultural Water Standards
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4. * Assar, S., ``Memorandum to the File--Summary of Stakeholder
Questions and Feedback on the Agricultural Water Requirements for
Produce (Other than Sprouts) Received During Educational Farm Visits
in 2018.'' October 5, 2021, FDA.
5. * Comment from California Walnut Commission, posted December 5,
2017, to Docket No. FDA-2017-N-5094. Available at https://www.regulations.gov, Comment ID FDA-2017-N-5094-0007.
6. * Comment from Western Agricultural Processors Association, dated
December 6, 2017, to Docket No. FDA-2017-N-5094. Available at
https://www.regulations.gov, Comment ID FDA-2017-N-5094-0014.
7. * Comment from California Farm Bureau Federation, dated December
7, 2017, to Docket No. FDA-2017-N-5094. Available at https://www.regulations.gov, Comment ID FDA-2017-N-5094-0015.
8. * Comment from Western Agricultural Processors Association, dated
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9. * Comment from Produce Marketing Association et al., dated
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to the Contamination of Romaine Lettuce Implicated in the Fall 2018
Multi-State Outbreak of E. coli O157:H7,'' February 13, 2019.
Available at: https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-summary-factors-potentially-contributing-contamination-romaine-lettuce-implicated-fall.
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List of Subjects in 21 CFR Part 112

    Dietary foods, Food grades and standards, Foods, Fruits,
Incorporation by reference, Packaging and containers, Reporting and
recordkeeping requirements, Safety, Vegetables.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, we
propose that 21 CFR part 112 be amended as follows:

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
1. The authority citation for part 112 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

0
2. Amend Sec.  112.3 by adding in alphabetical order the definitions
for ``Agricultural water assessment'' and ``Agricultural water system''
to read as follows:

Sec.  112.3   What definitions apply to this part?

* * * * *
    Agricultural water assessment means an evaluation of an
agricultural water system, agricultural water practices, crop
characteristics, environmental conditions, and other relevant factors
(including test results, where appropriate) related to growing
activities for covered produce (other than sprouts) to:
    (1) Identify any condition(s) that are reasonably likely to
introduce known or reasonably foreseeable hazards into or onto covered
produce or food contact surfaces; and
    (2) Determine whether measures are reasonably necessary to reduce
the potential for contamination of covered produce or food contact
surfaces with such known or reasonably foreseeable hazards.
    Agricultural water system means a source of agricultural water, the
water distribution system, any building or structure that is part of
the water distribution system (such as a well house, pump station, or
shed), and any equipment used for application of agricultural water to
covered produce during growing, harvesting, packing, or holding
activities.
* * * * *
0
3. In Sec.  112.12, revise paragraph (a) to read as follows:

Sec.  112.12   Are there any alternatives to the requirements
established in this part?

    (a) You may establish alternatives to certain specific requirements
of subpart E of this part, as specified in Sec.  112.45(b), provided
that you satisfy the requirements of paragraphs (b) and (c) of this
section.
* * * * *
0
4. Revise subpart E to read as follows:

Subpart E--Agricultural Water

Sec.
112.40 What requirements of this subpart apply to my covered farm?
112.41 What requirements apply to the quality of agricultural water?
112.42 What requirements apply to inspecting and maintaining my
agricultural water systems?
112.43 What requirements apply to assessing agricultural water used
in growing covered produce (other than sprouts)?
112.44 What requirements apply to agricultural water used as sprout
irrigation water and in harvesting, packing, and holding covered
produce?
112.45 What measures must I take for agricultural water to reduce
the potential for contamination of covered produce or food contact
surfaces with known or reasonably foreseeable hazards?
112.46 What requirements apply to treating agricultural water?
112.47 Who must perform the tests required under this subpart?
112.48-112.49 [Reserved]
112.50 Under this subpart, what requirements apply regarding
records?

Subpart E--Agricultural Water

Sec.  112.40   What requirements of this subpart apply to my covered
farm?

    This subpart applies to agricultural water used for, or intended
for use in, growing, harvesting, packing, or holding covered produce.
If you are using agricultural water for a covered activity listed in
the first column, then you must meet the requirements in the second
column. You also must meet the

requirements in the third column, if applicable.

