[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58433-58473]
[FR Doc No: 2014-22447]

Vol. 79

Monday,

No. 188

September 29, 2014

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 112

Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption; Proposed Rule

Federal Register / Vol. 79 , No. 188 / Monday, September 29, 2014 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2011-N-0921]
RIN 0910-AG35

Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; supplemental notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend certain specific provisions of the proposed rule, ``Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption.'' We are taking this action because the extensive
information received in public comments has led to significant changes
in our current thinking on certain key provisions of the proposed rule.
We are reopening the comment period only with respect to the specific
issues identified in this document.

DATES: Submit either electronic or written comments on the proposed
rule by December 15, 2014. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by December 15, 2014
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
(FDA-2011-N-0921) for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
Purpose of the Supplemental Notice of Proposed Rulemaking
Summary of the Major Provisions of the Supplemental Notice of
Proposed Rulemaking
Costs and Benefits
I. Background
II. Amendments to the Previously Published Proposed Rule
    A. Proposed Subpart A--General Provisions
    B. Proposed Subpart E--Standards Directed to Agricultural Water
    C. Proposed Subpart F--Standards Directed to Biological Soil
Amendments of Animal Origin and Human Waste
    D. Proposed Subpart I--Standards Directed to Domesticated and
Wild Animals
    E. Proposed Subpart R--Withdrawal of Qualified Exemption
III. Preliminary Regulatory Impact Analysis
    A. Overview
    B. Regulatory Flexibility Analysis
    C. Unfunded Mandates
    D. Small Business Regulatory Enforcement Fairness Act
IV. Paperwork Reduction Act of 1995
V. Analysis of Environmental Impact
VI. Comments
VII. References

Executive Summary

Purpose of the Supplemental Notice of Proposed Rulemaking

    To minimize the risk of serious adverse health consequences or
death from consumption of contaminated produce, FDA published the
proposed rule entitled, ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption,'' which would
establish science-based minimum standards for the safe growing,
harvesting, packing, and holding of produce, meaning fruits and
vegetables grown for human consumption (78 FR 3504, January 16, 2013).
FDA proposed these standards to implement section 105 of the FDA Food
Safety Modernization Act (FSMA) (Pub. L. 111-353). The comment period
for the proposed rule closed on November 22, 2013.
    Taking into account information we heard at public meetings, and
based on a preliminary review of written comments submitted to the
docket, currently available information, and our subsequent analysis of
the proposed provisions in light of this information, we are proposing
certain new provisions and certain amendments to our previously
proposed provisions.

Summary of the Major Provisions of the Supplemental Notice of Proposed
Rulemaking

    We are reopening the comment period to seek public comment on the
specific issues and amended and new proposed provisions that are
discussed in this document, which include the following: (1) Proposed
amendments to paragraph (a) of proposed 21 CFR 112.4 to exclude from
coverage of the Produce Safety proposed rule those farms or farm mixed-
type facilities with an average annual monetary value of produce (as
``produce'' is defined in Sec.  112.3(c)) sold during the previous 3-
year period of $25,000 or less (on a rolling basis); and corresponding
revisions to the definitions of ``very small business'' and ``small
business'' in proposed Sec.  112.3(b) to apply the monetary value
thresholds based on sales of produce; (2) proposed amendments to the
definitions of ``farm'' in proposed Sec.  112.3(c) responding to
comments about overlap between the produce and preventive control
rules, such that establishments that pack or hold produce that is grown
or harvested on another farm would now be subject to the produce safety
standards of proposed part 112 regardless of whether or not that farm
is under the same ownership; and corresponding revisions to the
definitions of ``covered activity,'' ``harvesting,'' ``holding,'' and
``packing'' in proposed Sec.  112.3(c); (3) proposed amendments to
Sec.  112.44(c) to update the microbial quality standard for water that
is used during growing of produce (other than sprouts) using a direct
application method in a way that is consistent with the U.S.
Environmental Protection Agency's (EPA) current recreational water
standard, i.e., a geometric mean of samples not to exceed 126 colony
forming units (CFU) of generic Escherichia. coli (E. coli) per 100
milliliters (mL) of water and (when applicable) a statistical threshold
value of samples not to exceed 410 CFU of generic E. coli per 100 mL of
water; (4) new proposed provisions within

Sec.  112.44(c) to incorporate additional flexibility and provide means
to achieve the proposed microbial quality standard for agricultural
water used for direct application during growing, i.e., by either
applying a time interval (in days) between last irrigation and harvest
using a microbial die-off rate of 0.5 log per day (proposed Sec.
112.44(c)(1)); and/or applying a time interval (in days) between
harvest and end of storage (including during activities such as
commercial washing) using appropriate microbial die-off or removal
rates, provided there is adequate supporting scientific data and
information (proposed Sec.  112.44(c)(2)); in addition, a new proposed
provision to provide for an alternative microbial die-off rate between
last irrigation and harvest in accordance with Sec.  112.12; (5)
proposed amendments to Sec.  112.45(b) and new proposed provisions
Sec. Sec.  112.45(c) and (d) to provide tiered-approaches for specific
testing frequency requirements to test untreated surface water as well
as untreated ground water, which would enable testing at a reduced
frequency than that proposed in the previously published proposed rule;
(6) a new proposed provision Sec.  112.45(e) to provide that a farm may
meet the requirements related to agricultural water testing using the
farm's own test results or data collected by a third party or parties,
provided the water source(s) sampled by the third party or parties
adequately represents the farm's agricultural water source(s) and all
other applicable requirements are met; (7) proposed removal of the 9-
month minimum application interval for use of raw manure in proposed
Sec.  112.56(a)(1)(i). FDA defers its decision on an appropriate time
interval until FDA pursues certain actions, including a robust research
agenda, risk assessment, and efforts to support compost infrastructure
development, in concert with the U.S. Department of Agriculture (USDA)
and other stakeholders. At this time, we do not intend to take
exception to the continuation of adherence to the National Organic
Program (NOP) standard; (8) proposed amendments to Sec.
112.56(a)(4)(i)) to establish that if the biological soil amendment of
animal origin is treated by a composting process and is applied in a
manner that minimizes the potential for contact with covered produce
during and after application, then the minimum application interval
(i.e., time between application and harvest) is 0 days; (9) new
proposed provision Sec.  112.84 to explicitly state that part 112 would
not authorize or require covered farms to take actions that would
constitute the ``taking'' of threatened or endangered species in
violation of the Endangered Species Act, or require covered farms to
take measures to exclude animals from outdoor growing areas, or destroy
animal habitat or otherwise clear farm borders around outdoor growing
areas or drainages; (10) new proposed provision Sec.  112.201(b)(1) to
establish that, before FDA issues an order to withdraw a qualified
exemption, FDA may consider one or more other actions to protect the
public health and prevent or mitigate a foodborne illness outbreak,
including a warning letter, recall, administrative detention, refusal
of food offered for import, seizure, and injunction; (11) new proposed
provisions Sec. Sec.  112.201(b)(2) and 112.201(b)(3) to establish
that, before FDA issues an order to withdraw a qualified exemption, FDA
must notify the farm of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the farm to respond to FDA's
notification; and that FDA must consider actions taken by the farm to
address the circumstances that may lead FDA to withdraw the exemption;
and (12) new proposed provision Sec.  112.213 to list the circumstances
under which FDA would reinstate a farm's qualified exemption that is
withdrawn.
    We are seeking comment on the issues discussed in this document by
December 15, 2014. The previously published proposed rule (78 FR 3504;
January 16, 2013) and the proposed amendments and new provisions
published in this document, taken together, constitute the entirety of
the proposed rule on ``Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption.'' At this time, we are
not seeking comment on any other provisions of the previously published
proposed rule that are not identified for public comment in this
document. We will complete our review of public comments received thus
far, and take into account comments received in response to this
document, in issuing a final rule.

Costs and Benefits

    We performed additional analyses to examine the impacts of the
amended and new proposed provisions described in this document. We
estimate the costs of the proposed rule as currently amended to be
$386.23 million annually for domestic farms, $143.39 million annually
for foreign farms covered by the rule (for a grand total of $529.62
million annually), resulting in $400.37 million annually in estimated
potential net benefits.

                     Summary of Costs and Benefits of the Proposed Rule as Currently Amended
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    Prevented
    foodborne        Total benefits     Total domestic     Total foreign       Total costs     Net benefits  (in
  illnesses  (in     (in millions)        costs  (in         costs  (in        (domestic +         millions)
    millions)                             millions)          millions)           foreign)
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           1.57            $930.00            $386.23            $143.39            $529.62            $400.37
----------------------------------------------------------------------------------------------------------------

    Compared to the previously published proposed rule, in total, this
represents a cost savings of $73.33 ($459.56 - $386.23) million for
domestic produce farms, and a decrease in overall net benefits of $7.19
($400.37 - $407.56) million.

I. Background

    To minimize the risk of serious adverse health consequences or
death from consumption of contaminated produce, FDA published the
proposed rule, ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption'' (hereafter referred to as
``the Produce Safety proposed rule'' or ``the previously published
proposed rule''), which would establish science-based minimum standards
for the safe growing, harvesting, packing, and holding of produce,
meaning fruits and vegetables grown for human consumption (78 FR 3504,
January 16, 2013). We later issued a notice to correct technical errors
and errors in reference numbers cited in the proposed rule (78 FR
17155, March 20, 2013).
    In the same issue of the Federal Register in which the Produce
Safety proposed rule was published, FDA published another proposed rule
entitled, ``Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Human Food'' that would apply to
human food and require domestic and foreign facilities that are
required to register

under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to have
written plans that identify hazards, specify the steps that will be put
in place to minimize or prevent those hazards, monitor results, and act
to correct problems that arise (hereafter referred to as ``the
Preventive Controls for Human Food proposed rule'') (78 FR 3646,
January 16, 2013). These proposed rules help form the foundation of,
and a central framework for, a new food safety system in the United
States.
    We requested comments on the Produce Safety proposed rule by May
16, 2013. We extended the comment period for the proposed rule and its
information collection provisions (which are subject to review by the
Office of Management and Budget under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520) (78 FR 11611, February 19, 2013; 78 FR
24692, April 26, 2013; 78 FR 48637, August 9, 2013; 78 FR 69605,
November 20, 2013). The comment period for the proposed rule closed on
November 22, 2013.
    Since publication of the Produce Safety proposed rule in January
2013, we conducted numerous outreach activities. For example, we held
three public meetings to solicit oral stakeholder and public comments
on the proposed rule, inform the public about the rulemaking process
(including how to submit comments, data, and other information to the
rulemaking dockets), and respond to questions about the proposed rule
(78 FR 6762, January 31, 2013, and 78 FR 10107, February 13, 2013). We
also traveled across the country and around the world to discuss the
Produce Safety proposed rule, as well as the other foundational FSMA
proposed rules (Refs. 1, 2, and 3).

II. Amendments to the Previously Published Proposed Rule

    In December 2013, FDA issued a public statement reiterating our
goal of ensuring produce safety, and indicating that, based on the
extensive input we have received from produce farmers, consumers, and
others in the agricultural sector, significant changes will be needed
in key provisions of the Produce Safety proposed rule, including those
related to water quality standards and testing, standards for using raw
manure and compost, certain provisions affecting mixed-use facilities,
and procedures for withdrawing the qualified exemption for certain
farms (Ref. 4). We also announced our intent to propose revised
regulatory requirements and request comment on them, allowing the
public the opportunity to provide input on our current thinking. In
this document, FDA is providing our current thinking on certain issues
discussed in the Produce Safety proposed rule that we previously
published, including certain amended and new proposed provisions, for
public comment. In addition, published elsewhere in this issue of the
Federal Register, we are also providing our current thinking on certain
issues discussed in the Preventive Controls for Human Food proposed
rule that we previously published, and seeking public comment on those
issues.
    To date, over 15,000 electronically submitted comments have been
received in the docket in response to the previously published proposed
rule. We are continuing to review all electronic and paper submissions
of comments to the docket. Taking into account information received at
public meetings, and based on a preliminary review of written comments
submitted to the docket, currently available information, and our
subsequent analysis of the proposed provisions in light of this
information, we are reopening the comment period to seek public comment
on certain specific issues described in this section.
    Importantly, the amended and new proposed provisions we have
included in the regulatory text are based on a preliminary review of
the comments. We will complete our review of comments previously
submitted and consider the comments responsive to this document in
developing the final rule.
    The previously published proposed rule and the proposed amendments
and new provisions published in this document, taken together,
constitute the entirety of the proposed rule on ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption.'' Throughout this document, we discuss amendments and
additions to the previously proposed part 112 and, in the codified
section of this document, we list each of the amended and new proposed
provisions of proposed part 112. For the convenience of readers and
ease of reference, we prepared a separate document to identify the
changes to the previously published codified provisions and provide the
complete proposed part 112, as amended through this document (Ref. 5).

