[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Proposed Rules]
[Pages 3504-3646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00123]



[[Page 3503]]

Vol. 78

Wednesday,

No. 11

January 16, 2013

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 1, 16, 106, Et al.





Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption; Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Human Food; Draft 
Qualitative Risk Assessment of Risk of Activity/Food Combinations for 
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm; Availability; Proposed Rules

  Federal Register / Vol. 78 , No. 11 / Wednesday, January 16, 2013 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 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.

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SUMMARY: To minimize the risk of serious adverse health consequences or 
death from consumption of contaminated produce, the Food and Drug 
Administration (FDA) is proposing to establish science-based minimum 
standards for the safe growing, harvesting, packing, and holding of 
produce, meaning fruits and vegetables grown for human consumption. FDA 
is proposing these standards as part of our implementation of the FDA 
Food Safety Modernization Act (FSMA). These standards would not apply 
to produce that is rarely consumed raw, produce for personal or on-farm 
consumption, or produce that is not a raw agricultural commodity. In 
addition, produce that receives commercial processing that adequately 
reduces the presence of microorganisms of public health significance 
would be eligible for exemption from the requirements of this rule. The 
proposed rule would set forth procedures, processes, and practices that 
minimize the risk of serious adverse health consequences or death, 
including those reasonably necessary to prevent the introduction of 
known or reasonably foreseeable biological hazards into or onto produce 
and to provide reasonable assurances that the produce is not 
adulterated on account of such hazards. We expect that the proposed 
rule, if finalized as proposed, would reduce foodborne illness 
associated with the consumption of contaminated produce.

DATES: Submit either electronic or written comments on the proposed 
rule by May 16, 2013. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by February 15, 2013 (see the 
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0921 and/or Regulatory Information Number RIN 0910-AG35, by any of 
the following methods, except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 must be submitted to 
the Office of Regulatory Affairs, Office of Management and Budget (OMB) 
(see the ``Paperwork Reduction Act of 1995'' section of this document).

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 Agency name 
and Docket No. FDA-2011-N-0921 and Regulatory Information Number RIN 
0910-AG35 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
Proposed Rule
I. Introduction
    A. Contamination With Microbiological Hazards
    B. Contamination With Chemical, Physical or Radiological Hazards
II. Efforts To Address Produce Safety
    A. Inspections and Investigations
    B. Guidance Documents and Letters to Industry
    C. Produce Safety Action Plan
    D. Public Hearings
    E. Partnerships and Collaborations
    F. Current Industry Practices
    G. 2010 Federal Register Notice and Preliminary Stakeholder 
Comments
    H. White House Food Safety Working Group
    I. Other Related Issues
III. Legal Authority
    A. Section 105 of FSMA and Section 419 of the FD&C Act
    B. Other Provisions of the FD&C Act
    C. The Public Health Service Act
    D. Legal Authority for Records Requirements
    E. Intrastate Activities
    F. Relevance of Section 415 of the FD&C Act to ``Farm'' 
Definition and Related Definitions
IV. Regulatory Approach
    A. Qualitative Assessment of Risk
    B. Focus on Biological Hazards
    C. Consideration of Differing Risk of Different Commodities and 
Practices
    D. Framework of the Rule
    E. Records
    F. Farm-specific Food Safety Plans
    G. Foreign Farms
    H. Consistency With Codex Guidelines
    I. Product Testing as a Strategy to Control Pathogens
    J. Effective Dates
    K. Compliance Dates
V. The Proposal
    A. Subpart A--General Provisions
    B. Subpart B--General Requirements
    C. Subpart C--Standards Directed to Personnel Qualifications and 
Training
    D. Subpart D--Standards Directed to Health and Hygiene
    E. Subpart E--Standards Directed to Agricultural Water
    F. Subpart F--Standards Directed to Biological Soil Amendments 
of Animal Origin and Human Waste
    G. Reserved
    H. Reserved
    I. Subpart I--Standards Directed to Domesticated and Wild 
Animals
    J. Reserved
    K. Subpart K--Standards Directed to Growing, Harvesting, Packing 
and Holding Activities
    L. Subpart L--Standards Directed to Equipment, Tools, Buildings, 
and Sanitation
    M. Subpart M--Standards Directed to Sprouts
    N. Subpart N--Analytical Methods
    O. Subpart O--Requirements Applying to Records That You Must 
Establish and Keep
    P. Subpart P--Variances
    Q. Subpart Q--Compliance and Enforcement
    R. Subpart R--Withdrawal of Qualified Exemption
VI. Preliminary Regulatory Impact Analysis
VII. Analysis Of Environmental Impact
VIII. Federalism
IX. Comments
X. References

Executive Summary

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
requires FDA to publish a notice of proposed rulemaking to establish 
science-based

[[Page 3505]]

minimum standards for the safe production and harvesting of those types 
of fruits and vegetables that are raw agricultural commodities for 
which we have determined such standards minimize the risk of serious 
adverse health consequences or death. Further, new section 419 also 
requires FDA to adopt a final regulation based on known safety risks, 
setting forth procedures, processes, and practices that we determine to 
minimize the risk of serious adverse health consequences or death, 
including those that are reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards into produce 
and to provide reasonable assurances that produce is not adulterated 
under section 402 of the FD&C Act.
    This proposed rule focuses on microbiological hazards related to 
produce growing, harvesting, packing, and holding. We conducted a 
``Draft Qualitative Assessment of Risk to Public Health from On-Farm 
Contamination of Produce'' and considered the findings of this 
assessment in developing this proposed rule. While we acknowledge the 
potential for chemical, physical or radiological contamination of 
produce, for reasons discussed in this proposed rule, we are not 
proposing specific standards for these hazards in this rulemaking.

Scope of Coverage of the Proposed Rule

    The proposed rule would apply to both domestic and imported 
produce. However, as explained in the remainder of this document, the 
proposed rule contains several exemptions:
     The proposed rule would not apply to certain specified 
produce commodities that are rarely consumed raw.
     The proposed rule also would not apply to produce that is 
used for personal or on-farm consumption, or that is not a raw 
agricultural commodity.
     The proposed rule would provide an exemption for produce 
that receives commercial processing that adequately reduces the 
presence of microorganisms (e.g. a ``kill step'') as long as certain 
documentation is kept.
     The proposed rule would not cover farms that have an 
average annual value of food sold during the previous three-year period 
of $25,000 or less.
     The proposed rule would provide a qualified exemption and 
modified requirements for farms that meet two requirements: (1) The 
farm must have food sales averaging less than $500,000 per year during 
the last three years; and (2) the farm's sales to qualified end-users 
must exceed sales to others. A qualified end-user is either (a) the 
consumer of the food or (b) a restaurant or retail food establishment 
that is located in the same State as the farm or not more than 275 
miles away. Instead, these farms would be required to include their 
name and complete business address either on the label of the produce 
that would otherwise be covered (if a label is required under the FD&C 
Act and its implementing regulations) or at the point-of-purchase. This 
exemption may be withdrawn in the event of an active investigation of 
an outbreak that is directly linked to the farm, or if it is necessary 
to protect the public health and prevent or mitigate an outbreak based 
on conduct or conditions on the farm that are material to the safety of 
the produce. As explained in the Preamble, these entities are either 
exempt from all the requirements of the rule or are subject to a 
narrower set of requirements.

Summary of the Major Provisions of the Regulatory Action

    The proposed rule would establish science-based minimum standards 
for the safe growing, harvesting, packing, and holding of produce on 
farms. We propose new standards in the following major areas:
     Worker Training and Heath and Hygiene
    [cir] Establish qualification and training requirements for all 
personnel who handle (contact) covered produce or food-contact surfaces 
and their supervisors (proposed Sec. Sec.  112.21, 112.22, and 112.23);
    [cir] Require documentation of required training (proposed Sec.  
112.30); and
    [cir] Establish hygienic practices and other measures needed to 
prevent persons, including visitors, from contaminating produce with 
microorganisms of public health significance (proposed Sec. Sec.  
112.31, 112.32, and 112.33).
     Agricultural Water
    [cir] Require that all agricultural water must be of safe and 
sanitary quality for its intended use (proposed Sec.  112.41). 
Agricultural water is defined in part as water that is intended to, or 
likely to, contact the harvestable portion of covered produce or food-
contact surfaces (proposed Sec.  112.3(c));
    [cir] Establish requirements for inspection, maintenance, and 
follow-up actions related to the use of agricultural water, water 
sources, and water distribution systems associated with growing, 
harvesting, packing, and holding of covered produce (proposed 
Sec. Sec.  112.42 and 112.46);
    [cir] Require treatment of agricultural water if you know or have 
reason to believe that the water is not safe and of adequate sanitary 
quality for its intended use, including requirements for treating such 
water and monitoring its treatment (proposed Sec.  112.43);
    [cir] Establish specific requirements for the quality of 
agricultural water that is used for certain specified purposes, 
including provisions requiring periodic analytical testing of such 
water (with exemptions provided for use of public water supplies under 
certain specified conditions or treated water), and requiring certain 
actions to be taken when such water does not meet the quality standards 
(proposed Sec. Sec.  112.44 and 112.45); and provide for alternative 
requirements for certain provisions under certain conditions (proposed 
Sec.  112.12); and
    [cir] Require certain records, including documentation of 
inspection findings, scientific data or information relied on to 
support the adequacy of water treatment methods, treatment monitoring 
results, water testing results, and scientific data or information 
relied on to support any permitted alternatives to requirements 
(proposed Sec.  112.50).
     Biological Soil Amendments
    [cir] 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, 
112.52)
    [cir] 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);
    [cir] 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);
    [cir] 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
    [cir] 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).

[[Page 3506]]

     Domesticated and Wild Animals
    [cir] 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, require, 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 (proposed Sec.  112.82); and
    [cir] If under the circumstances there is a reasonable probability 
that animal intrusion will contaminate covered produce, require 
monitoring of those areas that are used for a covered activity for 
evidence of animal intrusion immediately prior to harvest and, as 
needed, during the growing season (proposed Sec.  112.83).
     Equipment, Tools, and Buildings
    [cir] Establish requirements related to equipment and tools that 
contact covered produce and instruments and controls (including 
equipment used in transport), buildings, domesticated animals in and 
around fully-enclosed buildings, pest control, hand-washing and toilet 
facilities, sewage, trash, plumbing, and animal excreta (proposed 
Sec. Sec.  112.121-134); and
    [cir] Require certain records related to the date and method of 
cleaning and sanitizing equipment used in growing operations for 
sprouts, and in covered harvesting, packing, or holding activities 
(proposed Sec.  112.140).
     Sprouts
    [cir] Establish measures that must be taken related to seeds or 
beans for sprouting (proposed Sec.  112.141);
    [cir] Establish measures that must be taken for the growing, 
harvesting, packing, and holding of sprouts (proposed Sec.  112.142);
    [cir] Require that you test the growing environment for Listeria 
spp. or L. monocytogenes and that you test each production batch of 
spent irrigation water or sprouts for E. coli O157:H7 and Salmonella 
species and take appropriate follow-up actions (proposed Sec. Sec.  
112.143, 112.144, 112.145, 112.146); and
    [cir] Require certain records, including documentation of your 
treatment of seeds or beans for sprouting, a written environmental 
monitoring plan and sampling plan, test results, and certain methods 
used (proposed Sec.  112.150).
    As proposed, the effective date is 60 days after a final rule is 
published, however, we are providing for a longer timeline for farms to 
come into compliance. Small businesses (i.e., those subject to proposed 
part 112 and, on a rolling basis, the average annual monetary value of 
food sold during the previous three-year period is no more than 
$500,000) would have three years after the effective date to comply; 
for some of the water requirements, they would have five years. In 
addition, very small businesses (i.e., those subject to proposed part 
112 and, on a rolling basis, the average annual monetary value of food 
sold during the previous three-year period is no more than $250,000) 
would have four years after the effective date to comply; for some of 
the water requirements, they would have six years. All other farms 
would have two years after the effective date to comply; for some of 
the water requirements, they would have four years to comply.

Costs and Benefits

    The baseline estimate for preventing all illnesses associated with 
microbial contamination of produce covered by this proposed regulation 
is $1.6 billion; however, we do not expect that we will eliminate all 
illnesses associated with covered produce. Instead, we expect that the 
proposed produce safety regulation will prevent some portion of this 
illness burden from recurring. We estimate the number of foodborne 
illness prevented by this regulation to be 1.75 million, with an 
associated benefit of $1.04 billion, annually. As described in the 
Preliminary Regulatory Impact Analysis (PRIA), making a precise 
estimate of the rule's likely effectiveness is extremely difficult, 
because FDA has only limited data that would establish a clear baseline 
estimate of how contamination occurs and the likely impact of the 
proposed provisions on that baseline, with respect to causing human 
illness. We estimate the costs of the proposed rule to be $459.56 
million annually for domestic farms, $170.62 million annually for 
foreign farms covered by the rule (for a grand total of $630.18 million 
annually), resulting in $406.22 million annually in estimated potential 
net benefits.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Total domestic   Total foreign     Total costs
  Summary of Costs and Benefits of the       Prevented foodborne      Total benefits     costs (in        costs (in       (domestic +      Net benefits
           Proposed Rule \1\               Illnesses (in millions)    (in millions)      millions)        millions)         foreign)      (in millions)
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Total..................................  1.75......................       $1,036.40          $459.56          $170.62          $630.18          $406.22
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                                                                  Very small         Small            Large
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Average Annual Cost per Farm.................................          $4,697          $12,972         $30,566
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\1\ As described in detail in the PRIA, data to estimate the costs and benefits of this rule are limited. Best
  estimates were made for both the costs and the benefits of the rule, given the data available. We request
  comment on these estimations, and request, in particular, data related to the amount of contamination
  attributable to each potential pathway of contamination, the relative effectiveness of each provision at
  reducing contamination, and data related to current industry food safety practices.

Proposed Rule

I. Introduction

    Each year, about 48 million Americans (1 in 6) get sick, 128,000 
are hospitalized, and 3,000 die from foodborne diseases, according to 
estimates from the Centers for Disease Control and Prevention. The FDA 
Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law 
by President Obama on January 4, 2011, enables FDA to better protect 
public health by helping to ensure the safety and security of the food 
supply. FSMA enables us to focus more on preventing food safety 
problems rather than primarily reacting to problems after they occur. 
The law also provides us with new enforcement authorities to help us 
achieve higher rates of compliance with prevention- and risk-based 
safety standards and to better respond to and contain problems when 
they do occur. In addition, the law gives us important new tools to 
better ensure the safety of imported foods and directs us to build an 
integrated national food safety system in partnership with State and 
local authorities.
    Section 105 of FSMA adds section 419 to the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 350h) requiring FDA to publish a 
notice of proposed rulemaking to establish science-based minimum 
standards for

[[Page 3507]]

the safe production and harvesting of those types of fruits and 
vegetables that are raw agricultural commodities for which we have 
determined such standards are necessary to minimize the risk of serious 
adverse health consequences or death. Further, new section 419 also 
requires FDA to adopt a final regulation based on known safety risks, 
setting forth procedures, processes, and practices that we determine to 
minimize the risk of serious adverse health consequences or death, 
including those that are reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards into produce 
and to provide reasonable assurances that produce is not adulterated 
under section 402 of the FD&C Act. This proposed rule sets forth such 
standards, as well as certain exemptions from the standards, consistent 
with section 419 of the FD&C Act.
    Two additional proposed rules, with the produce safety proposed 
rule, will be the foundation of, and central framework for, a new food 
safety system in the United States. In an accompanying notice in this 
issue of the Federal Register, FDA is publishing the preventive 
controls proposed rule that would apply to human food and require 
domestic and foreign facilities that are required to register under the 
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.
    FDA also intends to publish the foreign supplier verification 
program (FSVP) proposed rule, which would help ensure the safety of 
foods imported into the U.S. by making importers accountable for 
verifying that the food they import is produced using processes and 
procedures that achieve the same level of public health protection for 
imported food as required of domestic growers and processors under 
FSMA's new standards for produce safety and preventive controls.
    Eating fruits and vegetables is an important part of a healthy diet 
(Ref. 1). FDA is responsible for ensuring the safety of all domestic 
and imported fruits and vegetables consumed in the United States. We 
place a high priority on identifying and implementing measures that can 
reduce the incidence of foodborne illness associated with produce and 
maintain a high level of consumer confidence in this important food 
category. Produce is vulnerable to contamination with microorganisms of 
public health significance (e.g., bacteria and viruses that can cause 
disease), as well as chemical, physical, and radiological contaminants. 
Contamination of produce can occur on-farm during growing (either in an 
open environment or in a fully- or partially-enclosed building), 
harvesting, packing, or holding; or elsewhere along the farm-to-table 
continuum.

A. Contamination With Microbiological Hazards

    American consumers enjoy one of the safest supplies of produce in 
the world. Over the last few decades, however, problems linked to 
produce, including the associated public health implications, have been 
reported in a number of countries worldwide. Many factors affect the 
occurrence of microbial contamination of fresh produce, including 
worker health and hygiene, the quality of agricultural water, the use 
of animal manure and other materials of animal origin as fertilizer, 
the presence of wild or domestic animals in or near fields or packing 
areas, growing and harvesting operations, and equipment and building 
sanitation. As discussed in more detail below, FDA has taken several 
steps to help reduce the likelihood of microbial contamination; 
significant advances have been made. However, in spite of these 
efforts, produce-associated foodborne illnesses continue.
    FDA has looked specifically at outbreaks where the point of 
contamination is likely to have happened early in the production chain, 
during growing, harvesting, manufacturing, processing, packing, 
holding, or transportation (Ref. 2). Of the total reported outbreaks 
and outbreak-related illnesses linked to FDA-regulated foods between 
1996 and 2010, in the FDA database, produce accounted for 23.3% and 
42.3%, respectively. Both domestic produce and imported produce were 
identified as vehicles in these outbreaks. From 1996 to 2010, 
approximately 131 produce-related reported outbreaks occurred, 
resulting in 14,132 outbreak-related illnesses, 1,360 hospitalizations 
and 27 deaths. These outbreaks were associated with approximately 20 
different fresh produce commodities (Ref. 3). Commodities associated 
with outbreaks during this time period included sprouts; leafy greens 
such as lettuce and spinach; tomatoes; melons such as cantaloupe and 
honeydew; berries such as raspberries, blueberries, blackberries, and 
strawberries; fresh herbs such as basil and parsley; and green onions 
as well as fresh-cut fruits and vegetables. FDA also has evidence that 
contamination occurs on some produce crops at least intermittently 
based on sampling performed as part of investigation, inspections, and 
FDA Domestic and Import Field Assignments and data from United States 
Department of Agriculture (USDA)'s Agricultural Marketing Service (AMS) 
Microbiological Database program (MDP) (Ref. 4 Ref. 5). For instance, 
in 2009, AMS tested eight types of produce for E. coli O157:H7, non-
O157 E. coli carrying shiga toxin and enterotoxin genes, and 
Salmonella. MDP identified 51 samples with E. coli carrying shiga toxin 
genes; however only 24 of these were determined to be pathogenic. MDP 
identified 32 samples with Salmonella confirmed by culture. The USDA 
AMS MDP was discontinued in 2012 and FDA is evaluating options for any 
future collection of similar microbiological data.
    The following commodities accounted for 88.5% of the total produce-
associated outbreaks:
     34 outbreaks associated with sprouts,
     30 outbreaks associated with leafy greens such as lettuce 
and spinach
     17 outbreaks associated with tomatoes
     14 outbreaks associated with melons such as cantaloupe and 
honeydew
     10 outbreaks associated with berries, such as raspberries, 
blueberries, blackberries and strawberries
     6 outbreaks associated with fresh herbs such as basil and 
parsley
     3 outbreaks associated with green onions.
 (Ref. 2)
    In the FDA database, fresh-cut fruits and vegetables accounted for 
16.8% of the total produce-related outbreaks. Generally, the most 
likely point of original contamination for the fresh-cut-related 
outbreaks, as determined by FDA and its federal and state partners 
during the outbreak investigations, appears to be during growing, 
harvest, packing or holding, while the commodity is still in its raw 
agricultural commodity (RAC) form, rather than during manufacturing/
processing of the fresh-cut product (Ref. 2). In a few instances, such 
as unwashed, field packed tomatoes being removed from a warm ripening 
room and placed in cold water to firm for slicing (which may have 
promoted infiltration of pathogens) (Ref. 6), it is possible that 
practices or conditions at the fresh-cut facility contributed to the 
contamination event. It is possible that the way product is handled 
during processing, including mixing large batches of fresh-cut product, 
may spread contamination across a larger volume of product, impacting 
the size and scope of an outbreak associated with fresh-cut

[[Page 3508]]

produce. However, there have also been a number of very large outbreaks 
associated with RACs.
    Pathogens associated with the produce outbreaks include bacteria, 
viruses and parasites. Between 1996 and 2010, the majority of fresh 
produce-related outbreaks and illnesses in the FDA database were 
associated with bacterial agents (86.5%), followed by parasites (11.6%) 
and viruses (1.9%). These outbreaks involved a number of pathogens, 
including E. coli O157:H7, E. coli O157, Salmonella species (Salmonella 
spp.), Listeria monocytogenes (L. monocytogenes), Cyclospora, Shigella 
sonnei, and Hepatitis A.
    In an accompanying document titled ``Draft Qualitative Assessment 
of Risk to Public Health from On-Farm Contamination of Produce,'' FDA 
has conducted a qualitative assessment of risk associated with growing, 
harvesting, packing, and holding of produce (hereafter referred to as 
the Qualitative Assessment of Risk (QAR)). In particular, the QAR is 
intended to address various risk management questions related to 
biological hazards of concern in fresh produce that can lead to serious 
adverse health consequences or death; potential routes of 
contamination; and the likelihood of contamination and likelihood of 
illness attributable to consumption among various types of produce 
commodities. The findings of this qualitative assessment of risk 
informed our regulatory approach and several proposed provisions. We 
provide a summary of the findings in section IV; additionally, we refer 
to the QAR throughout this proposed rule, including the discussion of 
proposed provisions in section V of this document.

B. Contamination With Chemical, Physical or Radiological Hazards

    Chemical contaminants of produce can originate from a variety of 
sources. Most common among these include soil (through previous 
chemical exposure), equipment (e.g., lubricants, fuels, and 
refrigerants), pesticides, insecticides and related agents, and 
cleaning compounds (e.g., sanitizers) normally used in the course of 
maintaining buildings and equipment. FDA monitors chemical and 
pesticide residues in foods through its regulatory monitoring programs 
with emphasis on raw agricultural commodities (RACs) and foods consumed 
by infants and children. Illnesses attributable to chemical hazards are 
rare (Ref. 7). In fact, between 1997 and 2011, there have been no Class 
I recalls of produce associated with a chemical hazard for which there 
is a reasonable probability of causing serious health problems or death 
(Ref. 8). Current monitoring, regulations, and industry practice have 
been sufficient to keep these hazards under control.
    Similarly, the potential public health consequences of physical 
hazard contamination (e.g. glass or metal fragments) in produce appear 
to be relatively (Ref. 7). Rarely do the physical hazards associated 
with produce suggest a risk of serious adverse health consequences or 
death for individuals that would consume the product. In fact, between 
1997 and 2011, there have been no Class I recalls of produce associated 
with a physical hazard for which there is a reasonable probability of 
causing serious health problems or death (Ref. 8).
    The presence of radiological hazards in foods is a rare event and 
consumer exposure to harmful levels of radionuclide hazards, outside of 
catastrophic events, is very low (Ref. 7. Ref. 9).
    While we acknowledge the potential for chemical, physical or 
radiological contamination of produce, based on our analysis (Ref. 7), 
and for the reasons discussed in section IV.B of this document, we are 
not proposing specific standards for these hazards in this rulemaking.

II. Efforts to Address Produce Safety

    FDA and others have taken a number of actions to address produce 
safety in the last two decades. This section describes several of these 
activities up to and including FSMA.

A. Inspections and Investigations

    We have conducted a number of inspections and investigations that 
have provided useful information about the routes of contamination. 
Investigations involved visiting multiple field locations and packing 
operations. Observations during the investigations revealed several 
areas of farm practices that seem most likely to have been possible 
routes of contamination for produce involved in the outbreaks. Our 
inspections, investigations, and surveillance sampling activities are 
described in more detail in accompanying documents.

B. Guidance Documents and Letters to Industry

1. GAPs Guide
    On October 2, 1997, President Clinton announced the ``Initiative to 
Ensure the Safety of Imported and Domestic Fruits and Vegetables'' 
(Produce and Imported Food Safety Initiative or PIFSI). As part of this 
initiative, the President directed the Secretary of the Department of 
Health and Human Services (HHS) and the Secretary of the U.S. 
Department of Agriculture (USDA), in cooperation with the agricultural 
community, to issue guidance on good agricultural practices (GAPs) for 
fresh fruits and vegetables. In October, 1998, we issued final guidance 
to industry entitled ``Guide to Minimize Microbial Food Safety Hazards 
for Fresh Fruits and Vegetables'' (GAPs Guide) (Ref. 10). This guide 
contains voluntary recommendations for good agricultural practices 
(GAPs) that growers and packers can undertake to address common factors 
contributing to contamination in their operations. The GAPs Guide is a 
broad scope guidance that takes into account the diversity of 
conditions and practices associated with the growing, harvesting, 
packing and holding of fresh produce. We noted that firms should use 
the general recommendations in the GAPs Guide to tailor practices to 
their individual operations. As the GAPs Guide notes, current 
technologies cannot eliminate all potential food safety hazards 
associated with fresh produce that will be eaten raw. Therefore, the 
focus of the GAPs Guide is on implementing measures to minimize the 
potential for introduction of such hazards.
    On September 2, 2008, we issued a notice in the Federal Register 
(73 FR 51306) requesting comments and scientific data and information 
to assist us in improving the GAPs Guide. We specifically asked for 
information about (1) current agricultural practices and conditions 
used to produce, harvest, pack, cool, and transport fresh produce; (2) 
risk factors for contamination of fresh produce associated with these 
practices; and (3) possible recommendations or additional measures that 
would enhance the safety of fresh produce. We also requested 
information about the estimated costs and benefits of current practices 
and/or the cost and benefits of any recommendations. We received 
approximately two dozen submissions from organizations and individuals, 
including: Industry, government, universities, environmental groups, 
consumers, and consumer groups. A number of comments discussed the 
value of performing operational assessments, developing food safety 
plans and record keeping but suggested that any updated guidance 
acknowledge that these activities should be commensurate with the 
complexity of an operation and associated risks. Other

[[Page 3509]]

comments requested additional information on microbial testing to 
ensure that when testing is done it is meaningful and cost effective.
2. Letters to Lettuce, Tomato, and Cilantro Industries
    On February 5, 2004, we issued a letter to firms that grow, 
harvest, pack or hold fresh lettuce and fresh tomatoes, expressing 
concern regarding outbreaks of foodborne illness associated with the 
consumption of these products, and recommending actions to enhance the 
safety of these products (Ref. 11). On November 4, 2005, we issued a 
second letter to firms that grow, harvest, pack, hold or manufacture/
process fresh and fresh-cut lettuce, reiterating concerns about 
continuing outbreaks (Ref. 12). In the November 2005 letter, we 
strongly encouraged applicable firms to review their current operations 
in light of the GAPs Guide, as well as other available information 
regarding the reduction or elimination of pathogens on fresh produce. 
We encouraged firms to consider modifying their operations to ensure 
that they were taking the appropriate measures to provide a safe 
product to the consumer. We recommended that firms from the farm level 
through the distribution level undertake these steps.
    In March, 2011, we issued a letter to firms that grow, harvest, 
pack or hold fresh cilantro, expressing concern about positive sample 
findings and recommending actions to enhance the safety of these 
products (Ref. 13). Between 2004 and March, 2011, there had been 28 
confirmed Salmonella positive sample results in fresh cilantro in, or 
entering into, commerce. Samples were of both U.S. and imported origin. 
As with earlier letters to the industry, we strongly encouraged 
applicable firms to review their current operations in light of the 
GAPs Guide, as well as other available information regarding the 
reduction or elimination of pathogens on fresh produce. We encouraged 
firms to consider modifying their operations to ensure that they were 
taking the appropriate measures to provide a safe product to the 
consumer. In addition, we encouraged these firms to assess hazards 
unique to the production of cilantro and to develop commodity-specific 
preventive control strategies. We recommended that firms from the farm 
level through the distribution level undertake these steps.
3. Guidances and Letters Regarding Sprouts
    On October 27, 1999, we published a notice of availability (64 FR 
57893) for two guidance documents to inform all parties involved in the 
production of sprouts (i.e., producers, conditioners, and distributors 
of seeds and beans used for sprouting, sprout producers) that sprouts 
have been recognized as an important cause of foodborne illness and to 
provide recommendations for preventive controls that we believed should 
be taken immediately to reduce the likelihood of sprouts serving as a 
vehicle for foodborne illness (Ref. 14).(Ref. 15) The first guidance 
document, ``Reducing Microbial Food Safety Hazards for Sprouted Seeds'' 
(the Sprout Guide), provides recommendations based on the 
recommendations of the National Advisory Committee on Microbiological 
Criteria for Foods (NACMCF) (Ref. 16). We also released a second 
guidance, ``Sampling and Microbial Testing of Spent Irrigation Water 
During Sprout Production'' (the Sprout Testing Guide), to assist 
sprouters in implementing one of the principal recommendations in the 
broader Sprout Guide, i.e., that producers test spent irrigation water 
for two pathogens (Salmonella spp. and E coli O157:H7) before product 
enters commerce. We refer to these guidances collectively as the Sprout 
Guides.
    On April 22, 2005, we announced in the Federal Register (70 FR 
20852) a public meeting to elicit information on current science 
related to foodborne illness associated with the consumption of 
sprouts. The meeting notice contained a series of questions to help 
focus comments, including questions regarding: (1) Practices that may 
contribute to contamination of seeds used for sprouting and 
intervention strategies that could help prevent, reduce, or control 
contamination of seeds used for sprouting; (2) Whether the preventive 
controls recommended in our Sprout Guides could be improved and, if so, 
how this might be done; (3) What can or should be done to increase the 
involvement of producers of seeds for sprouting and seed distributors 
to ensure the safety of sprouts; (4) How, if at all, should the actions 
to improve the safety of seeds for sprouting be structured to take into 
account variation within the seed and sprout industry, including 
variations in size of establishments, the types of seeds and sprouts 
produced and the practices used in production; and (5) Existing food 
safety systems or standards (such as international standards) that we 
should consider as part of our efforts to minimize foodborne illness 
associated with the consumption of sprouts.
    In general, comments expressed a need to include the seed industry, 
as well as the sprout industry, in efforts to improve the safety of 
sprouts. Several comments stated that any recommendations should be 
scientifically sound, based on appropriate (and feasible) expectations 
for risk reduction, and be easy to understand and implement. Comments 
expressed concern about the effect on worker health of treating seed 
with 20,000 ppm calcium hypochlorite. Comments were generally 
supportive of recommendations in the Sprout Guides to test spent 
irrigation water; several comments supported expanded testing, 
including seed testing by seed producers and distributors. All but one 
comment maintained that seeds were the primary source of contamination 
in sprout-associated outbreaks. Several comments discussed practices 
and conditions, such as animal grazing, which could contaminate seed in 
the field. One comment suggested the industry develop a GAPs guidance 
specific to the production of seed for use in sprouts. Several comments 
supported applying Current Good Manufacturing Practices (CGMPs) (21 CFR 
Part 110) to sprout facilities. A number of comments cited the 
diversity of sprout types currently being produced and noted this 
diversity of products is likely to continue to grow. These comments 
maintained it was therefore appropriate to provide flexibility for 
individual operations to select mitigations appropriate for the 
products they produce. Comments to the 2005 Sprout Public Meeting were 
considered in this rulemaking and will be further described when we 
discuss proposed provisions specific to sprouts in section V.M. of this 
document.
    On May 1, 2009, we issued a letter to suppliers and distributors of 
seeds and beans used for sprouting, and sprouters, to make firms aware 
of our serious concerns with continuing outbreaks associated with the 
consumption of raw and lightly cooked sprouts and to urge firms to 
review their operations in light of our Sprout Guides and other 
available information (Ref. 17), and to modify their operations 
accordingly to ensure they are taking appropriate measures to provide a 
safe product to consumers. We also shared a May 1, 2008, letter from 
the California Department of Public Health (CDPH) to the California 
sprout industry outlining several critical areas of concern identified 
in recent investigations and CDPH recommendations for controlling 
hazards associated with those observations (Ref. 18).
4. Draft Commodity Specific Guidances
    On August 3, 2009, we published a notice in the Federal Register 
announcing the availability for public

[[Page 3510]]

comment of draft commodity specific guidances (CSGs) for melons (74 FR 
38437), tomatoes (74 FR 38438) and leafy greens (74 FR 38439). The 
draft CSGs are intended for growers, packers, processors, transporters, 
retailers, and others throughout the supply chain. The draft CSGs, if 
finalized, would provide a framework for identifying and implementing 
appropriate measures to minimize the likelihood of microbial 
contamination of tomatoes, leafy greens, and melons. The draft CSGs 
reflect both commodity specific information, such as recommendations 
for tomato repacking, and advances in collective thinking in broader 
areas, such as assessing potential hazards in and near the field before 
beginning production and immediately before harvest, and protecting and 
maintaining water quality at its source and during distribution and 
use. The draft CSGs are designed to complement our GAPs Guide and 
Fresh-cut Guide. On November 4, 2009, we published a notice in the 
Federal Register, extending to January 4, 2010, the comment period on 
the draft CSGs. We have not yet issued these guidances in final form.
    In developing the draft CSGs, we relied heavily on existing 
industry commodity specific guidelines, our produce safety initiatives 
and programs, lessons learned from outbreak investigations, and other 
public and private programs. We have since received several dozen 
written comments, from industry, States, and individuals. Comments were 
generally supportive of the scope and objectives of the draft CSGs. 
Comments provided their views on both commodity specific issues (e.g., 
recommendations for field packing tomatoes, water quality for 
rehydrating leafy greens after harvest) and cross-cutting issues (e.g., 
management of wild animal intrusion, quality of water used in 
postharvest operations). A number of comments requested that we 
recognize different risks may be associated with different commodities 
within the commodity groups covered by the CSGs, noting, for example, 
that cantaloupe (not watermelon) have been identified as the vehicle in 
the majority of foodborne illness outbreaks associated with melons. A 
number of comments expressed concern about potential bias of the CSG 
approach (i.e., separate recommendations for different commodities) 
against small farms growing a diversity of crops, especially the 
concern that the CSG approach could require such farms to have multiple 
food safety plans to cover each of the commodities they grow. 
Additional comments will be discussed when we describe proposed 
provisions relevant to those comments.
5. Guidances Regarding Nuts
    On March 11, 2009, we published a notice in the Federal Register 
(74 FR 10598) announcing the availability for public comment of draft 
guidance for industry: Measures to Address the Risk for Contamination 
by Salmonella Species in Food Containing a Peanut-Derived Product as an 
Ingredient. Additionally, on June 29, 2009, we published a notice in 
the Federal Register (74 FR 310308) announcing the availability for 
public comment of draft guidance for industry: Measures to Address the 
Risk for Contamination by Salmonella Species in Food Containing a 
Pistachio-Derived Product As An Ingredient. These draft guidance 
documents were intended for manufacturers who use a peanut-derived 
product or pistachio-derived product as an ingredient in a food 
product. These draft guidances provide recommendations for evaluating 
the effectiveness of certain Salmonella control measures. We have not 
yet issued these guidances in final form.
6. Fresh-cut Guide
    On March 6, 2006, we published a notice in the Federal Register (71 
FR 11209) announcing the availability on our Web site of a draft 
Guidance for Industry entitled ``Guide to Minimize Microbial Food 
Safety Hazards of Fresh-cut Fruits and Vegetables'' (the Fresh-cut 
Guide). We received a number of comments from trade associations, 
consumer groups, and industry. Comments were generally supportive of 
the draft Guide. A few comments included questions about our draft 
definition of fresh-cut produce and whether the recommendations in the 
draft guidance were mandatory or voluntary, in light of the mandatory 
requirements in existing CGMPs.
    On February 25, 2008, we published a notice (73 FR 10037) 
announcing our finalization and the availability of our ``Guide to 
Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and 
Vegetables'' (the Fresh-cut Guide). The Fresh-cut Guidance complements 
the CGMPs in 21 CFR, Part 110 and provides recommendations for a 
framework for identifying and implementing appropriate measures to 
minimize the likelihood of microbial contamination during the 
processing of fresh-cut produce. Examples of recommendations for fresh-
cut processors in the Fresh-cut Guidance include: (1) Know your 
suppliers and have a mechanism to verify that your suppliers use good 
agricultural practices, good manufacturing practices, and other 
appropriate food safety practices; and (2) ensure equipment is designed 
to prevent water collection. While fresh-cut produce is not covered 
under the scope of this proposed rule, we include a reference to our 
guidance on fresh-cut produce as some of the measures recommended in 
that document are relevant to the requirements proposed for covered 
produce in this rule.

B. Produce Safety Action Plan

    On June 15, 2004, we published a Federal Register notice (69 FR 
33393) announcing a public meeting to elicit information from 
stakeholders concerning key elements of a draft produce safety action 
plan entitled ``Produce Safety From Production to Consumption: An 
Action Plan to Minimize Foodborne Illness Associated With Fresh 
Produce'' (the Produce Safety Action Plan or PSAP). We posted the draft 
PSAP on June 18, 2004 (Ref. 19). The draft PSAP continued the 1997 
Produce and Imported Food Safety Initiative, building on experience 
from earlier efforts such as the development and implementation of the 
GAPs Guide, inspections of farms and produce packing facilities, 
surveillance sampling assignments, and investigations of foodborne 
illness outbreaks. The draft PSAP addressed all principal points 
between the farm and table where contamination of produce could occur. 
It covered fresh fruit and vegetables in their native (RAC) form and 
raw, minimally processed products (i.e., fresh-cut produce) that have 
received some processing to alter their form but have not been subject 
to a thermal process that would eliminate microbial hazards. The draft 
PSAP was not intended to cover processed products such as juice, or 
agricultural products other than fruits and vegetables.
    After considering comments received from various stakeholders, in 
October 2004, we issued the final PSAP. In recognition that 
contamination of produce can happen at any point in the supply chain, 
the PSAP expands on the areas covered by the GAPs Guide (i.e., farms 
and packing houses) to extend to all parts of the food supply chain 
from farm through retail or consumer preparation and consumption. The 
PSAP does not cover frozen fruits and vegetables, fruit and vegetable 
juices, or nuts. The PSAP has four main objectives: (1) Prevent 
contamination of fresh produce with pathogens; (2) minimize the public 
health impact when contamination of fresh produce

[[Page 3511]]

occurs; (3) improve communication with producers, packers, processors, 
transporters, distributors, preparers, consumers, and other government 
entities about the safety of fresh produce; and (4) facilitate and 
support research relevant to the contamination of fresh produce. For 
each objective, the PSAP identifies steps or actions that could 
contribute to the achievement of that objective. The PSAP has 
measurable goals and outcomes, and several steps outlined in the PSAP 
are already in progress or have been completed. For example, we issued 
the Fresh-cut Guide and provided technical assistance to industry 
efforts to develop commodity specific supply chain guidance as part of 
the PSAP objective regarding prevention of contamination.

C. Public Hearings

    On February, 27, 2007, we published a notice (72 FR 8750) of two 
public hearings, and request for comment, on the safety of fresh 
produce. In that notice, we stated that we believe that the measures 
outlined in the PSAP, the GAPs Guide, and other public and private 
sector actions, when implemented, can be effective in reducing the 
likelihood of microbial contamination of fresh produce. However, the 
fact that outbreaks of foodborne illness associated with fresh produce 
continue to occur supports the need for a close examination of: The 
extent to which these measures have been implemented; whether they have 
been effective when implemented properly; and, what additional or 
different interventions might be appropriate to reduce the likelihood 
of future outbreaks.
    We held the public hearings to share information about recent 
outbreaks of foodborne illness associated with microbial contamination 
of fresh produce, and to invite comments, data, and other scientific 
information about: Current practices used to grow, harvest, pack, hold, 
manufacture/process, and transport fresh produce; risk factors for 
contamination of fresh produce associated with these practices; and 
measures FDA could take to enhance the safety of fresh produce. The 
notice of hearings included a list of issues and questions to help 
focus comments and asked for scientific information and data. We 
received approximately 48 submissions from industry, government, 
universities, environmental groups, consumers, and consumer groups. 
Recurring comments included: The importance of activities to promote or 
enhance rapid, accurate traceback; strengthened coordination and 
communication between all sectors (i.e., researchers, regulators, and 
industry) on available science and current unpublished data; and an 
integrated, multidisciplinary approach to identify best practices not 
currently incorporated by industry. A number of comments expressed 
concerns about the cost of third party audits and lack of 
standardization of such audits. Comments also indicated a desire for 
training. Comments were divided on whether we should continue to 
promote adoption of voluntary GAPs guidance or pursue rulemaking to 
establish mandatory requirements. Comments supporting mandatory 
requirements differed on what these requirements should look like; 
suggestions ranged from mandatory GAPs to a Hazard Analysis and 
Critical Control Point (HACCP)-like approach, or a combination of the 
two. Comments were in general agreement that, whatever regulatory 
approach was chosen, it should be consistent across the United States, 
based on sound science, and cover a broad range of commodities while 
being flexible enough to accommodate the needs of specific commodities, 
regions, operations, practices, and different sizes of operations.

D. Partnerships and Collaborations

1. Public and Private Standards
    Because the GAPs Guide is voluntary, FDA and food safety partners 
in the public and private sectors have emphasized education and 
outreach to industry to promote adoption of the guidance. Buyer 
requirements that producers and other suppliers provide self- or third 
party audit verification that they are following the GAPs Guide have 
further promoted adoption of the guidance. We have worked with the 
fresh produce industry since the release of the GAPs Guide to promote 
its recommendations and to advance the scientific knowledge applicable 
to enhancing the safety of fresh produce. For example, in conjunction 
with the PSAP, we have provided technical assistance to industry in 
developing several industry commodity specific guidelines that cover 
the entire supply chain, including commodity-specific guidelines for 
melons, leafy greens, tomatoes, and green onions; these commodities 
together accounted for 70 percent of the foodborne outbreaks associated 
with produce between 1998 and 2009 (Ref. 3). These industry guidelines 
were in turn helpful to us in developing FDA's draft commodity specific 
guidances for the same commodities (see section II.B.4 of this 
document). Additional industry guidelines have been developed or are in 
progress for a broad range of commodities, including: strawberries, 
mushrooms, watermelon, potatoes, storage onions, and citrus.
    We provided technical assistance to the Association of Food and 
Drug Officials (AFDO) to formulate a Model Code of Practice for the 
Production of Fresh Fruits and Vegetables (the Model Code) (Ref. 20). 
This work grew out of a request from the tomato industry in late 2006 
to address outbreaks of foodborne illness attributed to fresh tomatoes. 
However, the AFDO Board believed that it was also important to address 
GAPs in the production of a broader range of fresh fruits and 
vegetables. Thus, AFDO convened a working group to develop a Model Code 
for produce safety during growing, harvesting, packing and holding that 
could be considered as a model for guidance and/or regulation by 
Federal and State regulatory bodies, and for collaboration among such 
parties and the industry. The Model Code does not address the 
additional processing steps that may occur at a fresh-cut or other 
processing facility, which is covered by the CGMPs in 21 CFR part 110. 
The Model Code focuses on minimizing the potential for contamination of 
fresh produce with pathogens.
    Through cooperative agreement with Cornell University, FDA has, 
together with USDA AMS, established a jointly funded Produce Safety 
Alliance (PSA), based on the successful Seafood HACCP Alliance for 
Training and Education. The PSA is a public-private partnership that 
will develop and disseminate science- and risk-based training and 
education programs to provide produce farms with fundamental food 
safety knowledge, starting in advance of this proposed rule and 
continuing after the final rule is promulgated. The PSA includes active 
participation from the produce industry and academic institutions 
nationwide. The curriculum development process has already started, 
through establishment of topic-specific working committees charged with 
identifying challenges to understanding and implementing GAPs on farms. 
This first phase of work, in advance of a final rule, is intended to 
assist farms, especially small farms, in establishing appropriate food 
safety measures, consistent with the GAPs Guide and other existing 
guidances, so that they will be better positioned when we issue a final 
rule establishing produce safety standards under section 419 of the 
FD&C Act. As this rulemaking progresses, the PSA materials will be 
modified, as needed, to be consistent with the requirements in the 
rule.

[[Page 3512]]

2. Foodborne Illness Investigations--Environmental Assessment Model
    An ``environmental assessment,'' in the foodborne illness outbreak 
or food contamination setting, means an investigation that is triggered 
by an outbreak of foodborne illness or food contamination incident with 
the purpose of determining how the environment may have contributed to 
the introduction or transmission of pathogens or other hazards that 
caused illness or contamination. In addition to our more traditional 
investigational team approach, during this process we work 
collaboratively with a number of experts from CDC, State and local 
agencies, and industry.
    In 2010, we conducted an environmental assessment in response to a 
foodborne illness outbreak involving 33 cases of STEC O145 infection in 
5 States. While we have not made a definitive determination regarding 
how or at what point in the supply chain E. coli O145 contamination 
occurred, this assessment was important in a number of respects. As 
mentioned above, we worked collaboratively with a number of experts 
from CDC, State and local agencies, and industry. Working with this 
team, we assessed potential sources of E. coli O145 not just in the 
field of interest, but in the larger growing area surrounding the field 
of interest, along with the potential for E. coli O145 to be 
transported from a source in the surrounding area to the field where 
implicated lettuce was grown. This highly collaborative, systems-based 
approach allowed for the discovery of important environmental risk 
factors that would not typically be explored by conventional 
investigation methods (Ref. 21). On December 29, 2010, we posted a 
report, entitled ``Environmental Assessment: Non-O157 Shiga Toxin-
Producing E. coli (STEC): Findings and Potential Preventive Control 
Strategies'' (Ref. 21), outlining the environmental assessment approach 
used in this investigation, our observations and tentative conclusions.
    In 2011, we conducted an environmental assessment in response to a 
foodborne illness outbreak involving a total of 139 persons infected 
with any of four outbreak-associated strains of L. monocytogenes, 
including 29 deaths, in 28 States (as of November 1, 2011). On October 
19, 2011, we posted a report, entitled ``Environmental Assessment: 
Factors Potentially Contributing to the Contamination of Fresh Whole 
Cantaloupe Implicated in a Multi-State Outbreak of Listeriosis,'' 
providing an overview of the assessment process, potential contributing 
factors in this outbreak, and recommended measures firms should employ 
to prevent similar contamination (http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm276247.htm). As discussed further in sections III.F 
and V.A.2.b.i of this document, this proposed rule would not apply to 
off-farm packing facilities such as the packing facility associated 
with this cantaloupe outbreak--such facilities would instead be subject 
to existing part 110 and section 418 of the FD&C Act. However, we 
include the findings of this environmental assessment here because the 
contributing factors are relevant to both on-farm and off-farm produce 
packing practices.
3. Produce Safety Initiative Assessments
    In August 2006 we launched the Leafy Greens Safety Initiative 
(LGSI), a multi-year initiative which involved assessments of practices 
and conditions at select leafy greens farms and facilities in 
California (Ref. 22). In the summer of 2007, we began a multi-year 
Tomato Safety Initiative (TSI) to assess practices and conditions 
associated with growing and packing tomatoes on the Eastern Shore of 
Virginia, followed by assessments in three tomato growing areas in 
Florida (Ref. 23).
    The initiatives were conducted as part of a strategy to reduce 
foodborne illness by focusing food safety efforts on specific products, 
practices, and growing areas that have been identified in past outbreak 
investigations. The initiatives were a collaborative effort between FDA 
and the State health and agriculture departments in California, 
Virginia, and Florida, in cooperation with several universities and 
members of the produce industry. Both initiatives contained several 
important components, the most visible of which was a series of 
assignments to the field to assess conditions and practices at farms 
and packing houses that could lead to contamination and to observe 
actions taken by growers and packers in response to these conditions. 
Other important components of the initiatives included continuing 
communication and outreach with the industry at all points along the 
supply chain, facilitating and promoting research to enhance leafy 
green and tomato safety, and strengthening collaboration between 
Federal, State, and local public health officials in disease detection 
and response.
    Assessments of tomato packing facilities covered dump tank water 
quality parameters, employee hygiene, and facility cleaning and 
sanitation practices. Assessments of the farms addressed irrigation 
water sources (such as ponds and wells), source water and procedures 
for mixing crop chemicals, the potential impacts of weather events, 
such as drought and flooding, and animal proximity to growing fields. 
Assessments were scheduled to coincide with tomato production and 
harvest seasons on the Eastern Shore of Virginia and in three tomato 
producing regions in Florida.
    Where the teams observed conditions or practices at one or more 
locations that might be improved, they shared those observations 
directly with the individual firm and also shared observations in 
general terms at a post-assessment meeting so that all interested 
parties could apply the findings to their operations. For example, we 
identified issues related to proximity of portable toilets to 
irrigating ponds and harvesting of drops at one or more locations. The 
teams recommended that portable toilets should be distanced from the 
irrigation pond and policies that forbid the harvesting of drops should 
be strictly enforced. We also shared preliminary observations through 
other venues, including a tomato research priorities meeting in College 
Park (hosted by Joint Institute for Food Safety and Applied Nutrition 
(JIFSAN) and the University of Florida's Institute of Food and 
Agricultural Sciences) (JIFSAN 2010 (update)), a Leafy Greens Research 
Needs workshop hosted by United Fresh in Herndon, VA (United Fresh 
2008), and as technical assistance to public and private efforts to 
develop new or enhanced guidances.
4. Research
    FDA researchers have focused on refining or developing methods to 
detect, isolate and subtype pathogens of concern in produce, to enhance 
our ability to analyze samples in support of our compliance activities. 
As resources permit, FDA scientists also directly investigate questions 
about factors contributing to produce contamination. We also supported 
extramural research and collaborations with other Federal agencies, 
academic institutions, and industry-supported entities to leverage 
research efforts, expertise, and resources (such as experimental 
stations for field research). This includes successful collaborations 
with USDA on research of mutual interest. To fill knowledge gaps, thus 
facilitating implementation of any new policies, we have initiated new 
agreements with USDA to conduct research in key areas such as 
agricultural water and soil amendments (Ref. 24). Specifically, FDA has 
provided approximately one million dollars to sponsor research at USDA

[[Page 3513]]

ARS and to develop a produce safety rule research network at the 
Western Center for Food Safety at University of California Davis. We 
intend these collaborative efforts to result in the collection of data 
that may help resolve questions about the necessary time between 
application of raw manure or contaminated water and safe harvest of 
produce in key agro-ecological growing conditions and for key crops. 
Our goal is for this research to result in suggested protocols that 
farms could follow in compliance with a final produce rule, and for 
this process to be duplicated for other crops and regions as further 
funding is secured. This FDA sponsored research was initiated to 
demonstrate the commitment of federal agencies to address the needs of 
farmers, to provide initial data to finalize study protocols for 
further research, and to attract matching funds from industry.
    In partnership with academic institutions across the country, FDA 
has also created four Centers of Excellence (CoE), each housed at a 
university and charged with specific food-safety tasks (Ref. 25). In 
2008, a 5-year cooperative agreement was awarded to the University of 
California, Davis (UC Davis) to establish the most recent of these 
CoEs, the Western Center for Food Safety (WCFS). Through this 
agreement, FDA has been able to leverage the resources and expertise of 
UC Davis to study the impact of the unique geography and ecology of the 
growing regions of the Western United States.
5. Engagement With Other Federal Agencies
    FDA regularly consults and coordinates with other Federal agencies 
in the area of produce safety. Examples of these efforts can be found 
throughout this document and include collecting samples, sharing data, 
providing training and technical assistance to industry, and research. 
Our partnerships with USDA and CDC have been particularly valuable to 
our efforts.
6. Engagement with Industry and Academia
    We regularly engage with experts in the produce industry and in 
academia. These engagements serve to both educate the industry about 
our thinking, activities, and expectations, and to educate us about 
current industry practices and academic efforts to enhance the safety 
of produce.
    In addition to the collaborations mentioned above, we initiated 
multiple produce industry listening sessions across the country prior 
to the passage of FSMA. At these sessions, we provided local industry 
and academia an opportunity to ask questions and voice concerns about 
the potential for legislation impacting the produce industry. We 
visited a total of 13 States with significant produce production in 
2010. FDA and USDA technical experts, scientists and managers 
participated in these meetings, and we were able to tour large and 
smaller scale farms, and talk to people with practical experience in 
production and implementing food safety programs on farms.
    We also were involved with the Produce Safety Project (PSP), a 
research and advocacy organization based at Georgetown University and 
funded by the Pew Charitable Trust. The PSP provided four issue briefs 
(Ref. 26.Ref. 27.Ref. 28.Ref. 29) each focused on specific aspects of 
produce production, the risks they may represent, prevention and 
mitigation strategies to address these risks, and further research 
needs in the area. Further, PSP held 6 regional stakeholder discussion 
sessions to elicit comment and reaction from the produce industry, and 
to offer an avenue to speak directly to the documents' authors. A 
common message from the industry during these discussions was concern 
about food safety and a desire to know how to reduce risks. Small 
growers and packers in particular conveyed a need for information and 
technical support that would assist them in implementing food safety 
practices.

E. Current Industry Practices

    In response to foodborne illnesses associated with produce in the 
mid 1990s, the produce industry developed produce safety guidance, 
engaged in outreach regarding produce safety best practices, developed 
compliance auditing programs, and funded produce safety research.
1. Industry Produce Safety Best Practices Guidance
    In 1997, the International Fresh-cut Produce Association and the 
Western Growers Association published Voluntary Food Safety Guidelines 
for Fresh Produce, which provided generalized voluntary industry 
guidelines to minimize the potential for contamination for fresh 
produce in growing, packing, shipping and processing operations. After 
FDA issued our GAPs Guide, industry developed commodity specific 
guidances for various produce industry segments including: Commodity 
Specific Food Safety Guidelines for the Melon Supply Chain (2005), 
Commodity Specific Food Safety Guidelines for the Lettuce and Leafy 
Greens Supply Chain (2006), Commodity Specific Food Safety Guidelines 
for the Fresh Tomato Supply Chain (2006 1st Edition, 2008 2nd edition) 
and Commodity Specific Food Safety Guidelines for the Production, 
Harvest, Post-Harvest, and Valued-Added Unit Operations of Green Onions 
(2010). In addition, other industry segments including, but not limited 
to mushrooms, strawberries, watermelons, citrus, avocados, almonds, and 
dry bulb onions developed commodity specific guidances. The fresh-cut 
produce industry, via the International Fresh Produce Association, 
published in 1992 Food Safety Guidelines for the Fresh-cut Produce 
Industry and updated this publication periodically, with the 4th 
edition being published most recently in 2001.
2. Produce Industry Food Safety Compliance Auditing
    Shortly after the FDA GAPs Guide was finalized, a number of retail 
produce buyers informed suppliers that as a condition of sale, their 
produce suppliers must follow, and be third party audited for 
conformance with, the FDA GAPs guide (Ref. 30). In 1999 USDA AMS began 
developing a GAPs and Good Handling Practices (GAP & GHP) Audit 
Verification Program, in response to requests from growers and the 
Association of Fruit and Vegetable Inspection and Standardization 
Agencies. The program, based on the GAPs Guide, was piloted in 2000 and 
fully available later that same year. In September 2001 the United 
Fresh Fruit and Vegetable Association published guidance entitled Food 
Safety Auditing Guidelines: Core Elements of Good Agricultural 
Practices for Fresh Fruits and Vegetables to provide the basis for GAPs 
audits in the produce industry. In 2011 the United Fresh Produce 
Association published a Harmonized GAPs Standard for use by producers 
and third party auditors in the fresh produce industry.
    In 2007 leafy greens growers in California, with the assistance of 
the USDA AMS and CDFA, developed and implemented the California Leafy 
Greens Marketing Agreement (CA LGMA) (Ref. 31). The objective of the CA 
LGMA is to protect public health via compliance with the food safety 
practices accepted by the LGMA board, verified through mandatory 
government audits of members and signatories to the agreement by CDFA 
auditors trained and licensed by USDA AMS (Ref. 31). In 2007 leafy 
greens growers in Arizona also adopted a similar marketing agreement 
and audit structure for their growers (Ref. 32). At the request of 
industry, the USDA AMS in 2009 held seven hearings throughout the 
United

[[Page 3514]]

States to solicit input from the leafy greens industries across the 
U.S. regarding their desire to develop a proposed national marketing 
agreement for leafy greens (74 FR 45565). A decision regarding the 
proposed USDA AMS national marketing agreement for leafy greens is 
currently pending.
    In 2007, the Florida Legislature passed a law that provided the 
Department of Agriculture and Consumer Services with the authority to 
address safety concerns related to fresh tomatoes. Implementing 
regulations which became effective on July 1, 2008 (Florida Tomato 
Inspection Regulation 5G-6, 2007) adopted and incorporated by reference 
almost all of the recommendations in the Commodity Specific Food Safety 
Guidelines for the Fresh Tomato Supply Chain, 2nd Edition (July 2008).
    GAPs implementation and GAPs audits have now become common 
components of purchase specifications for produce in some market 
segments, and have been a significant force in increasing awareness of 
GAPs and promoting their implementation (Ref. 33). However, growers and 
packers who sell product through direct marketing channels, or to 
buyers who do not include GAPs as a condition of sale, may be less 
familiar with GAPs.
3. Produce Industry Produce Safety Education Outreach
    In addition to participation in the PSA housed at Cornell 
University (discussed above in section II.D. of this document), the 
produce industry promoted adoption and implementation of the 
recommendations in the FDA GAPs Guide through education and outreach 
efforts in cooperation with the land grant universities. The National 
GAPs Program at Cornell University, with collaborators at other land 
grant universities, developed a series of publications to train 
domestic growers and packers on the key principles of produce safety, 
including: Food Safety Begins on the Farm: A Grower's Guide (2000); 
Food Safety Begins on the Farm: A Grower Self Assessment of Food Safety 
Risks (2003); and, Fruits, Vegetables, and Food Safety: Health and 
Hygiene on the Farm (2004). These publications and others developed by 
land grant universities throughout the United States have been used to 
train the produce industry on produce safety best practices.

F. 2010 Federal Register Notice and Preliminary Stakeholder Comments

    On February 23, 2010, we published in the Federal Register (75 FR 
8086; 2010 FR notice) a notice opening a docket to obtain information 
about current practices and conditions for the production and packing 
of fresh produce. On May 20, 2010, we extended the original 90-day 
comment period for the docket until July 23, 2010 (75 FR 28263). We 
established this docket to provide an opportunity for interested 
parties to provide information and share views that would inform the 
development of (1) safety standards for fresh produce at the farm and 
packing house and (2) strategies and cooperative efforts to ensure 
compliance.
    In particular, we welcomed input on these general categories: (1) 
Role of the good agricultural practice recommendations in the GAPs 
Guide; (2) Standards for domestic and foreign growers and packers; (3) 
Identification and prioritization of risk factors; (4) Environmental 
assessment of hazards and possible pathways of contamination; (5) The 
impact of scale/size of growing operations on the nature and degree of 
possible food safety hazards; (6) Methods to tailor preventive controls 
to particular hazards and conditions affecting an operation; (7) 
Possible approaches to tailoring preventive controls to the scale of an 
operation so that the controls achieve an appropriate level of food 
safety protection and are feasible for a wide range of large and small 
operations; (8) Coordination of produce food safety practices and 
sustainable and/or organic production methods; (9) Coordination of 
produce food safety practices and environmental and/or conservation 
goals or practices; (10) Coordination of produce food safety practices 
and Federal, state, local and tribal government statutes and 
regulations; (11) Microbial testing; (12) Postharvest operations and 
the role of the CGMPs in 21 CFR part 110; (13) Records and other 
documentation that would be useful to industry and regulators in 
ensuring the safety of fresh produce; and (14) Strategies to enhance 
compliance.
    We further advised that information previously submitted to the 
dockets requesting comments on the draft commodity-specific guidances 
(CSGs), or to the docket requesting comments and scientific data and 
information to update the GAPs Guide, would be considered in this 
rulemaking and need not be resubmitted. Comments submitted to these 
dockets, i.e., dockets on the GAPs Guide update and draft CSGs, as well 
as comments at the Sprouts Public Meeting and Produce Safety Hearings, 
are discussed in sections II.B. and II.D. of this document.
    In response to the 2010 FR notice, we received about 880 comments 
from consumers, farmers and producers, industry groups and trade 
associations, consumer groups, environmental groups, academia, retail 
establishments, packers and handlers, food markets and coops, 
laboratories and public health facilities, and federal, state, local 
and foreign governments. The USDA Agricultural Marketing Service (AMS) 
submitted a record of their public hearings related to their proposed 
voluntary national marketing agreement for leafy green vegetables 
(NLGMA) (74 FR 45565, September 3, 2009 and 74 FR 48423, September 23, 
2009), and requested that we consider the contents of that record 
(which included testimony, exhibits, and written arguments or briefs 
based on evidence received at the public hearing) in our deliberations 
to develop safety standards for fresh produce. A summary of general 
comments received is presented in this section while specific comments 
relevant to the issues addressed in this proposed rule are discussed in 
sections V.C through V.R of this document.
1. Comments on Impact, Flexibility and Transparency
    Overall, a majority of stakeholders, including farmers, producers, 
consumers and industry, expressed concern about the scope and impact of 
regulation on the livelihoods of those who produce food and on their 
ability to produce food in an economically-feasible manner. Most 
comments supported a food safety system, grounded in science, for the 
production of produce in a fair and equitable manner for both domestic 
and imports. Comments noted that regulations developed should be 
science-based and provide for producers to manage risks in a manner 
appropriate to their operations. Several comments maintained that risk 
assessments, hazard assessments, operational assessments and 
development of food safety plans are vital tools for farmers to be able 
to demonstrate that the food safety practices they employ are 
effective. Conversely, others questioned the need for some industry 
segments, such as small farms or growers of ``low risk'' commodities to 
establish food safety plans. A majority of comments also stated that 
research is needed on various issues relevant to produce safety, 
including water quality, soil amendments, animals (both wildlife and 
domesticated), and worker health and hygiene. Comments urged the agency 
to tailor regulations to reflect variables such as farm size, markets 
served, growing conditions, and risk. In addition, comments highlighted 
the importance of transparency in the

[[Page 3515]]

development and implementation of food safety standards, and expressed 
that transparency provides regulators, buyers, and the public with the 
confidence they need to ensure that all reasonable and required 
practices have been put in place and that any specific producer or 
packer of produce is in compliance with required food safety practices. 
FSMA directs us to establish science-based minimum standards for 
produce safety. These standards are to include procedures, processes, 
and practices that we determine to be reasonably necessary to prevent 
the introduction of known or reasonably foreseeable biological, 
chemical, and physical hazards into covered produce and to provide 
reasonable assurances that produce is not adulterated under section 402 
of the FD&C Act. As discussed in section IV below, FDA intends to adopt 
a regulatory approach that considers the risk posed by both the 
commodity and relevant agronomic practices, and provides the most 
appropriate balance between public health protection and flexibility. 
We recognize the need to incorporate appropriate flexibility within 
regulations to reflect the diversity of commodities and associated 
processes, practices, and conditions covered within the scope of this 
rule. For example, exemptions based on monetary value of food sold by 
the farm and direct farm marketing, commercial processing of 
commodities, and other criteria are reflected in proposed subpart A. 
Under certain specified conditions, qualified exemptions and associated 
modified requirements in a calendar year are also provided under 
proposed subpart A. In addition, proposed Sec.  112.12 would establish 
a framework for alternatives to certain requirements of the rule. We 
realize that numerous differences exist among practices based on risk 
or agro-ecological conditions and therefore alternatives to certain 
requirements would be permitted when adequate and documented scientific 
data or information support such alternatives. Similarly, proposed 
subpart P sets procedures for a State or foreign country to request a 
variance from one or more requirements of this part when certain 
conditions are met, as required by Section 419(c)(2) of the FD&C Act. 
For example, a State or foreign country may consider that the 
historical performance of an industry within their jurisdiction (e.g., 
as indicated by the epidemiological record) and the combination of 
measures taken by that industry merits requesting a variance from some 
or all provisions of this proposed rule. In requesting a variance, 
among other things, the State or foreign country would submit 
information that, while the procedures, processes and practices to be 
followed under the variance would be different from those prescribed in 
this proposed rule, the requested variance is reasonably likely to 
ensure that the produce is not adulterated under section 402 of the 
FD&C Act and provide the same level of public health protection as the 
requirements of the final regulations (see proposed 112.173). FDA would 
encourage consideration of these kinds of submissions.
    Furthermore, in addition to soliciting comments on the proposed 
regulation through this notice, we will be holding public meetings in 
diverse geographic areas of the United States to provide persons in 
different regions an opportunity to comment, as required under Section 
419(a)(2) of the FD&C Act.
2. Comments on Environmental Considerations
    Several comments pointed out that there are a number of state and 
federal laws and programs that relate to environmental stewardship, and 
noted that environmental conservation and food safety are not 
necessarily cross-competing goals. Comments favored a uniform 
regulatory approach among Federal, State, local and tribal governments' 
statutes and regulations, and recommended that we consider the work of 
other Federal agencies, including the Environmental Protection Agency, 
the Department of Agriculture, and the Department of the Interior in 
developing proposed requirements for produce to ensure such 
requirements do not unnecessarily inhibit co-management of food safety 
and environmental concerns. In this regard, a few comments stated that 
while co-management of food safety and sustainability may be 
considered, ultimately, food safety has to be top priority and it is 
unacceptable to sell unsafe food to customers.
    Section 419(a)(3)(D) of the FD&C Act directs that this proposed 
rule take into consideration, consistent with ensuring enforceable 
public health protection, conservation and environmental practice 
standards and policies established by Federal natural resource 
conservation, wildlife conservation, and environmental agencies. As 
discussed further in Sections III.A.8 and V.I, we consulted with 
several Federal agencies in order to take into consideration 
conservation and environmental practice standards and policies 
established by those agencies. FDA also plans to work closely with 
Federal, State, and local agencies in implementing the final rule.
3. Comments on Guidance and Education
    A majority of comments also expressed the need for guidance to 
assist stakeholders in implementing the requirements established in 
final regulations. Moreover, several comments stressed the importance 
of educational programs and incentives in any effective food safety 
system.
    Section 419(e) of the FD&C Act requires FDA to publish updated good 
agricultural practices and guidance for the safe production and 
harvesting of specific types of fresh produce, in consultation with the 
Secretary of Agriculture, representatives of State departments of 
agriculture, farmer representatives, and various types of entities 
engaged in the production and harvesting or importing of fruits and 
vegetables that are raw agricultural commodities, including small 
businesses. In addition, section 419(e) of the FD&C Act requires FDA to 
conduct education and outreach regarding this guidance through public 
meetings in diverse geographical regions. FDA intends to provide ample 
opportunity for public consultation and input and will strive to 
develop stronger partnerships with the private sector to ensure optimal 
use of resources.
4. Comments Related to Foreign Producers
    A number of foreign governments expressed concerns with the foreign 
producers' ability to comply with and FDA's enforcement of the 
regulation, stressing the need for transparency. Some comments 
requested we consider convergence with existing private schemes, such 
as the Global Food Safety Initiative and Global G.A.P to avoid 
duplication of efforts while others urged us to consider recognition of 
foreign governments' produce safety initiatives.
    In implementing a final rule based on this proposed rule, we intend 
to provide equal treatment in the application, compliance, and 
enforcement of the proposed standards for foreign and domestic 
facilities. Recognizing that foreign farms in some countries may have 
difficulty in understanding the rule's applicability to them, we will 
partner with stakeholders to identify areas for outreach and technical 
cooperation to achieve greater understanding of the proposed 
provisions.
    Furthermore, consistent with section 419(c)(2) of the FD&C Act, in 
proposed subpart P, we establish a procedure

[[Page 3516]]

whereby a State or foreign country could request a variance from one or 
more requirements proposed in the rule, where the State or foreign 
country determines that (1) the variance is necessary in light of local 
growing conditions; and (2) the procedures, processes, and practices to 
be followed under the variance are reasonably likely to ensure that the 
produce is not adulterated under section 402 of the FD&C Act, and to 
provide the same level of public health protection as the requirements 
of this rule (see section V.P. of this document).

G. White House Food Safety Working Group

    In 2009, President Obama established a White House Food Safety 
Working Group to identify measures needed to upgrade our food safety 
laws for the 21st Century, coordinate Federal efforts, and develop 
short- and long-term agendas to make food safer. Specific objectives of 
this workgroup included: Fostering coordination of food safety efforts 
throughout the government and ensuring laws are being adequately 
enforced to keep the American people safe from foodborne illness. The 
workgroup was co-chaired by the Secretaries of the HHS and USDA. 
Participating agencies included FDA, USDA's Food Safety and Inspection 
Service (FSIS), CDC, the Department of Homeland Security, the 
Department of Commerce, the Department of State, EPA, and several 
offices of the White House.
    On July 7, 2009, the workgroup released its report ``Implementing a 
National Public Health Approach to Food Safety: Report to the 
President.'' This report included recommendations for a new public 
health-focused approach to the safety of all food based on three core 
principles: (1) Prioritizing prevention, (2) strengthening surveillance 
and enforcement, and (3) improving response and recovery. Workgroup 
recommendations and White House directives specific to produce included 
(1) issuing commodity-specific guidances to reduce the likelihood of 
microbial contamination in the production and distribution of tomatoes, 
melons, and leafy greens; and (2) taking steps (including seeking 
public comment) to establish required practices through regulation. The 
numerous steps we have taken in response to these directives are 
described throughout this section.

H. Other Related Issues

1. Tracking and Tracing of Produce
    Our regulations in 21 CFR part 1, subpart J require that persons 
who manufacture, process, pack, transport, distribute, receive, hold, 
or import food in the United States establish and maintain records 
identifying the immediate previous sources and immediate subsequent 
recipients of food. During an outbreak of foodborne illness, these 
records can help determine the source of the food implicated in the 
outbreak. Farms are excluded from the requirements of part 1, subpart 
J. We recently held public meetings to stimulate and focus a discussion 
about mechanisms to enhance product tracing systems for food in general 
(74 FR 56843; November 3, 2009) and for produce in particular (73 FR 
55115; September 24, 2008). Section 204 of FSMA now directs us to take 
a variety of different actions that will enhance our ability to track 
and trace foods, including to establish pilot projects to explore and 
evaluate methods to rapidly and effectively identify recipients of food 
to prevent or control a foodborne illness outbreak. Further efforts to 
enhance the tracking and tracing of food are outside of the scope of 
this proposed rule.
2. Transportation of Food
    On April 30, 2010 (75 FR 22713), we published in the Federal 
Register an Advance Notice of Proposed Rulemaking (ANPRM) as a first 
step in implementing the Sanitary Food Transportation Act of 2005 
(SFTA). SFTA requires the Secretary of HHS to issue regulations setting 
forth sanitary transportation practices to be followed by shippers, 
carriers by motor vehicle or rail vehicle, receivers, and others 
engaged in food transport. Section 111 of FSMA directs us to promulgate 
regulations to implement SFTA. We intend to focus our efforts directed 
to sanitary transportation practices as a separate rulemaking, already 
underway under the ANPRM. However, such efforts are outside of the 
scope of this proposed rule.

III. Legal Authority

    FDA is proposing this regulation under the FD&C Act as amended by 
FSMA, and the Public Health Service Act (PHS Act).

A. Section 105 of FSMA and Section 419 of the FD&C Act

    On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) 
(Pub. L. 111-353) was signed into law. Section 105 of FSMA, Standards 
for Produce Safety, among other things, amends the FD&C Act to create a 
new section 419 with the same name.
    Section 419(a)(1)(A) of the FD&C Act directs the Secretary of HHS, 
``in coordination with the Secretary of Agriculture and representatives 
of State departments of agriculture (including with regard to the 
national organic program established under the Organic Foods Production 
Act of 1990), and in consultation with the Secretary of Homeland 
Security,'' to ``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.'' In 
addition to this broad direction in section 419(a)(1)(A), section 
419(a)(3) establishes more specific requirements for the content of the 
proposed rule, including that the proposed rule:
     ``[P]rovide sufficient flexibility to be applicable to 
various types of entities engaged in the production and harvesting of 
fruits and vegetables that are raw agricultural commodities, including 
small businesses and entities that sell directly to consumers, and be 
appropriate to the scale and diversity of the production and harvesting 
of such commodities'' (section 419(a)(3)(A));
     ``[I]nclude, with respect to growing, harvesting, sorting, 
packing, and storage operations, science-based minimum standards 
related to soil amendments, hygiene, packaging, temperature controls, 
animals in the growing area, and water'' (section 419(a)(3)(B));
     ``[C]onsider hazards that occur naturally, may be 
unintentionally introduced, or may be intentionally introduced, 
including by acts of terrorism'' (section 419(a)(3)(C));
     ``[T]ake into consideration, consistent with ensuring 
enforceable public health protection, conservation and environmental 
practice standards and policies established by Federal natural resource 
conservation, wildlife conservation, and environmental agencies'' 
(section 419(a)(3)(D));
     ``[I]n the case of production that is certified organic, 
not include any requirements that conflict with or duplicate the 
requirements of the national organic program established under the 
Organic Foods Production Act of 1990, while providing the same level of 
public health protection as the requirements under guidance documents, 
including guidance

[[Page 3517]]

documents regarding action levels, and regulations under the FDA Food 
Safety Modernization Act'' (section 419(a)(3)(E)); and
     ``[D]efine, for purposes of [section 419], the terms 
`small business' and `very small business''' (section 419(a)(3)(F)).

Furthermore, section 419(b) of the FD&C Act establishes additional 
requirements that the final regulation:
     ``[P]rovide for minimum science-based standards for those 
types of fruits and vegetables, including specific mixes or categories 
of fruits and vegetables, that are raw agricultural commodities, based 
on known safety risks, which may include a history of foodborne illness 
outbreaks'' (section 419(b)(1));
     ``[P]rovide for coordination of education and enforcement 
activities by State and local officials, as designated by the Governors 
of the respective States or the appropriate elected State official as 
recognized by State statute'' (section 419(b)(2)(A)); and
     ``[I]nclude a description of the variance process under 
[section 419(c)] and the types of permissible variances the Secretary 
may grant'' (section 419(b)(2)(B)).

In section 419(c), the FD&C Act establishes criteria for the final 
regulation, including that the final regulation:
     ``[S]et forth those procedures, processes, and practices 
that the Secretary determines to minimize the risk of serious adverse 
health consequences or death, including procedures, processes, and 
practices that the Secretary determines to be reasonably necessary to 
prevent the introduction of known or reasonably foreseeable biological, 
chemical, and physical hazards, including hazards that occur naturally, 
may be unintentionally introduced, or may be intentionally introduced, 
including by acts of terrorism, into fruits and vegetables, including 
specific mixes or categories of fruits and vegetables, that are raw 
agricultural commodities and to provide reasonable assurances that the 
produce is not adulterated under section 402'' (section 419(c)(1)(A));
     ``[P]rovide sufficient flexibility to be practicable for 
all sizes and types of businesses, including small businesses such as a 
small food processing facility co-located on a farm'' (section 
419(c)(1)(B));
     ``[C]omply with chapter 35 of title 44, United States Code 
(commonly known as the `Paperwork Reduction Act'), with special 
attention to minimizing the burden (as defined in section 3502(2) of 
such Act) on the business, and collection of information (as defined in 
section 3502(3) of such Act), associated with such regulations'' 
(section 419(c)(1)(C));
     ``[A]cknowledge differences in risk and minimize, as 
appropriate, the number of separate standards that apply to separate 
foods'' (section 419(c)(1)(D));
     ``[N]ot require a business to hire a consultant or other 
third party to identify, implement, certify, compliance with these 
procedures, processes, and practices, except in the case of negotiated 
enforcement resolutions that may require such a consultant or third 
party'' (section 419(c)(1)(E);
     ``[P]ermit States and foreign countries from which food is 
imported into the United States to request from the Secretary variances 
from the requirements of the regulations, subject to [section 419(c)(2) 
of the FD&C Act], where the State or foreign country determines that 
the variance is necessary in light of local growing conditions and that 
the procedures, processes, and practices to be followed under the 
variance are reasonably likely to ensure that the produce is not 
adulterated under section 402 [of the FD&C Act] and to provide the same 
level of public health protection as the requirements of the 
regulations adopted under [section 419(b) of the FD&C Act]'' (section 
419(c)(1)(F)); and
     Establish requirements relating to variances, including 
that:
    [cir] ``A State or foreign country from which food is imported into 
the United States may in writing request a variance from the Secretary. 
Such request shall describe the variance requested and present 
information demonstrating that the variance does not increase the 
likelihood that the food for which the variance is requested will be 
adulterated under section 402, and that the variance provides the same 
level of public health protection as the requirements of the 
regulations adopted under [section 419(b) of the FD&C Act]. The 
Secretary shall review such requests in a reasonable timeframe'' 
(section 419(c)(2)(A)).
    [cir] ``The Secretary may approve a variance in whole or in part, 
as appropriate, and may specify the scope of applicability of a 
variance to other similarly situated persons'' (section 419(c)(2)(B)).
    [cir] ``The Secretary may deny a variance request if the Secretary 
determines that such variance is not reasonably likely to ensure that 
the food is not adulterated under section 402 and is not reasonably 
likely to provide the same level of public health protection as the 
requirements of the regulation adopted under [section 419(b) of the 
FD&C Act]. The Secretary shall notify the person requesting such 
variance of the reasons for the denial'' (section 419(c)(2)(C)).
    [cir] ``The Secretary, after notice and an opportunity for a 
hearing, may modify or revoke a variance if the Secretary determines 
that such variance is not reasonably likely to ensure that the food is 
not adulterated under section 402 and is not reasonably likely to 
provide the same level of public health protection as the requirements 
of the regulations adopted under [section 419(b) of the FD&C Act]'' 
(section 419(c)(2)(D)).
    In addition, section 105(c) of FSMA creates a new section 301(vv) 
in the FD&C Act (21 U.S.C. 331(vv)) to prohibit ``[t]he failure to 
comply with the requirements under section 419 [of the FD&C Act].''
1. Coordination and Consultation Requirements
    Consistent with section 419(a)(1)(A) of the FD&C Act, FDA has 
coordinated with the Secretary of Agriculture and representatives of 
State departments of agriculture (Ref. 34. Ref. 35) and consulted with 
the Secretary of Homeland Security regarding this proposed rule.
2. Definitions of Small and Very Small Businesses
    Section 419(a)(3)(F) of the FD&C Act requires that the regulations 
define the terms ``small business'' and ``very small business.'' These 
terms are significant because section 419 of FSMA contains provisions 
specific to such entities.

     ``With respect to small and very small businesses* * * 
that produce and harvest those types of fruits and vegetables that 
are raw agricultural commodities that the Secretary has determined 
are low risk and do not present a risk of serious adverse health 
consequences or death, the Secretary may determine not to include 
production and harvesting of such fruits and vegetables in such 
rulemaking, or may modify the applicable requirements of regulations 
promulgated pursuant to [section 419]'' (section 419(a)(1)(B) of the 
FD&C Act).
     ``[T]he regulations promulgated under [section 419 of 
the FD&C Act] shall apply to a small business* * * after the date 
that is 1 year after the effective date of the final regulation* * * 
[and] to a very small business* * * after the date that is 2 years 
after the effective date of the final regulation'' (section 
419(b)(3) of the FD&C Act).

    In section V.A. of this document, we discuss our proposed 
definitions of small and very small business. In section IV.K. of this 
document, we discuss our proposal to establish compliance dates for 
small and very small businesses that are three and four years, 
respectively, after the effective

[[Page 3518]]

date of the final regulation, with additional, more extended compliance 
dates for certain proposed provisions related to water. FDA has 
tentatively decided not to exempt or modify the requirements of the 
proposed rule with respect to small and very small businesses that 
produce and harvest certain types of produce based on a determination 
that such types of produce are low risk and do not present a risk of 
serious adverse health consequences or death using the discretionary 
authority provided by section 419(a)(1)(B). It is not necessary to use 
this discretionary authority in part because, as discussed in section 
V.A. of this document, FDA proposes in Sec.  112.2 to exclude certain 
types of low risk produce from the coverage of this rule without regard 
to the business size of the farm producing and harvesting such produce. 
As discussed in section IV.C.2. of this document, these exclusions are 
based on our tentative conclusion that science-based minimum standards 
to minimize the risk of serious adverse health consequences or death 
from biological hazards in these commodities are not warranted. Another 
reason it is not necessary to use the discretionary authority in 
section 419(a)(1)(B) is because, as discussed in section V.A. of this 
document, FDA proposes in Sec.  112.4 to apply this regulation only to 
businesses with an average annual monetary value of food sold during 
the previous three-year period of more than $25,000 on a rolling basis, 
based on a tentative conclusion that businesses with $25,000 or less in 
sales do not contribute significantly to the produce market (1.5% of 
covered produce acres) and, therefore, to the volume of production that 
could become contaminated. Accordingly, we tentatively conclude that 
imposing the proposed requirements on these businesses is not warranted 
because it would have little measurable public health impact. We note 
that such farms would continue to be subject to the applicable 
requirements of the FD&C Act.
3. Exemptions and Exceptions
    Section 419(f)(1) of the FD&C Act establishes an exemption from the 
requirements under section 419 based on average annual monetary value 
of the food sold directly to ``qualified end-users'' (as defined in 
section 419(f)(4)) as compared to all other buyers and average annual 
monetary value of all food sold. Section 419(f)(2) establishes 
requirements for consumer notifications with respect to food from 
exempt farms, and section 419(f)(3) provides that the Secretary may 
withdraw the exemption in specified circumstances. In sections V.A and 
V.R of this document, we discuss proposed Sec. Sec.  112.5 and 112.6, 
and subpart R, respectively, which would implement these provisions of 
the FD&C Act.
    Section 419(g) of the FD&C Act states ``[t]his section shall not 
apply to produce that is produced by an individual for personal 
consumption.'' In section V.A. of this document, we discuss proposed 
Sec.  112.2(a)(2), which would implement this provision.
    Section 419(h) of the FD&C Act states ``[t]his section shall not 
apply to activities of a facility that are subject to section 418.'' In 
sections III.F and V.A.2.b.i of this document we discuss proposed Sec.  
112.4(a), which would implement this provision.
4. Intentional Adulteration
    FDA proposes to implement section 105 of FSMA in two regulations, 
rather than a single regulation that covers all hazards relevant to 
produce. This rulemaking is not intended to address hazards ``that may 
be intentionally introduced, including by acts of terrorism.'' (Sec.  
419(a)(3)(C) and (c)(1)(A) of the FD&C Act). FDA plans to implement 
section 105 of FSMA regarding such hazards in a separate rulemaking in 
the future, and intends to consult with the Secretary of Homeland 
Security in that rulemaking, as required by Sec.  419(a)(1)(A) of the 
FD&C Act. FDA tentatively concludes that intentional hazards likely 
will require different kinds of controls and would be best addressed in 
a separate rulemaking.
5. Science-Based Minimum Standards Related to Specific Topics
    Consistent with the provisions in Section 419(a)(3)(B) of the FD&C 
Act that requires us to establish ``science-based minimum standards 
related to soil amendments, hygiene, packaging, temperature controls, 
animals in the growing area, and water,'' this proposed rule addresses 
specific topics relevant to production and harvesting of produce on 
farms. We address standards related to soil amendments in subpart F; 
standards for hygiene in subpart D, standards for animals in the 
growing area in subpart I; and standards for water in subpart E. We 
address packaging as part of our proposed standards for harvest, 
packing, and holding activities in subpart K; and temperature controls 
as part of our proposed standards for agricultural water in subpart E.
6. Providing Sufficient Flexibility To Be Practicable
    As required by section 419(a)(3)(A) and (c)(1)(B), this proposed 
rule would provide sufficient flexibility to be practicable for all 
sizes and types of entities engaged in the production and harvesting of 
fruits and vegetables that are raw agricultural commodities, including 
small businesses and entities that sell directly to consumers, and is 
appropriate to the scale and diversity of the production and harvesting 
of such commodities.
    As discussed in section IV of this document, we have chosen a 
regulatory approach that provides significant flexibility. We propose a 
variety of different types of measures (including GMP-type measures, 
numerical standards, requirements to monitor and take action under 
certain circumstances, and written plans) to tailor the requirements of 
the proposed rule appropriately and to be practical for the diversity 
of farms and commodities that would be covered by the proposed rule.
    Wherever possible, we have also attempted to fashion this 
regulation to be as flexible as possible to accommodate future changes 
in science and technology and the particularities of local growing 
conditions and commodities. As discussed in section V.B of this 
document, in proposed Sec.  112.12, we list the specific requirements 
established in this rule for which we would allow alternatives to be 
established and used in appropriate circumstances. This provision would 
provide significant flexibility by allowing individual farms to develop 
alternative standards suitable to their operations with appropriate 
scientific support. In addition, consistent with sections 419(c)(1)(F) 
and (c)(2) of the FD&C Act, in proposed subpart P, we provide for a 
mechanism by which a State or a foreign country from which food is 
imported into the United States may request a variance from one or more 
requirements proposed in this part, where the State or foreign country 
determines that: (a) The variance is necessary in light of local 
growing conditions; and (b) the procedures, processes, and practices to 
be followed under the variance are reasonably likely to ensure that the 
produce is not adulterated under Section 402 of the Act and to provide 
the same level of public health protection as the requirements of this 
part. Proposed subpart P would provide additional flexibility for 
alternative practices to be used where appropriate to specific local 
growing conditions and commodities.

[[Page 3519]]

7. Use of Third Parties
    In accordance with section 419(c)(1)(E) of the FD&C Act, we are not 
proposing to require a farm to hire a consultant or third party to 
identify, implement, certify, or comply with these produce safety 
standards. These standards are intended to be capable of implementation 
by those who engage in routine activities on the farm. As discussed in 
section II.D.1 and V.Q., FDA has, together with USDA AMS, established a 
jointly funded Produce Safety Alliance (PSA), a public-private 
partnership that will develop and disseminate science- and risk-based 
training and education programs to provide produce farms with 
fundamental food safety knowledge. Education and outreach through 
mechanisms like PSA and other sources of information that are familiar 
to the produce farming community (such as Cooperative Extension, land 
grant universities and trade associations) is the foundation of our 
intended compliance strategy. Through these mechanisms, FDA aims to 
assist farmers in gaining the food safety knowledge they will need to 
comply with the provisions of a final produce safety rule.
8. Consideration of Environmental Standards
    As required by section 419(a)(3)(D), in developing these produce 
safety standards and consistent with ensuring enforceable public health 
protection, we took into consideration conservation and environmental 
practice standards and policies established by Federal natural resource 
conservation, wildlife conservation, and environmental agencies. In 
developing this rule, we consulted with USDA's National Organic Program 
and Natural Resources Conservation Service, U.S. Fish and Wildlife 
Service, and the EPA to take into consideration conservation and 
environmental practice standards and policies established by those 
agencies (Ref. 34). Our proposed requirements encourage the application 
of practices that can enhance food safety, including sustainable 
conservation practices. Additionally, as discussed in section V.E of 
this document, this proposed rule is designed to be compatible with 
existing conservation practices in the management of agricultural water 
systems. Moreover, as discussed in section V.I of this document, this 
proposed rule would not require the destruction of habitat or the 
clearing of farm borders around outdoor growing areas or drainages.
9. Consistency With National Organic Program
    In accordance with section 419(a)(3)(E), this proposed rule does 
not include any requirements that conflict with or duplicate the 
requirements of the National Organic Program. In developing this 
proposed rule, we consulted with technical experts and representatives 
from the National Organic Program (Ref. 34). Compliance with the 
provisions of this proposed rule would not preclude compliance with the 
requirements for organic certification in 7 CFR part 205. Moreover, 
where this proposed rule and the National Organic Program would include 
similar or related requirements, we propose that our requirements may 
be satisfied concurrently with those of the National Organic Program 
(i.e., to the extent the requirements are the same, compliance with 
this proposed rule could be achieved without duplication). For example, 
proposed Sec.  112.54(c) would establish multiple options for 
composting processes used to treat biological soil amendments of animal 
origin used to grow covered produce, including two options (Sec.  
112.54(c)(1) and (2)) that are consistent with the options available to 
USDA-certified organic farms under the National Organic Program 
regulations in 7 CFR 205.203(c)(2).
    As another example, the National Organic Program application 
intervals for the use of raw manure as a soil amendment in 7 CFR 
205.203(c)(1) are 90 days and 120 days before harvest, depending on 
whether the edible portion of the crop contacts the soil. Proposed 
Sec.  112.56(a)(1)(i) would require a 9 month application interval for 
use of raw manure in the growing of covered produce when application is 
performed in a manner that does not contact covered produce during 
application and minimizes the potential for contact with covered 
produce after application. Proposed Sec.  112.56(a)(1)(ii) would not 
require an application interval for use of raw manure in the growing of 
covered produce when application is performed in a manner that does not 
contact covered produce during or after application. For certified 
organic farms growing produce that would be subject to this rule, the 
National Organic Program application intervals would run concurrently 
with the proposed application interval in this proposed rule, rather 
than consecutively. Organic farms (like other farms) using raw manure 
would either need to wait 9 months between application and harvest and 
use application methods meeting the proposed requirements for avoiding 
and minimizing contact between covered produce and raw manure, or apply 
the raw manure in a manner that does not contact covered produce during 
or after application. Doing so would not jeopardize their compliance 
with the requirements of the National Organic Program.
    In addition, this proposed rule would establish in proposed Sec.  
112.163 that records kept for other purposes could be used to satisfy 
the recordkeeping requirements in this proposed rule. Accordingly, 
records kept under 7 CFR 205.103 for the purposes of the National 
Organic Program that contain information that would be required in 
records under this proposed rule would not need to be duplicated.
    Further, while not critical to our conclusion regarding compliance 
with section 419(a)(3)(E) of the FD&C Act, we note that the provisions 
of the proposed rule are not in conflict with or duplicative of the 
non-binding recommendations of the National Organic Standards Board's 
Compost Tea Task Force (Ref. 36). Certified organic farms would be able 
to comply with the provisions of this proposed rule with respect to 
their use of agricultural teas while simultaneously meeting or 
exceeding the non-binding recommendations in the NOSB Compost Tea Task 
Force Report.
    We seek comment on our approach to ensuring that this proposed rule 
does not conflict with or duplicate the requirements of the National 
Organic Program while providing the same level of public health 
protection as required under FSMA.
10. Minimizing PRA burden
    In implementing section 419 of the FD&C Act through this proposed 
rule, FDA has complied with chapter 35 of title 44, United States code 
(commonly known as the ``Paperwork Reduction Act'' (PRA)), with special 
attention to minimizing the burden (as defined in section 3502(2) of 
such Act (44 U.S.C. 3502(2)) on the facility, and collection of 
information (as defined in section 3502(3) of such Act (44 U.S.C. 
3502(3)), associated with the proposed rule. Under section 3502(2) of 
the PRA, ``burden'' means the ``time, effort, or financial resources 
expended by persons to generate, maintain, or provide information to or 
for a Federal agency.'' Under section 3502(3) of the PRA, ``collection 
of information'' means, in relevant part, ``the obtaining, causing to 
be obtained, soliciting, or requiring the disclosure to third parties 
or the public, of facts or opinions by or for an agency, regardless of 
form or format, calling for * * * answers to identical questions

[[Page 3520]]

posed to, or identical reporting or recordkeeping requirements imposed 
on, ten or more persons.* * *'' In section X of this document, we 
discuss how this proposed rule complies with the requirements of the 
PRA. In addition, in implementing section 419 of the FD&C Act, we have 
paid special attention to minimizing burden and collection of 
information associated with this proposed rule.
    As discussed above, we are proposing requirements that provide 
significant flexibility for different sizes and types of farms. By 
making these requirements flexible enough to be practicable for 
different sizes and types of farms, the proposed rule also avoids 
creating unnecessary information collection burden for entities, 
because farms should be able to tailor their recordkeeping to their 
specific circumstances while still complying with the requirements of 
the proposed rule.
    In addition, as discussed in section IV.E. of this document, the 
only requirements we are proposing that constitute collections of 
information are those that are necessary to implement section 419 of 
the FD&C Act and for the efficient enforcement of the FD&C Act. We 
propose to require records under this rule only in instances where 
maintenance of detailed information is needed to keep track of measures 
directed at minimizing the risk of a known or reasonably foreseeable 
hazards, where identification of a pattern of problems is important to 
minimizing the risk of such hazards, or where they are important to 
facilitate verification and compliance with standards and this cannot 
be effectively done by means other than a review of records. These 
instances are discussed in more detail in section IV.E. of this 
document and throughout section V of this document. In addition, 
although we recognize their value and encourage their use, we are not 
proposing to require farms to conduct operational assessments or to 
develop written food safety plans akin to similar requirements for 
facilities subject to section 418 of the FD&C Act or our juice HACCP or 
seafood HACCP regulations.

B. Other Provisions of the Federal Food, Drug, and Cosmetic Act

    FDA's authority for this proposed rule also derives from sections 
402(a)(3), 402(a)(4), and 701(a) of the FD&C Act. Section 402(a)(3) of 
the FD&C Act provides that a food is adulterated if it consists in 
whole or in part of any filthy, putrid, or decomposed substance, or if 
it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act 
provides that a food is adulterated if it has been prepared, packed, or 
held under insanitary conditions whereby it may have become 
contaminated with filth, or whereby it may have been rendered injurious 
to health. Under section 701(a) of the FD&C Act, FDA is authorized to 
issue regulations for the efficient enforcement of the FD&C Act. The 
proposed rule includes many requirements that are necessary to prevent 
food from being adulterated (either because it consists in whole or in 
part of a filthy, putrid, or decomposed substance, because it is 
otherwise unfit for food, or because it has been held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health). A regulation 
that requires measures to prevent food from being held under insanitary 
conditions whereby either of the proscribed results may occur allows 
for the efficient enforcement of the FD&C Act. See, e.g., regulations 
to require HACCP systems for fish and fishery products (21 CFR Part 
123) and juice (part 120), regulations to require a safe handling 
statement on cartons of shell eggs that have not been treated to 
destroy Salmonella organisms and to require refrigeration of shell eggs 
held for retail distribution (parts 101 and 115), and regulations for 
the production, storage, and transportation of shell eggs (part 118).

C. The Public Health Service Act

    In addition to the FD&C Act, FDA's legal authority for the proposed 
rule derives from the PHS Act. Authority under the PHS Act for the 
proposed regulations is derived from the provisions of sections 311, 
361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable 
disease. The PHS Act authorizes the Secretary to make and enforce such 
regulations as ``are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the States * * * or from one State * * * into any other State'' 
(section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 
at 42 U.S.C. 202 for transfer of authority from the Surgeon General to 
the Secretary; see 21 CFR 5.10(a)(4) for delegation from the Secretary 
to FDA.) The provisions in the proposed rule are necessary to prevent 
food from being contaminated with human pathogens such as Salmonella, 
L. monocytogenes, and E. coli O157, and therefore to prevent the 
introduction, transmission, or spread of communicable disease from 
foreign countries into the United States, or from one state in the 
United States to another. As discussed in section II of this document, 
without appropriate prevention steps, certain practices on farms can 
lead to the contamination of food with pathogens, increasing the 
likelihood of foodborne illness. We tentatively conclude that the 
proposed provisions in this document are necessary to prevent the 
spread of communicable disease and to prevent food from containing 
filthy, putrid, or decomposed substances; being otherwise unfit for 
food, or being prepared, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health.

D. Legal Authority for Records Requirements

    We are proposing to use our authority under the FD&C Act and the 
PHS Act to institute certain records requirements as follows:
     For covered produce that is exempted from the requirements 
of the proposed rule because it receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance, the identity of the recipient that receives this produce 
(Sec.  112.2);
     For alternatives that farms may establish and use for 
certain requirements of the proposed rule, the scientific data and 
information used to support such alternatives (Sec.  112.12);
     Documentation of compliance with certain requirements 
related to training of personnel (Sec.  112.30); water monitoring and 
testing (Sec.  112.50); biological soil amendments of animal origin 
(Sec.  112.60); sanitizing of equipment used in growing operations for 
sprouts, or for covered harvest, packing, or holding activities (Sec.  
112.140), and sprouts (Sec.  112.150); and
     General requirements in subpart O that apply to records 
required to be established and maintained.
    As discussed further in sections V.A., V.B., V.C., V.E., V.F., 
V.L., V.M., and V.O. of this document, the proposed recordkeeping 
requirements are necessary for covered farms to ensure their own 
compliance with these aspects of the proposed rule and for FDA to 
ensure that covered farms are complying with the same aspects of the 
proposed rule. Therefore, these proposed requirements are necessary for 
the efficient enforcement of the FD&C Act because they will aid both 
farms and FDA in ensuring that food is not adulterated, and are 
necessary to prevent the spread of communicable disease because they 
will aid both farms and FDA in ensuring that food does not

[[Page 3521]]

become contaminated with human pathogens.
    In addition to having the authority under the FD&C Act and the PHS 
Act to require this recordkeeping, we also have the authority to 
require access to the records. Because the underlying requirements are 
necessary to minimize the likelihood of adulteration and the spread of 
communicable disease, access to records that demonstrate that a farm 
has followed those requirements is essential to confirm compliance and 
achieve the full benefits of the rule. We also have the authority to 
copy the records when necessary. We may consider it necessary to copy 
records when, for example, our investigator may need assistance in 
reviewing a certain record from relevant experts in headquarters. If we 
are unable to copy the records, we would have to rely solely on our 
investigators' notes and reports when drawing conclusions. In addition, 
copying records will facilitate follow up regulatory actions. 
Therefore, we have tentatively concluded that the ability to access and 
copy records is necessary to enforce the rule and prevent adulteration 
and the spread of communicable disease. In other relevant sections of 
this document, we explain in more detail the recordkeeping provisions 
that we believe are necessary and, because they are limited to what is 
necessary, that we believe do not create an unreasonable recordkeeping 
burden.