                        Table 1 to Sec.   112.40
------------------------------------------------------------------------
   If you use agricultural                            If applicable, you
   water for this covered       Then you must meet      also must meet
          activity              these requirements    these requirements
------------------------------------------------------------------------
(a) Growing covered produce   Sec.   112.41 (quality  Sec.   112.45
 (other than sprouts).         standard).              (measures).
                              Sec.   112.42           Sec.   112.46
                               (inspections and        (treatment).
                               maintenance).          Sec.   112.47 (who
                              Sec.   112.43            may test).
                               (agricultural water    Sec.   112.151
                               assessment).            (test methods).
                              Sec.   112.50
                               (records).
(b) Sprout irrigation water.  Sec.   112.41 (quality  Sec.   112.44(b)
                               standard).              (testing
                              Sec.   112.42            untreated ground
                               (inspections and        water).
                               maintenance).          Sec.   112.45
                              Sec.   112.44(a)         (measures).
                               (microbial quality     Sec.   112.46
                               criterion)..            (treatment).
                              Sec.   112.50           Sec.   112.47 (who
                               (records)..             may test).
                                                      Sec.   112.151
                                                       (test methods)
(c) Harvesting, packing, or   Sec.   112.41 (quality  Sec.   112.44(b)
 holding covered produce.      standard).              (testing
                              Sec.   112.42            untreated ground
                               (inspections and        water
                               maintenance).          Sec.   112.45
                                                       (measures)
                              Sec.   112.44(a)        Sec.   112.46
                               (microbial quality      (treatment)
                               criterion).
                              Sec.   112.44(e)        Sec.   112.47 (who
                               (additional             may test)
                               management and
                               monitoring).
                              Sec.   112.50           Sec.   112.151
                               (records).              (test methods)
------------------------------------------------------------------------

Sec.  112.41  What requirements apply to the quality of my agricultural
water?

    All agricultural water must be safe and of adequate sanitary
quality for its intended use.

Sec.  112.42  What requirements apply to inspecting and maintaining my
agricultural water systems?

    (a) Inspection of your agricultural water systems. At the beginning
of a growing season, as appropriate, but at least once annually, you
must inspect all of your agricultural water systems, to the extent they
are under your control, to identify any conditions that are reasonably
likely to introduce known or reasonably foreseeable hazards into or
onto covered produce or food contact surfaces, including consideration
of the following:
    (1) The nature of each agricultural water source (for example,
whether it is ground water or surface water);
    (2) The extent of your control over each agricultural water source;
    (3) The degree of protection of each agricultural water source;
    (4) Use of adjacent and nearby land; and
    (5) The likelihood of introduction of known or reasonably
foreseeable hazards to agricultural water by another user of
agricultural water before the water reaches your covered farm.
    (b) Maintenance of your agricultural water systems. You must
adequately maintain all agricultural water systems, to the extent they
are under your control, as necessary and appropriate to prevent the
systems from being a source of contamination to covered produce, food
contact surfaces, or areas used for a covered activity. Such
maintenance includes:
    (1) Regularly monitoring each system to identify any conditions
that are reasonably likely to introduce known or reasonably foreseeable
hazards into or onto covered produce or food contact surfaces;
    (2) Correcting any significant deficiencies (such as control of
cross-connections and repairs to well caps, well casings, sanitary
seals, piping tanks, and treatment equipment);
    (3) Properly storing equipment and keeping the source and
distribution system free of debris, trash, domesticated animals, and
other possible sources of contamination of covered produce to the
extent practicable and appropriate under the circumstances; and
    (4) As necessary and appropriate, implementing measures reasonably
necessary to reduce the potential for contamination of covered produce
with known or reasonably foreseeable hazards resulting from contact of
covered produce with pooled water (for example, through use of
protective barriers or through equipment adjustments).

Sec.  112.43   What requirements apply to assessing agricultural water
used in growing covered produce (other than sprouts)?

    (a) Elements of an agricultural water assessment. Based in part on
the results of any inspections and maintenance you conducted under
Sec.  112.42, at least once annually you must prepare a written
agricultural water assessment for water that you apply to covered
produce (other than sprouts) using a direct application method during
growing activities. The agricultural water assessment must identify
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce (other than sprouts)
or food contact surfaces, based on an evaluation of the following
factors:
    (1) Each agricultural water system you use for growing activities
for the covered produce, including the location and nature of the water
source (whether it is ground water or surface water), the type of water
distribution system (for example, open or closed conveyance), and the
degree of protection from possible sources of contamination (including
by other water users; animal impacts; and adjacent and nearby land uses
related to animal activity (for example, grazing or commercial animal
feeding operations of any size), application of biological soil
amendment(s) of animal origin, or presence of untreated or improperly
treated human waste);
    (2) Agricultural water practices associated with each agricultural
water system, including the type of direct application method (such as
foliar spray or drip irrigation of covered produce growing underground)
and the time interval between the last direct application of
agricultural water and harvest of the covered produce;
    (3) Crop characteristics, including the susceptibility of the
covered produce to surface adhesion or internalization of hazards;
    (4) Environmental conditions, including the frequency of heavy rain
or extreme weather events that may impact the agricultural water system
(such as by stirring sediments) or covered produce (such as damage to
edible leaves) during growing activities, air temperatures, and sun
exposure; and