A. Proposed Subpart A--General Provisions

    In the previously published proposed rule, under subpart A of
proposed part 112, we proposed various provisions to establish the
scope of, and definitions applicable to, the Produce Safety regulation,
and to identify who would be subject to the requirements of part 112.
Proposed subpart A also described the proposed modified requirements
and procedures governing qualified exemptions from the regulations. We
discussed each of the proposed provisions and explained our rationale
(78 FR 3504 at 3534 through 3551).
    We are reopening the comment period to solicit public comment on
our current thinking on two specific issues related to the general
provisions in subpart A: (1) Farm sizes based on monetary value of
total food sales to determine those farms that are not covered by the
rule and those that would qualify for extended compliance periods and
(2) definition of ``farm''. We describe our current thinking on these
two issues in this section.
1. Farms Sizes Based on Monetary Value of Total Food Sales
    In the previously published proposed rule, we proposed to apply the
Produce Safety regulation only to farms and farm mixed-type facilities
with an average annual monetary value of food (as defined under the
FD&C Act and including seeds and beans used to grow sprouts) sold
during the previous 3-year period of more than $25,000 on a rolling
basis (proposed Sec.  112.4). We explained that farms below this
$25,000 limit collectively account for only 1.5 percent of covered
produce acres, suggesting that they contribute little exposure to the
overall produce consumption. Based on a tentative conclusion that such
businesses do not contribute significantly to the produce market and,
therefore, to the volume of production that could become contaminated,
we tentatively concluded that imposing the proposed requirements of
part 112 on these businesses is not warranted because it would have
little measurable public health impact. We also noted that such farms
are and would continue to be subject to the applicable provisions of
the FD&C Act and applicable implementing regulations, irrespective of
whether they are included within the scope of the Produce Safety
proposed rule (78 FR 3504 at 3518 and 3549).
    In addition, we proposed to apply certain monetary value thresholds
based on total food sales to define those very small and small
businesses that would be eligible for our proposed extended time
periods to comply with the Produce Safety regulation. In proposed Sec.
112.3(b)(1), we proposed to define ``very small business'' to mean a
business that is subject to proposed part 112 and for which, on a
rolling basis, the average annual monetary value of food (as defined
under the FD&C Act and including seeds and beans used to

grow sprouts) sold during the previous 3-year period is no more than
$250,000. In addition, under proposed Sec.  112.3(b)(2), we proposed to
define ``small business'' to mean a business that is subject to
proposed part 112 and for which, on a rolling basis, the average annual
monetary value of food (as defined under the FD&C Act and including
seeds and beans used to grow sprouts) sold during the previous 3-year
period is no more than $500,000, and which farm is not a ``very small
business.''
    a. Relevant comments. We received several comments opposing our
tentative decision to identify farm sizes based on total food sales
either for coverage by the rule or for extended compliance periods.
Commenters recommended that farm sizes should be based on the sale of
``covered produce'' or ``regulated'' produce, rather than on the sale
of all food. Some of these commenters noted that the proposed coverage
of farms based on their total food sales would make it difficult for
midsize farms to diversify their operations. Other commenters
maintained that covering farms based on their total food sales would
have an adverse impact on diversified farms that primarily raise food
grains or dairy cattle (and produce dairy products) by forcing them to
comply with produce safety standards. Some commenters that recommended
identifying farm sizes (both those that would not be covered and those
that would be covered and considered as ``small businesses'' or ``very
small businesses'') based on monetary value of sales of ``covered
produce'' also recommended similarly applying the qualified exemptions
provided under proposed Sec.  112.5 to farms based on an average annual
monetary value of $500,000 or less of sales of covered produce, rather
than on sales of all food.
    b. FDA's consideration of comments. In response to comments
received, we considered what, if any, revisions are needed to the
proposed $25,000 limit as the threshold above which farms would be
subject to the Produce Safety regulation.
    As noted in the previously published proposed rule, farms with an
average annual monetary value of food sold of $25,000 or less
collectively account for 1.5 percent of covered produce acres,
suggesting that they contribute little exposure to the overall produce
consumption. Applying the $25,000 limit to an average annual monetary
value of produce (rather than food) sold would account for an estimated
total of 4 percent of covered produce acres and about 3.1 percent of
all produce acres in the United States. The amended proposal would
remove farms with produce sales of $25,000 or less from coverage,
resulting in removal of an additional 2.1 percent of produce acres from
coverage (after removal of acres as a result of the provisions related
to the qualified exemption, produce that is rarely consumed raw, and
produce destined for commercial processing that eliminates pathogens of
concern). Under this scenario, as with the previous proposed approach,
such businesses would not contribute significantly to the volume of
produce in the marketplace that could become contaminated and,
therefore, would have little measurable public health impact. We
believe that applying the $25,000 limit to produce sales would
accommodate the concerns expressed by some comments without adversely
affecting the level of public health protection, envisioned under our
previous proposal.
    We also considered applying the $25,000 limit to average annual
monetary value of ``covered produce'' sold, as requested by some
commenters. This scenario presented a number of challenges, including
the difficulty of determining the scope and public health impact of
excluding farms based on the sales of covered produce, particularly
considering the likely variability in produce commodities grown year to
year; variability resulting from provisions under which certain
commodities would not be considered ``covered produce'' (for example,
produce that is rarely consumed raw); changes in the amount of produce
that is used for personal consumption or for consumption on the farm or
another farm under the same ownership; and whether and how to account
for produce that would be eligible for exemption under certain
conditions, which may be inherently variable based on market conditions
(for example, produce that is destined for commercial processing).
Given these confounding factors and based on available data, at this
time, we are unable to determine the extent to which businesses with an
average annual monetary value of ``covered produce'' sold of more than
$25,000 would contribute to the overall produce market or the public
health impact of not covering such businesses under part 112. In
addition, the likely frequent change to a farm's covered or non-covered
status may also be challenging for compliance and enforcement purposes.
    For these reasons, we are proposing to amend paragraph (a) of
proposed Sec.  112.4 to establish that if you are a farm or farm mixed-
type facility with an average annual monetary value of produce (as
``produce'' is defined in Sec.  112.3(c)) sold during the previous 3-
year period of more than $25,000 (on a rolling basis), you are a
``covered farm'' subject to this part, and that if you are a ``covered
farm'' subject to this part, you must comply with all applicable
requirements of this part when you conduct a covered activity on
``covered produce.''
    In addition, we are proposing corresponding revisions to the
definitions of ``very small business'' and ``small business'' to apply
the monetary thresholds consistently across three size-based categories
of businesses that we proposed in the previously published proposed
rule. As revised, a very small business defined under proposed Sec.
112.3(b)(1) would mean a farm that is subject to part 112 and, on a
rolling basis, the average annual monetary value of produce (as defined
in proposed Sec.  112.3(c)) sold during the previous 3-year period is
no more than $250,000. As revised, a small business defined under
proposed Sec.  112.3(b)(2) would mean a farm that is subject to part
112 and, on a rolling basis, the average annual monetary value of
produce (as defined in proposed Sec.  112.3(c)) sold during the
previous 3-year period is no more than $500,000; and the farm is not a
very small business. Applying the monetary value limits for very small
and small businesses to produce rather than to food, as previously
proposed, would not alter the coverage of these businesses under the
Produce Safety regulation, although we expect that a greater number of
farms would likely fit within the revised definitions of very small
business and small business and, therefore, qualify for the extended
compliance periods we proposed for these businesses in the previously
published proposed rule. See Table 1 for summary of these three
proposed size-based categories, as revised.
    We seek comment on our current proposal to cover farms with an
average annual monetary value of ``produce'' sold of more than $25,000,
and the corresponding revisions to apply the relevant monetary
thresholds to the sales of produce to define small businesses and very
small businesses that would be subject to this regulation for the
purpose of establishing extended compliance periods. We also seek
comment on whether and how these monetary thresholds may be applied to
covered produce only.

               Table 1--Summary of Proposed Qualifications
    [On a rolling basis, average annual monetary value of produce (as
  defined in proposed Sec.   112.3(c)) sold during the previous 3-year
                                 period]
------------------------------------------------------------------------

------------------------------------------------------------------------
Above $250,000 and no more than      Small Business.
 $500,000.
Above $25,000 and no more than       Very Small Business.
 $250,000.
$25,000 or less....................  Not covered.
------------------------------------------------------------------------

