operations to be required to keep training records for personnel who
received training at another operation or for contract workers (e.g.,
harvest crew, sanitation crew). This comment recommends revising
proposed Sec.  112.30(b) to be limited to records of trainings
performed or paid for by the operation, supplemented by additional
records providing a rationale for personnel who did not receive such
training at or by the operation.
    (Response) We are not making the requested change. A covered farm
must ensure and keep records that document the required training
received by personnel, regardless of whether the training is offered
and the applicable records are generated by the farm or by another
entity, such as the harvest crew company (see also our response to
Comment 159). The records required under Sec.  112.30(b)(1) are
intended to enable a covered farm to track the content and timing of
training personnel have received, identify personnel and training
topics for periodic updates, and identify personnel that have the
necessary training for assignment to certain responsibilities; and to
allow FDA to verify compliance with the rule's training requirements.

XII. Subpart D--Comments on Health and Hygiene

    In subpart D of proposed part 112, we proposed minimum standards
directed to health and hygiene that are reasonably necessary to
minimize the risk of serious adverse health consequences or death from
the use of, or exposure to, covered produce, including those reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards into covered produce, and to provide reasonable
assurances that the produce is not adulterated under section 402 of the
FD&C Act. We asked for comment on our proposed standards directed to
health and hygiene, including provisions related to use of gloves and
antiseptic hand rubs (commonly referred to as ``hand sanitizers'');
provisions related to hand-washing; and our proposed requirements
related to worker health.
    We are finalizing these provisions with revisions (see Table 10).
We discuss these changes in this section.

             Table 10--Description of Revisions to Subpart D
------------------------------------------------------------------------
       Final provision                  Description of revisions
------------------------------------------------------------------------
Sec.   112.31................  --Fixed grammatical error in Sec.
                                112.31(a) (deleted ``a'' before
                                ``communicable illnesses'').
Sec.   112.32(b).............  --Updated list of examples of hand drying
                                devices in Sec.   112.32(b)(3) (deleted
                                ``clean cloth towels'' and added
                                ``electric hand dryers'').
                               --Revision to Sec.   112.32(b)(3) to
                                allow the use of ``other effective
                                surfactants'' in lieu of soap during
                                hand-washing.
                               --Added new Sec.   112.32(b)(5) to
                                require removing or covering hand
                                jewelry under certain circumstances.
                               --Added new Sec.   112.32(b)(6) to
                                prohibit eating, chewing gum, and using
                                tobacco products in areas used for
                                covered activities (except that drinking
                                beverages is permitted in designated
                                areas).
Sec.   112.33................  --Deleted proposed Sec.   112.33(a)
                                defining ``visitor'' (moved definition
                                of visitor to Sec.   112.3(c)).
------------------------------------------------------------------------

A. General Comments

    (Comment 165) We received several comments on this subpart, many of
which support the proposed provisions under subpart D. Many commenters
agree that personnel who work in an operation in which covered produce
or food-contact surfaces are at risk of contamination with known or
reasonably foreseeable hazards must use hygienic practices while on
duty to protect against contamination. Several comments note the
importance of health and hygiene and generally believe that the
proposed provisions are similar to those already established and
commonly recognized as basic requirements for personal sanitation and
hygiene. Another comment supports the promotion of hand hygiene as a
mandatory element for self-protection and protection of others for the
agricultural sector, including among small farms.
    (Response) Health and hygiene of personnel and visitors is a
crucial component of produce safety, and we are establishing certain
standards that are reasonably necessary to prevent personnel and
visitors from introducing known or reasonably foreseeable hazards into
or onto covered produce or food-contact substances in subpart D of part
112. Unless exempted or subject to any applicable modified
requirements, covered farms conducting covered activities on covered
produce are required to comply with the requirements for health and
hygiene in subpart D.
    (Comment 166) One comment suggests that FDA recognize that
postharvest treatment of food is an inadequate substitute for the
fundamentals of hygiene.
    (Response) FDA generally agrees with this statement and encourages
all firms to use appropriate hygienic practices in the production of
produce, regardless of whether they are subject to this rule. Under
Sec.  112.2(b) covered produce that receives commercial processing that
adequately reduces the presence of microorganisms of public health
significance is eligible for exemption from the requirements of part
112. In addition, produce that is rarely consumed raw (i.e., it is
typically cooked before consumption) is not subject to this rule under
Sec.  112.2(a). Thus, by definition, covered produce is produce that is
not likely to receive a postharvest processing or treatment step that
will adequately reduce the presence of microorganisms of public health
concern. Therefore, personnel and visitor hygiene, while always
important in the production of food, are particularly important with
respect to covered produce under this rule. Our rule takes an approach
consistent with the requirement in section 419(c)(1)(A) that this
regulation set forth the procedures, processes, and practices the
Secretary determines to be reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into fruits and
vegetables.

B. Ill or Infected Persons (Sec.  112.31)

    (Comment 167) Some comments seek clarification on compliance with
this provision and express concerns about the feasibility of
continuously monitoring workers for signs of illness. Some comments
state that ill workers do not notify supervisors of their illness, that
workers hide their illness due to fear of not being able to work, and
that employees may not be aware that they have an infectious disease
until days have passed and covered produce has already been handled.
    (Response) We are requiring you to take measures to prevent
contamination of covered produce and food-contact surfaces with
microorganisms of public health significance from any person with an
applicable health condition (such as communicable illnesses that
present a public health risk in the context of normal work duties,
infection, open lesion, vomiting, or diarrhea) (Sec.  112.31(a)). We
are correcting a grammatical error that appeared in this section as
proposed by deleting ``a'' before ``communicable illnesses.''
    One measure that you must take to satisfy this requirement is to
exclude any person from working in any operations that may result in
contamination of covered produce or food-contact surfaces with
microorganisms of public health significance when the person (by
medical examination, the person's acknowledgement, or observation (for
example, by a supervisor or responsible party) is shown to have, or
appears to have, an applicable health condition, until the person's
health condition no longer presents a risk to public health (Sec.
112.31(b)(1)). Note also that all personnel who handle covered produce
during covered activities or supervise such activities must receive
training on the importance of health and personal hygiene for all
personnel and visitors, including recognizing symptoms of a health
condition that is reasonably likely to result in contamination of
covered produce or food-contact surfaces with microorganisms of public
health significance (Sec.  112.22(a)(2)).
    Another measure we require is that you instruct your personnel to
notify their supervisor(s) (or a responsible party) if they have, or if
there is a reasonable possibility that they have, an applicable health
condition (Sec.  112.31(b)(2)). Consistent with the training
requirement in Sec.  112.22(a)(2), these requirements emphasize that
individual workers have a responsibility to take action to prevent
contamination due to their own illness or infection. Although we have
not specified, under Sec.  112.31(b)(1), when or how often workers'
health must be considered, we expect covered farms to take reasonable
measures, as necessary, to exclude infected or ill employees from
working in operations that may result in contamination of covered
produce until the person's health condition no longer presents a risk
to public health. For example, where harvesting of covered produce is
conducted over multiple days, a farm could have a supervisor inquire
about the health of the harvest crew daily when they report to work,
prior to allowing the crew to enter the field to begin harvesting, and
make appropriate decisions about whether

any workers should be reassigned to different duties.
    We provided other examples in the 2013 proposed rule. As one
example, if an employee tells you that his or her physician (by medical
examination) has diagnosed that the employee has a fever, and the
employee normally handles your covered produce, you must take steps to
ensure that the employee does not come into contact with your covered
produce because the fever may suggest that the employee has an
infection and there is a reasonable possibility of contamination. FDA
is not requiring (nor are we authorizing) you to obtain medical records
of your employees to determine or verify their applicable health
condition(s).
    Similarly, if you see that an employee has an open wound, boil,
cut, or sore, and the employee normally handles covered produce, you
must take steps to ensure that he or she is excluded from handling
covered produce if the wound, boil, cut, or sore could be a source of
microbial contamination. However, the employee may be allowed to handle
covered produce, for example, if the wound, boil, cut, or sore is
adequately covered (e.g., by an impermeable cover) in a manner that
prevents it from becoming a source of contamination for the covered
produce. In addition, note that applicable health conditions do not
include non-communicable diseases such as cancer, diabetes, or high
blood pressure, or non-communicable conditions such as pregnancy.

C. Personnel Hygienic Practices (Sec.  112.32)

    (Comment 168) Some comments raise concern with the provision that
would require washing hands after certain specified occasions. Some
comments point out that some farmers rely on working animals, and state
that a requirement to wash hands after every contact with animals would
be impractical and unnecessary, especially when contact with produce
following contact with animals, is not likely or expected. Instead,
these comments recommend requiring hand-washing before handling produce
and throughout handling, as needed, taking into account the presence of
debris or other unsanitary conditions. Another comment incorrectly
interprets proposed Sec.  112.32(b) to require that hands must be
sterile and free of microbial contaminants, and seeks clarification on
the type(s) of microbial pathogens that must be avoided.
    (Response) Section 112.32(b)(3) requires (in relevant part) the
washing of hands thoroughly, including scrubbing with soap (or other
effective surfactants) and running water, on specified occasions,
including as soon as practical after touching animals (such as
livestock and working animals) or any waste of animal origin. Hand-
washing, when done effectively, can significantly reduce both resident
bacterial populations (such as on the hands of a worker who may not
realize he or she is ill or infected) and transient microbial
contamination (such as bacteria, viruses, and parasites that gets onto
hands through contact with the environment). We are not requiring hands
to be sterile and free of microorganisms. Instead, we are requiring
reasonably necessary steps to be taken to reduce the likelihood of
potential presence of pathogens. Hand-washing is a key control measure
in preventing contamination of covered produce and food-contact
surfaces.
    We are not requiring personnel to wash their hands immediately
after touching animals or after every contact with animals or their
waste. Rather, we require washing hands as soon as practical after
contact with animals or any waste of animal origin, a requirement aimed
at minimizing the potential for transmission of pathogens from animals
onto produce. We recognize the importance of working animals on farms.
This provision ensures that farms are cognizant of the potential for
animals (including livestock and working animals) or their waste to be
a source of contamination of produce, and that appropriate measures are
taken to minimize or avoid such potential. Personnel working with
animals must know when and how to wash their hands. In addition, under
Sec.  112.32(b)(2), which requires taking appropriate steps to minimize
the likelihood of contamination when in direct contact with working
animals, particular attention should be given to clothing, especially
footwear, to ensure that fecal material from barns and barnyards does
not contaminate covered produce and food-contact surfaces.
    Note also, consistent with the revision to Sec.  112.130(b)(3), we
are making a revision to the examples of hand drying devices in Sec.
112.32(b)(3) to list ``single-service towels, sanitary towel service,
electric hand dryers, or other adequate hand drying devices.'' We refer
you to section XVII of this document for the corresponding discussion.
In addition, we are updating this provision to allow the use of other
effective surfactants in lieu of soap that is required during hand-
washing. This revision is consistent with Sec.  112.130(b)(1), which we
are retaining as proposed.
    (Comment 169) One comment suggests that FDA encourage use of
fluorescent substances to highlight unwashed or neglected areas of the
hands.
    (Response) We are not requiring this practice in this rule.
However, technologies such as these, when used in conjunction with
appropriate training, may be a useful tool to teach hand hygiene (Ref.
101) (Ref. 102).
    (Comment 170) One comment seeks more specific provisions under
proposed Sec.  112.32(b)(4) on glove use, specifically the type of
gloves to be used and the meaning of ``sanitary condition.'' The
commenter notes that, for example, farm workers in California use both
disposable gloves and reusable gloves for different activities, and
that whereas disposable gloves can be easily replaced, cotton or
leather gloves are more difficult to replace frequently and to
determine whether they are in a sanitary condition.
    (Response) We are not requiring the use of gloves, or that gloves,
when used, be of a certain type (e.g., disposable, cotton, leather, or
other types). Under Sec.  112.32(b)(4), if gloves are used in handling
covered produce or food-contact surfaces, you are required to maintain
the gloves either in an intact and sanitary condition, or else replace
them. We recognize that heavier gloves are commonly used during certain
covered activities, such as harvesting (for example, of tomatoes or
peppers), to protect workers' hands from cuts or blisters. We are not
aware of any reason to require that covered farm workers use only
certain types of gloves, and therefore we decline to do so. We
recognize that different types of gloves, or no gloves, may be
appropriate depending on the circumstances, and Sec.  112.32(b)(4) as
written provides covered farms with flexibility to choose the practice
that is appropriate for their operations. Regardless of the type of
gloves that a farm may choose to use, gloves would not be in an intact
and sanitary condition if, for example, they have visible feces on them
or have holes or cracks in them such that soil or contaminants can
enter the inside of the glove.
    (Comment 171) Some comments recommend that FDA expand requirements
for hygienic practices to include prohibitions on jewelry, gum,
spitting, chewing, eating, and drinking (excluding drinking water) in
growing areas.
    (Response) We are revising Sec.  112.32(b) to add two new
provisions. New Sec.  112.32(b)(5) requires removing or covering hand
jewelry that cannot be adequately cleaned and sanitized during periods
in which covered produce is manipulated by hand. This provision