F. Intrastate Activities

    FDA tentatively concludes that the provisions in the proposed rule 
should be applicable to activities that are intrastate in character. 
The plain language of section 419 of the FD&C Act directs FDA to 
establish science-based minimum standards for the safe production and 
harvesting of fruit and vegetable RACs to minimize the risk of serious 
adverse health consequences or death. Section 419 does not include a 
limitation to interstate commerce. In addition, the exemption provided 
in section 419(f) of the FD&C Act, based in part on the proportion of a 
farm's sales made to restaurants or retail food establishments 
intrastate or within 275 miles, suggests that Congress intended the 
rule issued under section 419 to apply to intrastate commerce because 
otherwise there would be no need to provide an exemption for farms 
whose sales are intrastate in character. In addition, section 301(vv) 
of the FD&C Act provides that ``[t]he failure to comply with the 
requirements under section 419'', or the causing thereof, is a 
prohibited act. Section 301(vv) does not require an interstate commerce 
nexus. Notably, other subsections in section 301 of the FD&C Act, and 
section 304 of the FD&C Act (21 U.S.C. 334) demonstrate that Congress 
has included a specific interstate commerce nexus in the provisions of 
the FD&C Act when that is its intent. Accordingly, it is reasonable to 
interpret sections 419 and 301(vv) of the FD&C Act as not limiting the 
application of the proposed rule only to those farms with a direct 
connection to interstate commerce.
    FDA is mindful that its interpretation of FSMA and the FD&C Act 
should not cast doubt on the constitutionality of those statutes. (See 
Solid Waste Agency of Northern Cook County v. U.S., 531 U.S. 159 
(2001)). FDA has considered the relevant provisions of FSMA and the 
FD&C Act, FDA's responsibilities in implementing those statutes, and 
the law interpreting the commerce clause of the Constitution (Article 
I, section 8). Congress's power to legislate under the commerce clause 
is very broad. However, such power is not without limits, see United 
States v. Lopez, 514 U.S. 549, 567 (1995); U.S. v. Morrison, 529 U.S. 
598, 618 (2000), and these limits have been construed in light of 
relevant and enduring precedents. In particular, in Lopez, supra, the 
Supreme Court acknowledged the continuing vitality of Wickard v. 
Filburn, 317 U.S. 111 (1942), noting that ``although Filburn's own 
contribution to the demand for wheat may have been trivial by itself, 
that was not `enough to remove him from the scope of Federal regulation 
where, as here, his contribution, taken together with that of many 
others similarly situated, is far from trivial.''' (514 U.S. at 556.) 
See also Gonzales v. Raich, 545 U.S. 1, 17-25 (2005). This principle 
applies to the application of sections 419 and 301(vv) of the FD&C Act, 
as added by section 105 of FSMA. Accordingly, given the collective 
impact on commerce of farms that grow, harvest, pack, or hold food that 
is sold in ``intrastate'' commerce, FDA tentatively concludes that such 
farms should be subject to the proposed rule unless an exemption from 
the rule applies (for example, if the farm is eligible for the 
qualified exemption in proposed Sec.  112.5, or if the farm only grows 
produce exempt from the regulation under one of the exemptions in 
proposed Sec.  112.2). This outcome is consistent with section 709 of 
the FD&C Act (21 U.S.C. 379a), which states that in any action to 
enforce the act's requirements respecting foods, drugs, devices, and 
cosmetics, any necessary connection with interstate commerce is 
presumed. Likewise, this outcome is consistent with FSMA's risk-based, 
preventive approach to food safety because the risk presented by unsafe 
food can be great, whether or not the food moves from one state to 
another. FDA seeks comment on the number of so-called ``intrastate'' 
farms that would not be exempt from the proposed rule either under the 
proposed exemption in Sec.  112.5 or as a result of growing only 
produce that would be exempt under proposed Sec.  112.2.

E. Relevance of Section 415 of the FD&C Act to ``Farm'' Definition and 
Related Definitions

    Section 419 directs FDA to issue a proposed rule ``for the safe 
production and harvesting'' of certain produce. Section 419 does not 
affirmatively identify the businesses to which the proposed rule must 
apply, but requires FDA to address ``with respect to growing, 
harvesting, sorting, packing, and storage operations * * * soil 
amendments, hygiene, packaging, temperature controls, animals in the 
growing area, and water'' (419(a)(3)(B)); frequently uses the term 
``farm'' (e.g., section 419(f)); and clarifies that section 419 does 
not apply to produce produced by an individual for personal consumption 
(section 419(g)) or activities of facilities subject to section 418 
(section 419(h)). FDA intends to issue a notice of proposed rulemaking 
implementing section 418 of the FD&C Act (section 103 of FSMA) in the 
near future. FDA tentatively concludes that ``activities of facilities 
subject to section 418'' are those activities triggering the 
requirement to register with FDA under section 415 of the FD&C Act (21 
U.S.C. 350d), ``Registration of Food Facilities.'' FDA therefore 
tentatively concludes that it is reasonable to apply this proposed rule 
to farms and activities of farm mixed-type facilities that are within a 
definition of ``farm'' consistent with that utilized in FDA's 
implementation of section 415 of the FD&C Act, except to the extent 
that such entities are producing fruits and vegetables for their own 
consumption. In the near future, we plan to address how we will 
coordinate the definitions in the section 415 registration regulations 
with the definitions we are proposing for the purpose of the produce 
safety proposed rule. Ultimately, FDA intends that the activities to be 
regulated under this proposed rule will not trigger the requirement to 
register under section 415 of the FD&C Act and as a result will not be 
``activities of a facility subject to section 418,'' consistent with 
the requirement in section 419(h). Moreover, the activities within the 
definition of ``farm'' we propose as part of this rulemaking closely 
track those identified in section 419(a)(3)(B), and

[[Page 3522]]

this interpretation is consistent with section 419(f)'s use of the term 
``farm.''
    Because section 418(o)(2) of the FD&C Act defines the term 
``facility'' for the purposes of section 418 to mean only those 
facilities required to register under section 415 of the FD&C Act, FDA 
tentatively concludes that Congress intended the exemptions from the 
registration requirement set forth in section 415 and FDA's 
implementing regulations in part 1, subpart H (including the farm 
exemption in Sec.  1.226(b)) to be meaningful for the purposes of 
defining section 418's applicability (and in turn, section 419's 
applicability). Thus, we tentatively conclude that activities within a 
definition of ``farm'' consistent with the definition utilized to 
implement the section 415 registration requirement are not subject to 
section 418 of the FD&C Act, but activities outside such a definition 
of ``farm'' are subject to section 418 when they cause a facility to be 
required to register with FDA under section 415. We discuss the 
proposed definition of ``farm'' and related definitions in section 
V.A.2.b.i of this document. We seek comment on these interpretations.

IV. Regulatory Approach

A. Qualitative Assessment of Risk

    As discussed below, we are proposing to adopt an approach that 
focuses on the likelihood of contamination of produce posed by the 
agricultural practices applied to the crop, while exempting only the 
lowest-risk produce. We conducted a qualitative assessment of risk 
(QAR) of hazards related to produce production and harvesting. The QAR 
indicated that produce commodities are potentially subject to similar 
microbiological hazard pathways: Commodities can potentially become 
contaminated from, for example, direct exposure to contaminated water 
or soil amendment. Therefore, we propose to adopt a regulatory approach 
for minimizing the risks associated with those hazards and, as 
appropriate, provide flexibility for the use of alternative measures 
that would provide the same level of public health protection as the 
proposed standard.
    The QAR addressed various questions related to produce safety, 
including: (1) What are the biological hazards of concern in produce 
that can lead to serious adverse health consequences or death? (2) How 
does produce become contaminated (i.e., routes of contamination) during 
on-farm growth, harvesting, and postharvest operations? (3) Does the 
likelihood of contamination vary among produce commodity types? (4) 
Does the likelihood of illness attributable to produce consumption vary 
among produce commodity types? (5) What is the impact of postharvest 
practices on the level of contamination at consumption? (6) What on-
farm interventions are available to reduce the likelihood of 
contamination? (Ref. 2). The qualitative assessment of risk document is 
currently being peer reviewed and changes can be reasonably anticipated 
based on the peer review. The peer review plan is available online at 
http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. We will 
consider peer reviewers' and public comments in finalizing the 
qualitative assessment and this proposed rule.
    While data and information available to us at this time permitted 
us to conduct only a qualitative (not quantitative) assessment, some 
important conclusions can be drawn, which provide a basis for our 
proposed science-based minimum standards for the safe production and 
harvesting of produce commodities. We provide below a brief summary of 
conclusions of the QAR.
    Key conclusions from this assessment are:
     Produce can be contaminated with biological hazards, and 
the vast majority of produce-related illnesses are associated with 
biological hazards.
     The most likely routes of contamination from growing, 
harvesting, and on-farm postharvest activities are associated with seed 
(for sprouts), water, soil amendments, animals, worker health and 
hygiene, and buildings/equipment.
     Although some types of produce have been repeatedly 
associated with outbreaks, all types of produce commodities have the 
potential to become contaminated through one or more of these potential 
routes of contamination.
     The specific growing, harvesting, and on-farm postharvest 
conditions and practices associated with a produce commodity influence 
the potential routes of contamination and the likelihood that the given 
route could lead to contamination and illness. Use of poor agricultural 
practices could lead to contamination and illness, even where the 
potential for contamination is relatively low.
     Postharvest practices such as cooking (and, possibly 
certain peeling) before consumption may have an impact on the 
likelihood of contamination of the edible portion and the likelihood of 
illness.
    Hazards of concern in produce--The scientific evidence from 
outbreaks, surveys and published literature establish that human 
pathogens (e.g., Salmonella, pathogenic E.coli, Shigella, Cyclospora) 
constitute a biological hazard with the potential to cause serious 
adverse health consequences or death and result in the vast majority of 
foodborne illness known to be associated with produce consumption.
    Potential routes of contamination--Based on our observations during 
inspections, investigations, and surveillance activities and other 
available information, we have grouped the possible routes of 
contamination into five major pathways: Water, Soil amendments, 
Animals, Worker health and hygiene, and Equipment and buildings. Seed 
is an additional route of contamination for sprouts.
    Likelihood of contamination--All produce commodities can be 
contaminated before, during, and/or after harvest through one or more 
of the potential routes of contamination. Although the likelihood of 
contamination varies by commodity, it appears to be dependent on the 
practices employed and, to a lesser extent, on the characteristics of 
the commodity. There appears to be greater variability in the 
likelihood of contamination among commodities during growing than 
during harvest or after harvest.
    Likelihood of exposure--Subsequent to any contamination on-farm, 
consumer and retail handling practices and produce consumption rates 
affect the likelihood that consumers will be exposed to contamination. 
Postharvest practices such as cooking (and possibly certain peeling) 
before consumption may have an impact on the likelihood of exposure if 
indeed the produce is contaminated.
    Risk of illness--Contaminated produce has the potential to cause 
illness. However, there are differences among commodities in the risk 
of illness primarily based on the routes of contamination associated 
with the commodity.
    Produce commodities that are ranked as ``higher'' risk of illness 
and those ranked as ``lower'' risk of illness share some of the same 
characteristics. Both categories include:
     Crops where the harvestable portion grows in the ground;
     Row crops where the harvestable portion grows on or near 
the ground;
     Crops where the harvestable portion grows above the 
ground;
     Crops where the harvestable portion grows on trees, high 
above the ground; and

[[Page 3523]]

     Crops that are generally grown without soil.
    Such diversity suggests that sorting commodities for risk based 
only on the manner in which commodities grow would be inappropriate. 
This diversity also characterizes commodities associated with 
outbreaks. Even within a commodity group, physical characteristics 
(such as texture of the fruit) of the commodity that could alter the 
potential for contamination and, therefore, association with an 
outbreak, do not always appear to do so.
    In summary, some produce types are repeatedly associated with 
reported foodborne illness whereas other produce types are only 
intermittently associated with foodborne illness. Still other produce 
commodities have not been associated with reported foodborne illness. 
Likely factors contributing to the likelihood of contamination, 
exposure, and illness include: Agricultural practices used during 
growing, harvesting, and postharvest; physical characteristics of the 
crop; consumer and retail handling practices (such as cooking and 
peeling); and rates of consumption. However, use of poor agricultural 
practices could lead to contamination and illness, even where the 
potential for contamination is relatively low.
    With regard to water as a route of contamination:--
     Agricultural water can be a source of contamination of 
produce.
     Public Drinking Water Systems (domestically regulated by 
the EPA) have the lowest relative likelihood of contamination due to 
existing standards and routine analytical testing.
     Groundwater has the potential to pose a public health 
risk, despite the regulation of many U.S. public wells being subject to 
regulation under the Ground Water Regulation.
     There is a significant likelihood that U.S. surface waters 
will contain human pathogens, and surface waters pose the highest 
potential for contamination and the greatest variability in quality of 
the agricultural water sources.
     Susceptibility to runoff significantly increases the 
variability of surface water quality.
     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.
     Proximity of the harvestable portion of produce to water 
is a factor in the likelihood of contamination during indirect 
application.
     Timing of water application in produce production before 
consumption is an important factor in determining likelihood of 
contamination.
     Commodity type (growth characteristics, e.g. near to 
ground) and surface properties (e.g., porosity) affect the probability 
and degree of contamination.
     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.
    With regard to soil amendments as a route of contamination--
     Soil amendments can be a source of contamination to 
produce
     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 (e.g., plant-
based soil amendments).
     Human waste is the most likely waste to contain human 
pathogens.
     Animal waste subject to treatments, such as chemical and 
physical treatments and composting, has relatively lower levels of 
human pathogens than untreated animal waste.
     Composting is less likely than controlled chemical or 
physical treatments to fully eliminate human pathogens from animal 
waste.
     Incompletely treated, or re-contaminated, biological soil 
amendments of animal origin may also contain human pathogens.
     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.
     Treatments, such as chemical and physical treatments and 
composting, can effectively reduce the levels of human pathogens in 
animal waste.
     Among application methods, application of soil amendments 
in a manner in which they contact the harvestable portion of the crop 
presents the greatest likelihood of contamination, especially when 
applied close to harvest.
    With regard to animals as a route of contamination--
     Animals can be a source of contamination to produce.
     Animal excreta poses a high likelihood of contamination of 
produce.
     Excreta from domesticated animals poses a greater 
likelihood of contamination of produce than does excreta of wild 
animals. However, domesticated animals can be expected to be more 
readily controlled (i.e., kept apart from produce growing, harvesting, 
and postharvest areas).
     Excreta from wild animals that rarely associate with human 
activities poses the least likelihood of contamination of produce.
     Human pathogens from animal excreta, once introduced to 
the growing environment, can be expected to eventually die off; but the 
rate of die-off is dependent upon a number of environmental, regional, 
and other agro-ecological factors.
    With regard to worker health and hygiene as a route of 
contamination--
     Humans (i.e., workers and visitors) are potential carriers 
of foodborne pathogens and can be a source of contamination of produce.
     Individuals with communicable diseases that can be spread 
via food who are engaged in activities in which they contact produce or 
food contact surfaces can result in contamination of the produce or 
food-contact surfaces with human pathogens.
     Hand-washing reduces the potential for contamination of 
produce. Its efficacy varies depending upon the use of soap, the 
quality of the water, and whether or not hands are dried after washing.
     Dirty and damaged gloves may contaminate produce.
     Workers or visitors that touch animals can contaminate 
produce or food contact surfaces.
     Poor hygienic practices, e.g. lack of hand washing, can 
lead to contamination of produce.
     The presence of adequate toilet facilities in reasonable 
proximity to growing areas can reduce produce contamination.
    With regard to equipment and buildings as a route of 
contamination--
     Food contact surfaces are potential routes of 
contamination of produce.
     Food contact surfaces such as equipment that are designed 
and constructed to be cleanable minimize the potential for 
contamination of produce.
     Pests in buildings used to grow or pack produce can be a 
source of contamination of produce.
     Waste material can be a source of contamination, or may 
become an attractant for pests and thereby act as a source of 
contamination to produce, if not properly contained, stored, and 
conveyed.
    The provisions proposed in section V of this document reflect the 
above conclusions drawn from our qualitative assessment of risk. We 
seek public comment on the QAR, conclusions drawn from that assessment, 
and our consideration of those conclusions in

[[Page 3524]]

developing the proposed requirements. We also request you to submit any 
data or factual information that may help the agency to conduct, as 
warranted, a thorough and robust quantitative assessment of risk 
associated with produce production and harvesting practices.

B. Focus on Biological Hazards

    Section 419 of the FD&C Act directs us to establish science-based 
minimum standards for the safe production and harvesting of those types 
of fruit and vegetable raw agricultural commodities (RACs) for which we 
determine that such standards minimize the risk of serious adverse 
health consequences or death (section 419(a)(1)(A) of the FD&C Act). 
These standards are to be based on known safety risks and to include 
procedures, processes, and practices that we determine to be reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable biological, chemical, and physical hazards into fruit and 
vegetable RACs and to provide reasonable assurances that produce will 
not be adulterated under section 402 of the FD&C Act (sections 
419(b)(1) and 419(c)(1)(A) of the FD&C Act).
    As discussed in the QAR, available data and information clearly 
establish that human pathogens constitute a biological hazard with the 
potential to cause serious adverse health consequences or death and 
result in the vast majority of foodborne illness known to be associated 
with produce consumption. By contrast, chemical, physical, and 
radiological hazards associated with produce rarely pose a risk of 
serious adverse health consequences or death for individuals that would 
consume the product (Ref. 7). Section 419(c)(1)(A) of the FD&C Act 
requires FDA to ``set forth those procedures, processes, and practices 
that the Secretary determines to minimize the risk of serious adverse 
health consequences or death, including procedures, processes, and 
practices that the Secretary determines to be reasonably necessary to 
prevent the introduction of known or reasonably foreseeable biological, 
chemical, and physical hazards * * * and to provide reasonable 
assurances that the produce is not adulterated under section 402 [of 
the FD&C Act].'' The frequency and nature of chemical, physical, and 
radiological hazards in produce are such that promulgation of a new 
regulatory regime for their control does not, at this time, appear to 
be reasonably necessary to prevent their introduction into produce or 
to provide reasonable assurances that produce will not be adulterated 
under section 402 of the Act. FDA tentatively concludes that existing 
programs, such as EPA registration of pesticides, and State and 
industry efforts to control the presence of pesticides and mycotoxins 
in produce, are sufficient to keep these hazards under control. In 
addition, under its broader food safety regulatory framework, FDA 
monitors natural toxins (e.g., mycotoxins), pesticides, industrial 
chemicals (such as dioxins; cooking or heating related chemicals, such 
as acrylamide), and other chemical contaminants, and radionuclides in 
foods.
    For these reasons, we tentatively conclude that the proposed rule 
should be limited in scope to biological hazards and science-based 
standards necessary to minimize the risk of serious adverse health 
consequences or death associated with biological hazards. Because of 
the proposed rule's focus on biological hazards, and because of the 
effectiveness of cooking and similar processes on the reduction of the 
likelihood of contamination of such hazards, as described in the 
Qualitative Assessment of Risk, we also propose to exempt produce that 
is rarely consumed raw or that receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance (see section V.A. of this document).
    We request comment on this approach, and specifically on whether 
there are practices that are reasonably necessary to prevent the 
introduction of known or reasonably foreseeable chemical, physical or 
radiological hazards into produce or otherwise to provide reasonable 
assurances that produce is not adulterated under section 402 of the 
FD&C Act because of chemical, physical, or radiological hazards. For 
example, proposed Sec.  112.11 would require covered farms to take 
appropriate measures to minimize risks of serious adverse health 
consequences or death from the use of, or exposure to, covered produce 
attributable to biological hazards that may arise unexpectedly and 
therefore not be reflected in a specific standard set forth in proposed 
subparts C to O of this rule, or when there are biological hazards 
specific to a covered farm's location or circumstances for which such 
measures would be appropriate. Should Sec.  112.11 also apply, for 
example, in the event of an accident or other unexpected event, such as 
a likelihood of radiological contamination relevant to a covered farm's 
location, to require that the covered farm take appropriate measures to 
prevent the introduction of radiological hazards into or onto the 
produce or by taking measures to provide reasonable assurances that the 
produce is not adulterated under section 402 of the FD&C Act? Such 
measures might include, for example, preventing covered produce from 
entering commerce if it may have been contaminated with radiological 
hazards that may render it injurious to health. As another example, if 
a covered farm's land was previously used for another activity that may 
have contaminated the soil with chemical hazards such that using the 
land to grow covered produce may cause introduction of those hazards 
into or onto the covered produce, should proposed Sec.  112.11 require 
the covered farm to take appropriate measures to prevent the 
introduction of the chemical hazards into or onto the produce or by 
taking measures to provide reasonable assurances that the produce is 
not adulterated under section 402 of the FD&C Act? Such measures might 
include, for example, collecting and analyzing soil samples for 
residues of pesticides that are typically used in the production of 
cotton, if you intend to use a former cotton field for produce 
production. We seek comment on whether, and to what extent, chemical, 
physical, or radiological hazards should be covered within the scope of 
this rule.

C. Consideration of Differing Risk of Different Commodities and 
Practices

    Section 419 of the FD&C Act also directs us to establish 
requirements that would provide sufficient flexibility to be applicable 
to various types of entities engaged in the production and harvesting 
of fruit and vegetable RACs, including small businesses and entities 
that sell directly to consumers, and to be appropriate to the scale and 
diversity of the production and harvesting of such commodities (section 
419(a)(3)(A) of the FD&C Act). Section 419 further directs us to 
acknowledge differences in risk while minimizing, as appropriate, the 
number of separate standards we apply to separate foods (section 
419(c)(1)(D) of the FD&C Act). We considered different approaches to 
determine how we might most appropriately respond to these directives, 
informed by the information contained in the Qualitative Assessment of 
Risk. These primarily included:
     Commodity-specific approach--covering only those produce 
commodities or commodity groups that might be described as posing a 
relatively higher risk of foodborne illness or applying different 
requirements to commodity categories based on relative risk of 
foodborne illness represented by the commodity category (such as 
higher, moderate and lower risk). A benefit of opting to pursue a 
commodity specific

[[Page 3525]]

approach would be a reduction in the costs of the proposed rule. Some 
commodities have little or no history of links to foodborne illness 
and, thus, exempting them from coverage could reduce costs to farmers 
with little or no reduction in calculated benefits from the rule. 
However, because foodborne illness outbreaks have regularly been 
associated with commodities that have previously not been linked to 
outbreaks, this approach carries the risk of failing to prevent future 
outbreaks.
     Integrated approach--covering all produce commodities 
except those that pose little or no risk of foodborne illness and then 
applying the most stringent requirements to agricultural practices that 
pose the greatest likelihood of contamination of the produce, 
regardless of the covered produce commodity. A benefit of selecting 
this option is that we would cover all commodities except those that 
pose little or no risk of foodborne illness, an approach that takes 
into account the sporadic and unpredictable nature of illness 
outbreaks, while still being sensitive to risk.
    As discussed below, we explored both approaches thoroughly using 
information available to us at this time, and propose to use an 
integrated approach. Based on available data, we have not been able to 
fully develop a commodity-specific approach that we believe would 
adequately minimize risk of serious adverse health consequences or 
death from biological hazards in produce. However, as discussed in 
section IV.C.1.b., we have tentatively identified an approach based on 
outbreak data, and we further explore that option in that section. We 
welcome comment on this approach and ask that you provide data and 
factual information that would help us to further consider developing 
this or another appropriate commodity-specific approach.
1. Commodity-Specific Approaches
    As noted above, there are multiple possible approaches that we 
could take with respect to produce. One of them is what we refer to as 
a ``commodity-specific approach'' in which this rule would apply only 
to those produce commodities or commodity groups that pose a relatively 
higher risk of foodborne illness. (We could also simply apply different 
or less stringent requirements to the relatively lower-risk 
commodities.) In theory, commodities might also be grouped into higher, 
moderate, or lower levels of risk with different levels of stringency 
applied to each. As discussed in section IV.A. above, we attempted to 
categorize commodities and commodity groups by risk in our Qualitative 
Assessment of Risk.
a. Relative Risk Considerations
    To fully explore the viability of a commodity-specific approach, we 
reviewed the relative risk of different commodities using four such 
data sources: Outbreak data; Pathogen surveillance data; Commodity 
characteristics; and Market channels. Our analysis shows that each data 
source presents certain gaps that make it challenging to develop a 
commodity-specific approach that would adequately minimize risk of 
serious adverse health consequences or death. We explain our analysis 
below and request data and factual information on how we might address 
these gaps and further develop and consider a commodity-specific 
approach.
    i. Outbreak Data and Commodity Risk: We reviewed FDA's data on 
produce-related outbreaks and considered categorizing commodities or 
commodity groups by risk based on documented association of specific 
produce commodities with specific outbreaks of human illness (Ref. 2). 
Using this approach, we could exempt certain commodities or commodity 
groups that had never been linked to human illnesses or were only 
rarely linked to human illness; this would allow us to reduce the costs 
of the rule with little or no reduction in calculated benefits. 
However, our QAR also leads us to tentatively conclude that past 
patterns of outbreaks by commodity have limitations which make it 
challenging to use as a key determining factor in establishing the 
scope of this proposed rule or how its provisions apply. We briefly 
discuss the reasons here (please refer to the QAR for more 
information).
    Our QAR concluded that some produce types are repeatedly associated 
with reported foodborne illness, whereas other produce types are 
intermittently associated with reported foodborne illness. Still other 
produce commodities have not been associated with reported foodborne 
illness. As such, five commodity groups (leafy greens, tomatoes, herbs, 
melons, and sprouts) together account for 77 percent of all produce-
related outbreaks from 1996-2010 (Ref. 3). These commodity groups also 
account for 54 percent of produce-related illnesses and 56 percent of 
produce-related hospitalizations. Sprouts account for a quarter of the 
produce related outbreaks (26%), 15 percent of the illnesses, 9 percent 
of the hospitalizations, and one death.
    As discussed in the QAR, because only a small percentage of 
outbreaks are both reported and assigned to a food vehicle, outbreak 
data may not provide a complete picture of the commodities upon which 
we need to focus to minimize current and future risk of illness. The 
food vehicle responsible for an outbreak is not identified in about 
half of all outbreaks. Identifying the vehicle of an outbreak in which 
the vehicle is contained in a multi-ingredient food (e.g., salsa, 
salads) is particularly challenging. As our abilities to detect 
outbreaks and to identify food vehicles responsible for an outbreak 
improve, including refining our approach to outbreaks associated with 
multi-ingredient foods, it is likely that previously unrecognized 
outbreak vehicles will be identified. A further complication to use of 
outbreak data as an indication of commodity risk is that, until a food 
is identified as a vehicle in an outbreak, public health officials may 
not be likely to include questions about that commodity when 
investigating an outbreak, making the attribution of outbreaks to 
commodities with no outbreak history more difficult.
    In addition, as discussed in the QAR, our data show that the 
patterns of outbreaks associated with produce commodities change over 
time. Some commodities have a continuing and repeated pattern of 
association with outbreaks, over multiple years, such as tomatoes and 
leafy greens (Ref. 2). On the other hand, occasionally a produce 
commodity is associated with an outbreak that had not been previously 
linked to foodborne illness. For example, prior to the 2008 Salmonella 
Saintpaul outbreak (Ref. 37), jalapeno and serrano peppers had not been 
identified as vehicles in a foodborne illness outbreak. Papayas had 
also not been associated with outbreaks, prior to an outbreak that 
occurred in 2011. Therefore, a regulatory approach that relied on a 
static list of commodities prepared solely from a history of outbreaks 
would not be able to prevent future outbreaks in commodities not 
previously associated with an outbreak.
    If we adopted an approach that exempted commodities without a 
history of outbreaks, we would likely need to add commodities as future 
outbreaks occur. For example, we could adopt a ``moving window'' 
approach that would consider only outbreaks over a given time period. 
For example, we could consider only the outbreaks over the most recent 
five years at any given time. Using such an approach, produce 
commodities or commodity groups might move onto and off of the higher 
risk list over time based on changes in outbreak data. The advantage of 
such an approach could potentially be to

[[Page 3526]]

recognize and reward efforts by industry segments that implement 
changes in practices contributing to reduced outbreaks associated with 
their commodities, and provide an incentive for other industry segments 
to enhance the safety of their practices. However, the adoption of such 
practices by an industry segment does not change the risk posed by the 
commodity in the absence of such practices, such as when practices are 
not universally adopted or they are discontinued. In the absence of 
those practices, illness outbreaks may resume. For example, sprout 
associated outbreaks appeared to decline after release of our Sprout 
Guides in 1999 and, for three years (2005-2007), there were no reported 
outbreaks associated with sprouts, presumably because of improved 
practices during the production of sprouts (Ref. 3). However, outbreaks 
have recurred since that time period, possibly because practices have 
regressed to some extent or possibly because of the entry of new sprout 
growers who were not familiar with the voluntary recommendations in the 
Sprout Guides and had not adopted them. In late 2008, there was one 
sprout-associated Salmonella outbreak; in 2009, a Salmonella outbreak 
associated with sprouts resulted in more than 200 illnesses; and in 
2010, there were 3 outbreaks associated with sprouts (Ref. 3). Further, 
as discussed in the QAR, some commodities (e.g., leafy greens) are 
consistently associated with outbreaks while others (e.g., grapes, 
jalapeno peppers) are only rarely associated with outbreaks. With a 
moving window approach those commodities that only intermittently are 
associated with outbreaks may cycle on and off the higher risk list, 
even though their risk may not have actually changed. For these 
reasons, we have tentatively concluded that a ``moving window'' 
approach for determining risk based on outbreak history is not viable.
    Grouping commodities based on outbreak history also has challenges. 
Within a commodity group, contamination may have been associated with 
relatively few types of produce, such as cantaloupe and honeydew melons 
within the melon group, which includes multiple species, or more 
broadly, such as roma, red round, plum, and grape tomatoes within the 
tomato group, which consists of multiple varieties within a single 
species (Ref. 3).
    Having considered that making exemptions solely based on outbreak 
data could significantly reduce the costs of the proposed rule with 
little or no reduction in calculated benefits, we have not selected 
this alternative, because we do not believe that the past history of 
outbreaks can be fully predictive of future outbreaks. Historically, 
outbreaks are sometimes linked to commodities that had no previous 
associated illnesses. If we were to develop a commodity-specific list 
of covered produce, we could add commodities to the list as more data 
became available. We request comment on whether this option would 
adequately minimize the risk of serious adverse health consequences or 
death and whether it would sufficiently move toward a prevention-based 
food safety system. We request comment on this determination and on the 
specific approaches we have outlined here. We are particularly 
interested in the marginal effects of adopting this approach: If we 
exempted commodities based on a history of outbreaks, what would the 
likely reductions in the costs of the rule be, and what would the 
likely increase in human illnesses be from this approach.
    ii. Pathogen Surveillance Data and Commodity Risk: As an 
alternative to categorizing and regulating commodities based on 
outbreak history, we considered using data on levels and frequency of 
pathogen detection, such as by surveillance sampling assignments in 
specific produce commodities. As demonstrated in the QAR, this approach 
would also present a number of challenges. Of most importance, our 
contamination data are limited in that most sampling programs have 
focused on produce commodities that have an existing history of known 
outbreaks, providing little additional information about the risk 
presented by commodities that do not have such a history. Given the 
potential for system failure and sporadic contamination, it is probable 
that testing of other produce commodities may eventually lead to 
positive identification of contamination. For example, when we added 
cucumbers to our surveillance sampling program in 2009, we found a 
significant number of positive samples for Salmonella spp. although, in 
previous years, cucumbers had not been identified as the vehicle of a 
foodborne outbreak in FDA's database. We also found pathogens in and on 
produce commodities such as broccoli, culantro, rapini, and radicchio 
that have not been currently identified in outbreaks (Ref. 3). For this 
reason, we do not believe that pathogen surveillance data alone can 
provide sufficient information for a risk-based exemption from the 
proposed rule's provisions. We request comment on this determination.
    iii. Commodity Characteristics and Commodity Risk: As an 
alternative to categorizing and regulating commodities based on 
outbreak history or surveillance data, we also considered using 
characteristics of produce commodities themselves, such as growth 
habit. In other words, if, for example, the risk of illnesses 
associated with tree fruit, were consistently lower than the risk of 
illness from commodities grown in the soil, such a distinction might 
provide the basis of an exemption. However, as demonstrated in the QAR, 
we found that it would be extremely difficult to make conclusions 
across commodity groups that are consistent with outbreak and 
surveillance data, in light of the diversity of commodities, practices, 
and conditions across operations.
    Attempts to categorize produce by commodity characteristics is 
confounded by the outbreak data, which show no consistent pattern that 
can be matched to commodity characteristics such as growth habit. As 
discussed in the QAR, the characteristics of approximately 20 produce 
commodities associated with outbreaks are diverse and include:
     Crops generally grown without soil, such as sprouts;
     Crops where the harvestable portion grows in the ground, 
such as green onions;
     Row crops where the harvestable portion grows on or near 
the ground, such as lettuce, spinach, basil, parsley and cantaloupe;
     Crops where the harvestable portion grows above the 
ground, such as tomatoes and chili peppers, raspberries and 
blueberries; and
     Crops where the harvestable portion grows on trees, high 
above the ground, such as mangoes and almonds.
    Moreover, as discussed in the QAR, even within what may be a 
reasonable set of commodities to group together, physical 
characteristics of the produce that could alter the potential for 
contamination do not always appear to do so. For example, within the 
melon group, cantaloupe has a netted rind, whereas honeydew has a 
smooth rind, seemingly making it less likely to harbor pathogens. 
However, both have been associated with outbreaks (Ref. 3).
    In addition, multiple characteristics would have to be considered 
to create commodity groupings, making such an approach very 
complicated. For example, while growth characteristics, such as 
distance between the edible portion of the plant and the ground, may 
make a commodity less likely to become contaminated through certain 
routes, (e.g., tree fruit may be less vulnerable to contamination from 
grazing animals), distance from the

[[Page 3527]]

ground does not necessarily provide an increased level of protection 
against other sources of contamination (e.g., direct contact with a 
crop protection spray if the spray mix were made using contaminated 
water). Furthermore, once the produce commodity is removed from the 
growing area, it may lose any safety advantage it had in the field 
based on growth characteristics if it is exposed to routes of 
contamination such as poor worker hygiene practices, contaminated 
water, or insanitary food contact surfaces. As another example, mangoes 
are an example of a produce commodity that may be thought to present 
relatively low risk of foodborne illness, but for which poor water 
quality management during insect disinfestation hot water treatment and 
cooling as part of harvest, packing, and holding resulted in an 
outbreak (Ref. 38). Some physical characteristics of produce 
commodities (e.g., netted rind of cantaloupe or large, rough surface 
area of some leafy greens) may increase the likelihood of contaminants 
being trapped and surviving long enough to cause illness, but as noted 
earlier, these characteristics do not necessarily determine whether 
contamination occurs or persists.
    For the reasons described here, we have tentatively determined that 
such an approach cannot serve as the sole basis for a risk-based 
exemption from the proposed rule. We request comment on this 
determination and on whether there are known produce characteristics 
that could serve as a reliable and practicable indicator of 
contamination and illness risk. We seek comment on this issue and data 
to inform commodity categorization.
    iv. Market Channel and Risk: We also considered whether different 
market channels might have an impact on the likelihood of contamination 
of produce and therefore whether use of certain market channels should 
be a factor in covering or regulating produce in this proposed rule. In 
particular, we considered whether there is a difference in the 
likelihood of contamination of produce that is sold directly to the 
consumer or end user (``direct market channels'') as compared to that 
of produce that is sold into other commercial channels. We are not 
aware of any data that would enable us to compare the likelihood of 
contamination in these two situations. We tentatively conclude that 
produce in both direct market channels and other commercial channels 
are subject to the same routes of contamination, although the number of 
opportunities for contamination during packing and holding may be 
greater for produce in other commercial channels as compared to produce 
in direct market channels if there are greater numbers of touch points 
and handlers in these channels than there are in direct market 
channels. We seek comment on this tentative conclusion.
    Section 419(f) of the FD&C Act provides a qualified exemption from 
this proposed rule for many farms selling directly to consumers or 
other ``qualified end users,'' and as a result, many farms that 
primarily use direct market channels will not be subject to the 
requirements of this proposed rule (with qualifications provided by the 
statute). Because the statutory qualified exemption addresses market 
channels as a possible risk factor, and because we identified no data 
that would allow us to otherwise use market channels as a factor in 
covering and regulating produce under this proposed rule, we 
tentatively conclude that we should not otherwise use market channels 
as a basis of risk categorization in this proposed rule. We seek 
comment on this tentative conclusion.
b. Considering an Appropriate Commodity-Specific Approach
    In the previous section, IV.C.1.a, we discuss four different 
relative risk considerations that might be used to develop an 
appropriate commodity-specific approach. Each has a set of challenges, 
as discussed above. Of the four, outbreak data provide the most direct 
representation of public health burden, even considering the confines 
associated with these data. In this section we further explore how 
outbreak data might be used to identify commodity groups or specific 
commodities to cover in this proposed rule.
    One possible commodity-specific approach would be to cover those 
commodity groups that have been associated with outbreaks. Commodity 
groups ``associated with outbreaks'' could be identified as, for 
example, commodity groups associated with one or more outbreaks during 
a set period of time. The remaining commodity groups could then either 
not be subject to the proposed rule, or be subject to the proposed rule 
but with less stringent requirements. A commodity-specific approach 
that covers the commodity groups associated with outbreaks would target 
the commodity groups that present the greatest public health burden. 
However, as discussed above in section IV.C.1.a., there are various 
drawbacks with using outbreak data in this way. For example, because 
only a small percentage of outbreaks are both reported and assigned to 
a food vehicle, outbreak data may not provide a complete picture of the 
commodities upon which we need to focus to minimize current and future 
risk of illness.
    Another possible commodity-specific approach that attempts to 
account for the drawbacks of the above approach would be to cover all 
of the commodities that have been identified as associated with an 
outbreak at any time. Produce commodities that have not been identified 
as associated with an outbreak could then either not be subject to the 
proposed rule, or be subject to the proposed rule but with less 
stringent requirements. This option would address more than the percent 
of known outbreaks addressed by the above approach in that it would 
address all known outbreaks. This approach would also significantly 
reduce the costs of the proposed rule by exempting produce categories 
that have never been associated with human illness. As discussed above, 
however, outbreaks have been associated with commodities without an 
illness history. Although we would expect to use additional data to 
update any list we might develop of commodities subject to the 
provisions of the rule, we would expect that this approach would not 
minimize the risk of occurrence of some number of additional outbreaks 
and illnesses.
    We have discussed limitations with each of the above methods of 
creating a risk-based exemption from the rule. We could also combine 
two or more of the approaches used above to create a more holistic 
picture of risk. For example, we might combine a history of outbreak 
data with the growing characteristics of a commodity or class of 
commodity. Such an approach could potentially exempt additional 
commodities that pose minimal or no risk (in addition to those we 
already considered in the proposed approach: Those specified as rarely 
consumed raw, and those that are receive commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance). If there were individual commodities or classes of 
commodities that have not been linked to human illness and we had 
reason to believe that they were unlikely to be linked to human illness 
in the future, we would consider exempting these commodities or classes 
of commodities from some or all provisions of the rule. This would 
reduce the cost of the rule without significantly reducing the 
calculated benefits of the rule. However, we have not been able to 
fully develop an approach that might combine a history of outbreak data 
with the growing characteristics of a commodity or class

[[Page 3528]]

of commodities to create risk-based exemptions from the rule and, thus, 
minimize the risk of serious adverse health consequences or death. We 
seek comment on this issue. Is there information in the QAR that could 
be used to develop such a system of risk-based exemptions? Are there 
commodity characteristics or growth conditions that could be used as a 
basis to develop such a system? Do the proposed provisions for 
variances (see section V.P. below) adequately address this issue?
    We ask for comment on all of the above approaches, and we 
especially ask for comment on the likely marginal effects of the 
different risk-based exemptions. If we adopted one of the approaches 
above, what would the likely reductions in the costs of the proposed 
rule be, and what would the likely increases in human illnesses be 
(using our proposed rule as a baseline). We also ask for comment on 
whether any of the above approaches would be sufficiently protective of 
the public health.
c. Need for additional data and information
    We seek comment on our analysis and considerations related to 
considering an appropriate commodity-specific approach that would 
adequately minimize risk of serious adverse health consequences or 
death from biological hazards associated with produce. We also request 
comment on whether and how different relative risk considerations, 
including outbreak data, pathogen surveillance data, commodity 
characteristics and/or market channels, could be used to develop a 
commodity-specific approach, and data and factual information that 
would address the drawbacks that are discussed in this section IV.C. 
that may be accounted for in such an approach. Specifically,
    [ssquf] Are there specific commodities or categories of commodities 
that should be excluded from the scope of the rule, based on data 
related to their relative risk considerations? (Note that under our 
proposed integrated approach, we propose to exempt certain commodities, 
including a specified list of produce that is rarely consumed raw, and 
produce that receives commercial processing that adequately reduces the 
presence of microorganisms of public health significance; see section 
V.A.2.a. of this rule.)
    [cir] For example, the QAR ranked certain produce commodities, such 
as bananas and coconuts, as lower risk for illness, in part because 
such commodities are peeled or shelled before consumption in a manner 
that can be expected not to transfer contamination onto the interior, 
edible portion of the commodity. Should such commodities be covered by 
the rule? Is coverage of these commodities unnecessary? Should they be 
covered but subject to a less stringent set of requirements?
    [cir] Certain commodities are ranked in the QAR as presenting a 
relatively lower likelihood of exposure, in part because such 
commodities have fewer potential routes of contamination and/or lower 
potential for contamination. In addition, some commodities are not 
known to have been associated with outbreaks. Some commodities (for 
example, pears, grapefruit, oranges, and lemons) meet both of these 
criteria, considering the rankings and outbreak data used in the QAR. 
Should commodities that meet both of these criteria be covered by the 
rule? Is coverage of these commodities unnecessary? Should they be 
covered but subject to a less stringent set of requirements? How should 
the rule address the changing nature of outbreak data over time?
    [cir] How should the agency account for uncovered commodities in 
considering a commodity-specific approach that relies on outbreak data?
    [ssquf] Are there pathogen surveillance data from sampling programs 
focusing on produce commodities that have no history of known outbreaks 
that would be useful in considering a commodity-specific approach?
    [ssquf] Can commodity characteristics be used as a basis to 
consider a commodity-specific approach? While the outbreak data show no 
consistent pattern that can be matched to commodity characteristics 
such as growth habit, our QAR shows that produce commodities that are 
ranked as higher risk of illness and those ranked as lower risk of 
illness do share some of the same characteristics. A further refinement 
of our assessment might be helpful in developing a commodity-specific 
approach based on commodity characteristics. Considering the 
qualitative nature of our assessment, are there quantitative data sets 
available that would enable a further refinement of our assessment?
    [ssquf] Are produce in both direct market channels and other 
commercial channels subject to the same routes of contamination? Is the 
number of opportunities for contamination during packing and holding 
greater for produce in other commercial channels as compared to produce 
in direct market channels? If yes, is this due to greater numbers of 
touch points and handlers in these channels than there are in direct 
market channels, or to other factors?
    [ssquf] Should market channels be used as a basis for risk 
categorization? If so, how? Is there a need to consider market channels 
in risk categorization, considering that the statutory qualified 
exemption already addresses market channels as a possible risk factor?
    [ssquf] Are other data or information available that would 
otherwise be useful in considering a commodity-specific approach?
2. Integrated Approach, as Proposed
    As discussed in section IV.A. above, our QAR indicates that some 
produce types are repeatedly associated with reported foodborne illness 
whereas other produce types are intermittently associated with 
foodborne illness. Still other produce commodities have not been 
associated with reported foodborne illness. Likely factors contributing 
to the likelihood of contamination, exposure, and illness include: 
Agricultural practices used during growing, harvesting, and 
postharvest; physical characteristics of the crop; consumer and retail 
handling practices (such as cooking and peeling); and rates of 
consumption. However, use of poor agricultural practices could lead to 
contamination and illness, even where the potential for contamination 
is relatively low.
    Therefore, we tentatively conclude that an integrated approach that 
focuses on the likelihood of contamination of produce posed by the 
agricultural practices applied to the crop, while exempting the lowest-
risk produce, would provide the most appropriate balance between public 
health protection, flexibility, and appropriate management of different 
levels of risk. We tentatively conclude that controls should be 
tailored, taking into account the analysis done by the farm in certain 
areas, to the potential routes of contamination that each commodity 
presents based on the agricultural practices employed, and the 
characteristics of the commodity and the environmental conditions under 
which it is grown.
    Based on our QAR, we are able to identify certain conditions under 
which produce commodities constitute very low to no risk with respect 
to biological hazards. We tentatively conclude that, under these 
conditions, science-based minimum standards to minimize the risk of 
serious adverse health consequences or death from biological hazards in 
produce are not warranted. As described in the QAR, such conditions 
include produce that receives commercial processing that

[[Page 3529]]

adequately reduces the presence of microorganisms of public health 
significance (proposed Sec.  112.2(b)); and produce commodities that 
are rarely consumed raw (proposed Sec.  112.2(a)(1)). In each of these 
cases the produce can be expected to receive commercial processing or 
other treatments that significantly minimize the risk of serious 
adverse health consequences or death from biological hazards associated 
with such produce.
    In addition, as discussed in section V.A. of this document, FDA 
proposes in Sec.  112.4 to apply this regulation only to businesses 
with an average annual monetary value of food sold during the previous 
three-year period of more than $25,000 on a rolling basis, based on a 
tentative conclusion that businesses with $25,000 or less in sales do 
not contribute significantly to the produce market and, therefore, to 
the volume of production that could become contaminated. Accordingly, 
imposing the proposed requirements on these businesses would have 
little measurable public health impact. In addition to these exclusions 
proposed by FDA, section 419(f) of the FD&C Act provides a qualified 
exemption for certain farms, which FDA proposes to implement in 
proposed Sec. Sec.  112.5 and 112.6, and subpart R, as discussed in 
sections V.A. and V.R. of this document.
    For produce commodities that would be covered within the scope of 
this rule (i.e., ``covered produce'' as defined in proposed Sec.  
112.3), we are proposing to establish science-based minimum standards 
to minimize the risk of serious adverse health consequences or death. 
Given our current understanding of existing microbiological hazards and 
current data limitations, as described in our QAR, we have determined 
that a regulatory approach that addresses the potential likelihood of 
contamination posed by procedures, processes, and practices employed in 
the growing, harvesting, packing, and holding of produce commodities 
will be more effective and appropriate than an approach based on the 
individual commodities' physical characteristics, known record of 
contamination, or known outbreak history. The only commodity-specific 
requirements proposed in this rule are those designated for sprouts, 
which have unique growing procedures (i.e., warm, moist nutrient-rich 
environment for an extended period of time that supports pathogen 
growth in addition to sprouting) and, therefore, present a unique risk 
profile (Ref. 16.Ref. 2). For this reason, and as discussed in section 
V.M. of this document, we tentatively conclude that a specific set of 
safety standards (proposed subpart M) for this produce commodity is 
warranted.
    The requirements of the proposed regulation would be based on 
identified routes of contamination and the associated practices that 
affect the likelihood that produce becomes contaminated: Agricultural 
practices that are more likely to contaminate produce would require 
more stringent measures to ensure that the likelihood of contamination 
is sufficiently minimized. For example, as discussed in section V.E. of 
this document, we are proposing the most stringent standards for water 
that is used in direct contact with the harvestable portion of covered 
produce during or after harvest activities (when there is little 
further opportunity for pathogen die off) and in certain other uses 
that present significant safety risk for the safety of the produce 
(such as irrigation of sprouts); less stringent standards for water 
that directly contacts the harvestable portion of covered produce 
(other than sprouts) during growing activities (when the opportunity 
for pathogen die off is greater); and no requirements when water is 
used during growing, but does not contact the harvestable portion of 
covered produce (other than sprouts). Similarly, we are proposing to 
prohibit the use on covered produce of biological soil amendments that 
present the greatest likelihood of pathogen contamination, i.e., 
untreated human waste (Ref. 39). Untreated manure or other untreated 
biological soil amendments of animal origin, which are less likely to 
be contaminated with human pathogens than human waste, but are 
relatively likely to be contaminated (Ref. 35. Ref. 36. Ref. 37), would 
be allowed, subject to stringent requirements; manure or other 
biological soil amendments of animal origin that have been properly 
composted to reduce the level of pathogens contained therein would be 
subject to less stringent requirements; and certain chemically or 
physically treated biological soil amendments of animal origin that 
receive more robust treatments to eliminate pathogens would be subject 
to the least stringent requirements.
    In addition, we are proposing to include other measures that would 
be broadly applicable (e.g., personnel qualifications and training 
requirements in proposed subpart C, health and hygiene requirements in 
proposed subpart D; requirements for equipment, tools, buildings, and 
sanitation in proposed subpart L) and the proposed standards for these 
are consistent for all covered growing, harvesting, packing, and 
holding operations.
    We tentatively conclude that the appropriate way to minimize the 
risk of serious adverse health consequences or death is to require all 
covered farms to comply with the standards in this proposed rule with 
regard to all but the lowest risk produce. Identifying the higher-risk 
agricultural practices and setting standards in which the stringency of 
the requirement tracks the risk of the chosen practices is appropriate 
from a public health risk mitigation standpoint and would also provide 
an incentive for farmers to move to lower-risk practices where such 
options are available. We also expect that our proposed approach is 
more workable for row crop farmers who may grow multiple produce 
commodities than it would be if we were to assign different 
requirements to specific commodities based on the risk of foodborne 
illness associated with those commodities. In these types of 
operations, many agricultural practices and agricultural inputs (such 
as water sources and distribution systems, soil amendments and their 
application methods) tend to be farm-specific and, thus, relatively 
consistent across produce commodities on a given farm. Requiring 
different measures from row to row based on the produce commodity in 
that row would likely pose a considerable burden on such farms. Setting 
standards that enable such farms to apply consistent measures to 
multiple crops is consistent with the statutory provision in section 
418(c)(1)(D) of the FD&C Act that directs the agency to ``acknowledge 
differences in risk and minimize, as appropriate, the number of 
separate standards that apply to separate foods.''

D. Framework of the Rule

    In developing a framework for this proposed rule we considered 
various models used in proposed and final FDA regulations, including 
those applied in: (1) The existing Current Good Manufacturing Practice 
in Manufacturing, Packing or Holding Human Food regulation (current 21 
CFR part 110; ``Food CGMP regulation''); (2) the Production, Storage, 
and Transportation of Shell Eggs regulation (21 CFR part 118; ``Shell 
Egg Regulation''); (3) the Hazard Analysis and Critical Control Point 
(HACCP) Systems (``juice HACCP'') regulation (21 CFR part 120); and (4) 
the Fish and Fishery Products (``seafood HACCP'') regulation (21 CFR 
part 123). None of these regulations applies to fruits and vegetables 
at the point at which we propose to regulate such food by this 
regulation (during growing, harvesting,

[[Page 3530]]

packing, and holding on farms), but as models they are instructive.
    Generally, the Food CGMP Regulation sets out mandatory, broad, 
generally-applicable practices and conditions that are required to be 
met, and the criteria and definitions in that part are applicable in 
determining whether the food is adulterated (1) within the meaning of 
section 402(a)(3) of the act, in that the food has been manufactured 
under such conditions that it is unfit for food, or (2) within the 
meaning of section 402(a)(4) of the act, in that the food has been 
prepared, packed, or held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health. The criteria and definitions in that part 
are also applicable in determining whether a food violates section 361 
of the Public Health Service Act. In some instances where the 
appropriate measures are universal and well recognized, the cGMP 
requirements are prescriptive (e.g., the requirement to remove 
unsecured jewelry at Sec.  110.10(a)(4), the requirement that each 
freezer and cold storage compartment be fitted with a temperature 
indicating thermometer, temperature measuring device or temperature 
recording device at Sec.  110.40(e)). However, more commonly, because 
of the diversity of operations subject to the regulation and the desire 
to provide flexibility for operators to put in place measures that are 
best suited to the specifics of their operation, the cGMP rule sets out 
more general requirements (e.g., the requirement that persons working 
in direct contact with food conform to hygienic practices to the extent 
necessary to protect against contamination of the food at Sec.  
110.10(b), the requirement that food that can support the rapid growth 
of undesirable microorganisms be held in a manner that prevents the 
food from becoming adulterated at Sec.  110.80(b)(3)). Many provisions 
of the Shell Egg Regulation also take a similar approach to the Food 
CGMP Regulation.
    The Juice HACCP and Seafood HACCP Regulations set out mandatory 
frameworks through which entities subject to those regulations assess 
the hazards that are reasonably likely to occur in their products and 
processes and design tailored controls to prevent or eliminate them or 
reduce them to an acceptable level. These regulations require the 
development of a plan, based on the assessment of hazards, which 
includes monitoring procedures, corrective action procedures, 
verification procedures, and recordkeeping procedures. The plan also 
includes the identification of the critical control points (CCPs) where 
the controls must be applied and critical limits, which are the set 
points for the process that must be met to ensure product safety.
    The Food CGMP Regulation and the Shell Egg Regulation do not use 
the structure applied in the other regulations identified here to 
ensure that the conditions and practices are keeping hazards in check 
as anticipated (through hazard analysis, establishment of critical 
control points, monitoring, corrective actions, verification, and 
recordkeeping in all applicable contexts). The Food CGMP Regulation 
preceded the HACCP regulations and is generally thought of as a pre-
requisite or foundation to those regulations. That is, it is generally 
recognized that HACCP-type regulations must build on the foundation of 
a good manufacturing practice (GMP)-type regulation in order to further 
reduce the risk of illness or injury to consumers associated with 
contaminated produce (Ref. 40 Ref. 41).
    In developing the framework for this proposed rule, we considered 
the following: (1) The produce farming community is very diverse, 
including very small and large farms, some with significant expertise 
in the area of food safety and others with minimal knowledge in the 
area, some located in the U.S. and some abroad; (2) there is a broad 
range of crops and agricultural practices employed by the produce 
farming community, such that a measure for addressing an on-farm route 
of contamination for one produce commodity in one region may not be 
practical or effective for another on-farm route of contamination, 
produce commodity or region; (3) this proposed rule is the first effort 
by FDA to regulate the produce farming community--the produce farming 
community does not have the history of regulatory interaction with FDA 
and the same experience with food safety regulations as does the food 
manufacturing industry; (4) the adequacy of some measures to control 
specific known or reasonably foreseeable hazards affecting produce is 
well established, while others are poorly studied, suggesting that 
future research may identify alternative measures that may be more 
effective and/or efficient; and (5) some on-farm routes of 
contamination occur in a relatively controlled environment (e.g., a 
fully or partially enclosed building), while others occur in an outdoor 
environment that may be beyond the control of the farm (e.g., an open 
field), affecting the ability of the farm to take measures that 
minimize the likelihood of contamination.
    Given these considerations, and the need to tailor the proposed 
requirements to specific on-farm routes of contamination (as discussed 
in section IV.C of this document), we propose an integrated approach 
that draws on our past experiences in the regulations discussed above. 
In some cases, we propose standards that are very similar to those 
contained in the Food CGMP Regulation, especially where the routes of 
contamination are well-understood and appropriate measures are well-
established and generally applicable across covered produce commodities 
(e.g., personnel qualifications, training, health, and hygiene; 
harvesting, packing, and holding activities; equipment, tools, 
buildings, and sanitation). We rely on this approach where possible, in 
part, because we tentatively conclude that compliance would be more 
suitable with this regulatory framework (given the diversity of the 
industry with respect to size, agricultural practices, and knowledge of 
food safety) than would be the case with a more complex framework such 
as one that also required an individual written plan.
    In other cases, we have proposed specific numerical standards 
against which the effectiveness of a farm's measures would be compared 
and actions taken to bring the operation into conformance with the 
standards, as necessary (e.g., proposed standards for agricultural 
water in subpart E; biological soil amendments of animal origin in 
subpart F; sprout environmental testing and spent sprout irrigation 
water testing in subpart M). We rely on such a numerical standards 
approach where the effectiveness of individual measures (e.g., 
protection of agricultural water sources from contamination, 
establishment of application intervals for certain soil amendments, and 
chemical disinfection treatment of seeds before sprouting) is not 
complete or fully known and/or because much of what affects the on-farm 
route of contamination is outside the control of the farm (e.g., the 
quality of a particular surface water source). In some of these cases 
(e.g., composting of biological soil amendments of animal origin in 
proposed Sec.  112.54) we have provided measures that are well 
established to meet the numerical standard under a wide range of 
conditions, while also recognizing that other measures, if properly 
validated, may also be suitable (see proposed Sec.  112.12, discussed 
in section V.B. of this document). Our proposed use of numerical 
standards is similar to the

[[Page 3531]]

requirement for egg testing in the Shell Egg Regulation.
    In still other cases, we have proposed a standard that requires the 
farm to inspect or monitor an on-farm route of contamination and take 
appropriate measures if conditions warrant. We rely on such a 
monitoring approach where the diversity of conditions that can be 
expected relative to an on-farm route of contamination is very high and 
it would be impractical and unduly restrictive to set out a standard 
that specifies the appropriate measures for each possible circumstance 
(e.g., requirements for monitoring for animal intrusion in proposed 
Sec.  112.83, requirement for inspection of agricultural water system 
in proposed Sec.  112.42). In addition, we propose this approach in 
instances where further research is needed to fully understand the 
effectiveness of measures to mitigate the risk of serious adverse 
health consequences or death. Our proposed use of inspection and 
monitoring followed by appropriate corrective action is similar to the 
requirement to monitor for rodent activity and take corrective action 
on egg farms in the Shell Egg Regulation (Sec.  118.4).
    Finally, in still other cases, we propose a standard that requires 
the farm to develop a written plan, committing itself to specific 
measures (e.g., sprout environmental testing and spent sprout 
irrigation water testing). We propose the use of written plans where 
the details of the measures to be taken are more than can be reasonably 
expected to be retained in memory, especially where the details may 
change over time and a historical record of the evolution of the 
measures is important for the operator to assess whether further 
changes to the measures are needed (e.g., changes or rotation in the 
sampling sites for sprout environmental testing). Such plans are also 
important for the efficient enforcement of the standard as they serve 
as a clear commitment on the part of the operator of the farm to a 
particular course of action, against which their actual performance can 
be judged by the regulator. Our proposed use of written plans in these 
specific instances is similar to the requirement for a written 
Salmonella Enteritidis prevention plan on egg farms in the Shell Egg 
Regulation (Sec.  118.4).
    We performed a quantitative risk assessment to estimate the 
predicted effectiveness of some of the provisions of the proposed 
regulation with respect to one example commodity and one example 
pathogen (Ref. 42). This quantitative risk assessment evaluated the 
combination of fresh-cut lettuce, enterohemorrhagic E. coli (EHEC), and 
irrigation water (with and without proposed measures in place), and 
concluded that a number of variables may influence the predicted EHEC 
illnesses associated with fresh-cut lettuce, as defined by the model 
scenarios that included contamination from irrigation water and other 
environmental sources on the farm, and changes in the contamination 
during the product life cycle from farm to consumption. The 
quantitative risk assessment document is currently being peer reviewed 
and changes can be reasonably anticipated based on the peer review. The 
peer review plan is available online at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. We will 
consider peer reviewers' and public comments in finalizing the 
quantitative risk assessment and this proposed rule.
    This rulemaking is not intended to address ``hazards that may be 
intentionally introduced, including by acts of terrorism.'' (Sec.  
418(b)(2) of the FD&C Act). FDA plans to implement section 103 of FSMA 
regarding such hazards in a separate rulemaking in the future. FDA 
tentatively concludes that intentional hazards likely will require 
different kinds of controls and would be best addressed in a separate 
rulemaking. However, we request comment on whether we should include 
standards related to preventing economically motivated intentional 
adulteration of produce in this rule. Is economically motivated 
adulteration of produce reasonably likely to occur and, if so, by what 
mechanisms may potential hazards be intentionally introduced in produce 
for economic reasons? If such adulteration is reasonably likely to 
occur, what standards should FDA consider for preventing such 
adulteration?

E. Records

    We are proposing to require that farms keep records as a component 
of the above described standards, under certain, limited circumstances. 
In determining those circumstances in which records are necessary, we 
considered the statutory direction in section 419(c)(1)(C) of the FD&C 
Act to comply with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) 
``with special attention to minimizing'' the recordkeeping burden on 
the business and collection of information as defined in that act.
    Records are useful for keeping track of detailed information over a 
period of time. Records can identify patterns of problems and, thus, 
enable a farm to find and correct the source of problems. Records are 
also useful for investigators during inspections to determine 
compliance with requirements (e.g., by FDA investigators to determine 
compliance with requirements that would be established by this rule, or 
by a third party auditor that a farm or retailer may voluntarily engage 
under a business arrangement between the farm and the retailer). We 
propose to require records in instances where they are important to 
facilitate verification and compliance with standards and this cannot 
be effectively done by means other than a review of records; where 
identification of a pattern of problems is important to minimizing the 
likelihood of contamination; and where maintenance of detailed 
information is needed by the operator in order to minimize the risk of 
contamination and demonstrate their compliance.

F. Farm-Specific Food Safety Plans

    Each farm has a unique combination of size, climate, crops grown, 
current and previous use of its own land and nearby land, sources of 
agricultural water, growing, harvesting, packing, and holding 
practices, animal grazing, potential for domestic and wild animals to 
enter growing or packing areas, and sewage or septic system. Relevant 
documents on produce safety, such as our GAPs Guide (Ref. 10), industry 
CSGs for melons, tomatoes, leafy greens, and green onions (Ref. 43. 
Ref. 44. Ref. 45. Ref. 46), the CA and AZ LGMA (Ref. 31. Ref. 32), the 
AFDO Model Code of Produce Safety (Ref. 20), the Codex Guide (Ref. 47), 
and Industry Harmonized GAPs (Ref. 48. Ref. 49) recommend that a farm 
tailor its food safety practices to the practices and conditions at its 
individual operation. In addition, many of these documents explicitly 
recommend that a farm conduct an assessment of its growing environment 
and may specify when assessments should be done (e.g., before planting, 
during production, and immediately prior to harvest) to identify 
potential food safety hazards in light of its particular commodities, 
practices and conditions (Ref. 43. Ref. 44. Ref. 45. Ref. 46. Ref. 40. 
Ref. 47).
    Several of these documents further recommend that a farm use the 
findings of its assessment to help establish a plan to control 
potential hazards (Ref. 43. Ref. 46. Ref. 48. Ref. 45. Ref. 49. Ref. 
28. Ref. 18)(Ref. 50. Ref. 51). For example, the introduction to the 
AFDO Model Code notes that a food safety plan should be commensurate 
with the size and complexity of an operation and the inherent risks of 
the commodities

[[Page 3532]]

grown, along with site specific practices and conditions. The purpose 
of a food safety plan is to establish measures designed to prevent the 
introduction of known or reasonably foreseeable food safety hazards 
into or onto produce in light of the crops, practices, and conditions 
at the physical location of the farm and would include, for example, 
measures applicable to an individual farm for agricultural water, 
animal grazing, and any specific hazards identified in the recommended 
operational assessment. The FDA draft CSGs recommend developing and 
maintaining written food safety plans and SOPs for areas such as 
handling and storage practices, field, facility, and vehicle cleaning 
and sanitation, and employee training programs. A number of comments to 
the 2010 FR notice maintained that the most effective approach to 
produce safety would be one that incorporates food safety plans 
developed at the operational level. Conversely, another group of 
comments questioned the need for some industry segments, such as small 
farms or growers of ``low risk'' commodities to develop or implement 
food safety plans. The above-mentioned documents provide guidance or 
recommendations for operators to consider and, as such, do not 
represent requirements that must be met. We recognize that requiring 
covered farms to conduct a hazard analysis and develop a food safety 
plan at the level required in our juice and seafood HACCP regulations, 
or prescribed by section 418 of FSMA for food manufacturing/processing 
facilities, may not be feasible. We also recognize that, at this time, 
only limited tools are available to help with the development of on-
farm food safety plans.
    Also as noted above, this proposed rule is the first effort by FDA 
to regulate the produce farming community. We have tentatively 
concluded, in part based on the statutory direction in section 419 to 
establish ``minimum science-based standards,'' and in recognition of 
the direction to pay special attention to minimizing recordkeeping 
burden and collection of information, that the most appropriate 
approach for this proposed rule is to establish standards of the type 
described in section D above. We are not proposing to require farms to 
conduct operational assessments or to develop food safety plans akin to 
similar requirements for facilities subject to section 418 of FSMA or 
our juice HACCP or seafood HACCP regulations. We acknowledge that 
operational assessments and food safety plans have a prominent place in 
many public and private produce guidance documents, as discussed above.
    The importance of tailoring what you do at an individual operation 
to your commodities, practices and conditions is commonly accepted, and 
an operational assessment and food safety plan could be valuable tools 
for farms to select and implement those recommendations which are 
appropriate for their circumstances. While we are not proposing to 
require farms to conduct an operational assessment or develop a food 
safety plan, we do recommend that farms do so, because this could help 
farms be more effective in protecting the safety of their produce.
    Further, we request comment on whether we should require that some 
or all covered farms perform operational assessments and/or develop a 
food safety plan, and if only some, what criteria should be used to 
separate those to whom the requirement would apply from those to whom 
it would not.

G. Foreign Farms

    The proposed rule would apply to foreign farms that meet the 
criteria to be covered farms and that grow, harvest, pack, or hold 
covered produce for import into the United States. This is protective 
of public health, as foreign farms have been implicated in foodborne 
illness outbreaks associated with contaminated produce consumed in the 
United States (Ref. 3). This is also consistent with the requirements 
of section 419 of the FD&C Act, which clearly contemplates that the 
rule issued under that authority will apply to foreign farms. This is 
apparent in sections 419(c)(1)(F) and (c)(2), which provide for a 
variance process in which states or foreign countries from which food 
is imported into the US may request variances from FDA. Foreign 
countries would not be eligible to request variances from this rule if 
Congress did not intend the rule to apply to farms in foreign 
countries.

H. Consistency With Codex Guidelines

    In developing our proposed approach, we considered the 
recommendations of relevant Codex guidelines, specifically, the Codex 
Code of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP 53-
2003) (the Codex Code). Many of the provisions proposed in this rule 
are parallel to or consistent with the recommendations in the Codex 
Code. For example, like our proposed approach of focusing on biological 
hazards, the Codex Code (while intended to help control microbial, 
chemical and physical hazards associated with production of fresh 
fruits and vegetables) pays particular attention to minimizing 
microbial hazards. It concentrates on microbial hazards and addresses 
physical and chemical hazards only in so far as they relate to good 
agricultural and manufacturing practices. The Codex Code recommends 
measures applicable to all stages of the production of fresh fruits and 
vegetables, from primary production to packing, with a particular 
emphasis on those intended to be consumed raw (Section 2.1 of the Codex 
Code). In proposed Sec.  112.2(a)(1), we propose to exempt a specified 
list of produce that is rarely consumed raw from the scope of this 
rule. Similarly, for those commodities not cooked before consumption, 
the Codex Code recommends a set of broadly applicable minimum 
standards, with risk-based adjustments.
    With respect to agricultural water, the Codex Code recommends the 
assessment of agricultural water for suitability for use; special 
attention to irrigation water that is directly applied to edible 
portion, especially close to harvest; and use of clean water for 
initial stages followed by potable water for later stages during and 
after harvest, including cooling (Section 3.2.1.1 of the Codex Code). 
Many of the proposed provisions described in section V.E. of this 
document are consistent with these recommendations.
    As another example, the Codex Code recommends that personnel follow 
health and hygiene requirements and that toilet and hand washing and 
drying facilities be provided during and after harvest, which are 
reflected in the proposed provisions described in section V.D. of this 
document. In addition, the proposed provisions described in section 
V.L. of this document and the Codex Code both recognize the importance 
of proper design, construction, maintenance and cleaning of buildings 
and equipment in ensuring produce safety.
    Moreover, the Codex Code recommends that ``manure, biosolids and 
other natural fertilizers which are untreated or partially treated may 
be used only if appropriate corrective actions are being adopted to 
reduce microbial contaminants, such as maximizing the time between 
application and harvest of fresh fruits and vegetables'' (Section 
3.2.1.2 of the Codex Code). The recommendation to consider maximizing 
time between application of untreated amendments and harvest is 
reflected in proposed provisions described in section V.F. of this 
document, in particular proposed Sec.  112.56, which stipulates 
application

[[Page 3533]]

intervals for different biological soil amendments of animal origin.
    The Codex Code also recommends that ``existing practices should be 
reviewed to assess the prevalence and likelihood of uncontrolled 
deposits of animal faeces coming into contact with crops. Considering 
this potential source of contamination, efforts should be made to 
protect fresh produce growing areas from animals. As far as possible, 
domestic and wild animal should be excluded from the area'' (Section 
3.1 of the Codex Code). We believe that the proposed provisions in 
Sec.  112.82, which requires an adequate waiting period between grazing 
by working animals and harvesting when under the circumstances there is 
a reasonable probability that grazing or working animals will 
contaminate covered produce, and Sec.  112.83, which requires 
monitoring for wild animal intrusion and assessment of safety of 
harvest where significant intrusion is evident if under the 
circumstances there is a reasonable probability that animal intrusion 
will contaminate covered produce, are consistent with (though not 
identical to) these Codex recommendations.
    Furthermore, the proposed requirements related to the maintenance 
of records (described in section V.O. of this document) are in concert 
with the Codex documentation and records recommendations for growers 
and packers, which states: ``Growers should keep current all relevant 
information on agricultural activities such as the site of production, 
suppliers' information on agricultural inputs, lot numbers of 
agricultural inputs, irrigation practices, use of agricultural 
chemicals, water quality data, pest control and cleaning schedules for 
indoor establishments, premises, facilities, equipment and containers. 
Packers should keep current all information concerning each lot such as 
information on incoming materials (e.g. information from growers, lot 
numbers), data on the quality of processing water, pest control 
programmes, cooling and storage temperatures, chemicals used in 
postharvest treatments, and cleaning schedules for premises, 
facilities, equipment and containers, etc.'' (Section 5.7 of the Codex 
Code). In the discussion throughout section V of this document, we 
point out where the proposed provisions are consistent with these and 
other recommendations of the Codex Code.

I. Product Testing as a Strategy To Control Pathogens

    We considered requiring microbiological product testing either 
routinely or under specific conditions as a strategy to minimize known 
or reasonably foreseeable hazards. While not widely adopted, product 
testing is being used by some in the produce industry. Some produce 
buyers for retail distributors require routine microbial testing of 
product as a condition of sale in their purchasing specifications (Ref. 
52). Individual fresh-cut produce companies began product testing in 
response to the 2006 E. coli O157:H7 outbreak associated with bagged 
fresh spinach (Ref. 53). At least one company is reported to use 
product testing to verify the efficacy of good agricultural practices 
programs and to prevent contaminated product lots from entering 
commerce (Ref. 52). The California Leafy Greens Marketing Agreement 
requires crop testing for E. coli O157:H7 and Salmonella spp. whenever 
a crop has been directly contacted with water that exceeds the 
agreements' acceptance criteria for generic E. coli (Ref. 31).
    Product testing, especially microbiological testing, for process 
control purposes presents several challenges. Pathogen prevalence in 
produce as a result of contamination events that occur during growing, 
harvesting, packing, or holding on farms are generally temporally 
intermittent, non-homogeneous in a lot or a field, and at low 
concentrations (Ref. 54). Therefore, unlike some processed foods that 
may consist of batches of homogeneous material (e.g., bulk flour, milk, 
juice), produce are best thought of as individual units, and while a 
positive test result for one unit does raise concern about the rest of 
the lot or the field subject to the same conditions, procedures, 
processes, and practices, any contamination present in one unit may not 
have necessarily spread to other units. In addition, it is generally 
recognized that negative product test results do not necessarily 
indicate the absence of a hazard, particularly when the hazard is 
present at very low levels and is not uniformly distributed (Ref. 55. 
Ref. 56). Sampling plans intended to ensure detection of contamination 
with a reasonable assurance of success in produce lots or fields can be 
cost-prohibitive, and may not be effective for use in produce. For 
example, for any given contamination rate, the probability of detecting 
Salmonella increases with the number of samples tested and it is not 
feasible to identify low levels of contamination in an individual lot. 
For example, when 30 samples in a lot are tested, the probability of 
detecting Salmonella is 1 percent when the contamination rate is 1 in 
3000, 26 percent when the contamination rate is 1 in 100, and 96 
percent when the contamination rate is 1 in 10 (Ref. 57). Both industry 
and FDA survey data indicate that contamination rates in produce 
(melons, greens, tomatoes), while variable, are typically very low 
(Ref. 58. Ref. 59). In addition, microbial testing can only detect the 
pathogens that the analytical procedures are designed to detect. 
Testing instead for indicator organisms may be a viable option, but is 
not without challenges, as discussed in section V.E.2. of this 
document.
    Another factor affecting the utility of product testing for 
pathogens as a control measure is that FDA recommends, and it is 
generally industry practice, to hold any batch of product from which 
samples are taken for testing to prevent the need for a recall should 
the test results demonstrate the presence of a pathogen. With a highly 
perishable product as is the case for most produce, storing product 
during such analyses would significantly reduce the shelf-life of the 
product. For these reasons, we tentatively conclude that product 
testing would be impracticable as a component of science-based minimum 
standards proposed in this rule except as set forth in proposed subpart 
M under certain circumstances for sprouts.

J. Effective Dates

    We are proposing that the effective date of this rule would be 60 
days after the date of publication of the final rule in the Federal 
Register with staggered compliance dates. The effective date is the 
date that provisions in the rule affect the current CFR.
    An effective date of 60 days after date of publication of the final 
rule in the Federal Register would be consistent with the effective 
dates in recent FDA rules directed to food safety. See, e.g., Federal 
Register of July 9, 2009 (74 FR 33029 at 33030), establishing an 
effective date of September 8, 2009, for a final rule for the 
prevention of Salmonella Enteritidis in shell eggs during production, 
storage, and transportation; and Federal Register of June 25, 2007 (72 
FR 34751 at 34752), establishing an effective date of August 24, 2007, 
for a final rule for current good manufacturing practice in 
manufacturing, packaging, labeling, or holding operations for dietary 
supplements.

K. Compliance Dates

    We are proposing that the compliance dates for entities subject to 
the rule would be based on the size of a farm and the effective date of 
the requirement, with additional flexibility

[[Page 3534]]

for compliance with proposed provisions for water quality in Sec.  
112.44 and related provisions in Sec. Sec.  112.45 and 112.50 
(specifically, 112.50(b)(5), 112.50(b)(6), and 112.50(b)(7)).
    The compliance date for very small businesses (those subject to 
proposed part 112 and, on a rolling basis, the average annual monetary 
value of food sold during the previous three-year period is no more 
than $250,000, as defined in proposed Sec.  112.3(b)(1)) would be four 
years from the effective date (with the exception of compliance with 
Sec. Sec.  112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and 
112.50(b)(7), as discussed below). The compliance date for very small 
businesses would not be in conflict with the requirement in section 
419(b)(3)(B) of the FD&C Act for the regulations promulgated under 
section 419 to apply to very small businesses ``after the date that is 
2 years after the effective date of the final regulation. * * *'' 
because this requirement specifies that the regulations shall apply 
after, not on, the date that is 2 years after the effective date. To 
provide additional flexibility to small businesses, we would provide 
two more years for very small businesses to comply with the rule than 
is required under section 419(b)(3)(B). Providing an extended 
compliance period to very small businesses as a means of providing 
additional flexibility is consistent with our approach to compliance 
dates in recent rules directed to food safety. (See, e.g., 74 FR 33029 
at 33034 and 72 FR 34751 at 34752.)
    The compliance date for small businesses (those subject to proposed 
part 112 and, on a rolling basis, the average annual monetary value of 
food sold during the previous three-year period is no more than 
$500,000, as defined in proposed Sec.  112.3(b)(2)) would be three 
years from the effective date (with the exception of compliance with 
Sec. Sec.  112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and 
112.50(b)(7), as discussed below). The compliance date for small 
businesses would not be in conflict with the requirement in section 
419(b)(3)(A) of the FD&C Act for the regulations promulgated under 
section 419 to apply to small businesses ``after the date that is 1 
year after the effective date of the final regulation. * * *'' because 
this requirement specifies that the regulations shall apply after, not 
on, the date that is 1 year after the effective date. To provide 
additional flexibility to small businesses, we would provide two more 
years than is required under section 419(b)(3)(A). Providing an 
extended compliance period to small businesses as a means of providing 
additional flexibility is consistent with our approach to compliance 
dates in recent rules directed to food safety. (See, e.g., 74 FR 33029 
at 33034 and 72 FR 34751 at 34752.)
    The compliance date for all other farms subject to the rule would 
be two years from the effective date (with the exception of compliance 
with Sec. Sec.  112.44, 112.45, 112.50(b)(5), 112.50(b)(6), and 
112.50(b)(7), as discussed below).
    The compliance dates for water quality requirements in proposed 
Sec.  112.44 and related provisions in Sec. Sec.  112.45, 112.50(b)(5), 
112.50(b)(6), and 112.50(b)(7) would be two years beyond the compliance 
date for the rest of the final rule applicable to the farm based on its 
size. We recognize that farms may need additional time to cope with 
implementation of the water quality testing, monitoring, and related 
record-keeping provisions. This additional compliance period would also 
be expected to permit farms to consider identifying alternatives to the 
standard in proposed Sec.  112.44(b) and developing adequate scientific 
data or information necessary to support a conclusion that the 
alternative would provide the same level of public health protection as 
the standard that would be established in this part, and would not 
increase the likelihood that the covered produce will be adulterated 
under section 402 of the FD&C Act, in light of the farm's covered 
produce, practices, and conditions. The extended compliance dates for 
the water quality testing, monitoring, and related record keeping 
requirements in proposed Sec. Sec.  112.44, 112.45, 112.50(b)(5), 
112.50(b)(6), and 112.50(b)(7) would then be six years from the 
effective date for very small businesses, five years from the effective 
date for small businesses, and four years from the effective date for 
all other farms subject to the rule.
    The compliance dates would apply to all farms subject to the rule, 
including those farms that satisfy the requirements in proposed Sec.  
112.5 for an exemption from most requirements of the rule, because such 
farms have modified requirements (proposed Sec.  112.6) to which they 
would be subject on the relevant compliance date.
    We seek comment on these proposed implementation periods. In 
addition, given that activities related to produce production, 
harvesting, packing, and holding may be affected by the produce growing 
season, we seek comment on whether these compliance dates sufficiently 
address any issues related to the seasonal nature of produce-related 
activities.

V. The Proposal

A. Subpart A--General Provisions

    As proposed, subpart A contains provisions that establish the scope 
of, and definitions applicable to, this regulation, and identifies who 
is subject to the requirements of this part. This subpart also 
describes the proposed modified requirements and procedures governing 
qualified exemptions from this rule.
1. Comments Related to Proposed Provisions
    We received several comments in response to the 2010 FR notice that 
addressed issues relevant to the general scope of this proposed rule. 
Some comments requested that tree crops be exempt from this regulation. 
For example, an apple grower asserted that apples are not as 
susceptible to E. coli and other pathogens as are lettuce and tomatoes, 
and therefore they should not be subject to the same controls and 
restrictions. Additionally, one grower stated that citrus fruits should 
be exempt because citrus fruits have not been identified to be the 
source of an incident of food-borne illness, a majority of such produce 
does not touch the ground, citrus fruit are washed during the packing 
process, and the peel is rarely consumed raw. Several comments from 
produce associations requested removal of watermelons from the 
``melon'' category, stating that they should have their own category 
since they have a different risk profile from other melons. In 
addition, comments from several tree nut growers stated that some tree 
nut commodities should have less rigorous requirements or be exempt.
    As we explained in Section IV.C, we tentatively concluded that an 
approach that considers both the risk associated with the commodity and 
that associated with the agricultural practices applied to the crop 
under the conditions in which it is grown, would provide the most 
appropriate balance between public health protection, flexibility, and 
appropriate management of different levels of risk. Under this 
approach, we considered available information on outbreaks and 
contamination as well as existing evidence on characteristics of the 
commodity (such as whether the commodity grows on trees or has a smooth 
rind). This evidence informed the proposed requirements, but we have 
tentatively concluded that limiting the scope of this rule based on 
outbreak data or on the levels of frequency of pathogen detection alone 
would not adequately address the risk of serious adverse health 
consequences or death. Therefore, as discussed in section

[[Page 3535]]

V.A.2.a. of this document, we are proposing to cover apples, citrus 
fruits, watermelons, and tree nuts in this proposed rule. Because the 
scope and stringency of the regulatory requirements depends in several 
cases on the types of practices employed within operations, producers 
of different commodities who use different practices will not be 
subject to all of the same controls and restrictions. We seek comment 
on our proposed approach. Because our regulatory approach does not 
depend on categorizing commodities based on risk profiles, we do not 
see the need to distinguish among fruits, including watermelons, on 
this basis. We do note, however, that in proposed Sec.  112.1(b)(1) we 
have listed watermelons separately from other melons. While we propose 
to cover tree nuts that do not meet the criteria we propose for 
``rarely consumed raw'' (see section V.A.2.a) in this proposed rule, 
such as walnuts and almonds, we recognize that many of these tree nuts 
receive commercial processing to adequately reduce pathogens and, thus, 
may be eligible for an exemption under proposed Sec.  112.2(b) 
(discussed in section V.A.2.a. of this document). Our main food safety 
concerns relevant to on-farm growing, harvesting, packing, and holding 
of tree nuts pertain to those tree nuts that would be sold raw and 
untreated. We request comments on our treatment of tree nuts in this 
proposal.
    We also received comments regarding various activities performed on 
produce in relation to the scope of this proposed rule. One comment 
stated that ``processing'' should not refer to rinsing heads of lettuce 
or bunches of greens before they are packed for market, but rather 
should be defined specifically to include other processes that appear 
to involve additional risk to the consumer. Some comments suggested 
that no grower should be exempt from these food safety regulations, 
whereas another stakeholder stated that the produce safety standards 
must be very clear as to what constitutes produce processing versus 
produce preparation for market acceptance and that Part 110 should be 
reserved for situations where extensive commingling, cutting, washing 
and bagging of produce are practiced. Finally, a comment suggested that 
growers who deliver produce to the consumer within 24-30 hours should 
be exempt from this regulation. As discussed in section III.F. of this 
document and further in section V.A.2.b.i below, this proposed rule 
would apply to activities of farms and farm mixed-type facilities that 
are within the definition of ``farm'' proposed here. A farm or farm 
mixed-type facility that washes its own covered produce would be 
harvesting within the farm definition and therefore that activity would 
be covered by this proposed rule unless another exemption applied. 
However, a farm mixed-type facility that washes covered produce not 
grown on that farm or another farm under the same ownership for 
distribution into commerce would be engaging in an activity outside the 
farm definition (i.e., a manufacturing/processing activity). Such 
activities would not be subject to this rule but instead would be 
subject to section 418 of the FD&C Act.
    As discussed in section I of this document and the QAR, produce is 
vulnerable to contamination by pathogens, which can occur at various 
points during growing, harvesting, packing, and holding. Although 
contamination usually occurs in low doses, even low doses of some of 
these harmful pathogens can result in human illness or death (Ref. 60). 
Thus, if produce is contaminated with a pathogen, there is a reasonable 
possibility that the amount of the pathogen present will be enough to 
cause serious adverse health consequences or death to a consumer even 
without an extended time period before consumption for the pathogen to 
grow and multiply. In addition, even in cases where the delivery time 
may not exceed 24-30 hours, consumers and other recipients may store 
produce (in a refrigerator or otherwise) thereafter and not consume it 
immediately, allowing additional time for pathogen growth. Therefore, 
FDA tentatively concludes it would not be appropriate to exempt any 
farms from this proposed rule based on the speed of their deliveries to 
the consumer.
2. Proposed Requirements
a. Food Covered by This Rule
    This proposal is applicable to certain farm activities performed on 
certain produce for use as human food. Section 105 of FSMA does not 
specify whether the rulemaking conducted under that section should 
apply to human food, animal food, or both. The general rulemaking 
requirements in 419(a)(1)(A), (b)(1), and (c)(1)(A) authorize FDA to 
establish standards for the safe production and harvesting 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. FDA tentatively concludes 
that the risk posed to animals, and to humans from contact with animals 
or consumption of animals as food, by farm practices in producing and 
harvesting fruits and vegetables does not merit imposition of new 
regulatory requirements at this time. Therefore, this proposal is 
limited to produce for use as human food. Produce that is intended for 
use as animal food would not be subject to the requirements of this 
rule. This is reflected in the title of the proposed rule (``Standards 
for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption'') and its proposed location in Chapter I, Subchapter B of 
Title 21, Code of Federal Regulations (``Food for Human Consumption'').
    As proposed, Sec.  112.1 establishes the scope of food that is 
subject to this rule. Under proposed Sec.  112.1(a), food that meets 
the definition of produce in Sec.  112.3(c) and that is a raw 
agricultural commodity (RAC) as defined in section 201(r) of the FD&C 
act, would be covered by part 112, unless it is excluded by Sec.  
112.2. Section 201(r) defines ``raw agricultural commodity'' as any 
food in its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form prior to 
marketing.'' This includes produce RACs grown domestically and produce 
RACs that will be imported or offered for import in any State or 
territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico. As discussed in section III and IV of this 
document, FDA tentatively concludes that proposed Sec.  112.1(a) is 
consistent with section 419(a)(1)(A) of the FD&C Act, which directs us 
to establish science-based minimum standards for the safe production 
and harvesting of those types 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.
    We propose to establish a definition of ``produce'' in proposed 
Sec.  112.3(c) (see section V.A.2.b.iii. of this document) that would 
be relevant to the use of that term in proposed Sec.  112.1. 
``Produce'' would mean any fruit or vegetable (including specific mixes 
or categories of fruits and vegetables) grown for human consumption, 
and would include mushrooms, sprouts (irrespective of seed source), 
peanuts, tree nuts and herbs. Within the definition of ``produce,'' we 
would further define ``fruit'' and ``vegetable'' to reflect the common 
meanings of those terms.
    We would define a fruit as the edible reproductive body of a seed 
plant or tree

[[Page 3536]]

nut (such as apple, orange and almond), such that fruit would mean the 
harvestable or harvested part of a plant developed from a flower. This 
is consistent with the common meaning of the term ``fruit,'' as 
demonstrated by the Merriam-Webster Dictionary definition of ``fruit'' 
to mean, in relevant part ``the usually edible reproductive body of a 
seed plant; especially: One having a sweet pulp associated with the 
seed * * * a succulent plant part (as the petioles of a rhubarb plant) 
used chiefly in a dessert or sweet course * * * a product of 
fertilization in a plant with its modified envelopes or appendages; 
specifically: The ripened ovary of a seed plant and its contents * * 
*'' (Ref. 61).
    We would define a vegetable as the edible part of an herbaceous 
plant (such as cabbage and potato) or fleshy fruiting body of a fungus 
(such as white button and shiitake) grown for an edible part, such that 
vegetable would mean the harvestable or harvested part of any plant or 
fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, 
bulbs, stems, leaves, or flower parts are used as food and includes 
mushrooms, sprouts, and herbs (such as basil and cilantro).
    This is consistent with the common meaning of the term 
``vegetable,'' as demonstrated by the Merriam-Webster Dictionary 
definition of ``vegetable'' to mean, in relevant part, ``a usually 
herbaceous plant (as the cabbage, bean, or potato) grown for an edible 
part that is usually eaten as part of a meal; also: Such an edible part 
* * *'' (Ref. 61).
    We are proposing to specify in the definition of produce that it 
includes mushrooms, sprouts, peanuts, tree nuts and herbs, to leave no 
doubt about the status of these foods. Taxonomically, a mushroom is a 
fungus (Ref. 62). For regulatory purposes in the United States, 
however, mushrooms have generally been treated as vegetables. Mushrooms 
are classified as vegetables by USDA AMS under the Perishable 
Agricultural Commodities Act (7 U.S.C. 499a-499t) (PACA) (Ref. 63), 
using a definition stating in relevant part that ``fresh fruits and 
fresh vegetables'' means ``all produce in fresh form generally 
considered as perishable fruits and vegetables * * *'' (21 CFR 
46.2(u)). The USDA 2010 Dietary Guidelines for Americans also include 
mushrooms in the ``vegetable'' food group (Ref. 64). In addition, the 
produce industry appears to recognize mushrooms as vegetables, as 
demonstrated by various industry documents (Ref. 65. Ref. 66). 
Moreover, the hazards and controls relevant to minimizing serious 
adverse health consequences or death during the growing, harvesting, 
packing, and holding of mushrooms are generally similar to those for 
other produce (Ref. 67). Accordingly, we tentatively conclude that it 
is reasonable to include mushrooms in the proposed definition of 
``vegetable.''
    Sprouts meet the definition of ``vegetable'' above from the 
Merriam-Webster Dictionary (Ref. 61). In addition, sprouts are 
classified as vegetables by USDA AMS under PACA (Ref. 63). The USDA 
2010 Dietary Guidelines for Americans also include ``bean sprouts'' in 
the ``vegetable'' food group (Ref. 64). In addition, the produce 
industry appears to recognize sprouts as vegetables, as demonstrated by 
various industry documents (Ref. 68). Moreover, the hazards and 
controls relevant to minimizing serious adverse health consequences or 
death during the growing, harvesting, packing, and holding of sprouts 
are generally similar to those for other produce, but with additional 
controls necessary due to the unique risks presented by sprouts (Ref. 
160. Ref. 161) (see section V.M of this document). Accordingly, we 
tentatively conclude that it is reasonable to include sprouts in the 
proposed definition of ``vegetable.'' Herbs meet the definition of 
``vegetable'' above from the Merriam-Webster Dictionary (Ref. 61). 
Herbs are generally consumed in combination with other foods (for 
example, in salads or as garnishes) rather than consumed as distinct 
servings, but they nonetheless satisfy the dictionary definition of 
``vegetable.'' In addition, USDA considers herbs to be covered 
commodities under PACA, such that they are classified as ``herbs'' but 
fall within the broader category of ``fresh fruits and fresh 
vegetables'' (Ref. 63). In addition, the produce industry appears to 
recognize herbs as vegetables, as demonstrated by various industry 
documents (Ref. 66). Moreover, the hazards and controls relevant to 
minimizing serious adverse health consequences or death during the 
growing, harvesting, packing, and holding of herbs are generally 
similar to those for other produce(Ref. 13. Ref. 50). Accordingly, we 
tentatively conclude that it is reasonable to include herbs in the 
proposed definition of ``vegetable.''
    Peanuts and tree nuts both meet the definition of ``fruit'' above 
from the Merriam-Webster Dictionary (Ref. 61). The Merriam-Webster 
Dictionary defines ``peanut,'' in relevant part, as ``a low-branching 
widely cultivated annual herb * * * of the legume family with showy 
yellow flowers having a peduncle which elongates and bends into the 
soil where the ovary ripens into a pod containing one to three oily 
edible seeds * * *,'' and ``nut,'' in relevant part, as ``a hard-
shelled dry fruit or seed with a separable rind or shell and interior 
kernel * * *'' (Ref. 61). In addition, the produce industry appears to 
recognize peanuts and tree nuts as produce, as demonstrated by various 
industry documents (Ref. 65. Ref. 66). Moreover, the hazards and 
controls relevant to minimizing serious adverse health consequences or 
death during the growing, harvesting, packing, and holding of peanuts 
and tree nuts are generally similar to those for other produce (Ref. 
69. Ref. 70). Specifically, peanuts and tree nuts share the significant 
hazard of pathogens with other covered produce. To a significant 
extent, this hazard is eliminated during manufacturing/processing 
operations, such as roasting, by facilities subject to section 418 of 
the FD&C Act, rather than through measures taken by farms subject to 
this regulation. However, as discussed in section V.A.2.a below, 
peanuts meet our proposed criteria for ``rarely consumed raw'' and 
therefore would be exempt from this proposed rule. Tree nuts that do 
not meet the criteria for ``rarely consumed raw'' would also be exempt 
from this proposed regulation if you establish and keep documentation 
that demonstrates that the recipient of the produce performs commercial 
processing in accordance with proposed Sec.  112.2(b)(1). For tree nuts 
that remain subject to the proposed rule, the kinds of measures 
necessary to minimize the risk of known or reasonably foreseeable 
biological hazards are the same as those in subparts A through O of 
this proposed rule (e.g., control of soil amendments, agricultural 
water, worker hygiene). Accordingly, we conclude it is reasonable to 
include peanuts and tree nuts in the proposed definition of produce as 
a ``fruit.'' We recognize that peanuts and tree nuts are not covered 
commodities under PACA ((Ref. 63. Ref. 71) and that the USDA 2010 
Dietary Guidelines for Americans consider nuts a ``protein food'' 
rather than as part of the ``fruits and vegetables'' group for the 
purpose of providing dietary advice (Ref. 72); however, in light of the 
treatment of peanuts and tree nuts as produce in common usage and in 
the produce industry, and the commonality of on-farm hazards and 
controls for peanuts, tree nuts, and other produce (Ref. 70. Ref. 69), 
we tentatively conclude that it is reasonable to include peanuts and 
tree nuts in the proposed definition of produce as ``fruits.''
    We propose to specify in the definition of ``produce'' that the 
term would not include food grains, meaning the small, hard fruits or 
seeds of arable

[[Page 3537]]

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 would include barley, dent- or flint-corn, sorghum, oats, rice, 
rye, wheat, amaranth, quinoa, buckwheat, cotton seed, and soybean. Our 
proposed definition of ``food grains'' is consistent with the common 
meaning of the term ``grain'' when used in the context of food, as 
demonstrated by the Merriam-Webster Dictionary definition of ``grain'' 
to mean, in relevant part, ``a seed or fruit of a cereal grass * * * 
the seeds or fruits of various food plants including the cereal grasses 
and in commercial and statutory usage other plants (as the soybean) * * 
* plants producing grain * * *'' (Ref. 61). In addition, the industry 
appears to recognize grains as a separate commodity group from produce, 
as demonstrated by various industry documents regarding ``produce'' and 
``fruits and vegetables'' that do not include grains (Ref. 65. Ref. 
66). Grains are not covered commodities under PACA (Ref. 63). The USDA 
2010 Dietary Guidelines for Americans treat grains as a separate food 
group from the ``fruits and vegetables'' food group (Ref. 73). In 
addition, the hazards and controls relevant to minimizing serious 
adverse health consequences or death during the growing, harvesting, 
packing, and holding of grains are significantly different from those 
relevant to fruits and vegetables (Ref. 74). Specifically, the hazards 
of concern in grains are primarily chemical hazards such as mycotoxins 
and pesticides, rather than biological hazards (which, as discussed in 
section IV.B. of this document, are the only hazards we currently 
propose to address in this rule, as they are the most significant 
hazards affecting covered produce), because grains are milled and/or 
cooked such that pathogens that may be present are reduced to a level 
where they are unlikely to present a risk to public health for most 
products. Accordingly, we tentatively conclude that it is reasonable to 
exclude grains from the definition of ``produce.''
    Proposed Sec.  112.1(b)(1) lists specific examples of produce 
covered by this rule. Such covered produce would include almonds, 
apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots, 
bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, 
cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus 
(such as clementine, grapefruit, lemons, limes, mandarin, oranges, 
tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic, 
grapes, green beans, guava, herbs (such as basil, chives, cilantro, 
mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, 
other melons (such as canary, crenshaw and persian), mushrooms, 
nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers 
(such as bell and hot), pineapple, plums, plumcot, radish, raspberries, 
red currant, scallions, snow peas, spinach, sprouts (such as alfalfa 
and mung bean), strawberries, summer squash (such as patty pan, yellow 
and zucchini), tomatoes, walnuts, watercress and watermelon.
    The list of fruits and vegetables provided in proposed Sec.  
112.1(b)(1) is not an exhaustive list of produce covered by this rule. 
This section is intended simply to provide examples of produce commonly 
consumed in the United States that would be included within the scope 
of this regulation. The absence of a specific fruit or vegetable from 
this list does not indicate that it is not covered, except where the 
specific fruit or vegetable is exempted from the regulation by Sec.  
112.2(a)(1). We request comment on the examples of fruits and 
vegetables listed in 112.1(b)(1).
    Proposed Sec.  112.1(b)(2) would clarify that mixes of intact 
fruits and vegetables (such as fruit baskets) are also covered by this 
rule. Proposed Sec.  112.1(b)(2) is consistent with section 
419(a)(1)(A) of the FD&C Act, which includes mixes or categories of 
fruits and vegetable RACs as part of the rulemaking requirement we are 
implementing through this proposed rule.
    As proposed, Sec.  112.2(a) identifies three types of produce not 
covered by this rule. First, proposed Sec.  112.2(a)(1) provides an 
exclusion for produce that is rarely consumed raw. FDA proposes to 
establish the following exhaustive list of specific fruits and 
vegetables that would be exempt under this provision: arrowhead, 
arrowroot, artichokes, asparagus, beets, black-eyed peas, bok choy, 
brussels sprouts, chick-peas, collard greens, crabapples, cranberries, 
eggplant, figs, ginger root, kale, kidney beans, lentils, lima beans, 
okra, parsnips, peanuts, pinto beans, plantains, potatoes, pumpkin, 
rhubarb, rutabaga, sugarbeet, sweet corn, sweet potatoes, taro, 
turnips, water chestnuts, winter squash (acorn and butternut squash), 
and yams. Because these listed fruits and vegetables are almost always 
consumed only after being cooked, which is a kill-step that adequately 
reduces the presence of microorganisms of public health significance, 
we propose that these listed produce be excluded from the requirements 
of this rule. Studies have shown that the numbers of microorganisms of 
public health significance (such as Listeria monocytogenes, Salmonella, 
shiga toxin-producing E. coli) are significantly reduced in produce by 
a variety of relatively moderate heat treatments (Ref. 75. Ref. 76. 
Ref. 77. Ref. 78). Therefore, we tentatively conclude that the cooking 
that the produce listed in Sec.  112.2(a)(1) receive before they are 
consumed, whether commercially or by the consumer, would be sufficient 
to minimize the risk of serious adverse health consequences or death.
    We note that all produce commodities are and will continue to be 
covered under the adulteration provisions and other applicable 
provisions of the Federal Food, Drug, and Cosmetic Act and applicable 
implementing regulations, irrespective of whether they are included 
within the scope of this proposed rule.
    We developed this list in proposed Sec.  112.2(a)(1) of produce 
that rarely is consumed raw by analyzing consumption data on selected 
produce commodities using data available from the National Health and 
Nutrition Examination Survey (NHANES) and other resources (Ref. 79). We 
looked at the percentage of the population consuming the produce 
commodity in fresh form as well as the percentage of eating occasions 
on which the produce commodity is eaten uncooked (Ref. 79. Ref. 80). As 
explained further in a memo to the record, we found that artichokes, 
asparagus, beets, bok choy, brussels sprouts, cranberries, eggplant, 
figs, ginger root, lima beans, okra, plantains, potatoes, rhubarb, 
sweet corn, sweet potatoes, turnips, and yams are eaten uncooked by 
less than 0.1% of the U.S. population and are consumed uncooked on less 
than 0.1% of eating occasions (Ref. 79). Other commodities, including 
black-eyed peas, chick-peas, collard greens, crabapples, kale, kidney 
beans, lentils, parsnips, peanuts, pinto beans, pumpkin, rutabaga, 
sugarbeet, taro, water chestnut, and winter squash (which includes both 
acorn and butternut squash) are included in the NHANES data set but 
their categories of reported consumption do not include ``uncooked,'' 
indicating that they are not consumed uncooked in any measurable 
quantity (Ref. 79). Still other commodities on the list, namely, 
arrowhead and arrowroot, are not identified in the NHANES data set as 
being eaten in the United States in any form, uncooked or otherwise 
(Ref. 79). Other references indicated that those commodities are 
typically consumed