    We also considered applying the monetary value limit to covered
produce sales, rather than to total food sales, in the criteria
applicable to farms that would be eligible for a qualified exemption
under proposed Sec.  112.5. In the previously published proposed rule,
we proposed that a farm would be eligible for a qualified exemption and
associated modified requirements in a calendar year if: (1) During the
previous 3-year period preceding the applicable calendar year, the
average annual monetary value of the food (as defined in proposed Sec.
112.3(c)) you sold directly to qualified end-users (as defined in
proposed Sec.  112.3(c)) during such period exceeded the average annual
monetary value of the food you sold to all other buyers during that
period; and (2) the average annual monetary value of all food (as
defined in proposed Sec.  112.3(c)) you sold during the 3-year period
preceding the applicable calendar year was less than $500,000, adjusted
for inflation (proposed Sec.  112.5(a)). As explained in the proposed
rule, proposed Sec.  112.5(a) establishes the criteria for eligibility
for a qualified exemption and associated special requirements based on
average monetary value of all food sold and direct farm marketing, as
mandated by section 419(f) of the FD&C Act (21 U.S.C 350h(f)). The
criteria established in proposed Sec.  112.5(a), including the
requirement that ``all food'' be considered in calculating sales, are
derived from section 419(f) of the FD&C Act. We, therefore, as a result
of the statutory language, cannot apply the monetary value limit to
covered produce sales, but instead must apply it to total or ``all''
food sales. Therefore, we are not able to make any change to the
provision that the average annual monetary value of all food (as
defined in proposed Sec.  112.3(c)) sold during the 3-year period
preceding the applicable calendar year must be less than $500,000, as
proposed in Sec.  112.5(a)(2)).
2. Definition of ``Farm'' (and ``Covered Activity,'' ``Harvesting,''
``Holding,'' and ``Packing'')
    In the previously published proposed rule, under subpart A of
proposed part 112, we proposed definitions for various terms used in
part 112. In proposed Sec.  112.3(c), we proposed to define ``farm'' to
mean to mean a facility in one general physical location devoted to the
growing and harvesting of crops, the raising of animals (including
seafood), or both. As proposed, the term '' farm'' included: (1)
Facilities that pack or hold food, provided that all food used in such
activities is grown, raised, or consumed on that farm or another farm
under the same ownership; and (2) facilities that manufacture/process
food, provided that all food used in such activities is consumed on
that farm or another farm under the same ownership. We also proposed
definitions for ``farm mixed-type facility'' and related activities,
such as ``manufacturing/processing,'' ``packing,'' and ``holding.'' In
developing these definitions, we considered the interrelationship
between farms and facilities, and articulated five organizing
principles to explain the basis for the proposed definitions that would
classify activities on-farm and off-farm for the purpose of the Produce
Safety regulation. See the discussion of this issue in the previously
published proposed rule (78 FR 3504 at 3539 through 3544).
    a. Relevant Comments. We received numerous comments regarding the
proposed definition of a ``farm,'' including concerns related to
packing or holding activities that routinely take place on a farm that
commenters believed should be considered under the farm definition but
would be instead covered under the proposed definition of a ``mixed-
type facility.'' In particular, commenters noted that, as proposed,
packing or holding of produce would be subject to either the Preventive
Controls for Human Food regulation or the Produce Safety regulation,
depending on whether or not the produce was grown on a farm under the
same ownership. Commenters expressed various concerns with this
proposed approach, including that: (1) This divergence in requirements
does not have a public health basis given that the activities of
packing or holding would present similar food safety risks regardless
of the ownership of the farm on which the produce was grown; (2)
subjecting a farm to the requirements of two different food safety
regulations would be burdensome and is arbitrary; (3) it is common
practice for a farm to buy and resell produce from other farms in order
to fill out the necessary scale of supply (for example, when supplied
to restaurants, retail establishments, or large wholesale markets), to
pack produce for a neighbor who lacks a packing house, hold produce
with a long shelf-life for a neighboring farm with limited storage
space, or to pack or hold produce grown on farms of different ownership
given costs associated with packing or holding activities; and (4) some
farms sell their produce through ``Community Supported Agriculture''
arrangements and such deliveries often include produce grown by other
farms not under the same ownership. We also received another comment
that opposed broadening the proposed ``farm'' definition due to
concerns that such changes could undermine the public health objectives
of the rule.
    b. FDA's Consideration of Comments. We tentatively concur with
commenters who stated that packing or holding of produce presents
similar reasonably foreseeable hazards regardless of whether the
produce is grown and harvested on farms under the same or different
ownership, and that such hazards associated with packing or holding
activities would best be addressed through the standards established
under the Produce Safety regulation.
    In response to the comments described above and similar public
comments received on the Preventive Controls for Human Food proposed
rule, elsewhere in this issue of the Federal Register, we are issuing a
notice to reopen the docket and seek public comment on certain specific
issues related to that proposed rule (referred to as ``amendments to
the Preventive Controls for Human Food proposed rule''). In that
document, we are proposing a revised definition of ``farm'' to mean an
establishment under one ownership in one general physical location
devoted to the growing and harvesting of crops, the raising of animals
(including seafood), or both. As revised, the term ``farm'' would
include establishments that, in addition to these activities: (1) Pack
or hold raw agricultural commodities (RACs); (2) pack or hold processed
food, provided that all processed food used in such activities is
either consumed on that farm or another farm under the same ownership,
or is processed food identified in subparagraph (3)(ii)(A) of the
``farm'' definition; and (3) manufacture/process food, provided that:
(i) All food used in such activities is consumed on that farm or
another farm under the same ownership; or (ii) Any manufacturing/
processing of food

that is not consumed on that farm or another farm under the same
ownership consists only of: (A) Drying/dehydrating RACs to create a
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and (B) Packaging and
labeling RACs, when these activities do not involve additional
manufacturing/processing. Under this amended proposed definition of
``farm,'' farms that pack or hold produce RACs that are grown on a farm
that is under a different ownership would no longer necessarily be
``farm mixed-type facilities'' subject to the requirements of the
Preventive Controls for Human Food regulation. Rather, packing or
holding others' produce RACs on a covered farm would now be subject to
the Produce Safety standards of proposed part 112 (unless the produce
is not covered by part 112, as described in proposed Sec.  112.2).
Similarly, we are proposing in that document to amend the definitions
of ``harvesting,'' ``holding,'' and ``packing,'' consistent with this
amendment to the farm definition and in response to other issues
discussed in that document. We refer you to the discussion of this
issue in section V of that document.
    Consistent with our proposed amendments to the definition of
``farm'' as it applies to proposed 21 CFR part 117, we are proposing to
amend the definition of ``farm'' as it applies to proposed part 112 to
include within that definition establishments that pack or hold RACs
that are grown or raised on another farm, whether or not under the same
ownership. In addition, we are proposing corresponding revisions to the
proposed definitions of ``covered activity,'' ``harvesting,''
``holding,'' and ``packing'' in proposed Sec.  112.3(c) to remove the
previous proposed restriction to encompass only RACs grown on farms
under the same ownership. As revised, ``covered activity,''
``harvesting,'' ``holding,'' and ``packing'' would encompass relevant
activities regardless of the ownership of the farm where the RACs are
grown.
    In the amendments to the Preventive Controls for Human Food
proposed rule, we are also proposing certain other amendments to the
definitions of ``farm,'' ``holding,'' and ``packing,'' taking into
account comments received. For example, as amended, the proposed
definition of ``farm'' also includes establishments that manufacture/
process food by drying/dehydrating RACs to create a distinct commodity,
and packaging and labeling such commodities, without additional
manufacturing/processing. The amended proposed definition of ``farm''
also includes manufacturing/processing food by packaging and labeling
RACs, when these activities do not involve additional manufacturing/
processing. In addition, the amended proposed definition of farm would
refer to ``establishments'' rather than to ``facilities,'' a term used
in the previous proposed definition. In addition, as a conforming
change relevant to this substitution, we are adding to the ``farm''
definition the criterion that the establishment is ``under one
ownership,'' to retain that aspect of the current ``farm'' definition
in the revised definition. As amended, the proposed definition of
``holding'' also includes activities performed incidental to storage of
a food (e.g., activities performed for the safe or effective storage of
that food and activities performed as a practical necessity for the
distribution of that food (such as blending of the same RAC and
breaking down pallets)). Finally, as amended, the proposed definition
of ``packing'' also includes activities performed incidental to packing
a food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)). We refer you to the
discussion of these issues in section V of that document. Consistent
with our proposed amendments to these definitions as they apply to
proposed part 117, we are proposing to amend the definitions of
``farm,'' ``holding,'' and ``packing'' as they apply to proposed part
112.
    Taken together, we are proposing to amend the definition of
``farm'' in proposed Sec.  112.3(c) to mean an establishment under one
ownership in one general physical location devoted to the growing and
harvesting of crops, the raising of animals (including seafood), or
both. The term ``farm'' would include establishments that, in addition
to these activities: (i) Pack or hold RACs; (ii) Pack or hold processed
food, provided that all processed food used in such activities is
either consumed on that farm or another farm under the same ownership,
or is processed food identified in subparagraph (iii)(B)(1) of the
``farm'' definition; and (iii) Manufacture/process food, provided that:
(A) All food used in such activities is consumed on that farm or
another farm under the same ownership; or (B) Any manufacturing/
processing of food that is not consumed on that farm or another farm
under the same ownership consists only of: (1) Drying/dehydrating RACs
to create a distinct commodity, and packaging and labeling such
commodities, without additional manufacturing/processing; and (2)
Packaging and labeling RACs, when these activities do not involve
additional manufacturing/processing.
    As amended, ``harvesting'' would apply to farms and farm mixed-type
facilities and means activities that are traditionally performed on
farms for the purpose of removing RACs from the place they were grown
or raised and preparing them for use as food. Harvesting is limited to
activities performed on RACs on a farm. Harvesting does not include
activities that transform an RAC, as defined in section 201(r) of the
FD&C Act (21 U.S.C. 321(r)), into a processed food as defined in
section 201(gg) of the FD&C Act. Gathering, washing, trimming of outer
leaves of, removing stems and husks from, sifting, filtering,
threshing, shelling, and cooling RACs grown on a farm are examples of
harvesting.
    In addition, as amended, ``holding'' would mean storage of food and
also includes activities performed incidental to storage of a food
(e.g., activities performed for the safe or effective storage of that
food and activities performed as a practical necessity for the
distribution of that food (such as blending of the same RACs and
breaking down pallets)), but does not include activities that transform
an RAC, as defined in section 201(r) of the FD&C Act, into a processed
food as defined in section 201(gg) of the FD&C Act. Holding facilities
could include warehouses, cold storage facilities, storage silos, grain
elevators, and liquid storage tanks.
    Finally, as amended, ``packing'' would mean placing food into a
container other than packaging the food and also includes activities
performed incidental to packing a food (e.g., activities performed for
the safe or effective packing of that food (such as sorting, culling
and grading)), but does not include activities that transform an RAC,
as defined in section 201(r) of the FD&C Act, into a processed food as
defined in section 201(gg) of the FD&C Act. (For reference, we
previously proposed to define ``packaging'' (when used as a verb) to
mean placing food into a container that directly contacts the food and
that the consumer receives.)
    The defined term ``covered activity,'' which establishes what
activities are subject to proposed part 112, is directly related to and
affected by the scope of the definitions of ``farm,'' ``harvesting,''
``packing,'' ``holding,'' and ``manufacturing/processing.'' We are
proposing to amend the definition of ``covered activity'' to mean
growing, harvesting, packing, or holding covered produce on a farm.
``Covered activity''

includes manufacturing/processing of covered produce on a farm, but
only to the extent that such activities are performed on RACs and only
to the extent that such activities are within the meaning of ``farm''
as defined in this chapter. This part does not apply to activities of a
facility that are subject to 21 CFR Part 110 of this chapter.
    We are proposing these changes to the definition of ``covered
activity'' to reflect the changes we are proposing to the definitions
of ``farm'' and related terms. First, we have removed the limitation
``provided that all covered produce used in covered packing or holding
activities is grown, raised, or consumed on that farm or another farm
under the same ownership'' to reflect our proposed expansion of the
farm definition to include packing and holding of others' produce RACs.
Second, because we are proposing to add some additional, limited types
of ``manufacturing/processing'' to the definition of ``farm,'' (and to
reclassify some activities from ``packing'' to ``manufacturing/
processing'') those activities should be subject to proposed part 112
when they are performed on a covered farm on covered produce. For
example, because the proposed definitions would now provide that
packaging RACs would be manufacturing/processing (rather than
``packing''), and would be within the farm definition if the packaging
does not include additional manufacturing/processing, that activity
should be covered by proposed part 112 when performed on a covered farm
on covered produce. For example, a covered farm placing strawberries in
a plastic ``clamshell'' package should be considered a ``covered
activity''.
    We seek comment on the amended definition of ``farm,'' and the
corresponding changes to the definitions of ``harvesting,''
``holding,'' ``packing,'' and ``covered activity.'' In addition, we
seek comment on whether the phrase ``in one general physical location''
should be included in the farm definition in the final rule. We are
aware that numerous produce farms own and grow crops in non-contiguous
parcels of land in various geographical locations, such as in multiple
States or even in more than one country. If finalized as proposed, how
should we interpret ``in one general physical location'' for the
purposes of enforcing this regulation? For example, farms that are in
separate geographical locations, although under the same ownership,
could be considered as different ``farms'' under this proposed
definition and, therefore, such businesses might qualify for extended
compliance periods that we proposed for ``small business'' and ``very
small business'' farms.
    In addition, we seek comment on whether to include in the final
rule a requirement that a farm supplying produce to another farm that
will pack or hold that produce should provide to the farm that receives
the produce its name, complete business address, and description of the
produce in any individual shipment. Under these circumstances, is it
appropriate to also require the farm that receives the shipment to
maintain such record of information and, if so, for what specified
period of time? Farms that pack or hold produce that is grown and
harvested on farms under a different ownership and that are currently
subject to the recordkeeping requirements of Subpart J of 21 CFR Part 1
may no longer be required to establish or maintain such records, if
they fit within the amended proposed ``farm'' definition. Information
about where the produce was grown or harvested may be important to
trace contaminated product during an illness outbreak or other adverse
event related to that produce and, therefore, we seek comment on
whether we should require such farms to continue to be subject to
recordkeeping requirements.
    Finally, we seek comment on whether on-farm packinghouses under
cooperative ownership by multiple growers should be considered under
the same ownership as any or all of the growers' farms, for the
purposes of this regulation.
3. Summary of FDA's Revisions and Request for Comment
    We are proposing to: (1) Revise paragraph (a) of proposed Sec.
112.4 to so that farms or farm mixed-type facilities with an average
annual monetary value of produce (as ``produce'' is defined in Sec.
112.3(c)) sold during the previous 3-year period of $25,000 or less (on
a rolling basis) would not be covered by the Produce Safety regulation;
and to make corresponding revisions to the definitions of ``very small
business'' and ``small business'' in proposed Sec.  112.3(b) to apply
the monetary value thresholds based on sales of produce; (2) revise the
definition of ``farm'' in proposed Sec.  112.3(c) such that
establishments that pack or hold produce RACs that are grown or
harvested on another farm would now be subject to the Produce Safety
standards of proposed part 112 regardless of whether or not that farm
is under the same ownership; and corresponding revisions to the
definitions of ``covered activity,'' ``harvesting,'' ``holding,'' and
``packing'' in proposed Sec.  112.3(c); and (3) revise the definitions
of ``farm,'' ``holding,'' and ``packing'' as they apply to proposed
part 112, consistent with the proposed amendments as these terms apply
to proposed part 117.
    We seek comment on our amended proposed provisions, including our
current proposal not to cover farms with an average annual monetary
value of ``produce'' sold of $25,000 or less and whether (and, if so,
how), as an alternative, we should apply this monetary threshold to
covered produce only. We also seek comment on the amended proposed
definitions of ``farm,'' ``harvesting,'' ``packing,'' ``holding,'' and
``covered activity,'' and whether the phrase ``in one general physical
location'' should be included in the farm definition in the final rule.
In addition, we seek comment on whether, in instances where a farm
supplies its produce to another farm to pack, hold, or store the
produce, the farms involved should be subject to a requirement to
establish and maintain a record of such produce shipment for tracking
purposes in the event of an illness outbreak. We also seek comment on
whether on-farm packinghouses under cooperative ownership by multiple
growers should be considered under the same ownership as any or all of
the growers' farms for the purposes of this regulation.