addresses the potential biological hazard posed by jewelry that is not
effectively cleaned and could serve as a harborage for pathogens. New
Sec.  112.32(b)(6) requires not eating, chewing gum, or using tobacco
products in an area used for a covered activity (however, drinking
beverages is permitted in designated areas). Eating, chewing gum (and
potentially spitting the gum out), and using tobacco products (and
potentially dropping used cigarettes or cigars or spitting chewing
tobacco juice) all constitute potential avenues of dissemination of
enteric foodborne pathogens (Ref. 103) (Ref. 104) (Ref. 105) (Ref.
106). However, we are not prohibiting the consumption of beverages by
personnel in designated areas. For example, drinking beverages is often
necessary to prevent dehydration during outdoor activities, including
in growing areas. The best practice is to have water (or other
beverage) and drinking cups readily accessible to workers near an area
where they are working outdoors, such as at the end of a row of covered
produce being harvested.
    These requirements are consistent with, although not identical to,
the requirements for food facilities, under the PCHF regulation (Sec.
117.10(b)(4) and (b)(8)), and our long-standing provisions in the Food
CGMP regulation (Sec.  110.10(b)(4) and (b)(8)).
    In addition, these requirements are consistent with the Industry
Harmonized GAPs standard for field operations and harvesting, which
recommends that operations have a policy that personal effects such as
jewelry, watches, or other items must not be worn or brought into
production areas if they pose a threat to food safety. This standard
also states that smoking, chewing, eating, or drinking (other than
water) should not be permitted in any growing areas, and recommends
that operations adopt a policy to prohibit these practices except in
designated areas (Ref. 49) (Ref. 50). Section 112.32(b)(5) is also
similar to provisions in another industry guidance (Ref. 60) and the
Codex Guide. Section 112.32(b)(6) is also similar to provisions in the
AFDO Model Code (Ref. 62), a marketing agreement (Ref. 40), and the
Codex Guide. In addition, the AFDO Model Code (Ref. 62) and a marketing
agreement (Ref. 40) direct farms to have a written policy regarding
jewelry. We believe many farms are already implementing the measures
required by Sec.  112.32(b)(5) and (6) based on these industry
recommendations, and we believe they are practical measures for produce
safety that are reasonably necessary to prevent the introduction of
known or reasonably foreseeable hazards into produce and to provide
reasonable assurances that produce is not adulterated under section 402
of the FD&C Act.

D. Visitors (Sec.  112.33)

    (Comment 172) One comment questions whether or how proposed Sec.
112.33 would help prevent the spread of foodborne illness, especially
if the visitor does not come into contact with the food and merely
tours the facility and observes the farm's operations. Other comments
express concern that these provisions hold the farm accountable for the
actions of customers who visit their operation. One of these comments
requests that we establish a requirement that farm visitors who are
sick must not enter areas where covered activities are taking place, or
that visitors who will be handling covered produce must notify a farm
of any significant health conditions before entering the farm.
    (Response) As with workers, visitors can transmit microorganisms of
public health significance to covered produce or food-contact surfaces.
For example, a visitor who is ill or infected touring a produce field
during a harvesting activity can be an indirect source of
contamination, even if the visitor does not come into direct contact
with the covered produce or a food-contact surface. We recognize that
visitors to a farm often enter areas where covered produce is grown or
harvested, particularly in the case where a farm offers consumers the
opportunity to pick their own fruits or vegetables. Section 112.33 is
not aimed at restricting visitors from entering your farm as part of
the routine course of your business. Rather, they are measures that
reasonably minimize the potential for visitors to become a source of
produce contamination, provide reasonable assurances that produce is
not adulterated under section 402 of the FD&C Act.
    As noted in response to Comment 114, we have included a definition
for the term ``visitor'' within Sec.  112.3(c) using the text in
proposed Sec.  112.33(a). As a result, we have eliminated proposed
Sec.  112.33(a), and we are renumbering proposed Sec.  112.33(b) and
(c) as final Sec.  112.33(a) and (b), respectively.
    Under final Sec.  112.33(a), you must make visitors aware of your
policies and procedures to protect covered produce and food-contact
surfaces from contamination by people, and take all steps reasonably
necessary to ensure that visitors comply with such policies and
procedures. For example, a farm could comply with Sec.  112.33(a) by
explaining the importance of health and personal hygiene, including
proper hand-washing procedures and the potential for contamination from
ill or infected visitors, to all visitors who are likely to come into
contact with covered produce or food-contact surfaces, at the beginning
of a visitor's visit. As another example, a farm could clearly post the
rules applicable to visitors where they are likely to be seen and read
at the beginning of a visitor's visit, such as near the entrance or
cash register at a ``pick-your-own'' farm operation. As another
example, a farm might choose to voluntarily establish a policy that
visitors who are visibly ill may not enter specific areas of the farm
(and/or during specific times, such as during harvesting). We are not
requiring farms to establish such a policy, however. For a farm with
such a policy, informing visitors of the policy and taking steps to
implement it would satisfy the requirements of Sec.  112.33(a).
    We believe that the requirements of Sec.  112.33 are those
reasonably necessary to prevent contamination of covered produce by
visitors. As such, we decline to include requirements that apply
directly to visitors.
    (Comment 173) Other comments express concern with proposed Sec.
112.33(c). Comments state that requiring full-scale bathroom and hand-
washing facilities in the fields would not be practical, and points out
that many operations can provide only portable toilets and hand
sanitizers for visitors. Stating that it is common courtesy for farms
to provide toilet facilities to visitors, another comment finds FDA's
requirement related to this issue unnecessary for the purpose of
ensuring food safety. This commenter also states that having personnel
and visitors share the same toilet facilities would increase the
likelihood of spreading infections. Another comment requests that
proposed Sec.  112.33(c) include a ``grandfather clause'' for current
farms.
    (Response) As discussed in section XVII of this document, under the
requirements outlined in subpart L of part 112, covered farms are
required to have clean and well-maintained toilet and hand-washing
facilities for their personnel as a measure to prevent contamination of
produce and food-contact surfaces (see Sec. Sec.  112.129 and 112.130),
and Sec.  112.33 establishes only the incremental requirement that such
facilities must be made accessible to visitors. This provision does not
prescribe the number, specific location, type, or designated use of
such facilities. Therefore, it is not required for a

covered farm to provide ``full-scale'' bathrooms in the field for
visitors to use; nor is it required for a covered farm to provide
separate toilet or hand-washing facilities for visitors and for farm
personnel. For example, portable toilets may be a feasible option for
use by personnel and/or visitors when in the field. Note, however, that
the general requirements that apply to toilet facilities and hand-
washing facilities are specified in Sec. Sec.  112.129 and 112.130,
respectively. As noted in the 2013 proposed rule, a farm could comply
with the requirements of Sec.  112.33 by, for example, indicating the
location of restrooms and hand-washing facilities that are accessible
to visitors and clearly posting rules applicable to visitors where they
are likely to be seen and read at the beginning of a visitor's visit,
such as near the entrance or cash register at a ``pick-your-own'' farm
operation. Given the minimal nature of this requirement, we disagree
that this provision causes undue economic burden to farms or is
impractical, or that a specific exemption(s) is warranted for certain
farms. We also disagree that visitors and personnel sharing the same
restrooms and/or hand-washing facilities would increase the risk of
spreading communicable disease and thereby contaminating covered
produce. Compliance with the provisions of the rule related to hand-
washing requirements and hygiene generally for personnel (Sec.
112.32), adequacy of toilet and hand-washing facilities (Sec. Sec.
112.129 and 112.130), and visitors (Sec.  112.33) are expected to
minimize risk, not to increase risk. Any possible increase in use of
toilet or hand-washing facilities caused by visitors should not
increase the risk presented to covered produce if the farm is in
compliance with these relevant provisions.

XIII. Subpart E--Comments on Agricultural Water

    In subpart E of proposed part 112, as described in the 2013
proposed rule and the supplemental notice, taken together, we proposed
science-based minimum standards directed to agricultural water that are
reasonably necessary to minimize the risk of serious adverse health
consequences or death from the use of, or exposure to, covered produce,
including those reasonably necessary to prevent the introduction of
known or reasonably foreseeable hazards into covered produce, and to
provide reasonable assurances that the produce is not adulterated under
section 402 of the FD&C Act. In addition, in the supplemental notice,
taking into account comments on the 2013 proposed rule, we proposed to
amend our water quality and testing requirements in proposed Sec. Sec.
112.44 and 112.45 (79 FR 58434 at 58440-58457).
    In the 2013 proposed rule and the supplemental notice, we asked for
comment on our proposed provisions, including the proposed requirements
that all agricultural water must be safe and of adequate sanitary
quality for its intended use; the measures that must be taken with
respect to agricultural water sources, water distribution systems, and
pooling of water; the treatment of agricultural water; the microbial
quality standards required for agricultural water used for certain
specified purposes; the testing required for agricultural water,
including our tiered approach to testing; the measures that must be
taken for agricultural water used during harvest, packing, and holding
activities for covered produce; and the requirements regarding records
related to agricultural water.
    In this section of this document we discuss comments we received on
the standards directed to agricultural water in the 2013 proposed rule,
but that we did not address in the supplemental notice. We also discuss
comments that we received on the new and amended proposed provisions in
the supplemental notice.
    We are finalizing these provisions with several changes. We re-
structured subpart E to better organize the requirements related to
agricultural water into the following categories: (1) General
requirements for agricultural water quality (Sec.  112.41); (2)
Inspection of agricultural water distribution systems and pooling of
water (Sec.  112.42); (3) Treatment of agricultural water (Sec.
112.43); (4) Specific microbial quality criteria for certain uses of
agricultural water (Sec.  112.44); (5) Follow-up measures or corrective
actions if agricultural water does not meet applicable requirements,
including microbial quality criteria (Sec.  112.45); (6) Frequency of
testing of agricultural water (Sec.  112.46); (7) Who must perform
water tests and what analytical methods must be used (Sec.  112.47);
(8) Agricultural water that is used during harvesting, packing, and
holding (Sec.  112.48); (9) Permitted alternatives (Sec.  112.49); and
(10) Records requirements (Sec.  112.50). In Table 11, we identify the
new final provision corresponding to each proposed provision, and
describe the nature of substantive revisions to that proposed
provision. We discuss all of the revisions to the proposed requirements
in this section.

