[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58434-58473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22447]
[[Page 58433]]
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
[[Page 58434]]
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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, 240-402-1636.
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
[[Page 58435]]
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
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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
[[Page 58436]]
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
[[Page 58437]]
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.
[[Page 58438]]
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
[[Page 58439]]
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''
[[Page 58440]]
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
[[Page 58441]]
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
[[Page 58442]]
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.
[[Page 58443]]
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
[[Page 58444]]
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
[[Page 58445]]
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
[[Page 58446]]
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
[[Page 58447]]
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).
[[Page 58448]]
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
[[Page 58449]]
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
[[Page 58450]]
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
source for the growing of produce (other than sprouts) using a direct
water application method.
Second, every year after this initial baseline survey, you must
conduct an annual survey to verify your water quality profile and
ensure that the way in which you are using the water continues to be in
accordance with Sec. 112.44(c). If your annual survey verifies your
water quality profile is still likely to be representative of the
quality of your water source, no additional steps would be necessary in
that year. If, however, the annual survey results are sufficiently
different from your existing water quality profile to suggest that the
profile is no longer representative of the quality of your water
source, you would be required to develop a new water quality profile
and make adjustments to the way in which you are using the water in
accordance with Sec. 112.44(c), as necessary. When developing a new
water quality profile for this purpose, you would be allowed to rely on
existing test results.
Third, you would be required to develop a new water quality profile
on a regular, 10-year schedule and as needed when you know or have
reason to believe that your water profile no longer represents the
quality of your water source (for reasons other than your annual survey
results). In both cases you would also be required to make
corresponding adjustments to the way you use the water, as necessary.
In the former case, you would be allowed to rely on existing test
results when developing your new water quality profile. In the latter
case, you would be required to use new test results to develop your new
water quality profile.
The steps identified in proposed Sec. 112.45(b) (i.e., the
baseline survey, annual verification testing and, as needed,
development of new water quality profiles) would be required to be
performed separately for each untreated surface water source used for
direct water application to covered produce (other than sprouts) during
growing. For example, if you have a surface water impoundment on your
farm that stores groundwater to be used for this purpose, but you also
sourced water from a river for the same purpose, you would need to
evaluate both bodies of water individually in compliance with the
requirements of proposed Sec. 112.45(b), as each delivers water that
is distinctly different in origin and likely to differ in overall
composition and characteristics.
We are proposing that the water quality profile of untreated
surface water sources include both a GM and a STV value, as reflected
in the proposed baseline survey and annual surveys used for
verification. This proposed
[[Page 58451]]
requirement is intended to serve two purposes. First, requiring both GM
and STV values would correspond to the microbial quality requirements
we proposed in Sec. 112.44(c) and, thus, allow a comparison of the
values derived from your surveys to the proposed microbial quality
standard. Second, using both GM and STV values would provide a profile
of the quality of your water source that reflects both its central
tendency (the GM) and the variation in its quality (the STV). This
information could be used to understand the effects of factors, such as
precipitation, flow rate, and changes in adjacent land use on water
quality, especially if characterization data are analyzed over
additional years.
To increase the accuracy of the water quality profile and the
annual survey data, samples should be collected at intervals over the
period immediately preceding harvest and under a variety of
environmental conditions (e.g., after precipitation), as appropriate.
We expect farms to determine the appropriate time period for sampling
to meet our proposed requirement that samples be collected during a
time period(s) as close as practical to harvest, while recognizing that
samples of water taken more than a few weeks prior to harvest are
unlikely to be relevant to the safety of the crop. In addition, we
would not consider samples collected in a single day solely to satisfy
the minimum sample number to provide adequate variation as the
distribution estimates resulting from such a sampling plan would defeat
the purpose of the survey.
We do not intend to limit data sharing among farms if, by
inspection, the characteristics of the shared water source are found to
be similar and no significant source of contamination is identified
between sampling sites of the different farms. In fact, we encourage
such sharing when appropriate. We have included a new proposed
provision (Sec. 112.45(e)) that would explicitly allow data sharing
under certain circumstances.
Similarly, we do not expect farms to incur additional sampling
costs to satisfy the baseline survey requirement proposed in Sec.
112.45(b)(1), if they already possess sufficient water quality data
(consisting of the minimum required number of samples) collected during
the required time period.
a. Baseline Survey--For the baseline survey described in Sec.
112.45(b)(1)(i) and (ii), we are proposing that the survey must be
conducted over a minimum period of 2 years, by calculating the GM and
STV values 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. You
would be required to test these samples for generic E. coli in
accordance with one of the appropriate analytical methods in subpart N,
and to develop a water quality profile consisting of the GM and
statistical threshold value STV of generic E. coli calculated using
this dataset. We tentatively conclude that sampling an untreated
surface water source over a period of 2 years is the minimum necessary
to provide an adequate representation of its quality to enable informed
decisions about its use in a direct application method. We also
tentatively determined 20 samples to be the minimum necessary for the
purposes of conducting such a baseline survey. We incorporated a
certain degree of flexibility in this proposed requirement to allow
farms to independently determine the appropriate number of samples
required to characterize an untreated surface water source based on
their knowledge of the water system, its inherent variability, and the
vulnerability of their water source to contamination. We seek comment
on these tentative conclusions.
Our analysis suggests that a minimum number of samples required in
``average'' surface water sources would be 20 samples. We based our
determinations of the minimum necessary sample size for the baseline
survey on an assessment of the relative precision of estimation of the
GM and STV (approximation of the 90th percentile) afforded by different
sample sizes when generic E. coli levels are log-normally distributed
(Refs. 18, 19, and 20). The precision of estimation of GM and STV
(approximation of the 90th percentile) of log-normally distributed data
depends upon the variation (i.e., standard deviation), which is likely
to be different for different sources of water and uncertain with
respect to any particular source of water. Precision of estimation will
be lower when variability is higher. However, for the purpose of
determining an appropriate sample size for ``average'' surface water
sources a standard deviation of 0.4 (of log abundance of E. coli) was
assumed based on estimates of variability of measurements of culturable
E. coli in samples of recreational waters as determined by EPA in the
2012 RWQC. Based on this assessment of precision, we propose a minimum
of 20 samples for the baseline survey in order to adequately
characterize the water in a manner that provides initial estimates of
GM and STV of E. coli distribution of sufficient precision to allow for
a determination of the appropriate use (or conditions of use) of an
untreated surface water source (Ref. 21). We would encourage farmers to
sample more than the minimum required 20 samples to build a robust
baseline characterization.
b. Annual Verification Survey--For the annual verification survey
described in Sec. 112.45(b)(2), we are proposing that the survey must
be conducted by calculating the GM and STV values of generic E. coli
(CFU per 100 mL) using a minimum number of five samples, consisting of
samples of agricultural water as it is used during growing activities
using a direct water application method. The purpose of the annual
verification survey is to verify the water quality profile described in
Sec. 112.45(b)(1) and to confirm that the way(s) in which the water is
used continues to be in accordance with Sec. 112.44(c). If your annual
verification survey detects a change in water quality that is no longer
consistent with current water use, you would be required to develop a
new water quality profile. As described in Sec. 112.45(b)(2)(ii), to
develop a new water quality profile, you would 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. Then, as required by Sec. 112.44(c)(1) through (3), you
would be required to modify your water use based on the new water
quality profile as soon as practical and no later than the following
year.
We have tentatively determined five samples to be the minimum
number necessary to calculate a GM and STV value appropriate for annual
verification purpose. Although the precision of estimation afforded by
five samples for annual verification is less than that afforded by the
20 samples proposed for the baseline survey, our assessment indicates
that five samples would be sufficient to provide adequate probability
of detecting large and substantial deviations in the GM (e.g., 0.5 log
or greater change from that of the baseline survey) for ``average''
water sources characterized by a standard deviation of 0.4 (of log
abundance of E. coli). Consequently, a sample size of five is judged to
be sufficient for annual verification of the water quality profile and
that the way(s) in which the water
[[Page 58452]]
is used, based on that profile, continues to be appropriate (Ref. 21).
Where the outcome of annual sampling provides a GM or STV value
that is inconsistent (e.g., 0.5 log or greater change) with the current
water quality profile GM or STV values, we expect the annual
verification to be used, in combination with previously or subsequently
conducted test result data to develop a new water quality profile, and
for farms to alter their current water use practices as necessary
during the current harvesting season if practical, and if not, to
modify practices for the following year. The new water quality profile
could be developed by combining the current year's annual survey data
(of a minimum of test results from five samples) with data obtained by
either collecting (and testing) additional, new samples (as described
in Sec. 112.45(b)(2)(ii)(B)), or using the test results from the most
recent previous years' annual or baseline surveys (as described in
Sec. 112.45(b)(2)(ii)(A)), in either case the data set must contain at
least 20 samples. For such revisions to the GM or STV values, we may
consider stipulating a time period beyond which the data would not be
appropriate to use because they would not be expected to provide a
current representative profile of the water quality. For example,
should we specify that when revising the baseline GM or STV values
based on annual survey results, the annual verification data may be
used, in combination with previously or subsequently collected baseline
or annual survey data, but not including data sampled beyond the
previous 3 years?
For example, in Year 1, Farm A conducts a baseline survey by taking
20 samples of its water source and testing them for generic E. coli, as
described under Sec. 112.45(b)(1)(i) and (ii), which indicates a GM of
125 CFU/100 mL and STV of 400 CFU/100 mL. This is the farm's initial
water quality profile for this water source. The farm's GM and STV are
below the GM and STV of the water quality standard in Sec. 112.44(c)
(GM of 126 CFU/100 mL, STV of 410 CFU/100 mL). Thus, based on this
water quality profile, the farm would not be required to and does not
implement any of the mitigation measures specified in Sec. Sec.
112.44(c)(1) through (c)(3) in Year 1. In Year 2, Farm A conducts an
annual survey by taking five samples of its water source and testing
them for generic E. coli, as described in Sec. 112.45(b)(2), and
determines that the GM and STV values based on these five samples are
500 CFU/100 mL and 1600 CFU/100 mL, respectively. The farm finds that
these Year 2 values are not consistent with the existing water quality
profile because there is greater than a 0.5-log difference between the
annual survey values and the water quality profile values. Therefore,
as required by Sec. 112.45(b)(2)(ii), the farm develops a new water
quality profile. To do this, the farm uses its 5 test results from Year
2's annual survey, combined with 15 test results representing the most
recently collected samples from the farm's earlier baseline data set to
make up a data set of 20 samples, as described in Sec.
112.45(b)(2)(ii)(A). The farm uses these 20 test results to develop a
new water quality profile. The farm's new water quality profile GM and
STV values are 200 CFU/100 mL and 600 CFU/100 mL, respectively. The
farm's water quality profile GM and STV are now above the GM and STV of
the water quality standard in Sec. 112.44(c) (GM of 126 CFU/100 mL,
STV of 410 CFU/100 mL). As a result, as required by Sec. Sec.
112.45(b)(2)(ii) and 112.44(c), the farm must either apply a time
interval as a mitigation measure (Sec. 112.44(c)(1) or (2)) or
discontinue using the water for direct water application during growing
covered produce until the water meets the water quality standard (Sec.
112.44(c)(3)). A 1-day time interval between last water application and
harvest (under Sec. 112.44(c)(1)) would be sufficient to meet the
microbial quality requirements specified in proposed Sec. 112.44(c)
because it results in calculated GM and STV values of 63 CFU/100 mL and
190 CFU/100 mL, respectively. The timing of the Year 2 crop cycle is
such that the farm is able to develop its new water quality profile and
take action prior to the end of the current harvesting season, and the
farm chooses to apply a 1-day interval between last water application
and harvest.
As another example, all of the circumstances for Farm B are the
same for Farm A, except that Farm B's Year 2 annual survey test results
are not available prior to the end of the current harvesting season. In
this example, the farm would modify its practices in Year 3 based on
the new water quality profile values developed in Year 2. Farm B
chooses to apply a 1-day interval between last water application and
harvest, as required under Sec. 112.44(c)(1), during Year 3.
As another example, Farm C conducts a baseline survey by taking 20
samples of its water source and testing them for generic E. coli, as
described under Sec. 112.45(b)(1)(i) and (ii). Using these test
results, the farm calculates a GM of 241 CFU/100 mL and STV of 576 CFU/
100 mL. This is the farm's initial water quality profile for this water
source. The farm's GM and STV are above the GM and STV of the water
quality standard in Sec. 112.44(c) (GM of 126 CFU/100 mL, STV of 410
CFU/100 mL). As a result, as required by Sec. Sec. 112.45(b)(2)(ii)
and 112.44(c), the farm must either apply a time interval as a
mitigation measure (Sec. 112.44(c)(1) or (2)) or discontinue using the
water for direct water application during growing of covered produce
until the water meets the water quality standard (Sec. 112.44(c)(3)).
The farm chooses to apply a one-day interval between last water
application and harvest. In Year 2, Farm C conducts an annual survey by
taking five samples of its water source and testing them for generic E.
coli, as described in Sec. 112.45(b)(2). The farm calculates that the
GM and STV values based on these five samples are 3000 CFU/100 mL and
5800 CFU/100 mL, respectively. The farm finds that these Year 2 values
are not consistent with the existing water quality profile because
there is greater than 1-log difference between the annual values and
the water quality profile values. Therefore, as required by Sec.
112.45(b)(2)(ii), the farm develops a new water quality profile. To do
this, the farm uses its 5 test results from Year 2's annual survey,
combined with 15 test results representing the most recently collected
samples from the farm's earlier baseline data set to make up a data set
of 20 samples, as described in Sec. 112.45(b)(2)(ii)(A). The farm uses
these 20 test results to develop a new water quality profile. The
farm's new water quality profile GM and STV values are 475 CFU/100 mL
and 1050 CFU/100 mL, respectively. These values are different from the
ones the farm used in Year 1 to calculate its time interval under Sec.
112.44(c)(1). The farm must now use the Year 2 new water quality
profile GM and STV values to reconsider and implement one of the
mitigation measures specified in Sec. Sec. 112.44(c)(1) through
(c)(3). A 2-day time interval between last water application and
harvest would be sufficient to meet the microbial quality requirements
specified in proposed Sec. 112.44(c) because, using the Year 2 water
quality profile values, a 2-day interval would result in calculated GM
and STV values of 48 CFU/100 mL and 105 CFU/100 mL, respectively. The
farm is able to modify its practices during the current season and
applies a 2-day interval between last water application and harvest.
c. Other Requirements to Update Water Quality Profiles--Under
proposed Sec. 112.45(b)(1)(iii)(A), we are proposing to require farms
to develop a new water
[[Page 58453]]
quality profile every 10 years. We tentatively conclude that re-
establishing the GM and STV values at least once every 10 years is
necessary to reevaluate your agricultural water source and its use in
light of potential changes over time of your farm's practices and
conditions and changes in the watershed from which you source your
water, even if the farm's annual survey data in any single year of the
10 years does not reveal a substantial deviation from the values in the
farm's then-current water quality profile. As proposed, a farm would be
able to use the test results obtained from annual verification testing
to develop the new water quality profile, so this provision would not
require any additional testing. For example, a farm that conducts
annual verification survey using five samples a year would be able to
use these data gathered over the previous 4 years to make up the
minimum number of 20 samples. All that would be required is for the
farm to use these 20 test results to calculate a new GM and STV value,
which would then represent the farm's water quality profile. The farm
would then use the new water quality profile to determine what water
use is appropriate under Sec. 112.44(c), including whether any steps
need to be taken under Sec. Sec. 112.44(c)(1) through (3). We expect
this proposed provision would serve to guide water management decisions
with minimal additional cost or resources expended.