B. Proposed Subpart E--Standards Directed to Agricultural Water

    Under subpart E of proposed part 112, we proposed science-based
minimum standards directed to agricultural water. Specifically, we
proposed various measures regarding agricultural water sources and
distribution systems (proposed Sec. Sec.  112.41 and 112.42);
requirements for treating agricultural water (proposed Sec.  112.43);
requirements for testing agricultural water (proposed Sec.  112.44) and
at certain specified frequencies (proposed Sec.  112.45); requirements
for water used in harvesting, packing, and holding activities (proposed
Sec.  112.46); and certain record-keeping requirements (proposed Sec.
112.50). We discussed each of the proposed provisions and explained our
rationale (78 FR 3504 at 3559-3573).
    We are reopening the comment period to solicit public comment on
our current thinking on three specific issues related to the provisions
for agricultural water: (1) Microbial quality standard for agricultural
water used during growing activities for covered produce (other than
sprouts) using a direct water application method; (2) frequency of
testing agricultural water; and (3) use of third party agricultural
water testing

data. We describe our current thinking on these three issues in this
section.
1. Microbial Quality Standard for Agricultural Water Used During
Growing Activities for Covered Produce (Other Than Sprouts) Using a
Direct Water Application Method
    In the previously published proposed rule, under proposed Sec.
112.44(c), we proposed to require that when agricultural water is used
during growing activities for covered produce (other than sprouts)
using a direct water application method, you must test the quality of
water in accordance with one of the appropriate analytical methods in
subpart N. We also proposed that if you find that there is more than
235 CFU (or most probable number (MPN), as appropriate) generic E. coli
per 100 mL for any single sample or a rolling geometric mean (n = 5) of
more than 126 CFU (or MPN, as appropriate) per 100 mL of water, you
must immediately discontinue use of that source of agricultural water
and/or its distribution system for the uses described in proposed Sec.
112.44(c). Moreover, before you may use the water source and/or
distribution system again for the uses described in proposed Sec.
112.44(c), we proposed that you must either reinspect the entire
agricultural water system under your 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 retest the water to determine if your changes
were effective; or treat the water in accordance with the requirements
of proposed Sec.  112.43.
    As explained in the proposed rule, our review of available
scientific literature led us to tentatively conclude that the above
described standards, which are consistent with the EPA recreational
water standards, provide an appropriate basis to establish the
microbial quality standard for agricultural water that is applied to
produce using a direct application method. We explained our rationale
and acknowledged the challenges related to identifying an appropriate
microbial quality standard for such use of agricultural water where the
water is intended to, or is likely to, contact covered produce or food-
contact surfaces during use of the water. For example, we acknowledged
that these EPA standards were developed from epidemiological studies
that correlated the risk of gastrointestinal illness to exposure to
marine and freshwater by swimmers rather than to consumption of
produce. These epidemiological studies were performed in beach areas
subject to point source fecal contamination rather than non-point
sources (e.g., birds, agricultural and livestock runoff), which may
impact agricultural water. We also noted that risks of adverse health
outcomes resulting from full-body contact in contaminated water may be
different than risks associated with consuming produce irrigated with
contaminated water, given the differences in the expected routes of
infection and pathogen mortality rates in the different environments
(bodies of water for the EPA recreational water standards; soil,
plants, and produce for this proposed rule). We considered other
options, including proposing a standard based on the EPA drinking water
standard or proposing a second lower microbial quality criteria for
water used in growing, but where the water used for direct application
is not reasonably likely to contact the edible portion of the covered
produce. However, we did not find sufficient scientific support for
such options. Moreover, we noted that we are aware that some industry
groups have adopted the generic E. coli component of the EPA
recreational water standards in the absence of sufficient information
to support a pathogen-based microbiological standard for water used in
the production of produce (78 FR 3504 at 3563 and 3569).
    Therefore, we tentatively concluded that the above described
generic E. coli criteria would serve to minimize risk of known or
reasonably foreseeable hazards when used as a standard for agricultural
water used on produce (other than sprouts) during growing in a direct
water application method. We discussed each of the proposed provisions
and explained our rationale (78 FR 3504 at 3563 and 3569).
    a. Relevant Comments. We received an extensive number of comments
on this issue, and a majority of them either questioned the scientific
rationale for the proposed microbial quality standard, emphasized the
burden placed on growers due to the stringency of this standard, and/or
urged us to consider other factors that would allow the safe use of
agricultural water that does not meet the proposed microbial water
quality standard in direct application during growing activities.
Commenters identified various concerns with the proposed microbial
quality standard for agricultural water used during growing activities
for covered produce (other than sprouts) using a direct water
application method, including the following: (1) The lack of adequate
data to inform a complete and thorough understanding of produce
contamination resulting from irrigation water. Some commenters noted
that there are relatively few confirmed cases of irrigation water as a
source of pathogens in any food borne illness outbreaks, while other
commenters thought that the proposed microbial quality standard
appeared to address risks that are unidentified and unsubstantiated,
without sufficient or meaningful underlying scientific rationale; (2)
concerns with using the water quality standards developed for
recreational water to determine acceptable levels of indicator
organisms in agricultural water. Commenters opposed using the EPA
standards and argued that it is not scientifically sound to apply the
recreational water standards that are developed based on
epidemiological data to irrigation water. Commenters also noted other
limitations to this approach, including that using a recreational
standard for water quality does not take into account the rapid die-off
rate that occurs post irrigation and prior to harvest; (3) the need for
education, guidance, and training to ensure growers understand the
elements embedded in the proposed requirement and know how to properly
sample, test, and make the necessary calculations to then determine
whether or not their water meets the proposed microbial quality
standard. Commenters also recommended simplifying the standard to
eliminate the requirement for a rolling geometric mean (n = 5) of no
more than 126 CFU (or MPN, as appropriate) per 100 mL of water, such
that the single sample limit would then be maintained as the
requirement. One commenter suggested that this proposed requirement
would create an opportunity for confusion and noncompliance due to
miscalculation or misunderstanding of the complex equation; (4)
concerns that the proposed water quality threshold is either more
stringent than or differs from other national or international best
practices, recommendations, or guidelines. Commenters noted that the
FDA proposed standard is more stringent than the World Health
Organization (WHO) thresholds and urged us to amend the provisions to
be more in line with WHO quality thresholds. Other commenters
recommended following the Codex Alimentarius Commission's global
standard (1,000 E. coli CFU/mL), the more stringent Canadian standard
(77 E. coli CFU/100mL), or other thresholds established in the European
Union; (5) concern that current science is inadequate to justify a
fixed, generally applicable test organism, quantitative

microbial quality threshold, or testing requirements. For example, one
commenter asserted that a different microbial standard should be
considered for overhead irrigation water that is applied prior to fruit
set or more than 14 days before harvest because, under field
conditions, water that does not meet recreational water quality
standards would be quite safe for such use. Another commenter cited the
lack of adequate scientific information to develop a generally
applicable microbial quality standard, and recommended that FDA employ
the generic E. coli standard as a voluntary measure until such time
that more scientific information is generated and FDA develops an
appropriate standard. Still others urged us to delay the use of a
quantitative standard to allow for new scientific information to evolve
in the future that would enable identifying microbial quality
thresholds specific to different regions and types of water; (6)
concern with the use of generic E. coli as an indicator to test safety
of agricultural water, including water used in direct application. One
commenter suggested including E. coli O157:H7, non-O157 Shiga toxin E-
coli, Listeria monocytogenes, and Salmonella spp. as pathogens to be
tested in water quality tests. Another commenter noted that researchers
have found that levels of E. coli present in water used for crop sprays
do not represent the microbial load on the surface of tomatoes at
harvest. This commenter also pointed out that tests conducted by a
major U.S. grower have demonstrated that the generic E. coli standard
can be exceeded without human pathogens being present, and it can be
met when human pathogens are actually present in high quantities, thus,
bringing into question the reliability of generic E. coli as an
appropriate indicator. Another commenter urged FDA to provide for
flexibility to allow alternative indicators of water safety. This
commenter pointed out that several States have replaced water testing
programs with a risk based computer modeling approach to address
recreational water safety, and instead of using test results to
determine if recreational water is safe, computer modeling programs
that calculate the risks of a given source are designed to accurately
predict when water will be outside acceptable ranges. The commenter
recommended that the final rule should allow flexibility within the
agricultural water section to allow this approach when an appropriate
model has been designed; and (7) concern that, in identifying the
microbial standard for direct application, FDA failed to consider
certain significant factors that affect whether and how the microbial
standard is applied to irrigation water used in different regions of
the country and for different types of crops. For example, it was noted
that farms in Maine use a wide variety of water sources, from city
water to wells to open water sources. Even with open water sources
there is a wide variety including rivers, ponds, streams and some water
bodies affected by ocean tides, which require site-specific timing for
water use. Another commenter stated that, in the Treasure Valley,
irrigation systems mix clean water with runoff water, and such inter-
mixing results in high counts of E. coli in irrigation water throughout
large parts of the water distribution systems during the growing
season. We also received a comment stating that surface water in some
regions or watersheds may regularly fail the generic E. coli test, and
that 30 percent of the samples of water collected at 22 surface water
sites in the southeastern Vermont region in 2012 had generic E. coli
levels that exceeded 235 CFU per 100 mL. The commenter further
explained that, without a real scientific justification, the rule would
remove an important source of agricultural irrigation to farmers in
that region at critical periods throughout the growing season. Yet
another commenter pointed out that, in eastern Oregon, growers
downstream will inherently have higher microbiological contaminant
loads than those upstream, due to runoff reuse systems and other water
conservation measures, and as proposed, the Produce Safety regulation
will undoubtedly injure downstream growers by preventing them from
utilizing their water for the use stated on their water permit or
certificate. Finally, we also received a comment that asserted that, in
some parts of the western United States where farmers do not control
the water, it would be extremely burdensome for FDA to require testing
and mitigation for unidentified and unsubstantiated risks that may not,
in fact, exist.
    We also received several other comments in relation to the proposed
requirement for testing water used for direct application. A commenter
pointed out that the scientifically observed rates of microbial decline
reported by some authors are vastly greater than the rates assumed in
FDA's assessment of risks. The commenter disagreed with FDA's proposed
microbial quality standard, and argued that FDA has chosen to regulate
all directly applied agricultural water over the entire production
season even though its own analysis supports regulating agricultural
water only within a short window of a few days before harvest, thereby
substantially increasing the costs associated with water quality
testing with little substantiated benefit. Another commenter urged FDA
to explicitly permit growers to use water testing data compiled by
other entities. According to the commenter, municipalities in New
Hampshire routinely test E. coli levels for recreational purposes, and
it would be unnecessary to require growers to test the same water
source for the same pathogens separately.
    In contrast, some other comments generally agreed with the use of a
numerical standard for testing water quality. These commenters
suggested that a numerical standard is necessary, particularly where
the effectiveness of individual control measures, such as to protect
the source of agricultural water from contamination, are either not
properly implemented or not fully known. In such cases, a numerical
standard would serve as an objective tool to monitor the water quality
on a specified schedule and trigger corrective actions, where
necessary.
    b. FDA's Consideration of Comments. As explained in the previously
published proposed rule, based on a qualitative assessment of risk, we
identified agricultural water as one of the most likely sources of
produce contamination. Our tentative conclusions included: (1) There is
a significant likelihood that surface waters may contain human
pathogens, and surface waters pose the highest potential for
contamination and the greatest variability in quality of the
agricultural water sources; (2) susceptibility to runoff significantly
increases the variability of surface water quality; (3) water that is
applied directly to the harvestable portion of the plant is more likely
to contaminate produce than water applied by indirect methods that are
not intended to, or not likely to, contact produce; (4) timing of water
application in produce production before consumption is an important
factor in determining likelihood of contamination; and (5) microbial
quality of source waters, method of application, and timing of
application are key determinants in assessing relative likelihood of
contamination attributable to agricultural water use practices (78 FR
3504 at 3522, 3523). Consequently, our proposed standards for
agricultural water including those for microbial quality of water and
testing frequencies for ground water and surface water, address these
potential contributing factors.