[[Page 3538]]

cooked (Ref. 63. Ref. 82). We request comment on the proposed criteria 
used for identifying the commodities that are rarely consumed raw. 
Further, we request comment on additional commodities that should be 
considered for inclusion in the list in 112.2(a)(1). As noted above, we 
analyzed consumption data on selected produce commodities to generate 
this list. We acknowledge that there may be additional commodities that 
would meet these criteria that we did not analyze. Also, we anticipate 
that, in the case of some commodities, the consumption rates in the 
United States may be too low for the NHANES data and other data sources 
used in our analysis to support a conclusion that the commodity is 
rarely consumed raw using our proposed criteria. We request comment on 
additional sources of information and/or criteria that should be 
applied in such cases.
    We also request comment on the inclusion of commodities that our 
analysis indicates are rarely consumed raw, but may not be prepared in 
a manner that would kill microbial contaminants, should they be present 
on the food. For example, we have included asparagus, bok choy, and 
cranberries in the list of commodities that will be exempt from the 
requirements of this rule in proposed Sec.  112.2(a)(1) because the 
NHANES data indicated that these commodities are consumed uncooked by 
less than 0.1% of the U.S. population and are consumed uncooked on less 
than 0.1% of eating occasions (Ref. 79). However, we are concerned that 
the method of food preparation that these commodities may be subjected 
(for example, stir frying bok choy) to prior to consumption may not 
constitute a kill-step that adequately reduces the presence of 
microorganisms of public health significance. We request comment on our 
tentative conclusions about these commodities and others proposed for 
exclusion in Sec.  112.2(a)(1).
    Second, Sec.  112.2(a)(2) proposes to exempt produce that is 
produced by an individual for personal consumption or produced for 
consumption on the farm or another farm under the same ownership. With 
respect to the exemption for personal consumption, section 419(g) of 
the FD&C Act specifically exempts food produced by an individual for 
personal consumption from this rulemaking, and proposed Sec.  
112.2(a)(2) implements this exclusion. With respect to the exclusion 
for produce for consumption on the farm or another farm under the same 
ownership, such activities are within the definition of farm that we 
propose here, and would therefore be subject to this rule without an 
exemption. To the extent that there is any difference between produce 
``for personal consumption'' and produce ``consumed on the farm or 
another farm under the same ownership,'' FDA proposes to exclude 
produce for either type of consumption from this proposed rule.
    Third, Sec.  112.2(a)(3) proposes to exclude produce that is not a 
raw agricultural commodity from this proposed rule. For example, this 
would exclude ``fresh-cut'' produce, which is subject to current part 
110 and to section 418 of the FD&C Act as applicable (Ref. 83). This is 
consistent with section 419(a)(1)(A) of the FD&C Act, which directs FDA 
to ``establish science-based minimum standards for the safe production 
and harvesting of those types of fruits and vegetables * * * that are 
raw agricultural commodities * * *.'' This is also consistent with the 
application of this rule to activities within the farm definition. In 
section V.A.2.b.i of this document, we discuss how we considered how 
the activities of farms relate to the concept of a RAC and tentatively 
concluded that the farm definition and related definitions in this 
proposed rule should be revised based on the concept that RACs are the 
essential products of farms. Accordingly, the definitions proposed here 
(for the terms farm, mixed-type facility, harvesting, manufacturing/
processing, packing, and holding) reflect the tentative conclusion that 
activities involving RACs that farms traditionally do for the purposes 
of growing their own RACs, removing them from the growing areas and 
preparing them for use as a food RAC, and for packing, holding and 
transporting them, should all be within the definition of ``farm.'' 
This is the case even if the same activities off-farm would be 
considered to be ``manufacturing/processing'' because those activities 
involve ``making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food.'' This special 
classification of on-farm activities, however, should only apply to 
RACs because only RACs, not processed foods, are the essential products 
of farms. For all of these reasons, RACs are a logical and appropriate 
focus for these produce safety standards.
    In addition to these three exemptions mentioned above, under the 
conditions specified in Sec.  112.2(b), we propose to allow covered 
produce which receives commercial processing that adequately reduces 
the presence of microorganisms of public health significance to be 
eligible for an exemption from the requirements of this part (except 
for subparts A, Q, and O). Examples of commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance are processing in accordance with the requirements of part 
113, part 114, or part 120; treating with a validated process to 
eliminate spore-forming microorganisms (such as processing to produce 
tomato paste or shelf-stable tomatoes); and processing such as refining 
or distilling produce into products such as sugar, oil, spirits, or 
similar products. As discussed in section IV.C. of this document, FDA 
tentatively concludes that such commercial processing significantly 
minimizes the risk of serious adverse health consequences or death 
associated with biological hazards for such produce, such that the 
produce can be considered to be low risk and the imposition of the 
requirements in this proposed rule is not warranted. We note that such 
produce is and will continue to be covered under the adulteration 
provisions and other applicable provisions of the Federal Food, Drug, 
and Cosmetic Act and applicable implementing regulations, irrespective 
of whether it is included within the scope of this proposed rule.
    As proposed, to qualify for the Sec.  112.2(b) exemption, proposed 
Sec.  112.2(b)(2) would require you to establish and keep documentation 
of the identity of the recipient of the covered produce that performs 
the commercial processing in accordance with the requirements of 
proposed subpart O. FDA tentatively concludes that such records are 
necessary for the efficient enforcement of the FD&C Act. Without such 
records, FDA would have no way to assess whether farms are complying 
with the terms of this exemption. In addition, proposed Sec.  
112.2(b)(3) would clarify that the requirements of subparts A and Q 
apply to such produce because subpart A includes relevant provisions 
such as the scope of this rule and definitions, and Q contains 
provisions relating to compliance and enforcement.
    It is important to note that any of the exemptions in proposed 
Sec.  112.2 are only applicable to the produce specified in the 
exemption. In other words, a covered farm may not rely on these 
exemptions for all of its covered produce simply because a subset of 
that produce is rarely consumed raw; is for personal or on-farm 
consumption; is not a RAC; or will receive the requisite commercial 
processing; in those instances, only the subset that meets the relevant 
exemption criteria would be exempt from this proposed rule. For

[[Page 3539]]

example, if you own or operate a farm that produces both tomatoes that 
will be processed into tomato paste, and tomatoes that will not receive 
any commercial processing to adequately reduce pathogens, and you do 
not qualify for any other exemption, you would be subject to the rule 
when you grow, harvest, pack or hold those tomatoes that will not be 
processed to adequately reduce pathogens. Likewise, if you produce both 
artichokes and lettuce, you would be subject to the rule when you grow, 
harvest, pack or hold lettuce, but you would not be subject to the rule 
when you grow, harvest, pack, or hold artichokes.
    We request comment on proposed Sec. Sec.  112.1 and 112.2, 
including the specific examples of produce that would be covered by the 
rule; the list of produce that would not be covered by the rule because 
it is rarely consumed raw; and the proposed exemption for produce that 
receives commercial processing, including the types of processing that 
should qualify for this exemption.
b. Definitions
    Proposed Sec.  112.3 would establish the definitions of terms for 
purposes of part 112. To the extent possible, the new definitions 
proposed in Sec.  112.3 are consistent with the common meanings of 
these terms as well as the definitions of the terms in other food 
safety regulations (see, e.g., current Sec.  110.3 and Sec.  111.3) and 
other applicable sources. As proposed in Sec.  112.3(a), to provide 
clarity and consistency, the definitions and interpretations of terms 
in section 201 of the FD&C Act will apply to such terms when used in 
part 112.
i. Definitions of ``Farm,'' ``Mixed-Type Facility,'' and Related 
Activities
    We are proposing to establish an inter-related series of 
definitions in this proposed rule that, collectively, would address 
several issues related to the scope of establishments (namely, 
``farms'') that would be subject to the rule. These inter-related 
definitions include two definitions for types of establishments (i.e., 
``farm'' and ``mixed-type facility'') and five definitions for types of 
activities (i.e., ``harvesting,'' ``holding,'' ``manufacturing/
processing,'' ``packaging,'' and ``packing'') conducted on farms and 
mixed-type facilities.
    These proposed definitions are based on definitions already 
established in our regulations (e.g., in Sec.  1.227 in the regulations 
for Registration of Food Facilities, established under section 415 of 
the FD&C Act; hereinafter the section 415 registration regulations). 
However, the definitions that we are proposing for the purpose of the 
produce safety rule have some differences relative to the current 
definitions established in the section 415 registration regulations. In 
the near future, we plan to address how we will coordinate the 
definitions in the section 415 registration regulations with the 
definitions we are proposing for the purpose of the produce safety 
proposed rule.
    In developing these proposed definitions, we considered how the 
activities of farms relate to the statutory concepts of ``raw 
agricultural commodity'' and ``processed food.'' The FD&C Act defines 
``raw agricultural commodity'' and ``processed food'' in relation to 
each other, and identifies certain activities that transform a raw 
agricultural commodity (RAC) into a processed food and others that do 
not. Section 201(r) of the FD&C Act (21 U.S.C. 321(r)) defines ``raw 
agricultural commodity'' to mean ``any food in its raw or natural 
state, including all fruits that are washed, colored, or otherwise 
treated in their unpeeled natural form prior to marketing.'' Section 
201(gg) of the FD&C Act (21 U.S.C. 321(gg)) defines ``processed food'' 
to mean ``any food other than a raw agricultural commodity and includes 
any raw agricultural commodity that has been subject to processing, 
such as canning, cooking, freezing, dehydration, or milling.'' In 
addition, section 201(q)(1)(B)(i)(II) of the FD&C Act (which defines 
pesticide chemicals) contains the following language regarding 
activities that do not transform a RAC into a processed food: ``the 
treatment [with pesticide chemicals] is in a manner that does not 
change the status of the food as a raw agricultural commodity 
(including treatment through washing, waxing, fumigating, and packing 
such commodities in such manner).''
    The status of a food as a RAC or processed food is relevant for 
many different purposes under the FD&C Act, including section 
419(a)(1)(A) of the FD&C Act, which authorizes FDA to establish minimum 
science-based standards applicable to certain fruits and vegetables 
that are RACs. For example, under 403(w) of the FD&C Act (21 U.S.C. 
343(w)), labeling requirements related to major food allergens apply to 
processed foods but do not apply to RACs. Under sections 201(q), 
403(k), 403(l), and 408 of the FD&C Act (21 U.S.C. 321(q), 343(k), 
343(l), and 346a), the status of a food as a RAC has an impact on the 
manner in which pesticide chemicals and their residues are regulated. 
FSMA created more provisions in the FD&C Act and elsewhere that take 
status as a RAC or processed food into account, including section 
417(f) of the FD&C Act (21 U.S.C. 350f(f)), establishing notification 
requirements for reportable foods that do not apply to fruits and 
vegetables that are RACs; section 418(m) of the FD&C Act, which 
authorizes FDA to exempt or modify the requirements for compliance 
under section 418 with respect to facilities that are solely engaged in 
the storage of RACs other than fruits and vegetables intended for 
further distribution or processing; and section 204(d)(6)(D) of FSMA 
(21 U.S.C. 2223(d)(6)(D)), which contains special provisions for 
commingled RACs applicable to FDA's authority under section 204 of FSMA 
to establish additional recordkeeping requirements for high risk foods.
    The term ``raw agricultural commodity'' and similar terms also 
appear in other Federal statutes. While these statutes are not 
implemented or enforced by FDA and do not directly impact the 
interpretation of the definitions in sections 201(r) and 201(gg) of the 
FD&C Act, they do provide some suggestions about what ``raw 
agricultural commodity'' and related concepts can mean in various 
circumstances. For example, the Secretary of Transportation may 
prescribe commercial motor vehicle safety standards under 49 U.S.C. 
31136, but the Motor Carrier Safety Improvement Act of 1999 (Pub. L. 
106-159, title II, Sec. 229, Dec. 9, 1999), as added and amended by the 
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A 
Legacy for Users (Pub. L. 109-59, title IV, Sec. 4115, 4130, Aug. 10, 
2005), provided an exemption from maximum driving or on-duty times for 
drivers transporting ``agricultural commodities'' or farm supplies 
within specific areas during planting and harvest periods. In that 
circumstance, ``agricultural commodity'' is defined as ``any 
agricultural commodity, non-processed food, feed, fiber, or livestock * 
* * and insects'' (49 U.S.C. 31136 note). Another example is 19 U.S.C. 
1677(4)(E), which provides for certain circumstances in which producers 
or growers of raw agricultural products may be considered part of the 
industry producing processed foods made from the raw agricultural 
product for the purposes of customs duties and tariffs related to such 
processed foods. In that circumstance, ``raw agricultural product'' is 
defined as ``any farm or fishery product'' (19 U.S.C. 1677(4)(E)). 
These statutes are informative in that they suggest that the ``raw 
agricultural commodity'' concept describes and

[[Page 3540]]

signifies the products of farms in their natural states, or, in other 
words, that which a farm exists to produce on a basic level.
    Because the status of a food as a RAC or processed food is of great 
importance in defining the jurisdiction of FDA and the U.S. 
Environmental Protection Agency (EPA) over antimicrobial substances, 
FDA and EPA have developed guidance regarding whether or not various 
activities transform RACs into processed foods. FDA and EPA jointly 
issued a legal and policy interpretation of the agencies' jurisdiction 
under the FD&C Act over antimicrobial substances used in or on food 
(hereinafter the ``1998 Joint EPA/FDA Policy Interpretation'') (63 FR 
54532, October 9, 1998). In 1999, FDA issued guidance addressing 
several of the issues discussed in the 1998 Joint EPA/FDA Policy 
Interpretation. (See Guidance for Industry: Antimicrobial Food 
Additives, July 1999 (hereinafter ``Antimicrobial Guidance'') (Ref. 
84)). Table 1 summarizes activities that cause food RACs to become 
processed foods and activities that do not change the status of a food 
RAC, as set out in the 1998 Joint EPA/FDA Policy Interpretation and the 
Antimicrobial Guidance.

        Table 1--The Effect of Activities on RACs That Are Foods
------------------------------------------------------------------------
  Activities that change a RAC into a     Activities that do not change
             processed food                    the status of a RAC
------------------------------------------------------------------------
Canning................................  Application of pesticides
                                          (including by washing, waxing,
                                          fumigation, or packing).
Chopping...............................  Coloring.
Cooking................................  Drying for the purpose of
                                          storage or transportation.
Cutting................................  Hydro-cooling.
Drying that creates a distinct           Otherwise treating fruits in
 commodity.                               their unpeeled natural form.
Freezing...............................  Packing.
Grinding...............................  Refrigeration.
Homogenization.........................  Removal of leaves, stems, and
                                          husks.
Irradiation............................  Shelling of nuts.
Milling................................  Washing.
Pasteurization.........................  Waxing.
Peeling................................  Activities designed only to
                                          isolate or separate the
                                          commodity from foreign objects
                                          or other parts of the plant.
Slaughtering animals for food and
 activities done to carcasses post-
 slaughter, including skinning,
 eviscerating, and quartering.
Slicing.
Activities that alter the general state
 of the commodity.
------------------------------------------------------------------------

    In developing the proposed definitions, we also considered the 
definition of ``manufacturing/processing'' that FDA established in 
Sec.  1.227. Under Sec.  1.227(b)(6), ``manufacturing/processing'' 
means making food from one or more ingredients, or synthesizing, 
preparing, treating, modifying or manipulating food, including food 
crops or ingredients. Examples of manufacturing/processing activities 
are cutting, peeling, trimming, washing, waxing, eviscerating, 
rendering, cooking, baking, freezing, cooling, pasteurizing, 
homogenizing, mixing, formulating, bottling, milling, grinding, 
extracting juice, distilling, labeling, or packaging. The summary in 
Table 1 demonstrates that the activities that transform a RAC into a 
processed food (and are sometimes therefore referred to as 
``processing'' in the context of a food's status as a RAC or processed 
food) are not coextensive with the definition of ``manufacturing/
processing'' that FDA established in Sec.  1.227(b)(6) for the purposes 
of the section 415 registration regulations. The definition of 
``Manufacturing/processing'' in that regulation includes most food-
handling activities because it is satisfied by any degree of ``making 
food from one or more ingredients, or synthesizing, preparing, 
treating, modifying or manipulating food.'' In contrast, transforming a 
RAC into a processed food seems to require meeting a threshold of 
altering the general state of the commodity (Ref. 3, section 7 and 63 
FR 54532 at 54541), sometimes referred to as transformation of the RAC 
into a new or distinct commodity (61 FR 2386 at 2388). Because the 
activities that transform a RAC into a processed food are not 
coextensive with the definition of ``manufacturing/processing'' in 
Sec.  1.227(b)(6), a given activity may be manufacturing/processing 
under the current definition in Sec.  1.227(b)(6) without transforming 
a RAC into a processed food. Examples of such activities include 
coloring, washing, and waxing.
    The current section 415 registration regulations demonstrate that 
some activities may be classified differently on farms and off farms. 
For example, ``washing'' is an example of manufacturing/processing 
under the definition of that term in Sec.  1.227(b)(6). However, 
``washing'' produce is identified as part of harvesting under the farm 
definition in Sec.  1.227(b)(3), so washing on farms is harvesting 
rather than manufacturing/processing under the Section 415 registration 
regulations. To date, we have not articulated organizing principles 
explaining these differences.
    In this document, we are tentatively articulating five organizing 
principles (summarized in Table 2 below) to explain the basis for the 
proposed definitions that would classify activities on-farm and off-
farm for the purpose of this proposed rule. In the near future, we plan 
to address how we will coordinate the definitions in the section 415 
registration regulations with the definitions we are proposing for the 
purpose of this proposed rule.
    First Organizing Principle. The statutes we describe above, and 
previous interpretations of the concepts of RACs and processed food as 
set forth in the 1998 Joint EPA/FDA Policy Interpretation and the 
Antimicrobial Guidance, lead FDA to tentatively conclude that the basic 
purpose of farms is to produce RACs and that RACs are the essential 
products of farms.
    Second Organizing Principle. Our second organizing principle is 
that activities that involve RACs and that farms traditionally do for 
the purposes of growing their own RACs, removing them from the growing 
areas, and preparing them for use as a food RAC, and for packing, 
holding and transporting them, should all be within the definition of 
``farm.'' This is because

[[Page 3541]]

the basic purpose of farms is to produce RACs (principle 1). This is 
the case even if the same activities off-farm would be considered to be 
manufacturing/processing, because those activities involve ``making 
food from one or more ingredients, or synthesizing, preparing, 
treating, modifying or manipulating food.''
    Third Organizing Principle. Activities should be classified based 
in part on whether the food operated on is a RAC or a processed food, 
and on whether the activity transforms a RAC into a processed food. 
This is because principle 2 (i.e., the special classification of on-
farm activities) should only apply to RACs. A farm that chooses to 
transform its RACs into processed foods should be considered to have 
chosen to expand its business beyond the traditional business of a 
farm.
    Fourth Organizing Principle. Principle 2 (i.e., the special 
classification of on-farm activities) should only apply to RACs grown 
or raised on the farm itself or on other farms under the same ownership 
because the essential purpose of a farm is to produce its own RACs, not 
to handle RACs grown on unrelated farms for distribution into commerce. 
(For the purposes of this discussion, we refer to RACs grown or raised 
on a farm or another farm under the same ownership as a farm's ``own 
RACs,'' in contrast to RACs grown on a farm under different ownership, 
which we refer to as ``others' RACs.'') Activities that farms may 
perform on others' RACs should appropriately be classified as 
manufacturing/processing, packing, or holding in the same manner as 
these activities are classified off-farm when the RACs are to be 
distributed into commerce. In general, when a farm opts to perform 
activities outside the farm definition, the establishment's activities 
that are within the farm definition should be classified as 
manufacturing/processing, packing, or holding in the same manner as for 
a farm that does not perform activities outside the farm definition, 
but the activities that are outside the farm definition should be 
classified in the same manner as for an off-farm food establishment.
    Fifth Organizing Principle. Manufacturing/processing, packing, or 
holding food-- whether RACs or processed foods, from any source--for 
consumption on the farm should remain within the farm definition 
because otherwise farms could not feed people and animals on the farm 
without being considered to have engaged in activities outside the farm 
definition.

  Table 2--Summary of Organizing Principles Regarding Classification of
                     Activities On-Farm and Off-Farm
------------------------------------------------------------------------
            Number                        Organizing principle
------------------------------------------------------------------------
1............................  The basic purpose of farms is to produce
                                RACs and RACs are the essential products
                                of farms.
2............................  Activities that involve RACs and that
                                farms traditionally do for the purposes
                                of growing their own RACs, removing them
                                from the growing areas, and preparing
                                them for use as a food RAC, and for
                                packing, holding and transporting them,
                                should all be within the definition of
                                ``farm.''
3............................  Activities should be classified based in
                                part on whether the food operated on is
                                a RAC or a processed food, and on
                                whether the activity transforms a RAC
                                into a processed food.
4............................  Activities farms may perform on others'
                                RACs should appropriately be classified
                                as manufacturing/processing, packing, or
                                holding in the same manner as these
                                activities are classified off-farm when
                                the RACs are to be distributed into
                                commerce.
5............................  Manufacturing/processing, packing, or
                                holding food--whether RACs or processed
                                foods, from any source--for consumption
                                on the farm should remain within the
                                farm definition.
------------------------------------------------------------------------

    We are proposing to include definitions for two types of 
establishments (i.e., ``farm'' and ``mixed-type facility'') and five 
types of activities (i.e., ``harvesting,'' ``holding,'' 
``manufacturing/processing,'' ``packaging,'' and ``packing''), to 
reflect the organizing principles articulated immediately above and to 
clarify how those definitions apply to specific activities depending on 
where the activities take place, the food used in the activities, where 
the food comes from, and where the food is consumed. We discuss these 
proposed definitions in this section because they are inter-related; 
however, we propose that they appear in Sec.  112.3(c) in alphabetical 
order with the other definitions discussed in section V.A.2.b.iii of 
this document below.
    We are proposing to define ``farm'' 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. The term 
``farm'' includes: (i) 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 (ii) 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. The proposed definition of ``farm'' is based on the 
definition already established in Sec.  1.227(b) in the section 415 
registration regulations, except that it does not include the statement 
``Washing, trimming of outer leaves of, and cooling produce are 
considered part of harvesting.'' The description of harvesting 
activities is included in a separate proposed definition of 
``harvesting'' and thus would be redundant in the proposed definition 
of ``farm.''
    We are proposing to define ``Mixed-type facility'' to mean an 
establishment that engages in both activities that are exempt from 
registration under section 415 of the FD&C Act and activities that 
require the establishment to be registered. This term and its 
definition were initially developed in the preamble to the proposed 
rule on food facility registration (68 FR 5378 at 5381) and in the 
interim final rule on food facility registration (68 FR 58894 at 58906-
7, 58914, 58934-8). The proposed definition would also provide, as an 
example of such a facility, a definition of a ``farm mixed-type 
facility.'' A ``farm mixed-type facility'' would be defined as an 
establishment that grows and harvests crops or raises animals and may 
conduct other activities within the farm definition, but also conducts 
activities that require the establishment to be registered. This 
definition is important to include in this rule because the activities 
of farm mixed-type facilities that are within the definition of 
``farm'' are potentially subject to this rule, as provided in proposed 
Sec.  112.4. FDA would apply this proposed rule only to the ``farm'' 
portion of these establishments' activities, and not to the ``non-
farm'' portion of their activities (which would be subject to section 
418 of the FD&C Act and therefore not subject to this proposed rule, 
consistent with section 419(h) of the FD&C Act). Put another way, farms 
and the ``farm'' portion of

[[Page 3542]]

the activities of farm mixed-type facilities would be subject to this 
proposed rule as applicable. For simplicity, FDA proposes to reference 
these activities collectively in proposed Sec.  112.4(a) as one aspect 
of what makes an entity a ``covered farm'' and then to refer only to 
``covered farms'' throughout the proposed rule. Thus, references to 
``farms'' and ``covered farms'' throughout this proposed rule should be 
understood to include the portion of a farm mixed-type facility's 
activities that are within the farm definition.
    We are proposing to define the term ``Harvesting'' to apply to 
farms and farm mixed-type facilities and be defined as activities that 
are traditionally performed by 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 would be limited to 
activities performed on raw agricultural commodities on the farm on 
which they were grown or raised, or another farm under the same 
ownership. Harvesting would not include activities that transform a raw 
agricultural commodity, 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. 
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 or another farm under the same 
ownership would be listed as examples of harvesting. This proposed 
definition would include the same examples of ``harvesting'' that are 
currently part of the farm definition in Sec.  1.227(b)(3) (washing, 
trimming of outer leaves, and cooling) and would add other examples to 
help clarify the scope of the definition of harvesting. ``Harvesting'' 
is a category of activities that is only applicable to farms and farm 
mixed-type facilities. Activities that would be ``harvesting'' when 
performed on a farm on the farm's own RACs would be classified 
differently under other circumstances, such as at a processing facility 
that is not on a farm, or when performed by a farm on others' RACs. For 
example, at an off-farm facility that packs tomatoes, washing the 
tomatoes after they are received would not be ``harvesting'' because it 
is not being performed on the farm that produced the tomatoes (or 
another farm under the same ownership). Instead, washing tomatoes at 
the off-farm packing facility would be ``manufacturing,'' because it 
involves preparing, treating, modifying, or manipulating food.
    We are proposing to define ``Holding'' to mean the storage of food. 
The proposed definition would state that, for farms and farm mixed-type 
facilities, holding would also include activities traditionally 
performed by farms for the safe or effective storage of RACs grown or 
raised on the same farm or another farm under the same ownership, but 
would not include activities that transform a 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. This would mean that more activities 
than just storage of food would be classified as ``holding'' when a 
farm or farm mixed-type facility performs those activities on its own 
RACs. For example, fumigating or otherwise treating a farm's own RACs 
against pests for the purpose of safe and effective storage would be 
``holding'' under this proposed definition. However, fumigating or 
otherwise treating food against pests under other circumstances (such 
as off-farm or by a farm handling others' RACs) would not be 
``holding'' food because it is not storage of food, which would remain 
the definition of holding applicable to most circumstances.
    We are proposing to define ``Manufacturing/processing'' to mean 
making food from one or more ingredients, or synthesizing, preparing, 
treating, modifying or manipulating food, including food crops or 
ingredients. The proposed definition would also state that, for farms 
and farm mixed-type facilities, manufacturing/processing would not 
include activities that are part of harvesting, packing, or holding. 
Under this proposed definition, the expanded definitions of ``packing'' 
and ``holding,'' and the extra category ``harvesting,'' would apply to 
activities performed by farms and farm mixed-type facilities on their 
own RACs. These expanded and extra categories would not apply off-farm 
or to foods other than a farm's own RACs or a farm mixed-type 
facility's own RACs. Thus, some activities that would otherwise be 
manufacturing/processing would instead be defined as packing, holding, 
or harvesting by virtue of being performed by a farm or farm mixed-type 
facility on its own RACs. Accordingly, these activities would not be 
manufacturing/processing because they would already be classified into 
the expanded definitions of packing or holding, or into the extra 
category of harvesting.
    We are proposing to define ``Packaging'' to mean (when used as a 
verb) placing food into a container that directly contacts the food and 
that the consumer receives. We are proposing to use the same definition 
of ``packaging'' as is currently established in Sec.  1.227.
    We are proposing to define ``Packing'' to mean placing food into a 
container other than packaging the food. The proposed definition would 
also state that, for farms and farm mixed-type facilities, packing 
would also include activities (which may include packaging) 
traditionally performed by farms to prepare RACs grown or raised on the 
same farm or another farm under the same ownership for storage and 
transport, but would not include activities that transform a 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. This would mean that more 
activities than just placing food into a container other than packaging 
would be classified as ``packing'' when a farm or farm mixed-type 
facility performs those activities on its own RACs. For example, 
packaging (placing food into a container that directly contacts the 
food and that the consumer receives) a farm's own RACs would be 
``packing'' under this definition because farms traditionally do this 
to provide greater protection for fragile RACs than would be possible 
if the RACs were placed in containers other than the consumer 
container, and because this activity does not transform a RAC into a 
processed food. However, packaging food under other circumstances would 
not be ``packing'' food because packaging is explicitly excluded from 
the definition of packing applicable to most circumstances (placing 
food into a container other than packaging). Other examples of 
activities that could be packing when performed by a farm or a farm 
mixed-type facility on its own RACs include packaging or packing a mix 
of RACs together (e.g., in a bag containing three different colored 
bell peppers, or a box of mixed produce for a community sponsored 
agriculture program farm share); coating RACs with wax, oil, or resin 
coatings used for the purposes of storage or transport; placing 
stickers on RACs; labeling packages containing RACs; sorting, grading, 
or culling RACs; and drying RACs for the purpose of storage or 
transport.
    Table 3 provides examples of how we would classify activities 
conducted off-farm and on-farm (including farm mixed-type facilities) 
using these proposed definitions.

[[Page 3543]]



                      Table 3--Classification of Activities Conducted Off-Farm and On-Farm
                                     [including farm mixed-type facilities]
----------------------------------------------------------------------------------------------------------------
                                                                                  On farm (including farm mixed-
                Classification                             Off farm                      type facilities)
----------------------------------------------------------------------------------------------------------------
Harvesting...................................  Notes: Not applicable.            Notes: Activities traditionally
                                                Harvesting is a classification    performed by farms for the
                                                that only applies on farms and    purpose of removing RACs from
                                                farm mixed-type facilities.       growing areas and preparing
                                                                                  them for use as food.
                                                                                  Harvesting is limited to
                                                                                  activities performed on RACs
                                                                                  on the farm on which they were
                                                                                  grown or raised, or another
                                                                                  farm under the same ownership.
                                                                                  Harvesting does not include
                                                                                  activities that change a RAC
                                                                                  into processed food.
                                                                                  Activities that are harvesting
                                                                                  are within the farm
                                                                                  definition.
                                               Examples: Not applicable........  Examples: activities that fit
                                                                                  this definition when performed
                                                                                  on a farm's ``own RACs'' (a
                                                                                  term we use to include RACs
                                                                                  grown or raised on that farm
                                                                                  or another farm under the same
                                                                                  ownership) include gathering,
                                                                                  washing, trimming of outer
                                                                                  leaves, removing stems and
                                                                                  husks, sifting, filtering,
                                                                                  threshing, shelling, and
                                                                                  cooling. These activities,
                                                                                  performed on a farm's own
                                                                                  RACs, are inside the farm
                                                                                  definition.
Packing......................................  Notes: Placing food in a          Notes: Placing food in a
                                                container other than packaging    container other than packaging
                                                the food (where packaging means   the food (using the same
                                                placing food into a container     definition of packaging), or
                                                that directly contacts the food   activities (which may include
                                                and that the consumer receives).  packaging) traditionally
                                                                                  performed by farms to prepare
                                                                                  RACs grown or raised on that
                                                                                  farm or another farm under the
                                                                                  same ownership for storage or
                                                                                  transport. Packing does not
                                                                                  include activities that change
                                                                                  RAC into a processed food.
                                                                                  Activities that are packing
                                                                                  are within the farm definition
                                                                                  when they are performed on
                                                                                  food grown, raised, or
                                                                                  consumed on that farm or
                                                                                  another farm under the same
                                                                                  ownership; under any other
                                                                                  circumstances they are outside
                                                                                  the farm definition.
                                               ................................
                                               Examples: putting individual      Examples: activities that fit
                                                unit cartons into a larger box    the definition of packing when
                                                used for shipping, and putting    performed on a farm's own RACs
                                                articles of produce in non-       include packaging, mixing,
                                                consumer containers (such as      coating with wax/oil/resin for
                                                shipping crates).                 the purpose of storage or
                                                                                  transport, stickering/
                                                                                  labeling, drying for the
                                                                                  purpose of storage or
                                                                                  transport, and sorting/grading/
                                                                                  culling. These activities,
                                                                                  performed on a farm's own
                                                                                  RACs, are inside the farm
                                                                                  definition.
                                                                                 Activities that fit the
                                                                                  definition of packing when
                                                                                  performed on a farm on any
                                                                                  other foods, including RACs
                                                                                  grown or raised on a farm not
                                                                                  under the same ownership,
                                                                                  include putting individual
                                                                                  unit cartons into a larger box
                                                                                  used for shipping, and putting
                                                                                  articles of produce in non-
                                                                                  consumer containers (such as
                                                                                  shipping crates)--the same
                                                                                  activities that fit the
                                                                                  definition of packing off
                                                                                  farm. These activities,
                                                                                  performed on food other than a
                                                                                  farm's own RACs, are outside
                                                                                  the farm definition unless
                                                                                  done on food for consumption
                                                                                  on the farm.
Holding......................................  Notes: Storage of food..........  Notes: Storage of food, or
                                                                                  activities traditionally
                                                                                  performed by farms for the
                                                                                  safe or effective storage of
                                                                                  RACs grown or raised on that
                                                                                  farm or another farm under the
                                                                                  same ownership. Holding does
                                                                                  not include activities that
                                                                                  change a RAC into a processed
                                                                                  food. Activities that are
                                                                                  holding are within the farm
                                                                                  definition when they are
                                                                                  performed on food grown,
                                                                                  raised, or consumed on that
                                                                                  farm or another farm under the
                                                                                  same ownership; under any
                                                                                  other circumstances they are
                                                                                  outside the farm definition.
                                               Example: storing food, such as    Examples: activities that fit
                                                in a warehouse.                   the definition of holding when
                                                                                  performed on a farm's own RACs
                                                                                  include fumigating during
                                                                                  storage, and storing food,
                                                                                  such as in a warehouse. These
                                                                                  activities, performed on a
                                                                                  farm's own RACs, are inside
                                                                                  the farm definition.

[[Page 3544]]

 
                                                                                 An activity that fit the
                                                                                  definition of holding when
                                                                                  performed on a farm on any
                                                                                  other foods, including RACs
                                                                                  grown or raised on a farm not
                                                                                  under the same ownership, is
                                                                                  storing food, such as in a
                                                                                  warehouse--the same activity
                                                                                  that fits the definition of
                                                                                  holding off farm. This
                                                                                  activity, performed on food
                                                                                  other than a farm's own RACs,
                                                                                  is outside the farm definition
                                                                                  unless done on food for
                                                                                  consumption on the farm.
Manufacturing/Processing.....................  Notes: Making food from 1 or      Notes: Making food from 1 or
                                                more ingredients, or              more ingredients, or
                                                synthesizing, preparing,          synthesizing, preparing,
                                                treating, modifying, or           treating, modifying, or
                                                manipulating food. Includes       manipulating food; except for
                                                packaging (putting food in a      things that fall into the
                                                container that directly           categories of harvesting,
                                                contacts food and that consumer   packing, or holding (see rows
                                                receives).                        above). Activities that are
                                                                                  manufacturing/processing are
                                                                                  outside the farm definition
                                                                                  unless done on food for
                                                                                  consumption on the farm.
                                               Examples: activities that fit     Examples: activities that fit
                                                this definition include           the definition of
                                                washing, trimming of outer        manufacturing/processing when
                                                leaves, removing stems and        performed on a farm's own RACs
                                                husks, sifting, filtering,        include slaughtering animals
                                                threshing, shelling, cooling,     or post-slaughter operations,
                                                packaging, mixing, coating,       irradiation, cutting/coring/
                                                stickering/labeling, drying,      chopping/slicing, canning,
                                                sorting/grading/culling not       coating with things other than
                                                incidental to packing or          wax/oil/resin, drying that
                                                holding, fumigating,              creates a distinct commodity,
                                                slaughtering animals or post-     artificial ripening, cooking,
                                                slaughter operations,             pasteurizing/homogenizing,
                                                irradiation, cutting/coring/      infusing, distilling, salting,
                                                chopping/slicing, canning,        smoking, grinding/milling, and
                                                artificial ripening, cooking,     freezing. These activities,
                                                pasteurizing/homogenizing,        performed on a farm's own
                                                infusing, distilling, salting,    RACs, are outside the farm
                                                smoking, grinding/milling, and    definition unless done on food
                                                freezing.                         for consumption on the farm.
                                                                                 Activities that fit the
                                                                                  definition of manufacturing/
                                                                                  processing when performed on a
                                                                                  farm on any other foods,
                                                                                  including RACs grown or raised
                                                                                  on a farm not under the same
                                                                                  ownership include washing,
                                                                                  trimming of outer leaves,
                                                                                  removing stems and husks,
                                                                                  sifting, filtering, threshing,
                                                                                  shelling, cooling, packaging,
                                                                                  mixing, coating, stickering/
                                                                                  labeling, drying, sorting/
                                                                                  grading/culling not incidental
                                                                                  to packing or holding,
                                                                                  fumigating, slaughtering
                                                                                  animals or post-slaughter
                                                                                  operations, irradiation,
                                                                                  cutting/coring/chopping/
                                                                                  slicing, canning, artificial
                                                                                  ripening, cooking,
                                                                                  pasteurizing/homogenizing,
                                                                                  infusing, distilling, salting,
                                                                                  smoking, grinding/milling, and
                                                                                  freezing--the same activities
                                                                                  that fit the definition of
                                                                                  manufacturing/processing off
                                                                                  farm. These activities,
                                                                                  performed on food other than a
                                                                                  farm's own RACs, are outside
                                                                                  the farm definition unless
                                                                                  done on food for consumption
                                                                                  on the farm.
----------------------------------------------------------------------------------------------------------------

ii. Proposed Definitions of ``Very Small Business'' and ``Small 
Business''

                   Summary of Proposed Qualifications
 [on a rolling basis, average annual monetary value of food sold during
                     the previous three-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..................  Excluded from coverage.
------------------------------------------------------------------------

    As required by section 419(a)(3)(F) of the FD&C Act, proposed Sec.  
112.3(b) defines the terms ``very small business'' and ``small 
business'' for purposes of this proposed rule only. FDA uses a measure 
of the average annual monetary value of food sold to determine farm 
size. This measure should serve as a valid proxy for both the volume 
and value of production within size category and commodities. The USDA 
National Commission on Small Farms recommended a definition for a small 
farm as a family farm with less than $250,000 annual monetary value of 
all commodities sold (Ref. 85). The Commission's recommendation was 
based on the reasoning that these farms are the likeliest to exit the 
industry, and have the greatest need to improve net farm incomes Ref. 
85). The Commission states that although 94% of all U.S. farms generate 
less than $250,000 annual monetary value of all commodities sold, their 
revenue constitutes only 41% of total gross revenue from all farms 
(Ref. 85). We propose to use the $250,000 annual monetary value of food 
sold threshold for our cutoff of a very small farm since the revenue of 
covered produce farms below this threshold constitutes only 12% of 
total gross revenue from food

[[Page 3545]]

sales by produce farms and make up 83% of all produce farms. We propose 
to use the statutory cutoff of $500,000 annual monetary value of food 
sold as one part of the criteria for the qualified exemption in section 
419(f) of the FD&C Act (implemented in proposed Sec.  112.5) as the 
threshold for a small farm. Farms below the $500,000 annual value of 
food sold cutoff make up 89% of covered farms, and their revenue 
constitutes 18% of total gross revenue from food sales by produce 
farms. We developed this proposed definition using sales class breaks 
found in generally available information from USDA (Ref. 86).
    Proposed Sec.  112.3(b)(1) would define your farm to be a very 
small business if it is subject to proposed part 112 and, on a rolling 
basis, the average annual monetary value of food you sold during the 
previous three-year period is no more than $250,000.
    Proposed Sec.  112.3(b)(2) would define your farm to be a small 
business if it is subject to proposed part 112 and, on a rolling basis, 
the average annual monetary value of food you sold during the previous 
three-year period is no more than $500,000; and your farm is not a very 
small business as provided in proposed Sec.  112.3(b)(1).
    For clarity, in both proposed Sec.  112.3(b)(1) and (2), the 
limitation ``if it is subject to this part'' is intended to exclude 
farms not subject to the proposed rule per proposed Sec.  112.4(a), 
that is, farms with $25,000 or less of annual value of food sold. As 
discussed in section V.A.2.c of this document, we propose to exclude 
such farms from the coverage of this proposed rule such that there 
would be no reason for them to be classified as small or very small 
businesses.
iii. Additional Proposed Definitions
    Proposed Sec.  112.3(c) would establish the following additional 
definitions that would apply for the purposes of part 112.
    We propose to define ``adequate'' to mean that which is needed to 
accomplish the intended purpose in keeping with good public health 
practice. This proposed definition is the same as the definition we 
have established in Sec.  110.3 with respect to current good 
manufacturing practice in manufacturing, packing, or holding human 
food. We have been applying this definition for the purpose of 
enforcing the regulations in part 110 for more than 40 years and 
tentatively conclude that it would be an appropriate definition to 
apply to part 112 as well. Throughout this document, we provide 
examples of what we mean by ``adequate'' for purposes of complying with 
specific proposed provisions.
    We propose to define ``adequately reduce microorganisms of public 
health significance'' to mean reduce the presence of such 
microorganisms to an extent sufficient to prevent illness. This 
proposed definition would establish in part 112 a definition that we 
have used in guidance associated with the risk of foodborne illness 
from pathogens (Ref. 87. Ref. 88). As discussed in those documents, the 
extent of reduction sufficient to prevent illness is usually determined 
by the estimated extent to which a pathogen may be present in the food 
combined with a safety factor to account for uncertainty in that 
estimate. For example, if it is estimated that there would be no more 
than 1,000 (i.e., 3 logs) Salmonella organisms per gram of food, and a 
safety factor of 100 (i.e., 2 logs) is employed, a process that 
adequately reduces Salmonella spp. would be a process capable of 
reducing Salmonella spp. by 5 logs per gram of food.
    We propose to define ``agricultural tea'' to mean a water extract 
of biological materials (such as humus, manure, non-fecal animal 
byproducts, peat moss, pre-consumer vegetative waste, table waste, or 
yard trimmings), excluding any form of human waste, produced to 
transfer microbial biomass, fine particulate organic matter, and 
soluble chemical components into an aqueous phase. Agricultural teas 
are held for longer than one hour before application. We developed this 
term to cover a wide range of ``teas'' used in production of fresh 
produce, but not to include ``tea'' served as a beverage. The term 
``agricultural tea'' was based in part on the definition of ``compost 
tea'' developed by the National Organic Standards Board (Ref. 89). 
Human waste would be excluded for consistency with proposed Sec.  
112.53 regarding the use of human waste as a soil amendment. The one 
hour limitation is intended to distinguish between agricultural teas 
and other liquids such as leachate and runoff and is consistent with 
the recommendations of the recommendations of the National Organic 
Standards Board (Ref. 36).
    We propose to define ``agricultural tea additive'' to mean a 
nutrient source (such as molasses, yeast extract, or algal powder) 
added to agricultural tea to increase microbial biomass. The term 
``agricultural tea additive'' was based in part on the definition of 
``compost tea additive'' developed by the National Organic Standards 
Board (Ref. 89).
    We propose to define ``agricultural water'' to mean water used in 
covered activities on covered produce where water is intended to, or is 
likely to, contact covered produce or food-contact surfaces, including 
water used in growing activities (including irrigation water applied 
using direct water application methods, water used for preparing crop 
sprays, and water used for growing sprouts) and in harvesting, packing, 
and holding activities (including water used for washing or cooling 
harvested produce and water used for preventing dehydration of covered 
produce). This proposed definition is different from our definition of 
agricultural water in our Good Agricultural Practices guide (Ref. 10) 
both because it is not limited to water in the growing environment, and 
because we have excluded water that does not contact covered produce 
from this definition based on the information in our QAR.
    We propose to define ``animal excreta'' to mean solid or liquid 
animal waste. By contrast, we are proposing to define ``manure'' to 
mean animal excreta, alone or in combination with litter (such as straw 
and feathers used for animal bedding) for use as a soil amendment. We 
are proposing definitions to distinguish ``animal excreta'' from 
``manure'' based on whether the animal excreta is used as a soil 
amendment because some proposed requirements make such a distinction. 
For example, the proposed requirements in Sec. Sec.  112.54 and 112.56 
are directed to the treatment and safe application of biological soil 
amendments of animal origin, including manure intentionally used as a 
soil amendment, and the proposed requirements in Sec. Sec.  112.82 and 
112.83 would be directed to preventing contamination of covered produce 
with animal excreta deposited by wild or domestic animals that intrude 
in an area where a covered activity is conducted on covered produce. 
The proposed definition of ``manure'' also accounts for the potential 
inclusion of animal litter that is collected with animal excreta, e.g., 
from barns.
    We propose to define ``application interval'' to mean the time 
interval between application of an agricultural input (such as a 
biological soil amendment of animal origin) to a growing area and 
harvest of covered produce from the growing area where the agricultural 
input was applied. The proposed definition would provide a simple term 
to use when describing such a time interval. The proposed application 
intervals for biological soil amendments in proposed Sec.  112.56 would 
establish requirements regarding such time intervals.
    We propose to define ``biological soil amendment'' to mean any soil

[[Page 3546]]

amendment containing biological materials such as humus, manure, non-
fecal animal byproducts, peat moss, pre-consumer vegetative waste, 
sewage sludge biosolids, table waste, agricultural tea, or yard 
trimmings, alone or in combination. We are proposing this definition as 
a means to distinguish soil amendments that contain biological 
components from those that do not (like chemical fertilizers). In 
addition, we propose to define ``biological soil amendment of animal 
origin'' to mean a biological soil amendment which consists, in whole 
or in part, of materials of animal origin, such as manure or non-fecal 
animal byproducts, or table waste, alone or in combination. The term 
``biological soil amendment of animal origin'' does not include any 
form of human waste. We are proposing this definition as a means to 
distinguish these biological soil amendments from soil amendments that 
are wholly plant-based (such as yard trimmings).
    We propose to define ``composting'' to mean a process to produce 
humus in which organic material is decomposed by the actions of 
microorganisms under thermophilic conditions for a designated period of 
time (for example, 3 days) at a designated temperature (for example, 
131[emsp14][deg]F (55 [deg]C)), followed by a curing stage under cooler 
conditions. The proposed definition is consistent with definitions or 
explanations of ``compost'' and ``composting'' in documents such as a 
State regulation (Ref. 90), Appendix B to 40 CFR part 503 (Ref. 91), 
documents prepared by the U.S. EPA (Ref. 92), and the Produce Safety 
Project Issue Brief on Composting of Animal Manures (Ref. 27).
    We propose to define ``covered activity'' to mean growing, 
harvesting, packing, or holding covered produce, 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. Covered activities would not include manufacturing/
processing within the definition elsewhere in proposed Sec.  112.3(c). 
As discussed in sections III.F and V.A.2.b.i of this document, 
manufacturing/processing on a farm is potentially subject to the 
coverage of Section 418 of the FD&C Act, unless all of the food used in 
such activities is consumed on that farm or another farm under the same 
ownership. Where all of the manufactured/processed food is consumed on 
that farm or another farm under the same ownership, the activity would 
be potentially within the scope of Section 419 of the FD&C Act and this 
proposed rule, except that Section 419(g) of the FD&C Act specifies 
that ``[t]his section shall not apply to produce that is produced by an 
individual for personal consumption,'' and section 419(c)(1)(B) of the 
FD&C Act also requires that FDA ensure that the final rule is 
practicable for ``a small food processing facility co-located on a 
farm.''
    FDA tentatively concludes that on-farm manufacturing/processing 
activities for on-farm consumption (like produce for individual 
consumption) should not be subject to this rule, either because it is 
automatically excluded by Section 419(g) or because, to the extent 
there may be any difference between produce ``for personal 
consumption'' and produce ``consumed on the farm or another farm under 
the same ownership,'' it is appropriate to exclude on-farm 
manufacturing/processing for on-farm consumption from the rule. The 
definition of covered activity would also specify, for clarity, that 
this part does not apply to activities of a facility that are subject 
to part 110 of this chapter .
    We propose to define ``covered produce'' to mean produce that is 
subject to the requirements of this part in accordance with Sec. Sec.  
112.1 and 112.2. The term ``covered produce'' refers to the harvestable 
or harvested part of the crop. We are proposing to define ``covered 
produce'' to provide a simple term to use when describing food that 
would be within the scope of the rule under proposed Sec.  112.1 and 
not exempt from the rule under proposed Sec.  112.2.
    We propose to define ``curing'' to mean the maturation stage of 
composting, which is conducted after much of the readily metabolized 
biological material has been decomposed, at cooler temperatures than 
those in the thermophilic phase of composting, to further reduce 
pathogens, promote further decomposition of cellulose and lignin, and 
stabilize composition. This proposed definition is consistent with 
definitions of ``curing'' in a State regulation (Ref. 93), documents 
prepared by the U.S. EPA (Ref. 92), and a glossary of composting terms 
prepared by the Cornell Waste Management Institute (Ref. 94).
    We propose to define ``direct water application method'' to mean 
using agricultural water in a manner whereby the water is intended to, 
or is likely to, contact covered produce or food-contact surfaces 
during use of the water. This proposed definition would provide a 
simple term to use when describing such water within regulations such 
as proposed Sec.  112.44(c). By cross-reference to the definitions of 
``covered produce'' and ``produce'', this term only applies to methods 
in which the water is intended to, or is likely to, contact the 
harvestable part of the covered produce.
    We propose to define ``food'' to mean food as defined in section 
201(f) of the FD&C Act and to include seeds and beans used to grow 
sprouts. We have long considered seeds and beans used to grow sprouts 
to be ``food'' within the meaning of section 201(f) of the FD&C Act 
(Ref. 95). Seeds and beans used to grow sprouts are both articles used 
for food and articles used for components of articles used for food. We 
are proposing to include them specifically in the definition of food 
for purposes of this rule for clarity because sprouts are covered by 
this rule.
    We propose to define ``food-contact surfaces'' to mean those 
surfaces that contact human food and those surfaces from which drainage 
or other transfer onto the food or onto surfaces that contact the food 
ordinarily occurs during the normal course of operations. ``Food-
contact surfaces'' includes food-contact surfaces of equipment and 
tools used during harvest, packing, and holding. This proposed 
definition of ``food-contact surfaces'' is consistent with the 
definition of this term in Sec.  110.3 except that we propose to add 
the phrase ``or other transfer'' after ``drainage'' definition of 
``food-contact surfaces'' to clarify that surfaces from which any 
transfer involving liquids or non-liquids onto the food or onto 
surfaces that contact the food are food-contact surfaces.
    We propose to define ``hazard'' to mean any biological agent that 
is reasonably likely to cause illness or injury in the absence of its 
control. The proposed definition is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, Federal HACCP regulations for 
seafood, juice, and meat and poultry, except that for the purposes of 
this rule the term would be limited to biological hazards because, as 
discussed in section IV.A. of this document, this proposed rule is only 
addressing biological hazards. The NACMCF HACCP guidelines (Ref. 41) 
and our HACCP regulation for juice (Sec.  120.3(g)) define ``hazard'' 
and ``food hazard,'' respectively as a biological, chemical, or 
physical agent that is reasonably likely to cause illness or injury in 
the absence of its control. The Codex HACCP Annex defines ``hazard'' as 
a biological, chemical or physical agent in, or condition of, food with 
the potential to cause an adverse health effect (Ref. 96). Our HACCP 
regulation for seafood (Sec.  123.3(f)) and the FSIS HACCP regulation 
for meat and poultry (9 CFR 417.1) define ``food safety hazard'' as any 
biological, chemical, or physical property that may cause a food

[[Page 3547]]

to be unsafe for human consumption. We recognize that there are other 
hazards relevant to produce safety on farm that would not be addressed 
in this proposed rule such as chemical, physical, and radiological 
hazards (see section IV.B. of this document) and do not intend to 
suggest by this definition that such hazards are not hazards. We 
request comment on whether we should instead use the term ``biological 
hazards'' in this rule.
    We propose to define ``humus'' to mean a stabilized (i.e., 
finished) biological soil amendment produced through a controlled 
composting process. We are proposing to use ``humus'' as the term to 
identify the final, mature product of composting for the purpose of 
this rule. Our proposed definition derives from our proposed 
definitions for ``composting'' and ``curing'' and the Cornell Waste 
Management Institute's glossary of composting terms (Ref. 94), which 
defines humus as a complex aggregate made during the decomposition of 
plant and animal residues; mainly derivatives of lignin, proteins, and 
cellulose combined with inorganic soil parts. However, other relevant 
documents (Ref. 27. Ref. 92. Ref. 97) refer to the production of 
``humus-like material'' through composting, and humus can be produced 
by mechanisms other than the action of microorganisms (Ref. 98). We 
request comment on whether our proposed definition and use of the term 
``humus'' for the final product of composting is appropriate for the 
purpose of this rule, or whether we should use a term other than 
``humus,'' such as ``mature compost.''
    We propose to define ``manure'' to mean animal excreta, alone or in 
combination with litter (such as straw and feathers used for animal 
bedding) for use as a soil amendment. As discussed above in the 
definition of animal excreta, this definition is intended to make a 
distinction between the terms ``manure'' and ``animal excreta.''
    We propose to define ``microorganisms'' to mean yeasts, molds, 
bacteria, viruses, protozoa, and microscopic parasites and to include 
species having public health significance. As proposed, the term 
``undesirable microorganisms'' includes those microorganisms that are 
of public health significance, that subject food to decomposition, that 
indicate that food is contaminated with filth, or that otherwise may 
cause food to be adulterated. The substantive difference between this 
proposed definition and that in current Sec.  110.3 is the addition of 
protozoa (e.g., Giardia lamblia) and microscopic parasites (e.g., 
Cyclospora cayetanensis). Because such microorganisms are relevant to 
produce safety, we tentatively conclude that it is reasonable to 
include them.
    We propose to define ``monitor'' to mean to conduct a planned 
sequence of observations or measurements to assess whether a process, 
point, or procedure is under control, and, when applicable, to produce 
an accurate record of the observation or measurement.
    We propose to define ``non-fecal animal byproduct'' to mean solid 
waste (other than manure) that is animal in origin (such as meat, fat, 
dairy products, eggs, carcasses, blood meal, bone meal, fish meal, 
shellfish waste (such as crab, shrimp, and lobster waste), fish 
emulsions, and offal) and is generated by commercial, institutional, or 
agricultural operations. This proposed definition reflects the use of a 
similar term in sources such as the State of Florida's regulations 
(Ref. 90). However, we are proposing to include more examples of these 
byproducts than are included in Florida's regulations to clearly 
communicate what we mean by the term. We propose to define ``pest'' to 
mean any objectionable animals or insects including birds, rodents, 
flies, and larvae. This proposed definition is consistent with the 
definition of ``pest'' in current Sec.  110.3.
    We propose to define ``pre-consumer vegetative waste'' to mean 
solid waste that is purely vegetative in origin, not considered yard 
trash, and derived from commercial, institutional, or agricultural 
operations without coming in contact with animal products, byproducts 
or manure or with an end user (consumer). As proposed, pre-consumer 
vegetative waste includes material generated by farms, packing houses, 
canning operations, wholesale distribution centers and grocery stores; 
products that have been removed from their packaging (such as out-of-
date juice, vegetables, condiments, and bread); and associated 
packaging that is vegetative in origin (such as paper or corn-starch 
based products). As proposed, pre-consumer vegetative waste does not 
include table waste, packaging that has come in contact with materials 
(such as meat) that are not vegetative in origin, or any waste 
generated by restaurants. This proposed definition is consistent with a 
State regulation (Ref. 90).
    For the purpose of this rule, we propose to define the term 
``produce'' to mean any fruit or vegetable (including mixes of intact 
fruits and vegetables) and includes mushrooms, sprouts (irrespective of 
seed source), peanuts, tree nuts and herbs. For the purposes of this 
rule, we propose to define ``fruit'' as the edible reproductive body of 
a seed plant or tree nut (such as apple, orange and almond) such that 
fruit means the harvestable or harvested part of a plant developed from 
a flower; and ``vegetable'' as the edible part of an herbaceous plant 
(such as cabbage or potato) or fleshy fruiting body of a fungus (such 
as white button or shiitake) grown for an edible part such that 
vegetable means the harvestable or harvested part of any plant or 
fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, 
bulbs, stems, leaves, or flower parts are used as food and includes 
mushrooms, sprouts, and herbs (such as basil or cilantro).
    For the purposes of this 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. With this 
definition, we are proposing to specifically include mushrooms, sprouts 
(irrespective of seed source), peanuts, tree nuts and herbs, and 
specifically exclude food grains. We explain our proposed definition of 
``produce'' in detail above, in section V.A.2.a of this document. We 
request comments on our proposed definition of ``produce.''
    We propose to define ``production batch of sprouts'' to mean all 
sprouts that are started at the same time in a single growing unit 
(e.g., a single drum or bin, or a single rack of trays that are 
connected to each other), whether or not the sprouts are grown from a 
single lot of seed (including, for example, when multiple types of 
seeds are grown within a single growing unit). Through this definition, 
we intend to treat as a production batch product that would be exposed 
to the same conditions during sprouting, such as multiple seed types 
grown in a common drum or multiple trays in a single rack that may be 
exposed to water that has contacted other product in the same growing 
unit. This term is used in proposed subpart M. Limiting the definition 
of ``production lot'' to a single growing unit would prevent sprout 
growers from ``pooling'' samples from multiple growing units within an 
operation whereby contamination in spent water in one unit could be 
diluted by non-contaminated water from other units to

[[Page 3548]]

the point where pathogens might not be detected. This proposed 
definition is consistent with our 1999 guidance for industry on 
sampling and microbial testing of spent irrigation water during sprout 
production (Ref. 15). We recognize that there are a diversity of 
growing practices and a variety of growing units that may represent 
different product volumes, so we request comment on this proposed 
definition.
    We propose to define ``qualified end-user,'' with respect to a 
food, to mean the consumer of the food; or a restaurant or retail food 
establishment (as those terms are defined in Sec.  1.227) that is 
located (i) in the same State as the farm that produced the food; or 
(ii) not more than 275 miles from such farm. The definition would also 
state that the term ``consumer'' does not include a business. This 
definition implements section 419(f)(4) of the FD&C Act. We note that 
section 419(f)(4)(A) of the FD&C Act does not provide for a different 
analysis for when an international border falls within the 275 miles; 
thus, we tentatively conclude that international borders should not 
affect the distance calculation. Thus, for example, a farm in Mexico 
selling food to a restaurant or retail food establishment in the U.S. 
that is within 275 miles of the farm could count that sale as a sale to 
a qualified end user. As another example, the same would also be true 
for a U.S. farm selling food to a restaurant or retail food 
establishment in Mexico that is within 275 miles of the farm. Finally, 
we also note that the requirements related to distance (in the same 
state or within 275 miles of the farm) only apply to restaurants and 
retail food establishment customers, and not to consumers. Thus, a farm 
may count any sale directly to a consumer as a sale to a qualified end-
user.
    We propose to define ``raw agricultural commodity (RAC)'' to mean 
``raw agricultural commodity'' as defined in section 201(r) of the FD&C 
Act. We propose to include this reference to the FD&C Act definition to 
provide additional clarity regarding the meaning of this term.
    We propose to define ``reasonably foreseeable hazard'' to mean a 
potential hazard that may be associated with the farm or the food. We 
provide a proposed definition for this term as it is used in section 
419(c)(1)(A) of the FD&C Act and reflected in several requirements 
proposed in this rule. As noted in the discussion of the proposed 
definition of ``hazard'' in this section, this definition would be 
limited to biological hazards because those are the only hazards we are 
currently proposing to address in this rule. We recognize that there 
are other reasonably foreseeable hazards relevant to produce safety on 
farm that would not be addressed in this proposed rule such as 
chemical, physical, and radiological hazards (see section IV.B of this 
document) and do not intend to suggest by this definition that such 
hazards are not reasonably foreseeable. We request comment on whether 
we should instead use the term ``reasonably foreseeable biological 
hazards'' in this rule.
    We propose to define ``sanitize'' to mean to adequately treat 
cleaned food-contact surfaces by a process that is effective in 
destroying vegetative cells of microorganisms of public health 
significance, and in substantially reducing numbers of other 
undesirable microorganisms, but without adversely affecting the product 
or its safety for the consumer. This proposed definition is consistent 
with the existing Sec.  110.3 definition for ``sanitize'' except that 
we propose to include the term ``cleaned'' before ``food-contact 
surfaces.'' It is well established that sanitizers can be inactivated 
by organic material and, thus, are not effective unless used on clean 
surfaces (Ref. 99). This proposed definition is consistent with the 
definition of ``sanitize'' in Sec.  111.3.
    We propose to define ``sewage sludge biosolids'' to mean the solid 
or semi-solid residue generated during the treatment of domestic sewage 
in a treatment works within the meaning of the definition of `sewage 
sludge' in 40 CFR 503.9(w). This proposed definition is consistent with 
that of the U.S. Environmental Protection Agency (EPA), which has 
regulatory jurisdiction over treated domestic sewage and has 
established terms to describe specific types of treated waste.
    We propose to define ``soil amendment'' to mean any chemical, 
biological, or physical material (such as elemental fertilizers, humus, 
manure, non-fecal animal byproducts, peat moss, perlite, pre-consumer 
vegetative waste, sewage sludge biosolids, table waste, agricultural 
tea and yard trimmings) intentionally added to the soil to improve the 
chemical or physical condition of soil in relation to plant growth or 
to improve the capacity of the soil to hold water. This proposed 
definition is consistent with commonly used definitions in industry 
guidelines and marketing agreements (Ref. 46. Ref. 31). We also propose 
to include within the meaning of ``soil amendment'' growth media that 
serve as the entire substrate during the growth of covered produce 
(such as mushrooms and some sprouts). While this inclusion is not 
consistent with the common usage of the term, it provides convenience 
since it is addressing the identical standards that we are proposing 
for identical hazards that exist for such growth media and soil 
amendments.
    We propose to define ``spent sprout irrigation water'' to mean 
water that has been used in the growing of sprouts. This definition is 
intended to minimize the potential for confusion between spent sprout 
irrigation water and water used for irrigation of other types of 
covered produce.We are proposing to define ``static composting'' to 
mean a process to produce humus in which air is introduced into 
biological material (in a pile (or row) covered with at least 6 inches 
of insulating material, or in an enclosed vessel) by a mechanism that 
does not include turning. As proposed, examples of structural features 
for introducing air would include embedded perforated pipes and a 
constructed permanent base that includes aeration slots. As proposed, 
examples of mechanisms for introducing air include passive diffusion 
and mechanical means (such as blowers that suction air from the 
composting material or blow air into the composting material using 
positive pressure). The proposed definition derives from definitions 
and explanations of ``static composting'' in documents such as prepared 
by the U.S. EPA (Ref. 92), the Produce Safety Project Issue Brief on 
Composting of Animal Manures (Ref. 27), and a report from the Food and 
Agriculture Organization of the United Nations (Ref. 100).
    We propose to define ``surface water'' to mean all water which is 
open to the atmosphere and subject to surface runoff, including water 
obtained from an underground aquifer that is held or conveyed in a 
manner that is open to the atmosphere, such as in canals, ponds, other 
surface containment or open conveyances. This proposed definition is 
consistent with EPA's definition and with common usage of the term 
``surface water'' (Ref. 101). We propose to define this term to 
distinguish ``surface water'' from other water, such as water from an 
underground aquifer that has not been held or conveyed in a manner open 
to the environment (``ground water'') because there is a greater 
likelihood that surface water could become contaminated, for example, 
by surface runoff.
    We propose to define ``table waste'' to mean any post-consumer food 
waste, irrespective of whether the source material is animal or 
vegetative in origin, derived from individuals, institutions, 
restaurants, retail

[[Page 3549]]

operations, or other sources where the food has been served to a 
consumer. This definition is intended to distinguish post-consumer food 
waste from pre-consumer vegetative waste.
    We propose to define ``turned composting'' to mean a process to 
produce humus in which air is introduced into biological material (in a 
pile, row, or enclosed vessel) by turning on a regular basis. Turning 
is the process of mechanically mixing biological material that is 
undergoing a composting process with the specific intention of moving 
the outer, cooler sections of the material being composted to the 
inner, hotter sections. The proposed definition is consistent with 
definitions or explanations of ``windrow composting'' in documents 
prepared by the U.S. EPA (Ref. 92. Ref. 91), the Produce Safety Project 
Issue Brief on Composting of Animal Manures (Ref. 27), and a report 
from the Food and Agriculture Organization of the United Nations (Ref. 
100). We are proposing to use the term ``turned composting'' rather 
than ``windrow composting'' so that the term describing this method 
would not be limited to use in ``rows.''
    We propose to define ``water distribution system'' to mean a system 
to carry water from its primary source to its point of use, including 
pipes, sprinklers, irrigation canals, pumps, valves, storage tanks, 
reservoirs, meters, and fittings. The proposed definition would provide 
a simple term to use when describing such systems.
    We propose to define ``we'' to mean the U.S. Food and Drug 
Administration.
    We propose to define ``yard trimmings'' to mean purely vegetative 
matter resulting from landscaping maintenance or land clearing 
operations, including materials such as tree and shrub trimmings, grass 
clippings, palm fronds, trees, tree stumps, untreated lumber, untreated 
wooden pallets, and associated rocks and soils. This proposed 
definition is consistent with a definition in State composting 
regulations (Ref. 90), except that we are proposing to use the term 
``yard trimmings'' rather than ``yard trash.'' We are proposing to use 
the term ``yard trimmings'' to avoid potentially negative connotations 
associated with the word ``trash,'' even though some components of our 
proposed definition (e.g., untreated wooden pallets) arguably are not 
``trimmings.'' We request comment on whether our proposed use of the 
term ``yard trimmings'' is appropriate for the purpose of this rule, or 
whether we should propose to use a term other than ``yard trimmings,'' 
such as ``yard trash'' or ``yard waste.''
    We propose to define ``you'' to mean a person who is subject to 
some or all of the requirements in this part.
c. Persons Subject to This Rule
    Proposed Sec.  112.4(a) states that, except as provided in 
paragraph (b) of that section, if you are a farm or farm mixed-type 
facility with an average annual monetary value of food (as ``food'' is 
defined in Sec.  112.3(c)) sold during the previous three-year period 
of more than $25,000 (on a rolling basis), you are a ``covered farm'' 
subject to this part; however, specific exemptions and partial 
exemptions apply. 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. We are proposing to 
apply this proposed rule only to farms and farm mixed-type facilities 
with an average annual monetary value of food (as ``food'' is defined 
in Sec.  112.3(c)) sold during the previous three-year period of more 
than $25,000 (on a rolling basis) because we have tentatively concluded 
that farms with $25,000 or less in sales do not contribute 
significantly to the produce market. Farms below the $25,000 limit 
collectively account for only 1.5% of covered produce acres, suggesting 
that they contribute little exposure to the overall produce 
consumption. We note that such farms are and will continue to be 
covered under the adulteration provisions and other applicable 
provisions of the Federal Food, Drug, and Cosmetic Act and applicable 
implementing regulations, irrespective of whether they are included 
within the scope of this proposed rule.
    As proposed, Sec.  112.4(a) would make clear that the rule applies 
to both farms and farm mixed-type facilities, and that such entities 
would be subject to the rule when they conduct a covered activity on 
covered produce, as those terms are defined in proposed Sec.  112.3(c). 
This would mean that, for example, a farm mixed-type facility that is a 
covered farm and that grows, harvests, packs, and holds its own lettuce 
would be subject to the proposed rule when conducting those activities 
(unless an exemption applies, such as that in proposed Sec.  112.4(b)). 
However, the covered farm would not be subject to the rule when 
conducting other activities that are not covered activities, or when 
conducting operations on food other than covered produce. For example, 
if the farm mixed-type facility applied a manufacturing/processing step 
(such as chopping) to its lettuce for distribution into commerce (i.e., 
not for consumption on the farm or another farm under the same 
ownership, or for personal consumption), this would not be a ``covered 
activity'' as that term is defined in proposed Sec.  112.3(c) and would 
therefore not be subject to this rule. In proposed Sec.  112.4(b), we 
propose to state that you are not a covered farm if you satisfy the 
requirements in Sec.  112.5 and we have not withdrawn your exemption in 
accordance with the requirements of subpart R of this part. This 
implements section 419(f) of the FD&C Act and is discussed further 
immediately below.
d. Qualified Exemptions
i. Criteria for Eligibility for a Qualified Exemption
    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. This 
exemption is mandated by Section 419(f) of the FD&C Act. Except as 
provided in Sec.  112.6, you would be exempt from all of the 
requirements of this part, except proposed subparts except A, Q, and R, 
in a calendar year if:
     During the previous 3-year period preceding the applicable 
calendar year, the average annual monetary value of the food you sold 
directly to qualified end-users during such period exceeded the average 
annual monetary value of the food you sold to all other buyers during 
that period (Sec.  112.5(a)(1)); and
     The average annual monetary value of all food you sold 
during the 3-year period preceding the applicable calendar year was 
less than $500,000, adjusted for inflation (Sec.  112.5(a)(2)).
    Proposed Sec.  112.5(b) provides that, for the purpose of 
determining whether the average annual monetary value of all food sold 
during the 3-year period preceding the applicable calendar year was 
less than $500,000, adjusted for inflation, the baseline year for 
calculating the adjustment for inflation is 2011. The conditions 
related to average annual monetary value established in section 
419(f)(1)(B) of the FD&C Act allow adjustment for inflation. To 
establish a level playing field for all farms that may satisfy the 
criteria for the qualified exemption, we are proposing to establish the 
baseline year for the calculation in proposed Sec.  112.5(a)(2). We are 
proposing to establish 2011 as the baseline year for inflation because 
2011 is the year that FSMA was enacted into law.
    Section 419(f) of the FD&C Act does not specifically target 
arrangements such as community-sponsored agriculture (CSA), you-pick 
operations,

[[Page 3550]]

or farmers markets. It does seem likely that many such operations will 
meet the criteria for qualified exemption. Each such operation would 
need to analyze its sales under the terms of Sec.  112.5 to determine 
its eligibility for the qualified exemption. For example, if a you-pick 
operation has an average annual monetary value of food sold during the 
relevant 3-year period of less than $500,000, and all of its sales were 
to individuals who come to the farm to pick their own produce, all of 
its sales would be sales to consumers (who are qualified end-users, 
regardless of location) for the purpose of determining the proportion 
of the sales that are to qualified end-users. In this example, the you-
pick farm would be eligible for the qualified exemption. As another 
example, if a CSA farm has an average annual monetary value of food 
sold during the relevant 3-year period of less than $500,000; and 25% 
of the monetary value of its sales comes from sales to individual 
consumers enrolled in the CSA, 50% of the monetary value of its sales 
comes from sales to restaurants in the same state as the farm, and 25% 
of the monetary value of its sales comes from sales to other buyers who 
are not qualified end-users; the CSA farm would be eligible for the 
qualified exemption. In this example, the CSA farm's sales to qualified 
end-users (consumers and in-state restaurants) make up 75% of the 
average annual monetary value of food sold, so the value of the farm's 
sales to qualified end-users exceed the value of its sales to all other 
buyers during the relevant time period.
ii. Applicable Requirements for Qualified Exemptions
    Proposed Sec.  112.6 establishes the requirements that apply to you 
if you are eligible for a qualified exemption in accordance with Sec.  
112.5. Proposed Sec.  112.6(a) explains that subparts A, Q, and R 
remain applicable to those who qualify for a qualified exemption under 
Sec.  112.5. This is because subpart A contains this provision and 
other general provisions such as definitions, Subpart Q contains 
provisions related to compliance and enforcement, and subpart R 
contains provisions necessary to implement section 419(f)(3) of the 
FD&C Act, as discussed further in section V.R. of this document. 
Consistent with section 419(f)(2) of the FD&C Act, proposed Sec.  
112.6(b) establishes the modified requirements (label or point of 
purchase display) applicable to those who meet the requirements under 
Sec.  112.5 for a qualified exemption.
    Specifically, proposed Sec.  112.6(b)(1) would require that, when a 
food packaging label is required on food that would otherwise be 
covered produce under the FD&C Act or its implementing regulations, you 
include prominently and conspicuously on the food packaging label the 
name and complete business address of the farm where the produce was 
grown. Proposed Sec.  112.6(b)(2) requires that, when a food packaging 
label is not required on food that would otherwise be covered produce 
under the FD&C Act, you prominently and conspicuously display, at the 
point of purchase, the name and complete business address of the farm 
where the produce was grown. As proposed, the name and address of the 
farm must be displayed on a label, poster, sign, placard, or documents 
delivered contemporaneously with the produce in the normal course of 
business, or, in the case of Internet sales, in an electronic notice. 
That is, if a label is otherwise required on the produce that would 
otherwise be covered (for example, tomatoes in a ``clam shell'' 
package) then the label must include the name and business address of 
the farm where the produce was grown. If a label is not required (for 
example, unpackaged tomatoes) then the name and business address of the 
farm where the produce was grown must be displayed at the point of 
purchase (such as on a poster, for example). These proposed provisions 
reflect our interpretation of section 419(f)(2)(A)(i) and (ii) as 
applying only to food that would otherwise be covered produce but for 
the qualified exemption. We tentatively conclude that this 
interpretation is reasonable because applying these consumer 
notification requirements to food that would not otherwise be covered 
produce would mean applying requirements to food that bears no 
relationship to the subject of this rulemaking (e.g., to milk from a 
farm that also grows and harvests produce and that meets the criteria 
for the qualified exemption from this proposed rule).
    Proposed 112.6(b)(3) states that the complete business address that 
you must include in accordance with the requirements of paragraph 
(b)(1) or (2) of this section must include the street address or post 
office box, city, state, and zip code for domestic farms, and 
comparable full address information for foreign farms. Proposed Sec.  
112.6(b)(3) would enable consumers to contact the farm where the food 
that would otherwise be covered produce was grown (e.g., if the 
consumer identifies or suspects a food safety problem with a the 
produce) irrespective of whether the produce bears a label. The use of 
the term ``business address'' in section 419(f)(2)(A) of the FD&C Act 
contrasts with Congress' use of a different term, ``place of 
business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)). 
Section 403(e) provides that foods in package form are misbranded 
unless the product label bears the name and place of business of the 
manufacturer, packer, or distributor of the food. Our regulations 
interpret ``place of business'' as requiring only the firm's city, 
state, and zip code to appear on the product label, as long as the 
firm's street address is listed in a current telephone directory or 
other city directory (21 CFR 101.5(d)). We tentatively conclude that 
the use of the term ``business address'' in section 419(f)(2)(A) 
demonstrates Congress' intent to require the farm's full address, 
including the street address or P.O. box, to appear on labels or other 
required notifications when the farm qualifies for the exemption in 
section 419(f) of the FD&C Act. If Congress had considered the less 
complete address already required under section 403(e)(1) of the FD&C 
Act and the ``place of business'' labeling regulation (Sec.  101.5(d)) 
to be adequate for notification to consumers for foods required to bear 
labels, there would have been no need to impose a new, more specific 
requirement in section 419(f)(2)(A)(1) for the farm's ``business 
address'' to appear on the food label. Requiring the complete business 
address for this purpose is consistent with our guidance to industry on 
the labeling of dietary supplements as required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (Ref. 103). 
When proposed Sec.  112.5(b) would apply to a food for which a food 
packaging label is required under any other provision of the FD&C Act, 
the complete business address would substitute for the ``place of 
business'' required under section 403(e)(1) of the FD&C Act and 21 CFR 
101.5(d) and would not impose any requirement for a label that would be 
in addition to any label required under any other provision of the FD&C 
Act. We seek comment on the feasibility of the labeling provisions in 
proposed 112.6(b), particularly in the case of consolidating produce 
from several farm locations.
    Section 419 of the FD&C Act does not explicitly require farms that 
meet the criteria for the qualified exemption to establish and maintain 
documentation of the basis for their exemption. FDA considers that it 
may be necessary for farms to maintain such records, and to allow FDA 
access to such records upon

[[Page 3551]]

request, in order to efficiently enforce section 419 of the FD&C Act. 
Otherwise we would have no way to determine whether a farm claiming the 
qualified exemption actually met the criteria for that exemption. This 
could be important, for example, if a farm claiming the qualified 
exemption is directly linked to a foodborne illness outbreak during an 
active investigation or if FDA determines, based on conduct or 
conditions associated with the farm that are material to the safety of 
the food produced or harvested at such farm, that it is necessary to 
protect the public health and prevent or mitigate a foodborne illness 
outbreak to withdraw the farm's qualified exemption (see section V.R. 
of this document discussing proposed subpart R). Because the withdrawal 
procedure in proposed subpart R would only apply to farms that are 
eligible for the qualified exemption, we would need to know whether the 
farm is indeed eligible for the exemption in order to select the 
appropriate and efficient enforcement strategy. We request comment on 
whether we should require farms to be able to provide adequate 
documentation, as needed, to demonstrate the basis for the qualified 
exemption. Specifically, we request comment on whether we should do 
this by requiring records to be established and maintained in 
accordance with the requirements of proposed subpart O, or if there is 
an alternative strategy by which we could require retention of and 
access to such records (such as by requiring farms only to retain 
records kept in the normal course of their business bearing on the 
criteria for the qualified exemption that they use to determine their 
eligibility and requiring FDA access to such records upon request).

B. Subpart B--General Requirements

    As proposed, subpart B discusses the general requirements 
applicable to persons who are subject to this part and alternatives 
from the requirements established in this part that would be permitted, 
under specified conditions.
1. Comments Relevant to Proposed Provisions
    We received several comments in response to the 2010 FR notice that 
addressed issues relevant to the general requirements established in 
this subpart of the rule. A consumer organization urged FDA to take 
additional steps to ensure the safety of bagged salads and all leafy 
greens. Some comments recommended that FDA include in this rule an 
amendment mechanism that can expeditiously accommodate new scientific 
knowledge.
    Section 402 of the FD&C Act specifies conditions under which a food 
is deemed adulterated, including if the food bears or contains any 
added poisonous or deleterious substance which may render it injurious 
to health (402(a)(1)); if it is unfit for food (402(a)(3)); or if it 
has been prepared, packed, or held under insanitary conditions whereby 
it may have become contaminated with filth, or whereby it may have been 
rendered injurious to health (402(a)(4)). In proposed Sec.  112.11, we 
would specifically require that covered farms take appropriate measures 
to minimize the risk of serious adverse health consequences or death 
from the use of, or exposure to, covered produce, including those 
measures reasonably necessary to prevent the introduction of known or 
reasonably foreseeable hazards into covered produce as well as to 
provide reasonable assurances that the produce is not adulterated under 
section 402 of the FD&C Act on account of such hazards. Such hazards 
would include all pathogens to the extent that they pose a risk of 
serious adverse health consequences or death, including Salmonella and 
E. coli O157:H7, in all covered produce raw agricultural commodities, 
including leafy greens. With respect to bagged salads, we note that 
such salads are manufactured in facilities that are required to 
register with us and, therefore, would be covered under section 418 of 
the FD&C Act and any regulations promulgated pursuant to that 
authority, rather than by this proposed rulemaking.
    We recognize the value in making this regulation flexible, where 
appropriate, to accommodate future changes in science and technology. 
In proposed Sec.  112.12, we list the specific requirements established 
in this rule for which we believe alternatives may be appropriate and 
the circumstances under which such alternatives could be used. In 
addition, consistent with section 419(c)(2) of the FD&C Act, in 
proposed subpart P, we provide for a mechanism by which a State or a 
foreign country from which food is imported into the United States may 
request a variance from one or more requirements proposed in this part, 
where the State or foreign country determines that: (a) The variance is 
necessary in light of local growing conditions; and (b) the procedures, 
processes, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulterated under 
Section 402 of the Act and to provide the same level of public health 
protection as the requirements of this part (see section V.P. of this 
document). We also intend to publish guidance, as appropriate, to 
provide updates on current thinking with respect to best practices in 
produce safety.
2. Proposed Requirements
a. General Requirements Applicable to Persons Subject to This Part
    As proposed, Sec.  112.11 establishes the general requirements 
applicable to persons who are subject to this rule. Proposed Sec.  
112.11 requires that you take appropriate measures to minimize the risk 
of serious adverse health consequences or death from the use of, or 
exposure to, covered produce, including those measures reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable hazards into covered produce, and to provide reasonable 
assurances that the produce is not adulterated under section 402 of the 
FD&C Act on account of such hazards.
    This provision is consistent with the requirements of section 
419(c)(1)(a) of the FD&C Act, which mandates, in relevant part, that we 
publish regulations that ``set forth those procedures, processes, and 
practices that the Secretary determines to minimize the risk of serious 
adverse health consequences or death, including procedures, processes, 
and practices that the Secretary determines to be reasonably necessary 
to prevent the introduction of known or reasonably foreseeable 
biological, chemical, and physical hazards, including hazards that 
occur naturally, may be unintentionally introduced, * * * into fruits 
and vegetables, * * * and to provide reasonable assurances that the 
produce is not adulterated under section 402.'' As discussed in section 
IV.B. of this document, we have tentatively concluded that this rule 
should focus solely on biological hazards.
    In subparts C to O, we propose science-based minimum standards 
related to the growing, harvesting, packing, and holding of covered 
produce that we believe are necessary to minimize the risk of serious 
adverse health consequences or death by preventing the introduction of 
hazards and providing reasonable assurances that the covered produce is 
not adulterated.
    Proposed Sec.  112.11 would require, for example, that whenever a 
standard specified in this part is not met, you would take those steps 
reasonably necessary to identify and evaluate the cause of the problem 
and ensure that it is rectified. Accurate identification of

[[Page 3552]]

the cause of the failure is critical to the success of any potential 
corrective actions. For example, if your employees are having 
difficulty identifying covered produce that should not be harvested due 
to potential contamination, you might initially think the answer is to 
provide more frequent training; however upon investigation, you may 
discover that the actual cause of the problem is that your employee 
training program is providing inaccurate information. In this case, to 
correct the problem, you would need to fix your training program. 
Promptly taking such follow-up actions once the cause of the problem 
has been identified is necessary to minimize the risk of serious 
adverse health consequences or death from the use of, or exposure to, 
your covered produce and to provide reasonable assurances that the 
product is not adulterated under section 402 of the FD&C Act.
    In addition, proposed Sec.  112.11 would require you to take 
appropriate measures to minimize risks of serious adverse health 
consequences or death from the use of, or exposure to, covered produce 
that may arise unexpectedly and therefore not be reflected in a 
specific standard set forth in proposed subparts C to O of this rule. 
For example, in the event of an unexpected event, such as receipt of 
information suggesting that your covered produce from a particular 
field is adulterated because it bears or contains a pathogen that may 
render the produce injurious to health, proposed Sec.  112.11 would 
require you to take appropriate measures to minimize the risk of 
serious adverse health consequences or death from the use of, or 
exposure to, your covered produce by preventing the introduction of 
biological hazards into or onto your produce or by taking measures to 
provide reasonable assurances that the produce is not adulterated under 
section 402 of the FD&C Act. Such measures might include, for example, 
conducting a root cause investigation to try to determine the source of 
the contamination, making appropriate changes to your conditions and 
practices suggested by the root cause investigation, including to 
produce in other fields, as appropriate, determining the extent of the 
impact of the root cause (i.e., within the suspect field and in other 
fields), and excluding adulterated produce from commerce. We note, 
however, that we do not intend for proposed Sec.  112.11 to suggest 
that you would need to take measures to exclude animals from outdoor 
growing areas, to destroy animal habitats near your outdoor growing 
areas, to clear farm borders around outdoor growing areas or drainages, 
or to take any action that would violate applicable environmental laws 
or regulations.
    We propose to include proposed Sec.  112.11 in order to account for 
the variety of possible circumstances that might arise in which an 
unexpected circumstance or unique farm characteristics would justify 
preventive measures to prevent introduction of hazards or provide 
assurances against adulteration in order to minimize the risk of 
serious adverse health consequences or death. We request comment on 
this approach, and on whether we should instead establish specific 
standards for any types of hazards that would be covered in proposed 
Sec.  112.11 but for which we have not proposed specific standards in 
proposed subparts C through O.
b. Alternatives to Certain Requirements
    As proposed, Sec.  112.12 allows for the use of alternatives to 
certain requirements of this part. Subparagraph (a) lists the specific 
requirements for which alternatives may be considered provided you are 
in compliance with subparagraphs (b) and (c), which describe the 
conditions for use of an alternative. Proposed Sec.  112.12(b) states 
that you may establish and use an alternative to any of the 
requirements listed in paragraph (a), provided you have adequate 
scientific data or information to support a conclusion that the 
alternative would provide the same level of public health protection as 
the applicable requirement established in this part (including meeting 
the same microbiological standards, where applicable) and would not 
increase the likelihood that your covered produce will be adulterated 
under section 402 of the FD&C Act, in light of your covered produce, 
practices, and conditions, including agro-ecological conditions and 
application interval. We do not propose to require you to submit such 
scientific data or information to us for review or approval prior to 
marketing. However, we would require that you 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.
    Proposed Sec.  112.12(c) clarifies that the scientific data and 
information used to support an alternative to a requirement may be 
developed by you, available in the scientific literature, or available 
to you through a third party, and further provides that documentation 
of such data and information must be established and maintained in 
accordance with the requirements of subpart O of this part. As 
discussed in section II.E.4. of this document, FDA is collaborating 
with partners on research that may provide scientific support for 
specific alternatives to certain of these requirements. FDA intends to 
issue guidance on specific alternatives that it may identify as meeting 
the requirements of the rule in order to assist farms in complying with 
the final rule. For example, a farm that applies crop protection sprays 
to the harvestable portion of crops (i.e., application of water 
containing crop protection substances using a direct water application 
method) several days before the crop is harvested using a water source 
that does not meet the requirements of Sec.  112.44(c) (i.e, EPA 
generic E. coli ``recreational water'' standard), may use an 
alternative measure provided by their Cooperative Extension agent, for 
example, as long as the measure is based on scientifically sound data 
and meets the conditions described above (i.e., provides the same level 
of public health protection as the applicable requirement and does not 
increase the likelihood that covered produce will be adulterated). For 
example, the study might demonstrate that the quality of water used for 
direct application method irrigation is not important as long as there 
are at least two days between application and harvest, or that water of 
some lesser standard than that in Sec.  112.44(c) could safely be 
applied immediately before harvest. The farm operator would maintain a 
copy of the information provided by the agent as documentation that the 
alternative measure was based on sound science. When FDA becomes aware 
of such information, it is our intention to include it in guidance, so 
that farm operators can also rely on FDA guidance for such alternative 
measures.
    As proposed in Sec.  112.12(a), you may establish alternatives to 
the following requirements:
    (1) The requirements in Sec.  112.44(c), for testing water, and 
taking action based on test results, when agricultural water is used 
during growing operations for covered produce (other than sprouts) 
using a direct water application method;
    (2) The composting treatment processes required in Sec.  
112.54(c)(1) and (2);
    (3) The minimum application interval established in Sec.  
112.56(a)(1)(i) for an untreated biological soil amendment of animal 
origin; and
    (4) The minimum application interval established in Sec.  
112.56(a)(4)(i) for a biological soil amendment of animal origin 
treated by a composting process.

[[Page 3553]]

    Under proposed Sec.  112.12(a)(1), you may establish an alternative 
to the requirements, established in proposed Sec.  112.44(c) for 
testing water, and taking action based on test results when 
agricultural water is used during growing operations for covered 
produce (other than sprouts) using a direct water application method. 
Under proposed Sec.  112.44(c), you must test the quality of water you 
use during growing activities for covered produce (other than sprouts) 
in accordance with one of the appropriate analytical methods in 
proposed subpart N. If you find that there is more than 235 CFU (or 
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 that paragraph and before you may use the water 
source and/or its distribution system again for those uses, you must 
either: (1) Re-inspect 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 (2) treat the 
water in accordance with the requirements of Sec.  112.43. As discussed 
in section V.E. of this document, we considered several factors and 
ultimately determined that the microbial standard in proposed Sec.  
112.44(c), which is based on certain aspects of U.S. EPA's recreational 
water standards is appropriate for the uses of agricultural water 
covered by proposed Sec.  112.44(c). We seek comment on this approach.
    However, we acknowledge that in specific circumstances an 
alternative standard (e.g., a standard that applies an application 
interval (time between application and harvest) in place of the 
112.44(c) water standard, but is limited 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. For example, 
we are working with USDA and other 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). Therefore, we 
tentatively conclude that it would be appropriate to allow for 
alternatives to the requirements in proposed Sec.  112.44(c).
    Under proposed Sec.  112.12(a)(2), you may establish an alternative 
to the treatment processes, established in proposed Sec.  112.54(c)(1) 
and (2), for composting, provided you comply with Sec.  112.54(c)(3). 
The processes established in Sec.  112.54(c)(1) and (2) as 
scientifically valid controlled composting processes demonstrated to 
satisfy the microbial standard in Sec.  112.55(b) for Salmonella and 
for fecal coliforms are: (1) Static composting that maintains aerobic 
(i.e., oxygenated) conditions at a minimum of 131 [deg]F (55 [deg]C) 
for 3 days and is followed by adequate curing, which includes proper 
insulation; and (2) Turned composting that maintains aerobic conditions 
at a minimum of 131 [deg]F (55 [deg]C) for 15 days, with a minimum of 
five turnings, and is followed by adequate curing, which includes 
proper insulation. We tentatively conclude that it would be appropriate 
to allow for the use of other static or turned composting protocols 
that maintain conditions for a combination of temperatures and time 
other than the temperature and times specified in proposed Sec. Sec.  
112.54(c)(1) and (2), and is followed by adequate curing, which 
includes proper insulation, if they achieve the same level of pathogen 
reduction (i.e., meet the microbial standard in Sec.  112.55(b)). In 
this sense, the microbial standards would provide a performance 
standard; practices that meet this objective measure would be 
acceptable. It would be your responsibility to consider the moisture 
content, pH, carbon to nitrogen ratio (C:N), feedstock, and any other 
appropriate consideration needed during composting to adequately 
achieve the microbial standards of proposed Sec.  112.55(b).
    Under proposed Sec.  112.12(a)(3), you may establish an alternative 
to the minimum application interval of nine (9) months, established in 
proposed Sec.  112.56(a)(1)(i), for an untreated biological soil 
amendment of animal origin that is reasonably likely to contact covered 
produce after application or for a compost agricultural tea that 
contains compost agricultural tea additives. As discussed in section 
V.F of this document, we have tentatively concluded that, under certain 
circumstances, the application interval in Sec.  112.56(a)(1)(i) 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. These circumstances could 
include differences in likelihood of contamination posed by the 
specific feedstock, application method or treatment method, especially 
given the potential for new innovations in such methods.
    Under proposed Sec.  112.12(a)(4), you may establish an alternative 
to the minimum application interval of 45 days, established in proposed 
Sec.  112.56(a)(4)(i), for a biological soil amendment of animal origin 
treated by a composting process in accordance with the requirements of 
proposed Sec.  112.54(c) that satisfies the microbial standard in 
proposed Sec.  112.55(b), and that is reasonably likely to contact 
covered produce after application. As discussed in section V.F. of this 
document, we are proposing a multiple-hurdle approach to minimizing the 
likelihood of contamination by addition of an application interval of 
45 days to any biological soil amendment of animal origin treated by 
composting that is reasonably likely to contact covered produce after 
application. This time period has been shown to be effective when the 
population of the pathogen is minimal (Ref. 104) as can be expected of 
a fully composted biological soil amendment of animal origin. This 
multiple hurdle approach and time interval has also been utilized in 
current industry standards for leafy greens (Ref. 31). We seek comments 
on this proposal. We have also tentatively concluded that, under 
certain circumstances, the application interval in Sec.  
112.56(a)(4)(i) may be more than what is necessary for minimizing the 
likelihood of contamination of covered produce that is grown in soils 
amended with a treated biological soil amendment, and that is 
reasonably likely to contact the soil after application. These 
circumstances could include differences in likelihood of contamination 
posed by the specific feedstock, application method or treatment 
method, especially given the potential for new innovations in such 
methods.
    As noted above, in any use of alternatives permitted in Sec.  
112.12(a)(1) through Sec.  112.12(a)(4), in accordance with proposed 
Sec.  112.12(b), you would be required to have adequate scientific data 
or information to support a conclusion that the alternative would 
provide the same level of public health protection as the requirement 
specified

[[Page 3554]]

in the proposed rule and would not increase the likelihood that your 
covered produce will be adulterated under section 402 of the FD&C Act. 
Further, in accordance with proposed Sec.  112.12(c), you must 
establish and maintain documentation of such scientific data or 
information, which may be developed by you, available in the scientific 
literature, or available to you through a third party. We are working 
with USDA and other stakeholders to conduct research on relevant 
alternative practices and intend to make the results of that research 
available in the future. We seek comment on whether we should require 
you to notify FDA of your conclusion to establish or use an alternative 
that is permitted under Sec. Sec.  112.12(a)(1) through (a)(4), and 
whether we should require you to submit relevant scientific data or 
information to FDA as part of such a notification.

C. Subpart C--Standards Directed to Personnel Qualifications and 
Training

    As proposed, subpart C discusses minimum standards directed to 
personnel qualifications and training that are reasonably necessary to 
minimize the risk of serious adverse health consequences or death from 
the use of, or exposure to, covered produce, including those reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable hazards into covered produce, and to provide reasonable 
assurances that the covered produce is not adulterated under section 
402 of the FD&C Act.
1. Comments Related to Proposed Provisions
    We received several comments in response to the 2010 FR notice that 
addressed issues relevant to personnel qualifications and training. 
Several comments expressed concern over language and educational 
barriers greatly impeding the farm's ability to effectively fulfill the 
training requirements for their field workers. They also stressed the 
need for far reaching, accurate, consistent, and well-rounded training 
programs with skilled trainers providing the same information to 
growers, processors and distributors. Comments further suggested that 
training materials should have addendums to reflect the differences 
among the varied growing regions, commodities, and production practices 
and processes, as well as train-the-trainer programs for individuals 
responsible for training farm workers. Many firms also urged 
organizations, universities, and extension agencies to share 
experiences and to provide resources for worker training. Several 
comments pointed out difficulties in training due to the transient or 
short term nature of farm workers and due to the seasonal relocation of 
their operations. In addition, comments expressed concern over the cost 
of implementation, including regular refresher courses and training 
materials, and the reliability of third-party training materials. One 
comment requested that individuals responsible for the training program 
and materials should ensure that curricula are updated to reflect any 
new scientific information.
    We believe that adequate and appropriate training of personnel who 
handle covered produce or food-contact surfaces, or who are engaged in 
the supervision thereof, is an essential component of standards for 
produce safety. Regardless of the nature of the farm workers, we 
propose that they must receive training upon hiring, at the beginning 
of each growing season, and with periodic updates as necessary in order 
to prevent contamination of covered produce. Farm workers need to know 
how to recognize potential contamination problems (e.g., a leafy green 
vegetable contaminated with manure) and to be trained to know what to 
do when those situations present themselves. The farm worker is a key 
component in the food chain for ensuring the safety of covered produce. 
No matter the transient nature, any worker can be a potential pathway 
for contamination of produce during growing, harvesting, packing, and 
holding (e.g., because of hygiene issues or illness) or fail to 
identify a situation that may result in contamination of the covered 
produce being grown, harvested, packed, or held if they are not 
cognizant of proper food safety procedures and standards. It is not 
uncommon for workers to change based on season and location and, 
therefore, proposed Sec.  112.21(a) would require personnel to receive 
training upon hiring and at the beginning of each growing season (if 
applicable). Proposed Sec.  112.21(a) would also require that personnel 
receive periodic updates as a way of reminding them of the proper 
procedures including any changes in those procedures. Such updates may 
not require full training sessions, but only short descriptive sessions 
to ensure that all personnel remain aware of all procedures necessary 
to maintain the safety of produce.
    Together with the USDA, Cornell University's National GAPs program, 
the Association of Food and Drug Officials (AFDO), and the National 
Association of State Departments of Agriculture (NASDA), we have formed 
the Produce Safety Alliance (PSA), which is a public-private 
partnership established to provide educational outreach assistance to 
fresh produce growers and packers. This program is in the process of 
creating training materials that will be both region- and commodity-
specific. We expect these materials to be standardized, multi-
formatted, and multi-lingual, and available in pictorial format to help 
overcome literacy issues. Specific focus areas for the PSA include GAPs 
and co-management education and outreach efforts for produce farmers 
and packers, with special emphasis on small-scale operations. This 
alliance will also include a train-the-trainer lesson plan and an 
education outreach program delivery for farmers, trainers, and 
regulators. We intend to explore the need for additional such 
partnerships, as appropriate, to address any commodity-specific needs 
for outreach and assistance. We welcome comments and suggestions for 
training development strategies.
2. Proposed Requirements
    Proposed Sec.  112.21 would establish requirements for the 
qualifications and training for personnel who handle (contact) covered 
produce or food-contact surfaces, or who are engaged in the supervision 
thereof. Having personnel follow proper food hygiene practices, 
including personal health and hygiene, can reduce the potential for on-
farm contamination of covered produce. Educating personnel who conduct 
covered activities in which they contact covered produce and 
supervisors about food hygiene, food safety, and the risks to produce 
safety associated with illnesses and inadequate personal hygiene is a 
simple step that can be taken to reduce the likelihood of pathogens 
being spread from or by personnel to covered produce.
    Most current FDA, private and international guidelines for the 
produce industry include provisions related to training food handlers 
in the importance of personal health and hygiene to food safety (Ref. 
10. Ref. 20. Ref. 50. Ref. 48. Ref. 96. Ref. 26). As described in the 
QAR, FDA's follow-up farm investigations in response to outbreaks and 
contamination events identified poor worker health and hygiene, unsafe 
produce handling and storage practices, and specifically poor training 
in these areas, as likely contributing factors to these events. This 
information reinforces the importance of training farm personnel, 
including supervisors, in food hygiene, food safety, employee health 
and personal hygiene.