Proposed Sec. 112.45(b)(3) would require you to develop a new
water quality profile 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 Sec. 112.45(b)(2) (i.e., reasons not
based on annual survey test results). Then, as necessary and required
by Sec. 112.44(c)(1) through (3), you would be required to modify your
water use based on the new water quality profile as soon as practical
and no later than the following year.
For example, if you know or have reason to believe that 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 water quality profile, you would be required to develop a
new water quality profile under this section. In this provision, we
listed some examples of events (such as land erosion) that may degrade
the quality of surface water sources such that the development of a new
water quality profile may become necessary, but we do not intend this
list to be all-inclusive. Alternatively, there may be circumstances
that lead to water quality improvements (for example, changes in
upstream water management practices) that result in a higher water
quality and may permit its wider use or use without specific time
intervals. We limited the application of this provision, which requires
development of a new water quality profile, to changes reasonably
likely to have adverse effects on water quality. We note that a farm
may become aware of a change likely to have a positive effect on water
quality and choose to voluntarily develop a new water quality profile
to evaluate whether the change has indeed improved the water quality to
an extent that could justify changes in water use practices under Sec.
112.44(c).
When developing a new water quality profile under proposed Sec.
112.45(b)(3), you would be required to 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. This is an important difference
from all the other circumstances in proposed Sec. 112.45 in which a
farm would be required to develop a new water quality profile, because
in this circumstance, the farm would not be allowed to use existing
test results predating the current annual survey test results for this
purpose. The farm would be required to conduct some new sampling and
testing to make up its new data set of at least 20 test results (unless
it opted to exceed the minimum annual survey requirements and already
conducted at least 20 tests as part of its current annual survey).
d. Requests for Comment on Proposed Sec. 112.45(b)--We ask for
comment on our proposed approach, described in amended provision Sec.
112.45(b), to testing untreated surface water that is used for the
growing of produce (other than sprouts) using a direct application
method. In particular, we seek comment on our tentative conclusions
related to the tiered approach (including the baseline survey, annual
verification testing, and requirements to develop new water quality
profiles), sampling requirements (including minimum sample sizes,
minimum sampling periods), and our determination that such an approach
would provide for a reduced required frequency of testing while
ensuring the quality and safe use of untreated surface water.
We acknowledge that there are certain limitations to our proposed
approach, particularly regarding whether and how annual verification
data (which can be based on as few as 5 data points, as proposed) may
be used to identify the need for changes to water use practices in the
current season and/or the need for a new water quality profile. We
request comment on whether there are scenarios that should warrant the
development of a new water quality profile using 15 new test results
(in addition to the 5 annual survey test results to meet the minimum
number of 20 samples), such as where the magnitude of the deviation
from the existing water quality profile GM and STV values that formed
the basis for the manner in which the water is currently used suggests
that those prior sample values are no longer representative of the
current agricultural water. For example, is there a threshold based on
magnitude of deviation indicated in an annual survey (e.g., a 1 to 2-
log change in the GM or STV value compared to the GM or STV of the
existing water quality profile) that would suggest that the existing
water quality profile is no longer representative of the current water
quality such that none of the sample data from that existing water
quality profile should be used to determine the current quality of the
agricultural water?
We plan to provide guidance to assist farmers to implement the
water testing requirements, if finalized. Among other guidance, we
expect to develop a tool(s) that you can use to derive the GM and STV
values based on your input of water testing data. We recognize that
there are different ways to determine STV values, including through
sample-based empirical estimation and model-based calculation. We
request comment on whether there is a specific statistical method(s)
that we should either require or recommend be used for the derivation
of GM and/or STV values.
We also request comment on whether we should require farms to alter
practices in the current season based solely on the annual survey data
under certain circumstances, such as where the annual survey test
results suggest a public health concern that must be addressed in a
timely manner. This would be different from what we are proposing,
which is to use the annual survey data set (which may be as small as 5
test results) solely for verification purposes, which may lead to
development of a new water quality profile (using at least 20 test
results), upon which farms would determine the need for changes to
their water use practices. If there are circumstances in which farms
should be required to change water use practices based solely on the
smaller annual survey data set, what results obtained in an annual
survey should require such immediate changes? For example, should a
substantial deviation in the GM or STV value indicated in an annual
survey (e.g., a 1 to 2-log change in the GM or STV value compared to
the GM or STV
[[Page 58454]]
in the existing water quality profile) require farms to institute
immediate corrections to current water use practices (such as
application of a time interval between irrigation and harvest) based
solely on the annual survey results? Note that under our proposed
approach, an annual survey can be based on a minimum number of five
samples. Should annual surveys be required to include more than five
samples? Should annual survey data based on greater than five samples
be used to support immediate changes to current practices?
We request comment on whether there are scenarios that might
appropriately trigger both of the potential requirements discussed
immediately above (i.e., development of a new water quality profile
using new test results and, in the interim, immediate changes to water
use practices based solely on annual survey test results).
In our analysis related to the number of samples needed in annual
verification surveys of untreated surface water, we used an estimate of
average standard deviation of log10 E. coli abundance
measurements in surface waters of 0.4 to characterize the variability
of an average water source (Ref. 21). We request comment on whether,
for a highly variable water source (e.g., moving water body), we should
require more than a five-sample annual verification survey. For
example, should we require that you establish a new water quality
profile annually using a minimum of 20 samples made up of the annual
survey data combined with data from the previous survey(s)?
We also seek comment on whether there are other data sources that
can be used in conjunction with water testing data to determine the
need for immediate changes to current practices. For example, would
data obtained through sanitary surveys conducted by farms be useful to
identify the need for immediate changes to current use of the
agricultural water?
In addition, we request comment on whether we should stipulate a
time period beyond which data would not be appropriate to use in a
water quality profile because the test results would not be expected to
provide a currently representative profile of the water quality. For
example, should we specify that whenever a farm is required to develop
a water quality profile under this proposed rule, the data relied upon
may only include samples collected within the last three calendar
years?
As previously noted, in certain cases, such as where multiple crops
are grown in a single year, harvesting will likely occur while the
total required five samples for annual verification are collected such
that it may be impractical to rely on the results of this verification
to determine the appropriate use of that agricultural water for any one
or more of those crops for the current harvesting season. We seek
comment on this issue, including whether there is an alternative
sampling scheme (in lieu of the one we proposed) that would be more
responsive to crop cycles and facilitate the use of annual survey
testing to make any necessary adjustments to water use during the
current harvesting season.
Although we proposed a tiered approach that is based on a baseline
survey, annual verification and, as necessary, developing new water
quality profiles, we acknowledge that there may be alternative schemes
to sampling and testing water quality. We seek comment on any such
alternative schemes we should consider.
e. Testing Untreated Surface Water for Other Purposes--New Sec.
112.45(d) would provide that if you use untreated surface water for
purposes that are subject to the requirements of Sec. 112.44(a), you
must test the quality of each source of the water with an adequate
frequency to provide reasonable assurances that the water meets the
required microbial standard and that you must have adequate scientific
data or information to support your testing frequency. As described in
the previously published proposed rule, the uses of agricultural water
listed in proposed Sec. 112.44(a) are agricultural water that is: (1)
Used as sprout irrigation water; (2) applied in any manner that
directly contacts covered produce during or after harvest activities
(for example, water that is applied to covered produce for washing or
cooling activities, and water that is applied to harvested crops to
prevent dehydration before cooling), including when used to make ice
that directly contacts covered produce during or after harvest
activities; (3) used to make a treated agricultural tea; (4) used to
contact food-contact surfaces, or to make ice that will contact food-
contact surfaces; and (5) used for washing hands during and after
harvest activities.
As proposed, the testing requirements in Sec. 112.45(b) apply when
the untreated surface water is used during growing for purposes of
direct application as specified in Sec. 112.44(c) only. We anticipate
that the primary use of untreated surface water would be in growing
activities (e.g., irrigation, crop protection sprays) although we are
not restricting it solely for those activities. For example, we are not
specifically prohibiting a farm from using untreated surface water for
any purpose described in Sec. 112.44(a), provided it meets the water
quality requirements for those purposes, as described in that section.
Although, in accordance with proposed Sec. 112.44(a), untreated
surface water that is used for any purpose described in Sec. 112.44(a)
would be required to meet the water quality parameters established in
that provision, at this time, we are not proposing, in amended Sec.
112.45, specific testing frequency requirements applicable to untreated
surface water when used for the purposes described in Sec. 112.44(a).
Instead, we are proposing to include new Sec. 112.45(d), which would
provide that if you use untreated surface water for purposes that are
subject to the requirements of Sec. 112.44(a), you must test the
quality of each source of the water with an adequate frequency to
provide reasonable assurances that the water meets the required
microbial standard and that you must have adequate scientific data or
information to support your testing frequency. We are also proposing to
require records of your supporting data in new Sec. 112.50(b)(9).
We seek comment on the prevalence of use of untreated surface water
for those purposes listed under Sec. 112.44(a), and on an appropriate
approach(es) to sampling and testing of untreated surface water
intended for such uses. Further, we acknowledge the challenge
associated with designing a sampling scheme that would provide
sufficient confidence that a source of untreated surface water, given
its inherent variability, will consistently meet the water quality
standard in proposed Sec. 112.44(a).
Under the Surface Water Treatment Rule (40 CFR 141.70-141.75), EPA
requires public water systems to treat surface water or ground water
sources under the direct influence of surface water to meet the
requirements of the Safe Drinking Water Act (SDWA) (42 U.S.C. 300f et
seq.). We seek public comment on whether we should likewise require
treatment of surface water sources used for the purposes specified in
Sec. 112.44(a), rather than provide for a testing scheme, if the
latter is not practical.
ii. Tiered approach to testing untreated ground water. Similar to
the tiered approach for testing untreated surface water for direct
application during growing, we are proposing a tiered approach to
testing ground water that is used for any of the purposes established
in Sec. 112.44. New proposed Sec. 112.45(c) would establish that if
you use untreated ground water for purposes that are subject to the
requirements of
[[Page 58455]]
Sec. 112.44, you must test the quality of each source of the water at
least four times during the growing season or over a period of 1 year,
using a minimum total of 4 samples collected during a time period(s) as
close as practical to harvest. If the samples tested meet the
applicable microbial standard in Sec. 112.44 (i.e., no detectable
generic E. coli per 100 mL under 112.44(a) or a GM of generic E. coli
of 126 CFU or less per 100 mL under 112.44(c), as applicable), you may
test once annually thereafter, using a minimum of one sample collected
during a time period as close as practical to harvest. You must resume
testing at least four times per growing season or year if any annual
test fails to meet the applicable microbial standard in Sec. 112.44.
We are not proposing that the STV component of the standard under Sec.
112.44(c) be applied in the case of ground water because the minimum
number of samples that we are proposing for collection would not be
sufficient for a reliable calculation of that value. However, we expect
you to apply the STV component of the standard in Sec. 112.44(c) if
the number of samples you collect allow for its calculation.
Under this approach, each ground water source would be required to
be tested initially by sampling a minimum of four times during the
growing season or over a period of 1 year using a total of at least
four samples (i.e., a minimum of one sample collected at each sampling
occasion). If the results of this initial testing show that the samples
meet the microbial quality requirements for their intended use (i.e.,
either Sec. 112.44(a) or Sec. 112.44(c), as appropriate), then
subsequent testing can be conducted only once per year using a minimum
of one sample. However, the failure of any annual test to meet the
appropriate requirement would result in resumption of the four times
per growing season or year testing frequency. We tentatively conclude
that our proposed testing frequency and sampling plan is the minimum
necessary to ensure the quality of ground water sources for their
intended use. We would encourage farmers to sample more than the
minimum required four samples to build a robust baseline
characterization. With this approach, we are responding to public
recommendation for less frequent ground water testing based upon
historically satisfactory test results in light of other requirements,
most notably the inspection requirements of proposed Sec. 112.42(b).
We seek comment on our proposed approach. We also request comment
on whether, similar to Sec. 112.45(b)(3) for untreated surface water,
we should require the development of a new water quality profile if you
know or have reason to believe that the existing water quality profile
no longer represents the quality of your untreated ground water. For
example, a compromised well seal, well casing or back flow prevention
device may lead to a rapid decline in well water quality.
iii. Sharing of water testing data. Under new proposed provision
Sec. 112.45(e), we are proposing that you may meet the requirements
related to testing of agricultural water that is required under Sec.
112.45(b), (c), or (d) using test results from your agricultural water
source(s) performed either by you or by someone else acting on your
behalf; or, alternatively, you may use data collected by a third party
or parties provided the water source(s) sampled by the third party or
parties adequately represent your agricultural water source(s) and all
other applicable requirements of part 112 are met. This provision would
provide flexibility for you to determine the appropriate means by which
to meet the proposed testing requirements in proposed Sec. 112.45. You
may conduct the necessary tests on your water source(s) or have those
tests conducted for you by an appropriate person, group, or
organization. Alternatively, you may use data collected by a third
party or parties, such as water distribution districts or cooperatives,
provided the water source(s) sampled by the third party or parties
adequately represent your agricultural water and all other applicable
requirements of the proposed rule are met.
A water source sampled by a third party would adequately represent
your water source if the third party takes its samples from the same
water source you use (e.g., the same canal, stream, or reservoir) and
there is no reasonably identifiable source of likely microbiological
contamination (e.g., an untreated sewage discharge point, a source of
significant amounts of untreated animal feces such as a livestock farm)
between the point(s) at which the third party collects its samples and
the point(s) at which you draw the water. Thus, under this provision,
farms that share a water source may share testing data from that water
source to meet the proposed testing requirements if there is no
reasonably identifiable source of likely microbiological contamination
between the sampling site(s) and the farm(s) involved. For example,
where there is water that is held in a reservoir, and multiple farms
draw from the reservoir, those farms are using the same water source.
The farms drawing from the reservoir may share their testing data as
long as there is no reasonably identifiable source of likely
microbiological contamination between the points at which the farms
sample and draw the reservoir water as agricultural water. We seek
comment on whether and what specific conditions we should establish in
this provision to identify circumstances where a third party's data
would not adequately represent your agricultural water source and to
preclude reliance on shared water testing data in such cases.
Under this proposed provision, farms using data collected by a
third party or parties must still satisfy all applicable requirements
of the proposed rule related to agricultural water testing. For
example, the proposed rule includes requirements related to the timing
of collection of samples and the number of samples collected (see
proposed Sec. Sec. 112.45(b), (c), and (d)), and recordkeeping (see
proposed Sec. 112.50). The proposed rule also includes other
applicable requirements such as specified analytical method(s) to be
used for testing (see proposed Sec. 112.151). For example, covered
farms sourcing water from a water distribution district may consider
using water testing data from the district sampling program. A covered
farm considering the district sampling program data would need to
determine whether the water source(s) sampled adequately represent the
covered farm's agricultural water. The covered farm would also need to
consider whether the district's data set includes samples collected
during a time period(s) as close as practical to the covered farm's
harvest time; whether the district's data set satisfies the minimum
number of samples the farm is required to have under the rule; and
whether the district's data were obtained using appropriate test
methods, as described in proposed subpart N of part 112. In addition,
the covered farm would need to get and keep records of the district's
testing that satisfy the rule's recordkeeping requirements.
We seek comment on this provision and on additional means FDA could
consider to provide flexibility for covered farms to meet the proposed
agricultural water testing requirements.
iv. Removal of general testing provision. Finally, with the
proposed tiered approaches described above for testing untreated
surface water used for the purposes of Sec. 112.44(c) and for testing
ground water used more broadly for purposes of Sec. 112.44, we find
our previous proposed general provision for testing of agricultural
water in proposed
[[Page 58456]]
Sec. 112.45(a) to be unnecessary. Therefore, under proposed Sec.