    We do not believe that FDA should reconsider the use of generic E.
coli as an indicator to test safety of agricultural water, including
water used in direct application. As discussed in the previously
published proposed rule, we proposed to use generic E. coli as an
indicator of fecal contamination. We acknowledge that the presence of
generic E. coli will not always correlate to the presence of pathogens
in water. However, the presence of fecal contamination, especially as
indicated by high levels of generic E. coli, may increase the
likelihood of pathogen contamination in water (Refs. 6, 7, and 8).
Therefore, the intent is to manage the presence of fecal contamination
as a proxy for potential pathogen contamination, similar to use of
fecal contamination as an indicator for the quality of water at
swimming beaches and waters for harvesting molluscan shellfish (Refs. 9
and 10). In addition, several commenters noted that generic E. coli is
an appropriate organism to use to characterize water quality and agreed
with our proposal to require such characterization; these commenters
expressed that generic E. coli provides the best and most practicable
quantitative criterion at this time. Further, testing for pathogens to
determine the appropriateness of the water would be more costly than
testing for generic E. coli because of the need to test for multiple
pathogens.
    We also acknowledge the limitations of a general requirement for
agricultural water for growing using direct application that is based
on a single microbial indicator and associated quantitative microbial
quality threshold, in that it may not adequately account for
differences in risk associated with irrigation practices used for
different commodities. Although we are proposing to retain a single
microbial quality requirement that would apply to all agricultural
water for growing using direct application, our proposed new provisions
in Sec. Sec.  112.44(c)(1) and 112.44(c)(2) provide for flexibility in
order to address comments that requested us to account for the wide
range of irrigation water sources, irrigation practices in different
regions of the country, and different types of crops. We also
tentatively determined that a quantitative microbial standard that is
enforceable and facilitates necessary action by industry to ensure the
safe use of water when used for direct application would be more
appropriate than a qualitative water quality standard.
    Taking into account comments received, currently available
information, and upon further analysis, we are proposing amendments to
proposed Sec. Sec.  112.44(c), 112.44(d), and 112.50(b) that,
collectively, result in the following changes: (1) Update the
quantitative microbial quality requirements in a way that is consistent
with the 2012 recreational water quality criteria (RWQC); (2) provide
an allowance for microbial die-off between irrigation and harvest using
a specified microbial die-off rate; (3) provide an allowance for
microbial reduction between irrigation and end of storage; and (4)
allow the use of an alternative in lieu of our specified microbial die-
off rate between irrigation and harvest.
    The scheme outlined above, each element of which is discussed in
more detail in the sections immediately below, is consistent with the
construct of the standard recommended by the WHO, although less
restrictive than that standard. The WHO approach rests on a multistep
process to achieve incremental microbial reductions to meet the overall
necessary scheme, yielding a tolerable disease burden due to raw
produce consumption that is no greater than that adopted for drinking
water (non-detectable E. coli per 100 mL) (Refs. 11a and 11b). The
initial step of the multibarrier process begins with wastewater
treatment, which is followed by subsequent preventive measures to
achieve the final health-based target of <=10-6 DALY
(disability-adjusted life year) per person, per year. Two specific
examples of the multi-barrier process discussed in the guidelines are
water qualities of 104 or 103 CFU E. coli per 100
mL, post-wastewater treatment, for use on surface and root crops,
respectively, followed by subsequent mitigation strategies (Ref. 11a).
According to the WHO analysis, using water of this microbial quality is
dependent upon a 2-log reduction due to die-off between last irrigation
and consumption (includes die-off in the field and during distribution)
and a 1-log reduction attributed to washing prior to consumption. The
WHO analysis recognizes the variable nature of die-off values, ranging
from 0.5 to 2.0 log per day. FDA's previously proposed standard of 235
CFU generic E. coli per 100 mL for any single sample (or a rolling
geometric mean of no more than 126 CFU per 100 mL) defined a microbial
level for agricultural water used during growing activities using a
direct water application method that would minimize the risk of serious
adverse health consequences or death throughout the diversity of
agricultural conditions, in addition to which alternatives could be
developed to provide for the reductions assumed in the WHO standard for
die-off in the field and during distribution and from activities such
as washing. In response to comments asking for consideration of die-off
and greater flexibility and to align with international recommendations
from WHO and also Codex, we are again proposing a generally applicable
microbial level for all agricultural water, but now allowing a standard
reduction due to die-off in the field before harvest and consideration
of additional die-off from activities such as storage or commercial
washing. As described in the sections immediately below, these
reductions would provide additional means to achieve our proposed
microbial quality standard for agricultural water used in a direct
application method of a statistical threshold value (STV) of 410 or
less CFU of generic E. coli per 100 mL of water or a geometric mean
(GM) of 126 or less CFU of generic E. coli per 100 mL of water, where
known microbial reduction occurs after application. We believe that
this approach is strongly supported by comprehensive risk management
frameworks and associated recommendations for managing health risks in
recycled wastewater use in agriculture (Refs. 11a and 12).
    As will be discussed in detail in section II.B.2., we are also
proposing certain amendments to proposed Sec. Sec.  112.45 that,
collectively, result in a proposed tiered approach to testing untreated
surface water and untreated groundwater. The proposed approach would
allow farms to make decisions about safe use of available water sources
prior to the beginning of the next growing season; adjust testing
frequencies dependent on long-term test results; and ultimately reduce
the required frequency of testing.
    i. Updating the quantitative microbial quality requirements. We
continue to find that the EPA generic E. coli criteria for recreational
water quality provides a quantitative microbial standard that is
generally applicable to minimize the risk of known or reasonably
foreseeable hazards associated with the use of agricultural water on
produce other than sprouts during growing in a direct water application
method. Further, the EPA analysis supporting the RWQC, while not
perfect for our purposes, was developed using the necessary scientific
rigor and describes illness rates due to incidental ingestion that can
be generalized across different bodies of water (Ref. 13).
    In addition, while commenters objected to the use of RWQC to
establish microbial quality requirements for agricultural water for
growing using

direct application, there is no consensus among commenters as to other
appropriate alternative criteria or methodology. A majority of the
concerns with using the RWQC appeared to center around the need to
account for circumstances that are unique to produce growing and
irrigation, such as die-off after application, which are factors that
would not have been accounted for in formulating water quality
requirements for recreational water purposes. We acknowledge these
shortcomings, but we also believe that our complete set of amendments
to proposed Sec.  112.44(c), including new provisions in paragraphs
(c)(1) and (c)(2), address these concerns.
    Therefore, we continue to see the value in using the EPA RWQC as
the starting point for a quantitative microbial water quality standard
for water that is used for growing of produce (other than sprouts) in a
direct application method in proposed Sec.  112.44(c) (with additional
provisions in proposed Sec. Sec.  112.44(c)(1) and (c)(2), as explained
in sections II.B.1.b.ii. and II.B.1.b.iii.). In the previously
published proposed rule, we proposed to use the EPA recreational water
criteria that were published in 1986 for this purpose. In November
2012, EPA recommended new RWQC to update their 1986 criteria (Ref. 14)
(hereafter referred to as ``the 2012 RWQC''). Unlike the previous
criteria, the 2012 RWQC specify a STV in conjunction with a recommended
GM to describe the magnitude of the relevant bacterial indicators. The
STV approximates the 90th percentile of the water quality distribution
and is intended to be a value that should not be exceeded by more than
10 percent of the samples taken. The 2012 RWQC recommend a culturable
E. coli level of a GM of 126 CFU per 100 mL of water and an STV of 410
CFU per 100 mL of water.
    The 2012 RWQC are based on several recent health studies and use a
broader definition of illness to recognize that symptoms may occur
without a fever, including a number of stomach ailments. Among other
evidence, EPA considered the latest research that demonstrates a link
between fecal contamination in recreational waters and illness, and
designed the criteria to protect primary contact recreation where
immersion and ingestion are likely. We refer you to EPA's 2012 RWQC and
accompanying documents for a full description of the new criteria and
the underlying scientific rationale (ibid.).
    Consistent with this new analysis, we are proposing to amend the
microbial water quality standard in Sec.  112.44(c) to reflect E. coli
levels that are consistent with the recommendations in both the GM and
STV values specified in the 2012 RWQC. As amended, proposed Sec.
112.44(c) would require you to develop and verify the water quality
profile of the water source as described in Sec.  112.45(b)(1), and
using your water quality profile as described in Sec.  112.45(b)(1),
take certain actions if you find that (when applicable) the estimate of
the STV of samples exceeds 410 CFU of generic E. coli per 100 mL of
water, or if you find that the GM of samples exceeds 126 CFU of generic
E. coli per 100 mL of water, in order for you to use this water for
direct application during growing of covered produce (other than
sprouts).
    As amended, proposed Sec.  112.44(c) would no longer include a
maximum threshold of E. coli in a single sample of 235 CFU per 100 mL.
Rather, a STV of water quality distribution of 410 CFU per 100 mL would
be used when there are sufficient numbers of samples to calculate it,
in conjunction with the GM in all cases. This standard would be similar
to the 2012 RWQC in that regard. Adoption of the STV, which
approximates the 90th percentile of the water quality distribution, as
a criterion acknowledges the inherent variability of E. coli
measurements in water systems, while continuing to be sufficiently
protective of public health. In addition, use of the STV does not
establish a single value that, if exceeded, would require immediate
corrective action. Instead, any value above 410 CFU per 100 mL may be
acceptable, as long as those values (each corresponding to a water
sample) do not result in a calculation of STV that exceeds 410 CFU per
100 mL. For example, a water source found to contain 2,100 CFU generic
E. coli per 100 mL in one of 10 samples analyzed may be appropriate to
use in direct application during growing, if the remaining 9 samples
are such that the STV (based on all 10 samples) is 410 CFU or less of
generic E. coli per 100 mL of water.
    We seek comments on the absence of such a maximum level of generic
E. coli, particularly in light of evidence that suggests that pathogen
levels can increase at higher levels of generic E. coli or other
indicators (Refs. 6, 7, and 8). In providing comments, we ask that you
take into account that pathogens can survive for months in the soil and
in crop tissue if they permeate that tissue, that soil or fecal
material on the surface of produce may permeate cut tissues and create
conditions to enhance the probability of growth of pathogens and other
microorganisms, and that colonization and biofilm development may
result in conditions that are protective for pathogens (Refs. 15 and
16).
    Some public comments, too, recommended that we consider the WHO
recommended levels of 1,000 CFU per 100 mL and 10,000 CFU per 100 mL
for root crops and surface crops, respectively, as adequate maximum E.
coli levels. Note, however, that the WHO values are better explained as
illustrations of how specific health protection measures could be used
together after treatment (e.g., treatment, die-off, and washing or
treatment and drip irrigation) to achieve the additional log reductions
recommended for waste water reuse. As such, those values are not to be
viewed as absolute end point or maximum permitted levels. Rather, under
new proposed provisions Sec. Sec.  112.44(c)(1) and 112.44(c)(1), we
are proposing to provide for a WHO-type scheme that could be used to
satisfy the proposed requirements for microbial quality of water. For
example, under this proposed approach, there would be no maximum
threshold for a baseline of generic E. coli above which the
agricultural water would be precluded from use in direct application
during growing such that you would not be able to apply an appropriate
time interval between last irrigation and harvest or between harvest
and end of storage. We seek comment on whether we should establish a
maximum level of E. coli (GM and/or STV) above which the water should
not be permitted for use in direct application (until specific followup
actions are taken to ensure it meets the recommended microbial quality
requirements) and, if so, what would be an appropriate maximum level.
    As amended, proposed Sec.  112.44(c) would continue to include a GM
value of no more than 126 CFU per 100 mL of water, which is intended to
be used in conjunction with the proposed STV explained above,
consistent with the 2012 RWQC. However, we are removing the previously
proposed requirement for a ``rolling geometric mean (n = 5)'' based on
the sampling criteria we proposed in amended Sec.  112.45(b), which is
discussed in section II.B.2.b.
    According to the 2012 RWQC, the waterbody GM should not be greater
than 126 CFU per 100 mL during any 30-day interval, and there should
not be greater than a 10 percent excursion frequency of 410 CFU per 100
mL based on the calculated STV during the same 30-day period (Ref. 14).
We considered whether to apply the 30-day interval of the 2012 RWQC as
a sampling frequency, and tentatively conclude that this criterion
would be difficult to apply