[[Page 3555]]

    Proposed Sec.  112.21(a) would require that all personnel 
(including temporary, part time, seasonal and contracted personnel) who 
handle (contact) covered produce or food-contact surfaces and their 
supervisors receive training that is appropriate to the person's 
duties, upon hiring, at the beginning of each growing season (if 
applicable), and periodically thereafter. Because ensuring that covered 
produce is not contaminated is dependent on personnel following proper 
food safety and hygiene practices, all personnel who contact covered 
produce and food-contact surfaces must receive training when hired, 
before they participate in the growing, harvest, packing or holding of 
covered produce in which they contact covered produce, and must be 
periodically reminded about the need to follow these practices through 
refresher training. When a farm hires workers after the beginning of a 
growing season, these workers would need to be trained upon hiring. 
Because the farm does not employ these workers at the beginning of the 
first growing season, the requirement for training at the beginning of 
each growing season would not be applicable to those workers until the 
beginning of the next growing season, if they are still employed by the 
farm at that time. Managers and supervisors must have the necessary 
knowledge of food safety and hygiene principles and practices to be 
able to assess whether their staff are following appropriate practices, 
and take the necessary action to remedy any deficiencies, which could 
include on-the-spot training for their staff.
    Periodic refresher training for all relevant personnel, including 
managers and supervisors, is necessary to ensure continual awareness of 
important food safety and hygiene principles. It is also important when 
new information is available about practices that may contribute to 
foodborne illness or when, for that reason or other reasons, changes in 
the farm's procedures are put in place. For example, during the past 
decade several segments of the produce industry reviewed and revised 
their industry guidelines or developed new guidelines to address 
current food safety concerns relative their specific commodity (i.e., 
lettuce, tomatoes, sprouts, and cilantro).
    Proposed Sec.  112.21(b) would require that all personnel 
(including temporary, part time, seasonal and contracted personnel) who 
handle (contact) covered produce or food-contact surfaces and their 
supervisors have the training, in combination with education or 
experience, to perform the person's assigned duties in a manner that 
ensures compliance with this part. Proposed Sec.  112.21(b) would 
provide flexibility for how personnel become qualified to perform their 
assigned duties by recognizing multiple pathways to obtain the 
necessary qualifications: Training (such as training provided on-the-
job), in combination with education, or experience (e.g., work 
experience related to an employee's current assigned duties). The 
standards in subparts C through O often involve action by farm 
personnel (e.g., monitoring of animal intrusion, inspecting 
agricultural water system) that require specific knowledge, skills and 
abilities, without which the standard could not be properly achieved. 
Proposed Sec.  112.21(b) requires that those farm personnel have the 
training so that they will have the necessary knowledge, skills, and 
abilities to perform their duties.
    Proposed Sec.  112.21(c) would establish requirements for training 
to be conducted in a manner that is easily understood by personnel 
being trained. The goals of training cannot be achieved if the person 
receiving the training cannot understand it. Training could be 
understood by personnel being trained if, for example, it was conducted 
in the language that employees customarily speak and at the appropriate 
level of education. In some cases in may be necessary to use easily 
understood pictorials or graphics of important concepts (Ref. 105).
    Proposed Sec.  112.21(d) would establish requirements for training 
to be repeated as necessary and appropriate in light of observations or 
information indicating that personnel are not adequately meeting 
standards established by FDA in subparts C through O of the rule. The 
goals of training are not achieved if the persons receiving the 
training do not correctly implement those standards taught. Moreover, 
repeated training as proposed in Sec.  112.21(d) is necessary when an 
employee that does not follow the correct food safety protocol, because 
such behavior may increase the likelihood of introducing a food safety 
hazard to covered produce. When an employee requires additional 
training, it may consist of informal on-the-spot instruction to focus 
on those measures not being adequately implemented as opposed to more 
comprehensive training. For example, if you observe an employee commit 
a minor error, such as an inappropriate method for recording monitoring 
information in a log, an appropriate action could be to show the 
employee the correct method of recording the information and contrast 
this with the inappropriate method the employee had been using. 
However, if an employee displays repeated mistakes or a fundamental 
misunderstanding of the correct procedures for handling covered 
produce, an appropriate action may be to have the employee repeat 
relevant training, or to attend a comprehensive training course. If you 
conclude that the employee may not have the skills to conduct certain 
covered activities, an appropriate action may be to train the employee 
for new responsibilities that are more suitable to his or her skills.
    Proposed Sec.  112.22(a) would require that, at a minimum, all 
personnel who handle (contact) covered produce during covered 
activities must receive training that would include: (1) Principles of 
food hygiene and food safety (proposed Sec.  112.22(a)(1)); (2) the 
importance of health and personal hygiene for all personnel and 
visitors, including recognizing symptoms of a health condition that is 
reasonably likely to result in contamination of covered produce or 
food-contact surfaces with microorganisms of public health significance 
(proposed Sec.  112.22(a)(2)); and (3) the standards as applicable to 
the employee's job responsibilities, including those established by FDA 
in subparts C through O of this part (proposed Sec.  112.22(a)(3)).
    We tentatively conclude that the broad topic areas addressed in 
proposed Sec.  112.22(a) are those minimum topic areas necessary to be 
covered during training for all employees who handle (contact) covered 
produce. Training in the principles of food hygiene and food safety are 
necessary to provide an overall framework for job performance. Training 
in health, hygiene, and disease control can teach workers how to 
minimize the likelihood of transferring pathogens to covered produce. 
These topics are covered in several currently used guidance documents 
(Ref. 10. Ref. 20. Ref. 50. Ref. 48. Ref. 96). In addition, training in 
the specific standards established in subparts C through O of this part 
which are necessary for the employee to use during the course of their 
duties will increase the likelihood that those standards will be 
implemented correctly and effectively. We seek comments on the scope, 
frequency, and methods outlined in the proposed training sections of 
the proposed rule.
    Proposed Sec.  112.22(b) would require that persons who conduct 
covered harvest activities for covered produce also receive training 
that includes all of the following: (1) Recognizing covered produce 
that should not be harvested, including covered produce that may be 
contaminated with known or reasonably

[[Page 3556]]

foreseeable food safety hazards (proposed Sec.  112.22(b)(1)); (2) 
inspecting harvest containers and equipment to ensure that they are 
functioning properly, clean, and maintained so as not to become a 
source of contamination of covered produce with known or reasonably 
foreseeable food safety hazards (proposed Sec.  112.22(b)(2)); and (3) 
correcting problems with harvest containers or equipment, or reporting 
such problems to the supervisor (or other responsible party), as 
appropriate to the person's job responsibilities (proposed Sec.  
112.23(b)(3)).
    We tentatively conclude that the topic areas addressed in proposed 
Sec.  112.22(b), in addition to Sec.  112.22(a), are those minimum 
topic areas necessary to be covered during training for persons who 
conduct harvest activities. Harvest workers need to learn how to 
recognize produce that should not be harvested (such as rotten or 
decayed fruit, ``drops,'' or harvestable items that have been 
contaminated with feces), because not harvesting such covered produce 
would be the first opportunity to prevent that produce from entering 
commerce, and as a practical matter may be the only such opportunity 
(for example, during a field-pack operation with no subsequent culling 
stage). Proposed Sec.  112.112 would require that farms take all 
measures reasonably necessary to identify and not harvest covered 
produce that is visibly contaminated with animal excreta.
    Harvest workers must be trained to both recognize this condition 
and to avoid harvesting covered produce that exhibits the condition. 
Harvest workers also need to know how to inspect harvest containers and 
equipment to ensure that they are functioning properly, clean, and 
maintained so that they will not act as a source of contamination or 
lead to damage of covered produce (damaged produce is more likely to 
harbor pathogens, and at a greater population, than is sound produce 
(Ref. 59. Ref. 106)). Harvest workers also need to know how to correct 
problems with harvest equipment or containers when they encounter them, 
or need to know that they should report such problems to someone who 
would be responsible for ensuring that the problem is corrected. These 
topics are covered in several currently used relevant documents (Ref. 
8. Ref. 33. Ref. 18. Ref. 89. Ref. 84). We acknowledge the challenge 
these training requirements may pose to farms that employ contracted 
harvest crews. In such cases, we expect that the harvest crew company 
could provide the required training to workers, who move from farm to 
farm under the employment of the harvest crew company. Farms on which 
such harvest crews work could request certification from the harvest 
crew company that their workers have received the required training. We 
seek comment on the feasibility of the proposed training requirements, 
particularly with respect to harvest activities.
    Proposed Sec.  112.22(c) would require that at least one supervisor 
or responsible party for your farm successfully complete food safety 
training at least equivalent to that received under standardized 
curriculum recognized as adequate by the Food and Drug Administration. 
Experience at farming does not necessarily convey knowledge of food 
safety, particularly that of microbial food safety hazards, and 
therefore specialized training is needed to address the specific 
concerns of on-farm food safety. The purpose of training a supervisor 
or other responsible party is so that person can help train other 
employees, recognize conditions that could lead to contamination of 
covered produce, and take action to correct those conditions. As 
discussed in section II.D. of this document, FDA has, together with 
USDA AMS, established the jointly funded PSA, a public-private 
partnership that will develop and disseminate science- and risk-based 
training and education programs to provide produce growers and packers 
with fundamental, on-farm food safety knowledge, starting in advance of 
this proposed rule and continuing after the final regulation is 
promulgated. A first phase of PSA's work is intended to assist growers, 
especially small growers, in establishing food safety programs 
consistent with the GAPs Guide and other existing guidances and 
requirements so that they will be better positioned to comply with a 
final produce rule. As this rulemaking progresses, FDA will work to 
ensure that the PSA materials are modified, as needed, to be consistent 
with the requirements of this rule. Included in that material will be 
the standardized curriculum against which FDA intends to compare other 
training programs. After reviewing the final draft of the PSA training 
materials, FDA intends to publish a notice of availability of the 
documents in the Federal Register. We would encourage trainers outside 
the PSA to evaluate their courses, past, present, and future, against 
the PSA materials when they become available and to modify or adapt 
curricula, where necessary, to ensure that they are consistent with, 
and provide at least an equivalent level of instruction to, the 
Alliance course. We have no plans to publish a list of ``approved'' 
courses other than the Alliance course materials. Proposed Sec.  112.23 
would require that you assign or identify personnel to supervise (or 
otherwise be responsible for) your operations to ensure compliance with 
the requirements of the rule. Oversight by a qualified individual is 
essential to the effective implementation of the rule. Under proposed 
Sec.  112.23, the personnel that you assign or identify to supervise 
(or otherwise be responsible for) your operations may be a single 
person (including yourself), or may be a team of individuals, each with 
specific areas of responsibility (e.g., you may assign or identify 
separate persons to be responsible for your water distribution system, 
your harvest activities, your sanitary accommodations, and your packing 
activities).
    Proposed Sec.  112.30(a) would require that you establish and keep 
records required under subpart C in accordance with the requirements of 
subpart O of the rule. Proposed Sec.  112.30(b) would require that you 
establish and keep records that document required training of 
personnel, including the date of the training, the topics covered, and 
the person(s) trained. An example of records that would comply with 
proposed Sec.  112.30(b) is an attendance sheet with the date, list of 
those in attendance, and the particular topics covered (such as proper 
hand washing or how to collect samples for water testing). The records 
required by proposed Sec.  112.30(b) would enable you to track the 
training personnel receive, thereby enabling you to identify personnel 
and training topics for periodic updates and personnel that have the 
prerequisite training for assignment to certain responsibilities. Such 
records would enable you to document that a person has, as would be 
required under proposed Sec. Sec.  112.21(a) and (b), successfully 
completed training as appropriate to the person's duties, upon hiring 
and periodically thereafter, including the principles of food hygiene 
and food safety and also the training that would be specific to a 
person's tasks and responsibilities.

D. Subpart D--Standards Directed to Health and Hygiene

    As proposed, subpart D discusses science-based minimum standards 
directed to health and hygiene that are reasonably necessary to 
minimize the risk of serious adverse health consequences or death from 
the use of, or exposure to, covered produce, including those reasonably 
necessary to prevent the introduction of known or

[[Page 3557]]

reasonably foreseeable hazards into covered produce, and to provide 
reasonable assurances that the produce is not adulterated under section 
402 of the FD&C Act.
1. Comments Relevant to Proposed Provisions
    We received some comments in response to the 2010 FR notice that 
addressed issues relevant to health and hygiene. Several comments noted 
the challenges of enforcing use of gloves and clean clothes. Others 
expressed concerns related to identifying sick employees who could 
contaminate covered produce or food-contact surfaces, while another 
comment asked about potential requirements on hygienic practices and 
questioned whether hand jewelry could contaminate produce such as leafy 
greens.
    We recognize the importance of taking appropriate measures to 
prevent sick or infected persons from contaminating covered produce or 
food-contact surfaces. In proposed Sec.  112.22(a)(2), we propose to 
require training of personnel to recognize symptoms of a health 
condition that is reasonably likely to result in contamination of 
covered produce or food-contact surfaces with microorganisms of public 
health significance. The proposed requirements for standards directed 
to health and hygiene focus on maintaining adequate personal 
cleanliness. Gloves can provide a barrier to reduce the potential for 
contamination; however, gloves themselves can transfer pathogens to 
covered produce if they become contaminated. Therefore, while we are 
not proposing to require the use of gloves, we are proposing to require 
the proper use of gloves when workers wear them (proposed Sec.  
112.32(b)(4)). Clothes should be adequately clean if by virtue of type 
of operation the workers are performing, the clothes could potentially 
contaminate covered produce with pathogens.
2. Proposed Requirements
    Proposed subpart D would require that you take those measures that 
we tentatively conclude are reasonably necessary to prevent personnel 
and visitors from introducing known or reasonably foreseeable hazards 
into or onto covered produce or food-contact surfaces. As discussed 
above (see sections I.A. of this document, and QAR), people can carry a 
wide variety of pathogens (including hepatitis A virus, Salmonella, E. 
coli O157:H7, Shigella, Cyclospora, and Cryptosporidium (Ref. 93) (Ref. 
107). Bacteria, viruses, and parasites are frequently transmitted from 
person to person and from person to food, particularly through the 
fecal-oral route (Ref. 95. Ref. 96. Ref. 97. Ref. 98. Ref. 93). Several 
of the provisions of proposed subpart D are similar to requirements in 
our Current Good Manufacturing Practice regulations for food and for 
dietary supplements (Sec.  110.10 and 111.10, respectively), and to 
provisions in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 20), 
various produce industry guidelines (Ref. 46. Ref. 44), a marketing 
agreement (Ref. 31), and international guidelines (Ref. 96).
    Proposed Sec.  112.31 would require that you take measures 
necessary to prevent ill or infected persons from contaminating covered 
produce with microorganisms of public health significance. Proposed 
Sec.  112.31(a) would require that you take measures to prevent 
contamination of covered produce and food-contact surfaces with 
microorganisms of public health significance from any person with an 
applicable health condition (such as communicable illnesses that 
present a public health risk in the context of normal work duties, 
infection, open lesion, vomiting, or diarrhea).
    Proposed Sec.  112.31(b)(1) would require that you exclude any 
person from working in any operations that may result in contamination 
of covered produce or food-contact surfaces with microorganisms of 
public health significance when the person (by medical examination, the 
person's acknowledgement, or observation (for example, by a supervisor 
or responsible party)) is shown to have, or appears to have, an 
applicable health condition, until the person's health condition no 
longer presents a risk to public health. Applicable health conditions 
would not include non-communicable diseases such as cancer, diabetes, 
or high blood pressure, or non-communicable conditions such as 
pregnancy, which would not present a likelihood of contamination to 
covered produce or food contact surfaces. For example, if an employee 
tells you that his or her physician has diagnosed that the employee has 
a fever, and the employee normally handles your covered produce, you 
must take steps to ensure that the employee does not come into contact 
with your covered produce because the fever may suggest that the 
employee has an infection and there is a reasonable possibility of 
contamination. Likewise, if you see that an employee has an open wound 
or sore, and the employee normally handles covered produce, you must 
take steps to ensure that he or she is excluded from handling covered 
produce if the wound could be a source of microbial contamination. 
Proposed Sec.  112.31(b)(1) is similar to requirements in current 
Sec. Sec.  110.10(a) and 111.10(a) and to provisions in our GAPs Guide 
(Ref. 10), the AFDO Model Code, various produce industry guidelines 
(Ref. 89. Ref. 84. Ref. 99), and a marketing agreement (Ref. 31), and 
the Codex Code (Ref. 96).
    Proposed Sec.  112.31(b)(2) would require that you instruct your 
personnel to notify their supervisor(s) (or a responsible party) if 
they have, or if there is a reasonable possibility that they have, an 
applicable health condition. Consistent with the training requirement 
proposed in Sec.  112.22(a)(2), we are proposing this requirement as a 
measure specifically directed at preventing sick or infected persons 
from contaminating covered produce or food-contact surfaces and to 
emphasize that individual workers have a responsibility--every day--to 
take action to prevent contamination due to their own illness or 
infection. In a small or very small business, such as a farm largely 
operated by a husband and wife, the impact of proposed Sec.  
112.31(b)(2) would, in essence, be for a sick worker to take 
appropriate steps to exclude himself or herself from working in any 
operations that may result in contamination of covered produce or food-
contact surfaces with pathogens. Proposed Sec.  112.31(b)(2) is similar 
to requirements in current Sec. Sec.  110.10(a) and 111.10(a) and to 
provisions in the AFDO Model Code (Ref. 20), and a produce industry 
guideline ( (Ref. 46). We seek comments on the notification and other 
proposed requirements related to workers health.
    Proposed Sec.  112.32 would require that personnel use certain 
hygienic practices. Proposed Sec.  112.32(a) would require that 
personnel who work in an operation in which covered produce or food-
contact surfaces are at likelihood of contamination with known or 
reasonably foreseeable hazards use hygienic practices while on duty to 
the extent necessary to protect against such contamination. Hygienic 
practices can prevent introduction of microbial (such as bacteria and 
viruses that could be present in saliva or on skin) contamination of 
covered produce (Ref. 108). Inadequate hygienic practices among workers 
have been associated with outbreaks transmitted by various produce 
commodities, including strawberries, green onions, mamey, leaf lettuce, 
and basil (Ref. 107). Proposed Sec.  112.32(a) is similar to 
requirements in current Sec. Sec.  110.10(b) and 111.10(b) and to 
provisions in our GAPs Guide (Ref.

[[Page 3558]]

44), the AFDO Model Code (Ref. 20), various produce industry guidelines 
(Ref. 46. Ref. 44), a marketing agreement (Ref. 31), and the Codex Code 
(Ref. 96).
    Proposed Sec.  112.32(b) would require that personnel who handle 
(contact) covered produce use specific hygienic practices to satisfy 
the requirements of proposed Sec.  112.32(a). Proposed Sec.  
112.32(b)(1) would require the specific practice of maintaining 
adequate personal cleanliness to protect against contamination of 
covered produce and food-contact surfaces. Requiring that workers 
maintain adequate personal cleanliness is similar to requirements in 
current Sec. Sec.  110.10(b) and 111.10(b) and to provisions in the 
Codex Code (Ref. 96). We would expect that maintaining adequate 
personal cleanliness would include wearing adequate outer garments as 
necessary and appropriate to protect against contamination of covered 
produce and food-contact surfaces. Outer garments (e.g., smocks, 
aprons, or coveralls worn over a worker's personal clothing) may be 
necessary and appropriate when a worker conducts an activity that has 
increased potential to contaminate the worker's personal garments with 
hazards that could be transferred to covered produce or food-contact 
surfaces during subsequent activities in which the worker may contact 
covered produce. For example, a worker's personal clothing could become 
contaminated with pathogens while a worker shovels manure, and such 
contamination could be transferred from the clothing to covered produce 
if the worker subsequently harvests covered produce wearing the same 
clothes. An apron, smock, or coverall worn over the worker's personal 
clothing while shoveling the manure could simply be removed before the 
worker moves on to a harvest activity, which would reduce the 
likelihood of contaminating covered produce during the subsequent 
harvest activity. We intend to provide further information about 
adequate worker personal cleanliness in guidance.
    Proposed Sec.  112.32(b)(2) would require that personnel avoid 
contact with animals other than working animals, and that personnel in 
direct contact with working animals take appropriate steps to minimize 
the likelihood of contamination of covered produce. Pathogens can be 
directly transmitted from animals to people when persons touch, pet, 
feed, or are licked by animals because animal hair, fur, saliva and 
skin can harbor pathogens (Ref. 98. Ref. 99. Ref. 100). For example, 
transmission of the pathogen Giardia lamblia from animals to humans was 
linked to an outbreak of foodborne illness associated with consumption 
of contaminated produce (Ref. 109).
    Proposed Sec.  112.32(b)(3) would require that personnel wash hands 
thoroughly, including scrubbing with soap and running water that 
satisfies the requirements of Sec.  112.44(a) (as applicable) for water 
used to wash hands, and that personnel dry hands thoroughly using 
single-service towels, clean cloth towels, sanitary towel service or 
other adequate hand drying devices on specified occasions. Those 
specified occasions include before starting work; before putting on 
gloves; after using the toilet; upon return to the work station after 
any break or other absence from the work station; as soon as practical 
after touching animals (including livestock and working animals) or any 
waste of animal origin; and at any other time when the hands may have 
become contaminated in a manner that is reasonably likely to lead to 
contamination of covered produce with known or reasonably foreseeable 
hazards. Under proposed Sec.  112.32(b)(3), we would not expect workers 
to immediately stop work and wash their hands each time hands become 
soiled during the usual course of farm work with dirt or plant litter. 
However, we would expect workers to have sufficient training to 
recognize potential sources of hazards and to wash their hands when 
appropriate. We tentatively conclude that proposed Sec.  112.32(b)(3) 
provides sufficient flexibility for operations to provide running water 
in a manner best suited to the conditions of use. For example, water 
can be supplied by a Public Water System, private well, or other source 
satisfying the requirements of Sec.  112.44(a) through plumbed 
connections to building faucets (e.g., inside a packing house) to 
supply running water throughout the facility. Alternatively, water 
supplied from sources above and used to fill clean, portable water 
containers suited to field use (such as a carboy, tank, water buffalo, 
or similar container) fitted with a valve, spout, or spigot such that 
water released passes over the hands also can provide adequate running 
water for washing hands. Under proposed Sec.  112.44(a), with certain 
exceptions set forth in proposed Sec.  112.45, you must test the 
quality of water used for hand washing during and after harvest to 
ensure that there is no detectable generic E. coli (see section V.E. of 
this document).
    Workers often touch produce with their bare hands, and the produce 
covered by this rule would not necessarily have a ``kill step'' to 
adequately reduce pathogens that could be transmitted through bare-hand 
contact. Hand-washing, when done effectively, can eliminate both 
resident bacterial contamination (such as on the hands of a worker who 
may not realize he is ill or infected) and transient microbial 
contamination (such as bacteria, viruses, and parasites that gets onto 
hands through contact with the environment) (Ref. 110). As a result, 
hand-washing is a key control measure in preventing contamination of 
covered produce and food-contact surfaces (Ref. 26). The effectiveness 
of hand-washing is determined by multiple factors, including whether or 
not soap is used, the quality of water used, the duration of scrubbing 
and rinsing, and whether hands are dried. Soap serves as an emulsifier 
that enables dirt and oil to be suspended and washed off (Ref. 110). 
Rinsing hands without using soap, and not drying hands after washing, 
can promote the spread of microorganisms. For example, rinsing hands 
without using soap can loosen microorganisms without removing them, 
leaving the microorganisms more readily transferable to the next 
surface touched (Ref. 110). An investigation in follow-up to an 
outbreak of foodborne illness caused by E. coli O157:H7 in Florida 
found an association between illness and visits to fairs where visitors 
came in contact with animals, and found that persons who washed their 
hands with soap and water had a decreased likelihood of illness (Ref. 
111). Drying hands is important because wet skin is more likely to 
transmit microorganisms than dry skin (Ref. 110). In addition, hand-
drying has been demonstrated to remove bacteria from the hands and 
decrease ``touch-contact-associated bacterial transfer'' after hand-
washing (Ref. 112). Proposed Sec.  112.32(b)(3) does not prohibit use 
of hand sanitizers as a part of the hand washing process. However, our 
review of hand washing indicates that soap and water are far more 
effective than sanitizers in removing pathogens. The effectiveness of 
hand sanitizers has been shown to be highly dependent upon the removal 
of organic material from the hands prior to their use, as the presence 
of dirt, grease, or soil significantly reduces their effectiveness in 
eliminating bacteria on hands (Ref. 107).
    Proposed Sec.  112.32(b)(3) is similar to provisions in our GAPs 
Guide (Ref. 10), the AFDO Model Code (Ref. 20), various produce 
industry guidelines (Ref. 89. Ref. 84. Ref. 99), a marketing agreement 
(Ref. 31), and the Codex Code (Ref. 96). Several differences exist 
between proposed Sec.  112.32(b)(3) and analogous provisions in current 
Sec. Sec.  110.10(b) and 111.10(b). For example, proposed

[[Page 3559]]

Sec.  112.32(b) would not specify, in addition to the requirements for 
hand washing, that hands also be sanitized if necessary to protect 
against microbial contamination, while both Sec. Sec.  111.10(b) and 
111.10(b) have such a requirement. We tentatively conclude that the 
circumstances where use of a hand sanitizer as an additional measure to 
reduce likelihood of contamination with pathogens would be limited on a 
farm. Hand sanitizers are less likely to be effective on a farm than in 
a processing plant, since growers' hands are more likely to get dirty 
during production on a farm and the resulting presence of organic 
material on the hands would impede the effectiveness of hand sanitizers 
(Ref. 113).
    In addition, proposed Sec.  112.32(b)(3)(v) would specifically 
require washing hands after touching animals, a requirement that is not 
included in current Sec.  110. We are proposing this requirement here 
because contact with animals is more likely to happen on a farm. In 
addition, the National Association of State Public Health Veterinarians 
has recommend washing hands after touching animals as a protection 
against outbreaks of E. coli O157:H7, Salmonella Enteritidis, 
Cryptosporidium parvum, non-O157 STEC, Salmonella typhimurium, and 
Campylobacter jejuni (Ref. 111).
    Proposed Sec.  112.32(b)(3) also would repeat some of the 
characteristics of an adequate hand-washing facility specified in 
proposed Sec.  112.130 (i.e., soap, running water of specified 
microbial quality, and adequate drying devices). Currently, in our CGMP 
regulation for food facilities, Sec.  110.37(e) identifies examples of 
how to achieve compliance with the requirements for an adequate hand-
washing facility, but it does not repeat them in the requirement in 
Sec.  110.10(b) regarding workers washing their hands. In proposed 
Sec.  112.32(b)(3) (and in proposed Sec.  112.130), we are proposing to 
identify specific characteristics of an adequate hand-washing facility 
because many of these facilities are likely to be in outdoor growing 
areas and be portable. Standard features that we have come to expect as 
a matter of course in a hand-washing facility in a building used for 
manufacturing/processing food may not be standard in a portable hand-
washing facility. Moreover, the outdoor nature of many areas where 
covered activities take place naturally presents workers with 
situations where they will get dirt on their hands, and workers may be 
routinely handling food, with their bare hands, that will not be cooked 
to adequately reduce pathogens. Therefore, we believe it is appropriate 
to repeat these requirements in the proposed provisions for workers to 
wash their hands as well as in the proposed provisions directed to 
hand-washing facilities. We seek comment on the hand-washing proposals 
described above.
    Proposed Sec.  112.32(b)(4) would require that, if you choose to 
use gloves in handling covered produce or food-contact surfaces, you 
maintain gloves in an intact and sanitary condition, and that you 
replace such gloves when you are no longer able to do so. We are not 
proposing to require the use of gloves, but gloves are used in many 
operations to protect workers' hands. While gloves also provide a 
barrier that can reduce the potential for pathogens on workers' hands 
to contaminate covered produce, gloves themselves, whether re-usable or 
disposable, can transfer pathogens to covered produce if the gloves 
become contaminated (Ref. 26). If gloves are used in handling covered 
produce or food contact surfaces, requiring that such gloves be either 
in an intact and sanitary condition, or else be replaced, reduces the 
potential for the gloves to be a source of contamination for covered 
produce. Proposed Sec.  112.32(b)(4) is similar to requirements in 
current Sec. Sec.  110.10(b) and 111.10(b). Our GAPs Guide (Ref. 10), 
various produce industry guidelines (Ref. 89. Ref. 84. Ref. 99) and the 
Codex Code (Ref. 96) include specific provisions directed to the use of 
gloves. The AFDO Model Code (Ref. 20) and a marketing agreement (Ref. 
31) direct farms to establish policies to ensure proper use of gloves. 
It has been reported that glove use can foster a ``false sense of 
security'' that can lead to less sanitary practices such as wearing the 
same pair of gloves for extended periods of time without cleaning them, 
or washing hands infrequently (Ref. 114). If your workers wear gloves, 
you should ensure that they know that wearing gloves in no way 
diminishes the importance of washing hands, and that gloves must be 
maintained and replaced, when necessary and appropriate.
    Proposed Sec.  112.33 would require that you take measures to 
prevent visitors from contaminating covered produce and food-contact 
surfaces with microorganisms of public health significance. Proposed 
Sec.  112.33(a) would define a visitor as any person (other than 
personnel) who enters your covered farm with your permission. Proposed 
Sec.  112.33(b) would require that you make visitors aware of policies 
and procedures to protect covered produce and food-contact surfaces 
from contamination by people, and that you take all steps reasonably 
necessary to ensure that visitors comply with such policies and 
procedures. Proposed Sec.  112.33(c) would require that you make toilet 
and hand-washing facilities accessible to visitors. In contrast to food 
processing facilities, on-farm visitors often enter areas where covered 
produce is grown and harvested, particularly on farms that offer 
consumers an opportunity to pick their own fruits and vegetables. As 
with workers, visitors can transmit pathogens to covered produce and 
food-contact surfaces. Thus, we are proposing to require that farms 
address the potential for visitors to contaminate covered produce, even 
though we have no similar requirements in regulations such as parts 110 
and 111. Proposed Sec.  112.33 is similar to provisions in our GAPS 
Guide (Ref. 10), the AFDO Model Code (Ref. 20), various produce 
industry guidelines (Ref. 89. Ref. 84. Ref. 99), a marketing agreement 
(Ref. 31), and the Codex Code (Ref. 96). A farm could comply with these 
proposed requirements by, for example, indicating the location of 
restrooms and hand-washing facilities accessible to visitors and 
clearly posting rules applicable to visitors where they are likely to 
be seen and read at the beginning of a visitor's visit, such as near 
the entrance or cash register at a ``pick-your-own'' farm operation.

E. Subpart E--Standards Directed to Agricultural Water

    As proposed, subpart E discusses science-based minimum standards 
directed to agricultural water that are reasonably necessary to 
minimize the risk of serious adverse health consequences or death from 
the use of, or exposure to, covered produce, including those reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable hazards into covered produce, and to provide reasonable 
assurances that the produce is not adulterated under section 402 of the 
FD&C Act.
1. Comments Relevant to Proposed Provisions
    We received some comments in response to the 2010 FR notice that 
addressed issues relevant to agricultural water. Several comments 
expressed concern that our proposed regulations could have an adverse 
effect upon or be in conflict with on-farm conservation or land 
management practices efforts; or that they could set standards for 
limiting all animal access to surface waters (e.g., by fencing or other 
barrier) or prohibit vegetation (normally used to stabilize soil or for 
use as a natural water filter) surrounding surface water sources.

[[Page 3560]]

    In developing the provisions in proposed part 112, we consulted 
with USDA's National Organic Program and Natural Resources Conservation 
Service, U.S. Fish and Wildlife Service, and the EPA (Ref. 115) to take 
into consideration conservation and environmental practice standards 
and policies established by those agencies. We recognize the importance 
of ensuring, to the extent possible, that our proposed provisions are 
compatible with existing conservation practices in the management of 
agricultural water systems. In proposed Sec.  112.42(a)(1)-(5), we 
would require that you inspect your entire agricultural water system at 
the beginning of every growing season, focused on identifying 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food-contact 
surfaces. A similar (re)inspection would be required in proposed 
Sec. Sec.  112.44(b) and (c) if the water you use for certain purposes 
does not meet the microbiological criteria described in those 
provisions. In each of these provisions, however, we do not describe 
specific inspection findings likely to adversely affect microbial water 
quality and relate them to specific required actions. For example, we 
do not propose that vegetation surrounding an on-farm pond be cut back 
and/or removed or that fencing must be used to prevent access to a pond 
by wildlife and domestic animals. We recognize that each farm, State, 
region, or produce commodity group may approach water management 
differently with respect to the likelihood of contamination of 
agricultural water and the use of specific conservation practices that 
may be appropriate or consistent with measures used to mitigate the 
likelihood of contamination. Practices used for one region or commodity 
may not be appropriate for others based upon historical experience. 
Under this proposed subpart, we would require that you address such 
issues only if they are reasonably likely to contribute to 
contamination of covered produce, and we would provide flexibility in 
the way in which you address any identified hazards, such that measures 
you implement to mitigate such hazards can be consistent with your 
current conservation practices. This approach allows you to put in 
place measures you deem most effective in addressing the potential for 
water contamination and to assess the effectiveness of those measures 
as they may be reflected in your microbial water quality data.
    We also received a number of comments expressing concern about 
costs and associated burden related to testing of agricultural water, 
including pathogen testing, indicators, and frequency of testing. As 
described in section in the QAR, pathogen presence and distributions in 
the environment and water systems can be expected to be sporadic, with 
survival dependent on a multitude of factors. Thus, broad 
generalizations concerning their presence or persistence in water or on 
produce are problematic, and their detection difficult. Therefore, 
rather than testing for the presence or levels of various pathogenic 
microorganisms, we propose to use a microbial indicator as a monitoring 
measure to assess the potential for contamination. After considering 
various microbial indicators of water quality (see section V.E.2. of 
this document), we tentatively conclude that generic Escherichia coli 
(E. coli) is best suited for this purpose. It can be found in at least 
90 percent of all human and animal feces (Ref. 116) and is most closely 
associated with incidents of fecal contamination (Ref. 107. Ref. 108. 
Ref. 109. Ref. 110. Ref. 108. Ref. 111. Ref. 112). There are multiple 
test methods, commercial kits, and formats available at relatively low 
cost, and the accuracy, precision, and sensitivity of these analytical 
testing options would meet the requirements in this proposed rule. 
Although the correlation between generic E. coli and fecal 
contamination is strong, as discussed in section V.E.2. of this 
document, generic E. coli does not always reliably predict the presence 
of pathogens despite fecal pollution being a known source of pathogenic 
microorganisms. This is explainable, however, considering the current 
understanding of pathogen occurrence and distribution described in the 
QAR and the taxonomic diversity of waterborne pathogens (e.g., 
bacteria, viruses, and protists). Thus, generic E. coli monitoring 
serves as a measure to assess the potential for fecal contamination, 
not to directly predict the presence of pathogens.
    Comments also emphasized that microbial testing should be performed 
at a frequency dependent upon the results of an assessment of the risks 
posed by your agricultural water system. We agree that the frequency 
should reflect the risk. In proposed Sec.  112.45(a), with certain 
exceptions, we propose to require you to test water used for certain 
purposes at the beginning of each growing season, and every three 
months thereafter during the growing season. We tentatively conclude 
that this frequency would provide sufficient information regarding the 
microbial quality of your agricultural water. We are proposing in 
addition in Sec.  112.45(b) that untreated surface waters must be 
tested more frequently than ground water sources because surface 
watersheds are subject to a greater number of external forces that 
shape their overall composition, chemistry, and microbial water quality 
(e.g., erosion, run-off, dust, suspended sediments). We seek comment on 
our proposed approach.
    A number of comments related to quantifying risks associated with 
the use of agricultural water as a function of water source, time of 
application, irrigation method, and commodity type. Our research shows 
that this is an extremely difficult task. In the QAR, we considered 
various factors relevant to produce production and harvesting, 
including water sources and use (See the QAR document). Some 
conclusions related to likelihood of produce contamination associated 
with water use can be drawn, although the relevance of these findings 
and whether they can be generalized across commodities, regions, and 
climates is not known. For example, Stine et al (2005) (Ref. 109) and 
Song et al. (2006) (Ref. 117) provide strong evidence that subsurface 
drip irrigation lowers the likelihood of waterborne contamination 
compared to furrow or overhead irrigation. These authors also suggest 
that proximity of the edible portion relative to water applied and 
surface texture of the edible portion play key roles in likelihood of 
contamination.
    In addition, according to a WHO risk assessment (Ref. 118) of 
wastewater use in agriculture, pathogen (bacteria, protists, and 
viruses) die-off during the interval between last irrigation and 
consumption is approximately 1 log per day, although the rate varies 
with climatic conditions. Other measures that can be protective include 
cessation of watering, choice of irrigation method (localized 
irrigation--bubbler, drip, trickle is more protective than flood, 
furrow, or spray/sprinkler), and food preparation measures (washing) 
(Ref. 118). It is difficult to determine to what extent this assessment 
can be applied to water systems that are not based on wastewater use 
where high pathogen loads can be expected. Produce grown with water of 
significantly higher water quality continues to be implicated in 
disease outbreaks (Ref. 119). These outbreaks not only illustrate the 
challenge in assigning absolute risk reduction values to measures used 
in the mitigation of risk, but also the sporadic nature of pathogen 
occurrence and localized conditions leading to the persistence of 
pathogens in the environment.

[[Page 3561]]

    A few comments recommended that equipment used to hold or convey 
water should be inspected to ensure that it is clean.
    We agree that equipment used to hold or convey water should be 
maintained in a manner necessary to protect against contamination. In 
proposed 112.42(c), we propose to require that all agricultural water 
distribution systems must be adequately maintained as necessary and 
appropriate to prevent the water distribution system from being a 
source of contamination to covered produce, food-contact surfaces, 
areas used for a covered activity, or water sources, including by 
regularly inspecting and adequately storing all equipment used in the 
system. In addition, in proposed 112.42(b), we propose to require that 
all agricultural water sources that are under the control of a covered 
farm (such as wells) must be adequately maintained by regularly 
inspecting each source and keeping the source free of debris, trash, 
domesticated animals, and other possible sources of contamination of 
covered produce to the extent practicable and appropriate under the 
circumstances.
    We seek comment on our proposals and approach related to 
agricultural water.
2. Water Quality Testing, Indicators, and Standards
    In this subsection, we present a technical discussion of issues 
related to water quality such as testing samples, microbial quality 
indicators, and microbial quality standards. We discuss these issues in 
greater detail in this subsection to further support the provisions 
proposed below related to water quality testing and microbial 
indicators.
    A fundamental component in assessing the adequacy of water for its 
intended use is a routine sampling and microbial testing program (Ref. 
120. Ref. 29). Water sampling and testing allows for informed decisions 
regarding the management of water use, such as choosing a water source 
and combining that selection with, for example, the irrigation method 
for a specific commodity or time period prior to harvest. Testing for 
microbial quality of water can identify possible fecal contamination at 
the water source or in a section of its distribution system (e.g., line 
break). Additionally, regular testing data may be used to identify 
seasonal (or other) trends and highlight areas of the system that may 
require attention. For example, regular testing results may show that 
periodic increases in indicator organisms are correlated with 
precipitation levels or suspended sediments in surface waters, 
providing useful information about when and how that water source can 
be safely used.
    Microbial water quality testing can be performed using a variety of 
methods that have been validated for water testing. A key element of 
any testing program is determining the indicator organism or specific 
pathogen(s) and the frequency of testing. The sensitivity of the method 
is also important, although most test methods available today have 
sensitivities that match or exceed requirements for EPA drinking water 
and FDA bottled water standards.
    Surface water quality and pathogen monitoring studies reported in 
the literature often quantify indicator organisms or pathogens on a 
monthly basis. However, most studies do not specifically address the 
impact of water quality on produce safety (Ref. 115. Ref. 116. Ref. 
117. Ref. 118). A lack of consensus among the different recommendations 
and approaches underscores the complexity and uncertainty in water 
quality sampling and testing strategies. Nevertheless, a vast majority 
of studies that address frequency of testing recommend that surface 
water sources should be sampled more frequently than ground water 
sources (Ref. 121).
    Two key determinants of an appropriate testing frequency emerge 
from this information: (1) Variability of the water source and (2) the 
extent to which it can be protected. The discussion above suggests that 
water obtained from a public water source is least likely to be a 
vehicle for pathogen contamination of produce, followed by water 
obtained from deep underground aquifers, shallow wells, and surface 
waters, in that order. This is consistent with findings reported in the 
literature (Ref. 122. Ref. 29). For purposes of defining likelihood of 
contamination, we further divide surface water into two types, based on 
the potential for contamination (through runoff), and the degree to 
which potential contamination can be recognized and controlled (i.e., 
(1) surface waters where runoff is difficult to recognize and control 
because of the size of the watershed (e.g., river or lake) and (2) 
surface waters where runoff can be easily detected and which can be 
managed so as to protect them from runoff (e.g., on-farm reservoir or 
pond)). Runoff is used here in differentiating the likelihood of 
contamination of surface water because it has the potential to carry 
pathogens and is known to mobilize pathogens from sediment reservoirs 
to the water column (Ref. 117. Ref. 120. Ref. 121. Ref. 122. Ref. 123) 
as well as carry pathogens to the surface water system from sources 
such as failing septic systems and deposited animal feces (Ref. 123. 
Ref. 124).
a. Microbiological Indicators of Water Quality
    A primary consideration in establishing a microbiological water 
quality testing program is the choice of target organism(s). Two 
general approaches are commonly used: Test for the presence of an 
indicator organism(s) that may signal the presence of pathogens or test 
for pathogens themselves. In the United States, bacterial indicators 
have a long history of being used to demonstrate the safety of drinking 
water and adequacy of its treatment at the source. They have also been 
used to monitor the status of drinking water in distribution systems 
and determine if surface waters are microbiologically safe for 
recreational use (e.g., swimming) and shellfish harvest (Ref. 123).
    Bacterial fecal indicators are non-pathogenic microorganisms that 
are commonly found in the intestines of warm-blooded animals that are 
easily isolated and quantified as a measure of fecal contamination and 
potential for enteric pathogens. Desired characteristics for effective 
indicator organisms include: Ease of detection; being present only when 
fecal contamination or pathogens are present; and, being in numbers 
that correlate with the amount of contamination, numbers of pathogens 
and risk of illness. Survival times of indicator organisms in sediments 
and in water should be equal (or greater) to those for pathogens and 
their detection should be accomplished by simple, rapid methods at low 
cost. Indicator microorganisms are widely used in water quality testing 
because of their broad utility across many types of water but no single 
indicator that is universally accepted (Ref. 123).
    Pathogen detection has the obvious advantage of directly targeting 
microorganisms in water that are a risk to public health. However, 
sampling water for pathogens may present additional challenges, 
including larger sample sizes to facilitate detection, inherently 
higher costs, and the wide array of potential target pathogens (i.e., 
the presence or absence of one pathogen may not predict for the 
presence or absence of other pathogens).
    A number of indicator microorganisms have been used to predict the 
presence of pathogens in water, with varying degrees of success. These 
include total coliforms, fecal coliforms, enterococci, generic E. coli,

[[Page 3562]]

and coliphages. However, their presence does not always signal the 
presence of pathogens and the absence in their detection is not 
assurance that pathogens are absent (Ref. 126. Ref. 127. Ref. 128. Ref. 
129. Ref. 130).
    Consequently, Gerba (2009) (Ref. 120) suggested indicators be 
defined by a purpose for which they are better suited instead as an 
indicator for pathogens. For example, efficacy of treatment (e.g., 
public water systems) or integrity in manufacturing processes (e.g., 
bottled water) can be effectively monitored by total coliforms because 
these environmental bacteria are not expected to survive the treatment 
conditions or be introduced during the manufacturing process. Their 
presence in treated municipal water or in bottled water may signal an 
inadequate treatment or deficient manufacturing step meriting 
investigation and subsequent corrective action to resolve the problems 
identified. Another example is using fecal indicator bacteria (e.g., 
enterococci or generic E. coli) to assess the risk of gastrointestinal 
illness (or other adverse health conditions) in marine and freshwater 
swimmers, because their presence is statistically correlated to adverse 
health outcomes in these groups (Ref. 119. Ref. 120). Generic E. coli 
alone, as an easily distinguishable member of the fecal coliform group, 
is more likely than the fecal coliform group as a whole to indicate 
fecal pollution (Ref. 120). Used in this way, indicator organisms are 
not used specifically to predict the presence of pathogens, but are 
useful predictors of undesirable conditions (e.g., ineffective 
treatment, defective manufacturing process, presence of fecal 
material).
    Total coliforms have frequently been used to assess water quality 
of several different types of natural waters (e.g., freshwater and 
marine) but their use for this purpose has decreased recently as they 
have been found to be present in natural water both because of fecal 
contamination and as natural environmental inhabitants. They are 
regularly isolated from soil, plants, vegetables, and effluents from 
agricultural and food industries but their presence does not reliably 
signal a fecal contamination event (Ref. 131. Ref. 112). Fecal 
coliforms share a similar problem. Fecal coliforms are coliforms that 
are capable of growth at higher temperatures, conditions similar to 
those which can be found in the mammalian gut. However, some of its 
members (e.g., Klebsiella, Citrobacter, Enterobacter spp.) can normally 
be found outside the intestine including soil, water, vegetation, fresh 
vegetables, silage, insects, and many others (Ref. 124) and there is 
ample evidence that they can grow and multiply there (Ref. 132. Ref. 
133. Ref. 114. Ref. 123). This makes using fecal coliforms as 
indicators for fecal contamination problematic, as it would be 
difficult to separate increases in their numbers due to natural forces 
(e.g., precipitation, erosion, wind, temperature) from increases due to 
fecal contamination events.
    Generic E. coli is a member of both the coliform and fecal coliform 
groups but has been shown to more consistently be associated with fecal 
contamination than other indicators (Ref. 134. Ref. 135. Ref. 133. Ref. 
136. Ref. 137. Ref. 138. Ref. 112). It can be found in at least 90 
percent of all human and animal feces (Ref. 108) (Ref. 116) where it 
persists, more than other transient fecal coliforms (Ref. 125. Ref. 
124). While its association with fecal contamination is very strong, it 
has also been isolated from environments with no apparent fecal 
contamination, including tropical watersheds (Ref. 126) and paper mill 
effluents (Ref. 127). Outside of these findings, reports of generic E. 
coli growth and proliferation outside the gut (e.g., in water) are 
generally rare. Generic E. coli demonstrates variable survival times in 
water but may only persist from 4 to 12 weeks at 15-18 degrees Celsius 
(Ref. 116).
    Generic E. coli has an extensive history of use as an indicator of 
fecal contamination and is considered the best indicator for monitoring 
water quality (Ref. 119). Its detection and enumeration can be 
performed using a variety of commercial products at relatively low 
cost. However, its ability to signal fecal contamination events is 
dependent upon sampling frequency and location relative to the source 
of contamination. Thus, instances of non-detection are not considered 
confirmation of the absence of fecal contamination because sampling 
frequency may not be adequate to detect events occurring over short 
periods of time. Sampling results can only be considered snapshots of 
water quality over time. Moreover, the fate and transport of generic E. 
coli in watersheds may be different than other fecal constituents in 
response to localized conditions (e.g., sunlight, temperature) (Ref. 
128. Ref. 129. Ref. 130).
    One challenge in using indicator organisms to predict water quality 
is correlating information concerning their numbers to the presence or 
absence of pathogens (as compared to the presence or absence of fecal 
material). Although generic E. coli is recognized as a good indicator 
of fecal contamination, pathogens are not always present in that fecal 
material because their distribution and persistence is sporadic. As a 
consequence, the record of generic E. coli as a predictor of pathogens 
is mixed. The Canadian Federal-Provincial-Territorial Committee on 
Drinking Water states generic E. coli is unsatisfactory in predicting 
the presence of Giardia, Cryptosporidium, and enteric viruses (Ref. 
119. Ref. 124) and Horman et al. 2004 (Ref. 131) found poor correlation 
between generic E. coli and the presence of pathogens (Campylobacter 
spp., Giardia spp., Cryptosporidium spp., and noroviruses) in Finnish 
surface waters. However, they did conclude that the absence of generic 
E. coli was a very strong predictor for the absence of pathogens. Duris 
et al (2009) (Ref. 132) found generic E. coli inconsistently correlated 
to genetic markers for generic E. coli O157 in Michigan and Indiana 
river water but suggested the relationship could be strengthened by 
increased sample size. Alternately, Wilkes et al., 2009 (Ref. 133) 
reported generic E. coli concentrations were the best indicator of 
pathogens (E. coli O157:H7, Salmonella spp., Campylobacter spp, Giardia 
and Cryptosporidium) presence/absence in Canadian watersheds. Others 
have noted that generic E. coli has a better record as an indicator for 
Salmonella than for E. coli O157:H7 (Ref. 134). Review of these studies 
illustrates the complexity of possible interactions between indicators 
and pathogens in water, and their potential for separate fates within 
those systems.
    Studies relating indicators, pathogens, and the risks associated 
with produce consumption are few and are complicated by the 
relationships described above. Different survival profiles between 
indicators and pathogens on produce may also affect risk. The World 
Heath Organization (Ref. 118) proposed a set of pathogen reduction 
measures that can be used alone or in combination to achieve a 6-7 log 
pathogen reduction they determined necessary to meet health-based 
targets. To verify the effectiveness of the measures, they recommend 
monitoring generic E. coli levels in treatment effluents and in crops 
at harvest. They noted that field pathogen die-off is variable (0.5-2 
log per day), dependent on temperature, sunlight, crop type, time, and 
other factors.
    Produce contamination events that occur during growing, harvesting, 
packing, or holding on farm are generally thought to occur 
intermittently and at low doses. As a result, the detection of human

[[Page 3563]]

pathogens in contaminated produce using available testing methodologies 
remains an arduous process. It is impractical to test 100% of the 
product; therefore sampling plans to collect a statistically 
significant subset must be devised. Unfortunately, although such 
testing has in the past prevented some contaminated product from 
entering the market when pathogens are found, it is also very possible 
that testing can entirely miss a point contamination, thus it cannot 
provide a litmus test for food safety because the sample size needed to 
detect low dose, low frequency, and non-uniformly distributed 
contamination is impractically large (Ref. 135). In addition, microbial 
testing can only detect the pathogens the analytical procedures are 
designed to detect, and we tend to only test for pathogens known to be 
of concern. Considering the range of potential pathogens, these are 
significant limitations.
b. Microbial Water Quality Standards
    The lack of sufficient information to support a pathogen-based 
microbiological standard for water used in the production of produce 
has led to the adoption of the generic E. coli component of the U.S. 
EPA recreational water standards (for frequently used beaches) by some 
industry groups (Ref. 44. Ref. 31). The EPA recreational water 
standards were developed from epidemiological studies that correlated 
the risk of gastrointestinal illness to exposure to marine and 
freshwater by swimmers (Ref. 136). Generic E. coli was found to be a 
good predictor of swimming associated illness in freshwater and the EPA 
recommended criteria include a geometric mean of 126 CFU per 100 ml and 
a single sample maximum for designated beach areas of 235 CFU per 100 
ml (Ref. 136). British Columbia, Canada has announced their intention 
to use a similar approach in setting generic E. coli criteria for 
irrigation water used on produce consumed raw. Their irrigation 
criteria (less than or equal to 77 CFU per 100 ml geometric mean) are 
the same as and were derived from those used for primary-contact 
recreation (Ref. 137). See section V.E. of this document for additional 
discussion of this issue.
    The U.S. EPA criteria were developed from epidemiological studies 
of beach areas subject to point source fecal contamination rather than 
non-point source contamination (e.g., birds, agricultural and livestock 
runoff). Non-point sources may also influence the quality of 
agricultural water. Further, adverse health outcomes as a consequence 
of immersion while swimming in contaminated water may be different from 
those as a result of eating produce irrigated with contaminated water. 
The routes of infection and pathogen mortality rates are different in 
each environment.
    Based upon a WHO analysis of tolerable risk for irrigation water, 
the minimum microbial quality for water used on root crops that are 
eaten raw is 1,000 CFU generic E. coli per 100 ml (10,000 CFU generic 
E. coli per 100 ml in leaf crops) (Ref. 120. Ref. 118). 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. This 
analysis recognizes the variable nature of die-off values, ranging from 
0.5-2.0 log per day (Ref. 118). The WHO analysis considers the need for 
a four log reduction through dilution, die-off, or treatment between 
the levels of generic E.coli in raw sewage (well represented in sewage 
by fecal coliform levels) and the levels in irrigation water used on 
root crops that are eaten raw (3 log for leaf crops), in addition to 
the 3 log reduction discussed above.
3. Proposed Requirements
a. General Requirement
    Proposed Sec.  112.41 would establish the requirement that all 
agricultural water must be safe and of adequate sanitary quality for 
its intended use. The principle of ``safe and of adequate sanitary 
quality for its intended use'' contains elements related both to the 
quality of the source water used and the activity, practice, or use of 
the water. Uses vary significantly, including: Crop irrigation (using 
various direct water application methods); crop protection sprays; 
produce cooling water; dump tank water; water used to clean packing 
materials, equipment, tools and buildings; and hand washing water. The 
way in which water is used for different commodities and agricultural 
practices can determine how effectively pathogens that may be present 
are transmitted to produce.
    Comparing the probability of contamination of covered produce 
associated with key practices at different stages of production and 
across a range of commodities, the interrelatedness of these factors 
becomes apparent. The QAR shows that the likelihood of contamination 
associated with indirect water use for irrigation is relatively low 
compared to irrigation water that directly contacts produce (Ref. 2). 
Therefore, in Section V.A.2.b (Definitions), we propose to define 
``agricultural water'' to mean water used in covered activities on 
covered produce, where water is intended to, or is likely to, contact 
covered produce or food-contact surfaces, including water used in 
growing activities (including irrigation water applied using direct 
water application methods, water used for preparing crop sprays, and 
water used for growing sprouts) and in harvesting, packing, and holding 
activities (including water used for washing or cooling harvested 
produce and water used for preventing dehydration of covered produce). 
As we propose in Sec.  112.3(c), ``covered produce'' refers to the 
harvestable or harvested portion of the crop. As proposed, 
``agricultural water'' does not include indirect water application 
methods used during growing. For example, generally, the water used for 
drip or furrow irrigation in apple orchards would not be considered 
agricultural water because the water is unlikely to contact the 
harvestable portion of the crop. As another example, generally, the 
water used for overhead spray irrigation of romaine lettuce would be 
considered agricultural water because the water is likely to contact 
the harvestable portion of the crop. We are proposing to distinguish 
between water that is intended to, or is likely to, contact covered 
produce or food-contact surfaces (e.g., direct water application method 
irrigation water) and water that is not intended to, or is not likely 
to, contact covered produce or food-contact surfaces based on the 
relative likelihood of contamination from water that contacts covered 
produce and the need for measures to minimize such likelihood.
    If finalized as proposed, indirect water application methods would 
not be subject to the requirements of this rule. While indirectly 
applied water is unlikely to contact produce or food-contact surfaces, 
we recognize that it presents the possibility of produce contamination. 
For example, use of contaminated water in drip or furrow irrigation may 
still serve as a vehicle for bringing contaminants into the growing 
environment which may potentially be transferred to produce by rain 
splash, workers, or equipment; use of contaminated water for dust 
abatement on farm roads may also be transferred to produce by run-off, 
rain splash, workers, or equipment.
    Indirect water application methods would remain subject to Section 
402(a)(4) of the FD&C Act. That is, indirect water application may

[[Page 3564]]

adulterate produce if, considering the water quality and the manner of 
its application, the use of the water causes produce to be prepared, 
packed, or held under insanitary conditions whereby it may have been 
contaminated with filth or rendered injurious to health. Moreover, if a 
pathogen is detected in or on produce, such produce would be considered 
adulterated under Sections 402(a)(1) of the FD&C Act, in that it 
contains a poisonous or deleterious substance which may render it 
injurious to health. Therefore, we tentatively conclude that indirect 
water application methods do not need to be covered within the scope of 
``agricultural water'' for the purposes of this rule.
    We ask for comment on the limited scope of ``agricultural water'' 
to only water that is intended to, or likely to contact covered produce 
or food-contact surfaces. We also seek comment on its resulting effect 
on the applicability of the general requirement in proposed Sec.  
112.41 that agricultural water must be safe and of adequate sanitary 
quality for its intended use, to only water that is intended to, or 
likely to, contact covered produce or food-contact surfaces. Water that 
is not safe or of adequate sanitary quality for its intended use may 
lead to contamination of covered produce, even where the water use is 
indirect. We have previously recommended measures such as indirect 
water use when water quality is poor or unknown as a measure to 
minimize risk (Ref GAPs Guide). Considering the FD&C Act would still 
apply to such uses, and that there is a lower likelihood of 
contamination of produce by indirect water use, is there a need to 
subject indirect water use, including water used for dust abatement, to 
the general requirement in proposed Sec.  112.41? We welcome comment on 
this approach, as well as other actions that have been found to be 
effective through practice and experience.
    We also considered proposing some requirements for water that is 
used during growing, but which does not contact the harvestable portion 
of covered produce. For example, water that did not contact produce 
would not have been subject to any testing requirement, although we 
considered requiring this water and all agricultural water to be of 
safe and adequate sanitary quality for its intended use (proposed Sec.  
112.41). We also considered requiring indirect water to comply with 
proposed Sec.  112.42(a) (sanitary survey) and Sec.  112.42(b) through 
(d) (adequately maintaining water sources under your control). If we 
did include both direct and indirect water use in the definition of 
``agricultural water'' in the final rule, which of the proposed 
requirements for agricultural water described in section V.E. of this 
document would (or would not) be appropriate for indirect water use? 
Are there other factors that we should consider? In every application 
of water, careful consideration should be given to what you know about 
the water's quality at its source, the impact your distribution system 
may have on the water quality, and when or how that water is to be 
used. For example, water that contains Salmonella would not be safe or 
of adequate sanitary quality for its intended use when used in a 
postharvest dump tank for tomatoes. Salmonella is a food safety hazard 
that is well-documented to present a risk of severe adverse health 
consequences or death, and tomatoes can become contaminated by water 
containing Salmonella (Ref. 138. Ref. 139. Ref. 140). As another 
example, when the surface water (e.g., river) that you use for crop 
irrigation using a direct application method has a noticeable decrease 
in quality due to an upstream event like the failure of a waste water 
treatment plant, resulting in the accidental discharge of untreated 
municipal sewage into the river, your water source would not be safe or 
of adequate sanitary quality for its intended use until the discharge 
is over and the water has been tested because the incompletely treated 
sewage in the discharge is likely to contain pathogenic microorganisms 
that could compromise the safety of irrigated covered produce.
    The most frequently used irrigation methods include overhead, 
surface and subsurface drip, furrow, flood, and seep irrigation (Ref. 
29). These practices may be commodity-specific and choices may be 
limited by the availability of different water sources, crop needs, 
climate, precipitation levels, or regional practices. Each irrigation 
method presents a different likelihood of contamination, independent of 
the water source and its application to a particular commodity. For 
example, the likelihood of produce contamination may be reduced if 
irrigation water is delivered by subsurface drip irrigation compared to 
using the same water to irrigate by overhead spray (Ref. 141. Ref. 
122). Researchers also concluded that both the physical properties of 
the edible portion of the crop, such as surface texture, and the 
location of the edible portion of the plant in relation to irrigation 
water played significant roles in contamination (Ref. 130). As 
discussed in the QAR, the timing of irrigation water application also 
plays a role in minimizing the persistence of contamination. For 
example, water containing elevated generic E. coli used in overhead 
irrigation shortly before harvest may increase the likelihood of 
covered produce being contaminated with the pathogen at harvest, but 
the same water could safely be used to establish a crop and throughout 
the majority of the growing season because, as discussed in the QAR, 
pathogens die-off over time on the surface of produce. Water used for 
washing hands during and after harvest, sprout irrigation, directly 
contacting produce during or after harvest (such as in washing and 
cooling, or to make ice that directly contacts produce), making treated 
agricultural tea, and water or ice that will contact food contact 
surfaces that contact covered produce presents an even greater 
likelihood of microbial contamination of covered produce (Ref. 131. 
Ref. 132). Waterborne pathogens can be transferred to covered produce 
with little opportunity for die-off if contaminated water is used for 
hand washing during or after harvest, or in harvest, packing or holding 
activities where it directly contacts produce or surfaces that contact 
produce and, therefore, it is important to ensure that the water is 
safe and of adequate sanitary quality for such uses. Moreover, the high 
nutrient, high moisture conditions inherent to sprout production and 
agricultural teas not only support pathogen survival but are also 
conducive to their amplification if present (Ref. 142. Ref. 16). Again, 
the selection of a water source for these uses must ensure that the 
water is safe and of adequate sanitary quality for that use.
b. Measures Regarding Agricultural Water Sources and Distribution 
Systems
    Proposed Sec.  112.42 would establish the measures that you must 
take with respect to agricultural water sources, water distribution 
systems, and pooling of water.
    Proposed Sec.  112.42(a) would establish that at the beginning of a 
growing season, you must inspect the entire agricultural water system 
under your control (including water source, water distribution system, 
facilities, and equipment), to identify conditions that are reasonably 
likely to introduce known or reasonably foreseeable hazards into or 
onto covered produce or food-contact surfaces in light of your covered 
produce, practices, and conditions, including consideration of the 
following:
    (1) The nature of each agricultural water source (for example, 
ground water or surface water);
    (2) The extent of your control over each agricultural water source;

[[Page 3565]]

    (3) The degree of protection of each agricultural water source;
    (4) Use of adjacent or nearby land; and
    (5) The likelihood of introduction of known or reasonably 
foreseeable hazards to agricultural water by another user of 
agricultural water before the water reaches your covered farm.
    Human pathogens can enter an agricultural water system anywhere 
from its source to point of use. Central to the prevention of pathogen 
contamination of agricultural water is an inspection of water source 
and the components of the distribution system to identify potential 
routes of contamination. Inspections of water sources and components of 
its distribution system are recommended by government and industry 
references (Ref. 10. Ref. 20. Ref. 45. Ref. 44).
    Generally, inspection of the agricultural water system under your 
control beginning at the water system source is the first opportunity 
for ensuring that it will deliver water that is safe and of adequate 
sanitary quality for its intended use. Inspection of your water source 
provides an opportunity to identify and characterize activities and 
situations that may lead to contamination of your agricultural water. 
Further, inspection results provide you with historical knowledge of 
your water sources, their quality, and factors that may affect their 
quality (Ref. 31). Inspection of the water source and any equipment 
used to obtain the water from the source (e.g., well head, pumps, 
pipes) can ensure that the water that enters the distribution system is 
suitable for its intended use.
    Proposed Sec.  112.42(a)(1) requires you to consider the nature of 
your agricultural water sources to identify conditions that are 
reasonably likely to introduce known or reasonably foreseeable hazards 
into or onto covered produce or food-contact surfaces. As discussed in 
the QAR, ground water which is often believed to be pathogen free can 
be contaminated. Ground water can also be compromised and its water 
quality degraded if wells are improperly constructed, poorly 
maintained, or improperly located (e.g., near areas of extensive 
livestock production or fields where manure is applied (Ref. 143. Ref. 
144. Ref. 122). U.S. water systems using ground water as source waters 
for drinking must operate in compliance with the U.S. EPA Ground water 
Rule (GWR) (40 CFR parts 141 and 142) to protect against illness from 
waterborne pathogens in ground water. However, the GWR does not address 
private wells because they are not under the jurisdiction of the Safe 
Drinking Water Act and are therefore not subject to EPA regulation. 
Thus, water quality and survey data on ground water used for 
agriculture are not publicly available. By their nature, surface waters 
are open systems, subject to the influence of various environmental 
factors that can impact the safety of the water. For example, increased 
precipitation levels, storm events, or wind may result in a spike in 
water turbidity, due to redistribution of sediments. We tentatively 
conclude that there exists significant potential for contamination of 
ground and surface waters and, therefore, we propose to require you to 
include both ground and surface water sources in your inspection of 
your agricultural water systems. We seek comment on this tentative 
conclusion and associated proposals.
    Proposed Sec.  112.42(a)(2) requires you to consider the extent to 
which you have control over your agricultural water source to identify 
conditions that are reasonably likely to introduce known or reasonably 
foreseeable hazards into or onto covered produce or food-contact 
surfaces. You may have more control over your ground water source 
(well) if it draws water from an aquifer beneath your property and 
which you protect from the influence of surface activities. You would 
likely have less control if your well is located near a concentrated 
animal feeding operation or is influenced by surface water (e.g., a 
shallow well). You may have greater access to and control of on-farm 
surface water sources such as impoundments, catches, and ponds, than 
you would for flowing surface waters that only course through but do 
not originate on your land.
    Proposed Sec.  112.42(a)(3) requires you to consider the degree of 
protection of each agricultural water source. Examples of protection 
for water sources include covers, containments, or fencing that exclude 
domesticated animals or other possible sources of contamination from 
the water source or earthen berms or other barriers that help minimize 
the influence of runoff on the water source.
    Proposed Sec.  112.42(a)(4) requires you to consider the use of 
adjacent or nearby land. Agricultural water may be affected by upstream 
agricultural practices and runoff from those operations into surface 
water sources that you use. For example, an upstream alfalfa grower may 
apply raw manure as a soil amendment, and irrigation water runoff from 
that field may flow into your agricultural surface water source. While 
you may have little or no control of other agricultural water user 
practices, this proposed requirement to consider those nearby uses of 
which you are aware will help you determine appropriate and safe use of 
that water source.
    Proposed Sec.  112.42(a)(5) requires you to consider the likelihood 
of introduction of known or reasonably foreseeable hazards to 
agricultural water by another user of agricultural water before the 
water reaches your covered farm. For example, if you use water from a 
river and are downstream from a waste water treatment plant that 
discharges into that river, this provision would require you to 
consider the likelihood that the wastewater treatment plant introduces 
hazards into the water before it reaches your farm. For example, you 
would consider the likelihood of accidental discharge of untreated 
municipal sewage into the river.
    Proposed Sec.  112.42(b) would require that you adequately maintain 
all agricultural water sources that are under your control (such as 
wells) by regularly inspecting each source and keeping the source free 
debris, trash, domesticated animals, and other possible sources of 
contamination of covered produce to the extent practicable and 
appropriate under the circumstances. Regular maintenance of your water 
sources is imperative to ensure the continued safety of your water. 
Maintenance of on-farm water sources may include upkeep and repair of 
berms, pipes, liners, or any structural elements, that are used to 
protect the source. Properly maintaining a well includes conducting 
wellhead inspections, during which time you check the condition of the 
well covering, casing, and cap to make sure all are in good repair, 
leaving no cracks or other entry points for potential contaminants. 
Properly maintaining a storage tank includes cleaning the interior 
surfaces of all rust scale, paint scale, dirt, and bio-film forming 
growths and inspecting exterior surfaces for corrosion which may become 
a route of contamination (Ref. 31). Properly maintaining a farm pond 
that is used for irrigation using a direct application method, with 
respect to keeping it free from domesticated animals, could mean 
fencing the pond if you keep domesticated animals in the area such that 
they would otherwise have access to the pond. On the other hand, if you 
treat the water before use in this way, you may not need to take steps 
to prevent access of the domesticated animals to the pond. 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 (16 U.S.C. 1532(19)) (i.e., to harass, harm, pursue,

[[Page 3566]]

hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to 
engage in any such conduct).
    Proposed Sec.  112.42(c) would require that you adequately maintain 
all agricultural water distribution systems as necessary and 
appropriate to prevent the water distribution system from being a 
source of contamination to covered produce, food-contact surfaces, 
areas used for a covered activity, or water sources, including by 
regularly inspecting and adequately storing all equipment used in the 
system. Regular maintenance of your agricultural water distribution 
system can be performed in conjunction with inspections and cleaning, 
as applicable. If not regularly maintained, portions of a water 
distribution system may fail, corrode, collect debris, or otherwise 
become a source of contamination. For agricultural water distribution 
system components that are underground, it would be important to look 
for signs of erosion or wet soil areas, as they may indicate a damaged 
underground component requiring further inspection and maintenance 
(Ref. 145).
    Proposed Sec.  112.42(d) would establish that you must immediately 
discontinue use of a source of agricultural water and/or its 
distribution system, and not use the water source and/or its 
distribution system when you have determined or have reason to believe 
that your agricultural water is not safe and of adequate sanitary 
quality for its intended use, until you either: (1) Re-inspect 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 test the water to determine if 
your changes were effective and to ensure that your agricultural water 
is safe and of adequate sanitary quality for its intended use; or (2) 
treat the water in accordance with the requirements of Sec.  112.43. 
Using agricultural water that is not safe or of adequate sanitary 
quality for its intended use may lead to contamination of covered 
produce. Lapses in sanitary quality of water can occur in any segment 
of a water system, from source to point of use. For example, if you 
find that water contains Salmonella at the point where it would be used 
in a dump tank for tomatoes, it would not be safe or of adequate 
sanitary quality for that intended use. As another example, your water 
would not be considered safe or of adequate sanitary quality for its 
intended use if you found detectable generic E. coli in a 100 ml water 
sample you obtained at the point where the agricultural water is used 
for washing produce as described in proposed Sec.  112.44(a). 
Similarly, your water would not be considered safe or of adequate 
sanitary quality if you found that test results exceeded 235 CFU per 
100 ml generic E. coli in a water sample you obtained from water used 
to overhead irrigate lettuce (a direct application method) as provided 
in proposed Sec.  112.44(c). We seek comment on these proposed 
thresholds.
    Under this proposed provision in Sec.  112.42(d)(1), for example, 
you would review your previous inspection results for the affected 
portion of your agricultural water system and compare those results to 
conditions you currently observe. You would identify changes likely to 
have an impact on the quality of water (e.g., evidence of runoff, 
animal intrusion, suspended sedimentation, changes in adjacent land 
use) or any lapses in your procedures (e.g., outdated well inspection, 
break in the water treatment schedule). You would test the water after 
you make changes you find necessary during your inspection. Under the 
proposed provision in Sec.  112.42(d)(2), you could instead choose to 
treat your water in accordance with the requirements of Sec.  112.43 to 
ensure its safety. We tentatively conclude that the measures proposed 
in Sec.  112.42(d) are necessary and adequate to address deficiencies 
that may exist in your water management system and practices so that 
your agricultural water does not serve as a source of contamination to 
covered produce. We welcome comment on this approach, as well as other 
actions that have been found to be effective through practice and 
experience.
    Proposed Sec.  112.42(e) would establish that, as necessary and 
appropriate, you must implement measures reasonably necessary to reduce 
the potential for contamination of covered produce with known or 
reasonably foreseeable hazards as a result of pooling of water. For 
example, such measures may include using protective barriers or staking 
to keep covered produce from touching the ground, or using an 
alternative irrigation method. Pooling may occur if excessive water is 
applied to a crop, especially in areas of poor drainage. Pooled water 
that remains for extended periods of time has been shown to increase 
likelihood of contamination (Ref. 10. Ref. 45). Further, if pooled 
water is in close proximity to the crop, it may serve as an attractant 
for pests. Mounding soil, staking, subsoil drip irrigation, drip tape 
or plasticulture (use of agricultural plastics) are methods that are 
used to reduce the potential for pooling or to separate the pooled 
water from the covered produce. We acknowledge the potential for small 
pools of water to temporarily form in field areas or at the base of 
plants after irrigation. Small amounts of water of this nature, which 
are temporary and occur in the normal course of irrigation practices, 
are not reasonably likely to contribute to the contamination of covered 
produce. We are not suggesting that it will always be possible to 
eliminate pooling. Avoiding pooling by careful control of irrigation is 
ideal; however, events such as rainfall or irrigation malfunction may 
sometimes make pooling inevitable. In those cases, the proposed 
requirement would require farms to take steps to protect covered 
produce from contamination that may build in the pooled water.
c. Requirements for Treating Agricultural Water
    Water treatment is an effective means of decreasing the number of 
waterborne outbreaks in sources of drinking water (Ref. 146). However, 
treatments that are inadequate or improperly applied, interrupted, or 
intermittent have been associated with waterborne disease outbreaks 
(Ref. 146). Failures in treatment systems are largely attributed to 
suboptimal particle removal and treatment malfunction (Ref. 147). For 
this reason, when treating water, it is important to monitor the 
treatment parameters to ensure the treatment is delivered in an 
efficacious manner. Monitoring treatment can be performed in lieu of 
microbial water quality monitoring, if under the intended conditions of 
the treatment, the water is rendered safe and of adequate sanitary 
quality for its intended use. Many operations choose to perform 
microbial water quality testing in addition to monitoring the water 
treatment as a further assurance of treatment effectiveness (Ref. 148).
    Proposed Sec.  112.43 would establish requirements related to 
treatment of agricultural water. Specifically, proposed Sec.  112.43(a) 
would require that you must treat any agricultural water that you use 
(such as with an EPA-registered antimicrobial pesticide product) if you 
know or have reason to believe that the water is not safe and of 
adequate sanitary quality for its intended use, whereas proposed Sec.  
112.43(b) would require that any method you use to treat agricultural 
water to satisfy this requirement in paragraph Sec.  112.43(a) must be 
effective to make the water safe and of adequate sanitary quality for 
its intended use. In addition, proposed Sec.  112.43(c) would require 
you to: (1) Deliver any treatment

[[Page 3567]]

of agricultural water required by Sec.  112.43(a) in a manner to ensure 
that the treated water is consistently safe and of adequate sanitary 
quality for its intended use; and (2) monitor any treatment of 
agricultural water at a frequency adequate to ensure that the treated 
water is consistently safe and of adequate sanitary quality for its 
intended use.
    If you choose to use water that is not safe or of adequate sanitary 
quality for its intended use, the water must be treated before it is 
put to such use to minimize the likelihood for contamination. For 
example, treating agricultural water with antimicrobial compounds can 
be an effective means to eliminate pathogens if done properly, 
including under conditions that ensure the effectiveness of the active 
ingredient (Ref. 149. Ref. 150). Any chemicals used in the treatment of 
water would require EPA registration under the Federal Insecticide, 
Fungicide and Rodenticide Act before they can be lawfully used. We 
note, however, that at the present time, no such registration for 
chemical treatment of irrigation water exists. We anticipate that the 
proposed delayed implementation period for water quality testing (see 
section IV.K. of the document) would provide industry adequate time to 
address such issues. We seek comment on this issue.
    To ensure water treatment is delivered in an effective manner, 
monitoring the conditions of treatment is also essential. An effective 
monitoring program would measure the level of active compound as well 
as those factors that may affect its activity, such as pH, temperature, 
and contact time. For example, monitoring water treated with 
hypochlorite in an orange postharvest wash would include, at a minimum, 
monitoring the level of active antimicrobial (free available chlorine) 
and pH, since it is known that hypochlorite activity is reduced both by 
organic material (e.g., soil, plant debris) and pH values outside its 
effective range (pH 6.0-7.5) (Ref. 149. Ref. 150). The concentration of 
active disinfectant and pH must be adjusted, as necessary, taking into 
account variations in water quality in order to maintain the 
effectiveness of the treatment. In addition, the frequency in which you 
monitor agricultural water treatment must be adequate to ensure that 
the conditions for proper treatment are consistently met and adjusted, 
as necessary, to result in water that is safe and adequate for its 
intended use. Research has shown that in other settings, monitoring of 
physical parameters, such as temperature, pH and disinfectant 
concentration, can be done in real-time and in an inexpensive, 
automated manner, facilitating good control of the process (Ref. 149). 
As a verification that the treatment process, monitored in accordance 
with the proposed requirements of Sec.  112.43(c)(2), is effective in 
achieving a certain microbial standard (e.g., no detectable generic E. 
coli in 100 ml of water), you may chose to perform periodic 
microbiological analysis of the treated agricultural water. We are not 
proposing at this time that treated water must be tested in this manner 
because we believe that the effectiveness of various treatment 
processes is well understood. However, we encourage farms to perform 
such testing to provide further assurance of the effectiveness of their 
treatment under the specific conditions that exist on their farm. We 
seek comment on this issue.
d. Testing and Frequency of Testing of Agricultural Water
    Proposed Sec.  112.44 would establish requirements related to 
testing of agricultural water and subsequent actions based on the test 
results. Specifically, proposed Sec.  112.44(a) would require that you 
test the quality of agricultural water according to the requirements in 
Sec.  112.45 using a quantitative, or presence-absence method of 
analysis provided in subpart N to ensure there is no detectable generic 
E. coli in 100 ml agricultural water when it 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; or
    (5) Used for washing hands during and after harvest activities.
    We seek comment on the appropriateness of these proposed categories 
in which testing would be required.
    Proposed Sec.  112.44(b) would require that if you find that there 
is any detectable generic E. coli in 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 Sec.  112.44(a). 
Before you may use the water source and/or distribution system again 
for the uses described in Sec.  112.44(a), you must either re-inspect 
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 and to ensure that the water meets the 
requirements of Sec.  112.44(a); or treat the water in accordance with 
the requirements of Sec.  112.43.
    We reviewed the most widely used indicator(s) or indicator groups 
for their potential in assessing the microbial quality of water used 
for purposes described in proposed Sec.  112.44(a) and all other uses 
of agricultural water as described in section V.E.2 of this document. 
We considered total coliforms and fecal coliforms as indicators of 
fecal contamination but determined that neither of them can serve as 
reliable indicators of a fecal contamination event (Ref. 124. Ref. 119. 
Ref. 151. Ref. 152). Generic E. coli is a member of both the coliform 
and fecal coliform groups but, unlike some members of those groups, it 
has been shown using various detection methods to be the only coliform 
consistently associated with fecal contamination (Ref. 132. Ref. 133. 
Ref. 134. Ref. 135. Ref. 136. Ref. 137. Ref. 108). Generic E. coli has 
an extensive history and support for use as an indicator of fecal 
contamination. Recently, it has emerged as the preferred indicator for 
monitoring water quality, not only because of the problems with other 
groups noted above, but also due to the development of superior methods 
of detection with greater accuracy, sensitivity, and simplicity over 
those previously used (Ref. 119). Despite widespread use and support 
for generic E. coli as an indicator of fecal contamination, its ability 
to signal contamination events is not without challenges. Sampling 
frequency and location relative to the source of contamination are 
reported to affect the performance of generic E. coli as an indicator 
of fecal contamination (Ref. 133. Ref. 143. Ref. 153. Ref. 131). Thus, 
non-detection cannot be considered absolute confirmation that fecal 
contamination has not occurred. Further, the fate and transport of 
generic E. coli takes different paths in different watersheds, and 
reservoirs have been identified, particularly sediments, where they may 
escape detection in the water column (Ref. 128. Ref. 129. Ref. 130. 
Ref. 154). Nevertheless, based on our review of the literature, we

[[Page 3568]]

tentatively conclude that generic E. coli serves as the most 
appropriate microbial indicator of fecal contamination of water at this 
time and, therefore, we propose to use a microbial standard of no 
detectable generic E. coli in 100 ml agricultural water when it is for 
the intended uses listed in Sec.  112.44(a). We seek comment on our 
selection of this indicator.
    As discussed in the QAR, water used for the purposes listed in 
proposed Sec.  112.44(a) has the potential to serve as a vehicle of 
pathogen contamination by direct contact with covered produce. Water 
used in sprout production must be free of fecal contamination because 
the conditions under which sprouted seeds are produced (warm, moist, 
nutrient-rich environment for extended period of time) are conducive to 
pathogen multiplication (Ref. 14). As discussed in section I.A. of this 
document, outbreaks associated with sprouted seeds are well documented; 
Salmonella and E. coli O157:H7 have been the major causes of sprout-
associated outbreaks (Ref. 14). Similarly, the conditions under which 
agricultural tea is produced (moist and nutrient-rich) are similar in 
that they support the multiplication of pathogens, if present (Ref. 
142). Even a low number of pathogens introduced into or onto covered 
produce through contaminated water could rapidly increase to levels 
that could present risk of serious adverse health consequences or death 
to those who consume the covered produce for which the tea was used. 
Further, water that is used in direct contact with produce or food 
contact surfaces, or in making ice that directly contacts produce or 
food contact surfaces, must also be free of fecal contamination and 
pathogens. These water applications normally occur during or shortly 
after harvest, leaving only a relatively short period of time before 
consumption for the environmental factors that drive pathogen die-off 
to exercise a significant effect (see the QAR). In addition, we propose 
to apply the microbial standard in proposed Sec.  112.44(a) to 
agricultural water that is intended for use in washing hands during 
harvesting, packing, and holding activities, where there is little 
opportunity for microbial die-off prior to consumption. Hands that 
contact produce during and after harvest must be free of microbial 
contaminants (Ref. 133). In the United States, the Occupational Safety 
and Health Administration (OSHA) of the U.S. Department of Labor has 
established requirements for water used for washing workers' hands. 
Under 29 CFR 1928.110(b), a hand-washing facility means ``a facility 
providing either a basin, container, or outlet with an adequate supply 
of potable water, soap and single-use towels;'' and potable water means 
``water that meets the standards for drinking purposes of the State or 
local authority having jurisdiction, or water that meets the quality 
standards prescribed by the U.S. EPA's National Primary Drinking Water 
Regulations [NPDWR] (40 CFR part 141).'' The OSHA requirements in 29 
CFR 1928.110 require that farms employing eleven or more employees 
engaged in hand-labor operations in the field for a period of more than 
three hours in a day provide water that satisfies the microbial maximum 
contaminant level (MCL) in the NPDWR, which states that any generic E. 
coli-positive repeat sample or generic E. coli-positive routine sample 
(which would include a finding of any detectable generic E. coli in 100 
ml of water using the methods of analysis in proposed subpart N) 
constitutes a violation of the MCL for total coliforms. Therefore, the 
microbial standard for hand washing water during harvesting, packing, 
and holding activities that is specified in proposed Sec.  112.44(a) 
would be consistent with the OSHA requirements.
    We acknowledge the difficulty of associating specific indicator 
concentrations with specific produce related health risks. Even so, we 
have tentatively concluded that such difficulty does not negate the 
value of applying generic E. coli test results to the requirement to 
discontinue use of a water source until compliance with applicable 
generic E. coli standard is again achieved, because elevated indicator 
organism concentrations indicate increased levels of fecal 
contamination and elevated potential for the presence of human 
pathogens of fecal origin (Ref. 154). The uses listed in proposed Sec.  
112.44(a) are similar in that, if pathogens or fecal contamination are 
present, it is reasonably likely they could be transferred directly to 
covered produce through direct or indirect (via food-contact surfaces) 
contact with the water. Therefore, testing the agricultural water used 
for these purposes to ensure that it is absent of generic E. coli would 
provide reasonable assurances that the water does not contain 
pathogens, and therefore that the water is not likely to introduce 
pathogens into or onto covered produce and to provide reasonable 
assurances that the produce will not be adulterated under section 402 
of the FD&C Act. Moreover, a requirement that there be no detectable 
generic E. coli per 100 mL of agricultural water used in these 
activities and practices would be consistent with EPA's MCLs for 
microbiological contaminants in public drinking water systems (40 CFR 
141.63(b)) and with our standard of quality for bottled water (21 CFR 
165.110(b)(2)(B)). We request comment on the need for, and 
appropriateness of, this proposed requirement and any other criteria 
that would ensure the safety of water for these intended uses.
    We tentatively conclude that we should require that if the water 
you use for the purposes listed in Sec.  112.44(a) does not meet the 
microbial standard of no detectible generic E. coli per 100 ml, you 
must immediately discontinue use of the water and/or distribution 
system for those purposes. Before you use the water source and/or 
distribution system again for those uses, you would need to either (1) 
re-inspect 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 and to ensure that the water 
meets the required microbial standard; or (2) treat the water in 
accordance with the requirements of Sec.  112.43 (proposed Sec.  
112.44(b)). This proposed requirement is parallel to the requirement in 
proposed Sec.  112.42(d), which is discussed above.
    Proposed Sec.  112.44(c) would 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. If you find that there is more than 235 colony 
forming units (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 Sec.  112.44(c). Before you may use the water source and/
or distribution system again for the uses described in Sec.  112.44(c), 
you must either re-inspect 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

[[Page 3569]]

effective; or treat the water in accordance with the requirements of 
Sec.  112.43. We seek comment on this approach.
    As discussed in section V.E.2 of this document, the WHO recommends 
monitoring generic E. coli numbers in treatment effluents as 
verification of wastewater treatment, and laboratory analysis of crop 
contamination levels with generic E. coli at harvest and in retail to 
verify pathogen mortality (die-off) (Ref. 118). However, they also 
noted the variability in pathogen die-off (0.5-2 log/day), dependent on 
temperature, sunlight intensity, crop type, time of water application, 
and other factors.
    Some industry groups have adopted the generic E. coli component of 
the U.S. EPA recreational water standards (for beaches used frequently) 
for certain uses of agricultural water (Ref. 31. Ref. 44). In this 
regard, EPA recommends that criteria include a maximum steady state 
geometric mean of 126 CFU of generic E. coli per 100 ml and a single 
sample maximum allowable density of 235 CFU of generic E. coli per 100 
ml (Ref. 136). British Columbia, Canada has announced their intention 
to use generic E. coli criteria for irrigation water used on produce 
consumed raw. Their irrigation criteria (less than or equal to 77 CFU 
per 100 ml geometric mean) are the same as and were derived from those 
used for primary-contact recreation (Ref. 137). Similarly, the generic 
E. coli component of EPA's recreational water standard (for beaches 
used frequently) serves as the basis for our proposed standard for 
microbial water quality for water used in direct application methods 
during growing (proposed Sec.  112.44(c)).
    It should be noted that EPA's recreational water standards for 
beaches used frequently also includes a recommendation for a maximum 
steady state geometric mean of 33 CFU of enterococci per 100 ml and a 
single sample maximum allowable density of 61 CFU of enterococci per 
100 ml (Ref. 136). Similarly, the current British Columbia criteria for 
irrigation water used on produce consumed raw is a geometric mean of 
less than or equal to 200 CFU fecal coliform per 100 ml and they have 
announced their intention to use a geometric mean of less than or equal 
to 20 CFU enterococci per 100 ml (along with generic E. coli, as 
discussed above). We have tentatively concluded to not include 
enterococci or fecal coliform in our proposed standard at Sec.  
112.44(c) because we believe generic E. coli to be the superior 
indicator of fresh water quality and do not believe that the added cost 
of testing for both generic E. coli and enterococci is warranted. Wade 
et al (2003) (Ref. 155) performed a systematic review of 27 studies of 
water quality indicators used for the regulation of recreational 
waters. They compared the ability of enterococci, fecal coliform, 
generic E. coli and total coliform levels to predict for the occurrence 
of gastrointestinal illness. They concluded that for freshwater, 
generic E. coli was the more consistent predictor. Working under the 
framework of a WHO project for setting guidelines for quality of 
recreational waters and bathing beaches, Pruss (1998) (Ref. 156) 
reviewed 22 studies on uncontrolled waters (seas, lakes, and rivers) 
for dose-related relationships between GI illness and bacterial 
indicator (most commonly generic E. coli, enterococci, and fecal 
coliforms) counts. The author found the two indicator organisms which 
correlate best with health outcomes were enterococci for both marine 
and freshwater and generic E. coli for freshwater.
    We considered proposing a drinking water standard for water used on 
covered produce other than sprouts during growing in a direct water 
application method, but tentatively conclude that such criteria would 
be unnecessarily restrictive as it would not sufficiently account for 
forces driving pathogen die-off (e.g., sunlight, competing 
microorganisms) (see section V.E.2 of this document). We also 
considered proposing a second lower microbial quality criteria for 
water used in growing, but where the water used for irrigation is not 
reasonably likely to contact the edible portion of the covered produce 
(e.g., surface irrigation of tree crops). However, we are not aware of 
another standard for which there is sufficient scientific support.
    We acknowledge that the EPA recreational water standards were 
developed from epidemiological studies that correlated the risk of 
gastrointestinal illness to exposure to marine and freshwater by 
swimmers (Ref. 136), 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. Further, 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 also acknowledge that the proposed standard is more stringent 
than the WHO standard. Based upon an analysis of tolerable risk for 
irrigation water, WHO recommends that the minimum microbial quality for 
water used on root crops that are eaten raw is 1000 CFU generic E. coli 
per 100 ml (10,000 CFU generic E. coli per 100 ml in leaf crops) (Ref. 
118. Ref. 120). 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. This analysis recognizes the variable nature of 
die-off values, ranging from 0.5-2.0 log per day (Ref. 118). The WHO 
analysis considers the need for a four log reduction through dilution, 
die-off, or treatment between the levels of generic E.coli in raw 
sewage (well represented in sewage by fecal coliform levels) and the 
levels in irrigation water used on root crops that are eaten raw (3 log 
for leaf crops), in addition to the 3 log reduction discussed above.
    We tentatively conclude that the recreational water 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 recognize that is somewhat more protective than 
the WHO standard, which we believe is appropriate given the uncertainty 
in die-off values. We request comment on the need for, and 
appropriateness of, this requirement or other criteria that would 
ensure the quality of agricultural water used for this purpose.
    We tentatively conclude that if agricultural water you use on 
produce other than sprouts during growing in a direct application 
method does not meet the microbial water quality described in Sec.  
112.44(c), you must immediately discontinue use of that source of 
agricultural water and/or its distribution system and either (1) re-
inspect the agricultural water system components under your control, 
identify conditions that are reasonably likely to introduce hazards to 
the system, make necessary changes based upon your observations, and 
retest the water to determine if your changes were effective; or (2) 
treat the water in accordance with the requirements of Sec.  112.43. 
This proposed requirement is parallel to the requirement proposed Sec.  
112.42(d), which is discussed above.

[[Page 3570]]

    We tentatively conclude that violation of microbial water quality 
standards proposed in Sec. Sec.  112.44(a) and (c) in and of itself 
would not necessarily establish evidence of adulteration of covered 
produce subjected to use of the water, nor would it necessarily mean 
that the food was contaminated. However, use of water that is shown to 
violate these standards would violate the requirement at proposed Sec.  
112.41 that all agricultural water must be safe and of adequate 
sanitary quality for its intended use. As described immediately above, 
these proposed standards are based on likelihood of fecal contamination 
(as indicated by the presence of generic E. coli), that we have 
tentatively concluded minimize the risk of serious adverse health 
consequences or death by preventing the introduction of hazards and 
providing reasonable assurances that produce is not adulterated under 
section 402 of the FD&C Act. Agricultural water in violation of these 
standards indicates increased likelihood of fecal contamination of the 
water and, consequently, increased likelihood of produce contamination 
with human pathogens, beyond that which is appropriate for the intended 
use. Therefore, we propose to require you to immediately discontinue 
use of that source of agricultural water and/or its distribution system 
until you have either followed certain prescribed steps to mitigate the 
problem or treated the water.
    Under the provisions of proposed Sec.  112.44, if covered farms 
choose to treat irrigation water in accordance with the requirements of 
proposed Sec.  112.43, any chemicals used in such treatment would 
require registration under the Federal Insecticide, Fungicide and 
Rodenticide Act before they can be lawfully used. At the present time, 
no such registration for chemical treatment of irrigation water exists. 
As discussed in section IV.K. of this document, FDA is proposing to 
delay implementation of certain provisions, including the water quality 
testing requirements in proposed Sec.  112.44, beyond the effective 
dates for other provisions of the rule. The proposed extended 
compliance dates for the water quality testing, monitoring, and related 
record keeping requirements in proposed Sec. Sec.  112.44, 112.45, 
112.50(b)(5), 112.50(b)(6), and 112.50(b)(7) are six years from the 
effective date for very small businesses, five years from the effective 
date for small businesses, and four years from the effective date for 
all other farms subject to the rule. We expect these extended 
compliance dates to provide adequate time for industry to address 
issues related to water quality testing. We seek comment on the 
adequacy of this timeline.
    Proposed Sec.  112.44(d) would also allow you to establish and use 
alternatives to the requirements established in proposed Sec.  
112.44(c) provided you satisfy the requirements of proposed Sec.  
112.12. As discussed in section V.B. of this document, under proposed 
Sec.  112.12(a)(1), you may establish an alternative to the 
requirements, established in proposed Sec.  112.44(c) for testing 
water, and taking action based on test results when agricultural water 
is used during growing operations for covered produce (other than 
sprouts) using a direct water application method. We acknowledge that 
in specific circumstances an alternative standard (e.g., a standard 
that applies an application interval (time between application and 
harvest) in place of the 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. Therefore, we tentatively conclude that it would be 
appropriate to allow for alternatives to the requirements in proposed 
Sec.  112.44(c).
    We are working with USDA and other 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).
    Proposed Sec.  112.45 would establish requirements related to 
frequency of testing agricultural water that is subject to the 
requirements of 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 three months thereafter during the growing season, 
except that there would be no requirement to test water 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 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 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.
    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 irrigation waters. 
Recommendations range from monthly testing to once each year, for 
sources with a history of compliance with commodity specific 
recommendations (Ref. 31. Ref. 44). Even for sources considered 
reliable (e.g., well water), a one year period between testing does not 
minimize the risk of known or reasonably foreseeable hazards because 
microbiological water quality, even when sourced from ground water 
sources, is too variable for this frequency of testing to be protective 
(e.g., effects of flooding, runoff) (Ref. 29). Alternatively, we 
tentatively conclude testing more frequently (less 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 established as a function of 
commodity, irrigation method (e.g., furrow, seep, subsurface 
dripfoliar), and timing of application (days prior to harvest), and 
concluded that the most effective approach is to test on a frequency 
related to the reliability of the agricultural water sources. We 
tentatively conclude that requiring testing as a function of time 
before harvest would be impractical for many farms as we have observed 
single sources (e.g., a well) providing water for multiple crops in 
different phases of production. We request comment on whether we should 
allow for adjustment of ground water testing frequencies dependent upon 
historical test results. For example, we are considering requiring 
testing ground water sources every three months for one year and yearly 
after that if the ground water consistently met the standard. We also 
request public comments on our proposed approach to frequency of 
testing, each of the options described here, and any other alternative 
testing frequencies that can be supported by water quality data.