112.45(a), we are proposing to remove the previous proposed provision
that stated ``You must 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,'' and
to simply retain the exceptions to that provision that we previously
proposed. As amended, proposed 112.45(a) would establish that there is
no requirement to test any agricultural water that is subject to the
requirements of Sec. 112.44 when: (1) You receive water from a public
water system, as defined under the SDWA regulations, 40 CFR part 141,
that furnishes water that meets the microbial requirements under those
regulations or under the regulations of a State approved to administer
the SDWA public water supply program, and you have public water system
results or certificates of compliance that demonstrate that the water
meets that requirement; (2) you receive water from a public water
supply that furnishes water that meets the microbial requirement
described in Sec. 112.44(a), and you have public water system results
or certificates of compliance that demonstrate that the water meets
that requirement; or (3) you treat water in accordance with the
requirements of Sec. 112.43. We refer you to a discussion of these
circumstances under which testing would not be required in section
V.E.3.d of the previously published proposed rule (78 FR 3504 at 3571).
3. Summary of FDA's Revisions and Request for Comment
With respect to the microbial quality standard for water that is
used during growing of produce (other than sprouts) using a direct
application method, we are proposing to: (1) Amend proposed provision
Sec. 112.44(c) to update the microbial quality standard in a way that
coincides with the current EPA recreational water standard, i.e., a GM
of samples not to exceed 126 CFU of generic E. coli per 100 mL of water
and (when applicable) a STV of samples, as an approximation of the 90th
percentile, not to exceed 410 CFU of generic E. coli per 100 mL of
water; (2) add two new provisions within proposed Sec. 112.44(c) to
incorporate additional flexibility for the use of agricultural water
for direct application during growing, i.e., either 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 (proposed Sec.
112.44(c)(1)); and/or 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 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 of your STV to 410 CFU or less per 100 mL, provided you have
adequate supporting scientific data and information (proposed Sec.
112.44(c)(2)); and (3) provide for the use of alternatives to the
microbial quality standard in proposed Sec. 112.44(c) and the
microbial die-off rate in proposed Sec. 112.44(c)(1).
With respect to frequency of testing agricultural water, we are
proposing to amend proposed Sec. 112.45(b) and add new provision Sec.
112.45(c) to provide for a tiered-approach to testing that would enable
testing at a reduced frequency than that proposed in the previously
published proposed rule. Specifically, we are proposing in amended
proposed Sec. 112.45(b) that if you use untreated surface water during
growing of produce (other than sprouts) using a direct application
method, you must conduct a baseline survey to develop the water quality
profile of your agricultural water source(s); conduct an annual survey
to verify the water quality profile of the water; and develop a new
water quality profile at least once every 10 years (using data
collected during the annual surveys) or sooner, if you know or have
reason to believe that your existing water quality profile no longer
represents the quality of the water. In addition, we are proposing to
add a new provision, i.e., proposed Sec. 112.45(c), to require testing
of ground water used as agricultural water at least four times during
the growing season or over a period of 1 year, and if the samples
tested meet the requirements of proposed Sec. 112.44, testing may be
done once annually thereafter. Testing frequency must return to at
least four times per growing season or year if any annual test fails to
meet the requirements of proposed Sec. 112.44. We are proposing to add
new provision Sec. 112.45(d), which would require that, if you use
untreated surface water for purposes that are subject to the
requirements of Sec. 112.44(a), you must test the quality of each
source of the water with an adequate frequency to provide reasonable
assurances that the water meets the required microbial standard, and
that you must have adequate scientific data or information to support
your testing frequency. Finally, in proposed Sec. 112.45(e), we are
proposing that you may conduct the necessary tests on your water
source(s) or have those tests conducted for you by an appropriate
person, group, or organization, or alternatively, you may use data
collected by a third party or parties, such as water distribution
districts or cooperatives, provided the water source(s) sampled by the
third party or parties adequately represent your agricultural water and
all other applicable requirements of the proposed rule are met.
We seek comment on our amended and new proposed provisions. With
respect to the amended microbial quality standard, we seek comment on
our decision to retain the general microbial quality requirements and
update them based on 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. We also request comment on the
appropriateness of permitting an adequate time interval between last
irrigation and harvest using a microbial reduction rate of 0.5 log per
day as a means to achieve the specified microbial quality requirements.
In addition, we seek comment on whether there is a specific microbial
die-off rate(s) or microbial removal rate(s) that we should establish
for applying an appropriate time interval between harvest and end of
storage. Finally, we request comment on whether there are other
provisions that we should consider to introduce additional flexibility,
for example, to allow alternative indicators of water safety.
With respect to the use of untreated surface water for the purposes
listed under Sec. 112.44(a), we seek comment on the prevalence of use
of untreated surface water for those purposes, and on an appropriate
approach(es) to sampling and testing of untreated surface water
intended for such uses. We seek public comment on whether we should
require treatment of surface water sources used for the purposes
specified in Sec. 112.44(a), rather than provide for a testing scheme,
if the latter is not practical.
With respect to the specific frequencies we have proposed for water
testing, we seek comment on our proposed tiered approach for testing
untreated surface water and ground water, including sampling
requirements, and our determination that such an approach would provide
for a reduced required frequency of testing while ensuring the quality
of agricultural water. We list a number of specific, detailed requests
for comment on issues related to testing frequencies for untreated
surface water in section
[[Page 58457]]
II.B.2.b.i. These include questions regarding whether there are
scenarios that should warrant the development of a new water quality
profile using 15 new test results (in addition to the 5 annual survey
test results to meet the minimum number of 20 samples); whether we
should require farms to alter practices in the current season based
solely on the annual survey data under certain circumstances; whether
annual surveys be required to include more than five samples; whether
there are scenarios that might appropriately trigger both development
of a new water quality profile using new test results and, in the
interim, immediate changes to water use practices based solely on
annual survey test results; whether we should require more than a five-
sample annual verification survey for highly variable water sources;
whether there are other data sources that can be used in conjunction
with water testing data to determine the need for immediate changes to
current practices; whether we should stipulate a time period beyond
which data would not be appropriate to use in a water quality profile
because the test results would not be expected to provide a currently
representative profile of the water quality; whether there is an
alternative sampling scheme that would be more responsive to crop
cycles and facilitate the use of annual survey testing to make any
necessary adjustments to water use during the current harvesting
season; and identification of any alternative schemes we should
consider.
We also request: (1) Data or information gathered from scientific
studies and/or surveys on the prevalence and population levels of
generic E. coli in untreated surface water sources of agricultural
water used during growing activities for covered produce (other than
sprouts) using a direct water application method; (2) data or
information gathered from scientific studies and/or surveys regarding
the regional- and/or commodity-specific microbial die-off rates of
generic E. coli between last irrigation and harvest of covered produce;
(3) data or information gathered from scientific studies and/or surveys
regarding the regional- and/or commodity-specific microbial reduction
rates of generic E. coli due to natural die-off during storage and/or
due to pathogen removal during certain post-harvest activities, such as
commercial washing; (4) information related to specific protocols for
testing, and reliability of specific methods for testing generic E.
coli in agricultural water; (5) information on seasonal water use of
agricultural water during the growing and harvest of covered produce;
and (6) information on current concerns based on the revised proposed
provisions on the microbial quality standard for agricultural water
used during growing activities for covered produce (other than sprouts)
using a direct water application method and frequency of testing
agricultural water.
C. Proposed Subpart F--Standards Directed to Biological Soil Amendments
of Animal Origin and Human Waste
In the previously published proposed rule, under subpart F of
proposed part 112, we proposed to establish various standards related
to the use of biological soil amendments of animal origin.
Specifically, we proposed to establish requirements for determining the
status of a biological soil amendment of animal origin as treated or
untreated, and for their handling, conveying, and storing (proposed
Sec. Sec. 112.51 and 112.52); prohibit the use of human waste for
growing covered produce except in compliance with EPA regulations for
such uses or equivalent regulatory requirements (proposed Sec.
112.53); establish requirements for treatment of biological soil
amendments of animal origin with scientifically valid, controlled,
physical and/or chemical processes or composting processes that satisfy
certain specific microbial standards (proposed Sec. Sec. 112.54 and
112.55), and provide for alternative requirements for certain
provisions under certain conditions (proposed Sec. 112.12); establish
application requirements and minimum application intervals for
untreated and treated biological soil amendments of animal origin
(proposed Sec. 112.56), and provide for alternative requirements for
certain provisions under certain conditions (proposed Sec. 112.12);
and require certain records, including documentation of application and
harvest dates relevant to application intervals, documentation from
suppliers of treated biological soil amendments of animal origin,
periodic test results, and scientific data or information relied on to
support any permitted alternatives to requirements (proposed Sec.
112.60). We discussed each of the proposed provisions and explained our
rationale (78 FR 3504 at 3573 through 3585).
We are reopening the comment period to solicit public comment on
our current thinking related to two issues: (1) The minimum application
interval for the use of an untreated biological soil amendment of
animal origin when it is applied in a manner that does not contact
covered produce during application and minimizes the potential for
contact with covered produce after application; and (2) the minimum
application interval for the use of a biological soil amendment of
animal origin that is treated by a composting process when it is
applied in a manner that minimizes the potential for contact with
covered produce during and after application. We describe our current
thinking on these issues in this section.
1. Minimum Application Interval for Untreated Biological Soil Amendment
of Animal Origin
In the previously published proposed rule, we proposed that, if the
biological soil amendment of animal origin is untreated and is applied
in a manner that does not contact covered produce during application
and minimizes the potential for contact with covered produce after
application, then the minimum application interval (i.e., time between
application and harvest) must be 9 months (proposed Sec.
112.56(a)(1)(i)). As described in the proposed rule and in the
conclusions of the Qualitative Assessment of Risk, soil amendments can
be a source of contamination to produce and biological soil amendments
of animal origin have a greater likelihood of containing human
pathogens than do chemical or physical soil amendments or those that do
not contain animal waste. We also noted that human pathogens in
untreated or composted biological soil amendments, once introduced to
the growing environment, will eventually die off, but the rate of die-
off is dependent upon a number of environmental, regional, and other
agro-ecological factors (78 FR 3504 at 3523).
As described in the proposed rule, we evaluated current scientific
evidence to determine an appropriate minimum application interval for
the use of untreated biological soil amendments of animal origin in a
manner where there is a reasonable possibility that it will contact
covered produce after application of the amendment (despite the fact
that application must be made in a way to minimize the potential for
such contact). We investigated the potential for survival of many
enteric pathogens of public health concern and determined that across
various pathogens and their potential environments, pathogen survival
and die-off time in soils amended with raw manures are extremely
varied. One consistency across many trials was an observed rapid early
die-off of many pathogens, followed by a prolonged survival of the
remaining low populations. It is unclear in the existing literature at
what point the population is low enough to minimize the potential
[[Page 58458]]
for contamination of covered produce, and it is reasonable to suggest
that once pathogen populations fall below detection limits, their risks
are minimized.
Some of the longest survival times involved organisms present at
very high initial populations (e.g., E. coli O157:H7 in sheep manure
surviving for 21 months) or involved certain pathogens such as
encysting parasites (Cryptosporidium parvum cysts surviving for over a
year or the eggs of parasitic flatworms (Ascaris ova) surviving for
over 15 years). Some enteric pathogens are reported to be more
resilient to deleterious effects of the environment than others (most
notably, Salmonella seems better attuned for survival outside of a host
than does E. coli O157:H7); those microorganisms that produce spores
are especially hardy. We noted that basing all manure application
standards on these extreme cases (i.e., spore-formers) would be
unnecessary. The majority of survival studies showed that most enteric
pathogens of public health importance, under the most common
conditions, would not survive in the soil past 1 year. Further,
organisms most commonly associated with produce outbreaks (such as E.
coli, Salmonella, and Listeria) are unlikely to survive at detectable
population levels in soil past 270 days. Therefore, we tentatively
concluded that utilizing a 9-month waiting period between the
application of an untreated biological soil amendment of animal origin
and the harvest of covered produce would be protective for the
preponderance of environments in situations where covered produce is
reasonably likely to contact the soil after application of untreated
biological soil amendments of animal origin. We further noted that this
time interval, although somewhat less restrictive, would not be
inconsistent with the 12-month restriction used by some segments of the
produce industry (78 FR 3504 at 3582).
Moreover, as described in the previously published proposed rule,
we tentatively concluded that, under certain circumstances, the
application interval of 9 months may be more than what is necessary for
minimizing the likelihood that covered produce that is grown in soils
amended with an untreated biological soil amendment, and is reasonably
likely to contact the soil after application, pose to the public
health. Under certain circumstances, an alternative standard may be
appropriate if it is shown to provide the same level of public health
protection as the 9-month minimum application interval requirement in
proposed Sec. 112.56(a)(1)(i), and not to increase the likelihood that
the covered produce will be adulterated. For example, alternatives to
the proposed 9-month minimum application interval could take into
account specific characteristics of the locality, crop and the agro-
ecological environment. Such alternatives could consider differences in
soil amendment feedstock, application methods, and treatment methods,
especially given the potential for new innovations in such methods.
Therefore, under proposed Sec. 112.12(a)(3), we proposed that you may
establish an alternative to the requirement for a minimum application
interval of 9 months, provided you have adequate scientific data and
information and satisfy other requirements established in proposed
Sec. 112.12 (78 FR 3504 at 3553 and 3584).
a. Relevant Comments. We received an extensive number of comments
on this issue, a large majority of which expressed strong concerns with
the proposed 9-month minimum application interval. Key concerns noted
by commenters included the following: (1) There is no conclusive
scientific evidence to support a 9-month minimum application interval
requirement, and in developing this proposed application interval, FDA
relied on the findings of a small number of published studies whose
methods and designs do not include the range and variety of important
factors and variables (e.g., climates, soils, management practices)
that can dramatically affect the viability of pathogens that may be
present in these materials; furthermore, FDA used certain scenarios to
assess pathogen risk from manure resulting in a cautious approach based
on selective science, which is inconsistent with FDA's mandate to
develop science-based produce safety rules; (2) a 9-month application
interval is not appropriate as a general requirement applicable to all
commodities, regions, and agro-ecological conditions; for example, such
an extended time period between application and harvest is either not
necessary or not practical in certain regions, such as the northeastern
and northwestern regions, of the United States considering their
climatic conditions and shorter growing seasons; (3) farmers currently
comply with the standards established under the USDA's NOP, which
specify a minimum application interval of 120 days for crops in contact
with the soil and 90 days for crops not in contact with the soil, and
the proposed 9-month application interval would be excessively
burdensome, i.e., a 9-month application interval could interfere with
full compliance with the USDA organic regulations by impeding soil
fertility and crop nutrient management practices and crop rotation
practices (see 7 CFR 205.203 and 205.205); (4) a 9-month application
interval requirement would have a negative impact on farmers' ability
to rely on raw manure as a primary source of nitrogen for growing of
crops; (5) a 9-month application interval requirement would disrupt
current crop rotation cycles and is likely to limit the production of
produce to only one cropping cycle per season; (6) raw manure has a
long history of use and the proposed requirement to apply a 9-month
application interval would pose severe economic and practical burdens
on farmers; (7) the infrastructure necessary to make the transition
from raw manure to compost is either lacking or not widely established;
and (8) a 9-month application interval could mean that manure is
handled in a less sustainable manner, could also result in greater use
of chemical fertilizer, and would run counter to the Natural Resources
Conservation Service's (NRCS) national campaign to dramatically
increase soil health in part by reintroducing manure into farming
systems. Commenters urged FDA to engage in a discussion of the growing
body of research regarding the importance of biologically active soils
in promoting pathogen die-off, and the harmful effects of soil
sterilization through chemical-intensive fertilization and pest
management practices. Some commenters also requested us to consider
allowing raw manure that has been tested to a known safety standard to
be held to lesser application restrictions.