in the context of our proposed sampling scheme. Instead, we are
proposing amendments to proposed Sec.  112.45 (see section II.B.2.)
that would establish specific sampling frequencies ranging from 2 years
for baseline characterization of water quality to annual verification
of water quality.
    We agree with comments that cited the need for education to ensure
that growers and other relevant staff are appropriately informed and
trained to properly test and perform the necessary calculations to
determine how best to use their water, particularly when it does not
meet the proposed microbial quality requirements. We have tentatively
determined that both the GM and STV values (when there are sufficient
samples to calculate STV), which reflect the central tendency (i.e.,
the extent to which statistical values fall around a middle value) of
the water and its variability, respectively, are necessary parameters
to properly characterize the water. We expect to issue guidance
document(s) to assist with education and training to help farmers
understand and implement any final requirements in Sec.  112.44(c).
    We seek comment on our proposed amendments, including our decision
to retain general microbial quality requirements and update them
consistent with the 2012 RWQC; the use of GM and STV values to
establish general microbial quality requirements; and the absence of a
maximum generic E. coli threshold.
    ii. Allowance for microbial die-off between irrigation and harvest.
In the previously published proposed rule, we acknowledged that in
specific circumstances an alternative standard (e.g., a standard that
applies a time between application and harvest in place of the proposed
Sec.  112.44(c) standard, but is specific to a specific commodity or
commodity group and region) may be appropriate if the alternative
standard is shown to provide the same level of public health protection
as the standard in proposed Sec.  112.44(c) and not to increase the
likelihood that the covered produce will be adulterated. Accordingly,
under proposed Sec.  112.44(d), we provided for the use of alternatives
to the requirements in proposed Sec.  112.44(c). We also noted that we
are working with stakeholders to facilitate research into application
intervals that would be commodity- and region-specific, such that water
not meeting the proposed Sec.  112.44(c) standard could be used in a
direct water application method for growing covered produce other than
sprouts as long as it was applied before the start of the
scientifically established application interval (i.e., at a certain
number of days before harvest or earlier) (78 FR 3504 at 3553).
    Comments, however, included concerns from growers that buyers would
demand that the grower meet the standard established in the Produce
Safety regulation rather than meet an alternative that had not been
explicitly sanctioned by FDA. A number of commenters that opposed our
previously proposed microbial quality requirements also cited the lack
of allowance for microbial reduction due to natural die-off in the
field after application and prior to harvesting of the crop. On further
consideration of this issue and relevant available scientific
information, we are proposing to add a new provision under proposed
Sec.  112.44(c) to explicitly provide for use of water that meets the
proposed microbial quality standard after accounting for microbial die-
off, if applicable to your crop and practices on your farm. We discuss
new proposed provision Sec.  112.44(c)(1) in this section.
    Proposed Sec.  112.44(c)(1) would provide one option by which you
would be able to achieve the microbial quality requirements for
agricultural water specified in Sec.  112.44(c). Under this option, you
must apply a time interval (in days) between last irrigation and
harvest using a microbial die-off rate of 0.5 log per day to achieve a
(calculated) log reduction of your GM of generic E. coli level to 126
CFU or less per 100 mL and of your STV to 410 CFU or less per 100 mL of
water. Examples of 0.5 log per day calculations follow this discussion.
    Based on a review of currently available scientific literature, we
tentatively determined that it would be appropriate to provide an
allowance for microbial die-off between last irrigation and harvest
using a proposed die-off rate of 0.5 log per day (Ref. 17). Survival of
pathogens and other microorganisms on produce commodities is dependent
upon several environmental factors, including sunlight intensity,
moisture level, temperature, pH, the presence of competitive microbes,
and suitable plant substrate. Generally, pathogens and other microbes
die-off or are inactivated relatively rapidly under hot, dry, and sunny
conditions compared to inactivation rates observed under cloudy, cool,
and wet conditions. The impact of these variables results in a range of
microbial die-off rates of 0.5 to 2.0 log per day (Refs. 11a and 12).
We have evaluated the relevant studies and acknowledge that die-off
rates below 0.5 log per day have been reported in the literature for
particular crop and pathogen types, but we conclude that a rate of 0.5
log per day provides a reasonable estimate of die-off under a broad
range of variables to include pathogen characteristics, environmental
conditions, crop type, and watering frequency.
    FDA is currently engaged in research activities in this area. In an
effort to support scientific research in the area of agricultural
water, one of FDA's Centers of Excellence, the Western Center for Food
Safety at University of California, Davis, 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. Research areas that
have received funding through this process include transfer and
survival of organisms on produce after exposure from contaminated
surface irrigation water, application of biocide technology on manure-
contaminated irrigation water, the potential role of overhead sprinkler
irrigation systems in the contamination of produce, and the survival of
pathogens during the growing, harvesting, and storage of dry bulb
onions after exposure with contaminated water.
    We seek comment on the appropriateness of the proposed 0.5 log per
day die-off rate. Note also that the proposed provisions in Sec.
112.44(d) would allow you to establish and use an alternative microbial
die-off rate between last irrigation and harvest (in lieu of the
proposed rate of 0.5 log per day), provided you satisfy the
requirements of proposed Sec.  112.12.
    When applying a microbial die-off rate of 0.5 log per day, as
proposed, the time interval (i.e., number of days) you apply between
last irrigation and harvest are the days necessary to achieve the
reductions in both the GM and STV values of generic E. coli to levels
at or below those expected on produce if it were irrigated with
agricultural water that satisfied the microbial quality requirements
proposed in Sec.  112.44(c). We tentatively conclude that use of such a
time interval would provide the same level of public health protection
as the standard in proposed Sec.  112.44(c) and not increase the
likelihood that the covered produce will be adulterated.
    This provision assumes that, for any given crop, the microbial
levels found on produce after accounting for die-off when it is
irrigated with water under the provisions of Sec.  112.44(c)(1) would
be approximately equal to or below the levels found if the crop were,
instead, irrigated with water of higher quality (i.e., that met our
proposed microbial quality criteria). Reductions to achieve

both GM and, when applicable, STV criteria are necessary to ensure that
risk thresholds determined in the 2012 RWQC are not exceeded.
    For example, if you determined (using the procedures described in
proposed Sec. Sec.  112.45(b) or 112.45(c), as applicable), that your
agricultural water which is to be used for the purposes described in
Sec.  112.44(c) has generic E. coli levels with a GM value of 241 CFU
per 100 mL and a STV value of 576 CFU per 100 mL, your water would not
meet the microbial quality specified in Sec.  112.44(c), in that your
values exceed both the GM value of 126 CFU per 100 mL and STV value of
410 CFU or less per 100 mL. Under proposed Sec.  112.44(c)(1), you
would be able to use this water by applying a calculated time interval
of 1 day between your last irrigation event (by direct application
method) and harvest of the crop. Using a microbial reduction rate of
0.5 log per day, a 1-day time interval would be sufficient to meet the
microbial quality requirements specified in Sec.  112.44(c) because it
would reduce your GM and STV values to 76 CFU per 100 mL and 182 CFU
per 100 mL, respectively.
    As another example, if you determined that your agricultural water
has generic E. coli levels with a GM value of 241 CFU per 100 mL and a
STV value of 4,600 CFU per 100 mL, your water would not meet the
microbial quality requirements specified in proposed Sec.  112.44(c).
Under proposed Sec.  112.44(c)(1), you would be able to use this water
by applying a calculated time interval of 3 days between your last
irrigation event (by direct application method) and harvest of the
crop. Using a microbial reduction rate of 0.5 log per day, 3 days
between irrigation and harvest would be sufficient to achieve a 1.5 log
total reduction and reduce your GM and STV to 8 CFU per 100 mL and 145
CFU per 100 mL, respectively.
    We agree with comments that cited the need for education to ensure
growers understand the elements embedded in our proposed requirements
for agricultural water during growing using direct application.
Relevant staff would need to be appropriately trained to properly
sample, test, and make the necessary calculations to determine how best
to use their water. We expect to work with the Produce Safety Alliance,
and will also plan to issue guidance document(s), as needed, to further
clarify our provisions and assist with such education and training, if
these proposed provisions in Sec.  112.44(c) are finalized, as
proposed. In addition, there are resources available that would enable
simply entering sample data into a form and automatically deriving the
GM and STV values and/or calculating the appropriate time interval
between irrigation and harvest, such that a farmer would not need to
perform the necessary calculations. We plan to identify and provide
such resources, if this proposal is finalized.
    We seek comment on our proposed approach and tentative conclusions,
including the appropriateness of permitting an adequate time interval
between last irrigation and harvest as a means to achieve the specified
microbial quality requirements, and the appropriateness of using a
microbial reduction rate of 0.5 log per day. In addition, we seek
comment on whether we should require farms to establish and maintain
any documentation in relation to the option to apply an adequate time
interval between last irrigation and harvest, as provided in proposed
Sec.  112.44(c)(1). For example, should we require that farms must keep
records that identify the time interval applied, how the time interval
is calculated, and/or the dates of last irrigation and harvest
corresponding to that time interval?
    iii. Allowance for microbial reduction between harvest and end of
storage. A number of comments that opposed our previously proposed
microbial quality requirements also cited the lack of allowance for
microbial reduction due to natural die-off during storage and/or due to
pathogen removal during certain post-harvest activities, such as
commercial washing, prior to consumption. On further consideration of
these issues and relevant available scientific information, we are
proposing to add another new provision under proposed Sec.  112.44(c).
We discuss the new proposed provision Sec.  112.44(c)(2) in this
section.
    Proposed Sec.  112.44(c)(2) would provide a second option by which
you would be able to achieve the microbial quality requirements
specified in Sec.  112.44(c). Under this option, you must apply a time
interval (in days) between harvest and end of storage 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 to achieve a (calculated) log reduction of your GM
of generic E. coli level to 126 CFU or less per 100 mL and (when
applicable) of your STV to 410 CFU or less per 100 mL, provided you
have adequate supporting scientific data and information. You may apply
this time interval in addition to the time interval in accordance with
112.44(c)(1). This provision would allow you to apply appropriate
microbial die-off or reduction rates post harvest (i.e., between
harvest and end of storage, and during activities such as commercial
washing), provided you have adequate supporting scientific information.
As discussed in the section immediately above, we expected that farms
would consider such factors as microbial die-off or microbial reduction
post irrigation and prior to consumption, as they are applicable to
their commodity and/or practices on the farm, and apply appropriate
scientifically-supported alternatives (such as time intervals) under
the provisions we proposed in Sec.  112.44(d). However, based on
comments, we are proposing new provision Sec.  112.44(c)(2) to
incorporate additional flexibility into our agricultural water quality
standards, and provide farms with yet another means by which to safely
use agricultural water by achieving our proposed microbial quality
requirements, without compromising the safety of produce that comes
into contact with such water. As previously noted, the WHO study
attributed a 1-log reduction in microbial load to washing (Ref. 11a).
In addition, it is reasonable to expect some die-off during post-
harvest storage, though the rate would be highly dependent upon the
conditions of storage. Farms would be able to more narrowly define die-
off rates associated with their specific production practices and apply
a time interval (in days) between harvest and end of storage,
calculated using microbial die-off rate(s) for the period between
harvest and end of storage, including any microbial removal rate(s) as
a result of commercial washing, as applicable to their commodity.
Regardless of the microbial rates applied, the total log reduction
necessary and the time interval required would need to be calculated
based on a comparison of the GM and (when applicable) STV values of
your agricultural water with the proposed microbial quality
requirements (GM of 126 CFU or less per 100 mL and STV of 410 CFU or
less per 100 mL) in Sec.  112.44(c).
    At this time, we are not proposing to establish a specific
microbial die-off rate(s) between harvest and end of storage or a
specific microbial removal rate(s) during post-harvest activities such
as commercial washing that can be broadly applied to calculate an
adequate time interval between harvest and end of storage. We do not
have sufficient information to support the derivation of an appropriate
broadly applicable microbial reduction rate(s) between harvest and end
of storage, or during activities such as commercial washing. However,
under this option, you would