[[Page 3571]]

    Proposed Sec.  112.45(a)(1) provides an exception to testing 
required in Sec.  112.45(a) when the water is sourced from a Public 
Water System or State authority approved to administer the SDWA public 
water supply program, and you have results of the water testing or 
certificates of compliance that demonstrate that the water meets the 
requirements of that program. These systems operate so that the water 
they deliver meets the microbial requirement in 112.44(a). In the U.S., 
Public Water Systems are required under U.S. EPA National Primary 
Drinking Water Regulations (NPDWR) in 40 CFR 141 to provide safe, clean 
water suitable for drinking and thus are at the lowest likelihood for 
pathogen contamination. Under the sampling, testing and reporting 
requirements of 40 CFR 141, we tentatively conclude that additional 
actions by the grower to assure its safety are unwarranted. Similarly, 
proposed Sec.  112.45(a)(2) provides for an exception to testing when 
the water is furnished from a public water supply that furnishes water 
that meets the standards of Sec.  112.44(a), and you have results of 
the water testing or certificates of compliance that demonstrate that 
the water meets that standard. The standard in Sec.  112.44(a) is 
derived from the EPA drinking water standard, and this provision is 
included to accommodate foreign public water supplies that are not 
governed by the requirements of the EPA drinking water program, but 
provide water of a quality that meets the microbial requirement of 
proposed Sec.  112.44(a). Where public water that meets or is 
comparable to (in other countries) EPA's drinking water standards is 
used in produce operations, we are not aware of anything suggesting a 
need for additional testing at its delivery point to the farm. We seek 
comments on this issue, including any practice(s) that could materially 
change the quality of public or municipal water between treatment and 
delivery to the farm, including changes in water quality during water 
distribution and holding. Finally, Sec.  112.45(a)(3) exempts from 
testing water that you treat in accordance with proposed Sec.  112.43, 
which is discussed above.
    Proposed Sec.  112.45(b)(1) would establish that if you use 
untreated surface water for purposes that are subject to the 
requirements of proposed Sec.  112.44, and 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)(2) would establish that if you use 
untreated surface water for purposes that are subject to the 
requirements of proposed Sec.  112.44, and 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 man-made water reservoir), then you must test the water at 
least once each month during the growing season.
    Surface water is subject to a great number of environmental factors 
that may alter its microbial water quality as discussed in the QAR and, 
when untreated, presents a significant source of pathogen contamination 
of produce. We tentatively conclude that the most important among these 
is runoff, 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 
(Ref. 157. Ref. 154). In proposing these testing frequencies, we 
tentatively divided untreated surface water into two categories based 
upon their potential to be impacted by runoff and the degree to which 
you reasonably could be expected to exercise protection and control 
over them. Flowing surface waters (e.g., river, stream, or creek) or 
sources that are not protected against runoff (e.g., natural ponds, 
lakes) must be tested at a relatively higher frequently than surface 
waters for which you have direct control and which you can manage in a 
way so to minimize the effect of runoff and other sources of 
contamination (e.g., on-farm reservoir or pond). Contamination events 
that can lead to surface water contamination can have profound effects 
on the quality of the water, but those effects can be fleeting, 
especially those involving runoff from rainfall (several days to 
several weeks). After the contamination event passes, water quality 
generally returns to background levels (Ref. 158). If sampling is less 
frequent than weekly from surface water sources subject to these kinds 
of contamination events, there is a good chance that some contamination 
events will go undetected. On the other hand, for surface water sources 
that are not subject to significant runoff, the water quality tends to 
remain stable, and the purpose of sampling is primarily to accurately 
characterize the background level. Monthly sampling provides 12 samples 
per year that give a good representation of the quality of water 
through the seasons. The sampling and testing frequencies proposed in 
Sec.  112.45(b) are the minimum that we tentatively conclude provide 
sufficient information concerning your source surface water quality for 
you to use in determining method of application and its timing for 
which the water is safe and of adequate sanitary quality. We encourage 
additional sampling if you have reason to believe that its quality may 
have changed from the previous test. We welcome comments on the need 
for, and appropriateness of, our proposed testing frequencies, 
including any alternative approaches and examples where testing should 
be more or less frequent based upon your experience or observation.
    The monitoring frequencies proposed in this rule are practical 
intervals that we tentatively conclude are reflective of the varying 
potential for changes in water quality between ground aquifers and 
surface watersheds. In proposing the monitoring frequencies for 
untreated surface waters, we considered factors that are most likely to 
impact water quality. Precipitation and its effects (e.g., discharge 
and flow rate) along with temperature are common factors reported to 
affect the microbial quality of watersheds with agricultural land 
inputs (Ref. 159. Ref. 158). Precipitation levels have also been 
successfully used to manage openings and closings of molluscan 
shellfish harvest areas. These harvest areas are well characterized in 
terms of changes in the microbial water quality due to non-point source 
runoff as a consequence of rainfall. However, we have not proposed 
surface water testing frequency based upon precipitation because such 
an approach would require full characterization of its effects (Ref. 
143) on the quality of surface water sources that are not likely to be 
generally useful across farms, States, or regions. Our approach to 
testing untreated surface water is 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. We welcome comments on this approach, including 
any alternate approaches, specifically if you believe that surface 
waters can be thoroughly characterized such that they require less 
frequent testing than proposed in Sec.  112.45.
e. Requirements for Water Used in Harvesting, Packing, and Holding 
Activities
    Proposed Sec.  112.46 would establish the measures you must take 
for water that you use during harvest, packing, and

[[Page 3572]]

holding activities for covered produce. Specifically, proposed Sec.  
112.46(a) would require that you manage the water as necessary, 
including by establishing and following water-change schedules for re-
circulated water, to maintain adequate sanitary quality and minimize 
the potential for contamination of covered produce and food-contact 
surfaces with known or reasonably foreseeable hazards (for example, 
hazards that may be introduced into the water from soil adhering to the 
covered produce). The proposed language allows sufficient flexibility 
for you to establish measures that are best suited to your needs based 
on practice and experience. For example, you may establish a water-
change schedule for water used in an apple flume based upon the rate of 
product flow, organic load, or other variables you determine best 
correlate with safety and sanitary quality of the flume water. Many 
commonly used wash water antimicrobials have decreased efficacy when 
organic matter is present in the water. For example, organic matter 
builds up in agricultural water flume systems from dirt and debris on 
the surface of fresh produce that are placed into the flume systems. 
Once the soluble and/or insoluble organic load builds up to 
sufficiently high levels, the addition of wash water antimicrobials 
becomes ineffective and inefficient. Changing the flume water on a 
regular basis, based on that system's unique operating conditions, can 
assure that wash water disinfection treatments are consistently 
effective (Ref. 149. Ref. 150). We point out that while water 
disinfection is one means to manage water quality, we are not 
specifically proposing to require disinfection treatment of re-
circulated or single use water that is used in harvesting, packing, or 
holding activities. We are proposing that re-circulated or single pass 
water must be safe and of adequate sanitary quality for its intended 
use (Sec.  112.41) and that it contain no detectable E. coli (Sec.  
112.44(a)). Further, if you have reason to believe that the water is 
not safe and of adequate sanitary quality for its intended use, 
proposed provisions in Sec.  112.43 for water treatment can be applied. 
However, we are not proposing treatment of water as the only option. 
Other options for farms include making changes to the system and 
retesting the water successfully (Sec.  112.42(d)) and using the same 
water source for other uses for which it does qualify. For example, 
using water that does not meet the zero E. coli standard but does meet 
the 235 CFU per 100 ml standard for direct application method 
irrigation of produce other than sprouts; or for water that does not 
meet the 235 CFU per 100 ml standard, applying the water for irrigation 
in a different manner that is not a direct application method (Sec.  
112.44). These provisions offer flexibility for farms to choose among 
different options to ensure that the water is safe and adequate for the 
purpose for which it is intended. Should farms choose to disinfect 
water as a measure to control waterborne hazards during handling during 
and after harvest, we tentatively conclude that an effective 
disinfection program would render such water safe and of adequate 
sanitary quality. However, we request public comment on the 
appropriateness of this tentative conclusion and on whether a provision 
specifically directed to disinfection of water used during and after 
harvest is needed. We also seek public input regarding practices or 
conditions when disinfection of re-circulated or single use water would 
be unnecessary, inappropriate, or impractical.
    Proposed Sec.  112.46(b) would require that you visually monitor 
the quality of water that you use during harvest, packing, and holding 
activities for covered produce (for example, water used for washing 
covered produce in dump tanks, flumes, or wash tanks, and water used 
for cooling covered produce in hydrocoolers) for build-up of organic 
material (such as soil and plant debris). Organic matter such as soil 
and plant debris has to the potential to adversely affect the quality 
of water; it may be a source of bacteria (including pathogens), support 
the growth of bacteria, and reduce the effectiveness of antimicrobial 
compounds (e.g., chlorine compounds) (Ref. 150). Such monitoring allows 
you to recognize conditions that require action, such as a water change 
in a dump tank.
    Proposed Sec.  112.46(c) would require that you maintain and 
monitor the temperature of water at a temperature that is appropriate 
for the commodity and operation (considering the time and depth of 
submersion) and is adequate to minimize the potential for infiltration 
of microorganisms of public health significance into covered produce. 
Water temperature can influence processes leading to infiltration of 
microorganisms into many types of produce. As discussed in the QAR, 
infiltration of water containing pathogens into produce has been 
demonstrated in apples (Ref. 160), oranges (Ref. 161), tomatoes (Ref. 
138. Ref. 139), and mangoes (Ref. 38) and was suggested to play a role 
in a 1999 Salmonella outbreak associated with mangos (Ref. 162). A 
recent study demonstrated that additional factors, such as tomato 
variety and the time delay between tomato stem removal and water 
immersion have a significant impact on the frequency and population of 
internalized Salmonella in tomatoes. (Ref 140). However, this study 
also demonstrated that Salmonella internalization of tomatoes via their 
stem scar can occur even under a zero temperature differential, and 
temperature differentials up to 10 [deg]F have no effect on the 
internalization frequency and have limited impact on Salmonella cell 
populations internalized in tomatoes.
    We considered proposing a single standard on temperature 
differential between water and product core temperature (e.g., water 
must be at least 10 degrees F warmer than core) but tentatively 
conclude that there is insufficient scientific evidence supporting such 
a standard across all covered produce. However, we recognize the North 
American Tomato Trade Work Group and California Tomato Commission have 
recommended such a standard (Ref. 44). We seek public comment on the 
need for, and appropriateness of, the proposed provisions, including 
any alternative approaches that you found to be effective through 
experience or observation.
f. Records Requirements
    Proposed Sec.  112.50 would establish requirements about the 
records that you would need to establish and keep under this proposed 
subpart E. Specifically, proposed Sec.  112.50(a) would require that 
you establish and keep records required under this proposed subpart E 
in accordance with the requirements of proposed subpart O. Proposed 
Sec.  112.50(b) would require that you establish and keep the following 
records:
    (1) The findings of the inspection of your agricultural water 
system in accordance with the requirements of proposed Sec.  112.42(a);
    (2) Documentation of the results of any analytical tests conducted 
to determine whether agricultural water is safe and of adequate 
sanitary quality for its intended use;
    (3) Scientific data or information you rely on to support the 
adequacy of a method used to satisfy the requirements of Sec.  
112.43(b) and (c)(1);
    (4) Documentation of the results of water treatment monitoring 
under Sec.  112.43(c)(2);
    (5) Documentation of the results of water testing you perform to 
satisfy the requirements of Sec.  112.44;

[[Page 3573]]

    (6) Scientific data or information you rely on to support any 
alternative to the requirements established in Sec.  112.44(c) for 
agricultural water used during growing activities using a direct water 
application method in accordance with the requirements of Sec.  
112.44(d); and
    (7) Annual documentation of the results or certificates of 
compliance from a public water system under 112.45(a)(1) or (2), if 
applicable.
    Proposed Sec.  112.50(b)(1) would require that you establish and 
keep records of agricultural water system inspection findings in order 
for FDA to verify compliance with the proposed requirement to inspect 
the agricultural water system. The records would also allow you to more 
effectively manage your agricultural water, to identify trends and 
changes in your agricultural water system over time, and to help 
identify potential sources of contamination of the water system and 
covered produce. In addition, these records may aid you in determining 
the most appropriate frequencies for maintenance of well and surface 
water sources, distribution and holding systems.
    Proposed Sec.  112.50(b)(2) would require that you establish and 
keep records of any analytical test results from any tests you may have 
conducted to determine if water meets the quality requirements proposed 
in Sec.  112.41. We have tentatively concluded that these records are 
necessary because otherwise FDA would have no way to determine whether 
you were making appropriate decisions about whether your water is safe 
and of adequate sanitary quality for its intended use. When such tests 
are conducted, results of those tests are also fundamental in making 
informed decisions concerning your use of water.
    We are proposing under Sec.  112.50(b)(3) and (4) that you must 
establish and keep scientific information or data documenting the 
effectiveness of the treatment method that you use and records 
demonstrating that you deliver the treatment consistently to ensure the 
water is safe and of adequate sanitary quality. These records may 
include information provided by the antimicrobial product supplier, 
product labels with instructions for use, product material safety data 
sheets (MSDS), batch test results demonstrating correct active 
ingredient concentration, mixing proportions, and schedules or 
application rates you have developed to ensure water is treated 
effectively. They may also include results of testing you perform to 
confirm your treatment methods are being followed, such as records of 
active ingredient concentration, pH, temperature, flow rate, immersion 
time, or water changes, if they significantly impact the effectiveness 
of the treatment. Monitoring frequency may be affected by product flow, 
organic load on incoming product, temperature, UV exposure, and 
consumption rates or breakdown rate (expected and observed) for the 
active antimicrobial compound, among other factors. These records are 
necessary so that FDA can verify your compliance with those 
requirements. They will also allow you to ensure your own compliance 
with the requirements for water treatment in proposed Sec.  112.43.
    We are proposing in Sec.  112.50(b)(5) that you must establish and 
keep records of the results of water testing you perform to satisfy the 
requirements of Sec.  112.44. For example, records for water tests you 
perform to ensure input water used in sprout production meets the 
requirements in Sec.  112.44(a) would include, at a minimum, the test 
date, specific water source (e.g., municipal water or well number 3), 
method name (e.g., multiple tube fermentation, membrane filter method, 
presence-absence test, and commercial product name, if applicable) and 
the test result (e.g., not detected, generic E. coli MPN or CFU, as 
applicable). Records you maintain to demonstrate the microbial water 
quality meets the requirements of Sec.  112.44(c) for foliar 
application of spinach would include, at a minimum, the test date, 
specific water source (e.g., ranch X, well 3 or canal collection point 
2), method name (e.g., multiple tube fermentation, membrane filter 
method, and commercial product name, if applicable) and the test result 
(e.g., E. coli MPN or CFU, as applicable). We tentatively conclude that 
documentation of the results of water testing are necessary to 
demonstrate that the water you use meets the requirements of Sec.  
112.44 and to provide a history of the microbial quality of your water 
system, which will be useful in spotting problems before they occur, 
minimizing the potential for water to be a source of contamination to 
covered produce. These records are necessary so that FDA can verify 
your compliance with those requirements and so that you can ensure your 
own compliance with the requirements for water testing and responding 
to test results in proposed Sec.  112.44. In proposed Sec.  
112.50(b)(6), we would require you to establish and keep that 
scientific data or information you rely on to support any alternative 
to the requirements established in Sec.  112.44(c) for agricultural 
water used during growing activities using a direct water application 
method in accordance with the requirements of Sec.  112.44(d). Such 
documentation will enable us to verify, and you to ensure, that the 
alternative standard you use provides the same level of public health 
protection as the standard in proposed Sec.  112.44(c) and does not 
increase the likelihood that the covered produce will be adulterated, 
in accordance with proposed Sec.  112.12.
    We are proposing in Sec.  112.50(b)(7) that if you use water from a 
public water system, you must establish and keep annual documentation 
(e.g., certificate of compliance, water quality testing results) 
demonstrating that system supplies water meeting the microbial 
requirements of Sec.  112.45(a)(1) or (2), if applicable. We 
tentatively conclude that maintaining such annual documentation is 
necessary for FDA to verify that the water you use is not subject to 
the requirements for testing under proposed Sec.  112.45 and to ensure 
that it meets the microbial requirements of proposed 112.44, and for 
you to demonstrate that those requirements have been met. We seek 
comment on the appropriateness of the proposed record-keeping 
requirements.

F. Subpart F--Standards Directed to Biological Soil Amendments of 
Animal Origin and Human Waste

    Proposed subpart F establishes standards directed to treated and 
untreated biological soil amendments of animal origin and human waste. 
These standards include requirements applicable for determining the 
status of a biological soil amendment of animal origin; procedures for 
handling, conveying, and storing biological soil amendments of animal 
origin; provisions regarding the use of human waste in growing covered 
produce; acceptable treatment processes for biological soil amendments 
of animal origin applied in the growing of covered produce; microbial 
standards applicable to treatment processes; application requirements 
and minimum application intervals; requirements specific to 
agricultural teas; and records requirements. The proposed requirements 
in subpart F derive from current recommendations in our GAPs guidance 
(Ref. 10), commodity-specific guidances (Ref. 31) (Refs. LGMA), State 
regulations (Ref. 90. Ref. 163. Ref. 164), other Federal Regulations 
(40 CFR 503, 7 CFR 205), and international guidelines (Ref. 100. Ref. 
51).
1. Comments Relevant to Proposed Requirements
    We received several comments in response to the 2010 FR notice that 
addressed issues relevant to biological

[[Page 3574]]

soil amendments of animal origin and human waste.
a. Definitions
    One comment stated that manure and compost are two different 
things, and the two words should not be used interchangeably as it 
causes confusion. We agree. As discussed in the QAR, and noted in the 
Produce Safety Project Issue Brief on Composting of Animal Manures 
there are documented differences in the populations and level of human 
pathogens in raw manure and animal feces and in properly composted 
manure (Ref. 27). We are proposing definitions that make the 
distinction clear. We are proposing to use the phrase ``untreated 
biological soil amendments of animal origin'' as a category that 
includes raw manure (see proposed Sec.  112.3(c) and section 
V.A.2.b.iii of this document regarding ``biological soil amendment of 
animal origin,'' and proposed Sec.  112.51(a) and section V.F.2.a of 
this document regarding ``untreated'' biological soil amendments of 
animal origin). We use the term ``treated biological soil amendments of 
animal origin'' to include treatments that meet the requirements of the 
standards presented in this subpart (see proposed Sec.  112.51(a) and 
section V.F.2.a of this document). To further alleviate confusion, we 
use the term ``compost'' as a verb, to mean the act of composting, and 
do not use it as a noun to describe a soil amendment that was treated 
by a composting method. Instead, we use the term ``humus'' in its 
common agricultural meaning (see proposed Sec.  112.3(c) and section 
V.A.2.b.iii of this document).
b. Consideration of Other Regulations and Guidances
    Comments from growers whose operations are certified for organic 
produce requested us to ensure that our regulations do not interfere 
with existing organic certification systems or organic production 
practices. Another comment stated that the California code of 
regulations for composting yards (Cal. Code Regs. title. 14, ch. 3.1) 
would be an acceptable starting point in developing our regulations.
    We consider that organic production practices and food safety are 
not cross-competing goals. In developing the provisions proposed in 
this rule, we consulted with technical experts and representatives from 
other Federal Agencies, including the Environmental Protection Agency, 
the Department of Agriculture (including both the National Organic 
Program and the Natural Resources Conservation Service), and the 
Department of the Interior (Fish & Wildlife Service) (Ref. 115). As 
discussed in section III.A.8. of this document, we tentatively conclude 
that compliance with the provisions of this proposed rule would not 
preclude compliance with the requirements for organic certification in 
7 CFR part 205, and we seek comment on this tentative conclusion. Use 
of organic practices alone is not sufficient to ensure food safety. 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. On this particular issue, and as discussed in 
sections II.E.4 and V.B of this document, we are 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 also note that we considered several regulations, 
recommendations, and guidelines that address soil amendments, including 
those from State, federal, and international agencies, industry, and 
trade associations (including the California code of regulations for 
composting yards). In addition, we consulted with experts from multiple 
organizations and academia for scientific and technical input on the 
issues addressed in these provisions. The provisions proposed take into 
account information and input gathered through these consultations.
c. Treatments, Processes, and Practices
    One comment suggested that many growers are accepting food waste 
compost, which has no manure in it but can often have a readily 
detectable level of Salmonella, and stated that ``green waste'' (or 
similar) does not necessarily equate to zero risk. Comments stated that 
if raw manure is used, there should be a science- and risk-based 
standard for determining the application-to-harvest waiting interval 
and that maximizing the time interval between soil amendment 
application and harvest is only logical if using fresh manure. 
Similarly, one comment stated that raw manure can be applied to soil if 
it is plowed and then given sufficient time before planting.
    Our review of various composting methods suggests that, regardless 
of the source, if the process is properly conducted (including proper 
turning of feedstock) the expected pathogen load and subsequent 
likelihood of produce contamination can be minimized. We agree that 
certain sources, including plant material (Ref. 165) and animal sources 
(Ref. 166), have differing likelihood of containing human pathogens or 
higher population levels of human pathogens. To address this concern, 
we propose separate, but related, provisions. First, we do not propose 
treatment or timing restrictions for biological soil amendments that do 
not contain any animal waste product or human waste (such as would be 
the case with yard waste, purely vegetative matter, or shrub trimmings, 
or agricultural teas made from such materials). Such biological soil 
amendments would not be subject to the requirements in proposed subpart 
F because they would not fit the definition of ``biological soil 
amendments of animal origin'' and they do not contain human waste. 
Further, in Sec.  112.51(b)(4) we propose that a biological soil 
amendment of animal origin contains a component that is untreated waste 
that you know or have reason to believe is contaminated with a hazard 
or has been associated with foodborne illness, you must regard it as if 
it were an untreated biological soil amendment of animal origin for 
application and treatment purposes if you still wish to utilize it. In 
addition, we treat ``table waste'' as ``animal waste'' for the purposes 
of the definition of biological soil amendments of animal origin. As 
discussed in the QAR, post-consumer waste, or table waste (such as 
plate scrapings), has a greater likelihood of being contaminated, or 
contaminated at higher populations, with human pathogens due to its 
unknown content (e.g., animal products, vegetable products, etc.) and 
its greater likelihood of containing human fluids or waste (e.g., 
spittle, vomitus, etc) (Ref. 167).
    Proposed Sec.  112.56(a)(1)(i) would require that if you apply a 
biological soil amendment of animal origin that is untreated (such as 
raw manure), where covered produce is reasonably likely to contact the 
soil after application, the material must be applied in a manner that 
does not contact covered produce during application and minimizes the 
potential for contact with covered produce after application and the 
minimum application interval is nine (9) months. In section V.F.2.f. of 
this document we discuss the reasons for this proposed requirement in 
detail. Proposed Sec.  112.56(b) would allow you to establish and use 
an alternative application interval under certain conditions (discussed 
further in section V.B. of this document). In situations where the 
covered produce will not contact the soil after application, proposed 
Sec.  112.56(a)(1)(ii) would require that the biological soil

[[Page 3575]]

amendment of animal origin be applied in a manner that does not contact 
the produce at or after application, but would not require an 
application interval. Also, as discussed in section II.E.4. of this 
document, FDA is collaborating with partners on research that may 
provide scientific support for specific alternatives to this proposed 
application interval.
    One comment stated that compost made with animal manure must meet 
temperature, mixing, and time requirements to ensure its safety, 
whereas another comment stated that biologically active soil suppresses 
pathogens and that E. coli pathogens decline more rapidly in soils with 
a large diversity of microorganisms rather than in sterile soils. One 
comment recommended that we require compost operations to have standard 
operating procedures, a quality assurance plan, compost testing within 
specified timeframes of sale, and a Hazard Analysis Critical Control 
Point (HACCP) program. According to this commenter, several growers are 
requesting testing prior to purchase, and are refusing compost that has 
not been recently tested.
    Based on our review of the literature and as discussed in our QAR, 
we determined that improper composting will not have the desired 
pathogen reduction effect, and may enhance the survival of pathogenic 
organisms (Ref. 168). Therefore, we propose specific time and 
temperature controls for composting procedures in proposed Sec.  
112.54(c), and further recognize the need for composters to consider 
other factors that will impact the successful treatment of their 
particular composting situation (e.g., feedstock, C:N ratios, pH). We 
consider that the potential effects of soil ecological diversity on 
pathogen populations are regionally specific, and may be highly 
effective under some circumstances, while potentially inert under other 
circumstances. We recognize the need for consistent treatment by 
suppliers of treated biological soil amendments of animal origin, and 
for assurance by those that use such amendments that the material has 
been produced under adequate conditions, to avoid it being a source of 
contamination. We have tentatively concluded that the most reliable and 
least burdensome proposal regarding the use of purchased treated 
biological soil amendments of animal origin is to require growers to 
obtain certain documentation (such as a Certificate of Conformance) 
from the treating operation that validated treatment methods were 
utilized, the treatment process is periodically verified through 
testing, and good handling practices were followed. This is proposed in 
subpart 112.60(b)(2) and we request comment on this proposed 
requirement, including periodic verification through testing.
d. Testing for Pathogens
    Several comments suggested that variable minimum application-to-
harvest waiting intervals should be applied using science-based 
knowledge about pathogen levels in and transfer from compost, and that 
if a compost tests pathogen-free, there should be no time limit between 
application, planting, and harvest. Another comment stated that 
pathogen testing has significant limitations, and that it would be more 
important to evaluate a treatment process to ensure that it is 
effective in inactivating pathogens.
    We considered testing of individual lots of biological soil 
amendments of animal origin as a means to determine if they were 
suitable for application to a fresh produce growing area and 
tentatively conclude that such testing is not a reliable means of 
determining the safety or expected likelihood of contaminating produce 
by use of biological soil amendments of animal origin. We have multiple 
concerns that led us to this conclusion. First, we were unable to 
determine standardized testing methods, such as sample collection 
methods, sample collection times, or location of sample collection, 
which would yield repeatable and reliable results under different 
circumstances. Second, we were unable to determine the frequency and 
sample size that would reliably indicate the microbiological safety of 
a given manure lot. Third, we recognize that there are numerous 
pathogens which may be present in biological soil amendments of animal 
origin and that pathogen testing would be necessary for all such 
potential contaminants, which would be a significant economic burden. 
Therefore, we tentatively conclude that an approach that is the most 
reasonable and the most protective of public health would involve the 
use of treatments that have been validated to meet certain specified 
microbial standards as proposed in this subpart.
e. Research Needs
    Some comments suggested that there is a need for research to 
identify means other than through heat to inactivate pathogens, and 
that such alternative approaches may be more practical for farmers. 
Comments opined on the use of chemical inactivation, and noted that the 
effectiveness of use of volatile acids or ammonia in the inactivation 
of pathogens is not fully established but that further research may 
help refine time and temperature parameters for chemical inactivation.
    We agree that further research and innovation may lead to 
alternatives to heat treatments. Proposed Sec.  112.54 addresses the 
use of physical processes, chemical processes, or combinations of 
physical and chemical processes, in addition to composting, that may be 
used as treatments for biological soil amendments of animal origin, 
provided that they meet the applicable requirements of Sec.  112.55 and 
the treated biological soil amendment of animal origin is applied in 
accordance with the applicable requirements in Sec.  112.56. We 
consider heat treatments to be physical processes within the meaning of 
that term in Sec.  112.54, and we have purposefully chosen the broader 
term ``physical processes'' to allow for possibilities other than heat 
treatment. Thus, these proposed requirements would allow for the use of 
alternatives to heat treatment, and are intended to be flexible to 
foster innovation and development of new means of treating biological 
soil amendments of animal origin to ensure produce safety.
2. Proposed Requirements
    As proposed in Sec.  112.3, ``soil amendment'' would be defined to 
mean any chemical, biological, or physical material (such as elemental 
fertilizers, humus, manure, non-fecal animal byproducts, peat moss, 
perlite, pre-consumer vegetative waste, sewage sludge biosolids, table 
waste, agricultural tea and yard trimmings) intentionally added to the 
soil to improve the chemical or physical condition of soil in relation 
to plant growth or to improve the capacity of the soil to hold water. 
Additionally, ``biological soil amendment'' would be defined in Sec.  
112.3 to mean any soil amendment containing biological materials such 
as humus, manure, non-fecal animal byproducts, peat moss, pre-consumer 
vegetative waste, sewage sludge biosolids, table waste, agricultural 
tea, or yard trimmings, alone or in combination. Finally, proposed 
Sec.  112.3 would define ``biological soil amendment of animal origin'' 
to mean a biological soil amendment which consists, in whole or in 
part, of materials of animal origin, such as manure or non-fecal animal 
byproducts, or table waste, alone or in combination, and would specify 
that the term does not include any form of human waste. See section 
V.A.2.b.iii. of this document. Proposed subpart F is focused on 
biological soil amendments of animal origin, which include animal

[[Page 3576]]

manures and other materials of animal origin that you intentionally add 
to a growing area, and on human waste. Standards directed to animal 
feces deposited by domestic or wild animals that are not a part of your 
planned growing activities (e.g., by working animals, by animals that 
graze or encroach into your growing areas) are proposed to be included 
in subpart I, as discussed in section V.I. of this document.
    As discussed in the QAR, animal waste is likely to contain 
bacterial pathogens (e.g., Campylobacter, Salmonella spp., 
enterohemorrhagic E. coli) and various other pathogens such as 
parasites (e.g., Cryptosporidium parvum, helminthes), which may infect 
humans. The type of pathogen that may be present, and the extent to 
which it may be present, is dependent on the source of the manure 
(e.g., E. coli is more common from ruminants such as cattle, whereas 
Salmonella is more common from fowl such as chickens) and the rearing 
practices of the source animals (e.g., animals from densely populated 
farms or farms with a high population of immature animals have an 
increased likelihood of harboring various pathogens) (Ref. 169). 
Enteric (or gastroinstestinal) pathogens are not generally considered 
to be environmental, and are more commonly expected to be derived (and 
in higher populations) from a human or animal source (e.g., through 
feces, mortalities, blood, spittle, etc.) (Ref. 170). Material that 
does not contain any animal waste is far less likely to harbor these 
food safety hazards at microbial populations that can reasonably be 
expected to lead to severe adverse health consequences or death (Ref. 
94). We have tentatively concluded that the likelihood of contaminating 
produce by use of biological soil amendments that do not contain animal 
waste or human waste (e.g., yard trimmings, pre-consumer vegetative 
waste) carrying human pathogens is low. Similarly, we are unaware of a 
situation in which chemical and physical soil amendments, such as 
elemental fertilizers (e.g., potash, aqueous nitrates), soil 
stabilizers (e.g., sand or crushed rock) or others typically made of 
mined or synthetic materials, have served as sources of microbial 
contamination and, therefore, neither chemical nor physical soil 
amendments are a focus of provisions of this rule. Therefore, in this 
proposed subpart F, we are proposing to focus on biological soil 
amendments of animal origin and human waste, which present a reasonable 
likelihood of harboring human enteric pathogens. Unless otherwise 
specifically noted, chemical soil amendments, physical soil amendments, 
and biological soil amendments that are not of animal origin (other 
than those that contain human waste, which are covered by proposed 
Sec.  112.53) are not covered by this rule. We encourage comment on our 
tentative decision not to provide requirements for the use of these 
kinds of soil amendments in this proposed rule.
a. Requirements for Determining Status
    Proposed Sec.  112.51 would establish requirements for determining 
the status of a biological soil amendment of animal origin for use in 
covered activities. Proposed Sec.  112.51(a) would categorize a 
biological soil amendment of animal origin as treated if it has been 
processed to completion to adequately reduce microorganisms of public 
health significance in accordance with the requirements of Sec.  
112.54, or in the case of an agricultural tea, the biological materials 
used to make the tea have been so processed and the water used to make 
the tea satisfies the requirements of 112.44(a). Section 112.51(b) 
would categorize a biological soil amendment of animal origin as 
untreated if: (1) It has not been processed to completion in accordance 
with the requirements of Sec.  112.54, or in the case of an 
agricultural tea, the biological materials used to make the tea have 
not been so processed or the water used to make the tea does not 
satisfy the requirements of 112.44(a); (2) it has become contaminated 
after treatment; (3) it has been recombined with an untreated 
biological soil amendment of animal origin; (4) it is or contains a 
component that is untreated waste that you know or have reason to 
believe is contaminated with a hazard or has been associated with 
foodborne illness; or (5) it is an agricultural tea that contains an 
agricultural tea additive.
    Proposed Sec.  112.51(a) would provide a simple method of referring 
to biological soil amendments of animal origin as treated if they have 
received one of the treatment processes described in proposed Sec.  
112.54. We discuss those treatment process options in detail in section 
V.F.2.d of this document. Agricultural teas are mentioned separately 
for two reasons. First, treatments are typically applied to the 
biological materials used to make agricultural teas rather than to the 
teas themselves and our explicit mention of this fact is intended to 
aid in clarity. Second, we specify that the water used to make a 
treated agricultural tea must meet the standard in proposed Sec.  
112.44(a) to prevent the introduction of pathogens into treated 
agricultural teas, which can be applied with fewer application 
restrictions than untreated agricultural teas in accordance with 
proposed Sec.  112.56. As discussed in section V.E.2.d of this 
document, the conditions under which agricultural tea is produced 
(moist and nutrient-rich) support the multiplication of pathogens, if 
present (Ref. 142). Even a low number of pathogens introduced into or 
onto covered produce through contaminated water could rapidly increase 
to levels that could present risk of serious adverse health 
consequences or death to those who consume the covered produce for 
which the tea was used (Ref. 142).
    Proposed Sec.  112.51(b) addresses the situations in which a 
biological soil amendment of animal origin should be regarded as 
untreated because they present a greater likelihood of contamination to 
covered produce than a treated biological soil amendment of animal 
origin. A treated biological soil amendment of animal origin can be 
expected to have a high content of available nutrients and minerals 
which can support rapid and prolific microbial population growth if 
sufficient moisture is available, possibly with limited competitive 
native microflora (Ref. 171) (depending on the specific treatment, 
treatment parameters, and handling used, (e.g., heat treated poultry 
manure pellets would be expected to have limited microorganism content 
including competitive native microflora, and composted manure would be 
expected to have substantial competitive native microflora)) (Ref. 171. 
Ref. 172). Accordingly, pathogens could grow prolifically in a treated 
biological soil amendment of animal origin if it were to become 
contaminated through contact or partial mixing with an untreated 
biological soil amendment of animal origin, or other potential 
contaminant source, and if sufficient moisture were available (Ref. 
171). Prolific microbial growth could also occur through premature 
termination of treatment, which could leave surviving microorganisms 
and a higher moisture content than after composting is completed. In 
addition, if a biological soil amendment of animal origin contains a 
component that is untreated waste that you know or have reason to 
believe is contaminated with a hazard or has been associated with 
foodborne illness, we tentatively conclude that the increased 
likelihood of pathogen presence in such materials results in a need to 
apply the most stringent controls to their use in the growing of

[[Page 3577]]

covered produce. Prolific growth of a human pathogen in a nutrient-
rich, possibly competition poor, biological soil amendment of animal 
origin could lead to the amendment acting as an inoculum that spreads 
microorganisms on any field or covered produce growing area to which 
the amendment may be applied, leading to a potential significant 
likelihood of produce contamination. To avoid such inoculation, we 
propose to require you to regard any biological soil amendment of 
animal origin that is partially or incompletely treated as an untreated 
biological soil amendment of animal origin. Finally, we tentatively 
conclude that agricultural teas that contain agricultural tea additives 
should be regarded as untreated biological soil amendments in light of 
their content and the likelihood that they contain human pathogens.
    As discussed in section V.F.2.f. of this document, we tentatively 
conclude that the treatment process (including composting processes) 
can reduce the populations of pathogens significantly. However, it has 
been recently reported that while pathogens that are present in 
agricultural teas made from properly composted humus are reduced to 
undetectable levels within 8.5 days, such agricultural teas with added 
nutrient supplements (i.e., agricultural tea additives) allow low 
populations of remaining E. coli O157:H7, Salmonella, and fecal 
coliforms to grow and multiply (Ref. 142). For this reason, we propose 
to impose the same application restrictions on agricultural teas that 
have been prepared with nutrient additives as those that we propose for 
the use of untreated biological soil amendments of animal origin, such 
as raw manure (proposed Sec.  112.56(a)(1)(i)), and seek comment on 
this proposal. See section V.F.2.f. of this document for further 
discussion of the reasons for these restrictions.
b. Requirements for Handling, Conveying, and Storing
    Proposed Sec.  112.52 would establish requirements for handling, 
conveying and storing soil amendments of animal origin. Specifically, 
we propose in Sec.  112.52(a) that you handle, convey, and store any 
biological soil amendment of animal origin in a manner and location 
such that it does not become a potential source of contamination to 
covered produce, food-contact surfaces, areas used for a covered 
activity, water sources, and water distribution systems. As discussed 
immediately above, prolific growth of a human pathogen in a potentially 
competition-poor, nutrient-rich, biological soil amendment of animal 
origin could lead to the amendment acting as an inoculum that spreads 
microorganisms on any field or covered produce growing area to which 
the amendment may be applied, as well as to food-contact surfaces, 
areas used for covered activities, water sources, and water 
distribution systems. To fulfill the proposed requirement in Sec.  
112.52(a), we would expect you to take specific measures to ensure that 
untreated biological soil amendments of animal origin do not 
contaminate covered produce directly or indirectly through contact with 
food contact surfaces, areas in which covered activities are conducted, 
water sources, or distribution systems. Such measures may include, for 
example, separation of treated and untreated manure (or other 
biological soil amendments of animal origin) and preventing any 
leachate originating from untreated biological soil amendments of 
animal origin from becoming a source of contamination for source water 
or water distribution systems (Ref. 173).
    As discussed in the QAR, any untreated biological soil amendment of 
animal origin that contaminates a food contact surface could be a 
source of further cross-contamination to covered produce. Moreover, a 
biological soil amendment of animal origin that has been treated by a 
composting process may still have a residual population of pathogens, 
since composting is not a complete kill step (Ref. 174); therefore, 
such biological soil amendments require a multiple hurdle approach to 
minimize the likelihood of introducing pathogens to a field on which 
they are applied. If composted material contaminates a food contact 
surface, the combined presence of available nutrients plus any 
pathogens that may have survived the composting process present a 
potential source of contamination for any covered produce that comes in 
contact with the contaminated food contact surface. Further, a fully 
heat-treated biological soil amendment of animal origin, while 
reasonably likely to be free of pathogens, may act as a source of 
nutrients for pathogens that might contaminate the food contact 
surface, thereby allowing them to multiply and pose a likelihood of 
contaminating any produce coming in contact with the food contact 
surface.
    As proposed, Sec.  112.52(b) requires that you handle, convey and 
store any treated biological soil amendment of animal origin in a 
manner and location that minimizes the likelihood of it becoming 
contaminated by an untreated or in-process biological soil amendment of 
animal origin. This proposed requirement is necessary because a 
biological soil amendment of animal origin previously treated to reduce 
pathogens can become re-contaminated by pathogens if not properly 
handled and stored (Ref. 175). For example, if you fully compost manure 
produced by your cows with the intent of using it to amend a field you 
use to grow covered produce, proposed Sec.  112.52(b) would require 
that you handle, convey, and store the fully composted manure in a 
manner and location to prevent its contamination by raw manure, or by 
manure in the composting process. This requirement is critical because 
bacterial pathogens, such as E. coli O157:H7 or Salmonella spp., if 
allowed to re-contaminate finished compost, may grow and spread to 
populations that present a significant likelihood of contaminating any 
environment in which the soil amendment is used (Ref. 171). An example 
of cross-contamination may include turning a pile of manure that is in 
the process of composting with a front-end loader, and then proceeding 
to handle fully composted humus from a mature pile with the same 
equipment. To avoid such cross-contamination, you could clean the 
front-end loader between manipulating an incomplete pile and 
manipulating a mature pile; move ``downstream,'' beginning with 
sanitary equipment and manipulating the most mature piles first, then 
proceeding to less mature piles; or designate certain equipment to only 
be used on piles of a certain maturity; or adopt other strategies that 
meet the same goals.
    Proposed Sec.  112.52(c) would require you to handle, convey, and 
store any biological soil amendment of animal origin that has become 
contaminated (for example, by an untreated or in-process biological 
soil amendment of animal origin) as if it was untreated. In other 
words, a treated biological soil amendment of animal origin that has 
become contaminated would need to be applied in accordance with the 
application and interval restrictions of proposed Sec.  112.56(a)(1) 
for untreated biological soil amendments of animal origin, or it would 
need to be treated in compliance with one of the options in proposed 
Sec.  112.54 and then applied in accordance with the applicable 
requirements in Sec.  112.56 for the treatment used. For example, if a 
treated or in-process biological soil amendment of animal origin 
becomes unintentionally contaminated (e.g., from runoff from an 
untreated biological soil amendment of animal origin), you would either 
need to treat that material in accordance with an option in proposed 
Sec.  112.54 and then apply it in

[[Page 3578]]

accordance with the applicable requirements in Sec.  112.56 for the 
treatment used, or you would have to follow the application 
requirements for untreated biological soil amendments of animal origin 
in proposed Sec.  112.56(a)(1) for the contaminated material.
c. Prohibition Regarding Use of Human Waste
    Proposed Sec.  112.53 would prohibit the use of human waste for 
growing covered produce, except sewage sludge biosolids used in 
accordance with the requirements of 40 CFR Part 503, subpart D, or 
equivalent regulatory requirements. Human waste has a high probability 
of containing multiple diverse human pathogens, including bacteria, 
parasites and viruses, at potentially very large populations, thus 
presenting a significant likelihood of harboring and spreading these 
various microbiological hazards (Ref. 92). We recognize that an 
application of untreated human waste could occur outside of your 
control (for example, as a run-off event from adjacent land not under 
your control), or may have occurred as a previous use of land before 
you took possession. If you know or have reason to believe such an 
event has occurred, we would expect you to take measures reasonably 
necessary to minimize the risk of serious adverse health consequences 
or death based on your specific circumstances. Such measures may 
include crop diversion, reconditioning or destruction, and/or land 
remediation, or other comparable methods.
    Under 40 CFR part 503 subpart D (Sec.  503.30, 31, 32 and 33), the 
U.S. EPA requires that the application of sewage sludge biosolids to 
fields in which food or feed crops are grown adhere to certain pathogen 
reduction requirements, and use certain vector attraction reduction 
options. Depending on which options are implemented, there are 
different ranges of wait periods between application of the soil 
amendment, and the harvest of the crop grown. For example, if an 
untreated human waste (i.e., equivalent to domestic septage: ``Liquid 
or solid material removed from a septic tank, cesspool, portable 
toilet'') (40 CFR 503.9(f)), is applied to a field used to produce a 
food crop, then ``Food crops with harvested parts that touch the sewage 
sludge/soil mixture and are totally above the land surface shall not be 
harvested for 14 months after application of sewage sludge'' (40 CFR 
503.32(c)(1), cross-referencing Sec.  (b)(5) of the same section). We 
agree these standards are appropriate for protecting public health and, 
therefore, we are not proposing to implement further restrictions. Our 
proposed definition of agricultural teas, discussed in section 
V.A.2.b.iii. of this document, would provide that agricultural teas are 
not made from any form of human waste because doing so would not be 
permissible under 40 CFR part 503 subpart B.
d. Acceptable Treatment Processes
    Although there is great variability in available data on pathogen 
survival in animal manure depending on the type and source of manure in 
question, the location and environment under which the manure is 
stored, and numerous other factors (Ref. 176. Ref. 177. Ref. 178) there 
are data to suggest it is reasonable to expect that, given the proper 
conditions, pathogens in certain animal manures may survive for months 
(Ref. 179), years (Ref. 180), or even indefinitely (Ref. 174). Because 
the use of soil amendments that contain materials of animal origin 
poses a significant likelihood of contaminating the growing environment 
and covered produce with human pathogens, we have tentatively concluded 
that such materials used as a soil amendment require some level of 
treatment, or other risk-reducing steps (such as application 
restrictions), for use in the growing of covered produce. Proposed 
Sec.  112.54(a)-(c) would establish acceptable treatment processes for 
a biological soil amendment of animal origin when applied in the 
growing of covered produce, along with associated microbial standards 
against which they must be validated in proposed Sec.  112.55. A 
validated process, when properly implemented and monitored, would be 
expected to meet the listed microbial standards and thereby reduce the 
likelihood of hazards associated with biological soil amendments of 
animal origin from contaminating covered produce. The microbial 
standards in proposed Sec.  112.55 are not meant as lot-by-lot 
microbial testing requirements. Instead, the person applying the 
treatment process would need to monitor the physical parameters of the 
process (e.g., temperature of a compost pile) to ensure that they meet 
the conditions under which the process was validated. In addition, 
proposed Sec.  112.54 would provide that the resulting biological soil 
amendments must be applied in accordance with the applicable 
application requirements in Sec.  112.56. We seek comments on this 
approach.
    The underlying framework for the provisions of Sec. Sec.  
112.54(a)-(c), 112.55, and 112.56 is that as the likelihood that a 
method of application of a biological soil amendment of animal origin 
will result in it contacting covered produce increases, the extent of 
measures taken to reduce the likelihood of known or reasonably 
foreseeable microbial hazards being present in the applied soil 
amendment must also increase. That is, for an application practice that 
is more likely to result in the amendment contacting covered produce 
(e.g., broadcast application of a soil amendment vs. subsurface soil 
amendment injection for the same crop, or in-row application of a soil 
amendment for a row crop vs. in-row application for a tree crop), it is 
more important to have stricter controls for known or reasonably 
foreseeable microbial hazards in the applied soil amendment than for 
another amendment whose application practice is less likely to result 
in the amendment coming into contact with covered produce. Therefore, 
proposed Sec.  112.54 consists of multiple acceptable options for the 
treatment of soil amendments and corresponding standards against which 
they are to be validated (as further described in Sec.  112.55). These 
proposed treatment options were designed to be flexible to allow you to 
determine what your operation's needs are, and select the option that 
best fits those needs. In developing these proposed requirements, we 
have taken into account the wide variation presented by different 
feedstocks used in preparing biological soil amendments of animal 
origin, the diversity of commodities, and various growing regions. In 
addition, we considered the likelihood of contamination posed by 
biological soil amendments of animal origin subjected to each of these 
multiple treatment options when determining the appropriate application 
requirements, as proposed in Sec.  112.56. We have tentatively 
concluded that the use of the physical, chemical, and composting 
treatments listed in proposed Sec.  112.54(a)-(c), when applied in 
accordance with proposed Sec.  112.56, are capable of adequately 
reducing pathogen levels in biological soil amendments of animal 
origin. We request comment on the appropriateness of each of the 
options considered, and discussion of any other options not listed in 
proposed Sec.  112.54.
    Physical treatments usually involve some form of high-heat 
treatment (cooking) of the biological soil amendment of animal origin 
to kill undesirable microorganisms. By contrast, chemical treatments 
usually involve greatly altering the pH of a biological soil amendment 
of animal origin, to the point that undesirable

[[Page 3579]]

microorganisms do not survive. In a study treating chicken manure with 
ammonia to reach high (alkaline) pH levels, a 3 to 4 log decrease of 
generic E. coli was observed over 6 days at 20[deg]C, and drying manure 
to 10% moisture content and exposing it to ammonia gas (1% of manure 
wet weight) reduced pathogen load by 8 log (99.999999% reduction) (Ref. 
181). To perform either physical or chemical treatments, the feedstock 
is generally placed in a large treatment container, and large amounts 
of energy are required in order to initiate the treatment. These 
factors alone make these forms of treatment impracticable for many 
farms. While such treatments can be expected to have a strong lethal 
impact on microorganisms present in the feedstock, they do not always 
result in complete elimination of pathogens. For example, chicken 
manure may be heat-treated to create a dried, pelleted material that is 
functionally sterile due to the high heat used during production; 
however, it has been observed that if the heat treatment is not 
uniform, the end product may still harbor human pathogens and pose a 
likelihood of the material being re-colonized by the microbial 
pathogen, leading to the possible contamination of any covered produce 
to which it is applied (Ref. 115).
    Biological soil amendments of animal origin may also be prepared by 
combining multiple treatments, either alone or in combination. For 
example, a single feedstock may be heat-treated (physical) while also 
drenched in strong ammonia (chemical) to acidify the material (Ref. 
182). Alternatively, feedstock may first be composted and then treated 
by heat to further reduce pathogens, effectively pasteurizing the 
material, as is common practice in the production of mushroom growth 
media (Ref. 183). These systems have been shown to be highly effective 
when proper controls are in place and monitored, but they also require 
significant inputs and capital investments.
    Proposed Sec.  112.54(a) would establish that a scientifically 
valid controlled physical process (e.g., thermal), chemical process 
(e.g., high alkaline pH), or combination of scientifically valid 
controlled physical and chemical processes that have been demonstrated 
to satisfy the microbial standard in Sec.  112.55(a) for Listeria 
monocytogenes, Salmonella spp., and E. coli O157:H7 is a treatment 
option for biological soil amendments of animal origin. This standard 
is currently used by the mushroom industry, which utilizes a two-phase 
process consisting of a composting treatment that meets the composting 
standard proposed in Sec.  112.54(c) followed by a subsequent heating 
process that meets the microbial standard of proposed Sec.  112.55(a). 
Together, the treatment reduces over 7 log cfu/g of Listeria, 
Salmonella, and E. coli O157:H7 to undetectable levels (Ref. 183). It 
also eliminates much of the native microflora (Ref. 183). We have 
tentatively concluded that a treatment meeting this standard would 
significantly reduce or eliminate known or reasonably foreseeable 
microbial hazards in biological soil amendments of animal origin, and 
would constitute the lowest expected likelihood of any of the proposed 
treatment options. We have also tentatively concluded that a biological 
soil amendment of animal origin that has been treated to this standard 
would be appropriate for use when the likelihood for contamination of 
covered produce is the highest, such as the substrate (growth media) 
used for growing mushrooms and some sprouts. Therefore, as provided in 
proposed Sec.  112.56(a)(2) and discussed further in section V.F.2 f of 
this document, any biological soil amendment of animal origin treated 
to this standard would have the fewest limitations on its application.
    Proposed Sec.  112.54(b) would establish that a scientifically 
valid controlled physical process, chemical process, or combination of 
scientifically valid controlled physical and chemical processes, that 
has been demonstrated to satisfy the microbial standard in Sec.  
112.55(b) for Salmonella and fecal coliforms is a treatment option for 
biological soil amendments of animal origin. We have tentatively 
concluded that a treatment meeting this standard would significantly 
reduce known or reasonably foreseeable microbial hazards in biological 
soil amendments of animal origin leading to minimal likelihood of 
contamination. A biological soil amendment of animal origin that has 
been treated to this standard would be appropriate for use when there 
is a high likelihood that the soil amendment will come into contact 
with covered produce. Moreover, as provided in proposed Sec.  112.56 
and discussed further in section V.F.2.f of this document, any 
biological soil amendment of animal origin treated to this standard 
would have minimal limitations on its application.
    Proposed Sec.  112.54(c) would establish that a scientifically 
valid controlled composting process that has been demonstrated to 
satisfy the microbial standard in Sec.  112.55(b) for Salmonella and 
fecal coliforms is a treatment option for biological soil amendments of 
animal origin. Two specific scientifically valid controlled composting 
processes that could be used to meet the requirements of proposed Sec.  
112.54(c) are provided: (1) Static composting that maintains aerobic 
(i.e., oxygenated) conditions at a minimum of 131[emsp14][deg]F (55 
[deg]C) for 3 days and is followed by adequate curing, which includes 
proper insulation; and (2) turned composting to maintain aerobic 
conditions at a minimum of 131[emsp14][deg]F (55 [deg]C) for 15 days, 
with a minimum of five turnings, and is followed by adequate curing, 
which includes proper insulation. These two composting processes are 
currently considered by the U.S. Environmental Protection Agency as 
Processes to Further Reduce Pathogens (Appendix B to 40 CFR part 503, 
part B.1). Both are recommended for use by the U.S. Department of 
Agriculture's Agricultural Research Service (Ref. 184), Natural 
Resources Conservation Service (Ref. 97), and National Organic Program 
(7 CFR part 205), and both are commonly accepted practices within the 
industry (Ref. 185). While there is robust discussion in the literature 
on times, temperatures, and other conditions (pH, moisture, oxygen 
levels, etc.) needed for significant reductions (albeit not 
elimination) of human pathogens in cattle, sheep and chicken manures, 
it is clear that composting cannot be considered as a pathogen-
elimination step because of the many variables that can affect the 
efficacy of the composting process (e.g., feedstock mixtures, climatic 
conditions, and various other physio-chemical parameters) (Ref. 174). 
These limits are currently used as composting endpoints by other 
federal agencies (40 CFR 503) States (Ref. 90. Ref. 164. Ref. 163), and 
industry (Ref. 31).
    Composting is generally the least expensive method with the lowest 
capital investment requirement, and if properly managed, can be 
expected to significantly reduce pathogen populations in feedstock 
materials (Ref. 186). As noted in the Produce Safety Project Issue 
Brief on Composting of Animal Manures, composting has been shown to 
reduce the overall concentration of nitrogen in the soil amendment, 
which poses a concern for some farmers, but it also has been 
demonstrated that the remaining nitrogen is both in a more bio-
available state (i.e., more easily utilized by plants) and will persist 
in the environment for a longer time (therefore providing nutrients to 
plants for a longer time) (Ref. 27). Composting leaves much of the 
native microflora intact (Ref. 187).

[[Page 3580]]

Proper composting is not difficult for most operations, but it does 
require a labor commitment to ensure conditions are met and maintained 
to achieve the desired effect. Some of the most critical elements of 
composting include proper stacking of a pile, proper aeration and 
turning, and ensuring the pile attains the proper temperature and is 
allowed to cool (cure) for an adequate time (Ref. 27). There are 
currently no federally mandated composting standards for food safety. 
The USDA/NOP offers standards that are meant to maximize soil fertility 
in 7 CFR 205.203 (these are required to achieve ``USDA Certified 
Organic'' status, but otherwise are recommendations only), and EPA 
standards in 40 CFR part 503 are specific to sewage sludge, not animal 
manures. While these standards were not developed for food safety, 
several studies suggest that they would be appropriate for use as food 
safety measures (Ref. 27). Proper handling and storage during and after 
composting to avoid cross-contamination of cured product and in-process 
or raw product is critical, as discussed in section V.F.2.b of this 
document above regarding proposed Sec.  112.52 of this rule. Other 
important factors in proper composting (such as the carbon to nitrogen 
ratio of the feedstock (C:N), the moisture content of the pile, the 
reaction to high cellulose-content material (i.e., plant material such 
as straw or vegetative waste), and the specifics of the beneficial 
microbial content will vary depending on the feedstock (Ref. 187). The 
person who manages the composting process would also need to consider 
such factors as the moisture content, pH, carbon to nitrogen ratio 
(C:N), and feedstock to achieve the microbial standards set forth in 
proposed Sec.  112.55. Many resources are available that discuss these 
details, such as the USDA NRCS handbook (Ref. 97). When composting 
processes are carried out in an incorrect manner, the organic matter in 
the finished product remains poorly stabilized and recontamination is 
more likely to occur, which can potentially result in the compost 
becoming a source of pathogens that could contaminate the field to 
which it is applied and any crops that are grown in the amended soil 
(Ref. 165).
    As noted in the Produce Safety Project Issue Brief on Composting of 
Animal Manures, adequate curing, including proper insulation (usually 
consisting of around one foot thick of insulating material, e.g., hay, 
straw, finished compost) is included as part of this proposed 
requirement, because curing is an important step in the composting 
process to further reduce the levels of pathogens, complete the 
chemical reactions of composting, and mitigate the impact that 
incomplete turning (creating temperature stratification within an 
active pile) would have on composting efficacy (Ref. 27). Proper 
insulation serves as a layer of protection from external influences 
(e.g., temperature changes, wild animal encroachment).
    The treatment processes proposed in Sec.  112.54(c), paragraphs (1) 
and (2), may not be the only means of achieving adequate composting to 
meet the microbial standards in proposed Sec.  112.55(b). Therefore, we 
have tentatively concluded that it would be appropriate to allow for 
the use of static or turned composting protocols other than those 
specified in Sec.  112.54(c)(1) and (2), if they meet the microbial 
standards for validation for composting in proposed Sec.  112.55(b). 
Proposed Sec.  112.54(c)(3) allows for the use of other scientifically 
valid, controlled composting processes, provided you satisfy the 
requirements of Sec.  112.12, including that the alternative has been 
demonstrated to satisfy the microbial standard in Sec.  112.55(b). No 
such alternatives are provided for the treatment requirements of Sec.  
112.54(a) and 112.54(b), because those parts do not explicitly define 
the processes to be conducted to meet the microbial standards 
presented; therefore, any scientifically valid controlled physical, 
chemical, or combination of physical and chemical processes that has 
been demonstrated to satisfy the relevant microbial standard in either 
Sec.  112.55(a), or Sec.  112.55(b) will meet the requirements of those 
subparts.
e. Microbial Standards Applicable to Treatment Processes
    Proposed Sec.  112.55 establishes microbial standards applicable to 
the treatment processes in Sec.  112.54. Proposed Sec.  112.55(a) would 
provide microbial standards for the treatment process in proposed Sec.  
112.54(a). It would require: (1) L. monocytogenes to be not detectable 
using a method that can detect one colony forming unit (CFU) per five 
gram analytical portion; (2) Salmonella spp. to be less than 3 most 
probable number (MPN) per four grams of total solids (dry weight 
basis); and (3) E. coli O157:H7 to be less than 0.3 MPN per 1 gram 
analytical portion. As discussed immediately above regarding proposed 
Sec.  112.54(a), these standards are the most stringent and meant for 
applications in which a biological soil amendment of animal origin 
would otherwise pose the greatest likelihood of transferring a known or 
reasonably foreseeable hazard to a covered produce commodity. These 
standards would also be useful if you wanted to use a biological soil 
amendment of animal origin with the least amount of application 
restrictions available under proposed Sec.  112.56. As previously 
noted, these microbial standards are currently used by the mushroom 
industry for growth media and reduce over 7 log CFU/g of Listeria, 
Salmonella, and E. coli O157:H7 to undetectable levels (Ref. 183).
    Proposed Sec.  112.55(b) would provide two microbial standards, 
both of which must be satisfied for the treatment processes in proposed 
Sec.  112.54(b) and (c). This section would require less than 3 MPN 
Salmonella spp. per 4 grams of total solids (dry weight basis), and 
less than 1,000 MPN fecal coliforms per gram of total solids (dry 
weight basis). These limits are currently used as composting validation 
endpoints by EPA (40 CFR 503), some States (Ref. 90. Ref. 164. Ref. 
163), and industry (Ref. 31). Ohio and California (Ref. 163. Ref. 164), 
industry (Ref. 31) and other nations such as Canada and the United 
Kingdom (Ref. 27) use both of these criteria, while EPA and Florida 
(Ref. 92. Ref. 90) allow for either criteria to be used. As noted in 
the Produce Safety Project Issue Brief on Composting of Animal Manures, 
the EPA requirement of validation with either Salmonella spp. or fecal 
coliforms is based on the observation that reduction in fecal coliforms 
is well correlated to reduction in Salmonella spp. when biosolids are 
composted (Ref. 27). However, we tentatively conclude that satisfying 
both of these criteria is necessary to significantly minimize known or 
reasonably foreseeable hazards when combined with the applicable 
application requirements in proposed Sec.  112.56. Monitoring the 
relative levels of indicator microbes such as fecal coliforms, which 
are predominantly E. coli in manures and freshly mixed compost, is 
advantageous in that they are abundant in manure. In the absence of a 
reliably present pathogen, fecal coliforms are useful to validate the 
efficiency of the thermophilic composting process (Ref. 27). 
Additionally, E. coli, the primary fecal coliform in manure, has been 
documented to be a good indicator of the inactivation of E. coli 
O157:H7 (Ref. 168). Validating solely with Salmonella spp. is not 
sufficiently protective or useful for validating the efficiency of a 
thermophilic composting process, since Salmonella spp. cannot be 
assumed to be present in all composting feedstock materials. On the 
other hand,

[[Page 3581]]

Salmonella spp. is the most common microbiological hazard associated 
with fresh produce (Ref. 3). As such, validating with fecal coliforms 
and Salmonella spp. not only assures the efficacy of the thermophilic 
composting process but also assures significant reduction of the 
pathogen Salmonella spp. when commonly used compost feedstocks are used 
that are likely sources of Salmonella spp. (e.g., cattle and poultry 
manure) (Ref. 188). We seek comment on these proposed microbial 
standards and potential alternatives.
    We do not intend this proposed provision to require that farms test 
their treated biological soil amendments for compliance with the 
microbial standards. Rather, we intend this provision to provide the 
standard against which treatment processes must be validated. Farms 
would be able to use treatment processes that are validated to meet the 
relevant microbial standard in this section without needing to test the 
end products of their treatments to confirm that the microbial standard 
was achieved.
f. Application Requirements and Minimum Application Intervals
    Proposed Sec.  112.56 establishes the application requirements and 
minimum application intervals applicable to biological soil amendments 
of animal origin. Proposed Sec.  112.56(a) would establish a 
requirement that, except as provided in subparagraph (b), any 
biological soil amendment of animal origin that you use must be applied 
with the application method requirements and minimum application 
intervals specified in the table presenting proposed Sec.  
112.56(a)(1)-(4). The different application method requirements and 
intervals for biological soil amendments of animal origin are presented 
so that you may determine the amendment, application, and interval that 
is most appropriate for your situation, based on the expected 
likelihood of contaminating produce by use of the biological soil 
amendment of animal origin you plan to use.
    In developing the application methods requirements of proposed 
Sec.  112.56(a)(1)-(4), we first considered specifications of each type 
of biological soil amendment of animal origin, and then considered the 
likelihood that the soil amendment will come into contact with covered 
produce. For example, those biological soil amendments of animal origin 
treated with a process or processes capable of consistently and 
reliably reducing or eliminating pathogens as per Sec.  112.54(a) do 
not have any application restrictions, and may come into contact with 
covered produce during harvest and growing (proposed Sec.  
112.56(a)(2)), such as in the growing of mushrooms and some sprouts. 
Conversely, those treatments that are expected to have some likelihood 
of harboring significant numbers of human pathogens, i.e., those 
treated in accordance with the requirements of Sec.  112.54(b) or (c), 
have proposed limitations on the method of application that minimize 
the potential for the treated biological soil amendment of animal 
origin to contact covered produce during and after application 
(proposed Sec.  112.56(a)(3), (a)(4)(ii)) and also allow for pathogen 
die-off when it is reasonably likely that covered produce will contact 
soil after application of the soil amendment (proposed Sec.  
112.56(a)(4)(i)). Requirements would include the application of 
untreated biological soil amendments of animal origin in situations 
where it is reasonably likely that covered produce will contact the 
soil after application of the soil amendment (Sec.  112.56(a)(1)(i)), 
where the amendment would be permitted to be applied in a manner that 
minimizes the potential for contact with covered produce after 
application, but with an additional food safety measure that it can be 
applied only in a manner that does not contact covered produce during 
application and using a minimum application interval of 9 months. By 
contrast, in situations where covered produce will not contact the 
soil, (Sec.  112.56(a)(1)(ii)), the amendment would be permitted to be 
applied without an application interval. We explain each of these 
proposals in detail below.
    Proposed Sec.  112.56(a)(1)(i) requires that if you apply a 
biological soil amendment of animal origin that is untreated, then the 
material must be applied in a manner that does not contact covered 
produce during application and minimizes the potential for contact with 
covered produce after application and the minimum application interval 
is nine (9) months. This provision would apply to any situation in 
which the covered produce is reasonably likely to contact the soil 
after application of the soil amendment. Proposed Sec.  
112.56(a)(1)(ii) requires that if you apply a biological soil amendment 
of animal origin that is untreated, and the material is applied in a 
manner that does not contact covered produce during or after 
application, there is no minimum application interval. This provision 
would apply to any situation in which the covered produce will not 
contact the soil after application of the soil amendment. The specific 
microbial populations of raw manure are generally unknown, but can be 
expected to be very high, and are likely to include zoonotic 
microorganisms that pose a food safety hazard (such as Salmonella spp. 
up to 10[supcaret]7 (Ref. 176) and E. coli O157:H7 up to 10[supcaret]6 
(Ref. 189)). Based on our QAR, we have determined that raw animal waste 
(manure, litter, mortalities, etc.) is likely to contain human 
pathogens and has the highest likelihood of contaminating covered 
produce. Therefore, we tentatively conclude that such material should 
only be used where, and in a manner, that such likelihood is minimized. 
As discussed above, the likelihood of produce contamination by an 
agricultural tea that contains agricultural tea additives is also high 
(Ref. 142). Given the desire to both allow for the continued use of raw 
manure, agricultural teas containing agricultural tea additives, and 
other untreated biological soil amendments of animal origin; and to 
minimize the risk of known and reasonably foreseeable hazards, we have 
tentatively concluded that we should require that untreated biological 
soil amendment of animal origin (including raw manure) applied in the 
growing of covered produce should either first be treated to reduce 
microbial food safety hazards; or if the covered produce is reasonably 
likely to contact the soil after application of the soil amendment, the 
untreated soil amendment should be applied in a manner that keeps it 
from coming into contact with covered produce during application, 
minimizes the potential for contact after application, and allows for 
the die-off of pathogens; and if the covered produce will not contact 
the soil after application of the soil amendment, the untreated soil 
amendment should be applied in a manner that keeps it from coming into 
contact with covered produce during and after application. In the case 
of agricultural teas containing agricultural tea additives, we 
tentatively conclude that because additional treatment is not an option 
they should be applied in the same manner as untreated biological soil 
amendments of animal origin. Proposed Sec.  112.56(a)(1)(i) would 
therefore establish such restrictions on the manner of application for 
these materials when they are reasonably likely to come in contact with 
covered produce after application, as well as a minimum application 
interval (waiting period) of nine (9) months from the application of 
untreated biological soil amendments of animal origin to the harvest of 
covered produce. On the

[[Page 3582]]

other hand, under proposed Sec.  112.56(a)(1)(ii), untreated biological 
soil amendments of animal origin would be permitted for use with no 
minimum waiting period when the soil amendment is applied in a manner 
that does not contact covered produce during or after application. We 
investigated the potential for survival of many enteric pathogens of 
public health concern (Ref. 190. Ref. 92) 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 (Ref. 191. Ref. 104. Ref. 192). It is unclear 
in the existing literature at what point the population is low enough 
to minimize the potential for contamination of covered produce; 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 initially 
present at very high initial populations (e.g., E. coli O157:H7 in 
sheep manure (Ref. 177) surviving for 21 months) or involved certain 
pathogens such as encysting parasites (Cryptosporidium parvum cysts 
surviving for over a year (Ref. 193) or the eggs of parasitic flatworms 
(Ascaris ova surviving for over 15 years (Ref. 174)). 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 (Ref. 
194)) and those microorganisms that produce spores are especially 
hardy. Basing all manure application standards on these extreme cases 
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 (Ref. 190). This 
includes organisms less commonly associated with fresh produce, such 
Cryptosporidium, Giardia, and Ascaris (parasitic flat worms). Organisms 
most commonly associated with fresh produce outbreaks (such as E. coli, 
Salmonella and Listeria) are unlikely to survive at detectable 
population levels in soil past 270 days (Ref. 181. Ref. 182. Ref. 183). 
Therefore, we tentatively conclude that utilizing a 9-month waiting 
period between the application of 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. This is not 
inconsistent with the 12-month restriction used by some segments of the 
produce industry (Ref. 31). Where the soil amendment does not contact 
covered produce either during or after application, we do not believe 
that a minimum application interval is reasonably necessary to prevent 
the introduction of known or reasonably foreseeable hazards into 
covered produce. Therefore, proposed Sec.  112.56(a)(1)(ii) provides 
for the option to use untreated biological soil amendments of animal 
origin with no minimum waiting period, provided the soil amendment is 
applied in a manner that does not contact covered produce during or 
after application. We seek comment on the proposed waiting period.
    One study, which specifically addressed considerations of microbial 
survival in soil and resulting transfer on to produce grown in the 
soil, suggested that, under ideal conditions for survival, organisms 
could survive for greater than 226 days (Ref. 191). The study was 
performed in the Southeastern U.S. (Georgia) and, therefore, is 
unlikely to reflect climatic conditions prevalent in other areas of the 
country, including the potential for the ground to freeze during 
winter. While microbes present on frozen ground can be expected to be 
reduced in population more rapidly (Ref. 195), those surviving are 
likely to persist for a longer time period in a state of dormancy (Ref. 
196). The dormancy of microorganisms also means that they will pose a 
likelihood of contamination for greater periods of time, creating a 
wider window of opportunity for covered produce to become contaminated. 
We request comment on whether and how, as an additional requirement for 
the application of untreated biological soil amendments of animal 
origin, the time period when the soil is frozen should count toward the 
proposed application interval. Further, it has been noted that rapid 
freeze-thaw cycles of weather may cause more rapid die-off rates of 
pathogens present in soils (Ref. 197). We request comment on the impact 
that freeze-thaw cycles may have on use of biological soil amendments 
of animal origin.
    Proposed Sec.  112.56(a)(2) would establish that the use of a 
biological soil amendment of animal origin treated by a scientifically 
valid controlled physical or chemical process, or combination of 
scientifically valid controlled physical and chemical processes, in 
accordance with the requirements of Sec.  112.54(a) to meet the 
microbial standard in Sec.  112.55(a), would have no application method 
restrictions and no minimum application interval. At this level of 
microbial reduction, a treated biological soil amendment of animal 
origin can be expected to present negligible likelihood of 
contamination. Therefore, we have tentatively concluded that no further 
action is necessary for the safe use of such a product in conjunction 
with covered produce.
    For example, unlike other biological soil amendments of animal 
origin, the nature of a growth medium that is a biological soil 
amendment of animal origin and is used for growing mushrooms, some 
sprouts and similarly grown produce, makes contact between the covered 
produce and the growth medium inevitable. This precludes the ability to 
utilize application restrictions as a meaningful measure to minimize 
the likelihood of pathogen contamination of covered produce through a 
multiple-hurdle approach, that would allow for the use of less robust 
treatment processes in combination with application manner 
restrictions. Therefore, we tentatively conclude that, such growth 
media must be treated by a scientifically valid controlled physical or 
chemical process, or combination of scientifically valid controlled 
physical and chemical processes, in accordance with the requirements of 
Sec.  112.54(a) to meet the microbial standard in Sec.  112.55(a).
    As proposed, Sec.  112.56(a)(3) would require that a biological 
soil amendment of animal origin treated by a scientifically valid 
controlled physical or chemical process, or a combination of 
scientifically valid controlled physical and chemical processes, in 
accordance with the requirements of Sec.  112.54(b) to meet the 
microbial standard in Sec.  112.55(b) be used in a manner that 
minimizes the potential for contact with covered produce during and 
after application, with no minimum application interval. We have 
tentatively concluded that treating a biological soil amendment of 
animal origin to meet the standards of Sec.  112.54(b) would 
significantly decrease the population of any microorganisms of public 
health significance that may have previously been present. Further, the 
proposed application restriction of minimizing direct contact of the 
amendment with the edible portion of covered produce would further 
reduce the likelihood of any remaining microorganisms in a treated soil 
amendment contaminating covered produce, as well as reduce the

[[Page 3583]]

likelihood that the soil amendment would provide a nutrient source for 
any microorganisms of public health significance already present on 
covered produce. We have tentatively concluded that the treatment of 
the biological soil amendment of animal origin, combined with 
minimizing its contact with covered produce would adequately reduce the 
likelihood of contamination and subsequent severe adverse health 
consequences or death. We have also tentatively concluded that, with 
the likelihood already minimized, it is unnecessary to implement a 
further burden by proposing a minimum application interval for soil 
amendments treated by physical or chemical processes, or combinations 
of such processes, to the standards of Sec.  112.54(b). For example, 
chicken manure pellets that have been treated by a controlled high-
temperature process according to a protocol that has been validated to 
meet the standards in proposed Sec.  112.54(b) could be used as an in-
furrow side-dress for leafy greens immediately before harvest. However, 
in this same example, the application could not be conducted by 
overhead broadcast spreading, since this method would not minimize 
contact of the biological soil amendment with the covered produce.
    Proposed Sec.  112.56(a)(4)(i) would establish requirements for use 
of a biological soil amendment of animal origin treated by a composting 
process in accordance with the requirements of Sec.  112.54(c) to meet 
the microbial standard in Sec.  112.55(b) in a manner that minimizes 
the potential for contact with covered produce during and after 
application and with a minimum application interval of 45 days. This 
provision would apply to situations in which the covered produce is 
reasonably likely to contact the soil after application of the soil 
amendment.
    Proposed Sec.  112.56(a)(4)(ii) requires that if you apply a 
biological soil amendment of animal origin treated by a composting 
process in accordance with the requirements of Sec.  112.54(c) to meet 
the microbial standard in Sec.  112.55(b), and the material is applied 
in a manner that does not contact covered produce during or after 
application, there is no minimum application interval. This provision 
would apply to any situation in which the covered produce will not 
contact the soil after application of the soil amendment. Although the 
microbial standards and application restrictions for biological soil 
amendments of animal origin treated to meet the requirements of 
proposed Sec.  112.56(a)(4) are the same as those described under 
proposed Sec.  112.56(a)(3), there is an additional 45 day application 
interval for Sec.  112.56(a)(4)(i) that would not be required in Sec.  
112.56(a)(3). We have tentatively concluded that process controls 
during chemical or physical treatments can be expected to be less prone 
to failure than process controls for composting. 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, is not 
homogeneous in nature and prone to having ``cold-spots'' that are not 
completely treated (even with proper turning) (Ref. 174). In general, 
in 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 (Ref. 174), although any such hazards 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. Examples of a system failure that may occur during 
composting, but would not be expected during a thermal or physical 
treatment, could include animal intrusion, incomplete turning, or 
reduced efficiency of composting due to environmental or climatic 
conditions (e.g., heavy rainfall or excessive cloud cover reducing the 
temperature of the pile or portions of the pile). Therefore, we propose 
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 (Ref. 92. Ref. 91) (Ref. 198), as can be expected of a fully 
composted biological soil amendment of animal origin. This multiple 
hurdle approach and time interval has also been utilized in a current 
industry standard (Ref. 31). Where a biological soil amendment of 
animal origin does not contact covered produce either during or after 
application, we do not believe that a minimum application interval is 
reasonably necessary to prevent the introduction of known or reasonably 
foreseeable hazards into covered produce. Therefore, proposed Sec.  
112.56(a)(4)(ii) provides for the option to use a biological soil 
amendment of animal origin treated by composting with no minimum 
waiting period, provided the soil amendment is applied in a manner that 
does not contact covered produce during or after application. We seek 
comment on the appropriateness of the proposed application period 
intervals.
    We have not proposed any provisions specific to the status of spent 
mushroom mulch (growth media already used in the production of 
mushrooms for subsequent use as a biological soil amendment of animal 
origin in the growing of other covered produce) and specifically 
request comment on how to classify its status. The practice of storing 
spent mushroom mulch for subsequent use in the growing of covered 
produce is not known to be a likely source of introduced contamination 
because the growth media would have been previously treated to 
eliminate pathogens (Ref. 62). Therefore, we tentatively conclude that 
spent mushroom mulch previously treated (in accordance with proposed 
Sec.  112.54(a), to meet the microbial standards of Sec.  112.55(a)) 
before use in the growing of mushrooms would still be considered as 
``treated'' to meet the standards of Sec.  112.54(c) after use for 
growing mushrooms, and for any possible subsequent use in the growing 
of fresh produce without any intervening treatment, unless you know or 
have reason to believe it has been otherwise contaminated with a hazard 
or has been associated with foodborne illness. We tentatively conclude 
that spent mushroom mulch should be considered, for the purpose of the 
application requirements in proposed Sec.  112.56, as though it has 
been treated by composting, instead of considering it as though it has 
been treated in accordance with the most robust chemical/physical 
treatment process (Sec.  112.54(a)), though it would have received such 
a treatment in accordance with proposed Sec.  112.54(a) before its use 
to grow mushrooms. This would have the effect of subjecting spent 
mushroom mulch used subsequently to grow other covered produce to the 
requirement to minimize the potential for contact with covered produce 
during and after application, and a minimum application interval of 45 
days. We consider the weathering process (the common practice of spent 
mushroom mulch being placed in a field

[[Page 3584]]

in windrow for further composting over the course of several weeks to 
years) to be similar to composting in terms of likelihood of 
introduction of contaminants. We request comment on this tentative 
conclusion.
    Under this proposal, you would, in most cases, maintain the 
flexibility to choose among a variety of treated and untreated soil 
amendments of animal origin based on the commodity being grown, growing 
conditions, and other factors relevant to your operation, but you would 
have to consider both the method of application (e.g., whether it would 
result in contact between the amendment and the produce) and, for 
certain amendments, the interval before harvest. We would expect you to 
determine which application method is most appropriate for your 
situation by selecting the application method and interval restrictions 
that would coincide best with your operation, and then purchase or 
treat a biological soil amendment of animal origin that meets the 
corresponding specifications (i.e., the first column in the table in 
Sec.  112.56(a)). For example, if you intend to apply a side-dress of a 
biological soil amendment of animal origin close to harvest, you would 
find Sec.  112.56(a)(1)(ii), (2), (3), and (4)(ii) have no minimum 
application interval. You would accordingly either use a controlled 
physical or chemical process that meets the requirements of Sec.  
112.54(a) and have no further restrictions, use a controlled physical 
or chemical process that meets the less stringent microbial standards 
of Sec.  112.54(b) if you can apply the treated biological soil 
amendment of animal origin in a manner that minimizes potential for 
contact with the covered produce during and after application, or use 
composted or untreated biological soil amendments of animal origin if 
you can apply them in a manner that ensures they do not contact covered 
produce during or after application (for example, if you are growing 
tree crops such as oranges, you apply the untreated soil amendment 
without causing it to contact the oranges, and you do not harvest 
oranges that have been allowed to come into contact with the soil after 
application of the soil amendment). Conversely, you may determine which 
application method and interval is most appropriate by evaluating which 
specification your biological soil amendment of animal origin meets, 
and then apply it according to the coinciding application method and 
interval restrictions. If, for example, you wish to apply raw manure to 
your field, you would find the requirements that apply to raw manure in 
Sec.  112.56(a)(1) and note that, if it is reasonably likely that your 
covered produce will come in contact with the soil (for example, where 
almonds are harvested by intentionally dropping to the ground) after 
application of the raw manure, the use of raw manure is restricted to 
application in a manner that does not contact covered produce during 
application and minimizes the potential for contact with covered 
produce after application, and may be applied no less than 9 months 
before harvest. On the other hand, if you can apply the raw manure in a 
manner that ensures it does not contact covered produce during or after 
application, you may use it without a minimum application interval. Any 
minimum application interval that you use can be concurrent with any 
application intervals that you are already required to, or voluntarily, 
apply. For example, if you are a USDA-certified organic grower, and 
utilize a 120-day application interval for the use of raw manure as 
part of participation in the National Organic Program, the proposed 9-
month application interval requirement in Sec.  112.56(a)(1)(i) would 
be concurrent, not consecutive, with the 120 days. Thus, your use of a 
9-month application interval for raw manure would satisfy both this 
proposed rule and the requirements of the National Organic Program. As 
another example, if you plan to apply a biological soil amendment of 
animal origin to a field of spinach that is nearing harvest for fresh 
market consumption, assuming the spinach is reasonably likely to 
contact the soil after application of the soil amendment, you could 
select a biological soil amendment of animal origin that is heat-
treated to meet the standards presented in Sec.  112.54(b) (e.g., 
chicken manure pellets), provided that you can apply it in a manner 
that minimizes the potential for contact with covered produce during 
and after application (e.g., used as a side-dressing), because there 
would not be an application restriction interval with that type of 
biological soil amendment of animal origin. If you plan to use manure 
as a biological soil amendment of animal origin for the same crop and 
plan to apply the amendment before planting, and do not wish to utilize 
a treatment such as described by Sec.  112.54(a) or (b), you would 
choose to compost the soil amendment to meet the requirements of Sec.  
112.54(c). Use of such a biological soil amendment of animal origin 
would only be restricted to application in a manner that minimizes the 
potential for contact with covered produce during and after 
application, and application at least 45 days prior to harvest.
    Proposed Sec.  112.56(b) would establish requirements for the use 
of alternatives to the minimum application intervals established in 
paragraphs (a)(1)(a) and (4)(a) of proposed Sec.  112.56, provided you 
satisfy the requirements of Sec.  112.12. We have tentatively concluded 
that, under certain circumstances, an alternative standard may be 
appropriate if it is shown to provide the same level of public health 
protection as the standard in proposed Sec.  112.56(a)(1)(i) and (4)(a) 
and not to increase the likelihood that the covered produce will be 
adulterated. For example, alternatives to the proposed minimum 
application intervals could take into account specific characteristics 
of the locality, crop and the agro-ecological environment. Such 
alternatives could consider differences in feedstock; application 
methods; and treatment methods, especially given the potential for new 
innovations in such methods. In any such case, as discussed below, we 
propose in Sec.  112.60(b)(5) that you establish and keep documentation 
of the scientific data and information you are relying on to support 
the use of an alternative minimum application interval. We do not 
propose that you would be required to submit such data and information 
to us for prior approval; we do, however, propose the requirement that 
you maintain a record of any such data and information for us to 
evaluate upon request.
h. Records Requirements
    Proposed Sec.  112.60(a) requires that you establish and keep 
records for subpart F in accordance with the requirements of subpart O 
of this part. Proposed Sec.  112.60(b) would establish requirements for 
records you must establish and keep regarding biological soil 
amendments of animal origin that you use. Proposed Sec.  112.60(b)(1) 
would require documentation of the date of application of any untreated 
biological soil amendment of animal origin (including raw manure) or 
any biological soil amendment of animal origin treated by composting to 
a growing area and the date of harvest of covered produce from that 
growing area, except when covered produce does not contact the soil 
after application of the soil amendment. These records would be 
required because the application of both raw manure and compost include 
minimum application intervals (Sec.  112.56(a)(1)(i) and (4)(i), 
respectively), so it would enable FDA to verify compliance with the 
application intervals associated with raw manure

[[Page 3585]]

and compost. These records would also allow you to keep track of the 
dates on which those biological soil amendments of animal origin were 
applied in order to determine when covered produce from those growing 
areas could be harvested in compliance with the rule. USDA-certified 
organic growers who already maintain records of when biological soil 
amendments of animal origin are applied in compliance with 7 CFR 
205.103 would not need to duplicate those records to meet the 
requirements of Sec.  112.60(b)(1).
    Proposed Sec.  112.60(b)(2) would require documentation (such as a 
Certificate of Conformance) for a treated biological soil amendment of 
animal origin that you receive from a third party. We have tentatively 
concluded that the information you will need both to verify that any 
biological soil amendment of animal origin you purchase for use in 
performing a covered activity is in compliance with this subpart F, and 
to inform your decisions on further handling, conveying, and storing of 
the purchased biological soil amendment of animal origin, includes the 
following: (i) The process used to treat the biological soil amendment 
of animal origin is a scientifically valid process that has been 
carried out with appropriate process monitoring; (ii) the applicable 
treatment process is periodically verified through testing using a 
scientifically valid analytical method on an adequately representative 
sample to demonstrate that the process satisfies the applicable 
microbial standard in Sec.  112.55, including the results of such 
periodic testing; and (iii) the biological soil amendment of animal 
origin has been handled, conveyed and stored in a manner and location 
to minimize the likelihood of contamination by an untreated or in-
process biological soil amendment of animal origin. Aspects (i) and 
(iii) of this proposed requirement reflect information that you would 
have if you treated the biological soil amendment of animal origin on 
your own farm in accordance with this proposed rule. Aspect (ii) of 
this requirement would provide you with reasonable assurances that your 
supplier is carrying out the applicable treatment process in an 
effective manner such that the biological soil amendment of animal 
origin that you purchase meets the applicable standards in proposed 
Sec. Sec.  112.54 and 112.55. We tentatively conclude that it is 
appropriate to require this additional level of assurance from your 
suppliers in order to allow FDA to verify your compliance with these 
requirements. These requirements will also provide you with a 
comparable level of control over your supplier's process of treating a 
biological soil amendment of animal origin as you would have if you 
were to apply the treatment process on-farm, where you would be able to 
monitor the process controls yourself. You would not be required to 
perform any treatment processes on a biological soil amendment of 
animal origin that you purchase and for which you have the appropriate 
documentation showing it has already been treated by a validated 
process in accordance with Sec.  112.55. These records would also allow 
you to ensure that a treated biological soil amendment that you 
purchase from a third party meets the requirements of this proposed 
rule and to determine the relevant application restrictions you must 
apply to such a soil amendment.
    Proposed Sec.  112.60(b)(3) would require documentation that 
process controls (for example, time, temperature and turnings) were 
achieved for any treated biological soil amendment of animal origin you 
produce for your own covered farms. This documentation is required to 
verify that the treatment or treatments you performed were properly 
carried out. For example, such records would inform you of any 
breakdown in the process or treatments, how they occurred or can be 
corrected, and create a history to help you predict and prevent any 
future breakdowns. Without such records, you would not be able to 
ensure, and we would not be able to verify, that the process or 
treatment you performed achieved the required parameters that are 
validated to meet the microbial standards of Sec.  112.55 or that the 
alternatives that you are using (if applicable) satisfy the 
requirements of proposed Sec.  112.12.
    Proposed Sec.  112.60(b)(4) would require documentation of 
scientific data or information you rely on to support any alternative 
composting process used to treat a biological soil amendment of animal 
origin in accordance with the requirements of Sec.  112.54(c)(3). 
Similarly, proposed Sec.  112.60(b)(5) would require documentation of 
scientific data or information you rely on to support any alternative 
minimum application interval in accordance with the requirements of 
Sec.  112.56(b). The records described in Sec.  112.60(b)(4) and (5) 
would be required only if you choose to use alternatives to those 
processes presented in Sec.  112.54(c)(1) and (c)(2) or application 
intervals in Sec.  112.56(a)(1)(i) and (a)(4)(i), respectively. This 
documentation would be required so that, as necessary, we are able to 
verify that use of your alternative process achieves the required 
parameters of proposed subpart F and satisfies the requirements of 
proposed Sec.  112.12.
    Finally, we seek comment on an issue that is not explicitly 
addressed in our proposed provisions. Biological soil amendments 
(including agricultural teas derived from biological materials) are 
nutrient rich and may support rapid and prolific growth of human 
pathogens, if pathogens are present. Seeds used for sprouting have 
repeatedly been demonstrated to have the potential to be contaminated 
with human pathogens and cause human illnesses. We note that the 
National Organic Standards Board Compost Tea Task Force recommended not 
allowing for the use of ``compost tea'' for the production of edible 
seed sprouts (Ref. 36). We are concerned that using a biological soil 
amendment (including agricultural teas derived from biological 
materials) could increase the likelihood of rapid and prolific growth 
of human pathogens, if present, during sprout growing. We request 
comment on whether sprouters currently use biological soil amendments 
(including agricultural teas made from biological materials, such as 
``compost teas'') in the growing of sprouts. In addition, we request 
comment on the likelihood of contamination presented by such a practice 
and whether the practice should be prohibited.

G. Subpart G--We Have Tentatively Reserved Subpart G of This Proposed 
Rule

H. Subpart H--We Have Tentatively Reserved Subpart H of This Proposed 
Rule

I. Subpart I--Standards Directed to Domesticated and Wild Animals

    As proposed, subpart I provides science-based minimum standards 
that are directed to domesticated and wild animals and are reasonably 
necessary to minimize the risk of serious adverse health consequences 
or death from the use of, or exposure to, covered produce, including 
those reasonably necessary to prevent the introduction of known or 
reasonably foreseeable hazards into covered produce, and to provide 
reasonable assurances that the produce is not adulterated under section 
402 of the FD&C Act.
1. Comments Related to Proposed Provisions
    We received several comments in response to the 2010 FR notice that 
addressed issues relevant to standards directed to domesticated and 
wild animals. Some comments expressed concern about requiring measures 
that prohibit the use of domesticated work animals on farms. Some 
comments

[[Page 3586]]

asserted that monitoring wildlife in a farm environment is untenable, 
whereas other comments recommended that we prepare a list of ``animals 
of concern'' to enable farmers to know where to target preventive 
controls for domesticated and wild animals. Some comments recommended 
that sustainable conservation practices should be adopted and 
recognized as enhancing food safety. Several comments noted that 
farmers are subject to State and Federal laws regarding wildlife (e.g., 
Endangered Species Act and Clean Water Act) and that there are programs 
that emphasize environmental stewardship (e.g., National Organic 
Program and programs of the Natural Resources Conservation Service). 
Others expressed concern about any requirements that would lead to 
destruction of habitat or clearing of farm borders.
    This proposed rule would not prohibit the use of on-farm 
domesticated working animals. Rather, this proposed rule would require 
you to take measures to prevent the introduction of known or reasonably 
foreseeable hazards into or onto covered produce, if you use working 
animals in a growing area where a crop has been planted and when, under 
the circumstances, there is a reasonable probability that animals will 
contaminate covered produce. We disagree with comments that asserted 
that monitoring for animal intrusion is untenable. Periodic monitoring 
for animal intrusion and deposition of their excreta is a necessary 
measure to prevent contamination of covered produce with biological 
food safety hazards when there is a reasonable probability that animals 
will contaminate covered produce. We consider that monitoring during 
the growing season and immediately prior to harvest is a practical and 
minimum necessary standard to sufficiently ensure that any potential 
hazards related to animal intrusion are identified for appropriate 
follow-up actions in these situations. Proposed Sec.  112.83 is 
intended to provide you with information about animal movements on your 
farm, allow you to recognize significant intrusion, and facilitate your 
taking appropriate measures following significant animal intrusion.
    While we recognize the value of establishing a list of ``animals of 
concern,'' we tentatively conclude that current scientific evidence on 
the extent to which specific animals present the greatest risk for 
pathogens is inadequate to develop such a list. Moreover, data on 
regional and seasonal variations in the prevalence of pathogens in 
different kinds of animals are scarce. We encourage the application of 
practices that can enhance food safety, including sustainable 
conservation practices. A 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. 199). 
This proposed rule would not require the destruction of habitat or the 
clearing of farm borders. Instead, we propose to require you to monitor 
those areas that are used for a covered activity for evidence of animal 
intrusion when, under the circumstances, there is a reasonable 
probability that animals will contaminate covered produce.
2. Proposed Requirements
    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. Proposed subpart I would not be directed to the 
potential for biological hazards from manure that may be used as a soil 
amendment; such requirements directed to biological soil amendments of 
animal origin are discussed in section V.F of this document.
    Consistent with sections 419(a)(1)(A), 419(a)(3)(E), and 
419(a)(3)(D) of the Act, we consulted with USDA's National Organic 
Program and Natural Resources Conservation Service, U.S. Fish and 
Wildlife Service, and the EPA (Ref. 115) to ensure that environmental 
and conservation standards and policies established by those agencies 
are appropriately considered in developing the requirements proposed in 
this subpart. Based on these consultations, we tentatively conclude 
that the provisions of proposed subpart I do not conflict with or 
duplicate the requirements of the National Organic Program. In 
addition, also based on these consultations, we tentatively conclude 
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. 
Furthermore, the provisions in proposed subpart I are consistent with 
current recommendations in our GAPs Guide (Ref. 10), the AFDO Model 
Code (Ref. 20), Commodity-specific industry guidances (Ref. 44. Ref. 
46), and the LGMA (Ref. 31). We seek comment on the interactions of the 
proposed rule with the National Organic Program and opportunities to 
streamline compliance with both programs.
    We acknowledge the longstanding co-location of animals and plant 
food production in agriculture. However, as discussed in the QAR, both 
wild and domestic animals may be a source of human pathogens. In fact, 
domesticated animals, due to their close proximity and interaction with 
humans, are generally more likely to harbor zoonotic pathogens than are 
wild animals (Ref. 200). Therefore we tentatively conclude that 
measures should be taken to minimize the likelihood of covered produce 
being contaminated by excreta from grazing and working animals. The 
likelihood of contaminating fresh produce with human pathogens from 
excreta from grazing and working animals is determined by numerous 
factors, including but not limited to the species of the animal, the 
number of animals per unit area of land, agro-ecological conditions, 
and the time period between animal grazing or working in fields and the 
harvest of fresh produce (Ref. 176. Ref. 169. Ref. 201. Ref. 202).
    Proposed Sec.  112.81(a) would establish that the requirements of 
proposed subpart I apply when a covered activity takes place in an 
outdoor area or a partially-enclosed building and when, under the 
circumstances, there is a reasonable probability that animals will 
contaminate covered produce. We have tentatively concluded that 
measures directed to domesticated and wild animals (such as cows, 
swine, and deer) are necessary when a covered activity takes place in 
an outdoor area or a partially-enclosed building if, under the 
circumstances, there is a reasonable probability that animals will 
contaminate covered produce, because it is reasonably likely that such 
animals will encroach on such areas and deposit excreta on covered 
produce or food contact surfaces. Some human pathogens of public health 
concern (e.g., E. coli O157:H7) that have been associated with produce 
foodborne outbreaks are zoonotic, meaning that they may originate from 
animals as well as humans. Therefore, animals, both wild and domestic, 
may be a source of human pathogens during the growing, harvesting, 
packing and holding of covered produce. We expect this provision to 
provide flexibility for farmers to consider the nature of covered 
produce and covered activities (including characteristics of covered 
produce) in light of the potential for contamination, and determine 
whether

[[Page 3587]]

the proposed requirements of subpart I would be applicable under the 
circumstances. For example, in the case of covered produce that grows 
completely underground, we expect that there would not be a reasonable 
probability of contamination of covered produce by domesticated or wild 
animals that may graze on or encroach into fields. The proposed 
requirements in Sec. Sec.  112.82 and 112.83, therefore, would not 
apply to covered activities taking place in an outdoor area or a 
partially-enclosed building when such activities relate to covered 
produce that grows completely underground. We note, however, that we do 
not intend the phrase ``under the circumstances'' in these proposed 
requirements to suggest that farms alter their surrounding environment 
in order to reduce the chances of animal intrusion, such as by clearing 
farm borders around outdoor growing areas or drainages. This proposed 
rule is not intended to require such actions. We intend the phrase 
``under the circumstances'' to refer to the nature of the covered 
produce (such as its growth habit) and the nature of covered activities 
(such as the manner in which working animals are used in growing 
areas). We request comment on this issue.
    Proposed Sec.  112.81(b) would provide that the provisions of 
proposed subpart I would not apply to fully enclosed buildings. We 
tentatively conclude that the measures proposed in this section 
directed to domesticated and wild animals (such as cows, dogs, swine, 
and deer) are not necessary when a covered activity takes place in a 
fully-enclosed building. Rather, we propose measures directed at 
domesticated and wild animals (such as horses, dogs, and rodents) in a 
fully-enclosed building in proposed Sec.  112.127 (see section V.L. of 
this document).
    Proposed Sec.  112.82 would establish requirements for measures 
that you must take, at a minimum, if you allow animals to graze or use 
them as working animals in fields where you grow covered produce and 
under the circumstances there is a reasonable probability that grazing 
or working animals will contaminate covered produce. Proposed Sec.  
112.82(a) would require you to implement an adequate waiting period 
between grazing and time of harvest for covered produce in any growing 
area that was grazed, to ensure the safety of the harvested crop. The 
potential likelihood of animals to act as vectors of human pathogens is 
determined by several factors, including but not limited to the type of 
commodity (as discussed above), and the species of the animal and its 
association with human or domesticated animal activity or waste (Ref. 
199). A suitable time period based on these and other relevant factors 
must be established for the purpose of reducing, via die-off, pathogen 
levels in the excreta that may be transferred to covered produce. We 
would not expect it to be necessary for such time periods to exceed 9 
months, which is the application interval we propose for use of raw 
manure as a soil amendment in proposed Sec.  112.56(a)(1)(i).
    Proposed Sec.  112.82(b) would require that, if you use working 
animals in a growing area where a crop has been planted, you must take 
measures to prevent the introduction of known or reasonably foreseeable 
hazards into or onto covered produce. For example, if you use draft 
horses as working animals in your covered produce fields, you could 
establish and use horse paths which are segregated from covered produce 
plantings, and minimize entry of the horses into covered produce 
plantings, thus minimizing the opportunity for horse excreta to contact 
covered produce or food contact surfaces.
    Proposed Sec.  112.83 would 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 are proposing to require that you monitor these areas as 
needed throughout 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 proposed Sec.  112.83(b) we would also 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.
    We acknowledge that when covered produce is grown in an outdoor 
environment, wild animals are likely to have access to production 
fields. The presence of animals in a production field of covered 
produce, in and of itself, is not a significant food safety risk. 
However, wild animals are known zoonotic disease reservoirs for human 
pathogens, and therefore their excreta may contaminate growing covered 
produce crops (Ref. 169. Ref. 203). Monitoring immediately prior to 
harvest will enable you to identify instances when covered produce 
cannot be safely harvested, such as when it is not possible to 
effectively avoid the harvest of covered produce that was directly 
exposed to animal excreta or that may be cross-contaminated during 
harvest (e.g., contamination of covered produce by contact with a food-
contact surface that contacted animal excreta), as provided for in 
proposed Sec.  112.112.
    Monitoring throughout the growing season may assist you in 
developing an understanding of when and the degree to which animal 
intrusion occurs throughout the production season from planting to 
harvest. 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 (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.