In contrast, a few other commenters emphasized the public health
concerns associated with the improper use of manure as a fertilizer,
and supported FDA's proposed minimum application intervals, including
the 9-month interval for use of untreated biological soil amendments in
a manner where the crop is reasonably likely to contact the soil after
application, urging us to maintain this waiting period to protect
public health. One of these commenters, however, also noted that FDA
must acknowledge that manure--raw and composted--plays an important
role in sustainable agriculture by returning nutrients to the soil and
reducing the need for chemical fertilizers.
Overall, there was widespread concern among commenters that the
proposed 9-month minimum application interval would be impractical and/
or unnecessarily
[[Page 58459]]
burdensome. Commenters urged FDA to evaluate and address concerns
identified for each specific commodity sector and region, and develop
and enforce a rule that sets a minimum standard for food safety that
would be appropriate nationwide. In addition, a majority of commenters
agreed that FDA should establish a process to engage the wider produce
community in discussions about currently available scientific evidence
on this issue; gaps in current scientific understanding; and the need
for concerted efforts among various stakeholder groups to not only fill
the research gaps but also build the necessary infrastructure to
support and promote practical and effective produce safety strategies.
Several commenters also urged FDA to publish a second set of revised
proposed provisions and provide an additional opportunity for public
input prior to finalizing the produce safety regulation.
b. FDA's Consideration of Comments. We considered the comments that
objected to the 9-month interval on the basis that it is not
scientifically sound. As described in the previously published proposed
rule, FDA relied on currently available scientific evidence to identify
the 9-month application interval as a general requirement broadly
applicable for all crops, soils, types of manure, and growing regions.
Our review of existing literature indicated a pattern of rapid early
die-off of pathogens, followed by a prolonged period of survival of the
remaining low populations. However, current data do not allow for a
determination of the point at which pathogen populations would be
considered too low to affect the potential for contamination of covered
produce. Nevertheless, it is reasonable to expect that the likelihood
of contamination is minimized when pathogen populations are below
detection limits and, therefore, we considered this in identifying a
minimum application interval. As explained in the previously published
proposed rule, the majority of survival studies indicate that most
enteric pathogens of public health importance, under the most common
conditions, would not survive in the soil past 1 year. Moreover,
organisms most commonly associated with produce outbreaks (such as E.
coli O157:H7, Salmonella, and Listeria monocytogenes) are unlikely to
survive at detectable population levels in soil past 270 days.
Consequently, we proposed 9 months as the minimum application interval.
We also acknowledged that shorter waiting periods may be
appropriate for some specific commodities and/or agro-ecological
conditions, although conclusive evidence is lacking. Recognizing the
limitations of available data, we provided for alternative application
intervals to be used where there is adequate scientific data and
information to support such alternative time intervals. Furthermore,
recognizing the time and resources necessary to conduct the scientific
investigations and/or gather the necessary data, we provided for
compliance periods of 2 to 4 years, depending on the size of the farm.
We considered comments that recommended using the application
intervals for raw manure established under the NOP. Under 7 CFR
205.203(c)(1), raw animal manure must be composted unless it is: (i)
Applied to land used for a crop not intended for human consumption;
(ii) incorporated into the soil not less than 120 days prior to the
harvest of a product whose edible portion has direct contact with the
soil surface or soil particles; or (iii) incorporated into the soil not
less than 90 days prior to the harvest of a product whose edible
portion does not have direct contact with the soil surface or soil
particles. The restriction on the application of raw manure is in
addition to the USDA organic requirements in Sec. 205.203(c), which
states in part that organic producers are required to ``manage plant
and animal materials . . . in a manner that does not contribute to
contamination of crops, soil, or water by . . . pathogenic organisms.''
In establishing this regulation, the Agricultural Marketing Service
(AMS) acknowledged that this raw manure standard is based on organic
crop production practices and noted the scarcity of scientific data on
the regulation of raw manure use and food safety. Specifically, in the
final rule that established this regulation, AMS noted the following:
``Although public health officials and others have identified the use
of raw manure as a potential food safety concern, at the present time,
there is no science-based, agreed-upon standard for regulating the use
of raw manure in crop production. The standard in this [NOP] rule is
not a public health standard. The determination of food safety demands
a complex risk assessment methodology, involving extensive research,
peer review, and field testing for validation of results.'' This
statement was provided by AMS in response to comments on a broader
discussion about the application of raw manure under NOP requirements.
The AMS also stated that it ``does not have a . . . capacity with which
to undertake a comprehensive risk assessment of the safety of applying
raw manure to human food crops'' and that ``the standard in this rule
is a reflection of AMS' view and of the public comments that this
standard is reasonable and consistent with current organic industry
practices and the NOSB [National Organic Standards Board]
recommendations for organic food crop production.'' Finally, AMS noted
that ``should additional research or Federal regulation regarding food
safety requirements for applying raw manure emerge, AMS will ensure
that organic production practice standards are revised to reflect the
most up-to-date food safety standard'' (65 FR 80548 at 80567; December
21, 2000). Therefore, we believe that the current NOP application
intervals for raw manure are not intended as science-based minimum
standards for the safe production and harvesting of produce or measures
reasonably necessary to minimize the risk of serious adverse health
consequences or death, which is the underlying basis for the standards
we proposed under part 112. Moreover, peer-reviewed literature suggests
that a 90-day or 120-day interval, as required under the NOP
regulations, does not sufficiently minimize the likelihood of
contamination in all circumstances (Refs. 22 and 23).
Some of the comments expressed concerns about field crops that rely
on the use of raw manure as a means of land-applied disposal of waste
raw manures produced through animal husbandry. We believe crops used in
such disposal of raw manure primarily include food grains such as dent
or flint corn, wheat, and rye. As proposed in the previously published
proposed rule, produce does not include food grains meaning the small,
hard fruits or seeds of arable crops, or the crops bearing these fruits
or seeds, that are grown and processed for use as meal, flour, baked
goods, cereals and oils rather than for fresh consumption (including
cereal grains, pseudo cereals, oilseeds and other plants used in the
same fashion). Examples of food grains include barley, dent- or flint-
corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat,
cotton seed, and soybeans (see definition of ``Produce'' under proposed
Sec. 112.3). Some non-food crops, such as cotton, may also be used for
disposal of raw manure, but non-food crops are outside of the scope of
this rule. Therefore, we do not expect the current practice of use of
raw manure in the growing of food grains or non-food crops to be
affected by the produce safety regulation.
We also considered comments that opposed the 9-month application
[[Page 58460]]
interval citing limitations related to the use of raw manure as a
source of nutrients. We recognize that nitrogen release from raw manure
is highest immediately following application of the manure to the soil,
and that nitrogen may be rapidly lost by volatilization (particularly
if surface applied) or leaching (when rainfall or irrigation follow
application) (Refs. 24, 25, and 26). Further, we recognize that many
covered produce crops have a shorter than 9-month growing period, which
complicates the synchronization of crop demand with nutrient
availability from manure application. We note however, that soil
amended with manure continues to benefit from manure applications after
the initial nitrogen release, both by slow release of nitrogen as
organic sources of nitrogen are mineralized, and by numerous benefits
associated with the enhancement of soil microbial community structures
and improvement of many soil physical and chemical properties,
including an increase in nutrient cycling (Refs. 27, 28, and 29). A
waiting period (either our previously proposed 9-month period, that
imposed by the NOP, or another waiting period) may affect the benefit
of raw manure as a nutrient supplement, but it is not expected that
these waiting periods will completely negate the value of raw manure as
a soil amendment. In addition, composted manure has stabilized forms of
nitrogen, which are less susceptible to leaching or runoff (Ref. 30),
but also retains many other key values of manure, including supply of
carbon to support diverse and abundant soil microbial communities,
which serve critically important functions in nutrient cycling,
conditioning of soil physical and chemical properties (Ref. 31) and, in
some cases, provide crop protection from phytopathogenic diseases (Ref.
32). We recognize that some loss of nitrogen during the composting
process is likely and that adjustments to fertility management will be
necessary when either allowing for a waiting period after applying raw
manure or shifting to use of composted manure (Refs. 31 and 33). We
believe increased use of composted manure offers significant food
safety benefits and retains much of the agronomic value of manure as a
resource for farmers, particularly those with animal components in
their farm operations. Overall, no new studies have been published
since the issuance of the previously published proposed rule that would
refute the scientific basis for our proposed 9-month waiting period.
Nevertheless, we recognize the limited body of scientific evidence, the
limitations associated with the studies we relied on, the use of a no
detectable pathogen level as the basis for identifying a minimum
application interval, and the need for additional research in this
area. The use of raw manure at a time close to harvest, during organic
or conventional production, presents a significant likelihood of
contamination of covered produce if produce is reasonably likely to
contact the soil. We continue to believe that a science-based minimum
standard to address this potential for contamination by such use of raw
manure must include an appropriate quantitative minimum application
interval. As noted in the previously published proposed rule, we are
currently working with USDA and other stakeholders to conduct research
on application intervals necessary to ensure the safety of covered
produce when raw manure is applied to a growing area and covered
produce is reasonably likely to contact the soil. We expect such
research will help fill the current gaps in science, and enable us to
identify specific agro-ecological or commodity-specific conditions that
would support alternative minimum application intervals.
FDA also believes that progress toward its food safety goal can be
achieved by facilitating the transition of farming practices, to the
extent feasible, toward the safer option of using composted manure
rather than raw manure. Our review of the scientific literature
suggests that, regardless of the source, composting that is properly
conducted (including proper turning of feedstock) can minimize the
expected pathogen load and subsequent likelihood of produce
contamination. Compost use can also result in a variety of
environmental benefits, including that compost enriches soils, helps
cleanup (remediate) contaminated soil, and helps prevent pollution
(e.g., by reducing the potential for nutrient rich run off as compared
to raw manure use), and also offers economic benefits (e.g., reduces
the amount of irrigation water, fertilizers, and pesticides needed, and
acts as an alternative to routing organic materials to landfills) (Ref.
34). A transition of farming practices from raw manure to composted
manure use would require a concerted effort by the regulatory agencies,
agricultural marketing agencies, academia, and the regulated community.
We acknowledge the various concerns--e.g., economic, scientific, and
practical--that we heard from stakeholders across the country and
foreign trading partners. We are also fully cognizant of not only the
need for additional scientific information but also resources to build
the necessary infrastructure to facilitate the use of appropriate
composting treatments.
Considering the strong concerns expressed by stakeholders, our
ongoing effort to build the scientific knowledge and infrastructure in
this area, and our overall commitment to adopt practical and effective
produce safety strategies, we have tentatively concluded that the
appropriate approach is to remove the 9-month minimum application
interval for use of raw manure that is specified in proposed Sec.
112.56(a)(1)(i) and defer our decision on an appropriate minimum
application interval until such time as necessary for us to pursue the
following actions.
First, we will conduct a risk assessment on the safe use of raw
manures in covered produce fields. Variables that may be considered in
such a risk assessment include the source and type of manure (for
example, animal type and animal diet); method of application (for
example, broadcast, incorporated, and subsurface incorporation);
climatic conditions (for example, temperature, days of sunlight,
sunlight intensity, and expected rainfall); type of commodity; and the
characteristics of the soil (for example, pH and moisture holding
capacity). We will also work with USDA and other stakeholders to
develop and implement a robust research strategy that will allow us to
supplement the science currently available on this issue, and further
develop our risk assessment model. As we explained in the previously
published proposed rule, we are currently working with USDA and other
stakeholders to conduct research on application intervals necessary to
ensure the safety of covered produce when raw manure is applied to a
growing area and covered produce is reasonably likely to contact the
soil. Our research will address various issues, including and, in
particular, whether and how application intervals can be tailored for
specific commodities, types of commodities, growing environment and any
other agro-ecological conditions. We encourage the farming community
and others to partner with us on this effort, including by
participating with academia, industry, and government on necessary
research activities.
Second, we will work with USDA and other stakeholders to encourage
the transition of the produce grower community to the use of compost
rather than raw manure. As noted above, use of compost is a safer
practice from a public health standpoint, and is also considered to be
a more sustainable
[[Page 58461]]
environmental practice. We encourage the farming community and others
to partner with us on this effort.
Third, although there will be no minimum application interval
requirement in Sec. 112.56(a)(1)(i) while we pursue the avenues of
scientific research and infrastructure development identified above, we
continue to believe that a quantitative application interval standard,
established in the produce safety regulation, is necessary to minimize
the likelihood of contamination of produce resulting from the use of
raw manure in a manner that contacts the crop. Our view remains that a
quantitative standard rather than a qualitative one (suggested by some
commenters) is the more effective and enforceable public health
standard. We are committed to revisiting this issue and identifying an
appropriate minimum application interval(s) for such use of raw manure
taking into account new information gathered from our ongoing risk
assessment and research efforts. We anticipate that these efforts will
take 5 to 10 years to complete. Following the completion of the risk
assessment and research work, we expect to: (1) Provide stakeholders
with data and information gathered from scientific investigations and
risk assessment; (2) consider such new data and information to develop
tentative scientific conclusions; (3) provide an opportunity for public
comment on our tentative decisions; and (4) consider public input to
establish an appropriate minimum application interval(s).
We acknowledge the comments that pointed out that many growers
currently employ the NOP standard of 90 days or 120 days, as specified
in 7 CFR 205.203(c)(1), and we recognize that such growers will likely
continue their current practice to use this standard in organic crop
production, in the absence of an FDA regulation that establishes a food
safety standard for minimum application intervals associated with the
use of raw manure. Given that the scientific literature demonstrates
that the probability of pathogen survival decreases as the length of
time between application of raw manure and harvest increases, and that
more rapid die-off occurs during the months immediately following
application (e.g., 3 to 4 months) as compared to subsequent months
(followed by prolonged survival of pathogens at low levels), we believe
adherence to the NOP standard to be a prudent step toward minimizing
the likelihood of contamination while the above described research
program is ongoing. At this time, we do not intend to take exception to
the continuation of this practice.
We request comment on our current thinking described above. In
addition, we seek: (1) Data or information gathered from scientific
studies on the persistence of human pathogens in raw manure in an open
environment (published or unpublished data) under various agro-
ecological conditions and the expected transfer of pathogens to various
commodities grown in soils amended with raw manures; (2) information
related to specific protocols for testing, and reliability of specific
methods for testing pathogens in manure; (3) information on nitrogen
availability and the costs associated with various fertilizer options
currently available to produce farms; (4) information on the methods of
use and prevalence of use of raw manure, including practices by small
farms; and (5) information on current barriers that will need to be
addressed to enable transition from use of raw manure to use of
compost.
2. Minimum Application Interval for Biological Soil Amendment of Animal
Origin Treated by a Composting Process
In the previously published proposed rule, we proposed that, if the
biological soil amendment of animal origin is treated by a composting
process in accordance with the requirements we proposed in Sec.
112.54(c) to meet the microbial standard we proposed in Sec.
112.55(b), 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) must be 45 days (proposed Sec. 112.56(a)(4)(i)).