   Table 11--Description of Re-Arrangement and Revisions to Subpart E
------------------------------------------------------------------------
                                                       Description of
      Proposed provision         Final provision         revisions
------------------------------------------------------------------------
Sec.   112.41.................  Sec.   112.41....  --No change.
Sec.   112.42(a), (b), (c)....  Sec.   112.42      --Revision to clarify
                                 (a), (b), (c).     inspection
                                                    requirement in Sec.
                                                     112.42(a) applies
                                                    to the extent
                                                    agricultural water
                                                    distribution systems
                                                    are under your
                                                    control, but
                                                    including
                                                    consideration of
                                                    factors that may not
                                                    be under your
                                                    control.
                                                   --Revision to replace
                                                    ``the entire
                                                    agricultural water
                                                    system'' with ``all
                                                    of your agricultural
                                                    water systems'' and
                                                    corresponding edits
                                                    to refer to ``water
                                                    sources'' and
                                                    ``water distribution
                                                    systems'' given a
                                                    farm may have
                                                    multiple
                                                    agricultural water
                                                    systems.
                                                   --Revision of Sec.
                                                    112.42(a) to clarify
                                                    inspection is
                                                    required at the
                                                    beginning of a
                                                    growing season, as
                                                    appropriate, but at
                                                    least once annually.
                                                   --Revision of Sec.
                                                    112.42(a)(4) to make
                                                    clear both adjacent
                                                    and nearby lands are
                                                    to be included in
                                                    required
                                                    considerations.
                                                   --Reordered Sec.
                                                    112.42(b) and (c).
                                                   --Revision of Sec.
                                                    112.42(b) to clarify
                                                    maintenance
                                                    requirement for
                                                    agricultural water
                                                    distribution systems
                                                    applies to the
                                                    extent such systems
                                                    are under your
                                                    control.
                                                   --Revision of Sec.
                                                    112.42(c) to clarify
                                                    measures required to
                                                    adequately maintain
                                                    agricultural water
                                                    sources.

Sec.   112.42(d)..............  Sec.   112.45(a)   --Revisions to
                                 and 112.45(b).     clarify measures
                                                    that are required
                                                    when agricultural
                                                    water is not safe or
                                                    of adequate sanitary
                                                    quality for its
                                                    intended use; does
                                                    not meet the
                                                    microbial quality
                                                    criterion in Sec.
                                                    112.44(a); or does
                                                    not meet the
                                                    microbial quality
                                                    criteria in Sec.
                                                    122.44(b).
                                                   --Revision to replace
                                                    ``the entire
                                                    agricultural water
                                                    system'' with ``the
                                                    entire affected
                                                    agricultural water
                                                    system'' to clarify
                                                    re-inspection
                                                    requirement.
Sec.   112.42(e)..............  Sec.   112.42(d).  --Revision to clarify
                                                    the intent to focus
                                                    on reducing the
                                                    potential for
                                                    contamination as a
                                                    result of ``contact
                                                    of covered produce
                                                    with'' pooled water.
Sec.   112.43(a), (b), (c)....  Sec.   112.43(a)   --Revision to clarify
                                 and (b).           that treatment of
                                                    water is one among
                                                    other permitted
                                                    options to ensure
                                                    the safety of water
                                                    for its intended
                                                    use.
                                                   --Revision to clarify
                                                    that water treatment
                                                    options are not
                                                    limited to chemical
                                                    methods, and to
                                                    include physical
                                                    treatment, including
                                                    using a pesticide
                                                    device, and other
                                                    suitable method as
                                                    additional treatment
                                                    options.
Sec.   112.44(a)..............  Sec.   112.44(a).  --Revision to
                                                    separate testing
                                                    requirements and
                                                    required follow-up
                                                    measures from
                                                    microbial quality
                                                    criteria.
                                                   --Revision to
                                                    prohibit use of
                                                    untreated surface
                                                    water for purposes
                                                    listed in Sec.
                                                    112.44(a).
                                                   --Revision to delete
                                                    proposed Sec.
                                                    112.44(a)(3)
                                                    reference to water
                                                    used to make
                                                    agricultural teas.
Sec.   112.47(b)..............                     --Rearrangement of
                                                    requirements to use
                                                    specified analytical
                                                    methods into a
                                                    separate provision
                                                    within Sec.
                                                    112.47.
                                                   --Requirement that
                                                    samples must be
                                                    aseptically
                                                    collected.
Sec.   112.44(b)..............  Sec.   112.45(a).  --Revisions to
                                                    clarify measures
                                                    that are required
                                                    when agricultural
                                                    water is not safe or
                                                    of adequate sanitary
                                                    quality for its
                                                    intended use, and/or
                                                    does not meet the
                                                    microbial quality
                                                    criteria in Sec.
                                                    112.44(a).
Sec.   112.44(c)..............  Sec.   112.44(b).  --Revision to
                                                    separate testing
                                                    requirements and
                                                    required follow-up
                                                    measures from
                                                    microbial quality
                                                    criteria.
                                Sec.   112.47(b).  --Rearrangement of
                                                    requirements related
                                                    to analytical
                                                    methods as a
                                                    separate provision
                                                    within Sec.
                                                    112.47.
                                                   --Requirement that
                                                    samples must be
                                                    aseptically
                                                    collected.
Sec.   112.44(c)(1), (c)(2),    Sec.   112.45(b).  --Revisions to
 and (c)(3).                                        clarify measures
                                                    that are required
                                                    when agricultural
                                                    water does not meet
                                                    the microbial
                                                    quality criteria in
                                                    Sec.   112.44(b),
                                                    including the timing
                                                    when such measures
                                                    must be taken.
                                                   --New limitation in
                                                    Sec.
                                                    112.45(b)(1)(i)(A)
                                                    that a time interval
                                                    of no more than four
                                                    consecutive days may
                                                    be applied between
                                                    last irrigation and
                                                    harvest to achieve
                                                    the microbial
                                                    quality criteria in
                                                    Sec.   112.44(b)
                                                   --Revision to provide
                                                    that an alternative
                                                    microbial die-off
                                                    rate permitted under
                                                    Sec.
                                                    112.45(b)(1)(i)(B)
                                                    may be accompanied
                                                    by a maximum time
                                                    interval, in
                                                    accordance with Sec.
                                                      112.49.
Sec.   112.44(d)..............  Sec.   112.49....  --Consolidation of
                                                    all provisions that
                                                    provide for the use
                                                    of alternatives into
                                                    new Sec.   112.49,
                                                    with additional
                                                    provisions to permit
                                                    alternatives to
                                                    testing frequencies
                                                    required under Sec.
                                                     112.46(b).
Sec.   112.45(a)..............  Sec.   112.46(a).  --Revision to add
                                                    reference to
                                                    relevant EPA
                                                    definition of a
                                                    State approved to
                                                    administer the SDWA
                                                    public water supply
                                                    program, in 40 CFR
                                                    141.2.
Sec.   112.45(b) and (c)......  Sec.   112.46(b).  --Revision to combine
                                                    testing requirements
                                                    for untreated
                                                    surface water and
                                                    untreated ground
                                                    water used for
                                                    purposes specified
                                                    in Sec.   112.44(b),
                                                    differing only in
                                                    number of samples
                                                    required for initial
                                                    and annual surveys.
                                                   --Revision to require
                                                    updating the
                                                    microbial quality
                                                    profile annually,
                                                    using annual survey
                                                    data and based on a
                                                    rolling dataset of
                                                    20 samples for
                                                    untreated surface
                                                    water or 4 samples
                                                    for untreated ground
                                                    water.
                                                   --Revision to require
                                                    that previous years'
                                                    data, when used,
                                                    must be limited to
                                                    samples collected
                                                    within the previous
                                                    4 years.
                                                   --Elimination of
                                                    requirement to re-
                                                    characterize the
                                                    water quality
                                                    profile every 10
                                                    years.
                                                   --Corresponding
                                                    revisions to
                                                    requirement to re-
                                                    establish the
                                                    microbial quality
                                                    profile if you know
                                                    or have reason to
                                                    believe that your
                                                    microbial quality
                                                    profile no longer
                                                    represents the
                                                    quality of water.
                                                   --Revisions to
                                                    clarify timing of
                                                    sample collection.
Sec.   112.45(c)..............  Sec.   112.46(c).  --Revisions to
                                                    separately state
                                                    testing requirements
                                                    for use of untreated
                                                    ground water for
                                                    uses specified in
                                                    Sec.   112.44(a).
Sec.   112.45(d)..............  Sec.   112.44(a).  --Revision to
                                                    prohibit the use of
                                                    untreated surface
                                                    water for the
                                                    purposes specified
                                                    in Sec.   112.44(a).
Sec.   112.45(e)..............  Sec.   112.47(a).  --No substantive
                                                    change.
Sec.   112.46.................  Sec.   112.48....  --No substantive
                                                    change.