be able to establish and apply an adequate time interval using a
microbial die-off rate(s) that is relevant to your covered produce and
dependent on practices and conditions on your farm, provided you have
adequate scientific data or information to support your conclusions.
    As we noted in the previously published proposed rule, we are
working with our stakeholders to facilitate research into application
intervals that would be commodity- and region-specific, such that water
not meeting the proposed Sec.  112.44(c) standard could be used in a
direct water application method for growing covered produce (other than
sprouts) as long as it was applied before the start of the
scientifically established application interval (i.e., at a certain
number of days before harvest or earlier). We will disseminate the
results of these investigations, when available, and issue commodity-
and region-specific guidance as appropriate, such that farmers would be
able to consider our recommendations and apply the new scientific
information to their current use of agricultural water, as appropriate.
    In addition, we are proposing to add a new provision, i.e.,
proposed Sec.  112.50(b)(8), to require you to establish and keep
records of such scientific data or information you rely on to support
the microbial die-off or removal rate(s) that is used to determine the
time interval (in days) between harvest and end of storage and/or other
activities such as commercial washing, as applicable, used to achieve
the calculated log reduction of generic E. coli in accordance with the
provision in Sec.  112.44(c)(2). This record-keeping requirement would
enable us to verify the scientific basis for your time interval, should
you choose to employ the approach permitted in Sec.  112.44(c)(2). As
in the case of alternatives permitted under Sec.  112.12, we are not
proposing to require farms to submit scientific data or information
relied on to support the microbial die-off or removal rate applied in
accordance with Sec.  112.44(c)(2) to us for review or approval prior
to marketing produce grown under those conditions. However, we would
require that farms maintain a record of any such scientific data or
information, including any analytical information, and make such data
and information available to us to evaluate upon request.
    We seek comment on this proposed provision, including on whether
there is a specific microbial die-off rate(s) or microbial removal
rate(s) that we should establish within this provision. We also seek
comment on whether and, if so, how we should introduce additional
flexibility.
    iv. Provision for use of an alternative microbial die-off rate. As
explained in section II.B.1.b., we are proposing to add a new provision
Sec.  112.44(c)(1) related to agricultural water used in a direct
application method to permit the use of an adequate time interval
between last irrigation and harvest, based on a microbial die-off rate
of 0.5 log per day, to achieve water quality that meets the proposed
microbial standard.
    We acknowledge that practices and conditions on a farm and
circumstances unique to a specific commodity or types of commodities
could result in higher die-off rates, especially under conditions of
high ultraviolet radiation, high temperature exposures or low humidity,
coupled with little precipitation. To account for such variability, we
are proposing a new provision, i.e., proposed Sec.  112.44(d)(2), to
specify that you may establish and use an alternative microbial die-off
rate (in lieu of the 0.5 log per day microbial rate that we proposed
under Sec.  112.44(c)(1)), to determine the time interval (in days)
between last irrigation and harvest, provided you satisfy the
requirements of Sec.  112.12. Among other requirements, the use of an
alternative microbial die-off rate would necessitate you to have
adequate scientific data and information to support your conclusions.
We refer to section V.B of the previously published proposed rule for a
discussion of the requirements of Sec.  112.12.
    Finally, as amended, proposed Sec.  112.44(c) would continue to
retain the previously proposed option to discontinue the use of water
that does not meet the proposed microbial quality requirements and take
corrective actions, prior to using that water for the same purposes.
Proposed Sec.  112.44(c)(3) would establish a third option, in lieu of
following the procedures in Sec. Sec.  112.44(c)(1) or 112.44(c)(2),
where if water does not meet the proposed microbial quality
requirements, you would immediately discontinue use of that source of
agricultural water and/or its distribution system for the uses
described in Sec.  112.44(c). Before you may use the water source and/
or distribution system again for those uses, you would be required to
either reinspect the entire agricultural water system under your
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 retest
the water to determine if your changes were effective; or treat the
water in accordance with the requirements of Sec.  112.43.
2. Frequency of Testing Agricultural Water
    In the previously published proposed rule, under proposed Sec.
112.45, we proposed to establish requirements related to frequency of
testing agricultural water that is subject to the requirements of
proposed Sec.  112.44. Specifically, proposed Sec.  112.45(a) would
require that you test any agricultural water that is subject to the
requirements of Sec.  112.44 at the beginning of each growing season,
and every 3 months thereafter during the growing season, except that
there would be no requirement to test water that meets certain
conditions specified in proposed Sec.  112.45(a)(1) to (a)(3) (i.e.,
treated water and water from a public water system).
    As explained in the previously published proposed rule, water
testing frequencies recommended by various industry documents vary
widely, in part, because there is a lack of publicly available
information pertaining to the quality of agricultural waters.
Recommendations range from monthly testing to once each year, for
sources with a history of compliance with commodity specific
recommendations. Even for sources considered reliable (e.g., well
water), a 1-year period between testing may not minimize the risk of
known or reasonably foreseeable hazards because microbiological water
quality is often too variable for this frequency of testing to be
protective (e.g., effects of flooding, runoff). Alternatively, we
tentatively concluded testing well water more frequently than every 3
months would not significantly improve the accuracy of your assessment
of ground water quality and would therefore be unnecessary. We also
considered proposing testing frequencies as a function of commodity,
irrigation method (e.g., furrow, seep, subsurface drip, foliar), and
timing of application (days prior to harvest), and concluded that the
most effective approach is to test at a frequency related to the
reliability of the agricultural water sources. We requested comments on
whether we should allow for adjustment of ground water testing
frequencies dependent on historical test results, for example, testing
ground water sources every 3 months for 1 year and yearly after that if
the ground water consistently met the standard. We also requested
public comments on any other alternative testing frequencies that can
be supported by water quality data (78 FR 3504 at 3570).

    In addition, under proposed Sec.  112.45(b), we proposed to
establish testing frequency requirements for the use of untreated
surface water for purposes that are subject to the requirements of
proposed Sec.  112.44. As proposed, if the untreated surface water is
from any source where a significant quantity of runoff is likely to
drain into the source (for example, a river or natural lake), then you
must test the water at least every 7 days during the growing season
(proposed Sec.  112.45(b)(1)). If the untreated surface water is from
any source where underground aquifer water is transferred to a surface
water containment constructed and maintained in a manner that minimizes
runoff drainage into the containment (for example, an on-farm manmade
water reservoir), then you must test the water at least once each month
during the growing season (proposed Sec.  112.45(b)(2)).
    In proposing these testing frequencies, we tentatively divided
untreated surface water into two categories based upon their potential
to be adversely affected by runoff and the degree to which you
reasonably could be expected to exercise protection and control over
them. We tentatively concluded that runoff is the most important
variable among the various environmental factors that may affect the
microbial quality of surface water, because it has the potential to
increase the number of pathogens in the water column if its origins
include human, livestock or wildlife feces and because it has the
potential to increase the amount of suspended sediments, which are
likely to harbor pathogens. We also considered other factors, such as
precipitation and its effects (e.g., discharge and flow rate) along
with temperature, which are common factors reported to affect the
microbial quality of watersheds with agricultural land inputs. However,
we did not propose a surface water testing frequency based on these
factors because such an approach would require full characterization of
its effects on the quality of surface water sources that are not likely
to be generally useful across all farms, States, or regions (78 FR 3504
at 3571).
    We also noted that our approach to testing untreated surface water
was to propose practical intervals of testing both because they are
likely to capture transient events that may degrade quality and because
they are useful regardless of geographic location. The sampling and
testing frequencies we proposed in Sec.  112.45(b) are the minimum that
we tentatively concluded provide sufficient information concerning your
source surface water quality for you to use in determining the method
of application for which the water is safe and of adequate sanitary
quality. We asked for public comments on our proposed testing
frequencies, including any alternative approaches and examples where
testing should be more or less frequent based on your experience or
observation, and specifically if you believe that surface waters can be
thoroughly characterized when tested at frequency less than that
proposed in Sec.  112.45 (78 FR 3504 at 3571).
    a. Relevant Comments. We received a number of comments on our
proposed requirements for frequency of water testing, many of which
voiced concerns and requested that FDA reduce the required testing
frequencies and apply a flexible approach that considers the specific
risks associated with the particular source of water and its use.
Comments related to the frequency of water testing highlighted various
issues, including the following: (1) Commenters recommended that FDA
should employ and allow the use of risk-based testing strategies that
account for the variability in risk associated with the specific source
of water and its use. For example, commenters noted that the proposed
testing frequencies do not consider the wide range of sources of
agricultural water, which include municipal water to rural rain water
catchment. Commenters also noted that frequent testing is either not
necessary or does not provide meaningful information where there is
inherently high variability in water quality due to rainfall or other
natural events. Commenters stated that microbial growth and survival
varies significantly by region and water source, and some open water
sources have sufficient microbiological stability that weekly testing
is unnecessary. In addition, commenters argued that the testing
frequency requirements should recognize the reduced risk (and
consequently, less frequent need for testing) associated with proper
design and maintenance of the water source to encourage growers to
implement preventive measures; (2) commenters stated that there is a
need to incorporate flexibility into the testing frequency requirements
so growers can determine appropriate frequencies, considering factors
specific to their source of water and its use. For example, commenters
asserted that testing frequencies should be tailored for farms using
short-term or intermittent irrigation. In addition, some commenters
stated that an assessment of risks associated with ground water should
be farm-based because not all ground water is equal or merits the
proposed testing frequency, and that FDA must permit alternative
practices for water testing based on sound science; (3) commenters
suggested that appropriate testing frequencies should be determined
depending on historical test results. Commenters maintained that a more
effective approach than the one proposed by FDA would be to take
baseline samples to determine water quality and then schedule routine
future testing based on the results of the baseline testing; (4)
commenters argued that scientific data to support the proposed testing
frequencies are lacking. For example, commenters opposed the specific
requirements related to testing of untreated surface water in proposed
Sec.  112.45(b), and asserted that general water testing requirement in
proposed Sec.  112.45(a) to test agricultural water at the beginning of
the growing and every 3 months thereafter during the growing season,
coupled with the requirements in proposed Sec.  112.42 to regularly
inspect and maintain agricultural water systems, is adequate.
Commenters who opposed the weekly testing requirement in proposed Sec.
112.45(b)(1) pointed out that, although they acknowledge the need to
test surface water sources more frequently than ground water sources,
there is no basis for the proposed weekly testing of untreated surface
water. One commenter also pointed out that a WHO analysis of tolerable
risk for irrigation water determined that harvesting 5 days after last
irrigation has a significant reduction in contamination. Other
commenters argued that human pathogens do not survive well on produce
in the field and, therefore, contamination that occurs early in a
growing season may not survive to harvesting, such that a requirement
to test at the beginning of each growing season would be of no value.
Some commenters requested more clarity regarding the frequency of
testing water that is used in harvest and post-harvest activities, and
the data that FDA used to determine the adequate testing frequency for
such use of water. Commenters also urged FDA to revisit the scientific
data supporting the testing intervals and validate the quality of those
data. Still other commenters encouraged FDA to create a separate rule
or guidance on testing frequency requirements after further research is
completed; and (5) commenters argued that the proposed testing
frequencies would pose an undue financial burden without providing
clear public health benefits. Commenters strongly opposed the weekly
testing frequency, in