As explained in the previously published proposed rule, we
tentatively concluded that process controls for composting can be
expected to be more prone to failure than process controls during
chemical or physical treatments and, therefore, proposed to apply a
minimum application interval of 45 days as part of a multiple hurdle
approach. For example, heat treatments are often conducted in enclosed
heat-treatment chambers (i.e., ovens), often with various means of
agitation (such as stirring rods, etc.), that can be accurately
monitored and controlled to reach the required treatment conditions
throughout the material being treated. Conversely, composting usually
occurs outdoors, is exposed to fluctuating environmental pressures and
wildlife activity, and is not homogeneous in nature and prone to having
``cold-spots'' that are not completely treated (even with proper
turning). In general, during composting, there is a higher likelihood
of having a systems failure, which is also more likely to go
undetected, should it occur. Composting may result in a treated
biological soil amendment of animal origin that may continue to harbor
human pathogens of food safety concern, although any such pathogens
that may be present can be expected to be present at low populations
and unlikely to survive for extended periods under normal environmental
conditions after application. Therefore, we proposed to impose an
additional mitigation measure in situations where covered produce is
reasonably likely to contact the soil after application of biological
soil amendments of animal origin treated by composting by requiring a
minimum application interval of 45 days. This time period has been
shown to be effective when the population of the pathogen is minimal,
as can be expected of a fully composted biological soil amendment of
animal origin (78 FR 3504 at 3583).
a. Relevant Comments. We received a number of comments on this
issue, many of which objected to the proposed 45-day minimum
application interval. Comments also included relevant data and factual
information. Concerns noted by commenters included the following: (1)
Farmers currently comply with the standards established under the NOP
for the use of composted animal manures to build organic matter in
production fields, in part, to avoid use of synthetic fertilizers, and
the NOP does not require any minimum application interval for composted
manures; (2) the proposed 45-day application interval would be
excessively burdensome; (3) there is a lack of scientific basis for the
45-day interval for compost and FDA has failed to show how the
literature supports this conclusion; (4) farmers who use compost would
be severely limited by the proposed 45-day interval in their ability to
utilize crop rotations for short-season crops and/or to maintain or
increase biodiversity, and in their use of compost during the growing
season for side-dressing; and (5) the burden on farms from using a 45-
day wait period for compost is unscientific, especially considering the
wealth of data showing that soil treated with compost is more
suppressive of human pathogens than soil not treated with compost. In
addition, commenters recommended eliminating the 45-day minimum
application interval for fully composted manures where the soil has no
contact with the crop, and where the soil amendment is handled in
accordance with the proposed time, temperature, holding, and microbial
testing requirements. Some other commenters recommended retaining the
45-day
[[Page 58462]]
waiting period only where the soil has contact with the crop and where
there is no testing conducted to confirm that the composting process
was properly implemented.
In contrast, some commenters suggested that FDA would do much more
for food safety if it required composting of all raw manure, or if it
required raw manure to be tested for pathogens and then be composted if
the pathogen load exceeded a certain quantity. Another commenter
suggested that all animal manure that is used for ``organic farming''
must be composted for a minimum of 2 years, and tested for proper
temperature range on a monthly basis, before its use on the farm.
b. FDA's Consideration of Comments. We proposed to use the 45-day
minimum application interval as part of a multiple hurdle approach to
the safe use of composted manures. Proposed Sec. 112.56(a)(4)(i)
refers to the use of composted manure under certain specified
mitigation measures: (1) It is properly treated in accordance with our
proposed requirements in Sec. 112.54(c); (2) it is properly treated to
meet the microbial standard we proposed in Sec. 112.55(b); (3) it is
applied in a manner that minimizes the potential for contact with
covered produce during and after application; and (4) there is a
minimum application interval of 45 days. Under the same treatment and
microbial standard requirements, but where the composted manure is
applied in a manner that does not contact covered produce during or
after application, we proposed no minimum application interval, i.e., 0
days (proposed Sec. 112.56(a)(4)(ii)). Therefore, our proposal to use
45 days as a minimum application interval was intended as one among
multiple mitigation measures that would be implemented in situations
where covered produce is reasonably likely to contact the soil after
application of the biological soil amendment of animal origin.
Further, we proposed to require certain records to document that
composting processes conducted by farmers or independent composters are
properly conducted and that the proposed minimum time between
application and harvest was observed, when applicable (proposed Sec.
112.60).
Overall, we believe that the use of proper composting methods in
accordance with appropriate handling, storage, treatment, and microbial
standard requirements that we proposed in Sec. Sec. 112.51, 112.52,
112.54(c), and 112.55(b) are sufficient to minimize the likelihood of
composted manure acting as a source of contamination and to provide
reasonable assurance that produce is not contaminated. This approach
also satisfies FDA's goal to reduce the risk to public health when
using composted manures, and to encourage and facilitate the transition
of farming practices that currently use raw manure to the safer option
of using composted manure. Further, the AMS, NRCS, EPA, and other
organizations support the use of composted manure given its benefits to
soil, cropland, and the environment, and/or recommend the use of
composted manure over raw manure (Refs. 35, 36, 37, 38, and 39). FDA
has considered this widespread understanding of the benefits of use of
compost, and the impact of proper composting treatments on the
microbial populations in composted manure.
In recognition of the expected benefit to public health when
composted manures are properly treated and handled, and to further
facilitate the use of composted manure rather than raw manure, we are
proposing to eliminate the 45-day minimum application interval for use
of composted manure in proposed Sec. 112.56(a)(4)(i). As amended,
proposed Sec. 112.56(a)(4)(i)) would establish that if the biological
soil amendment of animal origin is treated by a composting process in
accordance with the requirements we proposed in Sec. 112.54(c) to meet
the microbial standard we proposed in Sec. 112.55(b), 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.
We seek comment on these amendments.
3. Corresponding Proposed Amendments
As a consequence of eliminating the 9-month minimum application
interval in proposed Sec. 112.56(a)(1)(i) and of revising the 45-day
minimum application interval to 0 days in proposed Sec.
112.56(a)(4)(i), by cross-reference, we are also proposing certain
corresponding amendments. We are proposing to remove the proposed
provisions Sec. Sec. 112.12(a)(3), 112.12(a)(4), 112.56(b), which
would have provided for the use of alternative application intervals in
lieu of the previously proposed minimum application intervals, as these
provisions would no longer be needed. We are also proposing to remove
proposed provisions Sec. Sec. 112.60(b)(1) and 112.60(b)(5) thus
eliminating the documentation requirements relevant to the previously
proposed 9-month and 45-day minimum application intervals. In addition,
we are proposing to remove proposed Sec. Sec. 112.182(d) and
112.182(e), which listed variances from the 9-month and 45-day minimum
application intervals as examples of permissible types of variances.
Our current intent is that we will consider provisions for
alternative application intervals, documentation requirements, and
variances at the same time as provisions for an appropriate minimum
application interval(s) for the use of an untreated biological soil
amendment of animal origin (that is used in a manner that does not
contact covered produce during application and minimizes the potential
for contact with covered produce after application), after we first
complete the actions discussed in section II.C.1.b.
4. Summary of FDA's Revisions and Request for Comment
We are proposing to: (1) Remove the minimum application interval in
proposed Sec. 112.56(a)(1)(i) and defer our decision on an appropriate
minimum application interval while FDA pursues certain actions,
including a robust research agenda, risk assessment, and efforts to
support compost infrastructure development, in concert with USDA and
other stakeholders. Following the completion of risk assessment and
research work, FDA expects to share with stakeholders its tentative
conclusions, taking into account new data and information, and consider
public input to establish an appropriate minimum application
interval(s) for the use of an untreated biological soil amendment of
animal origin that is used in a manner that does not contact covered
produce during application and minimizes the potential for contact with
covered produce after application; (2) amend proposed Sec.
112.56(a)(4)(i)) to establish that if the biological soil amendment of
animal origin is treated by a composting process in accordance with the
requirements we proposed in Sec. 112.54(c) to meet the microbial
standard we proposed in Sec. 112.55(b), 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; and (3) in light of
the revisions explained in (1) and (2), eliminate the provisions to
permit the use of alternative application intervals or variances, or
require certain documentation related to the previously proposed 9-
month and 45-day intervals (i.e., delete proposed Sec. Sec.
112.12(a)(3), 112.12(a)(4), 112.56(b), 112.60(b)(1), 112.60(b)(5),
112.182(d), and 112.182(e)).
[[Page 58463]]
We request comment on our current thinking on the issues described
above. Specifically with respect to the use of untreated biological
soil amendments of animal origin, we seek comment, including scientific
data or information on the persistence of human pathogens in raw manure
under various agro-ecological conditions, and the transfer of pathogens
to various commodities grown in soils amended with raw manures;
specific protocols for testing, and the reliability of specific methods
for testing pathogens in manure; nitrogen availability and the costs
associated with current options for fertilizers; information on the
methods and prevalence of use of raw manure on small farms; and current
barriers related to use of compost.
D. Proposed Subpart I--Standards for Domesticated and Wild Animals
In the previously published proposed rule, under subpart I of
proposed part 112, we proposed certain standards related to
domesticated and wild animals. Proposed subpart I includes standards
that would be directed to the potential for biological hazards from
animal excreta to be deposited by your own domesticated animals (such
as livestock, working animals, and pets), by domesticated animals from
a nearby area (such as livestock from a nearby farm), or by wild
animals (such as deer and wild swine) on covered produce or in an area
where you conduct a covered activity on covered produce. We discussed
each of the proposed provisions and explained our rationale (78 FR 3504
at 3585 through 3587).
Specifically, in proposed Sec. 112.82, we proposed that if animals
are allowed to graze or are used as working animals in fields where
covered produce is grown and under the circumstances there is a
reasonable probability that grazing or working animals will contaminate
covered produce, you must employ, at a minimum, an adequate waiting
period between grazing and harvesting for covered produce in any
growing area that was grazed, and measures to prevent the introduction
of known or reasonably foreseeable hazards into or onto covered
produce. In addition, in proposed Sec. 112.83, we proposed to
establish requirements for measures related to animal intrusion in
those areas that are used for covered activities for covered produce
when, under the circumstances, there is a reasonable probability that
animal intrusion will contaminate covered produce. We proposed to
require that you monitor these areas as needed during the growing
season, based on the covered produce being grown and your observations
and experiences (proposed Sec. 112.83(a)(1)(i) and (ii)), and
immediately prior to harvest (proposed Sec. 112.83(a)(2)). In
addition, in proposed Sec. 112.83(b), we proposed to require that, if
animal intrusion occurs, as evidenced by observation of significant
quantities of animals, animal excreta or crop destruction via grazing,
you must evaluate whether the covered produce can be harvested in
accordance with the requirements of proposed Sec. 112.112.
As noted in the proposed rule, consistent with sections
419(a)(1)(A), 419(a)(3)(E), and 419(a)(3)(D) of the FD&C Act, we
consulted with the NOP and USDA's NRCS, U.S. Fish and Wildlife Service,
and the EPA to ensure that environmental and conservation standards and
policies established by those agencies were appropriately considered in
developing the requirements proposed in subpart I. We tentatively
concluded that the provisions of proposed subpart I do not conflict
with or duplicate the requirements of the NOP. In addition, we
tentatively concluded that the provisions of proposed subpart I are
consistent with existing conservation and environmental practice
standards and policies while providing for enforceable public health
protection measures. We also noted that the produce safety regulation
would not require the destruction of habitat or the clearing of farm
borders.
Specifically in relation to proposed Sec. 112.83, we noted that
this proposed provision should not be construed to require the
``taking'' of an endangered species, as the term is defined in the
Endangered Species Act (ESA) (16 U.S.C. 1532(19)) (i.e., to harass,
harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or
to attempt to engage in any such conduct), or to require farms to take
measures to exclude animals from outdoor growing areas or destroy
animal habitat or otherwise clear farm borders around outdoor growing
areas or drainages.
We are reopening the comment period to solicit public comment on
our current thinking on an issue related to the standards for
domesticated and wild animals, i.e., the potential impact of this
proposed rule on wildlife and animal habitat. We describe our current
thinking on this issue in this section.
1. Relevant Comments
We received various comments that expressed the concern that the
proposed rule, if finalized as proposed, would adversely affect
wildlife, including threatened or endangered species, and animal
habitat. Other comments noted that animal habitat, habitat
connectivity, and wildlife populations would be at risk if our proposed
provisions related to animal intrusion are perceived by produce growers
to mean that less habitat and/or more fencing in the production
environment is a necessary management strategy. Citing some of our
statements in the preamble of the proposed rule, comments acknowledged
FDA's interest in comanagement of both food safety and wildlife
conservation, and urged us to provide similar language in the
regulation.
2. FDA's Consideration of Comments
In publishing the Produce Safety proposed rule, we relied on a
categorical exclusion from the need to prepare an Environmental
Assessment (EA) or Environmental Impact Statement (EIS) under 21 CFR
25.30(j) (78 FR 3504 at 3616). However, as explained in the Notice of
Intent To Prepare an Environmental Impact Statement for the Proposed
Rule, Standards for Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption (NOI), based on currently available
information, including comments received, and upon further analysis,
FDA has determined that the proposed action may significantly affect
the quality of the human environment (21 CFR 25.22(b)), and therefore,
an EIS is necessary for the final rule (78 FR 50358, August 19, 2013).
In the EIS that will accompany the Produce Safety final rule, FDA will
evaluate the potential environmental effects of the rule, including
those resulting from the standards of domesticated and wild animals
established in subpart I of part 112.
In response to concerns that the Produce Safety regulation may
inadvertently promote practices that may adversely affect wildlife and
animal habitat, including impacts on threatened or endangered species,
we are proposing to include a new provision, i.e., proposed Sec.
112.84, within subpart I of proposed part 112. We consulted with USDA's
NRCS and the U.S. Fish and Wildlife Service to inform our current
thinking on this issue.
Proposed Sec. 112.84 would provide that the regulation in part 112
does not authorize or require covered farms to take actions that would
constitute the ``taking'' of threatened or endangered species in
violation of the ESA, as that term is defined by the ESA, i.e., to
harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or
collect, or to attempt to engage in any such conduct. Proposed Sec.
112.84 would also state that part 112 does not require covered farms to
take measures to
[[Page 58464]]
exclude animals from outdoor growing areas, or to destroy animal
habitat or otherwise clear farm borders around outdoor growing areas or
drainages.
As discussed in the previously published proposed rule, we
encourage the application of practices that can enhance food safety and
that are also consistent with sustainable conservation. We believe that
the provisions of proposed part 112, including subpart I, are
consistent with existing conservation and environmental practice
standards and policies. By adding proposed Sec. 112.84, we are
proposing to codify into the produce safety regulation that the
requirements of proposed part 112 do not require or permit the use of
practices in violation of the ESA, and that the regulation does not
require the use of practices that may adversely affect wildlife, such
as removal of habitat or wild animals from land adjacent to the produce
field. Rather, we encourage the comanagement of food safety,
conservation, and environmental protection. One set of examples of
biodiversity and conservation practices that may enhance food safety is
available from the Resource Conservation District of Monterey County,
CA (Ref. 40). We provide this information as a resource and do not
intend for it to suggest that we require or endorse a single approach.
Growers of produce should also be aware that clearing or
manipulation of habitats, including activities affecting water
resources, groundwater or natural vegetative cover, can affect species
listed as threatened and endangered. Growers can determine whether any
listed species may be present in their area by checking the U.S. Fish
and Wildlife Service's Endangered Species Web site and the Information,
Planning, and Conservation System Web site. You should coordinate with
your local U.S. Fish and Wildlife Service office on any activity that
could potentially affect listed species or critical habitat. We ask
that you contact your local U.S. Fish and Wildlife Service office for
any additional information.