Sec.   112.50.................  Sec.   112.50....  --Revision to combine
                                                    two proposed records
                                                    requirements related
                                                    to test results
                                                    (proposed Sec.
                                                    112.50(b)(2) and
                                                    (5)) into one
                                                    requirement (Sec.
                                                    112.50(b)(2)).
                                                   --Revisions
                                                    corresponding to
                                                    elimination of Sec.
                                                     112.161(b),
                                                    requiring records of
                                                    actions taken in
                                                    accordance with Sec.
                                                      112.45, and
                                                    establishing
                                                    specific
                                                    requirements for
                                                    application of time
                                                    intervals under Sec.
                                                      112.45(b) (Sec.
                                                    112.50(b)(6)).
                                                   --Revisions to
                                                    require records of
                                                    scientific data or
                                                    information related
                                                    to use of
                                                    alternatives
                                                    permitted under Sec.
                                                      112.49 (Sec.
                                                    112.50(b)(8)).
                                                   --Addition of new
                                                    Sec.   112.50(b)(9)
                                                    to require
                                                    documentation of any
                                                    analytical methods
                                                    used in lieu of the
                                                    prescribed method in
                                                    Sec.   112.151(a).
------------------------------------------------------------------------

A. General Comments

1. Research
    (Comment 174) Several comments state that further research is
needed to determine appropriate standards for water quality, and
recommend that FDA partner with various land grant universities, and
other agencies, including NRCS and EPA, utilizing both funded research
programs and incentive-based programs to promote safe water management
practices. Some comments suggest that FDA conduct a risk assessment
based on research findings and seek public comment on the results of
the risk assessment, prior to finalizing a standard(s) for the quality
of agricultural water. Other comments offer various suggested topics
for future research, including some comments that maintain that
landscapes, weather patterns, and water sources vary significantly and,
therefore, further research should be done to understand the physical
differences of the national landscape as it pertains to produce safety.
    (Response) We do not agree that more research, followed by a risk
assessment based on that research, is needed for us to finalize the
provisions of this rule relating to agricultural water. As discussed in
the 2013 proposed rule, the supplemental notice, and in the paragraphs
that follow, there is sufficient scientific information from which we
conclude that the requirements in this rule minimize the risk of
serious adverse health consequences and death, and are reasonably
necessary to prevent the introduction of known or reasonably
foreseeable hazards into produce and to provide reasonable assurances
that produce is not adulterated. In addition, as discussed in section V
of this document, we have conducted a qualitative assessment of risk of
hazards associated with produce production, which indicates that
agricultural water is a potential route of contamination of produce
during growing, harvesting, and on-farm postharvest activities and that
use of poor agricultural practices could lead to contamination and
illness even where the potential for contamination is relatively low.
The science-based minimum standards established in subpart E of part
112 address this on-farm route of contamination.
    However, we do support additional research as a means of
facilitating implementation of this rule and continuing advancement of
scientific knowledge in this area. As discussed in the 2013 proposed
rule, we are pursuing regulatory science and research activities in
collaboration with various partners. We have supported extramural
research and collaborated with other federal agencies, academic
institutions, and industry-supported entities to leverage research
efforts, expertise, and resources (such as experimental stations for
field research). For example, we are working with USDA to conduct
research of mutual interest in key areas, including agricultural water.
    In addition, FDA has provided funding to develop a produce safety
research network at the Western Center for Food Safety (WCFS) at the
University of California, Davis. Research studies at WCFS include
projects related to the microbiological quality of irrigation water in
catchments and distribution systems; evaluation of agricultural water
quality parameters and the cost-benefit of farm-level interventions;
and microbial water quality of moving surface waters. We intend for
these collaborative efforts to result in the collection of data that
will help advance the state of scientific knowledge on the safe use of
agricultural water. WCFS also partnered with the Center for Produce
Safety to provide seed money through a competitive grants program to
fund produce safety projects focused on agricultural water issues that
are topical and/or region specific. WCFS has further partnered with
academic institutions located in various regions in the United States,
including in California, Florida, Hawaii, Oregon, and Washington, to
conduct research on a variety of commodities including apples, citrus,
and onions. We intend to disseminate useful scientific information
obtained from these efforts, when available. We support additional
research as a means for forming a basis for possible future rulemaking
in this area.
2. Generic E. coli as an Indicator
    (Comment 175) Some comments consider testing for indicators of
water quality to be inappropriate because the final objective is to
prevent pathogen contamination. Therefore, these commenters believe the
microbiological standards for agricultural water in this rule should be
based on direct pathogen detection rather than on indicator
organism(s). These comments recommend that FDA provide a list of
pathogens of concern and specify the levels in agricultural water at
which they pose a risk. Some comments also suggest where water exceeds
any specified level of indicator organism, the farm should not be
required to discontinue use of the water, and instead should directly
test for specified pathogens of concern.
    (Response) We discussed our review of current scientific
literature, potential approaches, and complexity associated with
microbiological indicators of water quality in the 2013 proposed rule
(78 FR 3504 at 3561-3563; 3567-3568). As described in that document, we
considered two general approaches to establishing a microbiological
water quality testing program, i.e., to either test for the presence of
an indicator organism(s) that may signal the presence of pathogens or
test for pathogens themselves.
    In the United States, bacterial indicators have a long history of
being

used to demonstrate the safety of drinking water and adequacy of its
treatment. They have also been used to monitor the status of drinking
water in distribution systems and determine if surface waters are
microbiologically safe for recreational use (e.g., swimming) and
shellfish harvest (Ref. 107). Although no single indicator is
universally accepted, indicator microorganisms are widely used in water
quality testing because of their broad utility across many types of
water (Ref. 107). We acknowledge that pathogen detection has the
obvious advantage of directly targeting microorganisms in water that
are a risk to public health; however, we continue to believe sampling
water for pathogens presents additional challenges, including
significantly larger sample sizes, inherently higher costs, and the
wide array of potential target pathogens (i.e., the presence or absence
of one pathogen may not predict for the presence or absence of other
pathogens). The comments did not provide information from which we
could conclude that pathogen testing would be a viable approach, either
for initial testing or for follow-up testing as suggested by some
comments. Therefore, rather than requiring testing for the presence or
levels of various pathogens of public health significance, we are
requiring testing for a microbial indicator as a measure to monitor and
assess the potential for contamination in agricultural water.
    (Comment 176) Some comments support our proposal to use generic E.
coli as an indicator of water quality in the proposed standards for
microbial quality of water. These comments agree that, while imperfect,
it is the most indicative of currently available indicators of fecal
pollution and support its use to monitor the quality of agricultural
water. In contrast, some other comments argue that E. coli is not a
suitable indicator for monitoring water used in an agricultural
setting, and cite different reasons, including that (1) in the view of
these commenters, the correlation between pathogen presence and E. coli
presence is not strong and E. coli cannot predict the presence of
certain bacterial and non-bacterial pathogens; (2) pathogens may be
present even if the E. coli threshold in the microbial quality standard
is not exceeded, or conversely, that pathogens may not be present even
if the threshold is exceeded; and (3) although the proposed indicator
may provide valid information in one region of the country, it may not
provide valid information in another region. Some commenters also view
current data on the use of E. coli as an indicator organism to be
conflicting and, therefore, recommend waiting until science on this
issue evolves to identify better indicator(s) of fecal pollution,
rather than developing microbial quality standards based on E. coli as
an indicator, which they believe could be overly burdensome.
    (Response) A number of indicator microorganisms have been used to
predict the presence of fecal pollution (thereby the potential for
enteric pathogens) in water, with varying degrees of success. These
include total coliforms, fecal coliforms, enterococci, generic E. coli,
and coliphages. However, as comments noted, the presence of indicators
does not always signal the presence of pathogens, and the absence of
detection of indicators does not guarantee that pathogens are absent
(Ref. 108) (Ref. 109) (Ref. 110) (Ref. 111).
    We reviewed the most widely used fecal indicator(s) or indicator
groups for their potential in assessing the microbial quality of water
used for purposes described in Sec.  112.44(a) and (b). We considered
total coliforms and fecal coliforms as indicators of fecal
contamination but determined that neither of them can serve as reliable
indicators of a fecal contamination event (Ref. 112) (Ref.113) (Ref.
114). Generic E. coli is a member of both the coliform and fecal
coliform groups and it has been shown using various detection methods
to be the coliform most consistently associated with fecal
contamination (Ref. 112) (Ref. 113) (Ref. 115) (Ref. 116) (Ref. 117).
Generic E. coli alone, as an easily distinguishable member of the fecal
coliform group, is more likely than the fecal coliform group as a whole
to indicate fecal pollution (Ref. 118). Used in this way, indicator
organisms are not used specifically to predict the presence of
pathogens, but are useful predictors of undesirable conditions (e.g.,
ineffective treatment or presence of fecal material) that may lead to
contamination of water used in an agricultural setting.
    As explained in the 2013 proposed rule, generic E. coli has an
extensive history of and support for use as an indicator of fecal
contamination. Recently, it has emerged as the preferred indicator for
monitoring water quality, not only because of the problems with other
fecal indicator groups noted previously, but also due to the
development of superior methods of detection with greater accuracy,
sensitivity, and simplicity over those previously used (Ref. 113).
Generic E. coli is also recognized as a water quality criterion
indicative of the suitability of water for domestic, industrial, and
other uses (Ref. 100) (Ref. 116). We also recognize that, despite
widespread use of and support for generic E. coli as an indicator of
fecal contamination, its ability to signal contamination events is not
without challenges. Sampling frequency and location relative to the
source of contamination are reported to affect the performance of
generic E. coli as an indicator of fecal contamination (Ref. 107) (Ref.
119). Thus, non-detection cannot be considered absolute confirmation
that fecal contamination has not occurred. Further, the persistence and
transport of generic E. coli takes different paths in different
watersheds, and reservoirs have been identified, particularly
sediments, where E. coli may escape detection in the water column (Ref.
110) (Ref. 120) (Ref. 121) (Ref. 122). Nevertheless, based on our
review of current literature, we conclude that generic E. coli serves
as the most appropriate microbial indicator of fecal contamination of
water at this time. We are not aware of any new scientific data or
information, nor have the comments submitted any such data or
information, to support a different conclusion. Therefore, we are
finalizing our microbial quality criteria for agricultural water in
Sec.  112.44(a) and (b) relying on generic E. coli as the indicator
organism.
    We acknowledge the difficulty of associating specific indicator
concentrations with specific produce related health risks. Even so, we
conclude that such difficulty does not negate the value of applying
generic E. coli test results to the criteria in Sec.  112.44(a) and (b)
because elevated indicator organism concentrations indicate increased
levels of fecal contamination and therefore elevated likelihood of the
presence of human pathogens of fecal origin (Ref. 107) (Ref. 111).
    (Comment 177) Some comments recommend that FDA should allow covered
farms to develop alternative microbial water quality criteria to those
in proposed Sec.  112.44(c) using indicator organisms other than
generic E. coli.
    (Response) Sections 112.12(a) and 112.49(a) allow for the use of an
alternative microbial water quality criterion (or criteria) based on an
indicator of fecal contamination, in lieu of that established in Sec.
112.44(b) (proposed as Sec.  112.44(c)). A potential example of such an
alternative microbial quality standard is the use of a different fecal
indicator organism as a basis for a corresponding GM and STV that are
demonstrated to detect measurable levels of fecal