J. Subpart J--We Have Tentatively Reserved Subpart J of This Proposed 
Rule

K. Subpart K--Standards Directed to Growing, Harvesting, Packing, and 
Holding Activities

    As proposed, subpart K discusses science-based minimum standards 
directed to growing, harvesting, packing, and holding activities that 
are reasonably necessary to minimize the risk of serious adverse health 
consequences or death from the use of, or exposure to, covered produce, 
including those reasonably necessary to prevent the introduction of 
known or reasonably foreseeable hazards into covered produce, and to 
provide reasonable assurances that the produce is not adulterated under 
section 402 of the FD&C Act.
1. Comments Relevant to the Proposed Provisions
    We received some comments in response to the 2010 FR notice that 
addressed the adequacy and cleanliness of food-packing material and 
requested that reusable containers be allowed in packing produce 
commodities.
    It is important to ensure that food-packing material that is used 
in covered activities is adequate for its intended use, including that 
it is clean. In proposed Sec.  112.116 below, we address the adequacy 
and cleanliness of food-packing material. Specifically, proposed Sec.  
112.116(b) would require that if you reuse food-packing material, you 
take

[[Page 3588]]

measures to ensure that food-contact surfaces are clean, such as by 
cleaning and sanitizing, when necessary, food-packing containers or 
using a clean liner.
2. Proposed Requirements
    Proposed Sec.  112.111 would establish that if you grow, harvest, 
pack or hold produce that is not covered in this part (i.e., excluded 
produce in accordance with Sec.  112.2) and also conduct such 
activities on covered produce, and the excluded produce is not grown, 
harvested, packed or held in accordance with this part, you must take 
measures during these covered activities, as applicable, to: (a) Keep 
covered produce separate from excluded produce (proposed Sec.  
112.111(a)); and (b) Adequately clean and sanitize, as necessary, any 
food-contact surfaces that contact excluded produce before using such 
food-contact surfaces for covered activities on covered produce 
(proposed Sec.  112.111(b)). As discussed in the QAR, raw produce may 
have a variety of microorganisms in and on it, including, occasionally, 
human pathogens. The types of microorganisms, including human 
pathogens, detected on raw produce are diverse and may often be found 
in high numbers (Ref. 204. Ref. 205. Ref. 206). In addition, some human 
pathogens that are commonly isolated from the growing environment 
(e.g., L. monocytogenes) are reported to adapt and survive in the food 
production environment (e.g., food contact surfaces, floors, walls, 
drains, sinks, standing water, and seals) and, thus, pose a potential 
source of contamination (Ref. 207). The proposed standards included in 
this part are designed to reduce the likelihood that human pathogens 
are present in or on covered produce. For this reason, excluded produce 
that is not grown, harvested, packed and stored in accordance with the 
standards proposed in this part is likely to present a greater 
likelihood of contamination with human pathogens than would covered 
produce that is grown, harvested, packed, and held in accordance with 
this part. We tentatively conclude that for operations handling both 
covered and excluded produce, cross-contamination is reasonably likely 
in the absence of measures directed toward its prevention. Such 
measures include separation of the two types of produce to avoid 
physical contact and any transfer of pathogens from one to the other; 
and cleaning and sanitizing, as necessary, food contact surfaces used 
on such excluded produce before those surfaces come in contact with 
covered produce so that any pathogens picked up by the food-contact 
surface from excluded produce are not transferred to covered produce.
    Proposed Sec.  112.112 would require you to take all measures 
reasonably necessary to identify, and not harvest, covered produce that 
is reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard, including steps to identify and not harvest covered 
produce that is visibly contaminated with animal excreta. For example, 
you would comply with this provision by not harvesting a head of 
lettuce if you see evidence of bird excreta on the head of lettuce. As 
discussed in the QAR, it is well established that animal excreta is a 
source of pathogens. Transmission of pathogens from animal excreta to 
covered produce and, subsequently, to humans through consumption is 
reasonably likely in cases where the presence of animal excreta can be 
visually confirmed. Therefore, if the presence of animal excreta in a 
field of covered produce precludes your ability to safely harvest the 
covered produce, either because a significant portion of the covered 
produce has animal excreta on it or because the animal excreta that is 
present would be likely to contaminate food contact surfaces of harvest 
equipment, you must not harvest the relevant portions of that field.
    Proposed Sec.  112.113 would require that you handle harvested 
covered produce during covered activities in a manner that protects 
against contamination with known or reasonably foreseeable hazards, for 
example, by avoiding contact of cut surfaces of harvested produce with 
soil. As discussed in the QAR, research demonstrates that soil 
microorganisms, including human pathogens, may effectively colonize 
produce when the produce has lost its protective covering (e.g. 
cuticle) in the course of harvest activities (e.g., cutting or 
trimming) or when damaged during such operations (Ref. 208. Ref. 209). 
Once established, the high moisture content of produce provides a 
suitable environment for survival and growth of such pathogens. 
Pathogens, if present, may be transferred to cut surfaces of harvested 
produce from soil and, therefore, preventing unnecessary contact 
between such cut surfaces and soil will reduce the likelihood of such 
transfer. For example, you could take steps to temporarily place cut 
lettuce heads on clean cardboard or other clean surface during field 
packing, rather than placing them directly on the soil.
    We considered washing as a requirement to reduce the likelihood of 
contamination. Washing is an attractive option because it effectively 
removes excess dirt, debris, and other organic matter and its use 
incurs a relatively low cost allowing it to be employed across a 
variety of equipment (water flumes, hydrocoolers, dips, scrubbers, 
sorters, etc.) or steps in combination, or in sequence before 
packaging. Despite these advantages, a number of studies have concluded 
that wash water, with or without an active antimicrobial agent, does 
not completely disinfect produce that may contain microorganisms of 
public health significance (Ref. 206. Ref. 210. Ref. 209). Wash water 
containing an antimicrobial such as chlorine is reported to reduce 
microbial populations by two or three log units (100 to 1000 fold), but 
does not eliminate microbes (Ref. 211. Ref. 210). Bacteria may find 
harborage and protection on plants through hydrophobic areas, stomata, 
lenticels, punctures, and bruises and where it is not readily washed 
off (Ref. 212. Ref. 213). Of special significance to bacterial survival 
on plants are circumstances that lead to bacterial cells being drawn in 
or internalized inside the edible portion of the plant where they may 
escape the action of water altogether. This phenomenon, termed 
internalization, may occur as a consequence of temperature 
differentials created when warm produce (from field heat or daytime 
high temperatures) is submerged in cooler water. Under these 
conditions, infiltration of water occurs because intercellular air 
spaces within fruits and vegetables contract, thereby creating a 
partial pressure differential that draws the water into the internal 
compartments of the plant. If the cooling water contains human 
pathogens the fresh produce item will now be internally contaminated. 
This phenomenon has been seen with Salmonella and E. coli O157:H7 in 
tomatoes, oranges, or mangoes (Ref. 138. Ref. 139. Ref. 214). As part 
of a post-outbreak study, Penteado et al. 2004 reported evidence that 
Salmonella spp. may have internalized in fresh mangoes during a 
postharvest cooling step involving a water bath (Ref. 38). We seek 
comment on whether we should consider washing, alone or in combination 
with other measures, as a requirement to reduce the likelihood of 
contamination.
    Proposed Sec.  112.114 would prohibit you from distributing covered 
produce that drops to the ground before harvest (dropped covered 
produce) unless it is exempt under Sec.  112.2(b) (i.e. if it receives 
commercial processing to

[[Page 3589]]

adequately reduce the presence of microorganisms of public health 
significance). Dropped covered produce does not include root crops 
(such as carrots) that grow underground or crops (such as cantaloupe) 
that grow on the ground. However, produce that grows off the ground, 
such as tomatoes and apples, and that drop to the ground before harvest 
would be considered dropped covered produce. Evidence from studies of 
tree fruit (e.g., apples and pears) indicates that dropped and damaged 
fruit contain coliform bacteria in significantly higher numbers than 
intact tree fruit (Ref. 215). Risk assessment models for apple 
contamination (Ref. 216) show that dropped apples are more likely to be 
contaminated with bacteria than tree-picked apples, and dropped fruit 
used in the production of apple products (e.g., apple cider) are likely 
to increase rates of product contamination (Ref. 216). While data 
available to us is primarily derived from studies investigating apples, 
we tentatively conclude that all dropped covered produce is likely to 
present a potential likelihood for contamination, although to varying 
degrees. Studies have indicated that when produce drops to the ground, 
the produce can become structurally damaged, which is considered to be 
a factor for proliferation of human pathogens on such produce (Ref. 
217. Ref. 218. Ref. 219). Excluding dropped fruit from harvest is also 
recommended in some existing guidance documents (Ref. 220. Ref. 221. 
Ref. 44). However, some produce is dropped to the ground as a part of 
the harvesting practice (e.g., some tree nuts). We expect that such 
harvesting practices were developed because the fall does not damage 
the edible crop, because the crop is protected with a durable shell. 
Accordingly, we have defined ``dropped covered produce'' to exclude 
produce that is intentionally dropped as part of harvesting. Further, 
we do not propose to prohibit the use of dropped covered produce in a 
commercial process (e.g., canning) that is designed to adequately 
reduce the presence of microorganisms of public health significance. 
Therefore, dropped covered produce that is exempt under proposed Sec.  
112.2(b) may be distributed for such commercial processing as described 
in proposed Sec.  112.2 (see section V.A. of this document).
    We seek comment on this provision and whether specific commodities 
should be exempted from this provision based on the harvesting 
practices associated with the commodity and/or the nature of the 
commodity itself. If specific commodities should be exempted from this 
provision, please explain the practices, processes, and conditions 
associated with that commodity that would justify such exemption. We 
expect that this proposed provision would prevent the marketing for 
fresh use of produce that may have been bruised as a result of the 
fall. As noted above, damaged or bruised fruit provide an opportunity 
for pathogen intrusion into the edible portion and may liberate 
nutrients for pathogen growth. We note that produce that is 
intentionally dropped to the ground as part of the harvesting method 
would not be considered ``dropped covered produce'' as defined in 
proposed Sec.  112.114 (i.e., produce that drops to the ground before 
harvest). We seek comment on whether proposed Sec.  112.114 adequately 
takes into account produce that is intentionally dropped during 
harvesting and whether such harvesting practices do not cause damage to 
the produce. Proposed Sec.  112.115 would establish measures that you 
must take when packaging covered produce. Specifically, proposed Sec.  
112.115 would require that you package covered produce in a manner that 
prevents the formation of Clostridium botulinum toxin, if such toxin is 
a known or reasonably foreseeable hazard (such as for mushrooms). The 
potential for toxin production by C. botulinum in mushrooms packaged 
under reduced oxygen conditions is well-known (Ref. 222). Mushrooms 
grow close to the ground, which is a source of C. botulinum spores. 
Mushrooms remain metabolically active after harvest, which may quickly 
reduce the amount of oxygen, particularly when mushrooms are packaged 
under conditions that limit the transfer of oxygen across the layer of 
packaging (Ref. 223). In such reduced oxygen or anoxic conditions, C. 
botulinum spores can germinate resulting in the formation of botulinum 
toxin, which can occur before any overt signs of mushroom spoilage 
(Ref. 222). Modified or reduced-oxygen packaging of other produce may 
present a similar risk for botulinum toxin formation (Ref. 224). 
Perforated packaging film allows free air access to mushrooms and is 
recommended as a means to reduce the potential for toxin formation in 
mushrooms (Ref. 225). Other means of preventing toxin formation in 
modified or reduced oxygen packaging may include use of time-
temperature integrators on individual packages of produce to signal 
when a cumulative time-temperature combination has been reached that 
presents a risk for C. botulinum toxin formation or use of 
antimicrobial compounds (Ref. 224). We request comment on the need for 
this proposed provision and on the types or conditions of modified or 
reduced oxygen packaging methods that may or may not increase the risk 
of formation of botulinum toxin.
    Proposed Sec.  112.116 would establish measures that you must take 
when using food-packing (including food packaging) material. 
Specifically, proposed Sec.  112.116(a) would require that food-packing 
material must be adequate for its intended use. For example, food-
packing material that would be adequate for its intended use include 
plastic bins for holding fresh-picked fruit, wax-impregnated corrugated 
cardboard for broccoli to be hydrocooled or top-iced after packing, 
plastic clamshells used for packaging strawberries for retail sale, and 
single-use cardboard containers for packing tomatoes. Wooden bins or 
boxes, and canvas bags that may be used during harvest also would need 
to meet this requirement, and could be used if they are adequately 
clean and sanitary for their intended use. To implement this provision, 
you would have to use food-packing materials that are: (1) Cleanable or 
designed for single use and (2) unlikely to support growth or transfer 
of bacteria. In addition, proposed Sec.  112.116(b) would require that 
if you reuse food-packing material, you take measures to ensure that 
food-contact surfaces are clean, such as by cleaning and sanitizing, 
when necessary, food-packing containers or using a clean liner. 
Evidence from scientific literature indicates that the number of 
microorganisms detected on the surface of fruits is directly correlated 
to the amount of contact time between the fruit commodity and its 
packing material (Ref. 226. Ref. 227). Although some food-packing 
material is sufficiently sturdy to be used multiple times, it may serve 
as a source of contamination in the absence of regular cleaning and 
sanitizing between each such use. Further, certain food-packing 
material may have a serviceable shelf life beyond which it may not 
possible to effectively clean and sanitize the material. It is 
reasonably likely that such packing material, if it continues to be 
used, may serve as harborage sites for pathogens, if they become 
established on its surface.

L. Subpart L--Standards Directed to Equipment, Tools, Buildings, and 
Sanitation

    Proposed subpart L establishes science-based minimum standards that 
are reasonably necessary to prevent

[[Page 3590]]

equipment, tools, buildings, and inadequate sanitation from introducing 
known or reasonably foreseeable hazards into or onto covered produce or 
food-contact surfaces, and to provide reasonable assurances that the 
covered produce is not adulterated under section 402 of the FD&C Act.
    A few comments recommended that equipment used to hold or convey 
water should be inspected to ensure that it is clean.
    We agree that equipment used to hold or convey water should be 
maintained in a manner necessary to protect against contamination. In 
112.42 (b), we would require that you must adequately maintain all 
agricultural water sources that are under your control (such as wells) 
by regularly inspecting each source and keeping the source free of 
debris, trash, domesticated animals, and other possible sources of 
contamination of covered produce to the extent practicable and 
appropriate under the circumstances. In 112.42 (c), we would require 
that you must adequately maintain all agricultural water distribution 
systems as necessary and appropriate to prevent the water distribution 
system from being a source of contamination to covered produce, food-
contact surfaces, areas used for a covered activity, or water sources, 
including by regularly inspecting and adequately storing all equipment 
used in the system.
1. Comments Relevant to Proposed Provisions
    We received some comments in response to the 2010 FR notice that 
expressed that the use of animals on a farm or their presence near 
farming operations should not be prohibited.
    We address issues related to animals in and around farming 
operations in subpart I (see section V.I. of this document) of this 
rule. However, in this subpart, we address the presence of animals in 
fully-enclosed buildings. Specifically, proposed Sec.  112.127 would 
require that you take reasonable precautions to prevent domesticated 
animals, including guard and guide dogs, in and around a fully-enclosed 
building from contaminating covered produce, food-contact surfaces, and 
food packing materials with known or reasonably foreseeable hazards.
2. Proposed Requirements
a. Equipment, Tools, and Buildings That Are Subject to the Requirements 
of This Subpart
    Any equipment and tools used during covered activities that are 
intended to, or likely to, contact covered produce would be subject to 
proposed subpart L. In addition, instruments or controls used to 
measure, regulate, or record conditions to control or prevent the 
growth of undesirable microorganisms or other contamination would be 
subject to proposed subpart L. In proposed Sec.  112.121, we provide 
examples of such equipment and tools, i.e., knives, implements, 
mechanical harvesters, waxing machinery, cooling equipment (including 
hydrocoolers), grading belts, sizing equipment, palletizing equipment, 
and equipment used to store or convey harvested covered produce (such 
as containers, bins, food-packing material, dump tanks, flumes, and 
vehicles or other equipment used for transport).
    Proposed Sec.  112.122 would identify the types of buildings that 
are subject to the requirements of proposed subpart L. Such buildings 
would include any fully- or partially-enclosed buildings used for 
covered activities, including minimal structures that have a roof but 
do not have any walls (proposed Sec.  112.122(a)). Fully-enclosed 
buildings are typically used to grow covered produce such as sprouts 
and mushrooms and may be used to grow a variety of covered produce 
indoors to create or extend the growing season in a particular 
geographic area. Partially-enclosed buildings can be used to grow 
covered produce such as tomatoes, and are often used to pack covered 
produce. Buildings that are subject to the requirements of the rule 
would also include storage sheds, buildings, or other structures used 
to store food-contact surfaces (such as harvest containers and food-
packing materials) (proposed Sec.  112.122(b)). We are proposing this 
requirement because contaminated food-contact surfaces can contaminate 
covered produce (Ref. 182) (Ref. 228) and, thus, present a potential 
hazard.
b. General Requirements Applicable to Equipment and Tools
    As proposed, Sec.  112.123 establishes general requirements 
applicable to equipment and tools subject to subpart L. Proposed Sec.  
112.123(a) would require you to use equipment and tools that are of 
adequate design, construction, and workmanship to enable them to be 
adequately cleaned and properly maintained. For example, some lettuce 
coring knives currently used in the industry are designed in a way that 
gives them the propensity to transfer microbial contaminants from soil 
to the lettuce (Ref. 229). Using a tool that is designed to minimize 
the potential for pathogen transfer from soil to the produce and/or 
that allows for mechanical polishing to facilitate cleaning and 
sanitizing the tool would enhance food safety (Ref. 230).
    Proposed Sec.  112.123(b)(1) would establish that equipment and 
tools you use must be installed and maintained in a manner that 
facilitates cleaning of the equipment and of all adjacent spaces. For 
example, equipment that is permanently installed in an on-farm packing 
operation would need to be installed in such a manner that both 
maintenance and cleaning crews are able to easily access any food 
contact surfaces, protective covering or barriers, and any movable 
parts or other potential sources of contamination. A conveyor belt 
system that is part of a grading line would be considered properly 
installed if there is easy access to the belt (a food-contact surface) 
for cleaning. The proposed provisions in Sec.  112.123(b)(1) are 
consistent with the requirements in current Sec.  110.40(a) and Sec.  
111.27(a).
    Proposed Sec.  112.123(b)(2) would establish that equipment and 
tools you use must be stored and maintained to protect covered produce 
from being contaminated with known or reasonably foreseeable hazards 
and to prevent the equipment and tools from attracting or harboring 
pests. As discussed in the QAR, if farm equipment or tools are stored 
outside or in a partially-enclosed building, they may attract or harbor 
pests, which can carry human pathogens (Ref. 231). Appropriate 
practices for storing and maintaining equipment and tools can reduce 
the potential for these problems. For example, you would comply with 
this provision by storing equipment and tools indoors when practical, 
and when not practical, minimizing surrounding debris and checking 
periodically for pests.
    Proposed Sec.  112.123(c) would establish that seams on food-
contact surfaces of equipment and tools that you use must be either 
smoothly bonded, or maintained to minimize accumulation of dirt, filth, 
food particles, and organic material and thus minimize the opportunity 
for harborage or growth of microorganisms. This provision is consistent 
with current Sec.  110.40(a) and (b) and Sec.  111.27(a).
    Proposed Sec.  112.123(d)(1) would require you to inspect, 
maintain, and clean and sanitize (when necessary and appropriate) all 
food-contact surfaces of equipment and tools used in covered activities 
as frequently as reasonably necessary to protect against contamination 
of covered produce. This provision is intended to prevent transfer of 
contaminants on food-contact surfaces of equipment or tools (e.g., 
harvest knives, grading belts, or harvest

[[Page 3591]]

bins) to covered produce. As discussed in the QAR, for example, it has 
been documented that E. coli O157:H7 can be transferred to Iceberg 
lettuce from contaminated coring devices used in a simulated field 
coring (Ref. 229). Even food contact surfaces made of stainless steel 
can transfer pathogens to covered produce, if not properly cleaned and 
sanitized. For example, transfer of pathogens from stainless steel 
tools to lettuce has been demonstrated to occur to various extents, 
depending on the amount of water on the leaf surface (Ref. 232).
    Proposed Sec.  112.123(d)(2) would require you to maintain and 
clean all non-food-contact surfaces of equipment and tools subject to 
subpart L used in covered activities during harvesting, packing, and 
holding as frequently as reasonably necessary to protect against 
contamination of covered produce. The potential for an equipment or 
tool to come into contact with covered produce varies with the type and 
intended use of the equipment or tool. Non-food-contact surfaces of 
tools and equipment used in contact with covered produce can be sources 
of contamination. Therefore, it is important to maintain such surfaces 
of covered equipment and tools in a clean and sanitary condition. 
However, such surfaces may not require cleaning as frequently as those 
that come into direct contact with produce, and may not require 
sanitizing. An example of such a surface is the handle of a tool used 
when working directly with covered produce, although depending on the 
use, such equipment or tool may be or consist of a food-contact 
surface. For example, a truck used to harvest produce may not need to 
be thoroughly cleaned or sanitized; however, the flatbed of the same 
truck if used to haul un-packed/loose produce would be considered a 
food-contact surface.
    Proposed Sec.  112.123(e) would establish that, if you use 
equipment such as pallets, forklifts, tractors, and vehicles such that 
they are intended to, or likely to, contact covered produce, you do so 
in a manner that minimizes the potential for contamination of covered 
produce or food-contact surfaces with known or reasonably foreseeable 
hazards. For example, you may consider the appropriate route for any 
equipment to move in, through, and out of production fields, and when 
there may be a need to visually inspect and clean such equipment to 
prevent contamination or cross-contamination of covered produce. The 
potential for transfer of contaminants from tractors to covered 
produce, for example, if the tractors drive through or otherwise come 
in contact with manure is also highlighted in our GAPs Guide (Ref. 10). 
We seek comment on the appropriateness of the proposed cleaning 
provisions related to equipment and tools.
c. General Requirements Applicable to Instruments and Controls
    Proposed Sec.  112.124 would establish that instruments or controls 
you use to measure, regulate, or record temperatures, hydrogen-ion 
concentration (pH), sanitizer efficacy or other conditions, in order to 
control or prevent the growth of pathogens or other contamination, must 
be: (a) Accurate and precise as necessary and appropriate in keeping 
with their purpose; (b) adequately maintained; and (c) adequate in 
number for their designated uses. Proposed Sec.  112.124 is consistent 
with current Sec.  111.27(a)(6), and similar to requirements in current 
Sec.  110.40(f). Accuracy addresses whether the recorded measurements 
are equal to the true value of that which is being measured, while 
precision addresses whether individual measurements are close to each 
other when made under the same conditions. Both accuracy and precision 
are necessary to ensure the validity and reliability of measurements. 
The appropriate degree of accuracy and precision, however, would need 
to be determined based on the nature of the instrument and its specific 
use for the covered activity. Instruments must also be adequately 
maintained to ensure that they are functioning properly for their 
intended use. For example, an in-line water oxidation-reduction 
potential meter that is used to determine the approximate sanitizer 
concentration in a water flume system must be appropriately maintained 
to ensure that there is no debris build-up that would interfere with 
its proper operation. In addition, you must have an adequate number of 
instruments as needed for the designated use. For example, if you are 
composting a small pile of manure and monitoring the temperature, one 
thermometer may be sufficient. However, if you are composting large 
windrows in excess of several hundred yards in length, and using an 
automated system to monitor the internal temperature of the pile, you 
would need multiple thermocouples placed throughout the pile to get a 
good reading of the overall temperature.
d. Transport of Covered Produce
    Proposed Sec.  112.125 would establish that equipment subject to 
subpart L that you use to transport covered produce during covered 
activities must be: (a) Adequately clean before use in transporting 
covered produce; and (b) adequate for use in transporting covered 
produce. Transport equipment that is intended to, or likely to, contact 
covered produce that is not clean, or that is not adequate for the 
covered produce it is being used to transport, can be a source of 
cross-contamination of covered produce. Equipment used to transport 
covered produce would not be adequately clean if, for example, there is 
dirt, filth, organic material, particles of food, remains of previous 
shipping loads, or any other extraneous materials or contaminants on 
surfaces that are likely to come into contact with the produce. 
Equipment used to transport covered produce would not be adequate if, 
for example, the same equipment is used to haul live animals or garbage 
that is not completely contained, and the equipment is either not 
designed in a manner that allows cleaning and sanitizing or it is not 
cleaned or sanitized, before it is used to transport covered produce. 
Proposed Sec.  112.125 is consistent with recommendations in FDA's GAPs 
Guide (Ref. 10), the AFDO Model Code (Ref. 20), commodity-specific 
guidances (Ref. 85. Ref. 94. Ref. 27), and international guidelines 
(Ref. 96. Ref. 96).
e. Design and Construction Requirements Applicable to Buildings
    Proposed Sec.  112.126 would establish requirements applicable to 
the design and construction of buildings. As proposed, Sec.  112.126(a) 
requires that your buildings must be suitable in size, construction, 
and design to facilitate maintenance and sanitary operations for 
covered activities to reduce the potential for contamination of covered 
produce or food-contact surfaces with known or foreseeable hazards. For 
buildings to be suitable in size, it should have enough room for 
covered activities to be conducted without cross-contact between 
covered produce or food-contact surfaces and building materials, non-
food-contact surfaces, or clothing. Proposed Sec.  112.126(a)(1) would 
establish requirements that your building provide sufficient space for 
placement of equipment and storage of materials. This is necessary for 
the maintenance of sanitary operations and the conduct of covered 
activities. The proposed provisions in Sec.  112.126(a)(1) are 
consistent with requirements in current Sec.  110.20(b)(1) and Sec.  
111.20. Proposed Sec.  112.126(a)(2) would establish requirements that 
your buildings must permit proper precautions to be taken to reduce the 
potential for contamination of covered produce, food contact surfaces, 
or packing material with known or reasonably foreseeable hazards. The

[[Page 3592]]

potential for contamination must be reduced by effective design, 
including the separation of operations in which contamination is likely 
to occur, by one or more of the following means: Location, time, 
partition, enclosed systems, or other effective means. This provision 
provides flexibility in the precautions you take for your buildings and 
proposes separation of operations, such as by having sufficient space 
so that incompatible operations can be kept at a reasonable distance 
from each other, for example, so that spray coming off equipment being 
washed does not contact covered produce being packed. The proposed 
provisions in Sec.  112.126(a) are similar to requirements in current 
Sec.  110.20(b)(2) and Sec.  111.20.
    Proposed Sec.  112.126(a)(3) would require buildings to be 
constructed in a manner such that floors, walls, ceilings, fixtures, 
ducts, and pipes can be adequately cleaned and kept in good repair, and 
that drip or condensate does not contaminate covered produce, food-
contact surfaces, or packing materials. Buildings where covered 
activities occur must be suitably constructed to allow adequate 
cleaning and sanitizing in order to minimize the presence or 
persistence of hazards and the potential for damage or contamination of 
covered produce. Buildings should be kept in good repair so as to 
prevent drip or condensate from pipes or ceilings to drop onto covered 
produce or food-contact surfaces, and holes in walls of enclosed 
buildings from permitting pests access to covered produce or areas of 
covered activities. The proposed provisions in Sec.  112.126(a)(3) are 
consistent with requirements in current Sec.  110.20(b)(4) and Sec.  
111.20.
    Finally, proposed Sec.  112.126(b) would establish requirements 
that you provide adequate drainage in all areas where normal operations 
release or discharge water or other liquid waste on the ground or floor 
of the building. Standing water can attract pests and support the 
growth of pathogens, such as L. monocytogenes, presenting potential for 
contamination of covered produce. The proposed provision in Sec.  
112.126(b) is similar to requirements in current Sec.  110.37(b)(4) and 
Sec.  111.15(f)(4).
f. Domesticated Animals in and Around Fully-Enclosed Buildings
    Proposed Sec.  112.127(a) would require you to take reasonable 
precautions to prevent contamination of covered produce, food-contact 
surfaces, and food-packing materials in fully-enclosed buildings with 
known or reasonably foreseeable hazards from domesticated animals by: 
(1) Excluding domesticated animals from fully-enclosed buildings where 
covered produce, food-contact surfaces, or food-packing material is 
exposed; or (2) separating domesticated animals in a fully-enclosed 
building from an area where a covered activity is conducted on covered 
produce by location, time, or partition. As discussed in the QAR, 
domesticated animals can carry pathogens, potentially resulting in 
contamination of covered produce or food contact surfaces. However, 
consistent with current Sec.  110.35(c), we propose to permit guard or 
guide dogs in some areas of a fully-enclosed building if the presence 
of the dogs is unlikely to result in contamination of produce, food-
contact surfaces, or food-packing materials (proposed Sec.  
112.127(b)). You would need to take reasonable precautions to prevent 
contamination of covered produce, food-contact surfaces, and food-
packing material with hazards from such dogs. We believe that animals 
such as guard or guide dogs, when kept under control and where the 
activities of the animal can be contained, are unlikely to result in 
contamination of produce, food-contact surfaces, or food-packing 
materials. We seek comment on the appropriateness of this provision and 
whether proposed provision Sec.  112.127(b) should be extended to all 
working animals.
g. Pest Control
    As discussed in the QAR, pests such as rodents, snakes, lizards, 
turtles, iguanas, and birds are known to carry human pathogens, such as 
Salmonella spp. and, if not controlled, can cause the contamination of 
covered produce, food contact surfaces or food-packing materials. 
Therefore, in proposed Sec.  112.128(a), we propose to require you to 
take measures reasonably necessary to protect covered produce, food-
contact surfaces, and food-packing materials from contamination by 
pests in buildings, including routine monitoring for pests as necessary 
and appropriate. Furthermore, we propose to require you to take 
measures to exclude pests from fully-enclosed buildings (proposed Sec.  
112.128(b)) and to prevent pests from becoming established in 
partially-enclosed buildings (such as by use of screens or by 
monitoring for the presence of pests and removing them, when present) 
(proposed Sec.  112.128(c)). We recognize that it might be impossible 
to exclude pests, such as birds, from entering buildings that are not 
fully-enclosed. To comply with proposed Sec.  112.128(c), you would 
need to take those steps reasonably necessary to prevent birds or other 
animals from building nests in partially-enclosed buildings and, if 
possible, to find and remove any nests that become established. Any 
measures or steps taken under these provisions would need to comply 
with applicable wildlife conservation regulations.
h. Toilet and Hand-Washing Facilities
    Human feces may contain pathogens in relatively high concentrations 
(Ref. 233). The most basic measure to prevent the potential transfer of 
pathogens from human feces into or onto covered produce and food-
contact surfaces is to provide toilet facilities that collect and 
contain human feces. Proposed Sec.  112.129 would establish 
requirements related to toilet facilities, including that you must 
provide personnel with adequate, readily accessible toilet facilities, 
including facilities readily accessible to growing areas during 
harvesting activities (proposed Sec.  112.129(a)). In proposed Sec.  
112.129(b), we propose to establish that toilet facilities must be 
designed, located, and maintained to: (1) Prevent contamination of 
covered produce, food-contact surfaces, areas used for a covered 
activity, water sources, and water distribution systems with human 
waste (proposed Sec.  112.129(b)(1)); (2) be directly accessible for 
servicing, be serviced and kept clean on a schedule sufficient to 
ensure suitability of use, and be kept supplied with toilet paper 
(proposed Sec.  112.129(b)(2)); and (3) provide for the sanitary 
disposal of waste and toilet paper (proposed Sec.  112.129(b)(3)). 
These provisions are intended to contribute to an overall sanitary 
measure to help protect covered produce and areas where covered 
activities are conducted from contamination with pathogens. A portable 
toilet facility that leaks or a fixed toilet facility that lacks proper 
drainage or backflow devices would not be considered properly designed 
or maintained. As discussed in the QAR, runoff from such a toilet 
facility has the potential to directly contaminate covered produce, 
while contamination of soil and irrigation water from such runoff can 
have longer-lasting impact. To minimize the potential for contamination 
during events such as flooding or high winds, toilet facilities should 
be located away from water sources and water distribution systems, and 
at a reasonable distance from growing and packing areas. Sewage 
transport or other servicing trucks should have clear access to toilet 
facilities to ensure proper collection and disposal of wastes. In 
addition, workers are more likely to use toilet facilities that are 
clean, well-stocked, and in good condition (Ref. 234). We recognize 
that the growing area of a farm may spread

[[Page 3593]]

across several acres of land, and workers or visitors may be in growing 
areas for an extended period of time primarily during harvest 
activities. At times other than during harvest, we would consider 
toilet facilities to be readily accessible if, for example, the 
facility is available to workers at a farm building before and after 
they work in a growing area, or at a nearby public facility that is 
readily accessible to your workers. However, during harvest activities 
we consider it likely that workers and visitors will spend a 
significant amount of time in growing areas. We point out that the 
field sanitation requirements prescribed by the Occupational Safety and 
Health Administration (OSHA) under the Occupational Safety and Health 
Act, specifically 29 CFR 1928.110, describes the appropriate number of 
toilets to the number of workers, proper handwashing facilities, 
maximum worker-to-restroom distance, and frequency of cleaning 
facilities. Agricultural establishments subject to the requirements of 
29 CFR 1928.110(c)(2), must provide one toilet facility for each 20 
employees or fraction thereof (except that toilet facilities are not 
required for employees who perform field work for a period of three 
hours or less (including transportation time to and from the field) 
during the day).
    As discussed in the QAR, the fecal-oral route for contamination of 
food with pathogens is well-established and proper washing and drying 
of hands are fundamental practices demonstrated to be effective in 
breaking the fecal-oral route of contamination. Therefore, in proposed 
112.129(c), we would establish requirements that you provide a hand-
washing station during growing activities that take place in a fully-
enclosed building, and during covered harvesting, packing, or holding 
activities, that is in sufficiently close proximity to toilet 
facilities to make it practical for persons who use the toilet facility 
to wash their hands. We discuss the importance of hand-washing in 
presenting the proposed requirements for hygienic practices in section 
V.D. of this document.
    The provisions in proposed Sec.  112.129 are consistent with 
recommendations in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 
20), commodity-specific guidances (Ref. 85. Ref. 94. Ref. 194), and 
international guidelines (Ref. 96. Ref. 96). These provisions are also 
similar to requirements in current Sec.  110.37(d) and Sec.  111.15.
    With respect to hand-washing facilities, we propose to require you 
to provide personnel with adequate, readily accessible hand-washing 
facilities during growing activities that take place in a fully-
enclosed building, and during covered harvest, packing, or holding 
activities (proposed Sec.  112.130(a)). In addition, in proposed Sec.  
112.130(b), we would establish requirements that your hand-washing 
facilities must be furnished with: Soap (or other effective surfactant) 
(proposed Sec.  112.130(b)(1)); running water that satisfies the 
requirements of Sec.  112.44(a) for water used to wash hands (proposed 
Sec.  112.130(b)(2)); and adequate drying devices (such as single 
service towels, clean cloth towels or sanitary towel service) (proposed 
Sec.  112.130(b)(3)). As discussed in the QAR, hand-washing is a key 
control measure in preventing the spread of pathogens from ill or 
infected workers to covered produce and food-contact surfaces. Workers 
often touch produce with their bare hands. Hand-washing, when done 
effectively, can significantly reduce the number of resident bacteria 
on the hands of a worker who may not be aware of being ill or infected, 
as well as transient microbial pathogens that get onto hands through 
contact with the environment or other ill workers. The effectiveness of 
hand-washing is determined by multiple factors, including whether or 
not soap is used, the quality of water used, the duration of scrubbing 
and rinsing, and whether and how hands are dried. The frequency of 
hand-washing, as well as the efficacy of a single hand-washing event, 
may also be important factors in the spread of microbial pathogens by 
ill or contaminated workers (Ref. 107).
    Proposed subpart 112.130(c) would establish requirements that you 
provide for appropriate disposal of waste (for example, waste water and 
used single-service towels) associated with a hand-washing facility and 
take appropriate measures to prevent waste water from a hand-washing 
facility from contaminating covered produce, food-contact surfaces, 
areas used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonably 
foreseeable hazards. A hand-washing facility produces waste that can 
lead to contamination, and such waste needs to be controlled. For 
example, if the sink of a portable hand-washing station in field 
actively being harvested does not have a catch-basin or tank, but 
instead is open the ground, the waste-water from the sink can 
contaminate the soil. Finally, in proposed Sec.  112.130(d), we would 
establish that you may not use hand antiseptic/sanitizer as a 
substitute for soap and water. As discussed in the QAR, hand sanitizers 
have not been found to be effective substitutes for washing hands with 
soap and water, because the presence of dirt, grease, or soil reduces 
their effectiveness in eliminating bacteria. However, we are not 
proposing to prohibit the use of sanitizers as they may be effective as 
an additional measure in reducing the number of bacteria on hands after 
proper washing with soap and water followed by drying
    The hand-washing provisions in proposed Sec.  112.130 are 
consistent with recommendations in our GAPs Guide (Ref. 10), the AFDO 
Model Code (Ref. 20), commodity-specific guidances (Ref. 85. Ref. 94. 
Ref. 194), and international guidelines (Ref. 96). They are also 
similar to the requirements in current Sec.  110.37(e) and Sec.  
111.15(i).
i. Disposal of Sewage, Trash, Litter, and Other Waste
    As discussed in the QAR, human feces may contain pathogens in 
relatively high concentrations and, therefore, sewage must be properly 
disposed and sewage and septic systems must be maintained to minimize 
the potential for failure, leakage, or spills (and any leakage or spill 
appropriately managed) to prevent contamination of covered produce. 
Events such as flooding or earthquakes also have the potential to 
damage sewage and septic systems and impair their function and, 
therefore, it would be appropriate to assess your sewage systems for 
damage or other failures, following such events. Proposed Sec.  112.131 
would establish requirements that apply to the control and disposal of 
sewage, including that you must dispose of sewage into an adequate 
sewage or septic system or through other adequate means (proposed Sec.  
112.131(a)), which is consistent with current Sec.  110.37(c) and Sec.  
111.15(g); you must maintain sewage and septic systems in a manner that 
prevents contamination of covered produce, food-contact surfaces, areas 
used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonably 
foreseeable hazards (proposed Sec.  112.131(b)); you must manage and 
dispose of leakages or spills of human waste in a manner that prevents 
contamination of covered produce, and prevents or minimizes 
contamination of food-contact surfaces, areas used for a covered 
activity, agricultural water sources, or agricultural water 
distribution systems (proposed Sec.  112.131(c)); and that after a 
significant event (such as flooding or an earthquake) that could 
negatively impact a sewage or septic system, you must take appropriate 
steps to ensure

[[Page 3594]]

that sewage and septic systems continue to operate in a manner that 
does not contaminate covered produce, food-contact surfaces, areas used 
for a covered activity, agricultural water sources, or agricultural 
water distribution systems (proposed Sec.  112.131(d)). These 
provisions are consistent with recommendations in our GAPs Guide (Ref. 
10), commodity-specific guidances (Ref. 44. Ref. 46), and the AFDO 
Model Code (Ref. 20).
    Proposed subpart 112.132 would establish requirements that apply to 
the control and disposal of trash, litter, and other waste in areas 
used for covered activities. Proposed Sec.  112.132(a) would establish 
requirements that you convey, store, and dispose of trash, litter and 
waste to: (1) Minimize the potential for trash, litter, or waste to 
attract or harbor pests (proposed Sec.  112.132(a)(1)); and (2) Protect 
against contamination of covered produce, food-contact surfaces, areas 
used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonably 
foreseeable hazards (proposed Sec.  112.132(a)(2)). In addition, we 
propose to require that you adequately operate systems for waste 
treatment and disposal so that they do not constitute a potential 
source of contamination in areas used for a covered activity (proposed 
Sec.  112.132(b)). The provisions proposed in Sec.  112.132 are 
consistent with requirements in current Sec. Sec.  111.15(a) and (g) 
and similar to requirements in current Sec.  110.37(f). These 
provisions are also consistent with recommendations for packing areas 
in our GAPs Guide (Ref. 10), and commodity-specific guidance (Ref. 46).
j. Plumbing
    Proposed Sec.  112.133 would establish that plumbing must be of an 
adequate size and design and be adequately installed and maintained to 
(1) distribute water under pressure as needed, in sufficient 
quantities, in all areas where used for covered activities, for 
sanitary operations, or for hand-washing and toilet facilities 
(proposed Sec.  112.133(a)); (2) properly convey sewage and liquid 
disposable waste (proposed Sec.  112.133(b)); (3) avoid being a source 
of contamination to covered produce, food-contact surfaces, areas used 
for a covered activity, or agricultural water sources (proposed Sec.  
112.133(c)); and (4) not allow backflow from, or cross connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water used for a covered activity, for sanitary 
operations, or for use in hand-washing facilities (proposed Sec.  
112.133(d)). An example of a problem that may result from inadequate 
plumbing is improper drainage of refrigeration drip pans. If drip pans 
do not drain properly, they may drip onto covered produce or allow 
moisture to accumulate providing an environment that can support the 
establishment of and growth of L. monocytogenes. Proposed Sec.  112.133 
is intended to ensure that your plumbing and water distribution systems 
do not adversely affect the water you use in covered activities on 
covered produce. If the plumbing and water distribution systems are not 
adequately installed and maintained, they may contaminate your water 
supply and, in turn, contaminate your covered produce through direct 
contact (such as when you use water in irrigation or harvest 
activities), or through indirect contact (such as when the contaminated 
water is used to wash a food-contact surface). Such cross-contamination 
of clean water and waste water has been implicated in outbreak 
investigations (Ref. 235). It would also be important to prevent 
contamination of water that must meet the requirements under subpart E 
by water that does not meet the relevant requirements. For example, 
water used for irrigation of covered produce other than sprouts using a 
direct water application method would need to meet the requirements of 
Sec. Sec.  112.41 and 112.44(c) or (d), but would not necessarily meet 
the requirements of Sec.  112.44(a) (see section V.E. of this 
document). These provisions are consistent with the requirements in 
current Sec. Sec.  110.37(b) and 111.15(f), and with the 
recommendations in our GAPs Guide (Ref. 10), the AFDO Model Code (Ref. 
20), and commodity-specific guidances (Ref. 46. Ref. 44).
k. Control of Animal Excreta and Litter From Domesticated Animals
    In proposed Sec.  112.134(a), we would require that, if you have 
domesticated animals, to prevent contamination of covered produce, 
food-contact surfaces, areas used for a covered activity, agricultural 
water sources, or agricultural water distribution systems with animal 
waste, you must: (1) Adequately control their excreta and litter, and 
(2) maintain a system for control of animal excreta and litter. For 
example, you would comply with this provision by not locating manure 
piles adjacent to packing sheds in which covered produce is exposed. As 
discussed in the QAR, pathogens inhabit the gut of a variety of warm-
blooded animal species and are often shed in feces in high numbers. If 
not effectively controlled, such pathogens may persist in the 
environment for long periods of time (see the QAR) and may pose a 
threat to water quality from runoff and leaching (Ref. 236. Ref. 169), 
creating multiple opportunities for these pathogens to contaminate 
produce or food contact surfaces.
l. Record Keeping
    Proposed Sec.  112.140(a) would make clear that records required 
under this subpart L must be established and kept in accordance with 
the requirements of subpart O of this part. Records required to be 
established and kept under this subpart L include documentation of the 
date and method of cleaning and sanitizing of the equipment you use in 
growing operations for sprouts (proposed Sec.  112.140(b)(1)) and in 
covered harvesting, packing, or holding activities (proposed Sec.  
112.140(b)(2)). These documentation requirements are intended to enable 
us to verify and you to ensure that requirements of this subpart are 
met.

M. Subpart M--Standards Directed to Sprouts

    Proposed subpart M would establish science-based minimal standards 
for the growing, harvesting, packing and holding of sprouts that are 
reasonably necessary to minimize the risk of known or reasonably 
foreseeable hazards that are associated with serious adverse health 
consequences or death. As noted in section I of this document, sprouts 
have been frequently associated with foodborne illness outbreaks (Ref. 
3). As a result, we issued our first commodity-specific guidance for 
sprouts. Likewise, the Codex Alimentarius Commission supplemented its 
Codex Fresh Fruits and Vegetables Code with a Sprout Annex (Ref. 50).
    Sprouts present a special concern with respect to human pathogens 
than other covered produce because of the warm, moist, and nutrient-
rich conditions required to produce sprouts, the same conditions that 
are also ideal for the proliferation of pathogens if present (Ref. 208. 
Ref. 16). Therefore, we believe it is necessary to incorporate this 
additional subpart establishing standards specific to sprouts. The 
provisions of proposed subpart M are consistent with recommendations in 
FDA's Sprout Guides (Ref. 14. Ref. 15), industry guidance (Ref. 237), 
and international regulations and guidelines (Ref. 38. Ref. 191. Ref. 
192. Ref. 193).
    We are also seeking comment on whether, or to what extent, the 
measures in this subpart should be applied to soil-grown sprouts. The 
NACMCF Sprout White paper and our Sprout Guides do not distinguish 
soil-grown sprouts and hydroponic sprouts (Ref. 14. Ref. 15.

[[Page 3595]]

Ref. 16). However, we are not aware of any outbreaks associated with 
sprouts grown in soil or media, which could be because of the lower 
percentage of sprouts grown in that manner, the nature of the species 
of sprouts grown in that manner, or a difference in likelihood of 
contamination posed by that method and hydroponics. This could be the 
case because of the relative ease of transfer of pathogens between 
sprouts in a water environment and, possibly, a greater amplification 
of pathogens during hydroponic sprout production compared to the more 
stressful environment for pathogen growth posed by exposure to air and 
sunlight when seeds are grown under conditions more typical of a 
natural setting (soil and media methods). On the other hand, we expect 
that seeds or beans would be a potential vehicle of contamination, 
regardless of sprouting method employed. Seeds or beans (in the form of 
seed leaves or cotyledons) could be part of the food consumed, 
regardless of the method used for sprouting. In addition, flats of soil 
or media grown sprouts may be placed on a growing rack, similar to 
hydroponic sprouts grown in clamshells (as opposed to large bins for 
bean sprouts or rotating drums used to start green sprouts), with 
overhead sprout irrigation water, providing an opportunity for 
pathogens, if present, to be spread within a flat of sprouts and to 
other flats on racks below. Alternatively, flats may be placed side-by-
side in a growing area such as a greenhouse, where the likelihood of 
pathogen spread would presumably be lower than when a growing rack is 
used.
    Finally, as discussed in section IV of this document, while we 
recommend that farms conduct an operational assessment and develop a 
food safety plan, at this time, we are not proposing to require them to 
do so. We request comment on whether, in a final rule, a food safety 
plan and/or an operational assessment should be required for farms 
conducting covered activities related to sprouts, either in addition to 
or in place of the standards proposed in this subpart. We also request 
comment on whether a written plan similar to the type required under 
section 418 of the FD&C Act would be more appropriate for farms 
conducting covered activities related to sprouts.
1. Comments Relevant to the Proposed Provisions
    We received very few comments related specifically to sprouts. 
Those that were submitted were generally supportive of our efforts to 
create policies to prevent illness and produce safer sprouts, citing 
the need for addressing residual agricultural chemicals and microbial 
contamination of seed, seed disinfection treatments, worker health and 
hygiene, and sanitation. One comment hoped that we understood the 
realities currently facing the sprout industry worldwide, and would 
take actions to ensure truly practical measures that would be accepted 
by the sprout industry, questioning, for example, the need for 
extensive record keeping or monitoring sprout facilities for Listeria. 
This comment maintained that we should consider current production 
methods and consumption practices in establishing standards for 
sprouts.
    As discussed further in section V.M.3. of this document, our 
proposed rule carefully considers the various conditions under which 
sprouts are grown and consumed. The proposal provides flexibility to 
achieve the goal of minimizing the risk of known or reasonably 
foreseeable hazards that are associated with serious adverse health 
consequences or death. We consider that the proposed requirements for 
the growing, harvesting, packing and holding of sprouts, as well as for 
record keeping, are all practical and necessary to protect public 
health. With respect to consideration of the method of growth, as 
discussed above, we are seeking comment on whether soil-grown sprouts 
are subject to the same risk factors as hydroponic sprouts and to 
whether, or to what extent, the measures in this subpart should be 
applied to them.
    One comment recommended that bean sprouts be subjected to less 
stringent requirements compared to others, e.g., green sprouts, because 
bean sprouts are rarely consumed raw (less than 1% according to their 
estimates). This comment suggested that seed disinfection treatments 
might not be necessary (or argued for more disinfection method choices) 
for bean sprouts. Our 1999 Sprout Guides apply to all sprouted seeds 
and beans (Ref. 14. Ref. 15) and we are proposing in subpart M to cover 
all sprouts, including bean sprouts. Our earliest efforts to promote 
sprout safety, including consumer advisories, focused primarily on 
green sprouts, such as alfalfa and clover sprouts, where we were seeing 
sprout outbreaks and because we assumed bean sprouts were most often 
cooked before consumption (Ref. 238). However, in 2002, we updated our 
consumer advisories to include advice on the risks associated with 
eating all types of sprouts, including raw and lightly cooked bean 
sprouts based on four foodborne illness outbreaks associated with mung 
bean sprouts between 2000 and 2002 (Ref. 239). As noted in section 
V.A.2.a. of this document, we analyzed consumption of selected produce 
commodities to determine those that are rarely consumed raw. We 
included sprouts (alfalfa and mung bean) in our analysis, and based on 
data available from the NHANES, alfalfa and mung bean sprouts do not 
meet our criteria for rarely consumed raw commodities (Ref. 79).
2. Proposed Requirements
    Proposed Sec.  112.141 would establish measures directed to seeds 
or beans used to grow sprouts. Seeds and beans used for sprouting are 
believed to be the vehicle for contamination in most E. coli O157:H7 
and Salmonella foodborne illness outbreaks associated with sprouts 
(Ref. 3. Ref. 16). Proposed Sec.  112.141 is consistent with our Sprout 
Guide and other public and private programs (Ref. 50. Ref. 240).
    Proposed Sec.  112.141(a) would require that, if you grow seeds or 
beans for use to grow sprouts, you must take measures reasonably 
necessary to prevent the introduction of known or reasonably 
foreseeable hazards into or onto seeds or beans that you will use for 
sprouting. These measures would need to be taken during growing, 
harvesting, packing, and holding of seeds and beans, which include such 
activities as cleaning, conditioning, and blending.
    Various crops may be grown to produce seeds and beans for sprouting 
with different production practices, growing seasons, conditions, and 
crop needs. Some of these plants set seeds or beans without 
intervention from growers, while others (such as alfalfa) may require 
steps, such as being cut-back, to encourage seed set. Harvesting, 
packing, and holding may also vary by seed type and by the conditions 
needed to maintain seed quality, such as germination. Because of the 
diversity of practices, processes, and procedures, the controls 
reasonably necessary to prevent the introduction of known or reasonably 
foreseeable hazards into or onto seeds or beans that you use for 
sprouting may vary. Therefore, we are not proposing to prescribe 
specific measures that are reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards into or onto 
seeds or beans. However, you may refer to our recommendations in 
relevant guidances (Ref. 14. Ref. 10).
    It is well-established that sprouts can become contaminated through 
the use of contaminated seeds for sprouting. Therefore, we considered 
proposing a supplier approval and verification program for seeds and 
beans received by sprouters for sprouting purposes. Such

[[Page 3596]]

a program would provide assurance that seeds or beans received from a 
third party for use to grow sprouts are grown, harvested, stored, and 
handled using measures reasonably necessary to prevent the introduction 
of known or reasonably foreseeable hazards into or onto seeds or beans 
used for sprouting.
    However, a supplier approval and verification program may not be 
practical or effective for seeds and beans received by sprouters for 
sprouting purposes. For example, for most crops, only a small 
percentage of the harvested seeds or beans goes to sprout production 
(Ref. 16. Ref. 241). Several distributors sell seeds and beans 
primarily for agricultural use with little or no sales for sprouting 
(Ref. 16). Seeds and beans have a relatively long shelf-life, sometimes 
being stored for a year or longer, and they often pass through a number 
of business entities before their final sale. Therefore, the ultimate 
end use of seeds and beans will likely not be known by many growers, 
handlers, or distributors (Ref. 16. Ref. 196. Ref. 192. Ref. 197). We 
are also not aware of any regulatory standards that include a supplier 
approval and verification program for seeds and beans received by 
sprouters for sprouting purposes. For example, Food Standards Australia 
New Zealand (FSANZ) considered but did not require such a program (Ref. 
242). We ask for comment on this approach and whether there are 
additional practical steps or practices that can be taken to ensure the 
safety of seeds and beans used for sprout production. Specifically, we 
request comments on whether a supplier approval and verification 
program for seeds and beans intended for sprout production is practical 
and effective.
    We also considered whether to propose a requirement that you test 
incoming seeds and beans, and rejected this approach. Although 
epidemiological investigations often identify seeds and beans as the 
most likely source of contamination, contamination may be at very low 
levels (4 CFU/kg seed) (Ref. 16) and laboratory analyses have 
frequently been unable to isolate pathogens from implicated seeds or 
beans (Ref. 243). In a recent EFSA publication, the authors concluded 
that a 2-class sampling plan ``absence in 25g'', n=5; c=0, as specified 
in EC Regulation 2073/2005 for sprouted seeds, will not give sufficient 
confidence to demonstrate the absence of a target pathogen at these low 
levels in seeds. To increase the probability of rejection of a positive 
lot, the authors estimated that it would be necessary to analyze 
kilogram quantities of the sample (Ref. 244). Guidances from Canadian 
and Irish authorities include recommendations that seeds and beans be 
tested by the distributor, and that the sprouter obtain a Certificate 
of Analysis (CoA) for the seeds and beans (Ref. 240. Ref. 245), but 
recognize the limitations of testing seeds.
    While a negative test result is not a guarantee of the absence of 
pathogens, a positive test result would facilitate detection of 
contaminated seeds and beans for destroying or diverting to non-food 
use. Thus, we would encourage seed suppliers and sprouters to test seed 
using statistically valid sampling and testing protocols. However, we 
tentatively conclude that testing seeds and beans is not sufficiently 
reliable to include as a measure necessary to prevent the introduction 
of known or reasonably foreseeable hazards. Instead, we propose to 
focus on seed treatment (proposed Sec.  112.142) and testing spent 
irrigation water from each production batch of sprouts (or testing each 
production batch of sprouts at the in-process stage when testing spent 
irrigation water is not practicable) (proposed Sec.  112.143).
    When seeds or beans are used to produce sprouts, they are ``food,'' 
as defined in section 201(f) of the FD&C Act (Ref. 95). The definition 
of ``food'' in proposed Sec.  112.3 is consistent with this 
interpretation. When you grow, harvest, pack, and store seeds and beans 
for sprouting at your operation, you know the end use of the seeds and 
beans, and proposed Sec.  112.141(a) would require that you exercise 
control over that input into your sprout production. On the other hand, 
growers of seeds and beans may be unaware as to whether their crop will 
be used for sprout production. We seek comment on any provisions that 
would be effective in reducing the risk posed by contaminated seeds or 
beans in such cases, without also imposing an undue burden on the 
agricultural sector that produces seed used primarily for purposes of 
growing food or feed crops and not intended for use as food for human 
consumption as sprouts.
    Proposed Sec.  112.141(b) through (c) would establish additional 
requirements to ensure that seeds and beans do not serve as a vehicle 
for introducing contamination in sprouts. Proposed Sec.  112.141(b) 
would require that if you know or have reason to believe that a lot of 
seeds or beans has been associated with foodborne illness, you must not 
use that lot of seeds or beans to produce sprouts. Contamination of 
seeds and beans is generally at a low level and not distributed 
homogeneously throughout a seed lot. Thus, a seed lot may be in 
distribution for some time and in use by multiple sprout farms before 
it is known or suspected to be contaminated. As discussed in the QAR, 
we are aware of outbreaks associated with multiple sprout farms using 
the same lot of seed. In addition, pathogens, such as Salmonella and E. 
coli O157:H7, can survive for an extended period of time on seeds and 
beans, as evidenced by outbreaks linked to seed that is a year or two 
old, so setting aside a potentially contaminated seed lot for later use 
does not reduce the likelihood of producing contaminated sprouts from 
that lot of seeds or beans (Ref. 16. Ref. 243). For these reasons, we 
have tentatively concluded that, once you know or have reason to 
believe that a lot of seeds or beans is contaminated, through microbial 
testing or implication as the vehicle in an outbreak, there is reason 
to believe that other parts of that lot may also be contaminated, you 
must not use that lot of seeds or beans to produce sprouts. This is 
consistent with existing guidances and standards (Ref. 16. Ref. 18. 
Ref. 192. Ref. 193).
    Proposed Sec.  112.141(c) would require that you visually examine 
seeds and beans, and packaging used to ship seeds or beans, for signs 
of potential contamination with known or reasonably foreseeable 
hazards. Visual examination of seeds and beans for sprouting, and the 
packaging used to ship them, provides an opportunity to see signs of 
potential contamination, such as rodent or bird feces or urine, which 
may introduce pathogens into or onto sprouts (Ref. 241. Ref. 246). 
Feces from rodents and birds are known to carry pathogens (Ref. 247). 
This proposed provision is consistent with recent FDA and international 
guidance (Ref. 38. Ref. 18. Ref. 192. Ref. 193).
    Proposed Sec.  112.142 would establish measures you must take for 
growing, harvesting, packing, and holding sprouts. Specifically, 
proposed Sec.  112.142(a) would require that you grow, harvest, pack, 
and hold sprouts in a fully-enclosed building. Proposed Sec.  
112.142(b) would require that any food-contact surfaces you use to 
grow, harvest, pack, or hold sprouts must be sanitized after cleaning 
and before contact with sprouts or seeds or beans used to grow sprouts. 
As discussed in the QAR, although the source of contamination in 
outbreaks associated with sprouts has most often been incoming seeds or 
beans, pathogens can also be introduced during sprout growing, 
harvesting, packing, and holding.
    Therefore, we are proposing these additional requirements for 
sprout farms (i.e., conducting operations in a fully enclosed building, 
sanitizing food-

[[Page 3597]]

contact surfaces after cleaning) because we have tentatively concluded 
that the sprouting process represents a unique bacterial amplification 
step that requires a higher level of care compared to the growing, 
harvesting, packing, and holding of other covered produce. This 
proposed approach, a higher level of care compared to produce growing, 
harvesting, packing and holding generally, is consistent with Codex 
guidelines (Ref. 50).
    Proposed Sec.  112.142(c) would require you to treat seeds or beans 
that will be used to grow sprouts using a scientifically valid method 
immediately before sprouting to reduce microorganisms of public health 
significance. Consistent with our previous discussion of the term 
``scientifically valid'' with respect to testing in the proposed rule 
to establish Current Good Manufacturing Practice requirements for 
dietary ingredients and dietary supplements (68 FR 12157 at 12198), we 
use the term ``scientifically valid'' to mean using an approach that is 
based on scientific information, data, or results published in, for 
example, scientific journals, references, text books, or proprietary 
research. Methods used for reducing microorganisms of public health 
significance in seeds or beans for sprouting must be scientifically 
valid if they are to provide assurance that they are effective.
    Prior treatment conducted by a grower, handler, or distributor of 
seeds or beans, does not eliminate your responsibility to treat seeds 
or beans immediately before sprouting, at your covered farm. This 
proposed requirement is consistent with NACMCF recommendations and our 
Sprout Guide (Ref. 16. Ref. 14) and international guidance (Ref. 193. 
Ref. 191. Ref. 38). Specifically, NACMCF recommends that seed 
treatments that deliver less than a 5-log pathogen reduction be coupled 
with a microbial testing program. We did not cite any specific log 
reduction in our Sprout Guide as ``adequate to reduce pathogens.'' At 
that time, few if any seed treatments were thought to be capable of 
consistently delivering a 5-log pathogen reduction.
    A number of treatments have been shown to reduce levels of, but not 
eliminate, pathogenic bacteria present on seeds. Such treatments are 
likely to reduce the level of contamination if present and, in turn, 
decrease the risk for foodborne disease with sprouted seeds (Ref. 16). 
We cited in the Sprout Guide a 20,000 ppm calcium hypochlorite 
treatment as an example of a treatment that has been shown to be 
effective for the reduction of pathogens on seed. Scientific literature 
indicates that the 20,000 ppm Ca(OCl)2 treatment, widely 
adopted by sprouters who treat seed prior to sprouting, produces a 2.5 
log reduction, with a range of 1.0-6.5 log reduction (Ref. 192. Ref. 
201). Other chemical and physical seed disinfection treatments, alone 
and in combination, have been evaluated for efficacy but there is a 
high degree of variability in research results based on a number of 
factors (e.g., seed type, whether seed was naturally or artificially 
contaminated, level of initial contamination). In their evaluation of 
the current state of microbiological safety of seeds and sprouts, Fett 
et al. (Ref. 243) present a comparison of the efficacy of select 
aqueous chemical disinfection treatments with Ca(OCl)2 for 
sanitizing alfalfa seed from the literature. Canada recommends a lower 
level of calcium hypochlorite, 2,000 ppm (Ref. 245).
    We acknowledge that several outbreaks have brought into question 
the effectiveness of seed disinfection treatments. For example, an 
outbreak of Salmonella kottbus in alfalfa sprouts was linked to seed 
that underwent a chlorine sanitization step, although records indicate 
the concentration of chlorine was probably lower than the recommended 
20,000 ppm (Ref. 248). Conversely, in 1999, an outbreak of Salmonella 
enterica serotype Mbandaka occurred in Oregon, Washington, Idaho, and 
California. Based on epidemiologic and pulsed-field gel electrophoresis 
evidence from 87 confirmed cases, the outbreak was linked to 
contaminated alfalfa seeds grown in California's Imperial Valley. 
Trace-back and trace-forward investigations identified a single lot of 
seeds used by five sprout growers during the outbreak period. Cases of 
salmonellosis were linked with two sprout growers who had not employed 
chemical disinfection; no cases were linked to the three sprout growers 
who used seed disinfection (Ref. 249). In another outbreak of 
Salmonella typhimurium in clover sprouts linked to seed sold to 
multiple sprout operations, sprouters who had treated the seeds in 
20,000 ppm chlorine had fewer cases attributed to their sprouts 
compared to those that did not (Ref. 250). This is consistent with 
modeling work by Montville and Schaffner, indicating that, while 
disinfection of seeds prior to sprouting did not guarantee pathogen 
free sprouts, disinfection reduced the percentage of contaminated 
batches. Seed disinfection was most effective when contamination was 
sporadic and at low levels; at a low prevalence (1 out of 10,000 25-g 
samples are positive), as would normally be expected, the percentage of 
contaminated batches was reduced from 13.7 to 0.1%. Where the initial 
contamination was high and uniform, the proportion of contaminated 
batches was reduced only from 100 to 87.7% (Ref. 251).
    For these reasons we continue to believe that seed disinfection 
treatments are valuable as one of several measures necessary to ensure 
the safety of sprouts. We ask for comment on this approach.
    Proposed Sec.  112.143 would establish requirements for testing 
procedures you apply to the growing, harvesting, packing, and holding 
of sprouts. Specifically, proposed Sec.  112.143(a) would require that 
you test the growing, harvesting, packing, and holding environment for 
Listeria spp. or L. monocytogenes (Lm) in accordance with the 
requirements of Sec.  112.144. The proposed testing requirement in 
Sec.  112.143(a) is in response to emerging concerns about positive 
sample findings and multiple recalls associated with L. monocytogenes 
in sprouts (Ref. 17. Ref. 252). Between 2002 and 2010, there have been 
10 recalls involving multiple sprout types due to potential or 
confirmed contamination with L. monocytogenes (Ref. 253). In one of 
these recalls, the strain found in sprouts matched the strain isolated 
from 20 confirmed cases of listeriosis in 6 States and positive sample 
findings from an environmental investigation at the sprouting operation 
(Ref. 252).
    Contamination from L. monocytogenes from the environment is common 
(Ref. 207) and, thus, targeted preventive controls to minimize L. 
monocytogenes in RTE foods are warranted. While appropriate sanitation 
measures can minimize the presence of environmental pathogens in a 
sprouting operation, we tentatively conclude that environmental 
monitoring is still necessary for sprouting operations as an added 
safety measure. Such monitoring can be conducted by testing for the 
specific pathogenic microorganism or by testing for an ``indicator 
organism,'' which can indicate conditions in which the environmental 
pathogen may be present. Typically, a firm that finds an indicator 
organism during environmental monitoring conducts microbial testing of 
surrounding surfaces and areas to determine the potential source of the 
contamination, cleans and sanitizes the contaminated surfaces and 
areas, and conducts additional microbial testing to determine whether 
the contamination has been eliminated. Further steps may be necessary 
if the indicator organism is

[[Page 3598]]

found on retest. Tests for the indicator organism Listeria spp. detect 
multiple species of Listeria, including the pathogen L. monocytogenes. 
For example, USDA's FSIS regulations and guidelines use Listeria spp. 
as an appropriate indicator organism for L. monocytogenes in for RTE 
meat or poultry products exposed to the processing environment after 
cooking to prevent product adulteration by L. monocytogenes (Ref. 254). 
FDA's current thinking is that Listeria spp. is an appropriate 
indicator organism for L. monocytogenes, because tests for Listeria 
spp. will detect multiple species of Listeria, including L. 
monocytogenes, and because the available information supports a 
conclusion that modern sanitation programs, which incorporate 
environmental monitoring for Listeria spp., have public health 
benefits. The taking of actions based on the presence of an appropriate 
indicator organism is protective of public health, since there will be 
times when steps are taken in the absence of the pathogen. Therefore, 
we tentatively conclude that testing the growing, harvesting, packing 
and holding environment for Listeria spp. or L. monocytogenes is a 
necessary measure to ensure the safety of sprouts.
    Proposed Sec.  112.143(b) would require that you either: (1) Test 
spent sprout irrigation water from each production batch of sprouts for 
E. coli O157:H7 and Salmonella spp. in accordance with the requirements 
of Sec.  112.146; or (2) if testing spent sprout irrigation water is 
not practicable (for example, for soil-grown sprouts), that you test 
each production batch of sprouts at the in-process stage (i.e., while 
sprouts are still growing) for E. coli O157:H7 and Salmonella spp. in 
accordance with the requirements of Sec.  112.146. A production batch 
for which either of these pathogens is detected in the spent irrigation 
water for the sprouts would be considered adulterated under Section 
402(a)(4) of the FD&C Act, in that it has been prepared, packed, or 
held under insanitary conditions whereby it may have been rendered 
injurious to health. A production batch for which either of these 
pathogens is detected in the sprouts would be considered adulterated 
under Sections 402(a)(1) of the FD&C Act, in that the sprouts contain a 
poisonous or deleterious substance which may render it injurious to 
health. Therefore, we tentatively conclude that microbiological testing 
of spent irrigation water from each production lot (or of each 
production batch of sprouts) is necessary to provide reasonable 
assurances that sprouts are not adulterated under Section 402 of the 
FD&C Act. The proposed testing requirement in Sec.  112.143(b) to test 
spent sprout irrigation water (or sprouts) for Salmonella and E. coli 
O157:H7 would codify current recommendations in our Sprout Guides and 
is consistent with existing international guidelines and regulations 
(Ref. 38. Ref. 191. Ref. 193).
    We are proposing these testing requirements in Sec.  112.143(b) in 
addition to the proposed treatment requirements in Sec.  112.142(c) 
because pathogens that are merely injured, but not killed, by seed 
treatment could potentially grow out again when subjected to enrichment 
conditions, as experienced during sprouting (Ref. 16. Ref. 74). Because 
seed disinfection treatments can reduce, but may not eliminate, 
pathogens on seed, we are proposing to require microbiological testing. 
Spent irrigation water that has flowed over and through sprouts is a 
good indicator of the types and quantities of microorganisms in the 
sprouts themselves (differing by only 1 log or less from the level in 
the sprouts) and the microflora in spent irrigation water is fairly 
homogeneous (Ref. 15. Ref. 198. Ref. 209). The optimal time for testing 
is when pathogen levels are highest (approximately 24-48 hours after 
the start of sprouting), but also when it is early enough in the 
sprouting process to obtain results before product is shipped.
    We have emphasized testing irrigation water in proposed Sec.  
112.143(b) because testing sprouts has several significant 
disadvantages compared to testing spent irrigation water. First, 
contamination of sprouts is not likely to be as homogeneous as is the 
spent irrigation water (Ref. 243. Ref. 255). Second, multiple sprout 
samples must be taken from different locations in the drum or trays to 
ensure that the sample collected is representative of the batch. 
Furthermore, additional preparation (e.g., selecting representative 
subsamples for analyses, blending or stomaching) is required when 
testing sprouts. Each additional step introduces a possibility for 
error. Consequently, testing of spent sprout irrigation water is 
generally preferred over testing sprouts unless production methods make 
it impractical to test spent sprout irrigation water. For example, 
spent irrigation water may not be available when sprouts are grown in 
soil.
    We chose pathogen testing for Salmonella spp. and E. coli O157:H7 
because these pathogens are the two most common agents in sprout-
associated outbreaks in the U.S. (Ref. 3). Recently, EFSA concluded 
that there are currently no indicator organisms that can effectively 
substitute for the testing of pathogens in seeds, sprouted seeds or 
irrigation water (Ref. 244). We tentatively concur with this 
conclusion.
    In developing our Sprout Guides in 1999 and in deliberations for 
this proposed rule, we also considered whether to include testing spent 
sprout irrigation water for L. monocytogenes, in addition to testing it 
for Salmonella spp. and E. coli O157:H7. However, we tentatively 
concluded that testing spent sprout irrigation water for Listeria has a 
number of potential challenges. The warm, moist, nutrient-rich 
conditions during sprouting encourage the proliferation of Salmonella 
and E. coli O157:H7 and this proliferation increases the probability of 
their detection, if present. In contrast, Listeria may be a poor 
competitor at the warmer temperatures and against the high level of 
native microflora present during the sprouting process. In addition, 
Listeria is ubiquitous. We would expect frequent positives using rapid 
tests for Listeria spp., which would not necessarily mean pathogens 
were present. Such testing would need to be followed by confirmatory 
testing to determine whether or not L. monocytogenes was present in 
order to determine appropriate actions with respect to the product. 
While rapid test kits are now available to screen for L. monocytogenes, 
their use on spent sprout irrigation water or sprouts would need to be 
validated (Ref. 14). We tentatively conclude that environmental 
monitoring for Listeria spp. or L. monocytogenes is the most practical 
approach for control of this pathogen. We request comments on this 
tentative conclusion.
    We also considered the appropriateness of proposing provisions for 
testing spent sprout irrigation water for non E. coli O157:H7 shiga 
toxin-producing E. coli (STEC) which were involved in the recent large 
sprout associated E. coli O104 foodborne illness outbreak in Europe 
(Ref EU OB). The O104:H4 strain that caused the outbreak in Europe was 
an unusual strain that none of the tests that were being used to test 
for enterohaemorrhagic E. coli (EHEC) at that time would have picked it 
up. The challenge is that there are estimated to be 400 serotypes of E. 
coli that produces any one of the 3 Stx1 and/or 8 Stx2 subtypes and 
many of these are isolated from environmental and animal sources but 
have not been implicated in human illness. Many of the STEC strains 
entailed tedious plating and retesting to isolate and even longer to 
serotype (Ref. 256). For these reasons, we tentatively conclude that 
proposing to require testing spent sprout irrigation water for

[[Page 3599]]

non E. coli O157:H7 STECs would not be a practical approach at this 
time.
    We request comments on this tentative conclusion, and on whether 
pathogens in addition to E. coli O157:H7 and Salmonella spp. should be 
included in testing of spent sprout irrigation water or in-process 
sprouts, either by specifically listing the additional pathogens or by 
set criteria (e.g., association with one or more outbreaks linked to 
sprouts) for inclusion.
    Proposed Sec.  112.144 would establish requirements for how you 
test the growing, harvesting, packing, and holding environment for 
Listeria spp. or L. monocytogenes. Specifically, proposed Sec.  
112.144(a) would require that you establish and implement a written 
environmental monitoring plan that is designed to find L. monocytogenes 
if it is present in the growing, harvesting, packing or holding 
environment. Proposed Sec.  112.144(b) would require that your written 
environmental monitoring plan be directed to sampling and testing for 
Listeria spp. or L. monocytogenes. Proposed Sec.  112.144(c)(1) through 
(3) would require that your written environmental monitoring plan 
include a sampling plan that specifies: What you will test collected 
samples for (i.e., Listeria spp. or L. monocytogenes) (proposed Sec.  
112.144(c)(1)); How often you will collect environmental samples, which 
must be no less than monthly (proposed Sec.  112.144(c)(2)); and Sample 
collection sites. The number and location of sampling sites must be 
sufficient to determine whether measures are effective and must include 
appropriate food-contact surfaces and non-food-contact surfaces of 
equipment, and other surfaces within the growing, harvesting, packing, 
and holding environment (proposed Sec.  112.144(c)(3)). Proposed Sec.  
112.144(d) would require you to collect environmental samples and test 
them for Listeria spp. or L. monocytogenes according to the method in 
Sec.  112.152.
    Proposed Sec.  112.144(c)(1) would require that you specify whether 
you will be testing for the pathogen L. monocytogenes or the indicator 
organism, Listeria spp. As discussed above, FDA's current thinking is 
that Listeria spp. may be an appropriate indicator organism for L. 
monocytogenes, because tests for Listeria spp. will detect multiple 
species of Listeria, including L. monocytogenes. FDA expects 
environmental monitoring to be conducted with sufficient frequency to 
detect the environmental pathogen or appropriate indicator organism if 
present. We tentatively conclude that monthly sampling and testing is a 
minimum requirement (proposed Sec.  112.144(c)(2)). More frequent 
testing may be needed. For example, the frequency of monitoring for 
environmental pathogens should increase as a result of finding the 
environmental pathogen or an indicator of the environmental pathogen or 
as a result of situations that pose an increased likelihood of 
contamination, e.g., construction (Ref. 211. Ref. 212). The frequency 
of taking environmental samples will vary depending on existing data on 
the presence of the environmental pathogen of concern in the 
environment where foods are exposed to the environment. In the absence 
of information, data should be generated to assist in determining the 
frequency of monitoring (Ref. 257). We request comment on whether the 
minimum frequency of at least monthly for environmental monitoring is 
adequate to assess whether the measures taken to minimize the risk 
associated with L. monocytogenes in sprouts are effective. We 
tentatively conclude that specifying the frequency of testing in the 
written environmental monitoring plan is necessary to enable assurance 
by the operator and verification by FDA that testing efforts are 
consistent with a carefully thought through effort to find the 
environmental pathogen if it is present in the environment.
    The purpose of environmental monitoring is to verify the 
implementation and effectiveness of sanitation measures for controlling 
the presence of L. monocytogenes in the sprout production environment. 
The monitoring must be designed to find environmental pathogens that 
remain in the sprouting operation after routine cleaning and sanitizing 
procedures in order to prevent contamination of product that could lead 
to illness. To accomplish this purpose, there must be a scientific 
basis for the locations selected for sampling, the number of samples 
taken, the frequency of sampling, the sampling procedures used and the 
test methodology. The sampling must be biased--i.e., the locations to 
be tested must be those in which the environmental pathogens can enter 
the environment where the food is exposed and those areas where 
harborage of the pathogen is likely (Ref. 258).
    One approach to defining sampling locations is to divide the 
sprouting operation into zones based on the likelihood of contamination 
of the product. A common industry practice is to use four zones (Ref. 
213. Ref. 212): Zone 1 consists of food-contact surfaces; Zone 2 
consists of non-food-contact surfaces in close proximity to food and 
food-contact surfaces; Zone 3 consists of more remote non-food-contact 
surfaces that are in the area used for growing, harvesting, packing, 
and holding and could lead to contamination of zones 1 and 2; and Zone 
4 consists of non-food-contact surfaces, outside of the area used for 
growing, harvesting, packing, and holding from which environmental 
pathogens can be introduced into the growing, harvesting, packing, and 
holding environment. Generally the number of samples and frequency of 
testing is higher in zones 1 and 2 because of the greater likelihood of 
food contamination if the environmental pathogen is present in these 
zones. Information on appropriate locations for sampling within these 
zones can be found in the literature (Ref. 175. Ref. 212). Operators 
should become familiar with locations in which environmental pathogens 
have been found in other sprout firms and use this information in 
selecting sites to sample.
    L. monocytogenes frequently establishes itself in a harborage site 
on equipment and grows (increases in number) there, where both food and 
moisture are available. L. monocytogenes organisms work their way out 
of the harborage site during production and contaminate food. Testing 
food-contact surfaces for Listeria spp. is a commonly recommended 
verification measure for firms producing refrigerated RTE foods (Ref. 
175. Ref. 211).
    Examples of appropriate non-food-contact surfaces that could be 
monitored include exteriors of equipment, equipment supports, control 
panels, door handles, floors, drains, refrigeration units, ducts, 
overhead structures, cleaning tools, and motor housings. Standing water 
in growing, harvesting, and packing areas and areas that have become 
wet and then have dried are also appropriate places to monitor. Testing 
non-food-contact surfaces for L. monocytogenes or Listeria spp. is a 
commonly recommended verification measure for firms producing 
refrigerated or frozen RTE foods (Ref. 258. Ref. 259) and can detect L. 
monocytogenes that is brought into the plant by people or objects. 
Actions you then take can prevent transferring the organisms to a food-
contact surface (where they can contaminate food) or from establishing 
a harborage that can serve as a source of contamination.
    Proposed Sec.  112.145 would establish requirements for actions you 
must take if you detect Listeria spp. or L. monocytogenes in the 
growing, harvesting, packing, or holding environment, i.e., Conduct 
additional microbial testing of surfaces and areas surrounding the area 
where Listeria spp.

[[Page 3600]]

or L. monocytogenes was detected to evaluate the extent of the problem, 
including the potential for Listeria spp. or L. monocytogenes to have 
become established in a niche (proposed Sec.  112.145(a); Clean and 
sanitize the affected surfaces and surrounding areas (proposed Sec.  
112.145(b)); Conduct additional microbial sampling and testing to 
determine whether the Listeria spp. or L. monocytogenes has been 
eliminated (proposed Sec.  112.145(c)); Conduct finished product 
testing when appropriate (proposed Sec.  112.145(d)); and Perform any 
other actions necessary to prevent reoccurrence of the problem 
(proposed Sec.  112.145(e)). Testing the environment of a sprouting 
operation for L. monocytogenes (or for Listeria spp. as an indicator of 
potential contamination with L. monocytogenes), and taking actions to 
eliminate L. monocytogenes or Listeria spp. when found in the 
environment of a sprouting operation, is an important component of 
controlling microorganisms of public health significance (Ref. 175. 
Ref. 211). The actions we are proposing to require, including 
additional testing to determine the extent of contamination, ensuring 
contamination is eliminated and taking steps to prevent its recurrence, 
are consistent with recommendations in our Listeria Guide (Ref. 260).
    If an environmental pathogen or an appropriate indicator organism 
(the test organism) is detected in the environment, steps must be taken 
to eliminate the organism, including finding a harborage site if one 
exists (Ref. 175. Ref. 211) (Ref. 257). Otherwise, the presence of the 
environmental pathogen could result in contamination of food-contact 
surfaces or food. The presence of the indicator organism suggests that 
conditions exist in which the environmental pathogen may be present and 
could result in contamination of food-contact surfaces or food. Actions 
must be taken for every finding of an environmental pathogen or 
indicator organism in the environment to prevent contamination of food-
contact surfaces or food.
    Sampling and microbial testing from surfaces surrounding the area 
where the test organism was found (proposed Sec.  112.145(a)) are 
necessary to determine whether the test organism is more widely 
distributed than on the original surface where it was found and to help 
find the source of contamination if other sites are involved. Cleaning 
and sanitizing the contaminated surfaces and surrounding areas 
(proposed Sec.  112.145(b)) are necessary to eliminate the test 
organism that was found there. Additional sampling and microbial 
testing (proposed Sec.  112.145(c)) are necessary to determine the 
efficacy of cleaning and sanitizing. For example, detection of the test 
organism after cleaning and sanitizing indicates that the initial 
cleaning was not effective, and additional, more intensified cleaning 
and sanitizing, or other actions may be needed, including dismantling 
equipment, scrubbing surfaces, and heat-treating equipment parts (Ref. 
207). The finding of a test organism on a food-contact surface usually 
represents transient contamination rather than a harborage site (Ref. 
259). However, finding the test organism on multiple surfaces in the 
same area, or continuing to find the test organism after cleaning and 
sanitizing the surfaces where it was found, suggests a harborage site 
for the test organism. Mapping the location of contamination sites, 
whether the harborage site is on equipment or in the environment, can 
help locate the source of the harborage site or identify additional 
locations to sample (Ref. 257).
    Proposed Sec.  112.145 would not specify how certain actions must 
be performed, such as the number of sites to test when the test 
organism is found in a sprouting operation, or how to clean and 
sanitize the surfaces on which the test organism was detected. The 
number of sites appropriate for testing and the applicable cleaning and 
sanitizing procedures will depend on the sprouting operation and the 
equipment. We tentatively conclude that, when microbial testing is 
conducted as part of steps in light of the results of environmental 
monitoring, specifying such procedural requirements would not provide 
facilities with sufficient flexibility to develop and implement 
aggressive and appropriate actions to find and eliminate the source of 
the contamination in the environment. Such actions may involve 
investigative procedures when the initial measures have not been 
successful in eliminating the environmental pathogen or indicator 
organism. One example of an investigative procedure is taking samples 
from food-contact surfaces and/or produce at multiple times during the 
day while the equipment is operating and producing product (Ref. 207).
    Proposed Sec.  112.145(d) would require that if environmental 
monitoring identifies the presence of an environmental pathogen or 
indicator organism, the operator conduct finished product testing, when 
appropriate. As discussed in section IV.I. of this document, there are 
shortcomings for microbiological testing of food for process control 
purposes. Testing cannot ensure the absence of a hazard, particularly 
when the hazard is present at very low levels and is not uniformly 
distributed. If an environmental pathogen is detected on a food-contact 
surface, finished product testing would be appropriate only to confirm 
actual contamination or assess the extent of contamination, because 
negative findings from product testing could not adequately assure that 
the environmental pathogen is not present in food exposed to the food-
contact surface. If you detect an environmental pathogen on a food-
contact surface, the sprouting operation should presume that the 
produce is adulterated under Section 402(a)(4) of the FD&C Act.
    Finished product testing could be appropriate if an environmental 
pathogen is detected on a non-food-contact surface, such as on the 
exterior of equipment, on a floor or in a drain. The potential for food 
to be contaminated directly from contamination in or on a non-food-
contact surface is generally low, but transfer from non-food-contact 
surfaces to food contact surfaces can occur. Finished product testing 
can provide useful information on the overall risk of a food when 
pathogens have been detected in the environment.
    Proposed Sec.  112.145(e) would require that if environmental 
monitoring identifies the presence of an environmental pathogen or 
appropriate indicator organism, the operator perform any other steps 
necessary to prevent recurrence of the contamination. Actions taken as 
a result of monitoring for an environmental pathogen or an indicator 
organism for such pathogen must ensure these requirements are met. The 
measures for environmental monitoring specified in proposed Sec.  
112.145(a) through (d) are not all inclusive. Examples of measures that 
may be necessary include reinforcing employee hygiene practices and 
traffic patterns; repairing damaged floors; eliminating damp 
insulation, water leaks, and sources of standing water; replacing 
equipment parts that can become harborage sites (e.g., hollow conveyor 
rollers and equipment framework), and repairing roof leaks (Ref. 180. 
Ref. 219). Additional information on measures for environmental 
monitoring can be found in the literature (Ref. 180. Ref. 221. Ref. 
219). Proposed Sec.  112.145 is consistent with the FSIS Listeria 
Guidelines (Ref. 254).
    Proposed Sec.  112.146 would establish requirements for how you 
collect and test samples of spent sprout irrigation water or sprouts. 
Specifically, proposed Sec.  112.146(a) would require that you 
establish and implement a written

[[Page 3601]]

sampling plan that identifies the number and location of samples (of 
spent sprout irrigation water or sprouts) to be collected for each 
production batch of sprouts to ensure that the collected samples are 
representative of the production batch when testing for contamination. 
Additionally, proposed Sec.  112.146(b) would require that, in 
accordance with the written sampling plan required under paragraph (a) 
of this section, you aseptically collect samples of spent sprout 
irrigation water or sprouts, and test the collected samples for E. coli 
O157:H7 and Salmonella spp. using a method that has been validated for 
its intended use (testing spent sprout irrigation water or sprouts) to 
ensure that the testing is accurate, precise, and sensitive in 
detecting these pathogens. This proposed provision is consistent with 
recommendations in our Sprout Testing Guide, the Canada and Irish Codes 
and the FSANZ standard (Ref. 15. Ref. 206. Ref. 201. Ref. 203).
    One means to test for E. coli O157:H7 and Salmonella spp. as 
required under proposed Sec.  112.146(b) is to follow our guidance on 
sampling and testing spent irrigation water or sprouts (Ref. 15). The 
methods described in our guidance have been validated to be effective 
on spent sprout irrigation water and sprouts (Ref. 15. Ref. 223. Ref. 
224). The effectiveness of detection methods can vary depending on 
multiple factors, including but not limited to whether the sample 
tested is representative of the food, type of food, level of microflora 
present, the enrichment procedure and type of test used. Spent sprout 
irrigation water and sprouts have a high level of natural microflora 
that can interfere with detection (Ref. 15. Ref. 243). Therefore, other 
methods that have been validated to be effective for other foods may 
not work for spent sprout irrigation water and sprouts. Because the 
microflora in spent sprout irrigation water is more homogeneous 
compared to seeds or sprouts, sampling procedures described in our 
guidance for sprout irrigation water are relatively simple. In 
addition, spent sprout irrigation water can be used directly in the 
test procedures described in our guidance, thus reducing the 
possibility of error (Ref. 15. Ref. 243). Sampling spent sprout 
irrigation water or sprouts is an important testing procedure to ensure 
contaminated product does not enter commerce. The testing procedures 
described in our guidance give accurate results as quickly and simply 
as possible on the presence or absence of E. coli O157:H7 and 
Salmonella spp.
    Proposed Sec.  112.150 would establish requirements for records 
that you must establish and keep regarding sprouts. Under proposed 
Sec.  112.150(a), you must establish and keep the required records in 
accordance with the requirements of proposed subpart O. As discussed in 
section V.O. of this document, proposed subpart O would establish 
general requirements applicable to all records.
    Proposed Sec.  112.150(b) would require you to establish and keep 
the following records: Documentation of your treatment of seeds or 
beans to reduce microorganisms of public health significance in the 
seeds or beans, at your farm (proposed Sec.  112.150(b)(1)); your 
written environmental monitoring plan in accordance with the 
requirements of Sec.  112.144 (proposed Sec.  112.150(b)(2)); your 
written sampling and testing plan for each production batch of sprouts 
in accordance with the requirements of Sec.  112.146(a) (proposed Sec.  
112.150(b)(3)); the results of any testing conducted in accordance with 
the requirements of Sec. Sec.  112.143 and 112.144 (proposed Sec.  
112.150(b)(4)); any analytical methods you use in lieu of the methods 
that are incorporated by reference in Sec.  112.152 (proposed Sec.  
112.150(b)(5)); and the testing method you use in accordance with the 
requirements of Sec.  112.146(b) (proposed Sec.  112.150(b)(6)). We are 
proposing to require you to keep the above records specific to sprout 
operations in order to help document your compliance with the 
provisions of this rule. We tentatively conclude that such records are 
needed for us to verify and you to ensure that appropriate measures are 
being followed consistently and correctly (e.g., your sampling plan for 
spent sprout irrigation water from each production lot). The records 
would also allow FDA or you to identify trends that might signal a need 
to adjust the measures in your environmental monitoring plan to improve 
its effectiveness and reliability (e.g., test results from your 
environmental monitoring program may signal the need to enhance 
sprouting operation cleaning and sanitation).

N. Subpart N--Analytical Methods

    Proposed subpart N would specify methods of analysis for testing 
the quality of water and the growing environment for sprouts, as 
required under proposed subparts E and M (see sections V.E. and V.M., 
respectively, of this document).
    Proposed Sec.  112.151 would establish that you must test the 
quality of water to satisfy the requirements of Sec.  112.45 by one of 
three methods: (1) Official methods of analysis published by the AOAC 
International; (2) standards methods for the examination of water and 
wastewater as published by the American Public Health Association; or 
(3) methods prescribed in the FDA Bacteriological Analytical Manual, or 
by another method that is at least equivalent to the above-mentioned 
three methods in accuracy, precision and sensitivity in detecting E. 
coli.
    Proposed Sec.  112.151(a)(1) provides for the use of official 
methods of analysis published by AOAC International in the latest 
edition of their publication ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 18th edition, revision 4 
(published in 2011). The Official Methods of Analysis of AOAC 
International (18th Ed., revision 4, 2011) would be incorporated by 
reference with the approval of the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR Part 5.
    Proposed Sec.  112.151(a)(2) would establish that methods of 
analysis published in the Standard Methods for the Examination of Water 
and Wastewater (21st Edition, 2005), American Public Health Association 
would be acceptable for testing the quality of water. In addition, the 
Standards Methods for the Examination of Water and Wastewater, (21st 
Ed., 2005), would be incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 5.
    Proposed Sec.  112.151(a)(3) would establish that methods of 
analysis published in Chapter 4 of the FDA Bacteriological Analytical 
Manual (Edition 8, Revision A, 1998) (BAM), as updated in June 2011, 
would be acceptable for testing the quality of water. In addition, 
Chapter 4 of the BAM (Edition 8, Revision A, 1998), as updated in June 
2011, would be incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 5. With advances in science and as appropriate, 
FDA periodically updates the BAM to add newer methods or revise 
existing ones. For the purposes of this proposed rule, we refer to 
Chapter 4 of the BAM (edition 8, revision A, published in 1988) as 
updated in June 2011. However, should FDA update or revise the methods 
and procedures currently listed in Chapter 4 of the June 2011 version, 
for the purpose of testing the quality of water, we encourage industry 
to use such relevant, updated methods and procedures.
    Proposed Sec.  112.151(a)(4) would provide for the use of a method 
that is at least equivalent in accuracy, precision, and sensitivity to 
the methods in Sec.  112.151(a)(1), (a)(2) or (a)(3). Test kit methods 
are generally not published in the literature due to their proprietary 
nature. FDA is aware of

[[Page 3602]]

programs, such as the AOAC Research Institute's Performance Tested 
Methods Program that provides an independent third-party review of 
proprietary test method performance. Test methods demonstrated to meet 
acceptable performance criteria are granted Performance Test Methods 
(PTM) status. The PTM certification assures users that an independent 
assessment has found that the test method performance meets an 
appropriate standard for the claimed use. FDA would consider methods, 
particularly test kit methods, approved by the PTM program or other 
similar programs acceptable for testing the quality of water. FDA is 
also aware that there are numerous scientific testing and diagnostic 
development companies that have invented rapid tests and systems for 
pathogens and water quality. Many of these products undergo rigorous 
internal quality control and performance testing, as well as receive 
additional third-party and/or regulatory approvals. FDA is also aware 
that the Environmental Protection Agency (EPA) approves analytical 
methods that industrial and municipal facilities use to determine 
pollutants of wastewater (published in 40 CFR Part 136) and to meet 
federal requirements or to demonstrate compliance with drinking water 
and ground water regulations (40 CFR 141.402 and 40 CFR 141.403). For 
example, the EPA, has approved the use of E*Colite[supreg] Test, m-
ColiBlue 24[supreg] Test, and Colitag[supreg] Test for compliance 
monitoring related to EPA's Ground Water Rule. FDA would consider these 
tests acceptable for testing the quality of water to satisfy the 
requirements of Sec.  112.45.
    Proposed Sec.  112.152 establishes the methods you must use to test 
the growing environment for Listeria spp. or L. monocytogenes to 
satisfy the requirements of Sec. Sec.  112.143(a) and 112.144. As 
proposed, you must test environmental samples using the methods and 
procedures described in Chapter 10 of the BAM, ``Listeria 
monocytogenes, Detection and Enumeration of Listeria monocytogenes in 
Foods.'' Chapter 10 of the BAM (Edition 8, Revision A, 1998), as 
updated in April 2011, would be incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 5. With advances in science and as 
appropriate, FDA periodically updates the BAM to add newer methods or 
revise existing ones. For the purposes of this proposed rule, we refer 
to Chapter 10 of the BAM (Edition 8, revision A, published in 1998) as 
updated in April 2011. However, should FDA update or revise the methods 
and procedures currently listed in Chapter 10 of the April 2011 
version, for the purpose of testing the growing environment for 
Listeria spp. or L. monocytogenes, we encourage industry to use such 
relevant, updated methods and procedures.
    Proposed Sec.  112.152 would also provide for the use of a method 
at least equivalent in accuracy, precision, and sensitivity in 
detecting Listeria spp. or L. monocytogenes as is the method described 
in Chapter 10 of the BAM. For example, prescribed rapid detection kits 
with their respective enrichment media may be conditionally used to 
screen for presence of Listeria contaminants. Isolates may be rapidly 
positively or negatively confirmed as L. monocytogenes by using 
specific test kits. FDA is aware that there are numerous scientific 
testing and diagnostic development companies that have invented rapid 
tests and systems for Listeria spp. or L. monocytogenes. Many of these 
products undergo rigorous internal quality control and performance 
testing, as well as receive additional third-party and/or regulatory 
approvals. As discussed above in proposed Sec.  112.151(a)(4), FDA 
would consider methods, particularly test kit methods, approved for 
example by the AOAC Research Institute's Performance Tested Methods 
Program PTM program or other similar, acceptable for testing Listeria 
spp. or L. monocytogenes.

O. Subpart O--Requirements Applying to Records That You Must Establish 
and Keep

    As proposed, subpart O discusses the general requirements 
applicable to documentation and records that you must establish and 
maintain under proposed part 112.
1. Comments Relevant to the Proposed Requirements
    We received several comments in response to the 2010 FR notice that 
addressed issues relevant to establishing and maintaining documents and 
records. Comments expressed concern over the costs of complying with 
record keeping requirements. Several comments also stated that there 
should not be a requirement for electronic record keeping for farmers, 
especially if they are small-scale. One comment requested that, to 
protect the confidentiality of individual farm businesses, any 
recordkeeping requirements be accompanied by assurance that information 
accessed by federal government authorities with respect to food safety 
protocols will remain confidential. Another comment requested that we 
consider pre-existing records kept by the produce industry for other 
purposes, so as to avoid duplication, while another farmer commented 
that records or documents would not ensure safety and, therefore, asked 
that records should be required for only annual activities, such as 
employee training and surveys of surrounding land activities. Finally, 
several comments indicated that the current legal liability system in 
the United States serves to discourage any grower or packing house from 
keeping additional detailed records related to food safety and that 
such records are subject to intrusive judicial subpoena power.
    We believe that documentation of some practices is critical to 
ensure that science-based minimum produce safety standards proposed in 
this rule are adequately implemented on the farm. Records are useful 
for keeping track of detailed information over a period of time. 
Records can identify patterns of problems and, thus, enable a farm to 
find and correct the source of problems. Records are also useful for 
investigators during inspections to determine compliance with 
requirements (e.g., by FDA investigators to determine compliance with 
requirements that would be established by this rule, or by a third 
party auditor that a farm or retailer may voluntarily engage under a 
business arrangement between the farm and the retailer). Therefore, we 
tentatively conclude that records of only annual activities are 
insufficient to ensure produce safety. However, in determining those 
circumstances in which records are necessary as part of science-based 
minimum standards that minimize the risk of serious adverse health 
consequences or death and provide reasonable assurances that produce is 
not adulterated under section 402 of the FD&C Act, we considered the 
statutory direction in section 419(c)(1)(C) of the FD&C Act to comply 
with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) ``with 
special attention to minimizing'' the recordkeeping burden on the 
business and collection of information as defined in that act. We 
propose to require records in instances where maintenance of detailed 
information is needed to keep track of measures directed at minimizing 
the risk of known or reasonably foreseeable hazards, where 
identification of a pattern of problems is important to minimizing the 
risk of such hazards, or where they are important to facilitate 
verification and compliance with standards and this cannot be 
effectively done by means other than a review of records. See section 
IV.E of this document for further discussion.