3. Summary of FDA's Revisions and Request for Comment
We are proposing to add a new provision Sec. 112.84 to state that
part 112 does not authorize or require covered farms to take actions
that would constitute the ``taking'' of threatened or endangered
species in violation of the ESA, and that part 112 does not require
covered farms to take measures to exclude animals from outdoor growing
areas, or to destroy animal habitat or otherwise clear farm borders
around outdoor growing areas or drainages. We seek comment on our
current thinking, including on proposed Sec. 112.84.
E. Proposed Subpart R--Withdrawal of Qualified Exemption
In the previously published proposed rule, under subpart R of
proposed part 112, we proposed to establish the procedures that would
govern the circumstances and process whereby we may issue an order
withdrawing a qualified exemption applicable to a farm in accordance
with the requirements of proposed Sec. 112.5. Specifically, proposed
Sec. 112.201 listed the circumstances under which FDA may withdraw a
qualified exemption applicable to a farm, while Sec. Sec. 112.202 and
112.203 specified the procedure and information that FDA would include
in an order to withdraw such qualified exemption. In addition, proposed
Sec. Sec. 112.204 through 112.207 provided for a process whereby you
may submit a written appeal (which may include a request for a hearing)
of an order to withdraw a qualified exemption applicable to your farm,
and proposed Sec. Sec. 112.208 through 112.211 provided a procedure
for appeals, hearings, and decisions on appeals and hearings. We
discussed each of the proposed provisions and explained our rationale
(78 FR 3504 at 3611 through 3616).
We are reopening the comment period to solicit public comment on
our current thinking on two specific issues related to the provisions
for withdrawal of qualified exemptions: (1) The process under which FDA
would withdraw a qualified exemption and (2) provisions for
reinstatement of a qualified exemption that is withdrawn. We describe
our current thinking on these two issues in this section.
1. Process for Withdrawal
As described in the previously published proposed rule, proposed
Sec. 112.201 would establish the circumstances under which FDA may
withdraw an exemption applicable to a farm. Consistent with section
419(f)(3)(A) of the FD&C Act, we proposed that we may withdraw a
qualified exemption: (1) In the event of an active investigation of a
foodborne illness outbreak that is directly linked to your farm
(proposed Sec. 112.201(a)) or (2) if we determine that it is necessary
to protect the public health and prevent or mitigate a foodborne
illness outbreak based on conduct or conditions associated with your
farm that are material to the safety of the food that would otherwise
be covered produce grown, harvested, packed or held at your farm
(proposed Sec. 112.201(b)).
a. Relevant Comments. We received several comments expressing
concern that the circumstances under which FDA would withdraw a
qualified exemption, which are specified in proposed Sec. 112.201, are
unclear. In addition, some commenters urged us to provide for
intermediary steps prior to resorting to withdrawal of an exemption,
and recommended a three-tiered process that would include the issuance
of a warning letter, followed by a temporary conditional withdrawal,
and then a full withdrawal, as applicable. They noted that such a
flexible approach would allow a farm to take corrective actions before
having its exempt status fully withdrawn. Some other commenters
suggested partially withdrawing a qualified exemption, thus requiring
compliance with only those regulatory requirements that are related to
the reason(s) for which the exemption is withdrawn. Several commenters
also recommended that we establish a process that would require FDA to
provide justification to a farm of FDA's decision to withdraw the
farm's qualified exemption, and would provide an opportunity for the
farm to respond to and/or submit arguments challenging FDA's decision
to withdraw the exemption.
b. FDA's Consideration of Comments. We are proposing certain
amendments, including taking into account comments that suggested that
FDA consider other actions prior to invoking the provisions of subpart
R to withdraw a qualified exemption. Depending on the circumstances,
FDA may take a variety of actions, including education and warning
letters, as well as enforcement actions such as administrative
detention, seizure, and injunction to protect the public health and
prevent or mitigate a foodborne illness outbreak. FDA may consider
taking such actions prior to or in conjunction with a consideration to
withdraw the qualified exemption.
To make our intent clear that we would consider other actions, as
appropriate, before issuing an order to withdraw a qualified exemption,
we are proposing to add a new provision under Sec. 112.201. Proposed
Sec. 112.201(b) would establish that before FDA issues an order to
withdraw your 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 (proposed Sec. 112.201(b)(1)). If these other actions
address the circumstances that could lead FDA to withdraw the
[[Page 58465]]
exemption, then FDA would likely determine that withdrawal of an
exemption is not needed. We have provided two examples of potential
scenarios and actions FDA might choose to take in such scenarios.
Nothing in the discussion below should be construed to bind FDA in any
future situation, however.
For example, consider the situation in which Farm A is growing,
harvesting and packing heirloom tomatoes for sale to local restaurants.
An outbreak of salmonellosis is epidemiologically linked to raw
heirloom tomatoes served at those restaurants. The tomatoes are traced
back to the farm. An inspection of Farm A reveals that conditions and
practices at the farm appear to be generally consistent with good
agricultural practices and that management appears to be committed to
food safety, as evidenced by company policy documents, standard
operating procedures (SOPs), and the conditions and practices of the
operation. Inspectors note that the farm has two water sources, a
holding pond used for drip irrigation of tomatoes and a deep well for
any water use in the field where water directly contacts the tomatoes
and for post-harvest practices such as washing. Inspectors sample pond
water and find it is positive for Salmonella and that the isolate
matches the outbreak strain. Upon further investigation, several
workers admit that, when things are busy, especially close to harvest,
they mix crop protection sprays with pond water because the pond is
more conveniently located than the well, even though the farm's SOP
specifies that only well water should be used for activities where
water has direct contact with tomatoes.
We, in conjunction with State and local (or, if applicable,
foreign) officials, may provide education to Farm A to reinforce
awareness of the importance of ensuring that water that contacts
produce is safe and sanitary for its intended use, especially close to
harvest, and of managing water quality and use to minimize the
potential for contamination of food. We may ask the farm to correct its
water management procedures to minimize the potential for future
illnesses from contaminated agricultural water. The farm's corrective
actions might include taking steps, such as, remedial training,
enhanced oversight, and/or other procedural changes. If a recall
occurred, we may also work with the farm on its recall of any
implicated tomatoes that may still be on the market. If we find, during
a future inspection, that the farm has instituted procedures to
minimize the likely reoccurrence of the problem, we might not proceed
to withdrawal of the qualified exemption. However, if we find, during a
future inspection, that the farm has not voluntarily taken appropriate
steps to correct the conditions or conduct that led to the outbreak, we
may consider other actions, which could include withdrawal of the
qualified exemption.
As another example, consider the situation where routine
surveillance sampling results in positive sample findings for Shigella
in or on green onions. A traceback investigation identifies the source
of the green onions as Farm B, which grows, harvests, packs, and holds
its own green onions. An inspection of Farm B reveals a number of
conditions and conduct that are material to the safety of the food,
specifically: The farm does not have a training program for worker
health and hygiene, it has an inadequate number and servicing of
portable toilets for the number of people living at the farm, and it
does not have procedures for what to do in the event of leakage or
spilling of portable toilets in the field or housing area. In addition,
water used for all growing activities and for washing green onions is
from a well that is located in a depression and is not adequately
designed or constructed to protect it from surface contamination; the
farm does not test the microbiological quality of the well water that
contacts produce during growing or washing; the farm adds chlorine to
wash water but does not appear to have adequate procedures to
accurately measure the amount of chlorine added to wash water or to
monitor the levels of free chlorine available to maintain water quality
over time.
We may inform Farm B of our concerns, noting conditions that may
contaminate their food. We may ask the farm to correct their procedures
to minimize the potential for future illnesses from ill workers or
contaminated water. If the farm did not respond to FDA with the
corrections it will take as a result of our observations, or if we did
not believe the actions were adequate or timely, we may issue a warning
letter to the farm. (In the case of foreign farms, we may refuse
produce offered for import into the United States.) If a recall
occurred, we may also work with the farm on its recall of any
implicated food that may still be on the market. We, in conjunction
with our State, local (or, if applicable, foreign) counterparts may
provide education to the farm to ensure awareness of the importance of
managing hazards such as waste and sewage disposal, worker health and
hygiene practices and ensuring water that contacts produce is safe and
sanitary for its intended use to minimize the potential for
contamination.
If, during a subsequent inspection, we find continued conditions or
conduct that could result in unsafe food, we may decide that withdrawal
of the exemption is necessary to protect the public health and prevent
or mitigate a foodborne illness based on these conditions and conduct.
As an alternative to withdrawal of the exemption, or in addition to it,
we may seek an injunction to prevent the farm from producing
adulterated food.
We are also proposing amendments to proposed Sec. 112.201 to
ensure that, before FDA issues an order to withdraw a farm's qualified
exemption, the farm has the opportunity to respond to the problems
identified by FDA, and for FDA to consider the farm's response prior to
proceeding with issuance of an order to withdraw the exemption. This
intermediate step prior to FDA issuing an order to withdraw the
exemption would provide an additional opportunity for a farm to submit
information relevant to circumstances that may lead FDA to withdraw the
exemption (including, as appropriate, any corrective actions taken by
the farm), and for FDA to consider this information in making a
determination regarding whether or not to proceed with issuing an order
to withdraw the exemption.
Therefore, proposed Sec. 112.201(b) would also state that before
FDA issues an order to withdraw your qualified exemption, FDA must
notify the owner, operator, or agent in charge of the farm, in writing,
of circumstances that may lead FDA to withdraw the exemption, and
provide an opportunity for the owner, operator, or agent in charge of
the farm to respond in writing, within 10 calendar days of the date of
the notification, to FDA's notification (proposed Sec. 112.201(b)(2));
and FDA must consider the actions taken by the farm to address the
circumstances that may lead FDA to withdraw the exemption (proposed
Sec. 112.201(b)(3)).
Finally, we are also proposing corresponding amendments to proposed
Sec. 112.202 under paragraphs (a) and (b) of that section. As amended,
proposed Sec. 112.202(a) would make it clear that before an order to
withdraw a qualified exemption is issued, such order must be approved
by an FDA District Director in whose district the farm is located (or,
in the case of a foreign farm, the Director of the Office of Compliance
in the Center for Food Safety and Applied Nutrition (CFSAN)), or an FDA
official senior to such Director, must approve an
[[Page 58466]]
order to withdraw the exemption before the order is issued. In
addition, as amended, proposed Sec. 112.202(b) would establish that
any officer or qualified employee of FDA may issue an order to withdraw
the exemption after it has been approved in accordance with proposed
Sec. 112.202(a).
We seek comment on our current thinking on this issue, including
new proposed provisions Sec. Sec. 112.201(b), 112.202(a), and
112.202(b).
2. Reinstatement of a Qualified Exemption That Is Withdrawn
In the previously published proposed rule, under subpart R of
proposed part 112, we proposed to establish the procedures that would
govern the circumstances and process whereby we may issue an order
withdrawing a qualified exemption applicable to a farm in accordance
with the requirements of proposed Sec. 112.5. Our proposed procedures
did not include provisions for reinstatement of a qualified exemption
once it is withdrawn.
a. Relevant Comments. We received several comments requesting that
FDA provide for a process that would allow qualified farms to regain
their exempt status after corrective actions are taken. Some commenters
noted that FDA has a history of providing opportunities for facilities
to fix a problem identified by FDA prior to suspending a facility's
registration or starting an enforcement action, and that FDA should
provide the same opportunities to farms that have a qualified exemption
to fix the problems leading to the order to withdraw the exemption.
Conversely, at least one commenter argued that FSMA provides no
authority for restoring a qualified farm's exempt status after its
withdrawal, and opposed any changes to the procedures in subpart R to
provide for reinstatement of the exemption once it is withdrawn.
b. FDA's Consideration of Comments. We are proposing certain
amendments, including taking into account comments that recommended
providing a process for restoring the qualified exemption that was
withdrawn. We also considered legal arguments presented by the
commenter that opposed reinstatement of a qualified exemption. We have
tentatively concluded that the absence of a specific provision in FSMA
for the reinstatement of a qualified exemption that was withdrawn does
not preclude FDA from providing for such a process if FDA determines
that continued withdrawal is not necessary to protect the public health
and prevent or mitigate a foodborne illness outbreak.
Therefore, proposed Sec. 112.213 would list the process under
which FDA would reinstate a qualified exemption that was withdrawn.
Specifically, this new provision would establish that if the FDA
District Director in whose district your farm is located (or, in the
case of a foreign farm, the Director of the Office of Compliance in
CFSAN) determines that the farm has adequately resolved problems with
the conduct or conditions that are material to the safety of the food
produced or harvested at such farm, and that continued withdrawal of
the exemption is not necessary to protect the public health or prevent
or mitigate a foodborne illness outbreak, the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in CFSAN) shall, on his own
initiative or at the request of a farm, reinstate the qualified
exemption (proposed Sec. 112.213(a)). FDA would then notify the owner,
operator, or agent in charge of the farm of such reinstatement of the
qualified exemption.
In addition, proposed Sec. 112.213(b) would provide that a farm
may request FDA to reinstate a qualified exemption that has been
withdrawn under the procedures of subpart R using the following
procedure: (1) Submit a request, in writing, to the FDA District
Director in whose district your farm is located (or, in the case of a
foreign farm, the Director of the Office of Compliance in CFSAN) and
(2) present, in writing, data and information to demonstrate that you
have adequately resolved the problems with the conduct or conditions
that are material to the safety of the food produced and harvested at
your farm, such that continued withdrawal of the exemption is not
necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak.
Under proposed Sec. 112.213(c), we are proposing that if your
qualified exemption is withdrawn under Sec. 112.201(a)(1) (i.e., in
the event of an active investigation of a foodborne illness outbreak
that is directly linked to your farm), and FDA later determines, after
finishing the active investigation of a foodborne illness outbreak,
that the outbreak is not directly linked to your farm, FDA will
reinstate your qualified exemption under Sec. 112.5, and FDA will
notify you in writing that your exempt status has been reinstated.
Finally, under proposed Sec. 112.213(d), we are proposing that if
your qualified exemption is withdrawn under both Sec. 112.201(a)(1)
(i.e., in the event of an active investigation of a foodborne illness
outbreak that is directly linked to your farm) and Sec. 112.01(a)(2)
(i.e., if we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with your farm that are material to
the safety of the food that would otherwise be covered produce grown,
harvested, packed or held at your farm), and FDA later determines,
after finishing the active investigation of a foodborne illness
outbreak, that the outbreak is not directly linked to your farm, FDA
will inform you of this finding, and you may ask FDA to reinstate your
qualified exemption under Sec. 112.5, in accordance with the
requirements of proposed Sec. 112.213(b). Unlike under the provisions
of proposed Sec. 112.213(c) where FDA would on its own initiative
reinstate the qualified exemption, under this proposed provision Sec.
112.213(d) we are proposing that the owner, operator, or agent in
charge of the farm submit a request (in accordance with proposed Sec.
112.213(b)) to demonstrate that the problems with the conduct or
conditions associated with the farm that formed the basis, in part, for
the withdrawal have been adequately resolved and that these corrections
will be maintained if the exemption is reinstated.
We seek comment on our tentative decision to provide for
reinstatement of a qualified exemption that is withdrawn, the proposed
circumstances under which FDA would reinstate the qualified exemption,
and the proposed procedures for such reinstatement.
3. Summary of FDA's Revisions and Request for Comment
We are proposing to: (1) Add a 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; (2) add
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; (3) make corresponding amendments to proposed Sec. Sec.
112.202(a) and 112.202(b) to clarify the procedure for issuing an order
to withdraw a qualified exemption; and (4) add a new proposed
[[Page 58467]]
provision Sec. 112.213 to list the circumstances under which FDA would
reinstate a farm's qualified exemption that is withdrawn.