contamination in agricultural water used during growing of produce
(other than sprouts) using a direct water application method with at
least equivalent sensitivity to the criteria we established in Sec.
112.44(b). Farms may establish such alternative microbial criterion (or
criteria), provided that the farm has adequate scientific data or
information to support a conclusion that the alternative criterion (or
criteria) would provide the same level of public health protection as
the criteria in Sec.  112.44(b) and would not increase the likelihood
that the covered produce will be adulterated.
3. Scope of ``Agricultural Water'' and Applicability of Subpart E
    (Comment 178) Several comments request clarification on whether the
requirements in subpart E apply to water used during growing of various
types of crops. For example, some comments ask whether subpart E
applies to water used to irrigate root crops, such as onions and
carrots, using drip irrigation. Some comments also ask us to clarify
whether and how subpart E applies to water used during growing those
commodities, such as tomatoes, cantaloupe, or cucumbers, where the
produce may contact the ground or be in a splash zone versus those
commodities, such as tree crops, that do not come in contact with the
ground or irrigation water. One comment suggests produce grown using
drip irrigation or otherwise not directly exposed to irrigation water
should not be covered under subpart E.
    (Response) Section E establishes requirements applicable to
agricultural water. Whether or not water used during the growing,
harvesting, packing, or holding of covered produce is subject to the
requirements of subpart E depends on whether the specific use of the
water fits within the definition of ``agricultural water.'' If a
specific use of water does not fit within the definition of
agricultural water, then the provisions of subpart E do not apply to
that specific use of water. Because irrigation practices vary widely,
we do not believe it is necessary or appropriate to categorize specific
commodities or types of irrigation, generally, as being subject to or
not subject to the requirements of subpart E. In addition, we note that
subpart E applies to more than just water used during growing (e.g.,
irrigation water).
    For purposes of this rule, we define agricultural water as water
used in covered activities on covered produce where water is intended
to, or is likely to, contact covered produce or food-contact surfaces,
including water used in growing activities (including irrigation water
applied using direct water application methods, water used for
preparing crop sprays, and water used for growing sprouts) and in
harvesting, packing, and holding activities (including water used for
washing or cooling harvested produce and water used for preventing
dehydration of covered produce). Related to this definition is our
definition of ``direct water application method,'' which means
agricultural water used in a manner whereby the water is intended to,
or is likely to, contact covered produce or food-contact surfaces
during use of the water (Sec.  112.3(c)).
    Water that is intended to or likely to contact covered produce that
is a root crop, including water used for drip irrigation of root crops,
fits within the definition of ``agricultural water'' and the definition
of ``direct water application method.'' For example, irrigating carrots
using drip irrigation that is intended to filter through the soil and
contact the carrots growing underground is agricultural water applied
using a direct water application method because the water is intended
to, and likely to, contact the covered produce. Similarly, water used
to make a crop protection spray applied to tree fruit just before
harvest is agricultural water applied using a direct water application
method. However, irrigation water that is neither intended to nor
likely to contact covered produce, such as water used for drip
irrigation of tree crops that grow high above the ground and are not
likely to touch the ground, is not ``agricultural water'' and,
therefore, not subject to subpart E.

B. General Agricultural Water Quality Requirement (Sec.  112.41) and
Corresponding Corrective Measures (Sec.  112.45(a))

    (Comment 179) A number of comments agree that agricultural water
can be a source of contamination of produce and, therefore, support the
proposed requirement that all agricultural water must be safe and of
adequate sanitary quality for its intended use. Several comments
suggest modifying proposed Sec.  112.41 to require that all water used
in the production of covered produce, not just agricultural water as
defined in the 2013 proposed rule, must be safe and of adequate
sanitary quality for its intended use. These comments state that water
outside the definition of agricultural water could still spread
contamination through runoff or practices such as dust abatement in
close proximity to covered produce.
    (Response) Our QAR shows that water used in ways that are intended
to, or likely to, contact covered produce or food-contact surfaces is
more likely to contaminate produce than water that is not intended to,
or not likely to, contact covered produce or food-contact surfaces.
This rule, therefore, targets the hazards associated with water that is
intended to, or likely to, contact covered produce or food-contact
surfaces (``agricultural water'' as defined in the rule). We are not
expanding the scope of ``agricultural water'' (see section IX.B of this
document) or the applicability of the requirement in Sec.  112.41, to
include water that is not intended to, or not likely to, contact
covered produce or food-contact surfaces because we conclude it is not
reasonably necessary to apply the requirements in this rule, or in
Sec.  112.41 in particular, to such water to prevent the introduction
of known or reasonably foreseeable hazards into produce and to provide
reasonable assurances that produce is not adulterated.
    We agree, however, that water that is not intended to or likely to
contact covered produce or food-contact surfaces can still present a
possibility of produce contamination, albeit with lower likelihood than
that associated with agricultural water as defined in the rule.
Therefore, the safe and appropriate use of all water that is used in
growing, harvesting, packing, and holding of produce is important,
including water that is outside of the scope of ``agricultural water''
and, therefore, not subject to the standards in this rule. Uses of such
water that are outside the scope of ``agricultural water'' subject to
the standards in this rule may adulterate produce under section
402(a)(4) of the FD&C Act 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.
Moreover, if a pathogen is detected in or on produce, such produce
would be considered adulterated under section 402(a)(1) of the FD&C
Act, in that it bears or contains a poisonous or deleterious substance
which may render it injurious to health.
    (Comment 180) Some commenters request clarification regarding the
specific standard(s) that must be met to ensure agricultural water is
safe and of adequate sanitary quality in compliance with proposed Sec.
112.41. Comments also ask how the microbial quality criteria in
proposed Sec.  112.44 should be interpreted in relation to the
requirement in proposed Sec.  112.41.

    (Response) As discussed in the 2013 proposed rule, the principle of
``safe and of adequate sanitary quality for its intended use'' contains
elements related both to the attributes of the source water used and
the activity, practice, or use of the water. The way in which water is
used for different commodities and agricultural practices can affect
the risk of contamination of the produce, for example, the use of
overhead irrigation on lettuce versus drip irrigation of tree crops.
Moreover, as discussed in the QAR, the timing of irrigation water
application also plays a role in minimizing the persistence of
contamination.
    The requirements for agricultural water in subpart E of part 112
reflect our consideration of these issues. We are establishing a
general requirement in Sec.  112.41 that all agricultural water used in
the growing, harvesting, packing, or holding of covered produce must be
safe and of adequate sanitary quality for its intended use. We view
this requirement as a general standard of water quality applicable to
all covered activities that involve the use of water where the water is
intended to or likely to contact covered produce or food-contact
surfaces. In addition to this general water quality requirement, we are
establishing two separate microbial water quality criteria specifically
to address the potential for fecal contamination and relying on generic
E. coli as an indicator. These criteria apply to agricultural water
when used for certain purposes: The microbial water quality requirement
of zero detectable generic E. coli for agricultural water applies to
those purposes specified in final Sec.  112.44(a); and the microbial
water quality criteria of certain GM and STV values of generic E. coli
applies to agricultural water used during growing activities for
covered produce (other than sprouts) using a direct water application
method as stated in final Sec.  112.44(b). Each of these microbial
quality requirements has a different purpose, as discussed in the
paragraphs that follow.
    First, the microbial quality requirement of zero-detectable generic
E. coli, in final Sec.  112.44(a), for the purposes specified in that
provision, is intended to address the known or reasonably foreseeable
hazards associated with fecal contamination of agricultural water. In
addition, it is targeted at uses of agricultural water where if
pathogens or fecal contamination are present, it is reasonably likely
they could be transferred directly to covered produce through direct or
indirect (via food-contact surfaces) contact with the water. In this
regard, we consider the agricultural water that does not meet the
microbial quality requirement in final Sec.  112.44(a) also does not
meet the general requirement of safe and of adequate sanitary quality
in final Sec.  112.41. Therefore, in final Sec.  112.45(a), we
establish certain immediate corrective measures that you must take if
you determine that your agricultural water does not meet the microbial
quality requirement in Sec.  112.44(a), which are the same corrective
measures that are necessary when your agricultural water does not meet
the general requirement in Sec.  112.41.
    We note, however, that agricultural water that meets the microbial
water quality criterion in Sec.  112.44(a) may not necessarily be safe
or of adequate sanitary quality for its intended use. Section 112.44(a)
addresses the potential for agricultural water to be a source of fecal
contamination, and we have concluded that, at this time, generic E.
coli is the preferred indicator of fecal contamination. Nevertheless,
we acknowledge that generic E. coli has limitations as an indicator
organism and, therefore, non-detection of generic E. coli cannot be
considered absolute confirmation that fecal contamination has not
occurred. However, generic E. coli has been shown using various
detection methods to be the coliform most consistently associated with
fecal contamination. See discussion in the 2013 proposed rule (78 FR
3504 at 3562). Therefore, although a test result indicating the
agricultural water does not meet the applicable microbial water quality
requirement in Sec.  112.44(a) demonstrates that the water is not safe
or of adequate sanitary quality for those specified uses, the converse
is not necessarily true. That is, agricultural water that meets Sec.
112.44(a) may not be safe or of adequate sanitary quality, for example,
due to the presence of pathogenic organisms.
    Second, the microbial quality criteria of specified levels of GM
and STV values of generic E. coli, in Sec.  112.44(b), for agricultural
water used in a direct application method during growing of produce
(other than sprouts), like Sec.  112.44(a), are intended to address the
known or reasonably foreseeable hazards associated with fecal
contamination of agricultural water. However, we view this provision as
a water management tool for use in understanding the microbial quality
of your water over time, and determining how to appropriately use water
from that source, rather than as a direct indicator of the safety or
adequacy of the sanitary quality of water for its immediate purposes.
Consistent with our intent for Sec.  112.44(b) to support your long-
term strategy for use of water sources, under final Sec.  112.45(b), if
your water does not meet the microbial quality criteria in Sec.
112.44(b), we require you to take certain corrective measures as soon
as practicable, and no later than the following year. Those corrective
measures provide additional means by which to achieve the microbial
quality criteria, allowing you to continue to use agricultural water
that does not initially satisfy those criteria but that satisfies the
criteria after accounting for microbial die-off. Moreover, our
corresponding testing scheme (Sec.  112.46(b)) similarly facilitates a
long-term strategy to help covered farms to understand the quality of
their water sources and plan the use of water from those sources
accordingly, per Sec.  112.45(b).
    The stringency of the applicable microbial quality criteria (and
related flexibility) varies between Sec.  112.44(a) and (b), reflecting
the likelihood of microbial contamination of covered produce from
agricultural water when used for the respective specified purposes. In
both cases, however, meeting the microbial quality criteria in Sec.
112.44 ((a) or (b)) does not automatically ensure that the requirement
in Sec.  112.41 is satisfied. See also examples discussed under Comment
246.
    (Comment 181) Several comments state that many farms effectively
have only a single source of water that can be used to irrigate their
crops and that this is often a surface water source with the only
alternate source of water potentially requiring the construction of a
new ground water well. Some comments also note that, for many farms,
constructing a new well is often geologically or economically not
feasible and that this is a significant problem if the current water
source is not safe and of adequate sanitary quality for its intended
use as required by proposed Sec.  112.41.
    (Response) Under final Sec.  112.45, we are providing for different
options that a covered farm can consider when agricultural water is
found to be not safe or of adequate sanitary quality for its intended
use (including when water does not meet the microbial quality criterion
in Sec.  112.44(a)) (see Sec.  112.45(a)) or when agricultural water
does not meet the microbial quality criteria in Sec.  112.44(b) (see
Sec.  112.45(b)).
    Under Sec.  112.45(a), a covered farm can re-inspect the entire
affected agricultural water system to the extent it is under the farm's
control, identify any conditions that are reasonably likely to
introduce known or reasonably