    (5) Other relevant factors, including, if applicable, the results
of any testing conducted pursuant to paragraph (d) of this section.
    (b) Exemptions. You do not need to prepare a written agricultural
water assessment for water that you directly apply during growing
activities for covered produce (other than sprouts), if you can
demonstrate that the water:
    (1) Meets the requirements in Sec.  112.44(a), including the
microbial quality criterion, and if untreated ground water, also meets
the testing requirements in Sec. Sec.  112.44(b), 112.47, and 112.151;
    (2) Meets the requirements in Sec.  112.44(c) for water from a
Public Water System or public water supply; or
    (3) Is treated in accordance with Sec.  112.46.
    (c) Outcomes. Based on your evaluation under paragraph (a) of this
section, you must determine whether measures under Sec.  112.45 are
reasonably necessary to reduce the potential for contamination of
covered produce (other than sprouts) or food contact surfaces with
known or reasonably foreseeable hazards associated with your
agricultural water used in growing covered produce (other than
sprouts). You must record your determination in the assessment, and you
must take necessary and appropriate action, as follows:
    (1) If your agricultural water is not safe or is not of adequate
sanitary quality for its intended use(s), as required under Sec.
112.41, you must discontinue use of the water and take corrective
measures under Sec.  112.45(a) before resuming such use(s);
    (2) If you have identified a condition that is reasonably likely to
introduce a known or reasonably foreseeable hazard and is related to
animal activity, application of a biological soil amendment of animal
origin, or the presence of untreated or improperly treated human waste
on adjacent or nearby lands, you must implement any mitigation measures
under Sec.  112.45(b) promptly, and no later than the same growing
season as the assessment;
    (3) If you have identified no conditions that are reasonably likely
to introduce a known or reasonably foreseeable hazard for which
measures under Sec.  112.45 are reasonably necessary to reduce the
potential for contamination of covered produce (other than sprouts) or
food contact surfaces, you must:
    (i) Regularly inspect and adequately maintain your agricultural
water system(s) under Sec.  112.42; and
    (ii) Reassess your agricultural water annually and whenever a
significant change occurs (such as a change in the manner or timing of
water application) that increases the likelihood that a known or
reasonably foreseeable hazard will be introduced into or onto covered
produce or food contact surfaces; and
    (4) If your agricultural water does not meet the criteria in
paragraph (c)(1), (2), or (3) of this section, you must either:
    (i) Implement mitigation measures under Sec.  112.45(b) as soon as
practicable and no later than 1 year after the date of the agricultural
water assessment (as required by this section); or
    (ii) Test the water pursuant to paragraph (d) of this section,
consider the results as part of your assessment, and take appropriate
action under paragraph (c)(1), (2), or (3), or (c)(4)(i) of this
section.
    (d) Testing for assessment purposes. In conducting testing to be
used as part of your assessment under paragraph (a)(5) of this section,
you must use scientifically valid collection and testing methods and
procedures, including:
    (1) Any sampling conducted for purposes of paragraph (c)(4)(ii) of
this section must be collected aseptically immediately prior to or
during the growing season and must be representative of the water you
use in growing covered produce (other than sprouts).
    (2) The sample(s) must be tested for generic Escherichia coli (E.
coli) as an indicator of fecal contamination (or for another
scientifically valid indicator organism, index organism, or other
analyte).
    (3) The frequency of testing samples and any microbial criteria
applied must be scientifically valid and appropriate to assist in
determining, in conjunction with other data and information evaluated
under paragraph (a) of this section, whether measures under Sec.
112.45 are reasonably necessary to reduce the potential for
contamination of covered produce (other than sprouts) or food contact
surfaces with known or reasonably foreseeable hazards associated with
your agricultural water used in growing covered produce (other than
sprouts).
    (e) Reassessment. You must conduct an agricultural water assessment
and take appropriate action under paragraph (c) of this section:
    (1) At least once annually when you apply agricultural water to
covered produce (other than sprouts) during growing activities; and
    (2) Whenever a significant change occurs in your agricultural water
system(s) (including changes relating to animal activity, the
application of biological soil amendments of animal origin, or the
presence of untreated or improperly treated human waste associated with
adjacent or nearby land uses), agricultural water practices, crop
characteristics, environmental conditions, or other relevant factors
that make it reasonably likely that a known or reasonably foreseeable
hazard will be introduced into or onto covered produce (other than
sprouts) or food contact surfaces through direct application of
agricultural water during growing activities. Your reassessment must
evaluate any factors and conditions that are affected by such change.

Sec.  112.44  What requirements apply to agricultural water used as
sprout irrigation water and in harvesting, packing, and holding covered
produce?

    (a) Microbial quality criterion. When you use agricultural water
for any one or more of the following purposes, you must ensure there is
no detectable generic Escherichia coli (E. coli) in 100 milliliters