[[Page 3603]]

We appreciate the concerns expressed by some commenters with respect to 
cost and burden to farms. To the extent possible, we attempted to 
propose documentation requirements that are risk-based and capable of 
being tailored to your individual farm, taking into account the unique 
characteristics of the operation, the commodities handled, and the 
operation's growing, harvesting, packing, and holding procedures. A 
large majority of growers, farmers, and producers indicated during 
listening sessions and other stakeholder discussions that they already 
practice good agricultural practices and keep adequate records. They 
agreed that such recordkeeping is necessary. Moreover, they indicated 
that the cost of a large scale recall event would have the potential to 
far exceed the cost of routine record keeping.
    As proposed, the recordkeeping requirements allow the use of 
existing records and do not require duplication, provided such records 
satisfy all of the applicable requirements of this part (see proposed 
Sec.  112.163). In addition, per proposed Sec.  112.165, electronic 
records would be acceptable but would not be required by this subpart. 
Records would be acceptable under this subpart if kept in forms as 
diverse as hard copies of handwritten logs, invoices, and documents 
reporting laboratory results, provided that they are indelible and 
legible.
    We understand the concerns regarding confidentiality. Our 
disclosure of information is subject to the Freedom of Information Act 
(FOIA) (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 1905), the FD&C 
Act, and our implementing regulations under part 20, which include 
protection for confidential commercial information and trade secrets. 
We note that many segments of the food industry already are subject to 
food safety-related recordkeeping requirements similar to those 
proposed in this subpart. Other existing food safety regulations, such 
as the infant formula quality control procedures regulation (Sec.  
106.100), the dietary supplement regulation (Sec.  111.605 and Sec.  
111.610), the acidified foods regulation (Sec.  114.100), the 
regulation on production, storage, and transportation of shell eggs 
(Sec.  118.10), the juice HACCP regulation (Sec.  120.12), and the 
seafood HACCP regulation (Sec.  123.9) require similar record keeping. 
In addition, many farmers that are part of the various programs such as 
National Organic Program and LGMA already have similar recordkeeping 
requirements (Ref. 45. Ref. 261). Recordkeeping has proven useful for 
the above-mentioned food industries and, thus far, we are not aware 
that any of these industries has been adversely affected by excessive 
judicial subpoenas resulting from their recordkeeping.
2. Proposed Requirements
    Proposed subpart O would establish requirements that would be 
applicable to all records required by part 112. FDA tentatively 
concludes that the requirements in subpart O describing how records 
must be established and maintained, including the general requirements, 
record retention requirements, and requirements for official review and 
public disclosure, are applicable to all records that would be required 
under all subparts, because records that would be required under each 
of the subparts would aid farms in complying with the requirements of 
part 112; and allow farms to show, and FDA to determine, compliance 
with the requirements of part 112.
a. General Requirements
    As proposed, Sec.  112.161(a)(1) requires that your records 
include: (i) The name and location of your farm; (ii) actual values and 
observations obtained during monitoring; (iii) an adequate description 
(such as the commodity name, or the specific variety or brand name of a 
commodity, and, when available, any lot number or other identifier) of 
covered produce applicable to the record; (iv) the location of a 
growing area (for example, a specific field) or other area (for 
example, a specific packing shed) applicable to the record; and (v) the 
date and time of the activity documented.
    The name and location of your farm and the date and time would 
allow the owner, operator, or agent in charge of a farm (and, during 
inspection, an FDA investigator) to assess whether the record is 
current and establish the relevance of the record to your farm, which 
is necessary for review by regulators. An adequate description of 
covered produce would allow the farm to more readily track measures, 
identify a pattern of problems, and verify compliance. Such a 
description will also allow the farm to identify specific produce for 
which the standards of this part have not been met, and to take 
appropriate measures as provided for under Sec.  112.11.
    Recording actual values and observations during monitoring are 
necessary to produce an accurate record. Notations that monitoring 
measurements are ``satisfactory'' or ``unsatisfactory,'' without 
recording the actual times and observations (e.g., temperatures and 
turnings in treating biological soil amendments of animal origin) are 
vague and subject to varying interpretations and, thus, will not ensure 
that required measures have been taken or standards have been met. In 
addition, it is not possible to discern a trend without actual 
measurement values.
    Proposed Sec.  112.161(a)(1) is consistent with our HACCP 
regulations for seafood and juice. Our HACCP regulations for seafood 
and juice require that all records include the name and location of the 
processor; the date and time of the activity that the record reflects; 
the signature or initials of the person performing the operation; and 
where appropriate, the identity of the product and the production code, 
if any (Sec. Sec.  123.9(a) and 120.12(b), respectively). Our HACCP 
regulations for seafood and juice also require that records contain the 
actual values (such as temperature) and observations obtained during 
monitoring (Sec. Sec.  123.6(c)(7) and 120.12(b)(4), respectively).
    Additional requirements in proposed Sec.  112.161(a) include that 
records must be created at the time an activity is performed or 
observed (proposed Sec.  112.161(a)(2)); be accurate, legible, and 
indelible (proposed Sec.  112.161(a)(3)); and be dated, and signed or 
initialed by the person who performed the activity documented (proposed 
Sec.  112.161(a)(4)).
    These requirements would ensure that the records are useful to the 
owner, operator, or agent in charge of a farm in complying with the 
requirements of part 112, for example, in documenting compliance with 
monitoring requirements. These proposed requirements would also ensure 
that the records would be useful to FDA in determining compliance with 
the requirements of part 112. For example, the signature of the 
individual who made the observation would ensure responsibility and 
accountability. In addition, if there is a question about the record, a 
signature would ensure that the source of the record will be known. 
These proposed requirements are consistent with our HACCP regulations 
for seafood and juice. Our HACCP regulations for seafood and juice 
require that processing and other information be entered on records at 
the time that it is observed (Sec. Sec.  123.9(a)(4) and 120.12(b)(4), 
respectively).
    As proposed, under Sec.  112.161(b), when records are required to 
be established and kept in subparts C, E, F, L, and M of this part 
(Sec. Sec.  112.30, 112.50, 112.60, 112.140, and 112.150), you must 
establish and keep documentation of actions you take when a standard in 
those subparts is not met. This documentation is necessary to show that 
you have taken the steps reasonably

[[Page 3604]]

necessary to minimize the risk of serious adverse health consequences 
or death from the use of, or exposure to, covered produce, including 
those measures reasonably necessary to prevent the introduction of 
known or reasonably foreseeable hazards into covered produce, and to 
provide reasonable assurances that the produce is not adulterated under 
section 402 of the FD&C Act. For example, if under Sec.  112.44(b) you 
are required to discontinue the use of agricultural water and take 
corrective steps, this provision would require you to establish and 
keep a record of the corrective steps that you took.
    As proposed, Sec.  112.161(c) would require a supervisor or 
responsible party to review, date, and sign those records that are 
required under 112.50(b)(4), 112.50(b)(5), 112.60(b)(1), 112.60(b)(3), 
112.140, 112.150(b)(1), 112.150(b)(4), and 112.161(b). These records 
relate to certain of your testing, monitoring, sanitizing, and 
corrective action activities. As described above, one of the primary 
purposes for establishing and maintaining records is so that you can 
review the records to see if the requirements of this part have been 
met. Requiring a signature from a supervisor or responsible party for 
these records emphasizes the importance of such a review.
b. Storage of Records
    Proposed Sec.  112.162 would establish the requirements regarding 
where your records must be stored. Proposed Sec.  112.162(a) 
establishes that offsite storage of records is permitted after 6 months 
following the date the record was made if such record can be retrieved 
and provided onsite within 24 hours of request for official review. FDA 
realizes that the proposed requirements for recordkeeping could require 
some farms to store a significant quantity of records, and that there 
may not be adequate storage space in the farm for these records. 
Providing for offsite storage of most records after 6 months would 
enable a farm to comply with the proposed requirements for record 
retention while reducing the amount of space needed for onsite storage 
of the records without interfering with the purpose of record 
retention, because the records will be readily available. Proposed 
Sec.  112.162(b) would clarify that electronic records are considered 
to be onsite at your farm if they are accessible from an onsite 
location at your farm. For example, we would consider electronic 
records to be onsite if they were available from your computer, 
including records transmitted to your computer via a network connection 
or accessed from either the Internet or electronic or digital storage 
applications.
    Proposed Sec.  112.162 is consistent with our HACCP regulations for 
seafood and juice. Our HACCP regulation for seafood provides for 
transfer of records if record storage capacity is limited on a 
processing vessel or at a remote processing site, if the records could 
be immediately returned for official review upon request (Sec.  
123.9(b)(3)). Our HACCP regulation for juice permits offsite storage of 
processing records after 6 months following the date that the 
monitoring occurred, if such records can be retrieved and provided 
onsite within 24 hours of request for official review and considers 
electronic records to be onsite if they are accessible from an onsite 
location (Sec.  120.12(d)(2)). We seek comment on the appropriateness 
of the proposed recordkeeping requirements.
c. Use of Existing Records
    As proposed, Sec.  112.163 would clarify that the regulations in 
this part do not require duplication of existing records if those 
records contain all of the information required by this part. In this 
provision, we seek to minimize the burden of keeping records to that 
which is necessary to accomplish the intended purposes of this part.
    For example, as proposed, you are not required to duplicate 
existing records, such as records kept to satisfy the requirements of 
the National Organic Program, if those records contain all of the 
information required by this part. Additionally, you are not required 
to keep all of the information required by this part in one set of 
records. Similarly, if you have records containing some but not all of 
the required information, this proposed regulation provides you the 
flexibility to keep any additional information required by this part 
either separately or combined with your existing records. While we 
propose this provision to give you the greatest degree of flexibility, 
we remind you that keeping records together in one place likely will 
expedite review of records in the event of a public health emergency or 
during an FDA inspection or investigation.
d. Length of Time for Records Storage
    Proposed Sec.  112.164(a) would require that you keep records 
required by this part for two years after the date the record was 
created. Retaining records for at least this length of time is 
necessary to ensure that the records are available for reference during 
verification activities as well as during FDA inspections. It is also 
critical for documentation and observation of trends of the food safety 
risks that may affect your operation over time. Multi-year retention of 
records allows an owner, operator, or agency to better understand and 
proactively respond to the risk factors affecting his or her farm. 
Since many weather events, such as drought or floods, which have an 
influence on the safety of fresh produce are relatively rare; 
maintaining historical records to inform the development of preventive 
controls specific to a given operation is invaluable. Similarly, 
proposed Sec.  112.164(b) would establish that records that relate to 
the general adequacy of the equipment or processes being used by a 
farm, including the results of scientific studies and evaluations, must 
be retained at the farm for at least two years after the use of such 
equipment or processes is discontinued.
    Certain growers and packers of covered produce currently retain 
records for at least two years. For example, produce operations 
certified by the National Organic Program must maintain their records 
relating to the production, harvesting, and handling of ``organic'' 
agricultural products for at least five years beyond the creation of 
the records (7 CFR 205.103). USDA's Agricultural Marketing Service 
requires that restricted use pesticide records be maintained for two 
years from the date of pesticide application (7 CFR 110.3). Under 
USDA's regulations implementing the Perishable Agricultural Commodities 
Act, 1930 (PACA), packers who pack and sell another firm's produce and 
growers and packers who voluntarily obtain a PACA license are required 
to preserve records for two years (7 CFR 46.14). Under the Florida 
Tomato Rule (``Tomato Good Agricultural Practices [T-GAP] & Tomato Best 
Management Practices'') (Ref. 262), firms must keep records documenting 
adherence to T-GAPs, ``including those addressing environmental review, 
water usage, record of completed education and training, pest control 
and crop production practices for the operation,'' for at least three 
calendar years (Ref. 44). Participants in the California Leafy Green 
Marketing Agreement (LGMA) must maintain their records kept under the 
LGMA agreement for two years (Ref. 45).
e. Acceptable Formats for Records
    As proposed, Sec.  112.165 would require that you keep records as 
either: (a) Original records; (b) true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records); or (c) electronic records in 
compliance

[[Page 3605]]

with part 11. True copies of records should be of sufficient quality to 
detect whether the original record was changed or corrected in a manner 
that obscured the original entry (e.g., through the use of white-out). 
Proposed Sec.  112.165 would provide flexibility for mechanisms for 
keeping records while maintaining the integrity of the recordkeeping 
system. The proposed requirement allowing true copies is consistent 
with other regulations such as our Good Manufacturing Practices (GMPs) 
regulation for dietary supplements (Sec.  111.605(b)) and provides 
options that may be compatible with the way records are currently being 
kept in plants and facilities.
    Proposed Sec.  112.165 also would require that electronic records 
be kept in accordance with part 11 (21 CFR part 11). Part 11 provides 
criteria for acceptance by FDA, under certain circumstances, of 
electronic records, electronic signatures, and handwritten signatures 
executed to electronic records as equivalent to paper records and 
handwritten signatures executed on paper. The proposed requirement 
clarifies and acknowledges that records required by part 112 may be 
retained electronically, provided that they comply with part 11.
    FDA tentatively concludes that it is appropriate to apply the 
requirements of part 11 to the records that would be required to be 
kept under part 112. However, we request comment on whether there are 
any circumstances that would warrant not applying part 11 to records 
that would be kept under part 112. For example, would a requirement 
that electronic records be kept according to part 11 mean that current 
electronic records and recordkeeping systems would have to be recreated 
and redesigned, which we determined to be the case in the regulation 
Establishment and Maintenance of Records Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (69 FR 
71562; December 9, 2004 (the BT records regulation))? For the purposes 
of the records requirements in the BT records regulation, we concluded 
that it was not necessary for new recordkeeping systems to be 
established as long as current practices would satisfy the requirements 
of the Act and, therefore, we exempted the records from the 
requirements of part 11 (21 CFR 1.329(b)). We also exempted records 
related to certain cattle materials prohibited from use in human food 
and cosmetics from part 11 (21 CFR 189.5(c)(7) and 700.27(c)(7), 
respectively). We also seek comment on whether we should allow 
additional time for electronic records to be kept in accordance with 
part 11. Comments should provide the basis for any view that the 
requirements of part 11 are not warranted.
f. Making Records Available for Official Review
    Proposed Sec.  112.166(a) would require that you have all records 
required under this part readily available and accessible during the 
retention period for inspection and copying by FDA upon oral or written 
request, except that you have 24 hours to obtain records you keep 
offsite and make them available and accessible to FDA for inspection 
and copying. Our access to records required under this part would 
expedite efforts to document and ensure that covered produce is not 
adulterated, as well as to quickly and accurately identify any 
adulterated covered produce and prevent it from reaching consumers. For 
example, during a foodborne illness outbreak or contamination 
investigation, records access would help enable you and us to pinpoint 
the source and cause of contamination in a timely manner. This 
provision is consistent with our HACCP regulations for juice (Sec.  
120.12(e)) and seafood (Sec.  123.9(c)), and dietary supplement GMPs 
(Sec.  111.610(b)), which require that all records required under those 
rulemakings be available for review and copying at reasonable times. 
This provision also is similar to requirements in the infant formula 
quality control procedures regulation (Sec.  106.100(l)) stating that 
manufacturers make readily available for authorized inspection all 
records required under those regulations. In addition, this proposed 
provision is similar to provisions in the juice HACCP regulation (Sec.  
123.9(f)) and in the regulation on production, storage, and 
transportation of shell eggs (Sec.  118.10(d)) that require that firms 
be able to retrieve and provide any records stored offsite within 24 
hours of request for official review.
    Proposed Sec.  112.166(b) would require that if you use electronic 
techniques to keep records, or to keep true copies of records, or if 
you use reduction techniques such as microfilm to keep true copies of 
records, that you provide the records to us in a format in which they 
are accessible and legible. For example, you might provide us with an 
unencrypted copy of an electronic record or provide us with suitable 
equipment for viewing, printing, and copying a record. This provision 
would enable us to comprehend your records in a timely manner.
    Consistent with proposed Sec.  112.166(a), proposed Sec.  
112.166(c) would require that if your farm is closed for a prolonged 
period, the records may be transferred to some other reasonably 
accessible location but must be returned to your farm within 24 hours 
for official review upon request. Allowing for transfer of records will 
give practical storage relief to seasonal operations or those closed 
for other reasons for prolonged periods. Proposed Sec.  112.166(c) is 
consistent with our HACCP regulations for seafood and juice, which 
provide for transfer of records for facilities closed for prolonged 
periods (between seasonal packs, in the case of juice) if the records 
could be immediately returned for official review upon request 
(Sec. Sec.  123.9(b)(3) and 120.12(d)(3) for seafood and juice, 
respectively).
g. Disclosure Requirements
    Proposed Sec.  112.167 would specify that records required by this 
part are subject to the disclosure requirements under part 20 of this 
chapter. FDA's regulations in 21 CFR part 20, FOIA, the Trade Secrets 
Act [18 U.S.C. 1905], and the FD&C Act govern FDA's disclosures of 
information, including treatment of confidential commercial information 
and trade secret information. Our general policies, procedures, and 
practices relating to the protection of confidential information 
received from third parties would apply to information received under 
this rule. Proposed Sec.  112.167 is consistent with, but framed 
differently than, the disclosure provisions of the HACCP regulations 
for seafood and juice (Sec. Sec.  123.9(d) and 120.12(f), 
respectively). Proposed Sec.  112.167 is framed similarly to the 
disclosure provisions for records that must be kept under part 118 
(Prevention of Salmonella Enteritidis in Shell Eggs During Production); 
under Sec.  118.10(f), records required by part 118 are subject to the 
disclosure requirements under part 20.

P. Subpart P--Variances

1. Relevant Provisions of Section 419 of the FD&C Act
    In section 419(c), the FD&C Act establishes criteria for the final 
regulation, including that the final regulation ``permit States and 
foreign countries from which food is imported into the United States to 
request from the Secretary variances from the requirements of the 
regulations, subject to [section 419(c)(2) of the FD&C Act], where the 
State or foreign country determines that the variance is necessary in 
light of local growing conditions and that the procedures, processes, 
and practices to be followed

[[Page 3606]]

under the variance are reasonably likely to ensure that the produce is 
not adulterated under section 402 [of the FD&C Act] and to provide the 
same level of public health protection as the requirements of the 
regulations adopted under [section 419(b) of the FD&C Act]'' (section 
419(c)(1)(F)). Section 419(c)(2) specifies the following:
    ``REQUESTS FOR VARIANCES.--A State or foreign country from which 
food is imported into the United States may in writing request a 
variance from the Secretary. Such request shall describe the variance 
requested and present information demonstrating that the variance does 
not increase the likelihood that the food for which the variance is 
requested will be adulterated under section 402, and that the variance 
provides the same level of public health protection as the requirements 
of the regulations adopted under [section 419(b) of the FD&C Act]. The 
Secretary shall review such requests in a reasonable timeframe'' 
(section 419(c)(2)(A)).
    ``APPROVAL OF VARIANCES.--The Secretary may approve a variance in 
whole or in part, as appropriate, and may specify the scope of 
applicability of a variance to other similarly situated persons'' 
(section 419(c)(2)(B)).
    ``DENIAL OF VARIANCES.--The Secretary may deny a variance request 
if the Secretary determines that such variance is not reasonably likely 
to ensure that the food is not adulterated under section 402 and is not 
reasonably likely to provide the same level of public health protection 
as the requirements of the regulation adopted under [section 419(b) of 
the FD&C Act]. The Secretary shall notify the person requesting such 
variance of the reasons for the denial'' (section 419(c)(2)(C)).
    ``MODIFICATION OR REVOCATION OF A VARIANCE.--The Secretary, after 
notice and an opportunity for a hearing, may modify or revoke a 
variance if the Secretary determines that such variance is not 
reasonably likely to ensure that the food is not adulterated under 
section 402 and is not reasonably likely to provide the same level of 
public health protection as the requirements of the regulations adopted 
under [section 419(b) of the FD&C Act]'' (section 419(c)(2)(D)).
2. Proposed Requirements
    Consistent with the statutory provisions mentioned above, in this 
subpart, we propose a process by which variances from one or more 
requirements of part 112 may be requested by a State or foreign 
government, information that must accompany such requests, and the 
procedures and circumstances under which FDA may grant or deny such 
requests, and modify or revoke such variances. Variances approved by 
FDA would be limited to the requirements of part 112 specified by FDA, 
and have no effect on the application of other provisions of the FD&C 
Act.
    Consistent with section 419(c)(2)(A) of the Act, proposed Sec.  
112.171 would establish that a State or foreign country from which food 
is imported into the U.S. may request a variance from one or more of 
the requirements proposed in part 112, where the State or foreign 
country determines that the variance is necessary in light of local 
growing conditions (proposed Sec.  112.171(a)); and the procedures, 
processes, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulterated under 
Section 402 of the Act and to provide the same level of public health 
protection as the requirements of proposed part 112 (proposed Sec.  
112.171(b)). Such a determination would likely be based on the 
particular crop, climate, soil, geographic, and environmental 
conditions of a particular region, as well as processes, procedures, or 
practices followed in that region. Given the diversity of covered 
produce commodities and covered activities subject to the requirements 
of part 112, we tentatively conclude that this provision provides 
sufficient flexibility while ensuring the same level of public health 
protection for covered produce. For example, a State or foreign country 
may consider that the historical performance of an industry within 
their jurisdiction (e.g., as indicated by the epidemiological record) 
and the combination of measures taken by that industry merits 
requesting a variance from some or all provisions of this proposed 
rule. In requesting a variance, among other things, the State or 
foreign country would submit information that, while the procedures, 
processes and practices to be followed under the variance would be 
different from those prescribed in this proposed rule, the requested 
variance is reasonably likely to ensure that the produce is not 
adulterated under section 402 of the FD&C Act and provide the same 
level of public health protection as the requirements of the final 
regulations (see proposed 112.173). FDA would encourage consideration 
of these kinds of submissions, and welcomes requests for pre-petition 
consultations, including meetings, with interested States or foreign 
governments to facilitate the development of variance petitions, 
including data and information that would be needed to demonstrate that 
the variance is necessary in light of local growing conditions and that 
the procedures, processes, and practices to be followed under the 
variance are reasonably likely to ensure that the produce is not 
adulterated under Section 402 of the Act and provide the same level of 
public health protection as the requirements in this rule, when 
finalized. As discussed in section IV.K, FDA is proposing extended 
compliance dates for this proposed rule. We expect that these 
compliance periods would allow sufficient time for variance petitions 
to be developed, submitted, and reviewed by FDA. We request comment on 
the compliance periods.
    In proposed Sec.  112.172, we propose to establish that a request 
for a variance, as described in proposed Sec.  112.171, must be 
submitted by the competent authority (e.g., the regulatory authority 
for food safety) for the state or foreign government to FDA in the form 
of a citizen petition in accordance with 21 CFR 10.30.
    In proposed Sec.  112.173, we propose that, in addition to the 
requirements set forth in Sec.  10.30, the Statement of Grounds (which 
is specified under Sec.  10.30(b)) such petition requesting a variance 
must include a statement that the applicable State or foreign country 
has determined that the variance is necessary in light of local growing 
conditions and that the procedures, processes, and practices to be 
followed under the variance are reasonably likely to ensure that the 
produce is not adulterated under Section 402 of the Act and to provide 
the same level of public health protection as the requirements of this 
part (proposed Sec.  112.173(a)). In addition, the Statement of Grounds 
would be required to describe with particularity the variance 
requested, including the persons to whom the variance would apply and 
the provision(s) of part 112 to which the variance would apply 
(proposed Sec.  112.173(b)); and present information demonstrating that 
the procedures, processes, and practices to be followed under the 
variance requested are reasonably likely to ensure that the produce is 
not adulterated under Section 402 of the Act and to provide the same 
level of public health protection as the requirements of proposed part 
112 (proposed Sec.  112.173(c)). Under these provisions, a State or 
foreign country would be required to submit relevant and 
scientifically-valid information or materials specific to the covered 
produce or covered activity to support the petitioner's determination 
that the variance requested is reasonably likely

[[Page 3607]]

to ensure that the produce is not adulterated under Section 402 of the 
Act and to provide the same level of public health protection as the 
requirements of this part. This would include information about the 
crop, climate, soil, and geographical or environmental conditions of a 
particular region, as well as the processes, procedures, or practices 
followed in that region.
    Proposed Sec.  112.174 establishes our presumption that information 
submitted in a petition requesting a variance and comments submitted on 
such a petition, including a request that a variance be applied to its 
similarly situated persons, does not contain information exempt from 
public disclosure under part 20 of this chapter and would be made 
public as part of the docket associated with this request. We do not 
believe that information exempt from disclosure under part 20 of this 
chapter is the type of information that FDA is requiring to be 
submitted in such a petition or that would be relevant in any comments 
submitted on such a petition. We also believe that providing full 
public access to this information is important to ensuring transparency 
and for the opportunity for states and foreign governments to request 
similar variances for similarly situated persons. Therefore, we expect 
to make these submissions publicly available.
    Proposed Sec.  112.175 would establish the Director or Deputy 
Directors of the Center for Food Safety and Applied Nutrition (CFSAN), 
or the Director of the Office of Compliance, CFSAN as the responsible 
official for responding to a request for a variance from one or more 
requirements in proposed part 112.
    Proposed Sec.  112.176 would establish the general procedures 
applying to a petition requesting a variance from one or more 
requirements in proposed part 112. Proposed Sec.  112.176(a) would 
provide that the procedures sets forth in Sec.  10.30 govern the 
process by which FDA responds to a petition requesting a variance. 
Section 10.30 of this chapter specifies the requirements for any 
citizen petition submitted by a person (including a petitioner who is 
not a citizen of the United States) to FDA. Proposed Sec.  112.176(b) 
would establish that, under Sec.  10.30(h)(3) of this chapter, we will 
publish a notice in the Federal Register, requesting information and 
views on the filed petition, including information and views from 
persons who could be affected by the variance if the petition were to 
be granted (either because their farm is covered by the petition or as 
a person similarly situated to persons covered by the petition). For 
example, similarly situated persons may include those whose farm 
operates under similar circumstances with similar procedures, 
processes, and practices as those covered by the petition. Proposed 
Sec.  112.176(c) would establish that, under Sec.  10.30(e)(3), FDA 
will respond to the petitioner in writing and will publish a notice on 
our Web site announcing our decision to either grant or deny the 
petition. Proposed Sec.  112.176(c)(1) would establish that, if we 
grant the petition, either in whole or in part, we will specify the 
persons to whom the variance would apply and the provision(s) of this 
part to which the variance would apply. Proposed Sec.  112.176(c)(2) 
would establish that, if FDA denies the petition (including partial 
denials), FDA will explain the reason(s) for the denial in its written 
response to the petitioner and in the notice on our Web site announcing 
the decision to deny. Under proposed Sec.  112.176(d), we propose to 
make readily accessible to the public, and periodically update, a list 
of filed petitions requesting variances, including the status of each 
petition (for example, pending, granted, or denied). The provisions in 
proposed Sec.  112.176 would ensure transparency in FDA's activities 
and decision-making, which allows the public to better understand the 
agency's decisions, increasing credibility and promoting 
accountability.
    Proposed Sec.  112.177 would establish circumstances under which an 
approved variance could apply to any person other than those identified 
in the petition requesting the variance. Under proposed Sec.  
112.177(a), a State or a foreign country that believes that a variance 
requested by a petition submitted by another State or foreign country 
should also apply to similarly situated persons in its jurisdiction may 
request that the variance be applied to its similarly situated persons 
by submitting comments in accordance with Sec.  10.30. These comments 
must include the information required in Sec.  112.173. If FDA 
determines that these comments should instead be treated as a separate 
request for a variance, FDA will notify the State or foreign country 
that submitted these comments that a separate request must be submitted 
in accordance with Sec. Sec.  112.172 and 112.173. Moreover, under 
proposed Sec.  112.177(b), we propose that if we grant a petition 
requesting a variance, in whole or in part, we may specify that the 
variance also applies to persons in a specific location who are 
similarly situated to those identified in the petition. Consequently, 
under proposed Sec.  112.177(c), if we specify that the variance also 
applies to persons in a specific location who are similarly situated to 
those identified in the petition, we will inform the applicable State 
or foreign country where the similarly situated persons are located of 
our decision in writing and will publish a notice on our Web site 
announcing our decision to apply the variance to similarly situated 
persons in that particular location. We tentatively conclude that the 
provisions in proposed Sec.  112.177 ensure consideration of the 
application of variances to similarly situated persons to and provide 
for transparency and accountability in FDA's review of requests and 
decision-making.
    Proposed Sec.  112.178 would provide that we may deny a variance 
request if it does not provide the information required under proposed 
Sec.  112.173 (including the requirements of Sec.  10.30), or if we 
determine that the variance is not reasonably likely to ensure that the 
produce is not adulterated under Section 402 of the Act and to provide 
the same level of public health protection as the requirements of this 
part. For example, we would expect to deny a petition if the State or 
foreign government failed to submit scientifically-valid data, 
information, or materials to demonstrate that the procedures, 
processes, or practices to be followed under the requested variance are 
reasonably likely to ensure that the produce is not adulterated under 
Section 402 of the Act and to provide the same level of public health 
protection as the requirements of proposed part 112.
    Proposed Sec.  112.179 would specify that a variance approved by 
FDA becomes effective on the date of our written decision on the 
petition.
    Under proposed Sec.  112.180, we would be able to modify or revoke 
an approved variance if we determine that such variance is not 
reasonably likely to ensure that the produce is not adulterated under 
Section 402 of the Act and to provide the same level of public health 
protection as the requirements of proposed part 112. For example, we 
may deem it necessary to modify terms and conditions of the variance 
based on a review of updated scientific data or factual information 
that is applicable to the covered produce and procedures, processes, or 
practices followed under the variance.
    Proposed Sec.  112.181 would establish the procedures that apply if 
FDA determines that an approved variance should be modified or revoked. 
Under Sec.  112.181(a), we would provide notice of such a determination 
as follows: (1) We will notify a State or a foreign country directly, 
in writing at the

[[Page 3608]]

address identified in its petition, if we determine that a variance 
granted in response to its petition should be modified or revoked. Our 
direct, written notification will provide the State or foreign country 
with an opportunity to request an informal hearing under part 16 of 
this chapter; (2) We will publish in the Federal Register a notice of 
our determination that a variance should be modified or revoked. This 
notice will establish a public docket so that interested parties may 
submit written submissions on our determination; and (3) When 
applicable, we will: (i) Notify in writing any States or foreign 
countries where a variance applies to similarly situated persons of our 
determination that the variance should be modified or revoked; (ii) 
Provide those States or foreign countries with an opportunity to 
request an informal hearing under part 16 of this chapter; and (iii) 
Include in the Federal Register notice described in paragraph (a)(2) of 
this section public notification of our decision to modify or revoke 
the variance granted to States or foreign countries in which similarly 
situated persons are located.
    Under Sec.  112.181(b), we would consider submissions from affected 
States or foreign countries and from other interested parties as 
follows: (1) We will consider requests for hearings by affected States 
or foreign countries under part 16 of this chapter. If FDA grants a 
hearing, we will provide the State or foreign country with an 
opportunity to make an oral submission. We will provide notice on our 
Web site of the hearing, including the time, date, and place of 
hearing. If more than one State or foreign country requests an informal 
hearing under part 16 of this chapter about our determination that a 
particular variance should be modified or revoked, we may consolidate 
such requests (for example, into a single hearing); and (2) We will 
consider written submissions submitted to the public docket from 
interested parties.
    Under Sec.  112.181(c), we would provide notice of our final 
decision as follows: (1) On the basis of the administrative record, FDA 
will issue a written decision, as provided for under part 16 of this 
chapter; and (2) We will publish a notice of our decision in the 
Federal Register. The effective date of the decision will be the date 
of publication of the notice.
    We tentatively conclude that these provisions are necessary not 
only to ensure transparency and accountability in FDA's activities and 
decision-making, but also to provide relevant parties with an 
opportunity for due process.
    Finally, in proposed Sec.  112.182, we would provide examples of 
permissible types of variances. These examples of variances from 
certain requirements in proposed part 112 are consistent with our 
proposed provisions in subpart B for alternatives from requirements in 
proposed part 112. A State or foreign government may request a variance 
from other requirements in proposed part 112, provided the conditions 
described in proposed Sec.  112.171 are met.
3. Conforming Amendment to 21 CFR Part 16
    We propose to amend Sec.  16.1(b)(1) to include Section 
419(c)(2)(D) of the FD&C Act relating to the modification or revocation 
of a variance from the requirements of Section 419 of the FD&C Act, to 
the list of statutory and regulatory provisions under which regulatory 
hearings are available.

Q. Subpart Q--Compliance and Enforcement

1. Overall Strategy for Implementation and Compliance
    FDA expects this proposed rule to improve produce safety to the 
extent the proposed requirements related to practices are actually 
implemented by farms. Many farms already follow some or all of the 
proposed practices, but we recognize that, when finalized, the proposed 
rule will be the first national standard for on-farm practices related 
to produce safety and that it will take time and a concerted, 
community-wide effort for the wide range of farms to come into full 
compliance. FDA is committed to working with the produce community and 
with partners in the U.S. Department of Agriculture, State agencies, 
and foreign governments to facilitate compliance through education, 
technical assistance and regulatory guidance.
    We anticipate that compliance will be achieved primarily through 
the conscientious efforts of farmers, complemented by the efforts of 
State and local governments, extension services, private audits and 
certifications, and other private sector supply chain management 
efforts. We also recognize that the time needed to comply will vary, so 
we are proposing to phase in compliance dates based on farm size (see 
section IV.K of this document).
    Under the FD&C Act, FDA has authority to inspect produce farms and 
can take enforcement action when needed to prevent significant hazards 
from entering the food supply or in response to produce safety 
problems, although FDA faces severe constraints in inspection and 
enforcement when it comes to foreign farms. FDA's inspection resources 
are very limited, however, in relation to the number of produce farms 
and the many other food production, processing and storage settings for 
which FDA has regulatory responsibility. Thus, as outlined below, FDA 
inspection will play an important but necessarily limited role in the 
overall compliance effort. FDA invites comment on all aspects of its 
compliance strategy.
2. Education, Technical Assistance and Regulatory Guidance
    Education and technical assistance is the foundation of our 
intended compliance strategy. As discussed in section II.D. above, FDA 
has, together with USDA AMS, established a jointly-funded Produce 
Safety Alliance (PSA), a public-private partnership that will develop 
and disseminate science- and risk-based training and education programs 
to provide produce growers and packers with fundamental food safety 
knowledge. A first phase of PSA's work is intended to assist farms, 
especially small and very small farms, in establishing food safety 
programs consistent with the GAPs Guide and other existing guidances so 
that they will be better positioned to comply when we issue a final 
produce safety rule under section 419 of the FD&C Act. As this 
rulemaking progresses, FDA will work to ensure that the PSA materials 
are modified, as needed, to be consistent with the requirements of the 
produce safety rule. FDA intends to work with federal, State, and local 
officials, industry, and academia through the PSA to assist farmers to 
implement measures necessary to minimize the risk of serious adverse 
health consequences or death from consumption of covered produce.
    We also will work to provide education and technical assistance 
through other sources of information that are familiar to the produce 
farming community (such as Cooperative Extension, land grant 
universities, trade associations, and foreign partners and JIFSAN to 
reach farmers exporting covered produce into the U.S. in their local 
languages). We plan to work with these and other stakeholders to 
develop a network of institutions that can provide technical assistance 
to the farming community, especially small and very small farms, as 
they endeavor to comply with the provisions of the final rule.
    FDA intends to further facilitate compliance with a final produce 
safety rule through the development and dissemination of guidance, in 
multiple

[[Page 3609]]

languages, on procedures, conditions, and practices that farms can 
implement to reduce the risk of known or reasonably foreseeable 
hazards. Section 419(e) of the FD&C Act requires FDA to develop 
guidance ``for the safe production and harvesting of specific types of 
fresh produce under [section 419]'' and to hold at least three public 
meetings in diverse geographical areas of the U.S. as part of an effort 
to conduct education and outreach regarding the guidance. Consistent 
with this statutory provision, FDA plans to develop guidance materials, 
including additional guidances specific to commodities, practices, and 
conditions, as needed and informed, in part, by stakeholder input, 
including that received during public meetings.
    Section 419(a)(4) of FSMA states that ``the Secretary shall 
prioritize the implementation of the regulations under this section for 
specific fruits and vegetables that are raw agricultural commodities 
based on known risks which may include a history and severity of 
foodborne illness outbreaks.'' As discussed immediately above, we 
intend to fulfill this mandate by (1) conducting extensive outreach and 
educational efforts focused on the known risks of specific types of 
produce and specific types of agricultural practices applied to such 
produce; (2) focusing our inspection and enforcement efforts on farms 
that present the greatest risk based, in part, on past association with 
outbreaks, contamination, or the known risks of their agricultural 
practices and conditions and/or their specific types of produce; and 
(3) developing guidance materials related to the rule (including 
commodity-specific guidances) focused on known risks. We request 
comment on this approach and on specific strategies we should employ in 
order to best prioritize our implementation of the rule in this manner.
3. Supply Chain Management
    FDA anticipates that significant incentives and accountability for 
compliance with a final produce safety rule will come through non-
regulatory audits and supply chain management initiated by private 
entities.
    As discussed in section II.F.2. of this document, a number of 
retail produce buyers currently require, as a condition of sale, that 
their produce suppliers comply with and be audited by third parties for 
conformance with the FDA GAPs guide. USDA AMS also offers a GAPs and 
Good Handling Practices (GAP&GHP) Audit Verification Program. USDA AMS 
and the California Department of Food and Agriculture (CDFA) have 
developed and are implementing the California Leafy Greens Marketing 
Agreement (CA LGMA) to protect public health via compliance with the 
food safety practices that are accepted by the LGMA board (Ref. 45). 
Compliance with such practices is further verified for members and 
signatories to the agreement through mandatory government audits by 
CDFA auditors who are trained and licensed by USDA AMS (Ref. 263). 
Leafy greens growers in Arizona have adopted a similar marketing 
agreement and audit structure for their growers (Ref. 32).
    At the request of industry, the USDA AMS in 2009 held seven 
hearings throughout the United States to solicit input from the leafy 
greens industries across the U.S. regarding their desire to develop a 
proposed national marketing agreement for leafy greens. A decision 
regarding the proposed USDA AMS national marketing agreement for leafy 
greens is currently pending, but FDA and USDA are committed to working 
together to harmonize the provisions of any national or regional 
marketing agreements for produce with the provisions of any final rule 
FDA issues under section 419 of the FD&C Act. Rigorous audits conducted 
under national or regional marketing agreements can be an important 
tool for fostering compliance with the produce safety rule.
    FDA also intends to issue notices of proposed rulemaking 
implementing sections 418 and 805 of the FD&C Act (sections 103 and 301 
of FSMA). FDA is aware of the diversity in quality of audits and the 
need to strengthen that system, but we anticipate that audits will be 
an important source of accountability for compliance with a final 
produce safety rule.
4. Inspections
    With a community as large and diverse as the produce farming 
industry, it is not reasonable to expect that industry-wide compliance 
can be gained primarily through inspection and enforcement, though, of 
course, inspection and enforcement must be a component of our efforts. 
Inspections will, of necessity, be targeted to those farms that present 
the greatest risk based, in part, on their association with past 
outbreaks or contamination events and the risk associated with the 
agricultural practices they apply in the growing, harvesting, packing, 
and holding of covered produce.
    FDA intends to work collaboratively with our federal and State 
regulatory partners to use available inspection resources to conduct 
risk-based inspections of farms for compliance with a final produce 
safety regulation. Section 702(a)(1)(A) of the FD&C Act [21 U.S.C. 
372(a)(1)(A)] expressly authorizes FDA to conduct examinations and 
investigations for the purposes of the FD&C Act through any health, 
food, or drug officer or employee of any State, Territory, or political 
subdivision thereof (such as a locality), duly commissioned to act on 
behalf of FDA. Qualified State, Territorial, or local regulatory 
officials may be commissioned or serve under contract with FDA to 
conduct examinations, inspections, and investigations for purposes of 
the FD&C Act. In addition, section 702(a)(2) [21 U.S.C. 372(a)(2)] 
expressly authorizes FDA to conduct examinations and investigations for 
the purposes of the FD&C Act through officers and employees of another 
Federal department or agency, subject to certain conditions set forth 
in that section. We expect to continue to cooperatively leverage the 
resources of federal, State, and local government agencies in this way 
as we strive to obtain industry-wide compliance with a final produce 
safety rule.
    Section 419(b)(2)(A) of the FD&C Act specifically instructs FDA to 
``provide for coordination of education and enforcement activities by 
State and local officials, as designated by the Governors of the 
respective States or the appropriate elected State official as 
recognized by State statute.'' Consistent with this provision and with 
the direction to improve the training of State, local, territorial, and 
tribal food safety officials under Section 1011 of the FD&C Act (21 
U.S.C. 399c, added to the FD&C Act by section 209 of FSMA), FDA intends 
to work closely with extension and education organizations and State, 
local, territorial, and tribal partners to develop the tools and 
training programs needed to facilitate consistent inspection and 
regulatory activities associated with the requirements of a final 
produce safety rule. We expect to build on our collaboration with 
State, local, territorial, and tribal officials in the development of 
tools and training for use by inspectors in farm investigations on 
issues specific to food safety during growing, harvest, packing and 
holding produce.
    FDA anticipates that some States may choose to adopt requirements 
modeled after the provisions of a final federal produce safety rule and 
may choose to perform inspections under their own authorities to 
enforce those provisions of their state laws. Such actions would 
further drive compliance with a final federal produce safety rule.

[[Page 3610]]

5. Comments Related to the Proposed Provisions
    We received many comments on strategies for compliance, including 
comments from farmers, consumers, retail, State, federal and foreign 
governments, academia, trade associations and industry groups, and a 
non-profit research and advocacy organization. These comments broadly 
expressed strategies for compliance that included specific suggestions 
on how to ensure that all covered produce is in compliance with a final 
rule. Several comments recognized the importance of partnerships with 
respect to bringing about compliance with, and ultimately enforcing, a 
final rule. Comments urged the agency to work in cooperation with other 
federal, State, Territorial, tribal and local agencies with 
jurisdiction and expertise to ensure a coordinated and uniform approach 
to enforcement and compliance that will improve efficiency and 
effectiveness. Several comments noted that governmental testing 
laboratories should be recognized and funding should be provided to 
States to hire and train auditors.
    We agree that partnerships will play a crucial role in bringing the 
produce industry into compliance with a final rule. As discussed in our 
overall strategy above and reflected in proposed 112.193, FDA intends 
to work with State, Territorial, tribal, and local partners to develop 
the education and enforcement tools and training programs needed to 
facilitate consistent inspection and regulatory activities associated 
with the requirements of a final produce safety rule. Education and 
outreach through mechanisms like PSA and other sources of information 
that are familiar to the produce farming community (such as Cooperative 
Extension, land grant universities, and trade associations) are the 
foundation of our intended compliance strategy. We also plan to work 
with these and other stakeholders to develop a network of institutions 
that can provide technical assistance to the farming community, 
especially small and very small farms, as they endeavor to comply with 
the provisions of a final rule. Of course, although much of our initial 
effort will be focused on education and outreach, we will also inspect 
farms on a targeted basis for compliance with a final produce safety 
rule. Partnerships will play an important role with regard to 
inspections as well. FDA intends to work collaboratively with our 
federal, State, Territorial, tribal, and local regulatory partners to 
use available inspection resources to conduct risk-based inspections of 
farms for compliance with the final regulation. FDA intends to further 
facilitate compliance with our final regulation through the development 
and dissemination of guidance on procedures, conditions, and practices 
that farms can implement to reduce the risk of known or reasonably 
foreseeable hazards.
    Several comments noted that foreign governments could also play an 
important role in verifying compliance. Some noted that global 
recognition of food safety and food defense efforts should be 
developed. One country specifically requested that we recognize foreign 
fresh produce initiatives as equivalent oversight of the industry.
    We agree that foreign governments will play an important part in 
bringing about compliance with a final produce rule with respect to 
foreign products. We have already begun to reach out to foreign 
governments regarding the requirements of FSMA and will continue to 
provide technical assistance as we move closer to finalizing rules 
issued under FSMA authorities. There are several provisions of FSMA 
that directly relate to these partnerships. Section 305 of FSMA 
specifically directs us to develop a plan to build the capacity of 
foreign governments with respect to food safety that will include, 
among other things, training of foreign governments on our 
requirements, provisions for mutual recognition of inspection reports, 
and provisions for multilateral acceptance of laboratory methods and 
testing and detection techniques. Under section 307 of FSMA, which 
added section 808 to the FD&C Act [21 U.S.C. 384d], we are directed to 
establish a system for the recognition of accreditation bodies that 
accredit third-party auditors to certify that eligible entities meet 
certain requirements. Under that section, foreign governments or 
agencies of foreign governments, may be accredited as third party 
auditors who could help to ensure compliance with a final produce 
safety rule. Section 303 of FSMA amended section 801 of the FD&C Act 
to, among other things, allow us to designate an agency or 
representative of the foreign government of the country from which a 
food originated to provide certification or other assurances that 
certain foods are in compliance with the FD&C Act, if FDA chooses to 
require such certifications or assurances for certain foods. We are 
working to implement these provisions of FSMA. In addition, as set 
forth in subpart P of this proposed rule, foreign countries may request 
variances from requirements proposed in this rule, provided they meet 
certain conditions. See section V.P. of this document for further 
discussion of the process, conditions, and procedures related to a 
request for variance(s).
    In addition to partnering with other U.S. agencies and foreign 
governments, several comments discussed the strength of industry 
programs imposed throughout the supply chain and urged us to leverage 
these private sector efforts. Some commented on the importance of 
verification of compliance by qualified and independent third parties 
and recognition of third party certification. These third parties could 
be those hired by industry, including retailers, to ensure the safety 
of produce from their suppliers. However, some comments identified 
duplicative audits and excessive documentation as problematic, 
particularly for small growers. Other comments recognized that 
importers can play an important role in verifying compliance with a 
final produce safety rule and safety of imported produce.
    We agree that we should leverage the efforts of private supply 
chain management to further compliance with a final rule in this area. 
See discussion of our overall enforcement and compliance strategy 
immediately above. We also agree that importers will play an important 
role in ensuring the safety of produce grown in other countries and 
shipped to the United States. Under section 301 of FSMA, importers will 
have to verify that imported covered produce is produced in compliance 
with processes and procedures that provide the same level of public 
health protection as those required under section 419 of the FD&C Act.
    Other comments noted that compliance with produce safety 
requirements should be tiered to reflect farm size, market requirements 
and risk. One comment noted that there should be dedicated inspectors 
for identified groups that may need additional assistance.
    We agree that we should prioritize our compliance and enforcement 
efforts. As discussed above, we will be targeting our education efforts 
to the smaller businesses that may not be as familiar with our 
requirements as some of the larger farms. We also propose to give small 
and very small businesses extra time to comply with the final rule, as 
discussed in section IV.K of this document. With respect to 
inspections, they will, of necessity, be targeted to those farms that 
present the greatest risk based, in part, on their association with 
past outbreaks or contamination events and the risk associated with the 
agricultural practices they apply in the

[[Page 3611]]

growing, harvesting, packing, and holding of covered produce.
    A few comments mentioned that research can play an important part 
in bringing about industry compliance. Some noted that foodborne 
illness outbreak investigations needed to be improved and used as 
educational opportunities to support food safety research. They noted 
that better investigative methods should be developed to help reveal 
possible sources of contamination. FDA agrees, as reflected in the 
recent establishment of the Coordinated Outbreak Response and 
Evaluation (CORE) Network, which is a permanent cadre of FDA experts 
whose full time responsibility is to enhance outbreak detection, 
response, and follow up investigations to inform future prevention 
efforts. CORE will work with CDC, state and local partners, and the 
food industry to investigate root causes of major outbreaks and share 
findings with the food safety community.
    Comments also noted that a permanent institutional part of 
government should be developed to coordinate research, information, 
responses to, and control measures for, human pathogens and their 
evolution in the environment, including the farm environment, animal 
production, the industrial and commercial environment and the medical 
(healthcare) system. As discussed previously, we are pursuing 
regulatory science and research activities in collaboration with 
various partners. See section II.E. of this document for further 
information.
6. Proposed Requirements
    Proposed Sec.  112.191 states that the criteria and definitions in 
this part apply in determining whether a food is adulterated (1) within 
the meaning of section 402(a)(3) of the Federal Food, Drug, and 
Cosmetic Act in that the food has been grown, harvested, packed, or 
held under such conditions that it is unfit for food; or (2) within the 
meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic 
Act in that the food has been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with 
filth, or whereby it may have been rendered injurious to health. The 
criteria and definitions in this part also apply in determining whether 
a food is in violation of section 361 of the Public Health Service Act 
(42 U.S.C. 264).
    As discussed in section III of this document, FDA proposes these 
regulations under the FD&C Act as amended by FSMA, and the Public 
Health Service Act (PHS Act). We note that section 419(c)(1)(A) of the 
FD&C Act provides that FDA shall establish in this rulemaking 
``procedures, processes, and practices that the Secretary determines to 
be reasonably necessary * * * to provide reasonable assurances that the 
produce is not adulterated under section 402 [of the FD&C Act]'' and 
that similar references to preventing adulteration under section 402 of 
the FD&C Act also appear in section 419(c)(1)(F), (c)(2)(A), (c)(2)(C), 
and (c)(2)(D). In sections V.A. through V.O. of this document, we 
explain how the proposed provisions are necessary to protect against 
contamination with hazards that may adulterate food. We tentatively 
conclude that the link between the proposed provisions and the 
potential for adulteration provides a basis for applying the criteria 
and definitions in proposed part 112 in determining whether, under 
particular circumstances, a food is adulterated under section 402(a)(3) 
or (a)(4) or in violation of section 361 of the PHS Act. We also note 
402(a)(4) of the FD&C Act provides that food is adulterated if it has 
been ``prepared, packed, or held under insanitary conditions'' whereby 
either of the proscribed results may occur. ``Prepared, packed, or 
held'' includes growing, harvesting, packing, and holding. The common 
meaning of ``prepare,'' as represented by the dictionary definition is, 
in relevant part, ``to make ready beforehand for some purpose, use, or 
activity * * * to put together'' (Ref. 264). Growing and harvesting are 
operations that make food ready for use as food. In addition, growing 
and harvesting at times involve holding of food.
    Section 105(c) of FSMA amends section 301 of the FD&C Act (21 
U.S.C. 331) by adding a new section--(vv)--to the list of acts and the 
causing thereof that are prohibited. Under section 301(vv), the 
following act, and the causing thereof, is prohibited: ``[t]he failure 
to comply with the requirements under section 419 [of the FD&C Act].'' 
To clearly communicate that failure to comply with regulations 
established under section 419 is a prohibited act, proposed Sec.  
112.192 would establish that the failure to comply with the 
requirements of part 112, issued under section 419 of the Federal Food, 
Drug, and Cosmetic Act, is a prohibited act under section 301(vv) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(vv)).
    Proposed Sec.  112.193 provides that under Section 419(b)(2)(A) of 
the FD&C Act, FDA coordinates education and enforcement activities by 
State, Territorial, tribal, and local officials. As described above, we 
plan to work closely with State, Territorial, tribal, and local 
partners to develop the education and enforcement tools and training 
programs needed to facilitate consistent inspection and regulatory 
activities associated with the requirements proposed in subparts A 
through O.

R. Subpart R--Withdrawal of Qualified Exemption

    As proposed, subpart R establishes 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 Sec.  112.5. Specifically, proposed Sec.  112.201 lists 
the circumstances under which FDA can withdraw a qualified exemption 
applicable to a farm, while Sec. Sec.  112.202 and 112.203 specify 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 provide 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 provide a procedure for appeals, 
hearings, and decisions on appeals and hearings.
1. Requirements of Section 419 of the FD&C Act
    Section 419(f)(3)(A) of the FD&C Act specifies that, ``[i]n the 
event of an active investigation of a foodborne illness outbreak that 
is directly linked to a farm subject to an exemption under [section 
419(f) of the FD&C Act], or if the Secretary determines that it is 
necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or conditions associated 
with a farm that are material to the safety of the food produced or 
harvested at such farm, the Secretary may withdraw the exemption 
provided to such farm under [section 419(f) of the FD&C Act].'' Section 
419 does not expressly prescribe the procedures for withdrawing a 
qualified exemption provided to a farm under section 419(f). We 
tentatively conclude that it is appropriate to be transparent about the 
process we would use to withdraw a qualified exemption and that we 
should include the process in the proposed rule.
2. Proposed Requirements
a. Circumstances for Withdrawal
    Proposed Sec.  112.201 would establish the circumstances under 
which FDA can withdraw an exemption applicable to a farm. Consistent 
with Section 419(f)(3)(A) of the FD&C Act, it states

[[Page 3612]]

that we may withdraw your qualified exemption under proposed Sec.  
112.5:
    (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)).
    Proposed Sec.  112.201(a) would implement the statutory language of 
section 419(f)(3)(A) of the FD&C Act. An outbreak of foodborne illness 
is the occurrence of two or more cases of a similar illness resulting 
from the ingestion of a common food. Food can become contaminated at 
many different steps in the farm-to-table continuum: On the farm; in 
packing, manufacturing/processing, or distribution facilities; during 
storage or transit; at retail establishments; in restaurants; and in 
the home. When foodborne illness is associated with food, an 
investigation may enable us to directly link the illness to the farm 
that grew, harvested, packed, and/or held the food.
    Proposed Sec.  112.201(b) would also implement the statutory 
language of section 419(f)(3)(A) of the FD&C Act, which provides that 
FDA may withdraw a qualified exemption available to a farm under 
section 419(f) ``if the Secretary determines that it is necessary to 
protect the public health and prevent or mitigate a foodborne illness 
outbreak based on conduct or conditions associated with a farm that are 
material to the safety of the food produced or harvested at such 
farm.'' We tentatively conclude that the food to which this standard 
applies is food that would otherwise be covered produce, because that 
is the food that would be subject to this proposed rule if a qualified 
exemption is withdrawn. We also tentatively conclude that it is 
reasonable to interpret the word ``produced'' in this standard to refer 
to the activities within the farm definition other than harvesting, 
because this proposed rule would apply only to activities within the 
farm definition and the standard already uses the word ``harvested.'' 
Thus, proposed Sec.  112.201(b) would provide that FDA may withdraw the 
qualified exemption applicable to a farm under proposed Sec.  112.5 if 
FDA determines that it is necessary to protect the public health and 
prevent or mitigate a foodborne illness outbreak based on conduct or 
conditions associated with a farm that are material to the safety of 
the food that would otherwise be covered produce grown, harvested, 
packed, or held at such farm. As an example, we may receive reports to 
the Reportable Food Registry under section 417 of the FD&C Act about 
contamination of a food, and the reports may lead us to investigate a 
farm that grew, harvested, packed or held the food. If our 
investigation finds conduct or conditions associated with the farm that 
are material to the safety of the food that would otherwise be covered 
produce subject to proposed subparts B through O of this rule (for 
example, conduct or conditions that likely led to the contamination of 
the food), we would consider withdrawing the qualified exemption 
applicable to the farm under proposed Sec.  112.5 if doing so would be 
necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak. Likewise, if during a routine inspection of 
a farm to which the qualified exemption in proposed Sec.  112.5 
applies, we discover conditions and practices that are likely to lead 
to contamination of food that would otherwise be covered produce with 
microorganisms of public health significance, we would consider 
withdrawing the qualified exemption provided to the facility under 
proposed Sec.  112.5 if doing so would be necessary to protect the 
public health and prevent or mitigate a foodborne illness outbreak.
b. Procedure for Issuance of Withdrawal Order
    Proposed Sec.  112.202(a) would provide that, if FDA determines 
that a qualified exemption applicable to a farm under Sec.  112.5 
should be withdrawn, any officer or qualified employee of FDA may issue 
an order to withdraw the exemption. We intend to create and maintain a 
written record of a determination that the withdrawal of an exemption 
is warranted and to include the basis for the determination in the 
written record. Proposed Sec.  112.202(b) would require that 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 as part of the withdrawal determination procedure before the 
order is issued. A Regional Food and Drug Director is an example of an 
FDA official senior to a District Director. The Deputy Directors and 
Director of the Center for Food Safety and Applied Nutrition are 
examples of an FDA official senior to the Director of the Office of 
Compliance. Requiring prior approval of a withdrawal order by a 
District Director or an FDA official senior to a District Director is 
consistent with the approval requirement for a detention order in part 
1, subpart K (Administrative Detention of Food for Human or Animal 
Consumption). Requiring prior approval of a withdrawal order by the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition is consistent with current FDA practices when dealing 
with foreign firms. Proposed Sec.  112.202(c) would require that FDA 
issue an order to withdraw the exemption to the owner, operator, or 
agent in charge of the farm. We tentatively conclude that it would be 
appropriate for FDA to issue an exemption withdrawal order to any of 
these persons. Proposed Sec.  112.202(d) would require that FDA 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.
c. Information Included in FDA's Withdrawal Order
    Proposed Sec.  112.203(a) through (h) would require that an order 
to withdraw a qualified exemption applicable to a farm under Sec.  
112.5 include the following information:
    (a) The date of the order (proposed Sec.  112.203(a));
    (b) The name, address and location of the covered farm (proposed 
Sec.  112.203(b));
    (c) A brief, general statement of the reasons for the order, 
including information relevant to:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the farm; or
    (2) Conduct or conditions associated with a farm that are material 
to the safety of the food that would otherwise be covered produce 
grown, harvested, packed and held at such farm (proposed Sec.  
112.203(c));
    (d) A statement that the farm must comply with subpart B through 
subpart O of this part on the date that is 60 calendar days after the 
date of the order (proposed Sec.  112.203(d));
    (e) The text of section 419(f) of the Federal Food, Drug, and 
Cosmetic Act and of subpart R of the rule (proposed Sec.  112.203(e));
    (f) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 (21 CFR Part 
16), with certain exceptions described in proposed Sec.  112.208 
(proposed Sec.  112.203(f));
    (g) The mailing address, telephone number, email address, and 
facsimile number of the FDA district office and

[[Page 3613]]

the name of the FDA District Director in whose district the farm is 
located (or, in the case of a foreign farm, the same information for 
the Director of the Office of Compliance in the Center for Food Safety 
and Applied Nutrition); (proposed Sec.  112.203(g)); and
    (h) The name and the title of the FDA representative who approved 
the order (proposed Sec.  112.203(h)).
    FDA tentatively concludes that the requirements that we propose in 
Sec.  112.203 would provide the owner, operator, or agent in charge of 
a farm subject to a withdrawal with adequate notice of the basis for 
our determination to withdraw the exemption and of their opportunity to 
appeal our determination and to request an informal hearing. The 
proposed notification procedures are similar to and consistent with the 
notification requirements in other regulations involving administrative 
action, such as administrative detention of food under Sec.  1.393, 
orders for diversion or destruction of shell eggs under the PHS Act 
under Sec.  118.12(a)(i), and with procedures for an informal hearing 
in part 16. We seek comments on the proposed process for withdrawal of 
a qualified exemption.
d. Requirements When a Withdrawal Order Is Issued
    Proposed Sec.  112.204 would require that the owner, operator, or 
agent in charge of a farm that receives an order to withdraw an 
exemption applicable to that farm under Sec.  112.5 either (a) comply 
with applicable requirements of this part within 60 calendar days of 
the date of the order or, if operations have ceased and will not resume 
within 60 calendar days, before the beginning of operations in the next 
growing season; or (b) appeal the order within 10 calendar days of the 
date of the order in accordance with the requirements of Sec.  112.206. 
We tentatively conclude that either of the two circumstances that could 
result in our determination that an exemption should be withdrawn (as 
described in proposed Sec.  112.201) warrant prompt compliance with the 
rule in the interest of public health. We tentatively conclude that ten 
calendar days for the submission of an appeal from the date of the 
receipt of a withdrawal order is appropriate for purposes of the 
efficient adjudication of the appeal of a withdrawal order and would 
provide reasonable due process that comes to closure sufficiently in 
advance of the effective date of the order to provide an opportunity 
for the farm to come into compliance if we deny the appeal.
e. Procedure for Appealing a Withdrawal Order (Including Requests for 
Informal Hearing)
    Proposed Sec.  112.205(a) would establish that submission of an 
appeal, including submission of a request for an informal hearing, will 
not delay or stay any administrative action, including enforcement 
action by FDA, unless the Commissioner of Food and Drugs, as a matter 
of discretion, determines that delay or a stay is in the public 
interest. For example, the submission of an appeal of a withdrawal 
order with a request for an informal hearing would not prevent FDA from 
simultaneously detaining food from the farm under section 304(h) of the 
FD&C Act, seeking seizure of food from the farm under section 304(a) of 
the FD&C Act, or seeking or enforcing an injunction under section 302 
of the FD&C Act. Proposed Sec.  112.205(b) would require that, if the 
owner, operator, or agent in charge of the farm appeals the order, and 
FDA confirms the order, the owner, operator, or agent in charge of the 
farm must comply with applicable requirements of this part within 60 
calendar days of the date of the order or, if operations have ceased 
and will not resume within 60 calendar days, before the beginning of 
operations in the next growing season. Proposed Sec.  112.205(b) would 
make clear that the 60 calendar day time frame for compliance applies 
regardless of whether the owner, operator, or agent in charge of a farm 
requests, and FDA grants, a hearing. As already discussed, FDA 
tentatively concludes that the circumstances that lead to a 
determination that an exemption should be withdrawn warrant prompt 
compliance in the interest of public health.
    Proposed Sec.  112.206(a) would require that, to appeal an order to 
withdraw a qualified exemption applicable to a farm under Sec.  112.5, 
the owner, operator, or agent in charge of the farm must: (1) Submit 
the appeal in writing to the FDA District Director in whose district 
the farm is located (or, in the case of a foreign farm, to the Director 
of the Office of Compliance in the Center for Food Safety and Applied 
Nutrition), at the mailing address, email address, or facsimile number 
identified in the order within 10 calendar days of the date of the 
order; and (2) respond with particularity to the facts and issues 
contained in the order, including any supporting documentation upon 
which the owner, operator or agent in charge of the farm relies. 
Allowing the owner, operator, or agent in charge of the farm to submit 
an appeal in person, by mail, email, or fax would provide for 
flexibility as well as speed. For example, submitting in person would 
give the owner, operator, or agent in charge direct knowledge that the 
request for appeal had been delivered and received. Email and fax are 
instantaneous, and overnight mail delivery services are readily 
available to those who choose to use them; however, the ten day time 
frame for appeal of the order would not require the use of overnight 
mail delivery. For clarity, proposed Sec.  112.206(a)(1) would repeat 
the 10 calendar day time frame that would be established in proposed 
Sec.  112.204 and would not establish any new requirement. Any appeal 
would need to be written in order for FDA to evaluate the basis for the 
appeal. We are proposing that a written appeal would need to address 
with particularity all of the issues raised in the withdrawal order and 
include all supporting documentation so that we would be able to issue 
a final determination as to the disposition of the appeal solely on the 
basis of the materials submitted as part of the written appeal.
    Proposed Sec.  112.206(b) would provide that, in a written appeal 
of the order withdrawing an exemption provided under Sec.  112.5, the 
owner, operator, or agent in charge of the farm may include a written 
request for an informal hearing as provided in Sec.  112.207. 
Requesting an informal hearing does not mean that a hearing will be 
held, because we may deny the request (see discussion of proposed Sec.  
112.207(b) below). However, if the owner, operator, or agent in charge 
of the farm does not request an informal hearing at the time the 
written appeal is submitted, the owner, operator, or agent in charge of 
the farm will not be entitled to an informal hearing. Instead, FDA will 
make a final decision based on the written appeal and its supporting 
materials.
    Proposed Sec.  112.207(a)(1) would provide that, if the owner, 
operator, or agent in charge of the farm appeals the order, the owner, 
operator, or agent in charge of the farm may request an informal 
hearing. Proposed Sec.  112.207(a)(1) would restate an option that 
would be included in proposed Sec.  112.206(b) to highlight the 
opportunity to request an informal hearing. Proposed Sec.  
112.207(a)(2) would require that, if the owner, operator, or agent in 
charge of the farm appeals the order, the owner, operator, or agent in 
charge of the farm must submit any request for an informal hearing 
together with its written appeal submitted in accordance with Sec.  
112.206 within 10 calendar days of the date of the order. We 
tentatively conclude that requiring submission of a request for an 
informal hearing in writing at the time

[[Page 3614]]

that the owner, operator, or agent in charge of the farm would be 
required to submit a written appeal is appropriate for purposes of the 
efficient adjudication of the appeal of a withdrawal order and would 
provide reasonable due process that would come to closure sufficiently 
in advance of the effective date of the order to provide an opportunity 
for the farm to come into compliance if we deny the appeal.
    Proposed Sec.  112.207(b) would establish that a request for an 
informal hearing may be denied, in whole or in part, if the presiding 
officer determines that no genuine and substantial issue of material 
fact has been raised by the material submitted. Proposed Sec.  
112.207(b) would also provide that if the presiding officer determines 
that a hearing is not justified, written notice of the determination 
will be given to the owner, operator, or agent in charge of the farm 
explaining the reason for the denial. Under proposed Sec.  112.206(a), 
a written appeal would be required to respond with particularity to the 
facts and issues contained in the withdrawal order, including any 
supporting documentation upon which the owner, operator or agent in 
charge of the farm relies. If the materials submitted do not directly 
address the facts and issues contained in the withdrawal order in a 
manner that suggests that there is a genuine dispute regarding the 
material facts contained in the order, the presiding officer may 
determine that an informal hearing is not warranted. The presiding 
officer may include written notice of the determination that a hearing 
is not justified as part of the final decision on the appeal.
f. Procedure for Appeals (Including Informal Hearings)
    Proposed Sec.  112.208(a) would establish that, if the owner, 
operator or agent in charge of the farm requests an informal hearing, 
and FDA grants the request, the hearing will be held within 10 calendar 
days after the date the appeal is filed or, if applicable, within a 
time frame agreed upon in writing by the owner, operator, or agent in 
charge of the farm and FDA. We tentatively conclude that, if we grant a 
request for an informal hearing, holding the hearing within 10 calendar 
days, or within an alternative time frame as agreed upon in writing, is 
appropriate for purposes of the efficient adjudication of the appeal of 
a withdrawal order and would provide reasonable due process that would 
come to closure sufficiently in advance of the effective date of the 
order to provide an opportunity for the farm to come into compliance if 
we deny the appeal.
    Proposed 112.208(b) would establish that the presiding officer may 
require that a hearing conducted under this subpart be completed within 
1 calendar day, as appropriate. We tentatively conclude that, if we 
grant a request for an informal hearing, limiting the time for the 
hearing itself to be completed within 1 calendar day is appropriate for 
purposes of the efficient adjudication of the appeal of a withdrawal 
order and would provide reasonable due process that would come to 
closure sufficiently in advance of the effective date of the order to 
provide an opportunity for the farm to come into compliance if we deny 
the appeal.
    Proposed Sec.  112.208(c)(1) through (7) would establish that, if 
the owner, operator or agent in charge of the farm requests an informal 
hearing, and FDA grants the request, FDA must conduct the hearing in 
accordance with part 16, except that:
    (1) The order withdrawing an exemption under Sec.  112.5, rather 
than the notice under Sec.  16.22(a), provides notice of opportunity 
for a hearing under this section and is part of the administrative 
record of the regulatory hearing under Sec.  16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA District Director (or, in the case of a foreign farm, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition) as provided in the order withdrawing an exemption.
    (3) Section 112.209, rather than Sec.  16.42(a), describes the FDA 
employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a 
written report of the hearing. All written material presented at the 
hearing will be attached to the report. The presiding officer must 
include as part of the report of the hearing a finding on the 
credibility of witnesses (other than expert witnesses) whenever 
credibility is a material issue, and must include a proposed decision, 
with a statement of reasons. The hearing participant may review and 
comment on the presiding officer's report within 2 calendar days of 
issuance of the report. The presiding officer will then issue the final 
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report 
of the hearing and any comments on the report by the hearing 
participant under Sec.  112.208(c)(4) are part of the administrative 
record.
    (6) No party shall have the right, under Sec.  16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing pursuant to regulation in accordance with part 16, 
except that Sec.  16.95(b) does not apply to a hearing under this 
subpart. With respect to a regulatory hearing under this subpart, the 
administrative record of the hearing specified in Sec. Sec.  
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 112.208(c)(5) constitutes 
the exclusive record for the presiding officer's final decision. For 
purposes of judicial review under Sec.  10.45 of this chapter, the 
record of the administrative proceeding consists of the record of the 
hearing and the presiding officer's final decision.
    Under Sec.  16.1(b), the procedures in part 16 apply when a 
regulation provides a person with an opportunity for a hearing on a 
regulatory action under part 16. Section 419 of the FD&C Act does not 
expressly provide for a hearing if circumstances lead FDA to determine 
that a qualified exemption provided to a farm under proposed Sec.  
112.5 should be withdrawn. However, we tentatively conclude as a matter 
of agency discretion that providing an opportunity for a hearing by 
regulation in this subpart of the proposed rule would provide 
appropriate process to the owner, operator, or agent in charge of a 
farm subject to withdrawal of the farm's qualified exemption. We also 
tentatively conclude that the modified part 16 procedures contained in 
this proposed rule would provide the owner, operator, or agent in 
charge of a farm subject to a withdrawal order sufficient fairness and 
due process while enabling FDA to expeditiously adjudicate an appeal of 
a withdrawal order for which an informal hearing has been granted. We 
seek comment on this proposed process.
    Section 16.119 provides that, after any final administrative action 
that is the subject of a hearing under part 16, any party may petition 
the Commissioner for reconsideration of any part or all of the decision 
or action under Sec.  10.33 or may petition for a stay of the decision 
or action under Sec.  10.35. Proposed Sec.  112.208(c)(6) would specify 
that these procedures for reconsideration and stay would not apply to 
the process of withdrawing a qualified exemption provided under 
proposed Sec.  112.5. The circumstances that may lead FDA to withdraw a 
qualified exemption include

[[Page 3615]]

an active investigation of a foodborne illness outbreak that is 
directly linked to a farm, or our determination that it is necessary to 
protect the public health and prevent or mitigate a foodborne illness 
outbreak based on conduct or conditions associated with a farm that are 
material to the safety of the food that would otherwise be covered 
produce grown, harvested, packed, or held at such farm. Such 
circumstances require prompt action. Under Sec.  16.120, a farm that 
disagrees with FDA's decision to withdraw an exemption provided under 
Sec.  112.5 has an opportunity for judicial review in accordance with 
Sec.  10.45.
g. Presiding Officer
    Proposed Sec.  112.209 would require that the presiding officer for 
an appeal, and for an informal hearing, must be an FDA Regional Food 
and Drug Director or another FDA official senior to an FDA District 
Director. Under Sec.  16.42(b), an officer presiding over an informal 
hearing is to be free from bias or prejudice and may not have 
participated in the investigation or action that is the subject of the 
hearing or be subordinate to a person, other than the Commissioner, who 
has participated in such investigation or action. An order for the 
withdrawal of a qualified exemption applicable to a farm must be 
approved by a District Director or an official senior to a District 
Director. It is, therefore, necessary that appeals of a decision to 
issue a withdrawal order should be handled by persons in positions 
senior to the District Directors. The Regional Food and Drug Director 
is such a person and could be from the same region where the farm is 
located, provided that the Regional Food and Drug Director did not 
participate in the determination that an exemption should be withdrawn 
and is otherwise free from bias or prejudice. Alternatively, the 
Regional Food and Drug Director could be from a different region than 
the region where the farm is located, for example in the event the 
Regional Food and Drug Director for the region in which the farm is 
located is the FDA official who approved the withdrawal order. Any 
Office Director of FDA's Office of Regulatory Affairs could preside at 
a hearing, provided that the Office Director did not participate in the 
determination that an exemption should be withdrawn and is otherwise 
free from bias or prejudice.
h. Decisions on Appeals (Including Informal Hearings)
    Proposed Sec.  112.210(a) would require that, if the owner, 
operator, or agent in charge of a farm appeals the order without 
requesting a hearing, the presiding officer must issue a written report 
that includes a final decision confirming or revoking the withdrawal by 
the tenth calendar day after the appeal is filed. Under proposed Sec.  
112.201, FDA would issue a withdrawal order either in the event of an 
active investigation of a foodborne illness outbreak that is directly 
linked to a farm or if we determine that an exemption withdrawal is 
necessary to protect the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or conditions associated 
with a farm that are material to the safety of the food that would 
otherwise be covered produce grown, harvested, packed, or held by the 
farm. We tentatively conclude that we will need 10 calendar days to 
review the written appeal and the materials submitted with the written 
appeal, and that a final decision confirming or revoking a withdrawal 
order should be issued as quickly as possible in the interest of the 
public health and to provide reasonable due process that would come to 
closure sufficiently in advance of the effective date of the order to 
provide an opportunity for the farm to come into compliance if we deny 
the appeal.
    Proposed Sec.  112.210(b)(1) would require that, if the owner, 
operator, or agent in charge of a farm appeals the order and requests 
an informal hearing and, if FDA grants the request for a hearing and 
the hearing is held, the presiding officer must provide a 2 calendar 
day opportunity for the hearing participants to review and submit 
comments on the report of the hearing under Sec.  112.208(c)(4), and 
must issue a final decision within the 10-calendar day period after the 
hearing is held. We tentatively conclude that it is appropriate to 
grant the owner, operator, or agent in charge of a farm subject to a 
withdrawal order the opportunity to review and submit comments to the 
presiding officer's report because the report is part of the record of 
a final agency action (see discussion of proposed Sec.  112.211(d)) 
that is not subject to further reconsideration by FDA. The presiding 
officer would have discretion to determine whether to revise the report 
of the hearing in light of any comments that might be submitted by any 
of the hearing participants.
    Proposed Sec.  112.210(b)(2) would require that, if the owner, 
operator, or agent in charge of a farm appeals the order and requests 
an informal hearing and if FDA denies the request for a hearing, the 
presiding officer must issue a final decision on the appeal confirming 
or revoking the withdrawal within 10 calendar days after the date the 
appeal is filed. We tentatively conclude that ten calendar days for the 
presiding officer to issue a final decision is appropriate for purposes 
of the efficient adjudication of the appeal of a withdrawal order, 
would provide reasonable due process that would come to closure 
sufficiently in advance of the effective date of the order to provide 
an opportunity for the farm to come into compliance if we deny the 
appeal, and is in the interest of public health.
i. Revocation of Withdrawal Order
    Proposed Sec.  112.211(a) through (c) would establish that an order 
to withdraw a qualified exemption applicable to a farm under Sec.  
112.5 is revoked if:
    (a) The owner, operator, or agent in charge of the farm appeals the 
order and requests an informal hearing, FDA grants the request for an 
informal hearing, and the presiding officer does not confirm the order 
within the 10 calendar days after the hearing, or issues a decision 
revoking the order within that time (proposed Sec.  112.211(a)); or
    (b) The owner, operator, or agent in charge of the farm appeals the 
order and requests an informal hearing, FDA denies the request for an 
informal hearing, and FDA does not confirm the order within the 10 
calendar days after the appeal is filed, or issues a decision revoking 
the order within that time (proposed Sec.  112.211(b)); or
    (c) The owner, operator, or agent in charge of the farm appeals the 
order without requesting an informal hearing, and FDA does not confirm 
the order within the 10 calendar days after the appeal is filed, or 
issues a decision revoking the order within that time (proposed Sec.  
112.211(c)).
    We tentatively conclude that an order to withdraw an exemption may 
be revoked in one of two manners. First, we are proposing that the FDA 
officer responsible for adjudicating the appeal and presiding over a 
hearing, if one is granted, may expressly issue a written decision 
revoking the order within the specified 10 calendar day time frame. 
Second, we are proposing that the failure of the FDA officer 
responsible for adjudicating an appeal to issue a final decision 
expressly confirming the order within the specified time frames will 
also serve to revoke the order. We tentatively conclude that fairness 
would warrant the revocation of a withdrawal order if FDA is unable to 
meet the proposed deadlines for expressly confirming an order.
    Proposed Sec.  112.211(d) would establish that confirmation of a 
withdrawal order by the presiding

[[Page 3616]]

officer is considered a final agency action for purposes of section 702 
of title 5 of the United States Code (5 U.S.C. 702). A confirmation of 
an order withdrawing an exemption therefore would be reviewable by the 
courts under section 702 of title 5 and in accordance with Sec.  10.45 
(21 CFR 10.45).
3. Conforming Amendment to 21 CFR Part 16
    We propose to amend Sec.  16.1(b)(2) to include part 112, subpart 
R, relating to the withdrawal of a qualified exemption applicable to a 
farm, to the list of regulatory provisions under which regulatory 
hearings are available.

VI. Preliminary Regulatory Impact Analysis

A. Overview

    FDA has examined the impacts of this proposed rule 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). FDA has developed a preliminary regulatory impact analysis 
(PRIA) that presents the benefits and costs of this proposed rule (Ref. 
265). FDA believes that the proposed rule will be an economically 
significant regulatory action as defined by Executive Order 12866. FDA 
requests comments on the PRIA.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because many small businesses will need to implement 
a number of new provisions, FDA acknowledges that the final rules 
resulting from this proposed rule will have a significant economic 
impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    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, or innovation; or significant 
adverse effects on the ability of United States-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.

D. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA expects that the 
proposed rule will result in a 1-year expenditure that would exceed 
this amount.

E. 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). The collections of information in the proposed 
rule have been submitted to OMB for review under Section 3507(d) of the 
Paperwork Reduction Act of 1995. 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.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to [email protected]. All comments should be 
identified with the title ``Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption.'' In compliance 
with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the 
Agency has submitted the information collection provisions of this 
proposed rule to OMB for review. These requirements will not be 
effective until FDA obtains OMB approval. FDA will publish a notice 
concerning OMB approval of these requirements in the Federal Register.

F. Public Access to the Analyses

    The analyses that FDA has performed in order to examine the impacts 
of this 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) are available to the public 
in the docket for this proposed rule (Ref. 265).

VII. Analysis of Environmental Impact

    The agency has prepared a categorical exclusion determination 
relying upon the categorical exclusion at 21 CFR 25.30(j) and the 
determination that there are no extraordinary circumstances which raise 
the potential for this rule to individually or cumulatively have a 
significant effect on the human environment (Ref. 266). FDA requests 
comment on its analysis and determination. As set out in more detail in 
Section IX of this document, to the extent there are any environmental 
effects that FDA should take into consideration as it prepares a final 
rule, FDA requests public comment and supporting data or other 
information (e.g., studies, data, reports). The agency will evaluate 
the information and input received in response to this proposed rule, 
including the specific questions listed in section IX of this document. 
Although FDA finds that no EIS is necessary for this proposed rule, if 
in response to comment received, FDA prepares an EA or EIS, it will 
provide notice and an opportunity for public review and comment on any 
such document.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and

[[Page 3617]]

the States, or on the distribution of power and responsibilities among 
the various levels of government. Accordingly, the agency tentatively 
concludes that the proposed rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

IX. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.
    Comments on proposed provisions and related issues--We seek comment 
on the need for, and appropriateness of, the various provisions 
proposed in this rule and our accompanying rationale. Specifically, we 
seek comment on the following issues:
     Proposed provisions in subpart A, including:
    [cir] proposed Sec. Sec.  112.1 and 112.2, including the produce 
that would be covered or not covered by the rule; the list of produce 
that would not be covered by the rule because it is rarely consumed raw 
(including asparagus, bok choy, and cranberries); and the proposed 
exemption for produce that receives commercial processing, including 
the types of processing that should qualify for this exemption;
    [cir] proposed definitions in Sec.  112.3(c), including those of 
agricultural water, hazard, reasonably foreseeable hazard, produce, 
humus, production batch of sprouts, and yard trimmings;
    [cir] proposed definitions of small and very small businesses in 
Sec.  112.3(b); as well as the proposed exclusion of certain farms from 
the scope of this rule based sales in Sec.  112.4(a);
    [cir] whether and how we should require farms that meet the 
criteria for the qualified exemption to establish and maintain 
documentation of the basis for their exemption;
    [cir] the feasibility of the labeling provisions in proposed 
112.6(b), particularly in the case of consolidating produce from 
several farm locations.
     Proposed general requirements in Sec.  112.11, including 
on whether we should establish specific standards for any types of 
hazards that would be covered in proposed Sec.  112.11 but for which we 
have not proposed specific standards in proposed subparts C through O; 
and the proposed allowance in Sec.  112.12 for alternatives to certain 
specified requirements, including appropriateness of the list of 
permitted alternatives. Are there other proposed provisions for which 
we should permit alternatives and, if so, under what, if any, 
additional or different criteria than those proposed in Sec.  112.12(b) 
and (c)?
     Proposed provisions in subparts C and D directed to 
personnel training, and health and hygiene, including the proposed 
requirements for training on principles of food hygiene and food 
safety, and for the maintenance of adequate personal cleanliness and 
hygienic practices when handling covered produce or food-contact 
surfaces during covered activities, including the provisions relevant 
to use of gloves and hand sanitizers;
     Proposed provisions directed to water, including those 
related to water quality, microbial indicators, and testing in 
Sec. Sec.  112.41, 112.44, and 112.45; provision related to water 
sourced from public water systems in Sec.  112.45(a); and recordkeeping 
in Sec.  112.50; specifically:
    [cir] Are the provisions in Sec. Sec.  112.44-112.46 appropriately 
tailored to the risk posed by the manner in which the water is used?
    [cir] Are the microbial standards specified in these provisions 
appropriate for the specified intended uses? For example, are the 
microbial standards appropriately tailored to uses such as direct 
application of irrigation water?
    [cir] Are the provisions related to treatment of water sufficiently 
flexible to permit alternative safe uses of water that does not meet 
the specified microbial standard for its intended use?
    [cir] Is there a need for a provision specifically related to 
disinfection treatment of re-circulated or single pass water used 
during and after harvest?
    [cir] Are there any alternative options not considered in the 
proposed rule?
     Proposed provisions in subpart F directed to soil 
amendments, including those related to status, treatment, application 
restrictions, minimum application intervals, and recordkeeping 
(including the requirement related to documentation such as 
Certificates of Conformance); our focus on biological soil amendments 
of animal origin; any alternative options that we have not considered 
in this proposed rule; and the risk presented by the use of biological 
soil amendments in sprouting and whether that practice should be 
prohibited;
     Proposed provisions in subparts I, K, and L, including 
proposed Sec.  112.81 related to the scope of applicability of subpart 
I, proposed Sec.  112.114 related to dropped produce, and proposed 
Sec.  112.115 related to measures to prevent formation of botulinum 
toxin; specifically:
    [cir] Do you agree with our proposal to apply the proposed 
provisions in subpart I when covered activities take place in an 
outdoor area or a partially-enclosed building where there is a 
reasonable probability of contamination of covered produce, and our 
tentative conclusion that, accordingly, crops that grow completely 
underground would not be subject to the proposed provisions of subpart 
I?
    [cir] With respect to dropped produce, should proposed Sec.  
112.114 apply to all commodities or should we provide for certain 
exceptions (and, if so, under what criteria)? Does proposed Sec.  
112.114 appropriately address produce (such as almonds) that is 
intentionally dropped to the ground during harvesting and where such 
harvesting does not cause bruising or damage to the produce? Should 
produce with peelable skin be excluded?
    [cir] Is proposed Sec.  112.115 a reasonably necessary measure to 
ensure the safety of packaged covered produce? Are there specific types 
or conditions of modified or reduced oxygen packaging methods that may 
or may not increase the risk of formation of botulinum toxin?
     Proposed provisions specific to sprouts in subpart M, 
including treatment of seeds and beans; microbial indicators and 
frequency of environmental monitoring; and requirement to establish and 
implement a written environmental monitoring plan (Sec.  112.144(a)) 
and sampling plan for each production batch of sprouts (Sec.  
112.146(a)); as well as whether soil-grown sprouts should be subject to 
the proposed requirements, and whether and how to establish a supplier 
approval and verification program for seeds and beans used for 
sprouting;
     Proposed provisions in subpart N, including methods and 
allowance for alternative methods to be used provided they are at least 
equivalent to the proposed method in accuracy, precision, and 
sensitivity;
     Proposed requirements related to documentation and records 
in subpart O, including the requirement for a supervisor or responsible 
party to review certain records, and whether there are any 
circumstances that would warrant not applying part 11 to records that 
would be required to be kept under part 112;
     Proposed provisions in subpart P for variances, including 
related process and scientific data and information to

[[Page 3618]]

support a request for variance, and circumstances for approval or 
denial of a request for variance and for modification or revocation of 
an approved variance; Are there any specific concerns that we should 
consider in finalizing the procedures and processes for requests for 
variances, as applicable to foreign governments?
     Overall implementation and compliance strategy and 
proposed provisions in subpart Q, including specific strategies we 
should employ in order to best prioritize our implementation of the 
rule, and coordination of education and enforcement activities by 
relevant State, Territorial, tribal, and local authorities; and
     Proposed provisions in subpart R for withdrawal of a 
qualified exemption, including related process and timeframes for 
actions to be taken by FDA or farms.
     Regarding the scope of the recordkeeping requirements, are 
there alternative options that should be considered?
     Regarding the handwashing and toilet facility 
requirements, are our proposals reasonably consistent with current 
model practices or are there alternatives not considered in the 
proposed rule?
    Regulatory approach--As discussed in section IV of this document, 
we have tentatively concluded that we should use a regulatory framework 
based on practices, procedures, and processes associated with growing, 
harvesting, packing, and holding of all covered produce. We considered 
and rejected the option to develop a framework that (based solely on a 
history of outbreaks or illnesses associated with the commodity) would 
be applicable to individual commodities or classes of commodities. 
Relevant references on the subject of produce safety, as well as the 
QAR, identify common on-farm routes of contamination, such as personnel 
training, health, and hygiene; domestic and wild animals; biological 
soil amendments of animal origin; agricultural water; and equipment and 
buildings. Procedures, processes and practices in each of these on-farm 
routes of contamination have the potential to introduce biological 
hazards into or onto any covered produce. Therefore, we are proposing 
an integrated approach to prescribe standards for each of these on-farm 
routes of contamination that we have tentatively determined are 
reasonably necessary to prevent the introduction of known or reasonably 
foreseeable biological hazards and to provide reasonable assurances 
that produce is not adulterated under section 402 of the FD&C Act. We 
also recognize the need for additional standards specifically tailored 
to the growing, harvesting, packing and holding of sprouts, and have 
proposed minimum necessary standards for sprouts. We seek comment on 
our tentative conclusions related to this issue and the proposed 
regulatory approach described in section IV of the document. In 
addition, we seek comment on the following:
     Are there any alternative approaches that we should 
consider in establishing science-based minimum standards for the safe 
production and harvesting of produce and to minimize the risk of 
serious adverse health consequences or death?
     Are there specific commodities or categories of 
commodities that should be excluded from the scope of the rule, based 
on data related to their relative risk considerations? (Note that under 
our proposed integrated approach, we propose to exempt certain 
commodities, including a specified list of produce that is rarely 
consumed raw, and produce that receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance; see section V.A.2.a. of this rule.)
     For example, the QAR ranked certain produce commodities, 
such as bananas and coconuts, as lower risk for illness, in part 
because such commodities are peeled or shelled before consumption in a 
manner that can be expected not to transfer contamination onto the 
interior, edible portion of the commodity. Should such commodities be 
covered by the rule? Is coverage of these commodities unnecessary? 
Should they be covered but subject to a less stringent set of 
requirements?
     Certain commodities are ranked in the QAR as presenting a 
relatively lower likelihood of exposure, in part because such 
commodities have fewer potential routes of contamination and/or lower 
potential for contamination. In addition, some commodities are not 
known to have been associated with outbreaks. Some commodities (for 
example, pears, grapefruit, oranges, and lemons) meet both of these 
criteria, considering the rankings and outbreak data used in the QAR. 
Should commodities that meet both of these criteria be covered by the 
rule? Is coverage of these commodities unnecessary? Should they be 
covered but subject to a less stringent set of requirements? How should 
the rule address the changing nature of outbreak data over time?
     How should we account for uncovered commodities in 
considering a commodity-specific approach that relies on outbreak data?
     Are there pathogen surveillance data from sampling 
programs focusing on produce commodities that have no history of known 
outbreaks that would be useful in considering a commodity-specific 
approach?
     Can commodity characteristics be used as a basis to 
consider a commodity-specific approach? While the outbreak data show no 
consistent pattern that can be matched to commodity characteristics 
such as growth habit, our QAR shows that produce commodities that are 
ranked as higher risk of illness and those ranked as lower risk of 
illness do share some of the same characteristics. A further refinement 
of our assessment might be helpful in developing a commodity-specific 
approach based on commodity characteristics. Considering the 
qualitative nature of our assessment, are there quantitative data sets 
available that would enable a further refinement of our assessment?
     We seek comment on our tentative conclusion that produce 
in both direct market channels and other commercial channels are 
subject to the same routes of contamination, although the number of 
opportunities for contamination during packing and holding may be 
greater for produce in other commercial channels as compared to produce 
in direct market channels if there are greater numbers of touch points 
and handlers in these channels than there are in direct market 
channels.
     We seek comment on our tentative conclusion that because 
the statutory qualified exemption addresses market channels as a 
possible risk factor, and because we identified no data that would 
allow us to otherwise use market channels as a factor in covering and 
regulating produce under this proposed rule, we should not otherwise 
use market channels as a basis of risk categorization in this proposed 
rule.
     Are other data or information available that would be 
otherwise useful in considering a commodity-specific approach?
     We seek comment on the proposed effective and compliance 
dates.
     We seek comment on the appropriateness of the proposed 
exemptions and partial exemptions. Are there additional exemptions and 
relevant data to support such exemptions that we should consider?
    Qualitative assessment of risk--We seek comment on the QAR, 
conclusions drawn from that assessment, and our consideration of those 
conclusions in developing the proposed requirements described in this 
rule. We also request

[[Page 3619]]

you to submit any data or factual information that may help the agency 
to conduct, as warranted, a thorough and robust quantitative assessment 
of risk associated with produce production and harvesting practices.
    Chemical, physical or radiological hazards--We seek comment on our 
tentative conclusion that procedures, practices, and processes, which 
are proposed in this rule, are reasonably necessary to prevent the 
introduction of biological hazards only, and on whether, and to what 
extent, chemical, physical or radiological hazards should be covered 
within the scope of a final rule. Are there procedures, practices, or 
processes that minimize the risk of serious adverse health consequences 
or death and that are reasonably necessary to prevent the introduction 
of known or reasonably foreseeable chemical, physical or radiological 
hazards into produce or to provide reasonable assurances that produce 
is not adulterated under section 402 of the FD&C Act?
    Environmental testing for L. monocytogenes or Listeria spp for 
covered produce other than sprouts--Proposed Sec.  112.143(a) would 
require testing the growing, harvesting, packing, and holding 
environment for sprouts for Listeria species or L. monocytogenes; 
however, we have not proposed to require environmental testing for 
other covered produce. A recent outbreak of listeriosis from 
cantaloupes attributed to insanitary conditions at a facility that 
washed, packed, cooled and held intact cantaloupes (Ref. 267) raises 
the question as to whether specific measures are necessary to minimize 
the risk posed by L. monocytogenes as an environmental pathogen. As 
discussed in section V.A. of this document, this proposed rule would 
not apply to off-farm facilities such as the facility associated with 
this cantaloupe outbreak-- such facilities would instead be subject to 
part 110 and may be subject to section 418 of the FD&C Act. However, 
the same risk factors and potential measures for minimizing risk are 
relevant to both on-farm and off-farm produce washing, packing, 
cooling, and holding practices. Such measures could include 
environmental testing for L. monocytogenes or Listeria spp. to verify 
the adequacy of a covered farm's sanitation measures. Because L. 
monocytogenes is a ubiquitous microorganism, an intact fruit or 
vegetable could reasonably be expected to occasionally be positive for 
L. monocytogenes. Many studies have shown the presence of L. 
monocytogenes on fresh, intact produce, but there is limited 
epidemiological evidence associating listeriosis with produce, 
especially with intact fruits and vegetables (Ref. 268. Ref. 269. Ref. 
270. Ref. 271. Ref. 272. Ref. 267). However, this recent outbreak 
indicates that intact produce can be a vehicle for listeriosis. What is 
not known is the extent to which, and under what circumstances, whole 
produce contaminated with L. monocytogenes presents a risk to 
consumers. The outbreak of listeriosis due to contamination of intact 
cantaloupes appears to have occurred due to a combination of factors, 
including pooled water on the floor of the facility, which was also 
difficult to clean, poorly designed equipment that was previously used 
for other commodities, no pre-cool step, a truck parked near the 
packing area that had visited a cattle operation, and possible low 
level contamination from the growing/harvesting operation (Ref. 273). 
The contribution of internalization of the organism and growth within 
the fruit is not known. Moreover, it is not known whether all of these 
circumstances are needed for L. monocytogenes to present a risk on 
produce or whether any one or more would have been sufficient. We also 
do not know the prevalence of L. monocytogenes environmental 
contamination of fruit and vegetable packing facilities (both on- and 
off-farm), nor do we know the prevalence of L. monocytogenes on produce 
washed, packed, cooled and stored in such facilities. We encourage 
research to answer these questions. We request comment on whether we 
should require, in a final rule, any or all covered farms that wash and 
pack produce, or that only pack produce, to perform environmental 
testing for L. monocytogenes or Listeria spp., and any criteria that 
should be employed to determine which farms should be subjected to such 
a requirement.
    Operational assessment, food safety plans--As discussed in section 
IV of this document, while we recommend that farms conduct an 
operational assessment and develop a food safety plan, at this time, we 
are not proposing to require them to do so. We request comment on 
whether we should require, in a final rule, some or all covered farms 
to perform operational assessments and/or develop a food safety plan, 
and any criteria that should be employed to determine which farms 
should be subjected to such a requirement.
    Registration--We are also requesting comment about whether we 
should require, in a final rule, that covered farms, as described in 
proposed Sec.  112.4(a), register with FDA. We are not aware of a 
nationwide database of farms, nor an accumulation of statewide 
databases, that would enable us to identify the names and locations of 
all entities subject to this proposed regulation. This would enable us 
to better provide outreach and technical assistance to covered 
entities. In addition, while inspection is intended to be only a 
relatively minor part of our overall compliance effort (see section 
V.Q. of the document for more information on our overall strategy), we 
anticipate performing inspections for enforcement purposes. We would 
use the covered farm registration information to create a database that 
we would use to allocate inspection resources. We are also interested 
in the existence of databases that could help us identify covered farms 
in the absence of a registration system, and in the appropriate data 
elements that should be collected in a registration system, should we 
decide to set up such a system.
    Environmental issues--Consistent with Sec.  25.50, FDA is involving 
the public in implementing its NEPA procedures applicable to this 
proposed rule. The agency will evaluate the information and input 
received in response to this proposed rule, including the specific 
questions below, to determine further actions, as appropriate.
    Proposed subpart E would establish standards for an indicator 
organism in agricultural water applied to covered produce, and 
establish requirements for waters that do not meet those standards. We 
are soliciting comments on potential means or mechanisms for meeting 
the proposed standards. In your responses, please distinguish, to the 
extent appropriate, between sprouts and other covered produce.
    1. Do farms that would be covered by the proposed rule, if 
finalized, currently treat water used for irrigation directly applied 
to covered produce other than sprouts, or water used to irrigate 
sprouts (whether or not it is directly applied)? We are seeking 
comments on pesticides used to reduce concentration of organisms of 
concern in water used for such irrigation and not pesticides used to 
prevent biofouling (chemigation).
    2. What actions are currently being taken by farmers, either on 
their own or at the request of produce handlers or sellers to control 
the bacterial loads in water? Please provide data to support the 
information provided.
    3. What water treatment methods do farmers use to clean their 
irrigation systems, how broadly are they used, and what are the effects 
on the environment? In what amounts or frequency are each of these 
methods applied? Please

[[Page 3620]]

provide data to support the information provided.
    4. Do farms currently use municipal water sources to irrigate 
produce that would be covered by this proposed rule, if finalized? If 
so, please provide data on the use rate and prevalence of this 
practice, as well as data regarding effects on crop productivity of 
disinfection byproducts in municipal water used to irrigate produce 
that would be covered by the rule.
    5. What sources of irrigation water (for example, municipal water, 
surface water and groundwater) are most frequently used? If more than 
one source is available, is there a preference for using one source 
over another? Please explain why.
    In addition, we seek comment on potential effects of actions taken 
as a result of this rule on water rights/Tribal rights. Are water 
rights or Tribal rights likely to be affected by actions taken as a 
result of this rule? If so, how and to what extent?
    Proposed subpart F would require the use of application method 
restrictions, application intervals, and/or treatment of biological 
soil amendments of animal origin to reduce exposure of covered produce 
to organisms of public health concern. We recognize that the 
requirements in this section may represent a departure from current 
practices.
    1. How do farms that would be covered by the proposed rule, if 
finalized, currently manage solid animal waste? Manage liquid animal 
waste?
    2. What is the prevalence of composting on farms using methods 
described in proposed subpart F? Please provide data or other available 
information on the frequency of such composting.
    3. Are composting methods other than those described in proposed 
subpart F currently utilized on farms? To what extent? Please provide 
data or other available information on the frequency of such 
composting.
    4. Are currently utilized methods of composting governed by state, 
county or local laws, ordinances or regulations? Please identify in 
your comments any relevant laws, ordinances, or regulations, and 
include copies if reasonably feasible.
    5. What are the current laws, ordinances, or regulations in produce 
growing areas that govern manure handling and storage? How if at all do 
such laws, ordinances, or regulations address potential environmental 
effects from methane associated with manure? Ammonia? Nitrogen? 
Phosphorus?
    Under proposed subpart F, manure may be chemically treated as an 
alternative to composting that would not require use of an application 
interval. We are also soliciting comments on available chemical 
treatment methods.
    1. Do farms that would be covered by the proposed rule, if 
finalized, currently utilize chemical treatments to prevent or minimize 
pathogens in manure?
    2. What types and quantities of chemicals are used for chemical 
treatment of manure? Please describe the treatment protocols, including 
application time, containment methods, and temperature requirements.
    3. Please provide any data or other information relating to the 
effectiveness, and the relative effectiveness, of these chemical manure 
treatments, as well as any environmental effects of their use.
    Proposed subpart I would apply when under the circumstances there 
is a reasonable probability that animal intrusion will contaminate 
covered produce. In such circumstances, proposed subpart I would 
require monitoring of those areas that are used for a covered activity 
for evidence of animal intrusion immediately prior to harvest and as 
needed during the growing season. If significant evidence of animal 
intrusion is found, these provisions would require farms to evaluate 
whether the covered produce can be harvested in accordance with 
proposed subpart K. Proposed subpart K would require taking reasonable 
measures to identify, and not harvest, covered produce that is 
reasonably likely to be contaminated, including steps to identify and 
not harvest covered produce that is visibly contaminated with animal 
excreta. We are soliciting comments on current practices relevant to 
these provisions.
    1. What measures, if any, are currently being implemented to 
prevent harvest of produce contaminated by excreta deposited by wild 
animals? If there are preferred measures, please explain the rationale 
for such preference. Please provide data to support the information 
provided.
    2. Are farms removing vegetation bordering outdoor produce growing 
areas or drainages in an effort to deter wildlife from entering growing 
areas? If so, what is the current rate at which vegetation bordering 
outdoor produce growing areas or drainages is currently being removed? 
Are sediment basins or other conservation practices currently being 
removed and at what rate? Please provide data or other information to 
support the information provided.
    3. To what extent have farmers taken action to exclude wildlife 
from outdoor produce growing areas? What measures are being used for 
these purposes, e.g. construction of fences or other physical barriers, 
chemical deterrents, or other mechanisms around growing areas to 
exclude wildlife? Please provide data or other information to support 
the information provided.
    4. Has the implementation of measures to prevent animal intrusion 
negatively impacted habitat for rare or declining aquatic or 
terrestrial wildlife species or migratory birds? Please provide 
examples.