foreseeable hazards into or onto covered produce or food-contact
surfaces, make necessary changes, and take adequate steps to determine
if the changes were effective, and, as applicable, adequately ensure
that the agricultural water meets the microbial quality criteria in
Sec.  112.44(a). The covered farm may also treat the water in
accordance with the requirements in Sec.  112.43. Depending on the
circumstances, the farm may be able to use the water for a different
purpose, as appropriate (for example, agricultural water that does not
satisfy the more stringent microbial quality criterion in Sec.
112.44(a) may be appropriate for use as irrigation water for produce
(other than sprouts) if it meets the criteria in Sec.  112.44(b)). See
examples under Comment 246.
    Under Sec.  112.45(b), specifically in relation to irrigation water
and other water directly applied to covered produce other than sprouts
during growing, we have incorporated flexibility by providing
additional means to achieve the microbial quality criteria. A covered
farm may apply a time interval (in days) between last irrigation and
harvest using a microbial die-off rate of 0.5 log per day, but not more
than four consecutive days (Sec.  112.45(b)(1)(i)); and/or apply a time
interval (in days) using an appropriate microbial die-off rate between
harvest and end of storage and/or appropriate microbial removal rates
during activities such as commercial washing, provided the farm has
adequate supporting scientific data and information for the microbial
die-off and/or removal rates (Sec.  112.45(b)(1)(ii)). We also provide
for the use of an alternative microbial die-off rate between last
irrigation and harvest and an accompanying maximum time interval, in
new Sec.  112.49(b). We expect covered farms will be able to consider
and implement these options, as appropriate. In particular, we expect
the increased flexibility provided in Sec.  112.45(b)(1) to reduce the
likelihood that a covered farm will need to alter the source of its
irrigation water. In addition, when water subject to the Sec.
112.44(b) standard does not meet that standard, a farm may re-inspect
the entire affected agricultural water system to the extent it is under
the farm's control, identify any conditions that are reasonably likely
to introduce known or reasonably foreseeable hazards into or onto
covered produce or food-contact surfaces, make necessary changes, and
take adequate measures to determine if your changes were effective and
adequately ensure that your agricultural water meets the microbial
quality criteria (Sec.  112.45(b)(2)). It would also be an option for
the farm to treat agricultural water in accordance with Sec.  112.43
(Sec.  112.45(b)(3)). See examples discussed under Comment 246.
    We note, however, that there will likely be some situations in
which a farm's water source is unsafe and/or of inadequate sanitary
quality for a particular use, or where it cannot and does not meet the
microbial quality criteria in Sec.  112.44(b), such that it may not be
used for that specific purpose in compliance with this rule unless it
is treated in accordance with Sec.  112.43. Violation of this rule is a
prohibited act that may subject a farm to enforcement or other
appropriate action (see Sec.  112.192).
    (Comment 182) Some comments ask for clarification on whether
recycled, reclaimed, or gray water may be used during growing of
covered produce.
    (Response) The requirements for agricultural water quality
established in Sec. Sec.  112.41 and 112.44, apply regardless of the
source or type of water that you use as agricultural water, except that
untreated surface water is not permitted for uses identified in Sec.
112.44(a). You must determine the appropriate use of agricultural water
in light of the conditions and practices on your farm, and taking into
account the general safe and of adequate sanitary quality standard in
Sec.  112.41 as well as any specific microbial quality criteria
relevant to your intended use(s) of that agricultural water in Sec.
112.44. See also Comment 222. We will consider providing guidance on
the use of various types of water, including recycled, reclaimed, and
gray water, in the future.

C. Agricultural Water Sources, Water Distribution Systems, and Pooling
of Water (Sec.  112.42)

    (Comment 183) Several comments express concern regarding the
identification of conditions that are reasonably likely to introduce
known or reasonably foreseeable hazards into or onto covered produce or
food-contact surfaces in proposed Sec.  112.42(a). These comments state
that it is unclear what specifically should be considered to be
reasonably foreseeable hazards in making such a determination.
    (Response) In Sec.  112.3, we define ``known or reasonably
foreseeable hazard'' to mean a biological hazard that is known to be,
or has the potential to be, associated with the farm or the food. We
are establishing a definition for this term as this term is used in
section 419(c)(1)(A) of the FD&C Act and reflected in several
requirements in part 112. Under final Sec.  112.42(a), you are required
to inspect all of your agricultural water systems to the extent they
are under your control (including water sources, water distribution
systems, facilities, and equipment), to identify conditions that are
reasonably likely to introduce known or reasonably foreseeable hazards
into or onto covered produce or food-contact surfaces in light of your
covered produce, practices, and conditions. The specific known or
potential hazards that may be associated with your farm and food, in
relation to your agricultural water, will likely vary dependent on your
specific agricultural water source(s), water distribution system(s),
practices on your farm, and your covered produce. Section 112.42(a)
requires you to identify and characterize those activities and
situations that may lead to contamination of your agricultural water
with pathogens. Some examples of such activities and situations are
described in the 2013 proposed rule (see 78 FR 3504 at 3565). For
example, we noted that ground water could be compromised and its water
quality degraded if wells are improperly constructed, poorly
maintained, or improperly located (e.g., near areas of extensive
livestock production). As another example, we noted that if you use
water from a river and are downstream from a waste water treatment
plant that discharges into that river, this provision would require you
to consider the likelihood that the wastewater treatment plant
introduces hazards into the water before it reaches your farm, such as
the likelihood of accidental discharge of untreated municipal sewage
into the river. We will consider providing guidance on the
identification of conditions that are reasonably likely to introduce
known or reasonably foreseeable hazards in the produce safety
regulation implementation guidance to be issued in the near future.
    (Comment 184) Several comments express concern about the
identification of conditions that are reasonably likely to introduce
known or reasonably foreseeable hazards into or onto covered produce or
food-contact surfaces when the source of the hazards is out of their
control. A comment, agreeing with the proposed requirement in Sec.
112.42(a), states that farms should not shoulder the burden of ensuring
the quality of agricultural water when the source of water
contamination is off-farm. Several comments state that a farm cannot
assess the presence of hazards before the water reaches the farm and
external water sources (e.g., a canal) are neither under control of the
farm nor subject to decisions that are within the farm's control.

    (Response) As discussed in the 2013 proposed rule, inspection of
your water source(s) provides an opportunity to identify and
characterize activities and situations that may lead to contamination
of your agricultural water with pathogens. Inspection results (and
initial survey results, when required under Sec.  112.46(b)) provide
you with historical knowledge of your water sources, their quality, and
factors that may affect their quality. Inspection of the water sources
and any equipment used to obtain the water from the source (e.g., well
head, pumps, pipes) can ensure that the portions of the agricultural
water system(s) that are under your control are not likely to introduce
known or reasonably foreseeable hazards into or onto covered produce or
food-contact surfaces. We recognize that not all aspects of a water
source or system may be under your control and, therefore, under Sec.
112.42(a)(2), we are requiring you to consider the extent to which you
have control over your agricultural water source(s) to identify
conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food-contact
surfaces. For example, you may have more control over a ground water
source such as a small spring if the expanse of the spring is under
your control and you are able to protect the spring from the influence
of surface activities. You may have greater access to and control of
on-farm surface water sources such as impoundments, catches, and ponds,
than you would for flowing surface waters that only course through but
do not originate on your land. Similarly, under Sec.  112.42(a)(4), we
are requiring you to consider the use of adjacent and nearby land.
While you may have little or no control of other agricultural water
user practices, this requirement to consider those nearby uses of which
you are aware will help you determine appropriate and safe use of your
water source(s). Under Sec.  112.42(a)(5), we are requiring you to
consider the likelihood of introduction of known or reasonably
foreseeable hazards to agricultural water by another user of
agricultural water before the water reaches your farm. This, too, is
something over which you may have little or no control. Considering
factors such as these, which may affect the quality of your water
source(s) even though they are not necessarily under your control, is
an important part of evaluating whether your water source(s) meets the
requirement in Sec.  112.41 that your agricultural water must be safe
and of adequate sanitary quality for its intended use.
    We are also revising Sec.  112.42(c) to clarify that adequate
maintenance of your agricultural water sources includes regularly
inspecting each source to identify any conditions that are reasonably
likely to introduce known or reasonably foreseeable hazards into or
onto covered produce or food-contact surfaces; and correcting any
significant deficiencies (e.g., repairs to well cap, well casing,
sanitary seals, piping tanks and treatment equipment, and control of
cross-connections), in addition to keeping the source free of debris,
trash, domesticated animals, and other possible sources of
contamination of covered produce to the extent practicable and
appropriate under the circumstances.
    (Comment 185) One comment recommends that farm operators should be
allowed to design a water sampling program for their operations based
on the level of control over the water source and the manner in which
water is used. Acknowledging that proposed Sec.  112.42 requires every
covered farm operator to conduct an inspection of their water systems
to evaluate the associated risk of microbial contamination, the comment
proposes that farm operators should then be allowed to use information
from their inspection to tailor operation-specific sampling frequencies
and start-stop acceptance criteria based on the capacity of their
system.
    (Response) In the supplemental notice, which we issued subsequent
to the submission of these comments, we proposed to provide tiered
approaches for specific water testing frequency requirements to test
untreated surface water as well as untreated ground water, which would
entail testing at a reduced frequency than that proposed in the 2013
proposed rule. Under these tiered approaches to testing, we are
establishing a sampling design that incorporates flexibility for
covered farms to adjust the frequency and timing of sampling and number
of samples beyond the minimum necessary parameters, based on the farm's
operations. In light of comments in response to the supplemental
notice, some of which similarly request additional flexibility to
tailor water testing frequency based on operations on the farm, we are
providing, in new Sec.  112.49(c) and (d), for the use of an
alternative testing frequency for untreated surface water sources (in
lieu of those required in Sec.  112.46(b)(1)(i)(A) or Sec.
112.46(b)(2)(i)(A)), under the conditions specified in Sec.  112.12.
    (Comment 186) We received several comments that request
clarification on the phrase in Sec.  112.42(a), ``the entire
agricultural water system under your control.'' The requests for
clarification include questions regarding how far upstream farms are
responsible for monitoring for potential sources of contamination and
whether the responsibility stops at the farm's property line or extends
to properties beyond the farm's control. Comments also state that many
water systems are vast and incredibly complex, and the 2013 proposed
rule does not adequately or realistically account for such complexity.
    (Response) The agricultural water systems referred to in Sec.
112.42(a) include the water source(s), water distribution system(s),
facilities, and equipment. (See also Comment 192 regarding multiple
water sources and water systems.) Recognizing the diversity in water
sources and the extent to which you can protect the water source or its
distribution system, we incorporated into Sec.  112.42(a) a list of
factors that must be considered during an inspection of your
agricultural water system(s). The identification of potential hazards
related to agricultural water systems must consider the nature of each
agricultural water source (for example, ground water or surface water),
the extent of the farm's control over each agricultural water source,
the degree of protection of each agricultural water source, the use of
adjacent and nearby land, and 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. We
understand that water systems can be complex, and we are not requiring
covered farms to inspect portions of an agricultural water system that
are beyond their control. However, the extent to which you control your
agricultural water source(s), and certain factors over which you may
have little or no control will likely influence the identification or
characterization of potential hazards associated with your agricultural
water system(s), and evaluating these factors as part of your
inspection under Sec.  112.42(a) will help you determine the
appropriate and safe use of the agricultural water from your water
source(s). To make our intent clear, we are revising ``under your
control'' in Sec.  112.42(a) to read ``to the extent they are under
your control,'' and making similar changes in descriptions of
maintenance requirements for water distribution systems and water
sources