We seek comment on our new and amended proposed provisions,
including our tentative decision that we may consider other actions, as
appropriate, and we must provide certain specified intermediate steps
before issuing an order to withdraw a qualified exemption. We also seek
comment on our tentative decision to provide for reinstatement of a
qualified exemption that is withdrawn, the proposed circumstances under
which FDA would reinstate the qualified exemption, and the proposed
procedures for such reinstatement.
Finally, in the amendments to the Preventive Controls for Human
Food proposed rule, we are proposing to amend the timeframe for a
facility to comply with an order to withdraw an exemption from the
previous proposed ``within 60 days of the date of the order'' to
``within 120 days of the date of receipt of the order'' (see section
XIII.D. of that document). We seek comment on whether, similar to these
amendments to proposed part 117, we should amend the relevant
provisions in proposed part 112 (i.e., proposed Sec. Sec. 112.203(d),
112.204(a), 112.205(b)), which would require compliance within 60
calendar days of the date of the order, to require that a farm comply
with an order to withdraw its qualified exemption within 120 days of
the date of receipt of the order.
III. Preliminary Regulatory Impact Analysis
A. Overview
As explained in the Produce Safety proposed rule, FDA performed the
necessary analyses to examine the impacts of the previously published
proposed rule under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520). FDA also provided the analyses for public
input (78 FR 3504 at 3616).
We performed additional analyses to examine the impacts of the
amended and new proposed provisions described in this document under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is a significant
regulatory action as defined by Executive Order 12866. We present our
additional analyses, including the total estimated costs and benefits
of the Produce Safety proposed rule as amended (Ref. 41). We seek
comment on our additional analyses.
B. Regulatory Flexibility Analysis
FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities consistent with statutory objectives. FDA tentatively
concludes that the proposed rule will have a significant economic
impact on a substantial number of small entities. The Small Business
Administration (SBA) defines farms involved in crop production as
``small'' if their total revenue is less than $750,000 (Ref. 42).
Approximately 95 percent of all farms that grow covered produce are
considered small by the SBA definition.
The proposed rule reduces the burden on small entities in part
through the use of exemptions: Certain small entities are eligible for
a qualified exemption based on average monetary value of food sold and
direct sales to qualified end users (proposed Sec. 112.5). The
proposed rule additionally reduces the burden on small entities by not
covering farms with $25,000 or less of average annual monetary value of
produce sold (proposed Sec. 112.4(a)).
The proposed rule additionally provides all farms flexibility for
alternative practices to be used for certain listed requirements with
adequate scientific support. The proposed rule also provides for States
and foreign countries to submit a request for a variance for one or
more requirements of the proposed rule. To be granted, the procedures,
processes, and practices to be followed under the variance must be
reasonably likely to ensure that the produce is not adulterated under
section 402 of the FD&C Act (21 U.S.C. 342) and to provide the same
level of public health protection as the requirements of the proposed
rule.
Farms defined as small businesses have an additional 2 years to
comply with most provisions of the rule after the effective date of
FDA's final rule and farms defined as very small businesses have an
additional 3 years. There is also an extended 2-year compliance period
for certain proposed provisions for water quality in Sec. 112.44 and
related provisions in Sec. Sec. 112.45 and 112.50 (specifically,
Sec. Sec. 112.50(b)(5), 112.50(b)(6), and 112.50(b)(7)). The extended
compliance dates for these specific water quality standards would then
be 4 years from the effective date for small businesses and 5 years
from the effective date for very small businesses.
For a more detailed description of the full regulatory flexibility
options offered for this proposed rule, see the Preliminary Regulatory
Impact Analysis (PRIA) (Ref. 43).
C. Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement including an assessment of
anticipated costs and benefits before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the 2012 Implicit Price Deflator
for the Gross Domestic Product. FDA has determined that this proposed
rule is significant under the Unfunded Mandates Reform Act. FDA has
carried out the cost-benefit analysis in preceding sections. The other
requirements under the Unfunded Mandates Act of 1995 include assessing
the rule's effects on: Future costs; particular regions, communities,
or industrial sectors; national productivity; economic growth; full
employment; job creation; and exports.
The issues listed above are covered in detail in the cost benefit
analysis of the preceding sections and in the PRIA (Ref. 43).
D. Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of congressional
review as having caused or being likely to cause one or more of the
following: An annual effect on the economy of $100 million or more; a
major increase in costs or prices; significant adverse effects on
competition, employment, productivity,
[[Page 58468]]
or innovation; or significant adverse effects on the ability of U.S.-
based enterprises to compete with foreign-based enterprises in domestic
or export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, the Office of Management and Budget (OMB) has
determined that this proposed rule is a major rule for the purpose of
congressional review.
IV. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). A description of these provisions is given in
the following paragraphs with an estimate of the annual recordkeeping
and reporting burdens. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Standards for the Growing, Harvesting, Packing and Holding
of Produce for Human Consumption.
Description: Section 105 of the FDA Food Safety and Modernization
Act requires that ``not later than 1 year after the date of enactment,
. . . shall publish a notice of proposed rulemaking to establish
science-based minimum standards for the safe production and harvesting
of those types of fruits and vegetables, including specific mixes or
categories of fruits and vegetables, that are raw agricultural
commodities for which the Secretary has determined that such standards
minimize the risk of serious adverse health consequences or death . .
.''
Description of Respondents: The proposed rule applies to farms that
grow produce, meaning fruits and vegetables such as berries, tree nuts,
herbs, and sprouts. There are 40,211 farms in the United States, the
District of Columbia, and the Commonwealth of Puerto Rico, excluding
sprouting operations (Ref. 44), that would be covered by the proposed
rule. We estimate that there are approximately 285 sprouting operations
covered by this proposed rule.
The information collection estimate for the produce safety proposed
rule will change due to the number of farms that are affected by the
requirements and the revised testing requirements for agricultural
water. Table 2 provides the revised estimates of the recordkeeping
burden associated with supplemental requirements. The information
collection estimate for the produce safety proposed rule was 1,289,959
annual hours, when the number of covered farms was 40,211. Under this
supplemental codified, the number of covered farms is 35,503. After
accounting for the decreased recordkeeping burden due to the lower
number of farms, and the increased average hourly burden due to new
records that may accompany the relaxed requirement for water usage and
application intervals after, we estimate that it will take farms a
total of 1,197,369 hours to collect information under this supplemental
notice. This represents an annual hourly savings of 92,590 hours and
approximately $5.16 million. For full information on the calculation of
all recordkeeping hourly burdens please refer to the original PRA (Ref.
43). Estimates of two new information collections are presented in
Table 2: Sec. Sec. 112.50(b)(8) and 112.50(b)(9).
Section 112.50(b)(8) of this supplemental notice requires
scientific data or information farms rely on 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
Sec. 112.44(c)(2). Currently, no information is available to the
Agency to estimate how many farms would choose to apply a post-harvest
time interval that would require them to keep records to comply with
Sec. 112.50(b)(8). We do not expect this number to be zero annually,
nor do we expect the number to be very large. We believe that farms are
more likely to use the pre-harvest interval option offered in proposed
Sec. 112.44(c)(1), which would not require additional recordkeeping,
where the farm applies the proposed microbial die-off rate to calculate
an appropriate time interval. Based on our current understanding of
operations in the produce industry, for the purposes of this analysis,
it is estimated that, annually, 100 farms would choose to apply a post-
harvest time interval as a result of this supplemental notice. We
estimate that these farms will spend .33 hour (20 minutes) annually to
obtain and maintain this documentation. Therefore, 100 records x .33
hour = 33 annual hours for farms to comply with this requirement. We
acknowledge the uncertainty in these estimates. We request comment on
the number of farms that would choose to apply a post-harvest time
interval and the time needed to comply with this recordkeeping
requirement.
Section 112.50(b)(9) of this supplemental notice requires
scientific data or information you rely on to support your testing
frequency for untreated surface water used for purposes that are
subject to the requirements of Sec. 112.44(a). No information is
currently available that would allow us to estimate the number of farms
that would be subject to this requirement. However, we expect that it
would be extremely rare for a farm to use untreated surface water for
activities, such as hand washing, that would be subject to the
requirements of Sec. 112.44(a). Therefore, for the purposes of this
analysis, we estimate that one farm per year will engage in activity
related to the requirement of Sec. 112.50(b)(9) and that this farm
will spend .33 hour (20 minutes) annually to obtain and maintain this
documentation. Therefore, 1 record x .33 hour = .33 annual hours. We
acknowledge the uncertainty in these estimates. We request comment on
the number of farms that would use untreated surface water for purposes
listed in Sec. 112.44(a) (such as hand washing), and the time needed
to comply with this recordkeeping requirement.
[[Page 58469]]
Table 2--New Recordkeeping Hourly Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Scientific Data to Support Time Interval Between Last Irrigation and End of Storage
--------------------------------------------------------------------------------------------------------------------------------------------------------
112.50(b)(8)............................................ 100 1 100 .33 33 $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Scientific Data to Support Testing Frequency for Untreated Surface Water Used for Purposes Subject to Sec. 112.44(a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
112.50(b)(9)............................................ 1 1 1 .33 .33 $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
V. Analysis of Environmental Impact
In publishing the Produce Safety proposed rule, we relied on a
categorical exclusion from the need to prepare an EA or EIS under 21
CFR 25.30(j) (78 FR 3504 at 3616). However, as explained in the NOI,
based on currently available information, including comments received,
and upon further analysis, FDA has determined that the proposed action
may significantly affect the quality of the human environment (21 CFR
25.22(b)), and therefore, an EIS is necessary for the final rule (78 FR
50358, August 19, 2013). Accordingly, FDA is in the process of
preparing an EIS and, under that process, expects to provide a draft
EIS for public comment prior to preparing a final EIS document and
issuing the Record of Decision.
VI. Comments
Interested persons may submit either electronic comments regarding
the specific issues identified for public comment in this document to
http://www.regulations.gov or written comments to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
VII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
These references are also available electronically at http://www.regulations.gov. (We have verified the Web site addresses, but we
are not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.)
1. Taylor, M., ``Your Input Is Bringing Change to Food Safety
Rules,'' (http://blogs.fda.gov/fdavoice/index.php/tag/produce-safety-rule/), December 19, 2013. Accessed and printed on March 14,
2014.
2. Taylor, M., ``Getting Importers' Pulse About Food Safety Plans,''
(http://blogs.fda.gov/fdavoice/index.php/tag/fda-food-safety-modernization-act-of-2011-fsma/), November 4, 2013. Accessed and
printed on March 14, 2014.
3. Taylor, M., ``We're Partnering With Mexico to Keep Foods Safe,''
(http://blogs.fda.gov/fdavoice/index.php/2013/11/were-partnering-with-mexico-to-keep-foods-safe/), November 14, 2013. Accessed and
printed on March 14, 2014.
4. Taylor, M., ``Statement From FDA Deputy Commissioner for Foods
and Veterinary Medicine, Michael Taylor, on Key Provisions of the
Proposed FSMA Rules Affecting Farmers,'' (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery), December 19, 2013. Accessed and printed on
March 14, 2014.
5. FDA, ``Title 21 of the Code of Federal Regulations, Proposed Part
112--Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption, Tracked Changes Compared to Proposed
Part 112 issued on January 16, 2013,'' September 2014.
6. Cooley, M., D. Carychao, L. Crawford-Miksza, et al., ``Incidence
and Tracking of Escherichia Coli O157:H7 in a Major Produce
Production Region in California,'' PLoS One, 2:e1159, 2007.
7. Gemmell, M. E. and S. Schmidt, ``Is the Microbiological Quality
of the Msunduzi River (KwaZulu-Natal, South Africa) Suitable for
Domestic, Recreational, and Agricultural Purposes?,'' Environmental
Science and Pollution Research, 20:6551-6562, 2013.
8. Holvoet, K., I. Sampers, M. Seynnaeve, and M. Uyttendaele,
``Relationships Among Hygiene Indicators and Enteric Pathogens in
Irrigation Water, Soil and Lettuce and the Impact of Climatic
Conditions on Contamination in the Lettuce Primary Production,''
International Journal of Food Microbiology, 171:21-31, 2014.
9. EPA, ``Ambient Water Quality Criteria for Bacteria--1986,'' 1986.
10. FDA and Interstate Shellfish Sanitation Conference, ``National
Shellfish Sanitation Program: Guide for the Control of Molluscan
Shellfish--2009 Revision,'' 2011.
11a. WHO, ``WHO Guidelines for the Safe Use of Wastewater, Excreta
and Greywater,'' 2006.
11b. WHO, ``Guidelines for Drinking-Water Quality--Second Edition,''
1997.
12. National Resource Management Ministerial Council, Environment
Protection and Heritage Council, and Australian Health Ministers'
Conference, ``National Water Quality Management Strategy: Australian
Guidelines for Water Recycling: Managing Health and Environmental
Risks (Phase 1),'' 2006.
13. Ravaliya, K., Marianne, F., and Snellman, E., ``Memorandum to
the File--Review of Water Quality Standards in Development of
Proposed Microbial Standard in Sec. 112.44(c) of the Proposed
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption,'' September 2014.
14. EPA, ``Recreational Water Quality Criteria,'' 2012.
15. Beuchat, L. R., ``Ecological Factors Influencing Survival and
Growth of Human Pathogens on Raw Fruits and Vegetables,'' Microbes
and Infection, 4:413-423, 2002.
16. Islam, M., M. P. Doyle, S. C. Phatak, et al., ``Persistence of
Enterohemorrhagic Escherichia Coli O157:H7 in Soil and on Leaf
Lettuce and Parsley Grown in Fields Treated With Contaminated Manure
Composts or Irrigation Water,'' Journal of Food Protection, 67:1365-
1370, 2004.
17. Snellman, E., Marianne, F., Ravaliya, K., and Assar, S.,
``Memorandum to the File--Review of Microbial Decay Constants
Reported in Field Trials of Contaminated Produce,'' September 2014.
18. WHO, Monitoring Bathing Waters--A Practical Guide to the Design
and Implementation of Assessments and Monitoring Programmes, edited
by J. Bartram and G. Rees, London, E & FN Spon, 2000.
19. Kay, D., J. Bartram, A. Pruss, et al., ``Derivation of Numerical
Values for the World Health Organization Guidelines for Recreational
Waters,'' Water Research, 38:1296-1304, 2004.
20. Wyer, M. D., D. Kay, J. M. Fleisher, et al., ``An Experimental
Health-Related Classification for Marine Waters,'' Water Research,
33:715-722, 1999.
21. Bowers, J., ``Memorandum to the File--Minimum Sample Size for
Surveys of Water Quality of Surface Water Sources to be Used for
Agricultural Water,'' September 2014.
22. Ingham, S. C., M. A. Fanslau, R. A. Engel, et al., ``Evaluation
of Fertilization-to-Planting and Fertilization-to-Harvest Intervals
for Safe Use of Noncomposted Bovine Manure in Wisconsin Vegetable
Production,'' Journal of Food Protection, 68:1134-1142, 2005.
23. Hutchison, M. L., L. D. Walters, T. Moore, et al., ``Fate of
Pathogens Present in
[[Page 58470]]
Livestock Wastes Spread Onto Fescue Plots,'' Applied and
Environmental Microbiology, 71:691-696, 2005.
24. Rosen, C. J. and P. M. Bierman, ``Nutrient Management for Fruit
& Vegetable Crop Production: Using Manure and Compost As Nutrient
Sources for Vegetable Crops,'' 2005.
25. Goss, M. J., A. Tubeileh, and D. Goorahoo, A Review of the Use
of Organic Amendments and the Risk to Human Health, 2013.