X. 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. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. U.S. Department of Health and Human Services and U.S. Department 
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[[Page 3621]]

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production and shelf-life in Lleida (Catalonia, Spain).'' 
International Journal of Food Microbiology 108, (2006): 404-409.
227. Gagliardi, J. V., Millner, P. D., Lester, G. et al. ``On-Farm 
and Postharvest Processing Sources of Bacterial Contamination to 
Melon Rinds.'' Journal

[[Page 3627]]

of Food Protection 66, no. 1 (2003): 82-87.
228. Duffy, E. A., Lucia, L. M., Kells, J. M. et al. 
``Concentrations of Escherichia coli and Genetic Diversity and 
Antibiotic Resistance Profiling of Salmonella Isolated from 
Irrigation Water, Packing Shed Equipment, and Fresh Produce in 
Texas.'' Journal of Food Protection 68, no. 1 (2005): 70-79.
229. Taormina, P. J., Beuchat, L. R., Erickson, M. C. et al. 
``Transfer of Escherichia coli O157:H7 to Iceberg Lettuce via 
Simulated Field Coring.'' Journal of Food Protection 72, no. 3 
(2009): 465-472.
230. Zhou, B., Luo, Y., Millner, P. et al. ``Research Note, 
Sanitation and Design of Lettuce Coring Knives for Minimizing 
Escherichia coli O157:H7 Contamination.'' Journal of Food Protection 
75, no. 3 (2012): 563-566.
231. Cramer, M. M. Food Plant Sanitation: Design, Maintenance, and 
Good Manufacturing Practices. CRC Press, 2006.
232. Moore, C. M., Sheldon, B. W., and Jaykus, L.-A. ``Transfer of 
Salmonella and Campylobacter from Stainless Steel to Romaine 
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233. Carrington, E. G. Evaluation of Sludge Treatments for Pathogen 
Reduction--Final Report. 2001.
234. Bihn, E. A. and Gravani, R. B. ``Role of Good Agricultural 
Practices in Fruit and Vegetable Safety.'' In Microbiology of Fresh 
Produce, edited by Matthews, K. R., 21-52. Washington, DC: ASM 
Press, 2006.
235. ``Investigation of the Taco John's Escherichia coli O157:H7 
Outbreak Associated with Iceberg Lettuce, Final Report.'' California 
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236. ``The Fecal Bacteria.'' Sadowsky, M. J. and Whitman, R. L. 
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December 1, 2011. Last Modified 2011.
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Force. s.v. ``Sprout Safety Training Workshop.'' Accessed 2011.
238. Food and Drug Administration. s.v. ``HHS News, Consumers 
Advised of Risks Associated with Raw Sprouts.'' Accessed 1999.
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Associated with Eating Raw and Lightly Cooked Sprouts.'' Accessed 
2002.
240. Food Safety Authority of Ireland. s.v. ``Guidelines on Safe 
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2011.
241. California Department of Health Services and Food and Drug 
Administration. s.v. ``Safer Processing of Sprouts.'' Accessed 2000. 
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Seed Sprouts, Approval Report.'' Food Standards Australia New 
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Last Modified 2011.
243. Fett, W. F., Tortorell, M., and Fu, T. ``Seed Sprouts: the 
State of Microbiological Safety.'' In Microbiology of Fresh Produce, 
edited by Matthews, K. R., 167-219. ASM Press, 2005.
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Hazards (BIOHAZ). ``Scientific Opinion on the risk posed by Shiga 
toxin-producing Escherichia coli (STEC) and other pathogenic 
bacteria in seeds and sprouted seeds.'' EFSA Journal 9, no. 11 
(2011): 101-10.2903/j.efsa.2011.2424.
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246. ``Transcript of Proceedings of Public Meeting on Sprout Safety, 
May 17, 2005.'' http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm078701.htm. Last 
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247. Steinmuller, N., Demma, L., Bender, J. B. et al. ``Outbreak of 
Enteric Disease Associated with Animal Contact: Not Just a Foodborne 
Problem Anymore.'' Clinical Infectious Diseases 43, (2006): 1596-
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248. Winthrop, K. L., Palumbo, M. S., Farrar, J. A. et al. ``Alfalfa 
Sprouts and Salmonella Kottbus Infection: A Multistate Outbreak 
following Inadequate Seed Disinfection with Heat and Chlorine.'' 
Journal of Food Protection 66, no. 1 (2003): 13-17.
249. Gill, C. J., Keene, W. E., Mohle-Boetani, J. C. et al. 
``Alfalfa Seed Decontamination in Salmonella Outbreak.'' Emerging 
Infectious Diseases 9, no. 4 (2003): 474-479.
250. Brooks, J. T., Rowe, S. Y., Shillam, P. et al. ``Salmonella 
Typhimurium Infections Transmitted by Chlorine-pretreated Clover 
Sprout Seeds.'' American Journal of Epidemiology 154, no. 11 (2001): 
1020-1028.
251. Montville, R. and Schaffner, D. ``Monte Carlo Simulation of 
Pathogen Behavior during the Sprout Production Process.'' Applied 
and Environmental Microbiology 71, no. 2 (2005): 746-753. 10.1128/
?AEM.71.2.746-753.2005.
252. ``Recall--Firm Press Release, Amalgamated Produce, Inc. Recalls 
Sprouts in the North Eastern United States Because of Possible 
Health Risks.'' Food and Drug Administration. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2009/ucm135947.htm. Accessed December 
23, 2011. Last Modified 2009.
253. Food and Drug Administration. s.v. ``Recalls: Listeria 
monocytogenes in Sprouts.'' Accessed 2011.
254. ``Listeria Guidelines for Industry.'' U.S.Department of 
Agriculture and Food Safety and Inspection Service. http://www.fsis.usda.gov/OA/topics/lmguide.htm. Last Modified 1999.
255. Fu, T., Stewart, D., Reineke, K. et al. ``Use of Spent 
Irrigation Water for Microbiological Analysis of Alfalfa Sprouts.'' 
Journal of Food Protection 64, no. 6 (2001): 802-806.
256. Smith, M. A. and Food and Drug Administration, ``Memorandum to 
the Record'', 2011.
257. Chen, Y., Scott, V. N., Freier, T. A. et al. ``Control of 
Salmonella in Low-moisture Foods III: Process Validation and 
Environmental Monitoring.'' Food Protection Trends 29, no. 8 (2009): 
493-508.
258. International Commission for the Microbiological Specifications 
of Foods (ICMSF). ``Sampling to Assess Control of the Environment.'' 
In Microorganisms in Foods 7, 362-Kluwer Academic/Plenum Publishers, 
2002.
259. Tompkin, R. B. ``Control of Listeria monocytogenes in the food-
processing environment.'' Journal of Food Protection 65, no. 4 
(2002): 709-725.
260. ``Guidance for Industry: Control of Listeria monocytogenes in 
Refrigerated for Frozen Ready-To-Eat Foods; Draft Guidance.'' Food 
and Drug Administration. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodProcessingHACCP/ucm073110.htm. Accessed December 28, 2011. Last 
Modified 2008.
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Department of Agriculture. http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087110. Last Modified 2012.
262. Florida Department of Agriculture and Consumer Services. Tomato 
Best Practices Manual. Florida Department of Agriculture and 
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263. ``LGMA, California Leafy Green Products.'' 
www.caleafygreens.ca.gov./ Accessed February 23, 2012. Last Modified 
2012.
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Merriam-Webster Online. www.merriam-webster.com/dictionary/prepare. 
Accessed February 26, 2012. Last Modified 2012.
265. ``Fda's analysis to examine the impacts of the Produce Safety 
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 (Public Law 104-4), and the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520)''.
266. Proffitt, L. D. and McCarthy, A. M. s.v. ``Memorandum to the 
Record.'' Accessed 2012.
267. ``Multistate Outbreak of Listeriosis Linked to Whole 
Cantaloupes from Jensen Farms, Colorado.'' Centers for

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Last Modified 2011.
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Listeria, Listeriosis, and Food Safety, edited by Ryser, Elliot T 
and Marth, Elmer H., CRC Press, 2007.
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``Epidemic Listeriosis--Evidence for Transmission by Food.'' New 
England Journal of Medicine 308, no. 4 (1983): 203-206.
270. Ho, J. L., Shands, K. N., Friedland, G. et al. ``An outbreak of 
type 4b Listeria monocytogenes infection involving patients from 
eight Boston hospitals.'' Archives of Internal Medicine 146, no. 3 
(1986): 520-524.
271. ``FDA Lab Results Positive for Listeria at SanGar Fresh Cut 
Produce.'' Food and Drug Administration. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm232237.htm. Accessed December 28, 2011. Last Modified 2010.
272. ``Investigation of an Outbreak of Salmonella Saintpaul 
Infections Linked to Raw Alfalfa Sprouts.'' Centers for Disease 
Control and Prevention. http://www.cdc.gov/salmonella/saintpaul/alfalfa/archive/042709.html. Accessed December 28, 2011. Last 
Modified 2009.
273. ``Information on the Recalled Jensen Farms Whole Cantaloupes.'' 
Food and Drug Administration. http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm272372.htm#report. Last Modified 2011.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 112

    Foods, Fruits and vegetables, Incorporation by reference, 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 be amended to read as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
2. In Sec.  16.1:
0
a. In paragraph (b)(1), add an entry in numerical order.
0
b. In paragraph (b)(2), add an entry in numerical order.
    The additions read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) * * *
    Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act 
relating to the modification or revocation of a variance from the 
requirements of section 419 of the Federal Food, Drug, and Cosmetic Act 
(see part 112, subpart P of this chapter).
* * * * *
    (2) * * *
    Sec. Sec.  112.201 through 112.211, (part 112, subpart R), relating 
to withdrawal of a qualified exemption.
* * * * *
0
3. Add part 112 to read as follows:

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

Subpart A--General Provisions
Sec.
112.1 What food is covered by this part?
112.2 What produce is not covered by this part?
112.3 What definitions apply to this part?
112.4 Who is subject to the requirements of this part?
112.5 Who is eligible for a qualified exemption and associated 
modified requirements based on average monetary value of all food 
sold and direct farm marketing?
112.6 What modified requirements apply to me if I am eligible for a 
qualified exemption in accordance with Sec.  112.5?
Subpart B--General Requirements
112.11 What general requirements apply to persons who are subject to 
this part?
112.12 Are there any alternatives to the requirements established in 
this part?
Subpart C--Standards Directed to Personnel Qualifications and Training
112.21 What requirements apply regarding qualifications and training 
for personnel who handle (contact) covered produce or food-contact 
surfaces?
112.22 What minimum requirements apply for training personnel who 
conduct a covered activity?
112.23 What requirements apply regarding supervisors?
112.30 Under this subpart, what requirements apply regarding 
records?
Subpart D--Standards Directed to Health and Hygiene
112.31 What measures must I take to prevent ill or infected persons 
from contaminating covered produce with microorganisms of public 
health significance?
112.32 What hygienic practices must personnel use?
112.33 What measures must I take to prevent visitors from 
contaminating covered produce and food-contact surfaces with 
microorganisms of public health significance?
Subpart E--Standards Directed to Agricultural Water
112.41 What requirements apply to the quality of agricultural water?
112.42 What measures must I take with respect to my agricultural 
water sources, water distribution system, and pooling of water?
112.43 What treatment of agricultural water is required, and what 
requirements apply to treating agricultural water?
112.44 What testing is required for agricultural water, and what 
must I do based on the test results?
112.45 How often must I test agricultural water that is subject to 
requirements of Sec.  112.44?
112.46 What measures must I take for water that I use during 
harvest, packing, and holding activities for covered produce?
112.50 Under this subpart, what requirements apply regarding 
records?
Subpart F--Standards Directed to Biological Soil Amendments of Animal 
Origin and Human Waste
112.51 What requirements apply for determining the status of a 
biological soil amendment of animal origin?
112.52 How must I handle, convey, and store biological soil 
amendments of animal origin?
112.53 What prohibitions apply regarding use of human waste?
112.54 What treatment processes are acceptable for a biological soil 
amendment of animal origin that I apply in the growing of covered 
produce?
112.55 What microbial standards apply to the treatment processes in 
Sec.  112.54?
112.56 What application requirements and minimum application 
intervals apply to biological soil amendments of animal origin?
112.60 Under this subpart, what requirements apply regarding 
records?
Subpart G--[Reserved]
Subpart H--[Reserved]
Subpart I--Standards Directed to Domesticated and Wild Animals
112.81 How do the requirements of this subpart apply to areas where 
covered activities take place?
112.82 What requirements apply regarding domesticated animals that I 
allow to graze in fields or use as working animals where I grow 
covered produce?
112.83 What requirements apply regarding animal intrusion?
Subpart J--[Reserved]
Subpart K--Standards Directed to Growing, Harvesting, Packing, and 
Holding Activities
112.111 What measures must I take if I grow, harvest, pack or hold 
both covered and excluded produce?
112.112 What measures must I take during harvest activities?
112.113 How must I handle harvested covered produce during covered 
activities?

[[Page 3629]]

112.114 What requirements apply to dropped covered produce?
112.115 What measures must I take when packaging covered produce?
112.116 What measures must I take when using food-packing (including 
food packaging) material?
Subpart L--Standards Directed to Equipment, Tools, Buildings, and 
Sanitation
112.121 What equipment and tools are subject to the requirements of 
this subpart?
112.122 What buildings are subject to the requirements of this 
subpart?
112.123 What requirements apply regarding equipment and tools 
subject to this subpart?
112.124 What requirements apply to instruments and controls used to 
measure, regulate, or record?
112.125 What requirements apply to equipment that is subject to this 
subpart used in the transport of covered produce?
112.126 What requirements apply to my buildings?
112.127 What requirements apply regarding domesticated animals in 
and around a fully-enclosed building?
112.128 What requirements apply regarding pest control in buildings?
112.129 What requirements apply to toilet facilities?
112.130 What requirements apply for hand-washing facilities?
112.131 What must I do to control and dispose of sewage?
112.132 What must I do to control and dispose of trash, litter, and 
waste in areas used for covered activities?
112.133 What requirements apply to plumbing?
112.134 What must I do to control animal excreta and litter from 
domesticated animals that are under my control?
112.140 Under this subpart, what requirements apply regarding 
records?
Subpart M--Standards Directed to Sprouts
112.141 What requirements apply to seeds or beans used to grow 
sprouts?
112.142 What measures must I take for growing, harvesting, packing, 
and holding sprouts?
112.143 What testing must I do during growing, harvesting, packing, 
and holding sprouts?
112.144 What requirements apply to testing the environment for 
Listeria species or L. monocytogenes?
112.145 What actions must I take if the growing, harvesting, 
packing, or holding environment tests positive for Listeria species 
or L. monocytogenes?
112.146 What must I do to collect and test samples of spent sprout 
irrigation water or sprouts?
112.150 Under this subpart, what requirements apply regarding 
records?
Subpart N--Analytical Methods
112.151 What methods must I use to test the quality of water to 
satisfy the requirements of Sec.  112.45?
112.152 What methods must I use to test the growing environment for 
Listeria species or L. monocytogenes to satisfy the requirements of 
Sec.  112.143(a) and Sec.  112.144?
Subpart O--Requirements Applying to Records That You Must Establish and 
Keep
112.161 What general requirements apply to records required under 
this part?
112.162 Where must I store records?
112.163 May I use existing records to satisfy the requirements of 
this part?
112.164 How long must I keep records?
112.165 What formats are acceptable for the records I keep?
112.166 What requirements apply for making records available and 
accessible to FDA?
112.167 Can records that I provide to FDA be disclosed to persons 
outside of FDA?
Subpart P--Variances
112.171 Who may request a variance from the requirements of this 
part?
112.172 How may a State or foreign country request a variance from 
one or more requirements of this part?
112.173 What must be included in the Statement of Grounds in a 
petition requesting a variance?
112.174 What data and information submitted in a petition requesting 
a variance are publicly available?
112.175 Who responds to a petition requesting a variance?
112.176 What process applies to a petition requesting a variance?
112.177 Can an approved variance apply to any person other than 
those identified in the petition requesting that variance?
112.178 Under what circumstances may FDA deny a petition requesting 
a variance?
112.179 When does a variance approved by FDA become effective?
112.180 Under what circumstances may FDA modify or revoke an 
approved variance?
112.181 What procedures apply if FDA determines that an approved 
variance should be modified or revoked?
112.182 What are the permissible types of variances that may be 
granted?
Subpart Q--Compliance and Enforcement
112.191 How do the criteria and definitions in this part apply to 
the Federal Food, Drug, and Cosmetic Act and the Public Health 
Service Act?
112.192 What is the result of a failure to comply with this part?
112.193 What are the provisions for coordination of education and 
enforcement?
Subpart R--Withdrawal of Qualified Exemption
112.201 Under what circumstances can FDA withdraw a qualified 
exemption in accordance with the requirements of Sec.  112.5?
112.202 What procedure will FDA use to withdraw an exemption?
112.203 What information must FDA include in an order to withdraw a 
qualified exemption?
112.204 What must I do if I receive an order to withdraw a qualified 
exemption applicable to my farm?
112.205 Can I appeal or request a hearing on an order to withdraw a 
qualified exemption applicable to my farm?
112.206 What is the procedure for submitting an appeal?
112.207 What is the procedure for requesting an informal hearing?
112.208 What requirements are applicable to an informal hearing?
112.209 Who is the presiding officer for an appeal and for an 
informal hearing?
112.210 What is the timeframe for issuing a decision on an appeal?
112.211 When is an order to withdraw a qualified exemption 
applicable to a farm revoked?

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

Subpart A--General Provisions


Sec.  112.1  What food is covered by this part?

    (a) Unless it is excluded from this part under Sec.  112.2, food 
that is produce within the meaning of this part and that is a raw 
agricultural commodity (RAC) is covered by this part. This includes a 
produce RAC that is grown domestically and a produce RAC that will be 
imported or offered for import in any State or territory of the United 
States, the District of Columbia, or the Commonwealth of Puerto Rico.
    (b) For the purpose of this part and subject to the exemptions and 
qualified exemptions therein, covered produce includes all of the 
following:
    (1) Fruits and vegetables such as almonds, apples, apricots, 
aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian 
endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, 
carambola, carrots, cauliflower, celery, cherries, citrus (such as 
clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, 
tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes, 
green beans, guava, herbs (such as basil, chives, cilantro, mint, 
oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other 
melons (such as canary, crenshaw and persian), mushrooms, nectarine, 
onions, papaya, passion fruit, peaches, pears, peas, peppers (such as 
bell and hot), pineapple, plums, plumcot, radish, raspberries, red 
currant, scallions, snow peas, spinach, sprouts (such as alfalfa and 
mung bean), strawberries, summer squash (such as patty pan, yellow and 
zucchini), tomatoes, walnuts, watercress, and watermelon; and
    (2) Mixes of intact fruits and vegetables (such as fruit baskets).

[[Page 3630]]

Sec.  112.2  What produce is not covered by this part?

    (a) The following produce is not covered by this part:
    (1) Produce that is rarely consumed raw, specifically the produce 
on the following exhaustive list--arrowhead, arrowroot, artichokes, 
asparagus, beets, black-eyed peas, bok choy, brussels sprouts, chick-
peas, collard greens, crabapples, cranberries, eggplant, figs, ginger 
root, kale, kidney beans, lentils, lima beans, okra, parsnips, peanuts, 
pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga, 
sugarbeet, sweet corn, sweet potatoes, taro, turnips, water chestnuts, 
winter squash (acorn and butternut squash), and yams;
    (2) Produce that is produced by an individual for personal 
consumption or produced for consumption on the farm or another farm 
under the same ownership; and
    (3) Produce that is not a raw agricultural commodity.
    (b) Covered produce is eligible for exemption from the requirements 
of this part (except as noted in paragraphs (b)(1), (b)(2), and (b)(3) 
of this section) under the following conditions:
    (1) The covered produce receives commercial processing that 
adequately reduces the presence of microorganisms of public health 
significance. Examples of commercial processing that adequately reduces 
the presence of microorganisms of public health significance are 
processing in accordance with the requirements of parts 113, 114, or 
120 of this chapter, treating with a validated process to eliminate 
spore-forming microorganisms (such as processing to produce tomato 
paste or shelf-stable tomatoes), and processing such as refining or 
distilling produce into products such as sugar, oil, spirits, or 
similar products;
    (2) You must establish and keep documentation in accordance with 
the requirements of subpart O of this part, of the identity of the 
recipient of the covered produce that performs the commercial 
processing described in paragraph (b)(1) of this section; and
    (3) The requirements of this subpart and subpart Q of this part 
apply to such produce.


Sec.  112.3  What definitions apply to this part?

    (a) The definitions and interpretations of terms in section 201 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) apply to such 
terms when used in this part.
    (b) For the purpose of this part, the following definitions of very 
small business and small business also apply:
    (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 food (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 food (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) For the purpose of this part, the following definitions also 
apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Adequately reduce microorganisms of public health significance 
means reduce the presence of such microorganisms to an extent 
sufficient to prevent illness.
    Agricultural tea means a water extract of biological materials 
(such as humus, manure, non-fecal animal byproducts, peat moss, pre-
consumer vegetative waste, table waste, or yard trimmings), excluding 
any form of human waste, produced to transfer microbial biomass, fine 
particulate organic matter, and soluble chemical components into an 
aqueous phase. Agricultural teas are held for longer than one hour 
before application.
    Agricultural tea additive means a nutrient source (such as 
molasses, yeast extract, or algal powder) added to agricultural tea to 
increase microbial biomass.
    Agricultural water means water used in covered activities on 
covered produce where water is intended to, or is likely to, contact 
covered produce or food-contact surfaces, including water used in 
growing activities (including irrigation water applied using direct 
water application methods, water used for preparing crop sprays, and 
water used for growing sprouts) and in harvesting, packing, and holding 
activities (including water used for washing or cooling harvested 
produce and water used for preventing dehydration of covered produce).
    Animal excreta means solid or liquid animal waste.
    Application interval means the time interval between application of 
an agricultural input (such as a biological soil amendment of animal 
origin) to a growing area and harvest of covered produce from the 
growing area where the agricultural input was applied.
    Biological soil amendment means any soil amendment containing 
biological materials such as humus, manure, non-fecal animal 
byproducts, peat moss, pre-consumer vegetative waste, sewage sludge 
biosolids, table waste, agricultural tea, or yard trimmings, alone or 
in combination.
    Biological soil amendment of animal origin means a biological soil 
amendment which consists, in whole or in part, of materials of animal 
origin, such as manure or non-fecal animal byproducts, or table waste, 
alone or in combination. The term ``biological soil amendment of animal 
origin'' does not include any form of human waste.
    Composting means a process to produce humus in which organic 
material is decomposed by the actions of microorganisms under 
thermophilic conditions for a designated period of time (for example, 3 
days) at a designated temperature (for example, 131[deg]F (55 [deg]C)), 
followed by a curing stage under cooler conditions.
    Covered activity means growing, harvesting, packing, or holding 
covered produce, 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. Covered activity does 
not include manufacturing/processing within the meaning defined in this 
chapter. This part does not apply to activities of a facility that are 
subject to part 110 of this chapter.
    Covered produce means produce that is subject to the requirements 
of this part in accordance with Sec. Sec.  112.1 and 112.2. The term 
``covered produce'' refers to the harvestable or harvested part of the 
crop.
    Curing means the maturation stage of composting, which is conducted 
after much of the readily metabolized biological material has been 
decomposed, at cooler temperatures than those in the thermophilic phase 
of composting, to further reduce pathogens, promote further 
decomposition of cellulose and lignin, and stabilize composition.
    Direct water application method means using agricultural water in a 
manner whereby the water is intended to, or is likely to, contact 
covered produce or food-contact surfaces during use of the water.
    Farm means a facility (as defined in Sec.  1.227 of this chapter) 
in one general physical location devoted to the growing and harvesting 
of crops, the raising of animals (including seafood) or both. Farm 
includes:
    (i) Facilities that pack or hold food, provided that all food used 
in such activities is grown, raised, or consumed

[[Page 3631]]

on that farm or another farm under the same ownership; and
    (ii) Facilities that manufacture/process food, provided that all 
food used in such activities is consumed on that farm or another farm 
under same ownership.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes seeds and beans used to grow 
sprouts.
    Food-contact surfaces means those surfaces that contact human food 
and those surfaces from which drainage, or other transfer, onto the 
food or onto surfaces that contact the food ordinarily occurs during 
the normal course of operations. ``Food-contact surfaces'' includes 
food-contact surfaces of equipment and tools used during harvest, 
packing and holding.
    Growth media means material that acts as a substrate during the 
growth of covered produce (such as mushrooms and some sprouts) that 
contains, may contain, or consists of components that may include any 
animal waste (such as humus, manure, non-fecal animal byproducts or 
table waste).
    Harvesting applies to farms and farm mixed-type facilities and 
means activities that are traditionally performed by 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 the 
farm on which they were grown or raised, or another farm under the same 
ownership. 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 or another farm under the same ownership 
are examples of harvesting.
    Hazard means any biological agent that is reasonably likely to 
cause illness or injury in the absence of its control.
    Holding means storage of food. Holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, 
and liquid storage tanks. For farms and farm mixed-type facilities, 
holding also includes activities traditionally performed by farms for 
the safe or effective storage of raw agricultural commodities grown or 
raised on the same farm or another farm under the same ownership, 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.
    Humus means a stabilized (i.e., finished) biological soil amendment 
produced through a controlled composting process.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or 
packaging. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting, 
packing, or holding.
    Manure means animal excreta, alone or in combination with litter 
(such as straw and feathers used for animal bedding) for use as a soil 
amendment.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, 
and microscopic parasites and includes species having public health 
significance. The term ``undesirable microorganisms'' includes those 
microorganisms that are of public health significance, that subject 
food to decomposition, that indicate that food is contaminated with 
filth, or that otherwise may cause food to be adulterated.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) and activities 
that require the establishment to be registered. An example of such a 
facility is a ``farm mixed-type facility,'' which is an establishment 
that grows and harvests crops or raises animals and may conduct other 
activities within the farm definition, but also conducts activities 
that require the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether a process, point or procedure is under 
control and, when applicable, to produce an accurate record of the 
observation or measurement.
    Non-fecal animal byproduct means solid waste (other than excreta) 
that is animal in origin (such as meat, fat, dairy products, eggs, 
carcasses, blood meal, bone meal, fish meal, shellfish waste (such as 
crab, shrimp, and lobster waste), fish emulsions, and offal) and is 
generated by commercial, institutional, or agricultural operations.
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging 
the food. For farms and farm mixed-type facilities, packing also 
includes activities (which may include packaging) traditionally 
performed by farms to prepare raw agricultural commodities grown or 
raised on the same farm or another farm under the same ownership for 
storage and transport, 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.
    Pest means any objectionable animals or insects including birds, 
rodents, flies, and larvae.
    Pre-consumer vegetative waste means solid waste that is purely 
vegetative in origin, not considered yard trash, and derived from 
commercial, institutional, or agricultural operations without coming in 
contact with animal products, byproducts or manure or with an end user 
(consumer). Pre-consumer vegetative waste includes material generated 
by farms, packing houses, canning operations, wholesale distribution 
centers and grocery stores; products that have been removed from their 
packaging (such as out-of-date juice, vegetables, condiments, and 
bread); and associated packaging that is vegetative in origin (such as 
paper or corn-starch based products). Pre-consumer vegetative waste 
does not include table waste, packaging that has come in contact with 
materials (such as meat) that are not vegetative in origin, or any 
waste generated by restaurants.
    Produce means any fruit or vegetable (including mixes of intact 
fruits and vegetables) and includes mushrooms, sprouts (irrespective of 
seed source), peanuts, tree nuts and herbs. A fruit is the edible 
reproductive body of a seed plant or tree nut (such as apple, orange 
and almond) such that fruit means the harvestable or harvested part of 
a plant developed from a flower. A vegetable is the edible part of an 
herbaceous plant (such as cabbage or potato) or fleshy fruiting body of 
a fungus (such as white button or shiitake) grown for an edible part 
such that vegetable means the harvestable or harvested part of any

[[Page 3632]]

plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, 
tubers, bulbs, stems, leaves, or flower parts are used as food and 
includes mushrooms, sprouts, and herbs (such as basil or cilantro). 
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.
    Production batch of sprouts means all sprouts that are started at 
the same time in a single growing unit (e.g., a single drum or bin, or 
a single rack of trays that are connected to each other), whether or 
not the sprouts are grown from a single lot of seed (including, for 
example, when multiple types of seeds are grown in a single growing 
unit).
    Qualified end-user with respect to a food means the consumer of the 
food; or a restaurant or retail food establishment (as those terms are 
defined in Sec.  1.227) that is located:
    (i) In the same State as the farm that produced the food; or
    (ii) Not more than 275 miles from such farm. The term ``consumer'' 
does not include a business.
    Raw agricultural commodity (RAC) means ``raw agricultural 
commodity'' as defined in section 201(r) of the Federal Food, Drug, and 
Cosmetic Act.
    Reasonably foreseeable hazard means a potential hazard that may be 
associated with the farm or the food.
    Sanitize means to adequately treat cleaned food-contact surfaces by 
a process that is effective in destroying vegetative cells of 
microorganisms of public health significance, and in substantially 
reducing numbers of other undesirable microorganisms, but without 
adversely affecting the product or its safety for the consumer.
    Sewage sludge biosolids means the solid or semi-solid residue 
generated during the treatment of domestic sewage in a treatment works 
within the meaning of the definition of ``sewage sludge'' in 40 CFR 
503.9(w).
    Soil amendment means any chemical, biological, or physical material 
(such as elemental fertilizers, humus, manure, non-fecal animal 
byproducts, peat moss, perlite, pre-consumer vegetative waste, sewage 
sludge biosolids, table waste, agricultural tea and yard trimmings) 
intentionally added to the soil to improve the chemical or physical 
condition of soil in relation to plant growth or to improve the 
capacity of the soil to hold water. The term soil amendment also 
includes growth media that serve as the entire substrate during the 
growth of covered produce (such as mushrooms and some sprouts).
    Spent sprout irrigation water means water that has been used in the 
growing of sprouts.
    Static composting means a process to produce humus in which air is 
introduced into biological material (in a pile (or row) covered with at 
least 6 inches of insulating material, or in an enclosed vessel) by a 
mechanism that does not include turning. Examples of structural 
features for introducing air include embedded perforated pipes and a 
constructed permanent base that includes aeration slots. Examples of 
mechanisms for introducing air include passive diffusion and mechanical 
means (such as blowers that suction air from the composting material or 
blow air into the composting material using positive pressure).
    Surface water means all water which is open to the atmosphere and 
subject to surface runoff, including water obtained from an underground 
aquifer that is held or conveyed in a manner that is open to the 
atmosphere, such as in canals, ponds, other surface containment or open 
conveyances.
    Table waste means any post-consumer food waste, irrespective of 
whether the source material is animal or vegetative in origin, derived 
from individuals, institutions, restaurants, retail operations, or 
other sources where the food has been served to a consumer.
    Turned composting means a process to produce humus in which air is 
introduced into biological material (in a pile, row, or enclosed 
vessel) by turning on a regular basis. Turning is the process of 
mechanically mixing biological material that is undergoing a composting 
process with the specific intention of moving the outer, cooler 
sections of the material being composted to the inner, hotter sections.
    Water distribution system means a system to carry water from its 
primary source to its point of use, including pipes, sprinklers, 
irrigation canals, pumps, valves, storage tanks, reservoirs, meters, 
and fittings.
    We means the U.S. Food and Drug Administration (FDA).
    Yard trimmings means purely vegetative matter resulting from 
landscaping maintenance or land clearing operations, including 
materials such as tree and shrub trimmings, grass clippings, palm 
fronds, trees, tree stumps, untreated lumber, untreated wooden pallets, 
and associated rocks and soils.
    You means a person who is subject to some or all of the 
requirements in this part.


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 food (as ``food'' 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. 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.
    (b) You are not a covered farm if you satisfy the requirements in 
Sec.  112.5 and we have not withdrawn your exemption in accordance with 
the requirements of subpart R of this part.


Sec.  112.5  Who is eligible for a qualified exemption and associated 
modified requirements based on average monetary value of all food sold 
and direct farm marketing?

    (a) You are 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 Sec.  112.3(c)) you sold directly to qualified end-users (as 
defined in 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 
Sec.  112.3(c)) you sold during the 3-year period preceding the 
applicable calendar year was less than $500,000, adjusted for 
inflation.
    (b) For the purpose of determining whether the average annual 
monetary value of all food sold during the 3-year period preceding the 
applicable calendar year was less than $500,000, adjusted for 
inflation, the baseline year for calculating the adjustment for 
inflation is 2011.


Sec.  112.6  What modified requirements apply to me if I am eligible 
for a qualified exemption in accordance with Sec.  112.5?

    (a) If you are eligible for a qualified exemption in accordance 
with Sec.  112.5, you are subject to the requirements of:
    (1) This subpart A; and
    (2) Subparts Q and R of this part.
    (b) In addition, you are subject to the following modified 
requirements:
    (1) When a food packaging label is required on food that would 
otherwise

[[Page 3633]]

be covered produce under the Federal Food, Drug, and Cosmetic Act or 
its implementing regulations, you must include prominently and 
conspicuously on the food packaging label the name and the complete 
business address of the farm where the produce was grown.
    (2) When a food packaging label is not required on food that would 
otherwise be covered produce under the Federal Food, Drug, and Cosmetic 
Act, you must prominently and conspicuously display, at the point of 
purchase, the name and complete business address of the farm where the 
produce was grown, on a label, poster, sign, placard, or documents 
delivered contemporaneously with the produce in the normal course of 
business, or, in the case of Internet sales, in an electronic notice.
    (3) The complete business address that you must include in 
accordance with the requirements of paragraph (b)(1) or (b)(2) of this 
section must include the street address or post office box, city, 
state, and zip code for domestic farms, and comparable full address 
information for foreign farms.

Subpart B--General Requirements


Sec.  112.11  What general requirements apply to persons who are 
subject to this part?

    You must take appropriate measures to minimize the risk of serious 
adverse health consequences or death from the use of, or exposure to, 
covered produce, including those measures reasonably necessary to 
prevent the introduction of known or reasonably foreseeable hazards 
into covered produce, and to provide reasonable assurances that the 
produce is not adulterated under section 402 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 342) on account of such hazards.


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

    (a) You may establish alternatives to the following specific 
requirements of this part, provided that you satisfy the requirements 
of paragraphs (b) and (c) of this section:
    (1) The requirements in Sec.  112.44(c) for testing water, and 
taking action based on test results, when agricultural water is used 
during growing operations for covered produce (other than sprouts) 
using a direct water application method;
    (2) Composting treatment processes established in Sec.  
112.54(c)(1) and (c)(2);
    (3) The minimum application interval established in Sec.  
112.56(a)(1)(i) for an untreated biological soil amendment of animal 
origin that is reasonably likely to contact covered produce after 
application or for a compost agricultural tea that contains compost 
agricultural tea additives; and
    (4) The minimum application interval established in Sec.  
112.56(a)(4)(i) for a biological soil amendment of animal origin 
treated by a composting process that is reasonably likely to contact 
covered produce after application.
    (b) You may establish and use an alternative to any of the 
requirements listed in paragraph (a) of this section, provided you have 
adequate scientific data or information to support a conclusion that 
the alternative would provide the same level of public health 
protection as the applicable requirement established in this part 
(including meeting the same microbiological standards, where 
applicable), and would not increase the likelihood that your covered 
produce will be adulterated under section 402 of the Federal Food, 
Drug, and Cosmetic Act, in light of your covered produce, practices, 
and conditions, including agro-ecological conditions and application 
interval.
    (c) Scientific data and information used to support an alternative 
to a requirement listed in paragraph (a) of this section may be 
developed by you, available in the scientific literature, or available 
to you through a third party. You must establish and maintain 
documentation of the scientific data and information on which you rely 
in accordance with the requirements of subpart O of this part.

Subpart C--Standards Directed to Personnel Qualifications and 
Training


Sec.  112.21  What requirements apply regarding qualifications and 
training for personnel who handle (contact) covered produce or food-
contact surfaces?

    All of the following requirements apply regarding qualifications 
and training for personnel who handle (contact) covered produce or 
food-contact surfaces:
    (a) All personnel (including temporary, part time, seasonal, and 
contracted personnel) who handle covered produce or food-contact 
surfaces, or who are engaged in the supervision thereof, must receive 
adequate training, as appropriate to the person's duties, upon hiring, 
at the beginning of each growing season (if applicable), and 
periodically thereafter.
    (b) All personnel (including temporary, part time, seasonal, and 
contracted personnel) who handle covered produce or food-contact 
surfaces, or who are engaged in the supervision thereof, must have the 
training, in combination with education or experience to perform the 
person's assigned duties in a manner that ensures compliance with this 
part.
    (c) Training must be conducted in a manner that is easily 
understood by personnel being trained.
    (d) Training must be repeated as necessary and appropriate in light 
of observations or information indicating that personnel are not 
meeting standards established by FDA in subparts C through O of this 
part.


Sec.  112.22  What minimum requirements apply for training personnel 
who conduct a covered activity?

    (a) At a minimum, all personnel who handle (contact) covered 
produce during covered activities or supervise the conduct of such 
activities must receive training that includes all of the following:
    (1) Principles of food hygiene and food safety;
    (2) The importance of health and personal hygiene for all personnel 
and visitors, including recognizing symptoms of a health condition that 
is reasonably likely to result in contamination of covered produce or 
food-contact surfaces with microorganisms of public health 
significance; and
    (3) The standards established by FDA in subparts C through O of 
this part that are applicable to the employee's job responsibilities.
    (b) Persons who conduct harvest activities for covered produce must 
also receive training that includes all of the following:
    (1) Recognizing covered produce that should not be harvested, 
including covered produce that may be contaminated with known or 
reasonably foreseeable hazards;
    (2) Inspecting harvest containers and equipment to ensure that they 
are functioning properly, clean, and maintained so as not to become a 
source of contamination of covered produce with known or reasonably 
foreseeable hazards; and
    (3) Correcting problems with harvest containers or equipment, or 
reporting such problems to the supervisor (or other responsible party), 
as appropriate to the person's job responsibilities.
    (c) At least one supervisor or responsible party for your farm must 
have successfully completed food safety training at least equivalent to 
that received under standardized curriculum recognized as adequate by 
the Food and Drug Administration.


Sec.  112.23  What requirements apply regarding supervisors?

    You must assign or identify personnel to supervise (or otherwise be

[[Page 3634]]

responsible for) your operations to ensure compliance with the 
requirements of this part.


Sec.  112.30  Under this subpart, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
C in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep records of training that document 
required training of personnel, including the date of training, topics 
covered, and the persons(s) trained.

Subpart D--Standards Directed to Health and Hygiene


Sec.  112.31  What measures must I take to prevent ill or infected 
persons from contaminating covered produce with microorganisms of 
public health significance?

    (a) You must take measures to prevent contamination of covered 
produce and food-contact surfaces with microorganisms of public health 
significance from any person with an applicable health condition (such 
as a communicable illnesses that present a public health risk in the 
context of normal work duties, infection, open lesion, vomiting, or 
diarrhea).
    (b) The measures you must take to satisfy the requirements of 
paragraph (a) of this section must include all of the following 
measures:
    (1) Excluding any person from working in any operations that may 
result in contamination of covered produce or food-contact surfaces 
with microorganisms of public health significance when the person (by 
medical examination, the person's acknowledgement, or observation) is 
shown to have, or appears to have, an applicable health condition, 
until the person's health condition no longer presents a risk to public 
health; and
    (2) Instructing personnel to notify their supervisor(s) (or a 
responsible party) if they have, or if there is a reasonable 
possibility that they have an applicable health condition.


Sec.  112.32  What hygienic practices must personnel use?

    (a) Personnel who work in an operation in which covered produce or 
food-contact surfaces are at risk of contamination with known or 
reasonably foreseeable hazards must use hygienic practices while on 
duty to the extent necessary to protect against such contamination.
    (b) The hygienic practices that personnel use to satisfy the 
requirements of paragraph (a) of this section when handling 
(contacting) covered produce or food-contact surfaces during a covered 
activity must include all of the following practices:
    (1) Maintaining adequate personal cleanliness to protect against 
contamination of covered produce and food-contact surfaces;
    (2) Avoiding contact with animals other than working animals, and 
taking appropriate steps to minimize the likelihood of contamination of 
covered produce when in direct contact with working animals;
    (3) Washing hands thoroughly, including scrubbing with soap and 
running water that satisfies the requirements of Sec.  112.44(a) (as 
applicable) for water used to wash hands, and drying hands thoroughly 
using single-service towels, clean cloth towels, sanitary towel service 
or other adequate hand drying devices:
    (i) Before starting work;
    (ii) Before putting on gloves;
    (iii) After using the toilet;
    (iv) Upon return to the work station after any break or other 
absence from the work station;
    (v) As soon as practical after touching animals (including 
livestock and working animals), or any waste of animal origin; and
    (vi) At any other time when the hands may have become contaminated 
in a manner that is reasonably likely to lead to contamination of 
covered produce with known or reasonably foreseeable hazards; and
    (4) If you choose to use gloves in handling covered produce or 
food-contact surfaces, maintaining gloves in an intact and sanitary 
condition and replacing such gloves when no longer able to do so.


Sec.  112.33  What measures must I take to prevent visitors from 
contaminating covered produce and food-contact surfaces with 
microorganisms of public health significance?

    (a) A visitor is any person (other than personnel) who enters your 
covered farm with your permission.
    (b) You must make visitors aware of policies and procedures to 
protect covered produce and food-contact surfaces from contamination by 
people and take all steps reasonably necessary to ensure that visitors 
comply with such policies and procedures.
    (c) You must make toilet and hand-washing facilities accessible to 
visitors.

Subpart E--Standards Directed to Agricultural Water


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

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


Sec.  112.42  What measures must I take with respect to my agricultural 
water sources, water distribution system, and pooling of water?

    (a) At the beginning of a growing season, you must inspect the 
entire agricultural water system under your control (including water 
source, water distribution system, facilities, and equipment), to 
identify conditions that are reasonably likely to introduce known or 
reasonably foreseeable hazards into or onto covered produce or food-
contact surfaces in light of your covered produce, practices, and 
conditions, including consideration of the following:
    (1) The nature of each agricultural water source (for example, 
ground water or surface water);
    (2) The extent of your control over each agricultural water source;
    (3) The degree of protection of each agricultural water source;
    (4) Use of adjacent or nearby land; and
    (5) The likelihood of introduction of known or reasonably 
foreseeable hazards to agricultural water by another user of 
agricultural water before the water reaches your covered farm.
    (b) You must adequately maintain all agricultural water sources 
that are under your control (such as wells) by regularly inspecting 
each source and keeping the source free of debris, trash, domesticated 
animals, and other possible sources of contamination of covered produce 
to the extent practicable and appropriate under the circumstances.
    (c) You must adequately maintain all agricultural water 
distribution systems as necessary and appropriate to prevent the water 
distribution system from being a source of contamination to covered 
produce, food-contact surfaces, areas used for a covered activity, or 
water sources, including by regularly inspecting and adequately storing 
all equipment used in the system.
    (d) You must immediately discontinue use of a source of 
agricultural water and/or its distribution system, and not use the 
water source and/or its distribution system when you have determined or 
have reason to believe that your agricultural water is not safe and of 
adequate sanitary quality for its intended use, until you either:

[[Page 3635]]

    (1) Re-inspect 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 test the 
water to determine if your changes were effective and to ensure that 
your agricultural water is safe and of adequate sanitary quality for 
its intended use; or
    (2) Treat the water in accordance with the requirements of Sec.  
112.43.
    (e) As necessary and appropriate, you must implement measures 
reasonably necessary to reduce the potential for contamination of 
covered produce with known or reasonably foreseeable hazards as a 
result of pooling of water. For example, such measures may include 
using protective barriers or staking to keep covered produce from 
touching the ground or using an alternative irrigation method.


Sec.  112.43  What treatment of agricultural water is required, and 
what requirements apply to treating agricultural water?

    (a) You must treat any agricultural water that you use (such as 
with an EPA-registered antimicrobial pesticide product) if you know or 
have reason to believe that the water is not safe and of adequate 
sanitary quality for its intended use.
    (b) Any method you use to treat agricultural water to satisfy the 
requirement in paragraph (a) of this section must be effective to make 
the water safe and of adequate sanitary quality for its intended use.
    (c)(1) You must deliver any treatment of agricultural water 
required by paragraph (a) of this section in a manner to ensure that 
the treated water is consistently safe and of adequate sanitary quality 
for its intended use.
    (2) You must monitor any treatment of agricultural water at a 
frequency adequate to ensure that the treated water is consistently 
safe and of adequate sanitary quality for its intended use.


Sec.  112.44  What testing is required for agricultural water, and what 
must I do based on the test results?

    (a) You must test the quality of agricultural water according to 
the requirements in Sec.  112.45 using a quantitative, or presence-
absence method of analysis provided in subpart N of this part to ensure 
there is no detectable generic Escherichia coli (E. coli) in 100 
milliliters (mL) of agricultural water when it 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; or
    (5) Used for washing hands during and after harvest activities.
    (b) If you find that there is any detectable generic E. coli in 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 paragraph (a) of this section. Before you may use the 
water source and/or distribution system again for the uses described in 
paragraph (a) of this section, you must either re-inspect 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 and to ensure that the water meets the requirements of 
paragraph (a) of this section; or treat the water in accordance with 
the requirements of Sec.  112.43.
    (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. If you find that there is 
more than 235 colony forming units (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 this paragraph. Before you may use the water 
source and/or distribution system again for the uses described in this 
paragraph, you must either re-inspect 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 requirements 
established in paragraph (c) of this section, provided you satisfy the 
requirements of Sec.  112.12.


Sec.  112.45  How often must I test agricultural water that is subject 
to the requirements of Sec.  112.44?

    (a) 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 three months thereafter during the growing season, except 
that there is no requirement to test water 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 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, you must test the water as 
specified in the table in this paragraph.

----------------------------------------------------------------------------------------------------------------
                                                                       Then you must test the untreated surface
                 If the untreated surface water is--                                    water--
----------------------------------------------------------------------------------------------------------------
(1) From any source where a significant quantity of runoff is likely  At least every 7 days during the growing
 to drain into the source (for example, a river or natural lake).      season.

[[Page 3636]]

 
(2) From any source where underground aquifer water is transferred    At least once each month during the
 to a surface water containment constructed and maintained in a        growing season.
 manner that minimizes runoff drainage into the containment (for
 example, an on-farm man-made water reservoir).
----------------------------------------------------------------------------------------------------------------

Sec.  112.46  What measures must I take for water that I use during 
harvest, packing, and holding activities for covered produce?

    (a) You must manage the water as necessary, including by 
establishing and following water-change schedules for re-circulated 
water, to maintain adequate sanitary quality and minimize the potential 
for contamination of covered produce and food-contact surfaces with 
known or reasonably foreseeable hazards (for example, hazards that may 
be introduced into the water from soil adhering to the covered 
produce);
    (b) You must visually monitor the quality of water that you use 
during harvest, packing, and holding activities for covered produce 
(for example, water used for washing covered produce in dump tanks, 
flumes, or wash tanks, and water used for cooling covered produce in 
hydrocoolers) for build-up of organic material (such as soil and plant 
debris).
    (c) You must maintain and monitor the temperature of water at a 
temperature that is appropriate for the commodity and operation 
(considering the time and depth of submersion) and is adequate to 
minimize the potential for infiltration of microorganisms of public 
health significance into covered produce.


Sec.  112.50  Under this subpart, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
E in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records:
    (1) The findings of the inspection of your agricultural water 
system in accordance with the requirements of Sec.  112.42(a);
    (2) Documentation of the results of any analytical tests conducted 
to determine whether agricultural water is safe and of adequate 
sanitary quality for its intended use;
    (3) Scientific data or information you rely on to support the 
adequacy of a method used to satisfy the requirements of Sec.  
112.43(b) and (c)(1);
    (4) Documentation of the results of water treatment monitoring 
under Sec.  112.43(c)(2);
    (5) Documentation of the results of water testing you perform to 
satisfy the requirements of Sec.  112.44; and
    (6) Scientific data or information you rely on to support any 
alternative to the requirements established in Sec.  112.44(c) for 
agricultural water used during growing activities using a direct water 
application method in accordance with the requirements of Sec.  
112.44(d).
    (7) Annual documentation of the results or certificates of 
compliance from a public water system under 112.45(a)(1) or (a)(2), if 
applicable.

Subpart F--Standards Directed to Biological Soil Amendments of 
Animal Origin and Human Waste


Sec.  112.51  What requirements apply for determining the status of a 
biological soil amendment of animal origin?

    (a) A biological soil amendment of animal origin is treated if it 
has been processed to completion to adequately reduce microorganisms of 
public health significance in accordance with the requirements of Sec.  
112.54, or, in the case of an agricultural tea, the biological 
materials used to make the tea have been so processed and the water 
used to make the tea satisfies the requirements of 112.44(a).
    (b) A biological soil amendment of animal origin is untreated if 
it:
    (1) Has not been processed to completion in accordance with the 
requirements of Sec.  112.54, or in the case of an agricultural tea, 
the biological materials used to make the tea have not been so 
processed or the water used to make the tea does not satisfy the 
requirements of 112.44(a);
    (2) Has become contaminated after treatment;
    (3) Has been recombined with an untreated biological soil amendment 
of animal origin;
    (4) Is or contains a component that is untreated waste that you 
know or have reason to believe is contaminated with a hazard or has 
been associated with foodborne illness; or
    (5) Is an agricultural tea that contains an agricultural tea 
additive.


Sec.  112.52  How must I handle, convey, and store biological soil 
amendments of animal origin?

    (a) You must handle, convey and store any biological soil amendment 
of animal origin in a manner and location such that it does not become 
a potential source of contamination to covered produce, food-contact 
surfaces, areas used for a covered activity, water sources, and water 
distribution systems.
    (b) You must handle, convey and store any treated biological soil 
amendment of animal origin in a manner and location that minimizes the 
risk of it becoming contaminated by an untreated or in-process 
biological soil amendment of animal origin.
    (c) You must handle, convey, and store any biological soil 
amendment of animal origin that has become contaminated as if it was 
untreated.


Sec.  112.53  What prohibitions apply regarding use of human waste?

    You may not use human waste for growing covered produce, except 
sewage sludge biosolids used in accordance with the requirements of 40 
CFR part 503, subpart D, or equivalent regulatory requirements.


Sec.  112.54  What treatment processes are acceptable for a biological 
soil amendment of animal origin that I apply in the growing of covered 
produce?

    Each of the following treatment processes are acceptable for a 
biological soil amendment of animal origin that you apply in the 
growing of covered produce, provided that the resulting biological soil 
amendments are applied in accordance with the applicable requirements 
of Sec.  112.56:
    (a) A scientifically valid controlled physical process (for 
example, thermal), chemical process (for example, high alkaline pH), or 
combination of scientifically valid controlled physical and chemical 
processes that has been demonstrated to satisfy the microbial standard 
in Sec.  112.55(a) for Listeria monocytogenes (L. monocytogenes), 
Salmonella species, and E. coli O157:H7;
    (b) A scientifically valid controlled physical process, chemical 
process, or combination of scientifically valid controlled physical and 
chemical processes, that has been demonstrated to satisfy the microbial 
standard in Sec.  112.55(b) for Salmonella and fecal coliforms; or
    (c) A scientifically valid controlled composting process that has 
been demonstrated to satisfy the microbial standard in Sec.  112.55(b) 
for Salmonella and fecal coliforms. Scientifically valid controlled 
composting processes include:
    (1) Static composting that maintains aerobic (i.e., oxygenated) 
conditions at a minimum of 131[emsp14][deg]F (55 [deg]C) for 3 days

[[Page 3637]]

and is followed by adequate curing, which includes proper insulation;
    (2) Turned composting that maintains aerobic conditions at a 
minimum of 131[emsp14][deg]F (55 [deg]C) for 15 days, with a minimum of 
five turnings, and is followed by adequate curing, which includes 
proper insulation; or
    (3) Other scientifically valid, controlled composting processes, 
provided you satisfy the requirements of Sec.  112.12, including that 
the alternative process has been demonstrated to satisfy the microbial 
standard in Sec.  112.55(b).


Sec.  112.55  What microbial standards apply to the treatment processes 
in Sec.  112.54?

    The following microbial standards apply to the treatment processes 
in Sec.  112.54 as set forth in that section.
    (a) For L. monocytogenes, Salmonella species, and E. coli O157:H7, 
the relevant standards in the table in this paragraph or;

--------------------------------------------------------------------------------------------------------------------------------------------------------
             For the microorganism--                                                    The microbial standard is--
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) L. monocytogenes............................  Not detected using a method that can detect one colony forming unit (CFU) per 5 gram analytical
                                                   portion.
(2) Salmonella species..........................  Less than three most probable numbers (MPN) per 4 grams of total solids (dry weight basis).
(3) E. coli O157:H7.............................  Less than 0.3 MPN per 1 gram analytical portion.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     (b) Less than three MPN Salmonella species per four grams of total 
solids (dry weight basis); and less than 1,000 MPN fecal coliforms per 
gram of total solids (dry weight basis).


Sec.  112.56  What application requirements and minimum application 
intervals apply to biological soil amendments of animal origin?

    (a) Except as provided in paragraph (b) of this section, you must 
apply the biological soil amendments of animal origin specified in the 
first column of the table in this paragraph in accordance with the 
application requirements specified in the second column of the table in 
this paragraph and the minimum application intervals specified in the 
third column of the table in this paragraph.

----------------------------------------------------------------------------------------------------------------
  If the biological soil amendment of   Then the biological soil amendment of  And then the  minimum application
          animal origin is--               animal origin must be applied--               interval is--
----------------------------------------------------------------------------------------------------------------
(1)(i) Untreated......................  In a manner that does not contact      9 months.
                                         covered produce during application
                                         and minimizes the potential for
                                         contact with covered produce after
                                         application
(ii) Untreated........................  In a manner that does not contact      0 days.
                                         covered produce during or after
                                         application
(2) Treated by a scientifically valid   In any manner (i.e., no restrictions)  0 days.
 controlled physical or chemical
 process, or combination of
 scientifically valid controlled
 physical and chemical processes, in
 accordance with the requirements of
 Sec.   112.54(a) to meet the
 microbial standard in Sec.
 112.55(a).
(3) Treated by a scientifically valid   In a manner that minimizes the         0 days.
 controlled physical or chemical         potential for contact with covered
 process, or combination of              produce during and after application
 scientifically valid controlled
 physical and chemical processes, in
 accordance with the requirements of
 Sec.   112.54(b) to meet the
 microbial standard in Sec.
 112.55(b).
(4)(i) Treated by a composting process  In a manner that minimizes the         45 days.
 in accordance with the requirements     potential for contact with covered
 of Sec.   112.54(c) to meet the         produce during and after application
 microbial standard in Sec.
 112.55(b).
(ii) Treated by a composting process    In a manner that does not contact      0 days.
 in accordance with the requirements     covered produce during or after
 of Sec.   112.54(c) to meet the         application
 microbial standard in Sec.
 112.55(b).
----------------------------------------------------------------------------------------------------------------

     (b) You may establish and use alternatives to the minimum 
application intervals established in paragraphs (a)(1)(i) and (a)(4)(i) 
of this section, provided you satisfy the requirements of Sec.  112.12.


Sec.  112.60  Under this subpart, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
F in accordance with the requirements of subpart O of this part.
    (b) For any biological soil amendment of animal origin you use, you 
must establish and keep the following records:
    (1) Documentation of the date of application of any untreated 
biological soil amendment of animal origin (including raw manure) or 
any biological soil amendment of animal origin treated by composting to 
a growing area and the date of harvest of covered produce from that 
growing area, except when covered produce does not contact the soil 
after application of the soil amendment;
    (2) For a treated biological soil amendment of animal origin you 
receive from a third party, documentation (such as a Certificate of 
Conformance) that:
    (i) The process used to treat the biological soil amendment of 
animal origin is a scientifically valid process that has been carried 
out with appropriate process monitoring;
    (ii) The applicable treatment process is periodically verified 
through testing using a scientifically valid analytical method on an 
adequately representative sample to demonstrate that the process 
satisfies the applicable microbial standard in Sec.  112.55, including 
the results of such periodic testing; and
    (iii) The biological soil amendment of animal origin has been 
handled, conveyed and stored in a manner and

[[Page 3638]]

location to minimize the risk of contamination by an untreated or in-
process biological soil amendment of animal origin;
    (3) For a treated biological soil amendment of animal origin you 
produce for your own covered farm(s), documentation that process 
controls (for example, time, temperature and turnings) were achieved;
    (4) Scientific data or information you rely on to support any 
alternative composting process used to treat a biological soil 
amendment of animal origin in accordance with the requirements of Sec.  
112.54(c)(3); and
    (5) Scientific data or information you rely on to support any 
alternative minimum application interval in accordance with the 
requirements of Sec.  112.56(b).

Subpart G--[Reserved]

Subpart H--[Reserved]

Subpart I--Standards Directed to Domesticated and Wild Animals


Sec.  112.81  How do the requirements of this subpart apply to areas 
where covered activities take place?

    (a) The requirements of this subpart apply when a covered activity 
takes place in an outdoor area or a partially-enclosed building and 
when, under the circumstances, there is a reasonable probability that 
animals will contaminate covered produce.
    (b) The requirements of this subpart do not apply when a covered 
activity takes place in a fully-enclosed building.


Sec.  112.82  What requirements apply regarding domesticated animals 
that I allow to graze in fields or use as working animals where I grow 
covered produce?

    At a minimum, if you allow animals to graze or use them 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 take the following 
measures:
    (a) An adequate waiting period between grazing and harvesting for 
covered produce in any growing area that was grazed to ensure the 
safety of the harvested crop; and
    (b) If working animals are used in a growing area where a crop has 
been planted, measures to prevent the introduction of known or 
reasonably foreseeable hazards into or onto covered produce.


Sec.  112.83  What requirements apply regarding animal intrusion?

    (a) If under the circumstances there is a reasonable probability 
that animal intrusion will contaminate covered produce, you must 
monitor those areas that are used for a covered activity for evidence 
of animal intrusion:
    (1) As needed during the growing season based on:
    (i) Your covered produce; and
    (ii) Your observations and experience; and
    (2) Immediately prior to harvest.
    (b) If animal intrusion, as made evident by observation of 
significant quantities of animals, animal excreta or crop destruction 
via grazing, occurs, you must evaluate whether the covered produce can 
be harvested in accordance with the requirements of Sec.  112.112.

Subpart J--[Reserved]

Subpart K--Standards Directed to Growing, Harvesting, Packing, and 
Holding Activities


Sec.  112.111  What measures must I take if I grow, harvest, pack or 
hold both covered and excluded produce?

    If you grow, harvest, pack or hold produce that is not covered in 
this part (i.e., excluded produce in accordance with Sec.  112.2) and 
also conduct such activities on covered produce, and the excluded 
produce is not grown, harvested, packed or held in accordance with this 
part, you must take measures during these covered activities, as 
applicable, to:
    (a) Keep covered produce separate from excluded produce; and
    (b) Adequately clean and sanitize, as necessary, any food-contact 
surfaces that contact excluded produce before using such food-contact 
surfaces for covered activities on covered produce.


Sec.  112.112  What measures must I take during harvest activities?

    You must take all measures reasonably necessary to identify, and 
not harvest, covered produce that is reasonably likely to be 
contaminated with a known or reasonably foreseeable hazard, including 
steps to identify and not harvest covered produce that is visibly 
contaminated with animal excreta.


Sec.  112.113  How must I handle harvested covered produce during 
covered activities?

    You must handle harvested covered produce in a manner that protects 
against contamination with known or reasonably foreseeable hazards--for 
example, by avoiding contact of cut surfaces of harvested produce with 
soil.


Sec.  112.114  What requirements apply to dropped covered produce?

    You must not distribute covered produce that drops to the ground 
before harvest (dropped covered produce) unless it is exempt under 
Sec.  112.2(b). Dropped covered produce does not include root crops 
(such as carrots) that grow underground or crops (such as cantaloupe) 
that grow on the ground.


Sec.  112.115  What measures must I take when packaging covered 
produce?

    You must package covered produce in a manner that prevents the 
formation of Clostridium botulinum toxin if such toxin is a known or 
reasonably foreseeable hazard (such as for mushrooms).


Sec.  112.116  What measures must I take when using food-packing 
(including food packaging) material?

    (a) You must use food-packing material that is adequate for its 
intended use.
    (b) If you reuse food-packing material, you must take steps to 
ensure that food-contact surfaces are clean, such as by cleaning and 
sanitizing, when necessary, food-packing containers or using a clean 
liner.

Subpart L--Standards Directed to Equipment, Tools, Buildings, and 
Sanitation


Sec.  112.121  What equipment and tools are subject to the requirements 
of this subpart?

    Equipment and tools subject to the requirements of this subpart are 
those that are intended to, or likely to, contact covered produce; and 
those instruments or controls used to measure, regulate, or record 
conditions to control or prevent the growth of undesirable 
microorganisms or other contamination. Examples include knives, 
implements, mechanical harvesters, waxing machinery, cooling equipment 
(including hydrocoolers), grading belts, sizing equipment, palletizing 
equipment, and equipment used to store or convey harvested covered 
produce (such as containers, bins, food-packing material, dump tanks, 
flumes, and vehicles or other equipment used for transport that are 
intended to, or likely to, contact covered produce).


Sec.  112.122  What buildings are subject to the requirements of this 
subpart?

    Buildings subject to the requirements of this subpart include:
    (a) Any fully- or partially-enclosed building used for covered 
activities, including minimal structures that have a roof but do not 
have any walls; and
    (b) Storage sheds, buildings, or other structures used to store 
food-contact

[[Page 3639]]

surfaces (such as harvest containers and food-packing materials).


Sec.  112.123  What general requirements apply regarding equipment and 
tools subject to this subpart?

    All of the following requirements apply regarding equipment and 
tools subject to this subpart:
    (a) You must use equipment and tools that are of adequate design, 
construction, and workmanship to enable them to be adequately cleaned 
and properly maintained; and
    (b) Equipment and tools must be:
    (1) Installed and maintained as to facilitate cleaning of the 
equipment and of all adjacent spaces, and
    (2) Stored and maintained to protect covered produce from being 
contaminated with known or reasonably foreseeable hazards and to 
prevent the equipment and tools from attracting and harboring pests.
    (c) Seams on food-contact surfaces of equipment and tools that you 
use must be either smoothly bonded, or maintained to minimize 
accumulation of dirt, filth, food particles, and organic material and 
thus minimize the opportunity for harborage or growth of 
microorganisms.
    (d)(1) You must inspect, maintain, and clean and sanitize, when 
necessary and appropriate, all food-contact surfaces of equipment and 
tools used in covered activities as frequently as reasonably necessary 
to protect against contamination of covered produce.
    (2) You must maintain and clean all non-food-contact surfaces of 
equipment and tools subject to this subpart used during harvesting, 
packing, and holding as frequently as reasonably necessary to protect 
against contamination of covered produce.
    (e) If you use equipment such as pallets, forklifts, tractors, and 
vehicles such that they are intended to, or likely to, contact covered 
produce, you must do so in a manner that minimizes the potential for 
contamination of covered produce or food-contact surfaces with known or 
reasonably foreseeable hazards.


Sec.  112.124  What requirements apply to instruments and controls used 
to measure, regulate, or record?

    Instruments or controls you use to measure, regulate, or record 
temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or 
other conditions, in order to control or prevent the growth of 
undesirable microorganisms or other contamination, must be:
    (a) Accurate and precise as necessary and appropriate in keeping 
with their purpose;
    (b) Adequately maintained; and
    (c) Adequate in number for their designated uses.


Sec.  112.125  What requirements apply to equipment that is subject to 
this subpart used in the transport of covered produce?

    Equipment that is subject to this subpart that you use to transport 
covered produce must be:
    (a) Adequately clean before use in transporting covered produce; 
and
    (b) Adequate for use in transporting covered produce.


Sec.  112.126  What design and construction requirements apply to my 
buildings?

    All of the following design and construction requirements apply 
regarding buildings.
    (a) Buildings must be suitable in size, construction, and design to 
facilitate maintenance and sanitary operations for covered activities 
to reduce the potential for contamination of covered produce or food-
contact surfaces with known or reasonably foreseeable hazards. 
Buildings must:
    (1) Provide sufficient space for placement of equipment and storage 
of materials;
    (2) Permit proper precautions to be taken to reduce the potential 
for contamination of covered produce, food-contact surfaces, or packing 
materials with known or reasonably foreseeable hazards. The potential 
for contamination must be reduced by effective design including the 
separation of operations in which contamination is likely to occur, by 
one or more of the following means: Location, time, partition, enclosed 
systems, or other effective means; and
    (3) Be constructed in such a manner that floors, walls, ceilings, 
fixtures, ducts and pipes can be adequately cleaned and kept in good 
repair, and that drip or condensate does not contaminate covered 
produce, food-contact surfaces, or packing materials.
    (b) You must provide adequate drainage in all areas where normal 
operations release or discharge water or other liquid waste on the 
ground or floor of the building.


Sec.  112.127  What requirements apply regarding domesticated animals 
in and around a fully-enclosed building?

    (a) You must take reasonable precautions to prevent contamination 
of covered produce, food-contact surfaces, and food-packing materials 
in fully-enclosed buildings with known or reasonably foreseeable 
hazards from domesticated animals by:
    (1) Excluding domesticated animals from fully-enclosed buildings 
where covered produce, food-contact surfaces, or food-packing material 
is exposed; or
    (2) Separating domesticated animals in a fully enclosed building 
from an area where a covered activity is conducted on covered produce 
by location, time, or partition.
    (b) Guard or guide dogs may be allowed in some areas of a fully 
enclosed building if the presence of the dogs is unlikely to result in 
contamination of produce, food-contact surfaces, or food-packing 
materials.


Sec.  112.128  What requirements apply regarding pest control in 
buildings?

    (a) You must take those measures reasonably necessary to protect 
covered produce, food-contact surfaces, and food-packing materials from 
contamination by pests in buildings, including routine monitoring for 
pests as necessary and appropriate.
    (b) For fully-enclosed buildings, you must take measures to exclude 
pests from your buildings.
    (c) For partially-enclosed buildings, you must take measures to 
prevent pests from becoming established in your buildings (such as by 
use of screens or by monitoring for the presence of pests and removing 
them when present).


Sec.  112.129  What requirements apply to toilet facilities?

    All of the following requirements apply to toilet facilities:
    (a) You must provide personnel with adequate, readily accessible 
toilet facilities, including toilet facilities readily accessible to 
growing areas during harvesting activities.
    (b) Your toilet facilities must be designed, located, and 
maintained to:
    (1) Prevent contamination of covered produce, food-contact 
surfaces, areas used for a covered activity, water sources, and water 
distribution systems with human waste;
    (2) Be directly accessible for servicing, be serviced and cleaned 
on a schedule sufficient to ensure suitability of use, and be kept 
supplied with toilet paper; and
    (3) Provide for the sanitary disposal of waste and toilet paper.
    (c) During growing activities that take place in a fully-enclosed 
building, and during covered harvesting, packing, or holding 
activities, you must provide a hand-washing station in sufficiently 
close proximity to toilet facilities to make it practical for persons 
who use the toilet facility to wash their hands.


Sec.  112.130  What requirements apply for hand-washing facilities?

    All of the following requirements apply to hand-washing facilities:

[[Page 3640]]

    (a) You must provide personnel with adequate, readily accessible 
hand-washing facilities during growing activities that take place in a 
fully-enclosed building, and during covered harvest, packing, or 
holding activities.
    (b) Your hand-washing facilities must be furnished with:
    (1) Soap (or other effective surfactant);
    (2) Running water that satisfies the requirements of Sec.  
112.44(a) for water used to wash hands; and
    (3) Adequate drying devices (such as single service towels, clean 
cloth towels or sanitary towel service).
    (c) You must provide for appropriate disposal of waste (for 
example, waste water and used single-service towels) associated with a 
hand-washing facility and take appropriate measures to prevent waste 
water from a hand-washing facility from contaminating covered produce, 
food-contact surfaces, areas used for a covered activity, agricultural 
water sources, and agricultural water distribution systems with known 
or reasonably foreseeable hazards.
    (d) You may not use hand antiseptic/sanitizer or wipes as a 
substitute for soap and water.


Sec.  112.131  What must I do to control and dispose of sewage?

    All of the following requirements apply for the control and 
disposal of sewage:
    (a) You must dispose of sewage into an adequate sewage or septic 
system or through other adequate means.
    (b) You must maintain sewage and septic systems in a manner that 
prevents contamination of covered produce, food-contact surfaces, areas 
used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonably 
foreseeable hazards.
    (c) You must manage and dispose of leakages or spills of human 
waste in a manner that prevents contamination of covered produce, and 
prevents or minimizes contamination of food-contact surfaces, areas 
used for a covered activity, agricultural water sources, or 
agricultural water distribution systems.
    (d) After a significant event (such as flooding or an earthquake) 
that could negatively impact a sewage or septic system, you must take 
appropriate steps to ensure that sewage and septic systems continue to 
operate in a manner that does not contaminate covered produce, food-
contact surfaces, areas used for a covered activity, agricultural water 
sources, or agricultural water distribution systems.


Sec.  112.132  What must I do to control and dispose of trash, litter, 
and waste in areas used for covered activities?

    All of the following requirements apply to the control and disposal 
of trash, litter, and waste in areas used for covered activities:
    (a) You must convey, store, and dispose of trash, litter and waste 
to:
    (1) Minimize the potential for trash, litter, or waste to attract 
or harbor pests; and
    (2) Protect against contamination of covered produce, food-contact 
surfaces, areas used for a covered activity, agricultural water 
sources, and agricultural water distribution systems with known or 
reasonably foreseeable hazards.
    (b) You must adequately operate systems for waste treatment and 
disposal so that they do not constitute a potential source of 
contamination in areas used for a covered activity.


Sec.  112.133  What requirements apply to plumbing?

    The plumbing must be of an adequate size and design and be 
adequately installed and maintained to:
    (a) Distribute water under pressure as needed, in sufficient 
quantities, in all areas where used for covered activities, for 
sanitary operations, or for hand-washing and toilet facilities.
    (b) Properly convey sewage and liquid disposable waste;
    (c) Avoid being a source of contamination to covered produce, food-
contact surfaces, areas used for a covered activity, or agricultural 
water sources; and
    (d) Not allow backflow from, or cross connection between, piping 
systems that discharge waste water or sewage and piping systems that 
carry water used for a covered activity, for sanitary operations, or 
for use in hand-washing facilities.


Sec.  112.134  What must I do to control animal excreta and litter from 
domesticated animals that are under my control?

    (a) If you have domesticated animals, to prevent contamination of 
covered produce, food-contact surfaces, areas used for a covered 
activity, agricultural water sources, or agricultural water 
distribution systems with animal waste, you must:
    (1) Adequately control their excreta and litter; and
    (2) Maintain a system for control of animal excreta and litter.
    (b) [Reserved]


Sec.  112.140  Under this subpart L, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
L in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep documentation of the date and 
method of cleaning and sanitizing of equipment subject to this subpart 
used in:
    (1) Growing operations for sprouts; and
    (2) Covered harvesting, packing, or holding activities.

Subpart M--Standards Directed to Sprouts


Sec.  112.141  What requirements apply to seeds or beans used to grow 
sprouts?

    In addition to the requirements of this part, all of the following 
requirements apply to seeds or beans used to grow sprouts.
    (a) If your farm grows seeds or beans for use to grow sprouts, you 
must take measures reasonably necessary to prevent the introduction of 
known or reasonably foreseeable hazards into or onto seeds or beans 
that you will use for sprouting.
    (b) If you know or have reason to believe that a lot of seeds or 
beans have been associated with foodborne illness, you must not use 
that lot of seeds or beans to produce sprouts.
    (c) You must visually examine seeds and beans, and packaging used 
to ship seeds or beans, for signs of potential contamination with known 
or reasonably foreseeable hazards.


Sec.  112.142  What measures must I take for growing, harvesting, 
packing, and holding sprouts?

    You must take all of the following measures for growing, 
harvesting, packing, and holding sprouts:
    (a) You must grow, harvest, pack, and hold sprouts in a fully-
enclosed building.
    (b) Any food-contact surfaces you use to grow, harvest, pack, and 
hold sprouts must be cleaned and sanitized before contact with sprouts 
or seeds or beans used to grow sprouts.
    (c) You must treat seeds or beans that will be used to grow sprouts 
using a scientifically valid method immediately before sprouting to 
reduce microorganisms of public health significance. Prior treatment 
conducted by a grower, handler, or distributor of seeds or beans does 
not eliminate your responsibility to treat seeds or beans immediately 
before sprouting at your covered farm.


Sec.  112.143  What testing must I do during growing, harvesting, 
packing, and holding sprouts?

    All of the following testing must be done during growing, 
harvesting, packing, and holding sprouts:

[[Page 3641]]

    (a) You must test the growing, harvesting, packing, and holding 
environment for Listeria species or L. monocytogenes in accordance with 
the requirements of Sec.  112.144.
    (b) You must either:
    (1) Test spent sprout irrigation water from each production batch 
of sprouts for E. coli O157:H7 and Salmonella species in accordance 
with the requirements of Sec.  112.146; or
    (2) If testing spent sprout irrigation water is not practicable 
(for example, for soil-grown sprouts), test each production batch of 
sprouts at the in-process stage (i.e., while sprouts are still growing) 
for E. coli O157:H7 and Salmonella species in accordance with the 
requirements of Sec.  112.146.


Sec.  112.144  What requirements apply to testing the environment for 
Listeria species or L. monocytogenes?

    All of the following testing requirements apply for the growing, 
harvesting, packing, and holding environment for Listeria species or L. 
monocytogenes.
    (a) You must establish and implement a written environmental 
monitoring plan that is designed to identify L. monocytogenes if it is 
present in the growing, harvesting, packing, or holding environment.
    (b) Your written environmental monitoring plan must be directed to 
sampling and testing for either Listeria species or L. monocytogenes.
    (c) Your written environmental monitoring plan must include a 
sampling plan that specifies:
    (1) What you will test collected samples for (i.e., Listeria 
species or L. monocytogenes);
    (2) How often you will collect environmental samples, which must be 
no less than monthly; and
    (3) Sample collection sites; the number and location of sampling 
sites must be sufficient to determine whether measures are effective 
and must include appropriate food-contact surfaces and non-food-contact 
surfaces of equipment, and other surfaces within the growing, 
harvesting, packing, and holding environment.
    (d) You must collect environmental samples and test them for 
Listeria species or L. monocytogenes according to the method in Sec.  
112.152.


Sec.  112.145  What actions must I take if the growing, harvesting, 
packing, or holding environment tests positive for Listeria species or 
L. monocytogenes?

    You must take the following actions if you detect Listeria species 
or L. monocytogenes in the growing, harvesting, packing, or holding 
environment:
    (a) Conduct additional testing of surfaces and areas surrounding 
the area where Listeria species or L. monocytogenes was detected to 
evaluate the extent of the problem, including the potential for 
Listeria species or L. monocytogenes to have become established in a 
niche;
    (b) Clean and sanitize the affected surfaces and surrounding areas;
    (c) Conduct additional microbial sampling and testing to determine 
whether the Listeria species or L. monocytogenes has been eliminated;
    (d) Conduct finished product testing when appropriate; and
    (e) Perform any other actions necessary to prevent reoccurrence of 
the contamination.


Sec.  112.146  What must I do to collect and test samples of spent 
sprout irrigation water or sprouts?

    All of the following requirements apply for collecting and testing 
samples of spent sprout irrigation water or sprouts:
    (a) You must establish and implement a written sampling plan that 
identifies the number and location of samples (of spent sprout 
irrigation water or sprouts) to be collected for each production batch 
of sprouts to ensure that the collected samples are representative of 
the production batch when testing for contamination.
    (b) In accordance with the written sampling plan required under 
paragraph (a) of this section, you must aseptically collect samples of 
spent sprout irrigation water or sprouts, and test the collected 
samples for E. coli O157:H7 and Salmonella species using a method that 
has been validated for its intended use (testing spent sprout 
irrigation water or sprouts) to ensure that the testing is accurate, 
precise, and sensitive in detecting these pathogens.


Sec.  112.150  Under this subpart, what requirements apply regarding 
records?

    (a) You must establish and keep records required under this subpart 
M in accordance with the requirements of subpart O of this part.
    (b) You must establish and keep the following records:
    (1) Documentation of your treatment of seeds or beans to reduce 
microorganisms of public health significance in the seeds or beans, at 
your farm;
    (2) Your written environmental monitoring plan in accordance with 
the requirements of Sec.  112.144;
    (3) Your written sampling plan for each production batch of sprouts 
in accordance with the requirements of Sec.  112.146(a);
    (4) The results of all testing conducted in accordance with the 
requirements of Sec. Sec.  112.143 and 112.144;
    (5) Any analytical methods you use in lieu of the methods that are 
incorporated by reference in Sec.  112.152; and
    (6) The testing method you use in accordance with the requirements 
of Sec.  112.146(b).

Subpart N--Analytical Methods


Sec.  112.151  What methods must I use to test the quality of water to 
satisfy the requirements of Sec.  112.45

    (a) You must test the quality of water using a method of analysis:
    (1) As published in the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists (AOAC) International'' 
(18th ed., revision 4, 2011) which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the AOAC International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html; 
or
    (2) As published in the Standards Methods for the Examination of 
Water and Wastewater (21st ed., 2005), American Public Health 
Association (APHA), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the 
APHA, 800 I St. NW., Washington, DC 20001, 202-777-2742. You may 
inspect a copy at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2163, 
or at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html; or
    (3) As prescribed in Chapter 4 of the FDA Bacteriological 
Analytical Manual (BAM) (Edition 8, Revision A, 1998), as updated in 
June 2011. The Director of the Federal Register approves the 
incorporation by reference of FDA's BAM, Chapter 4 (Edition 8, Revision 
A, 1998), as updated in June 2011, in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 5. You may obtain a copy of the method from Office of 
Regulatory Science, Center for Food Safety and

[[Page 3642]]

Applied Nutrition (CFSAN), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-1990, or you may examine 
a copy at CFSAN's Library, 5100 Paint Branch Pkwy., College Park, MD, 
240-402-2163, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html; or
    (4) That is at least equivalent to the appropriate method of 
analysis in Sec. Sec.  112.151(a)(1), (a)(2) or (a)(3) in accuracy, 
precision, and sensitivity.


Sec.  112.152  What methods must I use to test the growing environment 
for Listeria species or L. monocytogenes to satisfy the requirements of 
Sec.  112.143(a) and Sec.  112.144?

    You must test the growing environment by testing for the presence 
of Listeria species or L. monocytogenes in environmental samples using 
the methods and procedures described in Chapter 10 of FDA's 
Bacteriological Analytical Manual (BAM) April 2011, Edition (Edition 8, 
Revision A, 1998), or a method that is at least equivalent in accuracy, 
precision, and sensitivity. The Director of the Federal Register 
approves the incorporation by reference of FDA's BAM, Chapter 10--
``Listeria monocytogenes, Detection and Enumeration of Listeria 
monocytogenes in Foods,'' April 2011, in accordance with 5 U.S.C. 
552(a) and 1 CFR part 5. You may obtain a copy of the method from 
Office of Regulatory Science, Center for Food Safety and Applied 
Nutrition (CFSAN), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 240-402-1990, or you may examine a copy 
at CFSAN's Library, 5100 Paint Branch Pkwy., College Park, MD, 240-402-
2163, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html.

Subpart O--Requirements Applying to Records That You Must Establish 
and Keep


Sec.  112.161  What general requirements apply to records required 
under this part?

    (a) All records required under this part must:
    (1) Include, as applicable:
    (i) The name and location of your farm;
    (ii) Actual values and observations obtained during monitoring;
    (iii) An adequate description (such as the commodity name, or the 
specific variety or brand name of a commodity, and, when available, any 
lot number or other identifier) of covered produce applicable to the 
record;
    (iv) The location of a growing area (for example, a specific field) 
or other area (for example, a specific packing shed) applicable to the 
record; and
    (v) The date and time of the activity documented;
    (2) Be created at the time an activity is performed or observed;
    (3) Be accurate, legible, and indelible; and
    (4) Be dated, and signed or initialed by the person who performed 
the activity documented.
    (b) When records are required to be established and kept in 
subparts C, E, F, L, and M of this part (Sec. Sec.  112.30, 112.50, 
112.60, 112.140, and 112.150), you must establish and keep 
documentation of actions you take when a standard in those subparts is 
not met.
    (c) Records required under Sec. Sec.  112.50(b)(4), 112.50(b)(5), 
112.60(b)(1), 112.60(b)(3), 112.140, 112.150(b)(1), 112.150(b)(4), and 
112.161(b), must be reviewed, dated, and signed, within a reasonable 
time after the records are made, by a supervisor or responsible party.


Sec.  112.162  Where must I store records?

    (a) Offsite storage of records is permitted after 6 months 
following the date the record was made if such records can be retrieved 
and provided onsite within 24 hours of request for official review.
    (b) Electronic records are considered to be onsite at your farm if 
they are accessible from an onsite location at your farm.


Sec.  112.163  May I use existing records to satisfy the requirements 
of this part?

    Yes. The regulations in this part do not require duplication of 
existing records if those records contain all of the information 
required by this part.


Sec.  112.164  How long must I keep records?

    (a) You must keep records required by this part for 2 years past 
the date the record was created.
    (b) Records that relate to the general adequacy of the equipment or 
processes being used by a farm, including the results of scientific 
studies and evaluations, must be retained at the farm for at least 2 
years after the use of such equipment or processes is discontinued.


Sec.  112.165  What formats are acceptable for the records I keep?

    You must keep records as:
    (a) Original records;
    (b) True copies (such as photocopies, pictures, scanned copies, 
microfilm, microfiche, or other accurate reproductions of the original 
records); or
    (c) Electronic records, in compliance with part 11 of this chapter.


Sec.  112.166  What requirements apply for making records available and 
accessible to FDA?

    (a) You must have all records required under this part readily 
available and accessible during the retention period for inspection and 
copying by FDA upon oral or written request, except that you have 24 
hours to obtain records you keep offsite and make them available and 
accessible to FDA for inspection and copying.
    (b) If you use electronic techniques to keep records, or to keep 
true copies of records, or if you use reduction techniques such as 
microfilm to keep true copies of records, you must provide the records 
to FDA in a format in which they are accessible and legible.
    (c) If your farm is closed for a prolonged period, the records may 
be transferred to some other reasonably accessible location but must be 
returned to your farm within 24 hours for official review upon request.


Sec.  112.167  Can records that I provide to FDA be disclosed to 
persons outside FDA?

    Records required by this part are subject to the disclosure 
requirements under part 20 of this chapter.

Subpart P--Variances


Sec.  112.171  Who may request a variance from the requirements of this 
part?

    A State or a foreign country from which food is imported into the 
United States may request a variance from one or more requirements of 
this part, where the State or foreign country determines that:
    (a) The variance is necessary in light of local growing conditions; 
and
    (b) The procedures, processes, and practices to be followed under 
the variance are reasonably likely to ensure that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 342) and to provide the same level of public health 
protection as the requirements of this part.


Sec.  112.172  How may a State or foreign country request a variance 
from one or more requirements of this part?

    To request a variance from one or more requirements of this part, 
the

[[Page 3643]]

competent authority (e.g., the regulatory authority for food safety) 
for a State or a foreign country must submit a petition under Sec.  
10.30 of this chapter.


Sec.  112.173  What must be included in the Statement of Grounds in a 
petition requesting a variance?

    In addition to the requirements set forth in Sec.  10.30 of this 
chapter, the Statement of Grounds in a petition requesting a variance 
must:
    (a) Provide a statement that the applicable State or foreign 
country has determined that the variance is necessary in light of local 
growing conditions and that the procedures, processes, and practices to 
be followed under the variance are reasonably likely to ensure that the 
produce is not adulterated under section 402 of the Federal Food, Drug 
and Cosmetic Act (21 U.S.C. 342) and to provide the same level of 
public health protection as the requirements of this part;
    (b) Describe with particularity the variance requested, including 
the persons to whom the variance would apply and the provision(s) of 
this part to which the variance would apply;
    (c) Present information demonstrating that the procedures, 
processes, and practices to be followed under variance are reasonably 
likely to ensure that the produce is not adulterated under section 402 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) and to 
provide the same level of public health protection as the requirements 
of this part.


Sec.  112.174  What information submitted in a petition requesting a 
variance or submitted in comments on such a petition are publicly 
available?

    We will presume that information submitted in a petition requesting 
a variance and comments submitted on such a petition, including a 
request that a variance be applied to its similarly situated persons, 
does not contain information exempt from public disclosure under part 
20 of this chapter and would be made public as part of the docket 
associated with this request.


Sec.  112.175  Who responds to a petition requesting a variance?

    The Director or Deputy Directors of the Center for Food Safety and 
Applied Nutrition (CFSAN), or the Director, Office of Compliance, 
CFSAN, responds to a request for a variance.


Sec.  112.176  What process applies to a petition requesting a 
variance?

    (a) In general, the procedures set forth in Sec.  10.30 of this 
chapter govern our response to a petition requesting a variance.
    (b) Under Sec.  10.30(h)(3) of this chapter, we will publish a 
notice in the Federal Register, requesting information and views on a 
filed petition, including information and views from persons who could 
be affected by the variance if the petition were to be granted (either 
because their farm is covered by the petition or as a person similarly 
situated to persons covered by the petition).
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the 
petitioner in writing and will also make public a notice on FDA's Web 
site announcing our decision to either grant or deny the petition.
    (1) If we grant the petition, either in whole or in part, we will 
specify the persons to whom the variance applies and the provision(s) 
of this part to which the variance applies.
    (2) If we deny the petition (including partial denials), our 
written response to the petitioner and our public notice announcing our 
decision to deny the petition will explain the reason(s) for the 
denial.
    (d) We will make readily accessible to the public, and periodically 
update, a list of filed petitions requesting variances, including the 
status of each petition (for example, pending, granted, or denied).


Sec.  112.177  Can an approved variance apply to any person other than 
those identified in the petition requesting that variance?

    (a) A State or a foreign country that believes that a variance 
requested by a petition submitted by another State or foreign country 
should also apply to similarly situated persons in its jurisdiction may 
request that the variance be applied to its similarly situated persons 
by submitting comments in accordance with Sec.  10.30 of this chapter. 
These comments must include the information required in Sec.  112.173. 
If FDA determines that these comments should instead be treated as a 
separate request for a variance, FDA will notify the State or foreign 
country that submitted these comments that a separate request must be 
submitted in accordance with Sec. Sec.  112.172 and Sec.  112.173.
    (b) If we grant a petition requesting a variance, in whole or in 
part, we may specify that the variance also applies to persons in a 
specific location who are similarly situated to those identified in the 
petition.
    (c) If we specify that the variance also applies to persons in a 
specific location who are similarly situated to those identified in the 
petition, we will inform the applicable State or foreign country where 
the similarly situated persons are located of our decision in writing 
and will publish a notice on our Web site announcing our decision to 
apply the variance to similarly situated persons in that particular 
location.


Sec.  112.178  Under what circumstances may FDA deny a petition 
requesting a variance?

    We may deny a variance request if it does not provide the 
information required under Sec.  112.173 (including the requirements of 
Sec.  10.30 of this chapter), or if we determine that the variance is 
not reasonably likely to ensure that the produce is not adulterated 
under section 402 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
342) and to provide the same level of public health protection as the 
requirements of this part.


Sec.  112.179  When does a variance approved by FDA become effective?

    A variance approved by FDA becomes effective the date of our 
written decision on the petition.


Sec.  112.180  Under what circumstances may FDA modify or revoke an 
approved variance?

    We may modify or revoke a variance if we determine that such 
variance is not reasonably likely to ensure that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 342) and to provide the same level of public health 
protection as the requirements of this part.


Sec.  112.181  What procedures apply if FDA determines that an approved 
variance should be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify a State or a foreign country directly, in 
writing at the address identified in its petition, if we determine that 
a variance granted in response to its petition should be modified or 
revoked. Our direct, written notification will provide the State or 
foreign country with an opportunity to request an informal hearing 
under part 16 of this chapter.
    (2) We will publish a notice of our determination that a variance 
should be modified or revoked in the Federal Register. This notice will 
establish a public docket so that interested parties may submit written 
submissions on our determination.
    (3) When applicable, we will:
    (i) Notify in writing any States or foreign countries where a 
variance applies to similarly situated persons of our determination 
that the variance should be modified or revoked;
    (ii) Provide those States or foreign countries with an opportunity 
to request

[[Page 3644]]

an informal hearing under part 16 of this chapter; and
    (iii) Include in the Federal Register notice described in paragraph 
(a)(2) of this section public notification of our decision to modify or 
revoke the variance granted to States or foreign countries in which 
similarly situated persons are located.
    (b) We will consider submissions from affected States or foreign 
countries and from other interested parties as follows:
    (1) We will consider requests for hearings by affected States or 
foreign countries under part 16 of this chapter.
    (i) If FDA grants a hearing, we will provide the State or foreign 
country with an opportunity to make an oral submission. We will provide 
notice on our Web site of the hearing, including the time, date, and 
place of hearing.
    (ii) If more than one State or foreign country requests an informal 
hearing under part 16 of this chapter about our determination that a 
particular variance should be modified or revoked, we may consolidate 
such requests (for example, into a single hearing).
    (2) We will consider written submissions submitted to the public 
docket from interested parties.
    (c) We will provide notice of our final decision as follows:
    (1) On the basis of the administrative record, FDA will issue a 
written decision, as provided for under part 16 of this chapter.
    (2) We will publish a notice of our decision in the Federal 
Register. The effective date of the decision will be the date of 
publication of the notice.


Sec.  112.182  What are the permissible types of variances that may be 
granted?

    Examples of permissible types of variances include:
    (a) Variance from the requirements, established in Sec.  112.44(c), 
when agricultural water is used during growing operations for covered 
produce (other than sprouts) using a direct water application method.
    (b) Variance from the process conditions, established in Sec.  
112.54(c)(1), for static composting;
    (c) Variance from the process conditions, established in Sec.  
112.54(c)(2), for turned composting;
    (d) Variance from the minimum application interval, established in 
Sec.  112.56(a)(1), for an untreated biological soil amendment of 
animal origin; and
    (e) Variance from the minimum application interval, established in 
Sec.  112.56(a)(4), for a biological soil amendment of animal origin 
treated by a composting process in accordance with the requirements of 
Sec.  112.54(c).

Subpart Q--Compliance and Enforcement


Sec.  112.191  How do the criteria and definitions in this part apply?

    The criteria and definitions in this part apply in determining 
whether a food is adulterated:
    (a) Within the meaning of section 402(a)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)) in that the food has been 
grown, harvested, packed, or held under such conditions that it is 
unfit for food; or
    (b) Within the meaning of section 402(a)(4) of the Federal Food, 
Drug, and Cosmetic Act in that the food has been prepared, packed, or 
held under insanitary conditions whereby it may have become 
contaminated with filth, or whereby it may have been rendered injurious 
to health. The criteria and definitions in this part also apply in 
determining whether a food is in violation of section 361 of the Public 
Health Service Act (42 U.S.C. 264).


Sec.  112.192  What is the result of a failure to comply with this 
part?

    The failure to comply with the requirements of this part, issued 
under section 419 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350h), is a prohibited act under section 301(vv) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(vv)).


Sec.  112.193  What are the provisions for coordination of education 
and enforcement?

    Under Section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350h(b)(2)(A)), FDA coordinates education and 
enforcement activities by State, Territorial, tribal, and local 
officials.

Subpart R--Withdrawal of Qualified Exemption


Sec.  112.201  Under what circumstances can FDA withdraw a qualified 
exemption in accordance with the requirements of Sec.  112.5?

    We may withdraw your qualified exemption under Sec.  112.5:
    (a) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to your farm; or
    (b) 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.


Sec.  112.202  What procedure will FDA use to withdraw an exemption?

    (a) If FDA determines that a qualified exemption applicable to a 
farm under Sec.  112.5 should be withdrawn, any officer or qualified 
employee of FDA may issue an order to withdraw the exemption.
    (b) 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.
    (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.


Sec.  112.203  What information must FDA include in an order to 
withdraw a qualified exemption?

    An order to withdraw a qualified exemption applicable to a farm 
under Sec.  112.5 must include the following information:
    (a) The date of the order;
    (b) The name, address and location of the farm;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the farm; or
    (2) Conduct or conditions associated with a farm that are material 
to the safety of the food that would otherwise be covered produce 
grown, harvested, packed and held at such farm.
    (d) A statement that the farm must comply with subparts B through O 
of this part on the date that is 60 calendar days after the date of the 
order;
    (e) The text of section 419(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350(f)) and of this subpart;
    (f) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this 
chapter, with certain exceptions described in Sec.  112.208;
    (g) The mailing address, telephone number, email address, and 
facsimile number of the FDA district office and the name of the FDA 
District Director in whose district the farm is located (or for foreign 
farms, the same information for the Director of the Office of 
Compliance in the Center for Food Safety and Applied Nutrition); and
    (h) The name and the title of the FDA representative who approved 
the order.

[[Page 3645]]

Sec.  112.204  What must I do if I receive an order to withdraw a 
qualified exemption applicable to my farm?

    The owner, operator, or agent in charge of a farm that receives an 
order to withdraw a qualified exemption applicable to that farm under 
Sec.  112.5 must either:
    (a) Comply with applicable requirements of this part within 60 
calendar days of the date of the order or, if operations have ceased 
and will not resume within 60 calendar days, before the beginning of 
operations in the next growing season; or
    (b) Appeal the order within 10 calendar days of the date of the 
order in accordance with the requirements of Sec.  112.206.


Sec.  112.205  Can I appeal or request a hearing on an order to 
withdraw a qualified exemption applicable to my farm?

    (a) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner of Food and Drugs, as a matter of discretion, determines 
that delay or a stay is in the public interest.
    (b) If the owner, operator, or agent in charge of the farm appeals 
the order, and FDA confirms the order, the owner, operator, or agent in 
charge of the farm must comply with applicable requirements of this 
part within 60 calendar days of the date of the order, or, if 
operations have ceased and will not resume within 60 calendar days, 
before the beginning of operations in the next growing season.


Sec.  112.206  What is the procedure for submitting an appeal?

    (a) To appeal an order to withdraw a qualified exemption applicable 
to a farm under Sec.  112.5, the owner, operator, or agent in charge of 
the farm must:
    (1) Submit the appeal in writing to the 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), at the mailing address, email address, or 
facsimile number identified in the order within 10 calendar days of the 
date of the order; and
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which the owner, 
operator or agent in charge of the farm relies.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec.  112.5, the owner, operator, or agent in charge of 
the farm may include a written request for an informal hearing as 
provided in Sec.  112.207.


Sec.  112.207  What is the procedure for requesting an informal 
hearing?

    (a) If the owner, operator, or agent in charge of the farm appeals 
the order, the owner, operator, or agent in charge of the farm:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
its written appeal submitted in accordance with Sec.  112.206 within 10 
calendar days of the date of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, a written notice of the determination will be given to the 
owner, operator, or agent in charge of the farm explaining the reason 
for the denial.


Sec.  112.208  What requirements are applicable to an informal hearing?

    If the owner, operator or agent in charge of the farm requests an 
informal hearing, and FDA grants the request:
    (a) The hearing will be held within 10 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon 
in writing by the owner, operator, or agent in charge of the farm and 
FDA.
    (b) The presiding officer may require that a hearing conducted 
under this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec.  112.5, rather 
than the notice under Sec.  16.22(a) of this chapter, provides notice 
of opportunity for a hearing under this section and is part of the 
administrative record of the regulatory hearing under Sec.  16.80(a) of 
this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA District Director (or, in the case of a foreign farm, the 
Director of the Office of Compliance in the Center for Food Safety and 
Applied Nutrition) as provided in the order withdrawing an exemption.
    (3) Section 112.209, rather than Sec.  16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a 
written report of the hearing. All written material presented at the 
hearing will be attached to the report. The presiding officer must 
include as part of the report of the hearing a finding on the 
credibility of witnesses (other than expert witnesses) whenever 
credibility is a material issue, and must include a proposed decision, 
with a statement of reasons. The hearing participant may review and 
comment on the presiding officer's report within 2 calendar days of 
issuance of the report. The presiding officer will then issue the final 
decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report 
of the hearing and any comments on the report by the hearing 
participant under Sec.  112.208(c)(4) are part of the administrative 
record.
    (6) No party shall have the right, under Sec.  16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under regulation in accordance with part 16 of this 
chapter, except that Sec.  16.95(b) does not apply to a hearing under 
this subpart. With respect to a regulatory hearing under this subpart, 
the administrative record of the hearing specified in Sec. Sec.  
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and Sec.  112.208(c)(5) 
constitutes the exclusive record for the presiding officer's final 
decision. For purposes of judicial review under Sec.  10.45 of this 
chapter, the record of the administrative proceeding consists of the 
record of the hearing and the presiding officer's final decision.


Sec.  112.209  Who is the presiding officer for an appeal and for an 
informal hearing?

    The presiding officer for an appeal, and for an informal hearing, 
must be an FDA Regional Food and Drug Director or another FDA official 
senior to an FDA District Director.


Sec.  112.210  What is the timeframe for issuing a decision on an 
appeal?

    (a) If the owner, operator, or agent in charge of a farm appeals 
the order without requesting a hearing, the presiding officer must 
issue a written report that includes a final decision confirming or 
revoking the withdrawal by the 10th calendar day after the appeal is 
filed.

[[Page 3646]]

    (b) If the owner, operator, or agent in charge of a farm appeals 
the order and requests an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is 
held, the presiding officer must provide a 2 calendar day opportunity 
for the hearing participants to review and submit comments on the 
report of the hearing under Sec.  112.208(c)(4), and must issue a final 
decision within 10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.


Sec.  112.211  When is an order to withdraw a qualified exemption 
applicable to a farm revoked?

    An order to withdraw a qualified exemption applicable to a farm 
under Sec.  112.5 is revoked if:
    (a) The owner, operator, or agent in charge of the farm appeals the 
order and requests an informal hearing, FDA grants the request for an 
informal hearing, and the presiding officer does not confirm the order 
within the 10 calendar days after the hearing, or issues a decision 
revoking the order within that time; or
    (b) The owner, operator, or agent in charge of the farm appeals the 
order and requests an informal hearing, FDA denies the request for an 
informal hearing, and FDA does not confirm the order within the 10 
calendar days after the appeal is filed, or issues a decision revoking 
the order within that time; or
    (c) The owner, operator, or agent in charge of the farm appeals the 
order without requesting an informal hearing, and FDA does not confirm 
the order within the 10 calendar days after the appeal is filed, or 
issues a decision revoking the order within that time.
    (d) Confirmation of a withdrawal order by the presiding officer is 
considered a final Agency action for purposes of 5 U.S.C. 702.

    Dated: January 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00123 Filed 1-4-13; 11:15 am]
BILLING CODE 4160-01-P