in Sec. Sec.  112.42(b) and (c). See also the discussion under Comment
184.
    (Comment 187) Several comments request clarification of the timing
of inspection, particularly in circumstances where crops are grown
throughout the year (such as almonds) or where covered farms have
multiple or year-round growing seasons. To account for such
circumstances, some comments suggest that the phrase ``at the beginning
of the growing season'' in Sec.  112.42(a) should be replaced with ``as
applicable or at least annually.''
    (Response) We recognize that many crops have year-round growing
seasons and also that covered farms may have operations or multiple
crops with year-round or staggered growing seasons throughout the year.
In light of these comments, and to make our intent clear, we are
revising Sec.  112.42(a) to require inspection of agricultural water
systems ``at the beginning of a growing season, as appropriate, but at
least once annually.'' Thus, for example, a farm that has multiple
crops that have different growing seasons is only required to inspect
once annually, at the beginning of one of the growing seasons. As
another example, a farm that has a single crop with a continual, year-
round growing season is also required to inspect at least once
annually, and such a farm may consider an appropriate time to be the
beginning of the growing season. We have incorporated flexibility in
this requirement to allow farms to independently determine the
appropriate timing and number of inspections that are necessary to
identify conditions that are reasonably likely to introduce known or
reasonably foreseeable hazards into or onto covered produce or food-
contact surfaces in light of the covered produce, practices, and
conditions and based on the knowledge of the water system, its inherent
variability, and the vulnerability of their water source to
contamination.
    (Comment 188) A comment suggests that the language of Sec.
112.42(a)(4) should be limited to adjacent land, and not include
``nearby land'' because ``adjacent'' is not the same as ``nearby''.
    (Response) We agree that ``adjacent'' and ``nearby'' have different
meanings, and we intend to require you to consider both adjacent land
and nearby land uses in identifying and characterizing the potential
hazards affecting your agricultural water system. By ``adjacent'' land
we are referring to land sharing a common border with the farm's land.
By ``nearby'' land we are referring to a broader category of land,
including land that does not adjoin the farm's land but has the
potential to affect the farm's water source(s) based on the land's
location. For example, agricultural water may be affected by upstream
agricultural practices and runoff from those operations into surface
water sources that are used as agricultural water even if the upstream
operations' lands are not adjacent to your farm's land. While you may
have little or no control of other agricultural water users' practices,
this requirement to consider those adjacent and nearby land uses of
which you are aware will help you determine the appropriate and safe
use of that water source. We are revising this provision to read ``use
of adjacent and nearby land'' to make clear that both adjacent and
nearby land uses are included.
    (Comment 189) Several comments request clarification on whether, if
there is a reason to believe that a farm's agricultural water is not
safe and of adequate sanitary quality for its intended use, the farm is
required to take measures specified in proposed Sec.  112.42(d)(1) or
proposed Sec.  112.42(d)(2), and whether or not the farm is required to
follow proposed Sec.  112.42(d)(2) if the requirements in proposed
Sec.  112.42(d)(1) are met. In addition, one comment focusing on
proposed Sec.  112.42(d) states that although it may be feasible and
reasonable to discontinue the use of water used in postharvest
activities when there are doubts about the sanitary quality of water
that is being used, immediately discontinuing the use of water used in
irrigation is not a feasible option for the health or maintenance of
the crop. This commenter also suggests specific thresholds or ``action
levels'' that could be identified for water used during postharvest and
growing activities.
    (Response) See our response to Comment 181 and Table 11. We have
now consolidated proposed Sec.  112.42(d) and proposed Sec.  112.44(b)
into final Sec.  112.45(a), which establishes the corrective measures
that must be taken, and the required timing, when agricultural water
does not meet the general requirement in Sec.  112.41 and/or when it
does not meet the microbial quality requirement in Sec.  112.44(a) for
those specified purposes. In addition, in final Sec.  112.45(b), we
specify the corrective measures that must be taken, and the required
timing, when agricultural water does not meet the microbial quality
criteria in Sec.  112.44(b) for the specified purpose.
    Specifically, Sec.  112.44(a) establishes the microbial quality
requirement for certain specified uses of agricultural water. Water
used for washing hands during and after harvest, sprout irrigation,
directly contacting covered produce during or after harvest (such as in
washing and cooling, or to make ice that directly contacts covered
produce), and water or ice that will contact food-contact surfaces that
contact covered produce presents a greater likelihood of microbial
contamination of covered produce and, therefore, we are applying a more
stringent standard for water quality without options to account for
die-off or other microbial reduction for these intended uses. For these
specified uses, we are retaining the requirement, in final Sec.
112.45(a), for you to immediately discontinue the use of the water that
does not meet the applicable microbial quality requirement until you
take the necessary required measures in Sec.  112.45(a)(1) or (a)(2).
    In addition, with respect to the microbial quality criteria in
Sec.  112.44(b) for agricultural water used during growing for covered
produce other than sprouts using a direct water application method, we
are retaining our proposed flexible options in the final provisions
Sec. Sec.  112.45(b)(1) and 112.49, making it less likely that a farm
will have to discontinue use of the water used for these purposes due
to small fluctuations in water quality. In addition, under Sec.
112.45(b)(2) and (3), farms also have similar options to those in Sec.
112.45(a). Moreover, under Sec.  112.45(b), these corrective actions
are not required to be taken immediately. They are required to be taken
as soon as practicable, and no later than the following year. See
examples discussed under Comment 246.
    With respect to thresholds suggested by one commenter, we have also
made revisions to the water testing requirements that eliminate the
need to re-characterize the water quality profile for Sec.  112.44(b)
uses in response to specific annual survey results that are over a
particular ``threshold'' (final Sec.  112.46(b)). This structure was a
limitation to our proposed tiered-approach that we acknowledged in the
supplemental notice (79 FR 58434 at 58453), which we believe is now
adequately addressed under our revised final testing scheme. See also
Comment 244.
    (Comment 190) Some comments, referring to proposed Sec.  112.42(e),
note that water pooling in produce fields occurs often and it would be
impractical to expect that all pooling water can or should be
eliminated. Some commenters also believe it is unclear how pooled water
increases the likelihood of produce microbial contamination,
particularly if agricultural water and soil amendments with only a rare
probability of containing human pathogens (in

accordance with proposed requirements) are used. Another comment states
that there should be a length of time identified for how long water can
stand before it is considered a potential hazard. This commenter states
that seasonal flooding causing water to pool and drain naturally should
not be considered the same as overflow from a polluted source of water.
    (Response) As noted in the 2013 proposed rule, we acknowledge the
potential for small pools of water to temporarily form in field areas
or at the base of plants after irrigation. Small amounts of water of
this nature are temporary and occur in the normal course of irrigation
practices. We are not suggesting that it will always be possible to
eliminate pooling. However, pooled water that remains for extended
periods of time can be a source of contamination (Ref. 14) (Ref. 40)
and pooled water in close proximity to the crop may serve as an
attractant for pests and other animals, which may in turn introduce
hazards into the pooled water that may contaminate produce. Therefore,
we are retaining this proposed requirement with some revisions. In
final Sec.  112.42(d), we clarify our intent to reduce the potential
for contamination as a result of contact of covered produce with pooled
water. After the phrase ``reduce the potential for contamination . .
.'' we have replaced ``as a result of pooling of water'' with the
phrase ``as a result of contact of covered produce with pooled water.''
However, we believe additional specificity in this requirement beyond
this revision, such as establishing a maximum acceptable length of time
for standing of pooled water, is unnecessary and would not provide
sufficient flexibility for covered farms to implement measures as
necessary and appropriate.
    (Comment 191) Regarding proposed Sec.  112.42(c), one comment
suggests adding the phrase ``under your control'' to the first sentence
as a qualifier applied to ``agricultural water distribution systems.''
    (Response) We agree with this recommendation, and are revising
final Sec.  112.42(c) to refer to agricultural water distribution
systems to the extent they are under your control.
    (Comment 192) One comment states that agricultural water entering
the produce production areas may be serviced by more than one ``water
system'' that is in turn fed by one or more water sources. The
commenter recommends that inspections should be conducted at each water
source and re-inspections under proposed Sec. Sec.  112.42(d)(1) and
112.44(b) and (c) should be limited to locations serviced by the source
where the problem was identified. The commenter suggests clarifying the
codified text to read ``the water system under your control that is
serviced by that source.''
    (Response) We consider each agricultural water source in your
operation to be from a discrete body of water (e.g., a canal, a pond, a
river) that represents the microbial quality of agricultural water as
it is used in your growing, harvesting, packing, or holding activities.
Where this rule establishes a testing requirement for a water source,
that requirement applies to each discrete source of water used for the
relevant purpose, regardless of whether the water is used for multiple
commodities, or applied over non-contiguous fields. The annual
agricultural water system inspection required under Sec.  112.42(a)
includes each discrete water source if a farm has more than one water
source, and must also include all relevant water distribution systems,
facilities, and equipment. We are revising Sec.  112.42(a) to reflect
this by clarifying that you must inspect ``all of your agricultural
water systems, to the extent they are under your control (including
water sources, water distribution systems, facilities, and
equipment).''
    When a re-inspection is conducted to satisfy Sec.  112.45(a)(1) or
(b)(2) after identification of a problem with agricultural water, such
re-inspection can be limited to the affected agricultural water system
with which a problem was identified, but the entirety of the affected
system must be re-inspected to enable potential problems to be
identified. We are revising Sec.  112.45(a)(1) and (b)(2) to specify
that such requirements apply to the ``entire affected agricultural
water system,'' which includes the relevant water source(s), water
distribution system(s), facilities, and equipment. For a discussion on
identifying a ``source,'' see our response to Comment 237.
    (Comment 193) Referring to proposed Sec.  112.42(d)(1), which
requires covered farms to take certain steps ``when you have determined
or have reason to believe that your agricultural water is not safe or
of adequate sanitary quality for its intended use,'' a commenter
asserts that this provision leaves the decision to test or not to test
agricultural water up to farms--and that such decision is dependent
upon knowing or having reason to believe that water is not safe or of
adequate sanitary quality for its intended use.
    (Response) We disagree with the interpretation offered by this
commenter, which appears to be based on proposed Sec.  112.42(d)(1)
alone, disregarding other applicable provisions in subpart E of part
112. Other provisions in subpart E establish the minimum science-based
microbial quality standards for agricultural water for specified
intended uses and for testing agricultural water (including minimum
sampling requirements) to ensure its safe and appropriate use
(Sec. Sec.  112.44, 112.45, and 112.46). See the discussion in section
XIII.G of this document.