26. Ketterings, Q. M., G. Albrecht, K. Czymmek, and S. Bossard,
``Agronomy Fact Sheet Series: Nitrogen Credits From Manure,'' 2005.
27. Hue, N. V. and J. A. Silva, ``Organic Soil Amendments for
Sustainable Agriculture: Organic Sources of Nitrogen, Phosphorus and
Potassium,'' in Plant Nutrient Management in Hawaii's Soils,
Approaches for Tropical and Subtropical Agriculture, Manoa, Chapter
15, pp. 133-144, University of Hawaii, 2000.
28. Spargo, J. T., M. A. Cavigelli, S. B. Mirsky, et al.,
``Mineralizable Soil Nitrogen and Labile Soil Organic Matter in
Diverse Long-Term Cropping Systems,'' Nutrient Cycling in
Agroecosystems, 90:253-266, 2011.
29. Russo, V. M. and M. Taylor, ``Frequency of Manure Application in
Organic Versus Annual Application of Synthetic Fertilizer in
Conventional Vegetable Production'' Hortscience, 45:1673-1680, 2010.
30. Miller, J. J., E. C. S. Olson, D. S. Chanasyk, et al.,
``Phosphorus and Nitrogen in Rainfall Simulation Runoff After Fresh
and Composted Beef Cattle Manure Application,'' Journal of
Environmental Quality, 35:1279-1290, 2006.
31. Rynk, R., M. van de Kamp, G. B. Wilson, et al., On-Farm
Composting Handbook, edited by R. Rynk, USDA Northeast Regional
Agricultural Engineering Service Cooperative Extension, 1992.
32. Bonanomi, G., V. Antignani, C. Pane, and E. Scala, ``Suppression
of Soilborne Fungal Diseases With Organic Amendments,'' Journal of
Plant Pathology, 89:311-324, 2007.
33. Mohler, C. L. and S. E. Johnson, Crop Rotation on Organic Farms:
A Planning Manual, NRAES 177, edited by C. L. Mohler and S. E.
Johnson, Ithaca, Natural Resource, Agriculture and Engineering,
2009.
34. EPA, ``Composting: Environmental Benefits,'' (http://www.epa.gov/composting/benefits.htm), May 13, 2013. Accessed and
printed on March 14, 2014.
35. Coleman, P., ``USDA Organic: Guide for Organic Crop Producers,''
(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5101542),
November, 2012. Accessed and printed on March 14, 2014.
36. NRCS, Part 637 Environmental Engineering National Engineering
Handbook: Chapter 2 Composting, USDA, 2000.
37. USDA and NRCS, ``Nutrient Management Technical Note No. 7:
Reducing Risk of E. Coli O157:H7 Contamination,'' 2007.
38. EPA, ``Resource Conservation: Composting for Facilities
Basics,'' (http://www.epa.gov/epawaste/conserve/composting/basic.htm), May 16, 2013. Accessed and printed on March 14, 2014.
39. Organic Trade Association, ``Manure Facts,'' (http://www.ota.com/organic/foodsafety/manure.html), June 7, 2011. Accessed
and printed on March 14, 2014.
40. Resource Conservation District of Monterey County, Handbook of
Agricultural Conservation Practices, Photos and Descriptions with
Food Safety Considerations, edited by S. Ruffoni and N. Strong-
Cvetich, 3rd ed., 2012.
41. FDA, ``Supplemental Notice of Proposed Rulemaking: Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption, Economic Impact Analysis,'' September 2014.
42. ``Small Business Administration Gopher Server,'' (http://www.sba.gov/content/small-business-size-standards), 2014. Accessed
and printed on September 4, 2014.
43. FDA, ``Analysis of Economic Impacts: Standards for the Growing,
Harvesting, Packing and Holding of Produce for Human Consumption,''
(http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM334116.pdf), 2013. Accessed and printed on September 4, 2014.
44. USDA, ``Census of Agriculture, 2007,'' (http://www.agcensus.usda.gov/Publications/2007/Getting_Started/Guide_to_Census_Products/), 2011. Accessed
and printed on September 3, 2014.
List of Subjects in 21 CFR Part 112
Foods, Fruits and vegetables, Packaging and containers,
Recordkeeping requirements, Safety.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR Chapter I, as proposed to be added on January 16,
2013 (78 FR 3504), be further amended as follows:
PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
0
1. The authority citation for 21 CFR part 112 continues to read as
follows
Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.
Subpart A--[Amended]
0
2. In Sec. 112.3, revise paragraphs (b)(1) and (b)(2) and in paragraph
(c), revise the definitions for ``Covered activity,'' ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing'' to read as follows:
Sec. 112.3 What definitions apply to this part?
* * * * *
(b) * * *
(1) Very small business. For the purpose of this part, your farm is
a very small business if it is subject to this part and, on a rolling
basis, the average annual monetary value of produce (as defined in
paragraph (c) of this section) you sold during the previous 3-year
period is no more than $250,000.
(2) Small business. For the purpose of this part, your farm is a
small business if it is subject to this part and, on a rolling basis,
the average annual monetary value of produce (as defined in paragraph
(c) of this section) you sold during the previous 3-year period is no
more than $500,000; and your farm is not a very small business as
provided in paragraph (b)(1) of this section.
(c) * * *
* * * * *
Covered activity means 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 raw agricultural commodities 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 part 110 of this chapter.
* * * * *
Farm means 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''
includes establishments that, in addition to these activities:
(i) Pack or hold raw agricultural commodities;
(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 paragraph
(iii)(B)(1) of this 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 raw agricultural commodities to create a
[[Page 58471]]
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and
(2) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing.
* * * * *
Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities on a
farm. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Gathering,
washing, trimming of outer leaves of, removing stems and husks from,
sifting, filtering, threshing, shelling, and cooling raw agricultural
commodities grown on a farm are examples of harvesting.
* * * * *
Holding means 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 raw agricultural commodity and breaking down
pallets)), but does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
* * * * *
Packing means 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 a raw agricultural commodity, as defined in
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act.
* * * * *
0
3. In Sec. 112.4, revise the first sentence of paragraph (a) to read
as follows:
Sec. 112.4 Who is subject to the requirements of this part?
(a) Except as provided in paragraph (b) of this section, 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.* * *
* * * * *
Subpart B--[Amended]
0
4. Section 112.12, is amended by adding the phrase ``as provided in
Sec. 112.44(d) and'' at the end of paragraph (a)(1); by removing ``;''
and adding it its place ``.'' at the end of paragraph (a)(2); and by
removing paragraphs (a)(3) and (a)(4).
Subpart E--[Amended]
0
5. Section 112.44, is amended by revising paragraphs (c) and (d) to
read as follows:
Sec. 112.44 What testing is required for agricultural water, and what
must I do based on the test results?
* * * * *
(c) 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 to develop and verify the
water quality profile of the water source as described in Sec.
112.45(b)(1). Using your water quality profile as described in Sec.
112.45(b)(1), if you find that (when applicable) the estimate of the
statistical threshold value (STV) of samples exceeds 410 colony forming
units (CFU) of generic E. coli per 100 mL of water, or if you find that
the geometric mean (GM) of samples exceeds 126 CFU of generic E. coli
per 100 mL of water (or an alternative microbial standard consistent
with paragraph (d)(1) of this section), you must either:
(1) Apply a time interval (in days) between last irrigation and
harvest using a microbial die-off rate of 0.5 log per day (or an
alternative microbial die-off rate consistent with paragraph (d)(2) of
this section) to achieve a (calculated) log reduction of your geometric
mean 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, or an
alternative microbial standard consistent with paragraph (d)(1) of this
section;
(2) 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 geometric mean 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 (or an alternative microbial standard consistent with
paragraph (d)(1) of this section), provided you have adequate
supporting scientific data and information. You may apply this time
interval in addition to the time interval in accordance with paragraph
(c)(1) of this section; or
(3) If options (c)(1) or (c)(2) are not selected, immediately
discontinue use of that source of agricultural water and/or its
distribution system for the uses described in this paragraph. Before
you may use the water source and/or distribution system again for the
uses described in this paragraph, 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 Sec. 112.43.
(d) You may establish and use alternatives to the following
requirements provided you satisfy the requirements of Sec. 112.12:
(1) Microbial quality standard established in paragraph (c) of this
section; and
(2) Microbial die-off rate established in paragraph (c)(1) of this
section that is used to determine the time interval between last
irrigation and harvest.
0
6. Section 112.45, is revised to read as follows:
Sec. 112.45 How often must I test agricultural water that is subject
to the requirements of Sec. 112.44?
(a) There is no requirement to test any agricultural water that is
subject to the requirements of Sec. 112.44 when:
(1) You receive water from a public water system, as defined under
the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that
furnishes water that meets the microbial requirements under those
regulations or under the regulations of a State approved to administer
the SDWA public water
[[Page 58472]]
supply program, and you have public water system results or
certificates of compliance that demonstrate that the water meets that
requirement;
(2) You receive water from a public water supply that furnishes
water that meets the microbial requirement described in Sec.
112.44(a), and you have public water system results or certificates of
compliance that demonstrate that the water meets that requirement; or
(3) You treat water in accordance with the requirements of Sec.
112.43.
(b) If you use untreated surface water for purposes that are
subject to the requirements of 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 (3).
(ii) The baseline survey must be conducted over a minimum period of
2 years by calculating the geometric mean (GM) and the statistical
threshold value (STV) of generic Escherichia coli (E. coli) (colony
forming units (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.
(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 dataset 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.
(c) If you use untreated ground water for purposes that are subject
to the requirements of Sec. 112.44, you must test the quality of each
source of the water at least four times during the growing season or
over a period of 1 year, using a minimum total of four samples
collected during a time period(s) as close as practical to harvest. If
the samples tested meet the applicable microbial standard of Sec.
112.44 (i.e., no detectable generic E. coli per 100 mL under 112.44(a)
or a geometric mean of generic E. coli of 126 CFU or less per 100 mL
under 112.44(c), as applicable), you may test once annually thereafter,
using a minimum of one sample collected during a time period as close
as practical to harvest. You must resume testing at least four times
per growing season or year if any annual test fails to meet the
applicable microbial standard in Sec. 112.44.
(d) If you use untreated surface water for purposes that are
subject to the requirements of Sec. 112.44(a), you must test the
quality of each source of the water with an adequate frequency to
provide reasonable assurances that the water meets the required
microbial standard. You must have adequate scientific data or
information to support your testing frequency.
(e) You may meet the requirements related to agricultural water
testing required under paragraphs (b), (c), and (d) of this section
using:
(1) Test results from your agricultural water source(s) performed
by you, or by a person or entity acting on your behalf; or
(2) Data collected by a third party or parties, provided the water
source(s) sampled by the third party or parties adequately represent
your agricultural water source(s) and all other applicable requirements
of this part are met.
0
7. Section 112.50, is amended by adding new paragraphs (b)(8) and
(b)(9) to read as follows:
Sec. 112.50 Under this subpart, what requirements apply regarding
records?
* * * * *
(b) * * *
(8) 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); and
(9) Scientific data or information you rely on to support your
testing frequency for untreated surface water used for purposes that
are subject to the requirements of Sec. 112.44(a).
Subpart F--[Amended]
0
8. Section 112.56 is amended by removing from paragraph (a)(1)(i) the
phrase ``9 months'' and adding in its place the phrase ``Reserved'';
removing from paragraph (a)(4)(i) the phrase ``45 days'' and adding in
its place the phrase ``0 days''; and removing and reserving paragraph
(b).
0
9. Section 112.60 is amended by removing paragraphs (b)(1) and (b)(5)
and redesignating paragraphs (b)(2), (b)(3), and (b)(4) as paragraphs
(b)(1), (b)(2), and (b)(3), respectively.
Subpart I--[Amended]
0
10. Add Sec. 112.84 to read as follows:
[[Page 58473]]
Sec. 112.84 Does this regulation require covered farms to take
actions that would constitute a ``taking'' of threatened or endangered
species; to take measures to exclude animals from outdoor growing
areas; or to destroy animal habitat or otherwise clear farm borders
around outdoor growing areas or drainages?
No. Nothing in this regulation authorizes the ``taking'' of
threatened or endangered species as that term is defined by the
Endangered Species Act (16 U.S.C. 1531-1544) (i.e., to harass, harm,
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to
attempt to engage in any such conduct), in violation of the Endangered
Species Act. This regulation does not require covered farms to take
measures to exclude animals from outdoor growing areas, or to destroy
animal habitat or otherwise clear farm borders around outdoor growing
areas or drainages.
Subpart P--[Amended]
0
11. Section 112.182, is amended by removing ``;'' and adding in its
place ``.'' at the end of paragraph (c) and removing paragraphs (d) and
(e).
Subpart R--[Amended]
0
12. Section Sec. 112.201, is revised to read as follows:
Sec. 112.201 Under what circumstances can FDA withdraw a qualified
exemption in accordance with the requirements of Sec. 112.5?
(a) We may withdraw your qualified exemption under Sec. 112.5:
(1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to your farm; or
(2) If we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with your farm that are material to
the safety of the food that would otherwise be covered produce grown,
harvested, packed or held at your farm.
(b) Before FDA issues an order to withdraw your qualified
exemption, FDA:
(1) 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;
(2) Must notify the owner, operator, or agent in charge of the
farm, in writing, of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the farm to respond in writing, within 10 calendar days of
the date of the notification, to FDA's notification; and
(3) Must consider the actions taken by the farm to address the
circumstances that may lead FDA to withdraw the exemption.
0
13. Section 112.202 is revised to read as follows:
Sec. 112.202 What procedure will FDA use to withdraw an exemption?
(a) An FDA District Director in whose district the farm is located
(or, in the case of a foreign farm, the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition), or an
FDA official senior to such Director, must approve an order to withdraw
the exemption before the order is issued.
(b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
(c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the farm.
(d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.
0
14. Add Sec. 112.213 to read as follows:
Sec. 112.213 If my qualified exemption is withdrawn, under what
circumstances would FDA reinstate my qualified exemption?
(a) If the FDA District Director in whose district your farm is
located (or, in the case of a foreign farm, the Director of the Office
of Compliance in the Center for Food Safety and Applied Nutrition
(CFSAN)) determines that the farm has adequately resolved problems with
the conduct and conditions that are material to the safety of the food
produced or harvested at such farm, and that continued withdrawal of
the exemption is not necessary to protect the public health or prevent
or mitigate a foodborne illness outbreak, the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in CFSAN) shall, on his own
initiative or at the request of a farm, reinstate the qualified
exemption.
(b) You may ask FDA to reinstate a qualified exemption that has
been withdrawn under the procedures of this subpart as follows:
(1) Submit a request, in writing, to the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in CFSAN); and
(2) Present, in writing, data and information to demonstrate that
you have adequately resolved the problems with the conduct or
conditions that are material to the safety of the food produced and
harvested at your farm, such that continued withdrawal of the exemption
is not necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak.
(c) If your qualified exemption was withdrawn under Sec.
112.201(a)(1) and FDA later determines, after finishing the active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to your farm, FDA will reinstate your qualified
exemption under Sec. 112.5, and FDA will notify you in writing that
your exempt status has been reinstated.
(d) If your qualified exemption was withdrawn under Sec.
112.201(a)(1) and (a)(2) and FDA later determines, after finishing the
active investigation of a foodborne illness outbreak, that the outbreak
is not directly linked to your farm, FDA will inform you of this
finding, and you may ask FDA to reinstate your qualified exemption
under Sec. 112.5, in accordance with the requirements of paragraph (b)
of this section.
Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-22447 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P