particular, and stated that farms do not have the necessary resources
or facilities to accommodate such frequent testing, and some growers
would have to ship their water samples to testing laboratories. Some
commenters also noted that many growers use more than one pond for
irrigation and using up to four ponds is not uncommon, such that costs
of testing could become prohibitively expensive. One commenter
estimated that the total cost associated with water testing
requirements could amount to about $11,550 annually (including costs of
labor and laboratory testing). Another commenter urged FDA to
explicitly permit growers to use water testing data compiled by other
entities. According to the commenter, municipalities in New Hampshire
routinely test E. coli levels for recreational purposes, and it would
be unnecessary to require growers to test the same water source for the
same pathogens separately.
    Commenters also recommended specific alternative testing
frequencies in lieu of our proposed provisions. Some commenters
mentioned that a more prudent testing requirement would be within a
timeframe closer to harvest, while others suggested that it would be
beneficial to require water testing at the outset for a new operation
or when a new water source is first brought into use. Other notable
suggestions included seasonal water sampling, or using the current
USDA's Good Agricultural Practices requirements for testing surface
waters at the beginning and the peak of the growing season and at
harvest time.
    Conversely, a few commenters agreed with the testing frequencies
that we proposed, stating that the proposed schedule of water testing
ensures the safety of water initially and during growing, harvesting,
and post-harvest activities.
    Overall, a majority of the concerns with the proposed testing
frequencies centered on the financial burden imposed on farms, in
particular, under a weekly testing requirement; that FDA did not
provide scientific data in support of the proposed testing frequencies;
and the need for a more flexible approach accounting for the
variability in water quality associated with various water sources and
the particular use of the water during growing, harvesting, or post-
harvest activities.
    b. FDA's Consideration of Comments. As noted above, a key objective
of our proposed approach to water testing was to establish a testing
frequency sufficient to adequately characterize the quality of the
agricultural water such that the information could lead farms to make
informed and appropriate decisions about its use and/or the need for
any appropriate corrective actions, prior to such use. Commenters
generally agreed with our intent to characterize the quality of the
water source, but argued that the frequency intervals proposed were too
short; and, as a consequence, would require more tests (and associated
costs) than necessary to accomplish the desired outcome, without a
commensurate gain in public health benefit. In view of comments
received, we reviewed our previous proposed frequencies to characterize
the quality of untreated surface water and untreated ground water
sources.
    Taking into account comments received, currently available
information, and upon further analysis, we are proposing certain
amendments to proposed Sec. Sec.  112.45 that, collectively, result in
a proposed tiered approach to testing untreated surface water and
untreated groundwater. The proposed approach would allow farms to make
decisions about safe use of available water sources prior to the
beginning of the next growing season; adjust testing frequencies
dependent on long-term test results; and ultimately reduce the required
frequency of testing.
    In the case of both untreated surface water and untreated ground
water, we are proposing to more narrowly focus the period of
characterization of water quality to those when the risk is greatest,
i.e., during periods when agricultural water is used immediately prior
to harvest. Currently available information indicates that the risk to
consumers is greater in relative terms when produce contamination via
agricultural water occurs closest to consumption. That is, agricultural
water used early in the growing season (e.g., seeding, plant
establishment) generally has less inherent risk associated with its use
than water used in harvest (e.g., field wash) or post-harvest
activities (e.g., washing, cooling). Requiring that water
characterization focus on periods when the risk is greatest reconciles
public comments with the scientific literature on the relative risks
associated with the timing of use of agricultural water. This approach
is supported by the discussion above concerning die-off rates between
application of water and harvest. With die-off rates of 0.5 log or
greater per day the impact of water quality more than a couple of weeks
prior to harvest is minimal. We expect this time period (i.e.,
immediately prior to harvest) to be variable and dependent on the crop
and length of time harvest activities are performed. It is reasonable
to conclude that it would include periods immediately prior to active
harvest of one commodity or variety, even though another continues to
mature but is not yet ready for harvest. To permit farms to tailor
their sampling of water to the unique circumstances relevant to their
crop(s) and practices and conditions on their farm, we are proposing as
a requirement that the samples required to be collected include those
``collected during a time period(s) as close as practical to harvest.''
We recognize that the timing of the use of agricultural water using a
direct application method varies by crop, region, season, and/or from
year to year. By using the term ``practical,'' we intend to convey that
agricultural water should be collected for analysis when, during the
characterization or verification period, agricultural water is applied
to covered produce, and not that samples would be collected from the
source water when it is not being applied to the crop. Timing of the
samples should be such that the last applications of agricultural water
prior to harvest are targeted, again recognizing that in some
circumstances such applications may not be preplanned (e.g., early
frost or unusually hot, dry weather). Further, timing of sample
collection should occur in the time period during growing and near
harvest, and be designed to represent events that can reasonably be
expected to both impact water quality (e.g., rainfall, high river
stage, wildlife and domesticated animal movement through upstream water
systems) and occur in the time period during growing and/or near
harvest.
    At this time, we are not proposing to further specify an
appropriate time period prior to harvest for sampling. We seek comment
on whether it would be practical to require sample collection during a
certain time period(s) such that the test results based on such samples
would be available in sufficient time to determine any changes to water
quality and, if necessary, adjust harvesting times accordingly or take
other corrective actions.
    i. Tiered approach to testing untreated surface water. We are
proposing to amend proposed Sec.  112.45(b) to establish a new proposed
tiered approach to testing untreated surface water that is used for the
growing of produce (other than sprouts) using a direct application
method. As amended, proposed Sec.  112.45(b) would establish that if
you use untreated surface water for purposes that are subject to the
requirements of proposed Sec.  112.44(c), you must take the following
steps for each source of the untreated surface water: (1) Conduct a
baseline survey to develop a water quality profile

of the agricultural water source. (i) You must conduct a baseline
survey in order to initially develop the water quality profile of your
water source. You must determine the appropriate way(s) in which the
water may be used based on your water quality profile in accordance
with Sec.  112.44(c)(1) through 112.44(c)(3). (ii) The baseline survey
must be conducted over a minimum period of 2 years by calculating the
GM and the STV of generic E. coli (CFU per 100 mL) using a minimum
total of 20 samples, consisting of samples of agricultural water as it
is used during growing activities using a direct water application
method, collected during a time period(s) as close as practical to
harvest. The water quality profile initially consists of the GM and STV
of generic E. coli calculated using this data set. (iii) You must
develop a new water quality profile: (A) At least once every 10 years
by recalculating the GM and STV values using a minimum total of 20
samples collected during your most recent annual surveys (which are
required under paragraph (b)(2) of this section); and (B) when required
under paragraphs (b)(2) and (b)(3) of this section. (2) Conduct an
annual survey to verify the water quality profile of your agricultural
water source. (i) After the baseline survey described in paragraphs
(b)(1)(i) and (b)(1)(ii) of this section, you must test the water
annually to verify your existing water quality profile to confirm that
the way(s) in which the water is used continues to be appropriate. You
must analyze a minimum number of five samples per year, consisting of
samples of agricultural water as it is used during growing activities
using a direct water application method, collected during a time
period(s) as close as practical to harvest. (ii) If the GM and/or STV
values of the annual survey samples do not support your water quality
profile and therefore your existing water use as specified in Sec.
112.44(c), you must develop a new water quality profile and, as
appropriate, modify your water use based on the new water quality
profile in accordance with Sec.  112.44(c)(1) through (3) as soon as
practical and no later than the following year. To develop a new water
quality profile, you must calculate new GM and STV values using either:
(A) Your current annual survey data, combined with your most recent
baseline or annual survey data from prior years, to make up a data set
of at least 20 samples; or (B) your current annual survey data,
combined with new data, to make up a data set of at least 20 samples;
and (3) if you know or have reason to believe that your water quality
profile no longer represents the quality of your water for reasons
other than those in paragraph (b)(2) of this section (for example, if
there are significant changes in adjacent land use, erosion, or other
impacts to water outside your control that are reasonably likely to
adversely affect the quality of your water source), you must develop a
new water quality profile. To develop a new water quality profile, you
must calculate new GM and STV values using your current annual survey
data, combined with new data, to make up a data set of at least 20
samples. Then, as required by Sec.  112.44(c)(1) through (3), you must
modify your water use based on the new water quality profile as soon as
practical and no later than the following year.
    The approach proposed in Sec.  112.45(b) is responsive to comments
that requested us to establish a risk-based, flexible testing approach
that accounts for variability in water quality from different sources,
considers the specific use of water from a particular water source, and
contemplates the reduced likelihood of contamination from well-designed
and adequately maintained water systems. In addition, this approach
also provides for use of longer-term ``good'' results as a basis to
support a reduced frequency of testing (compared to that previously
proposed) resulting in overall reduced economic burden associated with
testing of water. We also acknowledge comments that requested us to
consider how best to ensure that growers understand and are able to
implement our proposed requirements. We plan to provide guidance
regarding the proposed water testing requirements, if finalized.
    Proposed Sec.  112.45(b) would apply only to untreated surface
water that is used for the purposes specified in Sec.  112.44(c), i.e.,
for the growing of produce (other than sprouts) using a direct
application method. As proposed, the tiered approach for testing of
such agricultural water consists of three major elements.
    First, you must conduct a baseline survey over a minimum period of
2 years to develop a water quality profile of your water source, based
on which you would be able to determine whether the water meets the
microbial quality requirements established in Sec.  112.44(c). If it
does not satisfy those requirements, then you must consider and
implement any one of the options provided in Sec. Sec.  112.44(c)(1),
(c)(2), and (c)(3), as appropriate for your commodity and practices and
conditions on your farm, if you wanted to continue to use the water