D. Treatment of Agricultural Water (Sec.  112.43)

    (Comment 194) Several comments express concerns about the potential
adverse environmental impacts that could occur as a result of
implementation of the water treatment provisions in proposed Sec.
112.43. For example, one comment states that widespread use of
antimicrobial pesticides on ground water and surface water sources by
farms across the country would have a detrimental effect on the
environment, water quality, and human health. Citing the potential for
environmental contamination and destruction to soil health, some
comments also recommend that FDA should not encourage chemical
treatment of irrigation water. Some comments also worry that proposed
Sec.  112.43 would encourage the use of pesticides to treat
agricultural water because treating water may be the most viable option
for some farms, particularly when they are limited to a single water
source. One comment maintains that it is unlikely that any untreated
surface water would meet the proposed microbial standards and that, as
a result, farmers would be forced to either treat their water or find a
different water source. Another commenter states that some farms may
use unorthodox approaches to treating water, such as pouring bleach
into a pond, which could result in environmental problems. Yet another
comment recommends that FDA provide an option to develop practices,
such as an interval between irrigation and harvest, to reduce the
potential for antimicrobial treatment of irrigation water. Another
comment asserts that packing shed discharge may create significant
impacts on downstream water quality. In addition, some comments support
Sec.  112.43(a), as proposed, and affirm that treatment of water should
be an option available to farms who believe their water is
contaminated, based upon their experience and risk assessment. In
contrast, other comments state that the use of chemical sanitizers to
treat

irrigation water should not be allowed, encouraged, or required.
    (Response) Certain methods of treating water and wastewater are
effective means of achieving microbial reduction (Ref. 123). However,
water treatments that are inadequate or improperly applied,
interrupted, or intermittent have been associated with waterborne
disease outbreaks (Ref. 124). Failures in treatment systems are largely
attributed to suboptimal particle removal and treatment malfunction
(Ref. 125). For this reason, when treating water, it is important to
monitor the treatment parameters to ensure the treatment is delivered
in an effective manner. Therefore, we are retaining the provisions for
treatment of water in Sec.  112.43, with some revisions as explained
here.
    In Sec.  112.45, we are providing for different options that a
covered farm can consider when agricultural water is found to be not
safe or of adequate sanitary quality for its intended use and/or to not
meet the relevant microbial quality criteria in Sec.  112.44(a) or (b),
and treatment is only one of those options. In Comment 181 and Comment
189, we discuss the flexible options provided in final Sec. Sec.
112.45(a) and (b) and 112.49, and we anticipate that covered farms will
consider and implement these options, as appropriate, prior to or in
conjunction with considering whether to treat water to ensure that it
meets the applicable requirements for its intended use. As such, the
produce safety regulation does not require covered farms to consider
treating agricultural water as an immediate first step where the water
is not safe or of adequate sanitary quality for its intended use.
Rather, covered farms have a range of viable options to consider based
on practices and conditions specific to the farm, treatment of water
being only one such option. Indeed, we believe some of these other
options are likely to be more feasible than the option to treat water.
Moreover, covered farms will have two additional years (beyond the date
of compliance for the remainder of this rule) to comply with many of
the water provisions of this rule for covered activities involving
covered produce (except sprouts), which is intended to help farms to
consider and implement measures that are most appropriate for their
operations. See our discussion of compliance dates in section XIII.K of
this document.
    We acknowledge that proposed Sec.  112.43 might have been read to
suggest that the treatment of water is always a required measure to
ensure the safety of water for its intended use. We did not intend such
a meaning. In light of comments we received, and to make our intent
clear, we are revising the question and paragraph (a) in final Sec.
112.43 to read as follows: ``Sec.  112.43 What requirements apply to
treating agricultural water? (a) When agricultural water is treated in
accordance with Sec.  112.45 of this part: . . . .'' In addition, in
final Sec. Sec.  112.43(a)(1), 112.43(a)(2), and 112.43(b), we are
revising the purpose of treating water to acknowledge that treatment is
an option that a farm may use either to meet the general requirement in
Sec.  112.41 and/or to satisfy the microbial quality criteria in
Sec. Sec.  112.44(a) and/or (b).
    We recognize that improper use, management, or disposal associated
with chemical treatment of agricultural water can create adverse
environmental impacts. Subsequent to publishing the 2013 proposed rule,
FDA determined that the proposed produce safety rule may significantly
affect the quality of the human environment (21 CFR 25.22(b)), and,
therefore, an EIS is necessary for the final rule. In accordance with
the National Environmental Policy Act (NEPA) and its implementing FDA
regulations, we have evaluated the potential effects of the produce
safety regulation on the human environment in the United States. Our
evaluation and conclusions based on that evaluation are described in
the final EIS (Ref. 126). We refer you to that document for a detailed
discussion of the potential environmental effects of the produce safety
regulation, including those associated with the standards for
agricultural water in subpart E of part 112. This analysis includes
potential impacts related to pesticide use, chemical treatment of
agricultural water, changes in ground water demand, and existing water
quality standards.
    With respect to environmental concerns related to chemical
treatment of agricultural water, we note that environmental and health-
related risk assessments of pesticide products are conducted by EPA
prior to their registration and use. The FIFRA provides for federal
regulation of pesticide distribution, sale, and use. All pesticides
distributed or sold in the United States must be registered (licensed)
by EPA. For more information, see http://www2.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide#laws (Ref. 127). The EPA receives and examines
large amounts of test data from producers of pesticides demonstrating
that their products, if used, will not harm the environment or human
health. These data are reviewed by EPA during their determination of
whether to issue a registration for a pesticide product and/or a
specific use of that product (Ref. 52).
    (Comment 195) Several comments discuss the potential use of
chlorine, in particular, to treat agricultural water to meet the
proposed water quality standards. Noting that chlorine is likely to be
used to disinfect agricultural water because it is inexpensive and
readily available, these comments express various concerns, including
that: chlorine products pose a hazard to farmworker health and safety;
chlorine products can cause corrosive damage to stainless steel and
aluminum farm equipment; many crops and plants experience chlorine
damage, such as salt injury to fruit trees; applying large volumes of
chlorinated surface irrigation water on agricultural lands could result
in the formation of trihalomethanes; chlorine interacts with many crop
protection chemicals, potentially resulting in crop damage and reduced
efficacy; and water treated with chlorine can infiltrate soil, run off
into surface waters, and contaminate ground water, with potentially
toxic effects to soil microbes and aquatic organisms. Another comment
questions the ability of chlorine to kill pathogenic bacteria, and
states that its use to treat water can increase costs and contaminate
the environment, without concurrent benefit. Yet another comment
suggests that chlorine treatment of water is logistically challenging
for orchardists, in particular, due to the volume of water needed for
irrigation and cooling within orchards. Several comments also suggest
that FDA recommend that the residual effluent of any use of chlorine
should be limited to 4 ppm, consistent with the organic certification
and Safe Drinking Water Act standards.
    (Response) As noted in response to Comment 194, the produce safety
regulation does not require covered farms to consider treating
agricultural water as an immediate first step where the water does not
meet the applicable requirement for its intended use. Rather, covered
farms have a range of viable options to consider based on practices and
conditions specific to the farm, treatment of water being only one such
option. When a covered farm does choose to treat water, we are
providing for the treatment of water using any effective treatment
method (such as physical treatment, including using a pesticide device
as defined by EPA; EPA-registered antimicrobial pesticide product; or
other suitable method).

    FDA has analyzed the potential environmental impacts of the
agricultural water standard in Chapter 4.2 of the EIS. As part of the
analysis, FDA has determined that presently, there is no EPA-approved
chemical treatment for contaminated water used to irrigate cropland
(Ref. 128). FDA does not have specific information on the pesticides
that might be submitted to EPA for registration for uses to control
specific target organisms, such as pathogens, specifically in
agricultural water applied to produce. However, as described in greater
detail in Chapter 3.1 and 4.2 of the EIS, we agree that the most
commonly used antimicrobials for microbial population reduction are
chlorine chemicals, specifically sodium hypochlorite, calcium
hypochlorite, gaseous chlorine and chlorine dioxide. It is anticipated
that chlorine compounds would be among the preferred chemicals for
which industry would be likely to seek FIFRA registration. FDA has
considered the potential impacts of this rule on the environment and
worker health as part of the EIS (Ref. 126). With respect to
environmental concerns related to chemical treatment of agricultural
water, we note that environmental and health-related risk assessments
of pesticide products are conducted by EPA prior to their registration
and use (see Comment 194).
    Should a covered farm choose to treat their agricultural water to
ensure it meets the applicable requirements for its intended use, we
expect any treatment that is used would be applied in accordance with
all applicable federal, State, tribal, and local regulations.
    (Comment 196) Several comments discuss EPA's registration
requirements related to pesticide use. Acknowledging our statement in
the 2013 proposed rule that no EPA registrations currently exist under
FIFRA for chemicals used in the treatment of irrigation water, comments
express concern about the current lack of available EPA-approved
antimicrobial treatments for irrigation water and the purported lack of
an available EPA process by which such chemicals could be approved.
Such comments state diverse concerns, including that: providing
treatment of irrigation water as an alternative under the produce
safety regulation may not be a viable option; the absence of available
treatment methods may jeopardize the use of some agricultural water
sources and could force some farms to stop irrigating crops and to
suffer economic hardship; treating irrigation water without available
registered options is illegal, in that the use of unapproved substances
would violate both State and federal pesticide-use regulations; and,
due to the lack of approved treatments, farms may treat water with
unapproved methods that could lead to environmental and public health
concerns. Another commenter recommends eliminating proposed Sec.
112.43(a) because no approved treatment products for this use currently
exist. Similarly, another commenter recommends that the water treatment
provisions should not be implemented until a registry of approved water
disinfection agents exists.
    Several comments also request that FDA work with EPA and other
relevant agencies to provide clear direction to industry regarding
acceptable and available water treatment options. One commenter
believes that reliance on a process that is regulated by another
government agency may create uncertainty for farms. This commenter
recommends that FDA collaborate with EPA to: 1) Identify and make
information available about currently-registered compounds and 2)
establish a priority review process to ensure that farms have effective
options available for the treatment of irrigation water prior to the
compliance dates for the water requirements. One comment requests
clarification on the approval that would be required to use an existing
microbial pesticide to meet the requirement in Sec.  112.43.
    Other comments state that EPA-approved products for treating
irrigation water are currently available. For example, one comment
reports that the National Pesticide Information Retrieval System
(NPIRS) database shows that nearly 90 federally-registered disinfectant
products are available for uses in fruit or vegetable wash water or
processing water, and that other products are labeled for use in
treatment of agricultural and irrigation water systems, including drip
irrigation systems. Another comment provides an example of a treatment,
asserting that it is registered with EPA for use in all types of
irrigation water systems, including in USDA-inspected fruit and
vegetable wash water operations.
    (Response) We are retaining Sec.  112.43 with some modifications,
as explained under Comment 194. This provision applies to agricultural
water (as defined in Sec.  112.3) that is used in growing, harvesting,
packing, and holding activities related to covered produce. We
consulted with EPA on currently available options for treating
agricultural water in a manner consistent with Sec.  112.43.
    At this time, no EPA registrations exist for chemical substances
(classified by EPA as ``pesticide products'') for antimicrobial
treatment of agricultural water used during the growing of crops (Ref.
128). However, as discussed in Chapter 4.2 of the EIS, EPA maintains a
list of ``Antimicrobial Products Registered with the EPA as
Sterilizers.'' Each of these products received approval under FIFRA as
amended in 1996 (40 CFR parts 152, 156, and 158). Like all registered
pesticide products, registrations for antimicrobial products are
specific to the use that was considered as part of the registration
process, and thus the products may be legally used for the specified
registered use only. Among compounds on the list of EPA's registered
antimicrobial products as sterilizers are certain registered
antimicrobial washes, which are authorized for use during postharvest
fruit and vegetable washing. These products can be used to treat