Document ID: FDA-2011-N-0921-0973
Agency: fda
Document Type: Proposed Rule
Title: Standards for the Growing, Harvesting, Packing, and Holding of Produce for
Human Consumption
Posted Date: 2014-09-29T04:00Z

[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58433-58473]
From the Federal Register Online via the Government Printing 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
----------------------------------------------------------------------------------------------------------------
    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)
----------------------------------------------------------------------------------------------------------------
           1.57            $930.00            $386.23            $143.39            $529.62            $400.37
----------------------------------------------------------------------------------------------------------------

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

I. Background

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

[[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&utmmedium=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/GettingStarted/
GuidetoCensusProducts/), 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]

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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.
* * * * *
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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.
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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.
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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]

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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).
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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]

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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